In 2015, the United States spent a staggering $3.2 trillion on health care, or nearly $10,000 per capita–amounting to 17.8 percent of U.S. gross domestic product. Health care is one of the most expensive components of the federal budget, and health spending comes in a variety of different forms, including major public programs, direct subsidies, and a number of different provisions in the tax code.

While big insurance programs like Medicare and Medicaid tend to be the focus of most health care discussions, and account for most of the spending, the government provides and subsidizes health care in ways that many might not realize. Given the rising prominence of the health care industry in our budget and in our economy, it’s important to look at the current role played by the federal government. Read on to see how the government provides and incentivizes health insurance coverage and how much these efforts cost.

Government Health Care Programs

Two government programs account for a large portion of health care spending, and federal spending in general. Medicare and Medicaid are two entitlement programs that together account for roughly 25 percent of the federal budget. In 2016, the U.S. government spent a net total of $588 billion on Medicare, the health insurance program covering all Americans over the age of 65. Federal spending on Medicaid, which provides health insurance to people with disabilities, the elderly, children, and people with low incomes, totaled $368 billion last year. Because Medicaid is a federal-state partnership, states also account for a notable portion of health care spending. In 2016, federal funding covered about 63 percent of all Medicaid spending, excluding administrative costs. The remaining 37 percent, or about $204.5 billion, was held by the states.

It’s worth noting that along with Social Security, Medicare and Medicaid are the largest mandatory spending programs–spending that is built into existing laws and is not subject to annual appropriation bills. Forecasts predict that these programs will grow as a share of the federal budget in the coming years as the Baby Boomer generation retires. In its most recent forecast, the Congressional Budget Office (CBO) predicts, “outlays for mandatory programs increase as a share of GDP by 2.4 percentage points from 2017 to 2027–mainly because of the aging of the population and rising per capita health care costs. Social Security and Medicare account for nearly all of that increase.” Last year, Social Security amounted to 4.9 percent of U.S. GDP and spending on major health programs amounted to 5.4 percent of GDP.

In addition to Medicaid and Medicare, the government provides subsidies for people with incomes between 100 and 400 percent of the federal poverty level and who do not get health insurance through their employer. According to the CBO, the government spent $42 billion in 2016 on subsidies and other costs related to the individual insurance market.

The video below from the Brookings Institution gives an overview of health care spending trends over the past several decades:

The Tax Code

While the various provisions of the tax code that encourage individuals and companies to buy health insurance might not sound all that interesting, tax policy is a crucial part of the current health care system, and accounts for a significant amount of spending, or more precisely, foregone revenue.

Employer-provided Insurance

The government uses the tax code to encourage and discourage a wide range of behaviors. To encourage individuals and businesses to do certain things, the government uses tax expenditures, more commonly known as tax breaks. These provisions in the tax code forego tax revenue when people or businesses engage in certain activities. The largest of the existing tax expenditures deals with health care spending by employers. Specifically, the tax code excludes all spending toward employees’ health care premiums from taxation. This exclusion encourages employers to provide certain benefits to their employees because they can use pre-tax dollars to do so–if the same amount of money was given to employees in the form of traditional wages, it would be taxed. The exclusion is projected to cost about $260 billion in 2017, based on what the government would otherwise receive in payroll and income taxes. That annual cost makes the health care exclusion the third largest health care program, following Medicaid and Medicare.

The tax exclusion of employer provided health care dates back to World War II and emerged almost accidentally. In an effort to control inflation, the federal government froze wages, which prevented companies from paying their employees more. Instead, employers took advantage of an exception that applied to certain benefits–they started providing health insurance plans. Then in 1954, the IRS determined that payments toward employee health insurance are exempt from taxation. Over time, employer-subsidized health care became quite common, and today, most Americans get health care from their employer or a close family member’s employer.

While the tax exempt status of employer-provided health care has become particularly popular and politically durable–efforts to eliminate or even cap the tax benefits have not gotten very far–many economists believe that it has a distortionary effect on the health care system as a whole. The most frequent criticism of employer-subsidized health care is that it can spur growth in medical costs. Because premium payments are excluded from taxation, employers are incentivized to offer very generous health insurance plans instead of simply paying their employees higher wages. Economists argue that if more of the cost burden was placed on consumers when they use medical services, they would try to reduce those costs by searching for lower prices and avoiding unnecessary care. But when most of the cost of health care is masked by generous insurance plans, there is little incentive for individuals to cut costs.

Other criticisms of employer-subsidized health care focus on concerns about equity and progressivity. People with high incomes are more likely than those with lower incomes to benefit from health-related tax expenditures, of which employer-subsidized health care is by far the largest in value. Moreover, the nature of the tax exclusion makes it more valuable to people with high-incomes than those lower on the income scale. Because income tax is progressive–those with higher incomes pay higher tax rates–pre-tax money spent on health care is worth more to those with higher incomes because it would otherwise be taxed at a high rate. In 2015, about 45 percent of all benefits from health tax expenditures went to individuals with incomes in the top 20 percent, while just 0.5 percent of all benefits went to those in the bottom 20 percent.

Efforts to eliminate or curtail the tax preference for employer-sponsored health care date back to Reagan’s presidency, but few have made any notable progress. One notable exception is what’s known as the “Cadillac tax,” which was a part of the 2010 Affordable Care Act. The Cadillac tax, formally known as the high-cost plan tax, sought to rein in health care cost growth by discouraging employers from providing extremely generous health insurance plans. Health insurance premiums payments in excess of $10,200 for an individual or $27,500 for families will face a 40 percent excise tax. The tax was originally scheduled to take effect in  2018 but was pushed back to 2020 after widespread opposition in 2015. Both businesses and unions strongly protested the tax, which may be one issue that both Republicans and Democrats can agree on. While it is still scheduled to go into effect in a couple years, questions about its fate loom as recent health care legislation would push its implementation back even further.

Conclusion

Peter Fisher, a former under secretary at the Treasury Department, once famously advised, “Think of the federal government as a gigantic insurance company […] with a sideline business in national defense and homeland security.” When you look at the federal budget, you can see that Fisher’s comments are rooted in an important truth–health insurance is one of the most expensive aspects of the federal budget.

The government plays a large, if sometimes unnoticed, role in the American health care system. From major programs like Medicare and Medicaid, which together add up to roughly one-quarter of the entire budget, to tax provisions that encourage employers to provide insurance to their workers, the government has a hand in nearly everyone’s insurance. Rising health care costs have led to notable budgetary issues in the long term, particularly as the American population ages, which have led some to argue that entire programs need to be revamped to keep spending sustainable. While many agree that health care spending has gotten unusually high in recent years, actually controlling costs has proven challenging.

Kevin Rizzo

Kevin Rizzo is the Crime in America Editor at Law Street Media. An Ohio Native, the George Washington University graduate is a founding member of the company. Contact Kevin at krizzo@LawStreetMedia.com.

The post How Much Does the Government Spend on Health Care? appeared first on Law Street.

Last week, Judge Nicholas Francis of the Family Division in the U.K.’s High Court of Justice ruled that Charlie Gard’s parents had 48 hours to present evidence that experimental treatment will improve their son’s condition. At a subsequent hearing on Thursday, the judge decided that Gard should be evaluated by an American doctor who claims that an experimental treatment may improve his condition.

“I have to decide this case not on the basis of tweets, not on the basis of what might be said in the press, or to the press,” Judge Francis said last week as he gave his initial ruling, alluding to the global interest in the case.

But how has this case garnered so much attention from people in the U.K., people across the world, and even world leaders? Read on to learn more about the Charlie Gard case and the controversy surrounding it.

Who is Charlie Gard?

Charlie Gard, born August 4, 2016, suffers from a rare genetic condition known as mitochondrial DNA depletion syndrome (MDDS). It is caused by a mutation in which the cells’ mitochondria stop functioning. More specifically, Charlie has RRM2B encephalomyopathic MDDS, which progresses rapidly and can lead to death within a few months. There is currently no known cure.

Gard developed normally for the first two months of his life, but by mid-October, he was on life support at the Great Ormond Street Hospital (GOSH) in London. Today, at eleven months old, Charlie is unable to breathe without a ventilator, open his eyes, hear, eat unassisted, or move his limbs. His heart and kidneys are failing, and he suffers from persistent severe seizures.

What Can Be Done?

His parents, Chris Gard and Connie Yates, want him to undergo an experimental treatment called nucleoside therapy, which has shown some success in treating mitochondrial disease in laboratory mice.

The therapy was used in Baltimore on Arturito Estopinan, a boy suffering from TK2-related mitochondrial depletion system. His father, Art Estopinan, met with Gard and Yates and discussed the treatment. According to him, while the treatment is by no means a cure, Arturito is “getting stronger every day.”

The video below goes into more detail about Estopinan’s treatment.

The treatment has never been used on mice or humans suffering from RRM2B MDDS and it is currently unavailable in the U.K.

According to the family’s GoFundMe page, a doctor in the U.S. accepted Charlie into the treatment program of their own hospital. So far, the family has received over 1.3 million euros in donations to get Charlie to the U.S. and pay for the treatment.

The Court Battle

The doctors at GOSH, however, are opposed to the idea. Although they applied for and received ethical permission to treat Charlie with nucleoside therapy, the baby’s condition had worsened so drastically by that time that they decided against moving forward with the treatment. The view is that his brain damage is too severe for treatment to be of any help, and that it would be kinder to let Charlie die with dignity. Against the parents’ wishes, they planned to take Charlie off life support, court documents show.

In the U.K., when parents and doctors disagree over the treatment of a sick child, the courts step in. Gard’s case went to the High Court, with Justice Francis presiding. On April 11, he ruled, “with the heaviest of hearts” that the hospital “may lawfully withdraw all treatment, save for palliative care,” and that it was in Charlie’s best interest not to undergo the experimental therapy. The Court of Appeals upheld the decision on May 25. The Supreme Court reviewed the case on June 8 but ultimately agreed with the lower court’s ruling. The family’s lawyers then petitioned the European Court of Human Rights, but on June 27, the court rejected the plea and ruled that Charlie’s life support would be turned off on June 30. GOSH later extended the deadline after Gard and Yates posted a video message blasting the hospital for not allowing them to take their son home to die.

The World Weighs In

Before the extension was announced, Pope Francis tweeted a message of support to the Gard family:

To defend human life, above all when it is wounded by illness, is a duty of love that God entrusts to all.

— Pope Francis (@Pontifex) June 30, 2017

There may not have been any names, but papal spokesperson Greg Burke clarified the pope’s meaning the next day by retweeting the message and adding #CharlieGard.

“The Holy Father follows with affection and commotion the situation of Charlie Gard, and expresses his own closeness to his parents,” Burke said in a statement. “He prays for them, wishing that their desire to accompany and care for their own child to the end will be respected.”

In addition, the Vatican-owned Bambino Gesu Hospital in Rome asked to have Charlie Gard transferred there, but representatives from GOSH refused due to legal reasons.

The pope’s tweet may have come as a response to the Pontifical Academy for Life, which put out its own statement three days prior. While supportive of Gard and Yates, the statement, signed by Archbishop Vincenzo Paglia, vacillates between middle-of-the-road and sympathetic to the decision of the European Court of Human Rights. “The proper question to be raised […] is this: what are the best interests of the patient? We must do what advances the health of the patient, but we must also…avoid aggressive medical procedures that are disproportionate to any expected results,” the statement reads. The Academy’s words raised eyebrows and ire across the board.

Whether rebuking his fellows or not, the pope is not alone in his support for the family’s efforts. Three days later, on July 3, President Donald Trump weighed in on the case:

If we can help little #CharlieGard, as per our friends in the U.K. and the Pope, we would be delighted to do so.

— Donald J. Trump (@realDonaldTrump) July 3, 2017

The tweet brought Gard’s case to America’s attention and raised support among the president’s fellow pro-life conservatives. An unnamed U.S. hospital offered Gard free treatment. Congressmen Brad Wenstrup (R-Ohio) and Trent Franks (R-Arizona) have promised to introduce a bill to give Charlie Gard lawful permanent resident status in the United States when Congress returns from recess. Rev. Patrick Mahoney–a pro-life evangelical preacher and president of the Christian Defense Coalition–flew to the U.K. last week as a self-appointed spokesperson for the Gard family. He claims to have met with a senior White House official beforehand and says he is currently keeping President Trump updated on the case.

Meanwhile, Prime Minister Theresa May voiced support for the hospital, saying, “I am confident that GOSH have and always will consider any offers of new information that has come forward for the well-being of a desperately ill child.” Foreign Secretary Boris Johnson agrees. In a conversation with his Italian counterpart, Johnson said it is “right that decisions continued to be led by expert medical opinion, supported by the courts.”

Vice President Mike Pence referred to Charlie’s case during an interview on Rush Limbaugh’s radio show on Monday, adding fuel to the fire in an entirely different way. “We hope and pray that little Charlie Gard gets every chance,” he said, “but the American people ought to reflect on the fact that for all the talk on the left about single-payer, that’s where it takes us.”

Back in Court

On July 7, GOSH applied to the High Court for a new hearing in light of other doctors’ claims that the treatment may help Gard. While not changing its views on the treatment or its effect on Charlie, the hospital acknowledged statements made by doctors in the United States and Vatican hospitals and is willing to explore the claims that the treatment would benefit Charlie.

The following Sunday, Gard and Yates presented a 350,000-signature petition urging the hospital to allow their son to travel to the U.S. for treatment.

The July 10 preliminary hearing, prior to Judge Francis’ above ruling, was fraught with emotion, including an outburst from Chris Gard. “When are you going to start telling the truth?” he screamed at the lawyer representing the hospital. At a different point, when his own lawyer reported that a U.S. doctor estimated a 10 percent chance of saving Charlie with the experimental treatment, Yates asked the judge, “You would if it was your son, wouldn’t you?” Judge Francis assured her that he would take that into account during Thursday’s hearing. “I don’t think there’s anyone involved who wouldn’t want to save Charlie,” he added.

Two hours into Thursday’s hearing, there was another altercation between the judge and the parents. When Judge Francis paraphrased the parents’ earlier comments about not wanting their son to live if there were no prospect of improvement, Yates shouted, “I never said that” and reiterated that she did not think Charlie was suffering. She and her husband then stormed out of the courtroom but returned an hour later.

On Friday, Judge Francis said that Dr. Michio Hirano, a specialist in neurology at the Columbia University Medical Center, will evaluate Gard before the court makes its decision. According to  The Mirror, a lawyer for GOSH stated the hospital invited Dr. Hirano to see Charlie back in January, but the visit never happened. In addition, Dr. Hirano reportedly never saw Charlie’s medical records or MRI scans, only summaries. He did, however, claim in his testimony (via video link) that Charlie has somewhere between an 11 and 56 percent chance of improving with the therapy. Judge Francis then determined that Dr. Hirano should travel to the U.K. and assess Charlie in person. He arrived early last week and met with several of Charlie’s GOSH caregivers and other specialists, including a doctor from the Vatican Children’s Hospital.

Judge Francis hopes to give his final verdict by July 25.

Conclusion

What started as one family’s tragedy has become a worldwide phenomenon. A combination of public appeals through social media and support from high-profile individuals has put Charlie and his family in the spotlight. It is difficult to say, though, whether or not this attention will help them in the end. Many cynical observers have wondered if politicians are taking advantage of the Gard family’s situation to push their own agendas. A variety of issues–from health care to government overreach to the right to life–will be shaken by the case’s final verdict. For now, though, Charlie remains on life support, and the world joins his parents in watching over him.

Delaney Cruickshank

Delaney Cruickshank is a Staff Writer at Law Street Media and a Maryland native. She has a Bachelor’s Degree in History with minors in Creative Writing and British Studies from the College of Charleston. Contact Delaney at DCruickshank@LawStreetMedia.com.

The post Breaking Down the Charlie Gard Treatment Controversy appeared first on Law Street.

When Upton Sinclair wrote “The Jungle,” he intended to show the harsh conditions of poor immigrants working in the meat packing factories of Chicago. Published in 1906, his book ended up being one of the earliest catalysts for American food regulation. People were revolted by the unregulated food industry and the awful truth behind where their meat came from.  Sinclair’s book led to a public outcry, and many called for more regulations for the food industry. And for good reason–throughout American history up until that point there had never been any serious attempts to regulate the food industry. 

We now live in an age of big farms and monoculture. It used to be that most of the food you ate was grown or raised fairly close to where you lived. As technology and jobs changed, and the demand for meat grew, food began to be produced on a larger scale. Read on to learn more about the changing food culture and the concept of “food sovereignty.” 

Eating Local?

During President Theodore Roosevelt’s tenure, the U.S. began regulating food and drugs produced in the country with the Pure Food and Drugs Act of 1906. This act prohibited “misbranded and adulterated foods, drinks, and drugs in interstate commerce.” This was regulated by the Bureau of Chemistry in the Department of Agriculture, which eventually became the Food and Drug Administration (FDA) in 1930.

Today, food laws are still imperfect. But the American public is increasingly conscious of where and how food is produced. Debates regarding food production are happening all over the country. Most Americans eat three times a day. A 2011 study found that the average American eats roughly 1,996 pounds of food each year. With that much food at stake, it makes sense that people are concerned.

Recently in America there has been a push toward “eating local.” Many people want to go to farmers markets and buy their tomatoes and cabbage from the farmer who grew it. They want to buy their eggs from chickens that were raised in hen houses that they could visit, rather than from a place straight out of “Food Inc.” 

In short, people are more aware of where their food is coming from. And that is where “food sovereignty” comes in. It’s an issue that is starting to gain traction in the U.S. Those who advocate for food sovereignty feel that farming has become over regulated. The movement is global, and many farmers around the world are standing up for themselves and for food production as a whole.

What is Food Sovereignty?

La Vía Campesina, an international “peasant” movement, coined the term “food sovereignty” at the 1996 World Food Summit. The group defines it as such:

Food sovereignty is the right of peoples to healthy and culturally appropriate food produced through sustainable methods and their right to define their own food and agriculture systems.

With the increased demand for locally-grown produce in America, it’s becoming more popular for farmers to want to sell their produce to their local communities. But it’s also important to note that outside of the U.S., food sovereignty takes on a much more important role. Hannah Wittman, Annette Desmarais, and Nettie Wiebe, authors of “Food Sovereignty: Reconnecting Food, Nature and Community,” wrote: 

The stunted growth and high mortality rates of hungry children and the ill health and lost potential of malnourished adults are clear and tragic results of the chronic food shortages suffered by an increasing number of people. A growing number of households and communities fear for tomorrow’s meals, even though there may be enough food for today.

Shifting more power to local farmers would increase the availability of food. And food would not have to travel as much, making it less costly and more likely to be fresh.

In the U.S., Maine Leads the Way

The U.S. has very structured regulations for farmers. One state is breaking away from this model. On June 16, Maine Governor Paul LePage signed LD 725, or An Act to Recognize Local Control Regarding Food Systems. This act is the first of its kind in the United States. It shifts power from the state to local municipalities. The Bangor Daily News described the rationale behind the law:

Supporters of food sovereignty want local food producers to be exempt from state licensing and inspections governing the selling of food as long as the transactions are between the producers and the customers for home consumption or when the food is sold and consumed at community events such as church suppers.

There were already about 20 municipalities in Maine that had their own food sovereignty laws. Now with this statewide law, municipalities that apply for food sovereignty will be granted more control. 

The law allows small farmers to sell food within their communities with fewer government regulations. Maine Rep. Craig Hickman enthusiastically embraced the passage of the law. In an interview with the Bangor Daily News, he said, “Food sovereignty means the improved health and well-being of the people of Maine by reducing hunger and increasing food self-sufficiency through improved access to wholesome, nutritious, and locally produced foods.”

According to a 2012 USDA census, Maine has some of the youngest farmers in the country. And the field is drawing in more and more young farmers, partially due to the growing demand for local produce. As more farmers embraced this lifestyle, and consumers demanded local produce, Maine decided to change the regulations a bit to accommodate them.

In 2013, many municipalities in Maine fought for food sovereignty. One of their complaints was about a new law that allowed small farms that sold less than $1,000 worth of chicken a year to slaughter chickens on their own farms rather than go to a slaughter house. The regulations it sought to change would require those farms to spend as much as $40,000 to be able to properly slaughter their chickens.

The Advantages of Food Sovereignty

Less regulations may give pause to the more cautious eater or the revolted reader who cannot get the images of “The Jungle” out of his or her head. But many local Maine representatives feel that this new act is a good thing for Maine. So what regulations are being repealed exactly? While the law states that food produced locally must still adhere to federal standards, these local farms do not require state licensing, nor do they have to go through state inspections of food produced, sold, and consumed locally.

The new law does not apply to every food producer and seller, however. Chain grocery stores and establishments selling large quantities of food must still adhere to the old laws. The new act is specifically designed for small farmers selling within their communities.

Betsy Garrold, the acting executive director of Food for Maine’s Future, felt that this will encourage many young and burgeoning farmers to enter the trade. She told the Bangor Daily News, “This means face-to-face transactions are legal if your town has passed a food sovereignty ordinance [and] you can sell food without excessive government regulations,” she said. “If we can feed ourselves, no one can push us around.”

Garrold felt that with the amount of farms in Maine, large and small, it is hard to make one law that regulates everyone equally. “Now if a small vegetable farmer wants to diversify their holdings and run a few meat birds, they can,” she said.

But Not Everyone is Onboard

Maine might be alone in its quest to deregulate farmers for a while. As of right now, no other states are moving to enact food sovereignty laws.

There are national food sovereignty groups, like the U.S. Food Sovereignty Alliance (USFSA). However, the group is more engaged in activism than writing laws. USFSA “works to end poverty, rebuild local food economies, and assert democratic control over the food system,” according to its website.

And while other states do not seem to be following Maine any time soon, not even all Maine farmers are pleased with the new act. When Maine began allowing certain municipalities more sovereignty back in 2013, Kevin Poland, a local Maine farmer, was less than pleased.

“It has nothing to do with encouraging local farming,” Poland said in an interview with NPR back in 2013. “There’s plenty of that here. What there should be more encouragement of is food safety. The state of Maine has laws that work,” he added.

Perhaps this is why other states have not joined Maine in passing their own food sovereignty laws. With all of the criticism that the food industry faces, it could seem counterintuitive to try to ease regulations on those who provide us with our food.

Global Impact

While Maine may be the first state in the U.S. to enact a food sovereignty law, other global initiatives have been on the forefront of this movement for decades. La Vía Campesina (The Peasants’ Way) started in 1993 as a way to support small farmers. The group is now a huge global initiative that has been one of the largest advocates of food sovereignty. 

La Vía Campesina says on its website that it represents, “164 local and national organizations in 73 countries from Africa, Asia, Europe and the Americas. Altogether, it represents about 200 million farmers.”

Most recently, the group supported a rally in Morogoro, Tanzania on June 23. The protesters felt that the government was not acting in the best interest of the Tanzanian people. In a statement on its website, La Vía Campesina said, “We know that our African elites in the public and private sectors have been for many years colluding in corruption with the evil transnational corporations which today represent the new face of imperialist neo-colonialism.”

Conclusion

Food sovereignty is a topic that is gaining traction around the world. Those fighting for it do so because they cannot comply with the regulations imposed by the government that are intended for larger farms. For small farmers selling food within their community, these regulations can be damaging. In America, it is less dire that we change our food sovereignty laws, but in other countries, the consequences are higher. Food shortages and government corruption are why farmers around the world want to take their food back into their own hands. 

Anne Grae Martin

Anne Grae Martin is a member of the class of 2017 University of Delaware. She is majoring in English Professional Writing and minoring in French and Spanish. When she’s not writing for Law Street, Anne Grae loves doing yoga, cooking, and correcting her friends’ grammar mistakes. Contact Anne Grae at staff@LawStreetMedia.com.

The post Food Sovereignty: Shifting Control from the Government to Local Farmers? appeared first on Law Street.

As the national debate over health policy unfolds, it can be helpful to take a wider look at the health insurance landscape in the United States to understand how proposed changes would affect the system as a whole. A number of different ideas have been floated to restructure parts of the health care system, but looking at the system overall helps offer some important context to the current debate.  For example, when lawmakers propose reducing spending on Medicaid or changing the subsidies for the individual market, knowing how many people would see their finances change can put things in perspective. Read on to see where people get their health insurance and who remains uninsured.

Health Insurance Coverage in the United States

In the United States, people get insurance through a mix of government programs and private companies. Most Americans have private health insurance, the largest portion of which is provided through an individual’s employer, or their family member’s employer. Government programs provide insurance to about 35 percent of the population. Two government programs account for the vast majority of all people on public insurance, namely Medicare and Medicaid. Medicare is available to all adults over the age of 65 and is intended to provide insurance coverage for people as they age. Medicaid covers a more diverse group, including people with disabilities, the elderly, children, and the poor.

The chart below uses estimates from the Kaiser Family Foundation using 2015 data from the Census Bureau (note that the numbers are rounded and therefore add up to just over 100 percent).

As the chart shows, employer-provided insurance is the single largest source of insurance for most Americans, which is important to keep in mind when debating health policy changes. Private health insurance companies sell insurance to businesses in what’s known as the group market, while those who are not able to get insurance through their employer and do not qualify for public insurance can buy it on the individual market.

Much of the debate over health insurance regulation tends to deal with coverage sold through exchanges on the individual market, which actually apply to a relatively small portion of the entire population. About 7 percent, or 21.8 million people, buy individual health insurance for themselves and their family members–which includes people who buy insurance directly from insurance companies on and outside of public exchanges. Approximately 12.2 million people enrolled in a plan sold on one of the regulated exchanges at the beginning of 2017. Those insurance plans are the ones that are affected by the vast majority of the regulations that have become the focus of many policy debates. Notable examples of these regulations include rules that prevent insurers from denying coverage to people with preexisting conditions and ones that prevent or limit the the extent to which insurance companies can charge people more based on characteristics like health status or age.

One important exception is the Affordable Care Act’s ban on annual and lifetime limits, which prevent insurance companies from cutting off coverage after spending a certain amount. These limits apply to federally defined insurance benefits and affect almost all private health insurance plans including both employer-provided and individual coverage.

Who Are The Uninsured?

In 2015, approximately 9 percent of the population did not have health insurance, or about 29 million people in total. That number comes in the wake of the Affordable Care Act’s passage and enactment, which lead to a sharp decrease in the number of people without health insurance. The ACA increased coverage by expanding Medicaid eligibility and outreach while also creating subsidies to help individuals up to a certain income afford their health insurance premiums. The law also instituted a penalty, known as the individual mandate, for people who decide not to get insurance. So even after a massive effort to increase coverage, who remains uninsured and why?

According to survey data from the Kaiser Family Foundation, the most common explanation people give for not having health insurance is the cost of coverage–46 percent of respondents cited cost as the primary reason. However other reasons–like confusion about the requirement to obtain coverage, issues getting coverage, and preferring to pay the penalty rather than the cost of insurance–also explain why people do not have insurance.

Survey data indicates that the most of the people without health insurance are low-income. About 80 percent of the uninsured population have incomes below 400 percent of the federal poverty line–which is also the income threshold to qualify for subsidies under the Affordable Care Act, meaning that some federal funding is available to help them purchase insurance. There is evidence to suggest that a portion of the uninsured are not aware that they qualify for federal subsidies, and many who are aware may still forego insurance because even with financial assistance the cost remains too high.

While a plurality of the uninsured population is white, accounting for about 45 percent of the total, people of color are disproportionately more likely to not have insurance relative to their share of the total population. Approximately 15 percent of the uninsured population is black and just over 30 percent is Hispanic. Just over one-fifth of those without health insurance are not U.S. citizens, including both immigrants with and without legal status in the United States. Legal immigrants are eligible for subsidies when buying insurance on public exchanges, and after living in the country for more than five years, can be eligible for Medicaid.

Finally, legal challenges to the law resulted in the decision to expand Medicaid resting with the states, and several states–including ones with particularly large populations like Texas and Florida–chose not to accept funding from the federal government to help cover people with incomes up to 133 percent of the federal poverty line. Currently, 32 states including the District of Columbia opted to expand Medicaid, while 19 states have not. Because of this, there is a significant “coverage gap” in non-expansion states between the people who are eligible for Medicaid and those who are eligible for premium subsidies. The Kaiser Family Foundation estimates that more than 2.5 million people fall into this gap, as they would qualify for Medicaid if their state decided to expand coverage.

Conclusion

Health insurance coverage in the United States comes from a variety of different sources. Private health care continues to be the most prominent form of health insurance, with employer-provided coverage being the largest source. But the government also plays a particularly important role in the health insurance landscape. Medicare and Medicaid together provide coverage to nearly 35 percent of the U.S. population. Medicare provides health insurance to the elderly as they age, while Medicaid has grown to cover a diverse group of Americans who would likely have difficultly purchasing private insurance.

Recent efforts to increase insurance coverage, most notably the Affordable Care Act, led to a large reduction in the number of people without insurance, but despite those efforts, many remain uninsured. For a variety of reasons, roughly 9 percent of the population continues to go without health insurance, citing the cost of coverage as the primary reason. One way to reduce that number would be for all states to expand Medicaid, which would help resolve the coverage gap where many low-income Americans are stuck.

Recently, a lot of the discussion about health care has focused on regulations that affect individuals who do not get insurance through their employers. While people purchasing health care directly from insurers on exchanges account for a relatively small share of the overall population, their concerns have become particularly important to recent legislative debates. The cost of health insurance on the public exchanges have become unaffordable for many, and lack of competition in certain markets has left some areas with only one insurer to buy from. This problem many be getting worse, and next year, the number of insurers in some places may drop to zero. Given the pressing nature of these concerns, they tend to garner a lot of attention, and rightly so. But as we debate health policy, it’s important to keep in mind where the individual market fits into the overall landscape.

Kevin Rizzo

Kevin Rizzo is the Crime in America Editor at Law Street Media. An Ohio Native, the George Washington University graduate is a founding member of the company. Contact Kevin at krizzo@LawStreetMedia.com.

The post By the Numbers: Health Insurance Coverage in the United States appeared first on Law Street.

As the American Health Care Act works its way through Congress, much of the debate has recently focused on issues like health insurance regulation. While that debate reflects important issues, like protections for people with pre-existing conditions, there is another part that would arguably have even larger consequences: the proposed cuts and changes to Medicaid. The AHCA would fundamentally change the funding structure for the safety net program and could have wide ranging effects on millions of Americans who rely on Medicaid for their health care. Read on for an overview of what’s in store for the program that provides insurance to nearly 20 percent of the country.

Who is Affected

Medicaid is the largest health insurance program in the country, which combined with the related Child Health Insurance Program (CHIP), covered nearly 75 million people as of February. Medicaid covers a diverse group of people including low-income individuals and families, people with disabilities, and the elderly.

The video below explores what the Medicaid program is and how it is paid for:

To understand the scope of the proposed changes to Medicaid in the American Health Care Act, it’s important to look at how the bill it’s intended to repeal and replace–the Affordable Care Act, or Obamacare–changed health insurance coverage in the first place. Generally speaking, the Affordable Care Act sought to increase insurance coverage by expanding the Medicaid program–through both increasing outreach and eligibility–while also creating regulated insurance marketplaces and providing subsidies to make health insurance more affordable.

The Medicaid expansion was directed at the lowest income Americans, specifically, people living below 138 percent of the federal poverty level, while insurance subsidies targeted those who were slightly better off but would still have difficulty paying for health insurance, namely those with incomes below 400 percent of the federal poverty level. Regulations also ensured that individuals could buy insurance on public exchanges and that prices couldn’t vary much according to an individual’s characteristics like age, sex, or health status, which was another way to expand coverage to those who were either priced out of the market or denied insurance outright.

While several components of the ACA sought to lower the rate of uninsured Americans, the Medicaid expansion played the largest role in achieving that goal. The AHCA includes important changes for insurance subsidies and regulation–the proposed cuts and changes to Medicaid are considerably larger. The Congressional Budget Office analyzed the effects of the AHCA in March after it was initially introduced and found that overall, the law would reduce the number of people with health insurance by 24 million within 10 years. The biggest chunk of that decrease, 14 million, would come from the proposed changes to Medicaid. While the law would not technically take people’s insurance away from them–states would have to make difficult decisions about enrollment and eligibility–it would amount to a large cut in federal spending on the program. In total, the CBO estimates that the bill would lead to an $839 billion decrease in federal Medicaid spending over the next 10 years.

The AHCA includes two primary changes to Medicaid that would lead to a significant reduction in people enrolled in the program. First, the bill would phase out the ACA’s Medicaid expansion, decreasing the number of people that states would get a high percentage of federal matching funds to cover. Second, it would change the program’s funding model from an open-ended commitment to an amount per enrollee that gradually increases over time.

Ending the Medicaid Expansion

The Affordable Care Act offered states matching funds to insure a large number of people newly eligible for Medicaid. A 2012 Supreme Court decision made the Medicaid expansion optional at the state level, and since then, 31 states and the District of Columbia have chosen to take the federal funds. At first, the government would pay the full cost of insuring these newly eligible enrollees, but over time the government’s share would drop, and by 2020, it would cover 90 percent of the cost of coverage. The matching rate for the enrollees who gained coverage from the expansion is actually higher than the traditional matching rate that states have historically received for those who were already eligible.

The American Health Care Act plans to unwind the Medicaid expansion starting in 2020. While the plan will end up with an estimated 14 million fewer people on Medicaid relative to current law, the AHCA’s passage will not technically take health insurance away from these individuals. Instead, it grandfathers in all newly eligible enrollees who are already in the program by December 31, 2019–allowing states to continue to receive the 90 percent fund matching for those individuals. However, for people who sign up after that point, the funding would drop to regular matching levels. This means that states will likely decide to restrict their program’s eligibility and return to standards that were in place before the Affordable Care Act.

People on Medicaid tend to cycle in and out of the program relatively quickly, which means that even though the AHCA grandfathers in expansion enrollees, coverage numbers are expected to drop fairly quickly after 2020, when states get lower matching rates. The bill would also require people on Medicaid to re-enroll every six months, rather than every year under current law, to maintain their coverage. This requirement could make it easier for people to accidentally have a lapse in their coverage, which could make those who are grandfathered in unable to re-enter the program. Based on how quickly people have cycled out of the program in the past, the Congressional Budget Office estimates that two years after the expansion ends, fewer than a third of those who were grandfathered in will remain on Medicaid. By 2024, fewer than 5 percent will remain. While the federal government won’t technically take people’s insurance away from them, the drop in funding will likely force states to make the difficult decisions surrounding eligibility and enrollment.

It’s worth noting that politics are an important variable here, so estimating coverage changes can be more of an art than a science when the actions of state legislatures are involved. It’s likely that states will react to a decline in federal funding by reducing the number of people eligible for Medicaid benefits. They may even do so preemptively, as they know that their funding will soon be reduced. Generally, the law will sharply reduce federal funding for Medicaid, but changes will be determined at the state level as they start to shoulder more of the costs.

A New Funding Model

In addition to phasing out the Medicaid expansion, the AHCA intends to dramatically change the funding system for Medicaid. Currently, Medicaid operates as an entitlement program, meaning that the federal government has an open-ended commitment to pay for a large share of the program’s costs. This means that if more people enroll in the program, as is often the case during economic downturns, the federal government continues to bear much of the increase in costs. Similarly, if the cost of medical care increases significantly, as it has been for several decades, the federal commitment increases accordingly. The entitlement nature of Medicaid has been a target of Republicans for decades; however, this is the first attempt to restructure the program while Republicans maintain control of all three branches of government.

Under the AHCA’s per capita cap system, states will get a certain amount per person enrolled. Those amounts will vary based on the different groups eligible for Medicaid to avoid giving states an incentive to shift enrollment to lower costs. For example, the system is designed to prevent states from being pressured to drop enrollment for the elderly or disabled because they may cost more than children. Each year, the per capita cap will increase along with the changes in medical care services component of the Consumer Price Index, which tracks inflation. The medical services component is known as CPI-M. The per capita system will make funding responsive to enrollment changes, but if certain Medicaid costs outpace the overall cost growth for medical services, states will need to pay the additional amount. Generally speaking, shifting to a per person allotment will amount to a significant cut in overall Medicaid spending. The Congressional Budget Office anticipates that Medicaid costs will grow by 4.4 percent per year while CPI-M will grow at just 3.7 percent annually over the next 10 years.

Additionally, the amended AHCA allows states to opt for a block grant rather than a per person cap. This would give states a grant based on their Medicaid population and would give them a considerable amount of freedom in terms of how to use that funding. Proponents say that this would allow states to experiment with funds in order to find new ways to keep costs down and deploy spending more effectively. However, critics argue that a block grant could mean states could be forced to cover fewer people or services than under the per capita cap model, and considerably more so than the current law. This is because block grants would not respond to increases in eligibility, for example due to a recession, and like the per capita model, it would not respond to cost increases that result from new or more expensive types of care. States could charge enrollees more for their care and they could cap enrollment, which could mean even those who are eligible may not be able to join the program.

How it would Change Medicaid

To illustrate how different the system would be under a per capita cap, economists at the Kaiser Family Foundation ran the numbers for Medicaid outlays from 2001 to 2011 to see how tying funds to CPI-M would affect spending. The KFF finds that federal spending would have been $195 billion below actual spending during that period, which would amount to a drop of about 7 percent. Importantly, these changes have very different consequences for the costs involved in covering the different eligible groups in the Medicaid program. For example, spending tied to CPI-M would have been 6 percent lower than actual spending when it comes to the health care costs for the disabled, but it would have been 15 percent lower for children on the program. In both of these cases, states would have had to shoulder more of the costs, but the difference is considerably larger due to faster growth in child health care costs. There is also a lot of variation between states in terms of what they pay for the average Medicaid enrollee. In fact, spending varies so much per person, that 13 states would have actually seen an increase or no change in their overall funding if it was anchored to CPI-M. However, 37 states and the District of Columbia would have seen their funding drop. And for 26 of those states, the drop relative to existing law would have been larger than 10 percent.

Subsequent amendments to the AHCA–after the initial Congressional Budget Office analysis–increased the per capita spending for the blind, elderly, and disabled to CPI-M plus one percentage point. Those changes amount to an estimated $41 billion in additional spending over the next 10 years, according to revised CBO projections. While $41 billion is a significant increase it may not be in the scope of the overall cuts–instead of reducing Medicaid spending by $880 billion, the amended law is projected to drop spending by $839 billion. While the Kaiser Family Foundation estimates mentioned above are based on CPI-M, and AHCA increases that rate slightly for certain populations, its calculations remain instructive.

Critics of the plan argue that the proposed per capita spending caps would limit states’ ability to respond to changes and could leave them on the hook for a lot of spending if certain costs grow faster than overall medical inflation. And because these caps will effectively result in spending cuts relative to the current law, it will ultimately leave states with less funding while also reducing their responsiveness to cost changes. An example of where this could be a problem is in Medicaid’s role in addressing the opioid epidemic. Many people who joined the program after the Medicaid expansion were previously uninsured and did not have access to addiction treatment. Moreover, the entitlement nature of the program allowed the program to respond to costs related to the epidemic. This is important given the program’s role in treatment–in total, Medicaid and CHIP, the related health insurance program for children, cover thirty percent of the U.S. population dealing with opioid addiction.

Conclusion

The American Health Care Act includes a number of adjustments to the current health care system, but the most wide-ranging might be the proposed cuts and changes to the Medicaid program. President Obama’s health law led to a large increase in Medicaid enrollment and the AHCA would roll much of that back while going even further to change the funding structure of the entire program. Taken together these changes amount to an $839 billion spending cut over the next 10 years and 14 million fewer people with health insurance.

Advocates of the bill argue that it will rein in Medicaid spending levels to a more sustainable course while granting states the ability to experiment and cut costs. Critics argue that it will dramatically increase the number of people without insurance by reducing federal funding for Medicaid while not offering alternatives to those who can’t afford insurance. As Senate Republicans begin to work on their own version of the health care bill, these wide ranging changes to Medicaid will likely be an important part of the debate.

Kevin Rizzo

Kevin Rizzo is the Crime in America Editor at Law Street Media. An Ohio Native, the George Washington University graduate is a founding member of the company. Contact Kevin at krizzo@LawStreetMedia.com.

The post How the American Health Care Act Plans to Dramatically Change Medicaid appeared first on Law Street.

After Republicans’ first attempt to swiftly repeal and replace the Affordable Care Act failed, President Donald Trump finds himself in a difficult position: he has to administer a law that he has frequently called a “disaster.” The question now becomes: will President Trump and Tom Price, his Secretary of Health and Human Services, try as hard as possible to support the law that’s already on the books or will they take steps to undermine it?

As Republicans continue to try to broker a compromise between their more moderate and conservative wings–and there’s at least some evidence they are making progress–questions about the existing law may need to be answered before any new legislation makes its way to the president’s desk. While many of these pending decisions are somewhat small or would require a long time before taking effect, there’s one relatively arcane component of the Affordable Care Act–cost-sharing subsidy payments–that could swiftly pull the rug out from under the health insurance exchanges that about 12 million people rely on for health insurance. Read on for an overview of the Affordable Care Act exchanges and to see how a pending lawsuit gives President Trump unique control over the fate of a major part of his predecessor’s landmark accomplishment.

An Overview of the Health Insurance Exchanges

The Affordable Care Act, more commonly known as Obamacare, is an extraordinarily long piece of legislation that touched almost every part of the U.S. health care system–an industry that accounts for nearly one-fifth of the entire economy. One of the law’s primary goals was to lower the number of people without health insurance coverage. To do this, the law dramatically increased the number of people on Medicaid–the government-run health insurance program for low-income Americans–by expanding outreach and eligibility to a larger number of Americans. It also created federal and state-run health insurance exchanges on which people who do not get health insurance through their employer and also don’t qualify for Medicare or Medicaid can buy health insurance. While most of the coverage gains came from expanding Medicaid, creating regulated exchanges and offering subsidies made health insurance available to groups who previously did not have access to it on the individual market, notably those with preexisting conditions.

Individuals could buy health insurance before the Affordable Care Act’s passage, but insurers could charge people with chronic health conditions a lot more for insurance and could even deny coverage outright. The ACA introduced significant marketplace reforms to ensure that all insurance plans offered on the exchanges cover a minimum set of services, known as the 10 essential benefits, and prevented companies from denying anyone coverage because of a preexisting condition. The law also included provisions that prohibited charging people higher premiums based on certain characteristics like gender or health status. For other characteristics, the law set specific ranges at which companies can use to price premiums. For example, companies can charge no more than three times as much for their elderly customers as they can for their youngest customers.

The law had a number of provisions to try to make the marketplaces stable for insurers and consumers. One of the most discussed (and controversial) market stabilization components of the law is the individual mandate–the requirement that everyone get health insurance or pay a tax penalty. To help make insurance affordable for consumers, the ACA provided premium subsidies to people making less than 400 percent of the federal poverty line. The premium credits are tied to a benchmark plan to ensure that an individual or a family’s healthcare spending is capped at a certain percentage of their income. This means that if insurance premiums change dramatically from one year to the next then the subsidy will also adjust for those who are eligible. Finally, the law also had several stabilization programs that sought to reduce the risk that insurers would face when beginning to sell plans on the new exchanges.

Cost-Sharing Reductions

One of the many ways the law sought to make care affordable for low-income Americans is the cost-sharing reduction requirements. The cost-sharing reduction provision is relatively small in the overall scope of the law, but remains an important component because it addressed costs that people face when going to get care. In addition to premiums, health insurance plans typically include several forms of cost-sharing, which involve out-of-pocket costs when someone visits the doctor or fills a prescription. The Affordable Care Act sought to reduce these costs for people with incomes up to 250 percent of the federal poverty level. People who are eligible for cost-sharing reductions must enroll in silver insurance plans, the middle tier plans, on the insurance exchanges. Based on an eligible consumer’s income, insurers adjust the value of the plan to ensure that they cover a certain percentage of all costs. The government then provides a subsidy to insurers so they recoup those costs. A typical silver plan has an actuarial value of 70 percent, meaning that the insurance company will, on average, pay 70 percent of the cost for covered services–the other 30 percent typically comes through different cost-sharing. In plans eligible for cost-sharing reductions, the actuarial value of a silver plan increases based how close a person or family is to the federal poverty level. For the lowest income Americans who buy insurance on the exchanges, the actuarial value goes as high as 94 percent.

This year there are 7.1 million Americans who have plans with cost-sharing reductions, accounting for 58 percent of all plans on the exchanges. The total cost of the subsidies provided by the government is about $7 billion each year. This process–in which insurers are required to reduce cost-sharing for certain low-income customers and then the government subsidizes the insurers–is key to understanding the current challenge, which we’ll get to in the next section.

It’s worth noting that the law was not implemented exactly as it was designed, as legal and legislative obstacles played a significant role in the way the law took effect. Additionally, while the law has many provisions to reduce the burden on insurers and consumers, there are a number of local marketplaces that are particularly fragile at the moment. Several insurers have pulled out of the exchanges and there are several counties where people buying insurance on the health exchanges have only one insurance plan to pick from. At the same time, there are several places where the exchanges have been particularly successful–where strong competition between insurers has created a stable market for consumers. Debating the overall success of the Affordable Care Act and what should be done going forward is clearly important, but that is beyond the scope of this piece. What is clear is that the law led to a significant legal and political backlash, which brings us to the next part of the story.

The Lawsuit

The passage of the Affordable Care Act sparked a number of legal challenges, several of which have made their way to the Supreme Court. But the lawsuit that is the most important right now is the one challenging the cost-sharing subsidies. Interestingly, this lawsuit didn’t come from private citizens, small businesses, or religious institutions, but from another branch of the government.

In November 2014, Republicans in the House of Representatives filed a lawsuit against the executive branch to challenge two aspects of the ACA’s implementation. The lawsuit first argued that President Obama overstepped his constitutional authority by delaying the implementation of the employer mandate–a requirement that companies of a certain size must provide health insurance for their employees or pay a fine. Second, it claimed that the Obama Administration’s payments to insurers for the cost-sharing subsidies were illegal because the money had not been properly appropriated. A federal judge dismissed the first claim but allowed the second to proceed.

The Arguments

Both sides of the lawsuit agree that money cannot be spent unless it is properly appropriated, but the dispute focuses on the question of whether or not the current law amounts to an appropriation. House Republicans argue that although the ACA created the subsidy, the payments are not linked to a specific appropriation. Although the law calls for the payments to be paid, it doesn’t specify a source for the payments. This is not the case for the law’s premium subsidies, which are paid out in the form of refundable tax credits and are appropriated by the statute that allows the IRS to make refund payments. When the issue first emerged, President Obama asked Congress for a specific appropriation but Congress declined. After the lawsuit began, the Obama Administration argued that the same appropriation that is used for the premium subsidies can be used to make the subsidy payments to insurers.

Nicholas Bagly, a law professor and health care expert at the University of Michigan, has studied the implementation of the Affordable Care Act and argues that the Republicans’ lawsuit has a point. The justification used by the Obama Administration doesn’t quite make sense because tax credits are not the same thing as direct payments to insurance companies. As Bagley puts it, “It’s an enormous stretch to read an appropriation that governs refunds for individual taxpayers as also covering payments to insurers.” However, he also argues that the Republican lawsuit should have been thrown out by the courts in the first place. The White House and Congress are two coequal branches of government and they have the authority to resolve the dispute between themselves. If Congress has a problem with something the president is doing, it can pass a law that stops him from doing it. Congress could also pass a law appropriating the funding for the cost-sharing payments and the problem would be resolved. Allowing one branch to take an issue with another branch to the courts could set a problematic precedent as political disputes should ideally be resolved by elected officials.

What’s Next and Why It’s Important

After the district judge’s initial ruling–which allowed the cost-sharing subsidy claim to continue but dismissed the employer mandate claim–a separate ruling in 2016 ordered President Obama to stop making the payments. Obama immediately appealed the decision and the judge stayed her ruling so the White House could appeal. This means that right now, if President Trump decided to stop reimbursing insurers for cost-sharing reductions, he could drop the appeal and the judge’s injunction blocking the payments would stand. Doing so would have massive consequences for the fate of the health insurance exchanges. This is also something that the president has publicly considered, but the fate of these payments remains unclear.

On April 10, the Department of Health and Human Services told the New York Times that it planned to continue making the cost-sharing payments to insurers while the lawsuit was being litigated. But a few days later, in an interview with the Wall Street Journal, Trump said that he would consider withholding the payments as a way to force Democrats to negotiate on health care legislation. This was, in effect, a threat to undermine the insurance markets as a way to force a deal. Democrats have also reportedly considered demanding a specific appropriation for the payments for their support in a funding bill that will be needed before the end of April to avoid a government shutdown. While the politics of the issue remain unclear, the ultimate effects that ending the payments would have are fairly clear.

Consequences for Health Insurance Markets

Ending the cost-sharing subsidy payments would have dramatic consequences for the individual health insurance market. Ending the payments would not change the fact that insurers who sell plans on the exchanges would still need to provide cost-sharing reductions for customers who qualify–whether they get reimbursed by the government or not. The Kaiser Family Foundation, a non-partisan organization that analyzes health care policy, estimated that average premiums would need to increase by 19 percent to offset the lack of government funding. These estimates varied by location, ranging from a projected 9 percent increase in North Dakota to a 27 percent in Mississippi. Alternatively, insurers may simply leave the exchanges altogether.

After several insurance companies had difficulty turning a profit in the early years of the ACA’s implementation, several companies decided to stop selling plans in many markets. The current uncertainty surrounding the cost-sharing payments and health care policy more generally, could lead many companies to pull out from the exchanges. Trade groups have already started to warn lawmakers that blocking the payments may cause insurers to drop out of the markets. By June 21, all health insurers will need to decide whether or not they plan to sell insurance on the ACA exchanges next year. This year there are more than 960 counties in the country with just one insurer offering to sell plans on the exchanges, and if companies decide to pull out, several markets could collapse altogether.

Conclusion

As Republicans continue their efforts to repeal and replace the Affordable Care Act, President Trump may need to make decisions about the current law before he has an opportunity to sign a new law overhauling it. Arguably the most pressing of these challenges is what to do about the lawsuit challenging the cost-sharing subsidy payments. Trump could decide to stop the pending lawsuit and block the payments almost immediately, throwing exchanges that provide insurance to 12 million Americans into chaos. He could continue the current policy–allowing the appeal to move forward and payments to be made to insurers–or he could ask Congress to appropriate the required funding and resolve the issue once and for all.

In the meantime, the subsidy payments will continue to play an important role in legislative negotiations, particularly the funding bill needed to keep the government open past April 28. Meanwhile, insurers must deal with uncertainty as they decide if they want to continue to sell plans on the state and federal exchanges. While much remains in question, the end result will largely be the product of Congressional politics. Both parties seem to think they have the upper hand–assuming the other will be blamed if subsidy payments are blocked and insurers hike premium prices or leave the markets altogether.

Kevin Rizzo

Kevin Rizzo is the Crime in America Editor at Law Street Media. An Ohio Native, the George Washington University graduate is a founding member of the company. Contact Kevin at krizzo@LawStreetMedia.com.

The post Behind the Lawsuit that Could Upend the Affordable Care Act Exchanges appeared first on Law Street.

For most countries, health care is often a costly component of national budgets. That being said, the sheer volume of federal money spent on a nation’s health care system does not necessarily predict its efficacy. For example, the American health care system–with its rising premiums, drug costs, and glaring loopholes–could certainly be more efficient. The U.S. system has consistently ranked poorly among other industrialized nations, despite having the most expensive health care system in the world–17 percent of its GDP. As the White House grapples with how to handle health care under the new Trump Administration, American politicians may look to other countries for guidance.

One such country potentially worth emulating is the Netherlands. According to the global Prosperity Index, the Netherlands has one of the best health care systems in the world based on the country’s basic mental and physical health, health infrastructure, and availability of preventative care. Could this country’s critical health care reform and system structure be advantageous for the U.S.?

Netherlands Health Care Reform

In 1941, the Netherlands introduced a mandatory health insurance plan for low and middle income citizens. It provided most of the country’s population with basic health insurance, while wealthier citizens purchased private plans. But as the program grew, so did spending. In an effort to protect access to health care, the government passed the Health Care Prices Act in 1982 to control physician fees and revenues. Over the following decades, the Dutch started working toward creating a system that merged competition with universal access to health care.

Then, in 2006, the Netherlands passed the Health Insurance Act of 2006. This broad health reform law was intended to improve the health care system’s quality and efficiency by introducing uniform health insurance. Prior to the 2006 health insurance reform, the Netherlands health care system was comprised of four parts: long-term care insurance, supplementary private health insurance, social health insurance, and alternative private health insurance. After the reform, a new universal “private” social health insurance emerged, and long-term care and supplementary private insurance were maintained.

“Holland” Courtesy of Moyan Brenn : License (CC BY 2.0)

All people who legally live and work in the Netherlands are mandated to buy health insurance from a private insurance company. All insurers are required to accept each applicant, regardless of pre-existing conditions. Moreover, the plan is financed with individuals’ annual income-based contributions. Over half of all Dutch households also receive a subsidy from the government based on income. Since the system relies solely on a flat tax related to salary, the Dutch government does not have to shell out many resources to provide individuals with subsidies.

Today, the health insurance system appears to have more transparency than before. Consumers also have unrestricted choice between all insurance companies on the market. Interestingly, the Dutch approach is not a single-payer system. Instead, it combines mandatory universal health insurance with competition amongst private health insurers, creating more of a “risk equalization” system

Netherlands Health Care Structure

The Dutch do not aggressively regulate health care prices; instead, they’ve chosen to hone in on risk selection and primary care.  By tracking a myriad of factors such as: age, sex, pharmaceutical history, and hospital use, the government is able to determine which individuals are more risky to insure and how much it will potentially cost to cover them in the future. The government then pays more money to insurance companies taking on sicker patients. In an effort to offset these costs, each citizen is required to sign up for a general practitioner who acts as a “gatekeeper” to more expensive care and services. This allows the Dutch to cut back on unnecessary–and often costly–visits to specialized doctors. Individuals who are unhappy with their care have the option to change their insurance policy each year.

Insurers are also mandated to place all profits into a shared fund. That money is then distributed to other insurance companies whose patients are sicker than anticipated. Essentially, the Dutch have made insuring only the healthy a less viable and effective business strategy for insurance companies. The government has also set aside a health care budget, and still sets the price on most services. Since physicians are paid a lump sum each year–rather than fee-for-services–there is less incentive for them to overprescribe medications.

But no health care system is completely free from flaws. Cost-related access problems–not filling prescriptions, skipping recommended tests or treatments, or not visiting a doctor because of cost issues–still plague the Netherlands. However, timely access to health care, including elective or non-emergency surgeries, is much easier to receive in the Netherlands.

In many ways, the Dutch health care system is now an efficient “managed competition.” According to the United Nations’ 2017 World Happiness Report, the Netherlands ranked an impressive sixth out of more than 150 countries. While many factors were considered, health care coverage and life expectancy were integral in determining the overall happiness rankings.

What Can the U.S. Do?

In 2008, researchers noted that implementing a Dutch-like system in the U.S. could be attractive to many American citizens in an article entitled “Universal Mandatory Health Insurance In The Netherlands: A Model For The United States?” Consumer choice, in particular, is an aspect of the Netherlands’ health care overhaul that is incredibly desirable to Americans. The Affordable Care Act (ACA) may have been the U.S.’ first step toward implementing a health care system similar to the Dutch (insurance policy choices for consumers, attempts to insure more of the population, and coverage regardless of pre-existing conditions), but the system still has its glaring issues.

In 2014, the Commonwealth Fund produced a report that ranked the U.S. third out of 11 wealthy nations in timelines of care and effective care overall.  The Dutch, on the other hand, can provide universal coverage with very low out-of-pocket costs, while still maintaining speedy access to services. According to the study, the U.S. also ranked last on measures of equity; Americans with low incomes are far more likely than counterparts in other countries to not visit a physician when ill. Poor rankings in equity, efficiency, healthy lives, and cost-related access problems contributed to the U.S. ultimately ranking last overall in the study for the fifth time.

While the Dutch have managed to create an institutional framework to deliver universal access to health care along with market competition and consumer choice, the researchers found that the system still struggles to provide the most high-quality care. Meanwhile, the U.S. has integrated many high-caliber delivery systems, but fails to provide universal access to basic health insurance at an affordable rate. U.S. health care still remains the most expensive in the world, and yet it manages to underperform relative to other countries.

The U.S. and the Netherlands are perhaps most divided in the regulation of insurance companies. The ACA left a significant amount of diversity in the insurance marketplace, making it nearly impossible for the program to be fully transparent and simplified with the vast amount of choices. Obamacare offers four different varieties of insurance packages, while the Dutch program offers only one–which is probably most comparable to the Obamacare silver plans. Insurers in the U.S. are able to charge older customers up to three times as much as younger ones, adding even more complexity to the American system. Other researchers note that America’s “spend more, get less” model is tied to other issues–safe, affordable housing; employment prospects; reliable transportation; and consistent, well-balanced meals–that may be even more important to a population’s overall health than just specific medical care.

Conclusion

Building a perfect health care system is downright difficult, regardless of the country or government structure. However, the efficacy and success of the Netherlands’ universal system may be something the U.S. can learn from, and perhaps even integrate into its own system. While there is a lot of support for single-payer (“Medicare for all”), the Dutch system of health care isn’t too far removed from what President Barack Obama attempted to implement through the ACA. With more efficiency and management of the health insurance market, it’s possible the U.S. could save billions of dollars following a more Dutch-like system of health care.

Nicole Zub

Nicole is a third-year law student at the University of Kentucky College of Law. She graduated in 2011 from Northeastern University with Bachelor’s in Environmental Science. When she isn’t imbibing copious amounts of caffeine, you can find her with her nose in a book or experimenting in the kitchen. Contact Nicole at Staff@LawStreetMedia.com.

The post Could America Learn a Thing or Two From the Netherlands’ Health Care? appeared first on Law Street.

While on the campaign trail, President Donald Trump repeatedly vowed to “repeal and replace” the Affordable Care Act (commonly known as “Obamacare”). However, his first attempt at dismantling the federal statute crashed and burned before a single vote was even cast due to divisions among conservative and moderate Republicans on Capitol Hill. If passed, Trump’s health care bill would have slashed federal funding to Medicaid.

Now, in the wake of the embarrassing defeat, Trump’s fledgling administration is still looking to give the American people a better option for health care. Some experts believe this could still come in the form of reforms to Medicaid and Medicare, which have historically been mired in controversy.

So, lets take a look at how these health care programs, both enacted in 1965, have evolved over the years. How has the Affordable Care Act affected them? And what is the fate of these programs if a new health care bill is finally passed?

What is Medicaid?

Medicaid is a social health care program for certain individuals and families in the U.S. with limited income and resources. It was created through the Social Security Amendments of 1965–signed into law by President Lyndon B. Johnson–under Title XIX of the Social Security Act. It essentially acts as government insurance for those who are unable to pay for traditional health care costs.

The federal government matches state spending on Medicaid to enable states to provide medical assistance to residents who meet their individual eligibility requirements. While the program is jointly funded by state and federal governments, it is managed at the state level. Thus, every state has an immense amount of autonomy in determining who is eligible for the program. Since 1982, all 50 states have participated in the program–despite not being required to do so.

The Affordable Care Act (ACA) significantly expanded Medicaid eligibility, extending coverage to adults under 65 years of age who have incomes up to 133 percent of the poverty line, as well as making it available for low-income adults without dependent children. However, the Supreme Court’s ruling in National Federation of Independent Business v. Sebelius determined that states did not have to agree to the expansion. Thus, many states have continued to stay at pre-ACA funding and eligibility levels.

As a whole, Medicaid provides a variety of services for some of America’s most vulnerable populations. According to the National Council for Behavioral Health, Medicaid is the single largest payer of mental health services, paying for 25 percent of all mental health care and 20 percent of all addiction care. Four out of 10 children are treated under Medicaid, and a study published in Women’s Health Issues found that almost half of the 4 million births each year in the U.S. are covered by the program. Medicaid also often covers the costs of nursing homes and other long-term care options for elderly patients.

Medicaid Structure Explained

While poverty is a primary requirement for Medicaid eligibility, it alone does not qualify citizens for the program. Other categories, such as pregnancy, age, and disability, may also qualify a citizen for Medicaid eligibility. Interestingly, Medicaid also provided the largest portion of federal money for people with HIV/AIDS until Part D of Medicare was implemented (but more on that later). In most states, adults who receive Supplemental Security Income benefits (a federal income supplement program) are automatically enrolled in Medicaid. While state Medicaid programs are required by federal rules to cover comprehensive dental services for children, coverage for adult dental services is optional and oftentimes limited.

Some states choose to utilize the Health Insurance Premium Payment Program (HIPP). Under HIPP, a person under Medicaid is eligible to have private health insurance paid for by the Medicaid program. Essentially, the state pays the private insurance premiums for beneficiaries. States may also combine administration of Medicaid with other programs, such as the Children’s Health Insurance Programs (CHIP), for ease.

What is Medicare?

Medicare, in contrast, is a single-payer social health insurance program specifically for those aged 65 and older that has been administered by the federal government since 1966. With President Lyndon B. Johnson at the helm, Congress enacted Medicare in 1965 under Title XVIII of the Social Security Act. Medicare provides health insurance to some individuals under the age of 65 with disabilities as determined by the Social Security Administration. For example, any individuals with end stage renal disease or amyotrophic lateral sclerosis (ALS) are eligible for Medicare.

Those who have worked and paid into the system through payroll tax are eligible once they reach age 65, regardless of income or medical history. Currently, there are a number of private insurance companies across the U.S. under contract for administration of Medicare. It is funded primarily through payroll taxes, general revenues, and premiums paid by Medicare beneficiaries.

In 1966, Medicare spurred racial integration, by making desegregation of waiting rooms and hospital floors a condition of receiving Medicare funds. According to David Barton Smith, a professor emeritus in health-care management at Temple University, nearly 2,000 hospitals had integrated by July 1966 in order to remain connected to federal money for the program. Although some hospitals resisted integration, and those who complied found ways to restrict multi-bed rooms, Medicare still played an important role in integrating the nation’s hospitals.

Medicare Structure Explained

Structurally, Medicare is complicated. There are four parts: Part A, hospital and hospice insurance; Part B, medical insurance; Part C, Medicare Advantage plans; and Part D, prescription drug plans. Hospital and hospice insurance covers inpatient hospital stays, care in a skilled nursing facility, hospice care, and some home health care. Medical insurance under Part B is optional, and helps insured members pay for services and products that are not covered under Part A–usually outpatient care. Patients who miss their initial enrollment period for Part B incur a lifetime penalty of 10 percent per year on the premium.

Medicare Advantage plans under Part C are Medicare plans sold through private insurance companies. These plans are required to offer coverage that meets or even exceeds standards set by Original Medicare. However, they do not have to be identical in covering every benefit. These are considered “capitated” health insurance plans, which is a payment arrangement that pays a physician or group of physicians a set amount for each enrolled person assigned to them for a particular period of time, whether that person seeks care or not. The difference between Part C plans and Original Medicare is likened to the standard HMO versus non-HMO plan decisions other citizens make.

Finally, Part D covers prescription drug plans. It was created in 2003 under the Medicare Prescription Drug, Improvement, and Modernization Act and went into effect in 2006. Anyone with Part A or Part B is eligible for Part D, though the coverage is not standardized. Plans choose which drugs to cover, though they must cover at least two drugs in 148 categories and cover substantially all drugs in six protected classes (including antidepressants, antipsychotics, anti-convulsants, immuno-suppressants, as well as cancer, AIDS, and HIV drugs).

Medicaid and Medicare under the ACA

Medicaid was expanded extensively under the ACA. Currently, 73 million people are enrolled in Medicaid, and roughly 11 million are covered under the program because of the ACA expansion. States who chose to reject the Medicaid expansion are slowly facing the consequences of that decision. Reports issued by the Urban Institute, Lewin Group, and Rand Corp. have stated that these states are slated to lose billions of dollars–money that their own residents have paid in federal taxes.

The ACA expansion also made a number of changes to Medicare; many provisions were specifically designed to reduce the cost of Medicare. It was designed to help Medicare patients afford their prescription drugs by closing the Part D coverage gap, often referred to as the “donut hole,” by year 2020.

Furthermore, premiums under Part B and Part D were restructured; as a result, the wealthiest people with Medicare had their contributions increased. More oversight, stronger standards, and provider screenings were also enacted to prevent Medicare fraud and abuse.

What’s Next?

According to a recent Pew Research Center survey, 60 percent of Americans feel that the government should be responsible for ensuring everyone has health insurance. This number increased from 51 percent last year and has now reached its highest point in roughly a decade. Those on the other side of the argument–individuals who believe the government has no responsibility to provide health insurance for all–do, however, believe that the government should continue Medicaid and Medicare.

Following the death of Trump’s heath care bill that would have repealed and replaced the ACA, some states are looking to see if participating in the federally-funded Medicaid expansion is a lucrative path to take. As of last count, 19 states have opted out. Some contend that an expansion of Medicare may be a way to improve upon the ACA. Potentially lowering the age of eligibility of Medicare to 50 may also make private individual health more affordable. Moreover, offering Medicare as an option on health insurance exchanges could bring in younger people, reducing Medicare’s overall average costs by not just insuring those who cost the most to insure.

In contrast, there is also the option of implementing a full single-payer healthcare program, considered “Medicare for All”–a system that Senator Bernie Sanders has advocated for immensely. Under a single-payer system, any links between employment and health insurance would cease, as well as expanding the net for people over 65 to all Americans. Thus, the entire spectrum of care for every American citizen would be covered: primary, vision, oral, mental health, and more. Instead of paying a premium to for-profit insurance companies, Americans would merely pay a tax and employers would also pay taxes through payroll. Senator Sanders is poised to reintroduce the single-payer plan in the Senate, on the heels of the failed Republican ACA repeal attempt.

Conclusion

Despite the problems with the current health care system, such as rising premiums and fewer choices for citizens, Medicaid and Medicare have arguably been success stories in their more than 50-year history. Providing insurance and health care to the country’s most at-risk populations–the poor, the disabled, and elderly–is something to be lauded. What lies ahead for the programs, however, is up in the air until a new health care reform bill is passed.

Nicole Zub

Nicole is a third-year law student at the University of Kentucky College of Law. She graduated in 2011 from Northeastern University with Bachelor’s in Environmental Science. When she isn’t imbibing copious amounts of caffeine, you can find her with her nose in a book or experimenting in the kitchen. Contact Nicole at Staff@LawStreetMedia.com.

The post The Evolution of Medicare and Medicaid in America appeared first on Law Street.

In recent years, scientists have been paying a lot of attention to a striking development: the number of infectious diseases has increased considerably. That rise was not just one or two more diseases each year. In fact, over the last 100 years, the number of new infectious diseases discovered each year has quadrupled and outbreaks have tripled. What explains this dramatic increase in new infectious diseases? Read on to find out the answer to this question, how scientists are working to fight diseases, and what the consequences could be if we continue along this same trajectory.

Infectious Disease on the Rise

To begin to understand the rising levels of infectious disease, it is first imperative to understand the common terminology. Four terms, in particular, are used very frequently and require clarification. These terms are outbreaks, epidemics, pandemics, and endemic. An outbreak occurs when the number of cases of a specific disease in a specific community rises above what would normally be expected. Epidemics are, “a widespread increase in the observed rates of disease in a given population.” Pandemics are basically the multinational form of epidemics in that they encompass worldwide outbreaks beyond a particular population. Endemic is decidedly different than the other terms and essentially means a rate of disease that is consistently higher within a given group. These definitions are particularly important for the people treating an outbreak on the ground, as it helps them tune their methods to the reality of the situation. The following video gives an overview of how disease spreads:

Although that rise sounds troubling it is not all doom and gloom. While individual outbreaks are increasing, they are affecting fewer people now than before. Additionally, only a small variety of infectious diseases are responsible for the majority of outbreaks. Furthermore, of these strands, a little over half are zoonosis–diseases that are passed from animals to humans. Even among zoonosis, there are only a few zoonotic diseases that cause most outbreaks. In other words, outbreaks are on the rise but a decreasing number of diseases–passed from animals to humans–account for that rise. The question then becomes, what is leading to the rise in outbreaks?

Factors Leading to the Rise of Infectious Diseases

There are several reasons for this increase, but it starts with us and the actions we take. Many of the recent outbreaks are not new diseases, only new to us as a species. They have been incubating and traveling all across areas like rainforests for tens of thousands of years. However, with human encroachment in the form of farming, mining, housing, etc. people are starting to come into contact with these diseases more often and the results are not always good.

Other human manipulations of the environment are also leading to the rise of infectious diseases. These include seemingly benign activities such as reforestation, animal farming, and even flooding rice patties. Sometimes it can be a combination of human activity and environmental factors, such as when milder winters that are the result of global warming fail to kill off the usual number of pests. In fact, rising temperatures have the potential to be one of the greatest contributors to the continued rise of infectious diseases in the coming years, while ailments such as Malaria, which prosper in warmer climates, may become much more virulent. The video below details how global warming can increase the risk of infectious disease:

Other trends, like urbanization, may also contribute to the rise of infectious diseases. By clumping closer together, the chances of an infection spreading quickly are much higher. This is particularly true when urbanization occurs in poorer countries without effective public health monitoring and preventions systems. Similarly, more travel between countries and regions can introduce infections to places that have never seen them before and it can increase the likelihood that an epidemic becomes a pandemic. Even technology and modern supply chains can present a risk, as processing consolidation may increase the likelihood that contamination spreads.

Resistance to antibiotics and resulting superbugs are additional issues leading to the rising number of infectious diseases. However, this is also a problem for viral infections for many of the same reasons, including over prescription of certain medicines and prescribing the wrong medication for a specific disease. Viruses are especially problematic because they can evolve so quickly that it is impossible to stay ahead of them. The clearest example of this is influenza or the flu which changes from year to year. Along with antibiotics, many sanitation systems are also proving less useful than before. In this case, the issue has more to do with the lack of upkeep in existing public health systems that has led to outbreaks of old diseases such as cholera.

Efforts to Fight Outbreaks

Given this trend, what is being done to stem the tide? Actually, governments began addressing the rise of infectious diseases several years ago. A response was prompted back in 2014, following the outbreaks of MERS and bird flu. That year, the United States, along with dozens of countries and organizations, announced a plan to respond and treat new outbreaks where they start.

Currently, efforts to fight infectious disease in the United States fall under the authority of the Centers for Disease Control, or CDC. Specifically, many of those efforts are housed in the National Center for Emerging and Zoonotic Infectious Diseases or NCEZID. NCEZID focuses on reducing both illnesses and deaths that are associated with infectious diseases. It also strives to be proactive in protecting against the spread of infectious diseases.

At the international level, there is the World Health Organization (WHO). Much like the CDC in the United States, the WHO also focuses on reacting to and fighting epidemics. The WHO acts more like a clearinghouse encouraging individual countries to improve their own existing systems and work to integrate them internationally so a crisis in one country can be handled as effectively by its neighbor if it crosses international borders. When it comes to the spread of infectious disease, the WHO serves as an international monitor to identify and coordinate a response to outbreaks.

Conclusion

Foreseeing and preventing all outbreaks of infectious disease would be impossible. Just last year, for instance, several people in Russia were infected with Anthrax when frozen strains of the disease were released when permafrost melted. While this could easily lead to discussions about global warming, the truth is that it just as clearly exemplifies that it is impossible to anticipate everything. In fact, in some cases, efforts are even seen as misguided or unwanted.

Many recent efforts have focused on identifying and understanding new diseases, like those deep in the rainforest. However, such methods have also been criticized for spending scarce funding to search out new diseases when funds could instead be used for treating known maladies. Although it seems odd to criticize people for being proactive, that might be a fair critique in a world with finite resources. In fact, it might be fair to wonder why people are really that concerned with infectious diseases at all.

This is because non-communicable diseases, like cancer, which cannot be spread from one person to another, kill far more people each year than infectious diseases. However, those diseases also originate within us and frequently have to do with factors that we are less able to control, such as getting older. Conversely, based on the fact that only a few diseases cause most of the outbreaks, infectious disease can be managed and their threat reduced. Thus counteracting the rise of infectious diseases is likely to continue to be a mainstay of health policy both nationally and globally.

Michael Sliwinski

Michael Sliwinski (@MoneyMike4289) is a 2011 graduate of Ohio University in Athens with a Bachelor’s in History, as well as a 2014 graduate of the University of Georgia with a Master’s in International Policy. In his free time he enjoys writing, reading, and outdoor activites, particularly basketball. Contact Michael at staff@LawStreetMedia.com.

The post Are Infectious Diseases on the Rise? appeared first on Law Street.

Terminal illnesses are a heartbreaking reality of life–in many cases, doctors can only provide care to help patients feel less pain in their remaining days. But, some activists believe that it doesn’t have to be that way, and that patients with terminal illnesses should be able to have control over their deaths. Physician-assisted suicide is legal in six states in the United States, and multiple states have weighed whether or not to allow it in the last few years. Read on to learn what physician-assisted suicide is, where it’s legal, and the arguments for and against the controversial practice.

What is Physician-Assisted Suicide?

Physician-assisted suicide is the prescribing of some sort of life-ending drug to a patient by a doctor. The patient then takes the steps to end their own life. Physician-assisted suicide should not be confused with euthanasia–in euthanasia, the physician physically performs the death-causing act. There are other names for physician-assisted suicide, including “physician-assisted death,” “aid-in-dying,” “right to die,” and “death with dignity.”

Across states that have legalized the practice of physician-assisted suicide, the process varies. But there are some consistent elements–only licensed medical doctors (M.D.s) or doctors of osteopathy (D.O.s) can issue the prescription. Additionally, doctors must be willing to issue the prescriptions–by no means are they obligated to do so. Many of the states that have legalized physician-assisted suicide also require that there’s some sort of waiting period between when a patient requests the procedure and when it’s granted, and that multiple doctors are consulted in the decision.

Where is Physician-Assisted Suicide Legal?

Currently, there are six states where physician-assisted suicide is legal: Oregon, Washington, Vermont, California, Colorado, and Montana. It is also legal in Washington D.C.

Oregon legalized physician-assisted suicide in 1994, with 51 percent of Oregon voters voting for it. However it wasn’t enacted until 1997. That was just a few months after the Supreme Court decided in Washington v. Glucksberg that state laws banning physician-assisted suicide are not unconstitutional. This meant that the decision of whether or not to legalize physician-assisted suicide would be left up to each state to determine; other Supreme Court rulings have since continued to validate that it’s a matter for states to decide.

In 2008, Washington became the second state to legalize physician-assisted suicide, via a voter referendum. In Washington, terminally ill residents who have less than six months to live may request drugs that would end their lives.

In 2009, the Montana Supreme Court ruled on Baxter v. Montana, and became the first case to essentially legalize physician-assisted suicide through a court case. Although there was no regulatory framework for physician-assisted suicide set up in the state, it ensured that a doctor cannot be prosecuted for the act.

In 2013, Vermont became the first state to legalize physician-assisted suicide through its state legislature. Like many of the other laws, it includes caveats, including that terminally ill patients need to make multiple requests and wait 15 days after their initial request.

Then, in 2015, the California legislature passed the End of Life Option Act. Like the other states, California put certain restrictions on physician-assisted suicide. The patient must be at least 18, must have a diagnosis that will–within reasonable medical judgment–result in death within six months, and be deemed competent to make medical decisions, among other restrictions.

On November 8, 2016, Colorado voters voted in favor of Proposition 106, which legalized physician-assisted suicide in the state. Almost two-thirds of Coloradans voted in favor of the proposition, which like other states’ legalization measures, requires that the patient has less than six months to live, and is deemed competent to make a decision to end their life.

In late 2016, Washington DC’s council approved a Death with Dignity law, and Mayor Muriel Bowser signed it into law. However, based on the way that DC is set up, Congress has the ability to block laws enacted by the district. While Congress did not succeed in blocking this particular law, it has been known to prevent the city from setting up successful regulatory frameworks through budgetary measures, which could still happen.

Have Other States Tried to Legalize Physician Assisted Suicide?

Many states have introduced some sort of law or measure to legalize physician-assisted suicide recently, with most floundering. Michigan lawmakers proposed a physician-assisted suicide bill in late March 2017. Hawaii’s House of Representatives “deferred” a physician-assisted suicide bill, essentially killing it for now. New Mexico’s Senate just voted down a physician-assisted suicide bill. Other states have considered or may consider bills soon, including Maine, while others, like Kansas, are considering resolutions that would ban physician-assisted suicide. For many of the states considering legalizing physician-assisted suicide, it’s not the first time. In the mid-1990s, when the debate about physician-assisted suicide first began to heat up, measures failed in many states.

Arguments in Favor of Physician-Assisted Suicide

Most arguments in favor of physician-assisted suicide cite humanitarian arguments. Advocates of physician-assisted suicide argue that if an individual knows he’s going to die within the next six months, it’s cruel to force him to suffer through it. Instead, physician-assisted suicide allows him to end his life on his own terms, humanely and peacefully. Currently, mentally-competent people have the ability to refuse potentially life-saving treatments. Those in favor of legalizing physician-assisted suicide argue that it’s a similar concept.

Real Life Example: Brittany Maynard

In 2014, the story of Brittany Maynard captivated the nation. Maynard, a 29-year-old California woman, was diagnosed with an aggressive form of brain cancer. After trying treatments, none of which were successful in the long term, Maynard decided to end her own life. She became an advocate for physician-assisted suicide, and in many ways, a modern face of the movement. Maynard and her family moved to Oregon from California, as this was before California had legalized the practice. Maynard wrote an op-ed about her decision, explaining why she believed that physician-assisted suicide was the right choice for her, and explaining that her decision wasn’t about being “suicidal,” but about having an option at the end of her life:

I’ve had the medication for weeks. I am not suicidal. If I were, I would have consumed that medication long ago. I do not want to die. But I am dying. And I want to die on my own terms.

I would not tell anyone else that he or she should choose death with dignity. My question is: Who has the right to tell me that I don’t deserve this choice? That I deserve to suffer for weeks or months in tremendous amounts of physical and emotional pain? Why should anyone have the right to make that choice for me?

Now that I’ve had the prescription filled and it’s in my possession, I have experienced a tremendous sense of relief. And if I decide to change my mind about taking the medication, I will not take it.

Maynard did take her own life, in November of 2014, and remains a face of the movement to extend physician-assisted suicide.

Arguments Against Physician-Assisted Suicide

Those who disagree with the legalization of physician-assisted suicide argue that suicide, regardless of the reasons, is immoral and should not be condoned by the government in any way, shape, or form. Many religious institutions argue against physician-assisted suicide; in some ways, it’s become linked to the pro-life movement. Others argue that physician-assisted suicide inherently creates issues for doctors, as the Hippocratic Oath essentially prescribes that doctors are not supposed to harm their patients. There are also concerns about a slippery slope–if we make any sort of physician-assisted suicide legal, we may open up the door to euthanasia or other harmful practices. Some who advocate against physician-assisted suicide argue that there’s no way to definitively guarantee that it’s completely a patient’s choice to request medicine that would end his life–they worry that a doctor or family member could pressure a patient.

Real Life Example: Dr. Jack Kevorkian

Dr. Jack Kevorkian was known as an advocate for physician-assisted suicide, but was found guilty of second-degree murder for actually administering drugs to one patient himself, and served eight years in prison. Dr. Kevorkian, nicknamed Dr. Death, was believed to have assisted in over 130 suicides throughout his career. He used multiple methods, including setting up ways for patients to inject drugs into themselves, carbon monoxide poisoning, and his infamous “suicide machine,” which was built into the back of a van.

There were claims that Dr. Kevorkian crossed serious ethical lines with his practices. An analysis conducted by a team at the University of South Florida at Tampa of 69 assisted suicides supervised by Dr. Kevorkian claimed that 75 percent of his patients were not terminally ill.

While some defend Dr. Kevorkian as a pioneer, his methods remain controversial, and are often cited as an argument against physician-assisted suicide.

Conclusion

In addition to ethical and moral arguments, there are many other concerns that come to mind when considering physician-assisted suicide. For one, the drugs that are used for physician-assisted suicide are very expensive, and not necessarily easy to get. A patient looking to move forward with physician-assisted suicide must find a doctor willing to help, which can pose challenges, even in states that have legalized the practice. And while the publicity surrounding Brittany Maynard certainly garnered attention for the physician-assisted suicide movement, she died in 2014, and momentum for state laws may be waning. But one thing is certain: the debate over physician-assisted suicide is very far from over.

Anneliese Mahoney

Anneliese Mahoney is Managing Editor at Law Street and a Connecticut transplant to Washington D.C. She has a Bachelor’s degree in International Affairs from the George Washington University, and a passion for law, politics, and social issues. Contact Anneliese at amahoney@LawStreetMedia.com.

The post A Right to Die?: The Argument Over Physician-Assisted Suicide appeared first on Law Street.

A recent study found that there has been a rise in insurance claims for obesity-linked illnesses, such as high blood pressure, type 2 diabetes, and sleep apnea. While the results of this study–completed by the nonprofit Fair Health, a national clearinghouse for claims data–is nothing new, it is one of the first to use actual claims data. This is important because claims data shows treatments actually rendered, which can help illustrate the medical costs associated with high obesity rates. Beyond the results of this specific study, though, the fact is that obesity has become a major problem in the United States for people of all ages. Read on to learn more about the American obesity epidemic, what is being done to fight it, and the outlook going forward.

Obesity in America

Obesity is a somewhat mysterious term, so it first bears clarifying. According to the Centers for Disease Control (CDC), a person is obese when his or her Body Mass Index is above 30 percent. BMI is calculated by dividing a person’s height by weight. A BMI above 40 percent is considered extreme or severe obesity. While BMI is a useful tool to help assess health on a basic level, it does not directly measure the amount of body fat a person has.

In 2014, 36 percent of adults in the United States were obese. According to estimates from 2008, obesity cost the nation approximately $147 billion for medical costs. On a more individual level, people who are obese spend $1,429 more on medical costs per year than people of normal weight. Not only does obesity have negative physical effects, but it can also have negative mental effects and lead to depression.

From a demographic perspective, obesity tends to affect certain groups more than others. Non-Hispanic black Americans have the highest age-adjusted rate of obesity, at 48.1 percent. They are followed closely by Hispanics and non-Hispanic whites. The group with the lowest rate of obesity by far is Asian Americans, who have an average obesity rate of just 11.7 percent, which is well below the national average. Additionally, while obesity is on the rise in many demographic groups, middle-aged adults still have higher rates of obesity at 40.2 percent than both older adults and young adults.

Continuing along this same path, for men, there is not much of a correlation between income or education level and obesity. The one exception being that black and Mexican-American men with higher incomes are more likely to be obese than lower income men in the same groups. For women, a more widespread correlation exists–higher income and better-educated women of all races are less likely to be obese than women from the opposite income and education groupings. Geographically, there is a lower prevalence of obesity in states in the West and Northeast of the United States, with those in the Southeast having the highest rates of obesity. The following gives an overview of the facts behind the obesity epidemic:

Factors behind the Obesity Epidemic

So what causes obesity and what led to its rise? While many people may point to a simple lack of self-control to explain the prevalence of obesity, in many cases it is much more complicated than that. One of the major issues is genetics, namely different people absorb, store, and process food differently, which can make them more likely to gain weight.

In the same vein, medical problems that lead to inactivity, such as arthritis, can also contribute to obesity. Similarly, certain medications taken for completely unrelated conditions, such as depression, can cause weight gain. Age and pregnancy can lead to obesity as well, with people’s metabolisms generally slowing down as they get older and some women having difficulty losing weight after giving birth.

In addition to the physical factors, there are also several environmental factors at play. These include access to a place to exercise, knowledge of healthy cooking, and even being able to afford healthy food. Quitting smoking can affect someone’s weight as well, although its potential negative health effects are generally outweighed by its positives. Even a change in sleep patterns can lead to significant weight gain, as they can lead to hormonal changes that affect how food is digested.

Sometimes there are things completely beyond a person’s control, an example being meals at restaurants, which today are four times larger on average than they would have been back in the 1950s. Along with quantity and size, the cost of food also plays an important role in the rate of obesity. Since the 1970s the cost of food as a portion of income has gone down. Nor is all food is created equal, and while all food has gotten relatively cheaper, unhealthy foods tend to cost even less than healthy alternatives such as vegetables. Even if you set aside how healthy cheap food is, the sheer availability of food makes being obese more likely. While factors such as poor diet, family lifestyle, and inactivity can lead to obesity, they are clearly not the only causes.

Efforts to Reduce Obesity

While determining the causes of obesity has been a challenge, actually reducing it has been particularly difficult. However, that failure is not for a lack of trying. The CDC funds programs at the state and local level in an effort to reduce obesity by advocating for a combination of healthy eating habits and an active lifestyle. The CDC’s High Obesity Program provides grants to universities in areas with a high prevalence of obesity that involve a targeted approach to address the issue. Several states and cities have also implemented a range of policies to address health concerns, ranging from taxes on soda and sugary drinks to school nutrition programs.

There are many resources outside the government as well, in the form of non-governmental organizations that are focused on combatting obesity. A number of these organizations–like the Obesity Action Coalition or TOPS Club, inc–echo their government counterparts, preaching that a combination of education, healthy eating, and physical activity is necessary to combat the obesity epidemic.

The accompanying video looks at ways to fight obesity:

Nevertheless, for all the energy these organizations, government and non-government alike, are exerting their efforts seem to be in vain. In fact, despite major efforts in research, clinical care, and the development of various programs to counteract obesity, after more than 30 years there are few signs that suggest the fight against the epidemic is succeeding. While the overall trend has not reversed itself, some targeted efforts have managed to bring about success at the community level.

Going Forward

Obesity is a major factor in predictions that for the first time children growing up today may not outlive their parents. That is because obesity rates and body weights, in general, have skyrocketed over the last 40 to 50 years. From 1962 to 2006 the obesity rate among Americans grew from 13.4 percent to 35.1 percent. The average person today weighs 26 more pounds than he or she would have in the 1950s. A 2005 study found that if obesity trends continue on their current path, the life expectancy gains from the past several decades could flatline or even go in the opposite direction.

This troubling news concerning obesity comes at an especially bad time. With rates already increasing, government programs that target obesity prevention, in particular, could lose federal money. One of the many aspects of the Affordable Care Act involved the creation of a Prevention and Public Health Fund, which provided resources to important prevention programs–including some obesity-related grants–and makes up a sizable portion of the CDC’s total budget. With Congress debating whether or not to repeal the law, such funding could be cut. More than 300 public health organizations signed on to a letter to congressional leaders asking them not to get rid of the fund in January.

Investing in these public health interventions is becoming more important now than ever, as estimates indicate that the obesity epidemic will continue to be a problem in years to come. Two different studies predict that the obesity rate could continue to rise to 42 to 44 percent by 2030.

While this is an American epidemic, and America has the highest percentage of obese people, the United States is not the only place feeling the burden. Roughly 30 percent of the world’s population, or 2.1 billion people, are either overweight or obese. This trend affects both developed and developing countries alike, however, it affects them in different ways. In developed nations, men have higher rates of obesity whereas women in developing countries have higher rates.

Regardless of demographics, though, obesity rates are increasing all over the world much like they are in the United States. Also, like in the United States, preventive measures to reduce obesity have mostly failed. It has gotten to the point now that regions outside of North America and the West actually have the highest rates. Currently, the Middle East and North Africa have the highest adult obesity rates in the world.

Conclusion

While obesity tends to affect certain groups more than others, overall obesity rates have increased significantly in the past several decades. While obesity rates have leveled off among American youth in the past 10 years, they have continued to climb for adults and remain at record highs for both. Unfortunately, many of the attempts to reverse these trends have had little success so far. This is extremely troubling as obesity has gone from a problem to an epidemic.

The impact from rising obesity rates has the potential to be disastrous. Obesity already costs the United States alone hundreds of billions of dollars annually. For nations that cannot afford this level of care, obesity could lead many people to develop obesity-related diseases and complications without any way to treat or address them. While most efforts have failed to reverse the trend, some targeted interventions have been effective. Ultimately, the problem will need to be addressed at a larger scale for rates to decline.

Michael Sliwinski

Michael Sliwinski (@MoneyMike4289) is a 2011 graduate of Ohio University in Athens with a Bachelor’s in History, as well as a 2014 graduate of the University of Georgia with a Master’s in International Policy. In his free time he enjoys writing, reading, and outdoor activites, particularly basketball. Contact Michael at staff@LawStreetMedia.com.

The post The Obesity Epidemic: What’s Behind One of America’s Largest Health Problems? appeared first on Law Street.

Medical information is usually viewed as a private affair. But due to the proliferation of technologically advanced devices–heart monitors, X-ray devices, and even fitness trackers–the ability to gain access to a person’s sensitive health information may be easier than most realize. Unsecured devices could lead to disastrous consequences, as any alteration to a patient’s device could be a life or death situation. Medical device hacking may be the largest cybersecurity threat faced by Americans in the coming years. This gigantic security concern is quietly lurking in citizens’ insulin pumps and pacemakers.

Despite having federal and state guidelines to protect and secure individually identifiable health information, accessing a person’s most detailed medical information may be as simple as pressing a few buttons. New Food and Drug Administration (FDA) guidelines issued at the end of 2016 may be able to combat easy access to medical devices, but only with cooperation from device manufacturers. There are also no current plans for enforcement of these guidelines by the FDA, as they are non-binding recommendations. Read on to learn about the security concerns presented by medical devices.

What is a Medical Device?

A medical device, as defined by the FDA, is “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory” that is used “in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease.” Such devices are regulated by the FDA and may be utilized for animals as well as humans. Tongue depressors, bedpans, x-ray machines, and complex programmable pacemakers with microchip technology all fall under the broad definition of a medical device. Moreover, surgical lasers, wheelchairs, and even sutures and orthopedic pins are classified as medical devices. If the primary intended use of a product is achieved via a chemical reaction or metabolized by the body, then it will usually fall under the definition of a “drug.” The U.S. is the global leader in the medical device market, with a total market size of roughly $148 billion in 2016. The Department of Commerce determined that U.S. exports of medical devices in specific categories exceeded $44 billion in 2015. Research and development in this sector are also more than twice the average for all U.S. manufacturers.

Medical Privacy Laws

A person’s medical history is a deeply personal collection of information. Highly sensitive material ranging from mental health treatment and sexual history to genetic disorders and diseases can be contained in an individual’s medical file. Numerous laws have been passed in the U.S. on federal and state levels to ensure that Americans’ health information remains confidential and secure. The most comprehensive law ever passed in the field of medical privacy is the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The act required the Secretary of the Department of Health and Human Services to develop regulations to protect the privacy and security of certain medical information. Under HIPAA, the government established national standards to protect individuals’ medical records and give patients control over who can access personal health information. Essentially, without direct patient authorization, specific entities are limited on the uses and disclosures of individuals’ medical records.

“Paper files of medical records” Courtesy of Newtown grafitti : License: (CC BY 2.0)

In 2000, the Standards for Privacy of Individually Identifiable Health Information (the Privacy Rule) came into effect; the guidance comprehensively explains answers to questions about the privacy requirements of HIPAA. Generally, the Privacy Rule permits that incidental uses and disclosures are permissible only if they are a by-product of a reasonable or permissible disclosure. The rule requires covered entities to take reasonable steps to limit the use or disclosure of protected health information. It applies to health plans, health care clearing houses, and any health care provider who transmits health information in electronic form. Individually identifiable health information is information that relates to: an individual’s past, present, or future physical or mental health or condition, the provision of health care to the individual, or the past, present, or future payment for health care for the individual.

The Security Standards for the Protection of Electronic Protected Health Information (the Security Rule) also established national security standards for certain health information held or transferred in electronic form. The Security Rule particularly addressed technical and non-technical safeguards that covered entities must utilize to protect individuals’ electronic protected health information (e-PHI). Entities covered by the Security Rule must ensure the confidentiality and integrity of all e-PHI being received or transmitted, as well as protect against any reasonably anticipated threats to the security or integrity of such information. Under the intricacies of HIPAA’s Privacy Rule and Security Rule, the U.S. government has clearly gone to great lengths to protect citizens’ medical records from improper use or disclosure by entities without direct patient authorization. Certain medical devices utilized today may contain information regarding a person’s medical condition that is as detailed as their medical records–what ailments a person is being treated for, or what dosage of medicine a person takes daily. Therefore, protecting these devices from unwanted intrusion and hacking should be of the utmost importance to ensure patient health and privacy.

Medical Device Security and Privacy Concerns

The FDA has been warning hospitals and health providers for years that medical devices and hospitals are vulnerable to hackers. In early 2016, the Hollywood Presbyterian Medical Center in California fell victim to a ransomware attack, which infects a computer and then encrypts files until someone pays to have it unlocked. The attackers in California held patients’ medical data hostage until the ransom was paid, roughly $17,000 in bitcoin. Ransomware also hit other hospitals around the country.

One of the largest consumer concerns regarding medical devices is that individuals can do little to protect their devices themselves. It’s up to the manufacturers of a device’s hardware and software to employ proper security measures. Another issue plaguing medical devices is that most of the laws protecting medical privacy fall under the Health and Human Services’ umbrella; however, regulating medical devices falls in part under FDA jurisdiction. The disconnect explains how the interactions between medical device regulations and privacy laws lead to administrative issues. In a cybersecurity briefing, the U.S. government warned that pacemakers were easy targets for hackers.

Furthermore, in October 2016, Johnson & Johnson notified 114,000 diabetic patients that a hacker could potentially exploit one of its insulin pumps. The pump could be attacked by either disabling the device or altering the dosage of insulin. Some medical infusion pumps in hospitals are even connected wirelessly because it makes monitoring dosages easier. Patients in the hospital could potentially have their pumps controlled remotely by a hacker, which is relatively simple to do.

While the threat to medical devices has been common knowledge for the past few years, few people have attempted to rectify the glaring holes in the current system. Security researchers have managed to remotely control medical devices including pacemakers, insulin pumps, and defibrillators. Thus, it is quite possible that hackers may start setting their sights on specific medical devices, not just entire hospital systems. U.S. officials began investigating flaws in pacemakers in August 2016, when a batch ran out of battery three months earlier than anticipated. While that particular batch simply had a rare defect that caused them to fail, the months of investigation culminated in the FDA releasing 30 pages of guidance regarding medical devices’ security flaws.

New FDA Guidelines

The FDA first issued a guidance in October 2014 that contained recommendations for manufacturers to build medical devices with cybersecurity protections. These guidelines were expanded in December 2016; however, the recommendations to manufacturers were non-binding, making the document not legally enforceable and not a particularly strong stance on securing future medical devices. As part of the new recommendations issued, the FDA encourages manufacturers to swap information with each other and consistently deploy software patches and updates to fix any security vulnerabilities. Moreover, the agency has asked manufacturers to adhere to a checklist created by the National Institute of Standards and Technology. Early product development that focuses on protecting medical devices from hackers is of the utmost importance. The FDA also suggested that manufacturers join the Information Sharing and Analysis Organization to share details about detected security risks and attacks when necessary.

Conclusion

Researchers saw a rise in the occurrences of cyberattacks on a global scale in 2016. Technological advances in medical devices certainly encourage more effective health treatment, but the increasing reliance on vulnerable software potentially puts the health of citizens at risk. Thus, implementing a structured and comprehensive plan to manage cybersecurity risks is critical. While the new FDA guidelines are a respectable start to ensuring medical devices are free from cybersecurity threats, making the recommendations mandatory as opposed to voluntary may be the only way to keep individuals’ medical information safe from prying eyes. Many contend that while the recommendations could be more stringent, this is just the first step in a long road to addressing cybersecurity in the medical field. For now, the onus remains on the manufacturers to patch detected vulnerabilities in their devices and software and develop devices safe for consumers.

Nicole Zub

Nicole is a third-year law student at the University of Kentucky College of Law. She graduated in 2011 from Northeastern University with Bachelor’s in Environmental Science. When she isn’t imbibing copious amounts of caffeine, you can find her with her nose in a book or experimenting in the kitchen. Contact Nicole at Staff@LawStreetMedia.com.

The post Privacy Concerns: Can Your Medical Device Be Hacked? appeared first on Law Street.

Americans all have different relationships to food. I didn’t know that you could buy applesauce in a jar until I went to college. I was aware that you could get soup in a can but I had never experienced it personally. My mother and grandmother made these things from scratch. So there were no food labels indicating the nutritional value on any of these items, but following Michael Pollan’s advice to not eat anything that my grandmother would not have recognized as food, the nutritional value wasn’t something we worried about calculating with numbers. It just felt wholesome.

However, not everyone has the luxury of making food from scratch. Americans increasingly rely on processed foods to replace or supplement home-cooked meals. These foods are convenient and often a cheaper alternative. In some cases, they are the only option, since many Americans live in “food deserts.” A food desert is a location where grocery stores that carry fresh produce are more than a mile away and residents don’t have access to them via a car or public transportation. Neighborhoods like this tend to have grocery stores that only have processed food options. A lot of food deserts are in urban areas, but there are also some in rural communities as well, because if the nearest store where you can buy a tomato is five miles away and you lose or don’t have access to your car, you have a very long walk to purchase a tomato.

You can actually go to the U.S. Department of Agriculture website and take a look at food deserts around the country.

Since Americans are either being forced–through economic necessity or location–or choose to consume more processed foods, efforts have been made to make the labeling on these foods easier for consumers to understand. The strategy adopted by the White House, as part of Michelle Obama’s efforts to combat obesity, has been to modify our existing food labeling. But there may be other ways to label our food that better informs consumers and encourage them to make different choices.

Facts Up Front Food Labels

Our current food labeling method is called the “facts up front” system, which utilizes a black-and-white label on the back of the product, with some key facts also displayed on the front of the product. In the following video, Allison Aubrey of NPR explains some of the changes that were made to the facts up front system that will hopefully make it more user-friendly for consumers.

The two main changes to the labeling system, which are designed to promote healthier choices, are the modifications in serving size and the “added sugar” reference on the label. With the previous labeling system, it was not always clear to consumers that what they consider a “serving” and what a “serving” actually is for the purposes of calculating the calories are rarely the same thing. For example, a 24-ounce bottle of coke, which many adults would drink with their meal and think of as a “serving” because it was in one unit, might actually be 2.5 servings. So the number of calories listed was not the number calories in the bottle, which would be much higher than what people were actually consuming.

The other major modification designed to assist consumers is the “added sugar” valuation. Most people don’t realize that sugar is put into nearly all processed foods, even ones that aren’t sweet. Salad dressing, for example, often has sugar added to it. The added sugar value is designed to alert consumers to the hidden sugars in their foods, which are a huge driver for obesity and other health risks.

These changes to the food labels may, in fact, help consumers make better choices. A majority of Americans do look at food labels when they are deciding whether to purchase a food item, so making sure that they are better able to understand the number of calories and nutritional value of the food they are about to consume may help them avoid (at least most of the time) foods that are unwise to eat. If sales for a particular food decline because consumers are changing their behavior, that may even encourage manufacturers to alter the amount of sugar and fat they use to attract more health-conscious consumers.

But there is another way that we can label our food that might be even more beneficial to the consumer.

Traffic Light Labeling

This video explains some of the studies conducted that compare the facts up front food labeling system with an alternative option known as the “traffic light” system. As the name suggests, the traffic light labeling system uses red, green, and yellow/orange to indicate that a nutrient level is healthy or unhealthy. For example, a food that has low fat and low fiber would have a green circle that says low fat (which is a good thing) and a red circle that says low fiber (which would be bad). Glancing at it quickly, if you saw a string of red circles on the label you would know that this food should be eaten in moderation or avoided completely. In contrast, a food with a lot of green circles is something that you can eat more frequently.

Here is the good news: both kinds of food labels will be helpful if you are trying to decide between two different kinds of products. If your choice is between a bag of Fritos and a bag of sourdough pretzels then either the facts up front type of labeling or the traffic light labeling is going to help you know which choice is healthier. However, when you are looking at a product by itself and trying to decide if it is a good choice the traffic light system is much better at helping you make an informed decision.

The traffic light system may be of more use to people as they actually shop than facts up front food labels. It depends on how people make their purchasing decisions. If consumers are going to the store and holding two types of bread in front of them to try to figure out which one is healthier, then the facts up front label is just fine. But if they are reaching for a salad dressing on its own, not comparison shopping, a facts up front label may not alert them to the fact that it is a bad choice, whereas a traffic light label with a red warning circle that says “high sugar” may be more effective at steering consumers away from that product. In fact, there is evidence to suggest that a prevalence of red labels will lead to a reduction in purchases, which is why food manufacturers in Europe are resistant to the implementation of the traffic light label system. Its use in the U.K. is voluntary for manufacturers.

The facts up front system actually leads consumers to make the wrong estimates. It encourages people to think there are more good nutrients in a product than there actually are and fewer bad nutrients. Overall, the traffic light label was easier for consumers to understand, since it can be confusing to think about the recommended daily value of a nutrient and to make the necessary calculation. But a red warning on a package is immediately perceived as “don’t eat this!”

It’s unclear how the traffic light system might affect consumers and manufacturers but the system has been used in the U.K. to try to combat label confusion. Ideally, any labeling system that we use should tell consumers as clearly as possible which products are healthy and/or exactly how unhealthy for you a particular junk food is. And hopefully, that would reduce the amount of particularly unhealthy junk food people consume. But a good labeling system will also influence manufacturer behavior and the traffic light system may be even better at that than a facts up front label. Manufacturers may not want to put a series of red circles on their products, increasing the perception that they are unhealthy, so they might modify their product to get the label reduced from red to yellow.

Conclusion

In a perfect environment, the food labeling system could be complicated and consumers would have the time needed to analyze each product for its relative health merits. As a result, they would wisely avoid the foods they should. But we do not live in the perfect environment. Food shopping is something that many consumers engage in almost as muscle memory, relying heavily on brand loyalty and a general feeling that a product is wholesome. Even when consumers look at food labels, which most of them do, they may not understand them. They know that a bag of potato chips is bad, especially when comparing it to a rice cake, but they may not understand just how bad.

A traffic light labeling system should be explored to figure out if it does a better job accomplishing the goals of a labeling system, which are to inform consumers, modify their behavior where possible, and encourage manufacturers to make their products healthier in an attempt to capture market share. We put warning labels on dangerous products like cigarettes, but our food labeling system does not treat sugar with the same level of danger. Given the health crisis that overconsumption of these products has helped to create, perhaps we should.

Mary Kate Leahy

Mary Kate Leahy (@marykate_leahy) has a J.D. from William and Mary and a Bachelor’s in Political Science from Manhattanville College. She is also a proud graduate of Woodlands Academy of the Sacred Heart. She enjoys spending her time with her kuvasz, Finn, and tackling a never-ending list of projects. Contact Mary Kate at staff@LawStreetMedia.com

The post Food Labels: Is the ‘Facts up Front’ System Good for Consumers? appeared first on Law Street.

About a decade ago, public health researchers started advocating for implementation of a soda tax to combat consumption of sugary drinks. Soda intake has long been linked to the exacerbation of a series of potentially avoidable health problems including: obesity, diabetes, and tooth decay. After the recent election, four more U.S. cities voted to adopt a soda tax, spreading this new “sin tax” to more areas across the country. With more than one-third of American adults currently classified as obese, soda taxes could become a go-to method for combatting obesity, while simultaneously generating revenue for state budgets to fund local programs.

What are Sin Taxes?

Sin taxes are state-sponsored taxes that are added to specific products that are generally seen as vices, such as gambling, alcohol, and tobacco. In essence, by utilizing financial means, the government attempts to discourage individuals from engaging in a specific activity or using specific products without actually making those products or services illegal. Sin taxes are often compared to Pigovian taxes, which are taxes that generate negative externalities. In tax policy, a Pigovian tax is a fee assessed against private individuals or businesses for engaging in a specific activity; a negative externality occurs when an economic actor does not fully internalize the cost of activity. A simple example of a Pigovian tax is a pollution-related tax.

Currently, sin taxes are employed in a variety of sectors. Typically, they are added to liquor, tobacco, gambling, and other non-luxury items. There tends to be a decent amount of public support for sin taxes, as they are indirect and only affect those who use the specific products. Sin taxes are also extremely popular when trying to close large state budget gaps. Employing sin taxes for soda and sugar-sweetened beverages can help generate revenue and encourage public health initiatives. One research economist from the Research Triangle Institute has modeling data that suggests a six-cent tax on a twelve-ounce bottle of soda would lead consumers to drink 5,800 fewer calories from sugary drinks per year.

Using Soda Taxes to Combat Obesity

In 2014, voters in Berkeley, California passed the nation’s first soda tax, which went into effect in 2015. Additionally, in 2014, Mexico passed its own soda tax. After one year, sales of soda in Mexico fell as much as 12 percent, while bottled water purchases rose four percent. The researchers also found that while decline was seen across all socioeconomic groups, it was greatest among those who were low-income, with consumption falling 17 percent.

In the U.S., Berkeley’s tax was largely successful; research showed that soda consumption dropped in the city a staggering 20 percent. Philadelphia was the next city to follow suit, passing a soda tax earlier this year–thus becoming the first major city in the U.S. to do so. The tax, which is expected to generate $91 million annually, will be spent on pre-kindergarten programs in the city, creating community schools, improving parks and recreation centers, and libraries.

The beverage industry has fought extensively to keep soda taxes from passing elsewhere in the country. Advocates from the American Beverage Association, which represents all major soda brands, responded to the Philadelphia policy by arguing that the tax was regressive and unfairly singled out “low” and “no-calorie” beverages. In an effort to combat the tax, companies in the roughly $100 billion industry have focused their efforts on reformulating existing drinks to make them more healthy for consumers. However, even “diet” sodas are experiencing a sharp decline in sales, particularly because of increased suspicion regarding artificial sweeteners.

Soda Taxes Passed in November 2016

The World Health Organization recently recommended that governments impose soda taxes in order to combat a variety of diet-related diseases exacerbated by high soda consumption. Soda taxes were on the ballot in early November of this year in  three California cities–San Francisco, Albany, and Oakland–as well as Boulder, Colorado. The soda taxes passed in all four cities with fairly large margins of support, much to the dismay of the beverage industry. The American Beverage Association spent upwards of $9.5 million on an ad campaign opposing the measures entitled “Don’t Tax Our Groceries.”

The amount of tax in each city, however, varies. In San Francisco, Albany, and Oakland, the tax is one penny per ounce of soda. In Boulder, the tax is two pennies per ounce of soda, and the soda tax that passed earlier this year in Philadelphia was set at 1.5 cents an ounce. The disparities in the amount of tax per ounce are likely to continue as more jurisdictions follow suit.

These laws are also coming into effect at a time when soda consumption is down among Americans. In a 2014 Gallup poll, nearly two-thirds (63 percent) of Americans reported avoiding soda in their diet; in 2002 that number was only 41 percent. Moreover, over the last 20 years, sales of full-calorie soda have dropped by more than 25 percent. “Big Soda” is experiencing a substantial and sustained decline, while bottled water remains on track to overtake soda as the largest beverage category. The changing soda consumption patterns are noticeable in schools, where cafeterias and vending machines have stopped carrying regular sodas, and in many workplaces and government offices that have similarly limited sales. Soda, it seems, has now become the new tobacco: an unhealthy product that should be limited, if not outright banned, and taxed significantly.

“Soda” Image Courtesy of Rex Sorgatz : License (CC BY 2.0)

Issues with Soda Taxes

Not everyone is a fan of soda taxes. While the American Health Association has touted the win as a huge victory, many argue that the taxes affect low-income populations the most. Sin taxes arguably have a disproportionate effect on poor and less educated communities. Since sin taxes are typically regressive in nature, the less money a person makes, the larger percentage of his or her income the taxes take. Essentially, if comparing two “pack-a-day” smokers–one lower-income citizen and one high-income citizen–one can see that the two are spending the same amount of money on cigarettes and taxes each year. The taxes on those same cigarettes, however, are taking up much more of the lower-income citizen’s paycheck.

Additionally, the beverage industry contends that more taxes are not ideal when pursuing public health initiatives. Susan Neely, CEO of the American Beverage Association, stated that consumers don’t want these taxes. She also added that the industry is committed to reducing the amount of calories and sugar in these beverages and combating diet-related issues in a variety of manners. This includes partnering with Alliance for a Healthier Generation in order to try to change behaviors of people who may be receiving far too many calories from beverages. Other strategies include an ad campaign called “Balance What You Eat, Drink & Do” that encourages people to think more readily about the calories they are consuming. The beverage industry is also working with retailers to put more low-calorie choices at eye-level, so consumers will be more likely to pick those choices.

Conclusion

Whether you see soda taxes as a necessary movement or not, the U.S. is certainly grappling with an obesity epidemic. Educating the public about calorie and sugar consumption is critical to combating this public health crisis, in addition to making a myriad of low-calorie, no-calorie, and low-sugar choices more readily available in a variety of communities across the country. Sometimes, the easiest way to help people make changes is by utilizing financial means, and soda taxes may be an effective way to incentivize healthier behaviors. The law of demand works in practice, not just theory: when prices go up, people buy less.

For now, soda taxes seem to be here to stay, as they find their way into more cities across the country. “Big Soda” does appear to be in serious decline, and unless the industry can find a way to keep up with the public’s changing preferences, the downward trend may continue into the future. While the amount of a given tax will continue to vary depending on the jurisdiction, the long-term effects of taxes may be even more effective if taxes are increased and become more widespread. The amount of money generated from soda taxes has the potential to be large, and using the revenue to fund desperately-needed or underfunded programs, like Philadelphia intends to do, may be an ideal solution.

Nicole Zub

Nicole is a third-year law student at the University of Kentucky College of Law. She graduated in 2011 from Northeastern University with Bachelor’s in Environmental Science. When she isn’t imbibing copious amounts of caffeine, you can find her with her nose in a book or experimenting in the kitchen. Contact Nicole at Staff@LawStreetMedia.com.

The post Are Soda Taxes the New Sin Tax to Combat Obesity? appeared first on Law Street.

Fall has started and along with it comes several long-anticipated events like football season, changing weather, and Thanksgiving. But there’s something else associated with this time of year that no one is looking forward to–flu season. Despite being seemingly innocuous, the flu is one of the greatest scourges in the history of mankind and is still a potent killer. It has also given rise to a billion dollar vaccine industry bent on stopping it.

Read on to find out more about the history of the flu, the flu vaccine, and the business that it has spawned.

The History of the Flu

Human beings have been victims of the flu or influenza for as many as 6,000 years. While no precise date is readily available, it is believed that once humans started to domesticate animals they also started acquiring the flu from them, as many animal species carry flu strains. The name “influenza” originated in eighteenth century Italy where its outbreak was blamed on poor air quality.

Although the existence of the flu has been known for centuries, it is only within the last hundred years that it has been clearly identified. In 1918, a veterinarian actually discovered that a disease found in pigs was similar to one found in humans. In 1928 other researchers proved, through experiments on pigs as well, that the mysterious killer influenza was actually caused by a virus. Still, it was not until 1933 that scientists finally identified the specific virus that caused influenza.

The video below gives an overview of the history of the flu:

Types of Flu

Although the flu is commonly referred to as a monolithic thing, it is actually a combination of related viruses. There are two main types of flu virus: H-types and N-types. These letters correspond with genetic markers for two glycoproteins, hemagglutinin (H) and neuraminidase (N), which are the antigens the host of the virus develops an immunity to. Along with these are three major strains: A, B, and C. The A strain is the one that causes major outbreaks that lead to widespread deaths. There is also a D strain, which primarily infects cattle and is not known to harm humans.

The reason why the flu is so deadly is because of its genetic makeup. Since the genetic code of the influenza virus is made of RNA and not DNA, the viruses replicate very quickly and are more prone to mutations. Thus, viruses can change numerous times before a human, for example, can even build up an immunity to the original virus. This is done through two processes. The first is called antigenic drift, and it occurs when mutations change the virus over time eventually making it so immune systems can no longer recognize it. The second is called antigenetic shift, which involves a dramatic change in the composition of the virus, like combining with an animal subtype, which is often the process that leads to pandemics.

The flu generally hits elderly people, those with asthma, pregnant women, and children the hardest. For anyone who has had the flu before, the symptoms are familiar: fever, chills, coughing, sore throat, achiness, headaches, fatigue, vomiting, and diarrhea. The virus is usually transmitted through the air via respiratory droplets, but can also move through physical contact. Some people who get the flu are asymptomatic meaning, while they have the flu, they do not experience the typical symptoms, yet can still get others sick. The flu also triggers several related complications including, pneumonia and sinus and ear infections. It can worsen existing medical conditions such as chronic pulmonary diseases, or cause heart inflammation.

Deadliest Strains

While the flu is perceived as commonplace and not particularly dangerous today, it is still one of the deadliest viruses in human history. During the 16th and 18th centuries, there were a number of massive and deadly outbreaks. Since 1900 there have been four major flu pandemics. The Asian flu lasted from 1957-1958 and killed one to four million people. The Hong Kong flu circulated from 1967-1968 and killed one million people. The third was the Swine flu, or H1N1, which broke out in 2009. The greatest outbreak by far, though, was the Spanish flu that broke out in 1918, right on the heels of World War I. The epidemic killed as many as 50 million people worldwide, more than the war itself.

The accompanying video looks at the deadly 1918 pandemic:

Aside from these major outbreaks, the flu remains a virulent threat. Although it is hard to pinpoint exactly how many people die each year from the flu, the CDC estimates that more than 55,000 people died from influenza and pneumonia in 2015. But that is an estimate and the numbers often vary. An earlier estimate for the flu alone, by the CDC, put the yearly average somewhere between 23,000 and 33,000. The discrepancy is caused by outliers in yearly totals and different strains that respond to the flu vaccine differently.

The Flu Vaccine

If someone catches the flu there is little that can be done for them. Infected people can take over-the-counter remedies and in certain cases can even be prescribed antiviral medications, although many strains of the virus have grown immune to such treatments. Generally, the only way to consistently ward off the flu is by trying to prevent it in the first place with a flu vaccine.

Developing the flu shot has been a long process and one that is still in progress. The first step was on the heels of two important discoveries–scientists managed to grow the flu virus in eggs for the first time in 1931 and were able to isolate the virus itself in 1933. While Louis Pasteur was the first to actually attempt to make a flu vaccine, it was a Soviet researcher in 1936 who developed the first prototype. While this vaccine was used in the former USSR for 50 more years, it had the drawback of using a live strain of the flu.

However, scientists quickly overcame this by finding a new source of the dead, “inactivated” virus to use in vaccines instead. In 1940 a new problem arose as a second strain of the flu was discovered, leading to the bivalent vaccine in 1942, which targeted one A and B strain. The next major step in the development process occurred in 2007 when the source of the virus for vaccines moved from hen eggs to cell cultures, making reproduction and sterilization easier.

On top of the bivalent vaccine, trivalent and quadrivalent vaccines were developed, containing multiple A and B strains. Vaccines typically change each year because the virus itself mutates from season to season, often making old vaccines ineffective. Strains of the virus are actually monitored all year long, with the Northern Hemisphere monitoring what is circulating in the South and vice versa. When the prevailing strains are identified, a vaccine is tailored to them. Additional vaccines with other strains can also be created in emergencies. This system came about as a result of a WHO recommendation in 1973. Since 1999 WHO has issued two sets of vaccine recommendations each year, one for the Northern Hemisphere in February and one for the Southern Hemisphere in September.

The video below explains how the flu shot works:

The Business Side

Developing a flu vaccine and then redeveloping it each year to fight the different strains of the flu virus has been a long and arduous task. An estimated 171 to 179 million doses of the vaccine were created for the United States in 2015 alone. That amounts to a $1.61 billion industry in the United States and roughly a $4 billion one worldwide.

With an industry this large, it is fair to ask whether the pursuit of profits has overwhelmed the pursuit of health. Roughly 44 percent of Americans received the vaccine in 2015 and the shot is considered the best way to fight the flu. But because of the difficulty of matching the vaccine to the dominant strains, it is only 50 to 60 percent effective. Furthermore, there are different types of vaccines sold depending on how many strains the shot will protect against.

Conclusion

Each year, millions of people are infected with the flu and thousands or even tens of thousands die. It took centuries to identify the virus and much of what we know about the virus was discovered in the last hundred years. Given the nature of the virus and the rate at which it mutates, vaccines often have a hard time keeping up. The international community has developed a sophisticated monitoring system to identify and track new strains of the virus to ensure that vaccines are as effective as possible. But because of the frequent changes, new vaccines must be developed each year, prompting the development of a substantial industry.

Resources

CDC: Deaths and Mortality

CDC: Seasonal Influenza, More Information

WHO: Influenza: Surveillance and Monitoring

NPR: How Many People Die From Flu Each Year? Depends How You Slice The Data

Medical Ecology: Influenza

CNN: Getting a Flu Shot? It may be Better to Wait

The History of Vaccines: Influenza

Medscape: The Evolving History of Influenza Viruses and Influenza Vaccines

CNBC: The $1.6 billion Business of the Flu

Flucelvax: History of the Flu Virus and Influenza Vaccination

Michael Sliwinski

Michael Sliwinski (@MoneyMike4289) is a 2011 graduate of Ohio University in Athens with a Bachelor’s in History, as well as a 2014 graduate of the University of Georgia with a Master’s in International Policy. In his free time he enjoys writing, reading, and outdoor activites, particularly basketball. Contact Michael at staff@LawStreetMedia.com.

The post Feeling Okay? The History of the Flu and Flu Vaccines appeared first on Law Street.

There are many ways to explore and analyze public health. Oftentimes, scientists use a person’s DNA as a method to unlock underlying causes of diseases. However, the best health predictor may not be lying in genetic code, but in one’s ZIP code.

The connection between ZIP codes and human health has long been of interest to researchers desiring to find the best treatment and prevention strategies for some of our deadliest diseases. Land use laws and zoning regulations have transformed some communities and neighborhoods into dumping grounds for industrial plants or undesirable toxic waste. The long-lasting effects of housing segregation and envornmental racism have also had a disparate impact on minorities, reflected in subpar living conditions. Now, some scientists are attempting to explore the importance of ZIP codes as they relate to disease prevention. 

“ZNA”

Dr. Francis Collins, Director of the National Institute of Health, recently noted that our ZIP code at birth is our “ZNA,” “the blueprint for our behavioral and psychosocial make-up.” The air we breathe and the water we drink has just as much of an impact on human health as our genetic code, if not more so. While genetics can inform and shape our health, so too do three other factors: social determinants, community social environments, and physical environments.

Social determinants of health are aspects like income and inequality. Community social environments include crime rates or the particular affluence of a neighborhood. Physical environment means the walkability of a neighborhood or if industrial plants are located near one’s housing. All of these factors overlap each other, influencing one’s health in both direct and indirect manners–some of which may be invisible. Research has indicated that these determinants and influences may have a more powerful impact on health than individual biological differences do.

Housing Patterns and Health Consequences

There are a variety of ways that living in a particular community can affect one’s health. For example, the physical condition of a home can have a profound impact on residents’ health. Building codes in one neighborhood may be more dangerous than in a more affluent one. Disparities in health outcomes across communities are often demonstrated by lead poisoning and asthma. Older homes may have mold or cockroaches, which could also exacerbate underlying health issues.

Land use characteristics, such as residential density, employment opportunities, and walking trails or open spaces, can promote activity and foster a healthy living environment. Zoning also plays a critical role in determining public health. As noted by the Center for Disease Control (CDC), zoning can be instrumental in promoting healthy eating habits and physical activity. Zoning can be utilized to reduce the density of fast food restaurants in a community, incentivize farming in urban areas, and even restrict fast food spots from developing within a specified distance of schools. Additionally, requiring sidewalks, promoting parks and recreation, and widening access to public transportation all play vital roles in increasing physical activity through zoning measures.

Health Mapping

The growth of geographic information science (GIS) and the availability of electronic health records (EHR) now allow for scientists to analyze socioeconomic and environmental factors better than ever before. Health geography has long been an area of medical research that uses geographic techniques to study the impacts of one’s surroundings on their health.

One of the earliest studies employing maps to study dieases was in London, by Dr. John Snow, regarded as one of the fathers of epidemiology. To study the location of cholera outbreaks and deaths in the 1850’s, Dr. Snow used hand-drawn maps showing the location of cholera deaths and then superimposed those with maps of the public water supplies. This allowed him to uncover a cluster of deaths near a particular water pump. His research eventually became an area of study known as disease diffusion mapping, which refers to the spread of disease from a central source, spreading according to environmental patterns and conditions.

GIS utilizes digital software and data sets, along with spatial data, to map multiple aspects of a community. By using and manipulating this geospatial data, researchers are able to thoroughly study the relationship between health, illness, and place. Additionally, EHR can allow scientists to link collected data about the environment with patient medical records. The combination of these powerful tools lends itself well to a broader picture of the interrelationship between ZIP codes, housing conditions and patterns, and human health.

“Not In My Backyard” and Environmental Racism

When development is proposed for a particular community, the most powerful voices can be heard helping to shape the course of the project. “Not In My Backyard” or NIMBY, is a characterization of residents who concede that while a particular project may need to be completed, it should be further away from their community. Projects that could be opposed are practically limitless: any type of housing development, homeless shelters, adult entertainment clubs, and any type of hazardous plants or waste repositories, to simply name a few.

The people who have the power to shape zoning and land use laws in an area tend to be the wealthiest citizens, and usually are white. Thus, more dangerous or undesirable projects are pushed into communities without the bargaining power required to stop them. This type of thinking inevitability promotes environmental racism, utilizing segregated, low-income, minority neighborhoods as the dumping ground for toxic byproducts. This discrimination in land use and zoning policy, particularly fueled by “NIMBY” mindsets, is resulting in increasing health disparities.

What Has Research Uncovered?

Studies have documented that while genetics are an important predictor of health, these other factors have a more powerful impact on health than biology. Income and educational attainment are at least as strongly associated with hypoglycemia in patients with diabetes as particular clinical risk factors. Moreover, those living in areas with less resources for physical activity or healthy food choices have a much higher chance of being diagnosed with type 2 diabetes.

There are dramatic differences in life expectancy rates depending on where one was born in the U.S. In places in the Northeast, populations have a higher life expectancy, while places in the South have the lowest life expectancy rates. These inequalities in mortality rates are intimately tied to housing instability and crowded or subpar housing conditions. In a study of 12,000 New York City households, asthma was more prevalent in Puerto Rican households, immediately followed by other Latino and black households. Moreover, rates of asthma are twice as high in children under the age of 13 in the South Bronx, North/Central Brooklyn, and East/Central Harlem–the three neighborhoods with the highest rates of poverty, morbidity, and mortality in the city.

Additionally, another study utilizing four nationally representative studies noted that worsening economic standing was associated with poor healthcare access, a lack of health insurance, and far higher hospitalization rates. Research has also found that estimated cancer risks associated with ambient air toxics were highest in metropolitan tracts that were highly segregated, and that residential segregation is associated with elevated risks of adult and infant mortality.

The American Housing Survey (AHS) is sponsored by the Department of Housing and Urban Development (HUD) and is considered to be the most comprehensive national housing survey in the U.S. It takes a large representative longitudinal sample of houses on both the state and national level. The most recent survey was completed in 2013, and the results are telling. Data shows that 9.2 percent of non-Latino black homes and 7.2 percent of Latino homes have moderate or severe physical problems, compared with only 3.2 percent of non-Latino White homes.  These numbers are staggering, illustrating a serious issue across the country.

Conclusion

Health-related disparities due to housing can be eliminated if proper measures are taken. For example, childhood blood lead levels have improved by 90 percent since the 1970’s, after effective measures were implemented. Housing conditions continue to be among the greatest determinants of human health, as a large list of highly preventable diseases are intimately tied to poor housing. 

National research and multiple academic reports have continued to affirm that housing access and conditions are among the largest determinants of health, both physical and environmental. There are still numerous roadblocks preventing this issue from being rectified. Significant challenges remain when it comes to legislating and securing meaningful public policies that prevent exposure to physical and environmental hazards, whether it be minimizing indoor pollutants or building high-quality low-income housing. Pervasive housing segregation remains embedded in neighborhoods and cities across the country, adding another layer of difficulty. With the proper focus, combating some of America’s most problematic diseases could be more effective than any other previous attempts.

Resources

Primary

CDC: Zoning to Encourage Healthy Eating

CDC: GIS and Public Health at CDC

Additional

Newsweek: Why Zip Code May Influence Health More Than Genetic Code

Public Health Law Center: Land Use/Zoning

CityLimits.org: Building Justice: Genetic Code, ZIP Code and Housing Code All Affect Health and Equality

CityLimits.org: Builiding Justice: NYC’s Sacrifice Zones and the Environmental Legacy of Racial Injustice

EnvironmentalChemistry.com: Environmental Justice and the NIMBY Principle

GIS Lounge: Overview of Public Health and GIS

Nicole Zub

Nicole is a third-year law student at the University of Kentucky College of Law. She graduated in 2011 from Northeastern University with Bachelor’s in Environmental Science. When she isn’t imbibing copious amounts of caffeine, you can find her with her nose in a book or experimenting in the kitchen. Contact Nicole at Staff@LawStreetMedia.com.

The post ZNA: Could your ZIP Code at Birth Predict Your Health? appeared first on Law Street.

For decades, Americans have been grappling with what it means to eat a healthy, well-balanced diet as more information regarding our industrial food system comes to light. Now, it seems the Food and Drug Administration (FDA) has jumped on the bandwagon, revisiting food labels and the definition of “healthy” in an effort to redefine an outdated version.

Public health concerns over misleading food labels and nutrient content claims have increased rapidly, particularly because of the growing obesity epidemic in America. While it is sure to be a lengthy and laborious process, the FDA is seeking public comments to help shape the new definition of “healthy.” The original definition of “healthy” was created decades ago in the mid-1990’s. As nutrition science has evolved, food labels and FDA-regulated definitions of nutrient content claims have been exceedingly slow to catch up. 

Food Labels and Nutrient Content Claims

The FDA is responsible for ensuring that all food sold in the U.S. is safe and properly labeled, whether food is produced domestically or in foreign countries. The federal laws governing food products are primarily the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act. The FD&C Act is a set of laws passed by Congress in 1938 to give the FDA oversight in ensuring the safety of food, drugs, and cosmetics. These laws regulate many aspects of the food industry, including food additives, food coloring, and even bottled water.

The Fair Packaging and Labeling Act applies to labels on most consumer products. Passed under President Lyndon B. Johnson in 1966, it requires a label to state: (1) the identity of the product; (2) name and place of business of the manufacturer, packer, or distributor; and (3) the net quantity of contents. The Act applies to products considered “consumer commodities” to prevent unfair or deceptive packaging and labeling.

The Nutrition Labeling and Education Act (NLEA), however, amended the FD&C Act and gave the FDA explicit authority to require food labeling on most food packages and nutrients listed on the nutrition label. The NLEA was passed in 1990 by President George H. W. Bush. Moreover, the NLEA requires that all nutrient content claims, like “low fat” or “high fiber,” comply with the FDA’s regulations. The NLEA does not apply to food served or sold in restaurants, nor does it apply to meat or poultry products, which are regulated by the United States Department of Agriculture. The FDA  proposed a variety of new amendments and regulations, with a few goals in mind: clearing up any sort of confusion surrounding nutrition and food labels, assisting consumers in choosing healthier products, and finally, giving food companies an incentive to improve nutritional qualities of their products.

Nutrient content claims can be found plastered all over food products and packages. Under the NLEA, the FDA regulates the definitions of  “free,” “low,” “light,” “reduced,” “less,” “high,” and many more. In developing the criteria for each of the claims, the FDA looked to dietary recommendations for each nutrient, analytical methods, distribution and abundance of particular nutrients in the food supply, and other considerations.

“Healthy” Food

The push to change the FDA’s definition of “healthy” came originally from the makers of Kind bars, which are granola bars containing many fruits and nuts. The product is currently marketed as “healthy and tasty.” The problem, however, is that the amount of fat contained in the bars is far too high to comply with the FDA’s low-fat restrictions on healthy food. In May of 2016, the company challenged the status quo when the FDA complained that the label “healthy” on Kind bars was improper based on the current definition.

“Kind Snack Bars” Image Courtesy of Mike Mozart : License (CC BY 2.0)

Currently, if a food product is to be labeled “healthy,” the product must be very low in fat according to the regulations. Essentially, it is a nutrient content claim, meaning the term can only be used on a product if it has certain nutritional qualities based on attributes like levels of fat and sodium. While the rules themselves are highly complex, it boils down to the fact that a snack food, for example, can have no more than three grams of fat per serving to be considered “healthy.” It also must contain at least ten percent of the recommended daily value for vitamin A, vitamin C, calcium, iron, protein, or fiber per RACC (Reference Amounts Customarily Consumed). The definition differs for individual foods, seafood/game meat, and a meal or main dish.

Thus, under the current definition, nuts–which have long been known to be a high-fat food–cannot qualify as “healthy” under the current FDA regulations. While nuts are high-calorie, they are full of healthy fats that are known to be good for preventing cardiovascular disease, maintaining mental health, and are now seen as an ideal source of protein.

The term “healthy” was originally defined in 1994, at the height of the fat-free craze. Americans started replacing high-fat foods with more processed foods that were full of refined sugar, but still touted as healthy because they were “low-fat.” It was difficult to navigate a grocery store aisle without seeing “low-fat” labels plastered proudly on a variety of products, even ones that a consumer would not even think to have a high-fat content. We now know that consuming massive quantities of other food products with additives, like sugar, has far more negative consequences than eating plant-based food sources teeming with healthy fats.

The Future of “Healthy

Critics of the current definition of “healthy” have valid points. Under the current regulations, Frosted Flakes may be labeled “healthy” as the product is low-fat and fortified with vitamins, which is counterintuitive to what Americans know to be healthy food choices. While the FDA is determining how best to redefine “healthy,” it has stated it will exercise discretion in how it enforces the current rules. Thus, the agency will not be taking action against food manufacturers, like Kind, who produce foods that don’t meet the exact definition, but are still low in total fat and contain at least ten percent of the recommended vitamin D and potassium. The FDA issued guidance in September to reflect its newfound discretion, as prior public participation was not deemed feasible or appropriate.

Dietary guidelines have been more quickly catching up to changing nutritional science. Earlier this year, the dietary guidelines for 2015-2020 and the Nutrition Facts label were updated to recommend that people eat food rich in healthful fats. Over the next few years, nutrition labels will be updated to more accurately and clearly reflect a serving size, as well as how much added sugar is in a particular product. After decades of nutrition labels remaining mostly the same, this is a significant step in addressing the obesity epidemic in the U.S., particularly since many citizens rely on nutrition labels to provide them with reliable information. A governmental study showed that 77 percent of American adults say they read labels on food packaging when they shop.

When imagining how the new definition of “healthy” could unfold, it is likely there will be a focus on sugar. Current evidence demonstrates a link between excessive sugar consumption and obesity. Additionally, the new definition will likely redefine fat intake, particularly encouraging responsible consumption of healthy fats from plants and omega-3 sources, like fish.

Conclusion

These proposed changes clearly show the FDA is finally attempting to follow significant nutrition science breakthroughs. Ideally, people would not need food labels to tell them how to eat more healthfully and would simply make smarter food choices, like limiting processed foods and eating loads of fruits and vegetables. Famed nutrition scientist Marion Nestle argues against food labels, stating that companies utilize them to make misleading claims about their products.

Currently, many Americans still rely heavily on food labels to provide them with information about how to eat more healthfully. For now, nutrition labels and dietary guidelines are here to stay, particularly as this country attempts to combat a widespread obesity epidemic. Moreover, “healthy” isn’t the only label that may receive a significant overhaul; the FDA is currently reviewing giving “natural“a legal definition after receiving roughly 7,600 comments on the term.

The public has the ability to comment on the FDA’s website right now to help shape the new definition of “healthy” for the future. The changes may not be implemented for some time, but having a concrete voice in the FDA’s future rules and definitions is an important thing to consider. The comment period started on September 28, and will remain open for the time being. You may submit electronic comments and information to the Regulations.gov website or mail in written comments to the address listed on the FDA’s website.

Resources

Primary

FDA: Food Labeling Guide

FDA: Nutritional Labeling and Education Act (NLEA) Requirements (8/94 – 2/95)

FDA: “Healthy” on Food Labeling

FDA: Guidance for Industry: Use of the Term “Healthy” in the Labeling of Human Food Products

NIH: History of Nutrition Labeling

NIH: FDA Regulatory Requirements for Nutrient Content Claims

Additional

NPR: Why The FDA is Re-Evaluating the Nutty Definition of ‘Healthy’ Food

Wall Street Journal: FDA Takes Step Toward New ‘Healthy’ Labeling

CNN: Your Food Labels are Getting a Makeover, FDA Announces

NPR: FDA Is Redefining the Term ‘Healthy’ on Food Labels

Nicole Zub

Nicole is a third-year law student at the University of Kentucky College of Law. She graduated in 2011 from Northeastern University with Bachelor’s in Environmental Science. When she isn’t imbibing copious amounts of caffeine, you can find her with her nose in a book or experimenting in the kitchen. Contact Nicole at Staff@LawStreetMedia.com.

The post “Healthy” Food: FDA to Redefine the Term on Food Labels appeared first on Law Street.

When introducing a new drug into the consumer marketplace, companies must undergo a rigorous testing and approval process from the Food and Drug Administration (FDA). After a company obtains promising lab results, applications are then submitted to the FDA to implement clinical trials. Clinical trials can last for years before a new drug application (NDA) is submitted to the FDA for approval. To speed up this lengthy process, an initiative was passed in 2007 by Congress under the Food and Drug Administration Amendments Act (FDAA) that contained a special section for priority review vouchers. Drugs for specific tropical diseases and rare pediatric disorders are eligible for such a voucher.

Priority review vouchers allow a company to fast-track government review for a particular drug. These “golden tickets” can be extremely valuable for drug companies, since the difference in drug approval can be as long as seven months. Companies also have the option to sell the vouchers to the highest bidder; since vouchers do not expire, they can then be sold an unlimited amount of times. While this valuable program may incentivize the creation of drugs for problematic diseases and disorders, it has also been met with its critics who state the program is ineffective and simplifies complex issues.

Evolution of Priority Review Vouchers

The development of a new drug is an extremely long and cost intensive process. Drugs tend to be in the preclinical and discovery state for one to six years, and then enter the clinical phase for about six to eleven years before finally reaching the FDA for review. Normally, FDA drug review takes ten or more months, but can be upwards of two years before a drug is approved for the market.

The priority review voucher program was first introduced in a paper in March 2006, published in the Health Affairs journal, from a team of researchers at Duke University. In “Developing Drugs for Developing Countries,” the authors advocated for a priority review system, as there were no sufficient incentives for companies to produce drugs for neglected tropical diseases. The “prize” could either be redeemed by the recipient or sold to another company for use. The voucher does not guarantee approval by the FDA, but it does guarantee that a drug will be reviewed and have a decision rendered within six months in conjunction with the NDA.

In 2007,  the priority review voucher system became a reality when Congress passed the FDAA, which contained the provision “Priority Review to Encourage Treatments for Tropical Diseases” in Section 1102. Any drug intended to treat a number of diseases including: malaria, cholera, tuberculosis, and leprosy, among many others, was eligible to receive a priority voucher. These diseases were chosen because they tend to occur in poorer and developing countries that lack adequate market incentives to invest and develop treatments for “neglected tropical diseases” (NTD). As of April 19, 2016, Zika was also added to the list of tropical disease eligible to receive a priority review voucher.

Expansion of the Program

In 2012, the the priority review voucher program was expanded to include rare pediatric diseases. Under the Food and Drug Administration Safety and Innovation Act (FDASIA), Congress approved the voucher for additional therapies for rare pediatric subsets of other diseases. Section 908 of FDASIA has defined a “rare pediatric disease” as one which “primarily affects individuals aged from birth to 18 years, including age groups often called neonates, infants, children, and adolescents.” It is also a rare disease according to federal statute, meaning it affects 200,000 persons in the U.S. or fewer.

The expansion of the voucher system to rare pediatric diseases included some key differences. While modeled after the tropical diseases voucher, the rare pediatric voucher was much easier to use. For a tropical voucher, the FDA had to be notified 365 days prior to its use, while the rare pediatric voucher had a 90-day time frame. Moreover, the rare pediatric voucher was eligible to be sold an unlimited amount of times, while the tropical disease voucher could be sold only once.

In December of 2014, the stark differences were eliminated between the two vouchers under the law Adding Ebola to the FDA Priority Review Voucher Program Act. Now tropical vouchers may be sold an unlimited number of times and may be redeemed in just 90 days. Currently, the cost of the voucher fee for 2016 is $2.7 million, in addition to the NDA feed of $2.4 million.

Vouchers Awarded and Used

To win a voucher, a company requests a priority review designation from the FDA, which determines if the drug is significant enough to treat a particular condition. Once the FDA awards a company priority review designation, it will take another six months to determine if the drug should be awarded a priority review voucher. If a company receives or purchases a priority review voucher, it is then able to inform the FDA of its intent to use the voucher on an upcoming submission. The FDA will have the option to accept the voucher and agree to review the drug and come to a decision within six months.

Currently, the FDA has awarded nine vouchers–six for rare pediatric diseases and three for tropical diseases. Drugs for the NTDs malaria, tuberculosis, and leishmaniasis were awarded vouchers, as well as the drugs for the following pediatric diseases: Morquio A syndrome, high-risk neuroblastoma, rare bile acid synthesis disorders, hereditary orotic aciduria, hypophosphatasia, and lysosomal acid lipase deficiency.

Interestingly enough, five of the vouchers awarded have remained unused. Five of them were either transferred or sold, and to date, only four vouchers have been used. In total, two of the vouchers used have resulted in FDA approval, one has been rejected, and one is still in review.

The money these vouchers have been able to generate in the market has been staggering. BioMarin’s voucher from 2014, the first ever to be sold, was purchased for $67 million. Subsequent vouchers sold fetched even higher prices, with the most recent voucher sold in August 2015 by AbbVie, who paired $350 million for a voucher original awarded to United Therapeutics.

Efficacy of Priority Review Vouchers

Recently, priority review vouchers have come under fire for not necessarily incentivizing development in the areas the program was designed to assist, namely NTDs.  A few articles have emerged lambasting the use of priority review vouchers, denying that they are stimulating any sort of drug innovation and development.

For example,  the first priority review voucher was awarded to Novartis’ anti-malarial drug Coartem; however, the drug was widely used around the globe for almost a decade before the FDA approval. Thus, awarding a priority review voucher for this drug does not necessarily create an incentive for new drug innovation. Instead, it is merely a large sum of money that does not encourage new research and development. Moreover, Impavido, a treatment for leishmaniasis created by Knight Therapeutics, was largely developed by the World Health Organization and other partners back in the 1990s and approved in 14 countries before 2010.

This seems to be indicative of a loophole for pharmaceutical companies, one in which older drugs are are registered in order to obtain a highly valuable voucher. At least for NTDs, exploitive practices by companies appear to be the norm, most recently illustrated by KaloBios’ attempt to obtain a voucher for a widely used drug to treat Chagas’ disease after acquiring the rights to the drug from another company.

As for rare pediatric diseases, the U.S. Government Accountability Office has recently stated that it is still too early to determine whether the voucher program is working. The six drugs awarded vouchers were already in development before the program’s expansion in 2012. It is quite possible that drugs would have been approved without a voucher in the first place, and they were not developed with the incentive of a priority review voucher as the ultimate goal.

Other Concerns

Recent papers published earlier this year in an issue of Health Affairs note even more concerns with the priority review vouchers, as well as ways to strengthen the program. The availability and affordability of the drugs in the program are also a concern; after garnering a priority review voucher, there is no requirement that the drug be affordable or accessible. Global health advocates even requested that Sirturo, a tuberculosis drug awarded a voucher, be made more affordable for lower income families in areas where the disease exists the most.

The FDA has qualms that the voucher program is diverting resources away from other drugs still in review. The timelines between standard drugs and priority review voucher drugs differ substantially. By compressing the time frame significantly in which a drug must be reviewed, the FDA experiences more strain in trying to find qualified staff. Additionally, the drugs reviewed may be highly complex, which does raise some safety concerns.

Another significant concern is that the priority review voucher ignores a new drug’s actual utility, focusing only on a new drug’s ingredients. An effective drug that needs to be taken multiple times a day, something highly resource-intensive in developing countries, would be given priority over a following drug that was more sustainable from a cost and resource standpoint. Furthermore, drugs with little or no urgency may be able to have an accelerated review and approval, while drugs desperately needed on a much smaller timeline may have to wait years.

Conclusion

The lucrative nature of priority review vouchers is undeniable. The prize of a voucher means a swift path to a final FDA decision, which can put a company far ahead of the competition. Since the vouchers can then be sold an unlimited amount of times, the amount of money generated for already well-endowed pharmaceutical companies indicates that the program may need substantial review and an intensive overhaul. It may be critical to strengthen the qualifying criteria for obtaining a priority review vouchers to encourage new drug development or perhaps fixing the quantity of vouchers that can be available or redeemable at any given time.

The purpose of such a program is noble; for long-forgotten corners of the world, incentivizing the creation of drugs to combat and manage devastating diseases can be the difference between life and death. However, ensuring the drugs are not only new, but also accessible and affordable to those affected by severe diseases is of the utmost importance.

Resources

Primary

FDA: Development & Approval Process (Drugs)

U.S. Government Accountability Office: Rare Diseases: Too Early to Gauge Effectiveness of FDA’s Pediatric Voucher Program

Congress.gov: S.2512 – Adding Zika Virus to the FDA Priority Review Voucher Program Act

Additional

NPR: Are Golden Tickets That Speed Drugs Through FDA Worthwhile?

PriorityReviewVoucher.org

Regulatory Affairs Professeionals Society: Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers

Health Affairs Blog: Are Priority Review Vouchers The Answer To Incentivize Drug Development? Not So Fast.

Health Affairs: Prescription Drugs, Global Health & More

OxFam International: Robbing the Poor to Pay the Rich–Novartis’ Christmas Gift to Itself!

MarketWatch: KaloBios Approved for Chagas Disease Drug Deal

Aids-Free World: Open Letter: Reducing the Price of Bedaquiline

Nicole Zub

Nicole is a third-year law student at the University of Kentucky College of Law. She graduated in 2011 from Northeastern University with Bachelor’s in Environmental Science. When she isn’t imbibing copious amounts of caffeine, you can find her with her nose in a book or experimenting in the kitchen. Contact Nicole at Staff@LawStreetMedia.com.

The post FDA Priority Review Vouchers: Golden Tickets or Inefficient Incentives? appeared first on Law Street.

Every day, millions of Americans use antibacterial hand soaps and body washes. Fears of disease and infection have caused the ubiquitous use of these products in the home, at work, and at school. In 2009, the H1N1 virus caused Americans to buy antibacterial soaps in record numbers; it’s now difficult to even find a single soap on the market not dubbed as “antibacterial.” On September 2, 2016, the Federal Food and Drug Administration (FDA) rattled common conceptions about these antibacterial products in a final order issued by the administration.

According to the FDA, over-the-counter (OTC) antiseptic wash products with one or more of a specific list of 19 active ingredients can no longer be marketed to consumers. With the rising threat of antibiotic resistance, noted by the Center for Disease Control (CDC) in a report issued in 2013, this shows a dramatic shift toward limiting the daily use of antibacterial products by consumers. According to the CDC, washing with plain soap and water continues to be the most effective method for avoidance of illnesses and preventing the spread of germs. Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, stated that data now suggests long-term use of antibacterial ingredients may be doing more harm than good.  Keep reading to learn more about the history of antibacterial soaps and the potential hazards they possess. 

HISTORY AND EVOLUTION OF ANTIBACTERIAL SOAPS AND WASHES

Chemically, soap is a salt of a fatty acid that transforms insoluble particles to soluble ones in water, allowing them to be rinsed off. Oil particles, for example, become soluble in water with the addition of a few soap drops. Soap has been around for centuries, with the earliest record of its use found around 2800 B.C. in ancient Babylon. A formula for soap consisting of water, alkali, and cassia oil was even found on a Babylonian clay tablet dating back to that time period. The Latin word for soap, sapo, first appears in Pliny the Elder’s encyclopedia “Historia Naturalis,” which discusses the manufacture of it from tallow and ashes. 

In the past, bathing with soap was for social or ritualistic reasons rather than for cleanliness. Industrialized nations began using soaps more commonly due to an increased understanding of the role hygiene plays in reducing the size of microorganisms. Amidst the 16th century, more luxurious soaps started being produced in Europe using vegetable oils. The late 18th century gave rise to the first industrially manufactured bar soaps. Liquid soap was not invented until the 1800’s, and in 1865, William Sheppard patented a liquid version of soap.  

According to official records, antibacterial soap was invented in 1984 by David Poshi and Peter Divone, who filed for a patent in December of that same year. Poshi and Divone added triclosan to the formulation, an antibacterial and antifungal agent that breaks down bacterial cell walls to kill them. Triclosan had previously only been used in the 1970’s as a hospital scrub. Now, it can be found not just in soap, but shampoos, deodorants, mouthwashes, and toothpastes.  

Dial soap, however, was technically the world’s first antibacterial soap on the market. In 1948, chemists from Armour and Company, a meat-packing company, developed the soap and introduced it to the Chicago market. The antibacterial properties were from the chemical hexachlorophene, referred to as AT-7, and it promised “round-the-clock” protection. The company first advertised the product on the pages of the Chicago Tribune with scented ink, and it became the leading deodorant soap manufacturer in the U.S. By the 1970’s, however, hexachlorophene was removed from the market and restricted only to the hospital setting due to reports of the chemical causing infant neurological damage. Armour then replaced the ingredient with triclocarban. Currently, the United States spends about 1 billion dollars annually on products containing triclosan and triclocarban, and about 80 percent of all antimicrobial bar soap contains triclocarban.

GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE 

In 1938, Congress passed a set of laws known as the Federal Food, Drug, and Cosmetic Act to oversee and ensure the safety of food, drug, and cosmetic products in the United States. The Act defines “new drugs” as ones that have a “composition which has not been generally regarded as safe and effective by qualified experts.” The designation of generally recognized as safe and effective (GRASE) applies to particular old drugs that do not require prior approval of the FDA in order to stay or enter the marketplace because they have been recognized as generally safe and effective by medical professionals.

Essentially, a drug is not considered a new drug when it fits under the designation of GRASE. The FDA has three criteria for establishing a drug as GRASE:

1. The particular drug must have been the subject of adequate and well-controlled clinical investigations.
2. The investigations must be published in scientific literature available to qualified experts.
3. Experts must generally agree based on the published studies that the product is safe and effective for intended uses.

After reviewing available literature and research, along with hosting public meetings, the FDA has now determined that 19 chemicals used in antibacterial soaps and washes are no longer generally recognized as safe and effective.

POTENTIAL HAZARDS FROM DAILY USE

In 2013, the FDA proposed a rule after data suggested that long-term exposure to certain active ingredients in hand and body washes could pose serious health risks, such as bacterial resistance or hormonal effects. Manufacturers were then required to provide additional data to the agency regarding the general safety and effectiveness of particular ingredients in order to continue marketing these products.  This included a demonstration that the products were superior to non-antibacterial ones. Since then, manufacturers of antibacterial hand soaps and body washes containing these ingredients have not provided the necessary data to satisfy a designation of “safe and effective.”

Two of the most commonly used ingredients, triclosan and triclocarban, are two of the 19 chemicals included in the list. As indicated by the FDA, almost all soaps labeled as “antibacterial” or “antimicrobial” contain at least one of the 19 ingredients. Triclocarban has a hazard quotient of greater than one, which indicates adverse effects on organisms due to toxicity. It is found in extremely high concentrations in aquatic environments and may be disruptive to hormones critical for developmental and endocrine processes in wildlife. In tests conducted all over the globe, including the United States, scientists have detected triclosan in water supplies. Both triclosan and triclocarban have also been shown to be 100-1,000 times more effective in inhibiting and killing algae, crustaceans, and fish than they are at killing microbes. The Environmental Protection Agency currently regulates the use of triclosan as a pesticide.

“Antibacterial Soap Triclosan” Courtesy of [Mike Mozart via Flickr]

The high potential for triclosan-caused endocrine disruption in humans is also a significant hazard. While the rate of absorption in the skin is low and minimal interaction with the chemical may not have adverse effects, repeated low-dose exposure to triclosan could cause endocrine disruptions over time. Although there is not yet definitive proof that demonstrates triclosan is dangerous to humans, the information uncovered through years of animal studies suggests otherwise.

Moreover, research now demonstrates that it is critical to maintain exposure to bacteria to maintain a healthy human microbiology. A study published this month in Environmental Science and Technology noted a positive association between the concentration of antimicrobials and the abundance of antibiotic resistant genes. The team of scientists from the University of Oregon, Harvard School of Public Health, and Arizona State University found that particular dust samples collected with high levels of triclosan had higher levels of genes linked to antibiotic resistance. Even back in 2001, a team of scientists found that 76 percent of liquid soaps on that market contained antibacterial agents. They also found that no scientific evidence had ever been published to note that the use of such chemicals did anything to prevent infection.

CONCLUSION

Public health concerns over antibiotic resistance and deadly outbreaks from superbugs prompted this deeper inspection into antibacterial products and their efficacy. This final rule by the FDA impacts the soap industry on a massive scale, and some advocates are pushing back. A spokesperson for the American Cleaning Institute stated that “washing the hands with an antiseptic soap can help reduce the risk of infection beyond that provided by washing with non-antibacterial soap and water.”  

Manufacturers have only one year to comply with the final ruling by either reformulating the ingredients in their products or removing them from the marketplace altogether. Many companies have already started to phase these 19 chemicals out of their products after the 2013 FDA proposed rule, in an effort to stay ahead of the curve. Triclosan has now been replaced in products with one of three other chemicals: benzalkonium chloride, benzethonium chloride, or chloroxylenol. Companies have another year to provide data demonstrating their safety and effectiveness.

An important point to note is that this final rule does not apply to consumer hand sanitizers and wipes, or antibacterial products used in healthcare settings. For sanitizers, the FDA has requested additional information to support the safety and efficacy of those ingredients used in OTC topical consumers antiseptic products. Additionally, products such as toothpaste are not affected by this change, including all of the clothing, kitchenware, furniture, and toys that are formulated with triclosan to prevent bacterial contamination. Even with drastic industry changes ahead, it seems much research is still needed regarding antibacterial product use.

RESOURCES

Primary

U.S. Food & Drug Administration: FDA Issues Final Rule on Safety and Effectiveness of Antibacterial Soaps

U.S. Food & Drug Administration: GRASE

U.S Food & Drug Administration: Antibacterial Soap? You Can Skip It — Use Plain Soap and Water

U.S. Food & Drug Administration: FDA Requests Additional Information to Address Data Gaps for Consumer Hand Sanitizers

EPA.gov: Triclosan

American Cleaning Institute: Soaps & Detergents

Environmental Science & Technology: Antimicrobial Chemicals Are Associated with Elevated Antibiotic Resistant Genes in the Indoor Dust Microbiome

Additional

NPR: FDA Bans 19 Chemicals Used in Antibacterial Soaps

Funding Universe: The Dial Corp. History

Forbes: FDA Saves Us From Ourselves, Halts Overexcessive Use of Antibacterial Soaps

Nicole Zub

Nicole is a third-year law student at the University of Kentucky College of Law. She graduated in 2011 from Northeastern University with Bachelor’s in Environmental Science. When she isn’t imbibing copious amounts of caffeine, you can find her with her nose in a book or experimenting in the kitchen. Contact Nicole at Staff@LawStreetMedia.com.

The post 24-Hour Protection?: FDA Bans Common Chemicals in Antibacterial Washes appeared first on Law Street.

In August, Aetna announced that it was dropping its participation in many of the Affordable Care Act exchanges that it had previously used to provide insurance, citing significant losses as its reason. While this decision may have been made for other reasons, it will have major implications for the president’s landmark legislation commonly known as Obamacare. This problem goes beyond Aetna, which followed UnitedHealth’s decision to leave the exchanges in 2017–also pointing to significant losses as the motivation for its withdrawal. Read on to find out the full story behind the departures from the Affordable Care Act marketplaces, why companies are pulling out of it, and what implications this may have for the law going forward.

Brief History of Obamacare

Passing and then implementing the Affordable Care Act, or ACA, was no easy feat. A wide range of politicians, including the Clintons, have made efforts to reform American health care for years, but these attempts largely failed. However, that began to change in 2009 when support for an overhaul began to swell and Democrats held the presidency and both chambers of Congress. Following the untimely death of Senator Edward Kennedy and opposition from Republicans, a complex legislative process involving a filibuster, cloture, and budget reconciliation eventually led to the Affordable Care Act’s passage in March 2010.

The health care law included a number of protections for consumers, like eliminating insurance companies’ ability to deny someone coverage because of a pre-existing condition, eliminated lifetime and annual limits on coverage, and prevented rescission. It also created an appeals process so people could challenge insurance companies’ decisions and allowed children to stay on their parents’ health plan for longer. The law attempted to cater to businesses as well by providing them a time frame to offer coverage to employees and also provided a number of tax credits. It let certain people continue with their existing coverage if purchased before a certain date and encouraged new enrollees through a tax if they did not sign up. Importantly, the legislation also allowed states to expand Medicaid coverage, which contributed to a dramatic decrease in the number of people without health insurance.

The ACA was quickly challenged in the courts and after a long fight was largely upheld by a Supreme Court decision in 2012. While this was a major victory it was not the last issue to plague the Act. It has had to endure a number of problems from the online marketplace not working when it was initially launched to repeated, high-profile challenges in the House and Senate. As of February, approximately 12 to 20 million people had enrolled in health insurance either provided by the marketplace or through coverage expansion such as the one with Medicare.

Why Providers are Leaving

Aetna is likely leaving public exchanges for many reasons, but particularly it posted a $200 million loss in the second quarter of 2016 in its individual products. While it is not pulling out of all the states it was operating in, it is leaving 11 of the 15. Aetna’s decision actually leaves one county in Arizona without any coverage at all. Some evidence suggests that Aetna’s decision to leave the exchanges may have amounted to payback for the Justice Department’s efforts to block its merger with Humana. But Aetna argues that the decision was purely based on its recent losses on the exchanges.

The following video looks at Aetna’s pullback from the marketplace in terms of the company’s possible motives and the implications going forward:

The issue might be left at that, but Aetna is not the only company leaving the exchange. Along with Aetna, UnitedHealthcare and Humana–the company Aetna recently tried to merge with–are both leaving exchanges. On top of these departures are those of smaller providers, including several government-funded carriers. For many of these providers, the biggest problem is demographics. Namely, the people signing up for the program are older and sicker than expected. Some people may also be taking advantage of insurers by waiting until they are sick or need medical help to sign up. These people require higher costs, which are not being balanced out yet by new, healthier enrollees. Because of these unanticipated developments, insurers have had a hard time setting their prices and, as a result, they are losing money.

Adding insult to injury, the Affordable Care Act is dealing with more than just the loss of insurance providers. In a recent study done by the New York Federal Reserve, one out of every five businesses in that district has reported hiring fewer people because of the law. Additionally, there are now allegations that some healthcare providers are steering patients to Affordable Care Act policies instead of Medicare and Medicaid because they receive higher reimbursements. This would raise costs for insurers because sicker patients end up on the exchanges instead of government-run healthcare plans.

Implications

While it definitely sounds bad, what exactly does the departure of major providers from ACA exchanges mean for the law? For starters, it means there will be a lot less competition in many places. In fact, 36 percent of markets now will have only one provider, which is up from just 4 percent at the beginning of the year. In five states–Alabama, Alaska, Oklahoma, South Carolina, and Wyoming–there will be only the one provider. On top of this, 55 percent will have only two or fewer providers, which is also up from 33 percent at the beginning of this year.

The biggest issue here, aside from the fact that one county in Arizona may wind up with no coverage options at all, is that competition was supposed to be an important way to cut healthcare costs. Without a competitive market, insurance providers can offer lower quality service at higher prices because there is no alternative. The accompanying video looks at what the major insurance companies are doing:

The news is not all doom and gloom, however, as other carriers are expanding in certain areas including Cigna in Chicago and a startup call Bright Health in Colorado, which was actually founded by the leaders of United Healthcare. Additionally, not all insurers are losing money either in the Affordable Care Act exchanges. In fact, many smaller insurers, who have more experience in government healthcare markets like Medicare and Medicaid, are actually thriving. They are succeeding because the experience they have gleaned has helped them operate on more moderate government-style plans than the more expansive employer-sponsored plans that larger insurers like Aetna are most familiar with.

Even if these large insurers ultimately decide to pull out of the market now that does not prevent them from reentering in the future. In fact, the opposite is true, as along with its announcement that it was leaving the government exchange, Aetna also hinted at the possibility of a return when the market was more receptive to its practices.

Conclusion

Republicans have attempted to repeal all or parts of the Affordable Care Act as many as 60 times since it was passed without success. While politicians may have been unable to sweep away President Obama’s crowning achievement, the market may have succeeded. Losing yet another major healthcare provider, such as Aetna, deals a major blow to the Affordable Care Act as it decreases competition and brings into question the viability of the entire system.

At least that is how some perceive it. To others, it is simply the result of survival of the fittest, where the companies best equipped to do business in a government exchange are and are doing well. While insurance giants balk over reported losses, these companies may fill in the gaps and grow their own brands further. Many, including President Obama, believe that the recent difficulties in the exchanges should revive efforts for a public option akin to Medicare or Medicaid. But as competition decreases in many local markets, the system has many issues that need fixing.

The Affordable Care Act is unlikely to go away entirely. Even if insurers continue to leave Obamacare exchanges, the law will have allowed for a dramatic expansion in health care coverage. Instead of revolutionizing the way health insurance is provided to individuals, the Affordable Care Act may end up looking like a traditional entitlement program that made insurance available to more Americans. After all, only 11 million Americans get their insurance through exchanges, while around 150 million have employer-provided plans. But in order to ensure that the marketplaces are viable going forward, more people will need to enroll and insurance providers will need to return to provide coverage. And that is by no means a simple task.

Resources

The Atlantic: Why Is Aetna Leaving Most of Its Obamacare Exchanges?

CNN Money: Choices Dwindling for Obamacare customers

MSNBC: On Groundhog Day, Republicans vote to repeal Obamacare

Business Insider: Obamacare has Gone from the President’s Greatest Achievement to a ‘Slow-Motion Death Spiral’

CNBC: Health Providers May be Steering People to Obamacare to get Higher Reimbursement

The Daily Caller: Another Huge Insurance Company Is Leaving Obamacare

eHealth: History and Timeline of the Affordable Care Act (ACA)

Obamacare Facts: ObamaCare Enrollment Numbers

Michael Sliwinski

Michael Sliwinski (@MoneyMike4289) is a 2011 graduate of Ohio University in Athens with a Bachelor’s in History, as well as a 2014 graduate of the University of Georgia with a Master’s in International Policy. In his free time he enjoys writing, reading, and outdoor activites, particularly basketball. Contact Michael at staff@LawStreetMedia.com.

The post What a Major Insurance Provider Leaving the Obamacare Exchanges Means appeared first on Law Street.

We now know more than ever before about the relationship between our genetic heritage and disease. In previous centuries humans barely even understood the process of how an embryo was formed, or who a fetus “belonged” to. One of the most popular theories, posited by Aristotle, was that all of the genetic information to create a person was contained within the father’s sperm. The child’s mother was merely a vessel for its gestation, providing the raw physical material but nothing more.

Today we know that we inherit genetic information from both of our parents. This genetic inheritance can be a blessing, such as inheriting a combination of immunities that leave us less vulnerable to a variety of pathogens than either of our parents. It can also be a curse, passing on debilitating diseases that can kill or disable, as is the case with Huntington’s disease.

Scientists have been able to identify over 200 diseases that are passed down from a mother through the mitochondrial DNA in her egg. They have also developed a technology to prevent this DNA, and therefore these diseases, from being inherited. But in order to do that, they need to create something that was not possible in Aristotle’s day. A child with three parents.

All About Eve

Every human being on the planet can trace their mitochondrial DNA back to one woman. Known as “Mitochondrial Eve” this woman, who lived somewhere in eastern Africa, passed on her mitochondrial DNA to her daughters (and sons) who then passed it on to their children. It isn’t really that she was the mother to every future human, as the name Eve might suggest. Rather she is our “most recent common ancestor.” This means that Eve’s children continued to have children–specifically, female children because only females pass on their mitochondrial DNA–while the other ladies had no children or only males–their mitochondrial DNA lines died out. Scientists have been able to use mitochondrial DNA to illuminate the ancient migrations of humans out of Africa and all over the world.

Its use for tracing human migration, and the diseases that damaged mitochondrial DNA can cause, are the main contributions of mitochondrial DNA. It isn’t a very significant percentage of your genetic inheritance, only containing 37 genes, compared to the more than 20,000 genes that humans possess. However, these genes can cause seizure disorders and the disintegration of brain tissue in some of the most serious illnesses that they trigger. Women who have faulty mitochondrial DNA were previously unable to have healthy, genetically related children. But with modern technology that is now possible.

How Do We Get Three-Parent Embryos?

The mother, or “primary mother,” has her egg harvested and the nucleus is removed. The “secondary mother” donates her egg as well, and the nucleus from this egg is removed and replaced by the nucleus from the primary mother. This egg is then fertilized by sperm. The resulting embryo has the genetic information from all three parents. Take a look at this CBS Sunday Morning video which gives a brief explanation of how the process works. It also alludes to the technology’s future implications.

There are several caveats to the use of this technology. The first caveat is that, unfortunately, that it does not guarantee a disease-free child. Up to 4 percent of the mutated DNA in the primary mother’s mitochondria can transfer into the embryo. Meaning that it is still possible for the child to inherit the diseases that the procedure was designed to eliminate. The risk is significantly lowered, but still exists.

What Critics Say

There are also some who suggest that investment into this research is misplaced. Mitochondrial disorders affect a very small percentage of people and keep only a few women, statistically speaking, from having children that are genetically related to them and also free from disease. If a woman knows that her child would inherit her damaged genes and likely develop a disorder she can still have a child, just not one that shares her genetic makeup. Research that helps treat these diseases would be better. Better still would be research that focuses on diseases that affect greater numbers of people where investments would get more value in the reduction of human suffering.

Additionally, our understanding of the relationship between genes and inherited traits is imperfect. We can trace certain diseases back to mitochondrial DNA and we know that the disorders they cause are directly related to the inheritance of those genes. But the interplay between the genes we inherit and the traits that develop is not always clearly understood, and manipulating them may prove to be more art than science. We may have the best of intentions to eliminate these diseases but the technology we use to do it could cause other problems that we cannot foresee.

Some scientists fear not only that we may inadvertently create other disorders with gene manipulation, but that we might be tempted to go beyond the elimination of disorders and start trying to select for “desirable” traits. On PBS News Hour, scientists discussed some of the implications of this technology as it evolves.

The ability to create a child with three parents (although since the genetic inheritance from the “secondary mother” is so small that may not be a fair characterization) would have seemed like science fiction 20 or even 10 years ago. Just as the technology to implant an embryo from one woman into the womb of another was unimaginable… right up until the moment it became reality. Scientists who are advocating restraint–those who fear that we may be tempted to use this technology to manipulate traits so that children can be custom designed by wealthy parents–are speaking about an outcome that is not possible. Yet. And while they may sound paranoid, the time to worry about the ethical implications of a new medical breakthrough is, ideally, before it becomes a reality. Not when the genie is already out of the bottle.

Molecular Scissors

The technology that scientists are worried about is “gene editing.” It sounds even more like science fiction than a three-parent embryo, but is quickly becoming scientific fact. In April, Chinese researchers were able to alter a gene in non-viable human embryos that dealt with human resistance to HIV.

Instead of replacing one of the cell’s pieces, as is done in mitochondrial DNA replacement therapy, gene editing actually manipulates the genes that are inherited. Mitochondrial DNA replacement therapy is kind of like getting a donated organ. Your liver is malfunctioning and so a donor gives you their liver. Or, in the case of a live donor, a lobe. The science is not changing the essential character of a human liver and it is a classic caveat emptor situation. You’re getting the liver you’re getting, with any of the attendant issues the new liver may possess, and no guarantees. But gene editing is more like a scientist looking at your malfunctioning liver, saying ‘we can do better,’ and using science to modify how the human liver functions. It is much more exciting, much less predictable, and much more like “playing God.”

The danger in the three-parent embryo technology is not so much the abuse of this technology. Other than the transfer of the nucleus into the donor egg the process is not “designing” a child any more than in-vitro fertilization does without a mitochondrial donor. Not that the process of in-vitro fertilization is without ethical quandaries, for there are many who think that this technology is immoral. But the debates on the ethics of in-vitro fertilization center on the creation of embryos that may never be implanted and the alleged selfishness of investing so much in being able to have a biological child when adoption remains an alternative. However, the ethical debate over mitochondrial DNA replacement is focused not on the danger in this technology but in the next technology that it will enable. This could be a situation where we are not merely trying to keep embryos from inheriting a disease but actively trying to modify how the human body responds to its environment.

Conclusion

Here in the United States, the use of mitochondrial replacement therapy was recently deemed ethical, at least for the creation of male embryos, but the therapy is unlikely to be experimented on soon. This is because male embryos will never be able to pass on mitochondrial DNA to their offspring. As a result, any inadvertently created errors won’t affect the next generation, which is a reasonable precaution which gives one pause about what “errors” we could create that affect the current embryo. The FDA has not approved it for clinical trials, but last year the technology was approved for clinical trials in the U.K. for embryos of either gender. Whether these trials–and the possibility for women with mitochondrial mutations to have healthy, genetically related children–are worth the Pandora’s box they open remains to be seen.

Resources

Goodreads: The Gene: An Intimate History

NBC News: Three-Parent Babies Are OK, Experts Say

PBS: NOVA: Neanderthals On Trial

NPR: Babies With Genes From 3 People Could Be Ethical, Panel Says

The Washington Post: To Prevent Disease Ethicists Approve Creation of Embryos With Three Genetic Parents 

The Telegraph: Three-Parent Baby Technique Could Still Pass On Mutated DNA

Genetics and Society: About Human Germline Gene Editing

Smithsonian Magazine: U.S. Panel Deems Three-Parent Babies Ethical

The United Mitochondrial Disease Foundation: Mitochondrial Replacement Therapy

Mary Kate Leahy

Mary Kate Leahy (@marykate_leahy) has a J.D. from William and Mary and a Bachelor’s in Political Science from Manhattanville College. She is also a proud graduate of Woodlands Academy of the Sacred Heart. She enjoys spending her time with her kuvasz, Finn, and tackling a never-ending list of projects. Contact Mary Kate at staff@LawStreetMedia.com

The post Three-Parent Embryos: How Far Should We Take the Miracles of Modern Medicine? appeared first on Law Street.

America is getting older. In 2012, 43.1 million Americans were aged 65 and older. By 2050 it will be 83.7 million, nearly doubling. The surviving members of the baby boomer generation, my parents’ generation, will all be over the age of 85 in that year.

The United States is of course not the only country with an aging population. Many countries in Europe, as well as Japan, are facing a shift in demographics. Japan’s population, in particular, has a very high proportion of elderly citizens. More than a quarter of its population is over 65. It hasn’t reached “children of men” status there yet, but increased life expectancy and low birth rates can make it difficult for a society to function.

As our population gets older we are going to have to come up with ways to take care of our oldest citizens. Not all families are equipped to handle the level of care that the elderly require, particularly those in the 85 and older age range. For this reason, nursing homes and assisted living facilities have become increasingly common. And while the care and medical attention are positive aspects of this change, there are drawbacks such as less time spent with family and less interaction between older Americans and their communities. This can leave the elderly feeling disengaged from life, depressing them and causing a negative impact on their health.

In addition to the needs of our oldest citizens, we also have the needs of our future citizens to think about. Access to affordable daycare has long been a problem and in fact has become an increasingly visible issue in the 2016 election, with people from Hillary Clinton to Ivanka Trump citing the need to provide quality, affordable daycare to working families. Many working Americans, about 44 percent of them, have both dependent children and aging parents to care for. Providing daycare for their small children is often difficult or impossible. Families without means turn to unlicensed daycares or informal arrangements with neighbors.

There may be a way to deal with both of these concerns at the same time. If both the very old and the very young need care, one possible solution is to put both of these groups together. Which is exactly what intergenerational daycare facilities, like Mount St. Vincent in Seattle, do.

Present Perfect

There are more benefits to putting the old and the young together than just convenience for those in between. Increased social interactions have a positive impact on the health and quality of life for the elderly–delaying mental decline, reducing the risk of disease, and lowering blood pressure. The elderly residents aren’t in charge of caring for the children at Mount St. Vincent and facilities like it but they still participate in activities with them, which gives them a sense of purpose. This sense of purpose is one of the key components to fighting depression and some of the negative emotions associated with getting older.

Some of the negative emotions that come with aging, such as feeling that you are no longer useful, are culturally imposed. And they are stereotypes that increased interaction between generations can help eliminate. Take a look at this TedTalk by Evan Biggs, the maker of the film “Present Perfect,” which chronicles the Mount St. Vincent facility and how it works. It’s a long video but worth watching.

A culture that promotes the idea that people who are older have intrinsic value despite, or even because of, their age means that the elderly feel valued and live fuller lives. But establishing this type of culture is something that is done over a long period of time, which is where intergenerational daycare can provide an added benefit. They teach children from a very young age that the elderly have value and get them used to interacting with people from an age group that they might not otherwise come in contact with. In pre-modern societies the generations typically aren’t segregated from each other, but in our modern society, with an increased amount of elderly people living in nursing homes or otherwise apart from their grandchildren, effort needs to be made to bring these groups together.

Interacting with the elderly also allows these children to get even more attention and enriching activities than they would if it was only the staff of the daycare in attendance. There are just more adults around to participate. Take a look at this footage from PBS on the Mount St. Vincent daycare that shows residents and children interacting with each other.

If the elderly benefit and the children benefit, then what is the problem with putting nursing homes and nurseries together?

Drawbacks to Intergenerational Daycare

The most obvious drawback is the likelihood that residents will die and the children will be forced to deal with the question of death and mortality. There really isn’t an easy way around that problem, but it may not actually be a bad thing. At some point, children learn about death and get the sense of their own mortality. No method of discovering that is completely free from trauma. The key to dealing with this isn’t to delay learning about death as long as possible but rather to handle the topic in a compassionate and age-appropriate way.

Another concern is that some elderly residents may not actually want to spend time with children. Not everyone likes little kids or wants to feel responsible for interacting with them. In an effort to provide a way to feel useful we might be providing some people with a chore instead. That is why the amount of time they spend with children or if they spend any time with them at all should be completely voluntary for the elderly participants. Some may be interested in spending the majority of their free time with the children and some may not. Both age groups need to have their own space as well as the ability to opt in and out as they choose. The caretakers for the children and for the elderly should be the staff and the structure of the facility needs to reflect that.

There is a danger of infantilizing the elderly by having the two groups together that care providers should be aware of. Although they may have the need for some physical assistance the way small children do, the elderly are not like small children and may find that being in a facility with children obscures that fact. Providers should be aware that what might be an appropriate treatment for a small child, such as using “baby talk,” can be demeaning when directed at an elderly person. While these facilities serve both age groups they should do so knowing that they are two very different groups with different needs.

Investments and Quality

These are not insurmountable challenges. Managing an intergenerational daycare that benefits both young and old may be more challenging than running a nursing home and a daycare in separate facilities. But it is certainly something that can be successfully done, as long as care providers are able to treat each age group appropriately and the system is one based on voluntary participation.

Various private facilities, such as the Mount St. Vincent facility, are already using an intergenerational model with a lot of success. But this could be an area in which the government can encourage the development of more of these facilities. If we decide that the social benefits of these facilities–the improved emotional lives of the elderly and the increased social skills for the young–are an improvement on separate nursing and daycare facilities, then we have options to encourage their use. Because our population is aging we are going to have to invest in care facilities for the elderly. For new facilities that are built by private companies, governments can offer tax incentives or subsidies if those facilities also open their doors to children. The government could also sponsor facilities and provide subsidies for working families.

In Denmark, this is something that they already do for small children, typically covering 75 percent of the cost, which has resulted in Danish women having a much stronger presence in the workforce than, for example, in the U.K. where this is not the case. A similar program could be instituted for children here in the United States. And if we really wanted to encourage intergenerational daycare we could give added subsidies to parents who send their children to one, or include residence or daytime attendance at a daycare in the benefits we provide to the elderly.

Any and all of these ideas are obviously going to involve a huge investment in terms of money as well as cultural change and human capital. But the current childcare system is a crushing burden on working families. Child care is unaffordable for many families–in Nevada, 75 percent of families can’t afford it–and often poor in quality, with only 10 percent of daycares nationally being rated as “very high quality.” Providing a tax break to families so they can purchase childcare only works if there is childcare to be purchased that can meet scheduling needs and is high quality. All children and the elderly, deserve “very high quality” care.

Conclusion

As our population gets older we need to start thinking about how we are going to care for our aging citizens. And we already are faced with a childcare crisis that requires us to come up with a new solution. It need not be one solution. In fact, a combination of encouraging employers to provide daycare, subsidies, or income percentage caps, and even government facilities could all play a role. Intergenerational daycare could be a feature that allows us to take care of both of these populations while at the same time promoting cultural values of respect for the elderly and investment in children.

Resources

Census Bureau: An Aging Nation: The Older Population In The United States

The Japan Times: Japan Census Report Shows Surge In Elderly Population, Many Living Alone

Goodreads: The Children of Men

The New York Times: Daycare For All Ages

Atlantic.com: The Preschool Inside A Nursing Home

The Guardian: What Britain Could Learn From Denmark’s Childcare Model

The New York Times: Clinton’s Day Care Plan: A Good Start, But Not Enough

Metro.co.uk: This Nursery In An Old People’s Home Is Everything That’s Right With The World

ABC News: Seattle Preschool In A Nursing Home “Transforms” Elderly Residents

Wall Street Journal: Day Care Program Groups Toddlers With the Elderly

Mary Kate Leahy

Mary Kate Leahy (@marykate_leahy) has a J.D. from William and Mary and a Bachelor’s in Political Science from Manhattanville College. She is also a proud graduate of Woodlands Academy of the Sacred Heart. She enjoys spending her time with her kuvasz, Finn, and tackling a never-ending list of projects. Contact Mary Kate at staff@LawStreetMedia.com

The post Intergenerational Daycare: How Do We Deal With Care Across Generations? appeared first on Law Street.

Sponsored Content

Since 1990, the Society for Women’s Health Research (SWHR®) has been advocating for innovation in women’s healthcare. The organization is on the cutting edge of the newest research trends, and each year SWHR picks a different theme to highlight at its annual gala. At this year’s event, one message rang loud and true: we’re officially in the age of big data. Almost everything we do–from voting choices, to commercial purchases, to Netflix binge-watching, can be recorded and analyzed to glean patterns. But the incorporation of big data into healthcare is particularly exciting, and promises to revolutionize medical treatment for women. Read on for a sampling of how we’re now integrating big data into patient treatments, and what it means for women’s health.

Big Data & Women’s Health

First Things First: What exactly is big data?

It’s a fair question. We hear the term thrown around a lot, but there’s certainly no cut and dry definition. Essentially, big data is the collection and use of large amounts of information that are naturally generated from our everyday activities. Big data and healthcare can include things like our use of smartphones (and other technology like FitBit or the Apple Watch) to track our fitness levels, the prescriptions we are given, the information generated by clinical trials, the analysis of our genetic material, and so much more.

So how can big data affect women’s health?

It’s no secret that there are sex differences in health. Medical research has only recently begun to recognize these differences and incorporate them into the diagnosis and treatment of illnesses. While our understanding of sex differences and how they affect health have improved, discoveries are still being made about the different ways that certain diseases and treatments affect women. The ability to collect data and pinpoint patterns specifically for women will help inform how to treat them moving forward.

Big Data in Action 

Take for example, a project at Baystate Medical Center, in Massachusetts–the Breast Cancer Registry. Researchers there are creating a large database based on data collected from 400 women who have had breast cancer. The data will help the researchers find patterns in how different women respond to treatments, by acknowledging factors like genetics, age, weight, lifestyle, and other aspects of health. According to Dr. Grace Makari-Judson, chair of the Baystate Health Breast Network and co-director of the Rays of Hope Center for Breast Cancer Research:

What’s nice about the experience with the registry, we have a diverse group of individuals participating and they aren’t the highly selected people in clinical trial. You get more meaningful data (looking at) what is the use of this drug like in the general population.

The inclusion of women (especially minority women) into clinical trials has been a long fought battle, so the ability to collect and analyze this kind of data in the real world is invaluable.

Electronic Health Records 

Electronic health records are another innovative way to use the data already at our disposal. To many, it probably seems archaic that until recently, almost all of our medical information was kept in file folders. We now have the technology to process and incorporate massive amounts of data on patients–from childhood illnesses and injuries to family histories and genetic information.

As electronic health records start being implemented, evidence has begun to show that these records help doctors more effectively manage women’s health. A report in the Journal of the Medical Informatics Association showed that the presence of electronic health records make it more likely that doctors order essential tests like pap smears and breast exams for their female patients–leading to an overall positive impact on women’s health.

Examples of Individual Applications

Genomics

Genomics is the practice of mapping an individual’s genetic material. It’s a data-intensive process that requires serious computing power. Genomics can help provide patients with a predictive and more individual picture of their health. For women, one of the most visible developments in the field of genomics is the ability to test BRCA1 and BRCA2. Certain genetic mutations in those genes greatly increase the risk of ovarian and breast cancer. According to the National Cancer Institute:

Together, BRCA1 and BRCA2 mutations account for about 20 to 25 percent of hereditary breast cancers and about 5 to 10 percent of all breast cancers. In addition, mutations in BRCA1 and BRCA2 account for around 15 percent of ovarian cancers overall. Breast and ovarian cancers associated with BRCA1 and BRCA2 mutations tend to develop at younger ages than their nonhereditary counterparts.

In cases where BRCA1 and BRCA2 mutations exist, steps like enhanced screening, chemoprevention (the use of drugs to reduce the likelihood of or delay the onset of cancer), or preventative surgery might be considered. For example, actress and filmmaker Angelina Jolie tested positive for a BRCA1 mutation, and as a result chose to get a double mastectomy in 2013.

Precision Medicine

Precision medicine is an exciting new development that ties a lot of the tenets of big data together. Precision medicine uses big data, as well as other tools like genomics, to create more individualized treatment for patients. The Obama Administration has spearheaded the precision medicine initiative, and explains the aim in a press release:

The future of precision medicine will enable health care providers to tailor treatment and prevention strategies to people’s unique characteristics, including their genome sequence, microbiome composition, health history, lifestyle, and diet. To get there, we need to incorporate many different types of data, from metabolomics (the chemicals in the body at a certain point in time), the microbiome (the collection of microorganisms in or on the body), and data about the patient collected by health care providers and the patients themselves. Success will require that health data is portable, that it can be easily shared between providers, researchers, and most importantly, patients and research participants.

Conclusion

The expanded use of data in healthcare is the future, and the developments that we’re seeing in the present are already incredibly exciting. As SWHR puts it:

Data initiatives are revolutionizing healthcare and helping to improve every aspect of medicine, from bench to bedside. This data, which is being collected and utilized by healthcare providers, pharmaceutical and medical device companies, insurance companies, hospitals, and researchers, provides a wealth of healthcare information that can be used to better inform healthcare decisions and delivery for every woman.

Resources

Primary

SWHR: SWHR’s 26th Annual Gala: “Revolutionizing Healthcare & Research Through Data”

National Cancer Institute: BRCA1 and BRCA2: Cancer Risk and Genetic Testing

The White House: The Precision Medicine Initiative

Additional

Law Street Media: Precision Medicine: The Future of Health Care?

CB Insights: 13 Startups Working in Women’s Reproductive Health

Forbes: How Big Data is Changing Healthcare

Boston Business Journal: Focus on Women’s Health: Big Data, Registries Help Docs Understand Cancer

Radar: Genomics and the Role of Big Data in Personalizing the Healthcare Experience

New York Times: Angelina Jolie; My Medical Choice

Modern Healthcare: EHR Use Tied to More Women’s Health Tests: Study

Society for Women’s Health Research

The Society for Women’s Health Research (SWHR®), is a national non-profit based in Washington D.C. that is widely recognized as the thought-leader in promoting research on biological differences in disease. SWHR is dedicated to transforming women’s health through science, advocacy, and education. Founded in 1990 by a group of physicians, medical researchers and health advocates, SWHR aims to bring attention to the variety of diseases and conditions that disproportionately or predominately affect women. For more information, please visit www.swhr.org. Follow us on Twitter at @SWHR. SWHR is a partner of Law Street Creative. The opinions expressed in this author’s articles do not necessarily reflect the views of Law Street.

The post Big Data: A Revolution for Women’s Healthcare appeared first on Law Street.

One of the tendencies people have when combating a problem is the tendency to over-correct. Rather than taking a moderate approach in the first place, they move from one extreme to another. Our drug and alcohol policy sometimes appears to be following that same tendency. Like the boom and bust of capitalism, we put cocaine in our soda and then switched to putting those who use the drug in jail. In the current climate, we have gone from drug companies and doctors promoting opioid painkillers as a life-saving innovation to defeat pain, to restricting the drugs we can use to combat addiction out of fear that it might contribute to the problem even more.

It is of course not an either/or proposition, yet we currently don’t place restrictions on opioid painkillers in the way that we restrict drugs used to treat those who are addicted to opioids. The fear is that if people have unlimited access to drugs like Suboxone they will abuse them rather than use them in recovery. Suboxone is a drug that can mimic some of the effects that opioids have on the brain in order to diminish cravings for and withdrawal from actual opioids. Addicts might also sell drugs like Suboxone to others. We’ve seen this happen with prescriptions for other drugs–in fact, it continues to be a major contributor to the opioid epidemic–so it is not surprising that this fear exists.

Some people will undoubtedly abuse access to Suboxone and drugs like it, the same way that some people abuse cough syrup, which is now restricted in many places. But do the potential abuses of Suboxone and other opioid addiction treatment drugs justify how we restrict them? Or are they such a necessary tool in combatting drug addiction that we should look for alternate means to prevent their abuse so more people can utilize them?

The Devil In the Details

To better understand restrictions on drugs like Suboxone we first need to understand exactly what these drugs do and how they can be dangerous.

When you take an opioid painkiller the drug activates the opioid receptors in the brain, which both blocks pain and creates the high associated with opioids. The more you take the less it becomes about reducing pain and the more it involves achieving that high. Eventually, the brain becomes accustomed to the opioid’s presence and you need more to get high, or even just to maintain normalcy and avoid withdrawal. Because of the way the body processes opioids, once you are chemically addicted to the drug you’ll never get rid of that reaction to it; your brain is permanently wired that way. Many people can and do quit using opioids and avoid addictive behaviors, but the inability to reset your brain chemistry to where it was originally is one of the things that makes opioid addiction particularly difficult to overcome.

Drugs that activate these opiate receptors in the brain are referred to as agonists. A full agonist opioid is a drug like heroin. An antagonist is a drug that attaches to the opiate receptors in the brain but does so without activating them, therefore blocking the opioid from attaching to those receptors. Antagonists, such as Naloxone, are typically used to reverse opioid overdoses and can have no opioid effect at all.

Why People are Uncomfortable With Suboxone

The trouble with Suboxone, in terms of getting skeptics’ approval to use it for addiction treatment, is that while it acts as an antagonist (it blocks opioids) it also acts as a partial agonist. Meaning that it works the same way an opioid does but to a lesser degree. So Suboxone will have some opioid effect–such as suppressing withdrawal symptoms and cravings for an addict–without providing a high.

It is the unique nature of drugs like Suboxone, which are both antagonists and partial agonists, that makes them so effective for the treatment of opioid addiction. They are able to deal with the symptoms of withdrawal and cravings that make addiction recovery so difficult as well as prevent addicts who relapse from getting the chemical rewards for their slip, which keeps that behavior from reinforcing the addiction. But it has led some to argue that giving Suboxone treatment to addicts is simply replacing one addiction with another. This same rationale is what limits maintenance treatment in drug courts, which you can read more about here. It’s an understanding of addiction that focuses on willpower and personal responsibility–which are important elements in combating addiction–but doesn’t give full credit to the best practices determined by the science of how certain drugs affect the body.

This video introduces some of the reasons–from the perspective of an addict and from medical professionals–why treatments with drugs like Suboxone are so effective.

Why Suboxone?

In fact, using partial agonists like Suboxone in treatment isn’t just one effective treatment option, it is the most effective treatment option. Opioid addicts who use the more common rehabilitation model of a 12-step Narcotics Anonymous style program without using opioid replacement medications are twice as likely to have a fatal overdose compared with addicts who use these medications. There have also been numerous studies that show that using these medications leads to other improvements in quality of life and reduces HIV transmission.

This is not to say that psychological treatments and communal supports such as Narcotics Anonymous are not a key component to addiction recovery. But they are often not enough to help most opioid addicts. Most opioid addicts would benefit from access to medications as well. This is like treating a cardiac condition by reducing stress through yoga and getting a pet. Both of those things are treatments that can help in your recovery but are part of a more complex treatment plan that includes other lifestyle changes and medication. A drug addiction recovery plan that dismisses medication as a potential tool is, according to many medical professionals, as unethical as a treatment plan for heart disease that ignores medication.

Regulations and Restrictions

Because of the fear that addicts will personally abuse or sell Suboxone and other partial agonists, federal regulations restrict the amounts that doctors can prescribe. In their first year practicing, doctors can treat 30 patients, and in subsequent years, they can treat 100 patients. This may seem like a lot, but in communities with thousands of addicts needing treatment and few doctors, these restrictions can prevent many people from getting these medications. Senators Ed Markey and Rand Paul introduced a bipartisan bill last year, known as The Recovery Enhancement for Addiction Treatment Act, which would allow nurse practitioners and assistants to administer these drugs, raise the first year cap from 30 patients to 100, and create a pathway for certain doctors to eliminate the patient cap altogether after their first year.

Recently the TREAT Act passed through the HELP Committee (Health, Education, Labor and Pensions). In the video below, Senator Rand Paul gives a brief explanation of why he is promoting this policy change:

Restrictions on Suboxone reduce its supply, and therefore, curtail its potential for abuse. But since there is no similar restriction on the amount of painkillers that doctors can prescribe–which is a huge contributing factor to the massive increase in opioid addiction and the sale of opioids–it makes little sense to restrict Suboxone. The use of Suboxone and other partial agonists won’t actually produce a high for an addict so there is less incentive for an addict to try to obtain Suboxone illegally when he or she could try to get full agonists and get high.

There are some drugs that can be used to replace opioids that produce similar euphoric effects, in a lesser quantity, but not all of them do. At best, the use of Suboxone will prevent withdrawal symptoms and block a full opioid from taking effect, which is exactly why they are helpful to addicts trying to quit their addiction. So while they could be misused and sold, their misuse isn’t damaging in the same way that misusing a prescription for Vicodin would be.

A better strategy for curtailing drug abuse would be to regulate the amount of full agonists that can be prescribed; if we are going to regulate anything. But this regulation would run into some of the same concerns that the current regulations for Suboxone do. Rather than encouraging or requiring proper training for those who are allowed to prescribe these drugs, regulations place a one-size-fits-all rule in every community. There may be some doctors in areas that have more patients in real need of opiates, just as there are communities where the demand for Suboxone has far outstripped doctors’ ability to provide treatment. Like the current regulation of Suboxone, regulations for painkillers would also reduce the supply of the drugs–but placing restrictions that are too harsh on painkillers reduces everyone’s ability to get them–even those who legitimately need them.

Conclusion 

Regulations on drugs like Suboxone are an understandable reaction to a situation that has many lawmakers panicked. If the supply of drugs is causing a problem, then cracking down on the supply of drugs seems like the solution. The idea that the answer to bad drugs may be MORE drugs seems counterintuitive. And it is a tough sell in a culture that has been trained to treat addiction more like a psychological or spiritual dilemma than a medical one.

But drug addiction is a complex problem with psychological and medical components. Ignoring either of those elements makes combating addiction much more difficult and places more barriers in front of those in recovery. Changes in policy that allow patients to get individualized treatment for their illness, versus hoping you win the Suboxone lottery, will ultimately lead to better outcomes. Doctors do need appropriate training to deal with the specific issues involving opioid addiction. The medical profession has much to answer for when it comes to the promotion and prescription of unnecessary painkillers. But throwing the baby out with the bathwater and restricting their ability to prescribe effective treatment just because they had a hand in causing the disease is not effective.

Resources

The Washington Post: Getting Pain Killers Is Easy. Getting Help For Pain Killer Addiction Is Hard

The Huffington Post: Senate Bill Would Dramatically Alter Treatment For Heroin Addiction

Senator Edward Markey: TREAT Act One-Pager

The Daily Beast: Why Drug Rehab Is Outdated, Expensive and Deadly

Serenity Recovery: Kentucky Just Passed A New Law To Help Addicts

WJHL: New Tennessee Law Puts Restrictions on Suboxone, Subutex Prescribing

NAABT: What’s This Agonist/Antagonist Stuff?

PEWCharitableTrusts: States, CDC Seek Limits On Painkiller Prescribing

Mary Kate Leahy

Mary Kate Leahy (@marykate_leahy) has a J.D. from William and Mary and a Bachelor’s in Political Science from Manhattanville College. She is also a proud graduate of Woodlands Academy of the Sacred Heart. She enjoys spending her time with her kuvasz, Finn, and tackling a never-ending list of projects. Contact Mary Kate at staff@LawStreetMedia.com

The post Suboxone Restrictions: Is it Possible to Fight Fire with Fire? appeared first on Law Street.

Two years ago, Congress created a new program, the Veteran’s Choice Program, to fix the well-publicized problems facing health services at the Veterans Affairs Administration, known as the VA. These problems ranged from poor care to wait times to see a doctor that were so long a person was likely to end up dead before they could be told why they were dying. Two years later, the program meant to put an end to these issues is experiencing the same problems and may be even worse than it originally was.

How did the VA healthcare system get to this point? Read more to find out how the VA system was originally crafted, and the issues it faced and continues to face as those in charge search for answers.

The VA System

Since the beginning of war, disease–not actual conflict itself–has been the number one killer of soldiers. With that consideration in place, the United States has offered benefits of some kind to veterans going all the way back to the Revolutionary War. While the system is still serving veterans of wars long over, it became more codified in 1930 when President Hoover created the Veterans Administration. At the time of its inception, the system had 54 hospitals, served 4.7 million veterans, and employed 31,600 people. Over the following years, a number of other agencies were created, including the Board of Veterans Appeals in 1933, the Department of Medicine and Surgery in 1946, and the Department of Veterans Benefits in 1953. All of these departments were eventually organized under the singular umbrella of the VA, which was also made a cabinet level department in 1989.

Over the years, the system has grown in size to become a massive department today. Now, the Veterans Health Administration operates with an annual budget of $59 billion. This budget covers a lot; according to the VA, it funds “150 medical centers, nearly 1,400 community-based outpatient clinics, community living centers, Vet Centers and Domiciliaries.” The system also employs over 305,000 health care professionals. On top of this, the VA is the largest Medical training system in the United States, serving the most graduate-level students and contributing greatly to continued medical research and discovery. This includes 76,000 volunteers, 118,000 trainees, and 25,000 faculty.

Overall, this massive system serves over 9 million veterans in the United States. Based on VA guidelines, once enrollment is initiated veterans undergo a means test to see if they are a priority and if they are able to afford the co-pays. Once these steps are completed, veterans then go to see a doctor within 14 days if they are new patients and between 14 and 30 if they are existing members.

Problems with the VA

The issues plaguing the VA primarily center on wait times. This concerns one of the three branches covered by VA system, namely the Veterans Health Administration. The other two primary branches deal with benefits and burials for veterans. The VA scandal involved a variety of issues, but wait times and the difficulty that many veterans have merely accessing medical care garnered most of the public’s attention.

Some veterans have had to wait for longer than 125 days to see a doctor, a stark contrast to the 30 days required by the system. In facilities across the country, there have been allegations that administrators falsified records to make it appear as though patient wait times were not longer than required. It had gotten so bad that some may have even died while waiting; however, due to record keeping issues, we don’t know exactly how many veterans with pending records were actually waiting for care when they died.

These complaints were not isolated to just one or a few places either, locations in Phoenix; Fort Collins, Colorado; Miami; Columbia, South Carolina; and Pittsburgh, to name a few, all reported problems. There were also issues with claims, especially as more Vietnam veterans were included in disability coverage. Claims have no time limit and can be filed at any point. The primary backlog that most are concerned with is not for decisions on claim appeals, but for the initial claim decisions themselves. These issues were severe enough that the head of the VA resigned in 2014 after the extent of the scandal became known.

Two years after the initial reports broke, results are still not much better for the VA system. This year there have again been reports from states about inaccurate wait times, cost overruns, poor care, and refusal to discipline employees despite poor care.

The following video looks at the scandal with the VA system:

The New System and Lingering Issues

In an attempt to solve the problem Congress created the Veteran’s Choice program. At a cost of $10 billion, this program was supposed to put an end to the problems facing the VA system, particularly long wait times to see a doctor. Under the program, eligible veterans are able to get healthcare from nearby medical centers rather than traveling to VA facilities if wait times or distance are an issue. However, instead of helping, the effort has by many measures made things worse. Wait times have actually increased under the new program, though, according to the VA that is in part because so many veterans are trying to use it. In some places, veterans were never referred to the program or the doctor they were designated to see was too far away.

Based on the system’s structure, the patient had to be the one to initiate appointments, not the provider. However, that wasn’t entirely clear for everyone involved and many veterans were left waiting for calls to schedule appointments. And even in cases where veterans are able to schedule an appointment and see a doctor, the Choice Program has a long backlog of payments that prevents doctors from being paid on time. Doctors have reportedly waited for 90 to 180 days after a long claims process to simply get paid for their services. The situation got so bad that thousands of veterans referred to the new program actually ended up going back to the traditional VA system because it was more efficient.

Why Isn’t it Working?

So how has the new system that was meant to address these problems only exacerbated them in many cases? The answer starts with how the program was set up in the first place. The program’s basic tenet was to give veterans care faster and closer to home, specifically, this meant that if patients had to wait more than a month to make an appointment or drive over 40 miles to the nearest VA facility, they would be eligible. But the system has largely failed to live up to those promises largely because of how quickly the program was created and implemented.

Namely, once Congress approved funding and the president signed the Choice Program into law, the VA was only given 90 days to implement it. This was a program that would affect millions of veterans, hundreds of thousands of medical care professionals, and the families of both. The deadline was so short, in fact, that the VA quickly excluded itself from the process because it knew it would be unable to meet the requirements. This forced the agency to look to the private industry. However, most companies in the private industry were also turned off by the 90-day timeline.  While the VA was ultimately able to settle on two organizations, they have been scrambling to build the requisite network of health care professionals and still rely on the VA for referrals leading to the delays. The system proved to be too complicated and difficult to use for everyone involved, from veterans to doctors and VA administrators.

The accompanying video looks at the problems with the Choice Program:

Conclusion

When the true reality of the VA scandal broke two years ago, everybody agreed that the system was broken and needed to be fixed, fast. However, this is not the type of system that can be repaired and streamlined in just a few months. Unsurprisingly, the quick fix has turned into a disaster in need of a fix of its own. So what is the appropriate action moving forward?

Some have called for a total dismantling of the VA healthcare system as it is known today. Instead of providing care directly to veterans, the new system would simply pay for their care. However, critics are quick to denounce a system that would leave veterans to their own devices. It does seem unlikely an organization as sprawling as the VA will be torn down completely. Consequently, more internal reforms are likely. While the situation is in dire need of a solution, new fixes should not be rushed. Lawmakers will need to create a system that works well and gives veterans the care they need when they need it.

Resources

NPR: How Congress and The VA Left Many Veterans Without A ‘Choice’

NPR: For The VA’s Broken Health System, The Fix Needs A Fix

U.S. Department of Veterans Affairs: 10 Things to Know About the Choice Program

House Committee on Veterans’ Affairs: History and Jurisdiction

U.S. Department of Veterans Affairs: Veterans Health Administration

The Washington Post: Everything You Need to Know About the VA–and the Scandals Engulfing it

The Washington Times: VA Still Plagued by Problems Two Years After Scandal

The Military Advantage Blog: Care Commission Shocker: The Push to End VA Healthcare

Michael Sliwinski

Michael Sliwinski (@MoneyMike4289) is a 2011 graduate of Ohio University in Athens with a Bachelor’s in History, as well as a 2014 graduate of the University of Georgia with a Master’s in International Policy. In his free time he enjoys writing, reading, and outdoor activites, particularly basketball. Contact Michael at staff@LawStreetMedia.com.

The post Did the Program Meant to Rescue the VA Healthcare System Make it Worse? appeared first on Law Street.

Studying life expectancy allows us to understand what factors help people live longer and how changes in conditions affect people’s lives. Recent research shows how life expectancy varies among different groups of Americans, sparking some important questions about future policy decisions. While life expectancy has increased overall over the past several decades, those gains tend to vary widely among certain groups. This research has implications on a range of issues from public health and inequality to Social Security. 

Read on to find out more about the current U.S. life expectancy, how it has changed over time, and how American lifespans compare to those of people in other countries, particularly other advanced nations.

How long do People Live?

The most common way to measure how long people live on average is through life expectancy, which is the amount of time in years a newborn baby is likely to live based on current conditions and health trends. The average life expectancy at birth for Americans as of 2014 was 79.68 years, meaning a child born in 2014 in the United States could be expected to live to that age. While this provides a baseline, the numbers can be further divided among a variety of demographics, which tell a more in-depth story.

Life expectancies tend to vary among different groups, particularly when categorized by race, sex, and income levels. In the case of race, there is a wide disparity between black and white Americans. A Centers for Disease Control and Prevention report in 2009 found that the average life expectancy for black Americans was 75 years old, which was the same as it was for white Americans back in 1979. According to the CDC, the reasons for this disparity are higher rates of cancer, diabetes, homicide, heart disease, and perinatal conditions. Racial disparities are considerably larger when you further divide by education. Some of the largest gaps in life expectancy exist between white Americans with more than 16 years of education and black Americans with fewer than 12. One dynamic keeping this gap from becoming even larger is the much higher rate of suicide for whites.

Sex also plays a role in how long the average person can expect to live. In 2012, the average life expectancy for a male in the United States was 76.4 years and 81.2 years for women. This gap is not uncommon, however, as women tend to live longer than men for a number of reasons. One such reason is that women generally engage in less risky behavior and suffer fewer car accidents. These numbers hold even though more baby boys are actually born than baby girls, although that is mostly the result of female embryos having slightly higher rates of miscarriage than male embryos.

A third major factor that relates to life expectancy is income. In a recent study based on data from 2001 to 2014, researchers found that the average life expectancy for the richest men in the United States is approximately 87 years, which is about 15 years longer than the poorest. To put that in a clearer context, rich men in the United States live longer than men in any other country, while poor men live, on average, the same number of years as men in countries like Sudan and Pakistan. The numbers are similar among wealthy women who have an average life expectancy of 89 years old, 10 years longer than women in the lowest income group. Although researchers have not drawn a causal line between life expectancy and income to explain what drives this gap, a clear correlation exists between the two.

The accompanying video summarizes the study’s findings:

The numbers can also be parsed further. Although the rates for the richest men and women vary little depending upon the geographical area, the same is not true for the poor. On average, low-income people live shorter lives in the middle of the country compared to those who live in rich coastal cities. The study’s authors note that most of the geographical differences may be behavior-related and potentially explained by factors like rates of smoking and obesity. They also note that in wealthy cities with high levels of education and public spending, those at the bottom of the income scale tend to live longer than their counterparts in less affluent cities.

Changes in Life Expectancy

Life expectancy in the United States has changed dramatically over time. For example, in the 1930s, when Social Security was first introduced, the average man only lived to be 58 years old and the average woman 62 years old. Ironically, the retirement age for Social Security was set at 65. Another important consequence of the gap in life expectancy for the rich and poor is its effect on economic inequality and Social Security. As wealthy people live longer, they also receive more in Social Security benefits because they get additional payments over the course of their lives. Depending on how large the gap is, wealthy people may end up taking out a larger share of what they contributed relative to their income, which could reduce the progressivity of the Social Security program. This gap also has important consequences for the debate about retirement age, which many argue is necessary to keep the program funded as baby boomers retire.

While life expectancy has changed a lot over the past several decades, it has affected different groups in distinct ways. The clearest explanation comes in the same three characteristics mentioned earlier: sex, race, and income. In this instance, sex and race tend to blend together. Traditionally, white women have lived the longest, however, a recent study found that life expectancy for white women actually went down by a month. While this group still lives longest by far, the number has shrunk slightly due to a combination of factors, including rising suicide, drug overdose, and liver disease often caused by alcoholism. While white people, in general, suffer from these problems more than other groups, women have been particularly susceptible. This dip in life expectancy is actually the first one since totals have been calculated and happens at a time when other health concerns such as strokes and heart disease are causing fewer deaths.

The video below looks at this unexpected change:

While white women saw a reduction in life expectancy, several other groups saw an increase. Namely, black males and Hispanics of both sexes are expected to live longer. The third group, made up of white males and black females, saw no change in their life expectancy. Aside from sex and race, income level’s influence on life expectancy also changed. In the case of income, the richest people in America have gained three years in life expectancy from 2001-2014, while life expectancy for the poorest Americans did not change.

The United States Compared to the Rest of the World

Reliable data for life expectancy covers a relatively short time in history. In fact, for the United Kingdom, the country with the farthest reaching information, rates only go back to the 191h century. In the U.K., and virtually every other country, life expectancy was very short in the early 1800s, averaging between 30 and 40 years old; in South Korea and India, it was as low as 23. However, as healthcare and science improved, especially regarding infant mortality, life expectancy rose dramatically across the globe around the beginning of the 20th century.

This rapid improvement occurred in the United States as well, but the U.S. average of 79.68 years currently ranks 43rd relative to the rest of the world. Although countries with longer life expectancies may not be as large and diverse as the United States, it is important to ask why–for such a rich country–the U.S. life expectancy is relatively low, particularly compared to other developed nations.

The answer, according to the CDC, is threefold: drug overdose, gun violence, and car crashes. These three categories lead to injuries that account for roughly half of the deaths for men and a fifth for women in the United States. Americans, on average, live two years fewer than people in similarly developed countries. The effects of these, particularly drug overdoses, have been most acutely felt among middle-aged white Americans. Another important factor that contributes to America’s lower life expectancy is smoking tobacco. Many people in the United States started smoking earlier and in larger numbers than in other places.

Another major factor affecting life expectancy and keeping the United States behind other developed countries is the infant mortality rate. The infant mortality rate “compares the number of deaths of infants under one-year-old in a given year per 1,000 live births in the same year.” The infant mortality rate for the United States is 5.87. Although that is historically low, it is less impressive compared to other countries–the United States has the 167th highest rate out of 224 countries, and is a far cry from most other developed nations that average between two and four. Like life expectancy in general, infant mortality rates are also affected by things such as race and income with more affluent and white babies at a much lower risk of death than lower-income and black babies.

Conclusion

There is no conclusive way to say exactly how long a person will live, but life expectancy provides an effective measure to see how certain factors contribute to longevity. In the United States, these numbers have been broken down further to take into account the differences across a wide range of demographics. In general, the most recent data was positive, with groups either staying where they are or seeing life expectancy gains, except for a few cases. However, even these modest gains still leave the United States behind many other developed nations. The reasons for this shortcoming are manifold, ranging from high infant mortality rates to smoking tobacco. Regardless of the results, though, life expectancy can provide people with a good baseline for how long they might live and what factors contribute to longevity.

Resources

The World Bank: Life Expectancy at Birth

Infoplease: Life Expectancy for Countries, 2015

The Journal of the American Medical Association: The Association Between Income and Life Expectancy in the United States, 2001-2014

Social Security Administration: Life Expectancy for Social Security

The Washington Post: The Stunning–and Expanding–Gap in Life Expectancy Between the Rich and Poor

CNN: White Women’s Life Expectancy Shrinks a Bit

NPR: Life Expectancy Drops For White Women, Increases For Black Men

CNN: Why Americans Don’t Live as Long as Europeans

Population Reference Bureau: Smoking-Related Deaths Keep U.S. Life Expectancy Below Other wealthy Countries

Central Intelligence Agency: World Factbook

Our World in Data: Life Expectancy

USA Today: Life Expectancy in the USA Hits a Record High

Population Education: Why Are More Baby Boys Born Than Girls

USA Today: Infant Mortality Rates hits Record Low, Although Racial Disparities Persist

Business Insider: Huge Racial Gap in Life Expectancy

Michael Sliwinski

Michael Sliwinski (@MoneyMike4289) is a 2011 graduate of Ohio University in Athens with a Bachelor’s in History, as well as a 2014 graduate of the University of Georgia with a Master’s in International Policy. In his free time he enjoys writing, reading, and outdoor activites, particularly basketball. Contact Michael at staff@LawStreetMedia.com.

The post What Explains Life Expectancy in the United States? appeared first on Law Street.

Sponsored Content

Sleepless nights; nights full of tossing and turning. It happens to all of us–but for some it’s more frequent than others. In fact, an estimated 50 to 70 million American adults suffer from sleep disorders like insomnia or obstructive sleep apnea. Many turn to prescription sleep medications for relief– but women are more likely to take sleep drugs than men. About 3.1 percent of American men and 5 percent of American women report having used a prescription sleep medication within the last 30 days.

What does this use of sleep aids mean for women? Read on to learn more about sex differences in sleep and sleep drugs.

Sex Differences and Sleep

There are distinct biological and physiological differences between women’s and men’s sleep. According to the Society for Women’s Health Research (SWHR®), sex chromosomes, as well as gonadal hormones play a role in how individuals of each sex sleep, the sleep disorders they experience, and their responses to sleep medications. Examples of sleep differences between the sexes include women being more likely to experience disorders such as insomnia and restless leg syndrome (RLS); depression, pain, and stress are more likely to cause sleep disturbances in women than in men; and women being susceptible to changes in sleep throughout their lives, particularly at points when they experience hormonal and physical changes like puberty, pregnancy, and menopause.

Sex Differences and Sleep Drugs

Similar to how sex differences can impact sleep and sleep disorders, the way that these disorders are treated can also be affected by sex differences.

Case Study: Zolpidem

In 2013, the Food and Drug Administration (FDA) took a huge step by recommending sex-specific regulations for the prescription of sleep drugs that include zolpidem. This was groundbreaking in that it was the first time that the FDA had ever specifically recommended a sex-specific dosage for a particular medication. Zolpidem, which is used to treat insomnia, is found in Ambien, Edluar, and Zolpimist–all commonly prescribed sleep drugs. Zolpidem, a sedative-hypnotic, slows down activity in the brain.

The FDA reduced the recommended Zolpidem dosage for women to half of what was being prescribed. According to the SWHR:

This change in dosage was based on the discovery that women were metabolizing the same dose of drug 50 percent slower than men, which resulted in higher amounts of Ambien in women’s bloodstream leading to more excessive sleepiness in women compared to men.

Currently, the FDA is reviewing other popular sleep medications to determine if similar sex-specific recommendations should be issued for those as well.

Sleep Drugs and Contraceptives

We’ve all seen commercials for prescription drugs that recommend “talking to your doctor” before taking the advertised product, especially if currently using other medications. There’s a reason for that: drugs can interact and make other drugs less effective, causing unexpected side effects, or increasing the action of a particular drug. For women, it’s especially important to be aware of the interactions between hormonal contraception and sleep drugs.

Case Study: Modafinil

Combined hormonal contraceptives include the birth control pill, patches, injections, and vaginal rings like the NuvaRing. In the U.S., roughly 22 percent of women between the ages of 15 and 44 use contraceptives that fall into this category. Modafinil, which is a drug prescribed for certain sleep disorders like narcolepsy, sleep apnea, and excessive sleepiness, can lower the effectiveness of combined hormonal contraceptives. According to SWHR:

A specific enzyme in the liver breaks down modafinil to its composing molecules, which are then eliminated in the urine. The same enzyme that is responsible for clearing the body of modafinil also breaks down contraceptives. Studies have shown that, when taken together with modafinil, the overall blood levels of contraceptives decrease by 18 percent, resulting in potentially significantly lower effectiveness of the contraceptives.

Modafinil could also lower the effectiveness of other types of contraceptives, like emergency contraceptives such as the morning-after pill.

These interactions are also particularly concerning for women who become pregnant while still taking modafinil. Because modafinil lowers the effectiveness of contraceptives, this interaction is extremely unsafe for pregnant women and could potentially cause harm to a fetus.

Can contraceptives affect sleep?

Some evidence suggests contraceptives can cause changes in sleep for women. According to a 2001 study published in the European Journal of Physiology, oral contraceptives can affect sleep cycles and raise the body temperature of young women–another factor that plays a role in how well an individual sleeps. A woman’s menstruation cycle can also affect her body temperature, and therefore, how well she sleeps.

Sleep Drugs and Older Women

Women aged 55 and older are more likely to report sleepiness than men, and on average report 20 minutes fewer sleep per night than men. Post-menopausal women also report more fragmented sleep–they have a harder time staying asleep for long periods of time without waking up. According to the UCLA Sleep Disorders Center, physical factors can also disturb a post-menopausal woman’s sleep, such as arthritis and other pain-related conditions, chronic lung disease, heartburn, and a need to urinate more frequently.

But women aren’t alone in experiencing differences in sleep as they age–men do as well. As a result, both older men and women use sleep aids, which are often over-the-counter products. According to SWHR:

A recent health and wellness survey shows that 35 percent of people 60 years or older take OTC sleep medications at least 20 days a month. And 70 percent of them take OTC pain and sleep combination products, increasing the amount of the active ingredient in their system. This growing practice of self-medicating with OTC sleep products in an off-label way is alarming.

While those concerns are certainly valid–the mixing of medications, including over the counter drugs, can often cause problems; it’s still undetermined if there are any sex-specific effects of sleep medications on older women. Moreover, limited information is available as few sex-specific studies have been completed on how sleep medications and medications often taken by older women interact–a worrisome problem as older women continue to use these medications.

What’s Next?

The FDA is continuing to recognize that sex-differences are important when it comes to not only the differences in how American women and men sleep, but also how sleep medications can affect each sex. Additionally, nonprofits have been pioneering work studying and raising public awareness of these issues. Take, for example, the SWHR Interdisciplinary Network on Sleep. Launched in 2014, the network identifies areas in sleep health in which more work needs to be done specifically regarding women. According to SWHR:

The Society for Women’s Health Research is proud to bring together this interdisciplinary group to look at the critical issue of sleep in women’s health. We need greater focus on sex differences in sleep research to improve the diagnosis, treatment, and prevention of sleep disorders for both women and men. There continues to be knowledge gaps in the medical community regarding women and sleep. This SWHR Network is helping to address those gaps and highlight the importance of healthy sleep for everyone.

Sleep is important to all of us–woman or man, young or old. But recognizing the way different hormonal and physiological factors affect how we sleep, creating guidelines for medications based on those factors, and raising public awareness of risks associated certain sleep drugs and other medications are all steps in the right direction and will help us all sleep a little easier.

Resources

CDC: Prescription Sleep Aid Use Among Adults: United States, 2005-2010

Journal of Women’s Health: Exploring Sex and Gender Differences in Sleep Health: A Society for Women’s Health Research Report 

Huffington Post: Why We Need to Pay More Attention to Women’s Sleep

NIH/Medline Plus: Zolpidem

NIH/Medline Plus: Modafinil

FDA: Questions and Answers: Risk of Next-Morning Impairment After Use of Insomnia Drugs; FDA Requires Lower Recommended Doses for Certain Drugs Containing Zolpidem (Ambien, Ambien CR, Edluar, and Zolpimist)

Huffington Post: Are Your Sleep Drugs Hurting Your Contraceptives?

Guttmacher Institute: Contraceptive Use in the United States 

RareConnect: Oral Contraception / Birth Control and Modafinil

European Journal of Physiology: Oral Contraceptives Alter Sleep and Raise Body Temperature in Young Women

UCLA Sleep Disorders Center: Sleep and Women

Huffington Post: Beware Risky Sleep Drug Usage in Older Americans, All for a Good Night’s Sleep

Sleep Review: Society for Women’s Health Research to Study Sleep Differences

Society for Women’s Health Research: Interdisciplinary Network on Sleep 

Society for Women’s Health Research

The Society for Women’s Health Research (SWHR®), is a national non-profit based in Washington D.C. that is widely recognized as the thought-leader in promoting research on biological differences in disease. SWHR is dedicated to transforming women’s health through science, advocacy, and education. Founded in 1990 by a group of physicians, medical researchers and health advocates, SWHR aims to bring attention to the variety of diseases and conditions that disproportionately or predominately affect women. For more information, please visit www.swhr.org. Follow us on Twitter at @SWHR. SWHR is a partner of Law Street Creative. The opinions expressed in this author’s articles do not necessarily reflect the views of Law Street.

The post Sleep Drugs: What Every Woman Should Know appeared first on Law Street.

An estimated 15.7 million adults in the United States experienced at least one major depressive episode in 2014. Rates of depression have been on the rise in the United States for some time, causing some researchers to refer to it as an “epidemic.” The cause for this increase is unknown but some speculate that depression may be another “disease of modernity,” like obesity.

As with obesity, depression and the related condition of loneliness, are often linked to lifestyle. Modern life can isolate us from other human beings, causing loneliness and contributing to depression. Loneliness is more than just a negative feeling. It can have very real effects on a person’s health. Medical conditions like heart disease, cancer, and Alzheimer’s disease are all made worse by loneliness. Even our immune systems are weakened when we are lonely.

Depression is also more than just a negative feeling. Everyone has, at some point, felt depressed. Many people experience what is commonly referred to as “situational depression,” which does not rise to the level of a mood disorder. The death of a loved one or a job loss can trigger an episode of depression. This is the type of depression most of us are familiar with and while therapy helps situational depression, drugs are typically not part of the treatment. However, for people suffering from depression that rises to the level of a depressive disorder, a kind of “chemical depression” where the person’s brain chemistry is misaligned in some way, drugs can be an important part of treatment.

Modern psychiatry has made amazing developments in the treatment of mental illness with drug therapy. Just a short time ago, a patient whose depression was resistant to treatment through therapy and medication had the option to try electroconvulsive therapy or ECT. (Some patients were forcibly electroshocked without their consent, which is a whole other ball of wax). ECT is incredibly controversial and not for the faint of heart. Today there may be a new solution for patients who find that their depression does not respond to therapy or FDA-approved drug treatments.

This new solution is not quite as controversial as ECT but there are concerns about the use of this drug to treat depression. How worried should we be about introducing ketamine as a treatment for depression?

Off-Label

Ketamine is commonly used in veterinary medicine to tranquilize or euthanize animals and it is even used to tranquilize humans as well, typically for surgical procedures. It is also sometimes used as a date-rape drug and is probably best known by its nickname: “Special K.” Ketamine a psychedelic drug like LSD or mushrooms, which can cause hallucinations in addition to general euphoria. It’s typically found at raves and parties, but it does have several medical applications. While its medical use comes with few side effects, ketamine abuse can lead to amnesia, incontinence, and death. Unsurprisingly, it is also highly addictive.

Even so, medical professionals are impressed with ketamine and its potential to be a nearly miraculous treatment for depression. In the video below, Dr. Sanjay Matthew, an expert on depression and professor at the Baylor College of Medicine, explains the emerging research on ketamine as a treatment. What makes ketamine such an exciting new option is the speed with which it delivers results. Most depression drugs take weeks or months to start working for patients. The wait time to see if the medication will even be effective is not just an inconvenience, as many people who need treatment are at a high risk for suicide; a two to three-month wait for relief could be fatal.

As Dr. Matthew explains, ketamine works in hours, not weeks. For some patients, it could literally be life-saving. There is, however, a risk to the use of ketamine as a treatment. Like all medicines, there are potential side effects. In ketamine’s case, the main danger is the likelihood of addiction. That potential certainly does exist, much like opioid pain-killers have dramatically increased the number of people addicted to pain medication, often spurring them to try heroin as well.

How Does it Work?

Ketamine works differently than traditional anti-depressant medications and would be most helpful for patients who have “treatment-resistant” depression. As many as 40 percent of depressed patients don’t get symptom relief from traditional anti-depressants. Most traditional anti-depressants work by creating new synapses in the brain’s serotonin reception system, which is why that treatment can take several weeks to be effective. By contrast, ketamine treatment fosters the creation of enzymes required to stimulate connections between existing synapses, which may be why the results with ketamine are so immediate. While 40 percent of depression cases can be resistant to treatment, in ketamine trials 70 percent of people with resistant depression improved dramatically with its use. The National Institute of Mental Health sponsored randomized trials for both depression and bipolar disorder that have found significant benefits from the use of ketamine.

Risks and Concerns 

This story from NPR highlights some of the concerns surrounding the use of ketamine, including the fact that it is not currently FDA-approved to treat depression. Ketamine has been used as an anesthetic since the Vietnam War, but it can also cause hallucinations and lead to addiction. It was made a Schedule III substance in 1999, putting it on par with LSD in the eyes of the law. This is why many companies are seeking to create drugs that are similar to ketamine in their effect on depression but without the high. Both a nasal spray and a pill are being explored by two different companies as potential treatment options. These drugs are all still currently in the clinical trial phase, so it could be years before any of them are approved for depression treatment.

Using an unapproved drug when other treatments have failed is grounds for asking questions, but it isn’t necessarily too dangerous for us to feel comfortable with. Even if the drug is highly addictive, it is still being administered by a physician–the dose is highly controlled. And it is being used to treat a population of people, severely depressed and suicidal patients, who are more likely to be self-medicating with drugs and alcohol if they aren’t otherwise helped. Versions of ketamine, either in new sprays or pills as well as its current use intravenously, have been used successfully for years in various medical settings. And while ketamine can be addictive and dangerous, the cost-benefit analysis on ketamine has already been done in other medical situations.

Split Responsibilities 

Part of the problem with the use of ketamine is not necessarily its addictive potential or the possible medical complications, but that it spans two different medical categories and doesn’t really “fit” into either space. Doctor Carlos Zarate Jr., the chief of neurobiology at the National Institute of Mental Health, explains that ketamine is typically administered by an anesthesiologist, who isn’t qualified to determine if a patient should be taking it. But a psychiatrist, who could tell if the patient is a candidate for the drug or not–for example, a bipolar person on the verge of a manic episode–isn’t necessarily willing to administer the actual treatment. A specialty clinic or research trial would have both hands on deck–a psychiatrist to manage the psychological aspects of treatment and an anesthesiologist to handle the medical aspects and potential complications.

Ketamine already has an established track record in the medical community as a drug that can be used to stop physical suffering. It is actually the go-to drug in emergency rooms for children with serious pain. Ketamine can cause hallucinations and an “altered” sense of reality, even at the low doses that are used to treat adults with depression. But most of the negative consequences, such as hallucinations and addictive behavior, come from the drug being used in much higher doses and not under doctor supervision. The risk is still there but it has already been proven to be a risk that doctors are willing to take in other medical situations.

The problem with ketamine is much like the problem with opioid painkiller abuse. The opioid epidemic comes not from having and using opioids, when they are needed, but from not treating opioids in a way that acknowledges how dangerous they can be. It was caused by patients, doctors and drug companies that advertised, falsely, that the likelihood of addiction is low, pushing painkillers as the wave of the future. (If you’re interested in the institutional contribution to the rise of the opioid epidemic take some time to watch Frontline’s “Chasing Heroin”). But the lessons to be learned from the opioid epidemic are not to avoid new drugs that have addictive potential. Almost all powerful drugs have the potential for addiction and most medications have potential side effects. It’s a cautionary tale that speaks to the need to monitor treatment and remove financial incentives for over-prescribing and over-promoting new wonder drugs. We should approach the use of ketamine carefully, but not deny its potential usefulness because it can be abused.

Conclusion

Ketamine is not a miracle cure for depression. But, according to Dennis Hartman, who participated in a research trial for the drug treatment with the National Institute of Mental Health, it saved his life and allowed him to manage his depression the way one would manage any other chronic illness. In 2012, he helped found the Ketamine Advocacy Network, which advocates for the drug to be used as a treatment for depression. When you visit the website it starts a tracker which will count how many suicides have occurred, pharmaceutical sales have been generated, and how much economic loss has resulted from depression. If you check out the site, you will likely be surprised by how fast those numbers climb.

Sometimes the “next big thing” is a hoax or a Pandora’s Box with consequences we do not foresee–just as we did not have the foresight to anticipate the rampant abuse that would result from an effort to relieve pain with the development of opioid painkillers. But sometimes the “next big thing” in medicine is something like penicillin. If every time Alexander Fleming came across a moldy cantaloupe he threw it out, the world would be a very different (and far less populated) place.

Resources

The Washington Post: A One Time Party Drug Is Helping People With Deep Depression 

The Washington Post: Loneliness Grows From Individual Ache To Public Health Hazard 

The National Center For Biotechnology Information: Depression as a Disease of Modernity: Explanations For Increasing Prevalence 

DrugInfo: Australian Drug Foundation, Ketamine

NPR: Ketamine Depression Treatments Inspired By Club Drug Move Ahead In Tests

NPR: Club Drug Ketamine Gains Traction As a Treatment For Depression

Ketamine Advocacy Network

PBS: The Real Story Behind The World’s First Antibiotic

National Institute of Mental Health: Rapid Antidepressant Works by Boosting Brain’s Connections

Al Jazeera America: Could Ketamine Become the Next Great Depression Drug?

Mary Kate Leahy

Mary Kate Leahy (@marykate_leahy) has a J.D. from William and Mary and a Bachelor’s in Political Science from Manhattanville College. She is also a proud graduate of Woodlands Academy of the Sacred Heart. She enjoys spending her time with her kuvasz, Finn, and tackling a never-ending list of projects. Contact Mary Kate at staff@LawStreetMedia.com

The post Special K: “The Next Big Thing” in Psychiatry? appeared first on Law Street.

Every year 38,000 people in the United States kill themselves. In America, we have more people who are victims of suicide than are victims of homicide. Or car accidents. Or prostate cancer. Yet mental health care in the United States: how and whether it works, how it is funded, and  the challenges it faces, is rarely discussed. It isn’t something that we like to talk about.

In his book “A Common Struggle,” Patrick Kennedy goes into intimate detail about the alcoholism, drug addiction, and mental illness that he and his family have struggled with. As the title suggests it is a problem that is dealt with by millions of Americans–as patients, caregivers and loved ones. The book, in addition to trying to de-stigmatize mental illness, chronicles the passage of the Mental Health Parity and Addiction Equity Act of 2008. If you have no idea what that is you are not alone. According to a survey by the American Psychological Association, 96 percent of Americans have no idea that this law exists or that it requires insurance providers to treat a mental illness in the same way it would treat a physical one.

Mental Health and Mental Health Parity

Mental health care in the United States is faced with a two unique challenges: access and attitudes. The United States spends $113 billion a year on mental health care. Despite the significant investment, it is more difficult to get access to a provider for mental health services than it is to get access to a physical health provider. Nearly 90 million Americans live in a “shortage area” for mental health care providers–compared to 55.3 million Americans who live in a shortage area for primary care physicians. But an even greater barrier to treatment are the attitudes about mental health. When researchers looked into why people were refusing treatment, 71 percent said that they wanted to solve the problem on their own.

A response like that would be considered ridiculous if it was given after a cancer diagnosis. Yet, because mental illness is considered to be different from a physical illness, we don’t find this response as shocking in that context. Some people do deal with mental illness and addiction on their own, some people even do so successfully. But for individuals who want or need treatment, an attitudinal change that allows patients to believe they are entitled to receive it, and the ability to actually access it, is critical.

Take a look at this explanation of the situation given by Representative Jim Ramstad. This video was his commentary in favor of the Mental Health Parity and Addiction Equity Act of 2008. Essentially, this law requires that insurance providers treat a mental health issue the same way that they would treat a physical health issue, with the same co-pays, deductibles, and access to treatment, including treatment for substance abuse. Ramstad argues in favor of passing the law, citing himself as a success story for treatment.

The arguments dividing supporters and opponents on this issue are the same reasons that people don’t seek treatment: cost and attitude. The human cost of living with mental illness is very high but treatments for mental illness can also be extremely expensive. Treatment often includes therapy, which involves repeatedly engaging the services of a professional for hours each month. That’s a hefty price tag. When treatment involves medication, as it often does for serious mental illnesses like bipolar disorder and schizophrenia, the cost of the medications themselves can be staggering. This is often because the dosages need to be carefully calibrated, frequently adjusted, and generics are not always readily available. All of this involves more physicians and psychiatrists. Hospitalization and in-patient treatment can cost thousands of dollars for just a few days. Insurance companies are understandably reluctant to be responsible for providing these services.

The Costs of Mental Illness

It’s difficult to calculate society’s financial costs for the nearly 42 thousand deaths that were attributed to suicide in 2013. But a 2008 study by the National Institute of Mental Health attributed $193.2 billion dollars per year to lost earnings from mental health disorders in general–largely based on missed workdays because of mental health concerns. That study isn’t accounting for the lost productivity while at work or people who can’t work or are underemployed due to their mental illness. A more recent and more holistic view of the cost of mental illness would cite $444 billion, which includes treatment and the lost wages of patients but not caregivers, according to a report from USA Today. Even that isn’t taking into account the true total economic cost of mental illness.

In effect, what mental health parity does is shift some of the financial burden of treating mental illness to insurance companies, the same way that it does for physical illnesses. But it isn’t a bulletproof solution. One very key component in the bill, which Representative Ramstad addresses, is that mental health treatment would only be provided when it was considered a medical necessity. However, it isn’t clear what qualifies as a medical necessity.

Long-term therapy may be highly beneficial to an individual but may not be considered a medical necessity. A 72-hour psychiatric hold, also beneficial and potentially life-saving in terms of preventing immediate harm, might have a better chance of being considered a medical necessity. The long-term therapy, which could possibly prevent the need for the psychiatric hold, is in all likelihood the more expensive of the two options, just as physical therapy is a very expensive treatment for a chronic medical condition. Insurance companies can and do use medical necessity to thwart patients from using their insurance for treatment of mental illness.

The State of Mental Health Care in America

Mental health parity is an important step, but it does not do anything to address the problem of mental illness for the uninsured and doesn’t do enough to address mental health concerns for those on Medicare/Medicaid. It also does not deal with the much larger problems of access to appropriate treatment and the involvement of the criminal justice system.

The video below, an interview with Liz Szabo of USA TODAY about their series “The Cost Of Not Caring,” explains some of the economic costs of mental health care and how those costs are being borne by millions of Americans. The article that accompanies the series does an even better job of expanding on the concerns with the mental health care system in the United States.

Reduced investment in mental health services by state and local authorities produces a system where we still pay for the mentally ill, just in different ways than you might expect. The main effect of mental health parity is to move some of the burden from the individual to a private insurance provider. While the main consequence of reducing services for mental health shifts the burden from asylums, where the mentally ill used to go, and other institutions that were designed to deal with them, to hospitals and prisons. These already stressed institutions have difficulty coping with the added demands now placed on them, leading to a system that does an ineffectual job because it deals with the physically ill, the mentally ill, and criminals who actually need to be incarcerated as a unit–rather than dividing them into separate categories and treating them accordingly.

Better Alternatives

There are treatment options that can be tried, which may cost more at first, but produce better results in the long run for the individual with a mental illness and his or her community. To compare the problem to a physical one, if amputating a broken arm was cheaper than setting a broken bone and then using physical therapy to regain full range of motion–most of us would still not say that is the best treatment. Because in the long run, the loss of productivity to the individual and to society is much higher and the expense to fix the arm would be viewed as an investment in that person’s future. Why then, when someone comes to the hospital with a chemical imbalance in their brain, rather than misaligned bone fragments, do we not explore more expensive treatment options–ones that would be investments in that person’s most productive future given the nature of the illness.

In 2008, the National Institute of Mental Health began the RAISE project, to research Recovery After Initial Schizophrenia Episode. Researchers in the RAISE trial found that after the two-year study period was concluded, schizophrenic patients who received a model of treatment that included family counseling and help to secure a job–services that are not covered by insurance companies, which typically only pay for drugs and limited therapy for outpatient treatment–did better than patients who only got basic services.

The added cost for these services was about $3,600 a year for each patient and according to the researchers yielded a better quality of life for the patients. Which is, certainly, a difficult thing to quantitatively measure. Because the study only lasted for two years it is hard to say if, over the person’s lifetime with the illness, the initial investment will prove to actually prevent more costly complications like hospitalizations. But the initial results suggest that including this type of counseling and other services may be worth the long-term investment.

For a surprisingly cogent and unsurprisingly hilarious look at the issue of mental health and innovative treatment options, check out John Oliver’s segment on mental health:

Conclusion

Removing the stigma of mental illness by treating it in the same way you would treat a physical ailment is a positive first step towards dealing with the mental health care crisis in this country. But it is only the first step. Thousands of Americans die from mental illness every year. Millions suffer from it chronically and face the challenges of dealing with a mental disease daily.

Because it touches so many of us so intimately, mental health treatment in America is not an easy topic for most to discuss. Usually, it only becomes part of our public discourse in the wake of a mass shooting. But that’s like only talking about a disease if it is an air-born pathogen. Those diseases are the most obvious for us to see as a threat; nothing is sexier on the evening news than a flu pandemic. But it is the less glamorous food poisonings that might be more deserving of our attention. It’s messier and more embarrassing to talk about, but you are also more likely to be affected by it.

Resources

USA TODAY: Mental Health System Crisis

Goodreads: A Common Struggle 

American Psychological Association: Help Center: Parity Law Resources

Washington Post: Seven Facts About America’s Mental Health Care System 

The Kennedy Forum: Parity 

Centers for Disease Control: Mental Health 

The Huffington Post: US Mental Healthcare System

Slate: Is My Work Medically Necessary? How Insurance Companies Get Around Rules For Mental Health Care

New York Times: New Plan To Treat Schizophrenia Is Worth Added Cost, Study Says

Mary Kate Leahy

Mary Kate Leahy (@marykate_leahy) has a J.D. from William and Mary and a Bachelor’s in Political Science from Manhattanville College. She is also a proud graduate of Woodlands Academy of the Sacred Heart. She enjoys spending her time with her kuvasz, Finn, and tackling a never-ending list of projects. Contact Mary Kate at staff@LawStreetMedia.com

The post Mental Health Care: Should We Be Treating the Mind the Same As The Body? appeared first on Law Street.

Nearly 70 percent of American adults are overweight or obese. We spend trillions of dollars every year on healthcare and about half of that budget is spent treating so-called lifestyle diseases like diabetes and heart disease, types of which are largely preventable. The traditional image of a person in poverty being thin with hunger no longer rings true in the West and the developing world. The phenomenon of “fat with hunger” is now on the rise–people who can only afford cheap, processed carbohydrates that are bereft of nutritional value. They are consuming enough calories to live but they aren’t getting the appropriate nutrients to live well.

The problem is both cultural and personal. Americans have become more inactive in our jobs and our leisure activities and many people find it difficult to incorporate exercise into their schedules on top of their other responsibilities. In many areas, people are trapped in food deserts, where they have no access to nutritious options, or they simply cannot afford the types of foods they should be eating or a gym membership. These realities prevent many Americans from living a healthier lifestyle. But like other unhealthy habits, the structure of society can only take so much of the blame. Individuals still have a personal responsibility for their health.

If that is the case, how far should the government go to promote healthy choices? There are several tools that the government can use to encourage citizens to make certain choices. It can provide tax breaks or cash incentives, advocate, re-design cities, and punish those who don’t comply. But how much do we want the government to “help” us make good choices?

Carrots and Sticks

In policy making, as in diplomacy, there are carrots and sticks–where “carrots” are rewards and “sticks” are punishments. Both are used to incentivize positive behavior. Ideally, people will behave in such a way as to avoid the stick and/or get the carrot, and that behavior will benefit them and society. Mexico, which now has a rate of obesity similar to the United States, uses the carrot approach in Mexico City, where riders who do 10 squats are able to ride the subway for free. It’s a direct and immediate incentive to do some exercise. Mexico is also using the stick approach by taxing highly caloric food and beverages.

Take a look at this explanation of what Mexico is doing from PBS:

The program in Mexico is a good example of the four tools governments have at their disposal: direct policy and physical changes, financial rewards, financial punishments, and advocacy. Mexico gives free subway rides to participants, taxes products it doesn’t want citizens to consume, builds new public gyms in cities, and uses the bully pulpit to promote healthy lifestyles.

The United States is using some of these methods as well. In her Let’s Move campaign, First Lady Michelle Obama takes advantage of her unique ability to communicate with the public to advocate for increased physical activity and healthy eating, particularly for children and adolescents. She has taken some flak for her efforts but many Americans are supportive of public figures using their stature to promote healthy living.

Cities in the United States are also taking their own steps to change behavior. For example, Washington, D.C. is going to eliminate fees for residents in city gyms. It cuts revenues for the city, but officials believe that in the long run it will save money in terms of costs for treating chronic diseases that are associated with obesity. If free access to a gym encourages individuals to exercise who otherwise would not, those individuals will be healthier and it will cost less to treat diseases. Free gym access is not as direct a financial benefit as a free subway ticket, but it is an example of a direct financial reward that a city can offer to mold behavior. In Chicopee, Massachusetts, city employees can earn $25 dollars a month for walking 7,000 steps a day, five days each week. The cash incentives seem to work as participation increased significantly after a financial reward was put in place.

D.C. is also considering adding more bike lanes in areas where residents are commuting to work via bicycle, to further encourage this behavior. These changes are sometimes met with tension–bike lanes can reduce available street parking and may favor one group of citizens over another–and sometimes these proposals are viewed along racial and socio-economic lines. In D.C., altering the city’s landscape could adversely affect older, black residents in those neighborhoods who do not tend to bike to work. On the other hand, the understanding of who is actually biking to work may be mistaken.

Repeat Users

Companies actively market products that contain high levels of salt, sugar and fat to consumers. They have tapped into a delicious, deadly, and biologically motivated combination of chemicals that keep consumers coming back for more. Anyone who has ever had fast food can appreciate the unholy alliance of the salty and the sweet and food companies profit from the natural human tendency to seek out highly caloric food as a means of survival. The marketing of these products is part of the issue with the rise of obesity, according to Michael Moss the author of “Salt, Sugar, Fat: How The Food Giants Hooked Us.“

Watch the video below as Moss talks with a former CDC official on PBS NewsHour.

It is precisely the “heavy users” who we want to dissuade from purchasing fast food or unhealthy food in grocery stores. Taxes on these foods, like the ones used in Mexico, can alter these consumption patterns. But they might just be making it more expensive for people to purchase the foods they want or the only kinds of foods they have access to. These taxes are also difficult to achieve politically, with backlash from both consumers and the food industry.

Oklahoma City, a community where obesity rates have tripled in two decades, has made some progress in combatting obesity, but it did not have the political will or ability to do so by challenging the fast food industry. The principle way that Mick Cornett, the mayor of Oklahoma City, chose to combat obesity in his city was through the encouragement of individuals to take personal responsibility for their actions and to make better choices. Instead of taxing soda, or limiting the amount that can be sold, the emphasis was placed on encouraging people to not order a 40-ounce soda, even though they can.

The argument of personal choice also applies to school lunches. For example, in Oklahoma City, officials need to determine options to offer children. Kids want to eat burgers, pizza, and other unhealthy foods, which parents may not want their children consuming on a daily basis. But those are often the more affordable options to make, and what the kids will eat. Big businesses like Tyson, which supplies the chicken for Oklahoma City schools, have a stake in school menus. There are also cultural clashes that make encouraging healthier options more difficult.

Oklahoma City faces the same problems that America in general faces when combatting this issue: a powerful and well-organized lobby that fights against taxing sugar and fat as well as an addiction not just to their products but to the profits and tax revenue that they generate. Oklahoma City relies on fast food companies like Sonic to provide jobs that produce sales tax revenue because their budget is entirely made from sales taxes. Cities that are funded this way want fast food restaurants to move there, which means not having additional vice taxes on their products. Then they also have the added incentive to encourage people to eat there; creating a tug of war between the desire to keep citizens healthy and keep city coffers full.

Conclusion

Placing a prohibition on the consumption of sugar and fat may not be the answer to the obesity epidemic. In New York City, the court rejected a ban on how many ounces of soda a business can sell in a serving and Americans find restrictions on freedom when it comes to food to be unpalatable. But there are other means that governments can use to incentivize people to make different decisions when it comes to their food and health-related habits.

Given the political headwinds that cities face when taking on food companies it may be more effective to address the issue of exercise more directly rather than taxing unhealthy foods. These taxes are unpopular and can punish the very populations that these policies seek to help, even if they do have some success. By contrast, making it easier for people to have access to fitness classes and exercise in their communities can help save money in the long run. Doing so may also feel less invasive to people worried about the extent to which government is trying to govern our choices.

Resources

Slate: You Should Get A Tax Deduction For A Gym Membership

Quartz: Mexico City Is Offering Free Subway Rides In Exchange For Doing Squats

PBS: Did You Know? The Story of Theodore Roosevelt

White House: Let’s Move

Washington Post: DC Will Eliminate Fees At City’s Fitness Centers In 2016

WAMC: City Offers Employees Cash Incentives To Keep Fit

Washington Post: More Than 20 percent Of Residents Bike To Work in These Three D.C. Neighborhoods

GoodReads: Salt Sugar Fat

Politico: How America’s Top Junk-Food City Went On A Diet (And Fattened Its Economy)

NY Post: Highest Court In NY Refuses To Reinstate Big Soda Ban

Mary Kate Leahy

Mary Kate Leahy (@marykate_leahy) has a J.D. from William and Mary and a Bachelor’s in Political Science from Manhattanville College. She is also a proud graduate of Woodlands Academy of the Sacred Heart. She enjoys spending her time with her kuvasz, Finn, and tackling a never-ending list of projects. Contact Mary Kate at staff@LawStreetMedia.com

The post Should the Government Be Involved in Promoting Healthy Lifestyles? appeared first on Law Street.

To most people, it is a matter of common sense and good policy that governments should not subsidize illegal or immoral activities on the part of their citizens. The belief that governments should not only consider the practical effects of their policy decisions but also the moral implications of those policy choices can be found across the political landscape, often on both sides of a debate. It can also lead to policies that might otherwise have been enacted because of their practical value being dismissed.

One area in which the belief in the importance of government policies not promoting immoral behavior manifests itself is the issue of Needle Exchange Programs (NEPs). These programs, in place in many American cities and around the world, allow intravenous drug users to bring in used syringes and exchange them for clean needles. It keeps users from sharing needles with each other which prevents the spread of HIV, Hepatitis C, and other infectious diseases. It also gives users the tools necessary to get high. Despite the alarming increase in these illnesses, many are unwilling to use federal money to enable drug use and this reluctance has very real consequences. So where do the facts lie, and what effect does moral opposition have on an otherwise effective program?

Background

Every year, 50,000 Americans become infected with HIV. Of these, approximately 11-14 percent are the direct result of intravenous drug use from needle sharing. Hepatitis infections also affect intravenous drug users. An estimated 50 to 80 percent of users will become infected with Hepatitis C within five years of starting intravenous drug use. Based on a study of seven pilot needle exchange programs, the cost savings from preventing an HIV infection was about $20,000–a fraction of the cost of treating an individual who contracts HIV. In light of the growing use of intravenous drugs and the need to prevent the transmission of disease, Congress recently took another look at the largely moral argument that kept the federal government from funding needle exchange programs and decided to lift the ban.

The argument against providing federal funding for NEPs is essentially an ideological and moral one and not necessarily one about the effectiveness of these endeavors. Those who would like to ban funding these exchanges argue that using intravenous drugs is immoral and that providing clean needles to drug users will encourage them to use more drugs. Or, at the very least, sends the message that it is acceptable to use. Therefore federal funds would be encouraging an immoral activity and the programs shouldn’t be funded.

A Perverse Incentive?

In legalese, a “perverse incentive” is a consequence or behavior that was unforeseen by the creators of a policy or law when they enacted it–usually, a negative one that thwarts the purpose the law was intended to serve. Let’s say you have a lot of rats in your city and you want to encourage your citizens to kill rats to get rid of them. One way to incentivize them to do so would be to pay a bounty for each rat tail. Instead of killing rats, you might find that everyone starts farming them to make money. Not exactly what you had in mind, but a perfectly reasonable response to getting paid for rat tails.

Opponents of funding NEPs think that providing clean needles to intravenous drug users will have a similar result. It will lead to the use of more clean needles but would also cause an increase in use overall. Just as the rat-tail bounty lead to additional dead rats, it increased the number of living ones as well.

Advocates of lifting the ban on the funding argue that the evidence shows that intravenous drug use does not increase when clean needles are provided for users. In fact, the evidence shows that users come for the needles but often end up availing themselves of other resources, such as access to rehabilitation and counseling. To those advocating that the ban remain lifted the fact that providing clean needles may be tacit consent (more legalese) for using drugs shouldn’t be relevant. What matters, and what should matter to policymakers, is that the programs work.

Morals and Numbers

The former ban on federal funding for Needle Exchange Programs has been in effect since 1988, with a brief respite in the 2010-11 budget. The rationale for this ban was largely due to some lawmakers’ unwillingness–on this issue, it was typically Republican lawmakers–to promote drug use. Although there was clearly a need to take steps to prevent the spread of HIV/AIDS and other blood-born illnesses, lawmakers were unwilling to provide the funding for clean needles. Essentially arguing that providing that funding amounted to facilitating drug use, and that these programs may even encourage addicts to use more because of increased access to clean needles.

Federal funds could still be used to pay for other efforts in the fight against the spread of HIV/AIDS and hepatitis, such as educating intravenous drug users about the importance of clean needles and providing counseling and rehabilitation services. But clean needles, or even giving out bleach to clean the needles, wasn’t allowed. Nor were NEPs allowed to use federal funds to pay for administrative support for these programs, limiting them entirely to state and local funds.

Although Congress lifted the ban, federal funds still cannot be used to directly purchase the needles themselves. The change simply allows for the use of federal money to pay for everything but the needles involved in these programs. For some advocates of NEPs, such as Daniel Raymond of the Harm Reduction Coalition, it is a compromise that they are happy to make. In his recent interview with NPR, Raymond outlines the rationale for his support for lifting the funding ban.

Those in opposition to federal funding make an argument that resonates with our cultural sense of personal responsibility and our unwillingness to help make bad behavior easier. If it really is the case that an addict who has access to clean needles will continue or even increase their drug use, opponents argue that the federal government should not be a party to it. The goal should be to combat drug use and its effects and lawmakers see direct funding for NEPs as counterintuitive–giving an addict a needle so that they can more safely use while telling them they shouldn’t be using in the first place. To those opposing funding, an increase in drug use isn’t even a perverse incentive but a very foreseeable consequence.

A Closer Look 

Yet the numbers don’t support this conclusion. In fact, those users who go to a needle exchange program often also end up entering into a rehabilitation program. According to the ACLU, they are five times more likely than a user who never sought out an NEP to do so.

The reduction in rates of HIV infections can also be profound. In 2008, the ban on local funding for NEPs in Washington, D.C. was lifted. By 2010, the rate of new HIV infections decreased by 60 percent. There may  be a perverse incentive at work here, but not the one you would think. Addicts want clean needles if they are going to use and that draws them to the NEP. But many of them also want to not need the clean needles in the first place. Once their foot is in the door, drug users are met with the social services that can help them rehabilitate. By making drug use safer, the programs are also, ultimately, making drug use less likely.

The Profit Motive

There is also a second perverse incentive that leads many to oppose funding for needle exchange programs. At most NEPs there is no limit to how many dirty needles you can turn in for clean ones. Therefore enterprising individuals can collect dirty needles and get clean ones, then turn around and sell those clean needles to users, essentially making a profit off of the federal government’s support for clean needles. For those morally opposed to providing the clean needles in the first place, this is an added reason to reinstitute the ban. Now, instead of just giving the needles away, the federal government is creating a business for clean needle sales.

To opponents of the program, this second perverse incentive may be even worse than the first. There is a visceral discomfort with the idea that drug dealers might be benefitting financially from a federally funded program.

But this profit motive may, in fact, be a benefit for drug users (and taxpayers) as well as increase the effectiveness of the NEPs in general. Essentially, you’re taking the exchange program and making it mobile. Instead of needing to plan a trip to the NEP to get the tools necessary to use, an addict can go to an individual supplier, who may be more local. Or a drug dealer, who users will inevitably encounter, now has an ancillary business of providing clean needles.

The proximity of a clean needle to an addict when they need to use is probably the deciding factor in whether they use a clean needle or a dirty one. This makes the clean needle option much easier to choose and it gives the needle supplier/drug dealer an incentive to promote clean needles: they want to sell more needles. One could argue it also gives them an incentive to try to sell more drugs, which it certainly does. Yet, the incentive to sell as much as possible exists anyway. Dirty needles do not diminish that profit motive and they don’t decrease the demand. If an addict is willing to pay a small premium for a clean needle there is an economic incentive for dealers to have clean needles to sell. By tying an economic incentive to drug dealers, you end up promoting the use of clean needles.

Opponents would also point out that if users get needles from drug dealers and not from the NEPs that actually reduces the main ancillary benefit of the program–that addicts get the other social services in addition to the clean needles when they show up. But advocates for these programs would argue that the solution to this problem might be to take the economic incentive model and tie it to those social services as well. Essentially mimicking the drug dealers actions by making NEPs more mobile. In fact, many NEPs are in buses and vans, perhaps for this reason.

For many, this argument does not remove the opposition to letting drug dealers or addicts profit financially from these programs. Nor does the effectiveness of these programs make up for the essential problem addicts are being supplied with the tools they need to use, which is the very thing the government wants to prevent. Even if the program is effective that doesn’t make it morally right from everyone’s perspective; the ends-justifies-the-means argument does not always hold water.

Conclusion

There is an epidemic of intravenous drug use in the United States, and around the world, in addition to a concurrent epidemic of HIV/AIDS, hepatitis, and other illnesses that are transmitted through the use of dirty needles. You would be hard-pressed to find a community or a family in America today that has not been personally impacted by a friend or a loved one who is struggling with addiction.

Opponents of federally funding NEPs would argue that the federal government should not make it easier for addicts to use. Instead of devoting our resources to giving drug users clean needles, which gives them the ability to more safely use and even profit off federal funding, the government should be devoting all of the resources it has to other methods of combating intravenous drug use. There are ways to promote rehabilitation programs and other forms of help that don’t involve also promoting “safe” drug use.

But advocates of lifting the ban argue that while other services for drug users are critically important NEPs should be supported even if initially they seem to encourage drug use, because in the long run they decrease the transmission of disease and intravenous drug use through the social services they offer. The fact that users may ultimately profit from the sale of clean needles is not a reason to defund these programs if they are still working. If the program is reducing the spread of disease and decreasing drug use, then it should be funded.

The division of opinion on this issue is centered more on the conflict between ideologies than on the effectiveness of NEPs. The programs have been proven to be successful in combating the spread of disease as intended and the evidence does not show an increase in drug use where these programs are available. Ultimately, the question is which should matter more: the moral message that providing needles sends, or the effectiveness of the program itself.

Resources

Primary

University of Texas at Austin, Needle Exchange Program

Additional

Financial Transparency, Farming For Rats: Perverse Incentives and Illicit Financial Flows

New York Times, Surge In Cases of HIV Tests U.S. Policy on Needle Exchanges

NPR, Congress Ends Ban On Federal Funding For Needle Exchange Programs

NPR, Needle Exchange Program Creates Black Market In Clean Syringes

ACLU, Needle Exchange Programs Promote Public Safety

TIME, Clean Needles Saved My Life

The Atlantic, The War On Drug Users : Are Syringe Exchanges Immoral?

University of California San Francisco, Does HIV Needle Exchange Work? 

Mary Kate Leahy

Mary Kate Leahy (@marykate_leahy) has a J.D. from William and Mary and a Bachelor’s in Political Science from Manhattanville College. She is also a proud graduate of Woodlands Academy of the Sacred Heart. She enjoys spending her time with her kuvasz, Finn, and tackling a never-ending list of projects. Contact Mary Kate at staff@LawStreetMedia.com

The post Perverse Incentives: Are Needle Exchanges Good Policy? appeared first on Law Street.

In 2011, a personal injury complaint was filed in regards to Mirena, an intrauterine device (IUD) manufactured by Bayer Healthcare, one of the largest pharmaceutical companies worldwide. Since then, over a thousand lawsuits have been filed against the manufacturers of Mirena. Some Mirena users have suffered from uterine perforation, inflammation, organ damage, and a host of other medical complications. The Mirena IUD is Bayer’s most popular model worldwide, and the company markets the product as safe and efficient. Yet as the number of lawsuits continues to rise, Mirena’s reputation may take a hit. Take a look at the details behind Mirena and why these lawsuits are making the news.

Mirena by the Numbers

The three hormonal IUDs available in the United States: Skyla, Liletta, and Mirena. Both Skyla and Mirena are manufactured by Bayer while Liletta was developed by Actavis and Medicines360 specifically to be low cost and available to public health clinics. According to Mirena’s official website, Mirena is recommended for women who have already had a child. The IUD is marketed as a “hassle free” form of birth control for busy moms. The major benefits of the IUD are that it is effective, convenient, reversible (the IUD can be removed if you wish to become pregnant) and estrogen free (the IUD utilizes progestin).

However, in 2009, the FDA issued a warning letter to Bayer, arguing that the Mirena advertising campaign exaggerated the efficacy of the device, misleading consumers. The FDA singled out certain advertisements that failed to describe any of the risks associated with IUDs and sent a letter requesting the immediate termination of specific websites. The letter was meant to serve as a larger warning towards Bayer for future advertising campaigns: do not overstate Mirena’s positive effects while minimizing its negative impacts.

Despite the 2009 warning from the FDA, Mirena sales continued to rise. Once implanted by a medical professional, the Mirena IUD is expected to last for up to five years. Each Mirena IUD costs $800, which has generated over a billion dollars in revenue for the manufacturers. The risks of side effects for Mirena users is equivalent to the risk that oral contraceptive users face so many women who once relied on oral contraceptives have transitioned to the IUD, expecting minimal changes in their physical health. For the vast majority of women who have made that switch, that has held true–IUDs including Mirena largely are safe and effective forms of contraception. However, the plaintiffs in the the lawsuits filed against Mirena have experienced side effects including perforation of the uterus, pelvic inflammatory disease, and ectopic pregnancy (pregnancy that occurs outside the uterus). The most common complaint among the plaintiffs is device migration, during which the IUD shifts and eventually presses against organs or blood vessels, sometimes causing internal damage.

The Nature of the Lawsuits

Bayer is being sued in multiple states by thousands of plaintiffs, after more than 45,000 adverse event reports. These event reports usually involve medical side effects once the IUD has been inserted, but several cases have been filed regarding removal of the IUD. Mirena removal is meant to be simple but some women have needed surgical procedures to remove the device. These lawsuits are currently being filed on an  individual basis and in 2014, the US Judicial Panel on Multidistrict Litigation chose not to consolidate multiple claims into one. The differing nature of the claims against Mirena (uterine perforation, increased risk of neurological damage and painful surgical removal, to name just a few) make it difficult to consolidate the claims into a single case. However, as the number of lawsuits increases, the possibility of a class action suit has not been ruled out. According to Lawyers and Settlements,

A refusal to centralize lawsuits at this stage does not mean that the lawsuits will never be centralized. Plaintiffs in Lipitor lawsuits faced a similar situation in 2013, when their request to have lawsuits centralized was denied. At the time, the panel ruled that with only five lawsuits and 24 potential tagalongs, there was no need to consolidate. By 2014, however, the number of lawsuits had increased to 56, with 170 potential tagalongs. At that point the request to consolidate was approved. As of August 2014, there were approximately 1,000 Lipitor lawsuits filed.

If a sufficient number of Mirena users come forward with similar complaints, their cases could be combined into a single class action suit against Bayer. However, because Mirena is still a relatively new product, it may take years before a sufficient number of users come forward with similar complaints. There have been multiple online forums set up for women to discuss Mirena effects, including one established by famed activist Erin Brokovich, but for the time being, efforts to consolidate Mirena claims are at a standstill.

What Does this Mean for Bayer?

Bayer Healthcare Pharmaceuticals is a speciality pharmaceutical company that works in General Medicine, Hematology, Neurology, Oncology and Women’s Healthcare. Bayer Healthcare is one of 289 subsidiaries of the Bayer Group, based in Germany. As the parent company of Mirena, Bayer is being held liable for virtually all of the personal injury claims involving the product. Most plaintiffs have chosen to sue Bayer rather than their doctor, arguing that their medical side effects come from the IUD itself not from a poorly performed insertion. When the FDA submitted its 2009 letter to Bayer, it stated that Bayer had overstated the efficiency of the product (making unsubstantiated claims), omitted information about the risk of the product and ultimately made a serious of false or misleading statements in its advertising campaign. Bayer has claimed it was not aware of those side effects and that its marketing campaign should not be considered irresponsible.

Other Legal Concerns 

Besides the Mirena lawsuits, Bayer is also involved in a host of lawsuits regarding its birth control pill, Yaz. Research found that blood clot risk could be higher in women who used Yaz compared with women who used other oral contraceptives, and Yaz has been linked to many injuries and dozens of deaths. This is largely due to the presence of drospirenone in Yaz, which was found to “increase the risk of an embolism or thrombosis by up to three times compared to previous generations of contraceptive pill” according to DW.

A study in Denmark assessed the data of 1.6 million Danish women who took a drospirenone contraceptive pill for several years and found that the “risk of a heart attack or stroke was higher in these women than those using a non-hormonal method of contraception.”

Plaintiffs argue that Bayer downplayed the risks of the drug and exaggerated the benefits. There are further claims that the Bayer team did not complete sufficient research during product testing and failed to issue a recall once the side effects of the drug became apparent. The FDA has at least somewhat supported these claims, as it sent a warning letter to Bayer in 2008 discussing misleading marketing techniques used to sell Yaz. As of last year, Bayer had settled 8,250 cases for $1.7 billion but there are still lawsuits pending in national and state courts across the country. Onlookers point out that the number of settlements Bayer has made in the Yaz case may be promising for the plaintiffs in the Mirena cases. When Bayer’s oral contraceptives and IUD have come under significant criticism, both from the FDA and from individual users, the company has the potential to lose credibility. 

Conclusion

IUDs are a largely effective and safe form of birth control and a growing number of physicians have been recommending them to women. However, the lawsuits against Mirena should not be ignored and the manufacturers should strive to correct errors in their products in order to reduce the medical risks of their IUD. The lawsuits against Mirena do not only affect Bayer, they also affect the reputation of all versions of the IUD across the United States. If drug companies use misleading advertising to sell their products, the number of adverse event reports (and the lawsuits that accompany them) will swell in size. Birth control should not inspire fear in young women but should instead be seen as a safe and effective choice. Pharmaceutical companies have a duty to these women to present them with safe and effective products and to fully explain the medical risks associated with any form of birth control–we’ll have to see what the courts decide when it comes to whether or not Bayer took on that responsibility appropriately.

Resources

Primary

FDA: Notice of Violation Letter

FDA: Warning Letter

Additional

Injury Lawyer News: Mirena IUD Named in California Injury Lawsuit

Newsweek: The Courtroom Controversy Behind Popular Contraceptive Mirena

Lawyers and Settlements; More Mirena Lawsuits Expected with New Study

Drug Watch: Manufacturer:Bayer

The Henry J. Kaiser Family Foundation: IUDS: Access for Women in the United States

Deutsche Welle: Bayer Sued over Controversial Contraceptive Pill Yasminelle

The Richmond Legal Examiner: FDA to Review Essure Birth Control Device

Jillian Sequeira

Jillian Sequeira was a member of the College of William and Mary Class of 2016, with a double major in Government and Italian. When she’s not blogging, she’s photographing graffiti around the world and worshiping at the altar of Elon Musk and all things Tesla. Contact Jillian at Staff@LawStreetMedia.com

The post Legal Battles over the Mirena IUD: What’s Next? appeared first on Law Street.

Sponsored Content

Everyone uses cosmetics, lotions, soaps, and other personal care items as a part of daily life, and we trust that those products are safe. But who actually determines whether or not a personal care product is safe? The Food and Drug Administration (FDA) has jurisdiction over the regulation of personal care products, however, the Agency continues to follow outdated guidelines that don’t reflect recent scientific breakthroughs. In an attempt to change this outdated system, Senators Dianne Feinstein (D-California) and Susan Collins (R-Maine) introduced the Personal Care Products Safety Act (S. 1014) to the Senate in April. The proposed bill is a bipartisan initiative and has the backing of many cosmetic and personal care product companies and the support of advocacy groups such as the Society for Women’s Health Research (SWHR ®). Read on to learn about current personal care products regulation, attempts for reform, and the status of the Personal Care Products Safety Act.

Personal Care Products Regulation in the U.S.

Personal care products were first brought under the umbrella of the FDA with the passage of the 1938 Food, Drug, and Cosmetic Act, which provided for federal authority over such products. However, which products are defined as personal care products and which are defined as drugs is a nuanced question. According to the FDA, there’s no clear distinction under the law, but there are generalities that the agency uses to designate the category various products fall into. According to the FDA:

Under the law, some of the products commonly referred to as “personal care products” are cosmetics. These include, for example, skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, shampoos, permanent waves, hair colors, toothpastes, and deodorants. Some, however, are regulated as drugs. Among these are skin protectants (such as lip balms and diaper ointments), mouthwashes marketed with therapeutic claims, antiperspirants, and treatments for dandruff or acne.

Some personal care products can meet the definitions of both cosmetics and drugs when that product has two intended uses. For example, a shampoo is a cosmetic because its intended use is to cleanse the hair. An antidandruff treatment is a drug because its intended use is to treat dandruff. Consequently, an antidandruff shampoo is both a cosmetic and a drug, as it is intended to cleanse the hair and treat dandruff.

Regulations on drugs are obviously stricter than those on personal care products–understandably so– but there are some concerns over the ways that those personal care products are regulated.

What’s lacking from the FDA regulation of personal care products?

Guidelines that govern the FDA’s policies on personal care products haven’t been updated since the 1938 law that gave the Agency the authority to regulate these products. Yet, the science behind these products has evolved rapidly over the same time period. We now know more information about chemicals that could potentially be harmful. Additionally, many products contain new man-made chemicals, and the Agency should have policies in place that reflect the current state of the science governing these products.

Currently, the FDA cannot issue recalls of personal care products that it deems to be harmful. It can only recommend voluntary recalls, which critics are concerned aren’t strong enough to adequately remove dangerous products off the shelves in a timely fashion.

The lack of testing guidelines for personal care products are another area of concern for health advocates. Currently, the FDA doesn’t have the authority to mandate testing of ingredients before they go on the market, with one exception: color additives and no health studies or pre-market testing are required. Instead, the cosmetic industry is largely self-regulated through an organization known as the Cosmetics Ingredient Review (CIR). However, many advocacy organizations also question the efficacy of that group, particularly when it comes to CIR’s banning of substances. In the 36 years since its inception, the regulatory group has only 11 chemicals for use in personal care products, a stark contrast to the hundreds banned by European Union regulators.

Advocacy groups are also concerned over the labeling laws currently in place for personal care products. Currently, full ingredient disclosure isn’t required, which many criticize as a major loophole with regards to transparency and patient safety. There’s also no requirement for contact information, so people who may suffer from adverse reactions to products can’t always figure out how to get in touch with the manufacturer to report the problem.

Overall, the process for FDA approval of personal care products is significantly less strict than the process the Agency uses to approve drugs and medications.

What is the Personal Care Products Safety Act?

The Personal Care Products Safety Act would help remedy many of the regulatory loopholes cited above. and would give the FDA the regulatory authority it needs to issue recalls, improve testing guidelines, and require more stringent labeling.

Further, this legislation would mandate that the FDA take a proactive approach to ensuring that chemicals used in personal care products are safe by requiring that the FDA test and review at least five chemicals each year. The bill also lays out the first group of chemicals that would be reviewed, all of which have been subject to recent controversy. According to Senator Feinstein’s release on the act, that first group consists of:

Diazolidinyl urea, which is used as a preservative in a wide range of products including deodorant, shampoo, conditioner, bubble bath and lotions;

Lead acetate, which is used as a color additive in hair dyes;

Methylene glycol/formaldehyde, which is used in hair treatments;

Propyl paraben, which is used as a preservative in a wide range of products including shampoo, conditioner and lotion; and

Quaternium-15, which is used as a preservative in a wide range of products including shampoo, shaving cream, skin creams and cleansers

Additionally, the Personal Care Products Safety Act would require manufacturers of personal care products to register with the FDA. It would remove the protected status of “coal tar,” a carcinogen found in some hair dyes that currently is permitted as long as there are proper warning labels. It would also direct the FDA to come up with a list of “Good Manufacturing Practices” to guide producers.

The new programs and regulations instated by the bill would be funded by collecting user fees from personal care product manufacturers–this is a similar process FDA uses for the review and approval of prescription drugs.

Why is the Personal Care Products Safety Act particularly important for women?

While Americans use an average of roughly 10 personal care products each day, that number isn’t split up by sex. Women in particular use an average of 12 products, exposing themselves to 168 unique chemical ingredients each day. This puts women at a higher risk when it comes to being harmed by untested or unsafe chemicals. SWHR recognizes the impact that the Personal Care Product Safety Act, if it passes, will have on women’s lives and health. SWHR stated in support:

Women use these products daily, and safer, better-regulated personal care items means healthier women and families. SWHR commends this step towards advancing women’s health and the health of all Americans who use these products.

Where is the Personal Care Products Safety Act in the Legislative Process?

As of right now, the legislation has only been introduced into the Senate–it has a long way to go before it becomes a law. But there is some good news: the bill has bipartisan support, which in today’s political climate is certainly rare. Senators Feinstein and Collins are the original sponsors, but they’ve since been joined by four additional co-sponsors: Senator Barbara Boxer (D-California), Senator Amy Klobuchar (D-Minnesota), Senator Mark Kirk (R-Illinois), and Senator Mazie Hirono (D-Hawaii).

In addition to the SWHR, many other advocacy groups support the Personal Care Products Safety Act, including the Endocrine Society, the Environmental Working Group, and HealthyWomen.

Who Doesn’t Support the Personal Care Products Safety Act?

There are some who don’t agree with the tenants laid out in the Personal Care Products Safety Act. For example, People for the Ethical Treatment of Animals (PETA) has brought forth concerns that a greater concentration on testing means that there will be more testing on animals.

Others that disagree with the push for new regulations include members of the personal care products industry, including the Independent Cosmetic Manufacturers and Distributors (ICMAD) which says that it “places too large a burden on small business, stifles innovation in the cosmetics and personal care industry, and does not provide appropriate and significant national uniformity.”

Conclusion

The Personal Care Products Safety Act has a very long way to go before it could be enacted. But it reflects common sense approaches to regulating the personal care industry that haven’t been updated in almost 75 years. In order to ensure the health of all, particularly those who use these products on a regular basis, we need to make sure that there’s accountability and transparency in what goes into our personal care products.

If you would like to support the legislation, click below.

Resources

Primary

Society for Women’s Health Research: SWHR Proudly Supports Personal Care Products Safety Act

U.S. Senate: Personal Care Products Safety Act

GovTrack: S. 1014: Personal Care Products Safety Act

FDA: The 1938 Food, Drug, and Cosmetic Act

FDA: Are All “Personal Care Products” Regulated as Cosmetics?

Dianne Feinstein: Senators Introduce Bill to Strengthen Personal Care Product Oversight

Additional 

Harvard School of Public Health: Harmful, Untested Chemicals Rife in Personal Care Products

Environmental Working Group: Why This Matters–Cosmetics and Your Health

FDA Law Blog: Proposed Personal Care Products Safety Act Would Significantly Expand FDA Authority over Cosmetics

Washington Monthly: Beauty Tips for the FDA 

Women’s Voices for the Earth: Will the New Personal Care Products Safety Act Make Cosmetic Ingredients Safe?

The Huffington Post: New Bill Would Require FDA To Regulate Ingredients In Cosmetics & Personal-Care Products

PETA: Proposed Law Likely to Mean Tests on Animals for Cosmetics Ingredients in U.S.!

Society for Women’s Health Research

The Society for Women’s Health Research (SWHR®), is a national non-profit based in Washington D.C. that is widely recognized as the thought-leader in promoting research on biological differences in disease. SWHR is dedicated to transforming women’s health through science, advocacy, and education. Founded in 1990 by a group of physicians, medical researchers and health advocates, SWHR aims to bring attention to the variety of diseases and conditions that disproportionately or predominately affect women. For more information, please visit www.swhr.org. Follow us on Twitter at @SWHR. SWHR is a partner of Law Street Creative. The opinions expressed in this author’s articles do not necessarily reflect the views of Law Street.

The post The Personal Care Products Safety Act: Modernizing Outdated Regulations appeared first on Law Street.

For many couples, being unable to conceive naturally is a heartbreaking piece of news. Many turn to in vitro fertilization (IVF), which is successful about 30 percent of the time. However, when in vitro is successful, most couples have frozen embryos leftover and are asked what they would like to do with them. The majority of clinics offer four options: embryos can be donated to scientific stem cell research; they can be kept on ice for a several hundred dollar yearly fee; they can be destroyed by the clinic; or they can be donated to other families who struggle with infertility. This last option is called embryo adoption, or “snowflake” adoption. Embryo adoption is a largely unknown practice that has been gaining both notoriety and applause for its ability to help more couples go through the process of pregnancy and birth, giving them children who are not genetically related to their birth parents. Read on to learn about the background of frozen embryo adoption, the regulations on it, and what to expect moving forward.

What is frozen embryo adoption?

The process that leads to frozen embryo adoption usually begins with in vitro fertilization. It is often a practice for the doctor to harvest as many eggs as possible from the woman, thereby creating the maximum amount of fertilized eggs. A few of these embryos are implanted in the woman’s uterus, and the rest are frozen for later use. “Later use” refers to another round of IVF, either because the first round failed or because the couple wanted to expand their family some more. So what happens when a couple decides that their family is big enough? This is where embryo donation–and then adoption–sometimes comes into play.

The embryo donation and adoption process is pretty straight-forward–a couple who decides they want to donate their extra embryos after in vitro fertilization does so, and a couple (or a single woman, although some embryo adoption agencies only allow married couples to adopt frozen embryos) who wants to adopt embryos has them implanted into the woman’s uterus. Hopefully, the implantation takes. Then, a baby is born that is genetically the child of the donor couple.

What is responsible for the rise in frozen embryo adoptions?

The internet is rife with stories of couples who have struggled with infertility. It is a hardship that creates internet bonds between blogging wives and mothers, and fathers and husbands. Infertility is a deeply personal struggle, yet many people find that sharing that struggle online gains them the understanding that they can’t find in their offline life. In many stories of frozen embryo adoptions, this is how it starts. Maybe IFV was unsuccessful. Maybe the couple in question didn’t have the money for IFV at all. Maybe there is a woman who never found that perfect partner in life, and wanted to have a baby anyway. The reasons vary, but a fair number of the stories have similar beginnings–someone who is interested in an alternate path to having children sees an online posting, and then the embryo adoption process begins. A well-publicized example of this is the case of Glenda Lyons, Susan Lindeman, and Dana MacMillan, who all found each other on infertility message boards and are all raising children who are genetically Lyonses, although each family lives in a different part of the country. Their very unique story was documented in a 2009 article in Good Housekeeping.

There are of course many other ways for this process to occur as well. There are private companies that match donors with potential adoptive parents, such as BlessedWithinFertility. That process works much like a dating matchmaker, where the private company works as a consultant to arrange the perfect match between embryo donors and recipients. Clinics that offer embryo adoption have also been on the rise, building off of the Snowflakes Embryo Adoption Program, which began in 1997. The Department of Health and Human Services also has a grant program  to provide funding for clinics that offer embryo adoption as one of their services, and is working to increase public awareness.

It’s important to note that adoptive parents do not need to suffer from fertility issues in order to adopt frozen embryos–that is just the most common reason for deciding to pursue this particular route toward conceiving a child. There are very few guidelines surrounding embryo adoption in the United States, which means that the laws very from state to state. In most cases, anyone can adopt frozen embryos as long as they agree to the terms of the donor. In cases of private adoptions, the donors often set guidelines themselves for what they are looking for in adoptive parents; in the case of the Snowflakes Embryo Adoption Program, a written application and a home visit are necessary before applicants are paired with donors.

Who can donate a frozen embryo?

The market for frozen embryo donation is almost exclusively made up of couples who have successfully conceived through IFV and have embryos left over, and most embryo adoption websites appear to use rhetoric that is only addressed to couples. This makes the decision to donate remaining embryos an immensely personal decision that presumably many couples agonize over. The donation of embryos helps other couples realize their dream of going through pregnancy and childbirth. However, many couples struggle with the realization that there will be more of their biological children out there in the world whom they may never meet. Because of this emotional and personal factor in the embryo adoption process, many couples opt to choose their own embryo recipients, thereby alleviating some of their fears.

While most embryo adoption agencies target couples who have extra embryos left over, there is also the chance that a single woman successfully underwent IVF with a sperm donor and later will want to donate her frozen embryos as well. Since, in most cases of sperm donation, the sperm donor consents to giving up all parental rights, the woman would have the right to decide on her own what to do with the leftover embryos.

Frozen embryo donation is not the same thing as egg donation. Embryos are already fertilized eggs that have been frozen after the fertilization has been successful; egg donation is only the first part of that process, where eggs are harvested but have not yet been fertilized. While women are often actively recruited to donate eggs and are compensated generously for the time and effort, embryo donors are not compensated for their donation and do have other options for what to do with their leftover embryos.

Why is the frozen embryo adoption process controversial?

There are several reasons why embryo adoption is controversial in the United States, and they range from legal to religious in nature. One big reason is that there are no nationwide laws governing embryo adoption, which leaves the decision to each individual state. So far, ten states have enacted laws having to do with embryo adoption. For example, in Florida, Louisiana, Ohio, and Oklahoma, embryo donors have to give up all of their parental rights; in nine states, including Florida, Ohio, and Oklahoma, all decisions must be made in writing. As the topic gains more attention, more states will likely follow suit and regulate the process.

A second controversy falls in the camp of the ethical–if a donor couple decides to do a closed donation (meaning they would give up all right to contact with the recipient and the child), how would the families keep track of each other, and should they? These are just a couple of the reasons why this new process for helping families struggling with infertility is making some people (and lawmakers) scratch their heads in thoughtful silence. Would a federal law help regulate this extremely personal decision? Maybe, but a question asked by many others is whether the government should get involved in this process at all, since it is something that is based on a donor couple’s personal decision.

Are there any controversial supporters?

Many supporters of embryo adoption are devout Christians who oppose abortions. Much of this is based on their interpretation of what frozen embryos are. This makes the option of destroying frozen embryos akin to abortion in the minds of some outspoken supporters of embryo adoption, even if that is not scientifically accurate.

Are there people who oppose frozen embryo adoption?

Yes, there are people who don’t believe embryo adoption is a good idea, but many only balk at the rhetoric used.

To quote Dr. Owen Davis, president of the American Society for Reproductive Medicine (ASRM):

You are putting [couples] through a procedure more akin to adopting an actual live child who has attained personhood, and this is really not the same.

In an article by Aljazeera, the ASRM’s ethics committee was quoted saying that the term “adoption” was “deceptive because it reinforces a conceptualization of the embryo as a fully entitled legal being.”

In other words, many who are pushing back against embryo adoptions are doing so because they don’t believe the terms being used to describe the procedure are accurate.

Conclusion

The growing public knowledge of the process of frozen embryo donation and adoption is bringing the procedure into the forefront of public opinion like it has never been before. Since it is still a relatively new procedure–not quite two decades old–there is still much room for growth when it comes to legislation surrounding embryo adoptions. Currently, there is no national standard, and some people find the procedure to be controversial. It is likely that this process will continue as it becomes more common and more laws are added to the books regarding embryo donation and adoption.

Resources

Snowflakes Embryo Adoption Program: Snowflakes are Falling

WebMD: In Vitro Fertilization (IFV) and Infertility

Aljazeera America: Embryo Adoption Creates Babies – and Controversy

Good Housekeeping: Siblings of a Sort

Pacific Standard: The Frozen Children: The Rise – and Complications – of Embryo Adoption in the U.S.

NYU Langone Medical Center: Donating Your Eggs

National Embryo Donation Center: Donation – The Gift of Life

NPR: The New Frontier of Embryo ‘Adoption’

The New York Times: Industry’s Growth Leads to Leftover Embryos, and Painful Choices

Huffington Post: Evangelicals Embryo Adoption: Devout Christians Seek a Future for Thousands of Frozen Embryos

The Week: Inside the Rise of Embryo Adoption

USA Today: Couples Give Up Frozen Embryos for ‘Adoption’

Fusion: Enter the Wild West of the Embryo ‘Adoption’ Industry

Time: Get Used to Embryo Adoption

PeanutMom.com: The Embryo Donation Dating Game, Part 2

Legal Match: Sperm Donor Parental Rights and Obligations

Stockholm Law: Embryo Donation or Adoption – Which Laws and Policies Should Apply and Why?

Amanda Gernentz Hanson

Amanda Gernentz Hanson is a Minnesota native living in Austin, Texas. She holds a Bachelor’s degree in Chemistry from Hope College and a Master’s degree in Technical Communication from Minnesota State University, where her final project discussed intellectual property issues in freelancing and blogging. Amanda is an instructional designer full time, a freelance writer part time, and a nerd always. Contact Amanda at staff@LawStreetMedia.com.

The post Frozen Embryo Donation and Adoption: A New Trend? appeared first on Law Street.

Malaria is one of the world’s oldest and deadliest diseases. Although it is most prevalent in Africa, everyone is susceptible. Around fifteen hundred cases develop yearly here in the United States. Malaria is a global problem, systematically wreaking havoc on countries’ health cares and economies.

But there’s good news. Just this week, California-based scientists made a huge breakthrough in attempting to eradicate malaria for good. Scientists concluded that genetically modified mosquitoes released into the wild might be the answer. The science gets a little tricky, but the inevitable goal is that the global mosquito population in its entirety will no longer be able to pass on malaria to humans. The method is proactive versus reactive, and hits the source instead of medicating already infected people.

Recent Events

On November 4, researchers reported a medical breakthrough. Scientists had mutated and bred a specific strain of mosquito in order to eradicate malaria globally, according to a report from the Proceedings of the National Academy of Sciences.

Biologists used a gene-editing technology called CRIPR-Cas9. The technology allows scientists to remove segments of DNA from an organism and replace it with new ones. In this specific case, the California-based scientists added a set of malaria-resistant genes that could rapidly eradicate the disease from the mosquito population. The gene causes the mosquito to produce antibodies that kill the malaria parasite, making the mosquito unable to transmit the disease. The scientists used a genetic modification technique called gene drive, which ensures that the malaria-killing gene is effectively passed on to future generations.

So how does the gene drive work? Normally, an offspring receives half its traits from each parent, but the researchers found a way around that. With gene drive, the mutant mosquito passes its genes to both of the offspring’s chromosomes. In other words, one mutated mosquito parent will supply all the inherited traits to its offspring when it mates with another wild mosquito, ensuring that the malaria-resistant gene is passed on. In studies, the mutated mosquitoes with gene drive passed on their malaria resistance to 99.5 percent of their offspring. This kind of results can have enormous potential to spread rapidly in the wild. According to the New York Times, spreading genes at this rate could nearly eradicate malaria from mosquitos in as few as 10 generations. This means that a disease that causes about 600,000 deaths each year could be marginalized in just one season.

Anthony A. James from the University of California Irvine Campus led the development of the malaria-resistant genes while Valentino M. Gantz and Ethan Bier of the San Diego Campus led the research on gene drive. But despite their recent success, the scientists all agree that going forward they must tread carefully when implementing their research. Dr. James, Dr. Gantz, and Dr. Beir plan to further refine the mosquito’s genetics in isolated trials before conducting experiments out in the field. They hope that a malaria-endemic country will eventually invite then to conduct trials in the area.

Although the researchers don’t yet have evidence, there could be adverse health effects to releasing the genetically modified mosquitos into the wild. It remains to be seen what would actually happen when a genetically modified mosquitos bit a human or how the population of mosquitoes will be affected in a much larger trial. The most significant fear is that the created mutations would change in the wild. Natural selection could also favor other genes and the mutated the genes may not be passed down through generations. If biologists needed to keep going back and re-modifying the genes it would become uneconomical and possibly unsustainable.

In the mean time, the research remains under ethical review by a committee elected by the National Academy of Sciences.

Overview of Malaria

How is Malaria Transmitted?

Interestingly, only the female mosquitos of the genus group Anopheles can transmit malaria to humans–it’s actually quite a small group. Altogether, there are 3,500 species of mosquitos categorized into 41 different genera. In the Anopheles genus, there are around 430 species. And of these, only 30-40 species have the ability to transmit malaria.

These specific mosquitoes may transmit the disease if they carry the malaria parasite. The transfer happens when a parasite-carrying mosquito consumes the blood of a human. The maturation of the parasite inside of a mosquito host involves several factors, including temperature, humidity, and the life duration of the host. For example, the parasite generally must reside in the mosquito for 10 to 21 days–this is called the extrinsic incubation period. If the mosquito dies before the culmination of this period, the parasite cannot be transferred. The parasite does not negatively affect the mosquito’s health as it would a human.

Mosquitoes either prefer to feed on humans or animals, designated anthropophilic and zoophilic, respectively. Most Anopheles tend to be neither 100 percent anthropophilic nor zoophilic, meaning that they often don’t have a preference for humans over animals or vice versa. However, two species, An. gambiae and An. funestus, are strongly anthropophilic. This makes them extremely adept as malaria vectors for humans. Since they both reside in Africa, it makes sense that Africa is where we see the most malaria cases in the world.

Sub-Saharan Africa and parts of Oceania are prime locations for the malaria parasite to survive. The climate conditions are optimal–tropical and subtropical locations allow anthropophilic mosquitos to easily reach maturation and breed. For example, the parasite’s growth cycle will stop, preventing transmission, if the temperature is lower than 68 F degrees. High altitudes and deserts will kill the parasite as well. In some endemic areas, transmissions will be more seasonal if the region has a cooler climate.

Symptoms

The malaria parasite is called Plasmodium. Four different species of Plasmodium cause human malaria: P. falciparum, P. malariae, P. ovale and P. vivax. The P. falciparum species causes the most severe symptoms.

Symptoms can occur anywhere from a week to three months after exposure. In very rare cases, symptoms will occur later than three months. Initial symptoms can be relatively mild, including fever, chills, headache, muscular aching, weakness, vomiting, cough, diarrhea, and abdominal pain. These milder symptoms may or may not preface more severe ones, including renal failure, pulmonary edema, generalized convulsions, and circulatory collapse, followed by coma and death. Death can result if P. falciparum is not treated within one week of the beginning of clinical symptoms.

The other three parasites are rarely as life threatening but can still cause extreme distress. P. vivax and P. ovale can reside dormant in the liver for years, and may cause sporadic relapses months, or even years after the first exposure.

A typical malaria attack can last between six and ten hours. At first, a cold stage will bring on cold-like symptoms with shivering. This is followed by a hot stage consisting of fever, headaches, vomiting, and seizures in young children. The attack ends with excessive sweating, followed by the normalization of temperature and tiredness. These attacks will occur every other day or every third day with the P. malariae parasite.

People with weaker immune systems are at a greater risk of infection. These groups usually tend to be young children, pregnant women, people who are immunosuppressed, and elderly travelers. Infected pregnant women are at risk of maternal death, miscarriage, stillbirth, and neonatal death.

Treatment

Treatment for malaria is an ongoing battle. Scientists create a new drug, only for the parasite to alter itself and become resistant. Scientists go back and modify that drug, only for it to happen again. For example, chloroquine (common antimalarial drug) is, for all intents and purposes, useless in many endemic regions due to resistance. Other common antimalarial drugs include Quinine sulfate, Hydroxychloroquine, Mefloquine, and a combination of atovaquone and proguanil.

The recommended drug and the length of use both depend on the specific malaria parasite, symptoms, age, and whether the patient is pregnant.

Worldwide and the United States

Each year, there are 300 to 500 million clinical cases of malaria reported worldwide; 90 percent of these cases originate in Africa and approximately one million cases result in death. There are over 90 endemic countries globally, putting 40 percent of the world population at risk of malaria infection.

On average, a child dies from malaria in Africa every 30 seconds. The most common age of death is just four years old. Malaria kills 5 percent of African children. This equates to nearly 3,000 deaths each day. An estimated 23 percent of African infants are born with the malaria parasite. Many families simply cannot afford to be sick. A single malaria attack can cost approximately 10 to 20 working days in India and Africa.

Although most cases occur in Africa, the West is not immune. The Centers for Disease Control (CDC) reports 1,600 to 2,000 cases in the United States each year. But CDC believes only half of malaria cases in the United States are actually reported.

Americans that travel to endemic countries are also at high risk of contracting the disease. Biting an infected person who has previously traveled to an endemic country can infect a local mosquito, which can then continue to transmit the virus. In the past five years, there have even been cases of local transmissions in California, Texas, Michigan, and the greater New York City area.

Conclusion

This is exciting news! But this research still faces several challenges and will remain controversial. We do not yet know how introducing genetically modified mosquitos will affect the current population and many people are wary of manipulating genetics to this extent. Introducing anything into the wild could have unforeseen consequences to the environment and fragile ecosystems. But if this research continues its success, these scientists may have found the cure to one of the deadliest diseases in the world.

Resources

Primary

PNAS: Highly Efficient Cas9-Mediated Gene Drive for Population Modification of the Malaria Vector Mosquito Anopheles stephensi

WHO: Malaria

CDC: Anopheles Mosquitoes

CDC: About Malaria

CDC: Where Malaria Occurs

Additional

The National Academies of Science: Project Information

The New York Times: Engineering Mosquitoes’ Genes to Resist Malaria

Mayo Clinic: Malaria

The Washington Post: Scientists create a mutant mosquito that could help eradicate malaria

Jessica McLaughlin

Jessica McLaughlin is a graduate of the University of Maryland with a degree in English Literature and Spanish. She works in the publishing industry and recently moved back to the DC area after living in NYC. Contact Jessica at staff@LawStreetMedia.com.

The post Malaria: Did Scientists Finally Find a Solution? appeared first on Law Street.

Sponsored Content

Lately, we’ve been inundated with information on women’s underrepresentation in the fields of science, technology, engineering, and mathematics (STEM). But what doesn’t get a lot of recognition is that inequality in science doesn’t just apply to the gender of the people working on new developments–it can extend to the nature of the developments themselves. Medical research has a history of being disproportionately biased toward men, despite the fact that differences between the sexes affect everything from how diseases should be treated to how medications are developed. Bias in medical research extends beyond the lab, and that’s a problem. Read on to learn about the need for equality in medical research, and how ensuring that equality is a step toward good health for all.

History of Sexism in Science

Sexism has been endemic in many aspects of scientific research; a full historical review would be as lengthy as it would be disheartening. But it’s important to recognize a consistent tradition of sex-based inequality in medical research. It has long been assumed that conclusions can be applied generally to both men and women, without taking into account the need to design studies that focus specifically on the biological and physical differences between the sexes. There have been myriad reasons for this lack of female inclusion. Science was heavily focused on studying the “norm,” and the “norm” as pertaining to scientific research was a roughly 155-pound man. Moreover, it was believed that the only difference between men and women were their respective sex organs. Furthermore, concerns regarding testing on pregnant women, or potentially-pregnant women, and the harm that could happen to fetuses discouraged researchers from including women of child-bearing age, and sometimes women as a whole due to their changing hormone cycles.

However, those assumptions finally began to change, albeit slowly, in the later decades of the 20th century. In 1985, a report released by the Public Health Service Task Force on Women’s Health Issues concluded that “the historical lack of research focus on women’s health concerns has compromised the quality of health information available to women as well as the health care they receive.” Founder of the Society for Women’s Health Research (SWHR ®) Dr. Florence Haseltine, MD, PhD, was working for the National Institutes of Health (NIH) in the mid-1980s when she began championing the need for medical research that recognized differences between men and women. She eventually coined the term “sex-based biology,” essentially meaning the study of the sex differences between men and women and how they apply to different aspects of medical research and health. Dr. Haseltine worked to confront different ways in which this inequality was manifested, including by advocating for more women to be included in clinical trials. Despite the fact that the NIH had recognized that inclusion of women in clinical trials is essential, they still aren’t always included.

These revelations sparked action by government agencies including the NIH, the Food and Drug Administration (FDA), and the Congressional Caucus on Women’s Issues. But it correspondingly also sparked the need for an organization that could champion the cause of sex-based biology head on. The Society for Women’s Health Research (SWHR) was founded in 1990 to “bring attention to the lack of inclusion of women and minorities in medical research and clinical trials.”

While progress has been made in including women in scientific research, there’s still substantial work to be done. Women and minorities remain underrepresented in clinical trials and medical research.

Why is it so important that sex differences are taken into account in medical research?

Put simply: men and women are biologically different. Health differences between men and women range from a prevalence of a particular disease, to the ways in which it manifests itself, to the drugs used to treat it. For example, SWHR focuses on Alzheimer’s Disease and Cardiovascular Disease (CVD) as two of the many illnesses that deserve a look through a sex-based biological lens.

Alzheimer’s Disease 

Alzheimer’s Disease is one example of a condition that disproportionately affects women. In fact, women are almost twice as likely to be affected by Alzheimer’s as men. Overall, it is the fifth most common cause of death for American women. This increased prevalence for women isn’t just coincidental. There are specific sex differences that need to be taken into account when it comes to the study of how and why Alzheimer’s Disease strikes some and not others. According to experts at SWHR’s Alzheimer’s Roundtable, there are many different factors to consider:

Women suffering from depression have a 90 percent increased risk compared to men and an even greater risk after menopause, due to decreased estrogen levels. Another risk factor is having a hysterectomy and ovaries removed. Women who remove their ovaries before the age of 48 have a 70 percent increased risk of developing Alzheimer’s. However, if that woman used estrogen hormone therapy until menopause, she reduces her risk.

In order to prevent the devastating onset of Alzheimer’s–which is estimated to affect 15 million people over the next 15 years–it is essential to understand what role sex differences play and how women’s physiology can make them, in some cases, more susceptible.

Cardiovascular Disease (CVD)

Despite popular perception about its frequency in the male population, cardiovascular disease (CVD) remains an acute problem for women. In fact, CVD accounts for one in three deaths among American women–more than all cancers combined.

It’s also another example of an illness that can manifest differently between men and women, and has different risk factors. For example, CVD appears on average seven to 10 years later for women than men. There are also risk factors that are more visible for women than men, such as the fact that young women who smoke are at a higher relative risk for developing CVD than men who smoke.

Moreover, the way that CVD presents in women can be different than in men–sometimes leading to a failure by healthcare professionals to detect symptoms in a timely fashion. Women’s symptoms can include fatigue and indigestion, and can appear up to a month before a heart attack. These differences can also lead to misdiagnosis when a woman is actually experiencing a cardiac event–a study in The New England Journal of Medicine found that women under 55 were seven times more likely to be misdiagnosed than men. It’s important that researchers and doctors consider how not only different sex-based risk factors contribute to CVD, but also how different symptoms present themselves.

Another issue with a male-centric view of CVD is that symptoms that are more prevalent for men have been more widely publicized and focused upon in public service campaigns. As a result, women may not recognize the symptoms or risk factors themselves–the following video created by SWHR highlights some of the gaps in public knowledge:

Continued Underrepresentation in Clinical Trials and Research

It’s evident that progress has been made in including women in clinical trials–particularly when it comes to specific topics like heart disease and breast cancer. However, there’s still much work to be done. As recently as 2014, the FDA moved toward greater transparency in disclosing the sex breakdown of those who participate in clinical trials. However, that news was bittersweet–it confirmed long-standing concerns about the inclusion of women in clinical trials. SWHR released a statement about the FDA’s disclosure, stating:

We commend the FDA for the effort in collecting and releasing these data to the public and we believe it is an initial first step towards reducing the disparities and lack of information on sex and ethnic differences. But as is evident, the percentage of minority participation is dismal and while there are women in all of the trials, the numbers are not statistically significant to reach any clinical relevance.

So, where are researchers still struggling when it comes to including women in clinical trials and research?

Cardiovascular Disease Clinical Trials 

While the risk of CVD has been well-recognized by proponents of sex-based biology, and women have been increasingly included in studies about cardiovascular disease, there’s still a struggle to make sure that studies report on gender differences. According to a 2009 paper by the American Heart Association (AHA) on the “Status of Women in Cardiovascular Clinical Trials,” both government and non-government studies continued to fail to report on sex differences in CVD studies between 2000-2006. The AHA stated:

An analysis of trials included in Cochrane meta-analyses (Cochrane Systematic Reviews) for the inclusion of women in cardiovascular clinical trials and for the reporting of gender-based analyses showed similar results. Of 258 clinical trials studied, women constituted only 27 percent of the pooled population and of 196 trials which included both genders, only 33 percent reported gender-based outcomes. When analyzed by year of publication before or after 1993, there was no difference in the frequency of gender-based analyses.

In order to ensure that the differences in the ways that women and men present and experience CVD are taken into account, reporting on sex differences in clinical trials needs to be a priority.

Conclusion

There’s no doubt that we’ve come far in this field and an improved concentration on exploring sex-based biology has resulted in a better understanding of sex differences–but we need to continue to such efforts in order to promote good health for all men and women. Clinical trials need to be designed to ensure not only the inclusion of, but also the recognition of their differences. Working toward inclusivity of medical research will benefit us all by increasing our understanding of what causes various illnesses and how to treat them.

Resources

Primary 

Society for Women’s Health Research: History

Society for Women’s Health Research: Timeline

Society for Women’s Health Research: News

U.S. Department of Health and Human Services: Leading Causes of Death

Additional

Journal of Applied Physiology: Sex and Gender: What is the Difference?

American Heart Association: Status of Women in Cardiovascular Clinical Trials

Chronic Neuroimmune Diseases: Yes, Biologically Speaking, Sex Does Matter

American Journal of Nursing: Progress, Not Perfection

Newswise: Alzheimer’s and the Downward Spiral: SWHR Holds Congressional Briefing About Women and Alzheimer’s Disease

Netherlands Heart Journal: Gender Differences in Coronary Heart Disease

Heart Sisters: Heart Attack Misdiagnosis in Women

Society for Women’s Health Research

The Society for Women’s Health Research (SWHR®), is a national non-profit based in Washington D.C. that is widely recognized as the thought-leader in promoting research on biological differences in disease. SWHR is dedicated to transforming women’s health through science, advocacy, and education. Founded in 1990 by a group of physicians, medical researchers and health advocates, SWHR aims to bring attention to the variety of diseases and conditions that disproportionately or predominately affect women. For more information, please visit www.swhr.org. Follow us on Twitter at @SWHR. SWHR is a partner of Law Street Creative. The opinions expressed in this author’s articles do not necessarily reflect the views of Law Street.

The post Sexism in Science: Bias Beyond the Lab appeared first on Law Street.

A recent report from several environmental consumer advocacy groups graded of 25 of the leading fast food restaurants on the use of antibiotics in the meat they use, and for anyone concerned with the use of antibiotics in the food supply the results are illuminating. The report yielded some surprising ratings for America’s most popular fast food restaurants, giving only two an A grade.

We often hear about the use of things like antibiotics, hormones, and other additives in our food, but not everyone knows exactly what effects they have on our health. Read on to learn more about what’s in your food and what’s being done to make sure everything we consume is healthy.

 Antibiotics

When most people think about antibiotics the first thing that comes to mind is the medicine you get for strep throat or ear infections, so how are antibiotics important in terms of what we eat? The answer lies at the beginning of the food production, when farmers raise livestock for food.

The purpose of antibiotics is to kill harmful bacteria, which is important for both humans and for animals in the food supply. The problem is that they do not necessarily kill all the bacteria. For example, they may kill 99 out of 100 bacteria cells. However, the one percent that survives is immune to the antibiotic and reproduces. Over time, the resistant bacteria can reproduce, making the antibiotic no longer effective, which mean that a stronger medicine is needed to kill the bacteria. Resistant bacteria may also be transmitted to humans during consumption, which can lead to significant health concerns. The growing population of resistant bacteria could pose a significant health risk as antibiotics become less and less effective.

Farmers treat their animals with antibiotics for several reasons, but most importantly they do it because they want to keep the animals healthy. The use of antibiotics has also led to larger and heavier animals, which also means more profit. The central issue with the use of antibiotics in livestock is the fact that they are used when they are not actually needed. While few argue that antibiotics should never be used on animals, the use of “sub-therapeutic” doses, which are given when an animal is not sick is what most people have a problem with. Over time, these doses lead to resistant bacteria, which may be transferred to humans when consuming meat.

FDA regulations instruct farmers to use antibiotics only when an animal is sick or if there is an unusually high risk of disease, but that is not always the case. According to the Friends of the Earth and National Resource Defense Council mentioned above, 70-80 percent of the antibiotics used in the United States are given to animals. The report found that 20 of the top 25 fast food chains received a failing grade for their antibiotics policies.

Hormones

Like antibiotics, hormones are used to make animals bigger and stronger. But the hormones contained in the meat that people eat is passed along to humans as well. The FDA approves and regulates all hormones that are used in food production. The amounts allowed in food are determined by the FDA through research and are supposed to be well below the levels that naturally occur in the human body, thereby preventing any negative effects.

When it comes to hormones, there are a lot of gray areas in terms of their health effects. The two largest concerns associated with their use are a possible increased risk of cancer and the early onset of puberty in children. Existing studies suggest that lifetime exposure to hormones like estrogen can be linked to greater risk of cancer, and hormones previously used in animals have actually been tied to cancer risk. Diethylstilbestrol (DES), was a used in the 1960s and was connected to heightened risk of certain forms of cancer, but DES use ended after this connection was discovered. The amount of estrogen present in food is significantly lower than levels that naturally occur in our bodies. Currently, there is not sufficient evidence to draw a clear connection between growth hormone use in animals and an increased risk of cancer. Hormones given to animals are essential for growth and development, and the FDA regulates them to ensure that their presence in our food remains at safe levels. According to the FDA:

People are not at risk from eating food from animals treated with these drugs because the amount of additional hormone following drug treatment is very small compared with the amount of natural hormones that are normally found in the meat of untreated animals and that are naturally produced in the human body.

One issue that has a stronger connection to the use of hormones in the food supply is the early onset of puberty in children. On average, children have been starting puberty earlier than in the past, which some scientists have linked at least in part to the presence of hormones in food. While food still has relatively low levels of these hormones, their mere presence can cause children to reach puberty earlier. Although studies have found a connection, the use of hormones, like most many food-related health issues, still requires further research to clarify the link.

Pesticides

While antibiotics and hormones are designed to fatten animals, pesticides serve a similar purpose for fruits and vegetables. Pesticides do not increase the size of fruits or vegetables, but they do help ensure their survival from threats such as insects or weeds. They also kill potentially harmful organisms such as mold or fungus which can grow on foods.

Due to the widespread use of such chemicals on most foods the EPA and similar organizations in other countries have set tolerances for the amount allowed in foods. These tolerances are set after conducting risk assessments, which look at the potential health risks of individual pesticides. Once the tolerance has been set, it is then enforced by the USDA and FDA, or a corresponding agency in another nation. Yet several questions remain about the use of pesticides as well as their effects on humans and the environment. Pesticides are not allowed to be used on foods until they have gone through an assessment and they are also occasionally re-evaluated to make sure the set tolerance is appropriate. Re-evaluating pesticides is the primary way to address issues with tolerances and new information about health effects.

Preservatives

Preservatives, like other food additives, are in foods to serve a purpose beyond increasing profits, but they also come with their own risks. Generally speaking, the purpose of preservatives are to make food last longer and prevent rotting.

While preservatives help keep things fresh, they may also harm the people who ingest them. A recent study by immunologists at Georgia State University found that pesticides can erode a protective lining in the colon, which can lead to inflammation and even change the nature of bacteria located there. This has been linked to higher rates of inflammatory bowel disease and obesity.

Preservatives are regulated by the FDA, which has the final say on which additives are approved for consumption. While the FDA regulates the use of preservatives, most additives are never actually tested by the FDA. This is because the FDA uses the GRAS labeling system for many things that are added to food. GRAS, an acronym for the term “Generally Recognized As Safe,” allows producers to add things to food according to established practices, but without requiring pre-approval from the FDA. While this system expedites the rate at which new products can go on the market, there have been several instances where the FDA approved the use of a certain additive, only to repeal it later when they proved to be carcinogenic. Examples of this include Cyclamate, Safrole, Saccharine, and most recently, trans fats.

The video below looks at a variety of food additives and their uses:

The Future of Food

Organic Food, Buying Local, and Farmer’s Markets

According to the United States Department of Agriculture (USDA), organic food is “produced without antibiotics, hormones, pesticides, irradiation or bioengineering.” By its very definition then, organic food has the potential to alleviate many of the alleged effects of added ingredients simply because it does not have them. What’s more, becoming certified organic by the USDA is a long, difficult, and expensive process. As a result, the validity of this label also comes with a certain amount of clout. In 2014, the combined sales of organic food in the United States was up 11.3 percent from the previous year to $39.1 billion, approximately five percent of the entire food market.

The rise in organic food sales can, at least in part, be associated with the rise in farmers’ markets. Between 2006 and 2014 the total number in America rose 180 percent to 8,268. Farmers are also turning to selling to local restaurants, distributors and even directly to local schools. Aside from offering food that does not contain any of the additives listed above, doing so has the added impact of reducing fuel costs and pollution.

The Food Industry

Another major change is on the part of the traditional food industry, from grocery stores to restaurants. With organic food emerging as a major trend, supermarkets have been quick to respond. Chains such as Whole Foods have been some of the most successful stores, as their businesses operate on the notion of selling these types of foods.

Fast food, on the other hand, is under a tremendous amount of pressure to use healthier food with fewer additives. The industry has taken some important steps, but based on evaluations like the report mentioned at the beginning of this piece, it has a long way to go. Even before the release of that report, efforts had been underway to rid menus of additives, GMOs, and the equally demonized high-fructose corn syrup. Industry leaders like Panera and Chipotle stopped using these ingredients in their food long before the issue came back up in the news.

Like the use of additives, organic foods also have their own costs and benefits. The first is price–organic food is notoriously more expensive than its non-organic counterparts, as are the prices in restaurants that serve them. Additionally, it is still unclear if they offer any more nutritional value than non-organic foods beyond the absence of additives, hormones, and pesticides. The following video details the pros and cons of organic food:

Conclusion

When people eat food that has antibiotics, hormones, or preservatives, these additives become part of the body and may have adverse effects on their health. We have recently taken important steps to understand what exactly goes into our food and how that affects our health, but there is still a lot that remains unknown. Buying organic food and trying to reduce the use of pesticides and certain additives is an important step to ensure that everything we consume is healthy. But taking these steps to monitor what we eat is only part of the equation; we also need more research to determine exactly how our bodies react to various things that are added to what we eat. While the FDA, USDA, and EPA regulate food production to ensure pesticides, additives, and hormones do not exceed safe levels, these regulations evolve with research. It is up to every individual to make their own informed choice based on their own means. When choosing food people should identify what goes into what they consume and how it is produced. As research progresses, recommendations and regulations can and will continue to change.

Resources

Primary

FDA: Steroid Hormone Implants Used for Growth in Food-Producing Animals

EPA: Pesticide Tolerances

Additional

Frontline: Is Your Meat Safe?

CNN: Report Examines Antibiotics in Meat on Fast Food Menus

Nature: Food Preservatives Linked to Obesity and Gut Disease

Organic Trade Association: U.S. Organic Industry Survey 2015

NPR: Are Farmers’ Market Sales Peaking? That Could be a Good Thing for Farmers

RxList: Antibiotic Resistance

Health: America’s Healthiest Grocery Stores

Entrepreneur: 7 Major Restaurants That are Getting Rid of Artificial Ingredients

National Institute of Health: NIH Human Microbiome Project Defines Normal Bacteria Make-up of the Human Body

Sustainable Tables: Additives

Organic Consumers Association: Beef, Hormones Linked to Premature Onset of Puberty & Breast Cancer

Michael Sliwinski

Michael Sliwinski (@MoneyMike4289) is a 2011 graduate of Ohio University in Athens with a Bachelor’s in History, as well as a 2014 graduate of the University of Georgia with a Master’s in International Policy. In his free time he enjoys writing, reading, and outdoor activites, particularly basketball. Contact Michael at staff@LawStreetMedia.com.

The post What’s in Your Food?: A Look at Regulating the Food Industry appeared first on Law Street.

While many people from the United States often concern themselves with “female genital mutilation” in other countries, very few mainstream media sources focus on the nonconsensual surgeries on infants’ genitals that are frequently performed in hospitals in the United States. Approximately one out of every 1,200 births in the U.S. is an intersex child, and doctors generally treat these infants with genital surgeries.

What is the purpose of these genital surgeries, and why do intersex people and advocates often call these surgeries genital mutilation?

What Does it Mean to Have Intersex Traits?

Before discussing surgeries, it is first necessary to define what is meant by “intersex.” The Survivor Project defines intersex as:

The word that describes those of us who, without voluntary medical interventions, possess bodies that doctors can’t neatly classify as male or female. This includes people who have chromosomal sex other than XX (female) or XY (male), or primary or secondary sex characteristics that defy the medical definitions of male and female. Somehow, doctors [react negatively] when a newborn baby is found to be intersexed, and often mutilate her or his genitals to conform them to the doctors’ idea of what a normal baby should look like, even though intersex conditions usually do not threaten the health of the infant. Parents are often not given enough information or support to make an informed decision regarding their babies’ care.

Put another way, Inter/Act, a youth group for youth with intersex conditions, explains being intersex as:

An umbrella term describing people born with variations of internal and/or external sex anatomy resulting in bodies that can’t be classified as the typical male or female. We’re usually taught that sex is merely black and white, “male” or “female,” but that’s simply not true. There are a lot of awesome gray areas in the middle that could make someone intersex.

People with intersex traits are sometimes included in the LGBTQI acronym, but it is important to point out that being intersex does not necessarily mean that someone will not be straight. As a volunteer contributor to “Everyone is Gay!” and someone with intersex traits, Claudia of everyoneisgay.com writes of the debate regarding intersex inclusion and exclusion in queer circles:

People have questioned whether intersex issues really “fit” into the LGBT acronym or not. The LGBT acronym represents those with sexual orientations and gender identities outside the normative party line. And intersex isn’t a sexual orientation or a gender identity–it’s a bodily way of being. (Things can get a bit tricky here–some intersex people might identify their gender identity as “intersex,” and we need to allow intersex people–like all people–the room to identify however is authentic. Strictly speaking, however, intersex is about biology.)…Although intersex is about bodies, intersex people are fighting to be accepted, respected, and protected for being perceived as outside the norm. Since issues of bodily diversity are also often tied up in misunderstandings about how sex, gender, and sexual orientation fit together–hence, why so many people still advocate for “fixing” intersex people to make us “normal,”…including intersex people in LGBT issues makes a lot of sense…Many intersex people support adding the “I” and the LGBTQIA acronym, but some have been hesitant to support this inclusion because they don’t feel an affinity with the queer community. This stems (at least in part) from the perception that intersex people have to be L, G, B, or T in addition to being intersex for inclusion to make sense. But this doesn’t have to be the case.

What is Intersex Genital Mutilation?

Since the 1950s, when infants with intersex characteristics are born in the United States, doctors have chosen with overwhelming frequency to ignore the principles of informed consent and patient-centered models, instead choosing to follow concealment-centered models of care.

Doctors practicing concealment-centered models of care on intersex infants believe that genital “[r]econstruction to create normal functioning genitalia… performed using many different techniques” is a necessary part of giving infants with intersex traits a certain quality of life. To doctors who perform these surgeries, “the most important factors in the sex assignment of intersexed children are achieving a “normal” appearance of the genitalia in the assigned sex, and sexual function. If a male’s phallus is deemed unlikely to be able to “perform” adequately, then re-assignment as a female may become the preferred medical choice. But appearance and sexual function is not the only factor used in sex assignment – many laboratory tests are also done to determine the child’s genetics and potential for fertility.”

Before performing these surgeries, doctors evaluate certain standards before determining whether their surgical intervention will be aimed toward creating more male external genitalia or more female external genitalia. Some of these standards include the ability to ensure that children who will be raised as young boys can urinate while standing, and that children who will be raised as young girls will not have testes. Doctors make these determinations in order to allow children to grow up with genitalia considered typical for their gender.

This model of care encourages doctors to

Carry out largely unregulated and controversial surgeries that aim to make an infant’s genitals and reproductive organs more normal but can often have unintended consequences, according to intersex adults, advocates and some doctors…A long and gut-wrenching list of damaging side effects—painful scarring, reduced sexual sensitivity, torn genital tissue, removal of natural hormones and possible sterilization—combined with the chance of assigning children a gender they don’t feel comfortable with has left many calling for the surgeries to be heavily restricted.

Because one of the standards that doctors use to provide these surgeries is the potential for an infant to eventually have penetrative vaginal sex, many strenuously assert that surgeries on intersex infants is not about the health of the infant, but rather about their potential to successfully perform–both in genital appearance and in sexual activity–heterosexual sex.

Studies show that infants subjected to these surgeries, upon coming into adolescence and adulthood, are dissatisfied with the decisions and abuse inflicted on them by medical providers. Intersex advocates question both the legalities and the ethics of doctors who treat intersex infants with these surgeries. The website of Advocates for Informed Choice, an organization dedicated to the legal rights of those with intersex traits, explains:

These special legal needs are often neglected in the United States, but the Parliament of the European country of Malta has recently banned “normalization” surgeries on intersex infants. Maltese doctors are no longer permitted to perform medically unnecessary genital procedures on intersex babies. This ban is in keeping with a 2013 U.N. Special Rapporteur on Torture report, which acknowledges that intersexuality rarely poses a threat to a person’s health, and therefore, performing irreversible “normalization” surgeries to “correct a problem” that doesn’t medically exist is immensely harmful to intersex people.

What is Being Done?

Many intersex people who have been harmed by genital surgeries when they were infants become activists advocating against the future use of these irreversible, medically unnecessary procedures. By advocating for informed consent and patient-centered models of care, people with intersex traits are working to change the medical landscape to ensure that intersex genital mutilation is no longer the default response to intersexuality in infants born in the United States.

Resources

Inter/Act: What is Intersex?

Storify: Female Circumcision and White Savior Complexes

Organization Intersex International: Intersex Genital Mutilation

Organization Intersex International: Words from Malta, the First Nation to Ban Intersex Genital Mutilation

Everyone is Gay!: “Are Intersex People Inherently Part of the Queer Community?”

Gender Blender Blog: Why Surgical Sex “Correction” of Intersex Babies is Genital Mutilation

Survivor Project: Introduction to Intersexuality and Intersex Activism

U.C. San Diego LGBT Resource Center: Intersex: The Basics

Attorneys for the Rights of the Child: Lawsuit Filed Regarding Genital Mutilation of Intersex Children

Intersex Society of North America: Top 10 Myths

Intersex Society of North America: Frequently Asked Questions

Open Society Foundations: Why Are Doctors Still Performing Genital Surgery on Infants?

The Atlantic: Should We ‘Fix’ Intersex Children?

Jennifer Polish

Jennifer Polish is an English PhD student at the CUNY Graduate Center in NYC, where she studies non/human animals and the racialization of dis/ability in young adult literature. When she’s not yelling at the computer because Netflix is loading too slowly, she is editing her novel, doing activist-y things, running, or giving the computer a break and yelling at books instead. Contact Jennifer at staff@LawStreetMedia.com.

The post Infant Intersex Surgery: Genital Mutilation in the U.S.? appeared first on Law Street.

A report recently released by the National Center for Health Statistics revealed some good news for our nation’s population growth for the first time since the beginning of the Great Recession. According to the study, the number of babies being born and the fertility rate increased by one percent–the first birth rate increase since 2007.

Growing birth rates are very important for a nation for a number of reasons, and the recent surge in births also points to several positive indicators, such as greater financial security. Read on to learn about the fuss about the birth rate, what it means for America, and what we need to consider about population growth moving forward.

A History of Fertility

To start, it is important to understand the terminology associated with birth rates. This begins with Total Fertility Rates (TFRs). This measures the average number of children a woman will have over the course of her life. Another term to understand is replacement level. The replacement level is the TFR required to maintain zero population growth, basically the number of births needed to equally replace the adults who are having babies. The United States’ replacement level is roughly 2.1 births per women. It is higher than two because it factors in the unfortunate truth that some people will die before they reach adulthood and can reproduce.

Around the turn of 20th century, the fertility rate in the United States was over three. The rate then dropped precipitously following the Great Depression, but that trend somewhat reversed leading into World War II, and the TFR continued to stay above replacement levels until the 1970s. There was a slight drop in the rate in this era, during the oil crisis. However, when the economy began to rebound again, so did the nation’s TFR, which continued at or above replacement levels until the Great Recession. The video below shows the correlation between birth rates and the economy:

Based on this data, it seems obvious that the number of births in the U.S. is tied to the success of the economy. But a more nuanced explanation is also required. For example, even when birth rates cratered during the Great Depression, they still remained higher than the birth rates following the uptick of the 1980s and 1990s. Essentially, the economy plays an important role, but current culture does too.

Falling Birth Rates

The recent low birth rates in the U.S. are not unique. In fact low birth rates might be the clearest predictor of a country’s level of development. In several European countries and Japan, the birth rate is 1.5 or lower, meaning below replacement levels. So, why is this happening and what do these shrinking birth rates mean? First let’s analyze the “why.” One of the common threads between these countries, besides a higher standard of living, is the improved status of women.

More Access to Education

One of the major factors in dictating how many children a woman is likely to have is how educated that woman is. It has been repeatedly shown that women who are exposed earlier to education and continue with their studies have lower birth rates. Conversely, in other nations in which this is not true, such as Eritrea on the eastern horn of Africa, birth rates are much higher at 4.6. This stands in stark contrast to highly educated Japan’s birth rate of 1.4.

Having Children Later

While the recent data did indicate that American women had more children last year, it also revealed something else interesting. Most of the women having those children were older, in the age groups of 30-34, 35-39, and even 40-44. On the other hand, women in the age bracket spanning 20-24 saw their number of births continue to decline.

Although having children later is not the taboo it once was, having a baby after the age of 40 still carries with it an added weight of potential health risks. But thanks to the fact that older woman are often healthier, more prepared financially and mentally, and are generally better educated, many of these concerns can be off-set.

Immigration

Following the “why” is the “what”: what do shrinking birth rates mean? One of the most important is that low birth rates can have a dramatic impact on immigration. Namely, in countries with low birth rates like Japan or Germany, immigration is needed to simply maintain the current size of the population. Additionally, since many of these countries will start or have already started to have a disproportionately older population, immigration can provide a needed youth infusion.

Who is Going Pay for All This?

There is a lot riding on how these countries either maintain or increase their populations. Specifically, developed nations need people to pay for the wide-reaching entitlement programs enjoyed by older citizens as they retire, such as Social Security in the U.S. It becomes harder for the population to support these programs when the number of people paying into them shrinks. As populations grow older, the number of people depending on them will continue to increase. With this is mind, countries with low birth rates either need to accept immigrants or find new ways to boost their populations naturally.

The Future of Babies

How are countries trying to up their birth rates?

While these countries grapple with declining birth rates and the need for more immigration, to quote a poem by Dylan Thomas, they, “do not go gentle into that good night.” Indeed, many of these countries already have plans in place to reverse their falling birth rates.

In Japan nearly $30 million has been designated for encouraging young, single people to meet and eventually get married. In Russia, the government directly gives couples up to $12,500 for having a second child or adopting. Many European countries meanwhile, focus on benefits after the baby is born, providing lavish maternity leave or child care. The United Sates is actually an outlier on this front, as it does not offer guaranteed maternity leave and really only provides minor tax breaks to women having children. This may explain in part why older, more secure women are the ones increasingly having children in the US.

Assistance from Technology

Technology is also playing a greater role in the number of births each year. In the United States for example, approximately 2,000 more babies were born in 2013 than in 2012 through in vitro fertilization, when an egg is directly impregnated in a medical procedure. However, there are various kinds of fertility treatments–combined they accounted for 1.5 percent of all births in the U.S. in 2013.

Private companies are also stepping into the proverbial baby-making arena. Both Apple and Facebook are offering programs that will pay to have their female workers’ eggs frozen. The idea is that once these women are at a point in their career where family seems more accessible or appropriate they can then use their frozen fertilized eggs to have children.

This approach has received mixed reviews however. While some laud the efforts as providing an avenue through which women interested in pursuing a career and a family can still hope to travel, others see it differently. To the second group, this approach does nothing to address the reasons why women feel compelled to choose. Additionally the health risks associated with having children from frozen eggs versus unfrozen are no less diminished in older women.

Conclusion

Moderating population size is a tricky task. At times it has been predicted that the growing population is unsustainable and that we are headed for disaster. Conversely, people are currently concerned about not having enough children and the subsequent dangers that would present to society.

In the United States, the birth rate has been falling more or less steadily for the last one hundred years and now hovers right around replacement levels. While there seems to be optimism following last year’s uptick in births, it follows on the heels of several years of consecutive declines that put the U.S., like many of its developed contemporaries, below replacement levels. It is still unclear if the recent increase is sustainable.

Perhaps what the declining birth rates have revealed most clearly is the changing role of women and the continued changes necessary for women to have children and still be able to pursue a professional career. The importance of this issue can be showcased by both national and private efforts to address it. Still, as of right now, the issue remains unresolved and a remedy is unclear. Even with birth rates recently back on the rise, in the future the concerns may change from the number of mouths to feed to whether or not we even have enough people to help feed them.

Resources

Primary

United Nations: Total Fertility Rate

World Bank: Fertility Rate, Total (births per woman)

Additional

Time: Rising Birth Rates a Good Sign for the Economy

Deseret New National: Can Government Incentives Reverse Falling Birth Rates?

Population Reference Bureau: World Population Data Sheet 2012

Earth Policy Institute: Education Leads to Lower Fertility and Increased Prosperity

Time: Women Keep Having Kids Later and Later

Yale Global Online: The Choice: More Immigrants or Less Citizens?

Genius: Do Not Go Gentle Into That Good Night

Health Day: In Vitro births Continue to Rise in the U.S.

CNN: Egg-Freezing a Better Deal for Companies Than for Women

Michael Sliwinski

Michael Sliwinski (@MoneyMike4289) is a 2011 graduate of Ohio University in Athens with a Bachelor’s in History, as well as a 2014 graduate of the University of Georgia with a Master’s in International Policy. In his free time he enjoys writing, reading, and outdoor activites, particularly basketball. Contact Michael at staff@LawStreetMedia.com.

The post Falling Fertility: The Impact of Declining Birth Rates appeared first on Law Street.

Post-traumatic stress disorder, or PTSD, is often the subject of daily life experiences and intense internet debates on topics such as trigger warnings or the United States’ use of drones. Rates of PTSD are known to be dramatically affected by racism, sexism, queerphobia, and other forms of oppression.

But what about people who witness extreme traumas without necessarily experiencing the trauma themselves? Lawyers, doctors, social workers, and teachers all are at a high risk of experiencing something variously called vicarious trauma, secondary trauma, or compassion fatigue.

How might legal office cultures leave people from law students to defense attorneys extremely susceptible to vicarious trauma? And, significantly, what impact does this have on clients?

When Trauma is Contagious

Vicarious trauma is often popularly defined in terms of professionals, like lawyers, who work with people who have been traumatized. A form of PTSD in its own right, people enduring vicarious trauma experience symptoms similar to more widely recognized PTSD. The National Child Traumatic Stress Network refers to vicarious trauma as “secondary traumatic stress,” and defines it in this way:

Secondary traumatic stress is the emotional duress that results when an individual hears about the firsthand trauma experiences of another. Its symptoms mimic those of post-traumatic stress disorder (PTSD). Accordingly, individuals affected by secondary stress may find themselves re-experiencing personal trauma or notice an increase in arousal and avoidance reactions related to the indirect trauma exposure. They may also experience changes in memory and perception; alterations in their sense of self-efficacy; a depletion of personal resources; and disruption in their perceptions of safety, trust, and independence.

All of these trauma responses often lead to more commonly known experiences, such as anxiety, depression, sleeping problems, substance abuse, procrastination, and low self-esteem. The Vicarious Trauma Institute highlights, crucially, one of the key differences between vicarious trauma and directly experienced trauma: the intensity of vicarious trauma is dictated by being exposed, first-hand, “to traumatic stories day after day or respond to traumatic situations while having to control your reaction.” Not only are people being exposed to stories or direct experiences of violence, then, but lawyers, social workers, school counselors, teachers, etc. are trained or otherwise expected to keep a straight face and remain a bastion of calm for their clients and/or students. Commonly referred to as “burnout,” many professionals who chronically endure these feelings of vicarious trauma are forced to stop working, leave their field of specialization, or switch professions entirely.

Many who identify as working in a “helping profession”–doctors, lawyers, social workers, etc.–are affected deeply by vicarious trauma. At the Annual Convening of Crisis Intervention in Chicago in 1996, social worker Terri Spahn Nelson contributed the following perspective on vicarious trauma:

Many of us, especially those of us in a helping profession, are secondary witnesses to trauma almost everyday. As we listen to our clients tell about their trauma of incest, rape, domestic violence, alcoholic families or memories of childhood abuse, we bear witness to their victimization. We listen, we support and we validate their feelings and their experience. We offer them the opportunity to let go of some of their burden. As witnesses and healers, we can’t help but to take in some of the emotional pain they have left with us. As the client releases some of their pain, we take it in. By the end of the day, we’ve collected bits and pieces of accounts of trauma. We may have pictures in our mind or intense feelings running through our body. We’ve become a witness to rape, child abuse, domestic violence and death… In simple terms, this vicarious trauma as experienced by professionals and volunteers in the helping field.

By positioning oneself as being a “helping” professional, the burden of “taking in” clients’ trauma becomes a nearly unavoidable expectation. The sense of responsibility for clients–and attendant guilt for not having endured what clients did, especially when client outcomes are not positive–often prove overwhelming for professionals who enter fields expecting to “help” or “fix” clients’ lives.

Legal Burnout

This form of trauma is particularly prevalent in lawyers, who often witness clients’ trauma on a daily basis. Especially when responsibility is placed on lawyers to alleviate that trauma somehow–whether through their efforts to win a criminal or civil case–vicarious trauma can set in.

The lack of control associated with many cases deeply contributes to lawyers’ experiences of vicarious trauma: as Abby Anna Batko-Taylor and Melissa L. Shearer of the Voice of the Defense Online highlight, “In addition to dealing with interpersonal relationships with challenging clients, lawyers also experience personal and institutional pressure to produce results that many times are outside of their control.” Given the relationship between loss of control and trauma in general–traumatic events generally involve survivors losing control of some enormous aspect of life, and can result in a need to control as much as possible in order to feel safe–the feeling of not having control over the outcome of a case can deeply aggravate feelings of vicarious trauma for lawyers.

While issues of vicarious traumatization are not exclusive to lawyers, legal professionals often experience higher rates of vicarious trauma than professionals with similarly traumatized clients. In a study of criminal defense attorneys, defense lawyers were found to experience even higher rates of vicarious traumatization than mental health providers and social workers. Bigger caseloads and lack of supervision around trauma were offered as possible explanations for these higher rates.

According to a Science Alert report on a Macquarie University study on vicarious trauma among those who work in the field of criminal law, these attorneys experience disproportionately higher impacts and intensities of trauma from client interactions. The report goes on:

While often presenting an image of toughness and emotional detachment, it would seem that criminal defense lawyers and prosecutors are significantly more vulnerable to developing depression, stress and vicarious trauma than their non-criminal law colleagues.

These vulnerabilities have tremendous negative impacts on not only legal professionals, but on their clients. In an article for Canadian Lawyer Magazine, which includes clips from lawyers who experience vicarious trauma, cover story author donalee Moulton reports that:

Withdrawal is one of the common symptoms of vicarious trauma. Other symptoms include difficulties solving problems, a sense of being disconnected from work and home, and feelings of powerlessness. In response, lawyers and judges may take on greater responsibility, work longer hours, and attempt to exert greater control over others. They may also become more distant and withdrawn, more cynical, and even more accident prone. It is not unusual for victims of vicarious trauma to develop chronic health problems.

Withdrawal, difficulty solving problems, and issues with control all carry enormous risk of negatively impacting clients both on a case and an interpersonal level.

Despite the fact that unaddressed vicarious trauma is known to negatively affect clients, not to mention its chronic health impacts on lawyers themselves, many legal professionals do not seek or have access to affirmative work environments that can both assist with and help prevent vicarious traumatization.

What does office culture have to do with it?

Not only do many lawyers lack access to assistance and preventive care, but many legal cultures are such that vicarious trauma can take hold. Lack of trauma-related supervision and extremely high case loads as a measure of a lawyers’ skill contribute to a masculinized culture in which addressing and preventing vicarious trauma is perceived as taking time away from the ‘real work.’ In a similar way that the macho, product-oriented culture of journalism is often cited as a cause of vicarious trauma among journalists, lawyers–especially women and people of color–are often actively discouraged from emotional expression in the workplace. This emotional suppression alone has negative impacts on lawyers’ health, and also facilitates a masculinized culture that makes it nearly impossible to treat, let alone prevent, vicarious trauma.

While many workshops and presentations on vicarious trauma focus on individualized healing plans, it is more rare that action plans to ease vicarious trauma focus on organizational cultures. However, research shows that the most effective way to assist professionals who are likely to experience vicarious trauma is through structural changes to office and professional cultures, such as reduced and/or more diverse case loads, comprehensive healthcare provisions, holistic approaches to work and clients, effective supervision, explicit group support, and education.

So, What Can Be Done?

It is clear, then, that vicarious trauma impacts a vast array of people, particularly lawyer–most often defense attorneys and those who specialize in domestic violence, immigration, or family court. Emphasizing the importance of self-care is an important move toward providing healthy, effective, and sustainable services to clients, but it seems that structural changes to office and professional cultures, which are often very cut-throat, can go the longest way toward reducing the negative impacts that vicarious trauma has on both lawyers and clients.

Resources

Primary

Legal Profession Assistance Conference: A Desk Manual on Vicarious Trauma

University of Washington Center for Public Service Law: Secondary Trauma and Compassion Fatigue When Working With Clients in Crisis

National Child Traumatic Stress Network: Secondary Traumatic Stress

Vicarious Trauma Institute: What is Vicarious Trauma?

Additional

Voice for the Defense Online: Representing the Traumatized Client: The Case, the Client, and You

Pyscholawlogy: Lessons About Emotion Suppression for Lawyers

Science Alert: Crime Can Traumatize Lawyers

Huffington Post: A Mental-Health Epidemic in the Newsroom

Good Men Project: Escape the “Act Like a Man” Box

I

Jennifer Polish

Jennifer Polish is an English PhD student at the CUNY Graduate Center in NYC, where she studies non/human animals and the racialization of dis/ability in young adult literature. When she’s not yelling at the computer because Netflix is loading too slowly, she is editing her novel, doing activist-y things, running, or giving the computer a break and yelling at books instead. Contact Jennifer at staff@LawStreetMedia.com.

The post Vicarious Trauma: What is it and How Can Legal Culture Make it Worse? appeared first on Law Street.

You just sunk every penny you have into opening a restaurant. After spending years perfecting every detail from menus to music, you forgot one major element: an advertising budget. How will you make sure people experience your culinary genius? Fueled by passion, you do something you know you probably shouldn’t. You write a glowing review of your restaurant on Yelp.

Is the review a lie just because it came from the owner? Not necessarily. Just because a biased party tells you something is good doesn’t necessarily mean it’s not; their recommendation just holds less value than one from a disinterested party.

But, bias fueled by passion and economic interest happens in medical research all the time. Like you and your restaurant review, medical study funders often promote the information best for their cause. They finesse study designs and findings to make results seem more favorable for their product or service. A manufacturer of a new blood pressure drug might play up one specific benefit of their product in a way that makes you believe the drug beats others overall. It’s not fraud or misconduct, it’s just spinning results in a positive way–something any human with a vested interest in an outcome tends to do. Furthermore, data from a study means nothing by itself to most people, so invested parties can play with it as much as they want to tell a good story.

In discussing the interpretation of statistics in Made to Stick, authors Chip and Dan Heath put it this way:

Ethically challenged people with lots of analytical smarts can, with enough contortions, make almost any case from a given set of statistics.

Keep reading for more on funding bias and what you can do about it.

How is scientific research funded?

When you read a juicy new bit of research about something that might kill you or change the world as we know it, the study’s funding probably escapes your interest. But any study you read, whether it’s about drugs, medical treatments, nutrition, or even sleep, costs money. Where does the money come from? It can come from government grants, nonprofits, independent companies, and even you. When you buy dish soap, some of that profit might go to funding a Procter & Gamble study on a new cleaning chemical. Some portion of your taxes might trickle down to a government grant and end up in a laboratory. And of course, if you donate to a charity, that money might fund studies supporting that cause.

Money Talks

Since money fuels science, science itself can be shackled by economic interests, and interests of any kind can lead to bias. Even without fabricating results, funders have tools they can use to sway study results.

In a paper titled “Tobacco industry manipulation of research,” Dr. Lisa A. Bero calls out some reasons why research findings might not be as concrete as they seem:

• Any study has a context that can be skewed by framing the study, defining the problem, and sculpting that language of study questions and results.
• Data doesn’t present itself. It’s up to the funders and researchers to deliver it to the world, and this delivery can be nuanced to serve a given purpose.

That covers underlying reasons why bias happens, but how does it happen? The World Health Organization analyzed thousands of books, articles, and other materials to see how bias can occur in drug studies and promotions. Its paper, “Drug Promotion – What We Know, What We Have Yet to Learn,” outlined several ways researchers can skew results:

• Publishing results in multiple journals and with multiple authors. Different researchers can write papers on the same exact study. The multiplication of evidence revealing the same findings makes the results look more credible and can lead to a general overestimation of the studied drug’s treatment power.
• Leaving out unfavorable conclusions. Industry-funded studies left out negative results more often than their nonprofit counterparts.
• Using retrospective design, which looks backward to prove a determined outcome. With a known outcome, it’s easier to manipulate study designs to show X might cause Y.
• Putting focus on some features and leaving out others. Industry-funded studies tend to focus on acute benefits of drugs and stray away from ranking the drug’s benefits overall.
• Publishing only favorable results. If a study doesn’t achieve the desired outcomes, the industry funder can simply choose not to publish it, like a lie of omission.

Now let’s look at some real-world examples. In practice, a common method of skewing public scientific opinion involves funding counter blows to combat damaging research.

Bias in Practice

So we know bias happens, we know how it happens in theory, and in the real world the skewing attempts get even scrappier. In these examples, the industries used their funding prowess to spin the science of others.

Sugar

This NPR article relays the story of Dr. Christin Kearns, a dentist who was shocked when a handout of government advice about diabetes didn’t mention sugar. Detecting the scent of industry involvement, she began digging for evidence of similar foul play in the dental community.

After months of research and scouring through internal beet and cane sugar documents dating back to the 1950s, Kearns found that the industry does in fact push policy, especially when it concerns potentially damaging research. When the sugar industry caught wind of dental professionals’ intentions to tackle sugar consumption, they launched a counterattack to help people combat tooth decay while eating as much sugar as they wanted. They looked into enzymes that busted up plaque and other ways to fight tooth decay.

Tobacco

No surprise here: the tobacco industry’s efforts to combat damaging research have been fodder for many public health case studies. Tobacco companies specialized in contending with the findings of detrimental studies. Their philosophy read something like this: The longer you argue, the longer it takes to make decisions. And the longer it takes to make decisions, the more time we have to continue business as usual before we’re hampered with new policies. The tobacco industry used this philosophy to fight regulations for decades.

The 1950s and 60s saw tobacco companies fighting claims that smoking was bad for you. After that, they gracefully transitioned to denying the harms of secondhand smoke.

Here’s a commercial for Camel cigarettes showing doctors smoking and enjoying cigarettes and even recommending the Camel brand. Their decision to use a doctor as the main character sends a strong message to the public: If smoking was so bad, would a doctor do it?

In the 1990s, tobacco companies moved to using PR campaigns focusing on “junk science” to criticize reports on the risks of tobacco smoke, even from the government.

In 1998, big tobacco and the United States reached an agreement about how tobacco could be marketed and advertised. This Master Settlement Agreement surfaced documents outlining tobacco’s science-fighting strategy that confirmed what many had already suspected. When it came to steering science dialogue, tobacco’s policy was to:

• Pay for, publish, and promote research supporting their goals; and ,
• Suppress and criticize research going against their goals.

Tobacco’s efforts mark some of the first concerted and funded campaigns against science in history. Their efforts demonstrate the power of manipulating public opinion. Luckily, physician opinion is much harder to shape.

Does funding bias influence practice?

Good news: doctors know how to evaluate medical studies.

In a randomized study of physicians’ interpretations of funding disclosures published in the New England Journal of Medicine, researchers found a majority of physicians were fully capable of evaluating research based on academic rigor and were not fooled by common manipulations. In fact, the knowledge that a study was funded by industry caused their evaluation of the study’s rigor and likelihood of prescribing the studied drug to decrease.

What You Can Do

We can’t ignore oodles of research just because it might be biased. Luckily, there are safeguards in place. Title VIII of the Food and Drug Administration (FDA) Amendments Act of 2007 (FDAAA) made researchers start registering and submitting results to clinicaltrials.gov where you can check them out at any time. Individual journals also have publishing regulations protecting us from misleading science. For example, the New England Journal of Medicine publishes information on funding, protocols, and the funding organization’s involvement in the study with all of their articles.

But if you’re feeling less than trusting, you can develop your own methods of evaluating the research you read. When you see something new, check for other studies on the same subject to see if they coincide and take an extra careful look at the study’s design.

This graphic from Compound Interest ranks study methods on a descending scale. Keep this in mind when you’re evaluating research.

Even if it’s just something you see in a magazine, you can look up the original study to investigate the design for yourself and form your own opinion. We have access to more science than ever before. With that comes great power, but also great responsibility. Science can be biased but it’s still up to you whether or not to buy into the bias.

Resources

Primary

World Health Organization: Drug Promotion: What We Know, What We Have Yet to Learn

Additional

Washington Post: As Drug Industry’s Influence Over Research Grows, So Does the Potential For Bias

NPR: Documents Detail Sugar Industry Efforts to Direct Medical Research

Heath, Chip and Dan: Made to Stick

Plos Medicine: Sugar Industry Influence on the Scientific Agenda of the National Institute of Dental Research’s 1971 National Caries Program: A Historical Analysis of Internal Documents

Journal of the American Medical Association: Association of Funding and Conclusions in Randomized Drug Trials: A Reflection of Treatment Effect or Adverse Events?

University of California Museum of Paleontology: Who Pays For Science?

Public Health Chronicles: Tobacco Industry Manipulation of Research

Scientific American: Can the Source of Funding For Medical Research Affect the Results?

New England Journal of Medicine: A Randomized Study of How Physicians Interpret Research Funding Disclosures

New England Journal of Medicine: The Proposed Rule For U.S. Clinical Trial Registration and Results Submission

Ashley Bell

Ashley Bell communicates about health and wellness every day as a non-profit Program Manager. She has a Bachelor’s degree in Business and Economics from the College of William and Mary, and loves to investigate what changes in healthy policy and research might mean for the future. Contact Ashley at staff@LawStreetMedia.com.

The post Trusting Scientific Research: Who Funds Our Opinions? appeared first on Law Street.

Treating people when they’re already sick is like beating back invaders who have already breached your defenses. In either scenario, prevention through good defense saves money, time, and lives. But when it comes to boosting our nation’s wellness defenses through public health spending, America falls short.

When it comes to health, concerns abound that we’re wasting money, time, and lives by spending too much on treatment and recovery and not enough on prevention. Public health interventions like smoking cessation programs and disaster preparedness initiatives save lives. The more we learn about the power of these interventions, the more experts call to keep them afloat with better funding. Spending a few dollars to get a person to quit smoking makes more sense than spending thousands of dollars to try to treat their lung cancer several years down the road. Preparing for a natural disaster beforehand is preferable to picking up the pieces afterwards.

So what is public health? It’s something that aims to keep you alive as long as possible. From preventing diseases to preparing for disasters, public health programs keep a wary eye out for threats and then help populations avoid or mitigate them. For example, if data shows a high diabetes risk for a certain population, public health programs will target that population with preventative messages about diet and exercise. Public health departments might also help local school systems prepare for potential natural disasters, like Florida does with its Children’s Disaster Preparedness Program.

Read on to learn about public health spending in the United States, and where we might need to invest some more time and money.

Where’s the money?

In April, the Trust for America’s Health (TFAH) released its report Investing in America’s Health: A State-by-State Look at Public Health Funding and Key Health Facts. The report highlights many ways America falls short on public health spending. They say America’s public health system “has been chronically underfunded for decades.” In Why We Don’t Spend Enough on Public Health, author David Hemenway says this is because the benefits of public health spending today aren’t seen until potentially far in the future. Governments and politicians want to see the benefits of their investments in the present day, so they favor spending on medical treatment and other immediately fulfilling initiatives.

Here are some of the key findings:

Public Health Spending is Actually Shrinking

According to TFAH, when you adjust for inflation, public health spending in 2013 has sunk 10 percent from 2009. Many simply don’t see the benefits of spending on public health programs that yield intangible, future benefits when money could be spent on initiatives that produce immediate results like transportation or construction projects.

All States are Not Created Equal

States vary widely in what they spend on public health as funding is determined by the set-up of each state’s unique public health department. Indiana came in at a low of $15.14 per person, while Alaska spends $50.09 per person. This could be why health levels also vary widely from state to state.

Communities Aren’t Prepared for Public Health Emergencies

Public Health Emergency Preparedness (PHEP) Cooperative Agreement Funding helps communities respond to natural disasters, epidemics, and outbreaks. It was backed by $919 million in 2005. In 2013, it was supported by just $643 million.

Hospitals Aren’t Prepared for Public Health Emergencies

The Hospital Preparedness Program (HPP) gives healthcare facilities funding to beef up their preparedness measures. Funding for this program has been slashed by almost half, dropping from $515 million in 2004 to $255 million in 2015.

It’s estimated that 2/3 of all deaths in the United States result from chronic diseases typically linked to behaviors like diet or substance abuse. These diseases could be prevented by well funded intervention programs to decrease the behaviors that eventually lead to chronic diseases. Public health spending could save Americans millions in treatments for preventable diseases. Likewise public health under-spending could be costing us more than we’re saving.

In this video, the American Public Health Association outlines financial returns on every dollar of public health spending for different activities:

The above video states that every dollar spent on fluoride in our water supply could save $40 in dental care costs and that a dollar spent on nutrition education could save $10 in health care costs. The main point? Public health programs make for a smart investment.

The Consequences of Meagre Public Health Budgets

So, America spends too much money on treatment and not enough on prevention. The results aren’t pretty. In Integrating Public Health and Personal Care in a Reformed US Health Care System, authors Chernichovsky and Leibowitz write,

Compared with other developed countries, the United States has an inefficient and expensive health care system with poor outcomes and many citizens who are denied access.

The State of U.S. Health, 1990-2010 report put the U.S. up against other members of the Organization for Economic Cooperation and Development (O.E.C.D.), a program that advocates to improve economic and social outcomes. Since 1990, the U.S. has fallen in rankings for both life expectancy and healthy life expectancy. In 1990, the U.S. stood at the number 20 spot for life expectancy.  By 2010, it was down to number 27.  In 1990, the U.S. also enjoyed the number 14 spot for healthy life expectancy. The year 2010 found us in the 26th spot.

Under-spending in public health doesn’t just lead to generally poor health, it also impedes our ability to respond to emergencies. Assistant professor at the Harvard Business School, Gautam Mukunda, referred to Ebola as a “wake-up call” for the state of U.S. health preparedness. In Ebola as a Wake-Up Call he wrote,

Ebola may serve as a badly needed wake-up call about something the public health and biosecurity community has been banging the drum about for years: the U.S. has massively underinvested in public health.

Mukunda says the Ebola situation highlighted the measly number of extreme disease cases our U.S. hospitals can handle. Hospitals have decreased their capacity for extreme cases to increase their efficiency, only to lose the ability to treat patients when rare diseases strike. Although the need for extreme treatments arises only occasionally, hospitals should always be prepared for them. But with limited funding, it’s hard to be prepared for the unlikely “worst case scenarios.”

How does the future look?

The good news: The Senate finally passed a joint budget resolution after a five year absence of agreement.

The bad news:  Their budget slahes non-defense government spending by about $500 billion over the next 10 years.

The budget cuts spell trouble for discretionary educational public health programs. From disease prevention to health care worker training, programs to promote good health may suffer across the board.

In an APHA press release opposing the measure, Georges Benjamin, executive director of APHA, says,

Simply put, our federal, state and local public health agencies will not be able to do their jobs to protect the health of the American people if these drastic cuts are enacted.

The budget would also annihilate the Affordable Care Act, including the Prevention and Public Health Fund, a program that focused on moving America towards a preventative health model by funding prevention communications, research, surveillance, immunizations, tobacco cessation programs, health-care training, and more.

The resolution isn’t yet a binding law, but indicates a set of collective and alarming priorities that steer America farther from the path of an integrated, preventative public health system. The Appropriations Committee still has to draft the spending bills, so there’s room for opposition. President Obama for one said he’ll veto bills following the restrictive budget.

Evidence to Inform the Future

According to the article, Evidence Links Increases In Public Health Spending To Declines In Preventable Deaths, published in Health Affairs, mortality rates fall anywhere from 1.1 – 6.9 percent for every 10 percent uptick in public health spend. The researchers made observations over thirteen years and found that the localities with the highest upsurges in public health spending had the most significant reductions in preventable deaths. The relationship held true in multiple causes of death and across different demographics. While the study is only a correlation, the linkage presents compelling evidence for the death-decreasing value of public health spending. The researchers believe a lack of substantial evidence for the ROI of public health campaigns may have hindered spending in the past, and their report takes one step towards getting that evidence.

The Trust for America’s Health (TFAH) advocates for an America with increased core public health spending. They also recommend ways to spend the money correctly. They call for a solid public health foundation for all populations in all states so everyone can be healthy no matter where they live. After that’s established, they advise investing in strong, evidence-backed public health programs and efforts to fortify emergency preparedness. Finally, they believe public health expenditures should be completely transparent and accessible to the American public.

Experts at a recent forum of National Public Health Week looked past mere spending to consider the future of public health and consider novel ways of approaching health to make America a healthier nation. The speakers want to stretch health thinking beyond the doctor’s office to focus on environmental and lifestyle factors that promote well-being like employment, housing, education, and even racism.

These experts dream of an improved, 360 degree view of public health. But sadly, their dreams need funding to become reality. If we continue on this path, it will be very hard to become a more healthful nation.

Resources

Primary 

U.S. Department of Health and Human Services: Prevention and Public Health Fund

Additional

American Journal of Public Health: Integrating Public Health and Personal Care in a Reformed US Health Care System

The New Yorker: Why America is Losing the Health Race

Harvard Business School: Ebola as a Wake Up Call

Public Health Newswire: NPHW Forum: Creating Healthiest Nation Requires Addressing Social Determinants of Health

The Trust for America’s Health: Investing in America’s Health

The Washington Post: Senate Passes Budget Even as Impasse on Spending Continues

Public Health Newswire: House Adopts ‘Devastating’ Budget Agreement

Public Health Newswire: Senate Passes Budget that Batters Public Health

American Public Health Association: APHA Calls Budget Agreement Devastating

The Trust for America’s Health: Investing in America’s Health: A State-by-State Look at Public Health Funding & Key Health Facts

Health Affairs: Evidence Links Increases in Public Health Spending to Declines in Preventable Deaths

The National Priorities Project: Military Spending in the United States

New England Journal of Medicine: Why We Don’t Spend Enough on Public Health

Ashley Bell

Ashley Bell communicates about health and wellness every day as a non-profit Program Manager. She has a Bachelor’s degree in Business and Economics from the College of William and Mary, and loves to investigate what changes in healthy policy and research might mean for the future. Contact Ashley at staff@LawStreetMedia.com.

The post Are We Spending Enough on Public Health? appeared first on Law Street.

The miracle of childbirth morphs into a financial nightmare for mothers without insurance or without maternity coverage in their insurance. While we all know having a baby involves much more than a visit from the stork, you might be shocked by the convoluted web of hidden costs and insurance infrastructure behind pregnancy and early motherhood in the United States. The system favors planned pregnancy and hits unintended mothers hard with unexpected costs and complications.

A woman planning for pregnancy will surely have done her insurance research, selecting a plan to cover the services she wants for pregnancy, delivery, and the baby’s first months. Her monthly insurance premiums will probably run a few hundred more dollars per month, but she’ll be pretty well taken care of. But what happens to those who find themselves pregnant without insurance or locked into plans without maternity coverage? Let’s find out. (Hint: it’s expensive.) And since the CDC estimates about half of all pregnancies in the United States occur unplanned, many women could be burdened with heavy financial woes.

Babies: You Pay for Way More Than Onesies, Diapers, and Toys

How much does having a baby cost? WebMD gives an estimate of up to $15,000 for hospital costs alone. A report from Young Invincibles provides the whopping range of $10,000-$20,000 for delivery, not counting potentially expensive complications during pregnancy and childbirth. Finally, a Truven Health Analytics study put the bill for uninsured vaginal births at a crippling $30,000, and uninsured c-section births broke the bank at $50,000 and up. Estimates fluctuate so much because every little service involved in an American pregnancy gets nailed with a different price hinging on a number of factors. This means that every woman can wind up with a different bill depending on the care she needs, the care her baby needs, her insurance or lack thereof, the hospital she chooses, and even where she lives. This makes planning ahead challenging for both insured and uninsured women.

Even talking directly to service providers might not help matters much. In a New York Times article, Elisabeth Rosenthal recounts the struggle of one uninsured expectant mother trying to get answers:

When she became pregnant, Ms. Martin called her local hospital inquiring about the price of maternity care; the finance office at first said it did not know, and then gave her a range of $4,000 to $45,000. ‘It was unreal,’ Ms. Martin said. ‘I was like, How could you not know this? You’re a hospital.’

Pregnant women might not be able to get exact numbers, but they can expect their baby bills to be pricey.

To put it all into perspective, when Kate Middleton gave birth to Prince George, the bill was only $15,000 and Kate enjoyed a private suite, chefs, and other amenities uncommon in American maternity wards. Where Americans itemize every cost, other countries put a lump-sum premium on births.

Additionally, mothers face many other costs to “having a baby” other than just giving birth. There’s a whole slew of services involved in prenatal care like ultrasounds and other diagnostics tests moms and babies need to stay healthy. If you have maternity coverage through your insurance, many or all of these services will probably be covered. But if you’re uncovered, you could spend up to $2,000 on prenatal care alone. And the payments don’t stop after you’ve given birth. Both new baby and mom could require specialized postnatal care. If you need that, you might have to bump your tab up by a couple grand more.

The Complications of Coverage

Most individual health plans (outside of employer-sponsored healthcare) don’t include maternity coverage. Many women could easily have insurance that lacks maternity care without realizing it. They could also have maternity coverage they haven’t studied closely in the absence of baby plans, leading to many unexpected costs. Investigating maternity insurance is a formidable task, as you have to look at every detail on what the coverage will pay for before, during, and after the actual birth. Even if you do serious calculations for what percentage of the different services will be covered, you could still be surprised by the final bill as costs of medical care can change with the market.

Can you get coverage if you become unexpectedly pregnant?

The short answer? Kind of.

The Affordable Care Act (ACA) made it possible for women to sign up for pregnancy coverage in special enrollment periods. While that’s wonderful,  the coverage doesn’t go into effect until the day the baby is born which doesn’t help the mother at all for care she needs during pregnancy. I did an experiment through Healthcare.gov to see if I qualified for special enrollment under the Affordable Care Act. Sure enough, the questionnaire language read as “had a baby” and not “got pregnant.” At the end of the process, the vague answer I got from the marketplace was hardly what I would want if I were actually a pregnant woman hoping to get coverage:

It looks like you may qualify for a Special Enrollment Period. This means that you can probably enroll in a 2015 health plan through the Marketplace even though the annual Open Enrollment period is over.

The ACA helps when the baby arrives, but not so much with expensive prenatal care and the cost of actually having the baby. Women able to get coverage through special enrollment could still rack up a lot of debt if you don’t have thousands of dollars waiting comfortably in an emergency fund. On the up side, the baby will be covered when it’s born. The ACA does offer an enormous help to women with incomes below a certain amount. Women who qualify can apply to receive coverage through Medicaid and the Children’s Health Insurance Program (CHIP) at any time during their pregnancy. The women who suffer the most in our system are those who make enough on paper, but lack insurance prior to getting pregnant.

Should you be able to get coverage if you become unexpectedly pregnant?

Different stakeholders’ answers to this question shed some light on why the decision involves too many factors to merit a “yes” or “no” answer. To make the discussion simple, let’s see what two major sides of the argument say.

Advocacy Groups

Advocacy groups including Young Invincibles, Planned Parenthood, and March of Dimes believe women should be able to get coverage for being pregnant (not just having a baby) whenever they want. They affirm since nearly half of all pregnancies are unplanned, we need more flexibility in maternity coverage to keep women and newborns in the United States healthy. In addition to the potential for complications in the delivery room, access to prenatal care could help women with heart conditions, diabetes, or who are at risk of preeclampsia (dangerous high blood pressure during pregnancy) get the preventive care they need to stay healthy and also deliver healthy babies.

If a woman doesn’t have coverage, she might forgo the key preventive, yet expensive, medical services she needs to stay healthy. Advocacy groups find the situation unacceptable and look toward the government for change.

Insurance Companies

Insurance companies say if women can get maternity coverage at any time, more people will wait to get coverage. Insurance company costs would spike and eventually trickle down for others enrolled in their plans to absorb. They also argue more flexible maternity coverage would make predicting costs more difficult as the system could become even less predictable.

To this concern, the nonprofit Young Invincibles released a report saying since the Affordable Care Act’s enactment, more women get insurance and fewer leave out maternity coverage, mitigating these risks for insurance companies in offering more open forms of pregnancy coverage.

So, Plan Ahead…If You Can

According to Healthy People 2020 data, about 30 percent of pregnant women do not receive early or adequate prenatal care. While many factors could claim responsibility for this statistic, surely a lack of insurance or lack of ability to get insurance plays a part. Skipping out on prenatal care puts the mother at risk, triples her risk of having an underweight baby, and increases the baby’s risk of death.

So to summarize…what happens if you’re pregnant without insurance?

• You will probably pay a lot of money to have your baby;
• The ACA will help you change coverage once your baby is born; and,
• Calculating your spending will be a headache.

Our system favors planned pregnancy. If you’re a woman of childbearing age, you can start saving for a rainy (or pregnant) day, pay a few hundred dollars more a month for just-in-case coverage, or join the voices of advocates hoping to achieve more flexibility for one of life’s most beautiful accidents.

Resources

Primary

CDC: Unintended Pregnancy Prevention

Healthcare.gov: Health Coverage if You’re Pregnant or Plan to Get Pregnant

Healthcare.gov: Healthcare Insurance Marketplace

Healthy People 2020: Maternal, Infant, and Child Health

Additional

Kaiser Health News: Pregnant and Uninsured? Don’t Count on Obamacare

Childbirth Connection: Better Maternity Care Could Save $5 Billion Annually

Young Invincibles: Without Maternity Coverage

Parents.com: Hospital Birth Costs

WebMD: What it Costs to Have a Baby

U.S. News & World Report: Health Insurance Premiums to Fluctuate Under Obamacare

Childbirth Connection: The Cost of Having a Baby in the United States

Ashley Bell

Ashley Bell communicates about health and wellness every day as a non-profit Program Manager. She has a Bachelor’s degree in Business and Economics from the College of William and Mary, and loves to investigate what changes in healthy policy and research might mean for the future. Contact Ashley at staff@LawStreetMedia.com.

The post Pregnant Without Insurance? Prepare for a Big Bill appeared first on Law Street.

Counterfeit drugs pose both domestic and global threats, presenting serious health risks worldwide. Although the issue is most prevalent outside the United States, Americans aren’t immune to the illegal market’s reach, as there have been far-reaching counterfeit drug cases in the U.S. As a result, there’s been a large effort to combat the problem in America. Read on to learn more about the proliferation of counterfeit drugs, and what’s being done to stop them.

What are counterfeit drugs?

According to the World Health Organization (WHO):

Counterfeit medicine is one which is deliberately and fraudulently mislabeled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging.

The issue was first addressed in the 1995 WHO Conference of Experts on Rational Drug Use in Nairobi, Kenya. Since then, the market has expanded, but preventive measures have also multiplied. Most counterfeited drugs consist of antibiotics, hormones, analgesics, steroids, and antihistamines. In all, counterfeit drugs are divided into six categories: products without active ingredients (32.1 percent of counterfeits), products with incorrect quantities of active ingredients (20.2 percent of counterfeits), products with wrong ingredients (21.4 percent of counterfeits), products with correct quantities of active ingredients but with fake packaging (15.6 percent of counterfeits), copies of an original product (1 percent of counterfeits), and products with high levels of impurities and contaminants (8.5 percent of counterfeits).

The FDA believes the growth in the counterfeit drug market may be due to the escalating costs of prescription drugs, advanced technologies to develop counterfeit drugs, and the anonymity and ease of the internet.

Health Risks

The severity of the risk factors for any specific counterfeit drug will vary. Generally, they can actively cause unexpected side effects, an allergic reaction, the worsening of the existing medical condition, and/or prolong treatment periods.

A counterfeit drug that substitutes an inert substance for the active ingredient will not improve a person’s medical condition. For example, the main ingredient in Lipitor (a commonly counterfeited drug in the U.S.) is atorvastatin. Its purpose is to lower high cholesterol and triglyceride levels, and therefore reduce the risk of stroke and heart attack. If a patient believes he/she is taking atorvastatin, but in fact is consuming an inert substance, the consequences could be deadly. Even worse, in some cases, not all substituted or added substances are inert, but are instead hazardous.

 U.S. and Global Statistics About Counterfeit Drugs

The international counterfeit drug market amasses $200 billion a year. Internet sales make up $75 billion of that market. Most counterfeits are made in China and India. In the United States, 80 percent of counterfeit medicine is brought into the country from outside.

The WHO estimates that up to ten percent of the drugs sold internationally are counterfeit. In some countries this number can reach up to 50 percent. Developed countries that have strict regulations and institutions like the FDC, are estimated to sell less than one percent of counterfeit drugs. However, the United States has seen its share of highly publicized cases. With a few exceptions, the United States counterfeit market is generally focused on “lifestyle” drugs like diet, erectile dysfunction, and hair growth pills.

The counterfeit market is growing in the U.S. In 2014, an estimated 60 various Pfizer products were being counterfeited compared to just 20 in 2008. One of the most popular counterfeited pharmacy items is ChapStick. China reported holding 1,300 alleged counterfeiters and confiscating $362 million worth of counterfeit product in 2013.

According to the WHO, an estimated 200,000 people die a year due to “ineffective, fake, and substandard malaria drugs” that don’t eliminate parasites from a person’s system. To make matters worse, the fake drugs often contain a smaller dosage of the active ingredient than necessary. Thus the fake drug cures symptoms without curing the disease and fuels drug-resistant strands.

Counterfeit Drugs in the U.S.

A counterfeit maker of Avastin, a cancer drug, accessed the U.S. supply chain in 2012. This was the first major exception to the notion that counterfeits in the U.S. were limited to lifestyle drugs. Undetected, doctors and purchasing managers for oncology clinics “bought and administered the counterfeit medicines to their patients.”

In May 2012, a counterfeit version of Teva Pharmaceutical’s Adderall 30 mg tablets entered the market. The FDA labeled the counterfeit “unsafe, ineffective, and potentially harmful.” The counterfeit version did not contain the active ingredients dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amephtamine sulfate. Instead, it contained ineffective ingredients tramadol and acetaminophen. The original product is orange and peach in color with markings, while the counterfeit is white and devoid of any markings. Entering the counterfeit market for Adderall was probably seen as a lucrative opportunity, as Adderall is on the FDA’s drug shortage list, which means that it is dispersed only when available.

The drug Procrit, used to treat anemic patients with “cancer and other serious diseases,” had a large counterfeit scare in 2013. FDA investigators found three fake batches bearing three different lot numbers and expiration dates. The fake medicines contained a clear liquid with no active ingredient and two life-threatening strains of bacteria. Not only was patients’ anemia going unchecked, but already-weak patients were consuming potentially deadly bacteria. The FDA dispersed a warning to the public and provided ways to check the authenticity of the product.

Precautions to Avoid Counterfeit Drugs

There are ways to help ensure that patients and customers purchase legitimate prescription drugs. Most counterfeited drugs are sold through the internet. The National Association of Boards of Pharmacy investigated 10,000 pharmaceutical sites and found that only three percent of the sites appeared “to be in compliance with pharmacy laws and practice standards.”

Internet sites to be avoided include those outside the United States; those that don’t offer a physical address; those that don’t display a license by the applicable state board of pharmacy;  those that don’t provide a licensed pharmacist to answer questions; and sites that don’t require a prescription. Consumers should also look for the Verified Internet Pharmacy Practice Sites (VIPPS) seal. There are over 30 online pharmacies that display this seal, which was created by the National Association of Boards of Pharmacy to combat sites selling counterfeit drugs.

Consumers must also be cautious when inspecting the packaging of their product by looking for altered or unsealed containers or any physical differences in the appropriate packaging or product appearance. A change in taste and side effects could signal counterfeits as well.

 Actions Against Counterfeit Drugs

In 2012, the United States and 110 other countries participated in INTERPOL’s Pangea sting operation. The operation resulted in:

11,000 illegal online pharmacies being shut down, the removal 19,000 ads for fake drugs on social media sites, the seizure of 9.4 million doses of phony medicines…Google agreed to spend $50 million annually over the next five years to crack down on advertising for illegal online pharmacies.

Pharmaceutical companies also have their own internal investigations to fight against counterfeit medicines. For example, one method is similar to fingerprinting. Pfizer designed an infrared spectrometer that analyzes a product’s chemical bonds. Every drug has unique “reflected and absorbed wavelengths.” A graph will produce peaks and valleys–like a fingerprint–depending on the ingredients and their quantities. Those in the Pfizer lab can superimpose fake “fingerprints” over the real ones on the computer and note the differences. Further testing with X-ray diffraction can show exactly what ingredients the fake is composed of.

In 2014, Eli Lilly, an Indianapolis-based pharmaceutical company, invested $110 million in creating traceable, unique stamping codes for all of its products sold globally. The stamping codes will allow the company to trace each product from manufacturing facility to patient, and combat fakes.

The Legal Side of Drug Counterfeiting

The Prescription Drug Marketing Act of 1987 (modified in 1992) effectively closed off the United States supply chain. The law directly aimed at protecting American consumers and avoiding counterfeit drugs by providing legal safeguards. It “provides that prescription drug products manufactured in the United States and exported can no longer be reimported, except by the product’s manufacturer.” It also provides uniform standards for all distribution channels including hospitals and wholesalers.

The Food and Drug Administration Safety and Innovation Act was enacted in July 2012. It granted the FDA new and enhanced powers to regulate prescription drugs and combat counterfeit drugs in the U.S. The FDA, for example, can now “administratively detain drugs believed to be adulterated or misbranded, and the authority to destroy certain adulterated, misbranded, or counterfeit drugs offered for import.”

The 2013 Drug Quality and Security Act “outlines critical steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States.” Pharmaceutical companies must implement a tracking system by 2015 and tag serial numbers to each singular unit sold in the U.S. by 2017.

Conclusion

The counterfeiting of medicines is not a problem secluded to developing countries. Without proactive enforcement, counterfeit drugs could erupt in the United States. It is a highly lucrative industry for the black market. Pharmaceutical companies and consumers alike need to be responsible with prescription drugs, as the potential health risks can be deadly. This is a global problem that requires global cooperation.

Resources

Primary

FDA: Counterfeit Drugs, Questions and Answers

CDC: Counterfeit Drugs

FDA: Counterfeit Drugs

Additional

Nova Next: Cracking Down on Counterfeit Drugs

CBS News: Your Anemia Drug May Be Fake

Fierce Pharma: Lilly Steps up War on Counterfeits With $110M Serialization Program

HRF: 20 Shocking Counterfeit Drug Statistics

Medscape: Counterfeit Version of Adderall Unsafe, Ineffective, FDA Warns

PhRMA: Counterfeit Drugs

National Center for Biotechnology Information: The Prescription Drug Act of 1987

Jessica McLaughlin

Jessica McLaughlin is a graduate of the University of Maryland with a degree in English Literature and Spanish. She works in the publishing industry and recently moved back to the DC area after living in NYC. Contact Jessica at staff@LawStreetMedia.com.

The post The United States Isn’t Immune to Counterfeit Drugs appeared first on Law Street.

The United States spends more money on health care than any other developed country. At the same time, studies find that patients in other countries enjoy better quality and more accessible health care than Americans. Why is American health care so expensive and what are the underlying issues that hold the United States back from necessary reforms? Read on to learn more about the U.S. healthcare system and how it stacks up internationally.

How does the U.S. healthcare system compare internationally?

According to the 2014 Commonwealth Fund analysis of the U.S. healthcare system in comparison to other industrialized countries, the United States ranks last among peer nations. This poor ranking is not a one-time thing, as almost all previous editions of the report from 2004-2010 also ranked the American healthcare system the lowest in terms of both cost and quality. The report compares the United States to some of the most developed and industrialized nations in the world, including Australia, Canada, France, Germany, the Netherlands, New Zealand, Norway, Sweden, Switzerland, and the United Kingdom. All of these countries spend much less on health care and have higher-quality services.

What are the problems with the American healthcare system?

The United States adheres to a Selective Health Coverage (SHC) system, also called a hybrid healthcare system. Roughly half of healthcare spending comes from private funds, while the government covers the other half through federal, state, and local funds. The majority of healthcare costs are covered through private insurance companies that sell health coverage to employers and private individuals at different rates. The government provides coverage through Medicaid for low-income households, and Medicare for retired Americans.

High Costs 

As the United States has no universal health coverage, people mainly receive health insurance from their employers, the government, or purchase it through exchanges. The Affordable Care Act, which entered into force in 2013, made it easier to gain coverage, but 10 percent of Americans still lack health insurance.

As each insurance plan includes deductibles, co-pays, and out-of-pocket costs, even with insurance, it could be quite expensive to seek medical services. In 2014, the average household spent $8,000 in medical costs, including monthly insurance payments, taxes, lost wages, out-of-pocket care, and other costs. These prohibitive costs mean that Americans may skip physician visits, treatments, tests, or follow-up care, even if recommended by their doctor.

The American healthcare system is one of the most expensive in the world. Around 18 percent of the country’s GDP goes toward healthcare costs. The Netherlands ranks next, but spends only 12 percent of its GDP on health care. The government spends by various estimates between $8,500 to $10,000 per capita annually, and still requires high out-of-pocket costs for its citizens. Other industrialized countries spend from $3,000 to $5,500 per capita and manage to cover more people and offer better services. Overall, the U.S. ranks last on the Commonwealth Fund’s rankings for national health expenditures. There are plenty of reasons for that, including but not limited to high costs associated with administrative hassles and duplicate testing. The United States is also the only developed country where medical costs contribute toward, and in some cases directly lead to, personal bankruptcy. Even such business giants as Starbucks and General Motors have acknowledged the disproportionately high costs of providing health care to their employees.

Low Quality 

The healthcare system in the United States isn’t very efficient. While most other countries have adopted some kind of unified system of communication with patients and other providers, the U.S. system’s administrative hassles were cited as a problem by the Commonwealth Fund. The overall health of the American population is worse than that of other industrialized countries. The U.S. ranks last on all three measures of healthy living, including mortality amenable to medical care, infant mortality, and healthy life expectancy at age 60.

What types of healthcare systems do other countries have?

National Services

The most popular type of healthcare system in the developed world is a national health services system. In this type of system, necessary medical care is fully paid for by the government. Hospitals and clinics are publicly operated, but private sector institutions also exist. Private medical clinics may have specific regulations they must follow, while the government pays them certain fees. Or, private medical clinics could operate solely like businesses and profit by providing superior, more personal or elective medical care. Many countries employ this mode;, including the United Kingdom, Spain, and New Zealand.

In the United Kingdom, health care is largely supported by tax contributions that are then used by the government to cover the vast majority of its population’s medical costs. Private coverage also exists, often through employers, but these premiums are affordable as to allow competition with public health care, which is free of charge. The U.K. healthcare system ranks first on the Commonwealth Fund’s list among other industrialized countries, particularly when it comes to efficiency and access.

National Health Insurance System

In a national health insurance system, also called a single-payer system, the government pays for all costs, but doesn’t operate healthcare services. Canada, Denmark, Taiwan, and Sweden are among those countries that operate a single-payer healthcare system.

Taiwan has one of the best healthcare systems in Asia. Health providers are employed by the public or private sector, but are paid standardized fees, which eliminates price competition and adds quality competition. In 2010, Taiwan spent three times less (6.5 percent) than the United States (16 percent) in its healthcare expenditures, covering 99 percent of its population. Administrative costs are also extremely low (1.5 percent) in comparison with the U.S., which spends 20-30 percent of overall healthcare funds on administrative costs.

Multi-Payer Health Insurance System

This system of health care is operated by Germany, Japan, and France. According to this model, all physicians are paid from a special fund, which is designated for healthcare services. The rates are the same for all physicians, cutting administrative costs for government, and creating quality competition.

Germany is a great example of a system that provides quality and cost-efficiency. Health services in Germany operate through an alliance of around 240 not-for-profit insurance providers that cover about 90 percent of the total population and are paid from a specifically designated “sickness fund.” The other 10 percent are generally high-income households that prefer private health insurance with superior services and quality. Amazingly, government expenditures for health care in Germany are half those of the United States, and the quality of health care is very high. Insurance companies and medical providers are closely regulated by the government, while employers and employees assume shared responsibility to pay taxes towards the “sickness fund.” Such a system helps to decrease the government’s costs and and provide more people with health coverage.

Watch the video below to learn more about Germany’s healthcare system.

Why is health care in the U.S. so expensive?

The complexity and for-profit nature of the American healthcare system is the primary reason for its high cost. As insurance companies are concerned with profit, they are always looking for ways to minimize their expenses and make money.

Expensive Mix of Services

The United States’ healthcare system provides a very expensive mix of services:

• The U.S. sees more specialist visits than in other countries, which are two-to-three times more expensive than general physician visits.
• Specialists often order more diagnostic tests and medical procedures that rack up the total costs. In comparison, other industrialized countries offer considerably fewer MRI scans, C-sections, and other procedures that could be avoided and are not always medically necessary.
• Duplicate testing is another issue that plagues American health care. As physicians and specialists make money from procedures, they often order duplicate testing. For example, dermatologists can order  biopsies from several affected skin areas, even if only one such procedure is required  for diagnosis.
• American hospitals also contribute toward the country’s expensive mix of services. They admit fewer people and, therefore, charge higher prices for hospitalization. They treat elderly people in the intensive care units (ICUs), while other countries subscribe to more specialized, palliative care, which is less costly.

Administrative Costs

There are thousands of health insurance plans available in the market, leading to variations in coverage, deductibles, co-pays, premiums, and other features. Not only is this system confusing, but such a system increases administrative costs as all doctor’s offices, laboratories, and hospitals have to bill insurance companies and patients for each rendered procedure and each doctor’s visit. As insurance plans vary greatly, medical facilities and patients have to constantly phone insurance companies to clarify details of premiums to find out what procedures are covered by the insurance company. Such a system creates unnecessary administrative hassles and drives up overall costs. It’s estimated that the United States “wastes” half of the $361 billion spent on administrative costs by spending it on expenses that could be avoided and are not necessary.

Pharmaceutical Spending 

Medical facilities and insurance companies are not the only players in the healthcare market. Drug manufacturing companies charge higher prices in the U.S. than in other industrialized countries. For example, branded prescription drugs are twice as expensive in the U.S. than in the rest of the developed world. In 2011, the United States paid $985 per capita for prescription drugs and other medications. That’s almost double what most other high-income countries spent on pharmaceuticals. This difference is due to the fact that other industrialized countries are often able to negotiate lower prices as they purchase pharmaceuticals in large quantities to provide medications for the whole population.

Interestingly, innovations and new medical technologies also drive up the cost of health care. The United States has more high-tech medical equipment than other industrialized countries. On top of it, it also has more stand-by equipment than other countries. The need to pay for the maintenance of these state-of-the-art technologies results in higher prices for tests, scans, and analysis for patients.

More Chronic Diseases 

People in the United States are less healthy than in the majority of developed countries. Obesity and other chronic diseases are more common in the U.S. than in its peer countries. That means that insurance companies and the government will spend a lot of money on managing chronic conditions that often require constant treatment, high-tech tests, and frequent hospitalizations.

Will the American healthcare system change?

If the United States ranks so poorly in health care, why doesn’t it do something to fix the problems? The answer to that question lies in the intersection between money and politics.

Interest-Group Lobbying

Many profit from the current healthcare system, including drug manufacturers, medical equipment providers, specialist physicians, insurance companies, and others who have considerable influence on public policy. The interests of those who make a profit from the current healthcare system are well represented through lobbying. In 2009, around 4,525 healthcare lobbyists were hired by more than 1,750 companies, including 207 hospitals, 105 insurance companies, and 85 manufacturing companies. For example, Big Pharma spent $22 million on healthcare lobbying in 2011; Blue Cross Blue Shield and biotech companyAmgen spent $21 million each on healthcare lobbyingthat year. None of the players involved in the healthcare business wants to lose profits, so lobbyists are trying to block any efforts that can damage their clients, even if those efforts could bring better health care to millions of Americans.

What are the possible solutions?

Even after the implementation of the Patient Protection and Affordable Care Act in January 2013, roughly 10 percent of Americans are still uninsured. In order to fix that problem, the United States could work toward implementing another system of health care, but that’s unlikely to gain much ground.

There have also been alternative solutions offered, such as the so-called “managed competition” model proposed by Stanford University Business School professor Alain Enthoven more than two decades ago. According to this model, insurance companies, physicians, hospitals, drug manufacturers, and other actors in the healthcare industry could come together to form an entity that has the responsibility to provide care for specific municipalities based on an annual allowance. This strategy could produce higher quality and lower costs simultaneously.

Another proposed solution is based on the implementation of a universal tax credit, similar to the child tax credit, that provides a $1,000 reduction in income tax to families that have a child. Money for this tax credit could be obtained from existing health insurance subsidies, like Medicaid and Medicare.

Conclusion

The United States’ healthcare system has not served its people well, especially when looked at in comparison to its peer nations. There are many faults to the current system, including high costs, inefficient practices, and an unwillingness by many to change. In order to effectively provide health care to as many people as possible, more changes need to be made. While the Affordable Care Act was a step in the right direction, the United States is still at the bottom of the list when it comes to effective health care.

 Resources

Commonwealth Fund: How the U.S. Healthcare System Compares Internationally

CNN Money: Healthcare Lobbying Boom Continues

Department for Professional Employees, AFL-CIO: The U.S. Healthcare System: An International Perspective

Forbes: U.S. Health Care Ranked Dead Last Compared to 10 Other Countries

Forbes: Universal Coverage is Not “Single Payer” Healthcare

Forbes: Why We Should Replace Obamacare With a Universal Health Tax Credit

HealthPAC: How Other Countries Do it

Global Post: Eight Places That Do Health Care Better Than the US

Global Post: Special Report: Health Care in Taiwan

Atlantic: Why Do Other Rich Nations Spend So Much Less on Health Care?

Center for Public Integrity: Lobbyists Swarm Capitol to Influence Health Reform

Law Dictionary: How Many Americans Really Do Not Have Health Insurance?

U.S. News & World Report: Obamacare Enrollees, by the Numbers

Valeriya Metla

Valeriya Metla is a young professional, passionate about international relations, immigration issues, and social and criminal justice. She holds two Bachelor Degrees in regional studies and international criminal justice. Contact Valeriya at staff@LawStreetMedia.com.

The post American Health Care: Last Place Among Peer Nations in Latest Study appeared first on Law Street.

When we envision space, we tend to imagine an intense beauty unknown to this world. We certainly don’t imagine a junk yard. But what is space actually like? Well, unfortunately it seems to be moving a bit more in the junk yard direction. Last year, Alfonso Cuarόn’s Oscar-winning film “Gravity” brought attention to the issue. Although the movie was dramatized and at times inaccurate according to NASA standards, the problem of orbital debris–space trash–is very real.

There are millions of objects of varying sizes orbiting the Earth at any given moment, and even though these objects are visually hidden to us and thousands of miles away, orbital debris affects everyone. Satellites control aspects of our everyday life like On-Demand features, cellphones, Google Earth, weather reports, and navigation systems. More importantly, satellites facilitate military communication and intelligence. In response to the problem, a second generation Space Fence run by the U.S. Air Force (USAF) should be up and running by 2019. Read on to learn everything you need to know about orbital debris and the Space Fence.

What is Orbital Debris?

Orbital Debris, or space trash, consists of man-made objects currently orbiting the Earth that do not serve a useful purpose. Debris is created every time a spacecraft separates from its launch vehicle. It is also created from dead satellites, explosions, collisions, chipped paint from spacecrafts, and small particle impacts. Since humans started placing objects in orbit over the last 50 years, the amount of debris has only increased.

Orbital debris is placed into three categories based on size. Larger objects, above ten cm, account for some 21,000 pieces of orbital debris. Medium particles, between one and ten cm, account for approximately 500,000 objects. Smaller pieces, less than one cm, account for over 100 million objects. These pieces move extremely fast, reaching speeds of up to five miles per second or 18,000 miles per hour. A collision at this rate is devastating. NASA equates being hit by an orbital object less than half an inch around and moving at six miles per second to being hit by a bowling ball moving at 300 miles per hour.

Space Safety

All of this debris is ultimately dangerous for astronauts and the International Space Station. Spacesuits are designed to protect against micrometeoroids, which are pieces of orbital debris the size of grains of sand. They use materials like those used for bulletproof vests. The International Space Station is the “most heavily shielded spacecraft ever,” able to withstand impacts from smaller debris. The station can also alter course to avoid larger objects coming toward it. Space shuttles generally return to Earth with cracks and evidence of impacts on their windows. For this reason, windows are protected three fold and replaced every mission.

Orbital Duration

Most other orbital debris disintegrates reentering Earth. In the rare occurrences that objects do make it back, they generally fall into bodies of water or unpopulated land areas like the Canadian tundra or Australian Outback. Over the past 50 years, approximately one catalogued piece of orbital debris has landed on Earth each day and there have been no reported human injuries. The higher the altitude, the longer an object will stay in orbit. Debris in a lower orbit will remain for only several years. On the opposite side of the spectrum, debris above 1,000 km from Earth can remain in orbit for over a century.

What is the Space Fence?

The Space Fence aims to tackle the problem of orbital debris. The project is led by the U.S. Air Force Materiel Command’s Electronic Systems Center at Hanscom Air Force Base in Massachusetts. It is a system designed to track debris in the Space Surveillance Network in order to initiate a warning system. The idea is very similar to that of hurricane or tornado tracking systems. The term “fence” comes from the “narrow, continent-wide planar energy field in space” created from the transmitters and receivers used in the project. High frequency radar acts like a “flashlight beam in a dark room that illuminates the bits of dust swirling around.”

The first Space Fence was decommissioned in 2013. It initially tracked 5,396 objects in 1980 and was tracking 15,639 objects by 2010. There were a total of nine transmitters and receivers located at three transmitter sites: Jordan Lake, Alabama; Lake Kickapoo, Texas; and Gila River, Arizona. The six receivers were located at Tattnall, Georgia; Hawkinsville, Georgia; Silver Lake, Mississippi; Red River, Arkansas; Elephant Butte, New Mexico; and San Diego, California.

The new Space Fence’s higher frequency system, operating in the S-band frequency range, will allow the detection of much smaller satellites and orbital debris. Its “modern, net-centric architecture” will also allow more effective tracking in Earth’s lower and medium orbit. Over its lifetime, the new Space Fence is expected to be valued at $6.1 billion. The system will include “geographically dispersed ground-based radars to provide timely assessment of space objects, events, and debris.” There will be one large S-band radar placed in Kwajalein Atoll in the Marshall Islands, with an option for a second based on funding. The projects also rely on international cooperation as part of global Space Situational Awareness efforts.

Who is building the Space Fence?

Lockheed Martin Mission Systems and Training, located in Moorestown, New Jersey, won the initial $914.7 million contract to build the second generation Space Fence in June 2014. Lockheed Martin is a global security and aerospace company dedicated to researching and developing advanced technology systems, products, and services.

 Why are we building a new Space Fence now?

There are a few things we need to keep an eye on. The first major source of large orbital debris came from China’s intentional and sloppy destruction of its Fengyun-IC weather satellite in January 2007. The satellite was destroyed by an anti-satellite device that caused hundreds of pieces of varying sizes of orbital debris.

The second major event was the 2009 collision of the active American satellite Iridium and the defunct Russian satellite Cosmos. The American satellite weighed about 1,200 tons, making it the first large collision in space. The impact resulted in over 2,000 pieces of metal orbital debris. The video below shows a model of the collision and the debris it created.

Aside from these major events, researchers also fear the Kessler Syndrome. It is a theory, developed in 1978 by Donald Kessler, that describes a “self-sustaining cascading collision of orbital debris.” Essentially, the Kessler Syndrome is a domino effect. Two objects collide to cause pieces of debris that ultimately collide with one another to form more debris, and so on. The theory isn’t so far-fetched. In 2012, the United States issued over 10,000 close-call warnings that resulted in 75 avoidance maneuvers by satellite owners.

U.S. Policy on Orbital Debris

The U.S. first took an official stance to minimize orbital debris in 1988. A more recent June 2010 National Space Policy specifically addresses the issue of a clean space environment and orbital debris. NASA created an Orbital Debris Program Office at the Johnson Space Center in Texas. Its mission is to find ways for ventures to create less orbital debris and clean existing debris. Other U.S. agencies, like the Federal Aviation Administration and the National Oceanic and Atmospheric Administration, also need to follow specific guidelines for their spacecrafts. U.S. Orbital Mitigation Standard Practices were approved in 2001.

Guidelines are also followed by Russia, China, Japan, France, and the European Space Agency. Although there isn’t an international treaty surrounding orbital debris, the Inter-Agency Space Debris Coordination Committee was created among the leading international space agencies. Orbital debris is also a priority for the Scientific and Technical Subcommittee of the United Nations on the Peaceful Uses of Outer Space.

Legal Issues

There are some legal issues inherent to cleaning up all the space debris. Each piece of large debris, like a defunct satellite, is technically owned by a country. For example, the U.S. doesn’t have authority to destroy a Chinese or Russian satellite. As Professor Johnson-Freese from the Naval War College said, “there are no salvage laws in space.” Under the current laws, one has to seek out permission from a satellite owner to go anywhere near it. This can make cleaning up space pretty tricky.

Conclusion

Orbital debris affects us down on Earth. We depend on a clear and safe space for many of the luxuries we take for granted. The Space Fence is one tool in the mission to create a clean space environment, but it is not enough. The Space Fence is only a tracking system; a plan needs to be enacted to deal with the orbital debris already in space. Moreover, guidelines for minimizing debris creation don’t remedy the harm that’s already been done. Some have proposed an international user fee for every launch to go into a global fund for space clean up. That idea has its own problems to sort through, like fair division, but it’s a start. We need to start taking the issue of the space environment seriously before the next major collision.

Resources

Primary

NASA Orbital Debris Program Office : Orbital Debris

NASA: What is Orbital Debris?

Additional

Defense Industry Daily: Don’t Touch Their Junk

Washington Post: Air Force to Award ‘Space Fence’ Contract to Track Orbital Debris

The New York Times: Debris Spews Into Space After Satellites Collide 

Space Answers: How Have Space Technologies Affected Life Back on Earth?

Space News: China’s Anti-Satellite Test

Space Safety Magazine: Kessler Syndrome

Washington Post: Space Trash is a Big Problem

Jessica McLaughlin

Jessica McLaughlin is a graduate of the University of Maryland with a degree in English Literature and Spanish. She works in the publishing industry and recently moved back to the DC area after living in NYC. Contact Jessica at staff@LawStreetMedia.com.

The post Can a Space Fence Really Fix the Problem of Space Trash? appeared first on Law Street.

Many aspects of our lives have escaped the shackles of the real world and gone digital. Most of our music, movies, work files, and even financial data exist in digital and cloud-based worlds with no tangible counterparts. But the transition to the digital realm has been slow and laborious for the largest and possibly most important data set of all: health data. The health care system in the United States has proceeded towards digitization with prudent caution; a glitch in a digital health system means more than a corrupted music file, it could mean the difference between life and death.

It’s easy to get caught up in the vision of a completely digitized healthcare system. Faster and more effective treatments? Fewer forms to fill out? Massive data sets that could vastly improve public health? Who wouldn’t be excited? Most people believe in the benefits, but the digitization of health data involves much more than just desire and ability. Laws, protocols, and privacy concerns slow digitization efforts like well-placed speed bumps.

Here’s an overview of laws affecting health digitization, how some people innovate around them, and what’s coming up next for digital health.

Health Data Laws: Well-placed Speed Bumps

Your own personal health information isn’t always just about you. A doctor can use your health data in two basic ways:

1. To treat you and only you. This is called primary use.

2. To inform broader public health decisions, including things like disease prevention. This is called secondary use.  For example, a University of Pittsburgh project called Project Tycho collected 88 million disease reports from the CDC’s Morbidity and Mortality weekly report and incorporated them into an open-access database. They use it to study the long term implications of interventions, like the polio vaccine, over long periods of time. In this video, the Dean of Pitt Public Health explains that the project is named after Tycho Brahe, a Danish astronomer who mapped stars and planets–data that Johannes Kepler eventually used to derive the laws of planetary motion. He hopes researchers can build on existing work to make groundbreaking discoveries in disease prevention.

Health data gets complicated in secondary use. Laws protect individual privacy and ensure doctors don’t compromise personal health data for the sake of public health or research goals. As the technology for sharing and collecting health data has improved, legal applications have become more complicated.

Overall, different federal and state laws layer on top of each other to create a legal framework that protects health data privacy. The centerpiece of this framework is the Health Information Portability and Accountability Act of 1996 (HIPAA).

The Health Information Portability and Accountability Act of 1996 (HIPAA) and its Privacy Rule

This rule limits the use of protected health information (PHI), which is health information that might be used to figure out your identity. Basically, no one can use your info without your permission. It oversees the gambit of entities that might touch your info in the entire healthcare system.

The rule isn’t a nail in the coffin for the use of data in public health. Entities can use PHI without authorization for the prevention and control of disease, disability, or injury. The law also allows unauthorized use of PHI for matters of national security and for law enforcement activities. Working with these exemptions, public health entities can make brilliant use of PHI. For example, the University of Maryland Center for Substance Abuse Research’s National Drug Early Warning System supplements traditional health data with data found on social media tools to find patterns that indicate emerging drug trends and launches interventions to fight drug use.

The system is just one example of innovation in spite of laws that restrict health data use. But when it comes to innovation, the unregulated types of health data hold the most promise. Current laws do not cover information that is patient generated. Therefore, private companies and organizations have latched onto the idea of patient generated data and what it could mean for overall health.

Innovations in Patient-Generated Data

People share a lot of other things online, why not something as important as health data? That’s the simple philosophy behind many new, and perfectly legal, tools that count on people to opt into sharing their health information for the greater good. With no regulations on the use of patient generated data, the research and preventative implications could be revolutionary.

Here are just a few examples of tools using patient-generated data:

Apple’s ResearchKit

Apple’s new initiative harnesses the research potential of the iPhone, which has sophisticated abilities to track actions and record information. It allows individuals to participate in studies through self-reports using their iPhones instead of traveling to research centers. It’s a goldmine of quantitative data possibilities for researchers trying to understand certain diseases as the ResearchKit framework opens up endless possibilities for accessing patients. Researchers simply build an app that suits their study and launch it.

Mount Sinai, Weill Cornell Medical College, and LifeMap already used ResearchKit to develop the Asthma Help app that allows them to understand what might be aggravating asthma symptoms. It incorporates GPS data from the phones with city air quality data to advise asthma patients of locations where their symptoms could be the worst.

The Robert Wood Johnson Foundation Data for Health Initiative

This initiative doesn’t focus on collecting data, but dives into all of the data already being collected to determine what information has the potential to do the most good. According to the foundation, 40,000 health apps and wearable health devices already exist and produce a lot of useable data. They’re encouraging health professionals to look at data they already have in new ways.

University of Michigan’s Genes for Good Project

This project prospects Facebook as a potential recruiting ground for genetic research participants. The project aims to have people send spit samples to a laboratory and then fill out periodic follow up questions via a Facebook app. The participants’ personal information would still be protected. The researchers chose Facebook because it grants the ability to potentially recruit a more massive amount of participants than usual. As the researchers try to understand how the interplay of genes and the environment influence disease, more data helps make more robust conclusions.

How the Government Encourages Health Information Sharing

The government sees no reason for laws to limit innovation in the digitization of health care and has pushed out new programs that prove its commitment to digital efforts and information sharing.

In April, the HHS announced it would grant a million dollars to support community initiatives that promote the flow and sharing of health information. The money will support projects under what’s called the Community Interoperability Health Information Exchange (HIE) Program. The funds and the program will help the awardees use health information in effective, appropriate, and secure ways.

Additionally, the HHS also announced a new Federal Health IT Strategic Plan for 2015-2020. The plan tackles how to move forward in the collection, sharing, and use of health data in appropriate ways. The Nationwide Interoperability Roadmap came out in draft form this past January.

HHS Secretary Sylvia M. Burwell summarized the key purpose of the roadmap nicely:

A successful learning system relies on an interoperable health IT system where information can be collected, shared, and used to improve health, facilitate research, and inform clinical outcomes. This Roadmap explains what we can do over the next three years to get there.

What can we learn about health on social media?

Some people choose to take health matters into their own hands and social media empowers them to do so. As data and information becomes more readily available through social tools, previously unknown advantages and disadvantages could emerge.

Most recently in Belgium, a man became frustrated with the long wait times necessary to find a kidney donor in the traditional fashion. He took to Facebook to tell his story and recruit his own donors. He found eight volunteers but ultimately doctors refused to perform the surgery because it would be unfair to other patients waiting for traditional donors. This case provides a glimpse into issues of equality that might arise if more people use social tools to their advantage. Can someone use social media tools to find themselves organ donors when others can’t access the tools or even computers?

Social media has also taught us that more data isn’t always better. Not too long ago, Mark Cuban, the Dallas Mavericks owner, tweeted that people should get quarterly blood-work so they can better track their own health.

Doctors responded by saying that doing just that could have dangerous consequences. More testing produces more false or incorrect results and reveals other fluke abnormalities. The abnormalities might lead to unnecessary treatment that comes with potentially harmful side effects. Some did admit that Cuban’s vision might be one for the future–where tests have improved and the average person is well versed in analyzing his or her own medical data.

Prepare for Information Overload

The digitization of health care, whether done under HIPAA regulations or through open-source patient generated data, promises to usher in a new era of big data in health care that brings infinite possibilities for the health field. But more data does comes along with more complications. Will we be able to balance privacy with equality while actually using the data to our advantage? So far, we’re on the right track.

 Resources

Primary

Centers for Disease Control and Prevention: Federal Public Health Laws Supporting Data Use and Sharing

U.S. Department of Health and Human Services: HHS Announces $1 Million in New Grant Programs to Help Improve Sharing of Health Information

U.S. Department of Health and Human Services: New Federal Health IT Strategic Plan Sets Stage for Better Sharing Through Interoperability

National Institute of Drug Abuse: NIH System to Monitor Emerging Drug Trends

Additional

Public Health Reports: Big Data and Public Health: Navigating Privacy Laws to Maximize Potential

Robert Wood Johnson Foundation: Using Data to Build a Culture of Health

Robert Wood Johnson Foundation: Robert Wood Johnson Foundation Launches Initiative to Assess How Data Can Be Used to Improve Health

NPR: Tracking Your Own Health Data Too Closely Can Make You Sick

The Atlantic: Should Patients Be Able to Find Organ Donors on Facebook?

Apple: ResearchKit

Buzzfeed: A New Facebook App Wants To Test Your DNA

Ashley Bell

Ashley Bell communicates about health and wellness every day as a non-profit Program Manager. She has a Bachelor’s degree in Business and Economics from the College of William and Mary, and loves to investigate what changes in healthy policy and research might mean for the future. Contact Ashley at staff@LawStreetMedia.com.

The post Healthcare Digitization: Balancing Public Health and Privacy appeared first on Law Street.

One decade ago, the iconic Bald Eagle lived up to the American dream by defying extinction.

At the dawn of the 20th century, the majestic bird of prey found itself in peril, and not from natural causes. The Bald Eagle’s plight resulted from man-made difficulties. In the early years, hunting and logging threatened the birds, then the pesticide DDT came onto the scene. DDT ended up in the eagles’ food and caused them to lay weak, inviable eggs. Thus, the eagle population plummeted.

Americans scrambled to protect their favorite bird. The Bald Eagle Protection Act of 1940 outlawed the shooting, poisoning, or killing of Bald Eagles, DDT was banned, and Bald Eagles became one of the first species protected under the new Endangered Species Act of 1973.

In 2007, the government removed them from the endangered species list, proving the success of environmental programs and offering hope to species on the brink.

While Bald Eagles escaped extinction, many other species haven’t been so lucky. Habitat destruction, human construction, poaching, and even climate change close in on animals every day, threatening the balance of our interconnected ecosystem. Here’s an overview of what we’re doing to protect endangered species and what else we could be doing.

What does it mean to be an endangered species?

Here’s a quick rundown on how we define endangered species.

The Basics

“Endangered” is an official government designation created by the Endangered Species Act of 1973.

Animals who earn the title:

• Receive protection from potentially harmful federal activities, meaning that agencies have to consider endangered species in their authorization and funding decisions;
• Can’t be transported, sold, or “taken,” which bans any activities that can kill or harm the animal like shooting, trapping, hunting, and pursuing;
• Become eligible for U.S. Fish and Wildlife Service (FWS) recovery plans. The plans evaluate research and protocols to determine needs for successful species recovery; and,
• Could be supplied with habitats if needed, purchased by the  U.S. Fish and Wildlife Service (FWS).

Protection is enforced by the U.S. Fish and Wildlife Service (FWS), a section of the Department of the Interior and the National Marine Fisheries Service (NMFS), part of the the National Oceanic Atmospheric Administration.

How do animals get the designation?

Endangered species are simply species in imminent danger of becoming extinct. A “threatened” designation refers to species at risk for becoming endangered soon.

Common things that can endanger a species are:

• Destruction or alteration of habitat.
• Overuse for education, scientific, commercial, or recreational purposes.
• Disease.
• Predation.
• Any natural or man-made factors that affect survival, which could cover a number of human activities.

After establishing those factors, “candidates” for the list run through a thorough review process that could take up to two years. In that time, experts submit biological information on the species that will help inform the decision. In the review, experts consider the severity of the threat, how soon the extinction could happen, and the uniqueness of the species. You can check out the current list of candidates here.

Once a species gets on the list, the authorities reevaluate that case every five years to see if a classification should be removed or changed.

The ESA is an American law, yet many endangered species like tigers and gorillas aren’t in the United States. In these cases, the ESA enforces bans and limits on trade in endangered animal body parts.

Opposition to the Current Policies

Protecting species often clashes with other interests. Recently, the government listed the Long-Eared Bat as a threatened species. But farming, timber, oil, and gas interest groups claimed that protecting the bat restricts them from certain practices and would drive up costs of their operations. Use of wind turbines, natural gas wells, and pesticides would all be restricted in order to protect the bat. Organizations plan to continue voicing their concerns as the threatened designation moves toward enforcement next month.

Listen to more about the controversy via NPR:

Problems With the Current Policies 

Like the Bald Eagle, some species have recovered enough to be removed from the endangered species list. Sadly, those successes are mere droplets in an entire ocean of worry. Many of the vulnerable species at risk of extinction don’t even make it on to the endangered species list and have no other source of protection. For example, according to the World Wildlife Federation’s (WWF) 2014 Living Planet Report, the populations of all vertebrate species have declined by 52 percent in the last 40 years.

Extinction means more than the life or death of a given species, as many animals influence our ecosystem, economy, and food security in ways we can’t realize until they’re gone. The loss of one species could create a devastating domino effect. The case of the Bonobo, a type of chimpanzee, makes a perfect example of what can happen when species’ decimation continues unchecked.

The Plight of the Bonobo

Bonobos face extinction as a result of poaching from the bushmeat trade. But Bonobos themselves aren’t the only thing that we need to worry about when considering their extinction. Studies have found that a majority of plants and trees in the Democratic Republic of the Congo need Bonobos to spread their seeds and will not reproduce unless their seeds are first “processed” by the Bonobo; this means that the Bonobos’ stomach acids break down hard seed coatings and enable them to sprout. Plant growth depends on each Bonobo. On average, every Bonobo processes about 11.6 million seeds in its lifetime.

Their extinction would set off a chain reaction: loss of trees and plants, loss of other species that lived among the trees and plants, and eventually we’d reach a stillness known as empty forest syndrome, where large vertebrate populations dwindle to nothing. According to biologist David Beaune, the same thing could happen in ecosystems that unknowingly rely on other chimpanzees, gorillas, and apes that “process” and spread seeds.

U.S. Protective Actions

Last year, President Obama signed an executive order for a National Strategy for Combating Wildlife Trafficking to address the illegal wildlife trade. The strategy emphasized three priorities:

1. Strengthening enforcement of wildlife trafficking bans.
2. Cutting the illegal wildlife trade at home and abroad.
3. Strengthening partnerships in efforts to combat illegal wildlife trade and poaching.

Altogether, the strategy cracks down on the market for illegal wildlife trade as a strategy to protect animals. As Harrison Ford says in the PSA below, “When the buying stops, the killing does too.”

In February 2015, the Departments of State, Justice, and the Interior released the Implementation Plan for the strategy, which outlines specific steps that the President’s Task Force on Combating Wildlife Trafficking need to take and how its progress will be measured. You can access the full plan to read about the specific steps proposed to address the three strategic priorities bulleted above.

One example of the strategy at work is Operation Crash, a proactive criminal enforcement initiative that aims to search and reprimand people who hunt and kill rhinos or traffic their horns. Operation Crash has made 26 arrests and convicted 18 perpetrators. You can check out examples of the convictions here.

While this is excellent progress, the National Wildlife Federation recommends full participation in recovery programs and encourages stakeholders to produce measurable recovery targets that go beyond the safety net features of the Endangered Species Act. It acknowledges the need to stop the killing, but wants to see more proactive recovery assistance options.

Is “de-extinction” possible?

In the introduction of the WWF Living Planet Report 2014, Director General Marco Lambertini encourages people to take up the difficult but crucial responsibility of protecting wildlife.

Difficult, certainly, but not impossible – because it is in ourselves, who have caused the problem, that we can find the solution. Now we must work to ensure that the upcoming generation can seize the opportunity that we have so far failed to grasp, to close this destructive chapter in our history, and build a future where people can live and prosper in harmony with nature. We are all connected – and collectively, we have the potential to create the solutions that will safeguard the future of this, our one and only planet.

After all, we can’t bring species back once they’re gone. Or can we?

In the following video, writer Stewart Brand discusses the possibilities of a “dawn of de-extinction,” the reality of bringing species back from well beyond the brink by reassembling an entire genome using ancient DNA.  He discusses how geneticist George Church has created a multiplex automated genome engineering machine that tests ancient DNA combinations for viability in living organisms. Combinations that win can be used to synthetically hybridize the genome of an extinct species with the genome of its closest living relative.

So theoretically, we might be able to resurrect lost species. But in the meantime, we should focus on protecting the species that are still around.

Resources

Primary

White House: National Strategy for Combating Wildlife Trafficking & Commercial Ban on Trade in Elephant Ivory

U.S. Fish and Wildlife Service: Listing a Species as Threatened or Endangered

U.S. Department of State: Presidential Task Force Releases Implementation Plan for the National Strategy for Combating Wildlife Trafficking

U.S. Department of Justice: The Fight Against Wildlife Trafficking

Additional

National Geographic: Bald Eagles Soar Off Endangered Species List, But Will Act Be Weakened?

World Wildlife Federation: Living Planet Report 2014

National Wildlife Federation: Keeping the Endangered Species Act Strong

Oryx Journal: What Would Happen to the Trees and Lianas if Apes Disappeared?

Scientific American: If Apes Go Extinct, So Could Entire Forests

Society of Environmental Journalists: The Endangered Species Act at 40: Forty Things Journalists Should Know

Ashley Bell

Ashley Bell communicates about health and wellness every day as a non-profit Program Manager. She has a Bachelor’s degree in Business and Economics from the College of William and Mary, and loves to investigate what changes in healthy policy and research might mean for the future. Contact Ashley at staff@LawStreetMedia.com.

The post Endangered Species Protections: Are We Doing Enough? appeared first on Law Street.

The blanket ban on Medicare coverage of sexual reassignment surgery, which had been in place since 1989, was lifted in May 2014. With this move, Medicare officially recognized sexual reassignment surgeries as non-experimental and medically necessary for some suffering from gender dysphoria. Many consider the lifted ban a major victory for transgender rights; however, the move also sparked controversy as many people felt Medicare needs to prioritize the coverage of other medical concerns. Read on to learn how and why Medicare made the decision to lift its ban on sexual reassignment surgery.

What does it mean to be transgender?

According to GLAAD, transgender is “an umbrella term for people whose gender identity and/or gender expression differs from what is typically associated with the sex they were assigned at birth.” “Transsexual” is an older term “preferred by some people who have permanently changed–or seek to change–their bodies through medical intervention.” Gender identity is a person’s innate sense of being female, male, or other. Gender expression is how “a person communicates gender identity to others through behavior, clothing, hairstyles, voice, or body characteristics.”

It’s important to note that being transgender is not considered a mental disorder as it does not cause significant distress or disability; however, those who identify as trans* have difficulty finding “affordable resources, such as counseling, hormone therapy, medical procedures and the social support necessary to freely express their gender identity and minimize discrimination.” The culmination of these experiences can lead to higher levels of anxiety and/or depression than among the cisgender population.

What is Gender Dysphoria?

Gender Dysphoria It is a diagnosis given to people who “experience intense, persistent gender incongruence.” They do not identify with the physical sex they were assigned at birth. For an official diagnosis, the incongruence must last for at least six months. For children, the wish to be a different gender must be apparent and verbalized. People with gender dysphoria exhibit an overwhelming desire to be rid of his or her biological gender characteristics or “strong conviction that one has feelings and reactions typical of the other gender.” In order to cure gender dysphoria, some opt to undergo hormone therapies and or/medical surgeries.

The World Professional Association for Transgender Health (WPATH) recommends a “real-life experience” and hormone therapy before surgery. A real-life experience is a specific duration of time that a transgender person must completely live as their desired gender while maintaining a mentally healthy and active lifestyle. People transitioning from male to female take testosterone-blocking agents along with female hormones like estrogen and progesterone in order to develop characteristics such as breasts, softer skin, and less body hair. Female to male candidates take testosterone in order to deepen the voice, shrink the breasts, and increase physical strength.

After hormone therapy, there are a plethora of surgical options. People transitioning from male to female may choose to undergo a breast augmentation, orchiectomy (removal of the testicles), penectomy (removal of the penis), vaginoplasty (creation of the vagina), clitoroplasty (creation of the clitoris), and/or labiaplasty (creation of labia). The new constructions are generally built from penile tissue. There is also voice modification surgery to deepen the voice. Transitioning from male to female generally costs $40,000 to $50,000. Female to male transition surgeries are less medically successful. Trans males can undergo a mastectomy (removal of the breast tissue), hysterectomy (removal of the uterus), and salpingo-oophorectomy (removal of the fallopian tubes and ovaries). Patients can have a metoidioplasty (enlargement of the clitoris), but the construction of a penis has yet to be medically perfected. Collectively, transitioning from female to male costs about $75,000. Both trans females and trans males can receive cosmetic surgeries as well.

Medicare’s Prior Policy

Since 1989, Medicare specifically denied coverage for sex reassignment surgery under the National Coverage Determination 140.3. The decision was based on a 1981 National Center of Health Care Technology report, which stated:

Because of the lack of well controlled, long term studies of the safety and effectiveness of the surgical procedures and attendant therapies for transsexuals, the treatment is considered experimental. Moreover, there is a high rate of serious complications for these surgical procedures. For these reasons, transsexual surgery is not covered.

Basically, the surgeries were considered too risky and dangerous.

Since then, the American Medical Association, the American Psychological Association, and the American Psychiatric Association began advocating sex reassignment surgery as a productive, effective relief for victims of Gender Dysphoria. The U.S. Department of Health and Human Services Departmental Appeals Board overturned the decision in May 2014. The board stated that the policy was “based on outdated, incomplete, and biased science, and did not reflect contemporary medical science or standards of care.” This doesn’t mean candidates will automatically be approved for sex reassignment surgery, but approval or denial will be given based on individual cases, not a blanket policy.

Case Study: Denee Mallon

Medicare’s reevaluation of the ban started when 74-year-old army veteran Denee Mallon was denied her request for gender reassignment surgery by Medicare. In turn, she challenged the government insurance ban against sex reassignment surgeries.

After receiving the surgery, Mallon happily stated, “I feel congruent, like I’m finally one complete human being where my body matches my innermost feelings, my psyche. I feel complete.”

Mallon initially realized her gender identity when she was a 12 year old child in the 1940s. She continued to live as a man, having five kids and entering three marriages. When she could afford sex reassignment surgery in the late 70s and early 80s, her doctors refused to approve it because she was participating in consensual sex with women. When she finally received approval in the late 80s, she could no long afford it. She lived her life as a woman aided by hormonal therapy starting at age 40. She hid the fact that she was born male until 2012 when she became open about it and came out of what she calls “stealth mode.”

In response to critics calling being transgender a “lifestyle” choice, Mallon stated, “It’s far deeper than that. It’s so a part of my basic psyche, there’s no escaping it. I’ve tried to be the kind of man that society wanted and my feminine self just kept creeping up.”

Mallon decided to challenge Medicare after she was refused sex reassignment coverage by both her secondary private insurer and Medicare. She could not afford the expensive surgery living on $650 a month in Social Security income. The challenge and review process took about 18 months, before Medicare decided to lift the ban.

Pros of Lifting the Ban

Health Benefits

According to a British study, 88 percent of patients whounderwent male to female sexual reassignment surgery were content with the results. Those with Gender Dysphoria that undergo the transition process have substantial mental health improvement and a decrease in substance abuse and depression. According to a 2010 U.S. study, 41 percent of transgender people have attempted suicide. Sex reassignment surgery is a critical step in creating mental stability for some.

Marci Bowers, a transgender obstetrician and gynecologist in Burlingame, California, reported only two out of 1,300 people on whom she has performed sex reassignment surgery wanted to reverse the procedure. This is a 99.85 percent success rate.

Starting a Trend

The lifted ban is not only a significant win for transgender rights, but perhaps a catalyst for more change to come. Many public and private insurers take cues from the government. This could be the start of a long line of insurers securing coverage for these types of surgeries. In 2002, zero Fortune 500 companies offered transgender benefits. Ten years later, 19 percent did, and by 2014 it was 28 percent.

As of today, California, Colorado, Connecticut, Oregon, Massachusetts, Washington, Illinois, New York, Vermont, and Washington D.C. have banned anti-transgender discrimination in health insurance, and they legally require insurers to provide transgender health insurance.

Backlash

The first attempt to lift the ban came in 2013, but there were protests from conservative and religious groups. Defenders of the ban don’t believe these types of surgeries should be paid for by tax payer money.

Leanna Baumer, a senior legislative assistant with the Family Research Council, stated:

Real compassion for those struggling with a gender identity disorder is to offer mental health treatments that help men and women become comfortable with their actual biological sex — not to advocate for costly and controversial surgeries subsidized by taxpayers.

Frank Schubert, national political director for the National Organization for Marriage, doesn’t believe condoning the surgery sends the right message to America’s youth “to respect who they are, how they were born.”

Conclusion

There’s plenty of evidence to suggest that an overwhelming majority of those who undergo sex reassignment surgery for Gender Dysphoria find a substantial increase in their quality of life. In a demographic that experiences high rates of depression and suicide, the importance of these procedures is clear. The high expense of these surgeries essentially eliminates the option if they aren’t covered by insurance. Most people don’t have an extra $50,000 to spend on treatment for any medical condition. The lifted ban holds important symbolic value for the future and what’s to come.

Resources

Primary

American Psychological Association: What Does Transgender Mean?

Additional

Advocate: HHS to Reevaluate Ban on Gender-Confirming Surgeries

How Stuff Works: Stages of Gender Reassignment

NBC News: Sex Reassignment Surgery at 74

GLAAD: GLAAD Media Reference Guide

National Center for Transgender Equality: Know Your Rights

Trans Health Care: List of U.S. States That Have Banned Anti-Transgender Discrimination in Health Insurance

USA Today: Medicare ban on sex reassignment surgery lifted

Washington Post: Ban Lifted on Medicare Coverage For Sex Change Surgery

Washington Post: Here’s How Sex Reassignment Surgery Works

Jessica McLaughlin

Jessica McLaughlin is a graduate of the University of Maryland with a degree in English Literature and Spanish. She works in the publishing industry and recently moved back to the DC area after living in NYC. Contact Jessica at staff@LawStreetMedia.com.

The post Sexual Reassignment Surgery: The Path to Medicare Coverage appeared first on Law Street.

Tumultuous alcohol regulations speckle America’s past. Prohibition alone demonstrates our sometimes love/hate relationship with liquor. Some people loved alcohol enough to succumb to criminal behavior. Others hated it enough to dream of scourging it completely from the nation. Extreme feelings on both sides only led to fleeting Prohibition policies, blemishes on the Constitution, and a case study in alcohol regulation.

Today, we enjoy more balanced alcohol policies, but the system has yet to achieve the perfect balance of  freedom, safety, and economic gain. From a public health perspective, alcohol consumption still presents a regulatory challenge in avoiding preventable alcohol-induced illness and death. Alcohol has unflattering ties to illness, death, and economic burden. Every year in the United States, alcohol consumption causes 1.6 million hospitalizations and 80,000 deaths. Alcohol-related liver cirrhosis alone kills 26,000 a year.

Many interventions place focus on the individual, with programs to treat heavy drinkers or educate people who might become heavy drinkers. Unfortunately, many accidents result when habitually moderate drinkers engage in uncharacteristically risky behavior. To make sure everyone benefits from interventions, many experts seek changes in alcohol regulations that could benefit the entire population. Some recent studies have yielded compelling results on how increasing taxes and adding breathalyzers to cars could yield enormous benefits to our overall well-being.

 Regulation of Alcohol in the U.S.

You can strut around certain streets of Savannah, Georgia clutching an open container with no questions asked. Try that in any city in Virginia and you could face misdemeanor charges. Alcohol policies vary–sometimes dramatically–from state to state.

Alcohol regulations fall into four major subject areas:

• How alcohol is sold and distributed
• How alcohol is purchased and served
• Taxes, usually in the form of excise taxes on wine, beer, and hard liquor
• Blood alcohol content (BAC) laws for operating cars and machinery

Recent studies on the effects of taxes and BAC laws scrutinize current policies and call attention to possible changes. Keep reading to learn about the findings and how they could mix things up.

Higher Alcohol Taxes

One action that could potentially reduce alcohol-related deaths and boost the economy? Sounds like a great idea. Unfortunately, the idea is raising taxes, which immediately puts a sour taste in many mouths. Unpopular or not, the researchers assessing the relationship between alcohol and taxes have found tax increases could yield major benefits.

Increasing Taxes Decreases Alcohol Consumption.  

Raising alcohol taxes decreases alcohol consumption, and therefore indirectly reduces alcohol-related disease and death. Research has proven many times the inverse relationship between alcohol consumption and higher taxes and prices. Compared with other prevention policies, taxation tops the list of the most effective ways to reduce drinking. Models have found increasing alcohol taxes could reduce alcohol-related deaths by about 35 percent, lower crashes by 11 percent, and even reduce transmission of sexually transmitted diseases by 6 percent.

Increasing Taxes Could Actually Create, Not Destroy, Jobs

People who oppose an increase in alcohol taxes often cite job loss and other economic concerns to justify their positions. But researchers have found that the opposite might be true, and increased alcohol taxes could actually stimulate the economy. Researchers from University of Illinois at Chicago and the Center on Alcohol Marketing and Youth (CAMY) at the Johns Hopkins Bloomberg School of Public Health created an online tool that tests how different alcohol tax rates could impact the economies of all 50 states.  According to the model, a $0.05 alcohol tax increase in California could create about 21,500 jobs if the tax revenue goes into the government’s general fund. You can check out the tool here and even find out what increased alcohol taxes could do in your state.

Let’s give a possible increase in alcohol taxes some perspective. Alcohol taxes have pretty much avoided being adjusted for inflation since the 1950s. Since alcohol taxes didn’t adjust with the rest of the economy, in relative terms alcohol costs significantly less than it did in the 1950s. Take beer for example; most states calculate beer taxes per quantity, not based on price. By the year 2000, state beer taxes amounted to relatively about a 1/3 of what they were in 1968 as inflation spiked beer prices but taxes stayed stagnant. While some states adjusted for inflation, most states saw tax profit dwindle by over 50 percent since 1968.

That’s why Alexander Wagenaar, a professor at University of Florida, believes taxes should be raised and automatically adjusted for inflation. He estimates that every drink consumed costs society about $1.90 in healthcare and other burdens, but points out that alcohol consumers aren’t responsible for the extra costs incurred by their actions.

Will it happen?

Any attempts to raise taxes on alcohol have been met with firm opposition from liquor lobbies and the hospitality industry. As a result, most attempts at increasing alcohol taxes have failed, at least 335 out of 364 major attempts since 2001 in New Mexico, Minnesota, Maine, and Hawaii, just to name a few. In 2012, it’s estimated that the liquor industry spent $16 million on political candidates, solidifying their place in regulatory affairs.

Mandatory breathalyzers in our cars?

Had enough of grim DUI-warning commercials and high school “Grim Reaper” days? One policy could put an end to them by physically stopping would-be drunk drivers from starting their cars. One possible alcohol intervention involves installing alcohol ignition interlocks (a.k.a in car breathalyzers) that connect to the car’s ignition and lock it if the driver’s BAC is above a pre-set limit. This might seem extreme, but shine a spotlight on the problems with alcohol-involved motor vehicle crashes (AI-MVCs) and you’ll see why it’s appealing from a policy angle.

AI-MVCs rank as a major public health threat mostly because the dangerous actions of a few can end up hurting many innocent people. Awareness campaigns and laws have decreased the problem since the 1980s, but in 1994 AI-MVCs accounted for 30 percent of all traffic fatalities and since then that percentage hasn’t really budged.

Policies like BAC limits, zero tolerance laws, and license suspension work, but they place the burden of finding and penalizing perpetrators in the hands of police officers. Without a magical drunk radar, this means some people slip through and cause devastation. Some estimates find that repeat offenders often drive drunk as many as 80 times before they’re discovered and apprehended. Even license suspensions don’t stop them, as 50 percent to 75 percent of offenders keep on driving anyway.

Interlock devices cause prevention-minded experts to salivate at the idea of nipping fatal accidents in the bud.  But would interlock devices actually help in the real world?

In 2008, the National Highway Traffic Safety Administration (NHTSA) started a five year test to determine the viability and effectiveness of widespread use of the devices. The Driver Alcohol Detection System for Safety (DADSS) program sought to find out if mandatory adoption policies would have an impact on fatal and non-fatal AI-MCVs and if they could decrease economic costs associated with AI-MCVs.

Here’s what they found out:

Interlock devices would prevent deaths and injuries: 

Using a 15 year implementation model, the DADSS program estimated that 59,000 (83 percent) deaths and 1.25 million (84 percent-88 percent) of nonfatal injuries could be prevented.

Interlock devices would reduce AI-MCV costs: 

Again, assuming a 15 year implementation model, costs associated with fatal injuries could be reduced by $260 billion and costs associated with nonfatal injuries could be reduced by $83 billion. In perspective, if the devices each cost $400 and worked 100 percent of the time, the reduction in injury costs would outweigh the implementation cost after 3 years.

A required interlock device program has already been implemented in France, the wine mecca of the world. Drivers in France need to have breathalyzers on hand or face fines. After implementing the program, France went from having one of the highest alcohol-related traffic fatalities in the world to having one of the lowest.

Will it happen?

The researchers acknowledged that mandatory interlock devices would be a drastic change, would take many years to implement, and would need to pass through the National Highway Traffic Safety Administration as a new safety standard. They recommend strengthening current policies in the interim, such as having all states require interlocks among first time DUI offenders, requiring the device use for longer periods of time, and requiring their use in the pre-conviction time frame. The DADSS found the public receptive to the idea, with 64 percent of people surveyed saying they thought it was a good idea.

 Prevention instead of Punishment  

State alcohol regulations change constantly.  With an alcohol tax system that’s stuck in the 1950s and an AI-MCV rate that hasn’t budged since 1994, more changes are certainly in order. New policies would shift our alcohol intervention system from one of punishment, to one of prevention.

If either of these ideas seem extreme to you, remember that there are already some odd alcohol-related laws on the books. For example, in Massachusetts, discounted alcohol, even during happy hour, is prohibited. When dining at a restaurant in Utah, all alcohol bottles on display must be empty. We’ve endured these and other strange alcohol laws throughout the history of the United States. Surely interventions that could reduce alcohol-related fatalities, disease, and injuries will prove more palatable to many Americans. 

 Resources

Primary

US National Library of Medicine: Effects of Beverage Alcohol Price and Tax Levels on Drinking: a Meta-analysis of 1003 Estimates from 112 Studies 

Additional 

Science Daily: Alcohol Taxes Can Improve Health, Lead to More Jobs

Association of State and Territorial Health Officials: Reducing Alcohol-Impaired Driving Through Ignition Interlock Policies

Mothers Against Drunk Driving: Ignition Interlock Frequently Asked Questions

Pew Charitable Trusts: Liquor Lobby Fights Off Tax Increases on Alcohol

American Journal of Public Health: Modeling the Injury Prevention Impact of Mandatory Alcohol Ignition Interlock Installation in All New US Vehicles

American Journal of Public Health: Effects of Alcohol Tax and Price Policies on Morbidity and Mortality: A Systematic Review

Public Health Law Research: Raising Alcohol Tax Levels to Reduce Drinking

Public Health Law Research: Effects of Alcohol Taxes on Alcohol-Related Mortality in Florida: Time-Series Analyses From 1969 to 2004

Yale Law School: Liquor Laws and Constitutional Conventions: A Legal History of the 21rst Amendment

Ashley Bell

Ashley Bell communicates about health and wellness every day as a non-profit Program Manager. She has a Bachelor’s degree in Business and Economics from the College of William and Mary, and loves to investigate what changes in healthy policy and research might mean for the future. Contact Ashley at staff@LawStreetMedia.com.

The post Breathalyzers in Cars? Changes in American Alcohol Policies appeared first on Law Street.

Skin cancer is the most common type of cancer in the United States. Some forms of skin cancer cause disfigurements and some  are fatal. Either way, skin cancer is nothing to take lightly. There are a variety of factors that account for the prevalence of skin cancer. In recent years, tanning beds have especially come under attack for their part in steadily increasing skin cancer diagnoses in the United States, especially for young people. Fortunately, not all is lost. Researchers are creating innovative skin cancer trials that are seeing encouraging results, while government officials promote state and federal policies to reduce the risks of skin cancer.

What is Skin Cancer?

Skin cancer is defined as:

The uncontrolled growth of abnormal skin cells. It occurs when unrepaired DNA damage to skin triggers mutations, or genetic defects, that lead the skin cells to multiply rapidly and form malignant tumors.

What are the most common types of skin cancer?

Basal Cell Carcinoma (BCC) is the most common form of skin cancer. In the U.S., 2.8 million cases of BCCs were diagnosed in 2010 and those numbers continue to increase. BCCs are “abnormal, uncontrolled growths or lesions” that form in the skin’s basal cells. Basal cells outline the outermost layer of the skin. BCCs resemble open sores, red patches, pink growths, shiny bumps, or scars. In most cases, both long-term sun exposure and short intense sun exposure can lead to the formation of BCCs. In rare instances, other factors like contact with arsenic, radiation exposure, and burn complications can trigger BCCs as well. They are rarely life threatening, but can cause disfigurement and muscle or nerve damage.

Squamous Cell Carcinoma (SCC) is the second most commonly occurring form of skin cancer. It develops in the skin’s upper layer squamous cells. Approximately 700,000 cases of SCC are diagnosed annually in the United States. Reportedly, between 3,900 and 8,000 cases had fatal results in 2012. In the last thirty years, SCC cases have increased by 200 percent. They generally resemble “scaly red patches, open sores, elevated growths with a central depression, or warts” that may crust or bleed. SCCs are most often caused by ultra violet (UV) exposure whether through daily long-term sun exposure, short intense sun exposure, or tanning beds. With a few exceptions, SCCs occur on parts of the body most often exposed to the sun. Although previously associated with men over 50, SCCs are steadily increasing in women under 30. This phenomenon is largely attributed to tanning beds.

Melanoma is the most dangerous form of skin cancer. Melanoma tumors “originate in the pigment-producing melanocytes in the basal layer of the epidermis.” They resemble moles, and can develop from moles as well. Most often, they are black or brown. The main source of melanomas is intense, sporadic UV exposure regularly leading to sunburn. There is also a significantly higher risk for those with a genetic predisposition toward skin cancer. Melanomas account for 9,710 deaths in the U.S. annually. There are 120,000 new cases diagnosed each year. Early detection is key as the disease is harder to cure when the cancer metastasizes to other parts of the body.

Statistics

Each year there are approximately five million Americans treated for skin cancer. There are more new cases of skin cancer than incidences of breast, lung, colon, and prostate cancer combined. One in five Americans will develop skin cancer in his or her lifetime. There is a 40-50 percent chance that an American who lives to the age of 65 will either develop a BCC or SCC. Approximately 90 percent of non-melanoma skin cancers are developed from UV radiation from the sun. And surprisingly, more people develop skin cancer through tanning than lung cancer through smoking.

One person dies of melanoma every 57 minutes and one in every 50 men and women will be diagnosed with it in his or her lifetime. Melanoma is one of three cancers with an increasing mortality rate (liver cancer and esophageal cancer). It is the most frequently occurring cancer in young adults (25-29) and the second most frequently occurring cancer in young people (15-29).

 What Causes Skin Cancer?

There are a variety of contributing risk factors for skin cancer. Unprotected overexposure to UV radiation from both the sun and tanning beds is the predominant source of skin cancer. This can come from extended daily exposure over the course of a lifetime or short intense spurts that result in sunburn. It is generally the latter that causes melanoma.

As of September 2, 2014, the FDA reclassified tanning beds from low-moderate risk to moderate-high risk devices. Indoor tanning is linked to more than 419,000 skin cancer cases a year in the U.S. A one-time indoor tanning session increases a person’s risk of developing squamous cell carcinoma by 67 percent and basal cell carcinoma by 29 percent. Two to three million teens use indoor tanning beds every year and subsequently increase their risk of melanoma by 75 percent.

Other risk factors include having pale and easily sunburned skin, genetics/family history, workplace exposure to coal tar, creosote, arsenic compound or radium, moles, and previous severe sunburns.

 Skin Cancer Clinical Trials

Through the successes of clinical trials, the FDA has approved seven new treatments for advanced metastatic melanoma cancer since 2011. The new treatment options include targeted therapies and immunotherapies. Targeted therapies “disrupt specific molecules that help cancer cells survive and grow.” Researchers are particularly excited about innovative immunotherapies that restore and enhance the immune system’s ability to fight cancer

National Cancer Institute’s Howard Streicher stated the difference for patients diagnosed with advanced melanoma just 5 years ago and today “is like night and day.”

Targeted Therapies

Targeted therapies disrupt the vital communication route of the signaling pathway in tumor cells known as the MAP kinase or MAPK pathway. The pathway influences “critical functions such as cell division and cell death.” Two proteins involved in the makeup of the MAPK pathway are the BRAF and the MEK. More than half of advanced melanomas have mutations in the BRAF gene. Two of the recently approved FDA drugs specifically target BRAF proteins: vemurafenib and dabrafenib. Each drug was approved after findings from phase III trials that tested patients with tumors that had one or two specific mutations in the BRAF gene. Trial results proved a longer overall survival rate without the disease worsening compared to the drug used as the standard of care at the time.

Immunotherapies

Melanoma is particularly predisposed to inducing an immune response. Researchers realized that tumors can divert T-Cells (particular proteins on the surface of immune cells) and other immune cells from attacking them by manipulating the immune system. The tumors essentially mask themselves from the T-Cells, while “dial[ing] back the immune response.”

One of the new drugs, Ipilimumab, “targets a checkpoint protein on T cells called CTLA-4” that releases the T-cells to attack tumors. This drug came into effect after a phase III trial that tested patients with cancer no longer reacting to FDA-approved and/or common therapies.

The other newly FDA-approved drugs for both targeted and immunotherapies saw similarly encouraging results. Testing is still in a fairly new territory and final results await to be seen. Future inquiries include: what combination of drugs would be most effective and which patients necessitate which specific drugs? Researchers are also looking to further limit side effects. Although most side effects were minor, some included severe skin rashes, diarrhea, colitis, and fatal lung inflammation.

 Law and Policy Regarding Skin Cancer

For starters, the Surgeon General’s office published its most recent Call to Action in 2014 on preventing skin cancer. A Call to Action is a “science-based document to stimulate action nationwide to solve a major public health problem.” The aim of this specific document is to increase skin cancer awareness and to call on various organizations and sectors in the U.S. to become invested in skin cancer prevention. The Call to Action presents a five step plan: promote sun protection in outdoor settings, inform the public about UV exposure, promote policies that advocate skin cancer prevention, minimize side effects from indoor tanning, and “strengthen research, surveillance, monitoring, and evaluation related to skin cancer prevention.” It also emphasizes skin cancer as a major threat toward American youth. It calls for coordination and support from federal, state, and local sectors of the business, health, and educational communities.

In accordance with the Surgeon General’s emphasis on American youth skin cancer prevention, many states have banned indoor tanning for minors. Currently, these states include California, Delaware, the District of Columbia, Illinois, Louisiana, Minnesota, Nevada, Oregon, Texas and Vermont. In addition, 42 states regulate indoor tanning by minors in varying ways. For example, Alabama bans indoor tanning for minors below the age of 15. Counties and cities across the country have regulated the activity as well. Howard County, Maryland was the first county to ban indoor tanning for minors under 18.

California has some specific laws that deal with UV safety prevention. Billy’s Bill for Sun Safety requires schools to allow students to wear protective sun gear outside and wear sunscreen without a physician’s note or prescription during the school day. The California Labor Code also allows lifeguards who develop skin cancer while working with a public agency or the California Department of Parks and Recreation to be eligible for workers’ compensation. Lastly, minors under 14 are prohibited from indoor tanning and children between the ages of 14-18 must have a parent or guardian’s written permission.

In New York, aside from regulations for minors, tanners 18 and over must sign a statement acknowledging the dangers of indoor tanning before stepping into the tanning booth. Staff at tanning salons are required to wear protective gear as well. The state also requires sun-safety education and necessary equipment for state employees that spend five or more hours in the sun daily.

Altogether, it seems more and more states are getting on board regarding UV preventative regulation and informing the public.

 Conclusion

Skin cancer is definitely a major health concern in the United States. New clinical research and national legislation are at the forefront of the fight. On the public end, we need to stay informed, help educate others, and take simple preventative measures. By implementing everyday habits we can best fight skin cancer, such as regularly applying sunscreen and wearing proper attire. Moreover, as a society, we need to stop perpetuating the trend that tanned skin in more attractive. But in all, the strides fighting skin cancer look extremely promising and the efforts don’t show any signs of slowing down.

Resources

Primary

The Surgeon General: Call to Action to Prevent Skin Cancer

Additional

Skin Cancer Foundation: Skin Cancer Facts

American Cancer Society: Skin Cancer Facts

NCSL: Indoor Tanning Restrictions for Minors

NYSCOPBA: Sun Safety

Skin Cancer Foundation: Basal Cell Carcinoma

Skin Cancer Foundation: Melanoma

Skin Cancer Foundation: New York Tightens Tanning Laws for Teens

Skin Cancer Foundation: Skin Cancer Information

Skin Cancer Foundation: Squamous Cell Carcinoma

Jessica McLaughlin

Jessica McLaughlin is a graduate of the University of Maryland with a degree in English Literature and Spanish. She works in the publishing industry and recently moved back to the DC area after living in NYC. Contact Jessica at staff@LawStreetMedia.com.

The post Skin Cancer: Clinical Trials, Current Policies, and Certain Progress appeared first on Law Street.

“Natural” and “organic” labels on food have become a tremendously popular–and tremendously profitable–means of discussing, buying, and selling food.

But what do we really know about what it means when those $4.99 cherry tomatoes are labeled as “organic,” or when that chicken is marketed as “all natural”? And who are we really concerned about when we talk about food labels–only consumers, or the people who produce our food, as well?

 What’s so natural about “natural”?

The U.S. Food and Drug Administration (FDA) doesn’t seem to have a clear answer to this question. In regards to the definition of “natural” food, the FDA’s website states that it:

Has not developed a definition for use of the term natural or its derivatives. However, the agency has not objected to the use of the term if the food does not contain added color, artificial flavors, or synthetic substances.

Without any legally binding regulations to mark which foods can be sold as “natural” and which cannot, the meaning of the label is ambiguous at best. Since “natural” foods are defined inconsistently–perhaps in whatever way sells best–the label is often criticized as being both misleading and meaningless.

The definition of “natural” is, however, regulated for meat and poultry. The U.S. Department of Agriculture’s Food and Safety Inspection Service requires that, in the case of meat and poultry labeling, “natural” must mean:

A product containing no artificial ingredient or added color and is only minimally processed. Minimal processing means that the product was processed in a manner that does not fundamentally alter the product. The label must include a statement explaining the meaning of the term natural (such as ‘no artificial ingredients; minimally processed’).

This emphasis on fundamentally altering the product means that the natural label is determined not by the process of raising the animals involved, but in their preparation for being sent to grocery stores after death. This means that what is fed to animals before their death is not regulated by a “natural” label. As a Take Action petition for banning “natural” labels that confuse customers reminds us, this means that:

Meat labeled as ‘natural’ can come from animals that were raised with daily doses of antibiotics and other drugs, given artificial growth hormones, fed genetically engineered soy and corn feed and other artificial ingredients and continually confined indoors.

 How organic is “organic”?

The definitions of “organic” are more legally binding than those of “natural.” According to the U.S. Environmental Agency (EPA), there are standards of “organic farming” that determine whether or not a food item can be labeled and sold as organic. This emphasis on organic as a farming process means that organic definitions are less about ingredients and more about the process of growing and considering the treatment of the plants that were harvested for food.

However, this also means that–especially due to the many kinds of organic labels–foods marketed as “organic” can still be full of chemicals. An informal investigation of Whole Foods organic products by Duke University senior Emma Loewe revealed many additives that are permissible under organic labeling. She writes,

Over the course of my search, I came across organic trail mix that featured Silicon Dioxide, Cirtric Acids and Maltodextrin. Try saying that five times fast. The canned goods aisle brought me to organic soup made up of sodium citrate and a dash of ‘cheese flavor’ for good measure. The organic cereal I picked up was made with vegetable glycerin—a common additive in cosmetics and soaps because of its cooling effect on the skin.

These additives are permitted under “organic” labels largely because there are different kinds of organic. According to the National Science Foundation, the different means of organic phrasing–100 percent organic, organic, made with organic ingredients, and others–are held to a diversity of legal standards. In order to use the U.S. Department of Agriculture (USDA) Organic Seal, foods claiming to be 100 percent organic must be made with 100 percent organic ingredients, excluding water and salt. Foods using the label “organic” must have 95-99 percent organic ingredients. Foods can still call themselves organic by saying they are “made with organic ingredients” if between 70 and 84 percent of the ingredients are organic.

This brings us back to the question: what does it mean to be an “organic ingredient”? According to the U.S. Department of Agriculture’s Agricultural Marketing Service, the regulations for crops and animals are as follows:

Organic crops. The USDA organic seal verifies that irradiation, sewage sludge, synthetic fertilizers, prohibited pesticides, and genetically modified organisms were not used.

Organic livestock. The USDA organic seal verifies that producers met animal health and welfare standards, did not use antibiotics or growth hormones, used 100% organic feed, and provided animals with access to the outdoors.

Vague statements like “access to the outdoors” and “prohibited pesticides” raise a great number of questions and criticisms regarding loopholes in the standards of organic labeling.

 From the Farm: Labor and Labels

Discussions about food labels so often focus exclusively on the health of people consuming the food. However, these conversations generally erase a bigger conversation about health, that is, the health of the farm workers who are the human backbone of agriculture in this country.

Advocates hope that efforts like these and others, such as emphases on broader immigration reform and health care, can bring a more total picture of health into the conversation about the health issues surrounding “organic” farming and “natural” foods.

So Are “Natural” and “Organic” Foods Actually Healthier?

It is important to determine whose health we are asking about when we discuss the healthiness of “organic” and “natural” foods. Those who consider the health of farm workers that produce foods labeled “organic” and “natural,” worry that the production of these foods can generate horrible health consequences for the humans involved in the process.

As to the question of “is it healthier to consume these foods?”, the answer is perhaps not. It’s important to remember that many large corporations, such as Coca-Cola, own organic brands, which links organic brands to larger environmental devastation and labor exploitation that negatively impact global health.

Given the legal impotence and inconsistency of the label “natural” advocates against the labels argue that foods with this label have anything in common other than their respective corporations’ attempt to tap into a market that wants to eat “natural” foods. Regarding the consumption of “organic” foods, the Mayo Clinic states that while the jury is technically still out, studies conducted over the past fifty years do not make a convincing argument that there are any significant differences in nutritional content between “organic” and non-organic foods. So, next time you go to your grocery store, you may want to keep a close eye on more than just the labels on your food.

Resources

Primary

Food and Drug Administration: What is the Meaning of ‘Natural’ on the Label of Food?

U.S. Department of Agriculture: Meat and Poultry Labeling Terms

U.S. Department of Agriculture: National Organic Program

Environmental Protection Agency: Organic Farming

Additional

Farmworker Justice: Home

Agricultural Justice Project: Home

Grist: Workers on Organic Farms are Treated as Poorly as Their Conventional Counterparts

TakeAction: Stop Confusing Consumers: Ban the ‘Natural’ Label

EcoWatch: Organic Labeling: What You Need to Know

NaturallySavvy: The USDA Organic Program Faces Criticism

EarthJustice: Pesticides: The Workplace Hazard the EPA is Ignoring

Salon: California’s Rampant Farm-Labor Abuse

Jennifer Polish

Jennifer Polish is an English PhD student at the CUNY Graduate Center in NYC, where she studies non/human animals and the racialization of dis/ability in young adult literature. When she’s not yelling at the computer because Netflix is loading too slowly, she is editing her novel, doing activist-y things, running, or giving the computer a break and yelling at books instead. Contact Jennifer at staff@LawStreetMedia.com.

The post Natural or Organic: Not Just the Labels on Our Food appeared first on Law Street.

Could your surroundings impact your health as much as your diet, genetics, and lifestyle? The field of environmental health seeks to understand how the natural and manmade elements of our homes, work, and leisure environments impact health. To understand environmental impacts on health, experts examine a tremendous range of factors from community noise levels to the availability of public parks; some even look at dust.

I know that seems strange, because when you look at dust, I’m sure you probably see nothing but unsightly grime that makes you sneeze. But when researchers at the California Department of Toxic Substances Control look at dust, they see a possible indicator of chemicals people might be exposed to from various synthetic materials commonly found in homes.

Dust holds clues to multiple facets of your domestic life. Companies use an array of chemicals, including flame retardants, to manufacture your appliances, furniture, and even curtains. Your appliances, furniture, and curtains also contribute to the powdery detritus obscuring your coffee table. Dust offers researchers a way to investigate the holistic chemical composition of the average home atmosphere, all from the contents of a vacuum cleaner.

So why do we spend time studying dust and hundreds of other tiny environmental factors? Well, the experts in the University of Michigan video below estimate that 25-33 percent of disease globally stems from our environments. If we understood what specifically caused that percentage, we could take the first steps toward developing interventions.

With so many aspects to consider, it’s hard to make a solid connection between one environmental factor and a health outcome. But solid connections do make for golden evidence in influencing policy decisions that promote better health outcomes. A relatively new science called biomonitoring could help environmental health scientists make those golden connections by linking a pollutant directly to a health problem.

What is biomonitoring?

Biomonitoring quantifies bodily absorption of pollutants by measuring chemical amounts in human specimens like blood or urine. In the dust example mentioned above, researchers could incorporate biomonitoring by comparing the chemical composition of dust samples with the chemical levels present in residents’ blood or urine samples. This would allow them to look beyond what chemicals are present and find out if people are actually absorbing them, since atmospheric presence doesn’t automatically indicate absorption.

For example, an elemental mercury spill in a Massachusetts school caused panic when air samples revealed high mercury vapor air levels after the initial clean up. The Massachusetts Department of Public Health responded to the panic by offering urine tests. It turned out they had nothing to worry about–none of the samples indicated elevated urine mercury levels.

We worry about chemical levels in the environment because of what they might be doing to human health, but they need to be absorbed in order to cause harm. Environmental health scientists can bypass the need to study the presence of environmental pollutants one by one, by using biomonitoring to directly assess human impact. Outside of individual cases, cross-population biomonitoring data could reveal locations with disproportionate chemical exposures, a red flag that something fishy is going on.

According to the Association of Public Health Laboratories, manufacturers in the United States use more than 100,000 chemicals, yet we don’t understand what they could all do to human health. Combine this uncertainty with the rise of chronic diseases and you have a concerned public that demands many answers. Biomonitoring strives to find out which of these 100,000 chemicals make it into our bodies so we can figure out what to do about it.

How can biomonitoring affect health policy?

In the 1970s when researchers discovered that lead exposure could cause serious health problems, the U.S. implemented laws to bar it from many products like food cans, paint, and gasoline. Biomonitoring through blood testing has confirmed decreased blood lead levels since the laws were enacted, but also pointed out that low income and minority children still have levels above the CDC safe reference value, with lead in housing being the major source. After hearing these results, officials looked to housing policies as a way to decrease the problem:

• The U.S. Department of Housing and Urban Development (HUD) and the U.S. Environmental Protection Agency (EPA) required landlords to disclose lead hazards in all residences built before 1978.
• HUD made lead safety mandatory for federally funded housing and created grants for removing lead hazards from current buildings.
• The EPA began regulating painting and repair practices in all residences built before 1978.

These efforts achieved lower levels of lead hazards in government-funded housing, but did little to decrease levels in low-income or non-assisted housing.

At the state level, officials focused on finding children with elevated blood lead levels and then tried to remove lead from their environments. Some states, including Maryland, Massachusetts, and Rhode Island, implemented more prevention-based laws, but many still struggle with compliance.

To respond to a high concentration of children with elevated blood lead levels, Philadelphia officials combined public health with law in the Philadelphia Lead Court. The court was designed to increase compliance of city health codes related to lead hazards. If the court hears of a lead hazard, it issues an order to the property owner to remedy the situation. If they don’t complete hazard control activities, they’re sent to the Lead Court.

Before the court, property owners complied with lead regulations seven percent of the time. After the court was established, the compliance rate spiked to 77 percent.

These intervention successes were made possible through biomonitoring, and the connections between health and a contaminant that it revealed.

Biomonitoring and Fracking

Hydraulic fracturing (or fracking), a new and unconventional method for extracting natural gas, poses a possible health hazard to the people who live closest to fracking wells. Self reports show a disproportionate amount of respiratory problems like itchy eyes, coughing, and nose bleeds among people living near fracking wells.

Read More: Fracking is Short-Sighted in Light of Temporary U.S. Oil Boom

In this New Haven Register article, researcher Dr. Peter Rabinowitz summarizes the limitations of this self-reported data:

It’s more of an association than a causation. We want to make sure people know it’s a preliminary study. … To me it strongly indicates the need to further investigate the situation and not ignore it.

Use of biomonitoring in this instance could provide more clarity on which chemicals are present and could be causing health problems in the residents. A doctor from Aspen Integrative Health in Colorado has already tested some people who live close to drilling sites for chemical exposures. His results showed some elevated levels, but didn’t provide any conclusive links. The results could serve as a baseline comparison for other communities wishing to test residents.

The new federal rules on fracking don’t include any biomonitoring measures, but they take small steps toward understanding the possible health effects of fracking by requiring more care and accountability from drilling companies. Per the new rules, government workers can inspect fracking wells for safety, companies will have to tell the public what chemicals they use in their extraction processes, and companies will have to abide by new rules on chemical storage and disposal of flowback water.

Making Connections

The future of our health depends on our ability to make connections as we constantly introduce new chemicals into our lives through food, construction, manufacturing, and more. Environmental health scientists, supplemented by biomonitoring, work to make those connections in the hope that their findings will result in legal and policy decisions that keep people healthy.

Daunting as achieving these connections may be, daily advances, like this new University of Miami instrument to detect atmospheric mercury, bring us closer to understanding the interaction of our environment and our health. If we encourage advances in biomonitoring and other new technologies, all the vague correlations of the past could become solid connections.

Resources

 Primary

Environmental Health Perspectives: Proximity to Natural Gas Wells and Reported Health Status: Results of a Household Survey in Washington County, Pennsylvania

The Network for Public Health Law: Environmental Public Health

Additional

Association of Public Health Laboratories: Biomonitoring: Analysis of Human Exposure to Chemicals

Association of Public Health Laboratories: Measuring For Potentially Dangerous Chemicals

Public Health Law Research: Local Housing Policy Approaches to Preventing Childhood Lead Poisoning

Public Health Law Research: Public Health and Law Collaboration: The Philadelphia Lead Court Study

Public Health Law Research: Philadelphia’s Lead Court is Making a Difference

Association of Public Health Laboratories Blog: Biomonitoring and the Public Health Laboratory: Everything You Want to Know

Association of Public Health Laboratories: Biomonitoring: An Integral Component of Public Health Practice

EurekAlert: Researchers Develop New Instrument to Monitor Atmospheric Mercury

The New York Times: New Federal Rules Are Set For Fracking

Washington Post: Obama Administration Tightens Federal Rules on Oil and Gas Fracking

NPR: Interior Department Issues New Federal Rules On ‘Fracking’

The Network for Public Health Law: Environmental Public Health

Ashley Bell

Ashley Bell communicates about health and wellness every day as a non-profit Program Manager. She has a Bachelor’s degree in Business and Economics from the College of William and Mary, and loves to investigate what changes in healthy policy and research might mean for the future. Contact Ashley at staff@LawStreetMedia.com.

The post Biomonitoring: A New Way to Look at Health Policy appeared first on Law Street.

On July 20, 1969, man set foot on the moon for the first time in what Neil Armstrong famously called “one small step for a man, one giant leap for mankind.” After these first dusty steps, people pondered what giant leaps might be next, dreaming about lunar colonies, outer space tourism, and most recently, space mining.

Read More: Thanks to New Discovery Your Seat on Mars One is Looking Good

Recent unmanned moon expeditions detected a bounty of 1.6 billion tons of water ice and other rare earth elements (REE) lingering beneath the moon’s surface. Combine this enticing bounty with speedily developing technologies that make space travel more accessible and you’ve got a budding space mining industry. Space exploration technology has become infinitely cheaper, better, and smaller than it was back in 1969, pushing what was once only possible for national governments into the hands of private companies gearing up to tap into outer space resources

But one little hitch might hold them back. The only acknowledged international regulation on space travel, the Outer Space Treaty of 1967, left space property rights ambiguous. Companies and nations seem free to embark on all manner of expeditions, but the treaty doesn’t mention if they legally own any resources they pick up on the way. With hefty investments behind their ventures, space-faring companies demand assurance that they’ll be able to profit from the resources they might collect.

Will an old agreement keep businesses from capturing the teeming resources space has to offer?

Businesses With Extra-Terrestrial Aspirations

Lunar mining? Piece of cake. Tapping into outer space resources has officially graduated from being a remote possibility to a reality. Already many commercial companies are wooing investors and toiling over in-depth plans, all gearing up to get a piece of the space pie.

• The Shackleton Energy Company (SEC) plans to build the first space fueling station. Remember that 1.6 billion tons of water ice just waiting on the moon? When converted to liquid form, the hydrogen and oxygen in this ice creates a powerful chemical propellent–the most powerful we know of. Liquid hydrogen and liquid oxygen already power most space shuttle engines. SEC plans to mine the moon’s ice and set up a fuel station in Earth’s orbit. Fueling from this location instead of Earth could decrease costs by a factor of up to 20 to one.

• Moon Express developed a revolutionary vehicle, the MX-1 lunar lander, powered by sunlight and fueled by hydrogen peroxide. It will send the craft on speculating missions to investigate resources that might be mined. This company plans to perfect the safety and efficiency of lunar landings, making the moon as accessible as an eighth continent.
• Planetary Resources fixed its eye on asteroids, the most abundant sources of water that can be converted into hydrogen and oxygen rocket fuel. The company uses an algorithm to find asteroids and determine which ones might be resource rich.
• The Google Lunar X Competition offers incentives for discoveries that make getting to the moon easier and cheaper. Teams hoping to snag the $30 million grand prize have to land a robot on the moon, move it around, and send back HD Mooncasts for earth-dwellers. The competition is well under way and will wrap up in December 2016. Teams have already innovated promising robots, including this animated prototype rover named Uni from Team AngelicvM featured in the short video below.

Despite dazzling technology and high hopes, unclear space property laws pose major risks for commercial companies. Space travel costs have decreased relative to 1960s costs, but it’s still not cheap. Certainly not cheap enough that companies will launch rockets without solid assurance that they’ll own whatever resources they find on their missions. As you can see, these companies listed above, as well as many others, are ready to go. Let’s see what’s holding them back.

The Outer Space Treaty of 1967

The Outer Space Treaty of 1967 stands as the only cooperative international agreement governing space travel. The treaty clearly forbids countries from declaring sovereignty over celestial bodies in Article II:

Outer space, including the Moon and other celestial bodies, is not subject to national appropriation by claim of sovereignty, by means of use or occupation, or by any other means.

Mining isn’t specifically mentioned, but then again mining the moon was an outlandish possibility in 1967. The provision stood to bar nations from lassoing the moon, so to speak. Now as we look to extract resources from these common areas, many desire explicit, legal guarantees that they may do so–both for financial reassurance and to avoid conflict with other nations and companies wrestling over the same resources. Established property rights would provide the certainty necessary to encourage cultivating outer space for abundant natural resources.

Read More: FAA Allowing Companies to Call Dibs on the Moon

One company, Bigelow Aerospace, pushes adamantly for clarification on real property rights in space. In an internal report issued to NASA, Robert Bigelow, founder and president of the company, summarizes its desires well:

Without property rights, any plan to engage the private sector in long-term beyond LEO activities will ultimately fail. Companies and their financial backers must know that they will be able to enjoy the fruits of their labor relative to activities conducted on the Moon or other celestial bodies, and own the property that they have surveyed, developed, and are realistically able to utilize.

Who bears the burden of deciding the fate of Bigelow Aerospace and other hopeful companies? Article 6 of the Outer Space Treaty of 1967 specifies that governments bear responsibility for the activities of their nation and subjects in outer space, including the decision to authorize activities. Many U.S. government entities have a say in space happenings, but it’s the Federal Aviation Administration’s Office of Commercial Space Transportation (FAA-AST) and its advisory committee, the U.S. Commercial Space Transportation Advisory Committee (COMSTAC), that bears the burden of responding to recent requests to clarify commercial space laws.

During the most recent FAA-AST meeting in September 2014, Ken Hodgkins, Director of the Office of Space and Advanced Technology, acknowledged the number of private companies planning commercial ventures and how their activities question the legal frameworks around space exploration. He stressed balancing investment incentives with U.S. foreign policy obligations. Hodgkins stated concerns about proposed commercial activity falling in line with the Outer Space Treaty and encouraged further dialogue between private companies and U.S. agencies. He does not believe attempts at changing the treaty would result in faster resolution of the questions and assured meeting attendees that they are working with foreign nations to discuss the provisions in question.

Past Space Property Challenges

Very few cases have tested the limits of the Outer Space Treaty, so its enforceable interpretations remain unclear. However, a few incidents might influence the direction of space property rights decisions.

In one space property court case, Nemitz v. United States, a San Francisco district court ruled against a man’s claim of ownership on the asteroid 433, also known as Eros. Nemitz had filed a claim of ownership on the asteroid through a now-unpublished online database known as the Archimedes Institute. When NASA landed on his asteroid in 2001, Nemitz attempted to charge them parking fees. When they rejected him, he took his claim to court, where judges also dismissed his claim, stating that his assertion of ownership had no ground in law.

In a more powerful non-court precedent, moon materials from the Apollo landings in the 1960s have already been traded and sold. NASA traded lunar samples with the Soviet Union in exchange for their samples from robotic moon missions. Private individuals in Russia have even sold samples. These transactions imply outerspace materials can be owned, traded, and sold, giving hope to mining hopefuls.

New Space Legislation

Representative Bill Posey (R-FL) introduced H.R.1508 on March 15, 2015,

To promote the development of a United States commercial space resource exploration and utilization industry and to increase the exploration and utilization of resources in outer space

A more in-depth summary is not yet available, but you can be certain the measure will tackle legal barriers barring exploration of space resources. The bill now stands with the House Committee on Science, Space, and Technology.

Last month  the House passed the National Aeronautics and Space Administration Authorization Act of 2015, a near repeat of the National Aeronautics and Space Administration Authorization Act of 2014, which died in the Senate. The act authorizes NASA activities like space exploration, research, and education. While the bill doesn’t expressly cover commercial enterprise and space property rights, the sentiment of encouraging space-related innovation will serve commercial interests well.

Where no man has gone before…

As we speak, dreams of space colonies, moon mining, and even landing on Mars come closer to reality. This pulls legal questions and concerns to the surface, but only because we plan to go where no man has gone before. Establishing procedures will take time, cooperation, and patience, but it will be worth it to tackle our final frontier.

Resources

Primary

Federal Aviation Administration: Commercial Space Transportation Advisory Committee

U.S. Congress: Summary: H.R.810 — 114th Congress (2015-2016)

U.S. Congress: Summary: H.R. 1508 — 114th Congress (2015-2016)

United Nations Office for Outer Space Affairs: United Nations Treaties and Principles On Outer Space

Additional

Institute of Physics: Mining the Moon Becomes a Serious Prospect

Space.com: Mining the Moon? Space Property Rights Still Unclear

Washington Post: Looking for an Exotic Vacation? Here’s Why Moon Travel May Be Only 20 Years Away

Space.com: Moon Mining Idea Digs Up Lunar Legal Issues

Space Future: Real Property Rights in Outer Space

Wired: Space Law: Is Asteroid Mining Legal?

NASA Space Flight: Moon Property Rights Would Help Create Lunar Industry

Space Policy Online: Legislative Checklist 114h Congress: Major Space Related Legislation

Moon Express: Missions

Planetary Resources: NASA and Planetary Resources, Inc. Announce Results of the Asteroid Data Hunter Challenge

Space Foundation: U.S. Government Space Programs

SF Gate: Final Frontier For Lawyers — Property Rights in Space/Land Claims, Commercial Schemes and Dreams Have Legal Eagles Hovering

Space Policy online: House Passes 2015 NASA Authorization Bill

Ashley Bell

Ashley Bell communicates about health and wellness every day as a non-profit Program Manager. She has a Bachelor’s degree in Business and Economics from the College of William and Mary, and loves to investigate what changes in healthy policy and research might mean for the future. Contact Ashley at staff@LawStreetMedia.com.

The post Who Owns the Moon? Space Property Rights Are Nearing appeared first on Law Street.

Imagine ripping into a warm baguette with your bare hands. You owe its intoxicating fluffiness and delectable chewiness to gluten. A water insoluble protein found in wheat, gluten and its compounds bring us everything we expect from bread. It helps dough rise and hold its shape while also lending elasticity, making bread deliciously chewy.

Yes, we’re talking about the same gluten that has become a modern villain, misunderstood and widely hated. Popular books like “Wheat Belly and Grain Brain: The Surprising Truth About Wheat, Carbs” and “Sugar—Your Brain’s Silent Killers” turned gluten into poison in the public eye. Testimonials extolling the virtues of a gluten-free diet crusade the internet, converting many a faithful bread eater. In short, few foods have gained as much notoriety as gluten and many people think it equals anything bad in food.

Far from evil, gluten just presents a digestive challenge. When you digest wheat, the proteins break down into peptides with compact and complicated structures that cause adverse reactions in people with conditions like Celiac Disease, wheat allergies, or IBS. Unfortunately, in the past 60 years these conditions have become more common, stumping manufacturers and regulators who struggle to satisfy growing market demand for safe, gluten-free products. Read on to find out what they’ve done about gluten, and what they still have to figure out.

The anti-gluten craze: trend or reality?

Is gluten-hatred just a viral trend that people flock to like lemmings? Or is there some truth behind the gluten hate?

Scientifically, aspects of gluten-hatred hold water. Celiac Disease has quadrupled in the last 60 years. Celiac Disease is a disorder triggered by gluten that causes intestinal problems and poor absorption of vitamins and minerals.

Unfortunately, these statistics don’t point to an explanation, leaving scientists to toss around possible theories like darts. Some point the finger at wheat-breeding practices, others insist modern processing plays a part. At this point, only more well-controlled studies on the subject will lead to a consensus.

One study ruled out the possibility that the statistical growth in Celiac Disease results from better detection and diagnosis. A researcher at the Mayo Clinic analyzed existing blood samples from Air Force recruits taken between 1948-1954. He searched for the presence of transglutaminase, an enzyme that indicates Celiac Disease, and compared the percentage he found in the retro sample to the percentage he found in a modern sample of similar subjects. The percentage in the retro sample was significantly lower than what he found in the modern sample, leading him to conclude that something has happened since the 1950s to increase the overall rate of the disease–and it has nothing to do with diagnostics and detection.

The increase in Celiac Disease, combined with the increased demand for gluten-free products, even among people without diagnosed conditions, put pressure on regulators and producers. They responded first with better labeling.

Put a Label on it

In August 2013, the Federal Drug Administration (FDA) issued a final rule on gluten-free labeling that became enforceable the following year. The rule took nine years to develop and stems from the Food Allergen Labeling and Consumer Protection Act of 2004. It set a uniform protocol for companies wishing to market their products as gluten-free that established the acceptable gluten threshold at 20 parts per million (ppm). Why not zero ppm? Some processing techniques can remove most gluten from wheat-derived ingredients. The rule ensures these ingredients can’t add up to pass the safe threshold for people with gluten sensitivity. Furthermore, any food bearing a gluten-free label that lists wheat as an ingredient must also provide an explanation of how the wheat has been processed to remove the gluten.

The rule doesn’t expressly require testing and monitoring of gluten levels in ingredients to ensure compliance, but that would certainly be a safe bet for manufacturers. With the substantial list of ingredients from different sources going into processed foods, only diligent testing and monitoring can guarantee a gluten-free product. Even foods that don’t contain gluten can be cross-contaminated at some point in the long supply chain.

Per the rule, if a food labeled gluten-free actually contains gluten, it would be deemed misbranded by the FDA and subject to regulatory action. Depending on the nature of the offense, that could mean anything from a little warning letter to criminal prosecution.

Gluten Outlaws

Gluten labeling has lead to criminal prosecution before, and it happened when no FDA rule existed to break. In 2011, several customers of the Great Specialty Bread Co. in North Carolina found their Celiac symptoms became mysteriously aggravated after eating bread labeled “gluten-free.” These angry customers took their complaints to the North Carolina Department of Agriculture and Consumer Services, which passed it on to the Wake County District Attorney.

During the trial that followed, testimonies from injured customers forged a strong case against the company. One of them was a new mother whose Celiac reaction to the mislabeled bread caused her to prematurely deliver her baby. Other complaints included severe abdominal pain and rashes.

The owner of the company was ultimately found guilty of 23 counts of fraud and sentenced to nine to 11 years in prison.

Gluten: It’s Complicated

So we have an enforceable labeling policy and some criminal precedent for labeling abuse. What we lack to advance policies is a complete understanding of why gluten sensitivity is growing in the first place and how to control it.

Negative reactivity to gluten changes depending on the specific condition a person has and the variety of wheat that they eat, making gluten sensitivity hard to study as an overall subject. Gluten-sensitive conditions like Celiac Disease, wheat allergies, and other wheat sensitivities are also irritated by different compounds in wheat. Furthermore, separate varieties of wheat contain different amounts of gluten compounds and these amounts can fluctuate among the same variety depending on growing techniques and processing methods.

Growing Techniques

Studies have shown that reactivity of a wheat variety can change based on its growing location. Some compounds in wheat even increase with fertilization and in certain weather conditions. We don’t track gluten content from farm to table, so at present it’s impossible to isolate these factors to produce less reactive products.

Processing Techniques

Processing methods influence the reactivity of wheat products and stand as the prime suspect in explaining why wheat-related sensitivity has increased over the last 60 years. Of all the factors affecting the wheat industry, processing methods have changed the most. Today we favor refined white flour, we extract wheat proteins to use as additives, and we shorten the natural fermentation process using fast-acting yeast.

All of these complex factors complicate the study of gluten sensitivity and keep us from determining why conditions are growing. Any and all of these factors could be contributing to the problem. Costs and the complexity of food processing deter researchers and producers from tackling the issue, but only further testing can provide food manufacturers with the guidance they need to improve their growing and processing methods to lessen negative reactivity among their gluten-sensitive customers. While the process would be tedious, it could indicate what wheat varieties and techniques to favor in order to cater to the growing culture of wheat sensitivity.

Gluten, Still a Hot Topic

While many people mock the anti-gluten trend, a growing segment of our population needs to avoid gluten for medical purposes. Even so, a gluten-free lifestyle remains persistently trendy outside of that population. In the National Restaurant Association’s What’s Hot in 2014 survey, gluten-free took the #5 spot.

The trend ultimately helps people with diagnosed conditions as manufacturers and restaurants race to innovate tasty new products. If demand holds steady, it won’t be long until a perfect, gluten-free iteration of an exquisite baguette is within reach.

Resources

Primary

FDA: FDA Defines “Gluten-Free” for Food Labeling

FDA: Food Allergen Labeling and Consumer Protection Act of 2004 Questions and Answers

Federal Register: Food Labeling; Gluten-Free Labeling of Foods

Additional

Food Politics: Good News: FDA Issues Rules for a Gluten-Free Claim on Food Packages

New Yorker: Against the Grain

Comprehensive Reviews: A Grounded Guide to Gluten: How Modern Genotypes and Processing Impact Wheat Sensitivity

Food Liability Law: FDA Issues Gluten Free Labeling Compliance Guide

WRAL: Durham Bread Company Owner Sentenced For Fraud

Institute of Food Technologists: Testing for Gluten in Foods

National Restaurant Association: 2014 Culinary Forecast

Ashley Bell

Ashley Bell communicates about health and wellness every day as a non-profit Program Manager. She has a Bachelor’s degree in Business and Economics from the College of William and Mary, and loves to investigate what changes in healthy policy and research might mean for the future. Contact Ashley at staff@LawStreetMedia.com.

The post How to Regulate Gluten, the Modern Food Villain appeared first on Law Street.

Some say a paper cut is the most painful thing in the world. Others would vouch for bullet wounds. Many men moan that a swift kick in the pants trumps it all. Who’s right? No one. Pain is notoriously difficult to assess because many factors play a part in the overall sensation. But that hasn’t stopped us from trying to understand its secrets with new technology.

Functional magnetic resonance imaging (fMRI) allows us to peep inside a brain in action to see what processes and pathways light up during sensation. Pain-specific work with fMRI technology inches closer to a possible objective assessment of pain by carefully studying what happens in the brain during a painful event. This possible objective assessment of pain offers more than just proof that you’re in more pain than your friend with a paper cut. It could change the way we prescribe medications and alter the way we practice law–especially in personal injury cases.

To win a personal injury case, victims must prove that their injury resulted in damages like pain and suffering. You can easily find evidence to support that you’re in pain, but try to apply a price tag and it gets tricky. How do you put a value on pain if you can’t know exactly what the person feels other than what they say? Enter the fMRI pain scan, which provides tangible evidence of a victim’s pain and suffering.

The technology’s critics argue that we have too much to learn about fMRI pain scans before we allow them in court as a valid measure of pain. Proponents wonder if the sophisticated new technology could usurp otherwise primitive methods of assessing pain.

Here’s what you need to know about the intersection of pain, brain, and law to decide your stance.

Pain and the Brain

Pain blinds some people, sending them to bed at the first flutterings of a headache. Yet professional athletes and exercise fanatics actually find it manageable, and even exciting. Some can even meditate their way to a weakened perception of pain. Individual differences like these make pain assessment a jungle, especially when you’re shooting for precision worthy of the courtroom.

Despite these differences, researchers hope we might be able to measure pain more precisely because all human pain begins with a universal neurological process.

Say you’re stung by a bee. The moment that stinger pops through your skin, nerve cells called nociceptors send alert signals racing through your spinal cord and up to your brain. The brain then decides how to react to the alert signals. It activates your motor pathways so you automatically swat the bee away and releases endorphins and other chemicals to help you regulate and reduce the pain you feel. The same process happens in everyone, but the specific competence of your own personal brain circuits and systems determines exactly how you experience the pain. That’s why your friend can brush aside the same bee sting that makes you wail.

How do we assess pain now?

As individuals, the way we evaluate our own pain muddies up assessments. When we feel pain, we want to tell everyone how it makes us feel, which is sometimes like…well, you get the picture. We immediately react to pain with guttural and meaningless expletives like “ouch!” and many other choice words. When prompted, we might be able to describe our pain as “dull” or “sharp,” but these methods could benefit from more precision.

The way professionals evaluate our pain isn’t too much better.  A doctor will usually ask you to rank your pain on a scale of one to ten and then point to the emoticon the best represents your state of mind.

If you’re trying to win a personal injury case with nothing but a number five and a half-frowny face to prove your pain and suffering, you might not see the best results. Wouldn’t it be better if they could just plug you into a machine that described your pain in terms of brain waves instead of your unreliable human emotions and descriptors?

That’s why many believe fMRIs hold the key to objective assessment of pain and would lead to more fair court outcomes.

What fMRIs Teach Us About Pain

All roads leading to pain travel the same neural pathways and fMRIs let us watch those pathways in action. There must be something from those processes we can measure.

A few years ago, researchers from multiple universities came one step closer to pain assessment by finding a marker pattern specific to physical pain stable enough for interpretation. Even if someone can’t talk (like a baby), the pattern they discovered would help us understand their pain using brain scans. The marker distinguished physical pain from other aversive events, meaning they can use brain scans to measure the actual pain experienced as a result of stimulus instead of the clouded emotional judgment that comes with it.

The discovery accelerated understanding and interpretation of fMRI brain scans.

Implications in the Law

We’ve just started to explore the intersection of neuroscience with law–aptly named neurolaw–and the treasure trove of evidence to be found in it.

In the Supreme Court decision in Roper v. Simmons, brain scans revealed distinct differences between adult and juvenile brains in briefs submitted to the court. The court eventually ruled against the use of the juvenile death penalty in that case. On the other hand, judges have ruled against fMRI-based lie detection in the 2010 case, U.S. v. Semrau.

Since many personal injury cases settle outside of court, it’s difficult to find a personal injury case using brain scans that has actually been tried in a courtroom. However, in Carl Koch & Tracee Koch vs. Western Emulsions Inc, a truck driver named Carl Koch sued past employer, Western Emulsions, for damages from a melted asphalt-induced wrist burn. A year after the injury, Koch was still in pain.

The case involved a face off between neuroscientists. Koch’s neuroscientist tested him with a method she developed that distinguishes real, chronic pain from imagined pain by hooking him up to the scanner and lightly tapping both of his wrists to see the different fMRI readings produced by each. The neuroscientist in the Western Emulsions corner disputed the evidence produced by the tests, saying that the mere expectation of pain could have produced the same results.

Ultimately, the judge allowed the scan as evidence and the case settled for more than Western Emulsions originally offered. Koch benefited from evidence provided by the brain scan, but many critics echo the dissenting neuroscientist’s concerns about fMRIs in the courtroom.

What are the problems with fMRIs in court?

Cautious critics serve up many reasons why fMRI scans should not yet be allowed in court. Here are some of the top arguments.

Brain Scans Can Sway a Jury

Evidence shows that neuroscientific evidence interferes with a person’s ability to interpret logic. People receive poor arguments with open minds when they’re backed with illogical neurological evidence. It seems that the mere presence of neurological evidence satisfies people into credulity.

Many Lawsuits Deal with Chronic Pain, a More Difficult Study Than Acute Pain

Scientists breeze through the study of acute pain with fMRIs. Acute pain results immediately from a stimulus. If you’re hooked up to a scanning machine and researchers prod you with a hot poker, there’s no doubt about what action causes the pain patterns in the scan. Most people pursuing personal injury lawsuits aren’t hooked up to machines at the time of their accidents. Chronic pain that comes after the accident often mingles with other issues, like depression, which might interfere with neurological scans and make it harder to attribute to one specific cause.

The Technology is New and Untested

Despite numerous discoveries, neuroscientists still disagree on the reliability of pain scans.

Many believe even the expectation of pain or a slight tilt of the head is enough to skew the results of an fMRI pain scan. Even simply blurting out “ow” has an effect on pain. In a National University of Singapore study, researchers had people sink their hands into alarmingly cold water. People who allowed themselves to say “ow” withstood the pain longer than the silent ones. They believe the effort of forming the expletive might be enough to interfere slightly with brain activities dealing with perception of pain and lessen the effect. Fluctuations like this lead people to question the validity of the scans and demand years of tests before admitting them as evidence.

The Scans Can Be Tricked by Your Emotions

In the NPR story above, David Linden, a neuroscientist at Johns Hopkins University, explains that two different brain systems process the feeling of pain. One system looks at pain with nothing but logic, evaluating where the pain came from and if the sensation burns, stabs, or aches. The other, more emotional, system tells us how to feel as a result of the pain. He also explains that emotions can steer your perception of pain. Negative emotions can make pain feel more intense. Torturers have used this fact to their advantage to make their victims’ pain worse by mixing emotions like humiliation in with already excruciating torture methods. This suggests pliability in a person’s reaction that could twist fMRI scan results.

How will we assess pain in the future?

During the nomination hearing for Chief Justice John Roberts in 2005, then-Senator Joe Biden posed a prescient,yet rhetorical, question:

“Can brain scans be used to determine whether a person is inclined toward criminality or violent behavior?”

His question centered on violent behavior, but now we can replace the last phrase with many other possible scenarios. Can brain scans be used to determine how much pain a person feels? As the technology becomes more widespread, more courts will surely face this question. Pain assessments and pain scans have further to go before they become a precise and trusted method, but they’re on the way. It’s exciting and scary to think of the ways our brain activity might be interpreted in another ten years.

Resources

Primary

New England Journal of Medicine: An fMRI-Based Neurologic Signature of Physical Pain

Journal of Cognitive Neuroscience: The Seductive Allure of Neuroscience Explanations

Additional

NPR: Pain Really is All in Your Head and Emotion Controls Intensity

Telegraph: Saying ‘Ow’ Really Can Ease Pain

Slate: Neuroscientists: Mercenaries in the Courtroom

WebMD: MRI Shows People Feel Pain Differently

Wall Street Journal: Doctors’ Challenge: How Real is That Pain?

All Law: Two Ways to Calculate a Pain and Suffering Settlement

Brainfacts: Neurolaw: Neuroscience in the Courtroom

Duke: Proof and Evaluation of Pain and Suffering in Personal Injury Litigation

Nature: Neuroscience in court: The painful Truth

Ashley Bell

Ashley Bell communicates about health and wellness every day as a non-profit Program Manager. She has a Bachelor’s degree in Business and Economics from the College of William and Mary, and loves to investigate what changes in healthy policy and research might mean for the future. Contact Ashley at staff@LawStreetMedia.com.