The federal government is cracking down on the labeling of homeopathic remedies. The Federal Trade Commission (FTC) is going to require that producers of homeopathic remedies either present science to show that their products work, or label them in a way that makes it clear that there’s “no scientific evidence that the product works.”

The homeopathic market in the United States is near $3 billion annually, but there’s no actual evidence that most of these kinds of treatments work–it’s a sort of pseudoscience. Homeopathy is based on the concept that “like cures like”–essentially if you’re sick you should take or use something that mirrors your symptoms and your body will cure itself. So, if you’re itchy, you might take some version of poison ivy. And while this new regulation won’t mean that homeopathic remedies like the St. Ignatius bean (used for anxiety) and St. John’s wort (used for pain) will disappear from shelves, the hope is that it will become clearer to the people who turn to them that they’re not actually really doing much.

According to the FTC:

Homeopathy, which dates back to the late-eighteenth century, is based on the view that disease symptoms can be treated by minute doses of substances that produce similar symptoms when provided in larger doses to healthy people.

Many homeopathic products are diluted to such an extent that they no longer contain detectable levels of the initial substance. In general, homeopathic product claims are not based on modern scientific methods and are not accepted by modern medical experts, but homeopathy nevertheless has many adherents.

To be fair, these new warnings may not change much. People who use homeopathy usually do so based on a true belief that the science is correct, regardless of the evidence. But for those who walk into a drug store, see homeopathic remedies, and assume that they’re effective because they’re sold alongside real medicine, these labels could make a difference.

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 Homeopathic Treatments Will Now Need to Disclose if They’re BS 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

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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.

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.

Picture your Netflix homescreen. Besides some errant selections courtesy of your (ahem, tasteless) roommate, it’s pretty much a haven of your unique preferences. Like a doting butler, it recommends you watch “Breaking Bad” since you enthusiastically plowed through every episode of “Orange is the New Black.” Netflix knows you. Or think about Amazon. It’s your data-powered best friend. It recalls your purchase history and movie preferences better than you do. So what if this data-powered framework for knowing you is applied to healthcare? What if your doctor knows you as well as Netflix?

That’s what the Precision Medicine Initiative aims to do–unleash the full power of science and data to make our healthcare system better, more effective, and more specific to individuals and conditions. The new model proposes a system of health care that treats you like the complex human being you are. Just as Amazon cares deeply about your past purchase behavior, the new healthcare system would care about the science-based reasons you’re you: your genes, your lifestyle, and your environment. Instead of pushing purchases, it would use what it knows about you to determine what treatments and preventions work best for your health.

President Barack Obama announced the Precision Medicine Initiative during his 2015 State of the Union Address and since then people have been discussing the pros, cons, and implications. Here’s an overview of precision medicine and what it means for you.

What is precision medicine?

Take a look at the video below for a summary of precision medicine from Jo Handelsman, Associate Director for Science at the White House.

Precision medicine revolves around you. It uses your genes, environment, and lifestyle to determine what treatments keep you healthy.

The Precision Medicine Initiative may be new, but precision medicine has some history. Doctors already use it to treat conditions like cancer and Cystic Fibrosis. Examples of precision medicine in action include processes like blood typing and medications like Imatinib (Gleevec), a drug for Leukemia that inhibits an enzyme produced by certain genes. The new initiative plans to expand the reach of precision medicine to to tackle other diseases.

The plan stems from a  2011 report from the National Academy of Sciences. The report called out a major healthcare weakness: data suggests possible causes of deadly diseases, yet we don’t treat people until telltale signs and symptoms surface. You don’t wait until your friend’s liver is wrecked to stage an alcoholism intervention. Why wait for symptoms of a deadly disease when early risk factors might be available?

Great idea in theory, right? Of course, the execution promises far more complexity. Experts hope that precision medicine is within our grasp now because of recent scientific advances that make it easier to collect and analyze patient data.

Advances That Make Precision Medicine Possible

Advancement 1: New Methods of Uncovering Biological Data

It’s easier to understand patients and tumors on a cellular and genetic level more than ever before because of things like:

• The Human Genome Project, an initiative that aims to map the DNA sequence of the human genome to determine a sort of biological instruction manual for how humans function. The study of the genome is called genomics.
• Proteomics, a discipline that involves studying proteomes, the entire system of proteins in an organism. The goal is understanding changes, variations, and modifications in proteins over time to determine biomarkers for human diseases, especially cancer.
• Metabolomics, a field that leverages analytical tools to discover and quantify metabolites, which are substances produced by metabolism. Studying them provides experts with a glimpse of an organism’s physiological functioning as metabolism is a huge factor in overall health.

Advancement 2: New Tools For Biomedical Analysis

New analytic tools make it possible to decipher the intricate medical data collected by the disciplines above. Computers and programs help to collect, store, and study biological and medical information. Overall, the discipline is called bioinformatics.

Advancement 3: New Digital Health Tools That Make Large Datasets Manageable

I said large data sets. Sound familiar? Yes, we’re talking Big Data. You’ve probably heard enough about it, but it’s actually an amazing thing, especially when applied to healthcare. Take a look at the video below for more information.

From collecting to analyzing, sophisticated data management tools make the Precision Medicine Initiative possible.

Collectively, these advances create the right environment for the unified national effort that the Precision Medicine Initiative proposes.

How will it work?

The President’s 2016 Budget provides $215 million for the program. Four key agencies slated to do a bulk of the work each get a chunk of the budget.

National Institutes of Health (NIH)

Project Budget: $130 million.

Task: Recruit a volunteer research cohort and leverage existing data.

The National Institutes of Health must find 1 million American volunteers willing to provide medical records, gene profiles, lifestyle data, and more. While data drives the initiative, you need people to get the data. In addition to this, the NIH will find existing studies and research to build a foundation for the initiative. It’ll collaborate with stakeholders to determine approaches for collecting patient information.

National Cancer Institute (NCI)

Budget: $70 million.

Task: Find better cancer treatments.

The National Cancer Institute will explore precision treatments for cancer by increasing genetically based cancer trials, researching cancer biology, and establishing a “cancer knowledge network” to inform treatment decisions.

Food and Drug Administration (FDA)

Budget: $10 million.

Task: Develop safe, new DNA tests.

The Food and Drug Administration will seek technologies that rapidly sequence DNA and the human genome. Tests should make genetic data collection easier and more standardized.

Office of the National Coordinator for Health Information Technology (ONC)

Budget: $5 million.

Task: Manage the data.

The ONC has a tough job. It needs to figure out how to store, use, access, and exchange all of this medical data without any privacy concerns.

What Precision Medicine Could Mean For You

Here’s Notre Dame’s video on precision medicine in action:

Precision medicine could mean treatments more specific to you. For example, about 55-65 percent of women with mutations in the BRCA1 gene get Breast Cancer; only 12 percent of those without the gene get it. If the gene mutation is discovered, doctors can recommend enhanced prevention measures like increased cancer screenings or prophylactic surgery to remove at-risk tissue.

We hope more precise treatments lead to better outcomes. Using precision medicine, we hope to answer many questions, including:

• How can we treat this better?
• Is there a cure?
• Why does this disease happen in the first place?

The Downsides to Precision Medicine

Of course, the Precision Medicine Initiative has some drawbacks. The sheer amount of time it will take to collect and analyze all of this patient data leads the charge of negative comments. Below are some other downsides.

Interpretability

This article from the New Yorker calls out the problem of interpretability. To quote the author,l Cynthia Graber,

Many doctors are simply not qualified to make sense of genetic tests, or to communicate the results accurately to their patients.

Since doctors will be the sole executors of the initiative, more need to become fluent in the human genetic code. Programs like MedSeq have recognized this need and are already working to make genetic information translatable for practitioners.

The Budget Just Isn’t Enough

Experts say that even the $215 million proposed isn’t enough to meet the initiative’s lofty goals, like recruiting one million patient volunteers. One upside? Money can be saved by incorporating existing data, which the initiative plans to do.

Collecting the Data is Going to be Hard (This is an Understatement) 

If they do save money by integrating data from different studies, keeping the data clean will be hard considering the different time frames, constructs, and controls of various studies.

And as a practicing doctor writing for a New York Times blog points out, the lifestyle factors will be especially hard to study because of some uncooperative and intensely complex patients.

Insurance Companies May Not Pay For It

Precise matching of individuals to disease treatments sounds great, and extremely expensive, especially in the early days. Patients will need even more help determining what treatments suit them.

Hope For the Future

Sorry to bring up Netflix up again, but let’s face it, it’s very good at leveraging data to give you what you want. Consider any of its popular original series. Do you think Netflix just guessed what 50 million subscribers would like? Probably not. It used its massive stores of data to make informed decisions.

Early doctors and researchers puzzled over the symptoms of just a few patients, trying to find patterns, causes, and cures. While they did a fair job with the resources they had, trial and error medicine should be relegated to the less fortunate past. Today we have the power and knowledge to access data that helps doctors make more informed decisions on healthcare treatments.

Precision medicine will be complicated, difficult, time consuming, and who knows what else. But imagine what we can learn. We should be cautious, but we can also dare to hope.

Resources

Primary

White House: Infographic: The Precision Medicine Initiative

White House: FACT SHEET: President Obama’s Precision Medicine Initiative

White House: Precision Medicine is Already Working to Cure Americans: These Are Their Stories

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

National Institutes of Health: Precision Medicine Initiative

National Cancer Institute: What is Cancer Proteomics?

Additional

Nature: Obama to Seek $215 Million for Precision-Medicine Plan

New England Journal of Medicine: A New Initiative on Precision Medicine

National Academies: Toward Precision Medicine

National Institutes of Health: Precision Medicine Initiative

Nature: U.S. Precision-Medicine Proposal Sparks Questions

Brookings Institution: The Significance of President Obama’s Precision Medicine Initiative

New Yorker: The Problem With Precision Medicine

The New York Times: A Path For Precision Medicine

National Human Genome Research Institute: What is the Human Genome Project?

BioTechniques: What is Metabolomics All About?

Bioplanet: What is Bioinformatics?

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 Precision Medicine: The Future of Health Care? appeared first on Law Street.

Petri dishes do far more than indicate if you have strep throat. They were a key prop in the theater of antibiotic discovery. A mere glance in a petri dish ushered in the antibiotic revolution.

On a bright and sunny (just a guess) day in 1928, Alexander Fleming puzzled over what he saw in a petri dish of Staphylococcus bacteria. One small, moldy area of the dish had somehow dodged the enterprising colonization of the bacteria. Fleming speculated this was not a coincidence. He wondered if the mold, Penicillium Notatum, was somehow inhibiting bacterial growth. He experimented some more and eventually published his findings in the British Journal of Experimental Pathology. Fleming’s brick wall had been isolating the penicillin from the mold to use as a drug. Luckily his research eventually ended up in the hands of two scientists at Oxford who were ready to take up the challenge.

Penicillin — the first antibiotic — was used to treat a human patient in 1941. We’ve probably all taken them, but what are they really? Antibiotics are microorganisms (and now synthesized drugs) that attack the bacteria that cause infection in your body. Just as bacteria couldn’t grow on the moldy part of Fleming’s petri dish, bacteria cannot grow in a body on antibiotics.

World War II soldiers were among the first to benefit from penicillin before it was released to the general public in the late 1940s. Newspapers hailed it as a miracle drug.

The potential downside of this miracle drug had not evaded the experts, however. Alexander Fleming himself warned of microbes developing penicillin resistance in his acceptance speech for the Nobel Prize in Physiology or Medicine in 1945.

Miracles Happen

Antibiotics thwarted some of the leading causes of death in human existence. Childbirth, ear infections, and even simple skin scrapes were often deadly before these saviors entered the fray. Many children didn’t see their first birthdays, succumbing to infections we don’t think twice about today. Having surgery in the early 1900s? Just kiss your family goodbye before you go under the knife.

Antibiotics are microorganisms ideally adapted to kill other microorganisms while causing little or no harm to the host. The word “antibiotic” actually means “against life.”

Scientists design synthetic versions of these antibiotic microorganisms so we may have a profusion of drug options. About 150 million prescriptions are written for antibiotics every year.

And that’s a problem because…?

Antibiotics may be miraculous, but bacteria are not taking the challenge lying down. They’re fighting back by developing mechanisms to resist antibiotics. Don’t take it personally, it’s what any organism would do for the sake of survival. It turns out that bacteria are marvelous adaptors. Two million people in the United States suffer from antibiotic-resistant infections every year and many die as a consequence. Additionally, the CDC estimates a cool $20 billion in resulting economic burdens.

In short, our arsenal of antibiotics is losing efficacy. If this continues unchecked, we risk being thrust back into the dark ages of medicine when common ailments put many a healthy body six feet under. Antibiotic resistance is also detrimental to treatments for more serious illnesses. Therapies for cancer and organ transplants are often complicated with infection. Doctors rely heavily on antibiotics to keep their patients’ strained bodies free of infection. If antibiotics become ineffective, these life-saving treatments might be relegated to the past. It would mark one monumental step back in health care.

If you’re not scared yet…

Everyone loves a good villain to embody their fears. Emerging “superbugs” epitomize scary. When antibiotics were new, development was explosive. New drugs essentially kept microbes on their toes and resistance was less prolific. Invention of new drugs has now stagnated enough that bacterial evolution threatens to overtake our developmental countermeasures.

Welcome to the world of superbugs, aka resistant germs. These include nightmares like:

Carbapenem‐resistant Enterobacteri‐aceae (CRE): Literally nicknamed “nightmare bacteria.” It’s resistant to nearly all antibiotics and kills about half of the people infected by it.

Staphylococcus aureus (MRSA): MRSA usually manifests as a skin infection. Because of its resistant capabilities, it can wreak havoc by spreading through medical facilities.

These monsters aren’t made up, they’re frighteningly real and we may soon lose our ability to fight them.

Let’s Get “Sciencey”

Microbes are tricky little beasts. They will always evolve to develop resistance to what threatens them. The more bacteria are exposed to antibiotics (which we just learned is quite frequently), the more chances they have to develop resistance. When bacteria are exposed to antibiotics, susceptible strains die, leaving zero competition for the resistant ones so they are free to survive and flourish. Scientists call this selective pressure.

Resistant bacteria get that way by acquiring resistance genes through genetic mutation or getting the resistance from another bacterium. They can even get multiple resistant traits and end up developing resistance to multiple families of antibiotics.

Watch the video below for a perfect explanation of how this happens.

Why is this happening?

1. They’re over-prescribed: Antibiotics are some of the most commonly prescribed drugs used in medicine. For example, the first Ebola patient in the United States was sent home on antibiotics before doctors knew what he had. Antibiotics won’t do anything for Ebola or even the sinus infection they believed he had. Most sinus infections are viral so antibiotics don’t do anything — unless it was 1 out of the 100 cases where the sinus infection is caused by bacteria.
2. They’re mis-prescribed: Physicians often have to use incomplete or imperfect information. They prescribe antibiotics as a an all-purpose band-aid.
3. They’re used heavily: The chance of bacteria developing resistance increases with antibiotic use. Unfortunately, doctors must rely heavily on antibiotics to reduce risk of infection in critically ill patients. Furthermore, close proximity among sick patients in hospitals creates an ideal environment for resistant germs to spread.
4. They’re used in agriculture: Agriculture use accounts for half of the antibiotics produced in the United States. Scientists agree that adding antibiotics to feed is a key problem in developing antibiotic resistance. Agriculturally, antibiotics are used to promote animal growth and proactively prevent infections in addition to just treating sick animals.

Who is going to save us?

The CDC released a report on the threat of antibiotic resistance in 2013. It was the first exhaustive compilation of the health threats antibiotic resistance presents. If you’re not up to reading the whole 100 pages, here is a snapshot of the strategies they recommend to save us all from antibiotic resistance:

1. Prevent infections from happening in the first place: No infection, no antibiotics, and consequently less risk that resistance develops.

2. Track antibiotic resistance: Tracking will shed light on the specific mechanisms of resistance development. With this knowledge, intervention strategies will be more informed and more effective.

3. Change the way antibiotics are used: Antibiotics are generally overused. Up to 50 percent of antibiotic prescriptions are unnecessary. Physicians can take up the mantle of antibiotic stewardship by using antibiotics only when necessary.

4. Develop drugs and diagnostic tests: Bacteria develop antibiotic resistance as they evolve — it’s a natural process resulting from biological pressure. Introduction of new drugs will slow down this natural evolution. Diagnostic tests will allow us to understand and track the evolution in a more timely way.

Hey…did we budget for all of this?

Federal spending to combat antimicrobial* resistance has been limited. In 2014, the budget was $450 million. That figure sounds grand, but it amounts to just about $1.04 per American. On the other hand, antibiotic resistance costs the United States an estimated $55-70 billion each year.

A little bit lopsided, don’t you think?

*Antimicrobial resistance includes antibiotic resistance but also refers to resistance of other microbes like parasites and viruses. Antibiotic resistance refers specifically to bacteria that cause infection. Most strategies cover the more comprehensive antimicrobial resistance.

Making plans…

The Obama Administration announced a game plan in September for facing antimicrobial resistance. Here’s the to-do list:

• Leverage findings from the President’s Council of Advisors on Science and Technology (PCAST) report on combating antimicrobial resistance. The report suggests doubling the current federal investments from $450 million to $900 million a year. It also outlines recommendations for strong federal leadership, effective surveillance, research, clinical trials, increasing economic incentives for development, increasing stewardship for current antibiotic use, limiting agricultural use of antibiotics, and increasing international coordination.

• Implement the National Strategy for Combating Antibiotic Resistant Bacteria. The PCAST report was used to create a National Strategy for Combating Antibiotic Resistant Bacteria. The strategy focuses on five major goals:

Slow the development of resistant bacteria and prevent the spread of resistant infections; strengthen national one-health surveillance efforts to combat resistance; advance development and use of rapid and innovative diagnostic tests for identification and characterization of resistant bacteria; accelerate basic and applied research and development for new antibiotics, other therapeutics, and vaccines; and improve international collaboration and capacities for antibiotic resistance prevention, surveillance, control, and antibiotic research and development.

• Form a task force that combats antibiotic resistant bacteria. Established by Executive Order, the task force is responsible for implementing the National Strategy for Combating Antibiotic Resistant Bacteria. It is working on a detailed report of specific action plans due in February 2015.

• Finance diagnostic innovation. A $20 million prize, co-sponsored by the National Institutes of Health and the Biomedical Advanced Research and Development Authority, will be granted for a point-of-care diagnostic test that identifies antibacterial-resistant infections.

A little legal setback…

The July ruling in the NRDC v. US FDA case was marked as a major setback in the fight against antimicrobial resistance. The plaintiffs (including the Natural Resources Defense Council and Center for Science in the Public Interest) were dismayed that the court ruled against compelling the FDA to ban the use of antibiotics in healthy animals used for food.

The case overturned two other district court rulings that would have required the FDA to rescind approved use of antibiotics for purposes other than to treat sick animals. Companies could have gotten around the ruling if they proved the drug in question posed little risk for contributing to the development of antimicrobial resistance in humans.

Some other hangups

There are a few other pesky issues that might hinder some of the strategies for reducing antimicrobial resistance:

• Individual privacy could potentially get in the way of optimal surveillance of antibiotic resistance. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) guarantees privacy of health information that is individually identifiable. Patient preferences could determine what information can be used to track antimicrobial resistance.

• Companies lack incentives to create new antibiotics because the traditional sales volume and price linkage is missing. Because fighting antibiotic resistance forbids overusing one particular drug, companies would probably not get a good return on investment.

• Ponderous approval processes for new drugs might also hinder the speed of new antibiotic drug development. A balance will need to be struck in ensuring speed of innovation without compromising safety.
  

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So the government has antimicrobial resistance under control?

It has a robust plan for taking action against antibiotic resistance, but being an informed patient never hurt anybody. The CDC recommends a few steps you can take, including abstaining from antibiotic use for viral infections, not saving leftover antibiotics, and not taking antibiotics prescribed for someone else.

The fight against antimicrobial resistance is really no fight at all, but a call for permanent change in our medical and agricultural systems. As long bacteria exist and want to survive, our desire to survive must be stronger.

Resources

Primary

CDC: Antibiotic Resistance Threats in the United States, 2013

President’s Council of Advisors on Science and Technology: Report to the President on Combating Antibiotic Resistance

Additional

Cochrane Summaries: Antibiotics for Acute Maxillary Sinusitis

Food Safety News: White House Calls for Action Plan to Address Antibiotic Resistance

The White House: New Executive Actions to Combat Antibiotic Resistance and Protect Public Health

CDC: Untreatable: Today’s Drug Resistant Health Threats

Explorable.com: History of Antibiotics

American Chemical Society: Discovery and Development of Penicillin

National Institute of Allergy and Infectious Diseases: Antimicrobial Drug Resistance

World Health Organzation: Antimicrobial Resistance

Huffington Post: Feds Failing to Act on Antibiotic Resistance Despite Grave Threat

Natural Resources Defense Council: Food, Farm Animals and Drugs

CDC: Legal Issues Associated with Antimicrobial Drug Resistance

CDC: White House Announces National Strategy for Combating Antibiotic Resistance

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 Doing Enough to Prevent Antibiotic Resistance? appeared first on Law Street.

If you are going to a pharmacy for a particular drug, you’re often offered a choice — do you want the name brand or the cheaper generic? Generics have long been lauded for their ability to provide the same benefits to patients while also offering a less hefty price tag; however, recently generics have been getting more expensive, and people are wondering why. Congress announced this week that it’s going to launch an investigation into why the price of generic drugs is rising.

When a drug company develops a particular drug, it gets to hold the patent for approximately twenty years (some nations or jurisdictions give protections for a bit longer). During that period, that company is the only one that can produce that particular drug. After the patent expires, however, other companies can make a “generic” version of the drug.

There are certain regulations created by the Food and Drug Administration (FDA) to make sure that the generic drugs are able to be distributed. The FDA requires that a generic drug has the same active ingredients as the one that it is imitating, but not necessarily the same inactive ingredients (such as coloring). A generic has to perform the same function as the name brand, and it must of course meet the same health and safety standards.

Generic drugs tend to be less expensive than the name brands — and given the high cost of American health care, offer great and affordable options for consumers. However, it seems like the cost of these drugs is increasing. For example, the patent for Ambien, a popular sleep aid, recently expired. Now it’s a lot easier to get a generic version of Ambien for a cheaper price, and more people are able to get the product they need.

A study completed in August discovered that some generic prices have been dropping, while others have been rising almost exponentially. According to the Wall Street Journal:

The prices paid by pharmacies more than doubled for one out of 11 generics. And in a few cases – notably, the tetracycline antibiotic and the captopril blood pressure pill – the cost increases not only exceeded 1,000%, but topped 17,000%…. Yes, 17,000%.

Doctors have reported how troubling this kind of price increase can be in certain generic drugs for the patients who rely on them. Some patients who are on fixed incomes, such as those on Medicaid, may not be able to pay for the non-covered costs of the drugs if prices skyrocket that much. They may try to skip their prescriptions in an attempt to make ends meet. Not only is this obviously problematic for the patients themselves, but it also leads to more emergency room visits and a less healthy society in general.

That brings us to the investigation that Congress is evidently undertaking to try to figure out why exactly these generic prices are climbing so sharply and how to reverse the trend. The analysis is being pushed by Senator Bernie Sanders of Vermont and Representative Elijah Cummings of Maryland. We can all say a lot about the inadequacies of Congress, but this is a good move on its part. It’s really important that we get the prices of generics under control, because price increases like this are almost always passed directly to the consumer. With as many healthcare problems as we have, this is an issue that needs to be nipped in the bud as soon as possible.

—

Anneliese Mahoney (@AMahoney8672) is Lead 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.

Featured image courtesy of [Chris Potter/Stockmonkeys.com via Flickr]

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 Congress to Investigate Rising Generic Drug Costs appeared first on Law Street.

It seems like all anyone can talk about anymore is Ebola. Especially now that the first case of Ebola has been found in the United States, in Dallas, and the first case transmitted outside Africa reported in Madrid, people seem to be freaking out. One big concern has been that Ebola is going to become an issue in the U.S., which I just want to start by saying is unfounded and unrealistic. The public health infrastructure in the U.S., as well as our ability to isolate the disease make it incredibly unlikely that it becomes an epidemic. You’re still significantly more likely to die of the flu, or a car accident than even go near someone who has Ebola. As of press time, Thomas Eric Duncan — the man in Dallas who had contracted Ebola — has passed away of the disease, and while our thoughts and sympathy are with his family, this development does not change the risk factors in the U.S.

People are losing their minds over it. Seriously, check out #EbolaQandA on Twitter. It makes me terrified — not of Ebola, but at the extent to which our American education system appears to have failed people when it comes to very, very basic concepts of health and geography. Now Ebola is an incredibly important world issue right now, and combating it absolutely deserves our attention, vigilance, and support. That being said, we all need to take a deep breath over here in the U.S., and stop listening to misinformation and conspiracy theories, because this is getting silly. Here’s a helpful flowchart for anyone who’s concerned about the spread of Ebola in America.

Worried about Ebola? Here's a flowchart just for you! #diseases #outbreak #EbolaOutbreak #notenoughwine pic.twitter.com/U6uvQd8MKf

— Melody Butler (@MelodyButler) August 2, 2014

There have been many proposals to try to keep the United States from having Ebola-infected people cross over our borders. One of the most extreme is a “travel ban” aimed at West African countries with high infection rates.

This sounds like a good idea in theory, it really does. But in reality, it’s not something the U.S. will do, or should do. First of all, the best way to make sure that the United States does not experience problems with Ebola is to stop the epidemic. And if we restrict our access and communication with the affected region, it’s just going to get worse. When there’s not a huge risk of Ebola reaching any sort of epidemic levels in the United States, it doesn’t make sense to impede our relief efforts with a ban. A travel ban could mean that relief workers have a harder time going in, or refuse to go at all because they worry that they might not be able to get back.

Also, instituting a travel ban could make it more likely that someone with a case of Ebola makes it into the U.S. If we have a ban in place for countries heavily infected like Sierra Leone, Guinea, and Liberia, people are going to find a way around it. They could go to Senegal, or any other nearby nation where travel is not restricted. Because of the ban they may be incentivized to lie about whether or not they’ve been in contact with an infected person in hopes of not being prevented from getting on a plane. Right now we’re able to track people and examine them at the airport and upon arrival, and we’re going to strengthen our tools for that. We shouldn’t incentivize anything that makes it harder for us to do that.

I’m not an expert in public health; I don’t know what will happen with this epidemic. But what I do know is that panicking is going to do nothing. Educate yourself. Donate to the relief effort. Don’t feed the frenzy. This crisis needs a pragmatic approach, not a reactionary one.

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 Keep Calm and Carry On: You Don’t Have Ebola appeared first on Law Street.

The recent Ebola outbreak is plaguing thousands across West Africa with illness and even death. In the modern age of science, it seems incomprehensible that there is not yet a vaccine for Ebola. Though the virus is an urgent health concern, pharmaceutical companies have few incentives to develop drugs to combat the disease. Read on to learn what happens when economic incentives do not align with public health needs, and what better solutions may exist for drug development.

What is the status of the Ebola outbreak and vaccine?

Ebola virus disease is characterized by fever, intense weakness, and muscle pain, leading to more severe symptoms. Ebola was initially transmitted by animals and is now spreading between humans through contact with bodily fluids. The outbreak was first detected in Guinea, by which time it had already spread to Liberia, Sierra Leone, Senegal, and Nigeria. A separate outbreak occurred in the Democratic Republic of Congo, which is believed to be unrelated to the outbreak in West Africa. The virus has primarily infected villages where there is extreme poverty and insufficient medical care to combat the spread of the virus.

Statistics

Mortality rates for the Ebola virus are well over 50 percent. Since March, Ebola has killed more than 1,500 people, making it the deadliest outbreak of the virus in human history. The World Health Organization estimates that the Ebola outbreak could affect 20,000 within the next nine months, and that roughly half a billion dollars is needed to stop the spread. Watch the video below for more information on the outbreak:

Vaccines

Ebola first appeared in 1976, yet nearly 40 years later no approved vaccination exists. In part this is due to the nature of the virus. Since incidents of Ebola are rare and occur in remote villages, it is difficult for scientists to effectively obtain samples and study the disease. Scientists cannot predict when an Ebola outbreak will occur, and even during a typical outbreak there are rarely enough people for a vaccine trial.

Since the outbreak, scientists are furiously working on an Ebola vaccine, and requests for approval are being fast-tracked. In the United States, the National Institutes of Health partnered with GlaxoSmithKline to develop a vaccine. The potential vaccine tested very well on primates, but the trial on humans only began on September 1. Initial data from the trial will not be available until late 2014. A number of other prototype vaccines are being worked on across the world.

Other Treatments

ZMapp was the experimental drug given to two Americans who contracted Ebola this year. While vaccines are designed to prevent future infections, ZMapp was designed to treat an existing Ebola infection. Both Americans who took the drug recovered, but the company that manufactured ZMapp has exhausted its supply.

What is the drug development process like?

Developing a new drug or vaccine is an extremely long process due to stringent regulation. Candidates for a new drug to treat a disease range anywhere from 5,000 to 10,000 chemical compounds. Of these compounds, roughly 250 will show promise enough to warrant further tests on mice or other animals. On average, ten of these will then qualify for tests on humans. Since certain outbreaks, such as Ebola, do not lend themselves to have vaccines ethically tested on humans, the United States does provide a way for the drugs to be approved on animal tests alone.

Pre-clinical and clinical development for a new drug takes between 12 to 15 years, though the Ebola vaccine should come much sooner. Pre-clinical development includes testing the various chemical entities and meeting all regulations for use. Three sets of clinical trials are then conducted on humans. Clinical phases include trials on healthy humans to test for the safety of the drug. Testing then moves to those who are ill to see if the treatment is successful. If successful, the drug is submitted for further approval by the Food and Drug Administration. Other countries have similar regulatory bodies to the FDA. Internationally, the World Health Organization oversees which drugs can be used to combat a crisis like Ebola. Learn more details about the development process by watching the video below:

The problem is not that scientists lack the capability to create an Ebola vaccine, but rather that the economics of drug development do not entice companies to develop such a vaccine. Pharmaceutical companies estimate the cost of the entire process of developing a new drug to range from hundreds of millions to billions of dollars. Many times the drugs are not successful, in which case the companies have spent a huge amount of money and have no profit-making product. A Forbes analysis estimates that 95 percent of experimental drugs tested ultimately fail. Only one in five that reach the clinical trial phase are approved.

Given the low rate of success for potential drugs and the huge amounts of money that can be spent on research and development of drugs, cost plays a huge factor. In the United States, basic discovery research is funded primarily by government and philanthropic organizations. Development in later stages is funded mostly by pharmaceutical companies or venture capitalists.

Why do some see funding as a problem?

Funding for areas that support public health is a tricky issue. Since pharmaceutical companies are looking to make a profit, they have an incentive to make drugs that a large number of people will take and be on for a long time. Most research and development for these companies target diseases that affect wealthy people in primarily Western countries.

Targeting wealthier clients leads to a severe underinvestment in certain kinds of drugs. Diseases of poverty cannot compete for investment from financial companies looking for big return. Ebola infects relatively few and primarily affects the poor. Ebola is similar to diseases like malaria and tuberculosis, which kill two million people each year but still receive little attention from pharmaceutical companies. Watch the video below for more on the economics of drug development:

Neglected Tropical Diseases, a set of 17 diseases including Dengue Fever and Chagas Disease, affect more than one billion people each year and kill half a million. Most of these diseases could be completely eradicated, but the drugs are not widely available. One study found that of the more than 1,500 drugs that came to market between 1975 and 2004, only ten were aimed at these diseases.

Even though developing countries may experience an outbreak of a disease, the demand for new drugs is limited. In rural villages in Africa, many reject clinical drugs for diseases such as Malaria and Tuberculosis. Instead, they favor spiritual healers and herbal remedies.

What is being done to promote drug research of neglected diseases?

The Office of Orphan Products Development (OOPD) in the FDA was designed to advance development of products that could be used to diagnose or treat rare diseases affecting fewer than 200,000 people. Orphan diseases do not traditionally receive much attention from pharmaceutical companies. The program provides a tax credit of up to 50 percent for research and development of drugs for rare diseases. When these drugs do become available, however, there is still no guarantee that patients will be able to afford them.

Since 1983 the OOPD program successfully enabled the development and marketing of more than 400 drugs and products. In the ten years prior, only ten of these products came to the market. Learn more about the OOPD with the video below:

Additionally, in 2007 the FDA created a voucher program to encourage research for neglected diseases. If a company receives approval for a drug for neglected diseases, it will receive a priority review voucher to speed up the review time for another application. Only four of these vouchers have been awarded so far.

Are there better ways to fund drug research?

Some argue that researching very rare diseases is not worth the time, and that instead research should be focused on more prevalent diseases. Companies will naturally invest in research for the most pressing concerns that offer the greatest opportunity for profit. Drug development for rare diseases should not be encouraged since the diseases occur so infrequently. Others argue research for rare diseases is essential to public health. The case of Ebola shows that even rare diseases can have a disastrous world impact.

Bioterrorism

Beyond public health, knowledge about the workings of any serious virus or disease is important to combat threats of bioterrorism. Concerns of bioterrorism are what led to Ebola research in the past. Serious threats of bioterrorism force the government to partner with research institutions to learn more about rare diseases. In March, the University of Texas and three other organizations received $26 million from the National Institutes of Health to find a cure for Ebola and the Marburg virus in case they were ever used for a bioterrorist attack. Other groups partnered with the Department of Defense to find an injectable drug treatment for Ebola.

Prizes

Prizes and grants are seen as ways to incentivize companies to develop drugs for diseases they might otherwise ignore. Financial incentives would encourage speedy development for an Ebola vaccine. The World Health Organization has looked into building a prize fund, where a centralized fund would reward drug manufacturers for reaching certain research goals. These tactics are more cost effective for the government, since they only have to pay if the product actually works. By creating grants for specific drugs, the government can pull research into neglected areas. Most prizes and grants, however, are not offered until a severe outbreak occurs, by which time many people are already in need of drugs.

Partnerships

Others point to room for greater partnerships between various entities for drug development. The greatest area for partnerships is between development groups and pharmaceutical companies. For instance, if a company pays to research and develop a product, the government could pay the company for the right to the product and could then promote the product itself without worrying about profit. In another case, GlaxoSmithKline and Save the Children arranged for someone from the charity to be on GSK’s research and development board, so the groups can share expertise and resources.

The Ebola outbreak indicates areas in which our current drug development model is lacking. People are dying because no Ebola vaccine exists. When pharmaceutical companies search only for profits, drugs for rare diseases go neglected. By expanding partnerships and offering greater prizes and financial incentives, the government can encourage drug research for these otherwise neglected diseases.

Resources

Primary

WHO: Ebola Virus Disease

FDA: Developing Products for Rare Diseases

CDC: Experimental Treatments and Vaccines for Ebola

Additional 

CNN: Ebola Outbreak: Is it Time to Test Experimental Vaccines?

Vector: De-risking Drug Development

Guardian: Funding Drug Development for Diseases of Poverty

Reuters: Scant Funds, Rare Outbreaks Leave Ebola Drug Pipeline Slim

Explorable: Research Grant Funding

Vox: We Have the Science to Build an Ebola Vaccine

American Society for Microbiology: Ebola Virus Pathogenesis

NBC: No Market: Scientists Struggle to Make Ebola Vaccines

Wall Street Journal: Two Start-Ups Aim to Change Economics of Vaccine Production

NPR: Would a Prize Help Speed Up Development of Ebola Treatments?

Harvard Global Health Review: Funding Orphan Drugs

LA Times: U.S. Speeds Up Human Clinical Trials

Washington Post: Why the Drug Industry Hasn’t Come Up with an Ebola Cure

New Yorker: Ebolanomics

Alexandra Stembaugh

Alexandra Stembaugh graduated from the University of Notre Dame studying Economics and English. She plans to go on to law school in the future. Her interests include economic policy, criminal justice, and political dramas. Contact Alexandra at staff@LawStreetMedia.com.

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