The 21st Century Cures Act easily passed through the Senate on Wednesday by a vote of 95-4. With the inclusion of grants for mental health care and research on cures for life-threatening diseases, the bill enjoyed bi-partisan support in both chambers. Some progressives, like Elizabeth Warren (D-MA) and Bernie Sanders (I-VT), opposed the bill, fearing it could lead to unsafe drugs hitting the market, and could fail to curtail drug costs.

But President Obama, looking to build upon his health care legacy, which includes passing the Affordable Care Act, said last weekend that the 21st Century Cures Act is an “opportunity to save lives, and an opportunity we just can’t miss.” Highlighting the billions of dollars the bill will pledge toward Alzheimer’s and cancer research, as well as funds to combat the opioid epidemic, Obama added: “It could help us find a cure for Alzheimer’s,” and “could end cancer as we know it and help those seeking treatment for opioid addiction.”

Supporters tout the bill as the first major mental health legislation in nearly a decade. Included in the $6.3 billion package is money to create suicide-prevention programs, and grants to increase the number of  mental health professionals, like psychologists and psychiatrists. The bill also designates $1 billion in state grants to combat the opioid epidemic. It also includes a stipulation that is meant to speed up the approval process of breakthrough medical technologies, which is worrisome to some lawmakers who opposed the bill.

“I cannot vote for this bill,” Warren said last week, citing its watered down safety requirements for new drugs. “I will fight it because I know the difference between compromise and extortion.” And on Tuesday, Sanders, a longtime critic of Big Pharma, said “if you want to lower the outrageous cost of prescription drugs, vote against this bill.” He added: “It is time to stand up against the pharmaceutical industry and stand up with the American people who are tired of being ripped of by this extremely greedy industry.”

Vice President Joe Biden was one of the staunchest supporters of the bill, which includes $1.8 billion for the Cancer Moonshot Initiative, parts of which were recently named for Biden’s son Beau, who died last year from a brain tumor.

Alec Siegel

Alec Siegel is a staff writer at Law Street Media. When he’s not working at Law Street he’s either cooking a mediocre tofu dish or enjoying a run in the woods. His passions include: gooey chocolate chips, black coffee, mountains, the Animal Kingdom in general, and John Lennon. Baklava is his achilles heel. Contact Alec at ASiegel@LawStreetMedia.com.

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Just as Dracula drank blood from young humans to stay alive forever, scientists in California have found that injecting blood from young people into old mice rejuvenates the rodents. The young blood improved their memories, cognition, and physical shape. Earlier experiments had already shown that putting young mouse blood into old mice worked the same way. The older mice’s brains started looking younger and there was a definite rejuvenation effect. But for the younger mice it had an eerily reverse result, slowing them down and making their brains age faster.

After positive results from the mouse-only experiments, researchers at California company Alkahest were curious whether it would work with human blood too. So they injected some year-old mice (that is at least middle aged, in mice terms) with blood plasma from 18-year-old humans. And bingo! After three weeks of injections twice daily, the mice were running around and performing as well on memory tests as three-month old animals. It was also discovered that the brains of the treated mice created new neurons, a phenomenon called neurogenesis that is important to learning and memory.

Teens can be annoying but I hope we don’t drain their blood just to save some old mice https://t.co/V5hBHXdvCQ

— Ryan Teague Beckwith (@ryanbeckwith) November 15, 2016

Neuroscientist Tony Wyss-Coray led the mice-on-mice 2014 study at Stanford University and started Alkahest when he became interested in performing the experiments on people. And who doesn’t want to be young forever? Though it is unlikely that this technique would remove your wrinkles or make you live forever, scientists do believe that it could help people suffering from Alzheimer’s or other age related diseases. It has actually already been tested on people with Alzheimer’s, and Wyss-Coray is expecting to have some results by the end of 2016.

Hide now, teens. Or wear good blood armor https://t.co/xh9jysO4Mg

— Scott Stein (@jetscott) November 15, 2016

In August, a startup company called Ambrosia, also based in California and led by Jesse Karmazin, launched a program that will charge people $8,000 for a one-time injection of young blood plasma plus lab tests. Participants don’t need to be sick nor old–anyone over the age of 35 can join.

Though the concept is legal, it has drawn criticism for being unethical, with a huge cost and no certain results. “There’s just no clinical evidence [that the treatment will be beneficial], and you’re basically abusing people’s trust and the public excitement around this,” said Wyss-Coray. He also warned that it’s not a good idea to swap blood with someone at home, in case anyone felt inspired, since the blood needs to be screened for diseases and the plasma needs to be separated out. “Certainly you can’t drink the blood. Although obviously we haven’t tried that experiment,” he said.

Karmazin said he was inspired by vampire-like Russian scientist Alexander Bogdanov, who in the 1920s injected himself with young human blood that he claimed made him look younger. By August, Karmazin had enrolled three elderly people interested in his experiment, which is registered at the federal website ClinialTrials.gov. But according to some scientists, this experiment and an increasing number of other studies are dubious and are granted a fake legitimacy by being listed on that site. There are also concerns that the study isn’t being well run–there is currently no placebo group, and it will be very difficult to measure any progress if participants are as young as 35.

But as always, the rich and famous are interested in staying young forever and Karmazin’s project has caught the eye of billionaire and Trump transition team member Peter Thiel, who in August said he wants to try it. He has also spent millions of dollars on startup companies researching anti-aging medicine. And why save his money? After all, he’s not getting any younger.

Emma Von Zeipel

Emma Von Zeipel is a staff writer at Law Street Media. She is originally from one of the islands of Stockholm, Sweden. After working for Democratic Voice of Burma in Thailand, she ended up in New York City. She has a BA in journalism from Stockholm University and is passionate about human rights, good books, horses, and European chocolate. Contact Emma at EVonZeipel@LawStreetMedia.com.

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Comedian Will Ferrell has officially pulled out of a project that would satirize former President Ronald Reagan’s last years in office. The project allegedly features Reagan suffering from dementia while still in office, and Ferrell has received significant criticism for signing on to the project in the first place.

The controversy began after news broke that Ferrell had apparently optioned the comedy, but after the onslaught of criticism, Ferrell made it clear that he wasn’t going to move forward with the project. According to Ferrell’s spokesperson:

The REAGAN script is one of a number of scripts that had been submitted to Will Ferrell which he had considered. While it is by no means a ‘Alzheimer’s comedy’ as has been suggested, Mr. Ferrell is not pursuing this project.

Some of the criticism came from Reagan’s children Patti Davis and Michael Reagan, who stated “Alzheimer’s isn’t a joke” and called the movie cruel. The Ronald Reagan Presidential Foundation also put out a statement, and the Alzheimer’s Association reportedly said it was “appalled” at the project.

A movie about Reagan’s Alzheimer’s does sound like it could be in bad taste, however the Hollywood Reporter obtained a copy of the script, and reporter Seth Abramovitch stated:

Most of the criticism seems to have come from people who had only read the log line, not the script. THR obtained a copy of Reagan to see what Rosolio intended.

It turns out Reagan is actually a good-natured and well-researched comedy that offers an ‘alternate take’ on seismic events in American history — a direct descendent of 1999’s Dick, in which Kirsten Dunst and Michelle Williams play ditzy teens who unwittingly bring down Richard Nixon.

But it does revolve around the conceit that the 40th president had no knowledge of where he was or what he was doing throughout his entire second term.

Given the outpouring of controversy, it’s doubtful that this project will ever see the light of the day, but we’ll have to see if anyone else in Hollywood is willing to take the risk.

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 That Will Ferrell Comedy About Ronald Reagan’s Alzheimer’s Won’t Be Happening appeared first on Law Street.

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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.

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Here at Law Street, we really appreciate entrepreneurial spirit–especially when it creates cool new technology we can fawn over. Since Christmas is fast approaching, I decided to highlight some fascinating Christmas-themed inventions and innovations. Some of these are already in the works and some are future projects, but either way they’re sure to make your holiday bright!

[SlideDeck2 id=30195 ress=1]

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 Technology Innovations: Christmas Edition appeared first on Law Street.

Pretty much every big name in Hollywood has a preferred charity or two. You hear Elton John, and you think AIDS research. Similarly, Bono is well known for his charitable work in Africa. Before his death, Paul Newman’s charity created camps for children suffering from serious illnesses all over the United States. The work that celebrities do for charities is admirable, and I have no intention of discounting their efforts in any way. But there’s a fine line between being an invaluable part of a charitable movement, and being an expert in that field. And this week, some people are arguing that Congress has blurred that line.

Ben Affleck and Seth Rogen will testify in front of Congress about each of their pet charities. Affleck will speak to the Senate Foreign Relations Committee on the Democratic Republic of the Congo , and Rogen will go in front of a Senate Appropriations Subcommittee to talk about the economic impact of Alzheimer’s research. But does active involvement in related charities qualify them to testify about those causes?

These two scheduled appearances on Capitol Hill have spurred a series of debates over the validity of their Congressional testimonies. Regarding Affleck’s testimony, an anonymous GOP Senate Aide stated, “people serious about resolving problems – especially problems related to life and death – want to have serious conversations with experts and leaders in the field; not celebrities.” Another Republican aide said, “the meeting would be inappropriate given the wide offering of other experts available to speak on the issue.” Seth Rogen sparked slightly less ire, but critics did take to Twitter to mock his supposed expertise on Alzheimer’s.

Now at first glance, I agreed with these critics. But the more I think about it, the more I’m OK with celebrities testifying before Congress — if they’re qualified. So here are the top four reasons that we should be glad Affleck and Rogen are testifying this week.

4. They won’t be alone.

Both Affleck and Rogen will be involved in panel-style discussions, with the former appearing alongside Russell Feingold, the U.S. Special Representative for the Great Lakes Region of Africa; Roger Meece, former U.S. Ambassador to the Democratic Republic of the Congo; and Dr. Raymond Gilpin, Academic Dean of the Africa Center for Strategic Studies. Rogen will join Dr. Francis Collins, Director of the National Institutes of Health, and Dr. Michael Hurd, Director of the RAND Center for the Study of Aging, among others.

Neither of these celebrities is testifying in front of the panels as standalone experts who can give a full view of the problems surrounding the DRC or Alzheimer’s. Rather, they are focusing on their experiences in charity work, and their experiences with people directly affected by war and Alzheimer’s — both angles are important to consider. Affleck founded the Eastern Congo Initiative a few years ago to advocate for the people of that region and to provide much needed grants. Similarly, Rogen and his wife Lauren Miller founded Hilarity for Charity, a foundation to raise funds for and awareness of Alzheimer’s research. Now in my book, that makes them qualified to testify about their experiences with those foundations and the people they impact. Both of the panels will involve discussions of aid and money, and Affleck and Rogen can, at the very least, provide valuable insight into those topics.

3. They have unique access. 

Celebrities have unique access in a way that politicians and diplomats sometimes do not. Affleck has been to the DRC many times, and has interacted with a wide variety of players involved. In 2008 his travels were filmed by ABC in an effort to bring attention to the region. He met with refugees, child soldiers, members of parliament, and warlords.

Both of these men occupy places of financial privilege. They are able to travel the globe and talk to way more people than say, a professor with expert knowledge on the subject, or most diplomats. For them to be able to use that privilege to help people is pretty great.

 2. It brings media attention to the issue. 

Having celebrity spokespeople come and testify about something does cause a media buzz. I guarantee you that if these panels didn’t include Affleck and Rogen, they’d be getting almost no attention. Congress hears from experts all the time, but celebrities are rarer, and they bring  heightened attention to the issues. Obviously this is a phenomenon that should be used sparingly, but I think in the case of the Congo and Alzheimer’s, more media attention is deserved. The U.S. government spends around $500 million a year on Alzheimer’s research, which sounds like a lot, but is actually very little when you realize that 5.5 million Americans are estimated to have the degenerative illness. And the Congo, a region that has been war torn for years, does receive foreign aid, but not nearly enough to fix all the systemic issues there. I’m not necessarily suggesting that these issues should receive more federal funding, but attention to them from the private sector and the media can’t possibly hurt.

1. It makes them good role models. 

Americans, especially young people, look up to their favorite celebrities. Affleck and Rogen are well known faces, each with their own devoted fan bases. So, I can’t help but think that it’s a good thing for them to be so heavily involved in their charities that they are asked to testify before Congress. It shows that it’s sexy and cool to help others, educate yourself on contentious issues, and find causes about which you’re passionate. Despite some criticism, Affleck will be the new Batman.

Everyone loves Batman, and Affleck has the potential to affect the kids who grow up admiring their favorite superhero. He has the potential to be a great role model for those kids.

Same with Rogen, who I assume will continue his comedy career over the coming years. He’ll be another great role model for involvement and giving back. At the end of the day, say what you want about their qualifications to testify in front of Congress. In my book, their involvement in these great causes, and the fact that they are able to advocate for them in the public sphere makes them much better role models than most celebrities.

—

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 [WEBN-TV 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 4 Reasons Why Celebrities Testifying as Experts is Okay appeared first on Law Street.