It’s like the “X-Files,” but in real life! Researchers at the University of California, Davis want to create part-human, part-animal embryos, also known as chimeras, for the purpose of medical research.

The concept is that having access to an animal with certain human cells would allow for more accurate results when researching how different illnesses progress. The term “chimera” comes from Greek mythology–it’s a monster made up of several animals, for example a goat with a lion’s head and a snake’s tail. But actually creating chimeras in real life raises some important ethical questions. For example, the National Institutes of Health (NIH) has refused to fund the project, due to its controversial nature.

One of the possible end results would be to breed farm animals with human organs so that they could be donated to terminally ill people. But New York Medical School professor Stuart Newman thinks this is taking it a step too far: “You’re getting into unsettling ground that I think is damaging to our sense of humanity,” he told Boise State Public Radio.

Rob Stein, a Boise State Public Radio reporter, actually got a firsthand look at how the chimeras would be produced, by accompanying biologist Pablo Ross to his lab in California. They discussed a procedure that involved creating a human pancreas in a pig that could be eventually transplanted into a diabetes patient; it involves inserting human stem cells into pig embryos, and then implanting them in the pig.

These kinds of processes are where chimera critics worry things could go awry. Newman points out that if something were to go wrong, it could actually result in a pig with a human-like brain and some sort of human consciousness. Or an even weirder result–a pig giving birth to a part-human baby! As chimeras become a more likely reality, the question is if we really are willing to take that risk and cross those ethical lines.

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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Dr. Stanley Riddell’s team at the Seattle’s Fred Hutchinson Cancer Research Center earned themselves a place in medical history with the research they recently presented at the American Association for the Advancement for Science’s annual meeting. Riddell’s immunology team works with terminal patients. This new treatment engineers a patient’s own T-cells to target and fight back against the blood cancer cells that are attacking them–a major breakthrough in cancer research.

In the most recent trial, U.S. researchers used genetically modified T-cells in 35 terminally ill patients with leukemia, and 94 percent went into remission. Riddell’s T-cell research has only been applied to blood cancer but for the thousands of people in the United States alone suffering from blood cancer, this treatment could be the medical innovation they have waited years for. As with any new treatment, there is cause for caution–the data from this treatment is still being processed which means it still needs to be peer-reviewed and vetted by a host of evaluators. Furthermore, the risk involved in the treatment can be steep. For all the patients who witnessed major positive effects or full remission, there were several patients who were admitted to intensive care due to their treatment.

Cancer treatments are on the whole brutal and exhausting for the patient, but in this case, two of the participants in the study died because of adverse reactions to the treatment. It is important to remember that the patients for this trial were all terminal, which meant they were incredibly weak even as their newly trained T-cells tried to fight against the more aggressive cancer cells. However, members of the medical team believe they can minimize the dangers as time goes on by using lower doses of the therapy. This week, Dr Alan Worsley, from Cancer Research UK, told the BBC that while the field was incredibly exciting, “this is a baby step…the real challenge now is how do we get this to work for other cancers, how do we get it to work for what’s known as solid cancers, cancers in the tissue?”

Even though this research still has a long way to go before it becomes a typical cancer treatment, the attention that the stunning success rate has garnered will no doubt spark a wave of funding for similar T-cell therapy projects. There are dozens of top research institutions working around the clock to test experimental treatments and Riddell’s team is not the only one investigating the efficacy of engineering cells to fight off cancer attacks.

Nonprofits, corporate donors, and governments alike should all take note of this new T-cell trend and adjust cancer research funding accordingly. It can be difficult to divert funding into one particular branch of research when there are so many different forms of cancer that need cures, but if the results of T-cell training research continue to match the success rate of this study, the financial forces behind research hospitals may allocate more resources to this genetic branch of research.  Prioritizing treatment of one type of cancer over another may seem callous, but if this blood cancer treatment can be adapted to solid cancers then we may be looking at an actual cure for the disease as a whole–an opportunity it is difficult to ignore.

Jillian Sequeira

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

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Republican presidential candidate and outspoken opponent of abortion, Carly Fiorina, reportedly benefitted financially while on the board for a company producing vaccines using fetal stem cells taken from aborted fetuses, according to corporate documents obtained by Al Jazeera America.

Fiorina served on the board of directors for Merck & Co., an international pharmaceutical company, from April 1999 to December 2000, according to SEC filings for both 1999 and 2000. She was paid at least $83,000 for her two years and was eligible for an additional $1,200 for each board meeting she attended.

Fiorina has been very open when discussing her stance on abortion. During one of the first Republican debates in September, she challenged Hillary Clinton, Barack Obama, and everyone in America to watch a non-existent portion of the–at the time—shocking sting videos created by the Center For Medical Progress, a known anti-abortion group.

On January 25, two of the activists from the videos were indicted in Texas for issues regarding purchasing human organs and an additional charge for tampering with a government record.

Fiorina has continuously said on and off the debate stage that she wants to defund Planned Parenthood, a non-profit that provides healthcare services, including abortion, but declined to comment on whether it is worth shutting down the government for, which has been a big budgetary issue brought up by many candidates during this election cycle.

Other candidates have also discussed using fetal stem cells from aborted fetuses. Presidential candidate Senator Ted Cruz R-Texas has supported the John Paul II Medical Research Institute, which conducts ALS research that “respects human life,” according to a statement made on Cruz’s Facebook page. 

According to the Los Angeles Times, during Fiorina’s 2010 run for the California Senate, she was seemingly in favor of using aborted fetal stem cells for vaccines. During a 2010 debate she clarified her stance, saying, “It is when embryos are produced for the purposes of destruction, for the purposes of stem cell research that I have a great deal of difficulty.”

It is unknown as to whether or not Fiorina was aware that aborted fetal stem cells were being used to make the vaccines, but it’ll probably be brought into the discussion on one of the stages at the next Republican debate scheduled for February 6.

Julia Bryant

Julia Bryant is an Editorial Senior Fellow at Law Street from Howard County, Maryland. She is a junior at the University of Maryland, College Park, pursuing a Bachelor’s degree in Journalism and Economics. You can contact Julia at JBryant@LawStreetMedia.com.

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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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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.

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