Conflicts of Interest and Fraud in Medical Research | Chris Kresser
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Behind the Veil: Conflicts of Interest and Fraud in Medical Research

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Recent reports have revealed that conflicts of interest and research fraud are rarely reported in the scientific literature or announced to the general public, which raises questions about the integrity of clinical trials and the reliability of public agencies like the FDA and CDC.

Medical conflict of interest
Medical conflicts of interest are more prevalent than we think. zest_marina/iStock/Thinkstock

In this article, I’m going to discuss two other reasons that the public mistrusts scientific research: fraud, and conflicts of interest.

Why conflicts of interest and fraud harm the public’s trust of medical research.

Fraud in Medical Research: “Out of Sight, out of Mind, and out of the Peer-Reviewed Literature”

A large part of the subtitle above comes directly from a paper published in JAMA Internal Medicine, authored by Charles Seife. (1) In short, Seife discovered that clinical trial data determined to be fraudulent or mishandled by the FDA is rarely excluded from research studies published in scientific journals.

One of the FDA’s roles in the drug approval process is to inspect clinical trial sites to determine whether these sites are complying with FDA regulations. A typical inspection might involve auditing the records of the site, verifying that investigators adhered to the trial protocol, and comparing an investigator’s notes in hospital records with data reported to the study sponsor to ensure that there aren’t any discrepancies.

If there is a violation, the FDA classifies it in one of two ways: Voluntary action indicated (VAI) means the inspectors have found violations, but the problems aren’t serious enough to require sanction. Official action indicated (OAI) means that the inspectors have found violations significant enough to warrant official action.

Siefe and his assistants used the Freedom of Information Act to request information from the FDA, and supplemented that data with Google searches of the FDA database. They found 57 clinical trials that were directly linked to an OAI inspection.

The misconduct identified by the FDA in these cases included:

  • Falsification or submission of false information
  • Underreporting of adverse events
  • Failure to follow the investigational plan or other violations of protocol
  • Inadequate record keeping
  • Failure to protect the rights, safety, and welfare of patients
  • Use of experimental compounds in patients not enrolled in trials
  • Failure to supervise clinical investigations properly

The 57 trials Seife identified were in turn linked to 78 research articles published in the peer-reviewed scientific literature. 96 percent of these articles failed to mention the violations identified by the FDA inspection—despite the fact that in the majority of cases the inspection was completed at least 6 months before the article was published.

Doctors, researchers, and other health professionals rely on scientific studies to establish treatment protocols and public health policies. If the data in some of these studies are fraudulent, but the doctors and researchers have no way of knowing that, the decisions they make may be unsound and even put people at unnecessary risk.

I’d like to make the significance of these omissions even more clear by sharing a couple of examples mentioned in Seife’s paper.

One case involved a researcher who falsified lab test results to hide a patient’s impaired kidney and liver function in a trial comparing two chemotherapy regimens. The first dose of the regimen proved to be fatal to this patient, and the researcher was sentenced to 71 months in prison. Despite this episode being described in both FDA and court documents, not one of the studies in the peer-reviewed literature associated with the chemotherapy trial have any mention of the falsification, fraud, or homicide.

Another case involved a clinical site in China participating in a large trial of apixaban, an anticoagulant (i.e. anti-clotting) drug. The FDA determined that this trial site had altered patient records and falsified data. If the data from this site had been excluded, the mortality benefit for the drug would have disappeared. In other words, the “proof” that this drug saved lives was dependent on this fraudulent data. Yet none of this discussion appears in the scientific literature. In fact, studies since 2011 have consistently relied on the full data set (including the fraudulent data from the China trial site), and this was even true for an article published nearly 18 months after the fraud was discovered.

How can such egregious cases of fraud and misconduct go unreported in the scientific literature and in the media? The answer is almost hard to believe. The FDA does not notify journals when a site participating in a clinical trial receives an OAI inspection, nor does it typically make any announcement which would alert the media and general public to the issues it identified.

What’s more, the documents the FDA produces about these OAI inspections are heavily redacted, which makes it extremely difficult even for researchers like Seife who’ve invoked the Freedom of Information Act to determine which published clinical trials are tainted by misconduct. The FDA redacts these documents because it considers the identity of the drug company involved in the trial to be “confidential commercial information” that it is bound to protect.

In other words, the FDA appears to believe that it’s more important to protect private, commercial interests than it is to protect public health.

Seife’s says as much in the conclusion of his paper:

However, failing to notify the medical or scientific communities about allegations of serious research misconduct in clinical trials is incompatible with the FDA’s mission to protect the public health. Such allegations are relevant to include in the peer-reviewed literature on which physicians and other medical researchers rely to help them choose treatments that they offer to patients and other research participants.

The issues highlighted here raise serious concerns not only about the trustworthiness of the data in clinical trials and published research, but the reliability and motives of the agencies tasked with protecting public health.

Which takes us to the second reason that public mistrust of scientific research is sometimes well-founded: conflicts of interest.

Conflicts of Interest in Research Are Common—and Often Unreported

In my article about the disconnect between scientists and the public, I mentioned that two-thirds of medical research is sponsored by drug companies, and industry-sponsored trials are more likely to report favorable results for drugs because of biased reporting, biased interpretation, or both. (2) This is a well-established phenomenon, and it has been explored in both the media and the scientific literature:

Is it really a big surprise that the source of funding influences study results? After all, as Upton Sinclair famously said, “It’s difficult to get a man to understand something, when his salary is dependent upon him not understanding it.” The time-honored saying “don’t bite the hand that feeds you” also applies here.

Unfortunately, just as research misconduct and fraud is often not reported, conflicts of interest in academic research are rarely disclosed. According to a 2009 report issued by the Department of Health and Human Services, very few universities make required reports to the government about the financial conflicts of interest of their researchers—and even when they are reported, the universities rarely require those researchers to eliminate or reduce these conflicts.

In fact, 90 percent of universities relied solely on the researchers themselves to decide whether to report their potential conflicts of interest, and half of universities don’t even ask their faculty to disclose the amount of money or stock they make from drug or device makers.

This isn’t likely to change anytime soon, according to Eric G. Campbell, an associate professor at Harvard Medical School that was quoted in this New York Times article covering the report. He said that “universities had no interest in putting real limits on the incomes of their star researchers for fear that those researchers would leave for institutions with fewer restrictions.”

But conflicts of interest aren’t just a problem in academia; they’re also a problem on expert advisory panels that influence public health policy. For example, back in 2008 Dr. John Briffa linked to a web page disclosing the conflicts of interest in members of the National Cholesterol Education Program, a government organization that creates the official blood cholesterol target values for the U.S..

Are you ready for this? 8 out of the 9 doctors on the panel had direct ties to statin drug manufacturers. Here’s the complete list, excerpted from a post written by Dr. Stephan Guyenet in 2008 (the companies in bold are statin manufacturers):

Dr. Grundy has received honoraria from Merck, Pfizer, Sankyo, Bayer, Merck/Schering-Plough, Kos, Abbott, Bristol-Myers Squibb, and AstraZeneca; he has received research grants from Merck, Abbott, and Glaxo Smith Kline.

Dr. Cleeman has no financial relationships to disclose.

Dr. Bairey Merz has received lecture honoraria from Pfizer, Merck, and Kos; she has served as a consultant for Pfizer, Bayer, and EHC (Merck); she has received unrestricted institutional grants for Continuing Medical Education from Pfizer, Procter & Gamble, Novartis, Wyeth, AstraZeneca, and Bristol-Myers Squibb Medical Imaging; she has received a research grant from Merck; she has stock in Boston Scientific, IVAX, Eli Lilly, Medtronic, Johnson & Johnson, SCIPIE Insurance, ATS Medical, and Biosite.

Dr. Brewer has received honoraria from AstraZeneca, Pfizer, Lipid Sciences, Merck, Merck/Schering-Plough, Fournier, Tularik, Esperion, and Novartis; he has served as a consultant for AstraZeneca, Pfizer, Lipid Sciences, Merck, Merck/Schering-Plough, Fournier, Tularik, Sankyo, and Novartis.

Dr. Clark has received honoraria for educational presentations from Abbott, AstraZeneca, Bristol-Myers Squibb, Merck, and Pfizer; he has received grant/research support from Abbott, AstraZeneca, Bristol-Myers Squibb, Merck, and Pfizer.

Dr. Hunninghake has received honoraria for consulting and speakers bureau from AstraZeneca, Merck, Merck/Schering-Plough, and Pfizer, and for consulting from Kos; he has received research grants from AstraZeneca, Bristol-Myers Squibb, Kos, Merck, Merck/Schering-Plough, Novartis, and Pfizer.

Dr. Pasternak has served as a speaker for Pfizer, Merck, Merck/Schering-Plough, Takeda, Kos, BMS-Sanofi, and Novartis; he has served as a consultant for Merck, Merck/Schering-Plough, Sanofi, Pfizer Health Solutions, Johnson & Johnson-Merck, and AstraZeneca.

Dr. Smith has received institutional research support from Merck; he has stock in Medtronic and Johnson & Johnson.

Dr. Stone has received honoraria for educational lectures from Abbott, AstraZeneca, Bristol-Myers Squibb, Kos, Merck, Merck/Schering-Plough, Novartis, Pfizer, Reliant, and Sankyo; he has served as a consultant for Abbott, Merck, Merck/Schering-Plough, Pfizer, and Reliant.

Another 2009 report, also from the Department of Health and Human Services, revealed similar issues with expert panels that advise the Centers for Disease Control (CDC) on vaccine safety. The report found that 64 percent of experts who served on advisory panels in 2007 to evaluate vaccines for flu and cervical cancer had potential conflicts of interest that were never identified or resolvedThe report also revealed that the CDC failed nearly every time to ensure that experts adequately disclosed that they were being paid by vaccine manufacturers.

Can you see how these conflicts of interest might be a problem, when the advisory committees mentioned above strongly influence the sales of both statin drugs ($30 billion a year) and vaccines ($20 billion a year)? 

Sadly, these financial relationships between experts who influence or formulate guidelines and drug companies whose drugs are being considered are not the exception, they’re the rule. A study published in JAMA shows that 59 percent of the experts participating in guideline creation have such financial ties. (3)

Another related problem is the “revolving door” between public agencies like the CDC and FDA or institutions like the U.S. Congress, and pharmaceutical companies. A year after leaving her position as the director of the CDC in 2009, Dr. Julie Gerberding took a position as president of Merck Vaccines. Another former CDC employee, Dr. Thomas Verstraeten, took a position with GlaxoSmithKline (a vaccine manufacturer) while he was still involved in completing a major study on the possible negative side effects of thimerosal (a mercury-containing compound used in some vaccines) at the CDC. Finally, over half of the lobbyists employed by the pharmaceutical industry in 2008 had worked in Congress or another branch of the federal government, and 35 had been former members of Congress. (4)

These conflicts of interest do not necessarily lead to fraud or misconduct. There are surely many honest and unbiased researchers and physicians investigating controversial topics like cholesterol targets and statin drugs, vaccines, and genetically-modified foods. However, studies have confirmed what common sense and an understanding of human nature would also suggest: conflicts of interest can and do influence both individuals and institutions. For example, the financial interests of researchers are positively associated with outcomes favorable to the sponsor in medical studies, and research institutions can be influenced by industry sponsorships such as grants, endowed chairs, and other gifts. (5, 6, 7, 8)

Concluding Thoughts

My purpose here is not to attack the credibility of scientific research as a whole, or scientists as a group. But science is a human endeavor, and like all human endeavors, it is subject to the vagaries of human ethics and behavior. There is good science, and bad science; there is honest science, and dishonest science.

If you’ve been following my work for several years, you’ll know that my blog used to be called “The Healthy Skeptic.” I called it that because I believe that skepticism is healthy when it comes to science. Yet all too often I see this skepticism being applied in a biased or inconsistent manner.

For example, I’ve noticed that some people who are indignant about conflicts of interest in government agencies responsible for bank bailouts or among experts responsible for establishing blood cholesterol targets are completely unwilling to consider how similar conflicts might affect research on, say, genetically-modified foods.

I’ve also encountered people who are skeptical of any challenge to the status quo, but don’t apply their skepticism with the same rigor to the the status quo itself. On the other side of the coin are those that accept unconventional or alternative ideas (regardless of whether there is evidence to support them), and tend to reject anything that could be remotely construed as conventional or mainstream. 

Someday, perhaps we’ll be able to extricate the financial interests of Big Pharma from the behavior of medical scientists and regulatory agencies. Until then, our responsibility—whether we are clinicians, patients, researchers, or members of the media—is to acknowledge the influence these relationships may have on scientific research, and take that influence into account when considering controversial issues—especially when large amounts of money are at stake.

Now I’d like to hear from you. Were you aware that research misconduct rarely gets reported on in the media or scientific literature? Are you surprised by the extent to which conflicts of interest are present on advisory panels responsible for creating guidelines? How do you feel about this subject after reading this article? Let us know in the comments section.

126 Comments

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  1. Chris, thanks for the well thought out article. I really enjoyed it and there were a few new talking points that I was glad to learn. Also, thanks to the other readers who included a link to the informative and entertaining TED talk by Ben Goldacre. I’m becoming more and more skeptical the older and more educated I get. The sad part is that there are only so many hours in the day so ultimately I have to place my trust in a few people because I can’t effectively do an in depth research on everything that is important to me and my family.

  2. Very good article Chris. I have believed that this type of unscrupulous behavior by big Pharma and our government has existed for sometime. As a pharmacist it sickens me and saddens me. Also probably one of the main reasons why every day I am becoming more and more a natural pharmacist.

  3. I enjoyed this article, Chris, and interestingly just saw today that Mark Zuckerberg is having his ‘Facebook online book club’ read “On Immunity” today because, as he says, “the science is very clear” [that vaccines are safe and effective].

    http://www.theverge.com/2015/2/19/8060017/mark-zuckerberg-vaccine-denier-facebook-book-club-on-immunity

    Have you read this book, and if so, what did you think of it?

    I’m hopeful that new research (re: Human Microbiome, Toxicology, Immunology and Environmental Science) will help us move western medicine in general (and vaccine science in particular) into the 21st century. Baby steps, e.g.

    http://www.mountsinai.org/about-us/newsroom/press-releases/mount-sinai-childrens-environmental-health-center-publishes-a-list-of-the-top-ten-toxic-chemicals-suspected-to-cause-autism-and-learning-disabilities

    Today many Oncologists will admit that we’ll look back and find it barbaric how we treated cancer patients with chemo, radiation and surgery… and I suspect soon more Pediatricians will start to question and then publicly say that we’ll look back and find it barbaric that we injected 69 doses of 16 vaccines before age 18 in a ‘one-size-fits-all’ approach to our kids and added to their system overload.

    • Can someone tell Mark Zuckerberg to watch the Bought movie? I’m NOT on Faecesbook…

      Bought tells it all…

    • Hopefully by then we will have many more vaccines. Malaria, TB, HIV and many other diseases still ravage populations in many nations.

  4. Whenever I want to learn about something, I gather information from multiple sources and then form an opinion. Whenever the person or company presenting the information stands to make profit the information is probably skewed towards their favor for making a profit.

  5. Hi Chris.Wow. Love the way you’ve presented this. Such great info. There really is a disconnect in how we blindly accept research as ‘news of the day’ and we focus on the headline. If we shift this thinking into creating conversations and integrating ideas we might start to learn more. We are letting others decide for us rather than sharing the power.

  6. I have spent a bit of time recently reading material such as you offer mostly because I had a few pounds I wanted to get rid of and keep off, so that led me to the eating health side. Concerning this article’s subject, It finally dawned on me that the information, studies, etc. that is found thru studies and the like are put out to everyone as a group [how else would they do it.] But of course we are all individuals with different requirements but we consume the information as if it’s directed at us. It’s not their job to get it to the right consumer, but there is a part of where the public disconnects, not thinking of that, in general I’m speaking. thanks Mickey

  7. Great article on the FDA. I heard Charles Seife’s piece on NPR. I totally agree. Question is what can we start to do about cleaning up this mess? We dependant on having access to good sound unbiased science.
    Any suggestions on where to start? The problem has been well framed.
    Thanks Darcie

    • Didn’t realize this article was on the FDA. The article is on corporate scientists and scientists who receive funding from corporations and the potential conflicts that arise because of it.

  8. Chris, I recommend your site to all my patients and read it everyday. I tell everyone that you are the Yoda of human nutrition. Thanks for your work, it is much appreciated. As a neuroscientist and old hippie, I know what crap goes on among researchers with a passion to become famous, publish, and make more money.

  9. This is a truly excellent write-up of the fraud and misconduct in the scientific/medical world.

    I disagree with Chris on some aspects of metabolism and there being a distinction between ‘alternative’ & conventional medicine, but…this article is a good example of why I continue to read his material.

    So, thanks!

  10. I quit posting here because your site is f’d up. I just composed 2 replies, both wiped out. Do you not have an auto save?

    I like the site, I am in agreement with most of it. But I have problems with posting to it. But then I am not a medical person I do not even LIKE Drs. There is nothing that you can come down with that lifelong regimen of Scrips cannot cure according to them. BS. I take nothing not even Aspirin.

    I will continue to read but replies may be few and far between.

    George

  11. It’s not that I don’t believe vaccines are good (in theory) but it’s hard to support what is going on with the cheap materials, lobbying and profiteering. There is a lot of ego, personal bia, and bureaucracy in medicine, a subject that should have nothing to do with politics.

  12. Thank you for a wonderful article, and also thank you to everyone here who posted thoughtful, non-attacking responses. This is the first time I’ve read responses to an article and not wanted to bang my head against a wall. What intelligent readers you have! 🙂

  13. Yes, I was aware of this, after losing 20 years of my health and vitality and ability to function in life due to psychiatric medications. In the process of figuring out what had happened to me I read the book Anatomy of an Epidemic by Robert Whitaker, which I would add to your book list above. It’s specific to psychiatry and psychiatric meds but it’s so well-researched and readable that if you have any interest in the subject of pharmaceutical industry infiltration of medical education and marketing, it’s a must-read. This whole situation–in psychiatry and all other areas of medicine–is tragic, and criminal. And I think if doctors understood, first, that their education and their sources of information are not as reliable as they believe, and second, that they are rapidly losing the trust of patients (I can’t tell you often I hear survivors of antidepressant treatment say they will never trust a doctor again), that this would change a lot faster than otherwise. Unfortunately the culture of medicine and medical education includes a big component of “patients don’t know anything and can’t be trusted.” Doctors are trained to be gullible, way more gullible than an educated citizenry, in my opinion.

    Well enough of this rant, but this is a very, very important subject that cannot be emphasized enough. The medical/pharmaceutical/medical device complex is just as corrupt as the tobacco industry, and doing just as much harm, or more.

  14. Bravo Chris! Another reasoned, thoughtful and level-headed post. A few weeks back I posted on my fb timeline a few Green Med articles that questioned the recent media frenzy surrounding the measles outbreak and the call to remove the rights of parents to choose for their children. Wow! Emotions ran high just by suggesting there is another side to this issue, brought forth by intelligent and learned folks and by parents who care deeply for their children’s health.
    The Healthy Skeptic rides again!

  15. I feel it safe to say, I would never intentionally hurt anyone, many of my medical and nursing colleague’s hold the same ideal. The difference between side effect and adverse reaction, it is so laborious to report a reaction and when something is listed as a side effect we are endoctored to believe it is just the unfortunate person who has a difficulty with the drug, so we switch drugs. Vaccine history is rarely discussed, the time lapse is not something we consider, but we have chronically challenged immune systems, and manipulation of research can be seen in Louis Pastures claim to fame, poor Felix Pouchard was probably on the right path but Louis had an ego and a church in his pocket. So we got to treat the germ instead of promoting the good health of the organism is the human body. One in three children expected to be treated for cancer by the time they reach twenty, that is not fair. I applied to go to Sierra Leone four months ago. Ebola vaccine was patented by the CDC years ago, I think they tried to run another campaign of fear, mass vaccination, their prediction of 1.4 million by Jan, last I checked the figure was 8,200. No sense to a rapidly mutating blood bourn all of a sudden aeroslised virus, be cheaper to import the flying fruit bats?

  16. Chris,
    Thank you for this article. It should go to the editor of every newspaper in the country. I will see it gets to mine. I have 30 years of experience in Chiropractic and Alternative Medicine. I can’t tell you how many times I have seen this happen. Just in the past year our city got a ballot issue for voting on continuing to infuse our municipal water supply with toxic fluoride or to remove it. There was continuous dialog in the editor’s column prior to election and one of the favorite statements was that the science behind removal of fluoride was “junk science”. I provided the editorial column with many PubMed referenced articles. PubMed research is considered to be the “gold standard” in scientific literature. Still, removal of fluoride failed. I am also currently doing a lot of research on the product “salvestrols”, which is an alternative medicine treatment for cancer out of Canada and the U.K., which shows promising results. However, it continues to be blasted in the scientific community because it “lacks scientific data”. I agree that traditional allopathic medical “scientific literature” is ridiculously corrupt. The only saving grace will be when the medical system becomes so expensive that it cannot be afforded. Data.worldbank.org published 2012 data that places the US health care expenditures at 17.9% of the gross domestic product. In other words 18 cents of every dollar that gets spent is on health care. What happens when it reaches 50%? And it will, it’s just a matter of time. The system cannot sustain itself. That’s just my opinion! I could be wrong!

    • If every paper with a PubMed entry is considered “gold standard,” we’re in trouble. I read through some of that stuff for a living — not just the abstracts, but the full text of published papers, and an astounding number of them are pretty awful. I’m not saying they’re *all* bad, only pointing out that peppering things with links to PubMed doesn’t necessarily lend legitimacy. It will *look* legit, and more “impressive,” especially to people who have neither the time nor the inclination (not to mention the access) to go and read the full text, but that doesn’t mean it *is.*

      Again, not knocking your efforts to get the fluoride out of the water at all. (I support that, in fact.) Just saying that PubMed isn’t all it’s cracked up to be, unfortunately.

  17. I was not aware of this information about research misconduct or conflict of interest, so I’m grateful for your exposé. It is most interesting to me that you mentioned the conflict in the National Cholesterol Education program. I took myself off the statin drug I was on because I learned that the issues I was having with muscle weakness and cramping were most likely the result of being on a statin drug. I know that as a healthy older female, I do not fit the profile of the study group which was determined to get benefit from statins. I may be in for a fight with my doctor next week, but I’m staying off of that and the other unnecessary drugs that I was on. I feel that my quality of life is better, not to mention less expensive, when I’m on only vital drugs (like thyroid replacement since I have no thyroid).

    • Glad to hear you’re off the statins – Try doing some homework on the effects of Omega 3 and Salmon/Fish oil as a blood thinner and cholesterol reducer, the side effects are great – like better hair and skin and better GI function, been off statins for 3 years and life is a whole lot better – I’m a 50 year old woman.

  18. Chris, Your articles are always so thoughtful and balanced. Skepticism is always a good thing in balance with an open mind…if that makes sense. I always learn something valuable from what you write. This time I also learned a great deal from the comments made by so many people. This is a discussion that needs to continue.