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. Very disheartening stuff, but so important to make people aware of.

    Regarding even more reasons why fraud & deception occur, I think there is probably a great deal of just plain laziness among researchers and study authors. There’s so much pressure to “publish or perish,” and to conduct studies that show the “right” results” (*cough, cough*), that sometimes contradictory findings are downplayed or outright ignored, while supportive ones are emphasized. And let’s not forget the critical difference between statistical significance and *clinical* significance, never mind that the average person out there is almost clueless about statistics and relative risk vs. absolute risk.

    I do health research & writing for a living, and I am often stunned by the poor quality of papers I read on Pubmed — and I mean read, from start to finish, not just skim the abstract. (Far too often, the abstracts really do NOT reflect the actual findings, when you take the time to look at the data.)

    Another big, BIG issue, I think, especially at the highest levels of pharmaceutical companies, universities, and government health advocacy and regulatory agencies, can be summed up in two words: REVOLVING DOOR. When leaders float from agency to company, back to agency, to university, back to company, it becomes, for lack of a better word, incestuous.

  2. Remember Don Poldermans, a famous Dutch fraudulent researcher, a.k.a. Con Poldermans? More info at http://drmalcolmkendrick.org/tag/don-poldermans/

    Dear Donny has never been prosecuted, he’s still working as a ‘doctor’ at a hospital in Spijkenisse in the Netherlands.

    Should he not be in prison – like all other criminals? No, Dutch authorities (“Inspectie Volksgezondheid”) don’t hand over the facts, not even to an investing TV program. Big Pharma gangsters…

  3. This article does not surprise me. I was poisoned by Botox as have many other people. The product is not safe and despite hundreds of reports of adverse effects nothing has been done about taking this product off the market.

  4. Recently I read “Deadly Medicines and Organised Crime: How Big Pharma Has Corrupted Healthcare” by Peter C. Gotzsche. What you describe is general practice all over the world. Goetzsche’s advice is to only get medication that has been on the market longer than 7 years. The trials are falsified anyway and the really dangerous stuff is taken from market within the first 7 years.

    • For me the best thing to do is go one step further: treat all medicines as an absolute last resort after all other possible treatments options are exhausted. I have unwittingly taken part in an uncontrolled trial for the last 15 years (long term use of PPIs for GERD) believing there was no alternative. During those 15 years I’ve been a patient to a dozen or so general practitioners (I’ve moved around a lot). I recently experienced a complete remission of all symptoms by eating a carb and gluten restricted diet. No PPIs for 4 months now. Why didn’t any of my doctors suggest trying this?

      • “WHY ARE STATINS STILL ON THE MARKET”

        The statin study that propelled statin drugs to the biggest selling class of drugs of all time…

        Only 1 % of study participants benefitted, yet the FDA allows them to claim 36% less risk of heart attack based on the unbelievable SCAM of “Relative Risk”…

        In Lipitor newspaper ads there is an ASTERISK after 36%* And in tiny print at the bottom is says that this means (approx) 3% of people taking the drug, and (approx) 2% of people on the placebo benefited. The difference between (approx) 3% and (approx) 2% is 36%.

        Billions upon billions spent on these drugs for 1% benefit and lots of debilitating side effects, including increased risk of death.

        ANYONE put on a statin drug, or ANY drug should ask their doctor if the PERCENTAGE OF PEOPLE WHO BENEFITTED from the drug in the studies is based on “RELATIVE RISK”??? I have had 2 different doctors drop their jaw and not answer me when I asked them this question. I just looked at them waiting for a response until they changed the subject.

        • Pharma’s response when the newspapers exposed this was something like “Even if only 1% are protected, the more patients taking cholesterol lowering medicines, the more will benefit, and this will add up to a lot of people being protected.”
          WOW, so lets spend a few more billion on drugs that will send more people to an early grave than will benefit.

    • “… THE REALLY DANGEROUS STUFF IS TAKEN FROM THE MARKET WITHIN 7 YEARS”

      The FDA’s own statistics currently list prescription drugs as the 4th leading cause of death. (And the number of people who live with diseases and disorders caused by drugs is even greater.)

      See this FDA page:
      “FDA Why Learn About Adverse Drug Reactions (ADR)”

  5. For the best ever summary of what’s wrong with medical research you cannot do better than see Ben Goldacre’s brilliant
    17-min TED talk on the subject. No one should miss it.

  6. It is probably no coincidence that the examples are all from clinical trials. They decide on a specific medication and thus have the financial interests of a specific firm behind them. The result is also somewhat arbitrary, it is mostly statistics, there is no model to predict what should happen. (Within limits: to report no heart problems for a pill of a type that normally gives heart problems would be suspicious.)

    This is very different from (medical) research where the scientists want to understand the mechanisms, the reaction path ways, the communications within the body, and so on. That kind of research is interlinked, if someone does something wrong, the next studying that or a related problem things no longer fit together.

    In that respect, I hope that we move from evidence-based (clinical trails & pills) medicine to science-based (understanding and solving root cause) medicine.

    • I hope I see this change in my lifetime, but I am skeptical. Why? Because 2/3 of research funding comes from Big Pharma. Until we address that, I don’t think it’s likely to change much.

      • You are so right Chris, “He who pays the piper dictates the tune”. That is really unfortunate as they are simply putting money over human life ( the very same thing they are supposed to be protecting). What a sad irony.

  7. Hey Chris. This type of article really elevates your status as a medical practitioner. I’ve often tried to share your work with my old man who’s very analytical and he generally comes back with “He’s not an MD” and the consensus view of MD’s is X. This article shows clearly that the consensus has some pretty serious contamination issues. What really sells the article though is the calm and methodical approach you take to this stuff which I find consistent with all of your work. If you’d be willing to take some advice I’d say keep writing these types of articles! And thanks for your great work.

  8. Now who can and when can we make some changes? I mean why can’t the pharma companies donate money to fund these studies anonymously so that the scientists in question don’t know who contributed thereby concentrating on what’s important “the science” – money has to come from somewhere?

    Regulation needs to be more stringent and a private body needs to start implementing some strict changes, repercussions need to be swift to eradicate the soft handed action to date from FDA

    What also comes to mind is maybe by changing the way we research could it change the outlook of the results/studies? currently we look for conventional medicine to treat symptoms but what if research went deeper to treat the underlying cause? Research would be undeniable when a cure is explored.. The data could not lie. I understand how this is quite difficult but what if we try? Else scientists will forever look fr a quick fix and symptom chaser because that’s all that’s expected these days to show statistical significance?

    Just a thought ..

    • Wouldn’t it be nice to live in a world where Big Pharma would contribute money to a general research fund without any connection to the studies, researchers, or results? A fantastic idea, but one might argue that it’s more likely to snow in Houston in July.

  9. Also, make sure you read Harvey W. Wiley, M.D.’s
    “THE HISTORY OF A CRIME AGAINST THE FOOD LAW

    THE AMAZING STORY OF THE NATIONAL
    FOOD AND DRUGS LAW INTENDED TO
    PROTECT THE HEALTH OF THE PEOPLE

    PERVERTED TO PROTECT ADULTERATION
    OF FOODS AND DRUGS”

    Written in 1929. Wiley was the first Commissioner of the FDA writing about the corruption of the FDA from day one.
    http://www.soilandhealth.org/03sov/0303critic/030305wylie/030305toc.html

    This is nothing new. It is a systemic problem with the very nature of regulatory agencies. It cannot be fixed by reform and regulation.

  10. I think this was a great effort at investigative reporting Chris. Thanks for being one who is speaking in the public interest and who continues the quest to have some kind of oversight of our health oriented institutions. The current FDA can’t do it in spite of the funds they have at hand.

    We need reporting like this to help minimize the disease and degeneration that is spread by the current establishment that claims to be improving our health, but is doing nearly the opposite.

  11. Best article you’ve written Chris (at least in my opinion) because this is something I find concerning about skepticism and many “pro-science” blooggers.

    It seems that we have people embracing science not to further their own understanding but to attack people with opposing view points.

    I’ve seen so much ire and rage directed at Bill Nye & Michael Pollan because they questioned the use of GMO’s. They didn’t question the safety, just that the technology was being misused.

    I do find it concerning that many skeptics out there on the Interwebz are just defending the status-quo and challenging anything that’s new.

    Many skeptical writers are still hostile to dietary cholestrol, low carb diets etc. As I started diving more deeply into research myself I realized that the skeptic blogs I read were largely full of it on so many key topics.

    Somehow skepticism has become a movement and a tool to defend and preserve the status quo. It really undermines the revolutionary potential of scientific research.

    And now, the people who should be promoting truth and disturbing ideas are just relentlessly “debunking” anything that’s a threat to them.

    On my Facebook feed, I see dozens of groups formed around running coordinated attacks against the Foodbabe blogger. I’m all for people pointing out she’s wrong or perhaps has the wrong priorities – but the attacks are vile and really against any sort of activism at all (as if our food supply is perfect).

    Anyway, great post. It really hit home with me. This is why I love your site.

  12. One question I have is what percentage of clinical study sites are visited by the FDA? Do they actually visit 100% of the sites conducting trials, or only a random inspection of some? This makes a difference if not all trial sites are visited. The actual number of violations could be greater and underreported.

  13. Hmmm… I’m certainly not the researcher or the expert you are Chris, but I’m hoping to see a follow up to this series with something about vaccines. Obviously a controversial topic and one that I think is probably misunderstood by both sides of the argument when considering factors like microbiome and SNPs. I find myself flip flopping on both sides quite a bit and try to remain skeptical of the alternative medicine crowd as much as I do the mainstream the mainstream one.

    • Vaccines’ interaction with the gut microbiome is poorly understood, but what research there is suggests that vaccines are not only dependent on gut flora to be effective, but also not to cause great harm. In a recent polio outbreak in Pakistan children who had been vaccinated SEVEN times for polio acquired it due to their dysbiotic guts rendering the vaccination useless.
      Cuba has a very similar vaccination rate to the US’ schedule, with almost 100% compliance (no religious or personal exemptions) but almost none of the autism or explosion in autoimmune and chronic disease that the US is undergoing (almost 50% of US children now suffer chronic illness.). There are some fundamental differences between the two countries. Cuba reined in its use of antibiotic drastically in the 90s – only hospitals can dispense them and they don’t dump them all over their life stock, the fate of 80% of antibiotics in the US. Also, glutathione-depleting Tylenol is very hard to acquire – it’s prescription only there. They also eat a gut-supporting traditional diet.
      So many tales of autistic regression I’ve heard entail a sick child visiting the pediatrician, being given a bunch of catch-up vaccinations and antibiotics and then Tylenol for pain.
      Here is a great article, with links to many scientific studies, that describes vaccinations’ effect on gut flora: http://www.greenmedinfo.com/blog/vaccine-injury-biological-plausibility-microbial-predisposition
      In the article the author mentions the high rate of autism among Somali immigrants. This bears out in my son’s autism class. I live in a very homogenous county (almost all Caucasian) but almost all of his classmates are the sons of New Americans (Guatemala, Tunisia, Mexico, China). I suspect it’s something to due with an old world microbiome + the gut-harming standard American diet/lifestyle + heavy use of antibiotics + a heavy vaccination schedule.

      • Thank you for this comment. This is something I haven’t had time to research but feel it is one, possible the most important, white elephant in the vaccine saga. My personal experience reinforces the gut microbiome possibility. It is also the reason my first grandchild is not yet vaccinated as her mother and I believe her gut isn’t right and we r taking steps to heal it before any discussion on vaccines, spacings, etc takes place. Her diet is Not SAD but a whole foods, fermented foods great grandmother style diet and she still shows signs of gut disbosis. Scary but I believe epigenetics r at play as I am most likely the culprit in her microbiome unbalance. I have extreme gut issues, my daughter, born c section with antibiotics and a case of thrush at approx 3 weeks, got “lucky” with my gut bacteria, or lack thereof, and passed it along. Our children and grandchildren really do need us to recognize the whole epigenetics theory, correct our guts and possibly, only then, pass along a long healthy life to them. Again, a great comment on the whole screwed up mess named Vaccines we have here in the good old, corrupted, USA.

        • I also feel epigenetics and gut health issues are ignored at our peril. I wanted to share some of my story with Jenny, to support her in trusting her instincts and resisting the pressures of a one-size fits all approach.

          My Great-grandmother was a permanent invalid, due to a hole in the heart. She was too ill to breastfeed my Grandmother, who had a whole host of gut issues – diverticulitis, colitis and such extreme constipation she perforated her bowel. My mother was a twin and I’m afraid the breast milk went to the larger, healthier looking twin, who was also a boy and generally thought to be more important.

          My mother had terrible digestion, IBS, chronic fatigue, dairy intolerance and unremitting constipation. I was delivered naturally but she didn’t breastfeed, as she had to go back to work after 3 weeks. I had intense hayfever from the age of 2 which lasted 6 months of the year, escalating allergies to food from the age of 10 onwards, borderline inflammatory bowel disease. I had literally 20 courses of antibiotics, some via IV, by the time I was an adult because I was always ill.

          My own children were born by C-section, which was unlucky (not that I probably had such great bacteria to offer anyway) and to compound things, I couldn’t breastfeed either (I’d had surgery on both breasts much earlier in my life the tubes weren’t properly connected anymore).

          Both our boys had severe milk allergies which made them projectile vomit and covered them in weeping eczema from head to toe. They cried and writhed in agony all day and night, until we got them on a special amino acid formula (the eczema was gone in about a month and the pain went almost immediately). Despite a rigorously careful diet since then, they are still intolerant to lots of food groups, which make them break out in hives or burn through their digestive system like they’d eaten a vindaloo.

          Our oldest had a bad reaction to his Dtp boosters aged 6 months and a terrifying period of regression followed. I managed to resist the intense and unremitting pressure from the medical establishment, our families and even our friends and didn’t do another vaccination on him or his brother. He slowly improved, by 12 months we were getting some fleeting eye contact back and by 15 months we were getting a bit of copying. Then things got better and better.

          There was a period when I really thought we had lost him and I don’t wish the agony of that experience on anyone. Now at 3.5, he is completely transformed. No vaccines, a chemical-free home, simple, natural food, lots of outdoor exercise, no TV at all and almost no other digital media. He is a bright, bold, strong and energetic little boy, who is now far ahead of his peers physically and mentally. He has taught himself to read to first year of school level and has a wide, subtle vocabulary. He is an excellent problem solver and surprisingly good at self-regulation at an age notorious for the opposite. More importantly, he is gentle and kind, and loving and secure. He is fully alive in a way I feared he would never be.

          What I mean to say is pharmaceuticals do not have your best interests at heart. Most doctors I’ve consulted have conformity closer in their minds than your health. And even those that don’t, can’t seem to see you as a person, just a list of symptoms that can be paired with drugs. Keep your courage in defending your family! I wish you all great happiness and health.

  14. Typo alert: “8 out of the 9 doctors on the panel had direct dies to statin drug manufacturers.”

    Great article.

  15. Hi Chris! Love your site so much. I’m curious – given the rampant issues present in medical research, how do you personally go about verifying which studies to trust? It seems there are so many layers to verify before trusting the data. Can we ever really trust it, then? If you have a method, maybe you could share in a future post? (You know, in your abundant spare time…) 😉

    • It finally has to come down to patient progress. Chris is of the character where that will determine his actions. I don’t know why so many people go back to their doctor just to fall into further sickness. If people are getting sicker and feeling like crap all the time, who cares what so and so studies show? Statins are NOTORIOUS for this! Oh, great, your total cholesterol is down, but now you have memory problems and lost your sex drive? Huh? It’s junk medicine. Most MDs are guilty of not seeing the living human being in front of them and being genuinely concerned with how they are faring, but rather are stuck with managing symptoms or chasing numbers they find troubling in their blood work. They don’t see the forest through the trees. Fortunately, Chris and other functional practitioners are bringing wholeness back to medicine and using tools properly to sort out health issues. I am glad he isn’t an MD because he isn’t tempted by the script pad and it’s all-too-common corruption.

  16. Of course, you’ve only scratched the surface of the problem. Add positive publication bias, ghostwriting, failure to register trials before completion, changing primary results or follow up times during the trial, industry funding of the majority of physician education, pharma reps ability to influence prescribing behavior, and the revolving door between industry and government…there’s just so much to talk about.

  17. The roots of all of this is deregulation of course. Universities were hard up for cash about 30 years as more and more public money dried up; desperate, they turned to the private sector to prop them up. Universities have bills to pay too. We have a big problem on our hands; any suggestions on how to fix it?

    • Well you can teach everybody how to read stats properly, or you change to an entirely socialist system and take profit motive out of it. Whenever there is money involved, corruption follows “Behind every great fortune is a great crime”

    • “The roots of all of this is deregulation of course. ”

      Come on Josh. Regulation itself is the root of all this. Did you not read anything Kresser just wrote? Consider “Who Will Regulate the Regulators?” http://mises.org/library/3-who-will-regulate-regulators

      If there were no FDA, these problems would be readily exposed, not covered up. Granting the FDA a monopoly on access to drugs, etc is simply a tool that corporations use to maintain their own monopoly. Regulation does nothing but help corporations limit competition and cover their corruption. As Jonathan Latham (http://www.bioscienceresource.org/about-us/our-staff/) put it Monsanto would not exist without the marketing job the FDA does for it and the laws that protect them. Consumers simply would not trust the company (or others like it).

      The FDA (and all regulation) gives people a false sense of security. People put their guard down when they hear there is a benevolent nanny-state protecting them from any and all danger. So they assume that whatever exists is safe, rather than doing due diligence themselves. Consider this analogy from bungee jumping in Africa:

      On Dec. 31, Australian tourist Erin Langworthy became one of thousands of people to try bungee-jumping off the bridge that connects Zimbabwe and Zambia, within sight of the tourist mecca Victoria Falls. It’s 364 meters of sheer gravitational pleasure, followed by a gut-wrenching jerk just feet above the rapids below. The only problem, for Ms. Langworthy, is that her bungee cord broke and she fell into the Zambezi, which, in its quieter areas, is infested with crocodiles…

      [The reporter went on to make a few comments about being safe in Africa:]
      One: Tourists who come from litigious societies such as the United States may have an assumption that an activity is safe, because it is allowed to exist. Such an attitude may be reasonable in the US or Australia, but it doesn’t necessarily work in a country such as Zambia, where civil court cases can take decades to resolve…

      Langworthy’s plunge reminded me of the anecdote of a friend in Johannesburg, who took his clients on a year-end corporate junket to Victoria Falls. The last event was to be a bungee jump off the Victoria Falls bridge. All but one of the clients took the plunge. The one who didn’t jump had asked the bungee operator what would happen if the bungee cord breaks. The tour operator grinned: “We’ll replace it.”
      http://www.csmonitor.com/World/Africa/Africa-Monitor/2012/0109/Oh-snap!-Bungee-jumper-plunges-into-Zambezi-River-at-Victoria-Falls

      Look at the doctors Kresser mentioned. If the FDA and the entire medical establishment, with its regulations, did not exist, then doctors would have to exercise their own due diligence and not simply trust the FDA. The removal of this personal responsibility is what creates the problem and the ability for corporations to hide behind the veil of regulation.

      Pretending like the profit motive can be ignored is what gives “benevolent” regulatory agencies their existence and their power. Instead, recognizing that it exists and allowing it to exist *openly* is the solution. Are supplement manufacturers not motivated by profit? Of course they are. What’s the difference between them and Big Pharma? Government connections. Cut off the government connections by ending “regulation” and supplement manufacturers can compete freely with pharmaceuticals, rather than being tied down by laws. Both sides will then compete to inform consumers just like Microsoft and Apple do. Consumers will educate themselves, rather than trusting a regulatory agency. Why don’t we have these kinds of problems in the personal computing industry? Because no one thinks we need to be protected from Microsoft and Apple’s profit motive (obviously regulation exists even there – don’t stretch my comment further than it should be).

      Chris, please read “Designed to Fail: Why Regulatory Agencies Don’t Work” written by a former EPA employee for the Independent Science News (Jonathan Latham) http://www.independentsciencenews.org/health/designed-to-fail-why-regulatory-agencies-dont-work/

      Also consider “The Regulated Consumer” by Mary Bennett Peterson http://mises.org/library/regulated-consumer

      As well as http://mises.org/search/site/regulation
      and
      http://mises.org/search/site/fda

      • Read Upton Sinclair’s The Jungle. That’s what society was like pre-regulation. Or Drehe’s Triangle The Fire that Changed America. Or any history around what life used to be without regulations. People injured on jobs were fired immediately because they had become useless. There was no minimum wage and no maximum hours. China has fewer regulations than we do. Look at all the suffering and deaths that could be prevented. Regulation – clean regulations – are essential to everyone’s well-being. The regulators need to be required to be transparent. If there were no regulators the pharmacy companies wouldn’t even bother with research. They’d simply put the drug on the marker and see what would happen. Just because some people run red lights and even more speed, driving would be horrific if all rules and traffic signals were simply removed.

        • Loved this article and loved your comment.
          I would like to add that any snake oil supplement company can tout the wonders of their product, and said product may not even contain the “miracle” producing elements, but nobody stops them. There is so much fraud in the health food industry too, I have personally been poisoned by flaxseeds at just a couple tablespoons a day. After the fact, my research revealed that no culture ever used it as food for themselves or their animals. The high levels of thiocyanate in them block iodine reception in the thyroid gland and you won’t make the thyroid hormone. Animals get sick on flaxseeds too. The Agriculture Department found it was unhealthy for animals ages ago and told farmers not to feed animals flaxseeds. I am sticking to sardines for my omega-3s now after recovering from the thyroid issues. Tiny fish have less toxins.

        • Good people do not need laws to tell them to act responsibly, while bad people will find a way around the laws.

          Plato

  18. Intended or not, the effect of your article is to call into question large swaths of scientific research and its conclusions. When I look at my mother and her huge vat of pills she takes without any thought or knowledge of why she is taking them, I cannot help but think she would be better of if they were all flushed . . . My thought is to avoid the medical establishment at all costs, and I am disgusted that I am being forced to pay for those who are slowly (but happily) killing themselves on the SAD . . . If we changed food and exercise, we wouldn’t need the vast majority of the pharmaceuticals out there . . . Instead, some dietician tells these oldsters, have your OJ, booze, and oatmeal, just all in moderation (looking at the glass half empty today).

    • Well said Colleen. Healthcare costs should be more like 10% of what they currently are. If only national health care were focused on education and encouragement of lifestyle changes, we might reduce costs a full 90%.

      I’d love to see people become ancient, but still healthy. I’m betting a high percentage of 90 year olds would happily pass away with minimal treatments after living such a long, fruitful life. This would further decrease health care costs compared to our current situation where so many 50 and 60 year olds are fighting for their life and paying every last dime to get another 10 years, yet have no hope of a really pleasant life from now on due to their degenerated, unrecoverable condition that is greedily maintained by the medical system.

      • Isn’t it sad? My parents and parents-in-law are already reaching that age and starting to have problems. It’s hard to be the kid and teach them what they’re doing wrong after so many years of thinking they’re right. I try to be gentle but sometimes I lose my temper thinking about how I’ll be taking care of them in ten years, when I’m also raising my own kids. It’s too much, too soon.

  19. “Even when a claim is disproved, it hangs around like a deadbeat renter you can’t evict.” a quote from Dr John Ioannidis head of preventative medicine at Stanford .“‘When you do thousands of tests, statistics says you’ll have some false winners,’.

      • The problem of lying becoming an acceptable part of life began in the 1960’s. I remember a management training movie which contrasted generations highlighting this as a stark contrast beginning with those born post-WW2. Prior to that lying led to immediate dismissal. Today most of us assume that everyone lies unless proven otherwise. Society has even invented a multitude of new names for it such as misrepresentation or obfuscation. The National Nutritional Guidelines are based upon invalidated claims based upon fraudulent research. The guidelines have led to an epidemic of metabolic syndrome and premature death on a large scale yet the entire nutrition profession and associated organizations persist in denying the basic underlying science, established years ago, common to all metabolism text books and supported in large study after large study. No wonder so many people no longer trust what they are told supported only by the statement “trust me I’m a doctor or a scientist”. Fortunately the current situation with measles has brought it to a head and open discussions have begun in the press and media. Its simply a lie to say that vaccinations in general are safe. Some are and some are not. Take the measles example, why do we not vaccinate at birth? apparently this is not safe, why not and how do we know the current designated age for vaccination is in fact safe for all children, is everyone developing in an identical fashion?. In Veterinary medicine there seems to be more honesty and for each vaccination there is a judgement of risk-benefit so that only certain vaccinations are given in each situation depending upon the balance of risk. Vaccination sites ultimately resulting in cysts and eventually in cancer are not uncommon and a general precaution is to remove such resulting lumps to limit the possibility of cancer. I’ve had that done and just yesterday a friends dog was so identified. Everything in medicine has a risk-reward condition, medicine seems to pretend such a thing doesn’t exist for vaccination. Te only way out of this is to do the studies, have them audited, not in secret, and publish the results. The “trust me” argument is worn out. Show me large study data audited by a population cross-section or quit the BS because believing nothing we hear is today probably the safest path. Even photographic evidence is today no longer acceptable in some legal situations since lying with photographs (Photoshop) is a common occurrence.

    • I call those “medical urban legends.” Like “you have to take an antibiotic for ten days to prevent development of resistant bacteria.” That makes absolutely no sense in terms of genetics (in fact it’s the best way to make sure that ONLY antibiotic-resistant bacteria survive), but I’ve been hearing it since I was a teenager, and that was over 40 years ago. I highly doubt it’s ever been supported by any kind of studies. I suspect it came from drug company marketing, even back then.