Who’s running the show in industry-sponsored drug trials?

There is strong evidence that medical researchers’ financial ties to their industry funders may directly influence their published positions in supporting the benefit or downplaying the harm of the products they are “studying”. 

For example, there is often a demonstrated difference between internal drug company documents about the research trial results that they fund, and the articles reporting that research that end up in the medical journals that your doctor reads.  The New England Journal of Medicine has referred to this practice as ‘selective outcome reporting’.

But for the sake of clarity, let’s just call it ‘lying’.  

In other words, as a dull-witted heart attack survivor whose doctors have prescribed a fistful of daily cardiac meds, I have no clue which of those drugs has been recommended based on flawed research or tainted journal papers that have essentially been bought and paid for by the drug company who made my drugs. And, worse, neither do my doctors.

Here’s another textbook example: Dr. Mohammed Hassan Murad of Mayo Clinic reviewed* 202 published journal articles that addressed the now-recognized association between heart attack risk and the diabetes drug Avandia, made by drug giant GlaxoSmithKline. Among the journal article authors who (erroneously) concluded that Avandia does NOT increase the risk of heart attack, 86% had financial relationships with GlaxoSmithKline. But among authors of articles offering unfavorable reviews of Avandia, only 18% had relationships with GSK. For more on what can happen to you if you market your drugs like this, see the New York Times report, GlaxoSmithKline Settles Investigation with Record $3 Billion Fine in Avandia Settlement 

This financial conflict of interest problem is now considered so pervasive, in fact, that those who do the studies are being studied themselves.

Regrettably, it turns out that medical researchers working on clinical trials “may not always follow best practices” when it comes to avoiding or minimizing the powerful influences  of those who give them money, which is the charitably tactful assessment by Dr. An-Wen Chan, also of Mayo Clinic.

Reporting on his study of financial conflicts of interests (specifically when it comes to Big Pharma-sponsored drug trials), Dr. Chan told Heartwire interviewers:

“Clinicians and researchers need to be far more aware going into studies about what potential conflicts of interest might arise with their drug trial sponsor, and take steps to prevent them early on.”

Dr. Chan and his colleagues asked 1109 researchers about their experiences with clinical trials conducted from 2001 to 2006 (across all medical specialties), inquiring specifically about these “best practices.” These included:

1. Externally regulated best practices:

  • Were the trials registered?
  • Was there an institutional review of trial budgets and contracts?

2. Self-regulated best practices:

  • Did researchers have to sign restrictive confidentiality clauses?
  • Were investigators expected to provide their sponsors access to study data?
  • Did the investigators control all decisions about study design, analysis, interpretation, and manuscript content?

Dr. Chan reported that “clear problems” were identified – particularly in the industry-sponsored trials – when researchers were asked these key questions:

  • Had research investigators taken a lead role in such decisions as study design, analysis, and data interpretation?
  • Were ghost authors involved in the preparation of the study’s manuscript before submitting to a medical journal for publication?
  • Did they have to sign restrictive confidentiality clauses with the corporate funders of their research?

Conflicts of interests do not, of course, just impact researchers doing clinical drug trials. Consider these other examples of financial conflicts of interest reported from just one prestigious institution (Harvard University) as reported by the Center for Science in the Public Interest and their Integrity In Science conflict-of-interest project:

  • a Harvard pediatrician is paid by The Sugar Association to write good things about children and sugar
  • a Harvard doc is paid $100,000 cash by a major drug company to testify in court that their recalled drug does not cause deadly heart attacks
  • a Harvard astrophysicist banks over $630,000 in payments from ExxonMobil in exchange for co-authoring a report questioning climate change.

Which of these Harvard “experts” would you trust?

See also:

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* Murad MH. Association between industry affiliation and position on rosiglitazone and cardiovascular risk: A systematic review. Preventive Medicine 2010; February 19, 2010; Washington, DC. Abstract 212694.

11 thoughts on “Who’s running the show in industry-sponsored drug trials?

  1. This problem is out of control. Somehow we need a new model of medical research as the current one may be beyond repair. Government funding is also not “independent” as it has agendas too. The real need is to shift the focus away from new drugs being the only answer. Conditions caused by lifestyle require lifestyle changes not drugs!

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    • It’s truly pervasive – and from a patient’s perspective, very frightening. But how to disentangle ‘marketing-based medicine’ from its current influencers?

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  2. The ethical decline in American medicine – from research to clinical practice – has clearly reached a tipping point. As Dr. Kosterich notes, there are far better solutions in lifestyle changes than in more drugs, but these are harder to achieve – and less financially rewarding – than simply over-prescribing medications. Having researched the subject enough to write a book about it, I wholeheartedly concur in your bleak but realistic assessment of this dangerous situation.

    P.S. I love your site design. Great way to integrate the off-page and header images. Nicely done!

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    • Thanks, John. And speaking of prescriptions, some doctors are actually using the prescription pad to order regular exercise for their patients. For example, 50 Canadian physicians near Edmonton have adopted this practice en masse, handing out hundreds of exercise prescriptions since launching their initiative in November 2011; each Rx comes with a free one-month pass to a local recreation facility. The Canadian Diabetes Association also offers downloadable exercise prescription pads that provide doctors with five prescription options. Costs docs nothing, takes very little time or extra effort. Yet theheart.org reported last month that only 1/3 of physicians bother recommending exercise to their adult patients.

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  3. This is the kind of thing that makes me just want to pull the covers over my head and not even get up in the morning. HOW do these people live with themselves? Sickening. Just sickening.

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      • As I say in my book in addressing this subject…“A fish rots from the head down”. This corporate corruption is doubly corrupting: first, it corrupts the evidence on which our doctors rely, creating a ripple effect of victims as it’s applied in clinical practice; and second, it creeps into actual medical practice in the form of unethical practices and behaviors.

        When doctors see big corporations making billions by twisting the truth and hiding their failures, it’s only natural for them to follow suit.

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  4. I have to go back to my bedrock question: IS it natural to follow suit when making money, no matter how much, means lying and hurting people? I don’t think so. So how do people come to be this way? What makes people want money so badly that they would literally harm people to get it?

    There are tons of examples. Lies about the environment – well, that was in your list of articles, Carolyn. Lies about the safety of chemicals. Lies about just about everything that people want to make money on despite the fact that it will harm others or the earth we depend on for our lives. We’re still selling cancer causing sippy cups for Pete’s sake! We read about these things all the time.

    But WHY? I ask, underline, italicize, capital letters! WHY? In letters as tall as the empire state building! We’re not talking bank robbers or people raised in poverty and living in poverty. We’re talking doctors and scientists and the like. The people we think will, ON THEIR OWN, hold themselves to the highest standard.

    WHY?

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  5. How long are Drug companies, the CDC. and the AMA going to say thimerisol vaccines are safe? There Man who ran the vaccine studies in Denmark which supposidly proved Thimerisol is safe Dr Poul Thorsen Is in trouble with the law there because they are suspicious about where 1 million dollars paid for by the US for his bogus study went. He also held two jobs at once violating his work contracts in Denmark. He is indited in florida on money laundering charges. But saddest of all he has allowed so many children and adults to continue to be harmed by the horrible neurotoxin Thimerisol. Altzheimers and Autism are life distroying problems. Thimerisol is Mercury 10,oooo time more toxic than lead! Do you really want to be injected with that????? Or give it to your child??? read the package insert befor you submit to such a life damming situation for your self or your child.

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    • Hello Loraine,
      To my knowledge, few if any organizations are saying that Thimerosal is “safe”. Indeed, Thimerosal has already been removed from or reduced to trace amounts in all vaccines routinely recommended for children 6 years of age and younger, with the exception of inactivated influenza vaccine – but a preservative-free version of the inactivated influenza vaccine (contains trace amounts of thimerosal) IS available for use in infants, children and pregnant women.

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  6. The problem can’t be solved while we only think of the two corporate-funded political parties in the U.S. as “serious”.

    It’s time for more people to get “unserious” and vote for a party NOT on the corporate payroll, like the Green Party!

    This sends a message to the politicians on the take that selling out the people will cost them votes. (Unconditionally voting for them would send the opposite message.)

    VOTE GREEN 2012!

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