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The Medical Professionalism Blog

Physician Skepticism About Industry-Funded Clinical Trials

In a recent New England Journal of Medicine article “A randomized study of how physicians interpret research funding disclosuresDr. Kesselheim and colleagues found that internists harbor mistrust of industry-funded clinical trials. In his accompanying editorial, Dr. Jeffrey Drazen states that “how trials influence practice should be based on the quality of the information conveyed in the full study report” without regard for funding source.

While we applaud the efforts of the Journal to enhance transparency by posting study protocols on-line, we believe that it is appropriate for physicians to discount the findings of industry-funded trials.  Vioxx litigation has demonstrated that even editors may fail to discern bias in reports of industry-funded trials. Clinicians who lack training in trial methodology and results interpretation are ill-equipped to detect bias, even if they read the full study protocol.

Further, clinicians are unlikely to access full protocols; many in fact read only study abstracts. Routine conflict of interest (COI) disclosure is fundamentally designed to allow readers to weigh biases which may influence the generation and presentation of data. Kesselheim and colleagues demonstrated that COI disclosure can trigger appropriate physician skepticism and accomplish what it is intended to do.

Dr. Keyhani

Dr. Keyhani, UCSFDr. Salomeh Keyhani is an Assistant Professor in the Division of General Internal Medicine at the University of California, San Francisco. She is also a staff physician in the San Francisco VA Medical Center.  Her research interests include the examination of the quality of health care services and health care policy research. Her quality of care research to date has focused on examining the underuse and overuse of medical procedures. Her policy research has largely focused on areas important to health care reform. She has surveyed physicians on their views regarding coverage expansions (the public option and Medicare expansions), defensive medicine, comparative effectiveness research and reimbursement reform.

Dr. Korenstein

Dr. Korenstein, UCSFDr. Deborah Korenstein is an Associate Professor of Medicine at Mount Sinai School of Medicine. She is a clinician educator and health services researcher and was the founding Director of the Primary Care Residency Program at Mount Sinai. Dr. Korenstein currently serves as Director of Education of the DGIM at Mount Sinai and at the American College of Physicians as an Editor of PIER. Dr. Korenstein’s teaching and research interests are focused in evidence-based medicine (EBM), overuse of resources, and conflicts of interest in medical education and the medical literature.

1 Comment to Physician Skepticism About Industry-Funded Clinical Trials

  • December 5, 2012 at 10:19 am | Permalink

    Such a complicated subject. I agree with every word you wrote, and I want to take it a step further.

    I’m no professional researcher nor clinician, just a layman with a fair grasp of the scientific method, and a fair amount of exposure to conversations about how it all works out in reality.

    If our shared goal is to collect good, rigorous information about the best odds on treatment options for a given patient, then the quality of that information is core to the success of our methods. Toward that end we have a process – the scientific method and peer review.

    It’s a human endeavor operating within constraints largedly dictated by availability of cash. I learned in grade school that if I do an experiment reliably, another “researcher” also operating reliably should get a similar result. So I was astounded to learn a while back that most trials are never replicated – because of cost. (Heaven knows there are plenty of scientists who’d be happy to have the work!)

    Then at TEDMED last year I saw Ben Goldacre’s talk on “The Missing Data” – the many trials that are completed but never reported.

    I talked with him that night, and blogged about it on e-patients.net. The skewing is pretty stunning: “Goldacre says only about half the trials that are conducted are ever published, and (p=.0392) positive outcomes are twice as likely to be published as unfavorable ones.”

    So, to the editorial’s point: even if one trial’s protocol is sublime and the data flawless, it may not be the whole story. Whether you view that as sloppiness, accident, manipulation or corruption, the result is the same: perhaps what got published isn’t the whole story we could find if we had time to dig deeper.

    So we’re cautious.

    Fortunately, our clinicians are trained (as was I) to scrutinize studies and be vigilant about potential weaknesses. And in my view, that’s medical professionalism – a good topic for this blog.

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