Articles Posted in Conflicts of Interest

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The medical journal The Lancet is chiming in on the Avandia debacle. Back in 2009, The Lancet published a paper about the RECORD study (funded by Avandia manufacturer GlaxoSmithKline) which was widely criticized. The major complaint is that the article did not include the drop-out rate—without knowing which patients went off the drug, it is impossible to calculate the risk of Avandia-caused heart attacks. Now, The Lancet issued an editorial titled “Strengthening the credibility of clinical research.” It describes briefly the Avandia situation, likening the recent Senate Committee on Finance report to a John Grisham novel: “GlaxoSmithKline (GSK), intimidated researchers and manipulated the scientific process for commercial advantage.”

Here are some “talking points” from the editorial:

  • At a time when some pharmaceutical firms have received record fines for misconduct, the saga of rosiglitazone [Avandia] tests the limits of tolerance
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The Avandia debacle heats up, this time in the medical journal community. The editor of the premier medical journal, The Journal of the American Medical Association (JAMA) has taken other journals to task for their methods of publishing articles. Using the Avandia RECORD study as the example of the conflicts of interest rampant in the medical publishing community, the editor explains “concerns about preserving market share apparently trumped concerns about the potential for causing patient harm.” For the past ten years, JAMA has required:

…at least 1 author must show that she or he “had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Additionally, that author cannot be funded by any commercial funding source. The source for this criterion is the age-old Hippocratic Oath—that physicians, above all else, must do no harm. The JAMA editor understands that when industry pressures are brought to bear, physicians may be (and have been) influenced to in a manner inconsistent with good science. And the result is that people rely on bad studies, and patients take bad drugs with incomplete and faulty information. The editor further recommends that drug study data be freely available to academic researchers.

Not only will the editor’s suggestions (if enacted by other journals) provide a means to double-check data to ensure its quality, but it will provide an extra reason for scientists and researchers to do the right thing from the beginning, and to stay true to the scientific method.

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At the Medtronic annual shareholder meeting last week, CEO Bill Hawkins defended the company’s history of physician collaboration, though he noted that the relationships may create conflicts of interest.

However, the probes by the Justice Department and the Congress into the relationships prompted one shareholder to state that he was shocked by how much Medtronic paid physician “consultants.” For example, Medtronic paid Dr. David Polly the tidy sum of $1.2 million between 2003 and 2007. Hawkins says that his company monitors payments to physicians to avoid conflicts of interest.

Call us skeptical and jaded, but this is a story we’ve seen time and time again. It is interesting that Medtronic is professing themselves to be mostly free of blame—we look forward to the outcome of the investigations to see just how well Medtronic monitored the conflicts.

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A nice article from the Washington Post, Probing Doctors’ Ties to Industry, evaluates the recent movement for transparency in the relationships between the pharmaceutical and medical device companies and doctors. We’ve all been to the doctor and have seen pens and pads of paper touting the latest miracle drug, but that is only the tip of the iceberg. The pharmaceutical and medical device industry pays for doctors to attend symposiums (sometimes these are actually just really fancy vacations with a very small lecture component), dinners, and provides them with gifts of all kinds (from pens to much more valuable objects). It is estimated that Big Pharma spends over $20 billion per year pitching their wares to doctors.

What’s the impact? Like the rest of us, marketing influences doctors (if they weren’t, these industries would not be spending the money). So, a doctor is more likely to prescribe Drug A over Drug B if he just got a nice lunch from Drug A’s sales representative. You’d like to think that all doctors will sit in their library and compare the attributes of the drugs, poring over the Physician’s Desk Reference. But time is at a premium, and it’s often easier to listen to the sales reps (who are very rarely medically trained). The question is whether patients receive the proper drug or the properly marketed drug.

Of course, some donations are for the advancement of science. Doctors frequently receive free samples of drugs or devices for research studies they are performing—this helps pharmaceutical companies and medical device companies to determine the safety and efficacy of their products. Those should be reported as well, but they are less likely to influence a doctor’s prescribing habits.