1992 was a very big year in the history of the relationship between the FDA and the pharmaceutical industry. That year, Congress passed the Prescription Drug User Fee Act (PDUFA), allowing the FDA to charge pharmaceutical companies hundreds of thousands of dollars per drug for the drug approval process.
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Many readers have wondered why I decided to publish The Carlat Report. Well, back in the day, I was a member of the speaker’s bureau of four pharmaceutical companies. I would typically travel to the offices of primary care physicians nearby and talk up the sponsor’s drug.
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There is trouble for the pharmaceutical industry in CME City. The ACCME (Accreditation Council for Continuing Medical Education), which sets national standards for accredited CME activities, has tightened up its requirements for commercial support, which is giving drug companies, private medical education firms, and assorted hired guns a collective case of indigestion.
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Dr. Kassirer, thanks for agreeing to share some of your thoughts with our readers. I have to say that your book, On The Take, was one of the most powerful books I’ve read. I want to thank you for writing it!
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It probably comes as little surprise to most readers that manufacturer-sponsored research is more likely to yield an outcome favorable to the sponsored product than similar non-sponsored research. What may be surprising is that there is actually a good-sized body of published research (non-sponsored, of course!) on this very topic.
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So, you want to be a bias-buster? Gird yourself, because it’s not an easy task. In order to establish the presence of commercial bias, you have to demonstrate two things: first, that the activity is funded by industry; and second, that the content of the program is unreasonably slanted toward the sponsor’s product.
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Dr. Aiken is the Editor in Chief of The Carlat Psychiatry Report; director of the Mood Treatment Center in North Carolina, where he maintains a private practice combining medication and therapy along with evidence-based complementary and alternative treatments; and Assistant Professor NYU Langone Department of Psychiatry. He has worked as a research assistant at the NIMH and a sub-investigator on clinical trials, and conducts research on a shoestring budget out of his private practice. Follow him on Twitter and find him on LinkedIn.
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