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.

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.

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!

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.

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.

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.