New FDA Rule

In news today, the new FDA Commissioner, Dr. Von Eschenbach, is trying to impose a rule that would a) exclude persons from advisory boards if they received >$50,000 from that drug's manufacturer and b) allow persons who received <$50,000 to serve on advisory boards, but would not allow them to vote.

While I agree with one of the representatives interviewed in the article that loopholes are likely, I would like to applaud the commissioner for this move. As is also in the article, in 2005 when the Cox-2 inhibitors were under fire, 10 of 32 people on the advisory board that allowed Bextra to remain on the market and allowed Vioxx to return to the market had received funds from the manufacturers; had they not been allowed to vote, both drugs would have been removed from the market at that vote (which they later were).

Seriously, if you are an "expert advisor" on a drug, who also receives $30,000 a year from the manufacturer of that drug, then you have a vested interest in seeing that drug be successful. I believe that such a person also has the company's information on that drug pouring out their ears; where else would you get this information, unless you are simultaneously getting paid by a rival manufacturer?

One last word. Yesterday, my clinic had a drug-rep lunch (which was quite tasty, I might add). During this lunch, the drug reps had us watch a video describing the study that proved that this particular asthma/COPD medication (a combo inhaler) was better than either of its two components alone. It sounded like a good study: double-blind, stringent requirements for enrollment, good endpoints, almost 2 years of average follow-up. One of the doctors and I asked for a copy of the article in print, which we were promptly given. Indeed, it was published in a decent journal (although a doctor I used to work with would disagree--he used to be on the advisory board of said journal and said it was worthless), and the study's PI was from a well-known medical institution. Then, I flipped to the fourth page of the study, and in tiny print at the bottom, I learned that 12 of the 13 listed authors were direct employees of the drug company, and the 13th (the PI) had received massive research funding from the drug company.
It doesn't negate the fact that it appears to be a good study, but I definitely took their findings with more than a grain of salt afterwards.

(For more info, I recommend the book Powerful Medicines. It goes into a lot of back history of the FDA and the current drug approval process, and how bad drugs make it through (and good). At times a slow read, it is highly informative, and will certainly make you look more carefully at the drug reps who bring you free lunch. Even while you're (I'm) eating it.)