What’s Up with the FDA? – Part 2

May 15th, 2011 by MorganDowney Leave a reply »

I’m sorry are we bothering you with all this obesity stuff?

As you know the FDA was quite busy this last 12 months or so with reviews of Meridia, Qnexa, lorcaserin and Contrave. Meridia is off the market now while the other three are holding on for dear life. It came as no shock to those closely watching the meetings of the Endocrinologic and Metabolic  Advisory Committee that the FDA really doesn’t much like dealing with obesity. Now, we know why. They are not curing hypertension or diabetes. That’s what the head of the FDA drug center, Janet Woodcock, right,  wanted to see. And that’s what she told Reuters in this interview. FDA official sees drug approvals rising | Reuters

So, think about this for a moment, the top FDA drug official casually tosses off the FDA’s own guidances for developers of obesity drugs regarding efficacy and says, well, she wishes they were other drugs entirely. Imagine if she said, well, we have turned down this drug for breast cancer because it didn’t  improve Alzheimer’s disease or  cure multiple sclerosis. Or if she said of a drug rejected  for HIV/AIDs, that she would like to have seen it cure Parkinson’s disease?  Would she stay in office the rest of the day? Would it not be a huge embarrassment to the FDA, the HHS, the medical community, the Administration? Why is it  ok for obesity? Is is any less intellectually vapid?  Is that why one of people who works for her, running the Endocrinologic and Metabolic Advisory Committee process this year, apologized, APOLOGIZED! to the panel for “putting them through this unpleasantness.” The “unpleasantness” Dr. Coleman was referring to was the Committee’s job, namely, reviewing new drug applications for obesity. Dr. Coleman, went on to add, “I guess you should be thankful you don’t have to do this everyday for your living.” (See http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM232443.pdf at page  304) Is this a cry for an intervention, a plea for a new job? Or a sign of an institution so biased against all this obesity that no obesity drug will ever be approved no way, no how? Can these people give obesity drugs a fair hearing? The FDA has rules on Conflicts of Interest. How about rules on Lack of Interest?