Should the FDA relax in the search for new cures?

By Matthew Holt

Over at DiabetesMine #1 health blogger Amy Tenderich has very important post. She and several fellow travelers are appealing to the FDA to strike a balance between safety and progress in allowing new diabetes treatments.

The FDA of course has been beaten to a pulp these last few years because it’s played footsie with the drug industry and ignored several potentially damning studies, with the result that the number of drugs withdrawn from the market has been much higher than in previous years.(Vioxx, Phen-Fen, Baycol, et al).

I’ve always felt that the FDA’s role should not to be a black/white (dangerous/safe) stamp of approval, but instead it should be the honest broker of getting all the data out there. As Amy and her crew point out, some diabetics may be prepared to take a risk of higher long-term cardiac complications in return for a medium term gain from a new medication. Something similar is certainly true in terms of hormone replacement therapy.

Obviously it’s one thing to say that all the information should be released and then doctors and patients should make an informed choice on what they want to use. It’s another to actually get pharma companies to release negative results and for that matter for the FDA to release all its data. John Abramson’s Overdosed America shows the very nasty world of that cooperation, including his need to get a FOIA for the FDA to release information it had about Celebrex among other drugs.

And on the flip side we know that big Pharma is quite prepared to push drugs it knows have serious risks and just not disclose them. (Dodgeballl anyone?)

So the FDA has to live in a very imperfect world.

But with the rise of very informed patients, perhaps the new FDA Commissioner can aim to create a transparent environment in which everyone in the system (pharma, regulators, doctors and patients) gets to release and consider all the information about a product and are then expected to act like responsible grown-ups. It’s an ideal, I know, but one that someone should stake out. We don’t want to repeat the last 10 years.

January 9, 2009 in e-patients, FDA, Health 2.0, Patient Safety, Pharma, pharmaceuticals | Permalink

More transparency would be of real help and FDA should take stringent measures in this direction.

Posted by: Govindan | Jan 9, 2009 1:58:30 AM

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