Monday, February 20, 2012

Abolish The FDA


You  write "no one measures the costs, in shorter and less healthy lives, that the FDA has imposed on us by denying life-saving and life-improving food and drugs". Do you know of any such examples? In my field there are occasionally agents and treatments that gain traction in Europe before landing here. So there is perhaps some cost to patients. But those therapies cross the Atlantic within a relatively short time.

Here is the reason the FDA has maintained such annoyingly stringent standards for so long.

Phocomelia, which produces truncation of the upper and lower extremities as depicted above, is a direct teratogenic effect of thalidomide, a drug initially approved as a sedative and antiemetic. The drug was brought to market in 1957 by its German developer Grünenthal. Its anti nausea properties made it an attractive choice for pregnant women and it was widely used for that purpose. Because the FDA never approved the drug, only a tiny fraction of the 10,000 cases worldwide occured here before the thalidomide  was withdrawn from the market.

The decision to reject thalidomide was made a young physician Francis Oldham Casey, who fnished her training at the Pritzker School of Medicine and arrived in Washington to be given reveiw of the drug as her 1st assignment. Despite intense pressure from Grünenthal she held her ground, and in 1962 she received the President's Award for Distinguished Federal Civilian Service for her decision. She was also instrumental in shaping the Kefauver Harris Amendment, which provides the structure for a New Drug Application or NDA. I've produced an NDA as part of my previous research, and it's an onerous process. But I'm sure it's a lot less onerous that having to confront the mother of the infant in the picture above.

But of course, we don't need any of this you argue. The market would do it all for us. I can cite example after example of the failure of the market to do so, even after FDA approval. And I agree that regulation should be subject to a continuous assessment of the costs and benefits.

So I ask, respectfully, do you have data to support the alternative hypothesis, or is this simply about ideology?


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