FDA: Harsh Criticism From Within

[Dubya_B]

Old news, but a profoundly disturbing view of how the FDA operates:

http://www.cbsnews.com/news/fda-harsh-criticism-from-within/

In a surprise appearance before a Senate Committee last fall, Graham charged that not only had the FDA failed to act on Vioxx, it was likely to make the same mistake with other drugs because of what he says is a fatal flaw in the FDA’s makeup.

The FDA, he alleged, is a house divided. There are the scientists like him who study the long-term safety of drugs already on the market. But there are far more FDA scientists involved in the process of reviewing and approving new drugs.

“The people who approve the drug in the first place, within the FDA, and take pride in the fact that they’ve brought a drug to the market – that this is their baby. This is their drug,” says Graham.

“Most of the time a safety issue that comes up after marketing is something that wasn’t identified before marketing. It’s something that wasn’t anticipated. And it’s not like you’re pointing a finger of blame at them. But it gets interpreted that way, I think. There’s no equal power. We have no power and they have all the power.”…

…“The FDA has a system in place now that will guarantee that unsafe drugs will remain on the market,” says Graham…

…“If you’re a scientist, and you raise a safety question, almost all of the time, almost 100 percent of the time, pressure gets brought to bear on you to change your opinion,” says Graham…

…He says part of the problem is the way the FDA is funded. Approximately half of the FDA’s budget for regulating the drug industry comes from the drug industry itself, in the form of fees paid to speed up the process of drug approval. …

…“Scientists have to be free to speak the truth about the science without fear of having their careers be ruined,” says Graham. “The fact that FDA threatens and intimidates its scientists, that is a public health threat.”…

…The FDA adamantly denies Graham’s charge that it intimidates its staff. But according to one government survey of FDA scientists, Graham may not be alone.Nearly one in five scientists surveyed said they had been pressured to recommend approval of drugs they had reservations about.