Well, somehow I managed to miss the next round of American Idol this past Wednesday night and found myself watching 60 Minutes Wednesday night edition, with their interview of Dr. David Graham. Dr. Graham is a senior scientist within the FDA’s Office of Drug Safety and now a whistleblower at the FDA. Graham blames the FDA for allowing dangerous drugs to stay on the market. Specifically, he blames the FDA for not pulling a drug that he claims contributed to the deaths of thousands of Americans. He also points the finger at FDA management for running a dysfunctional organization.

In an 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 wouldn’t give 60 Minutes an interview, but it essentially calls that allegation nonsense. Publicly, FDA officials have denied just about everything else Graham says.

This 60 Minutes pieces comes the day after the Bush administration announced plans to create a new independent Drug Safety Oversight Board to monitor the safety of prescription drugs that have received approval from the Food and Drug Administration. The formation of this board is in response to widespread criticism of the government’s handling of drug safety problems. The main function of this board is to advise on drug complications and to warn patients about unsafe drugs.

Dr. Lester M. Crawford, the acting commissioner of the drug agency (Dr. Crawford was nominated Monday by President Bush to become the permanent commissioner of the F.D.A.), said the board would be made up of scientists drawn from throughout the federal government. The board, which is to make its conclusions public on a Web page, will not have independent power to force the withdrawal of drugs but will simply advise the F.D.A., Dr. Crawford said.

But U.S. Congressman Maurice Hinchey (D-NY) says the board is nothing more than a farce. He went on to say that despite claims that the board would be independent, the FDA announced that the panel would be made up of government officials from the FDA and other government health officials.

The Congressman is not alone and other advocates such as Dr. Sidney M. Wolfe, a director of the consumer advocacy group Public Citizen, have been calling for a more powerful drug safety center with far more employees that would be independent of the F.D.A. or at least independent of its drug review division. The advocacy group Public Citizen weighed in and called this “a cruel hoax and a frantic reaction to Congressional disapproval.”

Dr. Alastair Wood, an associate dean at Vanderbilt University who has long advocated an independent safety review board structured like the National Transportation Safety Board, said he was disappointed.
Currently, the F.D.A. is wholly reliant on voluntary efforts by drug makers to assess the safety of medicines once they are already being marketed.

I still have my migraine from earlier in the day. Can I still take two aspirin and call you in the morning? What do you think Simon, Paula and Randy would have to say about all of this? Would the FDA make it to the next round in regaining the public’s trust?

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    This makes me think of the phrase, “the inmates are running the asylum”.