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An Ailing, Failing FDA

November 23, 2004

As if any more evidence were needed that all is not well at the Food and Drug Administration, consider last week's testimony at a congressional hearing on the controversial painkiller Vioxx. FDA officials apparently showed favoritism to studies designed by drug maker Merck to play up Vioxx's easiness on the stomach while minimizing those that pointed out its increased heart risks.

Testimony also revealed that mid-level FDA officials who warned about Vioxx were silenced or ostracized by the agency -- calling to mind the treatment of CIA officials who tried to question the evidence that Saddam Hussein possessed weapons of mass destruction in the run-up to the Iraq war.

Merck pulled Vioxx off the market on Sept. 30 in response to studies suggesting it may be tied to 88,000 to 139,000 heart attacks, up to 40% of them fatal.

Chief Executive Raymond V. Gilmartin insisted at the hearing that Merck didn't have solid evidence of problems until days before it pulled the plug; in fact, he said, his own wife had been taking Vioxx. Yet studies had warned of dangers for years. A Merck memo released last week showed that company scientists signaled as early as 1996 that the drug might contribute to heart troubles.

Perhaps the most disturbing testimony involved the FDA's apparent complicity in keeping a dangerous drug on pharmacy shelves. Dr. David Graham, the associate director for science and medicine at the FDA's Office of Drug Safety, claimed his bosses had pressured him to change his negative conclusions about Vioxx.

Similarly, FDA drug safety advisor Curt Furberg said his invitation to participate in an FDA meeting about Vioxx in February was rescinded after the agency found that Furberg had "a point of view" on the drug and had done some research. The FDA has to be "pretty careful about" letting such people play an active role in drug safety discussions, an FDA spokesman said.

This defense, however, only highlights the problem: the agency's absurd insistence that only scientists who haven't studied a drug and have no point of view about it should be entitled to attend meetings to decide how it should be regulated.

As is true of the CIA and so many large bureaucracies, the FDA suffers destructive lack of respect and communication among its subdivisions.

The warnings from Graham's Office of Drug Safety were largely ignored by the more powerful Office of New Drugs, which approved Vioxx and was responsible for monitoring it. As Graham said, when "the same group that approved the drug is responsible for taking regulatory action against it, there is an inherent conflict of interest."

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