A sick agency in need of a cure?
Recall of a popular pain drug has focused attention on government drug regulation
The first product liability lawsuit against Bextra was filed last month in New York. Kyle Raymond, a 46-year-old New Jersey waste disposal driver who had taken Bextra for nine months for arthritis pain, suffered a heart attack in June and died in his sleep. His widow sued. If the case goes to trial, part of the evidence may be the research of Garret FitzGerald, the first scientist to suggest that Cox-2's might harm the heart. FitzGerald has identified one possible mechanism: The drugs suppress a protective lipid, which in turn leads to more clotting, increased blood pressure, and hardening of the arteries.
Palace intrigue. The FDA has scheduled a meeting in February to discuss these drugs. Curt Furberg, a colleague of FitzGerald and an FDA drug safety adviser, was originally invited to attend this meeting. "Then, I had a call from one of the administrators of the committee, and she said that I'd been disinvited because of statements I'd made in the New York Times, " he says. Furberg had expressed the opinion that Pfizer was trying to suppress the results of studies about Bextra.
A few days later, Furberg got a call from someone on the FDA's Ethics Committee who apologized, said that acting Commissioner Lester Crawford had not been informed of the disinvitation, and asked for a confidential copy of Furberg's draft manuscript about Bextra, which he provided. He's heard nothing more.
The FDA's Kweder insists that the agency is not trying to stifle scientific dissent and that she assumed Furberg's disinvitation had gone through Crawford's office. It hadn't.
So will Furberg be reinvited? Kweder hesitated: "No decision has been reached."
Long overdue. When the new Congress convenes in January, Sen. Charles Grassley plans to introduce legislation to establish an independent drug safety office, separate from the FDA, that will monitor safety, negotiate labeling changes, oversee post-market testing, and more. The Journal of the American Medical Association supported a separate drug safety agency this month. "My sense is now we have the momentum," says Furberg. Many scientists feel it's long overdue.
But the FDA opposes such an office as unnecessary. "I don't think there is a conflict of interest," says Kweder. "The decisions about safety and risk always have to be considered fully." She also believes that the FDA fosters a free-flowing exchange of ideas about drug safety: "We thrive on disagreements."
Three years ago, with FDA's support, Graham embarked on a large study of the heart risks associated with Vioxx in 1.4 million patients at Kaiser Permanente in California. Completed in September, just before Merck withdrew the drug, the study showed a more than threefold increase in serious cardiovascular events among some Vioxx patients. The study was accepted for publication by the Lancet , a highly regarded medical journal. Last week, it became public that FDA officials contacted the Lancet 's editor to complain about the study's "basic data integrity." The Lancet was not intimidated, but Graham decided to withdraw his study from the journal anyway. "Basically, I was threatened with punitive action," he says. "The article was censored."
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