FDA Removes Panel Member From Drug Review

November 12, 2004; Page A8

A researcher who publicly questioned the safety of Pfizer Inc.'s painkiller
Bextra was removed from a Food and Drug Administration advisory panel that
will review it and similar products next year.

Curt D. Furberg, a professor at Wake Forest University, Winston-Salem,
N.C., said he was informed by the agency that he no longer will participate
in the meeting in which the committee will examine the safety of Cox-2
inhibitors, the class of drugs that includes both Bextra and Vioxx, a
painkiller that Merck & Co. recently withdrew from the market. Dr. Furberg
said he was told by the FDA that his invitation was rescinded because he
was quoted in the New York Times as saying Bextra appeared similar to Vioxx
and that Pfizer sought to suppress that information.

"They'd said because I had taken a public position, I was disinvited," Dr.
Furberg said. He added that he felt he wasn't biased, and he was "trying to
be evidence-based" in making findings about Bextra from an analysis of
data. "I collected the information to get evidence to contribute to the
debate, I drew a conclusion, and I'm off," he said. Dr. Furberg said he
still is on the FDA's drug safety and risk management advisory committee,
but won't be part of the February Cox-2 meeting.

Sandra Kweder, acting director of the FDA's office of new drugs, said the
agency routinely screens advisory committees for possible conflicts,
including intellectual as well as financial interests. "If he's already
expressed a particular point of view, and especially written a paper on it,
it would be difficult to expect him to come to such a meeting and be
objective about the subject," she said. Dr. Furberg still could speak
before the panel as part of the public-comment period, she said.

The panel is set to review the safety of Bextra and Celebrex, another
Pfizer drug, as part of an examination of Cox-2 inhibitors. Vioxx was
withdrawn from the market in September by Merck following a clinical trial
showing that after 18 months, patients taking it had a higher risk of heart
attacks and strokes.

Dr. Furberg was quoted in coverage of an analysis he helped to do that
found that patients taking Bextra might be at higher risk for heart attack
or stroke.

Pfizer called the findings "unsubstantiated." A Pfizer spokeswoman said the
company had nothing to do with Dr. Furberg's departure from the panel.
"Pfizer would never intervene in any way with the FDA's regulatory
process," she said.