Critic Disinvited to FDA Painkiller Meeting
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of experts in February to discuss the safety of painkillers in the same
class as the now-withdrawn drug Vioxx, but one member of the panel was
asked not to come.
The doctor, a member of the panel, had his invitation rescinded after
he announced the results of a study finding that Bextra, a painkiller
similar to Vioxx, may also be unsafe.
The arthritis advisory committee should get a mound of paper to
consider before the meeting, including unpublished studies and new
results of long-term trials, the Associated Press reported Friday.
The prime question that an avalanche of test results may not completely
answer, however, is whether other painkillers called cox-2 inhibitors
may cause the increased risks of heart attack and stroke that led Merck
& Co. to withdraw Vioxx in September.
Other cox-2 drugs include the Pfizer medications Celebrex and Bextra,
which have been marketed as being kinder on the stomach than
traditional painkillers.
However, a new study whose results were released at an American Heart
Association meeting this week found that Bextra users with heart
disease had double the risk of heart attack and stroke as nonusers.
Pfizer dismissed the study's "unsubstantiated conclusions" that had not
been independently reviewed, the AP said.
Dr. Curt D. Furberg, a professor of public health sciences at Wake
Forest University School of Medicine and an author of that study, told
the Wall Street Journal that he was disinvited to the February meeting
based on what he had said. Furberg is a member of that committee. An
FDA official told the paper that it wasn't unusual for someone with a
potential conflict to be asked not to participate.
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