The tension and intrigue surrounding a crucial
federal drug advisory committee meeting, already high,
reached a boil when Senator Charles E. Grassley
charged that top federal drug regulators intended to
suppress an important study. The panel has been
convened to discuss whether Celebrex and Bextra,
heavily selling arthritis pills from Pfizer, hurt the
heart and are worth their potential risks. But top
officials of the Food and Drug Administration have
forbidden Dr. David Graham, a drug-safety officer at
the agency, to discuss before the panel a large study
of that very question, said Dr. Gurkirpal Singh of
Stanford University School of Medicine, Dr. Graham's
co-author. "We have significant new information that
will alter the thinking about these drugs," Dr. Singh
said. "I don't understand why they won't let us
present this information." Dr. Graham expressed
frustration that F.D.A. officials had instructed him
not to discuss the new study in a presentation he is
scheduled to give to the committee. "This study bears
directly on the whole reason why this advisory
meeting is being held in the first place," Dr. Graham
said. The latest charge suggests that the panel will
render judgment not only on the safety of Celebrex
and Bextra but also on how well the FDA is doing
its job.
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