Painkiller Trial Raises Questions for FDA, Pfizer

A controversial drug trial run by a prominent doctor may unnecessarily
put patients at risk, according to a host of medical critics, who say
that the trial wouldn't be needed at all if the FDA hadn't ignored its
own advisers in a 2005 review of painkiller risks. Those are among the
findings of a new investigative report, Painkiller Trial Raises Question for FDA, Pfizer, by the Center for Public Integrity.

The trial's leader,
Dr. Steven Nissen of the famed Cleveland Clinic, insists the PRECISION
trial is crucial to determining which of a trio of painkillers are
safest. The trial's sponsor, drug maker Pfizer, echoes Nissen's
contention. But some public health experts argue that the trial is
unethical, in part because human test subjects were not accurately
informed of the risks. They say the trial may needlessly put patients
at risk in order to get answers that, to a large extent, the medical
community already has regarding Pfizer's drug, Celebrex, and which
would be clear if the FDA had not muddied the waters with its 2005
ruling.

The story of the FDA's
2005 deliberations, the agency's subsequent decisions on painkillers
and the PRECISION trial also illustrates larger, more complex problems
at the FDA, which has been under constant fire for being too close to
the drug industry. The agency has previously defended its need to work
cooperatively with drug companies, but there's no shortage of experts
who believe the FDA is failing to protect public health. "At the FDA,"
says Dr. Curt Furberg, a professor of Public Health Sciences at the
Wake Forest University of Public Medicine, "they are judged by how many
drugs they approve, not by how many lives they save."

Support for this and other Center for Public Integrity projects is provided by Carnegie Corporation of New York, the Ford Foundation, the JEHT Foundation, the John S. and James L. Knight Foundation, the John D. and Catherine T. MacArthur Foundation, the Park Foundation, the Popplestone Foundation, the Rockefeller Brothers Fund, and numerous other generous institutional and individual donors.