FDA whistle-blower cites backlash
Published 9:00 pm Thursday, November 25, 2004
WASHINGTON – Dr. David Graham, the Food and Drug Administration scientist who publicly criticized the agency’s approach to drug safety during a congressional hearing last week, says he is facing pressure to transfer to a different job in the FDA – a move that he said was in retaliation for his remarks.
“What they want to do is move me out of drug safety into the office of the commissioner, where I will basically be exiled and won’t be able to do drug research,” Graham said Wednesday. “It’s a reprisal.”
Graham’s latest comments intensified the standoff between the career scientist and the agency where he has labored, largely in anonymity, for the last 20 years.
Graham was the star witness at a Nov. 18 Senate hearing into the prescription painkiller Vioxx. Its manufacturer, Merck &Co., pulled the drug from the market after research findings confirmed an increased risk of heart attack among patients taking the medication. Graham testified that the FDA ignored his warnings about the drug and attempted to suppress the results of his investigations.
He also asserted that the agency has abandoned its watchdog role in favor of a cozy relationship with the pharmaceutical industry and that the public can no longer expect to be protected from potentially hazardous medications. He identified five drugs that are on the market despite potentially severe side effects.
FDA officials have disputed Graham’s assertions, saying the agency that he described seemed nothing like the organization they know. They dismissed his estimates that Vioxx may have contributed to thousands of premature deaths, and they said the five drugs he criticized were safe when used properly.
The five drugs he named were Crestor, a cholesterol-lowering drug; Meridia, used for weight loss; Accutane, prescribed for acne; Bextra, a pain reliever, and Serevent, an asthma drug.
Graham is represented by lawyers from the Government Accountability Project, a nonprofit public interest organization and law firm that defends whistle-blowers.
“We are hoping to prevent Dr. Graham’s exile before it becomes a fait accompli,” said Tom Devine, the group’s legal director. “It is an inexcusable abuse of power that the FDA would sideline (this) scientist.”
