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FDA Incapable of Protecting U.S., Scientist Alleges

An interview with Dr. David J. Graham, associate director of the FDA's Office of Drug Safety



September/October 2005

Dr. David J. Graham, a scientist at the U.S. Food and Drug Administration for more than 20 years, says the agency could have prevented 60,000 deaths from the arthritis drug Vioxx. But Graham, the recipient of the ACFE's Cliff Robertson Sentinel Award, says the problems at the FDA go beyond the problems of one drug. 

The long, sloping wall of the Vietnam Veterans' Memorial in Washington, D.C., contains the names of 58,000 men and women who died during that war.

As Dr. David J. Graham, a scientist at the Food and Drug Administration, says, that's 2,000 less than the estimated U.S. citizens he believes have died from the effects of the arthritis drug Vioxx.

"Between 1999 and 2004, an estimated 20 million Americans took Vioxx, 80 million worldwide," said Graham, the recipient of the 2005 Cliff Robertson Sentinel Award, at the recent 16th Annual ACFE Fraud Conference & Exhibition. "We've estimated that up to 140,000 patients (who took Vioxx) suffered heart attacks. ... Of this number, 60,000 died," said Graham, associate director of the Food and Drug Administration's Office of Drug Safety and an employee of the agency for more than 20 years. "Vioxx is a poster child ... for what's wrong with the FDA and why I believe FDA reform is so urgently needed."

In November of last year, Graham testified before the Senate Finance Committee that the FDA had silenced him and his colleagues from reporting on the risks of Vioxx and other drugs. "The FDA has let the American people down and sadly betrayed a public trust," Graham said during his testimony. He alleged that because the FDA is unduly influenced by the pharmacy industry it is "incapable of protecting America against another Vioxx. We are virtually defenseless." Merck & Co Inc., the maker of Vioxx, has pulled the drug from the marketplace. Meanwhile, Vioxx civil trials continue.

Graham remains at the FDA but says he has been "marginalized by FDA management and not asked to participate in the evaluation of any new drug safety issues. It's a type of ostracism."

In the following interview with Fraud Magazine, Graham says that "if I failed to speak the truth, I would become part of the problem, and all these deaths would in part, be my responsibility, in the same way that FDA was and is, responsible for these deaths. The decision to speak the truth wasn't difficult. My conscience guided me in the way I should go."


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