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FDA Official David Graham Fights for Drug Safety

Posted on: Thursday, 7 July 2005, 12:00 CDT

The Association of Certified Fraud Examiners (ACFE), the world's leading provider of anti-fraud training and education, today announced Dr. David Graham, Safety Officer for the Food and Drug Administration (FDA), as its 2005 Cliff Robertson Sentinel Award recipient. Graham's ongoing crusade for drug safety, despite intense pressure from supervisors and drug manufacturers, earned him this prestigious award.

In August 2004, Graham informed FDA supervisors that high-dose prescriptions of the painkiller Vioxx appeared to triple heart attack rates in research studies. His position was that Vioxx should be banned. Graham was pressed to remain silent but remained steadfast in his efforts to put public safety first.

With public concern mounting, Merck pulled Vioxx from the market last September, after its own research found that the drug, even at low dosages, doubled the risk of heart attack. After weathering numerous attacks by FDA officials, Graham was invited to go before the Senate Finance Committee hearing on Vioxx in November 2004, where he described an FDA culture dominated by the industry it was supposed to regulate. Additional drugs were withdrawn or restricted in response to other issues raised by Graham.

"By my estimates, FDA's allegiance to the pharmaceutical industry and its blindness to safety caused the deaths of up to 60,000 Americans from heart attacks with Vioxx," said Graham.

Since last August, Graham says that the FDA has not involved him in any new drug safety issues, even though he is its most senior and experienced drug safety researcher. He believes that he has not been fired only because of the personal intervention of Senate Finance Committee Chair Chuck Grassley (R-Iowa).

"Because of inherent structural and economic conflicts of interest it is my opinion that the FDA's Center for Drug Evaluation and Research (CDER) views the pharmaceutical industry as its client and ally. As a result, I believe the public and the nation are virtually defenseless against new drug safety disasters. Unless Congress acts to reform FDA, history teaches us that there will be many more disasters in the future," says Graham.

"Strong whistleblower protection exists in some segments of the economy, but in the federal government it is too limited or ineffective in practice," says Toby Bishop, ACFE President and CEO. "Congress should pass the new whistleblower protection legislation that is being blocked from a floor vote in both houses."

The ACFE's Cliff Robertson Sentinel Award is given in honor of those who are brave enough to expose wrongdoing, even though they are frequently vilified.

The award was named for Oscar-wining actor Cliff Robertson, who first exposed corruption in Hollywood during the 1960s and carries the inscription "For Choosing Truth Over Self."

About the ACFE

The ACFE, the world's leading provider of anti-fraud training and education, has over 34,000 members, sponsors more than 109 chapters worldwide and provides anti-fraud educational materials to over 100 universities. Certified Fraud Examiners (CFEs) on six continents have investigated more than 1 million suspected cases of civil and criminal fraud. For more information visit www.CFEnet.com.

Source: Business Wire

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