FDA silenced expert who raised concerns about Vioxx: U.S. Senator
Wednesday, October 13, 2004
WASHINGTON (AP) - The U.S. Food and Drug Administration silenced one of its drug experts who raised safety concerns weeks before Merck & Co. yanked the blockbuster drug Vioxx due to increased risks for heart attack and strokes, the chairman of the U.S. Senate finance committee said Thursday.
Dr. David Graham, associate director for science in the FDA Drug Center's Office of Drug Safety, told Senate investigators he faced stiff resistance within the regulatory agency to his findings.
"Dr. Graham described an environment where he was 'ostracized, subjected to veiled threats' and 'intimidation,"' Senator Chuck Grassley of Iowa said in a statement after finance committee investigators interviewed the researcher Thursday.
Graham said Grassley's characterization was accurate. Raising safety concerns within the agency is "extremely difficult," the 20-year employee said, declining further comment.
In a prepared statement, the FDA said it "values open discussion and frank exchange about scientific and medical issues" and subjects its scientists to "more rigorous" scrutiny than typical scientific peer reviews.
The Government Accountability Office, an investigative arm of Congress, already has been asked to look into whether the FDA muzzled another staffer who linked antidepressants to raising the odds of children suffering suicidal tendencies. When Merck voluntarily pulled Vioxx from the market Sept. 30, the GAO was asked to roll the FDA's handling of that controversy into its inquiry.
That report is not expected for months. Grassley's committee is one of three in Congress also scrutinizing the FDA's actions.
A "picture is emerging of an agency that can't see the forest for the trees," Grassley said.
"Merck knew it had trouble on its hands and took action. At the same time, instead of acting as a public watchdog, the Food and Drug Administration was busy challenging its own expert and calling his work 'scientific rumour."'
Graham was lead author on a research project that studied the records of 1.39 million Kaiser Permanente patients, including 40,405 treated with Pfizer's Celebrex and 26,748 treated with Vioxx. The study found high doses of Vioxx, known as rofecoxib, tripled risks of heart attacks and sudden cardiac death.
The research team's original conclusion said high doses of Vioxx should not be prescribed or used.
Graham, scheduled to present those findings in late August during an epidemiology conference in France, said he ran into resistance when the FDA reviewed his abstract.
"I think the recommendation about high dose rofecoxib is unnecessary and particularly problematic since FDA funded this study and David's travel to France to present it," Anne Trontell, deputy director of the FDA's Office of Drug Safety, wrote in an Aug. 12 e-mail.
The internal e-mail exchange was released by Grassley.
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