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FDA Accused of Silencing Vioxx Warnings

Fri Oct 8, 7:18 AM ET


WASHINGTON - The Food and Drug Administration (news - web sites) 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 Senate Finance Committee said Thursday.

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Dr. David J. Graham, associate director for science in the FDA (news - web sites) 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,'" Sen. Chuck Grassley, R-Iowa, said in a statement after Finance Committee investigators interviewed the researcher Thursday.

Graham told The Associated Press that 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 on 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 rumor.'"

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 that high doses of Vioxx, known as rofecoxib, tripled risks of heart attacks and sudden cardiac death.

The research team's original conclusion said that 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 E. 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.

In the e-mail, Trontell suggested that Graham defer his presentation in favor of a journal article so dissenting scientists — including within the FDA — could comment.

She also said Merck should be alerted before the findings became public "so they can be prepared for extensive media attention that this will likely provoke."

Others within the agency suggested Graham's conclusion was too strongly worded, given the FDA had not added such warnings to Vioxx labels.

"I've gone about as far as I can without compromising my deeply held conclusions about this safety question," Graham replied in an Aug. 13 e-mail.

The FDA said such discussions are typical before scientific findings are published.

The conclusion Graham presented in France was revised: "This and other studies cast serious doubt on the safety" of Vioxx doses higher than 25 mg. per day.

The FDA said that Graham decided to revise his abstract conclusion. "He did so voluntarily," the agency said.

In testimony before a congressional panel in mid-September, Andrew Mosholder, an FDA epidemiologist, said his bosses asked him to soften recommendations about antidepressants.

Mosholder's analysis pointed to increased suicidal thoughts and behaviors among children taking antidepressants well before federal advisers pushed for strident warnings on the drugs. He suggested preferential use of Prozac, the only drug approved to treat depressed children and — according to his review — the one with the lowest risk.

His supervisors within the FDA told him to suggest that children use such medications "with caution," Mosholder told the Congressional panel.

Dr. Paul Seligman, acting director of the FDA's Office of Drug Safety, said the agency did not pressure Mosholder to change his conclusion.


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