FDA silenced expert who raised concerns about Vioxx: U.S. Senator
In the e-mail, Trontell suggested Graham defer his presentation in favour 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. a day.
The FDA said 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 behaviours 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 - his review said - the one with the lowest risk.
His supervisors within the FDA told him to suggest 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.
© The Canadian Press 2004
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