The FDA has reportedly silenced one of its experts who raised safety concerns some weeks before Merck & Co. removed the blockbuster drug Vioxx due to increased risks for heart attack and strokes. These charges were made from the chairman of the U.S. Senate finance committee.
Dr. David Graham, associate director for science in the
U.S. Food and Drug Administration
Drug Center's Office of Drug Safety, told Senate investigators he faced stiff resistance within the regulatory agency to his findings.
Dr. Graham talked about an environment where he was 'ostracized, subjected to veiled threats' and 'intimidation,"'
Raising safety concerns within the agency is "extremely difficult," the 20-year employee said, declining further comment.
In a prepared statement, the
U.S. Food and Drug Administration
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.
"Merck & Co. knew it had trouble on its hands and took action. While the Fda was busy challenging its own expert and calling his work 'scientific rumour."'
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