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December 03, 2004
When Merck's arthritis drug Vioxx was withdrawn from the
market in September, concerns over drug safety were pretty much under the
radar for the most part, but not today. Today, the acting head of the Food
and Drug Administration, Lester Crawford agreed to meet with a Republican
lawmaker intent on getting to the bottom of the Vioxx scandal.
Republican Sen. Charles Grassley, is concerned that a FDA
whistleblower will be punished by his employer, the FDA, for opening a
pandora's box.
David Graham, the FDA whistleblower, told a
Senate Finance Committee that his study earlier this year showed
Vioxx increased the risk of heart attacks and strokes, compared to other
similar painkillers. However, Graham said he faced intimidation within the
FDA when he brought the results of his study to his superiors.
Graham also told the committee that the FDA was "virtually
incapable" of protecting the public from unsafe drugs. He also raised
safety concerns over five other drugs on the market which he said could
become the next Vioxx.
Graham fears the FDA will retaliate by transferring out of
the Office of Drug Safety for blowing the whistle.
Grassley demanded the FDA respond to the allegations in a
letter dated November 29.
Crawford responded on Friday, indicating he takes all of
the Senator's concerns seriously, and agreed to a meeting. "FDA will also continue to use a transparent process
that not only respects the rights of all employees but also strives to
facilitate a meaningful dialogue between employees at the agency and
committee staff," said Crawford in his letter to Senator
Grassley.
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