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Medical whistleblowers speak out

The US Food and Drug Administration (FDA) was "the single greatest obstacle to doing anything effective" about Vioxx, said FDA drug safety officer David Graham at an unprecedented roundtable of medical whistleblowers sponsored by the Public Library of Science (PLoS) and the Government Accountability Project.

In comments that echoed his now infamous testimony to the US Senate Finance Committee, Graham said that, "Nearly 60,000 people probably died from that drug. That's as many of our soldiers that were killed in the Vietnam war [who] died as a result of Vioxx use. And FDA had the opportunity, the responsibility, to stop that and didn't."

Graham was one of five high profile medical whistleblowers invited by the medical investigative journalist Jeanne Lenzer to meet together in Washington DC on May 15th 2005 to share their accounts of practices in medicine and medical research that they believe are risking the public's health or safety. Lenzer's account of the roundtable, in which she outlines the lessons we can learn from these whistleblowers, is published in the open access international medical journal PLoS Medicine. One of the lessons, says Lenzer, is that "ties between drug regulators and industry may influence new drug approval." Graham said at the roundtable that the FDA was in "a collaborative relationship" with industry, and that the FDA gets money from drug companies through the Prescription Drug User Fee Act "to approve new drugs and approve them more quickly." A senior official at the FDA, said Graham, had told him, "industry is our client."

"The pharma-FDA complex has to be dismantled," he said, "and the American people have to insist on that, otherwise we're going to have disasters like Vioxx that happen in the future."

Another lesson, says Lenzer, is that "the race to approve new drugs without proper safety testing may be compromising the public's health." A research scientist from a major pharmaceutical company, who parti
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Source:PLoS Medecine


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