Let us not forget. And at this time, nothing has changed except that Merck is now having to make a multi billion $ payment over vioxx damages, and needs new profit $ to replace it. So when Merck, or some other Big Pharma, or even the FDA try to discredit someone, remember this case.
FDA, working hand in glove with Merck, tried to discredit the Doctor who blew the whistle on Vioxx. FDA Whistleblower Says Agency Smeared Him Over His Vioxx ViewsMay 31 2006 (Bloomberg)
A U.S. Food and Drug Administration whistleblower who claimed Merck & Co.'s Vioxx painkiller caused 140,000 heart attacks and strokes testified that co-workers at his agency tried to damage his reputation."I experienced threats, intimidation and actually what, in my view, appears to have been a very organized and orchestrated campaign to smear and discredit me," Dr. David Graham said in a May 9 videotaped testimony taken for Vioxx litigation.
FDA officials worked "hand in glove" with Merck to tarnish him, Graham said according to a sealed transcript of his remarks obtained by Bloomberg News.
...``The record shows that others in the agency felt that in his article there was evidence of data manipulation, and he makes speculative projections that have no sound basis in science,'' Mayer said. ``It's not surprising that he drew criticism with regard to those matters.''
He presented the new numbers to the Senate Finance Committee on Nov. 18, 2004, and included them in the article submitted to the Lancet, prompting Dr. Steven Galson at Merck to contact the journal's editor, Richard Horton. Merck's intervention delayed publication of the Lancet article, Graham testified.
...Notes of a meeting between a Merck scientist and an FDA official before the Senate testimony refer to ``an opportunity to get message out on Graham,'' according to Graham's testimony.
Dr Graham went to the Government Accountability Project for help, after being threatened with arrestDr. David Graham's Full StoryOn November 18, 2004, Dr. David Graham, a 20 year veteran Food and Drug Administration (FDA) scientist, rocked the pharmaceutical industry with Senate Committee testimony that shook six multinational corporations, and drew vital public attention to the secret life inside the FDA. His testimony exposed tragic public health consequences stemming from a legalized conflict of interest: the FDA is one of the few government agencies whose funding depends largely on the success of products of the industry it regulates. Due to Graham’s appearance, the deadly market for pain relievers will never be the same. Read Graham’s testimony.
Graham’s dissent already has made a threefold difference: In a preemptive move, the Merck Corporation withdrew Vioxx prior to the hearing, unable to discredit research by Graham and colleagues that the expensive painkiller had caused 88,000 to 139,000 heart attacks – 30-40% of which were fatal – over the previous five years. Congress is strongly considering legislation to address conflicts of interest contained within the Prescription Drug User Fee Act (PDUFA), a “Contract with America" reform linking the FDA’s budget to the number of new drug applications it approves.
Graham “committed the truth" and survived. His story may spark a rebirth of scientific freedom at the FDA. Despite contradictory rhetoric, this unusually repressive agency traditionally has not been content with firing whistleblowers, but has repeatedly sought criminal prosecution.
....Frightened by threats of incarceration, Graham sought help from GAP officials after being referred by congressional staff and members of the media. GAP Legal Director Tom Devine warned FDA investigators, outlining how they were incurring personal liability by violating laws such as the Whistleblower Protection Act and Anti-gag Statute, resulting in a swift halt of the investigation.
...Graham’s testimony at the hearing became front-page news after he identified the FDA’s handling of Vioxx as the worst public health disaster in its history, resulting in a probable 30,000-55,000 deaths. No official could credibly challenge his Vioxx findings, and he identified five other suspect drugs: Accutane, Bextra, Crestor, Meridia, and Serevent.
A week after the hearing, sympathetic insider colleagues and press contacts warned Graham that the FDA was finalizing plans to exile him from drug safety work within days. Sen. Grassley and the media rallied to his defense, and the FDA retreated. Commissioner Crawford issued a memo to all staff that they no longer need prior approval to communicate with Congress. Graham’s supervisors later approved publication of the study.
....For more then a decade GAP has defended FDA whistleblowers. However, it will take persistence and courage to break this ingrained pattern of whistleblower harassment. As GAP’s Devine summarized, “Secrecy enforced by repression is a severe threat to public health and safety. It prevents government scientists from warning the public of tragedies that don’t have to happen." Government Accountability Project • www.whistleblower.org
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