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FDA Webview: The Trojan Farce

June 26, 2007
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By GAP Food and Drug Safety Director Mark Cohen.

Dan Troy laments the development of what he terms “a whistleblower culture” at FDA (FDA Webview, 4/12). The former chief counsel of the agency made this remark at the recent annual conference of the Food and Drug Law Institute. There is too much irony here: Ask an FDA scientist or medical officer what drove them to blow the whistle and they are apt to cite the anti-regulatory culture fashioned by this very same Dan Troy.

Troy was appointed chief counsel by George W. Bush in 2001, the first Bush appointee to the agency. He apparently had earned his stripes by aggressive advocacy on behalf of Pfizer while in private legal practice.

Troy was the FDA chief counsel who led the First Amendment charge against regulating misleading drug advertising. He was the FDA chief counsel who fished around for opportunities to intervene in state court suits on behalf of drug and device manufacturers against injured plaintiffs. He was the FDA chief counsel who, irony of ironies, wrote Retroactive Legislation, arguing that laws should only apply prospectively. Yet it is Troy’s Rule at FDA preempting prescription drug injury suits from state court — a rule issued after most Vioxx personal injury suits were filed — that now threatens to cause the retroactive dismissal of thousands of Vioxx injury claims.

And what of Vioxx? But for the courageous whistleblowing before the U.S. Senate by FDA safety officer David Graham, Vioxx might still be on the market today. This drug alone likely caused more American deaths during Troy’s tenure than did the entire Vietnam War. Yet Troy’s FDA did everything it could to shield Merck from public accountability for the Vioxx debacle while aiming all its fire at the messenger Graham. Graham has since received the American Public Health Association “Award for Excellence” for his professional integrity regarding Vioxx. Is this the “whistleblower culture” that Troy bemoans?

What about the liver failure-inducing, garden-variety antibiotic Ketek that FDA management approved for upper respiratory infections during Troy’s tenure? FDA green-lighted Ketek despite fraudulent clinical trials; despite no evidence that it was even as effective as placebo; despite pressure on reviewers to change their negative conclusions about the drug; and despite commissioner Andrew von Eschenbach’s threats of firing medical officer David Ross and others who dared to blow the whistle on this unproven, dangerous drug to Congress and the media. FDA management has since had to withdraw its approvals for most Ketek indications. Had it not been for Ross and his conscientious colleagues, the Ketek body count today would no doubt be much higher. Is this the “whistleblower culture” that Troy so deplores?

With the eyes of the nation currently riveted on FDA’s failure to prevent pet food contamination, perhaps Dan Troy would like to come clean about his role in the removal of FDA veterinarian Victoria Hampshire from the review of a dog care product, ProHeart 6, associated with some 600 dog deaths. Hampshire was pulled from the review of this drug after its sponsor had a private meeting with Troy and FDA Acting commissioner Lester Crawford. Not only was she reassigned, Troy’s FDA launched a baseless criminal probe of Hampshire. Yes, she was ultimately totally exonerated and, in fact, named “Veterinarian of the Year” for her work on ProHeart 6. But FDA’s lack of openness and due process led Hampshire to share her harrowing saga with whistleblower champion, Senator Charles Grassley. Of course, even for a senator, investigating Troy’s ex parte contacts with drug companies is difficult because Troy notoriously failed to take notes or keep minutes of these sessions. Could it be that Dan Troy’s real nemesis isn’t a “whistleblower culture” but rather the prospect of real transparency at FDA?

If a “whistleblower culture” favoring safety over speedy approval has indeed gripped FDA, it unfortunately hasn’t yet trickled up to management. FDA officials referred Merck’s “Son of Vioxx” drug, Arcoxia, to an advisory committee because, in their words, they were “struggling” over whether it should be approved. The professionals on the advisory committee, however, had considerably less of a struggle, voting 20 to 1 against approval for this painkiller that apparently is too effective at killing and not too effective in reducing pain. The case against Arcoxia was such a slam-dunk that one committee member even wondered aloud, “Why is this meeting even being held?”

FDA is indeed a troubled agency. But whistleblowers, far from being the problem, may well be the agency’s best hope for salvation. It is they who are standing up for the public health and safety in the face of a Troy-like management that sees its central mission as championing rather than regulating bottom-line driven sponsors of drugs and devices. If Dan Troy truly wants to know who has brought FDA low he need only look in the mirror.

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