July 16, 2007 at 15:29:31

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Bush-Controlled FDA Moonlights as Big Pharma Pusher

By Evelyn Pringle (about the author)     Page 4 of 6 page(s)

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Critics say it's a toss-up between Vioxx and the SSRI's when it comes to the number of deaths and injuries that could have been prevented if the information about the serious health risks known to the drug makers had not been concealed.

Over the last 2 decades, SSRI's, which include Paxil, Zoloft, Prozac, Celexa, Luvox and Lexapro, have been prescribed off-label for uses not approved by the FDA more often than any other drugs in history. The Journal of Clinical Psychiatry found that 75% of SSRI prescriptions were written for unapproved uses in June 2005.

Critics say that the profits that have resulted from the massive off-label use of SSRI's, and especially with children, are a direct result of their illegal promotion by the drug makers. The success of the off-label marketing of SSRI's is evidenced by a June 29, 2007, report by Reuters that found the most commonly prescribed drugs in the US are antidepressants.

While most of the focus has remained on the risk of suicide, SSRI's have also been linked to extreme violence, including homicides, several life-threatening birth defects, abnormal uterine or gastrointestinal bleeding, a decrease in bone mineral density, sexual dysfunction, fertility problems and a severe withdrawal syndrome.

In September 2002, Mr Troy filed the FDA's first brief in support of preemption in the Zoloft suicide case of Motus v Pfizer, based on a request by Pfizer attorney Malcolm Wheeler. In the brief, Mr Troy claimed that warnings of a causal relationship between Zoloft and suicide would have misbranded the drug and that "any warning, no matter how worded, that could reasonably have been read as describing or alluding to such a relation would have been false or misleading, and therefore in conflict with federal law."

Baum Hedlund partner, Attorney Karen Barth Menzies, has been battling the SSRI makers in the legal arena for more than a decade in representing plaintiffs with claims involving Prozac, Paxil and Zoloft.

Ms Menzies says Mr Troy's argument is absurd because Wyeth strengthened the warning about suicidality on the label of Effexor in August 2003, without obtaining prior FDA approval, and the FDA did not sanction Wyeth or claim the label was false and misleading.

Ms Menzies has defeated the preemption arguments by Mr Troy offered in support of Pfizer and GlaxoSmithKline in a number of cases. The court never reached the preemption issue in Motus because the case was resolved on other grounds, but in September 2002, Mr Troy tried to use the same argument in a lawsuit that alleged Glaxo had failed to warn about the withdrawal effects of Paxil, and the judge stated the argument "contravenes common sense" and "vitiates, rather than advances, the purpose of protecting the public."

Pfizer also submitted Mr Troy's brief from Motus to support a preemption in the case of Witczak v Pfizer. In rejecting the argument, the court pointed out that: "State consumer-protection law compliments, rather than frustrates, the FDA's protective regime."

"This is especially apparent," the court said, "when one considers that prescription drugs were once marketed primarily to trained health care providers -- sophisticated and discerning intermediaries."

"Today, on the other hand, pill-rolling apothecaries and the mortar and pestle have disappeared," he stated. "They have been replaced by drug manufacturers who urge the use of their drugs in mass-market print and television advertisements targeted directly at the public," he said.

As an example, the judge noted that Glaxo had advertised the drug Paxil, "by personifying it as a happy, bouncing-oval cartoon character."

After effectively allocating the power of FDA to drug companies, in 2004, Mr Troy went back to representing the pharmaceutical industry with the preemption policy tucked in his back pocket.

But his departure did not stop Pfizer from trying to use the FDA preemption argument in the Zoloft suicide case of Cartwright v Pfizer, decided in 2005, in which the court rejected Pfizer's preemption argument, finding that Texas tort law "compliments and is parallel to the FDA's regulations regarding safety warnings and, thus, does not interfere with the objectives of the FDA."

The court further noted that the FDA mandates that "manufacturer[s] issue a warning whenever there is 'reasonable evidence of an association of a serious hazard with a drug; a causal relationship need not have been proved.'"

The truth is that the FDA knew about the risk of suicidality in children taking Zoloft, because the agency's review of Pfizer's clinical trial data in 1996 showed the risk to be five times that of adults on Zoloft and caused enough concern that FDA reviewer Dr James Knudsen wrote to Pfizer asking for an explanation.

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