LYCOS RETRIEVER 
Wyeth: Drugs
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* Wyeth mischaracterizes the First Amendment protections to commercial speech and misconstrues the U.S. Supreme Court's Western States ruling. Wyeth is trying to undermine the Supreme Court's decision, which found that "prohibitions on soliciting prescriptions for, and advertising, compounded drugs amount to unconstitutional restrictions on commercial speech." While the court ... affirmed that "misleading" advertisements are not protected by free speech -- a ruling IACP supports and its policy reflects -- Wyeth's condemnation of virtually any communication regarding BHRT is excessively broad, contrary to Western States, and would violate the First Amendment if enforced by the FDA.
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Wyeth recently committed to contributing an additional $1.275 billion to the original National Diet Drug Settlement separately funding a payment vehicle referred to as the Seventh Amendment. A hearing with respect to the fairness of the Seventh Amendment is scheduled to commence on January 18, 2005, before the Honorable Harvey J. Bartle. It is widely expected that Judge Bartle will approve the Seventh Amendment which, together with the initiation of the settlement process announced today, may be a significant step in bringing the diet drug litigation to a conclusion.
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Over a period of ten years, six million Americans took Fen-Phen, a drug Wyeth knowingly marketed and sold despite resounding evidence that it could cause serious -- even fatal -- heart and lung damage. When Wyeth knew they were caught, they asked for a class action settlement so they could control the number of lawsuits and limit the amount they would be required to pay victims. Victims were promised efficient processing of their claims in exchange for giving up their right to sue Wyeth for Fen-Phen damages.
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Critics of Wyeth's challenge to bio identical hormones contend that the action is designed to bolster flagging sales of the "Premarin family" of drugs. According to Wyeth (http://wyeth.com), profits for the synthetic hormones declined by 68% between 2002 and 2004 ($2,072,000,000 in 2002, $1,275,000,000 in 2003, $880,000,000 in 2004). Total profits for Wyeth in the same period have declined by 72% (2002:$4,447,000,000; 2003:$2,051,192,000; 2004: $1,234,000,000).
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As an example, Ruffolo described a recent experience at Wyeth with an unidentified drug. One statistical endpoint (out of four) was missed by a fraction of a hair. In their totality, all of the numbers trended in the right direction, with sufficient statistical power. But the FDA rejected the drug. Wyeth was forced to repeat a trial. In the pre-Vioxx/Ketek/Avandia era, Ruffolo suggested, that drug would have been approved.
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HCV-796 is an investigational non-nucleoside polymerase inhibitor compound for the treatment of hepatitis C that is being evaluated in ongoing clinical trials in combination with PEG-Interferon by ViroPharma and Wyeth. In previously disclosed results from the Phase 1b study of HCV-796 as a monotherapy, the patient cohort with the highest exposure to drug achieved a peak mean HCV viral load reduction of 1.4 log10, or 96 percent, on day four of a 14-day dosing period. HCV-796 was found to be generally well tolerated, with favorable pharmacokinetics and no dose-limiting toxicities. Mild to moderate headache was the most frequent adverse event reported overall. There were no treatment-emergent serious adverse events.
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