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Pfizer

Pfizer ends development of "blockbuster" cholesterol drug after excessive patient deaths

Monday, December 11, 2006 by: Jessica Fraser
Tags: Pfizer, cholesterol drugs, drug trials

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(NewsTarget) Pharmaceutical giant Pfizer announced that it has ended a clinical trial for the highly anticipated cholesterol drug torcetrapib -- which raises levels of "healthy" HDL cholesterol -- after a high number of patients participating in the trial died or experienced cardiovascular problems.

Pfizer, the world's largest drug firm, was informed over the weekend that an independent board monitoring a study of torcetrapib found that 82 patients out of 7,500 who were taking the drug had died. Fifty-one patients out of 7,500 in the same study who were taking Lipitor -- Pfizer's best-selling cholesterol drug -- also died, though the company said it was not concerned over Lipitor's safety.

According to Pfizer spokesman Paul Fitzhenry, the company is requesting that all clinical investigations of torcetrapib be halted, and patients taking the drug stop immediately. Previous studies had shown the drug to slightly increase blood pressure, but researchers were unclear on whether high blood pressure contributed to the patients' deaths or heart troubles.

Pfizer -- which spent roughly $800 million on the development of torcetrapib -- was counting on the success of the drug to invigorate slow sales. Several patent expirations are projected to cost the company $14 billion in annual sales between 2005 and 2007, and its patent on the world's best-selling drug, Lipitor, could expire by 2010.

Pharmaceutical industry critics say Pfizer's decision can be credited largely to more intense scrutiny of the safety of clinical trials following Merck's withdrawal of the painkiller Vioxx from the market in late 2004.

Consumer health advocate Mike Adams, author of "The Seven Laws of Nutrition," called Pfizer's decision to halt trials of torcetrapib a "tremendous victory" for the health and safety of patients around the world.

"I believe this decision would never have been reached without the increased scrutiny now being directed at Big Pharma," Adams said. "In my opinion, if this drug had been developed five years ago, the trial results would have been tweaked to make it appear safer, and the drug would have been released anyway."

Members of the committee that oversaw the study said they were surprised to discover the increased death rates, since earlier study results had been promising. However, Adams says the decision to abandon testing of torcetrapib -- which was made prior to FDA evaluation of the drug -- averted possible disaster in light of the FDA's shoddy track record of approving unsafe drugs.

"Pfizer announced just two days before this decision that it was seeking FDA approval for the drug," Adams said. "No one in their right mind should believe that the FDA would have denied approval for this drug, especially while the agency continues to support Vioxx, a drug that has killed more than 50,000 Americans."

In spite of the loss of projected "blockbuster" torcetrapib, Pfizer emphasized at a recent analyst meeting that it still has 242 research programs and other drugs in the pipeline.

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