Deaths Prompt Pfizer to End Cholesterol Drug Trials

NEW YORK, Dec. 2 -- Pfizer Inc. announced Saturday that it has cut off all clinical trials and development work for a cholesterol drug that was supposed to be a star product because of an unexpected number of deaths and cardiovascular problems among patients who used it.

The world's largest pharmaceutical company said it was told on Saturday that an independent board monitoring a study on torcetrapib -- a drug that raises levels of HDL, commonly known as good cholesterol -- recommended that the work be ended because of "an imbalance of mortality and cardiovascular events."

Pfizer said it is asking all clinical investigators conducting the trials to tell patients to stop taking the drug immediately.

The news is devastating to Pfizer, which had been counting on the drug to revitalize sales, which have been hurt by the expiration of patents on several key products.

Just two days earlier, Pfizer had said it hoped to file an application with the Food and Drug Administration for approval of torcetrapib by the second half of next year. But, on Saturday, the company said the loss of the drug will not affect its financial guidance for 2006.

New York-based Pfizer had expected to sell torcetrapib in combination with Lipitor, which lowers bad cholesterol and is the company's -- and the world's -- best-selling drug.

According to Pfizer spokesman Paul Fitzhenry, 82 patients taking the drug combination died, compared with 51 deaths in the portion of the study in which patients were taking Lipitor alone. Each arm of the study had 7,500 patients. Pfizer said the study did not raise any questions about Lipitor's safety.