Pfizer Cholesterol Drug Dies

Pfizer announced December 2, 2006 that in the interest of patient safety it is stopping all clinical trials with its investigational cholesterol drug torcetrapib and that it has informed the Food and Drug Administration (FDA). The company is in the process of notifying all of its investigators for these clinical trials as well as other regulatory authorities.

Torcetrapib clinical trials were stopped because an independent Data Safety Monitoring Board (DSMB) found an unexpected excess of cardiovascular problems and deaths in the study drug group. Pfizer has asked that all clinical investigators conducting trials with torcetrapib warn patients to stop taking the drug immediately.

Commentary: This is a great example of why FDA regulations regarding the need for large, randomized trials are so important -- to address not only how well a drug works to treat a disease, but also whether it is safe. Pfizer will discontinue development of torcetrapib. If you are participating in a clinical trial with torcetrapib you should contact your physician immediately.