In a major stumbling block for the worldÃ¢â‚¬â„¢s largest drug manufacturer, Pfizer announced over the weekend that it is halting all research and development on torcetrapib, their highly anticipated new cholesterol drug. In a press release, the company stated that it was immediately stopping all clinical trials of the drug after the independent Data Safety Monitoring Board (DSMB) Ã¢â‚¬Å“recommended terminating the study because of an imbalance of mortality and cardiovascular events.Ã¢â‚¬Â
According to the FDA, Ã¢â‚¬Å“The DSMB was conducting a monthly analysis of mortality data and a quarterly analysis of a number of outcomes including stroke, heart attack, and revascularizations (e.g., <"http://www.yourlawyer.com/topics/overview/drug_coated_stents">coronary stents or bypass surgery) to ensure the ongoing safety of patients in this trial.Ã¢â‚¬Â However, the DSMB found an Ã¢â‚¬Å“increased rate of mortalityÃ¢â‚¬Â among patients whoÃ¢â‚¬â„¢d been taking both torceptrapib and atorvastatin (Lipitor) in the trials when compared to those only taking Lipitor.
The clinical trials involved 15,000 patients and were scheduled to continue until 2009. Lipitor, also a Pfizer product, is currently the worldÃ¢â‚¬â„¢s top-selling medication (generating nearly $13 billion in annual sales), but PfizerÃ¢â‚¬â„¢s patent protection on Lipitor is set to expire in 2011. The company had hoped to develop torceptrapib to be used in combination with Lipitor. The new drug was supposed to increase levels of good (HDL) cholesterol while Lipitor worked to reduce bad (LDL) cholesterol. However, torceptrapib brought with it adverse side effects, most significantly an increase in blood pressure.
According to Pfizer, 82 of the 7,500 trial patients who took the combination of drugs passed away, compared to only 51 of the 7,500 patients taking only Lipitor. The safety issues derailed what was once PfizerÃ¢â‚¬â„¢s most promising experimental drug, and the termination of the research sent shockwaves through both the medical and financial communities.