Safety concerns bring Pfizer’s Cholesterol drug development to an end
Pfizer Inc., the world’s largest drug maker said Saturday it has cut off all clinical trials and development of torcetrapib, an experimental drug for the treatment of heart diseases, after a study reported that some cardiovascular problems and unexpected deaths were found in the people who used it.
Many cardiologists had viewed torcetrapib as a potentially major advancement in efforts to reduce heart attacks and strokes but Pfizer’s decision to stop the trial represents the failure of a drug which was designed to raise the levels of High-Density Cholesterol or what is commonly called ‘good cholesterol’.
Pfizer said that an independent Data Safety Monitoring Board (DSMB) conducted a study for torcetrapib and has recommended in interests of patient safety, that the work be stopped because of "an imbalance of mortality and cardiovascular events." The company also informed the Food and Drug Administration of the issue.
Dr. Philip Barter, who has overseen the study, said that "based on all the evidence we have seen regarding Torcetrapib and in light of prior study results, we were very surprised by the information received from the DSMB, the only body with access to the unblinded safety data."
The news is devastating to Pfizer which said it was spending around $800 million to develop Torcetrapib. The drug maker said that the loss of the product would mean an acceleration of cost cutting measures it promised in October.
Pfizer's Chief Executive Officer Jeffrey B. Kindler, called the DSMB information "surprising and disappointing," and pledged to inform the appropriate medical and regulatory authorities of the information as quickly as possible.
