Heartbreaking Results

The announcement over the weekend that Pfizer had halted development of a potential blockbuster drug intended to treat heart disease dealt a major blow not only to the company, but to heart patients everywhere. Researchers had hoped the drug, torcetrapib, would reduce the risk of heart attack by raising the level of HDL, the "good cholesterol," in the blood. But a clinical trial involving 15,000 patients was stopped when the drug was linked to 82 deaths. That number was significantly higher than the 51 deaths among people in the trial who had not taken torcetrapib. NEWSWEEK’s Julie Scelfo spoke with Dr. Steven E. Nissen, chairman of cardiovascular medicine at the Cleveland Clinic, about torcetrapib and the aborted study. Excerpts:

NEWSWEEK: Just last week Pfizer's chief executive, Jeffrey B. Kindler, said torcetrapib could be among the most important new developments for heart disease in decades. What changed?

Steven E. Nissen: The Data Safety and Monitoring Board for major ongoing trials was looking at patient safety and saw a major increase in risk of death of those patients that got the drug.

How common is it to discover such serious problems in a late-stage trial?

That's when it usually shows up. Until you get to stage three, you haven't exposed many patients to the drug so you really can't see these hazards until you've got thousands of patients taking the drug.

Why was there so much anticipation that this drug would make it to market?