Schwitzer health news blog

Something smelly about statin trial: Congress investigates

The Integrity in Science Watch project of the Center for Science in the Public Interest reports:

The investigations subcommittee of the House Energy and Commerce Committee last week gave Schering-Plough and Merck until Christmas to turn over documents from a clinical trial involving the cholesterol-lowering drug Zetia. The New York Times reported last month that the companies had failed to meet last spring's release date for a trial that compared the efficacy of a combination of Zetia and Zocor to Zocor alone. The companies then missed a fall deadline and said they wouldn’t release the data from the 720-person Enhance trial until next spring. They also wanted to change the trial's clinical endpoint, which drew heavy criticism from cardiologists who prescribe the drug. The companies backed off that decision last week and reinstated the original protocols of the trial, according to the Wall Street Journal.

The letter, signed by chairman John Dingell (D-MI) and investigations subcommittee chairman Bart Stupak (D-MI), wanted to know why the clinical trial wasn’t registered in the government’s database until 18 months after its completion. Until the recently enacted Food and Drug Administration reform law required registration of most clinical trials prior to their start-up, registration was voluntary. Zetia, whose generic name is ezetimibe, was approved by the Food and Drug Administration in 2002 because it lowered bad (LDL) cholesterol. But, unlike statin drugs, it has never been tested in a clinical trial to show that it actually decreases mortality from heart attacks and strokes. Even the Enhance trial will only measure the drug’s impact on arterial plaque, not if it reduces deaths from heart disease. The drug is sold primarily as part of Vytorin, a pill combining Zetia and Zocor (simvastatin) that has captured 20 percent of the cholesterol-lowering drug market.