Cholesterol drugs' cancer risk in spotlight

The drugs' makers, Merck & Co. and Schering-Plough Corp., will be looking to reassure nervous cardiologists--and investors--when academic researchers present data from two studies early Tuesday at the European Society of Cardiology conference in Munich.

Zetia and Vytorin, which is a combination pill that includes Zetia and Merck's now-generic Zocor, have been under scrutiny since late July. That's when European scientists, in a hastily arranged conference call, said early data from a study of Vytorin found it didn't slow hardening of the aortic valve as doctors had hoped.

Worse yet, there was a surprising 50 percent increase in new cancer cases in study participants getting Vytorin, compared with those taking a placebo. The scientists said that finding, in a study called SEAS, appeared to be due to chance.

Late last week, both the Food and Drug Administration and the House Committee on Energy and Commerce said they are investigating the possible cancer risk.

Now full results of the SEAS study, and a related report that looks at cancer risk by combining SEAS data with interim data from two ongoing studies of patients taking Zetia, will be presented for the first time Tuesday. All three studies are funded by the two drugmakers. The data will be published online by the New England Journal of Medicine that day.

"It will be more or less damage control to physicians," predicted analyst Manoj Garg of investment research firm American Technology Research. "There probably is some degree of nervousness" among them, he said.

Garg said national marketing data has not shown much effect on physician prescribing patterns since the issue came up in July. And he doesn't expect a big reaction from the stock market Tuesday.

Still, Garg noted the two Zetia studies haven't followed patients very long--less than three years--and it often takes a long time for cancer to show up.

Dr. Rob Califf, the vice chancellor of clinical research at Duke University and a co-author of the report on the combined cancer data from all three studies, said he thinks the average practicing cardiologist is waiting to see what the experts say once the new data is released.