Cholesterol Drug Controversy Continues

(Page 2)

Those questions have yet to be answered, Brown said. But, he added, "my sense is that this was the wrong population to study." Other studies now under way might provide an answer, but not until 2011 or 2012, he said.

Meanwhile, Brown said, "I agree with the statements made by the American Heart Association and the American College of Cardiology, to use ezetimibe if it is needed to get people down to a target level of LDL cholesterol."

Dr. Harlan M. Krumholz, a professor of medicine at Yale University School of Medicine and co-author of another of the journal papers, disagreed with Brown's view.

"For myself, I would not take the medication, and if I recommended it to anyone, it would be for the highest-risk patient who couldn't tolerate statins," Krumholz said.

The paper he co-authored compared use of Vytorin in the United States and Canada. The proportion of cholesterol-lowering drug prescriptions represented by Vytorin rose from 0.2 percent to 3.4 percent in Canada from 2002 to 2006. In the United States, the increase was from 0.1 percent to 15.2 percent of all such prescriptions.

"That is a pretty remarkable difference," Krumholz said. "If we had adopted the drug at the same speed as in Canada, we would have saved $1.5 to $2 billion in health-care costs. What did we get for that? Did it produce benefits for patients? We can't say we're sure of that."

It's also possible that the new cholesterol-lowering agent might turn out to be harmful, Krumholz said. He recalled the history of torcetrapib, a drug developed by Pfizer that increased blood levels of HDL cholesterol, the "good" kind that prevents plaque formation. Pfizer stopped tests of the drug in 2006 because of a trial showing higher mortality among those taking it.

"It was a new drug, the first in its class," Krumholz said. "The laboratory results looked great, and it ended up hurting people."

It's not clear whether the same will be true of Vytorin, he said. "The evidence we have on hand makes a benefit less likely," Krumholz said. "We have a $5-billion-a-year market without outcomes data."