Does Cholesterol Drug Increase Chance of Cancer?

Federal drug-safety regulators said Thursday they are investigating whether the cholesterol-lowering drug Vytorin can increase patients' risk of developing cancer.

However, Food and Drug Administration (FDA) officials said patients should not stop taking Vytorin, because the evidence of a cancer link is unclear. While one recent clinical trial indicated higher rates of cancer for patients taking the medication, two current studies have shown no increased risk, agency officials said.

Meanwhile, senior lawmakers in Congress demanded data on the clinical trial that indicated a cancer risk.

Vytorin, a combination of Merck's Zocor and Schering-Plough's Zetia, has been heavily promoted as a novel way to reduce cholesterol. Zocor, a statin, reduces the amount of cholesterol produced by the liver. Zetia limits the cholesterol absorbed through the digestive system. But the combination became a focus of controversy after a study this year showed it was no better at reducing the buildup of plaque in the arteries than simvastatin, the much cheaper generic form of Zocor.

Separately Thursday, leaders of the House Energy and Commerce Committee asked the companies for extensive data on the clinical trial that indicated a possible cancer risk for Vytorin.
Merck and Schering-Plough said they would cooperate with the panel. The companies defend the drug, saying it is effective at reducing cholesterol, its approved use.

Committee Chairman Rep. John Dingell and Rep. Bart Stupak, both Michigan Democrats, sent a letter to the chief executives of the drug companies, giving them two weeks to supply detailed information. The study showing a link to cancer was originally designed to determine whether Vytorin could help prevent a worsening of heart-valve disease, but found that it did not.

The FDA officials anticipate the agency's investigation and analysis will take about nine months.