Justice Department, Congress probe Vytorin maker

June 13, 2008

The Department of Justice has joined federal lawmakers in seeking information about why it took drug makers so long to report the negative results of a study of the cholesterol drug Vytorin.

Executives from Merck and Schering Plough, who make and market the drug in a joint venture, testified before House lawmakers at a hearing earlier this month, defending their decision to continue to promote the drug in ads after a study revealed that it was no more effective than the lower-cost generic Zocor, which is already on the market.

Three television ads have been discontinued after being criticized by some lawmakers as potentially misleading consumers. The study was completed in 2006, but the companies didn’t release the results until this past January.

“I saw a vigorous debate around the quality of that data,” Merck/Schering-Plough Senior Vice President Deepak Khanna explained to lawmakers at the hearing. “Ultimately we took steps to make sure the data was there and meaningfully analyzed before its release.”

But Rep. Bart Stupak, D-Mich., who chairs the House Energy and Commerce Committee’s oversight subcommittee, said he is considering new restrictions to “protect American consumers from manipulative commercials.”

Meanwhile, the drug companies also revealed that the Justice Department has requested interviews and documents on Vytorin from the companies.

Merck and Schering halted TV marketing for Vytorin after releasing the study results in January, but Stupak argues that their action came too late.

“Many consumers may not have taken Vytorin had they been aware of the study results,” Stupak said.