A study released in January by the pharmaceutical companies, called ENHANCE, found that Vytorin was no more effective at reducing plaque buildup than Zocor, its generic and much cheaper counterpart, though it did a better job of reducing low-density lipoproteins (LDL), or “bad cholesterol.” The study was concluded in April 2006, but was not released until January 15, 2008. Since the release of the results, 140 civil class action lawsuits have been filed alleging consumer fraud claims relating to cholesterol drugs Vytorin and Zetia, a component of Vytorin. Plaintiffs allege that Merck and Schering-Plough delayed the release of the study while falsely marketing that Vytorin reduced the plaque that can cause heart attack and stroke, and are seeking medical monitoring or asserting personal injuries.
The DOJ’s Civil Division is investigating whether the promotion of Vytorin resulted in false claims to federal health care programs, as well as whether the companies intentionally delayed releasing the study’s results to boost sales of their two cholesterol drugs. Both the Senate Finance Committee and the House Committee on Energy and Commerce’s Subcommittee on Oversight and Investigations are participating in the probe. They have also requested documents pertaining to another study, SEAS, which links Vytorin to a possible increased risk of cancers and shows that it doesn’t prevent deterioration, surgery, or death in patients with diseased heart valves.
If the Justice Department finds that the pharmaceutical companies made false claims to health care programs, the programs could recover the money they have spent on the drug. A spokesman for Merck stated that they are cooperating with the Justice Department’s requests, and are taking the matter very seriously.
Additionally, 35 state attorneys general are investigating whether Merck and Schering-Plough violated state consumer protection laws in their marketing of the drug.