The U.S. Department of Justice and 35 state attorneys general are investigating whether Merck & Co. and Schering-Plough Corp. violated rules in the promotion of their cholesterol drug Vytorin. The companies said they are cooperating with the investigations and working together in response.
Vytorin, a cholesterol-lowering medicine from Merck & Co. and Schering-Plough Corp., did not benefit patients with a grave heart-valve condition and seemed to raise their cancer risk, according to clinical-trial data presented Monday. Critics said the study highlights concerns about the drug's safety and efficacy. It is "too early to estimate the potential impact" of the trial in long-term guidance, Merck CEO Richard Clark said.
Schering-Plough CEO Fred Hassan told analysts the company will continue to make and market the cholesterol-reducing drugs Vytorin and Zetia, despite research questioning their efficacy. Hassan said the research caused "unwarranted confusion" about cholesterol management.
A panel of cardiologists on Sunday recommended that health care providers reduce use of Vytorin and Zetia -- cholesterol drugs marketed by Merck & Co. and Schering-Plough Corp. -- after the latest study findings backed evidence that they were no better than a generic drug in slowing heart disease progression. Both companies believe study patients previously treated with statins influenced the results. A Schering-Plough official said their products continue to be a "practical option" in cholesterol treatment.