Feds, State AGs Investigating Vytorin MarketingNov 4, 2008 | Parker Waichman LLP
Vytorin, Merck and Schering-Plough's controversial cholesterol medication, is the subject of two more state and federal investigations. In a regulatory filing, Merck revealed that the U.S. Justice Department and 35 state attorneys general have opened separate probes into the marketing of Vytorin.
Vytorin has been under the microscope since the ENHANCE study was released in January. That study showed that Vytorin was ineffective in preventing clogged arteries, and might actually increase plaque in some users. When ENHANCE was vetted during the annual meeting of the American College of Cardiology in March, doctors there recommended that it be used only as a last resort. “Our strongest recommendation is that people need to go back to statins,” said panel member Dr. Harlan Krumhotz.
While the ENHANCE results caused a stir, even more controversy surrounded the way it was handled. Merck and Schering-Plough delayed releasing ENHANCE for more than a year – something critics have likened to fraud. They also at one time attempted to change the study's endpoint - the main result it was meant to measure - after it was completed. It is generally accepted that for a clinical trial to be effective, a study’s endpoint must be set at its beginning and remain unchanged. In December 2007, in response to the ENHANCE delays and the attempt by Merck and Schering-Plough to change the endpoint, Congress initiated an investigation of the ENHANCE study. The companies dropped their attempt to change the ENHANCE endpoint shortly thereafter.
Vytorin took another hit over the summer, when the SEAS study was released. SEAS was designed to see if the drug helped people with aortic stenosis avoid heart attacks. Not only did SEAS show that Vytorin offered no additional heart attack prevention, but Vytorin patients enrolled in the study had higher rates of cancer than those taking a placebo. In the trial, 102 patients taking Vytorin developed cancer, compared with 67 taking the placebo. Of those, 39 people taking Vytorin died from their cancer, compared with 23 taking placebo. Researchers conducting the study said that while those numbers don’t prove a definitive cancer link, they were “statistically significant”, meaning the odds were less than 5 percent that they were the result of chance. Congress recently expanded its Vytorin investigation to include the handling of SEAS.
Now, the U.S. Justice Department is asking questions about the way Vytorin was marketed. According to Merck's filing with the Securities and Exchange Commission, the company was notified on September 19 via a letter that the Justice Department's civil division is investigating whether the promotion of Vytorin by Merck and Schering-Plough Corp. caused false claims to be submitted to federal health-care programs.
Merck’s filing also said the company has received five “civil investigative demands” from a multistate group of 35 state attorneys general who are jointly investigating whether Merck and Schering-Plough violated state consumer protection laws when marketing Vytorin.
Merck said in its regulatory filing it's cooperating with these investigations and working with Schering-Plough to respond to the inquiries. The companies have previously disclosed other inquiries by government entities, including Congressional committees and a limited number of state investigators.
In addition, at least 140 lawsuits have been filed alleging consumer fraud in connection with the sale and promotion of the drugs, Merck said.