Merck & Co. and Schering-Plough Corp. currently face around 140 Vytorin class action lawsuits involving their once-popular cholesterol drug, which has been shown to provide no medical benefits over cheaper generic alternatives. In addition, this week the drug makers disclosed that the U.S. Department of Justice is now investigating their marketing of the medication.
Vytorin is a combination of ezetimibe (Zetia) and simvastatin (Zocor). The anti-cholesterol drug was approved by the FDA in 2004 and heavily marketed as part of a joint venture between Merck and Schering-Plough.
One component of Vytorin is Zocor, which blocks an enzyme necessary for cholesterol production in the body, and the other component is Zetia, which inhibits intestinal absorption of cholesterol and decreases its delivery to the liver.
Vytorin was marketed as being more effective than the stand-alone drugs and was meant to provide better protection against heart attacks by reducing the buildup of plaque in the inner walls of arteries. The drug lowers total cholesterol as well as ‘bad‘ LDL (low density lipoprotein) cholesterol, while the level of ‘good’ HDL (high density lipoprotein) cholesterol is increased.
In January 2008, after months of delaying and stalling, the drug makers released data from a study that demonstrated Vytorin provides no significant medical benefits over taking Zocor alone, which is available as a generic at one-third the cost of the combination drug.
In July 2008, concerns emerged about a possible risk of cancer with Vytorin after data from a study known as SEAS found an increased incidence of cancer among Vytorin users. While the drug makers initially dismissed the findings as likely attributed to chance, an editorial published in the New England Journal of Medicine has indicated that it is too early to rule out the possible Vytorin cancer connection.
Vytorin lawsuits have been filed against Merck and Schering-Plough involving consumer fraud actions for selling a medication which provides no benefits, cases alleging personal injuries caused by the drug and claims to establish medical monitoring for users who were given the drug.
In a filing with the Securities and Exchange Commission (SEC) on Monday, Merck disclosed that the companies are also now facing an investigation by the U.S. Justice Department, who is looking into whether the drug makers’ promotion of Vytorin involved making false claims to federal health care programs, such as Medicare.
This could potentially result in the companies paying millions, or even billions, of dollars back to the government for prescription expenses spent on the drug.