CHOLESTEROL DRUG VYTORIN MAKES LEGAL HEADLINES
A wave of lawsuits involving the cholesterol drug Vytorin have been filed prompting the U.S. Department of Justice to investigate Merck & Co. and partner Schering-Plough Corporation. The Justice Department’s Civil Division notified Merck last September of complaints alleging that the drug makers misrepresented the safety and efficacy of the drug and that the results of the study were purposefully concealed in order to enhance sales of the drugs.
A group of 35 state attorneys general are jointly investigating whether the partners violated state consumer protection laws in their marketing of Vytorin. Subsequently, Merck has been served with or become aware of about 140 civil class action lawsuits alleging consumer fraud claims in connection with two cholesterol drugs sold and promoted by the partners’ joint venture. Some lawsuits allege personal injuries or seek medical monitoring for people who used the drugs.
Vytorin and one of its components, Zetia, have been promoted heavily in the fight against cholesterol, reaping revenues of $5.2 million in 2007. Troubling news about the drugs this year has cut revenue by approximately 15% since last fall, prompting layoffs at both Merck and Schering-Plough. In January, 2008, following prompting from Congressional investigators, the companies confirmed the results of a study indicating that Vytorin was no better at reducing plaque buildup than the generic cholesterol drug Zocor. The generic was one-third of the cost of Vytorin.
Vytorin has not been linked to any injures, but the drug was extremely expensive and many individuals as well as insurance companies have filed class action lawsuits to recover costs involved with the prescription.
Those revelations led to the investigations by Congressional committees as to whether the results of the study were delayed to reap revenue from the sale of Vytorin and Zetia. The companies have denied wrongdoing. Investigations are underway by the Senate Finance Committee as well as the House Committee on Energy and Commerce’s Subcommittee on Oversight and Investigations. They are conducting interviews and obtaining documents and information concerning the promotion of Vytorin. They are also investigating the delay in releasing results of the patient study, called ENHANCE, as well as stock sales by officers of the drug companies.
The Oversight and Investigations subcommittee is also compiling documents and information for a second patient study, entitled SEAS. That study linked Vytorin to a possible increase in several types of cancer and that showed the drug did not prevent heart valve deterioration, the need for heart surgery or death in patients with diseased heart valves.