Controversy surrounding Vytorin continues to escalate, this time as federal and state prosecutors investigate Merck and Schering-Plough’s conduct in marketing the drug. According to an article in the Wall Street Journal, many government officials suspect that the companies’ marketing of Vytorin may have been misleading and improper.

The U.S. Department of Justice notified Merck in a letter dated September 10 that it was launching an investigation into the promotion of Vytorin. The Justice Department suspects that the companies, who jointly manufacture Vytorin, may have deliberately misled the medical community with their marketing campaign, prompting false claims to be submitted to federal healthcare programs.

The premise of the investigation is that government programs spent millions of dollars on reimbursement for a drug that clinical trials showed to be no more effective than much cheaper generic statins in preventing aortic-valve and cardiovascular events. Another trial suggested that Vytorin may promote cancer and increase the risk of dying from cancer in patients who use the drug.

The Department of Justice does not stand alone. Many municipalities and states have begun filing suits. Currently, 35 state attorneys general are investigating to see if any state consumer protection laws were violated by the marketing.

Connecticut Attorney General Richard Blumenthal is one of the state attorneys investigating the matter. “We believe that there are very real and serious issues that may have affected consumer pocketbooks, if not their health, and we intend to pursue these issues vigorously,” he told the Wall Street Journal.

Merck and Schering-Plough, both New Jersey based corporations, said they were cooperating with the investigations and jointly responding to the inquiries.

Earlier this year, the House Energy and Commerce Committee launched an investigations into the safety of Vytorin and the ways in which the drug was marketed.

It is widely believed that Merck and Schering Plough concealed unfavorable ENHANCE trial results for up to two years in an effort to protect the drug’s stellar sales, which climbed to $5.2 billion last year ahead of all the negative news. Both companies deny the accusation that trial data were withheld.

Vytorin is already the subject of a number of lawsuits seeking class action status. Approximately 140 such suits have been filed across the country.



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