Vytorin Settlement: $5.4 Million to 35 States and DC

The makers of the controversial cholesterol-lowering drug <"http://www.yourlawyer.com/topics/overview/vytorin">Vytorin—Merck & Company and Schering-Plough Corporation—have agreed to settle allegations that they delayed the release of negative information derived from a study of the drug, reported Reuters. Merck and Schering-Plough will pay $5.4 million to 35 states and the District of Columbia, said Reuters, which explained that the two sell Vytorin via a joint venture and also sell Zetia, a “related” drug and a component of Vytorin.

The investigation that produced the settlement involved allegations that Merck and Schering-Plough did not notify consumers for nearly two years—20 months—about negative information concerning Vytorin and Zetia that was discovered during the drug makers’ ENHANCE study, according to Reuters. “As part of the resolution of the multi-state investigation, the companies agreed to reimburse the investigative costs of the 35 states and the District of Columbia which totaled $5.4 million,” the drug makers said in a joint release, quoted Reuters.

Vytorin, a combination of the statin Zocor (simvastatin) and Zetia, has been under the microscope since the ENHANCE study, which found the drug was no better than a cheaper, generic statin in preventing clogged arteries, was released in January 2008. Merck and Schering-Plough delayed releasing ENHANCE for more than a year; the trial was actually completed in 2006.

The state attorneys general allege that before the drug makers released any of the negative study results, both Merck and Schering-Plough conducted intense marketing of Vytorin through direct-to-consumer (DTC) advertising, Reuters pointed out.

The ENHANCE controversy spawned well over 100 lawsuits that allege Merck and Schering-Plough were fraudulent by withholding the study results for so long. Investigations into the ENHANCE debacle and the marketing of Vytorin are also being conducted in Congress, by the U.S. Justice Department, and several state attorneys general.

The drug makers say they are not mandated under the settlement to admit misconduct or issue additional payments, reported Reuters, which noted that a merger between the two is planned for 2009. The settlement does require, though, that the drug makers receive U.S. Food and Drug Administration (FDA) approval prior to airing television ads for the drugs; meet specific criteria when issuing information about clinical studies to the media; and are banned from “ghost writing” medical articles, by mandating individuals named as authors on “company-sponsored manuscripts” meet criteria specific to their involvement, explained Reuters. Also, according to Massachusetts Attorney General Martha Coakley, both companies are prohibited “from making false, misleading or deceptive claims about Vytorin and Zetia, said Reuters.

Meanwhile, last month we wrote that Vytorin was named in another lawsuit, that time by the Pennsylvania Employees Benefit Trust Fund (PEBTF), that alleged both Merck and Schering-Plough charged too much for Vytorin and Zetia.

According to Bloomberg.com, the PEBTF—an insurance fund for active and retired state employees–alleged that Merck and Schering-Plough’s misleading claims about Vytorin and Zetia caused consumers to pay too much for the drugs. The lawsuit claims that the companies “suppressed” the results of ENHANCE and used false and deceptive marketing techniques claiming Vytorin was more effective than, and just as safe as, the much cheaper, generic cholesterol drugs. The PEBTF is seeking to recoup more than $9 million spent on the two drugs since October 2002.

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