Merck, Schering-Plough agree to pay $5.4 million to resolve investigation by state attorneys general
SEATTLE – Marketers of the cholesterol-lowing drug Vytorin will pay $5.4 million to resolve an investigation by attorneys general into the companies’ delayed release of negative study results, Attorney General Rob McKenna announced today.
The Washington Attorney General’s Office will receive $100,000 from the agreement with 36 attorneys general and drug markers Merck & Co., Inc., Schering-Plough Corp, and their joint venture, MSP Singapore Company, LLC. The money will be used to reimburse the states for attorneys’ fees and legal costs.
Merck and Schering-Plough jointly sell both Vytorin and a second cholesterol drug, Zetia. Vytorin is a combination of Zetia and Zocor, which lost patent protection in 2006. Zocor is now available as the cheap, generic drug simvastin.
“Sales of Vytorin slowed like blood through a clogged artery after a study released last year questioned its effectiveness,” Assistant Attorney General Bob Lipson said. “The states’ investigation centered on whether any consumer protection laws may have been violated by the delayed release of those negative results.”
Results of a trial called ENHANCE showed Vytorin, which reportedly cost $100 a month, was no better than simvastin at reducing plaque in blood vessels in the neck. Although the trial ended May 2006, a partial report showing negative results didn’t occur until January 2008 and complete results weren’t published until April 2008. Prior to the release of the study results, Vytorin had been heavily promoted to consumers through TV commercials and print ads like this one that suggest Vytorin is effective at treating high cholesterol caused both by heredity and diet:
(Graphic Source: Wall Street Journal)
The drug companies pulled Vytorin advertising from the airwaves on Jan. 22, 2008.
Today’s agreement sets restrictions on how the companies’ market Zetia and Vytorin in the future. It applies the injunctive provisions that states reached in last year’s multistate settlement with Merck concerning its deceptive promotion of the painkiller Vioxx. The agreement prohibits ghostwriting articles and requires the companies to:
- Submit all consumer-targeted television commercials to the Food and Drug Administration for approval before they air.
- Comply with any FDA recommendation to modify advertising.
- Register clinical trials and post their results and comply with detailed rules prohibiting the deceptive use of clinical trials.
- Reduce conflicts of interest for Data Safety Monitoring Boards that ensure the safety of participants in clinical trials.
The following states and the District of Columbia participated in the agreement: Arizona, Arkansas, California, Colorado, Delaware, Florida, Hawaii, Idaho, Illinois, Iowa, Kentucky, Louisiana, Maine, Massachusetts, Michigan, Mississippi, Missouri, Montana, Nebraska, New Jersey, Nevada, New Mexico, North Carolina, North Dakota, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Vermont, West Virginia, Washington and Wisconsin.
ASSURANCE OF DISCONTINUANCE
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