Attorney General Corbett announces $5.4 million multi-state settlement over slow disclosure of negative drug study results

By THE OFFICE OF ATTORNEY GENERAL TOM CORBETT

HARRISBURG — Attorney General Tom Corbett announced that Pennsylvania, together with 35 other states, has reached a $5.4 million consumer protection settlement with Merck & Co. Inc, Shering-Plough Corporation, and a joint venture of the two companies, MSP Singapore Company.

Corbett said the Assurance of Voluntary Compliance (AVC) resolves an investigation into the companies’ lengthy delay in releasing negative results from a clinical study involving the cholesterol lowering drug Vytorin (a combination of the drug Zetia and simvastatin). The study indicated that Vytorin was no more effective in reducing formation of plaque in carotid arteries than a less expensive, generically available cholesterol lowering drug.

According to the settlement, the drug study ended May 2006, but a partial reporting of negative results did not occur for nearly two years – not until January 2008 – and complete results were not published until the following April. During that time, Vytorin was heavily promoted in direct-to-consumer advertisements.

Corbett said the AVC places a number of restrictions on the future promotion of Vytorin and Zetia, including:
Pre-approval from the U.S. Food and Drug Administration (FDA) for all direct-to-consumer television advertisements.
Complying with FDA suggestions to modify drug advertising.
Registering clinical trials and posting their results.
Prohibiting “ghost writing” of articles.
Reducing conflicts of interest for Data Safety Monitoring Boards that ensure the safety of participants in clinical trials.
Complying with detailed rules prohibiting the deceptive use of clinical trials.

The settlement also requires the companies to pay state investigative costs of $5,400,000, including $300,000 for Pennsylvania.

The 36 States participating in the agreement are 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 and the District of Columbia.

The Assurance of Voluntary Compliance was filed in Dauphin County Court of Common Pleas by Deputy Attorney General Timothy E. Gates of the Attorney General’s Health Care Section.

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