Office of the Attorney General
Attorney General Conway Announces Multi-State Settlement with Drug Companies over Slow Disclosure of Negative Drug Study Results
Attorney General Jack Conway, along with attorneys general of 35 other states, today announced a settlement with Merck & Co. Inc, Shering-Plough Corporation, and a joint venture of the two companies, MSP Singapore Company, LLC. The agreement, filed in Franklin Circuit Court, resolves an investigation into the companies’ delay in releasing negative results from a clinical trial involving the cholesterol lowering drug Vytorin® (a combination of the drug Zetia® and Simvastatin).
In the study, Vytorin was found to be no more effective in reducing formation of plaque in carotid arteries than the cheaper, generically available, cholesterol lowering drug Simvastatin.
Although the clinical trial ended in May 2006, a partial reporting of negative results did not occur until January 2008 and complete results were not published until the following April. Prior to release of the study results, the benefits of Vytorin had been touted to the public in direct-to-consumer advertisements. In 2007 alone, more than $200 million was spent on direct consumer advertisements for Vytorin, according to the an article in the New England Journal of Medicine.
"Kentucky consumer protection laws require drug companies to honestly and fully disclose to the public and health professionals results of clinical trials and facts relating to the safety and effectiveness of their medications," said General Conway. "My office will vigorously enforce those laws to protect Kentucky consumers."
The settlement requires the companies to follow certain practices with respect to promotion and marketing of Vytorin and Zetia, including:
- Obtain pre-approval from FDA for all direct-to-consumer television advertisements
- Comply with FDA suggestions to modify drug advertising
- Register clinical trials and post their results
- Prohibit ghost writing of articles
- Reduce conflicts of interest for Data Safety Monitoring Boards that ensure the safety of participants in clinical trials
- Comply with detailed rules prohibiting the deceptive use of clinical trials
In addition to agreeing to these injunctive terms, the companies agreed to pay the states’ investigation costs of $5.4 Million. For its work on this investigation, Kentucky will receive $100,000. The companies cooperated fully in the investigation.
The 36 states participating in today’s 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.