DENVER — Colorado Attorney General John Suthers announced today that Merck & Co. Inc, Schering-Plough Corporation and a joint venture of the two companies, MSP Singapore Company, LLC, have agreed to settle with 35 states, including Colorado, after it delayed the release of negative results from a clinical trial of its cholesterol lowering drug Vytorin.
Colorado will receive $100,000 of the $5.4 million the companies have agreed to pay as part of the settlement. The money will be used for reimbursing investigation costs and funding future investigations.
The companies agreed to settle with the attorneys general after an investigation revealed they failed to reveal test results that could have hurt drug sales. Specifically, the clinical trial indicated that Vytorin was no more effective at reducing the formation of plaque in carotid arteries than the cheap, generically available cholesterol-lowering drug simvastatin. The companies delayed the release of partial results from the clinical trial until January 2008, long after the trial ended in May 2006. The companies only released the full clinical trail results in April 2008.
The multistate investigation also showed that between the end of the clinical trial and the release of partial results, the companies had continued to promote Vytorin to consumers as a drug that could reduce the build up of plaque in arteries.
As part of the settlement, the companies will be required to:
- Obtain preapproval from the Food and Drug Administration for all direct-to-consumer TV ads;
- Comply with FDA recommendations to modify their advertisements;
- Register clinical trials and post their results;
- Prohibit the ghost writing of articles;
- Reduce conflicts of interest for Data Safety Monitoring Boards that ensuring the safety of participants in clinical trials; and,
- Comply with detailed rules prohibiting the deceptive use of clinical trials.
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. The District of Columbia also participated in the settlement.