Attorney General John Kroger announced a $5.4 million multi-state settlement that resolves an investigation into the delayed release of negative results of a clinical trial for the cholesterol lowering drug Vytorin.
"Protecting Oregonians from health care fraud is one of my highest priorities," Attorney General Kroger said. "The Oregon Department of Justice led the investigation into this case and is going to continue to be a national leader on multi-state pharmaceutical cases."
The Oregon Department of Justice is a national leader in protecting consumers from illegal pharmaceutical marketing. The department has led a multi-state legal fight that has forced drug-makers and other companies to pay more than $285 million in consumer protection-related settlements since 2007. The department's leadership has brought more than $13 million to Oregon in the last two years. Pharmaceutical companies that have paid settlements include Pfizer, Eli Lilly, Merck, Purdue Pharma and Bayer. The illegal marketing campaigns promoted Bextra, Zyprexa, Vioxx, Baycol, Neurontin and Oxycontin.
The settlement announced today is with Merck & Co. Inc, Shering-Plough Corporation, and a joint venture of the two companies, MSP Singapore Company, LLC. The settlement resolves an investigation into the companies' lengthy delay releasing negative results from the clinical trial called Ezetimibe and Simvastatin in Hypercholsterolemia Enhances Atherosclerosis Regression (ENHANCE). In this study, the cholesterol lowering drug Vytorin (a combination of the drug Zetia and simvastatin) was no more effective reducing the formation of plaque in carotid arteries than the cheap, generically available cholesterol lowering drug simvastatin. Although ENHANCE 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 study results, Vytorin had been heavily promoted in direct-to-consumer advertisements.
The settlement includes extensive injunctive relief, including requirements to:
• 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; and,
• Comply with detailed rules prohibiting the deceptive use of clinical trials.
In addition to these injunctive terms, the companies agreed to pay the states $5.4 million for their work on the investigation. As the leader of the investigation, the Oregon Department of Justice will receive $400,000.
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.
Senior Assistant Attorney General David Hart handled the case for the Oregon Department of Justice.