Austin, Texas - Texas Attorney General Greg Abbott and 35 other state attorneys general today reached a multi-million dollar agreement with pharmaceutical manufacturers Merck & Co. Inc., Schering-Plough Corp., and a joint venture between the two companies, MSP Singapore Company, LLC.
Together, the three manufacturers agreed to pay $5.4 million to resolve the states’ investigation, which examined the manufacturers’ delayed release of negative clinical trial results. Texas will receive $300,000 for its efforts to investigate this matter.
The manufacturers’ clinical trial indicated that the cholesterol lowering drug Vytorin – which is a combination of the drugs Zetia and simvastatin – was no more effective reducing formation of plaque in carotid arteries than the cheap, generic alternative, simvastatin. Although the study ended in May 2006, complete results were not published until April 2008. In the meantime, the companies heavily promoted Vytorin in direct-to-consumer advertisements.
Today’s settlement requires the companies to follow several requirements when promoting Vytorin and Zetia, including:
• Obtain pre-approval from the U.S. Food and Drug Administration (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.
The investigation was led by Oregon Attorney General John R. Kroger and an Executive Committee including the Attorneys General of Arizona, California, Florida, Illinois, New Jersey, Ohio, Pennsylvania, South Carolina, Texas, and the District of Columbia.
The 36 states participating in today’s agreement are Arizona, Arkansas, California, Colorado, Delaware, the District of Columbia, 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.
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