July 16, 2009
Thirty-six states and the District of Columbia have reached a settlement with Merck & Co. Inc, Schering-Plough Corporation, and a joint venture of the two companies, MSP Singapore Company, LLC.
The settlement resolves an investigation into the companies' lengthy delay in releasing negative results from a study of Vytorin, a cholesterol-lowering drug that is a combination of the drugs Zetia and Simvastatin. The settlement contains comprehensive injunctive terms that will prohibit the unfair and deceptive promotion of Vytorin and Zetia.
In addition, the companies have agreed to pay the states' investigation costs of $5.4 million.
"With the comprehensive injunctive relief achieved by this settlement, we are confident that consumers and health care providers will benefit from these more stringent standards," said Massachusetts Attorney General Martha Coakley. "This settlement protects consumers against deceptive advertising and provides consumers with adequate disclosures about the safety and efficacy of Vytorin and Zetia."
The settlement resolved an investigation by the Attorneys General, initiated in 2008, which focused on the companies' delayed disclosure of negative results from a clinical trial called, "Ezetimibe and Simvastatin in Hypercholsterolemia Enhances Atherosclerosis Regression (ENHANCE)."
In this study, Vytorin proved no more effective in reducing formation of plaque in carotid arteries than the inexpensive, generically available cholesterol-lowering drug, Simvastatin. Although the ENHANCE study concluded 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 releasing the study results, the companies promoted Vytorin heavily in direct-to-consumer advertisements.
The settlement applies the extensive injunctive terms from Merck's 2008 consent judgment with the states regarding the drug Vioxx to the marketing of Vytorin and Zetia, which had been carved out of the Vioxx settlement because Vytorin and Zetia are promoted by Merck as a joint venture with Schering-Plough.
In addition to generally prohibiting the companies from making false, misleading or deceptive claims about Vytorin and Zetia, the settlement requires that the companies:
Obtain approval from the Food and Drug Administration (FDA) before running any direct-to-consumer television advertisements and comply with suggested FDA revisions to the advertising;
Satisfy certain criteria when presenting information about clinical studies in media outlets;
Register clinical trials and post their results, as required by the FDA;
Prohibit "ghost writing" of articles, by requiring individuals who are named as authors on company-sponsored manuscripts to meet certain requirements regarding their level of involvement;
Reduce conflicts of interest for members of company-sponsored Data Safety Monitoring Boards; and
Comply with detailed rules prohibiting the deceptive use of scientific studies.
Joining Massachusetts in the settlement 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, Wisconsin and the District of Columbia.
