Attorney General Martha Coakley and 35 State Attorneys General Announce Settlement with Drug Company
"With the comprehensive injunctive relief achieved by this settlement, we are confident that Massachusetts consumers and health care providers will benefit from these more stringent standards," said Attorney General 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 today's 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.
The settlement was handled by Assistant Attorney General Emily Paradise and Acting Division Chief Thomas O'Brien of Attorney General Coakley's Health Care Division.