TRENTON—New Jersey has entered into a multi-state settlement with Merck & Co. Inc, Schering-Plough Corporation, and a joint venture of the two companies, MSP Singapore Company, LLC, resolving an investigation into a lengthy delay by the companies in issuing negative results from a clinical trial of their cholesterol-lowering drug Vytorin, Attorney General Anne Milgram announced today.
The clinical trial was called Ezetimibe and Simvastatin in Hypercholesterolemia Enhances Atherosclerosis Regression, or ENHANCE.
Under terms of the settlement, Merck & Co., Schering-Plough and MSP Singapore have agreed to pay the participating states $5.4 million to cover costs related to the investigation. New Jersey, as part of the multi-state group’s investigatory Executive Committee, will receive $200,000.
Among other things, the settlement requires Merck and the other entities to obtain pre-approval from the federal Food and Drug Administration (FDA) for all direct-to-consumer advertisements, and to comply with detailed rules concerning the use of information from clinical trials. Under the settlement, there is no admission of wrongdoing on the part of any of the three companies.
“This is an important settlement for New Jersey consumers. Consumers have a right to accurate information about the medications that are advertised and placed on the market and, potentially, prescribed by their physicians. This is particularly true when we’re talking about medications as vital as cholesterol-lowering drugs,” said Milgram.
In the ENHANCE study, Vytorin—a combination of the drug Zetia and simvastatin—was no more effective in reducing formation of plaque in carotid arteries than simvastatin alone. Simvastatin is an inexpensive, generically available cholesterol lowering drug. Although the ENHANCE study ended in May 2006, a partial reporting of negative results did not occur until January 2008. Complete results were not published until the following April.
Prior to the release of the negative study results, Vytorin had been heavily promoted in direct-to-consumer advertising.
Among the injunctive terms that now apply to Vytorin and Zetia are requirements to:
• Obtain pre-approval from the FDA for all direct-to-consumer advertisements;
• Comply with FDA suggestions to modify drug advertising;
• Register clinical trials and post their results;
• Prohibit the “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 multi-state investigation was led by Oregon. New Jersey was part of an investigatory Executive Committee that also included Attorneys General from Arizona, California, Florida, Illinois, Ohio, Pennsylvania, South Carolina, Texas and the District of Columbia.
Other states participating in today’s agreement include: Arkansas, Colorado, Delaware, Hawaii, Idaho, Iowa, Kentucky, Louisiana, Maine, Massachusetts, Michigan, Mississippi, Missouri, Montana, Nebraska, Nevada, New Mexico, North Carolina, North Dakota, South Dakota, Tennessee, Vermont, West Virginia, Washington, and Wisconsin.
Deputy Attorneys General Cathleen O’Donnell and Alina Wells, assigned to the Consumer Fraud Prosecution Section within the Division of Law, represented the state in this investigation.
Connect with NJTODAY.NET
Join NJTODAY.NET's free Email List to receive occasional updates delivered right to your email address!