Healthy Skepticism Library item: 15985
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: news
Seaman M.
Merck and Schering-Plough settle investigation
Yahoo Finance 2009 Jul 15
http://billingsgazette.com/business/article_5dc3a62d-3181-5771-991b-7a59873e2d80.html
Abstract:
Merck, Schering to pay $5.4M to resolve probes by 35 states into cholesterol drug studies
Full text:
Drugmakers Merck & Co. and Schering-Plough Corp. said Wednesday they will pay $5.4 million to settle a multistate investigation that the companies delayed the release of test results casting doubt on the effectiveness of two blockbuster cholesterol drugs.
The companies settled with attorneys general from 35 states and the District of Columbia. The investigation centered on allegations the companies kept quiet the results from an unfavorable study, violating consumer protection laws. Merck and Schering-Plough will pay back the costs of the investigation, but don’t have to make other payments or admit wrongdoing or liability.
In January 2008, the companies released study data showing Vytorin and Zetia, sold by the Merck/Schering-Plough Pharmaceuticals joint venture, were not more effective than an older, much-cheaper drug at reducing plaque buildup in the blood vessels of the neck. The testing was finished in 2006 and the companies faced criticism for not releasing the results sooner.
The study compared Zetia and Vytorin to Zocor, a drug that is one of Vytorin’s ingredients. Zocor is available as a low-cost generic drug. Later studies raised additional concerns about safety and effectiveness.
Kentucky Attorney General Jack Conway said the companies agreed to get advance Food and Drug Administration approval for all TV advertisements aimed at consumers and comply with FDA suggestions to modify that advertising. Additionally, the companies will register clinical trials and report results and agreed to comply with rules barring the deceptive use of those trials, avoid ghost writing of articles by physicians, and reduce conflicts of interest on boards monitoring clinical trials.
The state of Kentucky — where the agreement was filed — will receive $100,000 in the settlement.
Merck, of Whitehouse Station, N.J., and Schering-Plough, based in Kenilworth, N.J., said they will continue to comply with laws requiring the truthful and non-misleading marketing of their drugs. A study published in the New England Journal of Medicine showed Merck and Schering-Plough spent $200 million to market Vytorin and Zetia to consumers in 2007.
“We think this agreement is consistent with what we’ve said and what we believe, which is that the company conducted the ENHANCE trial in good faith and that our promotion of Zetia and Vytorin were in compliance with the law,” said Merck spokesman Ron Rogers.
Rogers said settling for legal costs was in the best interest of all concerned and lets Merck and Schering-Plough remain focused on creating new medicines and vaccines.
The settlement does not resolve all the lawsuits and investigations involving the drugs, however. In a May regulatory filing, Merck disclosed that subcommittees from the U.S. Senate and House of Representatives have asked the company and Schering-Plough to interview employees and examine documents related to Zetia and Vytorin. Merck also disclosed that the Justice Department is investigating the companies’ conduct in selling the drugs, and the possibility that they may have submitted false claims to federal health care programs as they promoted Vytorin.
Merck said it was then aware of 145 civil class action lawsuits related to the drugs.
The 35 states involved in Wednesday’s settlement are Arizona, Arkansas, California, Colorado, Delaware, Florida, Hawaii, Idaho, Illinois, Iowa, Kentucky, Louisiana, Maine, Massachusetts, Michigan, Mississippi, Missouri, Montana, Nebraska, Nevada, New Jersey, New Mexico, North Carolina, North Dakota, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Vermont, Washington, West Virginia, and Wisconsin.
Merck is in the process of buying Schering-Plough for $41.1 billion. Merck shares rose 55 cents, or 2 percent, to close at $27.71. Schering-Plough stock added 45 cents, or 1.8 percent, to $25.37.
