Jul 15, 2009 3:33 pm US/Central
Cholesterol Drug No More Effective Than Generics
CHICAGO (Sun-Times Media Wire) ―
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Drug developers Merck & Co. and Schering-Plough Corp. on Monday said patients with a predisposition to high cholesterol fared no better when taking their combination cholesterol drug Vytorin than with a high dose of the generic form of Zocor.
CBS
The attorneys general of 36 states including Illinois have reached a $5.4 million settlement with the makers of cholesterol-lowering drug Vytorin after its producers delayed releasing test results showing it was no more effective than a generic.
The AGs reached the settlement with Merck & Co., Schering-Plough Corp. and a joint venture called MSP Singapore Co. to resolve an investigation into the lengthy delay in releasing negative clinical trial results, according to a release from Atty. Gen. Lisa Madigan's office said.
The investigation focused on allegations the companies engaged in unfair and deceptive practices after failing to promptly report unsatisfactory results from a clinical trial about the health effects of Vytorin, a cholesterol-lowering drug found to be no more effective in reducing plaque in carotid arteries than a cheaper, generic equivalent.
At the end of the clinical trial in May 2006, the companies promoted Vytorin in consumer ad campaigns as more effective than other medications, a claim that was contrary to the clinical trial results.
Trial managers allegedly waited nearly two years until January 2008 to report the results and another four months to produce the complete results of the study, the release said. Throughout that lengthy period, the companies allegedly continued to promote Vytorin as a more effective cholesterol-lowering drug.
The settlement mandates that the companies to:
-- Obtain pre-approval from the FDA for all direct-to-consumer TV ads;
-- Comply with FDA suggestions to modify advertising;
-- Register clinical trials and post results;
-- Prohibit ghost writing of articles;
-- Reduce conflicts of interest for members of 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.
In addition, the companies agreed to pay the states' $5.4 million investigation costs, from which Illinois will receive $200,000.
Attorneys General from the District of Columbia and the following states also participated in today's agreement: Arizona, Arkansas, California, Colorado, Delaware, Florida, Hawaii, Idaho, Iowa, Illinois, 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.
(Source: Sun-Times Media Wire © Chicago Sun-Times 2009. All Rights Reserved. This material may not be published, broadcast, rewritten, or redistributed.)
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