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› $4.85 Billion settlement in drug case
The U.S. Food and Drug Administration announced today that it found no clear link between Merck’s blockbuster cholesterol drug Vytorin and increased risk of cancer, but it could not rule out the possibility that such a link exists. The agency reviewed data from three Vytorin trials, including the controversial SEAS trial results, which Merck had withheld from the public for 18 months as it aggressively marketed the drug.
Vytorin has struck out again, this time in a clinical trial that compared the drug’s safety and efficacy to a prescription form of the B vitamin niacin. The results of the trial, which the New England Journal of Medicine featured in an article and two editorials, were presented Sunday at an American Heart Association meeting and showed that in a direct comparison, niacin worked significantly better than Vytorin and Zetia in reducing arterial blockages. According to a report in NPR, “This study is the third to question whether ezetimibe drugs do what they’re supposed to.”
Merck and Schering-Plough, the pharmaceutical giants whose joint venture produced the blockbuster cholesterol drug Vytorin, agreed to pay $41.5 million to settle 140-plus New Jersey lawsuits lodged against the manufacturers for misleading and improper marketing of the drug and for withholding the results of a clinical trial that showed Vytorin to be a dud.
Vytorin has come in at the No. 3 spot on a list of the Top 10 Medical Stories of 2008 – and not in a good way. Dr. Kate Scannell, columnist for the Contra Costa Times, which serves the California Bay Area, listed the drug under the header “statin madness.”
Dr. Scannell said the drug made her list as a result of two studies that revealed Vytorin, which is a combination of simvastatin (Zocor) and ezetimibe (Zetia), did not reduce artery-clogging plaque buildup, although tests showed it reduced “bad” cholesterol levels.
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