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› $4.85 Billion settlement in drug case
More bad news for the cholesterol-lowering drug Vytorin. The drug has been under scrutiny lately for everything from elevated cancer risk and serious side effects to ineffectiveness. This week, the Food and Drug Administration (FDA) issued a safety announcement about simvastatin, one of the two active ingredients found in the medication, and an increased risk of a potentially life-threatening muscle injury.
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.
For a while it seemed as if sales of Merck’s blockbuster anti-cholesterol drug Vytorin would plummet into oblivion. Unfavorable and botched ENHANCE trial results, harrowing SEAS trial results, lawsuits filed on behalf of individuals and government, congressional inquiries, and so on plagued Merck and co-creator Schering-Plough because it looked as if Vytorin was at best a dud and at worst a cancer-inducing danger.
Should municipalities be allowed to reclaim the money it spent on expensive prescriptions if the prescribed drug turns out to be a dud? For the city of New Haven, CT, the answer is yes. According to a report in the New Haven Independent , the city’s top lawyer, John Ward, wants more than $400,000 back from Vytorin manufacturers Merck and Schering-Plough.
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