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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.
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.
Many Americans assume that the Food and Drug Administration adequately tests new drugs for safety before they go on the market and become available to the general population. If your doctor prescribes a new drug to help you lower your cholesterol or help you quit smoking, then that drug must be safe, right?
The answer is a surprising, and disconcerting, NO.
Clinical trials haven’t been kind to Vytorin, Merck and Schering-Plough’s cholesterol brainchild. The first blow was dealt by the ENHANCE study, which showed Vytorin to be no more effective than much cheaper generic statins. Next came results of the SEAS trial, which indicated a link between Vytorin and risk of cancer and death by cancer. A flurry of disputed interpretations, accusations, and controversy followed in the wake of the trials.
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.
Following Vytorin’s recent fall from its blockbuster status, Merck is ratcheting up studies of its new cholesterol fighting drug, The Washington Times reported.
MK-0524A, as the new drug is called, is the subject of a study based in Oxford University in England. Merck submitted the drug to the FDA for approval, but it was rejected last April. The FDA wanted results from the study known as THRIVE (Treatment of HDL to Reduce the Incidence of Vascular Events) before it made another ruling.
Suffolk County, New York, officials are seeking to recover public funds spent on Vytorin prescriptions for its employees. The county contends that defendants Merck and Schering-Plough delayed releasing the results of the ENHANCE trial, which indicated Vytorin to be ineffective and in some cases inferior in reducing the growth of fatty arterial plaque than generic statins alone. From April 2006 to mid-January of 2008, Merck and Schering-Plough withheld the ENHANCE trial results while they continued to aggressively advertise Vytorin.
Is Schering-Plough’s motto, “To Earn Trust, Every Day,” laced with a little irony these days? What about Merck’s maxim “Where patients come first?” Does it evoke feelings of warmth and trust or does it just induce rolling eyeballs?
As news of Vytorin’s lackluster performance in clinical tests circulates throughout the medical community, many prominent physicians are advocating a return to the use of statins to treat high cholesterol. Statins, such as Crestor, Zocor, and Lipitor, lower the liver’s production of LDL (bad) cholesterol. Research shows that statins also reduce cardiac events by 60 percent and strokes by 17 percent.
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