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› $4.85 Billion settlement in drug case
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.
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.
Cholesterol-fighting medicine may fail some people, as the controversial and embattled drug Vytorin illustrates, but now medical technology provides a solution for those who just can’t lower their cholesterol any other way: a low-density lipoprotein (LDL) apheresis machine.
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.
The cholesterol-fighting drugs Zetia and Vytorin, blockbuster drugs that once represented multi-billion dollar sales for Schering-Plough and Merck, now seem to be squeezing the pharmaceutical giants.
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.
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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