BREAKING NEWS (1/17/2008): A lawsuit has been filed by the law firm of Parker Waichman Alonso LLP to get a refund for those who use Vytorin.
The makers of Vytorin have been named as defendants in a lawsuit filed by a New York man who took the defective drug based on the belief that it offered more protection from clogged arteries, heart attacks and strokes than other, less expensive statin drugs. Sigmond Tomaszewski, who began taking Vytorin in January 2007, alleges that Merck and Schering-Plough knew in April 2006 that Vytorin was ineffective at reducing artery clogging plaque, heart attacks and strokes, but purposely kept that information from the public and the medical community. Tomaszewski is being represented by the law firm of Parker Waichman Alonso LLP...
1/16/08 Letter from Congress to Schering-Plough Merck PDF
1/16/08 Letter from Congress to FDA PDF
1/22/08 Letter from Congress to Centers For Medicare and Medicaid Services PDF
1/22/08 Letter from Congress to Schering-Plough Merck PDF
Vytorin Ineffective in Preventing Clogged Arteries
Vytorin, developed and marketed jointly by Merck and Schering-Plough, is a combination of cholesterol-lowering Zetia and the statin Zocor. Statins like Zocor reduce the amount of cholesterol produced by the liver, while Zetia lessens the amount of cholesterol in food that is absorbed in the intestines. High cholesterol levels put a person at risk of developing clogged arteries. It was thought that by using Vytorin to reduce both sources of cholesterol, the amount of artery clogging plaque would also be reduced.
A long-awaited study on the effectiveness of Vytorin called ENHANCE was finally released by Merck and Schering-Plough on January 14, 2008. ENHANCE had been designed to show whether Vytorin was more effective than Zocor alone in preventing progression of atherosclerosis in the carotid artery, which is in the neck. Such plaque buildup is a major risk factor for heart attacks and stroke.
The ENHANCE study focused on a group of 720 patients with a rare condition predisposing them to high cholesterol. The patients were given either Vytorin or a high dose of simvastatin, the generic form of Zocor. The ENHANCE study found that Vytorin worked no better to reduce clogged arteries than a high dose of a less-expensive, generically available statin alone.
Since its approval by the Food & Drug Administration (FDA) in 2004, an average of 1 million Vytorin prescriptions have been written each year. Countless people have taken the expensive drug believing it would reduce their chances of having a heart attack or stroke. Now it turns out that these Vytorin patients would have been just as well-served if they had simply taken a cheaper, cholesterol lowering statin.
Controversy Surrounding the ENHANCE Study
The medical community, eager to know if Vytorin lived up to its promise, had anxiously awaited the results of ENHANCE. But doctors and patients were forced to wait longer than expected for the ENHANCE data. The ENHANCE results should have been released by March 2007, but that didn’t happen. In November 2007, the doctor who supervised the ENHANCE trial told the New York Times that the drug’s’ makers, who controlled the study’s raw data, blocked its release. In December of that year, a congressional committee requested more information on the ENHA NCE study. Merck and Schering-Plough maintained that the ENHANCE results were delayed because of the complexity of the data. According to the New York Times, Merck and Schering-Plough also tried at one point to change the ENHANCE study’s endpoint. The endpoint is the main medical result the study was meant to measure, and it is generally accepted among scientists that for a clinical trial to be valid, the endpoint must never change. In December 2007, following a great deal of outcry, Merck and Schering-Plough scrapped plans to change the ENHANCE endpoint.
Some question whether or not the Merck and Schering-Plough decision to delay releasing ENHANCE and the attempt to change the study’s endpoint could have been inspired by the disappointing Vytorin findings. Combined Vytorin and Zetia sales were about $3.7 billion for the nine months ended September 30, 2007, up 33% from the year-earlier period. The results of ENHANCE put those Vytorin sales at risk, as many doctors may opt to prescribe the generic version of the Zocor alone, rather than the combo pill Vytorin. Generic versions of Zocor cost roughly $1 per pill, compared with about $3 per Vytorin tablet. Obviously, Merck and Schering-Plough had reason to protect the reputation of Vytorin.
Legal Help
Parker Waichman Alonso LLP is currently evaluating Vytorin product liability lawsuits against Merck and Schering-Plough. If you or a loved one used Vytorin under the assumption that it would reduce the risk of clogged arteries, heart attack and stroke, you may have valuable legal rights. Please fill out our online form or call our office a 1-800-529-4636 for a free case evaluation by a qualified drug side effects attorney.
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