Vytorin Lawsuit Alleges Merck and Schering-Plough Knew Drug Was Ineffective in 2006Jan 17, 2008 | Parker Waichman LLP
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 LLP along with Becnel Law Firm, Douglas & London, P.C., Levin Simes Kaiser and Gornick LLP, Bailey Perrin Bailey LLP, and Wietz & Luxenberg P.C. The Vytorin lawsuit, which was filed today in United States District Court for the Eastern District of New York, is seeking Class Action status to represent all Vytorin users in the U.S.
Vytorin, which was developed and marketed jointly by Merck and Schering-Plough, was approved for use by the Food and Drug Administration in 2004. Since it came on the market, Vytorin sales have reached $5 billion per year. Vytorin 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 – a major risk factor for heart attacks and strokes. Doctors and Vytorin users were led to believe that the drug would effectively reduce both sources of cholesterol, thereby lessening the amount of plaque build up in the arteries, as well as the risk of having heart attacks and strokes.
But Merck and Schering Plough knew in April 2006 that Vytorin was in fact not effective in reducing arterial plaque. It was then that the so-called ENHANCE study on the effectiveness of Vytorin in preventing progression of atherosclerosis – the buildup of artery clogging plaque – was completed. ENHANCE, which began in June 2002, 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. In fact, some of the Vytorin patients in ENHANCE actually developed more arterial plaque than those taking Zocor alone, putting them at an even greater risk of heart attacks and strokes.
The ENHANCE study was supposed to have been released by Merck & Schering-Plough in November 2006, but that was delayed by the companies until March 2007. Then Merck and Schering-Plough announced the release of ENHANCE would be delayed again until March 2008. The drug makers also announced that they would be changing the ENHANCE study’s endpoint – the main medical result the study was meant to measure. It is generally accepted that for a clinical trial to be effective, a study’s endpoint must be set at its beginning and remain unchanged. In December 2007, in response to the ENHANCE delays and the attempt by Merck and Schering-Plough to change the endpoint, Congress initiated an investigation of the ENHANCE study.
"Delaying ENHANCE and the attempt to change the study's endpoint is an attempted fraud on their customers, the public and the FDA," said Jerrold Parker, a partner in the law firm of Parker Waichman LLP, one of the firms representing Tomaszewski. "Merck and Schering-Plough knew Vytorin was ineffective, yet covered it up for nearly two years."
On January 14, 2008, the results of the ENHANCE study where finally published, and they where devastating. ENHANCE made it clear that Vytorin provided no added protection from clogged arteries, heart attacks and strokes. By concealing the results of the ENHANCE study for so long, millions of people continued taking Vytorin, unaware that the dangerous drug did nothing to lessen their risk of clogged arteries, heart attacks and strokes.