The Vytorin controversy is still hurting sales of the once-blockbuster cholesterol drug, with prescriptions down one-third this year. To stem the bleeding, Schering-Plough, which markets Vytorin with Merck & Co., has announced that it will be eliminating 20 percent of its sales force. The elimination of 1000 sales reps is part of companywide reductions announced earlier this year aimed at cutting $1.5 billion in costs by 2012.
Vytorin’s troubles started in January, with the release of the long-delayed ENHANCE study. That study showed that Vytorin was ineffective in preventing clogged arteries, and might actually increase plaque in some users. When ENHANCE was vetted during the annual meeting of the American College of Cardiology in March, doctors there recommended that it be used only as a last resort. “Our strongest recommendation is that people need to go back to statins,” said panel member Dr. Harlan Krumhotz.
While the ENHANCE results caused a stir, even more controversy surrounded the way it was handled. Merck and Schering-Plough delayed releasing ENHANCE for more than a year – something critics have likened to fraud. In addition, the companies attempted to change the study’s endpoint – the main result it was meant to measure – after it was completed. 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. The companies dropped their attempt to change the ENHANCE endpoint shortly thereafter.
Vytorin took another hit over the summer, when the SEAS study was released. SEAS was designed to see if the drug helped people with aortic stenosis avoid heart attacks. Not only did SEAS show that Vytorin offered no additional heart attack prevention, but Vytorin patients enrolled in the study had higher rates of cancer than those taking a placebo. In the trial, 102 patients taking Vytorin developed cancer, compared with 67 taking the placebo. Of those, 39 people taking Vytorin died from their cancer, compared with 23 taking placebo. Researchers conducting the study said that while those numbers don’t prove a definitive cancer link, they were “statistically significant”, meaning the odds were less than 5 percent that they were the result of chance.
At the time it released SEAS, Merck and Schering-Plough also released an analysis of ongoing Vytorin trials that they said showed the SEAS cancer results to be an anomaly. But not everyone is convinced, and Congress recently expanded its Vytorin investigation to include the handling of SEAS.
At its peak, Vytorin posted sales of $5 billion. With its sales now in the tank, Schering-Plough had to find ways to reduce costs. Schering-Plough Chief Executive Officer Fred Hassan said in April that the company would trim 10 percent off its 2007 costs to offset the decline. In addition to reducing the sales force, Schering-Plough is firing workers after acquiring Organon Biosciences NV.
“The company emphasized that it highly values the work of its sales professionals, and so the decision to eliminate positions was difficult,” Schering-Plough said in a statement announcing the cuts.