New prescriptions for Vytorin were down last week, following last month’s recommendations from some top cardiologists that Vytorin be used only as a last resort. That recommendation followed the release of the ENHANCE study that showed Vytorin worked no better than cheaper cholesterol medications.
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 the ENHANCE study, which was released on January 14, showed that Vytorin and Zetia were ineffective in preventing clogged arteries, and might actually increase plaque in some users. In spite of the findings, Merck and Schering-Plough delayed releasing ENHANCE for more than a year – something critics of the company have likened to fraud. Last month, the full ENHANCE study was vetted during the annual meeting of the American College of Cardiology. A panel of four doctors concluded that Vytorin should be used only as a last resort, considering that the expensive drug did not provide any added benefits. “Our strongest recommendation is that people need to go back to statins,” said panel member Dr. Harlan Krumhotz.
According to Verispan, a drug data research firm, total U.S. Vytorin prescriptions for the week ended April 4 were flat with the week ended March 28, at about 306,000. However, new prescriptions written last week – as distinct from refills of older prescriptions – fell about 6% for Vytorin.
Prescriptions for Vytorin and Zetia had already been on the decline since mid- January, when ENHANCE was first released. It was thought prescription volume would recover, but those hopes have mainly been dashed since the calls for reduced usage made at the medical meeting March 30.
Already, Schering-Plough – where sales of Vytorin and its sister drug Zetia accounted for 60% of profits – is bracing for the hit its bottom line will sustain from the debacle. Last week, the company said it planned to cut costs by $1.5 billion by 2012. Roughly 5,500 employees will lose their jobs, or about 10 percent of the company’s workforce. Manufacturing plants will be shuttered and layers of middle and senior management slashed. Sales and marketing staff will also take cuts, as will R&D.