Senator McCain Quit Vytorin After ENHANCEMay 28, 2008 | Parker Waichman LLP
Many former Vytorin patients switched off the expensive drug after a study -called ENHANCE - released earlier this year showed it was no more effective than cheaper statins. Now it turns out that one of those patients was none other than Republican presidential nominee Senator John McCain.
Vytorin, which was developed and marketed jointly by Merck and Schering-Plough, was approved for use by the Food & Drug Administration (FDA) 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 - known generically as simvastatin. 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. In March, the full ENHANCE study was vetted during the annual meeting of the American College of Cardiology (ACC). 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.
Last week, the McCain campaign released the Senators health records. Apparently, the presidential candidate was taking Vytorin until the ACC made its recommendation. At that time, Sen. McCain's internist had him start taking a generic statin instead. Since the switch, the Senator's LDL (bad) cholesterol has jumped from 83 to 123. Some doctors who spoke with The Wall Street Journal were of the opinion that Sen. McCain should be taking a higher dose of the generic statin, or should switch to a more potent type of statin.
Some Vytorin critics also told the Journal that it was patients like McCain that caused them to be concerned about the once-popular drug. Chris Cannon, a cardiologist at Brigham and Women’s Hospital, Boston said that there isn’t any evidence that combining 10 milligrams of Zetia and 10 milligrams of simvastatin reduces heart attack risk despite the lower LDL levels. But patients like McCain, by achieving an LDL of 83, might be lulled into thinking they were getting the benefit.