FDA Official Says Agency Won't Take Sides on Vytorin - Then Defends VytorinApr 11, 2008 | Parker Waichman LLP
Criticism of Vytorin is unfair, a Food & Drug Administration (FDA) official said this week. However, CDER director Janet Woodcock said the FDA wouldn't be wading into the Vytorin debate anytime soon for fear of appearing "defensive". Still Woodcock said in an interview that the FDA continues to consider Vytorin an effective means of heart disease prevention because it effectively lowered LDL - or bad - cholesterol. This despite the fact that a recent study showed Vytorin was no better at preventing clogged arteries than cheaper statin drugs. Furthermore, Woodcock's assertions contradict those of a panel of prominent cardiologists who last month said Vytorin should only be used as a last resort.
Vytorin, which was developed and marketed jointly by Merck and Schering-Plough, was approved for use by the 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. 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 (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.
But Woodcock, who after stating in a recent interview that the FDA wouldn't be taking sides, said during the same interview that Vytorin is being treated unfairly, and the media is hyping its problems. “I believe people are piling on right now on one side of the argument. Independent reporters and media, if they really want to have some reasoned approach, ought to step back from that. But what we see right now is everybody just piling on to the same message," Woodcock told the news site FDA Webview. “What happens with these is that there is some little point that the scientists are arguing about, and then the media get on it, and they start throwing the baby out with the bathwater.”
But the cardiologists sitting on the ACC panel weren't members of the media, and its hard to see how their concerns about Vytorin could be overblown. And right now, it appears the recommendations of the ACC panel are resonating with physicians. According to the website FiercePharma, a Deutsche Bank analyst surveyed primary care doctors and found that 75 percent expect usage of Vytorin and its sister drug Zetia will drop in their practices. The analyst now predicts that market share for Vytorin will drop to 9 percent from 16 percent. Zetia, one of the drugs in the Vytorin combo, will see its share drop to 6 percent from 9.5 percent, the analyst concluded.