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Vytorin Emails Raise Questions About ENHANCE Delay

Apr 1, 2008 | Parker Waichman LLP

The Vytorin fallout continues, with one lawmaker demanding that Vytorin's makers explain why the results of a crucial study were delayed for more than a year.  The request for more information on the delayed Vytorin study came just a day after a panel of prominent cardiologists recommended that Vytorin be used only as a last resort, because there is no evidence that the expensive medication provides any more benefits than a cheaper statin in preventing heart disease.

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 ENHANCE, which was released on January 14, showed that Vytorin was 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.

Over the weekend, 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.

Now, Senator Charles Grassley (R-Iowa) has sent a letter to Merck and Schering-Plough seeking more explanation on the delay in releasing ENHANCE.  According to The Wall Street Journal, Sen. Grassley, a member of the Senate Finance Committee, is among several lawmakers probing whether the companies deliberately withheld negative information to protect sales of Vytorin and a sister drug Zetia. The companies have denied that and said they were trying to resolve issues with flaws in the data.

At issue are a series of emails between company executives and the ENHANCE study's lead researcher, John P. Kastelein of Academic Medical Center, Amsterdam, that indicate that Kastelein was upset  with the companies decision to withhold ENHANCE from last November's America Heart Association meeting.  Excerpts of the emails were released in Sen. Grassley's letter.  "If this is true, [Schering-Plough] must have taken this decision without even the semblance of decency to consult me," Kastelein wrote in an email sent July 6.  "I can tell you if this is the case, our collaboration is over. This starts smelling like extending the publication [of the study] for no other [than] political reasons and I cannot live with that."  

Sen. Grassley's letter said the e-mails, supplied by the companies, indicated Schering-Plough and Merck may have delayed for more than a year releasing results ENHANCE, for "marketing purposes." Sen. Grassley also asked for details about payments made to researchers and doctors who promoted the Vytorin.


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