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Lawmakers Question Accuracy of Vytorin Meeting Minutes

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An investigation into the Vytorin mess has found that Merck and Schering-Plough’s explanation as to how a decision was made to change the endpoint of the ENHANCE study may not be accurate.  In November, the companies had announced that the endpoint – the main measure by which Vytorin would be evaluated – would change.   Merck and Schering-Plough had stated that a panel of experts had recommended the change, and minutes compiled by the companies from a November 2007 meeting on Vytorin reflect this explanation.  But according to documents released by a Congressional Committee investigating the way ENHANCE was handled, those minutes were written a full month after the meeting took place.  The documents also indicate at least one participant in that meeting raised concerns that those minutes did not accurately reflect what took place there regarding the Vytorin study’s endpoint.

According to The Wall Street Journal, Rep. John Dingell (D-Mich.) chairman of the House Energy and Commerce Committee, and Rep. Bart Stupak (D-Mich.) chairman of the Subcommittee for Oversight, sent a letter to Merck and Schering-Plough on Friday asking why minutes of the November meeting were “created after the fact” in December.

Documents obtained by the House of Representatives Energy and Commerce Committee show that Merck and Schering-Plough held a meeting to discuss ENHANCE on November 16, 2007. On December 19 – one week after Congress started investigating Vytorin – minutes for the meeting were circulated. According to The Wall Street Journal, the minutes suggest that at the November meeting, outside consultants had recommended that the companies make a critical change in the ENHANCE study’s primary endpoint — the main measure for how the drug would be evaluated.

But other documents released by the Congressional Committee dispute the minutes. After receiving the minutes, James Stein, a cardiac-imaging expert at the University of Wisconsin who was present at the November meeting, wrote in an email to a Schering-Plough scientist: “It was my understanding that there were no minutes or transcript of this meeting.” He also told a company scientist in an email: “We did not vote on this….It was the decision of the company to change the endpoint.”

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.

A Schering-Plough spokesperson told the Journal that only notes were taken at that meeting, and the minutes eventually were produced after the FDA requested them.

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. 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.

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