Lawmakers Pressing for Answers on Vytorin StudyAug 21, 2008 | Parker Waichman LLP
Two lawmakers want to know why the press release detailing a Vytorin study issued by drug makers Merck and Schering-Plough differed from information released by the study's authors. Rep. John Dingell, D-Mich., Chairman of the House Energy and Commerce Committee, and Rep. Bart Stupak, D-Mich., say they are "troubled" by the confusing nature of the information, and have written the companies, asking them to clarify which data are correct.
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 (ezetimibe) and the statin Zocor (simvastin). 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.
The study that has attracted the attention of Dingell and Stupak is known as SEAS. It involved 1873 patients, and investigated the effects of Vytorin in patients with aortic stenosis. Aortic stenosis involves partial blockage of the aortic valve in the heart. Left untreated, it can progress to death from heart failure or cardiac arrest. Aortic valve replacement for severe symptoms is the second most frequent type of heart surgery. Apart from surgery, there is no medical therapy known to prevent or heal this condition.
In addition to failing to show that Vytorin did much to help patients with aortic stenosis avoid other heart problems, a safety analysis of SEAS found that Vytorin patients in the study had higher rates of cancer and cancer deaths. According to information released by researchers, 102 patients taking Vytorin developed cancer, compared with 67 taking the placebo.
But Merck and Schering-Plough's press release said there were only 93 cancer cases among patients taking Vytorin, with 65 among people on a placebo. In the press release, the companies have maintained that the SEAS cancer findings are an anomaly, and said that an analysis of the findings authored by Sir Richard Peto, co-director of the Oxford University Clinical Trials Service Unit, had reached such a conclusion.
So far, Merck and Schering-Plough have not released that report to the House Energy Committee because the companies don't want it made public. However, the FDA has been given a copy of the report.
Dingell and Stupak said they found the companies' reluctance to furnish the study to the committee "questionable". They also question Peto's ties to both Merck and Schering-Plough, and want to know if he or the Clinical Trials Service Unit were paid by the companies.
The House Energy and Commerce Committee has been investigating Vytorin since January, when Merck and Schering-Plough finally released the long-delayed ENHANCE study. ENHANCE showed Vytorin 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.