Vytorin Probe Targets Message Board PostsFeb 14, 2008 | Parker Waichman LLP
The Vytorin probe in Congress took another turn this week, with investigators seeking information on several posts left on internet message boards frequented by people working in the pharmaceutical industry. Vytorin, and its makers Merck and Schering-Plough, have been under investigation by the House Energy and Commerce Committee since the release of the ENHANCE study earlier this month showed Vytorin was ineffective. The Vytorin congressional investigation is now focusing on postings to message boards on the website Cafepharma.com made by pharmaceutical sales representatives in 2007. These postings indicate that their authors were already aware of the ENHANCE results.
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 nearly 2 years – something critics of the company have likened to fraud.
The Cafepharma.com postings that have caught attention of congressional investigators where made in 2007, months before Merck and Schering-Plough released ENHANCE. One set of postings from March 2007 states "have a buddy at (Schering-Plough Research Institute). He says that the study is a bust. Adding Zetia to already maxed out statin is useless." Another from June 2007 said "heard it crashed and burned!"
Several lawmakers are concerned that the postings indicate Merck and Schering-Plough executives knew Vytorin was ineffective but deliberately kept the ENHANCE results from the public. "These Web site entries are obviously troubling and raise again the question of whether anyone within Merck or Schering-Plough knew the results of the Enhance trial prior to the official release," Michigan Reps. John Dingell and Bart Stupak said in a letter to the companies.
The lawmakers also sent letters requesting information about who may have posted the messages to Cafepharma.com and SoftLayer Technologies Inc, which they said operates the Web site. The sites Webmaster, Sarah Palmer, said in an e-mail sent to the Associated Press late Tuesday that the site does not collect user information with anonymous posts on its message boards and so she did not believe it had any user information to give the committee.