Vytorin Expert Panelist: ‘I’m An Honest Guy’

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james-stein.jpgSo says Jim Stein, the University of Wisconsin cardiology professor who participated in an expert panel convened last year to examine the infamous Enhance trial data. Stein was the expert whose review of a hastily composed summary of the meeting last November was released last Friday by the House Energy and Commerce Committee (look here). And his proposed revisions included remarks suggesting the initial draft contained a laundry list of inaccuracies, exaggerations and questionable assertions by Schering-Plough and Merck, which jointly market Vytorin.

The trial data was released this year and indicated that Vytorin failed to show any benefit over the much cheaper Zocor in reducing plaque in the carotid artery, and even showed a statistically insignificant buildup, although it did a better job of lowering LDL in a small group of patients with inherited high cholesterol. Three days after the panel met last fall, stories appeared about the ongoing delay in releasing data, raising questions about the motives of the drugmakers, which issued a press release saying, among other things, its expert panel recommended changing the primary endpoint.

By mid-December, the House committee began its investigation and, on the same day, the drugmakers announced they would not change the endpoint. Four days later, the proposed minutes were sent to Stein, who was surprised because he was told at the panel meeting that minutes weren’t being kept. In his view, the unexpeced draft read like an “incomplete summary.” And his proposed revisions to the draft confirm what the primary investigator, John Kastelein, maintained all along - the drugmakers suggested changing the primary endpoint.

“I’m an honest guy, and my first obligation is to tell the truth,” Stein tells Forbes. “Even if it means I’ll probably never get to do a scientific investigation with Schering-Plough again…We never made a recommendation to change any endpoints. We simply gave our opinion,” Stein tells Forbes. “At the end of the day, most people thought it was reasonable to change the endpoint. But we had no power to change the endpoint. That was in the hands of the principal investigator and the company. We never made that recommendation.”

“For anyone to say the data in the study are bad, they either need to say that John Kastelein is a liar, which I’m certain he is not, or they need to talk to the (Schering-Plough) statisticians for the study and ask them if there are any problems with the data,” he tells the mag. “All along I thought I was being asked for my honest scientific opinion. I never saw any signs anyone was trying to delay release of any data. But I only worked with a select group of people from the company…I’m not concerned with what Merck or Schering think of me, so long as they don’t call me dishonest.”

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  1. It’s really refreshing to hear someone speak out regarding their concerns about the way the pharmaceutical industry conducts its’ business. Jim Stein is an honest guy with a lot of courage. He values his integrity more than the consultant fees and business from the drug companies. How refreshing is that? Particularly given the blast of conflicts that have emerged over the past several months! We need more leaders in academia who share his approach of doing the right thing!

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