WSJ Health Blog Flogs Vytorin Again

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Scott Hensley of the Wall Street Journal Health Blog just posted this:

Merck and Schering-Plough attempted to recreate information from a crucial meeting about a major study on cholesterol blockbuster Vytorin after a Congressional panel began an investigation, according to documents obtained by a Congressional subcommittee, the WSJ reports.

In a letter Friday, Rep. John Dingell (D-Mich.) and Rep. Bart Stupak (D-Mich.) asked why minutes of the companies’ ad hoc expert panel, which had met in mid-November, had been “created after the fact? in December. Spokesmen for Merck and Schering-Plough couldn’t be reached immediately by the WSJ for comment.

The minutes, circulated Dec. 19, a week after Dingell’s investigation began, suggest that the companies’ experts had agreed to move the goal post for the study, which would have made Vytorin and its sister drug Zetia look better. Internal company documents released by the House Commerce Committee, which Dingell chairs, include strong complaints from one of the study panel members. Click on image at right to see the documents.

“It was my understanding that there were no minutes or transcript of this meeting,? James Stein, a cardiac imaging expert at the University of Wisconsin, wrote in an email to Schering-Plough. (See his comment to the same effect in the margin of draft minutes that appears in the image above.) Some of the new minutes of the Nov. 16 meeting didn’t accurately represent his recollections or details of the debate during the meeting said Stein in an email to Schering-Plough.

“It was the decision of the company to change the endpoint,? Stein wrote in comments back to company about the minutes.

The companies had issued a press release on Nov. 19, shortly after the consultants’ meeting saying the outside experts recommended such a change, which is contrary to generally accepted scientific practice.

Earlier this month the Merck/Schering-Plough joint venture that sells Vytorin made public an email exchange with John Kastelein, the cardiologist who ran the study called Enhance, and who had objected to the proposed change in the endpoint for the study.

In March, Forbes’ Matt Herper laid out the challenge for Dingell’s panel posed by the creation of minutes from the meeting after the fact. The retrospective memo writing, he wrote, “could also make it more difficult for the companies to defend their own decision making with regard to the study.?

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This page contains a single entry by Gary Schwitzer published on April 11, 2008 2:57 PM.

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