April 11, 2008, 2:46 pm
Minutes for Key Vytorin Meeting Were Written A Month Later
Posted by Scott Hensley
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. In a statement, Merck/Schering-Plough, the joint venture that markets Vytorin and a sister drug Zetia, said it is cooperating with the congressional committee on the investigation and that documents that were released “are entirely consistent with the account of the facts” the companies have disclosed publicly and to the committee staff.
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 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. He had objected to the proposed change in the endpoint for the study, whose results weren’t released until nearly two years after the last patient had completed the trial. Battles over the data and how they should be analyzed led Kastelein to call Enhance a “trial out of hell,” in an interview with the Health Blog.
In March, Forbes’ Matt Herper laid out the challenge posed for the Dingell investigation by the creation of meeting minutes after the fact. The retrospective memo writing, Herper wrote, “could also make it more difficult for the companies to defend their own decision making with regard to the study.”
In an interview with theheart.org about the panel last month, Stein said, “Maybe I’m naive, but I never got the sense that anything improper was going on.” He did say, however, “that it was ‘irregular’ that the results were delayed, that the panel was convened, and that the results were presented in a press release,” theheart.org wrote.
Health Blog Document Bonus: Deep in the PDF, you can find evidence of friction between Schering-Plough and Merck over Enhance. Hint: Page 52. 关键Vytorin专家会议纪要不准确有误导
A Key Vytorin Memo Was Misleading And Inaccurate
Last November 16, an expert panel meeting was held at the Omni Shoreham Hotel in Washington, DC, to review the results of the infamous Enhance trial that was designed to boost the prospects of the Vytorin cholesterol pill jointly marketed by Schering-Plough and Merck. The panel consisted of five outside experts and 11 employees of the drugmakers, which are being investigated by the House Energy and Commerce Committee for allegedly manipulating the trial data in order to maintain the multi-billion-dollar Vytorin cash cow.
But the meeting notes contain a plethora of inaccuracies, exaggerations and questionable assertions by the drugmakers, according to notes written in the margins by Jim Stein, a University of Wisconsin cardiology professor and one of the outside experts. The notes and related e-mails were released this afternoon by the House committee. (Here are the notes and e-mails).
In an e-mail to Schering-Plough’s John Strony, Stein writes that he initially was led to believe there were no meeting minutes so everyone could speak freely and remarks would “not get back to” John Kastelein, the primary investigator. But after reviewing what he calls an after-the-fact, “incomplete summary,” which claims Kastelein “recused himself” from the meeting, Stein adds that some statements “do not fit my recollection” and that he can’t approve them. An example - the ‘minutes’ say the panel decided to change the primary endpoint, when Stein says it was the drugmakers.
作者:admin@医学,生命科学 2011-02-11 05:14