On the SEAS-Vytorin-cancer debate -- do read the full article -- some of the latest pull-quotes, from experts attending the debate:
. . . .an editorial in the influential New England Medical Journal, which published the full data from the Vytorin study online, said the safety of the drug was now in doubt, and several leading doctors also expressed concerns.The full report on the trial, involving 1,873 patients, showed a total of 105 cancer cases among Vytorin patients compared with 70 taking a placebo. That was an upward revision from the totals of 93 and 65 reported in July.
Lead investigator Terje Pedersen of Ulleval University Hospital in Oslo, however, said cross-checks with cancer rates in two much larger, ongoing trials simply did not support the idea that Vytorin was linked to cancer.
Other leading cardiologists were not so sure.
"I think the jury is still out as to whether there's a cancer signal," said Dr. Gordon Tomaselli, chief of cardiology at Johns Hopkins Hospital, and spokesman for the American Heart Association. Tomaselli was not connected to the research. . . .
"I am quite concerned," Heinz Drexel, professor of medicine at the University of Innsbruck in Austria told Reuters. "At the moment, I would not take ezetimibe myself," Drexel said, although he urged patients not to stop treatment without consulting their doctor. . . .
This isn't going to play very well. . . . for Schering-Plough. I cannot explain why this ESC debate isn't the updated lede to the New York Times "Evidence Gap" series, this morning. . . .
2 comments:
Condor,
Take a look at Ed Silverman's latest article that Congress is concerned that there may have been a second 'secret' report on the Vytorin cancer risk that was not provided to Congress by FDA.
http://www.pharmalot.com/2008/09/was-the-fda-given-a-secret-vytorin-report/
Salmon
Thanks for the tip!
Now it's a new post!
Cheers!
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