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Doctors Divided Over Loss of Experimental Cholesterol Drug
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Page: << Prev | 1 | 2 | 3 Myerburg added, "I don't think there's any sense at this point of whether this is a class effect."
Heart patients still have other options, however, namely the cholesterol-lowering statins.
And, with the Pfizer study cut short, it's also unclear if torcetrapib would have turned out to be a blockbuster along the lines of Lipitor.
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"There was no reason to think that there would be this kind of harm, but the other side of the coin is how much added benefit would this strategy have given to what we already have," Myerburg said. "There could have been a surprise there. We could have been wrong on the upside as well."
Perhaps the only good news for Pfizer is that the negative study results came out in pre-marketing studies, thus avoiding the litigation problems Merck & Co. is now facing with its derailed arthritis drug Vioxx.
The torcetrapib study was large enough to detect a relatively small number of problems. Usually such issues only surface when a drug is approved and marketed.
"Most studies aren't that big," Myerburg said. "This is a statement about the importance of doing adequately sized trials and of doing post-marketing studies. Cut this study in half, and you might have seen a benefit but missed the adverse effects."
More information
For more on cholesterol and heart disease, visit the American Heart Association (www.americanheart.org).
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Copyright © 2006 ScoutNews, LLC. All rights reserved.
Last updated 12/4/2006
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SOURCES: Raymond Gibbons, M.D., president, American Heart Association, and professor of medicine, and co-director, Nuclear Cardiology Lab, Mayo Clinic, Rochester, Minn.; Daniel Fisher, M.D., clinical assistant professor of medicine, New York University School of Medicine, New York City; Robert J. Myerburg, M.D., professor of medicine and physiology, University of Miami School of Medicine; U.S. Food and Drug Administration statement, Dec. 4, 2006
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