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Nine Viagra Issues And the way To resolve Them

Nine Viagra Issues And the way To resolve Them

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If this is where clinical research is headed, that would be a terrible negative trajectory," he said. Dr. Topol - who drew attention last year with a finding that Celebrex and its competitor, Vioxx, appeared to raise the risk of heart attacks - said the Bextra studies did not include enough patients to justify drawing a broad conclusion. The average age of patients in the study, 23, did not represent the population likely to take the drug, he added. Yet through publication in the leading dental journal, the research helped Bextra's marketers shift attention away from the F.D.A.'s negative findings.

Do \Because of confidentiality rules, the F.D.A. cannot release any information about the earlier pain studies that failed to sway regulators. "Even though the study lacked some important proof, the real problem is that in the dental literature, this will be read," Dr. Topol said. "And dentists, who have to deal with trying to prevent or modulate pain, will be impressed." Judy Glova, a spokeswoman for Pharmacia, said the drug company stood behind the design and conclusions of the Scirex studies.

Pharmacia was not trying to bypass the regulatory process, she said, adding that the company is in discussions with regulators to have Bextra approved for acute pain. Scirex executives did not return repeated phone calls. Editors at The Journal of the American Dental Association said the Scirex article was reviewed by at least three scientists. One reviewer, Dr. Paul A. Moore, an associate editor of the journal, said the study was "carefully designed and rigorously performed.

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