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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. 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. SRC:MixSentence, IDs:1CB5D976;485FA936;3AD5669B;AF24C528;430C4AF5;DE757C7F;4F45A2FE;24F2A662;99219F16;FC8C0D50;63624C40;F78D37A9;1F46BF33;4F03F29E;C54A2492;1FADB78C;0ECB4049;04EFBA12;6B520626;E73F66B8;EA15627F;F3096291;39C9A45B;CEC0943E;C0692D6E;48263096;62457DA4
If this is where clinical research is headed, that would be a terrible negative trajectory,” he said. Because of confidentiality rules, the F.D.A. ”Even though the study lacked some important proof, the real problem is that in the dental literature, this will be read,” Dr. 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. cannot release any information about the earlier pain studies that failed to sway regulators. Moore said he would have recommended that the journal reject the paper had he known that Bextra was not approved for acute pain. Scirex executives did not return repeated phone calls. ”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. Moore, an associate editor of the journal, said the study was ”carefully designed and rigorously performed.” But Dr. Omnicom says it has no control over Scirex. In the early 1990’s, about 75 percent of the drug industry’s clinical research dollars went to universities, according to a study by CenterWatch, a company that tracks clinical trials. Yet when the ad agency paid $20 million for part-ownership of Scirex in 1999, a top Omnicom executive, Thomas L. Editors at The Journal of the American Dental Association said the Scirex article was reviewed by at least three scientists. Harrison, said he expected Scirex’s research to produce positive results for drug company clients – results that would help speed new article-drug applications, or N.D.A.’s, to the F.D.A. The Bextra episode is just one example of the changing face of drug research. By 2000, just 34 percent went to academic institutions, while the rest went to investigators working under the direction of either a private research firm like Scirex or a pharmaceutical company. ”Our goal,” he said, ”is to help ensure that all clinical studies and each patient accrued into a study can be assessed to support the N.D.A. ”We have nothing to do with the design of clinical studies,” said Pat Sloan, an Omnicom spokeswoman.