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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. Because of confidentiality rules, the F.D.A. 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. 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. ”Even though the study lacked some important proof, the real problem is that in the dental literature, this will be read,” 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. 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, an associate editor of the journal, said the study was ”carefully designed and rigorously performed.” But Dr. 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. Editors at The Journal of the American Dental Association said the Scirex article was reviewed by at least three scientists. The Bextra episode is just one example of the changing face of drug research. Moore said he would have recommended that the journal reject the paper had he known that Bextra was not approved for acute pain. 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. Harrison, said he expected Scirex’s research to produce positive results for drug company clients – results that would help speed new-drug applications, or N.D.A.’s, to the F.D.A. Omnicom says it has no control over Scirex. ”We have nothing to do with the design of clinical studies,” said Pat Sloan, an Omnicom spokeswoman. 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. ”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. Yet when the ad agency paid $20 million for part-ownership of Scirex in 1999, a top Omnicom executive, Thomas L.

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