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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. 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." But Dr. Moore said he would have recommended that the journal reject the paper had he known that Bextra was not approved for acute pain. The Bextra episode is just one example of the changing face of drug research. 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. 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. 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. Yet when the ad agency paid $20 million for part-ownership of Scirex in 1999, a top Omnicom executive, Thomas L. 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. "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.
If you liked this article and you also would like to receive more info pertaining to view full post here generously visit our site. CETIECAP - Compagnie des Experts Traducteurs et Interprètes en Exercice près la Cour d’Appel de Paris - The Company of Expert Translators and Interpreters Working in Paris Court of Appeal provides translations from and to 55 languages and aims to promote mutual support between its members, to ensure communication between the company and third parties and to defend the interests of its members by all legal means, among others. The association provides translation from 8 languages (English, Italian, German, French, Spanish, Greek, Russian and Dutch). VSenV - Dutch Association of Writers and Translators - The history of the Dutch Association of Writers and Translators goes back to 1905 when it as first created as an association limited to the literary field. Membership is open to all freelance interpreters, in-house translators and even students, but they have to prove their proficiency in the languages in which they translate and in the field of expertise. It aims to change the labour market of translators in Hungary, connect professionals in the field and offer legal assistance when necessary.