Word: review
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...older brother e-mailed my immediate family in December with a copy of the Zagat’s review...
Popular antidepressants including Prozac and Paxil have little impact on most patients, according to a comprehensive review of newly released data from trials that were conducted before the drugs were approved...
...makes this one so important - the results were front-page news across the U.K. on Tuesday - is that the researchers were able to track down comprehensive unpublished trial results from the drug makers themselves before the drugs were authorized for sale in the U.S., and include them in their review of the literature. The U.S. Food and Drug Administration (FDA) must receive records of all relevant pharmaceutical-company trials, both published and unpublished, before it will approve a drug. Under the Freedom of Information Act, the researchers writing in PLoS Medicine were recently able to obtain those FDA records...
...Drug companies claim the review is still flawed, however. One massive problem: there are many more recent studies than those surveyed in the article, which looked only at pre-approval trials conducted before 1999. Nicholas Francis, a U.K. spokesman for Eli Lilly and Company, which produces Prozac, says that the new study "does not take into account that today more than 12,000 patients have participated in Prozac clinical trials and thousands of scientific papers have referenced Prozac, supporting its use in the treatment of depression." Some 50 million people worldwide have taken Prozac, and in a company statement Lilly...
...information come from? In most cases, it's from industry-sponsored advertising, notes Watson. "The pharmaceutical marketing departments have appropriated the language of the empowered autonomous patient in the service of sales," she says. Moreover, while the FDA can request that pharmaceutical companies provide ads for the agency to review before airing, it does not have the authority to enforce this request. An agency spokesperson estimated that only one-third of such ads are actually reviewed by the FDA before airing. A proposal to increase funding for the FDA to conduct more such reviews was rejected last month...