Antidepressant Effectiveness Probably Overstated: Report(Page 2) "Research is not regulated by anyone, so therefore they don't have to submit to anyone, and that's really the key," Shamoo added. "It's a systemic failure." Other experts presented slightly differing points of view. "It's not that the drugs are ineffective, but that the public's perception is that they are more effective than they are [something the authors also point out]," said Dr. Julio Licinio, chairman of psychiatry and behavioral sciences at the University of Miami Miller School of Medicine. "The data was good enough for the drugs to get approval." "The concern that selective publication of clinical studies routinely overestimates the benefit of medical services is not new," added Dr. A. Mark Fendrick, a professor of internal medicine and health management and policy at the University of Michigan. "While the creation of clinical trial registries will enhance access to unpublished data, the availability of information alone will likely not be very useful to patients and clinicians unless the results can be analyzed in a careful manner, as performed in this important study." advertisement
The buzzword in health care these days is "evidence-based medicine," meaning therapies and preventive strategies that are based on careful, scientific evidence as reported in clinical trials. However, the study authors pointed out, such evidence-based practices are helpful only insofar as the data available is complete and unbiased. And, they said, it is difficult to study "selective publication" primarily because data from unpublished trials is hard to locate. "Pharmaceutical companies have responded to the heat," Turner said. "[But] it's hidden under our very noses." For example, as a result of a 2004 lawsuit, GlaxoSmithKline initiated a clinical trial registry. "I have yet to speak to a colleague who knew about that," Turner said, adding that physicians generally look to peer-reviewed journals for guidance. Licinio believes the reasons for the bias are a combination of people not submitting papers and editors/publishers not printing them. As the editor of the journal Molecular Psychiatry, Licinio receives more than 700 submissions a year and publishes an average of 144. "It becomes very difficult to select," he said. "There should be a national repository for these kinds of reports [that don't get published in journals]," Licinio added. "Those papers don't see the light of day." More information The FDA has more on safety issues related to the use of antidepressants. Related Links
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