Abstract:
:As a result of the growth of evidence-based practices across the world, health-care providers and policymakers in the United States, United Kingdom, and Europe have established institutes such as the United Kingdom's National Institute for Health and Clinical Excellence (NICE) to produce clinical guidelines that physicians are asked to use in their daily practice. This article discusses how the withholding of clinical trial information by pharmaceutical companies and academic researchers affects the reliability of clinical guidelines. It first offers a case study analysis of the U.K. drug regulator's failure to prosecute GlaxoSmithKline, manufacturer of the bestselling antidepressant Seroxat (manufactured as Paxil in North America), for withholding information on the safety of Seroxat from regulators. It next examines the idea of a "Sarbanes- Oxley for Science," a recent proposal that seeks to introduce legislation forcing companies to disclose clinical trials that have indeterminate or negative results. Legislation such as Sarbanes-Oxley for Science would solve some problems with the withholding of data, but not all. Until practitioners and policymakers address the political and legal barriers preventing full access to clinical trial data for all medical treatments, the ideals of evidence-based practice will remain elusive.
journal_name
Perspect Biol Medjournal_title
Perspectives in biology and medicineauthors
McGoey Ldoi
10.1353/pbm.0.0084subject
Has Abstractpub_date
2009-04-01 00:00:00pages
203-17issue
2eissn
0031-5982issn
1529-8795pii
S1529879509200044journal_volume
52pub_type
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journal_title:Perspectives in biology and medicine
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journal_title:Perspectives in biology and medicine
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