An editorial in the Journal of the American Medical Association (JAMA) has called for scientific publications to enact stringent reforms to ensure integrity and minimise the ability of corporations to conceal scientific data. The editorial has cited troubling behaviour by drug maker GlaxoSmithKline - and scientists on its payroll - in studies that it sponsored in an attempt to downplay the risk of health problems from Avandia, a top-selling diabetes drug at the time.
In the editorial, JAMA writers Dr. Catherine DeAngelis and Dr. Phil Fontanarosa have criticised GlaxoSmithKline’s activities in research over the potential side effects of Avandia. The authors cite GlaxoSmithKline’s RECORD trial, which was supposed to study the heart attack problems associated with Avandia. They have called the RECORD trial a disturbing case of improper conduct surrounding an industry-sponsored clinical trial of Avandia. The trial reveals a situation in which concerns about maintaining market share apparently trumped concerns about the potential for causing patient harm.
Among the industry-wide reforms proposed by the JAMA editorial, the authors have called for medical journals to necessitate an independent statistical analysis of all corporate-sponsored studies before publishing the articles. Further, the editorial notes that academic researchers should have full access to all clinical data.
Concerns about the risk of heart problems with Avandia first gained widespread attention in May 2007. A meta-analysis of 42 different clinical trials, published in the New England Journal of Medicine, suggested that users of Avandia had a 43 percent increased risk of a heart attack. Last month, a US Senate report blasted GlaxoSmithKline for trying to cover up heart attack risks associated with the drug.
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