Reply to Steinbrook: Clinical Trial Data Access
One of the great things about a blog is to be able to publish editorials that aren’t accepted for publication in an academic journal. The following letter to the Editor of the New England Journal of Medicine was recently rejected for publication. I offer it to readers of this blog for your consideration and comments.
The theme of Dr. Steinbrook’s editorial[1]—that drug companies are ethically obligated to provide full and unfettered clinical-trial data access to academics and other clinical researchers—is based on the implied premise that an unbiased authority is needed to protect the public from unethical drug-company publication practices. I agree that drug companies ought to be compelled to allow complete clinical-trial data access to an unbiased authority. In fact, they already are; in the U.S. it is to the FDA (which is not, however, charged with the responsibility of policing public dissemination of the results). I disagree with Dr. Steinbrook’s assertion that academics are similarly unbiased. The continuing pressures on academics to publish rapidly and frequently tends to counteract their motivation to educate without bias[2][3][4]. Furthermore, any argument by academics that provides for their unrestricted access to clinical-trial data for experimental drugs at early stages of testing (Phase 1 and 2) rests on a shaky foundation, as the benefits of such disclosure accrue far more to academics than to the public at large.
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[1] Steinbrook R. Gag Clauses in Clinical-Trial Agreements. NEJM 352:2160-2162, 2005.
[2] Begg CB, Berlin JA. Publication bias and dissemination of clinical research J Natl Cancer Inst. 81(2):107-15, 1989.
[3] Dickersin K, Min YI, Meinert CL Factors influencing publication of research results. Follow-up of applications submitted to two institutional review boards JAMA. 267(3):374-8, 1992.
[4] Krzyzanowska MK, Pintilie M, Tannock IF. Factors associated with failure to publish large randomized trials presented at an oncology meeting JAMA 290(4):495-501, 2003.
