Tuesday, November 6, 2012

Clinical trial data for all drugs in current use / BMJ

Re: Clinical trial data for all drugs in current use

31 October 2012

Dr. Godlee's editorial (BMJ 2012; 345 doi: http://dx.doi.org/10.1136/bmj.e7304) underscores the importance of the GlaxoSmithKline decision to allow access to anonymized patient level data from its clinical trials. Meta-analysts can now work more efficiently in summarizing knowledge relating to the benefits and risks of drugs and other medical interventions. As a result, the pace of evidence-based medical practice should pick up.
Open availability of data on which journal and other publications are based is wise public policy and one that is consistent with the replicability tenet of empirical science. Now selective reporting of findings by researchers should not go unnoticed for so long and thus draw swift deserved criticism and reprimand.
Yet the hold-outs may well be government agencies when their interests are threatened. My correspondence via registered mail to US Center for Disease Control (CDC) co-authors of an anthrax safety report that they had published in Vaccine (1) has gone ignored for almost 8 months--despite citation of the CDC policy relating to data release and copying my concerns to Dr. Thomas Freiden, CDC Director. The US Department of Health and Human Services, of which the CDC is a part, has been advocating a test of the anthrax vaccine in children in face of substantial doubt about the safety of the anthrax vaccine in adults. (2)
John H Noble Jr, Emeritus Professor
State University of New York at Buffalo, 508 Rio Grande Loop, Georgetown, TX 78633, USA

(1) Stewart B, Zhang Y, Rose Jr CE, Tokars JI, Martin SM, Franzke LH, McNeil MM. Health-related quality of life in the Anthrax Vaccination Program for workers in the Laboratory Response Network. Vaccine 2012;30 (10): 1841-1846.
(2) Alliance for Human Research Protection (AHRP), 18 May 2012. Anthrax vaccine trial ethics? Science? See: www.ahrp.org/cms/content/view/851/9.

No comments: