Clinical trial registry initiative: a correction
Article: WHO News 2006;84:10-11
1 February 2006 - The news item in the January 2006 issue of the Bulletin announcing a new WHO clinical trial initiative,(1) inappropriately and inaccurately refers to Merck, a company that has always been committed to the highest standards of scientific integrity and patient safety. Merck promptly and appropriately disclosed the results of Vioxx clinical trials — positive and negative — including VIGOR and APPROVe. Merck's behaviour over Vioxx is not that of a company “withholding negative research findings,” as your article inaccurately suggests.
We also wish to clarify the timing of certain events. The editorial by the International Committee of Medical Journal Editors (ICMJE) calling for registration of clinical trials as a condition of publication, which you cite in your news item, appeared online at www.nejm.org on 8 September 2004, and on 16 September 2004 in the print version of the New England Journal of Medicine, as well as in other ICMJE journals. This was several weeks prior to Merck's voluntary withdrawal of Vioxx on 30 September 2004, (2) i.e., not in response to the withdrawal as the Bulletin news item implies. Additional information can be found on our Vioxx information page at: http://www.merck.com/newsroom/vioxx_withdrawal/.
Merck has been an active participant in the WHO International Clinical Trials Registry Platform, taking part in meetings when invited, and commenting on proposals. Merck's commitment to registering all Phase II, Phase III, and post-marketing controlled clinical trials that we conduct anywhere in the world goes well beyond both the current U.S. law that mandates registration of clinical trials designed to test the efficacy of products for life-threatening or otherwise serious illnesses and the industry commitment to register all "confirmatory" trials. Our policy on the registration and publication of clinical trials is posted at: http://www.merck.com/mrl/swf/Merck_Position_on_Clinical_Trials_Registries.swf.
We look forward to continued dialogue with WHO and other stakeholders to promote transparency and allow patients and their health-care providers access to clinical trial information, while preserving protection of intellectual property.
Laurence J. Hirsch, MD.
- WHO clinical trials initiative to protect the public. Bull World Health Organ 2006;84:10-1.
- Clinical trial registration: a statement from the International Committee of Medical Journal Editors. New Engl J Med 2004;352:1250-1.
Laurence J. Hirsch. Executive Director, Medical Communications Merck Research Laboratories, 126 E. Lincoln Ave, RY34A-312, Rahway, NJ 07065, USA (email: email@example.com).