Much Clinical Trial Information Remains Concealed, Despite Promise To Disclose More Data

Main Category: Pharma Industry / Biotech Industry
Article Date: 01 Jun 2005 - 9:00 PDT

email to a friend   printer friendly   view / write opinions

The New York Times on Tuesday examined how the pharmaceutical industry remains "sharply divided" on how much information it reveals to the public about new and completed clinical studies. Journal editors and academic scientists in the last year have urged the industry to disclose more data after several drug companies failed to publish studies that showed their antidepressant medications were as effective as placebos (Berenson, ...New York Times, 5/31). Jeffrey Drazen, editor in chief of the New England Journal of Medicine, said last week that GlaxoSmithKline, Merck and Pfizer are not providing useful data on clinical trials they register on the site. In September 2004, the members of the International Committee of Medical Journal Editors announced that they will cease publishing studies that are not registered in an NIH database -- ClinicalTrials.gov -- at the time of their launches. The Pharmaceutical Research and Manufacturers of America and three other major pharmaceutical associations earlier this year recommended to their members that they submit clinical trial information to the public registry beginning in July (Kaiser Daily Health Policy Report, 5/24). According to the Times, "continued gaps in disclosure" have led to support among some members of Congress for new federal laws on the issue. Legislation proposed in February by Sens. Christopher Dodd (D-Conn.) and Chuck Grassley (R-Iowa) would convert ClinicalTrials.gov into a national registry for new studies and results and impose civil penalties of up to $10,000 per day for companies that fail to release trial data. However, Dodd said the bill's chances of passing in this Congress are uncertain (New York Times, 5/31).

The New York Times

"Reprinted with permission from kaisernetwork.org kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.