Drug company registration of trials

From: Bill (xxx_at_yy.zz)
Date: 07/06/04 

Date: Tue, 06 Jul 2004 22:00:00 GMT

Interesting article on Drug Company registration of trials

http://www.washingtonpost.com/ac2/wp-dyn/A29576-2004Jul5?language=printer

Bill

First Part:

Drugmakers Prefer Silence On Test Data
Firms Violate U.S. Law By Not Registering Trials

By Shankar Vedantam
Washington Post Staff Writer
Tuesday, July 6, 2004; Page A01

The pharmaceutical industry has repeatedly violated federal law by failing to
disclose the existence of large numbers of its clinical trials to a government
database, according to the Food and Drug Administration.

Doctors and patients say that compliance with the law would go a long way
toward addressing their growing concerns that they are not being given the
full picture about the effectiveness of many drugs because they are not told
about drug trials that fail. The issue has gained urgency with recent
disclosures that the publicly available research on treating children with
antidepressants obscured the fact that in most studies, the drugs were no
better than sugar pills. Drugmakers chose not to publish those studies.

The 1997 law is so little known that scientific journal editors and
professional medical associations have recently debated whether to create a
system of private incentives for disclosure of trials. When she was told the
law already requires companies to register trials, Catherine DeAngelis, editor
in chief of the Journal of the American Medical Association, said, "That's a
surprise to me. Tell me why it's not enforced."

Although the law was primarily passed for other reasons, DeAngelis said it
could very well address her concerns

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