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« I thought it would be sooooo much better with Federal employees handling screenings | Main | Poor folks are always the ones who pay »

July 06, 2004
Perfect parallel 

substantive law
n. law which establishes principles and creates and defines rights limitations under which society is governed, as differentiated from "procedural law," which sets the rules and methods employed to obtain one's rights and, in particular, how the courts are conducted.

The Conservative attack on civil rights takes the form of disabling the procedural law by underfunding and bad definitions. But the method has general utility to those who want their way but are too cowardly to just say what their way is. Case in point:

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.

The FDA acknowledges it has not enforced the law -- officials said the statute did not spell out penalties or explicitly give the agency authority to crack down on violators.



Posted by P6 at July 6, 2004 09:36 AM
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