The Washington Post ^ | July 6, 2004 | Shankar Vedantam
Posted on 07/06/2004 11:10:59 PM EDT by neverdem
Firms Violate U.S. Law By Not Registering Trials
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.
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Now that the companies have to submit the results of all tests of their drugs prior to FDA approval, as long as the FDA approved the drug, that should be the end of the matter, at least if it was prescribed for the approved indications. Docs should have patients sign waivers for adverse or allergic drug reactions. The same holds true for medical devices. The Congress needs to amend the law to give the FDA enforcement authority in order to levy fines where appropriate.
If I understand you correctly, you wish to allow the FDA to levy fines instead of allow patients to bring suits. I can't agree to that idea.
Let's say your mother takes a medication that causes permanant blindness. She and 250,000 other citizens are blinded. Do you think these folks should be unable to bring suit?
Sorry if I misunderstood you, but individual compensation is integral to a solution. I don't want to see folks given $10 million a shot, but it's a crime in and of itself to deny people recourse IMO.