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.
An FDA analysis found that in 2002 only 48 percent of trials of cancer drugs had been registered, and a preliminary review now indicates the listing rate for drugs for some other serious diseases is in the single digits. Some companies have listed no studies; some trials are listed without identifying the sponsoring company or the drug being tested.
As of Friday, the database, ClinicalTrials.gov, listed 5,754 ongoing studies, but only 13 percent were industry sponsored. The federal government, mainly the National Institutes of Health, accounted for 55 percent. Those proportions are in stark contrast to the true picture, DeAngelis said. "Over 80 percent of trials are funded by for-profit companies, not by the government," she said.
FDA officials said they are re-examining whether they have the power to step in. Members of Congress are also considering adding enforcement provisions to the law, which was part of the FDA Modernization Act of 1997.
The registry was begun in 1998 and the ClinicalTrials.gov site went online in February 2000, said Alexa McCray, director of biomedical communications at the National Library of Medicine, which hosts the registry. Since then, nearly 11,000 trials have been registered from all 50 states and 90 countries. Virtually all studies sponsored by the National Institutes of Health are listed, and industry trials started coming in after March 2002, when the FDA issued a formal "guidance" on implementing the law.
Although some companies say they are amenable to wider disclosure, the patient advocacy group that fought the hardest to create the requirement predicted it would never be enforced.
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