Drugmakers Prefer Silence On Test Data

The Washington Post ^ | July 6, 2004 | Shankar Vedantam

[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.

[neverdem]

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.

If you want to avoid WaPo registration, try BugMeNot.com

[neverdem]

PING

[JPJones]

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.

bump

[Blood of Tyrants]

The issue is John Edwards and his ilk. EVERY admission of ANY occurance of ANY negative side effect will immediately bring hordes of greedy lawyers with people looking to win at Litigation Lotto.

[bd476]

Thanks for posting this neverdem.

This is a dilemma. Some want less government intervention in allowing drugs to be available faster and cheaper for the market.

Others want more government oversight, control and regulation of pharmaceutical companies to prevent catastrophic side effects and death caused by patients taking new drugs which have had fewer practical clinical trials.

Pharmaceutical manufacturers want to reduce future liability from patients' catastrophic reactions to new drugs. They also want to prevent inter-industry theft while they are creating new drugs or running studies prior to release.

And everyone wants cheaper drugs costs.

The FDA is one Federal Agency which oversees pharmaceutical manufacturers and now there's yet another government hoop set up for drug companies?

[B4Ranch]

>>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.<<

Kinda sounds like the Homeland Security way of doing business.