Drugmakers may violate U.S. law (13022)

Pharmaceutical companies may have repeatedly violated a 1997 federal law by concealing the existence of large numbers of clinical trials, The Washington Post reports. The clinical trials were not entered into a government database as required, according to the Food and Drug Administration. Many of the trials that are not recorded are those that show certain drugs are ineffective or have severe adverse side effects. Doctors and patients have complained that they are often not given the full picture about the effectiveness and side effects of many medications because information from drug trials that fail is never made public. For example, recent reports show that some trials of antidepressants for children showed the drugs to be no more effective than placebos, but the drug companies failed to make the studies public.

The 1997 law is so obscure that even the editors of scientific journals were unaware that it required drug companies to register data from all FDA-approved clinical trials. "That's a surprise to me. Tell me why it's not enforced," Catherine DeAngelis, editor in chief of the Journal of the American Medical Association, told the Post. The FDA acknowledges that it doesn't enforce the law and that there are no prescribed penalties for drug companies that don't comply with its requirements. The government database, found online at www.clinicaltrials.gov, has about 5,800 ongoing studies currently listed, but only 13% of them were sponsored by the commercial pharmaceutical industry. Drug industry experts say, however, that more than 80% of all clinical trials are conducted by commercial drug firms, meaning that most drug company-sponsored studies are not being registered as required by law.

FDA officials say they are examining the issue and trying to determine if and how they can get involved in better enforcing the law. The agency issued a formal "guidance" letter to all sponsors of clinical trials in March 2002 about the law, but has taken little action since then. Sen. Edward Kennedy, who helped create the 1997 law, says he plans to introduce revisions to the measure to provide the FDA with greater enforcement tools.

But some activists say they doubt the law will ever be fully enforced. "I can guarantee you...that the full force of the drug industry will stop it," Abbey Meyers, president of the National Organization for Rare Disorders, told the Post. "They don't want you to know about clinical trials that fail. They are afraid what it will do to their stock price. A lot of trials are for drugs already on the market, and it would ruin their sales if the news got out."