GOVERNMENT and LAW

Calls mounting for drug research transparency

If clinical trial data become more easily available in the future, pharmacists can thank New York Attorney General Eliot Spitzer and the American Medical Association (AMA). The duo set off a wave of publicity that may move the pharmaceutical industry toward greater transparency in drug research.

In early June, Spitzer's office filed suit against GlaxoSmithKline. The drugmaker is charged with concealing clinical trial data showing that Paxil (paroxetine) is not safe for use in treating depression in children and adolescents. In mid-June, the AMA called on the federal government to create a public database to register all clinical trials conducted in the United States and report the results. Within days, GSK, Merck, Lilly, and other drugmakers announced plans to disclose more research results, negative as well as positive.

The International Committee of Medical Journal Editors expects to require study sponsors to register all future clinical trials in a public database and disclose all results as a condition for publication. Signatory publications include the Journal of the American Medical Association, the New England Journal of Medicine, Lancet, and the Annals of Internal Medicine.

By the end of June, the Pharmaceutical Research & Manufacturers of America had issued revised guidelines on the ethical conduct and communication of clinical research. The revised guidelines call for timely communication of meaningful results, positive or negative.

The storm over research disclosure has been building for years, said Anne Burns, group director of practice development and research for the American Pharmacists Association. APhA is examining the issue and may consider a policy change at its annual meeting in 2005.

Said Gary Smith, professor of pharmaceutical science at the University of Maryland, "Suppression of studies has always been a problem. In research as well as in clinical practice, the things that don't work are just as important as what does work."

Drug Topics readers agree. In July, an Instant Poll asked: "Should drug companies post the results of all their clinical drug trials on the Web?" The question produced unequivocal results. Eight-four percent of respondents said Yes; 15% said No; 2% weren't sure.

Drugmakers are already required to post many clinical trials on-line. The Food & Drug Modernization Act of 1997 (FDAMA) required the Department of Health & Human Services to establish a publicly accessible database of clinical trials for serious or life-threatening diseases. The Clinical Trials Data Bank, www.ClinicalTrials.gov, went live in 2000.

The Web site lists clinical trials to help physicians and patients who might want to participate, explained Theresa Toigo, director of the FDA's Office of Special Health Issues. It does not show study results.

To date, just 48% of industry-sponsored trials that should be listed actually are, Toigo said. That compares with 91% of trials sponsored by the National Institutes of Health. NIH trials generally included all required information, including sponsor and drug name. A significant number of industry-sponsored trials omit vital details.

More movement is on the horizon:

• GSK posted what the company says is all trial data submitted to the Food & Drug Administration and other regulatory bodies in support of its application for an indication for paroxetine in adolescents and children.

• Last month, GSK settled the Spitzer lawsuit for $2.5 million. The drugmaker also agreed to post summaries of all clinical trials conducted after Dec. 27, 2000. Summaries will include more than 20 categories of data—including safety, efficacy, side effects, original trial goals, whether the trial was ended early, and why. GSK will add summaries of new trials not later than 10 months after completion.

• Eli Lilly is building a Web site for all phase III and IV trials on marketed products.

It may go further. The World Health Organization wants an international clinical trial registry. The Cochrane Collaboration, an international not-for-profit healthcare information group, supports the idea. "A universal registry of trials gives you a common denominator for evaluating results," said Kay Dickersin, director of the U.S. Cochrane Center. "All results should be made available in a common format with all outcomes declared."

Fred Gebhart

Fred Gebhart. Calls mounting for drug research transparency.

Drug Topics

Sep. 13, 2004;148:47.