Schizophrenia Daily News Blog

Pressure for Unbiased Drug Trial Reports

Currently, there is no law requiring drug companies or other research entities to publish all data from their clinical trials. This can lead to biased reporting, as companies may only make public the most favorable studies. However, due to increasing criticism from patient and physician groups, this may soon come to an end.

For example, a new piece of legislation meant to force total disclosure of research data may make an appearance on Capitol Hill this week. According to the bill, the Institutional Review Board (IRB) would require all studies of new therapies to register their trials in a public database at the National Library of Medicine.

Both patients and physicians have expressed concern over the current policies, which don't require reporting of all study results. The recent focus on side-effects of antidepressants in children (whether SSRIs might raise suicide risks) is one such example of how withholding information might harm consumers.

Some clinicians also feel strongly that they should have access to all data, so they can prescribe therapies with maximum benefit potential and minimum risk. For example, with public disclosure of all study data, doctors might have a better idea of when a medication could work for an "off-label" purpose (i.e., a condition that the medication is not primarily approved for).

Joining the campaign for full disclosure are leading medical journals that publish research studies. Just recently, 12 leading journals (among them the prestigious New England Journal of Medicine and the Journal of the American Medical Association), have announced that they will only publish drug trials from companies that have publicly registered their study and all its results.

"We're tired of only receiving [for publication] studies that the pharmaceutical companies want published," said Catherine DeAngelis, JAMA's (Journal of the American Medical Association) editor-in-chief. "They're hot to tell us about studies that go the right way; we want them to be just as hot to tell us about the studies that don't."

The pharmaceutical giant GlaxoSmithKline is feeling the brunt of this contraversy; a recent high-profile lawsuit from New York Attorney General Eliot Spitzer accused the company of publishing bias with a drug used to treat major depressive disorder in children. GlaxoSmithKline denied the charges, but the company now voluntarily posts results from all trials in a public database.

For the full story, see "New bill targets drug data disclosure" - Sept 8, 2004. Available at http://www.cbsmarketwatch.com

Read a New York Times (http://www.nytimes.com) editorial - "For Honest Reports of Drug Trials" (Sept 11, 2004).

View GlaxoSmithKline's Clinical Trials Register, in which all company trial data is available to the public. (http://ctr.gsk.co.uk/welcome.asp)