Psychiatry Not Alone in Concern

The controversy over the pediatric use of antidepressants is just one example of concerns over the validity of the data from randomized controlled trials (RCTs) that medicine uses as its evidence base. The concern occurs throughout medicine.

A major source of state-of-the-art treatment data is the new research findings unveiled at medical meetings. These meetings present thousands of abstracts each year, many with data from the nearly 50,000 RCTs conducted in the U.S. annually.

But after the meeting, what happens to all that preliminary data? A mid-1990s study of research presented at an emergency medicine meeting found that of 223 unpublished abstracts, only 20 percent were published in peer-reviewed journals within the following three years.

A review last year found that of 510 abstracts of large, phase 3 RCTs presented at meetings of a major oncology group between 1989 and 1998, 81 percent were published within five years of the meeting at which they were presented; the remainder were not published within five years. Industry-funded RCTs with a positive outcome were significantly more likely to be published.

Another review this year again found that funding and outcome are significantly related to publication. Of 332 RCTs (158 on drugs, 87 on surgical treatments, 87 on “other therapies”) 37 percent acknowledged industry funding. Overall, those that were funded by industry were 1.9 times more likely to be positive toward the treatment studied. Surgical trials were eight times more likely to be positive, and drug trials were five times more likely to have pro-industry results.

Though psychiatry was at the forefront of the call for a clinical trials registry to help track RCT data, response has been broadly supportive from the AMA, National Institutes of Health, Food and Drug Administration, and Pharmaceutical Research and Manufacturers of America (the industry's main lobbying group). All seemingly agree that it's time to change the current system.