Healthy Skepticism Library item: 866

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

For Honest Reports of Drug Trials
The New York Times 2004 Sep 11

Full text:

A vast majority of patients and doctors would surely agree that pharmaceutical companies ought to reveal the results of clinical trials that suggest that their drugs don’t work or may even be harmful. Yet all too often such results are either suppressed or are buried in obscure locations, and only glowing reports are widely disseminated. This week a coalition of leading medical journals announced a publication policy that should help rectify the problem but is hardly a full solution. The industry’s trade group, meanwhile, offered a weak plan to quell the controversy without requiring much reform.

In response to legal pressures and a growing credibility crisis, some drug companies have agreed to disclose at least some of their trials and findings in public databases. And the trade group, Pharmaceutical Research and Manufacturers of America, said it was creating a Web site where members could post summaries of trial results. The problem with such voluntary approaches is that decisions on what to report will be left to the companies, whose financial self-interest is what got us into this mess in the first place. Companies that are more inclined toward openness than others should not suffer a competitive disadvantage.

A useful lever for reform was provided this week by the 12 leading medical journals that announced they would soon refuse to publish the results of any clinical trial that had not been registered at the outset in a public database. Registration would make it harder for companies to bury bad results. Since the journals include some of the most prestigious in this country, the new policy should put great pressure on drug companies and clinical researchers to register. Still, there are hundreds of other medical journals that would need to follow suit for this approach to be fully effective.

The best solution would be a federal law requiring that all significant clinical trials be registered in a public database and that results be made available. The American Medical Association favors a centralized registry covering drugs, biological agents and medical devices. Congressional leaders may be loath to offend the drug industry, so advocates of greater transparency have to move quickly before the pressure for reform dies out.