February 04, 2005


Thursday's announcement by the NIH that it will "request" that scientists who receive funding from the public agency to post their research on a freely-accessible website seems to have pleased no one. Is this an example of gutless policymaking, or a courageous refusal to give in to either side's extremists? Perhaps only NIH Director Elias Zerhouni knows for sure.

Regardless, it's more likely that NIH-funded scientists will respond to this request from Zerhouni than that big pharmaceutical corporations will comply with their trade association's request that they post the results of all clinical trials of their drugs on the internet. In the case of the individual scientists, any scepticism we may have about their likelihood of compliance is mere speculation. In the case of the big drugmakers, scepticism is demanded by their track record.

Last August, Glaxo SmithKline settled a lawsuit brought by Eliot Spitzer charging that it had suppressed unfavorable research data about the links between its antidepressant drug Paxil and suicidal thoughts in adolescents. The lawsuit drew attention to the distorting effects of the selective release of favorable data from drug company-funded clinical trials. The International Committee of Medical Journal Editors decided that they would not publish the results of trials that were not publicly registered at the time they were launched, and pressure mounted for Congress to mandate that all clinical trials be registered.

Big Pharma responded by announcing a new -- and entirely voluntary -- program for posting information about all "hypothesis-testing" clinical trials to an existing government site at www.clinicaltrials.gov. The information posted to the site would go well beyond the current requirements that companies post information about clinical trials involving treatments for diseases that are serious or life-threatening.

The problem is, the pharmaceutical industry isn't complying with the current mandatory reporting requirements for clinicaltrials.gov. On June 7, 2004 (before the Paxil scandal became news), Rep. Henry Waxman of the House Committee on Government Reform sent a letter (pdf) to the president of PhRMA describing the failure of the drug industry to post required information. The letter pointed out that FDA officials were concerned with the low rate of industry participation despite repeatedly sending notices describing the exact requirements of the law.

Even if PhRMA has a plausible argument for why drug firms were not required to post more often on the clinicaltrials.gov website, their reluctance to provide any more information than was absolutely required suggests that they might not choose to voluntarily comply with a request to post more data.

Requests can sometimes get the job done. This just might not be one of those times.

Posted by Carey at February 4, 2005 11:38 PM