Companies pledge more transparency in drug trials
By Lou Dobbs
(CNN) -- Facing growing scrutiny over the safety of their products, the leading global drug companies last week pledged to disclose more information about their clinical trials. Adoption of this new policy, however, is completely voluntary and does not require any disclosure of exploratory trials.
Drug makers are currently required to register information on clinical trials in an online government database, but only if those trials deal with life-threatening conditions. The industry's new policy asks companies to disclose information on all clinical trials, regardless of the condition under study. Pharmaceutical trade groups have backed the proposal, while critics call it another industry attempt to stave off regulation.
The new industry policy is still voluntary, but it "goes above and beyond the legal threshold" in providing information to the public, said Court Rosen, a spokesman for the Pharmaceutical Research and Manufacturers of America (PhRMA).
Not everyone is certain the industry's response is good enough. And after a year of industry troubles, lawmakers aren't convinced the industry can regulate itself. Several senators, including Republican Charles Grassley of Iowa, plan to introduce bills to the new Congress that would make it mandatory for drug companies to disclose the results of all their clinical trials.
Editors of medical journals have also taken a firm stand on the issue of disclosure. The International Committee of Medical Journal Editors (ICMJE) announced last year that its members would not publish the results of trials that have not been registered. Publication of studies in respected journals is critical to many decisions on the future of a drug, including whether Medicare will cover it, said Merrill Goozner, director of the Integrity in Science Project at the Center for Science in the Public Interest.
Pressure for a public database of trial data began to mount last year, after GlaxoSmithKline was accused of suppressing data on antidepressant use by children. In settling the lawsuit, GSK agreed to publicly disclose results of its clinical trials. Several other companies then announced their own data registries, and PhRMA later unveiled a Web site where companies could voluntarily post trial results.
Public concern grew in September, when Merck voluntarily withdrew its popular pain reliever Vioxx from the market after studies linked the drug to increased risk of heart damage. Pfizer later revealed similar results involving its competing drug Celebrex, which remains on the market. The scandals raised questions of whether the medical community would have known about the drugs' dangers sooner had the companies disclosed more trial data.
"Without a mandatory registration system, the companies would still have it in their interest to not publish certain trials," Goozner said.
Indeed, while the industry's new voluntary policy asks companies to supply information on "hypothesis-testing," or mid-to-late-stage trials, it does not ask companies to disclose exploratory clinical trials. One reason is that those studies often contain "very proprietary information," Rosen said.
Rosen added that results of these early stage trials aren't helpful to the public because the drugs tested in them may never reach the market.
"By and large if a medication goes to exploratory trial and fails, there's no reason to disclose that. Medically speaking, it's not relevant to patient care," he said.
But data from all stages of a drug's development are essential for scientific knowledge and public safety, Goozner said.
"Negative results, which often don't get published, also further medical knowledge, and those are the ones that independent researchers and regulatory people really need to get their hands on."
Whether the industry's new disclosures will satisfy those researchers is still unclear. A spokeswoman for the ICMJE, which represents the most prestigious medical journals, said the industry had not yet provided enough detail to determine if the new disclosures would meet the committee's publication criteria.