One of the issues that seems to be coming up again and again in recent months is disclosure of the results of clinical trials. Forest and GlaxoSmithKline must publish their results online under settlement agreements with NY's attorney general, Eliot Spitzer. Other major pharmaceutical companies have since also agreed to publish the results of their trials online.
Congress hasn't been soothed by these actions, though. Yesterday, the House Committee on Energy and Commerce had a hearing on Publication and Disclosure Issues in Anti-Depressant Pediatric Clinical Trials. The Committee members apparently took the FDA and pharma companies to task for not forcing the companies to disclose their results and not disclosing their results before the recent brouhaha, respectively.
Many of the pharmaceutical companies likely were hoping that the establishment of www.clinicaltrialresults.org (where many will post the results of their trials) would ward off any attempt by Congress to regulate their industry further and mandate disclosure and direct what must be disclosed. From the comments reported at the hearing yesterday, it might not be too long before the Representatives get serious about mandating disclosure. From the article in The Scientist:
Rep. Diana DeGette (D-Col.) called the PhRMA registry, which would be voluntary and will be online at www.clinicaltrialresults.org beginning October 1, "a commendable first step," but asked how meaningful and available the data will be to physicians and patients.
Rep. Henry Waxman (D-Calif.) slammed the proposal, saying that, "if it's voluntary, it's voluntary not to do it."
The hearings resume on Sept. 23rd, and we'll probably learn more by then whether Congress may step in and force the pharmaceutical companies to disclose all clinical trial results.
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