A watchdog group has released a report that accuses Congress of helping medical research groups conceal information after key lawmakers received big campaign donations.
According to The Sunlight Foundation, Congress in 2007 voted to keep results from clinical trials for unapproved medical devices out of eyes of the public. The provision was inserted into Food and Drug Administration Amendment Act after lobbyists for medical research firms argued that making the results public would reveal proprietary information and potentially hurt business.
The FDA posts information regarding ongoing trials at ClinicalTrials.gov.
Using information compiled by the Center for Responsive Politics, Sunlight found that pharmaceutical and medical device political action committees and executives gave $3.4 million to members of the legislating committees in 2007.
Sunlight says the bill, at 422 pages, was available for only one hour for House members to review before they voted on it in September 2007, and nobody objected to a last-minute alteration to exclude studies of unapproved medical devises from having to publicly reveal their findings.
The provision keeping the medical trial information secret is hurting patients, according to Sunlight. The group sites Bray Patrick-Lake, a clinical trial volunteer who last year agreed to participate in a clinical trial of a medical device to close a hole in her heart. The clinical trial is now cancelled, and Patrick-Lake has no access to any of the results or what side effects could occur from her participation.
“At the behest of the pharmaceutical and medical lobby, Congress undermined the FDA's ability to provide the public with essential information about medical research for government-regulated trials on ClinicalTrials.gov,” said Nancy Watzman, who led the investigation for the Sunlight Foundation.