Web Site Could Help Covid Drug Trials: Activists

Three healthcare activists whose suit persuaded a federal judge to order companies to add 10 years’ of information to the ClinicalTrials.gov Web site say that site could help inform the public about Covid-19 drug trials if government agencies would require companies to submit all their trial results. Writing in a StatNews online post, New York University Technology Law and Policy Project supervising attorney Christopher Morten, Center for Science in the Public Interest president Peter Lurie, and New York University professor and journalist Charles Seife say they worry that their court success will be a hollow victory unless FDA and the National Institutes of Health (NIH) step up enforcement of the law requiring drug companies to submit clinical trial results to ClinicalTrials.gov.

While FDA is good at what it does, the three write, it can make mistakes, and it needs oversight from scientists and researchers who give second opinions on clinical trial data.

Under the FDA Amendments Act of 2007, it is illegal for trial sponsors to cherry-pick results by publishing favorable data such as those showing safety and effectiveness and withholding unfavorable data such as toxicity or lack of effectiveness.

“If independent researchers have access to all of the data from all trials — favorable and unfavorable — they can double-check the work of FDA and help keep the public informed,” the three say.

However, the article continues, in 2016 HHS and NIH “created an illegal loophole that exempted many clinical trials of FDA-approved products completed between 2007 and 2017 from any obligation to ever file their results with the ClinicalTrials.gov database.”

When a trial sponsor fails to post results, FDA and NIH are authorized to impose penalties, including fines of up to $10,000 per day and termination of government grant money, for noncompliance. “Yet despite widespread noncompliance, these agencies have never imposed a single fine, withheld a single grant, or imposed any other penalty on a noncompliant trial sponsor,” the authors write. They cite estimates that FDA’s lack of enforcement is so severe and noncompliance is so widespread that the agency has forfeited billions of dollars in uncollected fines.

The post says that FDA and NIH have taken the position that enforcing the law is optional and that even determining whether clinical trials and trial sponsors are in or out of compliance with the law is a discretionary task that they choose not to do.

“If FDA and NIH prove unequal to the task,” the authors conclude, “Congress will have to step in to force the agencies’ hands.”