How the FDA could save 2,700 clinical trials from becoming research waste
Some American companies and institutions will simply refuse to make their clinical trial results public as required by federal law unless the U.S. Food and Drug Administration imposes fines on them, new data suggest.
CASE STUDY ONE: CUTERA
‘Medical aesthetics’ company Cutera appears unwilling to disclose efficacy and safety data from clinical trials of the medical devices it sells – unless and until the FDA forces it to put its cards on the table. TranspariMED has over the past two years repeatedly exhorted the company to come clean about its 16 overdue clinical trial results, and upload them onto ClinicalTrials.gov as required by law. Countless emails, Tweets, and blogs later, Cutera has still not made a single result public on the registry, making it America’s worst performer in relative terms.
CASE STUDY TWO: UNIVERSITY OF VIRGINIA
The University of Virginia currently owes its patients and the public the results of 28 clinical trials in violation of the law, making it by far the most profligate law-breaker among American medical research institutions. In early November last year, TranspariMED reached out to the university, pointed out the missing results, and encouraged it to fix the problem. Ten weeks later, the university has still not improved its performance. It is still the country’s worst performer in absolute terms.
The National Institutes of Health have the power to cut off future grant funding to the university over its legal violations, as Deborah Zarin, the former administrator of the ClinicalTrials.gov registry, pointed out on Twitter:
Reshma Ramachandran from the student campaign group Universities Allied for Essential Medicines told STAT News that:
"If the FDA is not willing to step in, perhaps the NIH should take a closer look at these and other non-compliant institutions before disbursing further grant funds.”
WHAT IS THE FDA DOING? FDAAA
By law, the FDA can and should fine Cutera and the University of Virginia over $10,000 per missing trial result per day.
If the FDA had enforced the law, it could already have collected over $155 million from Cutera and over $245 million from the university, according to the University of Oxford’s FDAAA Tracker. In total, the FDA could have collected nearly $28 billion in fines from law-breaking companies and institutions across the country.
Instead, the FDA is responding to the over 3,000 missing clinical trial results by sending out less than two letters per week, data obtained through a Freedom of Information request and made public by student group Universities Allied for Essential Medicines shows.
The few letters that the FDA did send hit the mark: In over 90% of cases, the recipients made the missing trial result public within less than a month.
DO THE REGULATORY MATH
Sending a letter for each of the 3,000 missing trial results would lead to 2,700 trial results being made public (90% response rate, see above)
The remaining 300 missing results would enable the FDA to collect over $3 million in fines per day
The cost of a postage stamp is 58 cents
Posting 3,000 letters would cost the FDA $1,740
Neither Cutera nor the University of Virginia have received a single FDA letter so far, records show.
TranspariMED will provide regular updates on America’s worst trial sponsors and FDA’s enforcement efforts as the year goes on. Meanwhile, the persistent gaps in the medical evidence base will continue to harm patients and undermine public health.
Download the report with data on all of America’s worst-performing companies and universities below.