Madelyn-Kumar
Two Yale Law School clinics celebrated after their successful legal battle pushed a federal judge to mandate the release of previously unreported clinical trial data from government agencies.
The ruling comes as a win for the Yale Media Freedom and Information Access Clinic and the Yale Collaboration for Research Integrity and Transparency, two groups affiliated with the Yale Law School that have worked on the case since the MFIA sued in December 2018. Students from the MFIA helped argue the case, with the support of CRIT, to push the U.S. Department of Health and Human Services as well as related agencies to release the information dating back a decade. According to professor of Medicine and Public Health Joe Ross, who is also the faculty co-director of CRIT, this ruling will help clinicians make more informed decisions about the treatments they give to patients.
“It’s pretty unusual to beat the federal government,” he said. “It felt great in the sense that this is the right thing to do.”
According to court records, New York University professor Charles Seife and President of the Center for Science in the Public Interest Peter Lurie sued the DHHS, Food and Drug Administration, National Institutes of Health and their associated directors. The lawsuit says that for 11 years, these agencies failed to comply with statutory reporting obligations for clinical trials regarding human subjects. In addition, their claim alleged that they neglected to notify the public of those failures.
According to ClinicalTrials.gov, parties that fail to comply with result submission requirements may face civil monetary penalties and could lose grants for federally funded projects.
Seife said that in his capacity as a journalist, he noticed that several of the records he requested from the federal trial database ClinicalTrials.gov were incomplete or missing. After joining with CRIT members — with whom Seife had worked on an earlier case — they formally filed the suit.
“The teams have done an amazing job, these are some very intricate legal arguments and having an agency roll back a regulation is no small thing,” Seife said. “I’ve seen several rounds of students, and they’ve all been great, so it’s been an amazing experience from my point of view.”
According to Seife, while the FDA Amendments Act of 2007 aimed to create a complete, centralized record of clinical trials, the law did not require every trial administrator to post their results. As a result, the database was replete with missing data and records, which Seife said was a “real problem,” for researchers like him.
Lurie did not respond to a request for comment. Yale Law School Dean Heather Gerken declined to comment.
Ross explained that trial results often go unreported on purpose. If, for example, a clinical trial for a popular drug reveals doubts over its effectiveness, some researchers may decide not to publish their results. This decision can lead to a body of scientific work that is not objective, he said, and can in turn affect medical decisions.
“What you end up with is a medical literature where all the positive results are published and the negative ones are not,” he added.
Simon Brewer ’16 LAW ’20 got involved in the case when he joined the MFIA clinic in 2018. Brewer said the HHS interpretation was that the regulation could make FDA-approved products exempt from disclosure. The latest ruling overturned this interpretation and deemed it unlawful. Their victory, he explained, “will help ensure that patients and their doctors can make the most informed decisions possible using all available data.”
“Judge Buchwald’s decision will make nearly a decade’s worth of clinical trial data available to physicians, patients, researchers, and the public. All of us deserve to know whether the drugs and medical devices we use are safe and effective,” he wrote in an email to the News.
The MFIA was established in 2009.
Matt Kristoffersen | matthew.kristoffersen
Valerie Pavilonis | valerie.pavilonis@yale.edu