Five Yale law, medicine and public health professors, along with a national team of scientists, signed an open letter last week addressed to U.S. Secretary of Health and Human Services Alex Azar LAW ’91 calling for greater transparency in COVID-19 vaccine clinical trials.
The letter, which was written in collaboration with Yale Law School’s Media Freedom and Information Access Clinic, urges Azar to release information to the public about ongoing COVID-19 vaccine clinical trial designs and data collection. Given the remarkable speed at which public and private sector scientists have been working on COVID-19 vaccines, the authors argued that more openness will improve public confidence in the safety and efficacy of the vaccines once they become available, while also protecting the long-term reputation of public health agencies in the United States.
“We write at a critical moment,” the letter states. “Many Americans are nervous about the possibility of a rushed or politicized decision. We write to urge you to provide researchers and the public with greater transparency regarding clinical trial design for all ongoing COVID-19 vaccine studies being conducted by any company that receives federal funding.”
The HHS did not respond to multiple requests for comment.
One of the letter’s signatories, professor of medicine Harlan Krumholz ’80, said that some work to increase research transparency is already being done, on the part of both the University and pharmaceutical companies — the Yale Open Data Access project has been working for several years with the pharmaceutical corporation Janssen to make clinical trial data and case report forms accessible to the broader scientific community.
However, the letter still urges that more information be made available to the general public. This information would include all versions and amendments of protocols, statistical analysis plans, stopping rules, blank consent forms and agreements with government agencies for vaccine trials.
Krumholz emphasized that trust in government institutions and pharmaceutical companies –– which comes from holding these groups accountable and requiring a greater level of transparency –– will be crucial for a COVID-19 vaccine to be successful.
“People are uncertain and need good information so they can make informed choices,” Krumholz wrote in an email to the News. “The political polarization, misdeeds and misinformation has led people to be confused about who is telling them the truth. Without trust in science and credible voices who communicate about science, we will have trouble fostering the behaviors and implementing public health measures that are necessary to prevent and mitigate harms from the pandemic.”
Department Chair of Epidemiology Albert Ko described that calls for transparency in COVID-19 vaccine clinical trials must be balanced with efforts to protect patient confidentiality. According to Sam Aber ’17 LAW ’22, who is part of the MFIA Clinic and helped draft the letter, there are “no privacy issues” because the information does not contain individual patient-level data.
Ko stressed that the issue of transparency is not unique to COVID-19 trials. He said that holding pharmaceutical companies and government institutions accountable to the public is something that should be standard practice in medicine and science.
Aber explained that current Federal Drug Administration regulations require that most clinical trial protocol information be released when the trials are complete.
However, he and the other authors of the letter believe that the current circumstances call for a more immediate release, especially given the possibility of an Emergency Use Authorization for a vaccine. Aber said that the politicization of the regulatory process, the growing vaccine hesitancy, the substantial public investment in Operation Warp Speed vaccines and the massive guaranteed purchase orders for other vaccines make the current situation special.
“The Freedom of Information Act permits federal agencies like HHS to withhold certain commercial information, but it does not require them to do so,” Aber wrote in an email to the News. “So HHS is free, legally speaking, to release this stuff –– they just need to meet the exigencies of the moment.”
The letter also requested that Azar issue a statement by this Tuesday identifying all information that is in the possession of HHS agencies –– including the FDA and the National Institute of Health –– and providing a timetable for its public release.
Azar did not release any such statement, as of Wednesday evening.
“Especially in a context where there is a lot of valid concern about political influence at HHS and its agencies, we think that greater secrecy can only increase skepticism and suspicion by people on all sides,” Aber wrote in an email to the News. “Transparency here would also be consistent with scientific norms, if not necessarily commercial ones.”
Azar is the 24th secretary of health and human services.
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