During Pittsburgh seminar, FDA chief lays misinformation battle on doorsteps of universities, health systems

The head of the Food and Drug Administration called on academic and health systems such as the University of Pittsburgh to take a stance in the battle against misinformation, calling it the “problem of our time.”

The call for action from Dr. Robert Califf, FDA commissioner, came during a virtual seminar Thursday that celebrated the 40th anniversary of Pitt’s Epidemiology Data Center in the Graduate School of Public Health. The talk centered around short-term goals for clinical trials and policy, as well as misinformation, which was brought to light during the pandemic.

“What’s holding us back is we don’t have societal agreement in the U.S. about who trusts whom and for what reasons,” Califf said. “The government is not going to solve that problem. I actually think universities bear — I know I’m picking on you guys — universities bear the major responsibility here. You are not-for-profit because you are acting in society’s interest. … I hope you all will spend a lot of energy on (it).”

The talk came after the FDA was thrown into the spotlight during the covid-19 pandemic as it granted emergency use authorizations for vaccines and issued guidance.

A May 2021 poll by the Robert Wood Johnson Foundation and the Harvard T.H. Chan School of Public Health at the time found that 37% of respondents said they trust the FDA a great deal, 38% trusted the organization somewhat, and 24% said they did not trust it at all.

At that time, misinformation was circulating, largely focused on the full threat of the virus — while raising questions about government efforts such as masking and stay-at-home orders to help curb the spread — and the viability of the vaccine, which likely resulted in people questioning whether they would receive both doses.

“It would be beyond my imagination that you would have a free vaccine that reduces your risk of death by 90% and a substantial portion of our population would elect not to take it,” Califf said. “Not only do I say it reduces it by 90%, we have phase 3 definitive randomized trial data and very definitive real world evidence from practices in multiple countries and millions of people showing exactly the same thing. And yet people are distracted by all sorts of information.”

The solution to misinformation, he said, is having face-to-face conversations with trusted members of the community including doctors, pharmacists and religious community members.

That solution, according to Califf, can also be used to help battle misinformation regarding clinic trials.

A large chunk of Califf’s talk centered around educational and medical organizations working to streamline clinical processes. At Pitt, the Epidemiology Data Center conducts research on complex health questions through biology and statistics. Califf called the organization “a renowned clinical machine.”

“We need the academic systems and the health systems to participate also with a focus on what do we do to make sure the most important questions are answered as quickly as possible so people know what they should do in their prevention and health care,” he said.

According to Califf, the manner in which trials are conducted in the United States often leads to major questions not being answered.

He suggested following a system similar to the United Kingdom’s, where critical questions are identified and various groups work to answer them.

“The result was they’ve answered question after question definitely much more effectively than we have in the U.S.,” he said. “The exception of this was the vaccine trials, where I think the lesson from that is where we really have a clear objective and it’s all hands on deck and there’s an ecosystem of industry health systems … all working together to one objective.”

He identified several other goals for the FDA moving forward, including having engaged participants and clinicians during trials while working on communication across the health care industry.

“We need to align the system so we’re acting on behalf of the patients,” he said.