ARTICLE | Regulation

Ex-FDA chiefs see distrust in science rising, offer Califf starting solutions

Former FDA commissioners fear politics will continue to fuel misinformation, but say the agency’s hands aren’t completely tied

January 21, 2023 1:37 AM UTC
BioCentury & Getty Images

FDA Commissioner Rob Califf is making it a priority to battle misinformation about science, and his predecessors have a few suggestions for where to start.

They all agree that the spread of health misinformation and disinformation is reaching a crisis point. And though they have differing degrees of pessimism, their consensus is it will get worse before it gets better, and that public health officials alone can’t battle this. The village needs to step in. 

At the UCSF-Stanford CERSI meeting in San Francisco on Jan. 8, Califf called misinformation “the leading cause of death right now in the U.S.,” a problem he says stems in part from the lack of preparedness for the influence of the internet. “Whether we’re looking at COVID or chronic disease, people are making bad choices, driven by the information they get,” said Califf.

And yet, the answer may be to fight fire with fire. While social media is broadly seen as the major driver for the spread of harmful misinformation, it’s also a key part of the strategy to counter it. 

The third annual summit of the Centers of Excellence in Regulatory Science and Innovation (CERSI) discussed the problem of misinformation during a panel of “FDA Chiefs,” with Califf joined by former commissioners Scott Gottlieb, Margaret Hamburg, Mark McClellan and Janet Woodcock, who served as acting commissioner. The panel was moderated by Andy Plump, president of R&D at Takeda Pharmaceutical Co. Ltd. (Tokyo:4502; NYSE:TAK).

While they all acknowledged it’s an uphill battle to counter the political forces that continue to fuel misinformation and seed distrust in science, they stopped short of naming names.

Distrust in science exploded during the pandemic, but biopharma leaders were slow to speak out in combating the spread of misinformation, and public health officials stood by and stayed silent while leaders such as then-President Donald Trump touted spurious and even harmful supposed cures.

The fallout has continued beyond Trump’s tenure and the grip of the pandemic. The FDA chiefs agreed that the current political climate is stoked against public health agencies and professionals. 

“We’re going to go through a political cycle where there will be multiple national politicians campaigning against public health,” said Gottlieb. 

“What you call a political cycle could end up with people who actually don’t believe in public health, in charge of public health,” added Califf.

The consequences could be long-lasting. “These things become generational,” said Gottlieb.

Safe harbor for truth

Speed of response is essential for combating misinformation, but companies need to be empowered to publicly refute incorrect and misleading messaging without worrying about implications for their product label, said Gottlieb. 

Gottlieb, who served as commissioner in 2017-19, carved a communication strategy that heavily involved social media. At the meeting, he said Twitter offered him an opportunity to rapidly respond without going through layers of clearance, noting that he “wasn’t completely shooting from the hip” and used his team to vet his messaging.

“If we didn’t respond within an hour or two, it was going to be viral across social media, it would be on TV on cable news, and we’d lose control of the ability to shape the narrative.”

But while the agency can weigh in on FDA-related topics, defending product-specific issues is the responsibility of the sponsor. That will require creating a safe harbor that gives companies more latitude to respond to statements that are false or misleading to the marketplace, said Gottlieb. “There needs to be a standard for speech that allows sponsors to respond quickly based on substantial clinical experience, real-world evidence, that doesn’t necessarily rise to the kind of standard that you would require for something that goes into the label.” 

He said such a safe harbor should include guidelines, such as replying to clearly false and misleading statements, responding within a similar channel, and involving a standard of evidence that allows use of real-world evidence. It should stipulate boundaries as well, for example, that the response cannot create a new intended use. 

As things stand, sponsors are generally slow to line up their internal communications, and regulatory considerations add a layer of complexity that means the lawyers get brought in, so companies “end up not responding,” said Gottlieb.

A precedent, said Gottlieb, lies in the safe harbor created around payer communications that allows drug and device manufacturers to respond to payer requests about off-label use of products.

“I do think we need to think about a different framework for communications if we’re going to create a marketplace for good ideas to respond to a lot of the deliberate misinformation that we’re seeing,” said Gottlieb.

FDA’s inflection point

FDA is facing issues over its own credibility, which have left it with little influence to leverage in building trust in science and medicines more broadly. Restoring its reputation will require a lot more transparency over decision-making, and using its advisory committees to bring different perspectives into the public domain.

None of the FDA chiefs directly criticized the agency, its actions or its decisions, but they acknowledged the challenge. 

“FDA is also at a critical inflection point in terms of doing everything it can to ensure there’s trust and confidence in FDA as an agency,” said Hamburg, who led FDA during 2009-15.

FDA’s standing within the biopharma industry has been deeply scarred by the Aduhelm aducanumab-avwa debacle, in which FDA granted accelerated approval to the Biogen Inc. (NASDAQ:BIIB) drug for Alzheimer’s disease. The decision was one of the most controversial in decades, with FDA’s decision-making, independence and scientific integrity coming under heavy fire across the spectrum, from biopharma insiders to Congress. 

Moreover, FDA took several missteps during the pandemic that damaged its standing in the public eye.

At the start of the COVID crisis, the agency failed to oversee and implement broad testing at a time when other countries had deployed effective testing systems. FDA’s authorization of hydroxychloroquine and convalescent plasma, and more recently its confusing communications about boosters, have contributed to the skepticism about public health institutions that is at least partly responsible for the abysmal record of uptake of vaccines in the U.S.

Hamburg noted that beyond the anti-vaxxers, there was a substantial subset of the public that was genuinely concerned about whether the vaccines would be safe. “This new untested mRNA technology, the whole Operation Warp Speed moniker, and was the vaccine development being accelerated so fast that it couldn’t be trusted?” were valid concerns, she said. These played out against nefarious political narratives to escalate public wariness to the point of paranoia, she said.

Hamburg said there are concrete steps FDA can take, and that it needs to open up areas that have historically been viewed as a black box. Lack of understanding makes people more suspicious, which feeds belief in misinformation. Opening up the decision-making process, and publicly explaining the criteria on which decisions are made, are key to winning public trust.

She cited one lesson from COVID as how the agency was clear about what the standards would be for assessing safety and efficacy of vaccines. That helped in “bringing a lot of people along,” she said.

McClellan, who headed FDA in 2002-04, also said FDA should focus on providing more transparency, particularly on issues where there is controversy. It has mechanisms such as “advisory councils,” he said, that bring together different perspectives and can “air it out publicly,” especially where issues don’t have “fully fleshed out definitive answers,” as happens during a public health emergency. Then there need to be active efforts to convey the findings to healthcare providers and other groups that can curry more influence with the public. 

He said FDA has been good about creating forums to discuss different science-based views about products where there are controversies in terms of clinical decisions on the product. “But it hasn’t done as much for what should clinicians be talking to their patients about with respect to this product or this area of care, and the misinformation that’s out there.”

Bringing in the village

While FDA and public health agencies are important, they can’t be the whole answer, because their stock has gone down as a result of the pandemic, coupled with the politicization of science.

“We need other spokesmen now,” said McClellan. “If you look at where trust still resides, it’s in people’s physicians.” McClellan said that engaging community leaders and physicians is a way to bridge to the public.

For example, reinforcing the ability of manufacturers to respond, within the label of their products, is one step, but that information needs to be made more effectively available to healthcare providers and local community organizations, “who have not been as effective a voice either in some of these debates.”

Woodcock, who was acting commissioner in 2021-22 and is now principal deputy commissioner, noted that patient organizations are “very trusted” and largely aligned with FDA, which has broad support among those groups. However, that trust extends mostly to people who are ill or diagnosed, rather than the general public. “When you get into prevention or treatment of very common diseases where there isn’t a lot of advocacy, then really misinformation can proliferate,” said Woodcock.

Califf said the academic community had not only failed to help combat misinformation, but had exacerbated the problem with very public criticisms of FDA, which are taken out of context or not understood. He believes that feeds an erosion that can hurt the agency long term.

“I don’t want to suppress the fact that as a public agency we need to be critiqued, but I think that often the people that are doing the critiquing assume that the agency’s going to be there in the future in the way that they expect it to be there, so they’re critiquing to make it better. But to a lot of unsuspecting people that hear it, it just completely erodes their belief in the institution,” said Califf.

He said criticism of FDA by academics should be made carefully and in front of the right audience. Critics need to consider “the impact that it has on middle-of-the-road Americans who are just trying to decide who to believe and what the truth is.”