Remarks by FDA Commissioner Robert M. Califf at the National Press Club Headliners Luncheon February 14, 2024

Speech | Mixed

• Speech by: Robert M. Califf, M.D., MACC ; Commissioner of Food and Drugs - Food and Drug Administration

(Remarks as prepared for delivery)

Good afternoon. Thank you for inviting me to be with you today.  

It’s somewhat fitting, given my background as a cardiologist, that I’m speaking to you on Valentine’s Day. And for that reason, I’m going to start out with some tough love for the members of the Fourth Estate. But rest assured, I'm also the grandson of a Baptist minister and I'm well aware that we are all sinners.

First, let me say, I’m an avid consumer of news. Of course, I believe in both the importance of free press, as well as the power of the press and the responsibility to society that comes with it. I’m also a recovering former reporter -- I was a beat reporter for the Duke Chronicle during my freshman year.

A free press is an essential element of a strong America. The first amendment is first for a reason. 

Some have called journalism the first rough draft of history. And while this role as chronicler remains true, we all know that changes in technology and across society mean that journalism is a very different creature since this description was first coined.

The growing number of traditional and social media outlets provide more opportunities to share information, spark meaningful conversation, invite calls to action, as well as to provide vast amounts of information about diverse peoples, their communities, their triumphs, and their needs. And this ocean of information is augmented and shaped by so many new and non-traditional venues for exchange of information and opinions.  

I was drawn to a 2023 report from Stanford on science education that said: “An overwhelming body of evidence suggests that students are not so much digital natives as digital novices. They may be in a digital sea, but they are rudderless, lacking the basic navigational tools that would ensure they are not deceived.” If this is true of high school and university students, what about the general public?

Indeed, this vast information environment that offers so much opportunity to enrich our society also has the potential to cause enormous harm.  

What you publish, the words you use, and who you quote to provide context and authority has tremendous implications for every issue you discuss, perhaps nowhere more than the area in which I spend most of my waking hours -- public health and the choices of individual people—health professionals, patients and consumers -- in their health behavior.  

As I’ve grappled with the impact of communications (and miscommunications) on health – particularly what the FDA and others can do in this space – there are several aspects specifically related to the media that I feel are especially important to discuss. 

We currently are in the midst of a significant decline in life expectancy in the U.S., and our health outcomes and life expectancy lag almost all other high-income countries. The proximal causes are not mysterious: Covid and other respiratory viruses, suicide and overdose, gun violence and underlying it all is a base of an increasing toll of chronic, non-communicable disease. We also have very high levels of fetal and maternal mortality compared with other high-income countries. The way information is conveyed to consumers and patients through the media and other sources about this issue and the factors which are causing it, and what individuals and society can do to reverse it, directly impacts the health of our nation. 

A recent series of articles in the Washington Post painted a vivid picture of this impact, documenting the direct link between the communication of bad information, bad decisions at the individual and policy level, bad health and higher rates of death. 

Some of you have likely heard me talk about this issue before.  Indeed, throughout my career, I have been fascinated and concerned about the ways we use information to make decisions. In three decades of work as a busy clinician and researcher in the fields of clinical trials and health outcomes and quality, it was striking to observe the difference when expert clinicians were armed with high quality evidence about the best practices and interventions. But these days, even high-quality evidence can be distorted and misrepresented in ways I would not have imagined in the past. 

I’m sure you all agree that the internet and digitization of our world has dramatically changed the way we learn, communicate, and share information—with profound consequences for health.  

Given that the way information is presented in this new and rapidly evolving environment can and does directly affect the decisions people make for themselves and their families about their health, a critical question is how each of us as individuals and professions should adapt our approaches to meet the moment.

The influence of information presentation and the way people digest it on what medications people take; what foods they eat or don’t eat; whether they choose to smoke or vape, and whether people get vaccinated, or which vaccines they get and when—all of these decisions truly have life and death consequences.

COVID vaccination, unfortunately, remains the most salient example.  

With over a billion doses of these life-saving vaccines administered, the scientific evidence presented in countless studies has demonstrated the safety of these vaccines as well as the dramatic reduction in the risk of death, hospitalization and serious illness afforded by them. Just in the past month, Europe and the UK have published the evidence that since the start of the pandemic enormous numbers of lives have been saved and hospitalizations prevented. These findings complement the Commonwealth Fund’s definitive work on the huge beneficial effect of the Covid vaccines on the U.S.  And just last week a major report from Sweden and Norway showed that babies born from mothers with updated vaccination had lower rates of death and other adverse events of infancy. 

Yet the ongoing proliferation of misinformation and disinformation about these facts, and the failure to provide adequate and continued attention to the clear risk reduction provided by these vaccines, has resulted in a distorted view in the population about COVID vaccination and this incorrect perception has led to lower vaccine uptake. This is now “spilling over” into the general vaccination issue, as evidenced by the recent re-emergence of measles.

What this unfortunate trend means is continued death and serious illness toll of COVID-19 – much of which could have been prevented through the use of readily available safe and effective vaccines and therapies. 

Let me offer you a recent example of a situation where the focus on the sensational took precedence on this topic.  

Several weeks ago, media outlets from around the world reported on the Florida surgeon general’s unfounded call to halt the COVID vaccines. It was a splashy news story, easy to report and filled with conflict, albeit unmerited.

In fact, only a few weeks earlier, the FDA publicly shared a letter we sent to the Florida surgeon general on the precise underlying issue he raised. We outlined the implausibility of it, and reinforced the thorough scientific assessments that give the FDA confidence in the quality, safety, and effectiveness of the vaccines. No drama, just facts. Not surprisingly, only one or two reporters wrote about it then.  

Make no mistake. It’s important for the public to understand a range of views to help inform their own opinion. But too often the panoply of stories to which people are exposed causes them to lose sight of the underlying issues that would enable them to live longer free of hospitalization and disability.

Instead, they often give equal or greater print or airtime to a relatively small, but persistent group of stories and opinions that have the benefit of generating controversy, even when those reports are based on views that disagree with and do not represent the vast majority of expert opinions.   

This trend of “Bothsidism” or “false balance” has been the focus of much discussion relating to environmental issues such as global warming, and it has been quite noticeable in recent vaccine discussions, contributing to the issue of vaccine hesitancy. 

In the example I just noted, the stories were about one outspoken surgeon general who opposes vaccines. A simple review of the landscape reveals that almost all the other surgeons general and state health officials support the widespread use of vaccines.  

There’s another key impact growing out of the way information is conveyed by the media that goes beyond individual health decisions. It can profoundly and inaccurately alter the trust the public has in institutions like the FDA -- whose primary mission and mandate are to protect and promote public health, and whose work is based on science and data. 

A single decision made by the FDA can elicit a multitude of reactions from scientists, industry and others.  

I’ve often heard folks at FDA and elsewhere say that if everyone is mad at us, then we’re doing our jobs. Gauging by the headlines we see, then I guess we’re really good at our jobs.  

But the reason I bring this up is that it means that there is always the opportunity to portray decisions made by the agency in a negative light – if that’s the approach someone wants to take. This exists even when there are many more people who have reacted positively or benefited by FDA action. 

How a story or headline on an issue is framed makes all the difference in the world for the public. And far too many stores are written leading with experts denigrating an FDA decision that could just as easily be written using other experts lauding that same action. 

The relationship of a headline to the rest of the article has long been a source of consternation and attention. The headline is almost always couched in more vivid, negative terms than the body of the article.   

The reason is obvious—the goal of the headline is to entice the reader into “clicking” on or reading the article. A 2023 publication documented what headline writers have long known—negative words entice readers more than positive words. This effect is not trivial. 

Now, I’m not saying this because I expect everything written about FDA to be positive, nor are we expecting that journalists and others won’t question our actions. But what you write and how you write it has a tremendous impact. 

Journalists have a real opportunity to help educate the public on complex health issues in a way that arms people with accurate, actionable information to make decisions to improve the health of themselves and their families.  

Many news organizations have continued to take up the time-honored standard mantel of fact-checking efforts and have come to our team for factual information to bat down viral misinformation. And I know many news organizations are working to be more thoughtful in their approaches to stories that tangible impacts on things like public health. 

But, let me be clear, in the world of media, of course, the impact of information on health decisions isn’t limited to the news media. This is an enormous challenge that will take all of us, including the media, the FDA and the health care community, to help collectively address.  

The world has changed. At this point, there are many voices in a constant stream of information and opinion. For example, some social media influencers and podcasters have millions of subscribers, vastly exceeding our standard news outlets; New York Times has just over 10 million subscribers and Washington Post has 2 to 3 million. Less than 8 million watch each of the traditional nightly news broadcasts. And influencers on media such as TikTok or Instagram are affecting very large parts of our population. And of course, expertise in biomedical science and fact checking are not required to be an influencer on social media.

Over the past few years, the FDA has increasingly used multiple communications strategies to deliver accurate, understandable and timely health information to the public, including: 

• helping news media with fact-checking viral misinformation; 
• creating resources for our website and social media to address common questions about the products we regulate or counter dangerous misinformation and rumors; 
• posting videos with subject matter experts on social media;  
• livestreaming our media and stakeholder calls;  
• increasing interviews and engagements with agency subject matter experts; and 
• providing public health stakeholders with toolkits of resources and accurate information on FDA actions. 

I’ve been lucky to have the support of a talented and experienced Office of External Affairs and a broad network of communicators across the FDA centers. We’ll continue to do our best to represent the FDA in a way that gives the press and the public access to the truthful information. 

Yet we are a tiny spec in this universe of information. And despite our efforts and the efforts of others, health misinformation is pervasive and health literacy remains a barrier to access -- causing significant harm and delaying prevention or treatment for real people. 

While the FDA remains steadfast in its efforts, all parties in the public health ecosystem – from regulated industry and academic institutions to medical associations and local health care providers – need to take an active role. 

The clinical and biomedical expert community has a particularly important role to play as trusted intermediaries to convey reliable information to patients and consumers. I feel that this group is also overwhelmed with information—the proliferation of journals and internet sources makes it more and more difficult for busy professionals to keep up. Polls continue to reinforce, however, that people trust their local clinicians—doctors, nurses, pharmacists and others. We are redoubling our efforts to communicate effectively with these learned intermediaries who are having personal interactions every that can counter misinformation.

Given the primary priority of preserving freedom of the press and freedom of speech and the enormous changes in the environment in which we all operate, I want to challenge you as journalists – just as we’re challenging ourselves at the FDA – to continue striving for approaches that benefit public health in the best possible manner.   

Thank you, and I look forward to your questions.