Remarks by FDA Commissioner Robert Califf to Health Connect South September 22, 2022

Speech | Mixed

• Speech by: Robert M. Califf, M.D., MACC

(Remarks 

Thank you, Russ [Lipari]. I’m pleased to join you today for the Health Connect South meeting. I’m just sorry I can’t be with you in person, particularly at such a wonderful venue as the Georgia Aquarium.  I’ve been told that you will all be able to see me on screen as I’m speaking, but I won’t hold it against if you prefer to just listen while watching the Beluga whale that I understand is front and center in the room.   

Let me begin by acknowledging the essential work and mission of Health Connect South, and particularly your focus on collaboration and building partnership opportunities to serve and strengthen the health care community.  As someone who comes from “this neighborhood,” I have special appreciation for the impact of the work you do in this region.  Having grown up in South Carolina and spent almost all of my professional education and practice in North Carolina, I also know just how important the support of regional partnerships can be for our communities.  When it comes to basketball we have Duke Blue and Carolina Blue, but when it comes to health we do best when we have shades of blue that are blended to benefit our patients and population.

This impact is only heightened during times of turbulence.  And we’ve certainly had our share over the past few years, thanks in large part to the Covid-19 pandemic.  The pandemic has not only had a direct impact on individual health, but those effects have been compounded by the related impact on supply chains, the economy, and in other areas.  

All of which has served to underscore the significance of health care -- and in too many cases the lack thereof -- in the daily lives of so many.  And it has made crystal clear the essential role that clinicians, provider organizations and public health clinicians and entities of all types have played in helping to respond to a crisis and meet the needs of our communities.  So let me thank you for your caring and commitment.

Of course, the pandemic didn’t occur in isolation.  Even as we’ve responded to that crisis, all of us in the health care community have continued to meet our regular and essential public health responsibilities, and, unfortunately, have had to respond to other public health crises.  

In the case of the FDA workforce, for instance, our 18,000 employees have been working nonstop to carefully review and authorize new safe and effective treatments, including vaccines, boosters, and antivirals to treat COVID-19, all the while keeping unsafe products off the market, but they have had to deal with a host of other crises, such as our work to increase the supply of infant formula and our interventions to counter the monkeypox outbreak.  And we’ve also continued to make important strides in other critical areas of public health that are causing harm, such as the opioid crisis and continued use of tobacco products, both of which continue to evolve and lead to a staggering loss of life—more than Covid at this point-- as well as many related costs as people and families grapple with substance use disorder. 

Among your institutions, clinicians have continued to provide care despite the overwhelming pressure caused by the stress of human need and the evolving shortage of qualified professionals, and American innovators have continued to be the envy of the world, despite the limitations of resources engendered by the pandemic.  

So, there is no doubt we face many challenges.  And all of you who are here today from across the region, have made important contributions in response.  Both individually, and through creative collaborations and partnerships you’ve built – among local and community clinicians and provider organizations, national and international organizations and governments, researchers and academics, scientists and doctors, and industry – we’ve worked to address these challenges in new, creative, and productive ways. 

Collaboration is a powerful concept, nowhere more so perhaps, than in health care and the industries that support health care and public health.  I say that not simply because I’m speaking to a group that has collaboration as a guiding principle, but because it is also central to what makes the FDA tick.  Every day, throughout our agency, scientists and regulators work with other government agencies, as well as with patient advocacy groups, organizations focused on speeding the development of treatments for individual diseases, developers, and many other stakeholders in support of our mission to protect and promote public health. 

Today I want to celebrate collaboration exemplified by achievements such as the development, evaluation and distribution of vaccines and antiviral and other therapies for Covid 19.  But I also want to ask a fundamental question, thereby hopefully stimulating your creative thought: What is the fundamental purpose of our collaborations?   Is it possible that in pursuing collaboration focused on our mutual business interests we’ve somehow missed the mark?  

I can cite many successful collaborations in our country and the southeast region that have made our businesses more successful and improved the health of specific groups of people or patients.  But right in front of us, we’ve seen a dramatic decline in the health of the people we’re supposed to be serving in our not=for-profit and for-profit organizations.

Let’s reflect on some numbers.  The U.S. has experienced a flattening or down-trend in life expectancy for almost a decade, and now for the past two years we’ve seen a dramatic decline.  China passed us in life expectancy this year—I would never have imagined in my lifetime that people in China would live longer than we do in the U.S.  Our average life expectancy is five years shorter than the average of other high-income countries.  These differences are expanding, not declining.  

Within the U.S. we see enormous differences as a function of demographics -- race, ethnicity, wealth and education.  Minorities and people with lower education and wealth levels have a shorter life spent, on average, in poorer health.  As a man. I must point out that the gap between women and men is growing again with more than a five year advantage for women.   

But the largest change is now occurring as a function of geography — that is, where we live.  People in rural settings in general are seeing a dramatic decline in health and life expectancy.   Within Southern states, health status and life expectancy in the cities and university towns is good and improving, while the opposite is happening in surrounding counties.  The net effect on all this is that the Southeast, already starting with a health deficit, is seeing the largest decline in health and life expectancy in the nation.  

The reasons for these disturbing trends are not mysterious.  While we are all familiar with the term “social determinants of health,” identifying the problems and solving them are two different things.  What has captured my attention lately is the combination of two facts:  First, the health manifestation of these social determinants is through common chronic diseases—heart, vascular, lung and kidney disease; mental health issues, including depression and suicide, drug use disorder and gun violence.  I do want to point out that unprecedented collaboration on cancer and rare genetic disease has led to an improvement in outcomes in these diseases — countercurrent to the main trends.  

Second, our health and medical care institutions are among the greatest concentrations of wealth and capital in our society, and by a large margin the top or second largest employers.  Altogether, we spent over four trillion dollars on healthcare in this country last year.  Until recent times we were able say with a straight face — those social determinants are not the business of healthcare.  That’s not so easy now.

So, my hope is that as you think about the many opportunities for collaboration in this meeting, consider how collaboration could align success in the business of sustaining our organizations with improvement in health.  Can we consciously improve employment in disadvantaged rural areas and neighborhoods with higher minority status?  Can we develop collaborative programs that address the root cause of the big health problems driving death and disability?  

Let me give you a few examples where FDA collaboration and effective regulatory paradigms may be critical:

Digital technology and ubiquitous internet are in our national plans.  Can the combination of our amazing reservoir of innovators and appropriate regulation lead to a renaissance of community and home-based prevention and health?  Is it possible that systems of community health workers in rural and underserved communities, supported by digital technology to provide expert backup, might be a great source of employment and better health?  

We need a new era of therapeutics for common, chronic diseases, mental health conditions, pain and substance use disorder.  Can we turn the tide through a combination of human and technology systems that apply what we already have in our therapeutic armamentarium and breakthrough therapies?

We need renewed focus on reducing harm from tobacco products.  The FDA has the primary responsibility at the federal level to regulate tobacco and vaping, but this is a national problem, like most others, with disproportionate impact in the South.  What kinds of partnerships can lead to a package of effective services that care for 30 million Americans still using tobacco and the millions of teenagers addicted to nicotine from vaping?  

The FDA regulates over 75% of the food supply and has responsibility for nutrition fact labels and standards for food.  Obesity and diabetes with resultant vascular disease and cancer—remember that obesity is as big of a risk factor for cancer as it is for heart disease—these are moving rapidly in the wrong direction.  Given the climate change we’re experiencing, we need fundamental innovation in food production. It seems entirely possible to produce nutritional fruits and vegetables and protein sources in an environmentally friendly manner with resilience to climate stresses and freedom from toxins that are pervasive in our current food supply.  But, by the way, in addition to better nutrition, the unraveling of the neuroendocrine systems that drive our appetite is opening up the possibility that pharmacology could be a major addition to our efforts to curb the obesity, diabetes, cardiovascular and cancer epidemics.

All of the issues I’ve mentioned are either disproportionately affecting the South, moving in the wrong direction in the region, or both.  

While I’m focused on the big issues driving our declining health status, I’d be remiss if I didn’t point out the great collaborative successes we’ve had in working with consortia on rare and genetic diseases and cancer.  Many Southern health sciences centers are participating in consortia solving problems in gene therapy and genetic modification, cancer clinical trials and public private partnerships.  At the FDA we’re eager to work with all willing partners.  FDA staff bring a unique set of skills and knowledge to the table. In the medical product arena, for example, we have the awareness and understanding of the success and failure of all products in development, and can provide greater regulatory clarity helping identify the best and most efficient pathways, preventing wasted or duplicative efforts, and ensuring speedy development of the best and most effective products.  With the shared expertise of other stakeholders we can build effective partnerships that can generate actionable solutions for the development of new treatments.   This is just one of many ways that we’re open for the collaboration business.

Finally, I want to mention one related area in which you can play an important role, and that is in combatting the rampant misinformation and disinformation that is polluting communication, undermining confidence in science and the work we do and, weakening faith in governmental and other institutions, including the FDA.  It is helping to destroy all of the good work you are doing.

This kind of misinformation, spreading largely through social media, is leading people to make plainly uninformed and adverse choices regarding their health, from continuing to use tobacco products or vape, or eating a poor diet or failing to adhere to effective medicines, including vaccines and antivirals that are available for Covid 19.  They are doing this in the face of definitive facts that not only make clear these actions are harmful.

It is perhaps the greatest challenge we face in public health right now and to combat it will require a true collaborative effort that goes well beyond the FDA – involving the development of a proactive network that includes not just our Federal partners, but regulated industry, health systems and clinicians and universities, not to mention public health and advocacy groups.  

Each of you here today can play a role in this battle for the truth.  Through your connections of work, family, communities, and on social media you have the ability to help break through the disinformation echo chamber.  And by engaging and connecting people across the health care continuum to achieve this goal we will make more viable all of the other extraordinary collaborative efforts that you are engaged in. 

I hope that before you leave this conference you will seriously consider what you can do to combat the misinformation about vaccines and antivirals for Covid 19.  Although we’re all tired of the pandemic, we’re still losing over 300 Americans per day to this virus and our models predict a significant risk of a “winter wave.”   

One could just as easily say that these Americans are dying from misinformation.  Almost no deaths are occurring to people who are updated on their vaccinations and treated with antivirals if they are infected and high risk.  Regrettably, the greatest resistance to vaccination is in the South and increasingly, the deaths and hospitalizations are concentrated in the rural South.  For most people the most important single thing one can do to remain around for this next holiday season is to get the updated vaccine and get appropriate medical care if infected.

I am under no illusion that more exhortation from the federal government will move large numbers of vaccination resistant people—although we will certainly try.  But you can have a huge effect if you choose to do so in your own organization and through face to face contact in the clinic, family and social interactions.

We face great challenges in health care.  But we do have the potential to join together and overcome them.  I look forward to working with you to forge collaborations that reverse the trends I’ve discussed today.   

Thank you.