You're listening to Beyond the Endpoint, a podcast from the Duke Clinical Research Institute. In this series, we're demystifying clinical research and answering your pressing questions about health and healthcare. You can find our full episodes at dci.org.
So in 1997, I was an intern in the Duke CCU. I'll just tell you, our next guest shared with me a simple but profound truth about medicine that's stuck with me ever since. There are really only three things you can do for a patient, he said. You can make them feel better, live longer, or avoid an unpleasant event. But how we approach these goals, particularly at a population level, has become more and more complex. We've had a shift in our public understanding of health, the spread of misinformation, and certainly how we approach medicine. I'm excited to have the world's foremost expert in not just how we think about medicine, but how we do the trials and regulatory science, Dr. Robert Califf. He's going to join us to explore how we navigate these challenges while continuing to improve how we deliver on helping our patients feel better and live longer. I'm Dr. Manesh Patel. I'm the chief of the division of cardiology and clinical pharmacology here at Duke and a member of the Duke Clinical Research Institute. I'm joined today by my co-host and fellow DCI member, Dr. Emily O'Brien, an associate professor of population health sciences and neurology at Duke.
Hey, thanks, Manesh. I'm excited to welcome Dr. Califf to our podcast today. Rob's a cardiologist and founding director of the Duke Clinical Research Institute. He served as the commissioner of the US FDA not once but twice, from 2016 to 2017 and again from 2022 to this year. Since completing his most recent stint at the FDA, we're excited to welcome Dr. Califf back to Duke at the School of Medicine and the DCI as an instructor of medicine. He's a leader in the field of medical research and regulatory science. He's widely recognized for his contributions to clinical research, cardiovascular medicine, and healthcare quality in the United States. Rob's from a small town in rural South Carolina. Rob, welcome to Beyond the Endpoint.
Thanks, Em. Good to be here.
One of the things people don't talk a lot about, we didn't put in your CV, was that you actually won a basketball state championship in South Carolina. Tell us a little bit about what that was like.
I didn't win it, but I was captain of the team in 1969. That was a long time ago. We were 4A state champions. That was a great night, and the next morning was tremendous. Then you're right back to being a normal high school student with all the problems that occur after that. But a lot of great memories of that team and all the things that built up to it. A lot of lessons in life from that too.
Of course, I bring it up, Rob, because I suspect that's a lot like when you become asked to be the FDA director. It's like an exciting moment. You go through a bunch of stuff and then get back to working on teams and things, and it leads to, I think, the moment we're at now, which is how do we think about health broadly. I know there's a lot going on. One of the biggest challenges we see is that the ability to get evidence and things that work to our communities is hardest. I guess I'd start the conversation by saying, what do you think the biggest challenges are of us getting things that work to our patients?
If we're speaking about the United States, I think we have special problems and issues here, many similarities to everyone else in the world, but also some big differences. We are currently settled into last place in large high-income countries in terms of life expectancy and healthy life expectancy. That is, we have more years of disability in addition to living a shorter life in this country. And we're unique among high-income countries in not seeing healthcare as a right, as a fundamental property of human existence in a society. And so for a whole variety of historical reasons, we have this hodgepodge of insurance coverage and tremendous financialization of the system. I had a very interesting day yesterday. I was down in Houston with a lot of old friends at Methodist Hospital and their cardiology group, which does a tremendous job. You go to that complex in Houston, you've got 52 institutions, mostly completely devoted to high-tech healthcare, MD Anderson and three medical schools, and it goes on and on. Then you go a couple hundred miles away in Texas, and you have some of the worst health in the world with inadequate access to basic services. And I think a lot of that is just because of the way that we pay for things, and that distorts a lot of things about our system. Now, if the goal of the system is to provide excellent care for the wealthy and well-to-do, we are doing a great job of that.
That gets to, I think, something that we're all struggling with right now in this current moment. And I'll just say it's been incredibly challenging to watch some of the changes that have come down the pike, not necessarily at Duke, but at other institutions where faculty members are being told that equity is no longer on the table as a topic. I'll just be candid. I think you feel this too. It's a pretty depressing time for public health, given that I think we were just starting to make some pretty good strides into recognizing some of the disparities that you're talking about. How do we get back there? Can we get back there to a point where people really appreciate how where you live and who your parents are has such an influence on your health and life expectancy? What do you think it'll take to get back?
This has been quite a journey for me too, and I feel at age 73, I've been through a lot of ups and downs in my career in terms of what I thought should happen. Things go back and forth. I also think it's important to point out that acting like something doesn't exist or pretending it doesn't exist doesn't make it go away. If we say we're not going to, we're going to claim that there are only two sexes and that gender and sex are the same thing, that doesn't mean that it's true, and all the issues are still going to be there whenever open discussion of issues comes back into play. So on the more mundane, everyday level, but very important, we are talking about the issue of what can we do to create systems that improve the lives of people who don't have excess money, who don't have connections. Right now, as you all know, just getting a primary care appointment anywhere in the United States is almost impossible. Makes it pretty hard for us to argue that we're patient-centered. So it's tough for people who think like I do. On the other hand, I'm widely promoting the Humpty Dumpty nursery rhyme as the key here. I've learned that about 100% of Americans know the first verse: all the king's horses and all the king's men couldn't put Humpty Dumpty back together again. But if you read the whole thing, at the very last verse, Humpty Dumpty actually did get put back together again. I just think we need to be as steady as we can be now. Emily, you raised another point. Just to be very direct about it, I think we also have to be smart because people like Manesh who are leading institutions may want to, let's say, protest or act like there are no pronouncements from the government, but he's got a whole bunch of employees who will have their funding cut off if he says or does certain things. So we have to be smart in how we're going to deal with this. The great opportunity is at some point in the future, I have no doubt the system is being disassembled in the way we used to think of it. The great opportunity is it's going to need to be put back together again, and it will be a chance for people to put it back together, often doing things that people who believed in things that I do just couldn't do them because the system made it impossible to do them.
Yeah, Rob, maybe I'll pull on that thread. I think maybe I'm a glass-half-full guy all the time, but the disruptions that are happening do provide this opportunity for us to at least reimagine what would be a way in which you get health to everyone everywhere. And one of the things I remember again about our history, or at least your history, is that you ushered in some of the modern cardiovascular era by traveling to our remote counties in North Carolina and making sure those patients got into studies that opened up their heart arteries and thought about that. And I think about that because today there are discoveries that we have that don't get to the people that need them. How do you see that potentially being put back together in your Humpty Dumpty analogy?
I mean, this should be a glorious time for what we call clinical research. A lot of it looks eerily similar, and I'm not the first person to say this, to what happens at the checkout counter at the grocery store. The average grocery store clerk is actually doing more research than the average doctor these days in the United States because every move that's made by the grocery store clerk and everything that you buy is being measured. It's being fed into analytical methods, and of course, the goal, the output that's desired there is happier customers spending more money in the store. I think the question for us is, can we overcome the historical cultural issues that have caused us to block the flow of information and create a similar system that was envisioned 30 years ago by the old HMOs, that every healthcare transaction becomes a source of potential knowledge, analytics are always humming in the background, and we're learning as we go. And I think you'd agree we're far from that now. If you talk with our average clinician on the front lines, they're getting very little learning occurring through the practice. It's just so hard to get your hands on the data in the current configuration, but we're ever so close. There is no technical limitation on it now in one phase of research, that is knowing what to do, what's best, what the best alternatives are. We should have a renaissance coming up very soon in which we're learning in everything that we do. And of course, now we can bring in personal devices and sources of information to learn. I'll just say another thing about Houston. You know, they were telling me about the new hospital they're building, which is essentially no computers. You walk in and it's all voice-activated and all AI-driven. But that gets to the core existential issue. I think what I positioned yesterday was a column about professionalism in all of the biomedical enterprise and a column about financialization. And the values of those two components of our being are in a great, just to put it mildly, in a great state of tension. My thesis right now is that financialization is dominating over professionalism. I think this is a source of so many people having what's called moral injury when they practice medicine. I think it's less a technical issue now, more a matter of whether we carry the day in terms of what the purpose of all this is. Is it to generate profits for the systems that employ us? Yes, of course, you have to make money. I feel like it's foolish to say, well, it's not about that. Of course it is. But we've got to balance that with continuous learning and standing up for the patients and populations that we serve.
This is Beyond the Endpoint, a podcast where we bring personal and expert perspectives on healthcare and clinical research to the casual listener. Stay tuned after the interview for a breakdown with the hosts. They'll talk through key takeaways and what this week's topic means for you.
So Rob, it sounds like one of the important constructs here is really one about values. And to me, when you're trying to put a system back together in a way that's more efficient, inevitably you're going to work or need to work with people who have different values than you do. And I remember during the pandemic, Francis Collins used the term fringe epidemiologists to describe some of the folks who may have had non-mainstream views in terms of diverging a bit from public health experts and what they recommended. And, you know, for the first time, I think, at least to this extent, we're seeing that the fringe is now in charge. What do you think this means in terms of what the American public thinks about science and who should really be leading a lot of these efforts? And are there any aspects that you might actually agree with, that, yeah, you can appreciate that our outcomes maybe aren't what they could be with the amount of money that we spend, or, yeah, lots of areas that we could improve? Are you sympathetic at all with that sort of fringe perspective? And how do you think we can best kind of work together to build things back to where they should be?
