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Robert Califf
Former FDA Commissioner; Vice Chancellor for Health Data Science, Duke University

Dr. Robert Califf | Centennial Oral Histories

📅 Nov 18, 2024 Duke University 63 MIN 990 VIEWS 87 SEGMENTS · 3 SPEAKERS
Currently serving as commissioner of ‪@US_FDA‬, Dr. Robert Califf is a Duke alumnus and renowned cardiologist who has held prominent leadership roles at Duke including founding director of the Duke Clinical Research Institute. In this interview with Dr. Adrian Hernandez, Vice Dean and Executive Director of the Duke Clinical Research Institute, Dr. Califf talks about his life, his mentors, and the emergence of data-drive research. Centennial Oral Histories Duke University’s Centennial Oral Histories Program includes one-hour videotaped interviews with former and current leaders of Duke Univers...

Questions asked in this interview

12
  1. 0:39Or were there any influences there later in life?
  2. 4:58And was there any idea about either playing at Duke, or being recruited to Duke for basketball?
  3. 9:06You eventually graduated with a major in psychology, which is kind of interesting, seeing the role that you have now dealing with a lot of people and a lot of different organizations. How did you pick that?
  4. 12:53And so, when you went to Duke Med School, what was that like?
  5. 17:12What year was this? What years?
  6. 21:41What was that like during a residency at UCSF?
  7. 26:56And so those were some of your first clinical trials?
  8. 35:07So do you want to say that you all were completely crazy?
  9. 38:01And what were the key things that happened during that time?
  10. 41:34What were the key things there that you focused on?
  11. 44:20So, what attracted you to go there?
  12. 53:30What's one of your proudest moments at the FDA so far?
Narrator 0:02 ↗
Welcome to Centennial Oral Histories, a series featuring former and current leaders of Duke University and Duke Health, sharing memories of their time at Duke and their hopes for Duke's future. Enjoy this discussion with Doctor Robert Califf, Commissioner of Food and Drugs, who served two separate terms. Doctor Califf is a Duke alumnus and renowned cardiologist who has held prominent leadership roles at Duke, including founding director of the Duke Clinical Research Institute. He is interviewed by Doctor Adrian Hernandez, vice dean and executive director of the Duke Clinical Research Institute.
Adrian Hernandez 0:39 ↗
Hi, I'm Adrian Hernandez. I want to welcome you to Duke's Centennial Oral History Program. I'm here with Robert Rob Califf, who spent a number of years at Duke. And we're going to have a conversation about his time before Duke, during Duke, and what he's doing now, and looking into the future. So, Rob, let me start off, first, to hear a little bit about your background. You were born in South Carolina. What was that like? Or were there any influences there later in life?
Robert Califf 1:10 ↗
I think we're all heavily influenced by our youth. And in my case, my dad was an architect, and he was teaching at Clemson University when I was born. So at heart, I'm actually a Clemson guy. But when I was five, we moved to Columbia, the capital of South Carolina, and he was very involved in designing buildings there. My mom was a schoolteacher. It was a very, I would say, intellectual and academically-inclined family, with dinner table conversations about politics and the direction of things. And of course that time, the early-to-late 1950s, was sort of a stable time as I think of it in American history. But then the 1960s were a very tumultuous time and particularly shaping me was this integration that was happening in the South. And I think a lot of people who are younger don't even realize how recent that was. I started out in totally segregated schools, and it was during my high school years that integration occurred.
Adrian Hernandez 2:23 ↗
And during that time, as you were in high school, were there things then that made you interested in pursuing healthcare or research later? How did that come about?
Robert Califf 2:38 ↗
When I was in high school, I was mostly interested in basketball. I ended up being captain of the state championship basketball team for South Carolina. Probably the pinnacle of my career in anything was the day after I won the state championship. That night, you're on top of the world. Then you recede back into normal life. It's kind of deflating. But I also would say I had a very political period then. It turned out one of my friends through school, all the way, was Lee Atwater, who was the famous Republican strategist. I was on the other side of the fence. We were arguing even back in junior high and high school. But I really didn't have designs on medicine or healthcare. It is noticeable that during that period of time, every year you took an aptitude test for what you should do with your life. And they kept saying I should be a doctor. And I mostly rejected that idea. It was only later, my junior year at Duke, that I switched to Pre-Med.
Adrian Hernandez 3:46 ↗
Well, interesting. I imagine some of the things that you're dealing with in terms of political science actually came together later in life. Now, going to the basketball team, I imagine touring around the state and playing other teams during that time was probably pretty interesting, especially this era where there was integration and playing different teams.
Robert Califf 4:08 ↗
It was a fascinating time. There was a rule in South Carolina that the coach couldn't coach the team during the summer. And so as captain, I was actually sort of the proxy coach. And one thing that we did, I still have vivid memories of this. We had Black players on our team, but there were still all Black high schools. So we toured the all Black high schools and scrimmaged them, which was a spectacle. The crowds were -- it was a full packed gymnasium every time, with cheers that I had never heard growing up in the other schools that were a little bit disconcerting. But that toughened us up quite a bit. And I think it was part of the story of how we ended up eventually winning the state championship.
Adrian Hernandez 4:58 ↗
Well, that's pretty awesome. And was there any idea about either playing at Duke, or being recruited to Duke for basketball?
Robert Califf 5:06 ↗
I had brief dreams of a college career, and I got some letters from, I would say, the lower-ranked schools, not the 1A schools. Also in 1968 and 1969 the assassinations had occurred, the Vietnam War was going strong. And at that point, I really sort of lost the intense focus on staying in shape and playing sports. Although I did play a lot of intramural basketball at Duke, and I switched to other interests at that point.
Adrian Hernandez 5:47 ↗
So you showed up to Duke in the late 1960s. What led you to Duke? How did you choose Duke?
Robert Califf 5:54 ↗
Well, my older brother had come to Duke, and he was a couple of years ahead of me. And when I came to Duke, it literally was the furthest north I had been in my life. You know, travel was different then. And I never really had hardly been to North Carolina for anything, other than up in the mountains occasionally when we lived in Clemson. So it was actually a big journey for me to come to Duke. And quite startling to walk into House L, the freshman dorm, with all these people from all over the country. It was an amazing experience. So the draw was really good academics and good sports, and kind of like the way it is now when I look at undergrads.
Adrian Hernandez 6:45 ↗
And during that time, what was it like with your fellow students?
Robert Califf 6:51 ↗
Well, I just remember it being intense, and we made a lot of friends. And in fact, last year we had our 50th Duke reunion. And although we had gone all over the country, in different parts of the world, doing very different things, it was as if we were back together again 50 years later. Still able to relate to each other very easily and just having amazing conversations. But the other part of it was, it was such a tumultuous time. In the history of the University, too. The year before had been the takeover of the Allen Building. The year before I came. Integration on the campus was a big deal. Not so much the students, as I remember it, but the workers in the hospital. It was a huge deal. But we didn't have classes most of the second semester because of the Vietnam War. And although I spend a lot of time in Washington now, my first visit to Washington was on a bus where I got tear-gassed. I take the Red Line transit line in Washington now, from my apartment building to the HHS offices next to the Capitol. And every time I go through DuPont Circle, I have a brief recollection of running into the basement of a church at DuPont Circle, having been tear-gassed. So the absence of classes was a remarkable period, I think, in the University's history. But things held together, and became more regularized as all that worked out.
Adrian Hernandez 8:28 ↗
Now, it's pretty amazing to go to your 50th anniversary. And I imagine most people didn't go into medicine like you did, or the types of careers that people went into.
Robert Califf 8:40 ↗
Gosh, we had city administrators, dentists, people who wrote for newspapers or wrote books, engineers. It was really an eclectic mix from all over the country, and just about every profession that you can imagine. But we still had so many things in common, and it was easy to hang out together and chat.
Adrian Hernandez 9:06 ↗
You eventually graduated with a major in psychology, which is kind of interesting, seeing the role that you have now dealing with a lot of people and a lot of different organizations. How did you pick that?
Robert Califf 9:22 ↗
Well, I developed a deep interest in psychology, actually back in high school, and was very focused on it. I was going to be a clinical psychologist, and I ended up working in the South Carolina state prisons for two summers, which was a tremendous experience. But I sort of concluded after that first summer that maybe I wanted to do something that was a little bit more tangible. It was tough to be -- it turned out some of my high school competitors are now inmates in the prison. And I got to see how difficult it was to exert change. So I've always had a lot of respect for people who work in the mental health field ever since then. But it sort of hit me that, maybe for me, I should do something that had a little more concrete application, where you might see a problem and could help fix it. And medicine, ultimately cardiology, really fits the bill. When you see someone in ventricular fibrillation and you apply some Duke power and defibrillate that person from being dead to being alive, that's pretty concrete. So that was a big switch. I had taken no science courses until basically finishing my junior year. So after graduating from Duke, I took a year off and worked as an orderly, because I had crammed all those science courses.
Adrian Hernandez 10:50 ↗
At Duke Hospital?
Robert Califf 10:51 ↗
No, I was over in Greensboro. Got married. My now-wife Lydia Califf was in school at UNC-Greensboro. And that was an amazing experience. Well, the whole thing of marriage has been amazing. 1973 to 2024, we've had a long and great marriage. But serving the needs of people at a basic level is humbling. It also, I think, teaches you a lot of things that I worry a lot of medical students never think about until they may be too far along.
Adrian Hernandez 11:35 ↗
Well, talk about that theme, about caring about the front line. It sounds like you had some of that direct experience that's continued on. So you went on and decided to go into medicine. You chose Duke Medical School. Was that an easy choice? How did you get there?
Robert Califf 11:53 ↗
Well actually, it was surprising. I thought I was saying goodbye to Durham. And, you know, you mentioned Washington. This came up last night. I can't quite get over it. But one of the fellow awardees with me at the Founders' Day celebration last night is an animal behavior expert who had mentioned that there was a goat colony that Duke kept up for people to study animal behavior. And I actually did that for a semester, studying the hierarchical behavior of goats. It turns out that has been a fabulous background for dealing with Washington politicians. Very similar. Behavioral economics, quite interesting. There's a hierarchy, and the goats know exactly which goat gets dominance over the others in different situations. And I think the same thing -- it's pretty obvious in politics that it works that way.
Adrian Hernandez 12:53 ↗
And so, when you went to Duke Med School, what was that like?
Robert Califf 12:59 ↗
So, I was not expecting to come back to Durham. And I'd actually paid the down payment at Tulane University when the Duke admission came through. And it was a hard decision. Tulane would have been great, but it ultimately, I think, worked out really well for us. You know, we didn't have a lot of money. We had a very meager subsistence, but Lydia was working as a nurse at Duke Hospital. She had gotten her nursing degree at UNC-Greensboro, and it was just a fabulous culture and experience. But, my first day we went to a medical grand rounds and got to see Duke's Dr. Eugene Stead in action. A neurologist was presenting a case and halfway through it, Dr. Stead got up and basically told the neurologist, 'You're wrong.' They got into an argument. And it was quite an introduction to the complexity and personalities in medicine. But what a bond that first year at Duke. Early on, Duke took this position to compress the basic sciences into one year. Very intense. And so you talk about friends and relationships, that first year class was remarkable and still something I think about a lot. And then that second year you're out there taking care of patients. An amazing experience in the old Duke hospital. Learned so much.
Adrian Hernandez 14:35 ↗
So when did you get exposed to research? You said some in undergraduate time. But medical research, when was that?
Robert Califf 14:44 ↗
Yeah, I would say most of my undergraduate research was some observations and a little bit of writing, not heavy-duty research. But I needed to work part-time while I was a medical student to help pay the bills. And I end up working with this new thing called a computerized database that had been developed, actually by Dr. Stead. And it was amazing to me because at the time all medical communication, as you know, was handwritten. Including the orders for the patients and the clinic notes. Essentially everything was handwritten. And so doctors got to be well-known, basically by having good memories, or being able to concoct stories about their memories that were believable to other people. But it turned out when you had computerized data, very simple things that we take for granted today -- you could say that a lot of the recollections and beliefs of the doctors were just flat-out wrong. And the ability to aggregate information over time, it was just -- Dr. Stead was way ahead of his time, as he was in some other things. In this regard, he not only realized that capturing information in computers was important, but the longitudinal nature of the disease and outcomes was also. His rule that he put into place was that once you got entered into the database, you were followed for life. And there's so many cognitive tricks that we know about now but people still fall prey to them. Like how someone looks initially after a treatment is instantiated into your mind as that's how the treatment works. But there are many treatments that either have no effect early, or even a detrimental effect early, that show later benefit. And of course at the time, coronary bypass surgery was brand new. So he would take me to conferences, because every case was reviewed, and the cardiologists and surgeons would look at the old cinifilms.
Adrian Hernandez 16:59 ↗
This is when you were a med student?
Robert Califf 17:01 ↗
When I was a med student. And he would say, 'They're going to say X, Y, and Z, but here's the computerized data and they're making the wrong decision.' Really.
Adrian Hernandez 17:12 ↗
What year was this? What years?
Robert Califf 17:14 ↗
1976, 1977. Wow. Okay. And so to this day in my job at FDA, I still see so many situations where common sense beliefs by doctors and patients and other practitioners don't fit with what the data actually show. And it's a lesson I think we have to learn over and over.
Adrian Hernandez 17:39 ↗
Now, give us a sense of what you mean by computer. Like it's not just, say, a laptop or something.
Robert Califf 17:47 ↗
No, we had a thing called a PDP-11 that took up an entire room in Duke South. And you would enter your code, and for most things we did, you would come back the next day. It would run all night, and then you would get your answer to the question. This, of course, was a more genteel time of academic medicine. I was a student and I was working with all the cardiology fellows and they had a team -- it was a unique thing at the time -- but a multidisciplinary team. One of the original biostatisticians, Kerry Lee. One of the original engineers who worked with software, Frank Starmer. And one who sort of bridged it, Ed Hammond. Ed, of course, is still around. The team built new things and broke a lot of ground. This was a tremendous education for me, because I went with them to some NIH site visits where their pioneering work was not very well-received. It was considered avant garde and upstart. And in fact, one of the most important things Dr. Stead did, which you could never do now, is he took a grant that was given for physiologic monitoring -- again, hard for young people to believe, but we were just beginning to put rhythm monitors on people in intensive care units. But he took the money and built this database to measure patient outcomes over time. They did reverse site visits at the time. He totally shocked the site visitors. 'You gave me the money for this, but here's what I did with it.' They were not too happy. But at the time you could get away with that. And the kind of creativity that was shown in this group just -- I was sold. I mean, there was no way I was going back.
Adrian Hernandez 19:38 ↗
What a special time. I mean, almost 50 years ago, to think about something that now we take for granted -- computerized medicine.
Robert Califf 19:45 ↗
There's another thing that happened which was that the death rates at the time, coronary care units were filled with 50-to-60 year old people, mostly men who were cigarette smokers. And they died at alarming rates. And the Holter monitor had just come out, speaking of monitoring. So my project as a student was to put Holter monitors on people. I only needed 386 people, and then I followed them while I was still a student, like for a year. So many people died that we had very meaningful outcome data. And the question was, could we predict sudden death? And it turned out, the hypothesis was that the arrhythmias shown on this new Holter monitor would be the best predictor. And I put the data together and brought it to Kerry Lee, the statistician. He ran some regression analyses. And lo and behold, it wasn't the cardiac arrhythmias. It was the underlying left ventricular function. So we brought that up, and it was not a popular message. It was not well-received. People didn't believe it. And I went on out to UCSF for my internship. But our abstract was accepted to the American Heart Association in Miami. And it was one of those things where I just barely got a couple days off and got on the plane. At the time we had the slide carousels with our slides. I ran into the Fontainebleau Hotel, gave my talk, and the commentators just basically said I was stupid and I had gotten it wrong. But the conclusion of our study was that treating sudden death was going to be a matter of identifying people with impaired left ventricular function. Guess what? We were right.
Adrian Hernandez 21:36 ↗
So what's the criteria now for a defibrillator?
Robert Califf 21:39 ↗
It's LV function.
Adrian Hernandez 21:41 ↗
So that's a really interesting insight. Just shows the power of data and making sure to eliminate, as much as possible, biases. So you spent time in the Bay Area. You eventually get back there. What was that like during a residency at UCSF?
Robert Califf 21:56 ↗
I loved it. There was an event that happened. Our first child was born, just as I was finishing that fourth year of medical school. And it turned out she had really serious congenital heart disease. But it was actually not diagnosed at Duke, even though she was not thriving. So we traveled across the country not knowing why our baby was not growing at a normal rate. And for people that have been to San Francisco in the summer, you'll relate to this story. But we arrived in June, started the internship, I took Sharon out on the porch on a July day when the fog was in. It was like 45 degrees in July. And she turned blue, right in my arms. And she ended up having a huge operation while I was an intern. So we would make rounds on all the adult patients while I was a medical intern. We would go around on my daughter in the ICU. That was a month of my internship. But, you know, it's amazing. The people everywhere are pretty much the same. They took really good care of us. We made friends for life. And I know you spent time there, too. So you have a sense of the community there. I fell in love with San Francisco. And it actually turns out San Francisco and Durham, in my opinion, have a lot in common. They're very heterogeneous towns. And the people in San Francisco tend to be really friendly and easy to talk with. Much like the people in Durham. It doesn't matter what your background or skin color is, you pretty much get along with everybody. I find Durham to be similar, and increasingly so, as a melting pot community. And I also think of the sense of collaboration at the university. Same thing in both places.
Adrian Hernandez 23:57 ↗
Now, you came back to Duke for cardiology. I assume there were some things here that you still wanted to continue to pursue when you came back for cardiology?
Robert Califf 24:08 ↗
Yeah, that was actually a really hard decision. You know, those were the days of short-tracking in medicine. So I had done two years and had conversations about being a chief resident, which is a very prestigious thing at a place like UCSF. But I was addicted to the computer. And now you would never believe it, but the Bay Area was way behind in computing. Duke was way ahead. And in addition, Sharon was still -- you know, we'd been through quite a traumatic thing, and we wanted to be closer to family. So we came back, and I went right to work as a fellow and had a fabulous time.
Adrian Hernandez 24:55 ↗
And then you came on the faculty shortly after that. What was that time like? 80% protected time for research and occasionally you'd see patients?
Robert Califf 25:12 ↗
Once again, two years into the fellowship, the Coronary Care Unit director, Eric Conn, went into practice in Chattanooga. And Joe Greenfield, the chief of Cardiology, called me in and he said, 'I think we need you to be the attending on the Coronary Care Unit while you finish your fellowship.' So, somehow that was managed. And that's actually what I did. I was on call for both Duke and what is now Duke Regional Hospital. It was Watts Hospital or Durham County at the time. So I was on call 12 out of 14 nights. That first year when I took over the...
Adrian Hernandez 25:48 ↗
12 out of 14?
Robert Califf 25:52 ↗
Yeah. The first year was that time when the first coronary angiograms were done showing that what caused heart attacks was a blood clot. Hard to believe that I was taught as a medical student that blood clots did not cause heart attacks. It took some adventurous cardiologists doing acute angiograms to see that. But then the race was on. What do you do about it now? You know, the leading cause of death. I was losing 4 or 5 people a day on the Duke Coronary Care Unit, because we essentially had no treatment. And dissolving the blood clot was something that we knew could be done. So that set off a race. So, the 12 out of 14 nights were literally very often coming in to see a chronically ill person and put them on a protocol. And very few other institutions were doing this kind of work. So it was very high-stakes and high-profile.

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APA

Califf, R. (2024, November 18). Dr. Robert Califf | Centennial Oral Histories [Interview transcript]. Duke University. CEOInterviews.AI. https://ceointerviews.ai/interview/3075299/

MLA

Robert Califf. "Dr. Robert Califf | Centennial Oral Histories." Duke University, 18 Nov. 2024. Transcript, CEOInterviews.AI, https://ceointerviews.ai/interview/3075299/.

BibTeX
@misc{califf2024_3075299,
  author       = {Robert Califf},
  title        = {Dr. Robert Califf | Centennial Oral Histories},
  howpublished = {Interview transcript, Duke University. CEOInterviews.AI},
  year         = {2024},
  month        = {nov},
  url          = {https://ceointerviews.ai/interview/3075299/},
  note         = {Speaker-attributed transcript with timestamps}
}