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Bonus Episode: The Commissioner

Robert Califf, MD, spent the majority of his career as a physician, administrator, leader, and innovator at Duke University. Most recently, he was vice chancellor for health data science; the Donald F. Fortin, M.D. Professor of Cardiology; and the director of Duke Forge, an initiative using data science to improve health outcomes.

Dr. Califf also served as commissioner of the Food and Drug Administration under President Barack Obama.

Oral historian Josephine McRobbie caught up with Dr. Califf to ask about his early work and how it prepared him to be a presidential appointee.

“I think the best way to test out your ideas is to have people attack them from every angle because no one knows everything,” said Califf. “You really learn how to articulate what it is you’re really saying.”

Dr. Califf now works at Verily Life Sciences and Google Health.

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Transcipt

Anton Zuiker: Prior to his November 2019 hire at Alphabet as head of health strategy and policy for Verily Life Sciences and Google Health, Dr. Robert Califf spent the majority of his career at Duke University. Most recently, he was vice chancellor for health data science, the Donald F. Fortin, M.D., Professor of Cardiology, and the director of Duke Forge, an initiative using data science to improve health outcomes. Dr. Califf also was an early supporter of Voices of Duke Health and we’re delighted to bring you this interview with him. Dr. Califf spoke with oral historian Josephine McRobbie about his tenure as commissioner of the Food and Drug Administration and how his life experiences shaped him to take on the challenge of being a presidential nominee.

Robert Califf: The nomination process itself is very complicated. It’s very, very political. There are all sorts of people who want to have a voice and who a presidential nominee is. I had this weird set of experiences where people would drop by and say, ah, you know, when are they going to ask you to be commissioner?

Josephine McRobbie: It was 2015. Duke University cardiologist, researcher, and administrator Dr. Robert Califf was serving as the deputy commissioner for medical products and tobacco at the Food and Drug Administration. He’d ended up in this policy-setting position when Margaret Hamburg was commissioner during the Obama Administration. When she stepped down six years in, Dr. Califf was her preferred successor. But as one might expect, it wasn’t your typical job opening.

Califf: What happened was I was preparing a briefing for President Obama on whole genome sequencing, a big issue of technology development and regulation. And I got a call at 4:00 in the afternoon and it said, you know, that briefing you’re preparing, you’re gonna give it and it’s tomorrow at noon. And that was you know, kind of an amazing experience. I’d never been in the White House. So I went into the Roosevelt Room. And, you know, it was quite interesting because as I later learned in the many meetings I was part of, the President read everything the night before. So you didn’t have to go over the material that you had. He already knew. And it seemed to go well. And as I was walking out, they said, why don’t you come to the Oval Office tomorrow.

McRobbie: Growing up in South Carolina, Dr. Califf was an avid athlete and captain of a championship winning basketball team.

Califf: But it was also a very tumultuous time. The South was being integrated. I started out in all-white schools and our basketball team was sort of the tip of the spear and South Carolina for integration because it was mostly the athletes that came across the lines to start with. And, you know, we had a super team that was mixed race. Some members of our class were featured in Time magazine at the time because of all the tension that was in play. It really wasn’t an issue in basketball. It was all about the team gelling to win. But, you know, there’s much history wrapped up and concentrated in that short period of time. 1969 was the peak of the Vietnam War. So, you know, the Kennedys had been assassinated, Martin Luther King had been assassinated, and friends and family were going off to a war a lot of people didn’t believe in. So we had quite a bonding of our high school class. So when I came into the Oval Office, of course, during that short period of time, the handlers had gotten a hold of me and they said, we notice that you were a captain of your high school basketball team. President Obama was also captain of his high school basketball team, and he’s very competitive, so you can expect he’s gonna give you a hard time. Sure enough, we had a half an hour, and the first 10 minutes were spent on the fact that he loves UNC basketball. His personal manager, early years in the White House, was Reggie Love, who had been a Duke basketball player and football player, and they had quite a rivalry. So we had a good back and forth about that.

McRobbie: In college, Dr. Califf initially majored in psychology. He was fascinated by what made people tic and had some vivid experiences to draw from.

Califf: Another notable thing about the high school is one of my classmates was Lee Atwater, who is well known posthumously for being the architect of the Southern Strategy of the Republican Party and I spent a lot of time with Lee. We were sort of frenenemies, I guess you would say, we had very different views of the world. You know, like all people, Lee was complicated. He had many good things about him, but he also, at least in my view, promoted a philosophy which has caused a lot of destructive things to happen. You know, in junior high and high school, he was the life of the party. He literally spent Saturday nights at a township auditorium in Columbia, which is where all star wrestling takes place. His goal was to be a promoter of all star wrestling, you know, the fellow with the microphone that introduces the wrestlers and manages the wrestlers. And he was not a great student, but a lot of fun to be around. And then his freshman year, he went to Newbury. I came to Duke. We spent the whole summer after that together, working in a gravel quarry that a friend’s dad owned. And over that freshman year at Newberry Lee had been to a barnstorming speech by Strom Thurmond and they just immediately hit it off. And Lee literally told me that summer that managing politicians was the same as managing wresters, just can make a lot more money and have a lot bigger impact.

McRobbie: Dr. Califf had a different path, to say the least. While in college, he decided to switch his major and go into medicine. In the year before beginning medical school, he worked as an orderly at a hospital in Greensboro.

Califf: It was meaningful work at a different level that most doctors, I think had just no understanding of. These kind of things still play out today in terms of the gaps we have in healthcare, which are less related to use of high end technology and much, much more related to very fundamental things that people need that they’re having trouble getting. You learn a lot about people by emptying their bedpans and putting in Foley catheters and doing all the things that have to be done for people to get through the day when they’re sick.

McRobbie: As Dr. Califf sat in the Oval Office, President Obama changed the topic from sports to the regulation of new health technologies.

Califf: Basically, he had become convinced that the fourth industrial revolution was happening. Getting that right was the most important thing in the future of the American economy and its health. He knew that the current FDA paradigm was not suited and something different had to be done. But he also strongly believed that regulation was essential because a lot of technology people were arguing at the time that regulation was just an impediment to innovation and was unnecessary and everything would work out fine. So, you know, those are also beliefs that I share.

McRobbie: Dr. Califf had been working with technology since his third year of medical school at Duke in the mid 70s. At that time, he’d worked closely with bio statistician Dr. Carrie Lee, computer scientist Dr. Frank Starmer, and his mentor, Dr. Eugene Stead.

Califf: Well, one of the funny things about it is I’m basically hapless with, I’m just a user of computers. But I’ve always for some reason have been able to work well with people who are the deepest computer-type people. And you know, what Dr. Stead taught me right away very early on, you know, one of his things was there’s no way a human being can integrate all the information that’s needed to make the best decisions about health, particularly because many health decisions, you have to understand the importance of time, that decisions that may look better immediately actually turn out to be worse and vise versa. That’s just too complicated a problem for the human brain to comprehend. And, you know, you could fast forward to deep learning today and say, when it comes to artificial intelligence, the whole purpose is to unearth attributes that are not visible to the eye and then develop ways of assuring that your integration of information is yielding something that’s truthful and predictive.

McRobbie: President Obama and Dr. Califf for wrapping up their meeting.

Califf: He offered me the job. The problem with that is, as I walked out, the handlers showed up and just reminded me, they said, you don’t have the job until the Senate confirms. So the President can offer you the job, but can’t actually give you the job. And this is gonna be hard because it’s not good between the Senate and the White House. This is going into the last year of the Obama administration.

Califf: I think the best way to test out your ideas is to have people attack them from every angle because no one knows everything, and you learn from having people disagree and you really learn how to articulate what it is you’re really saying, if people attack what you’re saying because then you have to defend it. This became critical when I was nominated for FDA commissioner because the exercise in and of itself is making your entire life exposed to the public for attack. There’s a thing that happens for nominees called murder boards. Basically, you sit in a room and people imitate the people who are gonna attack and they take on that persona and you have to defend yourself as if you were in the real room.

McRobbie: The real confirmation hearings for justice challenging. While he had support over all, several senators voiced concerns about Dr. Califf’s experiences working with the pharmaceutical industry to facilitate clinical trials.

Califf: You’re sitting there with no notes. You’re there on your own. You’re on TV and people go after you. Just the way it is.

McRobbie: From mentors like Dr. Stead, Dr. Califf had learned the value of critique and intellectual exchange in medicine early on in medical conference settings.

Califf: The head of neurology was presenting the case, and right in the middle of his presentation, Dr. Stead stood up and just started berating the guy, so much so that he actually walked out and it was over. And none of us knew what to make of it at the time. But what I learned later was a slightly toned down Dr. Stead I think is a really good thing. That is, people actually really say what they mean when they’re in meetings and sometimes they can get emotional and tough. But if you’re gonna have a meeting, if you don’t have differences of opinion, there’s first of all, there’s no reason to have a meeting. And if you do have differences, you ought to really express them.

McRobbie: Dr. Califf is now known as a pioneer of clinical trial research methods. He solidified infrastructure for clinical trials at Duke by founding the Duke Clinical Research Institute.

Califf: My general view is that there is an element of health care which is human and there’s an element of health care which is technological. It’s the companies that make the technology that enables treatment or diagnosis to be more effective. If we don’t work together, how are we ever gonna advance the technology in the way it needs to be advanced. But I also believe it ought to be done by a set of rules about how the engagement is done. Now, I had to I actually had to deal with Senator [Elizabeth] Warren in great detail about this because she started out thinking I was another bad industry person. We spent many hours together, I actually had to make a list of all the clinical trials I had led–there were 64–and what the results were, who had sponsored this study, whether the result helped the sponsor or hurt them. I don’t know if it’s good or bad, but the majority of trials that I led had a negative result for the sponsor. And I think as we discussed it, I think she came to realize that it’s better to engage the clinical community with the industry and do the tests and report the results honestly.

McRobbie: In February of 2016, the U.S. Senate confirmed Dr. Califf as commissioner of the FDA by a vote of 89 to 4. During his term, Dr. Califf tackled issues as diverse as genetic engineering and food poisoning. He worked on policy for approval of new drugs, began developing the framework for software as a medical device, and solicited research and recommendations for the opioid epidemic.

Califf: Almost every day in that job, there’s a big issue because you’re regulating something like 20 percent of the economy.

McRobbie: Per tradition, Dr. Califf submitted his resignation at the close of the Obama Administration, bringing back with him many lessons from Washington.

Califf: I was surprised by the ambiance of the Obama-Biden Team. It was an odd team because Obama was very left brain, very analytical, very mathematical actually, which is unusual for a lawyer. Biden is almost completely right brain. He lives on stories. But the combination, creating an atmosphere where people said what they thought and they felt like they were working on a team for a purpose. And I think if you talked to anybody that was involved in the HHS environment at the time, they felt like if we just had four more years with that team–you know, forget all the other political stuff, just talking about health, I felt like when I was in the White House with them, it was always the smartest people they could find on whatever the topic was. So January 20th, 2017, I drove out of Washington having served my term.

Zuiker: If you like what you just heard, we hope it will spur your own conversations. Ask a friend what inspires them or what they’re grateful for. And let us know if you would like to record a conversation in our listening booth Visit www.listeningbooth.info to learn more. Voices of Duke Health receives support from the Duke University Hospital, Duke University’s Department of Medicine, and the Duke University Medical Center Archives. This episode was narrated by Josephine McRobbie. Music was from SoundCloud Creative Commons by ablaut, Yasuhiro Mori, and kt springer. I’m Anton Zuiker. Thank you for listening.