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An Interview with Robert Califf.

In the late 1970s, when Robert Califf was in medical school, the heart was still a kind of medical terra incognita. Most cardiologists believed that a class of untimely heartbeats, known as premature ventricular contractions (PVCs), could predict sudden cardiac death. During his third year at Duke University Medical School, Califf, and his colleagues, showed that impaired left ventricular function was the true culprit. A few years later, as new clot-busting agents were being developed, Califf, by then a Duke faculty member, and colleagues predicted that one of the drugs, tissue plasminogen activator (tPA), would be most effective when followed immediately by angioplasty. They ran a multicenter clinical trial--the first of a series collectively known as Thrombolysis and Angioplasty in Myocardial Infarction (TAMI)--which showed the opposite: waiting to do the artery-opening procedure led to better outcomes.

Inspired by the power of clinical trials to topple even his own beliefs, Califf embarked, with colleagues, on an ambitious series of groundbreaking trials comparing tPA and another clot-buster, streptokinase. The study-known as the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO)--established the superiority of tPA and also Califfs reputation as one of the most creative clinical scientists of his generation. In 1995, he founded the Duke Clinical Research Institute, which has grown to become one of the world's largest academic research organizations, having enrolled more than 1.2 million participants in 65 countries and with over 1300 employees.

Admired for his ability to bring people from academia and clinical medicine together with members of industry--a connection that caused some to object when he was later nominated by President Obama for the post of Commissioner of the Food and Drug Administration (FDA)--Califf is also one of the top 10 most cited medical authors. Until recently, he continued to see patients in clinic and in rounds at the Coronary Care Unit at Duke University Medical School. In 2014, he left Duke, where he was Director of the Duke Translational Medicine Institute and Vice Chancellor for Clinical Research, to become Deputy Commissioner for Medical Products and Tobacco at the FDA. Ayear later, in February 2016, he became Commissioner--at a time when politicians and the public had begun pushing for an overhaul of the way the FDA approaches clinical trials. He took time from his summer vacation to speak with me.

From the beginning of your career, you've been inspired by a desire to bridge the gap between the laboratory and the clinic--to get new drugs, tests, and devices into the hands of doctors and patients. You've also been devoted to protecting the health and safety of the public. Becoming commissioner of the FDA would seem to be a perfect fit. Does it feel in any sense like a dream job?

I think it's fair to say that I'm thoroughly enjoying the job. There are new challenges every day but they are of the type that you describe--balancing the appropriate need for new technologies to help people and ensuring that the evaluation is correct so that the ones that don't work are weeded out and the ones with benefits are well described so people can make good decisions. So the short answer is, yes--it's a great job.

You were Deputy Commissioner of Medical Products and Tobacco before becoming Commissioner. What has surprised you most about your new position?

In general, not much because I've done so much work with the FDA before. But one thing that has been a bit of an adaptation in thinking is, very often at the FDA you see things that you'd like to intervene on but it's actually quite complicated because there are many checks and balances in the system. I'm not arguing that's a bad thing. But sometimes you have a perception that the FDA can just decide to do something and do it. In fact, there are many levels of checks and balances that make it more complicated.

Many people want the FDA to move drugs and other medical products along the pipeline faster and may believe that these checks and balances get in the way.

Well, like everything at the FDA it's a matter of balance because speed is not necessarily the only desirable attribute. If you sped products onto the market that didn't work or were dangerous it would be terrible. [That said,] if you look at the time from submission of documents to the FDA until a decision is made about approving or not approving, it's a very tiny fraction of the total development time of the medical product. What's undervalued--and we are going to make an effort to make sure more people understand--is that since the FDA gets to see essentially all technology development in the aspects of the economy that it's regulating, meetings that occur between the FDA and companies as they're going through their development cycles turn out to be really critical. For example, over 90 percent of drugs that enter phase 1 don't make it to market. What [the FDA] can do is help people design their clinical trials or their manufacturing processes so that they're optimized to really determine the balance of risk and benefit. A lot of the public discussion is still about FDA cycle times but the real action is going to be in making development better so that things that aren't going to work get stopped more quickly and don't waste a bunch of R and D money, and things that are going to make it get sped through with very good studies that yield clear results. The FDA is all about interpreting data. Where we have really good data, there still are arguments to be had but they're relatively civil and understandable. Even when people are disappointed by the decisions, they can typically understand the rationale. But when we have to make a decision and we have lousy data it gets very opinionated and generally no one is satisfied, nor should they be. The big deal is helping the whole ecosystem generate better evidence.

You've talked about the inherent tension in the FDA's mission between innovation and regulation. You've also talked about how smart regulation can bring about innovation. Is that what you're talking about here?

Yes, I appreciate your bringing that up. The Next Generation Sequencing guidances that we just put out are a really good example of that. You have a field where you're measuring three billion base pairs in every person--there's no way by traditional science or traditional regulation that you could speed understanding of what all those polymorphisms mean. But by creating precisionFDA--a public space for working through the informatics pipelines--along with the Data Commons, the genomics data network that NIH is already putting together, and hopefully many others, the relationship between polymorphisms and the clinical outcomes can move much more quickly. No single company could do that on its own. By creating a regulatory environment that stimulates collaboration in the competitive arena, that's going to create more innovation. It enables people to overcome the limitations they have due to the size of their own companies or academic medical centers.

Talking about genomic databases, there are privacy issues and other ethical implications. People may know that they are at risk for a disease but what if there are no treatments? What if an employer gets hold of a person's genetic information? Is this something that enters into your consideration?

Ethical issues are paramount. It's well known that we're in the final stages of the update of the Common Rule, which is basically a federal guidance on all human research. The Office of Civil Rights is very involved in that, and of course the NIH, and 18 different federal agencies. The ethics are absolutely an essential part of what we do. A good example of that for laboratory people is return of research results. There's an expectation growing that if you participate in research you should have access to the results of the research. This is playing out in a major way in the Precision Medicine Initiative [the White House plan to study one million people to precisely target therapies], which the FDA has a major role in and the NIH is the lead agency. We'll be asking Americans to volunteer to make their electronic health records and biological data available to researchers in a very carefully constructed system, which assures confidentiality and privacy but which also, hopefully, will really speed up the research findings that people depend on to find cures or treatments for their diseases.

You've talked recently about the role of big data in medicine. Is this something you could use in a clinical trial framework?

The future--it's just [a] question of how long it takes to get there--will be that we'll conduct clinical trials much more efficiently at a drastically lower cost because we'll already have high quality data in the electronic health records. I was just in a discussion the day before yesterday with somebody who is very knowledgeable about biological data and the point that person was making is that computation has reached a point where, let's say you have whole genome sequencing done using next generation technology, those 3 billion base pairs can be in your medical record and stored in a place that doesn't eat up all the transactional storage capacity but would be there for any learning activity that you are participating in. So let's say you enter a clinical trial. The trial wouldn't have to collect a blood sample and sequence your genome because that would've already been done as part of your routine care. You can see how all this begins to fit together in a tipping point sort of way where the rate of new knowledge is going to continue to accelerate. But you're also right to point out that the primary limiting factor is not technology, it's now culture and making sure we get the ethics right for respecting people's autonomy and ensuring that society benefits from the knowledge that we generate.

I already sense the breadth of your thinking and the scope of your interests. Many people think you have a combination of experience, talent, and expertise that really suits you to this position. The Senate confirmed your nomination almost unanimously. Which of your talents do you feel have come in most handy over the past few months?

[Laughs]. It's a little uncomfortable answering this kind of a question. I'd say there are two areas where I hope my talents have been a help. I have been involved personally in a lot of technology development in many aspects, not just the industry side but also the NIH side, and I've been very involved in empirical ethics work. That broad perspective hopefully helps discussions. Because the Commissioner's job is really almost never to make a decision about an individual product--that's done at the level of each center that's responsible for the product. The commissioner's job is more following the principles of policy--running the organization of the FDA and seeing how it fits in with the rest of the government. The other thing that I hope I'm good at is listening. We have a lot of smart people in the FDA and there are certainly people outside the FDA who are not shy about expressing their opinions about what we're doing. A big part of my job is assimilating all of these opinions and not shutting them out because of previous bias. I hope I'm a good listener.

I heard that earlier in your life, you wanted to become a clinical psychologist. That's a listening profession!

Yes.

So medicine was not something you gravitated to early in your life--you didn't dream of becoming a doctor when you were growing up.

That's right.

You were born in Anderson, South Carolina, in 1951. I've heard Anderson described as the 'friendliest city in South Carolina.'

Actually, I lived the first five years in Clemson, which probably is one of the friendliest places on earth. The hospital is over in Anderson.

So you were born in Anderson but you grew up in Clemson.

Yes. Growing up in Clemson was idyllic because it's just a pure college town. People are nice. It's a combination of a rah-rah college and intellectual environment. My dad was teaching in the architecture school when he decided to go into practice. I was five and we moved to Columbia. It was tough being a Clemson guy in Gamecock country. The University of South Carolina Gamecocks are in Columbia.

You've described your family household as fairly progressive.

My mom was a school teacher and my dad was an architect. We had a lot of discussions about current events and political things all the time. They both read a lot and kept up with what was going on. It was a very active intellectual household.

In a mock election at your school, you cast a Democratic vote while the vast majority voted Republican.

When we moved to Columbia, I grew up in a place called Republican Hills. One of my close friends growing up was Lee Atwater who was fairly famous for having engineered the southern strategy for the Republican Party. He was the older Bush's campaign manager. Unfortunately, he died of a brain tumor at a very young age--a very controversial guy. I still remember the mock election, Kennedy versus Nixon. I was one of 13 or so who voted for Kennedy out of the whole school. It was a very Republican area.

Why did your progressive parents choose to live there?

I would just say they were independent thinkers. They're also deep South Carolinians. They come from South Carolina families. They're both still alive at age 94 and 88.

What kind of student were you?

I was interested in doing reasonably well in school but I loved sports. I became very focused on basketball.

What captivated you about the game?

It's a team sport, good exercise, good competition, and a lot of fun.

Are you competitive?

I have a fair amount of competitive spirit. I've always tried to keep it in check in terms of enjoying the sport and not getting lost in the competition.

I've heard you say that part of the appeal of the game is the pure escape. But it's also about beginning again and again--each game is its own thing. Rather than dwell on the losses, you just start all over again when it comes to the next game. I was struck by that.

[Laughs]. I think that's almost Biblical actually, right? Every day is a new start. One thing about sports, it's true, you always come to the next game ready to play and the score is zero to zero when you start. It's been kind of interesting at the FDA. There are these really serious decisions that have to be made that sometimes are not entirely clear. But you come to work the next day and go to work on the next set of decisions. So it's realizing that things can change. There are a lot of lessons about life from sports. If I had to pick one now, it relates to Coach K. [legendary Duke basketball coach Mike Krzyzewski] who I had the fun of living with during my time at Duke, as his career was evolving. He has this great motivational thing he does in his speeches where he uses his hand and shows his five fingers. And then he says, 'Would you rather have 5 independent fingers or would you rather have a fist?' And he shows a fist. The point is, the power of team work is profound. That's a key issue in health care delivery but it's also a key issue in organizational behavior.

Now you're coach of one of the biggest teams that any one might think about leading!

That's one way of thinking about it.

You came of age in the late 1960s, which were tumultuous times--the Vietnam War, the push for integration and civil rights, the counter cultural movement. How were you affected by all this?

You mention three things there. The segregation past of the South is something that continues to have effects, which we're still overcoming. So there were major lessons there about how things have to change, how you have to be tolerant of different points of view as we figure out how to adapt to change. The Vietnam War was just tough for everybody because it wasn't clear what should have been done. People had to take positions because people were dying and being drafted. I was in the draft and ended up with a very high draft number, which meant I didn't have to go. But a lot of people in my class did--the class of 1969 was sort of at the peak of being deployed. It brought up a lot of questions about government and how it should work. At least for me, a big part of all of that was growing comfortable in a changing landscape. I've certainly seen that some people are very averse to change but I'm not in that group. I'm someone who likes change and likes to be oriented towards the positive future. When you asked about my parents and their progressiveness, I would say that was an aspect of this.

Another area defined by change is music. I've heard that you love to listen to music.

It's true.

I'm wondering about your favorite groups. Were your musical tastes shaped during this period?

I would say my musical tastes got stuck during that period. I love old fashioned rock and roll. Just this morning I was walking on the beach and I was listening to the Grateful Dead. The Beatles, the Rolling Stones, Jimi Hendrix--I sort of got stuck in the music of the Sixties and Seventies. I come from a family with a lot of musical talent except for me. I just listen but I have no ability to play. I would add that I've really grown to love symphony and quintets where parts of instruments weave together. One nice thing about being around a university for most of my life is that there's always live music to go to.

You went to Duke for college. Your older brother was there.

Yes.

You majored in psychology, with the thought that you might become a clinical psychologist. What drew you to that?

A lot of the reading I was doing towards the end of high school was about what motivated people to do what they did--trying to understand people. I took some introductory psychology classes and I found them fascinating so I thought that would be great. But it was really more of an intellectual pursuit.

I'm thinking that the dinner table conversations you had with your family might have played a role.

Oh yes.

What about siblings--you have an older brother.

I have an older brother and a younger brother who is an orthopedic surgeon now. And a younger sister who does information technology for health systems. So a lot of us ended up in the health care arena one way or another.

You were very interested in Eastern religion during college. I was wondering which aspect and whether it has had a lasting effect on your outlook.

I was interested in just about everything--the religion department at Duke was really good. I would say what I've seen is a commonality among religions. One of the great things I've had the good fortune to do is travel a lot, when I was doing these large global clinical trials, and to see different cultures and religions in practice. I think the take away lesson is, there's much more in common than there is different among the world's great religions. I carry the Golden Rule with me every where I go. It's pretty simple. But the equivalent of the Golden Rule really exists in every religion. It's not something that's unique to one particular religion.

Why did you decide to go to medical school? I heard it had something to do with a summer job.

I could be real specific about this. I worked in a prison work release program in South Carolina for two summers. One weird thing about it is I ended up with some of the guys I played basketball against. They were inmates by that time. We had a little prison basketball team. I drove the bus and we went around and played against other teams. My conclusion from that experience was that psychology was interesting but I felt drawn to something that would have a more tangible effect in a shorter period of time. Medicine was a good extrapolation.

You weren't necessarily planning to go back to Duke for medical school. You got into Tulane. What made you decide to go to Duke?

I had just gotten married. We were quite poor at the time--poor but happy. We'd already put down a deposit at Tulane but when the acceptance came to Duke I just thought this looks like it's going to be a great opportunity. I was also drawn to the curriculum which was unique and so unusual in that you spend the whole third year doing research. Most medical schools you show up on day one and you spend four years getting trained as opposed to getting educated so much. This was a real opportunity to have freedom to do some independent thinking.

You had an 'Aha' moment during your third year--at least that's the way you describe it. You were involved in measuring health outcomes and were putting holter monitors on patients to measure premature ventricular contractions (PVCs).

Holter monitors had just been invented. There was a view that premature ventricular contractions would precipitate sudden death. We thought we had it all figured out and we were going to prove it with holter monitors. But we had also measured left ventricular (LV) function. When we did the regression analysis, that was the only function that was important, not the PVCs so much. It was a very counterculture conclusion. We had a very hard time having people accept it. It turned out to be right. Now that we have implantable cardiac defibrillators, the key indication is impaired LV function. So it really was a huge lesson that there's no substitute for good data and good analysis. The human brain is not configured to be able to integrate all this information.

It sounds like it was also a lesson in prevailing ideology in medicine because you presented your findings at an American Heart Association meeting....

Yes, I went up to do my internship in San Francisco and my abstract was accepted to the American Heart [Association meetings]. As I remember they gave me a couple of days off to fly from San Francisco. I arrived to do the presentation and there was a huge room of people who were almost making fun of my conclusion--like, 'What's wrong with this guy, he doesn't understand.' As I look at it now, the inverse lesson is really important in that I see a lot of people who only want to talk about research that fits into the current way of thinking. It may be more important to talk about the research that doesn't fit in.

The problem is getting funding to support innovative thinking.

It's a complicated problem. We need to keep struggling to figure out how to break out of a mold. But you can't take every crazy idea, especially now that research is so expensive.

I was wondering about your mentors. I've read that you were deeply influenced by Eugene Stead [who was the Chair of the Department of Medicine at Duke].

He trained something like 35 or 40 people who went on to be chairs of medicine elsewhere. He was really known for being a contrarian so he would see everything from a different perspective than most other people did. He had a real way of stimulating people around him to think differently, look at problems from a different perspective. That had an enormous impact on me. Until he died in his nineties, he would send me a Christmas letter that in great detail told me everything that I'd done wrong the year before. I also think that, when it comes to mentorship, you should have a team because no one in this life gets it all right. There are certainly a number of other people who had a big influence. One of my key mentors, Galen Wagner, just died a month ago. A quality of a great mentor is that you know they care more about your well being than their own well being when they're advising you. I was lucky to be surrounded by a lot of people like that as I was coming up through the system.

It also sounds like you were very lucky to have found a life partner during this phase of your life. You married your wife Lydia in 1973--that was actually before medical school.

Yes, we were high school sweethearts.

You were!

Yes. We met in high school. She went to nursing school at UNC Greensboro. And we dated through college and got married at the end of college. I was really lucky to meet her. It's been a great life with plenty of ups and downs, but we're good for each other. We're at the beach today and still together.

You had a daughter--the first of three kids--not too long after, in 1976.

Right at the end of medical school.

Your daughter was born with congenital heart disease and was treated while you were an intern at UC San Francisco. Did that in any way influence your decision to go into cardiology--or to really embrace it?

I'd already decided to go into cardiology so it's a little ironic that Sharon was born with congenital heart disease. But it certainly, as you said, helped me embrace it as a meaningful discipline that really makes a difference for people. Her heart surgeon was a guy named Paul Ebert--an amazing guy, he was 6'8". He had been an All-American baseball and basketball player at Ohio State--a huge guy who would operate on these little babies. In addition to just being a great surgeon, he had an amazing team of people. You could just see how they were orchestrated to deliver very high quality care in a complex environment. It was quite an experience to make rounds as an intern and then the whole team would go down and see my daughter, because she was in the ICU for a month while I was an intern. Now she's 38 and she's got a 12-year-old daughter. It doesn't always work out that way but we were lucky.

It put you in the shoes of the patient.

Yes. For sure.

One of the doctors on the team turned out to have faked his credentials.

This was a guy who we had a lot of confidence in. He was a very caring doctor. He did the procedures--the cardiac cath, not surgery. But doing cardiac cath on a 4-month-old baby is not a trivial procedure. It turns out, he'd been a medic in Vietnam and had faked the credentials from a cousin to go straight to internship and bypass medical school. My role in medicine, in addition to being a practitioner, has been to measure things and to help judge the veracity of things. This was certainly another lesson along the way.

Another memorable moment was when Gene Stead took you aside and told you how doctors, even the best ones, will often draw upon their most recent patient cases to guide them in the future, when in fact a more objective look would show that this was a biased perspective.

That's a slightly different point than outright lying about your credentials, which is what this guy did. But I think that even the smartest people are subject to cognitive issues in their decision-making. One of them is immediacy bias where you remember most vividly the things that just happened. It's very hard to integrate more complex information that may be more abstract and distant. In the ideal world, your goal as a doctor for the patient in front of you is to help them understand what's likely to happen if you take one of several courses of action, like have a diagnostic test or take a drug or have a device implanted. Just remembering your last few patients is not the best way to help a person understand what's likely to happen to them. It's more the integration of all that knowledge. A simple way of thinking about it is a doctor alone has certain limitations. A computer alone can't interact with a human being on the other side of the clinical relationship. It's really a combination of a good doctor--these days you say a good healthcare provider--and decision support from technology. That combination is really what will lead to the best decisions.

Your first faculty position was as director of the Coronary Care Unit at Duke University Medical School. It was there that you made the career-defining decision to go into clinical trials. How did that happen?

I had been very focused on using data bases to aid clinical practice. But it became very frustrating because often the question was, "What is the best treatment?" And so the big event that occurred was that some enterprising cardiologist did angiograms of people with heart attacks. Before that we didn't really have the proximal cause of a heart attack. They did angiograms and you could just see the big blood clots in the coronary arteries. So we had a target to go for. A lot of people were developing new treatments. Because we had access to computers, we got involved in doing clinical studies and eventually did a randomized trial. At the time, we were aggressive young cardiologists. We were sure that doing an angioplasty right after giving the blood clot dissolving medicine would be the best approach, as opposed to waiting to do the angioplasty. I still remember when the statistician pressed the button to unblind the trial. It was exactly the opposite of what we expected. Waiting was better. The combination of all the theory and the practical event really convinced me that randomization is an essential tool and that a lot of the future was going to be clarifying what actually worked through randomization.

Your early clinical trials were considered groundbreaking. What made them groundbreaking--was it the way you designed the randomization?

It was really the globalization that was groundbreaking. We were involved in some of the earliest global megatrials, as they were called. That involved working with dozens of countries and different systems and approaches to scale up the research enterprise so that it wasn't just done in one place but done in hundreds of places all at the same time. One thing you normally wouldn't think of is, how do you distribute expensive research therapies to hundreds of research sites at a time when the manufacturing isn't scaled up? It's pretty trivial now but there were all kinds of inventory issues and distribution issues that had to be worked out. I'd also say that working out how you rapidly translate from a clinical trial result into practice using registries. That is something that cardiology, I think, has done exceptionally well and a lot of other fields are still struggling to do. It was back in those early randomized trials that I had my initial interactions with the FDA and could see the power of the FDA in helping academia and industry do the right thing.

You would go on to design clinical trials for a wide variety of therapies, beginning with clot-busting drugs in the 1980s, and then, though the Duke Clinical Research Institute, in areas outside of cardiology. Now--and here I'm leaping over many years--you're leading the FDA. When did it occur to you that this might be something you would want to do?

I've always looked at other jobs and have always advised people working for me, or mentees, to look. It's only by comparing what you're doing now to what's actually out there that you can make a good decision about where you belong. I guess I did reach a point at about the time that Peggy Hamburg [former FDA Commissioner] called me to talk about the FDA job where I had pretty much played out the main things that I wanted to do. They weren't finished but they were far enough along that I could see they were going to get finished. Starting up a new series of things to do was an option. But I could see that in the role at FDA--in particular, if I became Commissioner--the chance to bring together on a much larger scale the ideas that were in play. To be clear here, none of the ideas I've had are unique to me. They're mostly things that have evolved through teamwork and groups of people--large scale globalization of clinical trials, the integration of quality measures, now that we all have electronic health records. But the chance to work directly with Centers for Medicare and Medicaid Services (CMS) as head of an agency working with another head of an agency ... so we can do clinical trials at a much lower cost and answer more questions, all these things were possible. It just seemed like the right time to do it.

Earlier I asked you about traits that suit you for the job. From what I gather, there are three that you really seem to value--humility, loyalty, and integrity. You've said about the last, 'You can be really good at something but at the end of the game, when you call it quits, the only thing you've really got is your integrity.' Would you say a little more?

It's a fundamental belief that I was taught and I hope I've really instantiated it. If you look at the academic world or the political world, and I guess probably the therapeutic development world too, things happen along the way where you might have to take an unpopular stand or you may have to do something that affects people in a way that they don't understand yet and can't see the logic of. Or it might be easier to go along with something but you know it's not right. My personal view is that it's much better to keep your internal compass, even ifit means that you lose out on certain things because it wasn't popular or didn't go along with the flow. These things are easy to say, and no one is perfect, but I think of it just as a general guide for how to lead and how to live. I've always felt that people who worked with you knew the difference between someone with a high degree of integrity and someone who was more playing the game.

The humility part is really hard because leading means that you have to take positions and you need to defend them. It can seem like you're not humble when you do that. But man, all you've got to do is run clinical trials to realize how often you're wrong in things that seemed like they were obvious. A clinical trial is an exercise where you put your belief to the test. In a properly designed trial you don't know the answer until you press the button at the end. You're wrong a lot of the time. This links together with listening and being humble enough to admit that you got it wrong when you get it wrong.

I was struck by a recent conversation you had with your colleague Clyde Yancy about how doctors are human beings after all, with all their imperfections. At the end, you said, there's a Southern expression 'We're all sinners, there's no doubt about it,' meaning we all have imperfections--that's what connects us and makes us human. I'm wondering how that plays out in your work and life--this concept of imperfection.

It drives me towards empiricism--that is, evidence-because we all have opinions and we can be wrong. We can make decisions that are wrong, so we have to be prepared to change them. It's one of the beauties of the FDA that when the evidence changes, we change our opinion and our guidance. It's a constant struggle to be able to do that in a reasonable and efficient fashion, as many people like to point out. Part of what makes the FDA a gem in the federal government is that it's driven by evidence. It's not that there is some oracle that knows the truth. We have to be constantly in communication, hearing from all aspects, including industry, patient groups, and so forth. In Washington sometimes, there's a tendency to lay blame. Something goes wrong and there's an effort to find the scapegoat. The way I see it, we all contribute, in one way or another, when things don't go right. It's much better to try to understand why things went wrong but the key is what you do going forward. I think people in organizations are much better judged not by whether they have failures but how they respond to the failures, how they pick up and go on.

And start all over again, like in a basketball game. [Laughs]. Yes. Another thing I carry around, which I didn't really know about until I got to Washington, is a Teddy Roosevelt speech called "The Man in the Arena." He gave it at a time when he was down about things but resilient. The message was, it's better to be in the arena fighting the fight, even if you get beat up and you end up on the canvas and you're picking yourself up bloodied, than it is to be on the sidelines commenting on the fight. If we accept that we all have imperfections and we do the best we can, it's best to just get in there and keep going.

Sponsored by the Department of Laboratory Medicine, Boston Children's Hospital

Misia Landau

e-mail Misia.landau@gmail.com

DOI: 10.1373/clinchem.2016.254623

Caption: Image courtesy of U.S. Food and Drug Administration.

Caption: [C]Jeremy M. Lange/The New York Times/Redux. Reproduced with permission.

Caption: Dr. Califf's internship basketball team (1979-University of California Medical Center). Image courtesy of Robert M. Califf, MD.
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Title Annotation:Interview
Author:Landau, Misia
Publication:Clinical Chemistry
Article Type:Interview
Geographic Code:1USA
Date:Jan 1, 2017
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