Claude Lenfant
Year: July 29th, 2002
Location: Bethesda, Maryland
Interviewed by: Nichaman, Milton
Abstract
Claude Lenfant, MD is French-American, French-trained, and worked in pulmonary physiology at the U. of Washington before heading the Lung Program at NHLI, now NHLBI, starting in 1970, and subsequently served 21 years as NHLBI director from 1982 to 2003. He presided over lean and fat budget years and basically supported a broadbased extramural program including CVD epidemiology and prevention.
His heart remained in clinical investigation and he came under pressure over the duration and cost of epidemiological studies and trials and then progressively instituted policies to control prevention activities with special approvals along in-house program policy lines and independent of scientific merit scores. He battled his staff on issues of study performance and the prevention community on issues of funding. Despite a clinical bias he generally supported prevention research, which was useful to him and the institute in its relations with Congress, and some of the more expansive of CVD studies were carried out on his watch, including the Lipid Clinics Research Program, and The Multiple Risk Factor Intervention Trial (MRFIT), and the community studies at Stanford, Minnesota, and Rhode Island.
In this interview with Milt Nichaman he explains why the Division of Epidemiology and Clinical Application (DECA) was created in 1984, provides insight into the progression and 1972 rejection of the Diet-Heart Study, and discusses the growth of ARIC and the difficulty, he felt, of keeping the study focused on the original target, that is, reporting incidence and surveillance data. He discusses a number of studies designed to identify risk factors such as hypertension, cholesterol, blood pressure, and more recently physical activity and exercise, which have been supported by NIH, as well as, trials with the primary goal of disease prevention.
He talks about the friction between NIH staff and the epidemiologic community regarding certain projects and discusses the importance of epidemiological studies and their cost, allocation of funding, and priority setting within epidemiological research and within the institutes of NIH. (Henry Blackburn)
Quotes
Of course the Diet-Heart Intervention Study was discussed ad nauseum, ad nauseum! We finally reached a decision that we just could not do it because it would be too expensive. That was basically the reason. Difficult, but also tremendously expensive. You know, nutrition then was not exactly what it is today and so I think there were also some concern about what precisely could be done. All I can tell you is that this office where you are here today is the one where Cooper was, and that was Cooper’s desk. Nothing has changed in this office in 30 years. And Ted always would come very early and I also come to work very early. And I would come and I would sit in this chair and we would talk about all kinds of things. Ted and I had developed a very nice personal relationship and he would talk to me about The Diet-Heart Intervention Study and should we do it, shouldn’t we do it, and what if we do it, all those things we won’t be able to do because it would be so much money.
And then little by little and that was really how astute and forward-looking Ted was, he started discussing all these issues with the community, you see, that brought issues to him. He started discussing it back and telling the community all the problems that would result from that study – the uncertainty whether it would really work, what specifically we would do, and the cost. That led the community to finally back-off and the thing died. That’s my recollection of it. (pg. 6)
And I think the flagship of epidemiology forever will be the Framingham Study because it is really where this fellow Dawber, I believe, put forward the concept of risk factors, which were born and developed, you see, and grew into what we know today. It’s interesting that a concept that is now 51 or 52 years old is still going very strong and, in fact, I would say, has increased in importance. (pg. 2)
I had never done epidemiology or I had never done a clinical trial. But I was absolutely fascinated by the potential of these things – evidenced-based medicine on the one hand, knowing better how disease comes about, or involvement in the broad sense. But it occurred to me that epidemiology and clinical trials did not have an institute or place that they deserved. They were in the Division of Heart and Vascular Disease. Actually they were a branch, and trials was a branch of that. That became a problem. But still it was not an independent thing with the possibility to flourish.
So I made the decision to take it out from there and to create a division that we have now of Epidemiology and Clinical Application (DECA) which has two programs; one which is epidemiology and the other which is clinical trials. That must have been in 1984. I think that Manning Feinleib was the first director of that division;… the second director… was Bill Friedewald. Bill Friedewald was so successful that Jim Weingarten who was Director of NIH took him away to make him an Associate Director of NIH for Prevention. Then Bill Harlan became the Director and he, too, was eventually taken away and replaced by Larry Friedman who was replaced by Peter Savage who is, of course, now the Director. But during that time I think epidemiology has prospered a lot, lots, in many ways. (pg. 8)
Bethesda Control
When asked about a shift to more involvement by Institute personnel than it had previously – following the investigator-initiated Coronary Drug Project, Lenfant responded:
That is correct. I mean Zukel was a little bit of the force behind that, I think. And Bill Friedewald, too, was after, when Zukel worked under Friedewald. When they started to involve the staff and I can tell you, (and I may be dead when your thing will be published so it does not matter). . . I think that that has created a real problem in the relationship between the Institute and the community. I personally am a firm believer that the scientific community must be the driving force. And that shift occurred [in control] and that has created a number of, should I say, differences of opinion.
[For example, ARIC] . . I think with influence of the staff it became something very different, you see. It became a much broader thing and actually incidence fell by the wayside and surveillance fell by the wayside. I said, “Just a minute. What’s going on here? We’re not doing what ARIC was about.” . . .the scope of ARIC was modified. Then we had P-Day and then we had another major study. History will decide, but I think I supported those, I really did.
In talking about this friction between the Institute staff and the epidemiologic community, Lenfant said, “Yeah, we are trying to ….. we’re working on it. You know, our worst enemy is personalities.” (pg. 10)
You know, there are two issues, I think, that are facing us now. The first one is that there is in the scientific community an ever-increasing concern that epidemiology studies and prevention, clinical trials, go on forever. The second thing is the advent of genetics, you see. And there is a little bit of a belief that if you throw in come genetic measures in all of these things, everything is going to be solved. Which, of course, is a bunch of baloney. (pg. 11-12)
On NHLBI Education Programs
You know, my personal view is that of all these clinical studies that one that has been the most successful is the education program, the most successful has been the cholesterol one. Certainly more successful than blood pressure. I don’t know why. But, we have been able to reduce the average plasma cholesterol quite significantly in the last 20 years and it’s still going down. But, of course, today we’re confronted with obesity, which is the other side of the coin. And unless we do something good there then we are going to have a tremendous problem in the future. (pg. 14)
Wrap up
You know, there are two issues, I think, that are facing us now. The first one is that there is in the scientific community an ever-increasing concern that epidemiology studies and prevention, clinical trials, go on forever. You know, in epidemiology studies that’s the beauty of the thing, you see. You have a cohort, you want to keep it and work on it until the people disappear because you still learn from them. But, epidemiology is part of a broader scientific community and the broader scientific community says, “Now just a minute, what is going on here that they have these studies going on 20 years, 25 years.” And, of course, it has to be the same investigators, you see, because that’s where the people are, that’s where the cohorts are. So that creates some interesting discussions.
Then the second thing is the advent of genetics, you see. And there is a little bit of a belief that if you throw in come genetic measures in all of these (epidemiological) things everything is going to be solved. Which, of course, is a bunch of baloney. But, you know, there is a movement out there and it’s very difficult to reverse it.
Well, interesting business, very interesting. I think epidemiology has a good future ahead of it. I think that the problem it will have to arrest, the epidemiologists will have to arrest, is the duration of all these studies, you see. That is really a problem, I think. So I’m sure you know that people are talking a lot about biomarkers and the influence, of surrogate markers, surrogate influence. It will be interesting to see if that gets anywhere. (pg. 15-16)
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