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Jerome Green

Year: May 23rd, 2003
Location: Bethesda, Maryland
Interviewed by: Nichaman, Milton

Abstract

This is a far-ranging chat about early days and later at the National Heart Institute with Jerry Green, an outstanding scientific administrator centrally involved with the early Diet-Heart Study and the Coronary Disease Project, who eventually and skillfully directed the DRG, the institute’s Division of Research Grants.

He outlines how free and informal the operation was at the beginning and how the institute showed the way in many areas of research and NIH operations, eventually having many of its creations copied or transferred to other entities, particularly its biostatistical and chronic disease training grants and trial expertise. He gives much credit to the two infectious disease epidemiologists who first directed the Institute: Cassius Van Slyke and James Watt, for foresighted programming.

He recites the familiar history of the conflicted Intra and Extramural systems in respect to commitments, loyalty, and funding and runs usefully through the administrations of all the Directors. We get a clear picture of the birth, rearing, and death of the National Diet-Heart Study, and how it panicked the NIH powers-that-be.

He confirms one of the themes of our analysis of NIH operations, the essential conflict of interest and central control in major epidemiological studies by their conversion from investigator-initiated grants to forms of contract research with administration by NIH staff having conflicted academic roles and interest in the studies they are assigned to administer. He is agin’ it. (Henry Blackburn)

Quotes

Institute Autonomy

But there’s one other example I want to give of Jim WattPaul Dudley White, a couple of other people. In those early days they did an unheard of thing. They made a site visit to the Soviet Union and they went to the southern parts of Russia and there they saw subhuman primates being raised and studied in a large laboratory situation. They were being raised. So they came back and said, “You know, we ought to have primate research centers in this country. We ought to have chimps, we ought to have monkeys, we ought to use these kinds of animals as animal models of all kinds of diseases, certainly cardiovascular.” So the Heart Institute established primate centers in this country. Supported them for about 10 or 15 years until, again, another part of NIH was established, the Division of Research Facilities and Resources, DRFR. And they had primate centers.

Life and death of the Diet-Heart Study

So there were three diets and it worked. When the report came to the Council and to the Institute they didn’t know what the hell to do with it. They just didn’t know what to do with it. And it’s a reflection of a different attitude. I’m describing to you the early days when the Council or the Institute’s staff were gung ho, “Let’s do this. Let’s try it. It’s risky, but it’s worth it. We’re talking about something that is vitally important.”

It comes now to the Institute where at the time the budgets are beginning to level. That era of logarithmic growth that Shannon presided over was coming to an end. The budgets were beginning to plateau and people were starting to talk about, “Oh, this is going to cost millions!” True, it would. So they put together at the Institute another consultant group, an advisory group to help decide should we launch a definitive Diet-Heart Study. That outside group was chaired by Pete Ahrens of the Rockefeller. Ahrens is a wonderful guy, very knowledgeable. His whole orientation at the Rockefeller was to take patients, pick subjects, put them into the Rockefeller under lock and key for four months, five months, and feed them various diets to see what the lipids were… Maybe you could do this with the U.S. Army. Maybe you could do this with a prison population. In any case, the size of the venture, the concerns about money, the concerns about adequate compliance killed it. So it never got off the ground.

Bethesda Central Control of Epidemiological studies and trials:

Yeah, they’re tough to run [large studies and trials]. Particularly when you get a group like the CDP investigators who are knowledgeable, adept, who are spending full-time thinking about this and who are ambitious. And then as far as some staff is concerned, they may view this as a study that’s out of control so that it becomes a conflict. I mean, that’s very unfortunate. It’s very unfortunate.

My own attitude for years has been that I vastly prefer the grant mechanism of support to the contract method of support. For one thing, frankly, I have seen what I consider almost conflicts of interest on the part of staff. Where staff is deeply involved in running a trial on the contract basis, contract support, and publications begin to come out and their name is on it as one of the authors. Now I consider that a conflict of interest. They are very influential in what’s happening within the study. They are controlling the flow of dollars to a considerable extent. They are privy to the results. But mind you, they are sitting here in Bethesda as managers. They are not investigators. They are not seeing patients.

One Institute got into a lot of trouble with that and that was the Cancer Institute. The Cancer Institute has always had a much, much larger proportion of research supported by contract and some of their people would develop bibliographies of 300-400 publications based on the contracts that they administered. Not good, not good.

Politics in grant awards:

But it always seemed to me, you see, that it was difficult to get the right kind of mix on the Advisory Council. In 1955 when I joined the Institute and started to work with the Advisory Council, Eisenhower was President and there were a whole series of checks that you had to do with the White House. You couldn’t make a grant unless you had sent down the list of names. Here are the people who we are going to give research grants to. And they would check. And the White House would let you know whether it was ok. And I was there when one of them came back, “No, you may not make a grant to this guy called Linus Pauling because he is a security risk.”

Funding of epidemiology and trials:

These, of course, are large amounts of money. A Heart Council that is used to giving out $30,000, $40,000, $50,000 is suddenly faced with an application that’s half a million dollars. And right away you heard comments of, “That’s 12 research grants!” As if you could equate them in some way. So it led to all kinds of problems in dealing with them.

Even early on though, people like Paul Dudley White would say, “Let’s not worry about the money at this point. Let’s worry about the opportunity, the scientific question. Are they asking a good question? Is the protocol right? Is it reasonable? Do you trust these people to do good work? Then if we have all of that, let’s let the Institute worry about raising the money and they can do that when they testify for their appropriation. They can do that by talking toMrs. Lasker and get her to talk to Lyndon or whoever.”

So there were some of these people who were more broadly based, I would say, rather than the people who just thought about how many research grants. And there were cardiologists, there were people on the Advisory Council who were outstanding people in clinical cardiology who didn’t have that. . .Weltanschauung.

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