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Gerald Cooper

Year: February 14th, 2005
Location: Atlanta, Georgia
Interviewed by: Labarthe, Darwin

Abstract

This interview of the pioneer of laboratory standardization, Gerald Cooper, illuminates his unique qualities of curiosity, methodological discipline and tenacity, and great good will, as he had provided a crucial service to world laboratories for CVD epidemiology and trials. He gives all credit to the support of NIH in the CDC endeavor and tells the story of providing service on a shoestring budget while developing a standard for standards internationally, and even guidelines to thousands of domestic laboratories. Gerry’s devotion to this work remains active and influential after 52 years of intimate involvement. We all owe him a great debt. (Henry Blackburn)

Quotes

How the Lipid Standardization Program began

It really came because I attended epidemiologic conferences to really learn about the problems going on in cardiovascular disease. In Chicago, Oley Paul headed up an epidemiologic conference there for a year in January when it was really cold and it was there that presentations were made and problems were pointed out about lack of standardization and Henry Blackburn, particularly, spoke up and wanted to make sure that all measurements were standardized and at every meeting he practically stated that we should have a standardization program for the clinical trials.

Then how we really got involved was that Tom Dawber and George Mann and the statistician there [at Framingham] who is Tavia Gordon were asked by the Epidemiology Society to come to CDC and ask if we would serve as a central, say neutral, and they emphasized the word neutral, laboratory to help standardize the laboratories serving [population studies and] clinical trials. We told them we hadn’t had any experience in it, but we would try, and that was 1957. So in 1961 we started our first standardization program, which was called the Cooperative Standardization Program with seven laboratories in the United States. At that time it showed up considerable variation, but the Abel-Kendall method is used in most of the laboratories and it showed that that was actually a better method in our hands.

. . . But, we really didn’t get highly involved until Jim Watt at the National Institutes of Health in about 1963 or ’64 evaluated the grants and found out that the reason for failure to gain the objective was the cholesterol measurement. So he invited me up there to talk and in our discussions we decided to form a partnership between the National Heart and Lung Institute and CDC to start a standardization program for clinical trials. And in very short time we had as many as 70 laboratories participating, because they knew they had to be standardized for their grants. And that’s what really got us started to where we were working very closely with the different clinical trials.

The National Program

When we were involved with the Heart Disease Control Program we were placed in the Heart Disease Control Program by Jim Watt. . and we served as the epidemiologic laboratory for the different clinical trials funded by NIH and became a part of the Heart Disease Control Program. And that was when our program really grew, when we developed close relations with the epidemiologists who were running the different clinical trials and what happened was that the Heart Disease Control Program had been placed in the so-called Chronic Disease Center that they had formed up. And when the Lipid Research Clinic Program was brought forward it was so expensive Congress said to NIH, “What are you going to delete in order to pay for, say, the Lipid Research Clinic Program?” And the whole Chronic Disease Center was eliminated. And when the Chronic Disease Center was eliminated, of course our laboratory was eliminated. So there was a stressful situation. But the Surgeon General and the Public Health Service and CDC got together and we were placed on a nutrition budget.

Standardizing the standard laboratories

I think you have to progress in that area. You first have to gain experience by serving as a central laboratory, then afterwards work with a few laboratories and let them be the laboratory and you be their central standardization and that’s what’s happened.

The very interesting thing is that Diet Study. I’d say the best cholesterol values are as good as ever made if not the best ones ever made were made for Dr. Frantz [and those] in that original Diet Study. We set up a semi-automated Abel-Kendall method and I couldn’t help but appreciate the letter from the head of the statistics group at the University of North Carolina saying, “We didn’t believe those values. We checked you every way, but you always were perfect.” So that letter was a very precious letter.

That is how our standardization program has evolved and today our standardization program is working for the laboratory that is serving the clinical trial and we have, I don’t know, but we have over 100 laboratories that are now either a research laboratory, methodology and so forth, either clinical trial or in a public health prevention program. That’s how the standardization program has evolved and NHLBI has been a wonderful partner with us all the way and we call that program now the CDC/NHLBI Lipid Standardization Program.

The International Program

Jim Watt again. He was on a committee that met about cardiovascular disease at WHO and the number one subject that they discussed was standardization of cholesterol and lipid measurements. And Jim Watt told me later that he said, “Why don’t you get Gerald Cooper to work with you and develop an international program?”

Well, they followed up and they got it. I wrote back and said we were working on a national program, let us work up our problems in it and then we’ll be glad to do it.

Boy, right back came a letter to the Surgeon General saying that I didn’t want to work with them. I’m telling you, the next day after CDC got the letter I was [in Geneva].

So I went over and wrote up an international program for them and it included two things: one is that we get a WHO collaborating center for reference and research in blood lipids so that we have an excuse for working with the international labs, because NHLBI, where we were getting our money, really is a national lab. And the second thing was I realized that they just didn’t have any money. I realized that nothing was going work internationally if we depended on money from anywhere and so what we decided to do was to superimpose the international program that I wrote up for them on top of our national NHBLI/CDC program and just go on and do it.

And that’s what happened. So we have now running about . . 45 international laboratories that we have standardized under the WHO collaborating center. . . 

So standardization is needed for all of the new emerging, say, risk factors. We feel that total cholesterol, triglyceride, and HDL are the basic risk factors for heart disease and that they can be used if you know what it is in a patient as sort of a comparison between patients and groups, so that we have spent our time almost exclusively to . . make sure that those three measurements [are] the standard . . . At the present time for most of the emerging, say, risk factors we do not really set up standardization programs. Can’t afford it; don’t have the money. But we can have conferences with partners, like with the C-reactive protein with the American Heart Association and other public health associations and groups. We put on a conference where all aspects are studied and recommendations are made to the clinicians and to the laboratories. So we feel that’s how we can at least help out some.

Well, we find that a combination of epidemiologists, statisticians, and laboratorians is a strong attacking force on standardization problems. We have benefited, in fact, we would not have been able to do what we did without the close associations with the epidemiologists and statisticians. You take the Coronary Drug Project, working with Jerry Stamler and Chris Klimpt. We were just with them all the time and we learned a lot and working together we solved a problem right when it happens. So you just can do so much more when you work together.

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