Interview Topics:
Interviewers: James Harvey
Young (JY), Robert G. Porter (BP)
Date: 8-9 March 1985
Place: Chicago, Illinois
Editor's Note
Dr. Alexander M. Schmidt passed away
on 28 January 1991, before he could
do a final review of this transcript.
The FDA History Office acknowledges
Dr. Schmidt's wife, Patricia W. Schmidt,
for her assistance in the editing.
Also, the reader should be aware
that this transcript follows as closely
as possible the guidelines of The
Chicago Manual of Style, 13th edition;
references to names and terms are
capitalized (or not) accordingly.
BP: This recording is one in the series of oral history interviews with former Food and Drug Administration employees. Today we are interviewing Dr. Alexander Schmidt, now Vice-Chancellor for Health Affairs of the University of Illinois Health Sciences Center, and former Commissioner of the Food and Drug Administration. Present in addition to Dr. Schmidt, are James Harvey Young of Emory University and Robert G. Porter of the Food and Drug Administration. The date is March 8, 1985. The interview is taking place in Dr. Schmidt's office in Chicago, Illinois.
JY: Dr. Schmidt, in these interviews we like to begin with some autobiography. Would you please start at the beginning of your life and carry it up to the time that you were chosen as commissioner?
AS: Well, that is a long question. I was born in Jamestown, North Dakota on January 26, 1930. My father was with the J. C. Penney Company and had requested to go to North Dakota to work because my mother was from a little town named Bottineau, North Dakota, up on the Canadian border. She wanted to be closer to her home than Chicago, where my parents had been living shortly after they were married. My father was from Chicago and went to Northwestern and they met at Northwestern University, and started out married life here. Chicago was a bit much for my mother, so they went up to Jamestown, North Dakota, a town of 2,000 people. My father lived through the dust bowl and drought in North Dakota, but requested of the Penney company a little more water, so he was sent to Scottsbluff, Nebraska, which is in an irrigated valley not depending on rainfall for the crops. So, we lived in Scottsbluff, Nebraska for a while and then Ogden, Utah, which I really considered my home since high school.
Northwestern was the family school. I went to undergraduate college at Northwestern University. The intent was to follow the path of some of my relatives and go to Northwestern Medical School, but several different factors entered into my going to Utah University College of Medicine instead of Northwestern.
JY: Had you thought of being a physician before you went to college?
AS: Well, yes. My lifelong hero was my maternal grandfather, who was a physician, and knew Sir William Osler and was really a great man in many respects. He was a practitioner of medicine in Bottineau, North Dakota. He took care of many people throughout southern Manitoba and northern North Dakota. He was kind of my role model in many respects.
It was either human medicine or veterinary medicine. Almost up to the time I went to medical school, I didn't know whether I would be going to medical school or vet school because I grew up with animals and loved animals. I was kind of intellectually drawn to medical school and emotionally drawn to vet school. Finally, I think my parents and other friends sort of pressured me in the direction of medical school saying that my talents, such as they might be, might be better occupied in human medicine than in animal medicine. I've never been certain whether that was absolutely correct, but as it turned out I went to medical school.
At the time I was deciding where to go to medical school, I think the main factor was that I missed the West and missed the mountains and missed my animals. I had one or more horses that I missed. I preferred the lifestyle of the West, and the idea of living and working in downtown Chicago, which I now do, didn't really thrill me at that time.
The second thing was that Utah had just started up and had got going what was a first-class medical school with superb people. Rocky Miller, who was president of Northwestern University, and Richard Young, who was dean of Northwestern University Medical School, had both been at Utah. As a matter of fact, Rocky Miller recruited Young, who was dean at Utah, to come here to be dean at Northwestern. There was always a fairly strong connection between Utah and Northwestern in a lot of different ways. Richard Young suggested that Utah might be a good place for me to go.
So I did go to University of Utah Medical School, and to this day have been grateful for that opportunity because it was a marvelous place to get an education. The quality of the people that were there then was spectacularly good. Classes were very small. Some of my closest friends were department heads and faculty of that school.
JY: Who had the most influence upon you, would you guess?
AS: Well, that's easy to say. The head of the Department of Medicine, Max Wintrobe, the great hematologist, had a great influence over everybody who came into contact with that school. Most certainly me. I worked with Hans Hecht in cardiology at times when I was in medical school. Then, of course, I went into cardiology and trained with Hans Hecht in the Department of Medicine.
The summer between my second and third year, I worked with Lou Goodman in the Department of Pharmacology. One of my close friends through all of these years has been Lou Goodman. I think, obviously, he's one of the great pharmacologists of the country and one of the authors of Goodman and Gillman, the standard textbook in the field.
Lou Goodman and Hans Hecht and Max Wintrobe--I think those were the three people with the greatest influence. But there were others there, Horace Davenport of the ABC, of acid-base chemistry. Horace was head of physiology. And Tom Doherty, the lymphocyte man, was head of anatomy.
So many of the people there were first rate. The intellectual excitement and stimulation of that place in those days, I've never seen any other place I have been. I think it's gone from Utah now, too. In those early days in Utah, Max Wintrobe would invite the Department of Medicine and some students to his home for Thanksgiving dinner. Can you imagine a thing like that, given the numbers in departments of medicine today? The way we were able to get to know those people was really something very special. Certainly my interests were formed very much in that medical school.
It was a small school and a lot of the people were from Hopkins. I suppose there was much about Hopkins at Utah in those days. Phil Price, the head of surgery, Max Wintrobe, and George Cartwright, who later was head of medicine there--all these people were at Hopkins.
JY: You stayed on?
AS: The idea was that the cream of the crop, so to speak, stayed at Utah. To be invited to be a straight medicine intern at Utah for the Utah student was better than going to Harvard or Stanford or anyplace else. Max first invited me to be one of his straight medicine interns, and then one of his residents in medicine. As I looked at the other opportunities, other places to live in the country, or other places to train, I really couldn't think of another place I would rather live in those days. I was convinced then, and am still convinced, that the training I got there was as good as anyplace I could have gone.
So, with a two-year period out in the Army in the middle of my training, I was at Utah for my whole formative career in medical school--a straight medicine internship, a residency in internal medicine, and then a two-year public health research fellowship in cardiology with Hans Hecht.
JY: Did the Army experience have any relevance that you can think of to your later commissionership?
AS: Not a hell of a lot. I think I learned something about administration in the Army. How both to do it and not to do it. My Army experience was in Germany, first as a surgeon with a field artillery battalion for approximately half the time and then as a C.O. of a thirty-two-bed station hospital.
The second half of my time, what I tried to do there was to practice good medicine. I think probably the most important thing that happened to me there was that I had a patient, a young woman, with anemia, and I did the standard University of Utah anemia workup and still didn't know what the cause of the anemia was. So, I sent her and the workup I'd done up to Frankfurt to the 97th General Hospital. She came back that night in tears because I had reassured her that if she went up to the big hospital in Frankfurt, they would take care of her and find out what was wrong. She really wasn't feeling too well. She went up there to whatever receiving part of the hospital it was, and they looked at the workup I'd done with the little lab I'd set up in my little hospital. They told her that I'd done more than they knew how to do and that it was ridiculous for her to be in that hospital and to go back and let me take care of her because I obviously knew more hematology than they did. Well, most people out of Utah knew more hematology than most people.
The next day I was called up to Frankfurt and interviewed. They wanted to transfer me to Frankfurt to be the Usura area hematologist. But since I'd moved too quickly or something, I couldn't do that. So, I ended up being hematologist to the Army in Europe from my little hospital in Darmstadt. I really spent that time trying to take very good care of the many people that I had responsibility for.
As far as the Food and Drug Administration went . . . Well, I never thought of this before, but I did have a couple of veterinarians that were under my administrative control who did meat inspections and food inspections. I remember once, I had to settle a dispute between a veterinarian of mine who said that a semi-trailer truckload of hamburger was good and the mess officer who said it was rotten. A semi-trailer truckload of hamburger was worth a lot of money. The mess officer wouldn't serve it because he said it was putrid. The veterinarian said it had just aged a little bit and was fine and to serve it. I had to . . .
JY: Play Solomon.
AS: Well, they opened the back of that truck, and this awful odor came out and it was all brown on top and this water ran out of the back of the truck. I turned to the veterinarian. He said, "It's all right, captain. It's just a little watery." So, he fried up some hamburgers and he ate one and he wanted me to eat one. I finally decided I had to support my veterinarian, so I ate one of the hamburgers. Actually, it tasted pretty good. So, I declared the meat all right, and it was served. Fortunately, nobody got anything.
But, in reality, there was nothing in that experience that would have given me any particular interest in or expertise, either, in the matters that fall within FDA's purview.
JY: How were you chosen to go to the National Institutes of Health?
AS: You mean the first time I went to Washington?
JY: The Division of Regional Medical Programs.
AS: Okay. After I finished my cardiology fellowship, Hans Hecht and Max Wintrobe both asked me to stay on and be on the faculty at Utah. And once again, it was a small faculty even when I joined it. I considered that a great honor to be asked by Wintrobe to be a member of his department, and I was delighted to stay. So stay I did. Hans Hecht left Utah and went to the University of Chicago and wanted me to go with him. I looked at the University of Chicago and decided to stay in cardiology at Utah and got more and more involved.
One year Hans was on a sabbatical in Europe, and I was sort of acting head of Cardiology. We did a number of things, including getting involved early in a program called regional medical programs, which some people called the heart disease, cancer, and stroke program that grew out of a report by Michael DeBakey that called for regional centers for heart disease, cancer, and stroke. This became transmuted in wending its way through Congress into the regional medical programs. But a very large part of it was cardiology. At Utah we wrote one of the first grants and we were one of the first regional medical programs established. It was really a highly successful effort.
JY: So that that really was, in a sense, financed by NIH, but it was done in Utah.
AS: Well, the Regional Medical Program was a national program. It was started in Jim Shannon's office in the National Institutes of Health. Bob Marston, who later had a series of jobs, including being director of NIH and, most recently, president of the University of Florida, was brought into Jim Shannon's office by Jim to run this national program. The intermountain area was one of the regional medical programs. Many others across the country were formed so that finally all parts of the country fell under one or another regional medical program.
Bob Marston asked me to come to Washington in the early days of that program and help get it started. So, I took a leave of absence from Utah and went to Washington in 1966 and spent a little over a year and a half with RMP in Washington.
I think there was one other factor, and that is that while in Utah, I had been selected to be a Markle scholar in medicine. The Markle program has since been stopped by the Markle Foundation--it's gone into other areas. But at that time the Markle program was very important to academic medicine. It gave relatively large awards to young faculty. It was a process of identifying young faculty who, in the view of the Markle Foundation, were capable of doing things that were good for academic medicine.
The reason that was important is that if you look today at a roster of Markle scholars, you will find major figures in American medicine in the past twenty years. Bob Marston was a Markle scholar. The dean of Harvard Medical School is a Markle scholar. John Cooper, the long-term president of the AAMC, is a Markle scholar. Surgeon generals have been Markle scholars.
I was president of my class of Markle scholars and was involved in most of the meetings over a several-year period and got to know all of these people. Some of them were truly the leaders of American medicine, in and out of government. So, I was invited to come to Washington, essentially, by a couple of Markle scholars. The initial conversation I had was around the table at an annual Markle meeting, where I was sitting with Jim Shannon and the then surgeon general and Bob Marston and others, talking about RMP and what we were doing in Utah. Within days I got a call that said, "You've got to come and help us do this."
RMP was a very prominent program in those days. Lyndon Johnson and others were watching the program with personal interest. And I was assigned by Jim Shannon to the White House for a number of weeks while I was there, so I was able to meet people, including the president and his staff and others and worked directly in the White House. I had a temporary office, right in the East Wing of the White House, so that I got to know people.
JY: That was really building all kinds of bridges of importance.
AS: Well, that's right. It was learning things and getting to know people, and learning how things worked and learning how to get things done. Particularly, it was fun to talk to Lyndon Johnson, which I had the opportunity to do briefly on a couple of occasions about how to get things done in government and so on.
And it was fun. There were good people in the White House. I remember that there was one presentation that I was at that was made by a young lawyer from the Defense Department. Lyndon Johnson took a liking to him and had him brought into the White House. His name was Califano and he was at the beginning of his career.
So, you meet people and you establish some kind of a reputation for yourself and you stick in some people's minds. In particular, if you're a Republican working in a Democratic administration, you stick in people's minds. There's always a lot of teasing and so on going on.
JY: How were you invited here, then, the first time?
AS: Well, my intent was to spend up to two years with the regional medical programs in Washington and then go back to Utah. But another very important figure in American medical education, if not American medicine, was a man by the name of George Miller. And George was here at the University of Illinois directing the Office of Research and Medical Education. George started what is now commonplace in American medical education, that is, formal offices of research and medical education. He was very well known. He was on the review committee for the regional medical programs. RMP was set up much like NIH institutes because it was in Jim Shannon's office, so it was natural that RMP take the shape of one of the institutes of health.
So, we had a National Advisory Council. We had study sections. As I recall, George was on the study section, and I got to know him well, and he got to know me. The University of Illinois was beginning a major revision of its medical education program. It was really almost a total redo of the organization and of the curriculum and so on. The college was contemplating, essentially, doubling its size, setting up programs in Rockford, Illinois; Peoria, Illinois; Urbana Champaign on the other campus, greatly expanding its activities and launching a huge building program. You're sitting in the middle of the largest medical center in the country right now. They were planning a total redo of curriculum, as I said.
They needed somebody to come and do that: to plan that and to oversee it and to carry it out. So George said, "Come to Illinois and meet the chancellor and meet some people and just talk to them and see if you'd be interested in coming to Illinois, because it's going to be a very exciting place in the next five to ten years." So, I came here. I'll never forget walking the first time on this campus with these huge gothic buildings. It was almost like walking down a canyon. Here outside my window, the buildings . . . To come from Utah, where in medical school we were in wooden barracks from the old Fort Douglas, and to see what there was here in the richness and the amount of state funds coming in here, I couldn't get over it. The opportunity that they offered me was something I just couldn't turn down.
JY: The chance to create.
AS: Well, there were resources that were here. And there were resources in the city of Chicago. I'm fond of telling people that a lot of what you hear about Chicago is true. It may have been a little more true when Mayor Daley was alive than is true now, but it was a city that worked in many respects. Of course, there are some of the unfortunate aspects of the city that slowly are being addressed, that have to do with the poor and minorities and so on. But let's talk just for a moment about what the university was trying to do and how we were trying to do it. It was a city that you could get things done in. At any time I could pick up the phone and get to Mayor Daley. And if we had a good idea, he'd say, "That's a good idea, let's do it." And then you could do it.
The state of Illinois, by and large through the years, has supported in hard money this institution very well. When I came here, as one example, nobody, no faculty person could be in a tenure track position unless there was a hard line in the state budget for that person. And, in essence, the faculty were a hundred percent supported by hard monies appropriated by the state. In Utah we could stay there as long as we supported ourselves. The luxury of not having to worry about where your salary was coming from was a big change to me.
JY: Not having to write grant applications all the time.
AS: Yes. Now, you know, there's a good side and a bad side to that. The bad side to that was Utah had a hell of a lot more research going on than was going on here.
BP: What year did you come here?
AS: Well, I was with RMP in Washington in '66 and '67. I moved here near Thanksgiving. So, I came here Thanksgiving of '68. Under, of course, the chancellor and the dean, I was called the executive associate dean of the College of Medicine. My responsibility, literally, was to be dean in the absence of the dean. To be kind of number two. But my principle responsibility was to plan what was referred to as the reorganization and expansion of the College of Medicine. And I did that, essentially, full time, and was very pleased that when we finished the job of planning--we being the faculty committees I set up and so on--and took it to the executive committee of the college, it was voted as approved almost unanimously. One person voted no, and everybody was so surprised that this individual was asked why he voted no. He said, "Because something this important should never be unanimous." But this was against the background of an earlier attempt to reorganize and expand the college having been voted down by the faculty. And when I first came, the institution was hostile to the idea of doubling its size and setting up regional programs.
When we did then reorganize, I became dean of what was the old College of Medicine here in Chicago. I forget exactly when I became dean; I think early 1970. From then until I did go to FDA, which was mid '73, those three-plus years I was dean of the medical school here in Chicago.
JY: Just a kind of personal question: Did you know Harry Dowling before you came here?
AS: No, I did not. And actually, I didn't know him when I came here either, because he was on a leave. Nicholas Cotsonas, who came from Georgetown with Harry Dowling when he came here, who is now the editor of Diseases of the Month, was acting head of Medicine. I didn't meet Harry until he came back from his sabbatical, which was some number of months after I came.
I was familiar with his name, though, having been in internal medicine and academic medicine, but Harry didn't figure in all of this until 1973 really.
JY: Then how was it that when 1973 came you were chosen? What were the dynamics underlying that important step?
AS: Well, I'm not sure I know. I've read interviews of other commissioners and most commissioners get asked, with varying degrees of surprise in the voice, the question, "How did you ever end up being commissioner?"
JY: I hope I didn't have that tone.
AS: I've been asked that question, and I've always said I don't know, which, if I were forced to a short answer, would be the most truthful short answer. I really don't know very much about it.
But I do know the following: one is that I knew a lot of people in Washington. I knew a lot of people in Washington because I was a Markle scholar and there are a lot of them in Washington, and I knew all the Markle scholars, or a great number of them.
Secondly, I had been in Washington for a year and a half and had been in a very visible program in a very visible way in Jim Shannon's office and Bob Marston's office. Bob and I and a couple of others planned the reorganization of the Public Health Service that was presented to Phil Lee and Lyndon Johnson. Bob Marston was superb at taking me where he went. And Jim Shannon, they were both interested in young people. They would say, "We're going over to the White House; why don't you come," and things like that.
So, if I count my heroes, I've given you my grandfather. I named Max Wintrobe, Hans Hecht, Lou Goodman. Then I got to Bob Marston and Jim Shannon, because they really taught me a tremendous amount. In a year and a half I learned a fantastic amount from those two guys by watching them and listening to them. Bob and I used to fall into a conversation sometimes at 5:00 and we would just keep talking until 9:00 about whatever issue. And he would give me that kind of time to teach me.
Then, after I came to Illinois, Illinois was prominent in medical education circles because of George Miller, Harry Dowling, and George Jackson, the people that were here. And I was doing a number of things in Washington. I stayed involved with RMP. I was chairman of their study section. And after I had been away from programming an appropriate period of time, I was doing things with the AAMC, so that I knew a number of people.
JY: Had your research in any way been related particularly to the kinds of things that the Food and Drug Administration was concerned with?
AS: No. First of all, my research career has not been one of the more exciting aspects of my life. When I first started out in cardiology, I was doing some research, but I fell into the category of faculty that, because of interest and because I could write and because I was a little bit of a showman, I think, I was given a lot of teaching to do. I also was the principal, clinical cardiologist. The research I did was largely in the cath lab and with pulmonary physiology and the interaction between pulmonary and cardiovascular physiology. But the research was not a major part of my career. After Hans Hecht left Utah, I very quickly became an administrator, as you said earlier, by having to fund myself and others. I wrote a good part of the RMP grant, which is a very large grant.
And then I was one of the people working with the people in Washington, even when I was back at Utah, to formulate a program that became known as cardiovascular research and training centers. There were three or four of us, people around the country, who talked the Heart Institute into starting this new program. And then, of course, I wrote a grant for that. And it was funded, so I became director of the Cardiovascular Research and Training Center at Utah. It was very heavily an administrative job, and actually led to my being appointed as a dean in charge of planning of the Utah Medical School.
So, I was into planning, administration, and management very early in my career, much to Max Wintrobe's dismay. He used to call me in and chew me out and say I would never amount to anything because I was spending too much of my time doing things that wouldn't advance my career. And I'd say, "But Dr. Wintrobe, you asked me to do those things." And he would say, "Well, that's because you're so good at it." And I'd say, "Well, quit asking me." And he'd say, "Well, I can't." And I'd say, "Well, then quit chewing me out." And he'd say, "I can't." It really was one of the reasons that I left, in a sense, to go to RMP, because I was better at making arrangements of things. I liked to look at a problem and arrange people, events, dollars, and space or whatever it is, so that the goal could be accomplished. In RMP it was arranging the country, getting the country organized to do things with the advances of medicine.
JY: So that your reputation for these things, you think, is obviously an important factor in your choice to do that kind of thing at FDA?
AS: Well, yes. I was not thought of because I was a superb scientist. That would be clear to me and, I think, everybody else. I think I have a pretty good feeling for science and what it is and what is necessary to science, and I've actually done some writing on that. I think I've done enough investigation to have a feel for it. Yet, if I was known for anything, it was being a manager, not being a scientist. I was known for being a teacher and not a scientist. I was known for someone who could write well and speak reasonably well in public, but not as a scientist.
[Interview with Alexander M. Schmidt: Part 1 | Part 2 | Part 3 | Part 4]
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