FDA Oral History Program

Interview with Alexander M. Schmidt
Commissioner of Food and Drugs (1973 - 1976)
(Part 4)

Interview Topics:

Clark Clifford
Art Buchwald
Gerry Ford, relations
with HHS officials
Dr. Edwards
Antibiotic residue
in animal feed
Clinical investigator integrity,
Searle investigation,
Walter Sheriday
Swine flu, Jack Walden,
Department and OMB
interference with FDA
Disappointments
FDA staff
More on swine flu
Tripartite staff meetings
International meetings

JY: Moving right along and shifting gears here, in a speech that you made at Tulane in 1975, where you looked ahead to 1985, the current year . . .

JY: I've got a copy with me, would you like to have a copy? I'd like to keep it.

JY: Okay. You seemed to be countering threats that the Food and Drug Administration was going to be splintered, that was your word, broken up. What did you have in mind? It was rather vague in the speech. Do you remember what you had in mind about the threats?

AS: I remember that speech and I think that was because I was not as mature as commissioner as I was when I left the agency. You have to remember that that was against the backdrop of the Kennedy hearings. And what was going on at that time made me feel a little less secure than I would in the same circumstance today, knowing what I now know. But at the time, some people were talking about the agency being restructured because of its lack of effectiveness and it had "sold out to industry," and all that crap was floating around. And there were some people who were saying, "Well, maybe the agency has too much to do and it should be broken up." And the other thing is that the Department of Agriculture has always been after the food part of FDA. And so there were some people in agriculture, who were taking advantage of the attacks being made on FDA at that time to say, "Well, give us . . ." and so on.

And what I was doing was sort of saying to people that FDA wasn't about to be broken up; "Knock it off" sort of thing.

AS: But the friends of FDA were concerned. You know, a lot of people who don't track this, even as closely as I do now, were concerned for FDA and would say to me, "I read someplace that FDA is going to be broken up." So, I was just answering that question.

JY: Fending that off. It wasn't nearly the real problem, I think, at your period as it had been some years before.

AS: Well, what you hear now is whether all food shouldn't come to FDA. One of the features of the reorganization of FDA into centers is that--and the clever aspect, I suppose of a center for food safety--is that people would say, "Well, gee, we have a center. We ought to group things together with that." So, the way things are going now, I think if a switch were made, it would be a switch from agriculture to FDA. Some of the reasons are just as stupid as going the other way, and that is that agriculture has "sold out to industry" or that the department isn't being kind to farmers nowadays and let's punish them and that sort of thing.

JY: Right. Nutrition policy has been one of those amorphous things spread around, about which there's been a lot of debate. Where should it mainly be centered?

AS: Right. Yes. That's another dumb issue. My response to anything like that is, quit arguing about it and do it and then it'll be done. Quit arguing about patient package inserts; just do a couple. Quit arguing about the drug compendium; do it. Quit arguing about . . . you know, do it. It's more fun, less work, and easier all the way around to argue than it is to do something. And I see that every day here in the university. People would much rather stand in the halls and gossip than get to work.

JY: Yes. The people in a bureau aren't much different from faculty members on a campus in ways like that, I imagine.

But one other thing that I noticed in going through the annual reports for your years as commissioner, might be grouped under the heading, "Danger in the Products that the Agency Regulated." There were issues that came up, some of which we mentioned in connection with the artificial sweeteners: saccharin is still a problem; aspertame was approved in July 1974 with some debate still; there was a crisis over mushrooms; there was a minor crisis involving a couple of antibiotics; DES as a residue in meat kept being mentioned; there was the ozone crisis; food additives continued occasionally to be attacked. (One instance involved the alleged impact on hyperactive children.) So here is a kind of conglomeration of things. Probably during any period you could go and look and find these sorts of things. Do you want to say anything about this matter of dangers coming along day by day, now here now there?

AS: I think if you plotted it on a piece of paper, you'd start it at the left-hand end with cranberries, at least in the modern era, and get a big blip with cyclamate, but what you'd find is a concentration in that period that I was there. I picture the world forming with a kind of a fog first and gradually getting denser and denser and then suddenly you've got a planet, or over a few billion years you've got a planet. I could see on the television screen a kind of a fog of issues sort of coalescing and becoming more concrete during that period, where you had a sharper definition of what you were talking about, and how you handled it and so on. And that was a product of a number of things coming together. One was science and technology, which really were being applied at that period. Another was that the agency itself was better prepared to engage the issues and discuss them. The products of a lot of consumer activism were becoming apparent. Nader and Sidney Wolf were at the height of their powers. They've been on the downhill side the last eight to ten years. All of those things came together.

I think, that while we still have issues coming along, I think, probably, the number and intensity of discussions during that period was greater than it's been since or greater than it will be. People learned by that, and that was an early formative period in the issues. You know, it was learned that some friends could turn against you. I could add to that list, one biggie was the Dalkon Shield. Another one was the oral contraceptive.

I used to laugh and joke, in a sense, about the Friday afternoon crisis because what would happen in the rhythm of the agency is that inspectors would go out Monday and Tuesday, and analyze Wednesday, and discover a problem Thursday, and boot it up to headquarters on Friday. Then they'd go home for the weekend and we would have this dead cat that came in over the wire sitting in front of us. The agency would look at it Friday morning, and it would arrive in my office Friday afternoon at 2:00--and there went the weekend. That was true for mushrooms and it was true for all sorts of things.

AS: Well, yes. First of all, we developed a system for getting Friday night dinners brought in.

We also developed a number of other things. This was a period where we established the Science Advisory Board. It gets back to this common thread that runs through this discussion, and that is the application of science to FDA issues. The advisory committees were one approach; Peter and I and others, Dick Merrill when he came, spent a lot of time discussing the basic concept of the science court. And what the Science Advisory Board was, was our version of the science court. We established that, and my intent was to use it for the several purposes of sharpening issues, defining issues, educating people about issues in a neutral forum with the world's best people, and then providing advices to the interpretation of science that could allow the regulators to answer that last question I mentioned yesterday, which is "What do you do about it?"

JY: Does the concept of a science court have precedents in history? Or was this a kind of creation that you yourselves were forming?

AS: Well, the concept has been around for some time. I haven't done the research to know where the concept of a science court came from. The science court is to be found more in literature than in real life. However, I think there are real-life precedents and one of them is to be found in the World Court. Scientific issues are decided by the World Court. It will set up panelists to decide scientific issues and scientific disputes, largely among industries.

For instance, I was once asked by the World Court to be one of the judges in a dispute between two pharmaceutical houses on a matter of the application of science. And that comes close to being one version of a science court.

JY: But you thought of this as a useful internal mechanism for all these things that were coming from every direction.

AS: Yes. It's only been used twice by the agency, and I think if I'd stayed with the agency, it would have been used a lot and refined and made useful. As it is, it's still not thought of by a lot of people as being all that important and useful, in part because both times it's been used there have been some problems with it.

AS: Well, most recently it was used for aspartame. I was going to use it for aspartame, and it finally got used for aspartame. The court's verdict was overturned by the commissioner, I think properly so. But that didn't help it exactly.

It was used for aspartame and it was used for something else that escapes me at the moment, but I'll think of it.

JY: Right. In connection with these crisis issues that came on Friday afternoon, I thought of a question that Fred Lofsvold wanted us to ask, and that had to do with your interface with the press. Did you do things in connection with the agency in relationship to its general approach toward structure and attitude toward the press, point one? Second point, your own relationship with members of the press. You mentioned you knew Mintz and so on. Did you often go on television or hold key interviews in connection with some of these crises or more fundamental things?

AS: Well, it's a sad truism that the best preparation for being commissioner of food and drugs is to be commissioner of food and drugs. I think when I left the agency, I was much better prepared for the job than I was when I arrived. Were I to do it again, as I said recently in a speech, a thought far more disturbing to me than anybody else, I would try to do a much better job with the press than I did my first couple of years. Coming out of the academy, I viewed dealing with the press not as important as managing the agency, and straightening out the administration, and doing the other things we've been talking about that I felt were important. I know now that dealing with the press was far more important than I thought early on in my administration. Jack Walden, who is first rate, did look after me in that aspect relatively well. I think I was more reluctant to do some of the things he was suggesting than I should have been.

I did go on the offensive after the Kennedy hearings to defend the agency, and that included things like being on Face the Nation, and the Today Show, but I didn't do enough of it. Today I would do more of it. It is a bully pulpit and I didn't use it enough.

I said earlier that I like people and I am generally fascinated by people and like to get to know them, and I did that. I did several things. One is, I went down to the Washington Post and met the editor and publisher and the editorial writers. I got so I could call up Colman McCarthy or other people. I got to know Colman. I went down and sat with Morton Mintz one day and discovered what made him tick. You know, you have somebody like Morton Mintz, there's a reason that he's like he is. I wanted to discover what that reason was. He turns out to be a very open and honest guy who had a family tragedy that one of his own kids had involving drugs. That led him to become interested in and finally outraged by what went on in the drug area. Once I understood that and once he understood me, we got along fine. In a sense, he treated me better because he understood who I was and what I was trying to do. He ended up being one of my questioners on Face the Nation once, for example.

I got to know Lesley Stahl reasonably well and enjoyed knowing her. FDA was such an easy target and there were so many issues--you just enumerated some of them, and there were many more. We were just grist for everybody's mill, and grind they did. Again, there was nothing really personal in it. I was attacked personally only by a few people, and only by one that really was offending me; and she didn't understand me or what I was saying and misinterpreted it.

AS: She gave me a bad, really a lousy interview someplace. That was a woman who wrote for the Washington Post, and I'm even blocking her name right now. I felt badly about that because, in a way, I gave a bad interview and she misinterpreted it. That was just generally a bad scene.

By and large, I would give myself a C or a C+ on what I did and how I did it. I think I could do much better now.

JY: Here's a chapter in what every young commissioner ought to know. A book that, in retrospect, you might write. Are there other chapters?

AS: Well, the problem with that job is that unless you are an old Washington hand, you go into it quite naive and you don't know things you should know. My maturing took a huge step a few weeks after that first Kennedy hearing. I didn't know what in the hell was going on or what in the hell was happening to me. And somebody, whose name I won't mention, said, "Let me do you a favor. I want you to spend some time with Clark Clifford." So, this individual called up Clark, and I don't know to this day whether Clark was paid for this or not--I kind of think he was not--but I got a call from this person who said, "Call Clark Clifford. He's expecting a call from you." So I called Clark Clifford and we made an appointment in Clark's office at 2:00 in the afternoon or something like that.

So I went down and, you know, he had this lovely office. Clark Clifford is a lovely man and a very imposing person. I went in the office and introduced myself, and we chatted, and he said, "Well, tell me. I understand you're having a little difficulty. Tell me about it." So, Clark is an awfully good listener; I got wound up and I delivered myself finally. I started out just saying, "Well . . . " and so on, but I really got into it and ended up talking about twenty minutes. And I noticed as I was really getting wound up, he was . . . A little smile was playing around the corners of his mouth, and finally he just couldn't contain himself. He started to laugh. And he laughed and laughed. And he said, "Oh, you are really marvelous. My, what you have to learn." And we ended up spending hours together that day.

Then, subsequently, at other times I would consult with him because he was a master at the Washington scene, and what the meaning of things were, and how you should respond, and what you should do. And I didn't know a lot of that when I went to FDA.

AS: Yes, I think Clark Clifford sort of glued me back together, in a sense, after that onslaught of the Kennedy hearing. And I really didn't know. I was confused. I didn't know what was going on. And he told me what was going on.

I think of three people who really helped me quite a bit. This'll sound funny, but one of them was Clark Clifford and the other was his Republican counterpart who was another lawyer who worked for Eisenhower and was always, you know, on the "in" in the Republican administration. And Clark Clifford was more on the "in" in the Democratic administration, although they were both important no matter what happened in Washington. I'm blocking the name of the Republican lawyer. He's sort of the Republican Clark Clifford and I just can't think of his name right now. And the third person was Art Buchwald, because Art understood Washington just as well as the other two, but had this marvelous ability of saying things in a funny way and in an amusing way, but yet struck right to the heart of it. I used all three of these individuals. I'd pick up the phone and call them and ask them what the hell was going on, or what this meant, or what I should do, or would this be wise to do. And I learned from those people.

Cap Weinberger, obviously, was somebody else who knew the Washington scene, but was a little less useful in the sense of explaining things to me. Cap knew, but he wasn't quite as good a teacher as Clark Clifford.

Of course, one of the characteristics of my tenure was that every time I turned around, somebody would be gone. Just stop and think about it for a minute. I was there for three and a half plus years. And I worked for two secretaries and three under-secretaries and, I think, three assistant secretaries, two presidents and three vice presidents. It is true that, of the people at the cabinet level or agency level or White House level, only Arthur Burns and I were left of the entire administration, at the time I left. I was once with him at a party, and we compared notes. You know, the president, the vice president, all cabinet officers had turned over at least once during that three and a half years, so that, in a sense, it was kind of hard to cultivate people.

Consider the minority leader in the House. When I went there, I called on him. He was important to the medical device legislation; he was important to my working in the House, particularly since it was a Republican administration. And I got to know him and we started to work together. He was very concerned about one of his kids who was going to Logan, Utah, and I knew about Utah State. And then I turn around and he's gone. And that's Gerry Ford; he's vice president. Well, that's kind of slick. But, nevertheless, he was gone. Then suddenly he's president. That element made it difficult.

In a way, it was not a stable environment for learning what I should have learned, because the teachers kept going away, and the scene kept changing.

JY: And your set lines of communication that you'd established had to be done all over again. Did you automatically talk to the secretary every so often and personally bring before him the major concerns?

AS: Yes. I came into contact with the secretary at regular staff meetings. You see the assistant secretaries were Charlie Edwards and then Ted Cooper. They were both friends of mine. They both trusted me. Both of them felt that if there was something important coming out of FDA that the secretary should hear . . . I had free and direct access to the secretary. Then you have to know who the secretaries are, because Cap and I became reasonably friendly. He was kind enough to take my wife and me and my kids with him to Camp David and stuff like that. We became friends. I understood Cap and what he wanted and gave it to him, and he developed a trust in me. No matter where he was or what he was doing, if I called, he'd immediately come to the phone. I never wasted his time, and he appreciated that.

Then the next secretary was David Matthews, whom I had known. He was president of the University of Alabama and was an academic. I mean, he was really academic. To tell you the truth, the longest conversation I had with him was one time we spent hours talking about Greek poetry, about which he knew a tremendous amount. He knew nothing about FDA or FDA matters and didn't really want to be bothered. So I kept him informed of things that were going to be in the newspapers and be big issues. By then, Ted Cooper was assistant secretary, and Ted and I were good friends. And Ted understood about FDA because he had worked with FDA for years, from the Heart Institute, and so on, on the medical device legislation. And he was instrumental in getting that. And he trusted me and left me alone.

But the subject we are discussing is sort of the greening of Schmidt, and where I could have done better. And I think that I could have done . . . If I did it again, I'd make the same mistakes, if they were mistakes. Because what the agency needed was attention to its internal matters. As I said before, Charlie had really shaken the place up and it needed settling down, and I'm a good settler-downer. I'm less good than Charlie at massaging Congressmen and pressing the flesh and scanning cocktail parties for the right person to talk to. I'm not too good at that right now. I will go to a banquet like last night. Charlie Edwards, if he went to the banquet last night, would be talking to me but scanning the room for somebody he needed to see or ought to see or should see.

What I liked to do was find somebody fascinating, go over in the corner and spend the evening getting to know them. That doesn't help you a hell of a lot to survive as a commissioner of FDA. It's interesting that I have left, though, with good and deep and friendships for instance--with Morton Mintz. Believe it or not, I've had to do with some serious things with Morton Mintz just in the last few weeks. Also there are other people in Washington who are deep and good friends.

JY: I get the impression you feel a very loyal and dedicated alumnus, that you feel you're still serving the agency in a whole host of ways. Not necessarily because it's the agency, as such, but because of the commitment to the kinds of problems in society that it was and is involved in.

AS: Yes. I think that's right. Once an FDAer, always an FDAer. I think Charlie feels that way, but he's in California. But, as you pointed out, he did make a speech just a week or two ago. That's certainly true of Peter Hutt, who is extremely active--in part, because that's also his vocation.

JY: All kinds of historical, but also present interpretive articles come out in that journal which I get of the Food and Drug Law Institute that must be helpful to the agency. Although sometimes what it is is an ongoing debate.

JY: Right. Well, I'm just kind of checking. We've alluded to the antibiotic residue in animal feeds and the implications for human health. That was one of the dangers. Is there any more about that particular thing which continues that you feel you'd like to say something about?

AS: Well, that's a difficult issue. It's a classic example of what I was talking about before: where there's science, which takes you so far, but then there are a couple of other questions that aren't science. Science right now has not provided any great help in answering the questions about antibiotic resistance. What seems to be true is that England banned the use in animal feed of antibiotics that were useful in human therapy, but that hasn't lessened their incidence of resistance in bacteria. And the use in this country hasn't seemed to increase it. What there is, is a theoretical possibility that has not been proved yet. Whether that's good enough for the agency to act on, I don't know.

To tell you the truth, if I were commissioner right now, I don't know where I'd come down on that. At the time, we were proceeding to get rid of them.

AS: And I can't tell you how sophisticated I was at that time in terms of this sort of issue. But we were told by Congress to get more data, and that's been the consistent response of Congress to the agency. That's not all bad; that's not stupid to say, "Here's an important issue and it ought to be studied." I think what we've learned is that studying it is harder than most people thought. The answer to it is going to be like the answer to the non-nutritive sweeteners, and that is to find alternatives that will be better. The sweetener issue is going to be resolved by a lot of sweeteners coming along eventually, although more slowly than I would have thought. I think the ultimate answer to the antibiotics in animal feed will be molecular biology and genetic engineering--or else some other kind of growth promoter, whether it's growth hormone or a variant of that. Something will come along.

JY: One other particular area that I had written down. There was a good deal of pressure through your term for improving both the good manufacturing procedures and the good laboratory procedures. Involved in that were problems of the integrity of clinical investigators. Any personal involvement in that that might be on the record?

AS: Well, this grew out of the agency's own work. We had a unit that was looking at the integrity of the data and the studies that we were using. This was in Frances Kelsey's shop. They turned up some stuff that didn't look right that had to do with studies that had been reported by Searle. Once we discovered that, then we launched a thorough going investigation of Searle, and, like a lot of things, it led to Searle's contract labs and then, finally, to a broader survey. And the agency would have gone ahead and we would have done what we did in any case. It wouldn't have become such a well-known matter had it not been for the fact that for most of the time I was there and sometime before I was there, Ted Kennedy had in the agency a full-time investigator.

AS: He assigned him to the agency. His name was Walter Sheridan. He was a former, if my memory serves me right . . . He had been with the FBI. He had been an employee of Bobby Kennedy's. Bobby Kennedy had used him to nail Jimmy Hoffa. Walter Sheridan was one of those people intensely loyal to the Kennedy family and the Kennedys, and when Bobby was killed, Ted picked him up. He was a first-rate investigator, and Ted assigned him to the FDA. He was full time in the FDA. He walked the halls of FDA and he talked to people, and he had full congressional authority to pick up any piece of paper. There was nothing that could be kept from Walter Sheridan, and he was an investigator. He knew more than I knew what was going on in the agency, without any question. Because that was what his job was.

So he picked this up, and we had a set of hearings on the integrity of the investigative process that led to, finally, recommendations from us to the Justice Department to prosecute certain individuals in Searle. That led, eventually, to a massive shake-up in Searle. Particularly when management of Searle changed and Don Rumsfeld went in: he cleaned house at Searle. It resulted in the prosecution and conviction of people in some contract labs. And it resulted in the establishment of the good laboratory practice regulations and a work force to police universities and contract labs and pharmaceutical houses, in the conduct of their animal and clinical experimentation. The need for this program was discovered and it was established while I was there.

I remember one hearing, Kennedy asked me how much it would take to police the effort. As I remember, I said $16.5 million, which is what we'd calculated for staff and so on, and he said, "You got it." Within about two weeks we had $16.5 million and set that program up.

You know, if you read the hearings, I made some statements that are still sort of reverberating around. The most recent I've seen my statements quoted was in Common Cause Magazine. They did a very large piece on aspartame, within the last month or two or three, calling for the removal of aspartame and investigation and so on. The lady that wrote that article went back to those hearings, the Kennedy hearings of Searle, and was using some of my statements about sloppy research and all that kind of stuff. Sort of taking some of it out of context, and since Searle was also involved in aspartame, saying at that time their research was . . . and so on. It's still bouncing around though.

JY: But this was still a major trouble-shooting job that you had to confront.

AS: No question about it. But again, I think the agency did very well with it.

You know, some other things had come along that are major that the agency handled well; one was Walter Sheridan and Kennedy's turning it into another circus.

AS: Another bit of theatre, as you'll read in the paper. Did you pick up the paper?

AS: Do me a favor, as long as I'm spending all this time. Read my paper on hearings, and then drop me a note and tell me what you think of it.

JY: There are kind of close-out questions. Let me mention all of them and we can take them up in what seems to be the right order. We talked about the circumstances that surrounded your going into the commissionership. I'd like to know the circumstances about your leaving it and coming back here. Fred wanted us to ask what were your most important accomplishments and what were your biggest disappointments. And maybe we can deduce that, but it might be interesting just to have a first blush response to the question. Is there anything you want to put on the record that we haven't touched on? And particularly judgments of people and policy that we might have a special section on if you want to be really frank and candid and perhaps block the record for some time. You've been very outgoing, I think. But I don't think there's very much that you said that you'd want to block. And then what is the outlook, as you see it, for the future of FDA? There are elements of all of these that are inherent in what you've said, and I think this has been an excellent interview.

BP: Could I just add here if, in case, you do wish to say some things that you want to block. The way we handle that is that I personally type it up. And there are only two copies made. One goes to you and one's put in a sealed envelope to the National Library of Medicine with the date for opening. That's our practice.

JY: Jim Goddard. I did a lot of interviews right after he got out of the office, and he sealed the whole thing--because it was sort of hard to detach, where he felt he was extra candid from the rest of it--for fifteen years, I think. And next Thursday it comes to open up.

AS: No, I don't . . . I don't think there's anything in me that I would say about anybody . . . If there's anything in me that I would have to say about somebody that would have to be sealed, it would have been something I would have said to them, because it would be so important.

The whole business of FDA. When I was thinking about going to Washington, I talked to a number of people. And somebody said, "If you're going to do that, be sure you go on leave from your university." Now, I was dean of a medical school, and I was perfectly happy, and this came out of the blue. I wasn't seeking a job in Washington. And I don't think there was anybody more surprised than I, that I was called into the White House and asked if I would be interested in taking a look at FDA.

I can't remember who suggested it, but I did ask the university for a leave of absence. Now, you get leaves from a university for a year. This was not a sabbatical. This was a leave without pay, and that's usually for a year. On occasion it gets extended for two years. But that's it.

I went to Washington. I was talking not too long after I had been there to Henry Kissinger, and we were joking about something. He was in hot water for something at the moment. And he said, "Well, I can always go back to school." Then he said to me, "Are you on leave?" And I said, "Yes." And he said, "Don't ever let that go, because someday you'll need it." And as it worked out, this university was kinder to me than Harvard was to Henry, because it finally ended up that he couldn't go back.

So, my intent was to be there during that four years and then come back to the university. All along that was my intent. So, as the time wound down, I spent August in Montana, my place in Montana. I often would stop here in Chicago to see my friends or my wife's parents or whatnot. My wife's parents live in River Forest. So we were here once a year, or I was here for a speech or something and would talk to the people at the university. They said, "When are you coming back?" And I said, "Well, I hope the Board of Trustees will extend my leave so I can finish out, and then I'll come back." So, I'm very grateful to the university's Board of Trustees that extended my leave of absence so that I could come back.

But my plan always was to come back. Then in August of 1976 with the election in November, I came back and talked seriously with Joe Begando, who was sitting in this office at the time. And I said, "Are you going to have something for me to do? Is there some way I can be useful to the university?" And he said, "Absolutely yes, we want you to do this and come back." And I said, "Fine, I'm coming." So, then I went back and I hadn't talked to anybody about this. And I wondered, "Well, now what am I going to do because I'm going to leave, and how do I leave gracefully and stay friends with everybody." One thing I've observed about institutions is that, by and large, when people leave an institution, the institution stops liking them for some reason or other. It's hard to leave gracefully.

I don't even remember what happened. I think it was announced by the university here a little prematurely. I don't remember how it got out. But I remember a lot of people said, "Boy, you're really stupid, you know, because you could stay and you should stay. The agency needs continuity, and you know Gerry Ford and he's going to get re-elected." Remember that Gerry Ford did not have a full term, and a lot of people felt that he should have a full term, and he had the advantage of the incumbency and so on and so on. And they said, "You know, you should at least wait and find out how the election is going to turn out and then quit." But my plan always had been and was to come back to the university. Also, I said to my wife early on that Jimmy Carter was a populist, and this was a good time for populists to run and I thought he would probably win. Well, as it turned out, as I was leaving Washington everybody said to me, "How come you were so smart?" But that was just simply my plan and what I intended to do.

My father was puzzled, because he thought I should take any number of offers that were being made to me by industry. He felt I could have a secure financial future if I took one of a number of fairly attractive offers from industry. I tried to explain to him that I belonged in a university, and that was my life, and I was going to go back to it.

AS: Well, I said yesterday, when we first started to talk, that I always seemed to be moving to Chicago at Thanksgiving.

JY: Thanksgiving. So that the election had taken place, but you had set up ahead of time and predicted exactly when you'd go . . .

AS: Oh yes. It was knowing that I was coming back to the University of Illinois in September, I think September.

JY: So that, rather through it all, you kept thinking of yourself as an academic . . .

JY: And you thought of this as a deviation from your main thing for your own interest and the public service?

AS: Well, no. First of all, I don't like your word "deviation." If you study that word a little bit, it's not quite right.

AS: I've never been devious or deviant. You see, you have to go back to my Markle business. Markle scholars were people who became deans and administrators, department heads, division heads. They were people who ended up interested in the broader picture than just strictly the research laboratory. Some people would head toward a Nobel prize, others might head down the Markle scholar path, but they weren't the same path.

A Markle scholar named Bill Mayer, whose path and mine, in a way, have been similar, and several others felt that it was important for people in the academy to be familiar with Washington and how it worked in Washington agencies, and that the experience of being in Washington was extremely valuable.

Now, you see, I mentioned Bob Marston who'd been dean in Mississippi and went to Washington then back to Florida, the University of Florida. Bill Mayer was at RMP and went back to the University of Missouri. I was at Utah and went into RMP and came back to Illinois. John Gronville was with us in Washington and came back to be dean of the Michigan Medical School. I could go on and on and on and give you Markle scholars, which is really a club of people who were deans of medical schools and went to Washington and then back to the academy. I viewed leaving the university and going to FDA as not a deviation at all, but something that was good to do. It was good for me; it was good for the university. One hoped it would be good for the government and FDA, as an example of an exchange between the academy and government. Henry Kissinger, John Kennedy's use of people from Harvard; the exchange of individuals . . .

And then, one thing we've done here is bring government people to the university for six months or one or two years and then back to government. And the Markle Foundation . . . Bill Mayer and I and a couple of others tried to get the Markle Foundation to do something like the White House fellows program. So that I viewed this as a natural progression of my career.

AS: Sure. Now I'm involved a little bit in industry. What I get to do is a lot of fun. And that is I get to view my world of interests from the vantage point of the academy, from government, and a little bit from industry, so I get a broader perspective, and that's of value to me.

JY: Of course. There wasn't anything of boredom bringing you back; you were still as interested day-by-day in the kinds of challenges FDA had?

AS: Sure. I could have been happy staying at FDA. When I've seen some of the things that happened, in a sense, I regretted leaving because, by God, I wouldn't have allowed some of the things that have happened to happen. Chances are that I would have gotten fired, maybe, but . . .

AS: Well, I told the story yesterday of fending off the department . . . FDA matters sometimes are sexy and are attractive to politicians. You can see that in hearings and the people lined up to hold hearings on FDA matters. Certainly people in the secretary's office would salivate over the press coverage FDA got.

Starting with Schweiker--well, starting before that. I got along beautifully with Cap Weinberger and with David Matthews as secretaries. When the secretary's press officers would lean on Jack Walden, I would call up the secretary and say, "Call those idiots off." And he would.

Which reminds me of another thing we haven't mentioned that took place while I was there, and that was the whole swine flu business.

AS: Which was another fascinating episode. Now, there's something I might lock up. The reason that popped into my mind was because that was one time when the department wanted to move in on Jack Walden on swine flu; he saw that as something getting a lot of press coverage, and I was smart enough to tell him to give it away, because I was very uneasy about the whole swine flu business, and, frankly, didn't want any part of it. FDA came out unscathed, you'll notice, on the swine flu thing, and that was because I distanced the agency from it, because I just didn't like the smell of it from the start.

But starting with Kennedy and Califano, Don Kennedy and Califano did not have the relationship that I had with Cap Weinberger and David Matthews. That was the point I started on. There were no difficulties with the secretary's office when I was there. With Charlie Edwards, who had been at the agency; and Ted Cooper, who knew all about it (and we were good friends, the three of us); and Cap and David Matthews. It literally was sweet and light. If an idiot downtown started to do something with the agency, I'd say something rude or call the secretary or Charlie. Charlie wouldn't brook any interference with me or FDA.

But with Califano, he started to speak for FDA. And Schweiker started to pull back the authorities. And under Schweiker, there began to be stripped away from the commissioner the delegations that allowed him to run the agency. That has accelerated and has been increased with Heckler and now with OMB, to the point now where the commissioner can't run the agency. I think that that's bad for the American people; I think it's bad for the agency; I think it's bad government, because, as Charlie said (we pointed out yesterday), you get it up there and it gets politicized. And I said that in talks, including a number I've given just on this subject.

I think that the agency should be established as an independent agency by law, with the commissioner approved by Senate confirmation. I think the commissioner ought to be protected from politics to the extent of that kind of appointment. I think the agency ought to be left in HHS, but be independently chartered by legislation. And I think that the delegation thereby, then, of the authority to the commissioner would be by law, and that would solve an awful lot of problems.

Now I tried to do that, by the way. We had the bill all prepared. We'd got to the point where the administration was going to support it, when all my friends were there. Then I forget what happened, but the thing fell apart, and we couldn't get it through.

JY: Since there's been slippage, do you think the outlook for that kind of an FDA in the future is very good? Can the agency win back the sort of independence that you think . . .

AS: Well, the way things are going now, if my predictions are true (that is, that Frank Young goes up and leaves the agency), or if people start bailing out and the agency gets into trouble, then you'll be back to the cycle of, well, maybe it should be broken up, or all that stuff.

What I would do, at that point, is get on the horn and call all of the former commissioners and gather a group together to try to do just what I'm talking about. And that might be an opportunity to do it.

AS: Well, maybe I can get Reagan to do me a favor as he leaves and set the agency up or do something. But, I mean, Margaret Heckler is not the right person to be making these judgments.

JY: Yes, time marches on. Do you think that, inherent in the kind of emphasis that you gave as we've talked about these things, we've got enough about the answer to Fred's question, what you would deem your most important contributions and your biggest disappointments?

AS: Well, my biggest disappointment, I suppose, would be the time I wasted with the commissioner's investigation and the commissioner's report, and just a set of really wasteful hearings--some of them downright dishonest. I tried--in the speech you have there on hearings where I described hearings as theatre--I was being sort of nice in calling them theatre. Some of them were just offensive, because they were intellectually dishonest, and they were set-ups, and they were intellectually sleazy. I just resented and was offended by having to spend my time with that sort of garbage. You can say, "Well, that's show biz," or you can say, "That's politics," or you can say, "That's Larry Horowitz." You can say whatever you want, but the net result was that the agency, to a degree, took a beating; I took a beating.

You know, if I go down as the commissioner that was there during the Kennedy hearings, that'll be too bad, because what that will mean is that the very real accomplishments of the agency are obscured by a heap of garbage. And I'll come back and haunt Ted Kennedy, or I'll do something to gain my just historical desserts.

But, I think the record will show, and I think the things that you have talked about will show, that a tremendous amount was accomplished during that time.

JY: Particularly effectuating some of the changes that Dr. Edwards adumbrated, or initially pointed to.

AS: Yes. I just . . . You know, I pay immense amount of credit to the individuals that I've been talking about and some that I haven't mentioned. I was really privileged and honored to be able to come into an agency at that particular point and work with the people who were there and the things that had been initiated.

I think that, of the things that I enjoyed most--I think the Policy Board would be one thing I point to that I'll take great pleasure in, because it was a success. It was effective, and it's continued. It's not been as effective since Young is there, because his style, apparently, is a little more like Charlie's. Charlie would not have used the Policy Board, or he didn't set it up. He wouldn't have conceived of it, because that isn't the way he operated. Once I set it up and it worked, though, I knew it would keep going, because the Policy Board wouldn't let it stop. And, indeed, that's the way it's been.

AS: Well, I mentioned people generally through the agency. I think that John Jennings was an old pro and was very helpful and was a good teacher. Mark Novitch . . . An interesting story that only he and I know is that he really got tired of being under John Jennings and chafed in his position. He and I talked and I urged him to be patient; but he was impatient, and he left the agency. I told him when he left that he was making a mistake and he shouldn't do that, but if that's what he wanted to do, I'd help him. I also told him he could come back.

Well, as it turned out, I was right, and he did make a mistake; but he, in a sense, was embarrassed and didn't want to come back. I waited until I figured it was about time that he was maybe wishing to be back in the agency. We got together and I brought him back in the agency, which was good for both Mark and the agency because, obviously, he's been one of the most important people in the agency in the last few years.

JY: Yes. And if there's turmoil now, his being gone will be one of the tough things.

AS: I made a few good appointments. One of them was Kay Hamric, my administrative secretary, who was one of the more effective employees of the government, I think.

I was responsible for the appointment of the first woman director of an NIH institute. The director was looking for a director for the National Institute of General Medical Sciences. I suggested Ruth Kirschstein, whom I had appointed as an associate commissioner for science.

I steered her over to NIH, thereby losing a valuable person, but helping her become the first woman institute director. I'm pleased with some people things.

I'm pleased that people were happy and had fun while I was there. I'm pleased that people looked forward to the meetings, because they were never quite sure what would happen or how I'd behave or what I'd say. We had a good time together and we became good friends.

AS: Jake Barkdoll, a marvelous person. You know, I was told that FDA was one of the two best-run agencies in federal government when I was there, and I think it's true. The morale was good in spite of the Kennedy hearings. Jake Barkdoll and that planning staff was excellent. Jerry Meyer was a superb administrator and so on. There were just a lot of good people for whom I feel--and always will--a great deal of affection. It's funny that people refer to my time there now to me frequently. Maybe they are just doing it to make me feel good, but they're calling it "the good old days."

When you were there, I don't think a lot of people would have said this is going to be a time when it was "the good old days." But it was "the good old days," because after I left, the proud, old agency, the independent, fiercely independent, proud agency began to change away from that. And it is not that now. Ask Taylor Quinn. You can't do anything without OMB's permission right now, and the agency is going to get in trouble because of that. Margaret Heckler should get in trouble; but the agency will get in trouble.

People think back then to some of the meetings where we were . . . I made that Policy Board sit and go over Peter Hutt's re-write of the regulations, so that they would know them and understand them and understand what they meant; understand what they would then have to do in their bureaus. People think back to that now and think that was great fun.

JY: Two names. Does a second chance bring to mind the Republican counterpart of Clifford? And there was the girl from the Washington Post and the unfortunate interview.

AS: I think it was Judy Randall, but I'm not sure. Judy Randall's name springs to mind. The Republican lawyer was Bryce Harlow.

BP: There's time on the tape to make some kind of a closing statement if you desire.

AS: I hope to continue to be involved in FDA things, and kind of be helpful where I can, but try to work when I can, to restore some of the authorities to the commissioner. I'm really concerned the way things are going with the agency right now.

I guess you could say, "Well, you're concerned because there's been change," and so on, but I'm not the only one that's concerned. Everybody I've talked to has been concerned, and that's not been the case before.

We mentioned the swine flu thing, and I'll just say that, because I knew Gerry Ford and talked to him, I'll say that was a fascinating business; because the president of the United States was had. I saw it happen. I know exactly what happened and why it happened. I knew it was happening at the time, or I had a sense it was. There was nothing you could do about it. Here you're sitting watching a nation be had, essentially, by a couple of people and a set of circumstances. And it was a fascinating business.

JY: You think that's as far as you want to go on the people? Or even the circumstances. Was it political, economic?

AS: No. Having said what I said, I should explain it. I think there was an error in judgment on the part of Dave Sensor, who was running CDC at the time. Whether Dave truly believed in his heart-of-hearts what he was saying, or intellectually believed it, or thought it was good or just what, I don't know, and Dave may not know either. Dave pushed hard the idea that there was the possibility of a pandemic of this flu in the United States, and knowing that, the president or the nation could not not do something.

Well, FDA obviously got involved very, very quickly, because we controlled the vaccine. And the question was, do you vaccinate everybody in the country, or do you immunize everybody in the country? You know, where does the vaccine come from? Who makes it? It's a rush job, and all that. So FDA--bang!--was right in the middle of this.

Jack Walden sensed that it was going to be a big story and could have the agency look good. I was just very concerned. I asked to see the data. You know, we had the three soldiers in Fort Dix, or whatever it was. I was a little familiar with the whole thing, because I was in the army and C.O. of this little hospital I mentioned in Darmstadt, Germany when the Asian flu came across the United States. This is the truth: the Asian flu arrived in Europe via Darmstadt, Germany and my base hospital, because they gyroed a unit in . . . They used to do what they call gyroscope units. They'd pick an entire unit up and move it and bring in another entire unit in its place instead of transferring individuals.

We had a unit brought in that was incubating the Asian flu from this country, and that's how the Asian flu arrived in Europe. We had a mess on our hands for a number of weeks. So, I was a little familiar with flu epidemics and what the flu could do.

But I looked at the data. And going from a couple of guys at Fort Dix to a national pandemic seemed to me possible, but remotely possible. And not likely.

Exactly how it happened, I don't know, but we had a meeting in the White House in the Roosevelt Room, which is my favorite room. The president, Gerry Ford, and Dave Sensor and I and Ted Cooper, and then all of the great gods of virology were in the room and the president was seeking their advice. Albert Sabin was there and Jonas Salk was there. I kept my mouth shut at that meeting on purpose. Dave Sensor carried the ball and laid this out and spelled out the horrors.

President Ford went around the room and asked everybody around the room to speak up and give their advice. To a man, everyone in the room, including Albert Sabin, said, "Yes, Mr. President, there's a possibility, and you should have a massive immunization." Everybody said it; it was unanimous.

Now, the fact of the matter was that when we walked out of the room, he walked into a press conference and read a press release that had been written before the meeting. So, in a way, it was a set-up.

JY: He could've jerked the press release if the words around the room had not been that way.

AS: Well, if you wanted to do the research and study in particular what Albert Sabin said afterwards . . . He sort of weaseled on his position.

The thing was less than honest. As I sat there in the room, I thought, here's the president of the United States, and here is this thing and it isn't real. It isn't the way to come to grips with this issue. It's not the soundest way possible to make a decision. I think, basically, the error was that the president was misled by his government advisors--that is by CDC.

Now, obviously, if there had been a pandemic, I wouldn't be sitting here saying this. The other thing is that I don't think it was . . . I mean, it's been called the swine flu disaster. I don't think it was a disaster. I think it was one of the most highly successful immunization programs in the history of the country in many respects.

Further, all of the things that happened to people were to be expected. When you immunize a lot of people, you're going to have some deaths and some Guillain Barr�. It may sound hard-nosed, but that's what you get.

So I'm not bothered by that; I think it was a great immunization program, and the vaccine was safe. In many respects, it was a marvelous . . . It was like one of these disaster rehearsals we have here, when we pretend the elevated train crashed, and we make up everybody and rush around and rehearse disasters.

AS: And you see it reflected today in the DPT thing: you know, the problem with the pertussis vaccine. It's had an impact on lawsuits, product liability suits. It was a bad scene, regardless of what I've said, because of the way it turned out.

But one of the pictures on the stairs going up to my studio at home, which is on the third floor--I have my gallery of plaques and things--one of the pictures is of me standing and talking to a press conference we had at NIH on swine flu. Ted Cooper is sitting beside me and I'm standing talking, and it's a picture taken over my shoulder. It's the best picture I have, in a way, of a press conference. The picture amuses me because there's a forest of microphones in front of me: there must be thirty or forty microphones. It's just a solid electronic mass in front. The back of the room is a solid bank of national media and television. The front row, kneeling down, all of the familiar and famous faces of the Washington press corps, looking up, pencils poised, and so on. Every time I walk upstairs, I get a chuckle out of that picture, because that was another event that was time consuming in the life of the commissioner.

No, I think the FDA is a great agency. Poll after poll and study after study has showed that it's well run, that the people of this country understand it, trust it. The people of the world follow its lead.

I haven't mentioned some of the international activities. Again, Charlie set up something we called the Tripartite Group. What's funny is that Charlie, I think, set it up, but only attended one meeting or so. So, here I was again, another good idea that I got to implement.

The Tripartite Group was, essentially, about four people from FDA--myself, John Jennings, Peter Hutt or Dick Merrill, and then depending, sometimes Dick Crout or Virgil Wodicka, just those top people--who would meet with our counterparts of Canada and England every three to four months, rotating it between Ottawa, London, and Washington. That was highly useful, because if we got together and compared notes and knew what each other was going to do we could get out of the mode of our approving saccharin and removing cyclamate, and Canada approving cyclamate and removing saccharin--which is exactly what happened, as you know. There was some really silly stuff going on. So we met and, again, became friends, and that led to some fun stuff--again, part of the fun of being at FDA.

One thing I got asked to do was to referee a dispute in the Common Market over chocolate and the standard of identity for chocolate. I thought that would be kind of fun and easy to do, so I went to Brussels or wherever it was--and barely escaped with my life. It was straight out of vaudeville, you know, with me, essentially, running down the street, being pursued by people who were trying to kill me, because I hadn't recognized the distinctions between Swiss chocolate and German chocolate and Belgian chocolate and English chocolate. And secondly, the passion with which they viewed chocolate. That's sort of an amusing little story. Of course, they're still fighting about chocolate and they always will. But the idea was that the FDA was good at standards of identity, and so why didn't they get a common standard of identity for chocolate in the EEC.

AS: I haven't the foggiest idea. I would sort of doubt it, because again, it was one of those things that was internal to the agency. See, if I had done the courting of Congress and the courting of the press that we talked about earlier, I wouldn't have had time to do some of these other things that I did inside the agency.

JY: Now, you went to a proprietary association meeting in Japan. Wasn't that it, an international . . .

JY: Yes. Which is another kind of international forum to talk about common problems, I take it.

AS: Yes. Well, there's a group called the World Federation of Proprietary Medicine Manufacturers, the WFPMM, or something like that. I've been to two of their meetings, just talking about broad issues.

JY: Well, there are international dimensions to all of these that your chocolate episode and your trip to Japan and . . .

AS: Well, I traveled to Japan when I was commissioner, and visited there and dealt with the government of Japan and had a marvelous party I was able to host in the embassy in Tokyo, because we were between ambassadors: Mike Mansfield hadn't come, and the embassy was empty. So, I got to use the embassy and throw a party for the Japanese government officials and pharmaceutical officials in the embassy, which was great fun.

I did a couple of other things. Of course, FDA has always been involved in the FAAO. I first got involved with WHO there. Now at the University of Illinois and WHO, we're doing some things that have the potential for being very exciting. Just next week or so the deputy director of WHO, Tom Lambo, is visiting here, and this will be his second or third trip to the University of Illinois. So, these things kind of feed.

JY: To advance medical education and the whole realm of attendant activities here.

AS: Right. Well, then, as I mentioned, I'm on the board of directors of American Cyanamid, which is worldwide, and that board also makes trips. So again, a year ago, I was in Japan (this time with Cyanamid) and Taiwan. We met with the premier and the minister of health. I walk in and I had been there a year before, so you can keep the contact going. They sort of say, "What hat have you got on this time?" because it could be quasi-FDA or University of Illinois or Cyanamid or whatever. Each activity helps the other one.

Well, the other thing that's pleasing is that I've been invited to speak to AFDO in June. When is the annual meeting of AFDO?

Paul Hile called me and said, "They have a named lecture." I forget the name of the lecture, but it's a named lecture. He said, "We were just sitting around thinking of who we'd like to hear from. You were unanimously . . . We thought, well, maybe you could do this." So, I was flattered, and said, "Sure." You know that's fun.

AS: Well, I don't think I was the best commissioner, and I know I wasn't the worst commissioner.

Like a lot of people say, "Boy, I wish I knew then what I know now." I suppose, if I had a wish, I would wish that I could start over again, but with the wisdom that I've accumulated by having done it: that would be my fondest wish.

I wish the agency well. I wish, somehow or other, that all of the good stuff of the past could come back to the agency and all the bad stuff would go away. That's what I would wish.

JY: That's a noble hope that we might close on, perhaps, Dr. Schmidt, with our gratitude and with the hope, too, that history, made up of research in archives and reflective comments like your own, may itself turn out to be a help to FDA's future.

FDA Oral History Program

Interview with Alexander M. Schmidt Commissioner of Food and Drugs (1973 - 1976) (Part 4)

Interview with Alexander M. Schmidt
Commissioner of Food and Drugs (1973 - 1976)
(Part 4)