FDA Oral History Program

Interview with Alexander M. Schmidt
Commissioner of Food and Drugs (1973 - 1976)
(Part 2)

Interview Topics:

Dr. Schmidt's background Max Wintrobe, Hans Hecht, Lou Goodman Military Service Regional medical programs Jim Shannon, Bob Marson Markle Foundation George Miller, University of Illinois Dean, College of Medicine On becoming commissioner Cap Weinberger, Charles Edwards Peter Hutt Dr. Goddard Dr. Edwards, Sherwin Gardner

Watergate, Richard Nixon Early relationship with the Department and OMB Kennedy hearings Drug lag Ralph Nader, Sidney Wolfe, product liability FDA reorganization, Cardiovascular Division Scientific competence "Once an FDAer, always an FDAer" Pink Sheet, Wally Werbel Cyclamates Policy and FDA business Schmidt's management style, policy board

Quackery, Laetrile Vitamin and mineral supplements Patient package inserts, National drug compendium OTC Review, DESI Review Health claims on food labels Advisory committees Dalkon Shield NCTR, drug postmarket surveillance Predicted changes in FDA Dangerous products Friday afternoon crises Science Advisory Board Press relations

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: Who approached you from the Food and Drug Administration? How were you approached?

AS: None of the above. You have to remember, now, that this was the beginning of Nixon's second term. And you have to remember that toward the end of his first term, he asked for a lot of people's resignations and he turned over a lot of the cabinet. And, as you see now with Reagan, the Nixon administration wanted a certain kind of appointment. One of the things I think that was going on is that they were literally looking for Republicans, or moderates. They weren't looking for spendthrift liberals--that's for sure. I probably had, over the years, maybe someplace between twelve and twenty people tell me that they were the one that suggested me to the White House. John Cooper said that. There were just many, many people who said that.

And then the other thing was, at that time, management was considered important. Nixon was one of the many presidents who said he wanted to try to manage the bureaucracy. All presidents have said that; few have done it. But Nixon was interested in management talents, and I think the people who were looking at FDA believed that management was important--management skills were important at that stage of FDA's evolution.

I was sitting in my office here as dean of the medical school one morning when my secretary came in and said, in effect, "There's some nut on the phone who says he's calling from the White House." So I really don't think she thought it was for real. So I picked up the phone. The first contact was with the chief headhunter at the White House. I was recruited by the White House, not FDA and not the department, although I know that before I was brought in, I had been discussed with Cap Weinberger and Charlie Edwards.

JY: Edwards was still in FDA?

AS: Edwards was just sort of in between when I first showed up. He was still at FDA when I first visited.

JY: Was he briefly the associate secretary for health or whatever it was called within the department before he left?

AS: Charlie was commissioner of FDA. Then Cap Weinberger asked him to become assistant secretary for health, which opened up FDA. NIH was open at the same time, and they were looking to fill, simultaneously, both NIH and FDA.

In my initial conversations with the White House, the conversation was about both NIH and FDA. They were looking at me to see if I was fit, I guess, for anything, or NIH or FDA. And I very quickly said to them the same thing I just said to you, and that is that my main credentials and accomplishments to that date had not been in science. And NIH needed a leader from science more than I was. And our conversations led fairly quickly to FDA and its need for a commissioner. Parenthetically, they finally got Bob Stone to head NIH. He was, in many respects, similar to me in that he was dean of a medical school and more a manager than a scientist.

So, in a way, I think I fit what the administration was looking for, and that was a Republican person from the academic field who had some management skills and might be able to manage FDA.

JY: Did you have any conversations before you accepted the position, or afterwards, in which you were given any kind of instructions as to what the White House or the department had in mind for you to do besides being a good manager? Any policy counsel you were given?

AS: Well, the first time I went into Washington to talk, I spent the entire day in the White House and did not meet Secretary Weinberger or Charlie Edwards or anybody else. That was just a general set of interviews with the White House staff on what they were trying to accomplish and what kinds of people they were looking for and what they were trying to do, and to get acquainted and sizing up and all that kind of stuff.

JY: It was more general level policy than it was things particular . . .

AS: Very, very much so. They were giving me their view of NIH and their view of health and their view of the needs for health and national health insurance and their views of HEW and how it was run and testing me and asking me questions. You know, some of the questions were a little off-the-wall and were a little startling to me. I mean, you know, I'm dean of a medical school and a good kid from the Midwest who grew up in Utah, and all of a sudden I'm talking to the likes of Ehrlichman and Haldeman and so on,

JY: What kind of off-the-wall questions do you mean? Do you remember an example?

AS: Well, just things asking about management philosophy. There was only one question that I thought was bizarre that had to do, for instance, with what would you do if you want something done and people refuse to follow the order or some such thing like that. But for the most part, it was very general. I suppose there were four or five hours worth of meeting people and chatting. And a lot of it was about fishing and mountains and the West and California. A lot of those guys are from California. So, a lot of it was just talking about the West.

Well, I came back here and promptly forgot about it, but within a week I got a call, "Would I come back and have some serious talks?" So, I went back. And again, I started in the White House, spent about an hour in the White House, was driven up to HEW and then spent about an hour, hour and a half, with Cap Weinberger, which for Cap Weinberger is a long time because, you know, he's a very efficient person with his time, and you cover a lot of territory in a short period of time. And then he introduced me to Charlie Edwards. I can't remember if I had known Charlie before. If I had met him before, I didn't know him well. Then I spent time with Charlie and then I spent time with Peter Hutt, and those were the people I met on the second visit.

JY: How would you characterize them? Did you rather think of yourself as being quite similar in ideas to Dr. Edwards, so that your going into FDA was kind of a continuation of policy that had existed or was this in any way a break?

AS: I think I'm a very different style of person than Charlie Edwards. There are many differences in our outlook and on some things, certainly, our administrative styles are different. But we were similar in other ways. I think Charlie had a very good sense of what the organization was when he took it over and what the organization was when he was leaving it and what the organization needed. I was able to get that fairly quickly from Charlie.

One of the things I did then, following that talking to people, was testing what Charlie said and seeing if it was right or wrong and correcting it or making adjustments until finally I could evolve my own feeling of the agency and where it was and what it needed.

I think Charlie was fairly accurate. Peter's approach was different. From what Peter and then-bureau directors and others I talked to said, I was able to build a more complete picture that all seemed pretty much to fit.

JY: Can you sketch in the broad outlines of that picture? What did the agency need as you came to sum it up at the beginning of your commissionership?

AS: Well, to start with my conclusion, what it seemed to me was that the agency needed some settling down. It had undergone a tremendous amount of change. That was something I was very familiar with. I haven't talked about some of the things I've done or studied as I learned administration, but certainly change in organizations and how it's accomplished and what change does to an organization is something I was very interested in and had studied and saw. Remember, also, that I came to Illinois here to change it in very dramatic ways. And planning change and accomplishing change in the least traumatic way was something I was interested in.

I think with FDA, starting with Goddard, things began to change. I think that Goddard sort of signaled the modern era for FDA. I don't think Goddard was the modern era. I think he was almost sounding a warning trumpet or something for the agency. He was a big change in administrative style for the agency and the country, for that matter . . . I think that Goddard began an era of change and of buffeting and of difficulty with FDA that went on then for a decade. Goddard didn't last long. Nobody lasted long. As a matter of fact, my tenure as commissioner of FDA is longer than anybody in modern history.

JY: Anybody since Larrick, yes.

AS: For whatever that means. But Goddard was followed by Herb Ley, who I think held the shortest tenure of anybody in modern times. The whole cranberry business and all of that really shook the agency.

There were questions about its efficiency, and about its management, about its organization; there were all kinds of questions. Studies had started at FDA. Charlie Edwards was really brought in to change FDA. That's why he was hired. Remember, Charlie came to FDA from Booz, Allen, Hamilton, a management consulting firm. And he brought with him Sherwin Gardner, or recruited Sherwin from Booz, Allen. And Sherwin came out of management. Sherwin was not a health professional. Sherwin was an engineer who was a management engineering consultant for Booz, Allen.

Charlie was brought in, in a sense, to bring the agency up to the speed necessary in the 1970s. And Charlie did that.

JY: How would you characterize, quickly, the ways that he did it, to bring it up to the seventies? What main things?

AS: Well, he reorganized it. He set up a different way for it to do business. And he brought in a bunch of new people--very good people, indeed. So that, particularly in the drugs area, there had been dramatic changes in the organization of the bureau. Well, Charlie just picked up the agency and gave it a good shake and then set it on its feet and said, "All right. Go." And then about that time he left.

And what I saw was an agency that had just been picked up and given a good shake. In a sense, its teeth were still rattling a little bit. In many respects the hard work had been done. The job that I saw to do then was to make the organization that was there work, because it had not been given a good try yet.

So, I saw an organization with good people. Virgil Wodicka in the Bureau of Foods was first rate, and he had a very good staff. Taylor Quinn just retired a week ago. The people of Taylor's calibre . . . Howard Roberts and so on . . . That bureau had excellent people in it.

And the Bureau of Drugs--Henry Simmons was director and then Charlie took Henry downtown. But I was able to appoint Dick Crout, who was on board, and had been recruited by Charlie.

Sherwin Gardner was there; John Jennings was there; Mark Novitch was there: many of the people who had been very important to the agency and still are. Hank Meyer was there. John Villforth, a superb administrator, was there.

So, my job wasn't to go in and reorganize. My job was not to go in and recruit a whole bunch of people. Charlie had done both of those things. My job was one that I thought I was particularly suited to do, which was to make it work, to manage it, to make people feel good about what they were doing and to have it run efficiently and effectively and do some of the things then that had been promised in terms of making the organization work. Some of it you can do and some of it you can't do.

JY: Of course the environment in which an agency operates keeps changing, too.

AS: That's the understatement of the year, because when I first went to the White House, while Watergate had occurred, it wasn't there yet. And, of course, there were several major events that impacted one way or another on the agency while I was there, that I didn't expect when I walked in.

One was the set of Kennedy hearings on the drug approval process, which some people will always associate with me and my time at FDA, and kind of think of that era with regard to the Kennedy hearings. They were certainly prominent with regard to newspapers and so on, and were one of the more prominent parts of my administration of the agency, although far and away from being the most important. But then the whole Watergate thing, the dissolution of the executive branch of the government, which happened right before my eyes. Max Wintrobe and Bob Marston and others, Cap Weinberger, were very good to me and spent a lot of time with me. As Watergate began to unfold and come to an end with the president resigning, Cap--who was close to Nixon--suffered through that and I was able to see that. None of that was expected when I went to Washington.

JY: How did that affect your plans? Did the break-up of the Nixon administration make administering FDA more difficult?

AS: In a few minor areas it made it more difficult, but largely it made it easier.

One thing that I think is important is that when Charlie Edwards was there and when I was there, the commissioner had delegated to him the authority to run the agency and make decisions. That has changed dramatically to this day.

But one of the things I was concerned about when I went there was that I'd be commissioner of Food and Drugs and I'd be able to run the agency. I talked to the people at the White House and I talked to Cap Weinberger and sort of made a deal. And that was that I would keep Cap and the White House informed of anything they needed to be or should be informed of so they wouldn't be surprised and they wouldn't get hit on the back of the head with a wet fish or whatever, and I would run the agency well. And in return for that, they would leave me alone.

And that's the way we operated, and I was very firm in turning back any approach to the agency, either from downtown or, on one or two occasions from the White House or one or two occasions from the OMB, when they made a move that might "usurp" our prerogatives. You know, the FDA is a proud and distinguished agency and in those days was very proud of its independence. It knew what it was doing, it knew how to do it, and it wanted to be left alone to do it. It was made very clear to me by the professionals in the agency that one of my jobs, by God, was to be sure that it stayed that way. And one of the things I did, even on a couple of occasions, was to say, "Look, you want to be commissioner, you be commissioner. You don't need me; I'll go home."

JY: Do you want to be more specific about an example of an occasion?

AS: Well, I just read about it, as a matter of fact. I was reading about somebody writing about somebody going after Dick Crout once and wanting to fire Dick Crout.

JY: Where did you read this?

AS: Well, I'd have to stop and think. It pointed out that I'd said, "Well, you can fire Dick Crout if you'd fire me first." And that was the end of that.

On one occasion Jerry Meyer came into my office and said that he'd just received a telephone call from the secretary's office, you know, somebody "downtown" was the word used, and it was some ridiculous thing. It was truly a dumb thing, to use Sherwin Gardner's favorite word for such things. "That's dumb," Sherwin would say. And that was dumb.

So, in a jocular mood I used a phrase that's kind of crude that I picked up in the Army. But I was really irritated. I said, "Jerry, just tell them to pound sand up their ass." And Jerry looked at me and he said, "Now really, what should I say?" And Sherwin says, "You heard him." So, Jerry laughed and went out of the office. Sherwin and I fell back to talking about what we were talking about. About half an hour later, Jerry Meyer came back in, kind of red in the face and laughing. And he said, "Well, I took care of it." And I said, "You took care of what?" And he said, "What I told you about earlier." And I said, "Oh, what did you tell them?" He said, "I told them just what you said. I told them to pound sand up their ass." And he laughed. And I said, "You didn't." And he said, "Yes, I did." I said, "What did they say?" They said, "Oh." That's all they said.

Well, we never heard anything more. As a matter of fact it was probably two or three months before we even heard from downtown again, which was fine.

What I like to do is be given a job, understand the job, feel comfortable that I have the tools, then be left alone. We had several advantages. One was Charlie Edwards was, in effect, my immediate boss. And Charlie knew the FDA and he knew what needed to be done, and he felt comfortable with what I was doing and how I was doing it. Charlie and I spent a lot of time together so that our communication was good. When I needed to see Cap, it was no problem with Charlie, and Charlie and I went or I went by myself. The secretary was very supportive. There is an advantage to being a member of the party in power. The White House left me alone. I was Republican. I come from a Republican family. My father was well known in Republican circles. He had known the famous senator from Illinois here for many years who was still alive the first time I went to Washington, and I knew him.

BP: Dirksen?

JY: Dirksen.

AS: Ev Dirksen. Ev took me to a party once, and that doesn't hurt.

JY: Then they were preoccupied, too?

AS: Well, then the White House just sort of fell apart. I made peace with the OMB very early on. Again, I used weapons that I found had been very handy for me all my life, which is humor, and a little entertainment, a little showmanship, and so on. And early on I went to OMB and we did a show for them that they never forgot. I knew the guy who ran OMB. His girl and my girl were classmates in school and we lived near each other. And OMB was pleasant, if you can believe that. If you look back at the whole time I was at FDA, you will never find reference, the whole time I was there, you will never find reference to the White House or the OMB. It was almost as if they did not exist. And I literally had total authority over the agency and what it did and regulations and decision making and so on. There was one exception, one major exception. And that's when I needed help and asked for help and got help.

JY: What was that?

AS: That was with the Kennedy hearings.

JY: Yes.

AS: The one area where the secretary stood beside me and, in effect, took over was when things were not going well with the whole Kennedy business. I had done my own investigation of the agency, which was not a mistake, but which was insufficient to the cause. It was necessary for the secretary to do something to change what was becoming a more and more difficult situation. So, the secretary set up a panel that was run by Norm Dorson. It was the result of a conversation between Ted Kennedy, the secretary, and myself in the Senate hearing chamber. During a recess, I went over to Ted Kennedy, whom I knew personally. Personally we are on the best of terms. He recessed the hearing and he wiggled his finger at me and I walked over and he said, "Mack, what are we gonna do?" The secretary was at that hearing at my request. I needed some muscle. He wiggled his finger at the secretary, who came over, and he said, "What are we gonna do?" And in about fifteen or twenty minutes we'd agreed that the secretary would establish another panel to investigate the charges that had been brought by the FDA employees, and so on.

Other than that particular thing, everything that I did, I did. Everything the agency did, including some things like banning the red dye number . . .

JY: Ten?

AS: Number two. That thing was a big deal then. All the controversy and everything that happened was within FDA. Now it's in the secretary's office.

JY: Did you have the feeling that you, in a sense, inherited the dissidents, as they came to be called? And was it just sort of bad fate that their protest came after you arrived, or did you take this personally?

AS: Well, first of all, most of the dissidents were there and had been there and had been dissidents for a long time.

JY: That's what I meant by inherit, yes.

AS: I inherited that situation. Any person who became commissioner of food and drugs when I became commissioner of food and drugs would have been at the same hearing in the same way that I was. Whether they would have handled it the way I handled it and so on is open to question. But John Nester was going to say that come hell or high water. And Kennedy and Larry Horowitz were going to have that hearing. So, it was just my bad luck, if you want to look at it that way, to have it happen to a brand new commissioner. I didn't know a goddamn thing about either what was going to happen or how it was going to happen until it happened. And neither did anybody else. This was a plot. This was a planned ambush of Peter Hutt and myself.

JY: So, the general account of it that you were absolutely surprised, that really is true, when you went to that hearing?

AS: I had no inkling. I went prepared to talk about the drug approval process. And I got ambushed, pure and simple. I was in a state of shock. Again, here is a little country boy, comes in and gets subjected to a beating up like that at the hands of a senator of the United States, and so on. It took me a little while to glue myself back together after that.

I only got mad, really angry, once. That is when I thought Ted Kennedy really overreached and said some things that really ticked me off. I thought he was getting awful close to wondering about my integrity. And I'm not sure that he was exactly the individual to question my integrity, which has never been questioned. That's too much. So, at the end of the hearing, I went charging up, but he ducked out the back and was gone. In that building there are special elevators for the senators that the common man can't get on, so I had to take another public elevator. By the time I got to his office, he was just disappearing in his office and I yelled at him. You know, I was really angry. I was about ready to do bodily harm. And he turned around and he saw me and he said, "Oh, Mack. I wanted to ask you about Saturday." Art Buchwald and I were going to be judges at Ethel's animal-kid day on Saturday, or something like that. And then he stopped and he said, "Are you mad?" I said, "Yes, I'm mad." So, then he gave me a little lecture about taking things personally and so we talked it through.

After the initial shock of it, that was the only time I really got angry, got personally involved in it. Otherwise it was just a royal pain in the ass.

JY: You settled down and used a lot of patience and spent a tremendous amount of time studying the thing.

AS: It burned agency resources; it wasted a lot of time. What really was kind of bad about it was that almost everybody knew that a lot of it was crap. It was a charade, and a lot of people knew it was a charade. But yet you had to go through with it. I didn't know, when I first heard these things whether they were true or not, and right there at that very first hearing, I said, "I'm shocked at what I'm hearing; I will investigate it." I mean what else is the head of an agency going to say?

In retrospect, I should have investigated it myself, but probably earlier, and I should have had some other independent verification of either my study or another study. At home hanging on my wall someplace I have the original of Herblock. When I said I was going to do this myself, Herblock drew a cartoon that really pissed me off. Here I am in the Washington Post stamping myself okay. I should have anticipated that, but the counsel I was getting said, "No, you should do it. Be firm and be in charge of your agency and do it." What they didn't tell me was that once I did it, it would be thrown out as not being believable because I had done it.

To this day, however, it stands as an accurate assessment. Nobody there said I was wrong. It was just that it was not persuasive. So Norm Dorson comes out and, in essence, verified my findings.

I gave a talk last week in Washington on congressional hearings. After all this time, it was sort of interesting. In that talk I pointed out what bad hearings like these can do to an agency.

JY: Do you think we could get a copy of the text?

AS: Sure. But I pointed out there are really four bad things. And I was thinking of the Kennedy hearings. I think that four bad things came out of that set of hearings.

One was the sheer waste of my time and other people's time. You know, Dick Crout and I and Peter Hutt and Bill Vodra and Sherwin, important people--at least important to the agency--spent days and days and weeks of time responding to all of this. We could have otherwise been approving new drugs and so on. It affects the morale of the people in the agency without any question. It undermines the authority of the managers of the agency.

Having said that, yet that was by far and away not one of the more important things that happened while I was there.

JY: Right. At the same time there was this criticism, which in a sense some of the consumers groups were also making of the agency, that there was not enough caution within the agency about approving new drugs. There came from the industry side a continuation of the drug lag critique of the agency, so that the agency was getting it in publication from two polarized sides. Do you want to talk about how you view, in retrospect, that matter? One of the things that you were doing and that you were speaking about, publicly, was looking at the agency from the point of view of its machinery of approving NDAs. And you were doing various things to expedite that machinery, as I look at the things that I've seen. As you look back at that whole drug lag debate from this perspective, do you want to say anything about that with relationship to your commissionership?

AS: Well, there's an old saying in FDA that if you're being criticized just about equally from opposite sides of a question, you're probably about where you ought to be. And, you know, there's a little bit of wisdom to that saying.

My feeling about the drug lag was, first, to discover what the agency was saying about it. Henry Simmons had done a piece when he was there that, in effect, denied that there was a drug lag. And Charlie denied there was a drug lag. I said, "Well, what are we saying about that?" And everybody said, "Well, we're saying there isn't one." And I said, "Well is there one?" And I noticed some eyes flickering around the table. And, in talking to Dick Crout about this subject, it appeared to me that the United States had a fairly rigorous drug approval process, and that we did demand things that a number of other countries did not demand, and that that was more time-consuming. We did take longer than some countries to approve some drugs. And some other countries took longer than we did to approve some drugs. At that time, it depended in part on where the pre-clinical work was done, where the clinical studies were done, what data--FDA was then not accepting foreign data. A lot of drug companies were starting their drugs out in Europe because it was easier to do clinical studies there than in the U.S., and they were registering drugs first in other countries before they even submitted an NDA in the U.S.

And, as I looked at all of this stuff, it became apparent to me that we should quit denying that there was a drug lag. Because, first of all, like any term, the term itself gets you into trouble. It's a negative term.

I can give you an example from here. A week ago there was an issue that had to do with somebody named Tom Beckham. Tom is a fine fellow and a close friend, and it had nothing to do with Tom. The issue didn't have a name. So, I was thinking one night as I was driving home how I was going to address this issue the next day. In a major meeting with university officials, I called the issue the Beckham problem. It was a problem that had to be solved, in good part, for Tom Beckham. By giving it the name "the Beckham problem," that was picked up immediately and everybody started talking about it as the Beckham problem. Within a relatively short time, it got solved, and it was a two-year-old problem. Because people hadn't been thinking of it as a problem. When I gave it the name of the Beckham problem, everybody laughed loud and long, started to call it the Beckham problem; it got labeled as a problem and therefore something to be solved.

You call something a drug lag, you got one. It's got a name, so it must exist. So, that was really stupid. So, if you go back and look, you will see that Dick Crout, in a speech that I consulted with him on, for the first time said, "We have a marvelous system here. Some other countries don't do what we do and you're going to pay a price for that, and that price is in time and in dollars." And we started to say that.

Further, since we've mentioned John Nester, it is simply a fact that the cardiovascular division--and remember I'm a cardiologist and had worked with Lou Goodman and I did know something about at least cardiovascular pharmacology--that division hadn't approved anything in year after year after year. There was not a slowness because of caution, but there was a drug lag in the cardiovascular field, and Dick Crout admitted that in public.

So, we changed the tune of the agency. In a way, the drug lag issue has totally disappeared. It started to disappear in 1974 because we started to treat it, in my view, much more honestly than it had been treated before. And also the agency did a number of things that responded to the valid criticism. I said, "Look, what are the valid criticisms?"

Well, one is that we spend a lot of time treating drugs alike, and drugs are not alike. You know there are some drugs that are just "me too" drugs. They are copies of other drugs that present no therapeutic advantage. There are other brand new chemical entities that might be lifesaving where there is nothing else available. If you don't distinguish and differentiate between those two, you know, that's ridiculous.

JY: That was one of your innovations. Kind of a fast track for . . .

AS: The fast track and the labeling of the fast track came later. I wish I had been smart enough to label what we were doing. But we did begin paying attention to the distinctions between drug entities. And the way we did that was by classifying them as important new chemical entities, or me too's, or by advantages, and so on. But labeling is important. And I've got to hand it to whoever it was--I think it was Don Kennedy, during his time at . . . Dick Crout was still there. But saying we have the fast track and then putting one drug through it and getting one drug through in six months: that single thing did more to do away with the drug lag than anything else over a decade before that.

The other side of it was Ralph Nader saying we were sold out to industry and in bed with industry and approving unsafe drugs. I remember one meeting I laughed and said, "Is it possible, somehow or other, very, very slowly to approve a set of very, very bad drugs? Because if I put together all of the charges, you've got an agency that takes forever to approve a very, very bad drug. Is that what we're doing?" Everybody laughed. Up to that point, we'd been saying we were being charged with opposite sins, and I was able to put it together in one big sin, which everyone recognized as being ridiculous.

JY: Did you ever converse personally with Nader about these problems?

AS: Oh sure. I got to know Ralph Nader well, and Sidney Wolf well, and a lot of congressmen and senators and people downtown. I became good friends with Morton Mintz. You know, I enjoy people and I like people and I like most everyone I dealt with. I also disagree with a lot of people. But I enjoy them and like them. You know, Ralph Nader is a very likable chap. You can disagree with his thesis that all American industry is dishonest, but you can like him as an individual and a person. And I got to know him and Sidney.

As a matter of fact, one very funny remembrance that I don't think I ever told anybody because I sort of promised Ralph I wouldn't, was one time when we were appearing together in a panel. When it was over and we were standing in back of the podium, I said, "You know, I have to go down to FOB-8. Do you want a ride?" And he said, "Yeah, I'd love a ride." So, we went out and got in my car, which was a government car. I did a lot of work in it, and I would have a briefcase open by my side and I would sit sideways to work. I didn't like the seat belts and I finally got tired of them. So, I told the driver to take the back seat out, just drop the seat belts down to the floor, so I wouldn't be sitting on them.

Well, we got in the car. Ralph sat down and I told the driver where to go and the car took off at a fairly rapid clip, and Ralph was feeling around for the seat belt and he couldn't find any. So, he figured they were shoved down in between the bottom of the back cushion and the seat. So, he turned around and knelt down on the seat and had his fingers slipped in that crevice. We were kind of careening down the road, and I finally said, "Ralph, would you please turn around and sit down. You're gonna get killed." Here he was riding backwards down the street on his hands and knees in an unstable state looking for those damn seat belts.

I think the drug lag issue started to fade about midway through my tenure, and I think now it's essentially gone.

JY: Industry is trying to work for a law related to simplifying the new drug development, new drug process, though, isn't it?

AS: Well, just recently the final draft of the NDA re-write came out and the industry doesn't like some of that because it isn't as simple as some of the industry wants. I think that industry would like a much simpler process. It's interesting, I don't think that many of the drug companies would be able to do much less than they are now doing, FDA or no. It's just the case now that we can do so many different things and should do so many different things that are difficult and time consuming and expensive in order to know whether a drug is safe and effective.

With the product liability situation the way it is today, any company left on its own devices without FDA would probably end up doing more than they are doing now and be as slow or slower, because to a degree FDA offers drug companies a protection. When FDA sets standards, and those standards are followed, and FDA says they are followed well, if FDA approves the drug for marketing, like it or not, in a sense that is a sample of government approval. If FDA went away and a company had a new chemical entity they wanted to market, what would happen in that company would be that the lawyers in that company would decide when it could be marketed. And those lawyers would be protecting the financial interest of the company against what now are becoming ridiculous product liability lawsuits and awards by judges and juries. There's a national competition going on right now among courts and judges and juries about who can give out the largest sum of money.

You pick up any story about a major award and it'll say it was the second largest award. You'd think it was the high jump. The largest award. There's a contest going on. And lawyers would protect their companies from that. They would make them do more, I swear to God, than FDA is now doing, because FDA protects the companies against certain claims. I think the thoughtful people and the good companies are content with knowing that if they've got an important new drug, FDA can get it through in the eighteen months and will. And otherwise, you know, let the contest go on.

JY: The fact that a great many new chemical entities have come along from new experiments, including new basic science to draw on, has also probably had something to do with lessening the industry pressure, hasn't it?

AS: I think FDA has been doing a better job in the last ten years than they had been doing eight years previous to that. I mean, like it or not, breaking up that cardiovascular division did accomplish something.

JY: Did you do that? Or was that done later? I didn't remember that.

AS: Part of it was done when I was with the agency, in that some individuals were transferred and so on. I didn't know all of the history and I was fairly new at the agency. What I remember was that Dick Crout and probably John Jennings and maybe one or two others laid before me a reorganization plan and said, "We're having problems, and we're going to make these transfers and do these things." I said, "Great, it sounds good to me." And here I think your point is valid in that nobody said, "Oh, by the way, one of them is John Nester and let me tell you a little bit about John Nester." I didn't know who the hell John Nester was, prior to the hearing. But prior to the hearing I did know there were some transfers going on, and I wasn't smart enough or skilled enough or knowledgeable enough, whatever it was, to do what I would do now and have done ever since. That is to say, "Tell me a little bit about who these people are and is there anything hidden?" You've got to learn stuff like that, and I hadn't learned that by that time.

It is true that I knew that some transfers were being made. But who it was and how they were being made and the reasons and so on, I did not know about prior to the Kennedy hearings. We keep coming back to that because it's interesting, but it really isn't important.

JY: You wanted, for the Food and Drug Administration, more scientists. And coming from academia, you suggested that there ought to be a campus atmosphere--you had Beltsville in mind. You thought that there should be an opportunity for the scientists to engage in fundamental research. Commissioner Young still occupies the same office that you occupied in Rockville, and there isn't a Beltsville.

AS: Well, there's a Beltsville.

JY: Beginning.

AS: Well, the first part of that is almost done, or done.

JY: Well, do you want to talk about the scientific competence of the agency? Your evaluation and what lay behind your making these suggestions?

AS: Well, again, I'll reference another piece I wrote. I was asked by the Food and Drug Law Institute last December at their annual education conference, the big one, to give a talk on science and the Food and Drug Act. I did a piece on that that kind of expresses my views. And again, I can give you a copy of that. I put down what I thought in that paper. In essence, what I said and what I would say is that I went to FDA believing that the rigorous application of good science would make less controversial and better the decisions that FDA had to make in many areas. Much to my dismay, what I learned was that, by and large, that was not true.

JY: Why not? Can you explain that?

AS: Well, because most people who instigate the controversy or fight with FDA don't understand science or what science is or the limitations of science or when science leaves off and something else begins. That something else is really politics. The principle reason is that there is not a rigorous differentiation of science and politics.

You see, I often have explained this by saying that if you take an experiment, it begins with posing a question that nature can answer for you. It's usually in the form of a hypothesis that's going to be tested. Then you set up conditions that will provide data that will allow you to answer that question. Then you conduct the experiment. And then you get the data and you analyze the data. And from those data you say with what probability under what conditions is such-and-such truth or false. Now there science ends.

But in FDA there are two more questions. One is what does the experiment mean? What do the data show? That's still science. But then, the next question everybody asks is, well then what does that mean generally to the human condition? Now that's interpreting something. That is clearly going beyond science, because science can't answer that.

But then the last question is, what should we do about it? And that has nothing to do with science. That's regulation or that's public policy.

JY: And it's got to be black and white, yes or no.

AS: That's right. Science is always wrong. I quoted George Bernard Shaw in my paper and said that science is always wrong; it never answers a question without asking twenty more. Science is not absolute. The most you can say in science is that, under a certain set of conditions, the probabilities are something. That's all you can say in science. There is no absolute in science. The problem is that the Food and Drug Act seems to require absolutes that are not present in science.

Ralph Nader and Sidney Wolf are very black and white people, and science is shades of grey. So that when I would try to apply science and do that, it wouldn't help because the difficulties weren't really with the science. The difficulties weren't really with the interpretation of the data. Because I would get, no matter what area it was--you know, saccharin, cyclamates, or red dye number two or four or whatever it was--I would get the scientists out. Sometimes I reviewed data myself, or sometimes I met myself with advisory committees. We'd almost always come to, these data mean this. But then you say, "All right, but what does that mean to the human condition?" And it would just fall apart at that point. We would be able to agree that what the experiment showed was that so many mice got so many tumors of a certain kind. Now, to make that jump to what that means to the human condition and to make another jump as to what the means with regard to a product, that's where the difference lay; that's where the controversies always lay. And that is not subject to science.

So I was bitterly disappointed, in a sense, that my rigorous application of good science did not really help with many of the difficulties that had to do with science. They were difficulties that had to do with the absence of public policy, the presence of a bad piece of legislation, and so on.

JY: Regulation has to be categorical, and then, politically speaking, somebody's bound to be offended.

AS: Sure.

JY: I took out of Food Chemical News a quotation from Dr. Edwards that he gave late last month, in which he was addressing this kind of problem. And he said, "Nonetheless, it should be FDA that should have the flexibility to make these decisions. Then if the courts wanted to overrule them, all right; but these weren't the kinds of problems that you could correct by legislation. That was more unscientific then letting FDA be flexible."

AS: I think Charlie said that it ought to be left to FDA because they were best suited to make these judgments, and I strongly agree with that. It should not be elevated to the secretary's office, where it became highly political. And I agree with that. I have talked directly with Secretary Heckler about re-delegating to the agency some of the authority that ought, rightfully, to belong to the agency and the people in the agency.

(Interruption)

JY: This is James Harvey Young of Emory University. Robert Porter and I are in Chicago in the office of Alexander M. Schmidt, former commissioner of the Food and Drug Administration, continuing to visit with him about his experiences in that office.

I think it might be good for the record to indicate that you haven't left your interest behind coming back into academia, but have done a number of things to keep up with the problems, especially the drug problems of the agency and to give your services in ways that might actually continue to help in policy formation. Would you just repeat some of those things for the record?

AS: There is an old saying among FDAers: Once an FDAer, always an FDAer. And I've certainly found that to be true. I've done a number of things that have sort of kept me up to speed. I think more in the drug area, obviously, than other areas.

One is, I get FDA's news clips, which have proved very helpful to me, because they cover things like the articles that appear in magazine sections of the New York Times or Washington Post. And they clip from the Wall Street Journal, and the Times, and the Post, and other major papers so I can follow the stories and the issues and get a sense of the political background of things. Of course, I subscribe to the Food Chemical News, which probably, of that sort of publication, is the most useful long-run in FDA issues, because the Food Chemical News is pretty sound and unbiased coverage of FDA issues.

JY: I'd appreciate your evaluation of the current pink sheet (F-D-C Reports).

AS: Well, I think the pink sheet was, in some ways, better when Wally Werbel was alive and doing it because he had such a deep interest in FDA and its activities, and he was eminently a fair person and was highly indignant when FDA suffered. His reporting was a little more political than it is now. I think that the pink sheet now is a more staid reporting of facts sort of thing that doesn't give you the music of what's going on nearly as well as Wally did--Wally Senior.

JY: It doesn't seem to me to show what's happening inside the agency as well as it did in his day.

AS: No, it does not. Wally, Ray Gallant, and people like that have a lot of friends in the agency who will sit and chat with them and give them the straight story, and I don't think that the current people at the pink sheet have that intimate relationship with old-line FDAers. Then, unfortunately in many respects, a lot of the old-line FDAers are retiring or leaving for one reason or another. So things change.

But I read the pink sheet and the blue sheet. And just in the course of things, the Food and Drug Letter, and so on.

There also is a group of people that would include Charlie Edwards and Sherwin Gardner and Peter Hutt and Dick Merrill, Dick Crout, Lou Lasagna and myself and a few others--a group of people who stay in touch. I talk to Peter Hutt every few weeks on the telephone or in person. And we tend to gather at seminars and meetings of various kinds and be on panels together. And I've stayed active in that sort of thing. I've been a director of the Food and Drug Law Institute and a frequent speaker at the annual session, which probably is one of the more important FDA meetings. That gathers just about everybody at least once a year. I've spoken at that meeting more times than I haven't in the last ten years. I've been asked by Congress to do things, by the Proprietary Association to do things. In the university here we have a very active international program. When I was at FDA, I made a lot of contacts in different countries around the world, and then in my university role here, I also have activities associated with WHO and so on. These things kind of tend to come together so that when I go to Japan, which I've done a number of times, I tend to do both sorts of things: university activities and then consulting with governments or universities about regulatory public policy sorts of things.

Just this last year, for example, I made a trip. I was in Japan for a week on drug issues and then went to China on university business and sort of combined the two.

So, in many respects, I've kept up more than I thought I would've, and I think more than some others. Don Kennedy, for example, does some things, but he is so incredibly busy as president of Stanford that he hasn't enjoyed, probably, the time that I have had to keep up with FDA sorts of things.

[Interview with Alexander M. Schmidt:   Part 1   |  Part 2   |  Part 3  |  Part 4]

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