a An Interview With Mr, Boisfeuillet Jones This is an interview with Mr. B o i s f e u i l l e t Jones, President of the Emily and Ernest Woodruff Foundation, being held i n h i s of- f i c e in Atlanta, Georgia, on January 26, 1968. I am Harvey Young, Professor of History a t Emory University. Dr. Y.: B o i s f e u i l l e t , you went t o Washington a t the c a l l of President Kennedy in 1961. Is t h a t r i g h t ? Mr. J.: That is correct--January of '61. Dr. Y.: And you went as a s s i s t a n t f o r matters pertaining t o h e a l t h t o the Secretary of Health, Education, and Welfare. Mr. J.: The position w a s a s t a t u t o r y one, t h e t i t l e "Special A s s i s t a n t t o the Secretary f o r Health and Medical Affairs." It was an advisory position a t the r i g h t hand of the Secretary t o oversee medical and s c i e n t i f i c a l l y related a c t i v i t i e s . Dr. Y.: And you stayed there during Kennedy's presidency and i n t o Johnson's presidency u n t i l J u l y of 1964 when you came back t o Atlanta accepting 2 t h i s position a s President of the Woodruff Foundation. Mr. J.: That's correct. Dr. Y.: One of the key agencies involving h e a l t h t h a t was under your admin- i s t r a t i v e r e s p o n s i b i l i t y then was the Food and Drug Administration. Hr. J.: That's correct. Dr. Y. And a t the time t h a t you went there, one of the key problems t h a t confronted the agency was the choice of a new medical d i r e c t o r . They had been without one f o r soia? t i m e , as I understand it, and had been urged by the Second C i t i z e n s Advisory Cormnittee t o g e t one of the h i g h e s t competence and a b i l i t y , and so t h i s was a prob- l e m t h a t was, i n a sense, l a i d i n your l a p r a t h e r quickly a f t e r you got on the scane. What's the s t o r y of the search t o f i n d the medical d i r e c t o r ? Mr. J.: Conmissioner Larrick, who i n my judgsPant was a very a b l e public servant and administrator and who did a very good job with FDA over a long period of time, was considered t o be oriented primarily L 3 toward enforcement r a t h e r than toward s c i e n t i f i c investigation, s c i e n t i f i c a p p r a i s a l of FDA r e s p o n s i b i l i t i e s . I think t h e com- petence of FDA s c i e n t i f i c a l l y was underrated. Nevertheless, the s c i e n t i f i c cormunity f e l t t h a t i n terms of new drugs, p a r t i c u l a r l y , there was a lack of coaipetence on a broad f r o n t properly t o eval- uate the e f f e c t s of drugs. Mr. Larrick was q u i t e aware of t h i s and undertook t o find a strong d i r e c t o r f o r the Bureau of Medicine i n the F M under whom the medical a c t i v i t i e s , the evaluation of new drugs and the l i k e , came. His d i r e c t o r had resigned and he had been without one f o r a while. Mr. Larrick had d i f f i c u l t y i d e n t i f y i n g the individual he wanted. A t one point along the way he did i d e n t i f y three people, any one of whom he thought might s a t i s f a c t o r i l y do the job. Of these three, he picked one and recoemended him, Dr. Charles May. I advised him t o go ahead and make contact with Dr. May, determine whether o r n o t he would be available. Meanwhile, i t seemed t h a t he would be. There would be the normal f i e l d i n v e s t i g a t i o n of Dr. May before appointment t o a major p o s i t i o n of t h i s kind. Dr. Hay was then a research professor of p e d i a t r i c s a t New York University and had been very prominent i n research, p a r t i c u l a r l y i n the use of drugs, pharmaco- logy, through the years. He looked good on paper. Commissioner Larrick determined t h a t Dr. May would be a v a i l a b l e and t h a t he would be very i n t e r e s t e d in having the job. W n t h e preliminary f i e l d i n v e s t i g a t i o n came in, there were some questions, n o t as t o Dr. May's s c i e n t i f i c competence, but as t o some broader judgments and personal t r a i t s t h a t indicated he would have some d i f f i c u l t y , perhaps, i n securing support from the s c i e n t i f i c cornunity i n be- h a l f of FDA s c i e n t i f i c evaluacions. It seemed very apparent t o sora? of us t h a t the job the FDA had t o do could n o t be done alone by FDA personnel. Panels of experts from the s c i e n t i f i c connaunity, primarily the academic coarenmity, would be r e q u i r e d f o r s o p h i s t i c a t - e d judgrsants on complex questions having t o do, say, with drugs or with the e f f e c t of products regulated and approved by FDA. These questions t h a t seemed t o be r a i s e d in connection with the prelim- inary i n v e s t i g a t i o n led t o the need f o r a f u l l f i e l d investigation of Dr. May. "his would require s e v e r a l months. While t h i s inves- t i g a t i o n was going on, Dr. May became somewhat restless a t a delay, a f t e r having been approached. There were some i n t e r e s t s desirous of having Dr. May in the job, p a r t i c u l a r l y those who, both within and outside of FDA, were c r i t i c a l of FDA's s c i e n t i f i c competence. Dr. Hay, when there was delay i n h i s appointment, f i n a l l y s a i d through Mr. Larrick t h a t unless he had word by such and such a date he would ask t h a t h i s name be withdrawn from consideration. This matter was presented t o Secretary Ribicoff by me. The Secre- tary s a i d he would n o t waive the requirement f o r f u l l f i e l d i n v e s t i - gation, as he had the r i g h t t o do, on the b a s i s of information then available. This was relayed back t o Conmissioner Larrick by me. A week or so l a t e r , word came back t h a t Dr. May would be able t o delay h i s decision a t l e a s t s e v e r a l months longer. Dr. Y.: He kept h i s name i n the pot. Mr. J.: He kept h i s name i n the pot. Meanwhile, Secretary Ribicoff had resigned and Secretary Celebreeze had replaced him before the f u l l f i e l d i n v e s t i g a t i o n was completed. When t h i s r e p o r t was a v a i l a b l e , which obviously was a very c o n f i d e n t i a l document, b u t one t h a t is usually-is always--available f o r a major appointment, d e n t h i s r e p o r t was made a v a i l a b l e t o ate I went over i t myself and then had Conmissioner Larrick review it. In my judgment, because of q u a l i - t i e s o t h e r than s c i e n t i f i c competence t h a t had t o do, again, w i t h judgment and a b i l i t y t o work with o t h e r people primarily, i t seemed t o me unwise t h a t Dr. May be given t h a t kind of responsibility. In answer t o a d i r e c t question from me as t o whether he thought Dr. Hey could handle the job and whether he would be successful i n it, Commissioner Larrick s a i d that he thought the chances were about 50-50 t h a t he would be successful. I then s a i d , "Cotmissioner Larrick, would you be w i l l i n g t o appoint a man i n a major job of t h i s kind you thought had only a 50-50 chance of being successful?1' H e s a i d , "In t h i s case, yes, because I have no o t h e r alternative." I disagreed that t h a t kind of percentage w u l d be i n the public i n t e r e s t f o r t h a t important a job. However, the whole matter with L 6 the f u l l r e p o r t w a s presented t o Secretary Celebrezze who, on con- s i d e r a t i o n , but without much h e s i t a t i o n , s a i d he would n o t approve the appointment. Conmissioner Larrick then s a i d he had done a l l he could t o f i l l the job; he'd have t o leave i t i n the hands of others. That meant t h a t I had the r e s p o n s i b i l i t y then t o i d e n t i f y a person acceptable t o Commissioner Larrick and t o the Secretary who could be appointed t o the position. That was the s t o r y of Dr. May a t t h a t p a r t i c u l a r time. Dr. Y.: Now, t h i s was used l a t e r on by c e r t a i n groups, the f a c t t h a t Dr. May was n o t appointed, i n a way t o r a t h e r belabor both the Agency and the Secretary's o f f i c e , wasn't it? Yes, i t was. This was done i n a committee hearing of the Senate Sub-Committee on Government Operations, chaired by then Senator Hubert Humphrey a t a public hearing a t which he had Dr. May t e s t i f y along with Dr. Nestor, the disgruntled employee of the Bureau of Medicine of FDA, whose testimony was p u t together i n collabora- t i o n with Mr. J u l i u s Cahn on Senator Humphrey's committee s t a f f . This mtter was mentioned i n the public heartng very strongly by Senator Humphrey who s a i d t h a t he understood Dr. May's testimony before h i s conunittee was very good and incidently, I thought SO myself, in c o n t r a s t t o Dr. Nestor's which I d i d n ' t think was good, L but Senator Humphrey r e f e r r e d t o the excellence of Dr. May's presentation. He s a i d he understood t h a t he had been blocked as the medical d i r e c t o r of FDA. He couldn't understand why t h i s w a s so; he intended t o f i n d o u t who was responsible and to g e t t o the bottom of it. Dr. Y.: You were there t h a t day yourself. Mr. J.: I s a t i n the hearing. I was n o t t e s t i f y i n g t h a t day. However, a f t e r s e v e r a l attempts t o discuss the matter with Senator Humphrey, attempts which I think were blocked by h i s s t a f f who d i d n ' t want me t o deal d i r e c t l y with the Senator, although I s a w him s o c i a l l y s e v e r a l times, each time saying t h a t I ' d l i k e t o see him. He was very c o r d i a l but I never got an appointment f o r t h i s purpose. On the t h i r d occasion, however, the Senator s a i d he wanted to see me and would work i t o u t i f I ' d c a l l a c e r t a i n person on h i s s t a f f , which I did, and I did g e t an appointment and in a very s h o r t period I explained the whole May s i t u a t i o n t o him. Dr. Y.: This was while you were i n a car, I t h i t k you s a i d . Mr. J.: Well, my appointment was interrupted, even before I got t o it, by a 8 c a l l from the White House requiring Senator Humphrey's presence and o u r conversation was i n h i s c a r r i d i n g from h i s o f f i c e i n the Capitol Building t o the White House. Dr. Y.: He seemed persuaded? M r . J.: Well, he s a i d t h a t "If I ' d known what Dr. Nestor's testimony was going t o be, I wouldn't have had him testify". I s a i d , "Mr. Cahn of your s t a f f knew what the testimony w a s going t o be, and I was surprised t h a t they would have t h a t kind of testimony under those circumstances." In any event, I explained the s i t u a t i o n concerning Dr. May t o Senator Humphrey., There was e v e r any f u r t h e r public mention of it from Senator Humphrey o r h i s s t a f f , and some months later, when I saw the Senator i n an e n t i r e l y d i f f e r e n t context, he volunteered a statelllent t o me. H e said, "Bo, I have learned more about the s i t u a t i o n concerning Dr. May and I agree t h a t he should n o t have been given the job". Dr. Ye: h,t o go back: When you had decided and the Secretary had agreed t h a t t h i s appointment shouldn't be made, the task of finding a medical d i r e c t o r was placed i n your la$? Mr. J.: Yes. I might add t h a t we had a l o t of pressure from those who were sponsoring Dr. May t o explain why he wasn't appointed, and we took the position t h a t we never explained why anybody wasn't appointed a s there were many people who were n o t appointed t o public office. We would defend any appointment t h a t was made. Dr. Y.: What was the n a t u r e of the motivation of the groups t h a t were c r i t i c a l ? Mr. J.: Jh. Nay had made something of a name f o r himself f o r being a very strong advocate of t i g h t c o n t r o l s over new drugs and products put on the market by pharmaceutical manufacturers, and i t was assumed by those who were very heavily consumer-oriented o r anti-business t h a t there was undue influence from manufacturers which blocked Dr. May's appointment. This was absolutely untrue. I t had nothing t o do with i t a t a l l . Dr. Y.: It was e n t i r e l y an impersonal evaluation of Dr. May's f i t n e s s f o r the position? Mr. J.: T h a t ' s correct. And Senator Humphrey was one of the strong con- sumer advocates. 10 Dr. Y.: Now there were representatives of the press i n t h i s camp. Is that right? Mr. J.: Well, p a r t i c u l a r l y , I think Mr. Mintz of the Washington Post. Besides him, I don't i d e n t i f y off-hand o t h e r s i n t h i s camp. Dr. Y.: Within the Food and Drug Administration, there were people who sided with t h i s f a c t i o n ? M r . J.: A few. Dr. Y.: On what grounds? Mr. J.: These were professional judgments which I was n o t q u a l i f i e d a s a non-professional t o evaluate, but the issue seemed t o be t h a t the leadership and the consensus on evaluation of c e r t a i n drug products, f o r example, reached by the Bureau of Medicine was n o t compatible with the ideas of one o r two o r three of the team making the eval- uation, and, instead of accepting the judgment of the department of which they were a p a r t , they would c r i t i c i z e t h e i r colleagues t o people like Mr. Cahn of Senator Humphrey's s t a f f , and the s t a f f 11 of Senator Kefauver who was very much i n t e r e s t e d i n drug matters. In e f f e c t , they were staying i n the organization and c r i t i c i z i n g the organization of which they were a part. This d i d n o t seem t o be proper procedure. As a matter of f a c t , Mr. Cahn as s t a f f mem- ber f o r Senator Humphrey asked Commissioner Larrick f o r permission t o t a l k with Dr. Nestor and one of his a s s o c i a t e s i n the prepara- t i o n of material f o r Senator Humphrey's committee, presumably c r i t i c a l of c e r t a i n decisions made by FDA. Comissioner Larrick agreed t h a t Dr. Nestor and any o t h e r of h i s s t a f f could say what- ever they wished t o the committee s t a f f , but he would l i k e a t r a n s c r i p t of what they s a i d or have a r e p r e s e n t a t i v e present during the questioning. Mr. Cahn objected t o t h i s saying t h a t i t would lead t o incrimination i f the FDA d i d n ' t l i k e it. The matter was r e f e r r e d t o me by Commissioner Larrick and the Secretary backed me. "We would be glad t o have them give you any testimony they want, but we have a r i g h t t o know what i t is they say, no matter how c r i t i c a l , with assurance t h a t there w i l l be no adverse procedure a f f e c t i n g these career people." Wr. Cahn s a i d t h a t i f we d i d n ' t allow the p r i v a t e interviews, he would have no recourse but t o have open hearings and have i t a l l come o u t i n the open. I t o l d Mr. Cahn myself t h a t we would much p r e f e r the open hearings, however c r i t i c a l , t o a s t a r chamber session. The hearing a t which both Dr. Hay and Dr. Nestor appeared and a t which t h Senator Humphrey c r i t i c i z e d the f a i l u r e t o appoint Dr. May as Director of the Bureau 12 of Medicine f o r the FDA was a d i r e c t outgrowth of t h a t episode with Mr. Cahn. Dr. Y.: So t h a t DT. Nestor could say, and the records show what he did say, what h i s own opinion was. Do you have the f e e l i n g t h a t there had been personal collaboration between Mr. Cahn and Dr. Nestor p r i o r t o h i e tes timony? Mr. J.: Well, there usually is with a s t a f f m e m b e r and a witness--not exactly collaboration but comparing of notes and agreement on the area t o be covered. I f e e l , i n t h i s case, t h a t there was a very close con- sultation. This is only i l l u s t r a t i v e of the type of pressure t o which the regulatory agency was subjected by the s t a f f of a com- mittee of Congress exercising a legitimate function of the committee. Dr. Y.: Of course. And there were real problems about the s c i e n t i f i c competency of the agency which d i d need t o be confronted, of which the s e l e c t i o n of the proper medical d i r e c t o r was one? Mr. J.: With t h i s background, then, the s e l e c t i o n of a d i r e c t o r f o r the Bureau of Medicine became a very s e n s i t i v e matter both s c i e n t i f i c a l l y and p o l i t i c a l l y . So t h a t we had t o be absolutely c e r t a i n t o g e t an 13 individual of considerable s t a t u r e and p r e s t i g e i n the s c i e n t i f i c community, t o overcome t h i s type of sniping, t h i s type of criticism as t o the s c i e n t i f i c competence of the FDA, some of which, I might add, was j u s t i f i e d . Dr. Y.: You were a c t u a l l y wishing the same kind of man as your c r i t i c s were wishing from the p o i n t of view of r i g o r and q u a l i t y ? Mr. J.: No difference there, and Commissioner Larrick was i n f u l l agree- ment. He j u s t couldn't g e t one. Dr. Y.: Now, what was the procedure you followed in seeking t o make t h i s appo inmen t? Mr. J.: Immediately I got i n contact with the leading pharmacologists of the country, primarily i n academic c i r c l e s , one by one t o express the Depattment*s deep concern that the leadership of t h i s very important regulatory a c t i v i t y of FDA be i n the hands of s c i e n t i f i c competence of the h i g h e s t order. I made i t very c l e a r t h a t it would be necessary f o r the s c i e n t i f i c community through panels of experts t o p a r t i c i p a t e with FDA i n s c i e n t i f i c judgments r e l a t e d t o the evaluation, p a r t i c u l a r l y of new drugs, as they were presented 14 f o r approval by FDA. The s o p h i s t i c a t i o n of chemical compounds, the very rapid development i n t h i s f i e l d through research sponsored by pharmaceutical houses, and o u t s i d e of the cormnercial range a l s o , was such as t o r e q u i r e the b e s t of judgment as t o s i d e e f f e c t s , deleterious e f f e c t s , weighed a g a i n s t the b e n e f i c i a l e f f e c t s . The FDA, n e i t h e r then nor ever, would have the f u l l range of competence Y, to make these sophisticated judgments. Therefore, the s c i e f t i f i c leadership had t o be such as t o secure sympathetic response from the e x p e r t s i n the country wherever they may be, p a r t i c u l a r l y i n the academic i n s t i t u t i o n s . Through a s s o c i a t i o n c o n t a c t s , through individual c o n t a c t s , we reached personally, probably a hundred of the leaders of pharmacological competence t h a t were n o t d i r e c t l y r e - l a t e d t o business t h a t would be regulated. W e o f f e r e d the job a c t u a l l y t o about f i v e o r s i x of the top people. Dr. Y.: A s an i n d i c a t i o n of the q u a l i t y , could you give some of those names? Mr. J.: Yes. Dr. Harry Dowling, University of I l l i n o i s ; Dr. Dickinson Richards who had r e t i r e d a s Chairman of the Department of Medicine a t the College of Physicians and Surgeons of Columbia, who was a Nobel laureate. I could mention o t h e r s ; these a r e i l l u s t r a t i v e of the types of people whose competence we f e l t w a s required. 15 Dr. Y.: The f a c t t h a t they d i d n ' t take the position d i d n ' t i n d i c a t e any- thing about t h e i r a t t i t u d e toward the agency? The reasons were purely personal, I take it. Hr. J.: In both cases, the reasons were personal, so much so t h a t I waited i n each instance t h r e e o r four months t r y i n g t o g e t t h e i r s i t u a - tion such t h a t they could accept the position. I n both instances, reasons of h e a l t h m i l i t a t e d a g a i n s t it. I n the case of Dr. Richards, I might add t h a t President Kennedy himself a t our r e - quest talked with Dr. Richards t o encourage him t o accept the position. The only reason he d i d n ' t was because of the advice of h i s physician by v i r t u e of the f a c t t h a t Dr. Richards had had a h e a r t a t t a c k some months previously and i t was f e l t t h a t the pressures of the j o b would be too much f o r him. This is the kind of competence we were seeking, and there were s e v e r a l o t h e r s whom we sought t o r e c r u i t of the same c a l i b r e generally. And I think the word g o t around i n s c i e n t i f i c c i r c l e s , and I s a i d so d i r e c t l y to about 100 i n on8 group, t h e r e was no point i n having t h a t p a r t i - c u l a r group continue t o c r i t i c i z e the s c i e n t i f i c competence of FDA u n t i l some among t h e i r number were w i l l i n g t o take some responsi- b i l i t y f o r t h i s a r e a of FDA activities. This h i t a responsive chord and the academic community became i n t e r e s t e d i n helping find the r i g h t person. We f i n a l l y found the r i g h t person i n my 16 judgment i n Dr. Joseph Sadusk who was then a t George Washington University i n Washington, who had had a distinguished career i n medicine, both as a c l i n i c a l p r a c t i t i o n e r , as a f a c u l t y member a t Yale and a t George Washington University, who ha been chairman and s t i l l was of AM's--American Medical Association s--d i v i s ional council -- Dr. Y.: On drugs? Mr. J.: No, on l e g a l medicine. Dr. Lhwling had been chairman of AHA'S Council on Drugs a t one time. Dr. Sadusk was i n the same c a l i b r e of leadership we were seeking, and by g r e a t a s s i s t a n c e from Dr. John Parks, Dean of the George Washington School of Medicine, under whom Dr. Sadusk w a s then working, with f u l l cooperation of the University, a f t e r considerable meditation, Dr. Sadusk agreed t o undertake the job. When he came i n t o i t , I think he did extremely well, i n i d e n t i f y i n g the problems, i n a t t r a c t i n g the s c i e n t i f i c conununity, and i t was very s h o r t l y a f t e r he took over t h a t I, my- s e l f , resigned t o r e t u r n t o Atlanta. Dr. Y.r The matter i n connection with the medical d i r e c t o r is j u s t sympto- matic of problems t h a t , according t o the record, the Food and Drug Administration had i n the realm of developing i t s s c i e n t i f i c 17 competence t o the l e v e l t h a t was required by the drug p i c t u r e of our day. There had been criticisms i n a couple of C i t i z e n s Ad- visory Conmittee r e p o r t s about t h i s , so t h i s was solving one problem i n a c e r t a i n sense, the appointment of Dr. Sadusk, b u t there i s some i n d i c a t i o n t h a t i t may n o t have been a complete solution, s i n c e the key administrators remained people who had come up through the ranks i n the regulatory s i d e and f o r whom q u i t e n a t u r a l l y the increasingly complex s c i e n t i f i c problems t h a t were confronted must have been somewhat overwhelming. They needed the best advice t h a t they could get. Mr. J.: My impression was as Dr. Sadusk came i n t o the p o s i t i o n and he was received w i t h a g r e a t deal of warmth and appreciation. Of course, Conmissioner Larrick was f u l l y a p a r t i c i p a n t i n the choice and s e l e c t i o n of Dr. Sadusk when I was able t o i d e n t i f y him as one available, and as f a r as I could t e l l the whole FDA s t a f f , includ- ing those i n the Bureau of Medicine, responded to t h i s kind of leadership. Dr. Y.: Now, a f t e r you had come back t o Atlanta, Mr. Larrick decided t h a t he would retire as Conmissioner of Foods and Drugs and, by t h i s t i m e , there was a new Secretary of Health, Education and Welfare, Secretary Gardner, and the t a s k of s e l e c t i n g Mr. Larrick's successor 18 confronted im. A committee was s e t up to chose the new Commis- sioner of Food and Drugs and you were a member of t h i s committee. As i t turned out, i t seems to me, t h i s was one of the most im- portant t r a n s i t i o n s i n the leadership of the Food and Drug Administration of a l l i t s h i s t o r y since 1906, because i t was the f i r s t time t h a t the new Commissioner was chosen from outside the agency r a t h e r than from having r i s e n within the ranks of the agency and it was the f i r s t t i m e , too, f o r , oh, 40 years, a t any r a t e , t h a t a man of s c i e n t i f i c t r a i n i n g became the new Comissioner. I think it's important i n the h i s t o r i c a l record to r e f l e c t on how t h i s comaittee, of which you were a member, went about the task of s e l e c t i n g the new Cornaissioaer a f t e r Mr. Larrick had submitted h i s resignation. Nr. J.: I think the f i r s t thing I should say is t h a t the committee was not to s e l e c t but only to i d e n t i f y appropriate condidates f o r the Secretary t o consider. The committee met several times. It p u t i n t o consideration names which the individual members of the com- mittee themelves wished to see considered. It accepted recom- mendations from whatever source names came. Dr. Y.: Did a good many names come i n ? L 19 Mr. J.: Not too many, r e a l l y , but enough f o r a considerable breadth of selection. Dr. Y.: Did you sense t h a t industry, the d i f f e r e n t segments of the regu- l a t e d i n d u s t r i e s , presented w h a t might be considered candidates? Mr. J.r No, my own f e e l i n g , and t h i s is impressionistic, because you never can r e l y completely on motivations t h a t others have, i n terms of your a p p r a i s a l of them, but my own impression was t h a t the regu- l a t e d i n d u s t r i e s , p a r t i c u l a r l y the pharmaceutical industry which had been publicized p r e t t y l a r g e l y through new drug regulation problems w a s very anxious t o see competence. They d i d n ' t much care about individuals so long as they f e l t t h a t there was good administration and a sense of fairness. And as f a r a s I could t e l l they were n o t i n t e r e s t e d i n t r y i n g t o influence the s e l e c t i o n in one d i r e c t i o n o r another, but only t o t r y t o help suggest strength i n t h e i r p o s i t i o n from the standpoint of both administra- tive competence and f a i r judgment. Dr. Y.: Many of t h e i r j o u r n a l s argued p r e t t y strongly t h a t the choice should be made from within the agency. 20 Mr. J.: This may have been so. It d i d n ' t influence the connuittee one way or the other. The committee would have preferred, I thiiak, a s I would a s an administrator, t o promote from within. This leads to morale-building, i t recognizes experience, rewards those who have contributed. But the committee was not bound by t h i s , a l - though i t would have preferred t o be a b l e t o recormend an hppoint- ment from within. Dr. Y.: As I read what l i t t l e has come o u t i n connection with t h i s , p a r t i c u l a r l y the document the c o r n i t t e e i t s e l f submitted, I g e t r the idea t h a t before the committee r e a l l y t r i e d t o pick a person, i t drew up a p r e t t y comprehensive l i s t of c r i t e r i a as t o the q u a l i t i e s t h a t the person picked should have. Mr. J.: Before names were even l i s t e d , the c o r n i t t e e , in i t s f i r s t meet- ings, decided on t h i s procedure, t h a t is, a l i s t i n g of c r i t e r i a on which selections would be made and then would consider in- dividuals a g a i n s t t h i s l i s t of criteria. Obviously, no individual would be 100 percent responsive t o each c r i t e r i o n l i s t e d , but the c r i t e r i a were important i n objective judgment as t o the type in- dividual should be i n the job. Dr. Y.: Now, was t h i s a kind of consensus conversation i n which.... Mr. J.: Oh, yes. It was a very small committee and everything was reached by consensus. Dr. Y.: You s a t around and talked about the q u a l i t i e s t h a t the Comissioner should have--somebody kept notes and.... Mr. J.: That is correct. Dr. Y.: Made an organization, a l i s t i n g of these, t h a t were submitted t o you so t h a t you a l l shared i n t h i s drawing up of the l i s t ? Mr. J.: That's correct. Dr. Y.: When the l i s t #S drawn up, i t c e r t a i n l y was a l i s t t h a t p u t s c i e n t i f i c competence of the agency, which we've been t a l k i n g about i n connection with the medical d i r e c t o r , very high as a responsi- b i l i t y e i t h e r o f the new Commissioner o r of h i s Deputy o r of an a s s i s t a n t o r a s s o c i a t e conrmissioner of science. t 22 Mr. J.: The connuittee recognized the importance of hating e x c e l l e n t s c i e n t i f i c competence somewhere very high i n the policy l e v e l of FDA, and i t had t o be one of the top two o r three p o s i t i o n s i n the judgment of the committee. Dr. Y.: Now, a f t e r the l i s t was drawn up, what was the procedure toward winnowing the l i s t of names t h a t you had acquired from various sources? Mr. J.: This then became a subjective a n a l y s i s of objective data. I can't describe how a group of f i v e o r s i x people evaluate these things, any more so than you do how a j u r y a r r i v e s a t a decision. Dr. Y.: The coamittee was a group session, by conversation, talking the names over one by one? Mr. J.: And r e l a t i n g the data concerning one individual t o the c r i t e r i a t h a t had been established. Dr, Y.: Dr. Goddard, I take it, rose from the discussion t o the l e v e l of choice on the p a r t of the coamittee as a person t o recommend t o 1 23 the Secretary. Mr. J.: This is correct. I might say, c e f e r r i n g back t o the e a r l i e r p a r t of our conversation, t h a t Dr. Goddard was one of those with whom I discussed the p o s i t i o n as Director of the Bureau of Medicine. I gave you two names--Dr. Goddard was a t h i r d one. He was then Director of the Comorunicable Disease Center of the Public Health Service, where he had done an outstanding job. H e was well known f o r the competence of h i s administrative procedures and the vigor of h i s i n t e r e s t i n p u b l i c h e a l t h and h e a l t h protection matters. Again, Dr. Goddard was one of those who, f o r h e a l t h reasons, was unable t o take the job, b u t it was the h e a l t h of a member of h i s family, n o t of himself, and by the t i m e the committee considered - t h i s proposition, i t had been determined t h a t t h i s problem had been resolved, and t h a t Dr. Goddard, i f he were s e l e c t e d and i f he were i n t e r e s t e d , could make the t r a n s i t i o n . Dr. Y.: Did the White House have any r o l e a t a l l i n t h i s s e l e c t i o n ? Mr. J.: None a t a l l . Obviously, the White House was g r e a t l y i n t e r e s t e d because t h i s was a matter of p u b l i c debate in some segments of the press and a mather of concern t o important members of Congress. Thereforp, the White House E W concerned b u t i t did n o t p a r t i c i p a t e 24 o r have a hand i n the decision, leaving the judgment t o the Depart- ment. Dr. Y.: And so, of course, I presume t h a t when the Secretary made the decision, the White House was informed and agreed before the formal o f f e r was made. Is t h a t t r u e ? Mr. J.: Well, I don't know because I was then only a consultant, but I would presume, as is t r u e i n major appointments of t h i s kind, t h a t White House clearance is a customary procedure, properly so. Dr. Y.: Surely. The White House expressed i t s i n t e r e s t by announcing the appointment, as I understand it, i n any case. Did you personally t a l k t o Dr. Goddard about t h i s as an o f f i c i a l r e p r e s e n t a t i v e of the c o r n i t t e e , while i t was i n the discussion s t a g e ? Mr. J.: When i t was c l o s e t o decision, the Conrmittee informally authorized me t o determine whether o r n o t Dr. Goddard w a s i n a position t o ac- c e p t the place o r would be i n t e r e s t e d i n it. This was because I knew personally of the f a c t t h a t he could n o t move t o Washington before. I d i d make inquiry of Dr. Goddard d i r e c t l y , and he explained the s i t u a t i o n which had been a d e t e r r e n t before as now being removed, t h a t he, i f he were wanted, would be available. One of the p l u s f a c t o r s concerning Dr. Goddard was t h a t he w a s a c a r e e r o f f i c e r with the Public Health Service, and one of the concerns was t h a t the FDA and the Public Health Service needed t o operate i n as c l o s e collaboration as possible since they were sister agencies i n the same Department and had supplementary o r p a r a l l e l r e s p o n s i b i l i t i e s which, i f n o t c a r e f u l l y understood, could be competing o r d u p l i - cating responsibilities. I think there was some considerable s a t i s f a c t i o n t h a t a competent person i n the c a r e e r service, i n the Public Health Service, acceptable t o the FDA people, too, a s we learned by d i s c r e e t inquiry, was a v a i l a b l e , although t h i s was n o t the determining f a c t o r by a long shot. Dr. Y.: Surely. One reads over the l i s t of c r i t e r i a and then thinks of Dr. Goddard's background and s e e s why he would be a strong choice f o r the committee t o come to. I ' d l i k e t o go back t o the period when you were i n Washington. One of the major problems t h a t t h e Food and Drug Administration wrestled with f o r a long time was the problem of Krebiozen, and I remember from perhaps the f i r s t time t h a t I saw you i n your o f f i c e there t h a t this was one of your msjor problems t h a t r e l a t e d t o the agency-was the matter of Krebiozen. You had a l e t t e r on your desk about i t when I came i n t h a t day. One of the things about the Krebiozen problem t h a t went on over a number of years, t h a t made i t t r i c k i e r than o t h e r promotions of 26 unorthodox cancer cures, so-called, was t h a t i t was bolstered so s t r o n g l y by Dr. Andrew Ivy whose s c i e n t i f i c reputation w a s known, and another reason was t h a t i t was supported so strongly by Senator Paul Douglas of I l l i n o i s . Did you have any personal contact during your concern w i t h t h i s problem w i t h e i t h e r Lk. Ivy or with Senator Douglas t h a t you could t a l k about, and I ' d be i n t e r e s t e d i n your own speculation as t o their motivations in being involved i n a matter of t h i s kind. Mr. J.: I think I should say f i r s t t h a t when I was e s t a b l i s h e d i n the p o s i t i o n in Washington, Commissioner Larrick made known t o me t h a t FDA had been concerned f o r some y e a r s with the d i s t r i b u t i o n of Krebiozen as a new drug d i s t r i b u t e d f o r experimental purposes which was within the l a w generally. He s a i d t h a t the f e e l i n g generally was t h a t i t was worthless; t h a t the National I n s t i t u t e s of Health of the Public Health Service, p a r t i c u l a r l y the National Cancer I n s t i t u t e , f e l t the same way about it, but t h a t they were n o t able e f f e c t i v e l y t o evaluate Krebiozen and i t was a problem f o r them. I said: "Well, i f i t ' s been a problem t h i s long, why haven't the two agencies done something about i t ? " I got no satis- f a c t o r y answer, so I said: "Well, i t ' s time t o do something about it". Then the new drug regulations came o u t which tightened the b a s i s upon which experimental drugs could be d i s t r i b u t e d and t h i s gave an opportunity f o r FDA t o review Krebiozeo a s a new drug being 27 used f o r experimental purposes. Regulations required the sub- mission of data having t o do with t h e manufacturing standards of t h i s p a r t i c u l a r product. The experimental program f o r i t s use, the competence of the people who were managing the use, the re- porting system, and the like. There was some question as t o whether t h i s was a drug under FDA regulatory supervision o r a biological under the supervision of the NIH which had the biologic standards... Dr. Y.: Branch? Yes, a branch of the Public Health Service administered under NIH. So I got representatives of the Public Health Service and FDA to- gether t o discuss the matter and there was e n t h u s i a s t i c response toward a proper evalubtion of Krebiozen o r an e f f o r t t o h a l t its d i s t r i b u t i o n in the absence of conformity with requirements f o r the use of experimental drugs by the sponsors of Krebiozen. That's the way the matter s t a r t e d . Dr. Andrew Ivy had been a very highly distinguished research s c i e n t i s t i n cancer chemotherapy. He published many research papers. He, f o r some years, had been the leading proponent of Krebiozen f o r use i n the treatment of cancer. The real producers Were two brothers known as Durovic--D U R 0 V I C - - . It was v i r t u a l l y impossible t o g e t from the Durovic brothers o r from Dr. Ivy information on which an evaluation could be made of the 28 product, t h a t is, standards of production, so t h a t the government agencies would know t h a t a product they t e s t e d would be the same product t h a t would be produced the next time under the same standards. It w a s very d i f f i c u l t t o g e t samples and impoksible t o g e t any information as t o standards of production f o r the product. I won't go i n t o d e t a i l , but Senator Douglas had been a very c l o s e personal f r i e n d of Dr. Ivy and had g r e a t confidence i n Dr. Ivy and f e l t that Dr. Ivy would n o t be supporting t h i s product unless Dr. Ivy had good s c i e n t i f i c reasons f o r it. The controversy had gone on f o r a long time. There were hundreds of people who, we found, were paying o r making contributions t o the Krebiozen foundation, so-called, v o l u n t a r i l y f o r Krebiozen which was then administered t o them, sanetimes by t h e i r own physicians, but a l - ways on the demand of the p a t i e n t who may have bean beyond hope i n terms of known methods of therapy, surgery, r a d i a t i o n and chemi- cals. When t h e i r own doctors had given up hope of cure o r even c o n t r o l of the condition, then the victims and t h e i r f a m i l i e s would look t o any source they could t h a t o f f e r e d hope. Krebiozen was t h i s source of hope f o r many of them. The FDA, then, launched an investigation. The evidence eventually w a s such a s t o support an indictment of the Durovic brothers and of Dr. Ivy. The case w a s t r i e d , one of the longest t r i a l s i n I l l i n o i s h i s t o r y , and the j u r y exonerated these people, although FDA kept the product from d i s t r i b u t i o n i n i n t e r s t a t e commerce. 29 Dr. Y.: The company submitted a plan f o r i n v e s t i g a t i o n a l use before a c e r t a i n deadline, but then before the deadline came, they with- drew the plan again. Now, i n the course of t h i s tortuous series of events, d i d you t r y t o di{uade Senator Douglas from h i s com- mitment? Mr. J.: It was the o t h e r way around. Senator Douglas, through pressure on President Kennedy, had sought t o have FDA and the department of HEW cease and d e s i s t the u n f a i r persecution of the promoters of Krebiozen o r e l s e t o give i t a f a i r t e s t a t the Cancer In- stitute. A f a i r t e s t i n Senator Douglas' nomenclature was impossible because the National Cancer I n s t i t u t e could n o t g e t the b a s i c d a t a on which t o make a test. A l l i t had were case h i s t o r i e s prepared by Dr. Ivy and h i s a s s b c i a t e s which could n o t be evaluated. Dr. Y.: Expert committees looked a t them and decided. Mr. J.: Well, we s e t up an expert committee, both i n house, t h a t is, f u l l - time s c i e n t i s t s a t the National Cancer I n s t i t u t e i n Bethesda, and experts i n the f i e l d from primarily academic i n s t i t u t i o n s a l l over the country. They took a hundred and some-odd case h i s t o r i e s t h a t Dr. Ivy had submitted and supplemented t h e case h i s t o r i e s w i t h f u l l h o s p i t a l records secured with p e w i s s i o n of the patients' families through FDA agents. A f u l l record on each and every case w a s there and there was absolutely no basis, according t o the r e p o r t of the National Cancer I n s t i t u t e ' s s e l e c t committee, t o j u s t i f y the claim t h a t there was e f f i c a c y i n the use of Krebiozen f o r cancer. Meanwhile, the FDA d i d g e t samples, very small samples, of the product c a l l e d Krebiozen, subjected t h i s t o a n a l y s i s and with a s t r o k e of great, good luck based on highly competent s c i e n t i f i c study, they d i d d i s - cover t h a t , i n a d d i t i o n t o mineral o i l , which w a s the base of Krebiozen, there was a product i n i t which turned o u t t o be nothing b u t creatine--C R E A T 1 N E--which i s a product nor- mally i n the blood anyway. This product could be bought very inexpensively from supply houses, chemical supply houses, b u t the Durovics claimed t h a t t h i s was a product prepared from the blood of horses t h a t had been innoculated through a procedure. Well, the evidence t h a t FDA i n v e s t i g a t o r s got f u l l y s u b s t a n t i a t e d indictment a g a i n s t these people. My own personal f e e l i n g is t h a t only the emotion of cancer p a t i e n t s who thought they were being helped by Krebiozen and the age and previous reputation of Dr. Ivy saved Dr. Ivy and the Durovic brothers from paying the f u l l penalty f o r t h i s kind of alleged fraud. Dr. Y.: Well, when Senator Douglas brought pressure on President Kennedy, did he come over t o see you then? Did the President r e f e r him... M r . J.: No. This matter was r e f e r r e d t o me by the President, and Senator Douglas m a t , probably more than once, but a t one time with Dr. Kenneth Endicott who d i r e c t e d the National Cancer I n s t i t u t e , and Dr. Endicott agreed with Senator Douglas on the b a s i s on which the National Cancer I n s t i t u t e could give a c l i n i c a l t e s t of K r e - biozen. Senator Douglas agreed t h a t i f the Durovics and Ivy did n o t agree t o t h i s , then he was through. The Durovics did n o t conform, although they claimed they did. They did n o t supply the samples. They d i d n o t give the b a s i s upon which the product was produced t o assure the product t e s t e d could be reproduced by them, without revealing t h e i r s e c r e t s even, and Senator Douglas never accepted the f a c t t h a t the agreement had n o t been l i v e d up to, althoukh he was p r e t t y sure of it. Some months later while- t h i s went on f o r a long time--some months l a t e r a f t e r Hr. Johnson became President, almbst i m e d i a t e l y , i n a s h o r t while, a t least, Senator Douglas again sought t o remove t h i s i n v e s t i g a t i o n through pressure from the White House. I happened t o be i n the o f f i c e of Mr. Feldman, Special A s s i s t a n t t o the President, when the President c a l l e d him and wanted t o see him. Senator Douglas had j u s t called t h e President about Krebioeen, and Mr. Feldman s a i d , "You come go 32 with me". He t o l d the President he had the man who knew most about i t there. I explained t o President Johnson what the matter was. He s a i d , "Well, you c a l l Senator Douglas and t e l l him I've r e f e r r e d i t t o you and you go see him." I made an appointment then with Senator Douglas, which was my f i r s t d i r e c t contact with him, and went over a t 4 o'clock i n the afternoon and s a t with him and h i s administrative a s s i s t a n t u n t i l 7 o'clock t h a t n i g h t f o r three s o l i d hours. During t h a t t i m e , discussion on the mat- ter...it was q u i t e c l e a r t h a t Senator Douglas was involved because of l o y a l t y t o h i s friend, in my judgment. Senator Douglas d i d say t o me, a t one time, he s a i d , "The Durovics may be crooks, and I'm inclined t o believe they a r e , but I think Dr. Ivy is sincere." Well, I never could q u i t e equate t h i s f e e l i n g with h i s continued public support backing of the product Krebiozen. Dr. Y.: You did have a f e e l i n g when you went away t h a t , despite your b e s t e f f o r t s , you r e a l l y hadn't gotten through t o him anymore than o t h e r s who t r i e d had done? Mr. J.: This is q u i t e correct. He s a i d , "I don't say t h a t Krebiozen is effective. A l l I say is t h a t i t ought t o be tested." And y e t when, having agreed t o the ground r u l e s on which any drug could be tested, he would n o t accept the f a c t t h a t the Durovics had 33 n o t conformed t o the requirements f o r an adequate test. This was where I think Senator Douglas was wrong, a s did n e a r l y everyone else who experienced t h i s whole episode. Dr. Y.: And t h a t was your only personal conversation w i t h Senator Douglas during the course of the s e r i e s of events about Krebiozen? Mr. J.: Yes, t h a t ' s correct. I had some extended correspondence with him and did t a l k t o h i s administrative a i d e once o r twice. Dr. Y.: I n t h i s conversation, your e f f o r t w a s t o l a y o u t the data t h a t had been accumulated as f a c t u a l l y as you could? Mr. J.: Yes. A t t h a t time, we d i d n ' t have as much d a t a a s we acquired l a t e r when we r e a l l y swung i n t o f u l l i n v e s t i g a t i o n of t h e matter, b u t i t was enough t o i l l u s t r a t e t h a t the Durovics and Dr. I q were n o t operating in the generally accepted p a t t e r n of respon- sible scientific activity. Dr. Y.: Did you have any personal conversation with Dr. Ivy during the course of a l l t h i s ? Mr. J.: Yes. Dr. Ivy and the Durovic brothers came t o see me p r i o r t o f i l i n g the new drug a p p l i c a t i o n as required by l a w as of a certain t i m e , and I had present t h e responsible people from both FDA and the National Cancer I n s t i t u t e , a f u l l - d r e s s meeting. We laid out the requirements of the new drug regulations f o r an experimental drug concern. "hey agreed t h a t they would submit an a p p l i c a t i o n which they did. But p r i o r t o the t i m e of an evaluation of t h e i r application, they withdrew it, and i t was q u i t e obvious to me and t o the experts wbo were concerned t h a t they withdrew because they knew they could not stand up t o the investigations t h a t would come from t h e i r submission of data. It then became an emotional f i g h t , a p u b l i c i t y campaign, t h i s kind of t h i n g and very s t r o n g criticism of FDA and its methods. The FDA, i n my judgment, p e r - formed superbly as d i d the National Cancer I n s t i t u t e , and I think t h a t there wasn't any question but t h a t the f a c t s j u s t i f i e d the indictment and, I think, conviction. Dr. Y.: It looks t o me as i f t h i s tape is about finished, so I'm going t o turn i t o f f with appreciation f o r your t i m e and recollections. INDEX Cahn, J u l i u s , 6-9, 11-12 Celebrezze, Anthony J., 5-6, 11 Douglas, Paul, 26-33 Dowling, Harry, 14, 16 Durovic brothers, 27, 30, 32, 34 Endicott, Kenneth, 31 Feldman, Myer, 31-32 Gardner, John W., 17, 24 Goddard, James L . , 22-25 Humphrey, Hubert H . , 6-11 Ivy, Andrew, 26-34 Johnson, Lyndon B., 1, 23-24, 31-32 Kefauver, Estes, 11 Kennedy, John F., 1, 15, 29-31 Krebiozen, 25-34 Larrick, George P., 2-6, 11, 13, 17-18, 26 May, Charles, 2-12 Medical d i r e c t o r , FDA, 2-25 Mintz, MoTton, 10 National Cancer I n s t i t u t e , 26, 29-31, 34 Nestor, John O., 6-8, 11-12 Parks, John, 16 R i b i c o f f , Abraham J . , 4-5 Richards, Dickinson, 14-15 Sadusk, Joseph, 16-17 Second C i t i z e n s Advisory Committee, 2, 1 7 Senate Sub-Committee on Government Operations, 6 , 10-12 Washington Post, 10