An Interview with Mr. Gilberts. GoldhatI100r Dr. Y.: This is an interview with Gilberts. Goldhammer at his home in the District of Columbia on August 26, 1968. I am James Harvey \ Young of Emory University. Gilbert, you have bad a career in the Food and Drug Administration that lasted thirty-one years. f About that. Dr., Y., 3 Would you please go over your career and indicate what its nature was? Well, Harvey, I will be glad to. I came into the Food and Drug Administration in the summer of 1935, after about five years teaching of chemistry in the New York City high school system. I was given the job of inspector, although I. bad a choice of a job as ~ chemist or an inspector, but the FDA official who inter- viewed me painted such a rosy picturo of the inspector's job 9 I ,_,.., decided to set aside my plans to be a chemist, and, instead, I became an inspector. l worked as an inspector from i35 to '43~ In 1943, l was appointed chief inspector of the Buffalo Station, 2 as it was called at that timee In 1945, I went to Philadelphia Station to serve as chief inspector there, and in June of 1946 I came to Washington as one of the administrative assistants to the Commissioner ,.-ho was then Dr .. Paul B. Dunbar. I served in the Comnissioner's office until 1948 when a Division of Litiga• tion was established •nd l was Asked to serve in that division., I became Deputy Director of tbat division about four years later., The Division of•Litigation; which was the name under which the . ' di·,ision was initially established, later bec'1me the Division of Regulatory Management. In 1961, I became the Director of that division and served es its Dire_ctor until 1963, when, with a re .. organization and the establishment of a new Bureau, known as the Bureau of Regulatory Compliance, I became its Assistant Director for regulatory operations. I retired in l>ecember of 1964, only to be asked to serve in a special capacity to assist in the preparation and presentation of the Krebiozen case., And this I die until the spring of '66 when I retired a second time. And I've been retired from the Government since4 Dr. Y. s You still go back occasionally to help with the training program, isn' t that true? 3 Mr. G. & Yes. I have developed a course in Food and Drug Law for super- visory personnel of the Food and Drug Administration, and I've given some six or seven semina~s of a week•s duration to FDA supervisory personnel; and I'm scheduled to give three more to FDA inspectional, administrative, and laboratory perso*nel during '>j_.. the 1970 fiscal year. In addition, I've developed a cour,se on Food and Drug law for State officials, and I have given thre~ such seminars of a week•s duration each to St.ate officials in charge of food and drug programso l'm scheduled to give another one in Texa$ in 1970 • probably in April~ Dr. Y" i So you still keep your hand in with the agencyo l <loo One of the things that twas particularly interested in was the way, when you were with the bureaus, Regulatory Compliance and Regulatory Management, you developed a kind of team of experts there concerned with quackeryo You mayuhave been concerned E: !tJ!iiH ma: ILL &21LJ&A&!i&ii££@£££ 1t m.usa a wwwm aerna UL LU ■ 4 with other problems, too, but there was a team, as I understand it, of people who had had background in this area and bad de• veloped considerable know•how, that really regulated and man- aged the whole.anti-quackery program of FDA. Now I would be interest.id in hott this teaci came about; how it was organbed; what kind of people it had on itJ and how it operated; how you made your decisions; and what was involved in various waya in developing a major case. Mr. G.,: The Division of Litigation was established in 1948 by Coll'lll\is- sioner Charles w. Crawford., He wanted a division in FDA which would concern itself almost solely with the handlkg of cases that were already in court and the development of new cases which were particularly complex, or which were of national scope and importance~ At that time the sixteen local field stations of the Food and Drug Administration would develQp their own cases within the framework of programs set up by Washington. It was the experience of the Food and Drug Admin~ istration that, when a case was complex or gne of national in° terest and importance, Washington, gooner or later, had to get into the picture and assutae the handling of the case. The FDA field offices just weren't equipped to handle a particularly 5 complex case. Commissioner Crawford recognized this for a long time and ultimately, in 1948, he set up the Division of Litigation with the express purpose of overseeing the handling of!!!. cases that were in court anywhere in the country. The field districts were to develop cases as be• fore only if they were routine ~ases. But once the eases were in court, and there was intimation of contest, the Division of Regulatory Management, or its predeeesso;, the Division ~o:f. ,t.itigation, took over the eases and monitored :.. 1 th-em unttL ,final itdjudicat.:~on. tte ::eviewed the r.ases '::'"" t::Jf-n;,-"'.; ., ., }· :·:···?·:r-:,:11·r~·i-,~ thm~uti.ghl:ir examined the available evidence, determined its r,ia.3fficiency, and decided what else needed to be done to in- sure victory. A second function of the division was to initiate, direct; supervise, -nd follow through right to the end, any complex case or special investigations Quackery is in the category of comple~ cases. These cases are very important, and badly prepared cases make bad lawo Bad law can stymie enforcement for yeers to come. Tho$e staffing the ! Division of Regulatory Management were men who had had long experience in the development of cases and in the art of in• vestigation. They were knowledgeable in what it tekes to make a caseJ in how and where the evidence can best be ac- quired; and in the investigational skills that are necessary 6 ·to get the evidence. In addition, they had the qualities of leadership to lead and work with diverse groups, within and outside of FDA, involved in tbe development of our cases, such as inspectional, scientific• and legal sections or g1:oups. Beside yourself, who were some of the important men who were brought in to form this group? Kenneth E~ Monfore, who was the District Director of SeQttle District, Seattle StationJ James C. Pearson, who was Director of Atlanta District; myself, who was inf the CQtMlissione:r•s 'of,,.'',, fice; John T. Cain, who had many years of experience as one of FDA•s ace investigato.-sa Van w. Smart, who bad a c.onsiderable amount of experience in the handling of cases in court 1n the Western district area as an associate or an assistant to Mr~ Harvey. Mr~ Harvey was the chief of the Westem district which. I cover~d the western third of the eountry4 He was brought in to Washington in 1948 to bead up this newly organized Division of Litigation. Mr. Harvey is a lawyer and had years of experience as an inspector, and station and district director. Prior to 1948 the country was divided into three districtaa Eastern, 1 Central and Western, and Harvey headed up the last. The men who staffed the Division of Litigation, end its successor, the Division of R~gulatory Management, were outst$nding men who had made reputations for being able to develop cases• to get the evidence and win·in court. Right,.. Now, getting back tQ the question of quackery, almost all Carefui planning is necessary in dealing with quacl(ei-y, parti~ eularly where the product involved is one which is recommended for the treatment of chronic and pretty much incurable diseases, such as arthritis; or ·cane.er. X mention cancer as being in• eu,:able in the accepted sense. The fact is that two•thirds of those who are afflicted with cancer are not curedo They . ,. die of C4ncer. So, essentially, ca.ncer is still an incurable .,,,-iv 1 disease. When a product is marketed to treat such a disease, where modern medicine itself is helpless in most cases, 'except for aome pain ~e1ief or paliiative treatment, the fact that the product failed in any given case is not aub$tantial evidencee You've got to establish that the product_never succeeds; and 8 this is a tall order., For this reason such cases, by their very nature, are complex end difficult to prove., So, as a matter of policy, FDA decided that cancer and other difficult quackery cases were to be centrally initiated in Wa$hington, that is, i.n the Division of Regulatory Management, centrally directed and supervise1, .and the case itself handled from WasU.ngton even after its r:eferral to the United States attorney; which is a. departure fl'om the routine case whicJl is initiated .and windled by the local FDA District headquarters,. Dr~ Y.,s They take it to the u. s. attomey themselves 11 They take it to the u. $., attorney and work with the U., S, attomey until its final adjudication, with only nominal assistance from Washington., B1.1t not so in cases which a,:e extraordinarily difficult or which are of national scope and importance, and that•s when we came into the picture from the very beginning. Dr. Y.s In the~!!!!!, Drug Review• the house organ for FDA, in an article about you, some of the cases that were listed as "major 9 cases" in which you participated, dealt with such quackery in• vestigations as the Hoxsey case and the Krebiozen case which you have already mentioned, and then there was listed the Flantation Extract case which dealt with extract, particularly false vanilla. Mr. G,.a Yes, that was the case which ••• 1 think was the first war frauds case brought during World War 11 or just before World War It~ ·xt involved bribery of government offic!also It did involve vanilla aud other foods. Dr. Y.: And the case involving, or cases involving, adulterated olive oil, the incubator e~i reject racket and so on,. Now tbustl we-re some of the caaes that were listed. Would you \td.-ud selecting one of the cases that might appeal to you for the purpose and showing how the principles t~at .you have explained in connection with this team were applied to the given, case? Mr. C.s Well,- I think the Hoxsey case is a good oneo The Krebiozen · case is an excellent one but there were complications in that case. 10 t want to ask you about that latex. All right. so, perhaps the Hoxsey case, which, incidently• 1 became involved in in 1.946 1 and from 1946 1 ®land off, · that ~se was an active case un~il 1961 when the last nails were hammered into its coffin. But, you might aay, that l spent almost a lifetime on the Hoxsey usee We had three trials . which went to the J,upreme f."JUrt p<'ss't.hly half a cfo~en timese I said "three trialso" Actually, the'L.s were fou-r trialst tne was of a suit brought by Hoxsey himself against the Postmaster General, the Secretary of HEW, and the Co!Wlissioner of Food and Drug, to enjoin them and to require them to remove from • post offices our poster displayed there warning the American public that the Hoxsey trea.ttaent was dangerous~ I und~1:stand, incidentally• that you drafted th.at poster. Yes, I worked with the Post Office Depat:tment on it and 1 drafted it. Now, getting back to bow we happened to get in• volved ill developing a case: geueially, we get word of the 11 existence of a quack t"emedy either through advertising or through alertness on the part of inspectors who, as you probably know• are re.forred to as the eyes l!lnd ears of FDA. The Hoxsey medication came to our attention through our resiQ dent inspector in -Pallas, Texas, who noticed Hoxsey's estab• lishment there. Dr. Y.a Who was he, do you remember? Yes, B~eaux, Willard Breaux BR E,A U ! x. He's now a hospital administratora He happened 1 to be driving psst a building and he saw the sign, "Hoxsey Cancer Clinic." Having the curiosity of a good food and drug enforcement egent, he investigated and reported Hoxsey's Dallas venture to bis chief in New Orleans. FDA knew about Hoxsey, but he had drifted from state to state, and Breaux's report constituted the first knowledge the Food and Drug 12 Administration bad that Hoxsey had established himself in Dallas and was operating there. Dr .. Y.a You may have heard about his earlier history. Mrb C,. s Oh 9 we knew about Hoxsey for a long time~ His father, in the Twenties, was a figure of national attention because of his sponsorship of the "Hoxide Treatment,." The American Medical Association, also back in the Twenties, had an expose of the Hoxide Treatment in its Journale It's interesting that both Hoxsey's father ~nd mother died of cancer, and when they died Hoxsey inherited the lioxide Treatment. The Uoxide Treatment was an exte_rnal cancer preparation. It was applied to the skin where the cancer was visibhr,. It had in it corrosive chemicals which would destroy tissue. This is known as an escharotic substance. The cancer would, in fact, be destroyed, but so would a lot of good normal tis$ue$ ~scharoties are generally not used in the destru~tion of external cancer since a much cleaner job can be done through surgical excisiono ln the expose by the American Medical Association, the great harm he had done to persons with simple cancers that could have easily been excised, was pointed out. Skin cancer, as you ;g&&&,b&..AWi&: £ 13 know, is almost 100 percent curable, especially if it's caught in its t'!arly stages. But he ~aused great needless disfigure• JOOnt, even death, to persons who could easily have be~n cured by surgery. Hoxsey's father was prosecuted by 111:lnoise Harry Hoxscy, his son, carried on with this eseharoti~, and he did pretty much what bis father had been doing,. And he, too; was prosecuted; West Virginia, Illinois, Iowa, Michigan, 'lnd Ohio, all took action against him. Others attempted to. Ue went from etate to state, but he couldn't get bis roots es• tablished anywhere. He was always in troubleo But when he got to Texas, he found a fu.ven. There be solicited the aid of a doctor of osteopathy, and they set up a "clinic" with Hoxsey as the boss of the clinic, and the D. o. as the frouto But it was Hoxsey's business. There was no question about th_at, and he got himself a good foothold in Dallas. Now; it doesn•t require very much to make a success of a quack cancer remedy. Just get it rumored around that you've got something which max, be of v-alue in the treatment of cancet', I especially in terminal cases given ·up for hopeless by the aedica.l profession. tet it be known that you have something which remotely may be effective, and those unfortunate patients and their relatives will be battering your doors down to get the treatment. It •asn•t long before the Hoxsey Clinic was growing by leaps and bounds. Once ha got started, it was like 14' •snowball rolling down a snO'W' covered hill. Dr. Y.: He changed his plan of operation at this point 1n Dallas to add to the esebarotic which he and his father had employed an internal cancer treatment. K:r. G~ i ·Yes. Some time before he came to Dallas, he was associated with a notorious quack by the name of Norman Baker who operated a clinic in Muscatine, Iowa. Norman 14ker had the internal medicineJ Hoxsey had the external medicine, the eseharotic; and they divided their responsibility there. Hoxsey confined his treatment to external cancer; Baker, to internal cancer, with his internal remedy. The State of Iowa stepped in, en• joined this combine, and Hoxsey set off on his own, and when be did. he bad an internal remedy which was very similar to the one that Norman BakeT bad been peddling~ When he opened his nelinic" in Dallas in the mid-Thirties he had an internal medicine. And so now, he peiiled treatments for both external and internal caneers~ So we knew about Hoxsey. We knew he was being driven from place to place. For instance, when I was Chief Inspector in FDA Philadelphia headquarters we had just completed an investigation of his activities 1n New Jersey !ll!il!Ellll!IIIL 111 15 in the early Thirties. He had to leave New Jersey in a hurry. He went to Pennsylvania, and he had to leave Penn• sylvania in a hurry. As I said before• lie was going from state to state and getting into trouble, but in Dallas, Texas, be was able to operate, seemingly legallyo Texas State officials considered for a long time the possibility of taking action against him• and, ultimately, they dido. But they lost the case in the Texas Court of Appeal$o He was ~xonerated aud, in iffect, g!v~n a free hand to pperate there~ And there, as I say, he a~bieved bis greatest sue~ cess. In 1946, when Inspc~tor Breaux investigated his clinic FDA again gave.consideration to stopping this acti• vity. By this time we had gottf.n .a Supreme Court decision which was very iruportant in shaping FDA•s decision that action should be instituted. That was the Lelord Kordel decision which defined the scope of labelingo It was ap~ perent that the literature distribution plan for Hoxsey•s medications fell within the 15cope of the Supreme Court's I interpretation of labeling, thus giving FDA jurisdiction. i Accordingly, the order was given to develop a ~ase .... The main point there is that Hoxsey was sending his printed matter separate from his medicine. 16 That's right. Prior to the Kordel decision there was doubt as to 'Whether Hoxsey•s printed matter was labeling. If it wasn't, FDA had no jurisdiction over Koxsey's operation. way Hoxsey operated was as follwu consumer or patient in• quiry about the treatment would be $ent to Hoxsey by mail, and he would, in reply, send his literatu~• which contained false and,~isl~adiug statements about its value. • '. ., ·,•,:•,;;.•_·f The Supreme Court held in the Kordel Case that au~h literature comprised labeling; fF6it was labelinf: fr?~ ff Jrtd false and lidsleadtng sta ments, the d'1.'ugo when ffltt~1 tll interstate corJJtterce to per•<W§ ~eceiving the literature, was then ro.isbTanded. The Federal Food, Drug and Cosmetic Act prohibits the interstate shipment of misbranded drugs. And despite the fact that, os• tensibly; a doc tor, namely the D. o. • who was the front for Hoxsey, was administering the drugs in his practf.ee of medicine, and that FDA could not legally interfere in the legitimate practice of medicine, the Food and Drug Ad~inistration telt th4t.the facts in the case, nevertheless, Added up to a ~iola• tiou/ of •the Fedet:al Food, Dru6 and. Cosmetic Aet. The l>ivis:l.on of Litigation was given the job of preparing the case. :t was the one~ the Division who was assigned to the caac--to prepare it• initia.te it, manage it, and carry it through to its completion. REimemhex- that in C$ c.~se like this, in order to win in court, 17 you •ve got to prove th.\;.t tbe preparations are totally incf • fective for eancer, and when used in or on persons with can• cer, failure of cure o't benefit results ,,very single time. Now, it's a peculiar fact of life when you're dealing with quack preparations, that no matter h<Y~ fantastic the ;re• paration is, no matter how worthless it is; no matter what its composition :ls, and th~ r,-=:-oduct may be nothing more than distilled water, or, maybe, just air, no matter howworthl~ss it is f oi: .cancer, there will be persons ~h,~ ,~ill be <:onvincEldt .f:lfter taking the treatment, that th""Y were helped., lt is not surprising that Htsxev in h5.s literatur~ reported •• J '!1-)\•.,-.- .. , hundreds of ,-d~t testimcnials or' claim@ll cu-res and claimed benefits., Such patient acceptance end prai"le creates a tremendous hur• dle in winning n case involving cnncer quackeryp Because cancer is a disease whtc.h, for the most part; is not curable; ~nd if Hoxsey is abla to convin~ a judge ar jury. t~at ha cured~ person, the government-wouldn't stand a chance. The fact that you can prove that he failed in a hundred eases is meaningleeis 1 because it :ts easy enough to prove a hundred· caaes of failur~ by surgery or chemotherapy or radiation thetapye That wouldn't mean that surgery or radiation therapy are inef• fective. So failure means nothing. You must prove it never succeeds. How do you overcome Hoxsey•s cases of claimed benc• fit? The answe:i:- to this lies in a carefully planned investigation 18 to get all the facts about Hoxscy•s operationo In cases like this the first thing we do is to pretend to be cancer patients. We write to the firm a realistic sounding letter. We tell them that someone who is dear to us, a relative or a friend, has cancer. The cancer is identified, such as cancet of the prostate• the breast• the brain, or whatever. We in• quire as to whether the Hoxsey treatment will be of any bene• fit. The object in this is to determine, without visiting the firm, what its promotional end labeling practices areo The answer that Hoxsey sends out is lRbeling within the meaning of the law, if the product is then purchased, and product 4,ind literature are brougbt together. There is then an ac- companiment of product and literature as enunciated in the Supreme Court deeision in the Lelord Kordel caseo This is a necessary prerequisite for a charge of misbranding or violation of the law. So, without going to the firm, we write first to get the literature, or labeling, and claims for the drugs. Let•s say the first letter that he sends is. non.,.cpmmittal. In that case, we put ourselves in the position of the patient who may have received such a non•committal letter. What would he do? I believe he would want more in~ formation. The logical thing for him to do is to write another letter and say, "1 don't know from your letter vhether your medicine is of value for my wife's case. I don't want to make 19 the trip fnom New York to Texas or from Seattle to Texas on the basis of what you told roe. What I want to know is, can it do my wife any good?" So we send a follow•up letter which any interested person who is trying to help an afflicted can- ear patient might write and generally this results in a reply which is more definite, such as, "We have helped cases like yours.," In pr~parini these letters., do yo11 get help from the Bureau of Medicine7 Yes, but fundamentally we draw upon our own knowledge and experience. We have had many instances 'Where weive gotten copies of letters which were actually written by cancer patients or their relatives and we know what they ask tor and how they ex:press themselves. We try to make our letters as realistically sounding as possiblee Hoxsey bas received i many such letters from actual patients or their relatives. Now the second letter received rMY be a little stronger than the first in claims of value of the treatment• and this would make our case stronger, because it would help to explain what the literature says. The literature may be bedgedo It may be 20 couched in terms which allow for more than one inteI"pretat1on. In this way the promotel" of the treatment thinka he protects him.self. He may argue, "I don• t cl.aim cure of cancel"", and when a charge of violation is brought against him that is his defense, "We don' t claim to cure cancer." But we tty to show th~ough wb.at he writes in his letters that he does make such claims. So, it 9 s ver.y important 1n the planning stage to •et up the back-drop of the case being developed. Aftex getting these preliminaries, that is ~be letter writing phase, out of the way, we will then order the p1:oduct for shipment to US& Dr. Y.a Would he ship direct to people? Mr. C.: When we first instituted our cas.:; ho woul.'1 ship directly to people. Later he stopped that practice aad made patients cou1e to Dallas to receive the drugb. Now we have the shii>"' 1nent of the product. ; We also have the labeling. Orgina-rily · this ~ould b~ enough to make~ caae, but wa don't stop with that alone. We would have several other agents ,,.. ·' ' write in from varicus ~ectious of the country, telling them exactly what should be written. We would send to the ag(nts copies of pre- pared letters, an..: say, "This is what you should say. Let us 111 21 kno~ immediately when you get your reply and send it to us irmnediately." When the reply camia in then we would write back and say, "Now follow it up with this letter. 1• And 1n time additional shipments of drugs would be !nducedo Dr. Y.1 Wauld these letters go in under real n•mes? Mr., O.,c ·res. Usu4Uy thos\il of ch~r..iists Ot' huipectors. Of course, the conbauts of the letters titere false. But the courts have held that tbis is not ~ntrapment. As long as you give the promoter the opportunity to do what he -would normally do under similar situations, the falsity of the letter did not i-esult in entrapping him into violating the law when he shipped the misbranded drug. lf it 1s entrapment the defend• ant hats not violated any law$ By f~ntrapraent" we meau the creati,on in the mind of the defendant the idea for tha com., mission of a crime. In this case, if the federal government hadn't written to the promoter, be wouldn•t have violated the law in ahipping bis products to our agents. Is this entrap• ment? Tbe courts have said "no." This 1s not entrapment because, if there were a bona fide situation lib the one the government created, Hoxsey would have shipped his products 22 under those same circumstances. So, the government merely gave Hoxsey the opportunity of doing what he would do, nor~ malty. In proving our case we would have to show by evidence what he would do normally. Now, how do we get that evidence? F.irst, we try to find out to whom be has shipped. Many pet'• sons would come to Hoxsey from out of the state. They would park their cars outside the clinic, and they'd go in and would be given the medicines, and, in due time, ehipment• would also be made to them. Our men maintained surveillance at the "clinic" and eopi~d license numbers of ears that came trom out of the state. We then ascertained the identity of the owners of those cars and visited them. More often than not we encountered considerable opposition from the patientso Tht?y had been propagandized by Hoxsay about government intef• ference. Hoxsey stressed that the government was a tool of the ·Af-fA, that the AMA had tried to get his treatment and had failed and was getting its revenge by having the government destroy· t.'le Hoxsey treatment. Hoxsey hammered away that the government was not to be trusted. He told his patients in direct ;terms not to cooperate with the government. But among the~ny patients who vis 1ted Hoxsey and who la ~~t his medicines, were some who did cooperate. The majority did not. But it was a matter of plugging away-~persisting in our efforts until we encountered a patient who was not persuaded 23 by Hoxsey, and such patients established for us a pattern of behavior and activity by Hox.sey in their cases which fitted almost exactly the pattern in the shipments of Hoxsey drugs induced by the government. You did this by having the lists checked and then sending inspectors out to these homes? Exactly. The assigned inspector was told that he should ex• pect to meet with opposition; that many would not let him in the house or talk to him once they learned that he was an in• spector.-He-was----instructed to be polite and sympathetic, and that he was not to get into any arguments~ Rather 1 he should solicit their cooperation. But if cooperation were not given, he should not become overly persistent nor do anything which tnight ! be offensive, or subject to misinterpretations, . or lead ·t'-; to an accusation of harassment. In this type of investigation you simply had to persevere with visits to hundreds of pe<.1ple9 If you could find two or three who were cooperative, you could make • showing that what happened in the case of the government• s induced shipment is p!"ecisely what happens in the case of actual cancer patients who get Hoxsey 9 s medicines. And we did find an 24 adequate_nw.nber to show a pattern. Therefore, our induced ship~nts were taken out of the category of entrapment. When our evidence of shipment and labeling was complete, we made an official inspection of lloxsey•s clinic. Even before that, however, wu enlisted the b~lp of several cured uucer patients to get them to do undercover inapections. They went to Hoxsey under our·tnst-ruetlons and guidance with the •tory that th~y had had cance~. Their hospital records and their medical r,ecorcts showed that they bad cancer, and these were taken and shown to Hox.sey. The cured eancer p.etients pre- tended that they were fearful that their cancers were re• turning; and they inqui:red, "Will your medicine prevent its 1wtum?" Inva:d.ablJ, they wet'e told, "Yes, it would." m addition, one Food and Orug 1ns~ctor was sent from Alabama to Te)CSS to visit Hoxsey ~s a possible cancer patient. He wes per fee tly beat thy, but he told Hoxsey that he fear<1d he bad cancer. He left the elinic with a stateaent from. one of Hoxaey•s physicians that ttYou cMltl to us in the nick of tlrAe. You have cancer of the lung. You can• t 1 i ve more than eix or eight month_s. We think we can save you." From the HoxNy Cancer Clinic this inspecto~ wnt to doctors of our chooetng for a comp-J.ete~-c.beck,up and• of course, he ~d no detectable cancer: of any kind. Tbis ease illustrates bow Hoxsey sets the #tage for claiming • cure. Many a bypochc>ndriac with a 25 cancer phobia, coming to Hoxsey, was falsely told he bad cancer and bad only a short time to livee He took the Hoxsey treatment. He didn't die, •nd after the Hoxsey treabn~nt all eupposed evidence of CAncer di~appeared, and bere is a case of cure for Hoxsey. The inspector who posed · as a patient was perfectly heal thy., He• s alive toclay., He testified about his expe-riences at the clinic at the trial of the case instituted against Ho~sey., His testimony was very impre,ssive. I t:eMte tbis to show another aspec~ o~,, our planning to gethe,: evidence to show how far Hoxsey would go in this quackery venture., After the official open inspection, we try to correlate our s&mples and our witnesses' atatementR with what the inspector observes in the planta In that inspection he talks to patients, gets their names and add:restes, finds cut about their conditions. In addition, of course, be determines the labelingJ he tries to aind oui the c.ompositions of th4:. products, the finanelal aspects of the venture, etc. He makes as complete an in• spection as he possibly can. He tells them who he is at chis point? 26 Oh, yes, he tells them who he 1s. However, Inspector Gulledge who went in as a potential cancer patient• did not tell them he was with the Food and Drug Administr-tion. He went in simply as an individual who was fearful that be had cancer. They confirmed his fears that be had cancer, which of course, be didn't have. We •ent •notber in~pector to the clinic in the same way with a pretense of C4tlcer of the prostate$ They confirmed it. He had no eancer of the prostate; we knaw he had no cancer of t~1e prostate, but he went in there v!th the decle-ration that he bad certain symptoms and they told him that he had cancer of the prostate. Which led us to believe that anybody who went to the clinic with the. feeling that per• haps he had cancer was informed that he did, in fact, have cancer. Then his failure to die would illustrate the effect• iven.ess of the Hoxsey cancer treab:uent.. Hoxsey bad hundreds and hundreds of persons who felt that they were benefitted by the treatment. Now we bad our samples; we bad our literature; we had:' information as to what goes on in the clinic; we had our official open factory inspection; and we had our bona fide patients. Our next task was to show that the Hoxsey treatment never ever helped anybody. Tbis meant we bad to find out one way or another the aame and address of every per• son who Hoxsey claimed was beuefitted. lf we left one such &&&£&£ ass 1•1 . a: JC 27 person uninvestigated, we would lose the case. Therefore, it became very important to learn from Hoxsey or any other source the identity of those who were represented to have been benefitted by the Noxsey treatment. Hoxsey was mighty proud ofth:1.s claimed benefits and he publicized them for promotional purposes. He had a booklet with perhaps fifty pages .which bad the names and addresses,of persons who allegedly bad been. benefitted 1 elassifted by' type of cancer. Hoxsey advieed persons to whom he mailed this booklet, "If you have any questions, write to these people."· This was bis means of convincing doubters who were wavering about taking the txeat~ ment that they should take the treatment. 1 should say• by that time, the Hoxs:.:,,y Clinic had grown from a clinic with one doctor to a clinic with twenty-six doctors. It had all the trappings of a hospital ••• x-ray machines ••• X-ray techni• cians ••• lt had the appearance of being a bona fide clinic; whereas, it was nothing but a' bous~ of quackery. We were able by digging up almost everything that Hoxsey had wt'itten, ' everything that Hoxsey had said abo~t bis treatment publicly, every publication that Hoxsey bad.had printed, to amass the names of hundreds and hundreds of claimed cure, or benefits~ How many did you have to investigate? You say, "hundreds and 28 hundreds." l wouldn't be surprised, Harvey, if it totalled over a thousand Now this was an enormous undertaking. And, yet, we bad to do it, if we were successfully to sgeelch Hoxsey•s treatment. It meant going to the aatisfied patient and getting his eo~ operation. How could we get his cooperation in the light of the antagonism engendered by Hoxsey? We vent to Hoxsey and said to him, «Look, ve are going to investigate your cases in which you claim benefit. We have to do this because we have an obligation to decide whether or not your treatment is of any value. Now, can we say to them that you gave us their name,~; that we are investigating your treatmentr:i3:n,4 that we'd like to know from them what their experience with the drug had been? l$ that all right with you, Mr. Hoxsey?" Mr. Hoxsey took the bait and agreed because he felt that these people would give 'at-rong testimonials for the Honey treatment, and whuld convince the goverruaent to give its blessings to the treatment. I'm sure he felt be would get FDA off his beck if they visited and talked to the patients who felt they had '1 been cured or helped. After all, they were his strongest supporters~ Consequently, we were able to go to these people and say, "The government is investigating the Hoxsej treatment, 29 Mr. Hoxsey has given your name as that of a person who has used his treatment. Mr. Hoxsey •ays he bas no objection to our interviewing you 9 and your giving us information as to your experience." With this approach the patients bec.ame completely cooperative, wherea$ before,tbey were ant.tgoniatie. Before, they would slam doors in our investigators• faces. But n0lt 1 they gave us everything--names of their physicians, the hospitals they steyed at, and their complete histories., This was exactly what we needed0 And we investigated these cases of chimed benefits thoroug'ltr.. We visite~ the phyd.ci,nn who treated before Hoxsey, the hospitals where they were treated, etc., and in this way, we were able to adduce evidence to show that in not one of these cases was Hoxsey justified in claiming benefit~ Were there any cases in which these patients had never been to any other physician except Hoxsey? I Yes. there were instances of that sort. Dr. Y.,1 How would you tie those down to prove that there had been no 30 · be11efits? There was no biopsy. Consequently, there was no conclusive evidence of ea.near. As long as there was no evidence of can• cer, it is entirely ·possible, and ~ven probable in these particular cases• that.cancer did not existo Hoxsey can no.~ cl,iim benefit from his .treatment if he hadn't esublished that the patient had bad cancer. Hoxsey's Clini¢ did not do biopsies. Hoxsey's philosophy was, "Do not·let them cut. Do not let them bum~" By that, he meant use X•rayo "Be• cause cutting spreads the cancer and X-rays burn and barbecuea" So he could not espous~ that theory, and at the same time, have biopsies taken of these persons who came to himo They did do a few biopsies, didn•t they? On on~ or two skin cancers, they did biopsies to establish that they bad cancer, only for propaganda purposese They knew that if the cancer were small, very small, the cancer could be re• moved, so that where a person had a very small cancer, they'd have the cancer removed during the biopsy to establish the .. U&JJC L &ZE&Zb LLUJM!il&!!!&t& &&emzu:ca 31 presence of cancer of the skin, but the removal of the -:ancer cured the patient. Then they would apply the escharotic. The escbarotic would eat away a lot of additional tissue and guarantee the removal of the cancer, but would disfigure a person. We bad any number of instances in which simple early c&ncers, that shouldn!t have left even a scar if removed by surgery were treated by Hoxsey with the escbarotic which ,.'>(, caused great destruction of normal tissue with consequent disfigurement;. One man who thought Hoxsey had cured hi~ of c4ncer bad his chin completely eaten awaya He had a siw• ple early lip cancer that was probably cured by the biopsy, and the escharotic wasn't necessary at alls Hoxsey used it anyway, as I sayo When the patient testified, he could hardly talk. Half of his chin was gones Yet he testified that Hoxsey cured him$ So, we were able to show that in every instance Hoxsey was not justified in claiming benefitq We ehowed that all claimed benefits fell into one of thl:ee classes: (1) tbe patient never had cancer, or,~, had cancer and was adequatclyttreated before taking the Hoxsey treatment, ; or (3) had cancer, went to Hoxsey, and died. But Hoxsey con~ tinued to ,~~!!~ir:e the testimonials that patients wrote after a month or;,- two of the treatment, that they were feeling mu(;h better under the Hoxsey treatment, and Hoxsey never took the trouble of keeping himself posted on their actuc!lcondition<t liilttl!ILl!!ldllillilll!l1&•2111&1!fal!Ll!ll:Zllil!ldllHll!II&!■ _ IISWlll!lll&IIIII.JSIIIJ!IIIJ!!)§l!IIL_ _ _ _ _ _ _ _ _ _ _ _ _ 32 Any number of these persons who had been so loyal to him were dead within two or three months after starting his treatment~. Now, the fact that they were feeling bette~ really didn't mean anything, because generally they went to Hoxsey after surgery or X•ray therapy because they didn't feel well after the surge~y or X-ray tre~t.t:~nt, for a pro• u:acted period of time. Not everybody recovers fr<>m aurgety immediately. The $&me is true with X•rayto Tc some it•s followed by a period of protracted discomfort, and just about thF- time they had given themselves up for lost and thought, the surgery or othe~ treatment was non•successful, that•s about the time that the body was about ready to take a turn for the better; but by that time the patient had gone to Hoxsey- He took the Hoxsey treatment, but was already re• covering from the previous treatment. His feeling better was attributed, of cou~se, to the last medicine he bad taken, which ~re the Hoxsey drugs. So it is not st-range that Hoxsey waD able to get testimonids from,persons who T-eally had can .. cer th~t the medicine was helping them. But at any rate, we were ~ble to develop a very strong case to show that the Hoxsey treatment was misbranded and that it had never benefitte~ anybody. 33 Dr. Y.& Now up to this time your team in Washington had been sitting there writing these letters, setting this network. of inspectors at work investigating each of these individual cases. That 1 il right,; And all of this data had been pouring in at headquarters. Right. Now this data would be reviewed, and -where there was some abbiguity, the inspector would be required to clear up the ambiguities, to complete the medical records, and then a deeieion was ultimately made as to which eases we wanted to present in court., These were not siriply c.a1;1es of failu-ret·'<t because a ease of failure doesn't mean anything. We pat on ca$eS to sho,~ that the claim of benefit in the labeling i for these cases was not true. In other words, the claim of benefit for. ther.e cases was a false statement, and if we could prove it to be a false atawment, then the product was misbr&uded by that false statement and was illegal. We made a selection of thirteen such cases for presentation at the BE&&SZJ&!!L&ld&&Itl&t 212:ZSJ Li l&iiL£&212& i 2 .lid I a EE 2 • 34 trial in Dallas. These were their prize cases that they had proclaimed as cures in their labeling. We decided we would put on those thirteen cases. Now this involved a tremendous risk because the patients in these thirteen cases attributed cures to Hoxsey. So they were all witnesses for Hoxseyo Mr,. G.. : Actually they were our witnesses ainee we put on their cases but they were very ho$tile to the government. In cross-exam• inaticn, they would say unequivacally that Hoxsey cured tbemo But, nonetheless, we felt that we could establish in an in .. junction suit_,and that's what we filed in Dallas, that these thirteen cases were falsely represented to have been cured or benefitted by the Hoxsey treatment• thereby, establ!Rhing at least one aspect of misbranding. Now, the other ce~es we investigated ! . were to be used only iri refutation, ' in rebuttale We anticipated that Hoxsey would put on so•ca.lled benefits• persons who won1-d tetttfy that they took the Hoxsey treatment,. that they were given up for lost, that Hoxsey cured them. To win, the government would have to devastate such testimony and this was done in rebuttal when the government prnsent$d the 35 true facts about their cases. Or. Y.a Now in some cases you could count .on tbe judge restricting teetimony by laymeu along lines l.ike that., Dr .. Y .. a But in this particular case, you were aware ahead of time you couldn't count on that. Mr., O.a Yes, in tbtl case that we brought in Dallas in 1949 0 November of 1949, we. knew that the senior judge in charge of ell civil eases, Judge Atwell, would preside., Judge Atwell, it was . rumored; and I might say, later confi.rmed by statement of Hoxaey•·a at.tomey, was a patient of Hoxsey, and he believed that he had been cured of cancer by Hoxsey after taking the Hoxsey treatment. Now, this was rumor, as l said, but we were well aware of it., Later 9 in 1961 or 1962, it was cone firmed. I might deviate a little to tell you about the in• junction suit that Hoxsey brought when the warning poster I 36 mentioned earlier was issued and placed in federal and state buildings and in post offices. Hox•ey sued for an injunction in Federal Court, Washington, D. c. to restrain us from using that poster and to make us tab down the posters. At that time Judge Holt&off, the judge who heard Hoxsey'a injunction suit, Wa$ addressed by the attorney for Hoxsey who made this at.ate• ment, and these are about the words that he used: "Judge, you know 3udge Atwell. He thinks very highlt of this treatment." And he held up the ffoxsay p:Uls•-the internal tre.a.tment. ffJudge, as a matter of fact, Judge Atwell takes these pills. And be thinks they helped him." Now this is in the record of that case. So Hoxsey's attorney, himself, confirmed what was rumot'ed in 1949. By the way, Judge Holteoff refused to grant Hoxsey•s request for an injunction. of us. The poster is on exhibit in the Medicine display of the Smithsonian Instltutton in the section devoted to Quackery. To add to our difficultie$ in Dallas, Judge Atwell, the year before tn 1948, bed decided a case which Hoxsey bad brought to recover damages of one ' million dollars against the He•rst publications, the American Medical Association and Dr. Morris Fiehbein, then the editor of the Journal of the Ao Mo A. Allegedly, they bad all called Hoxsey a quack. In that case Judge Atwell ruled that Hoxsey cured cancer. Having so ruled in April of 1948, we bad every rea•on to believe that he would rule similarly, no matter what 37 evidence we put on, in 1949 when we brought our caseo · Yet we brought the case knowing full well we would lose. We planned to put on as strong a case as possible; build the best possible record in the hope that the anticipated ad• verse findings of Judge· Atwell in our case would be re• versed by a court of appealso And so we con.eentrated on developing a case which was ut1beatable. Now~ Just let ma ask you. You got all the eviden~e; you weTe ready to bring the case. Now, what is the procedure that is involved in your group in Washington getting the case· set up in Dallas? Mr. G.a All right. Now we were ready to go. Tbe next question was1 "What kind of case shall we bt:ing? Shall we· pro•ecutet»• This would~ a criminal case where proof beyond a reasonable doubt is req-.iired. It would be in Texas. Nobody had ever beaten· Hoxsey in Texas., Many had sued him. The State of Texas and many persons had sued Hoxsey for malpractice, for fraud, but be had never lost a case in Texas. We took due cogni&anee of that .. So we set aside the idea of prosecution., We could ~ro• ceed by injunction, or we could seize the product. We decided 38. that since injunction would mean going before Judge Atwell this, too, was risky. The decision was reached that we would try sei:ure where he shipped across the state line in a aufficiently large amount to justify sei~ure •. We found such an amount in Colorado in the hands of a doctor of osteo• pathy. We seized, in the hope that Hoxsey would contest; bu~ Hoxsey was too foxy; be was too smart. He didn•t con• test. He made no appearance, and he let the seizure go by default so there was no trial. Our strategy failedo Our plan was to provoke a trial outside of texas where we would stand a better chance of getting a just hearing, but Hoxsey apparently saw through our plan. If there was to be a trial he wanted it in Texas. The only other ~lte:rnative then was to proceed with a complaint for injunction. And this we did. We prepared a form of complaint in our office end sent it to the Gene~al Counsel's office where it was perfected and sent to the u. s. Attorney General with a request for the institu--. tion of injunction.proceedings. The· Department of Justice concurred• and sent the complaint and request for injunction to the u. s. Attorney in Dallas. He, too, concurred, and filed the complaint. The ease came up before Judge Atwell. Judge Atwell at the time was about 80 years old, and he did not accept tba government's contention that a lay person auf• fering from cancer is not qualified to testify about bis 39 condition or about any betterment of his condition from any therapy given. The Judg~ felt that a person who has cancer knows this perhaps better than anyone else. We felt that proof of the existence of cancer can only be established through competent expert medical,testimony and proof based on m1cro$cop:i.c examination or tissue taken from the patient 9 and that the patient's knowledge as to his condition was of a hearsay nature, $nd hearsay testimony is not admissable in a court of law. Dr. Y• I Well; aft~r you'd spent these months gathering all this material with the big network of inspectors working on it, you had the data assembled. Now did you check this out with Billy Good• rlch's office here in Washington before you took it down to Texas? Mr. G.: Yes. As I said before, we prepared our concept of the ease with a recommenda tlon which went to Billy Goodrich, our General Counsel. In doing so, we even went so far as to prepare a pro.;i\ posed complaint and the Geuer~l Counsel 8 s office,· of course, ,,:, revised it, polished it, tave it its finishing touches• and sent it to the Attorney General, where it was further considered• 40 and then sent to the United States attorney in Dallas, Texas. Again it was reviewed by him so that there was check upon check to be sure that the case was a sound one. The United States attorney then gave his acquiescence, and tho ease was filed. Dr. Y.: Now when it's filed and then about to come to trial, do you go do-wn with a staff from headquarters? I and a member of the Bureau of Medicine went down to Dallas for that case with an attorney from the General Counsel's , office. This man was Goodrich's first assistant, Joe McGuireo The physici.an of the Bureau of Medicine who accompanied us was Dr. Gordon Granger. We constituted the team that worked with the Assistant United States Attorney in the preparation and presentation of the ease~ f It was our. duty in the Division of ' Regulatory Manag~ment, at that time the Division of Litigation, to prepare a fact sheet for the testimony of each government witness. This was given to the United States Attorney in Dallas who would have something to take honeand study. Rather than to tell him verbally who tbe witnesses are and wnat they would testify to, we prepared the testimony in writing for each 41 witness in a form that would make his use of it easy for him in his preparation of questions. Dr. Y.: He has a terrific job. You•ve been working months on it 9 and then he has a short time relatively to get familiar with it, and yet he's the man who's up there and ean•t make a mistake. He does all of the interrogation. You are right. He cannot · makld a mistake. Consequently, the burden apon us b gt'eat to prepare him adequately so that he can capa-bly handle the case. He is not a physician; he's not even an expert in Food and Drug law, because the United States Attorney o-r hb as .. sistants, and this was an assistant in the United States Attorney's office ••• Who was he, do you remember? Mr. G.: A man by the name of Harrel, HARREL, I believe. necessary for him to prosecute cases of all sorts under the law••income tax, interstate commerce, Federal Trade Commission, 42 any act on the books. Consequently, he cannot be an expert in all phases of crimiual law, and generally, he is certainly not an expert on Food and Drug law; but, if he is properly prepared by us, he can do a creditable job, and he dido He did an excellent job. Now, as I mentioned before, it was our idea to put on so strong a case that &ny adverse decision by Judge Atwell would be overruled by a Coutt of Appeals. -Tudge Atwell• during the eourse of the trial, made Boy· errors in law. He pennitted witnesses for the defense to t~stlfy that they bad cancer, that they wet:e tre4ted by Hoxsey, and that they were ~ither cured or benefittedo Hoxsey did not put on any physicians for these patients, but reliev solely upon the testimony of Dr. Durkee who was the doctor of osteopathy who served as the front for ffoxsey9 This exposed Atwell to a revers~!, because certainly a patient is not in a position to testify whether or not a certain drug benefitted him. And this the courts have held consi$tently. That was a question of law. But to get ~~te- vers,1 on the facts, that•s a really hard thing to do. The Courts of Appeal have consistently taken the position that the trier of the facts had the right to decide his concept of the facts, and "Findings of Facts" of the judge sitting· in a case,, such as this one, which wa':i an injunction case, are almost neve~ reversed. This is so because the Judges of. tho 43 Courts of Appeal are not present at trial and do not listen to the testimony for the facts. They are to decide the validity of the findings upon a record, and they have said consistently that the tri~r of the facts is in a better position to judge the facts than the Court of Appeals because the trier of facts is able to decide for himself the ci:edi- bility of the witnesses. He can tell by the witnesses• de• meauot, whether they give evasive answers, by their facial e..i..p.:essions, etc.J whether or not the witnesses are tellini, the truth. This is uot available to the Court of Appealso So the Courts of Appeal have been very loath to reverse jutlges on findings of facts. And that's what we were up against. Judge Atwell, after hearing some hundred witnesses in about a six•day period, f<>und as the facts that Ho""sey cures cancer and that bis treatment is at least as good as surgery, radiation, er chemotherapy. Judge Atwell ruled against us and refused to grant the injunction. But our case W'as so! good, it was so strong, that tl~e Court of Appeals, when ww appealed, he~d the judge would have had to be blind or deaf not to have seent heard and understood the evidence that the government had put on. The Court of Appeals said that they had a distinct feeling that 4 uiscarriagc of justice had occurr~d here. They reversed Judge Atwell on 44 the findings of fact, which, as 1 say, was a rare thing in~ deed. So, our strategy paid off, and we did get the injunc• tion. This wai appealed by Hoxsey to the Supreme Court, but the injunction was sustained and Hoxsey was enjoined. But this didn't stop him. Now, I'd just want to ask a few more questions about the trial·. You .also bad expe-rt witnesses, besides the witnesses whom you used tei try to sh~ that this had Jone nc. g1,od~ Mr. G.: Yes. Dr. Y.: For them. Right.· Dr. Y•: The patients of Hoxsey. Now, were these expert witnesses also assembled as a task of your team at headquarters? 45 Mr. G.1 They were assembled EX, the team, but they did not become a part of the team. Dr. Y.: Yes, but it was your responsibility to select the best pos• sible witnesses to ••• Mr. O.: That's right" Dr. y.' ••• describe what real cancer therapy was and to criticize the kind of therapy that Hoxsey was givingo Mr~ 0.1 Yes. This was part of our role. We not only decided which witnesses were necessary, but we actually went out and sol1• cited their cooperation and engaged them as expert witne$ses. Then as another aspect we also planned animal studies or whatever investigations could be made in the laboratory or ,,, perhaps in a hospital to show- the inefficacy of Hoxsey med! .. cations. When it comes to cancer therapy, you can't have a clinical trial, because you're dealing with a quack remedy 46 and in order to determine its effectiveness in a clinical trial, you would have to take a cancer patient off competent therapy. This would be d~adly to the r~tient if a quack remedy is substituted so we don't do it. The next best thing is to see how it works on animals with cancer, and we did undertake a clinical trial at the Jackson Memorial Labor• atories in Bar Harbor, Maine. J•ckson Memorial Laboratories are nationally kno~. They experiment with mice and rats. T~~y have developed colonies or strains of mice that are in demaud for reu,n:cb purposes throughout the countt"/o . F01; instance, they bad a colony of mice, every female member of which would develop spontaneously cancer of the breas;, and these were the mice that we used the Ro:x:sey treatment on to determine whether 1., it would retard development of cancer of the bre$st and 2., whether it would have any effect on the course of the disease. And• of_course, it didntt. That testimony was put on during the course of the trial. We did this• k~owing full well that there are limitations to the applicability of animal work to the evaluetion of therapeutic agents in human beings. But still, it did show, that in no way did it alter the course of the cancers in the mice. Then we engaged an individual who had done work on the role of potassium in cancer• Dr. Max Gold~hier, an endocrinologist, from New York, who had done extensive work on potassium and 47 its effect on terminal cancer. He concluded from his work that there was a godd likelihood that potassium enhanced the growth of cancer. Dr. Y.: Now the point of th.t.t was that potassium iodide was part of Hoxsey•s internal cancer treatment. That's right. Seventy•five grams of potassium iodide was in a dose of Hoxsey•s internal cancer remedy, so that not only would you not expect the Hoxaey treatment to be of ~ny value, but there was also the possibility, remote or not, that the ·. ·" :1 potassium in the drugs would;enhance the growt.h of cancer. So, that was another aspect of the c.ase that was presented., At any rate our strategy did pay off and we did with Dr. Y.s Now, you were there At the trial. Yes. I I I ; I 48 Dre Y. I And I presume, in addition to the briefing that you had given the Assistant District Attorney prior to the trial, there were lengthy nightly meetings to get things sharpened up for eacb day's ••• Mr. G, c Yes. We would anticipate c-coss-e~mination in our own case, and plan ways of meeting it. When the defense case was on, we planned cross-examination. We anticipated the testimony of the witnesses and planned for ~ross-exc.ruination ~f those witnesses. That was a very important role in preparing the United States attorney. In addition to that, we sat at the counsel table• and we would transmit notes to the United States attorney to keep him from erring. If he committed an error, or if he failed to cover a point, ol:' if something of significance arose by reason o~ the examination of the wit• ness which had not been previously discussed with the United State$ attorney, we would prompt bimo So we served a vital role •itting there at his elbow to guide him and to make sure that all of the evidence -went in. Dr. Y.: Now, Hoxsey, himself, in this case, did be appear as a 49 witness in his own defense? Mr. G. s No. He did not. He relied enti~ely upon Joe Durkee, the D. o. Dr. Y.s You did, noa:etheless, have an opportunity to observe Hoxsey to some degree during the course of the trial? Mr. G.: Yes. He sat at the counsel table witb his attorney. Dr. Y.s Trying to do the same kind of job for his attorney that you were doing for the district attorney. Dr. Y.1 I've been interested in Hoxsey as a person. How would you describe bun and his demeanor and the way he behaved himself while you had an opportunity to observe him? 50 Mr. G. 1 I had an opportunity to observe him on two occasions. We had another trial of the Hoxsey treatment up in Pittsburgh, Pennsylvania, in 1956, after Hoxsey was instrumental in opening a Hoxsey Cancer Clinic in Portage, Pennsylvania, a little mining town about seventy-five miles from Pitts~ burgh. He'& an impressive fellow. There itn't eny ques• tiou about it. He•s tall end he is not shy. Hc 0 s quite aggressive. His love of money is considerable. I had one little experience in the trial up in Pittsburgh where, du-r- ing a recess, I was on my feet, giving myself a rest ofter having be.en sitting all momi'ng. I was flipping a dime in the cout:troom, at'd the dime got away from ine ~ud rolled half ... way between me and Hoxsey. lfoxsey saw me approaching the coin, buthhe appro,•ched faster, bent over, picked up the dime, just as I vas getting ready to bend over, turned his back on me, walked over to his side of the courtroom, and loudly proclaimed, flYou see, I'm always lucky iu a court• room.ri And he put the dime in bis pocket. So he owes me a dime. Dr. Y.i Well, tbat•s a good, vivid, symbolical illustration, l think. I've read lots of things that Hoxsey mote or that were Min I .; Jidli CW1 id 51 written over his na."Deo These are written in pretty good English. From other tbmigs that I have heard, t•ve_ had the feeling that perhaps som~thing of the coal-mining background that Hoxsey had earlier in Illinois before he got underway on this Hoxsey promotion ••• on his cancer p1:'omotiono •• might have •~uek with hime When he spoke in eonversation, were there eiidences of this? Did he speak good English? Mr. G.. s Yes. He spoke acceptable English. It wasn't English tpat a coll.ego professor would use but he was articulate., His Eng• lish, I'm sure, if it were reduced to print as he spoke it, would be full of grammatical errors, but he eould get his point across. You know, of course, he had nothing tn()re than an eighth grade educ~tion. And apropos of y6ur point as to what sort of a man he was, let me tell you what his lawyer told me he was. He told me du-ring the course of the trial in Pittsburgh that Hoxsey was par ·excellence the con. man~ Now, that was bis lawyer's words, not mine., In his office, ha had a little placque which read• "The world is made up of two kinds of peoples those that take and those that get took.w Now, for one who's in the habit of taking, the way be was, this thing had particular signifiean~e, t think. This was his philosophyo 52 Right. Did you get the idea that he was in any sense a crude man? Yes. In a way he was quite crude~ He wasn't polished, by any means. A blurt man. Mr. G.,: · A blunt man. Jut,iin today's world, this is quite acceptable. You listen to people on television in high positions, and they're just as crude as he was. In his day, in those days, t think it was unusual for a man who was crude to achieve any great success in politics or in the professions. But judging by today•s standards, l'd say• he was quite acceptable in his ! Dr. Y.: He must have talked with patients. Of course, he did talk with patients, as you found out, and he must have had a sales• man•likc per3u~sivencss in his raanner of speech., 11.M A &MAW& ii LIH&ifi Aiiii ·SSH iii lid §ff RP Ld 53 Mr. G.s Yea. And that persuasiveness wa$ attributable to the fact that Jae gave hope to these people who came to him. Many of them laad been told by their physicians that their conditions were limpeless and that modern~11nedicine could do nothing more for tam. They wen~ to him and he gave them hope. He crit1~ eized t.fie medical profession for. giving up on these patients, and wareas he did not promise that he would cure them, .he would make statements which wo1,1ld encourage hope; He would tell ,tnem, for instance, that ttWhile I can't ptomise you that I'm ge!ng to help you, I h;:.Ye bclped dozen3 of ca..;es just like yours.,." This ~-s enough. So this was his charm, in -:hat he was kltad to these unfortunate people and he gave them hope. He would encour..:~e them, tell them, "Don't wo::ry, we'll halp you." nut that wazn 't motivated-•! 1 m convinced of this--by any hunane or hm:uanitarian impulse., He was looking for the income to be derived from this person who was about to be taken. Dr. Y.~ Did the words of his attorney that he was a con inan agree with the impression you tot that he wasn't like some peopl~ who may be called "quacks•" persuaded by his own gospel. You. have the feeling that he was aware most of ~he time that he really was ••• 54 Mr. G.s I would think so. As a matter of fact, I think it was his attorney who told me that he was convinced, that is, his attorney was convinced, that if Hoxsey ever came down with cancer, he would not rely upon bis OW!l medicine to help him, but would go to a doctor and have surgery. Dr. Y.s I heari a rumor the other day that Hoxsey is in some Tex&s establishment with cance~. Mr. G.: I heari that rumor, too. lt may be more than a rumora You might check this out with Brandenburg who asked that an in~ vestigation be made to establish if it was a rumor or not. Dr. Y.• r I see.· So that is being looked into. Mr. G.1 That ls being looked into, from the st,-.ndpoint of interest more titan anything else. 55 Sure. From the point of view of the issue of Hoxsey'a in• tegrity or lack of integrity, wasn't there some episode in conn~ction with the death certificate of his father which might throw light on that point? Yese The <!-:.~th certificate of his father actually on file at the State Health Department in Illinois showed that his father had died of cancer. In his book, .,You Don't Rave to fJie", Hoxsey stated that the death certificate of his father had disappeared from the State Health Departmenes files be• caune it sho~ ed that the cause of de& th was not cancer e The death certificate that Hoxsey had published in his book showed that a Hoxsey, but with initials different from his father•s 9 had died of cancer, and he contended that this death certifi~ cate wasnnot for his father's death. We got hold of the auth• entie death certific~te at the Health Department as it was 1 filect, and it was identical to the ona in his book in all de• tails, except that the initials of his father were changed on Hoxsey•s copy, @pparently by Hoxsey, b~fore he photographed the death certificate for incorpol'ation in his .book as a photograph of the death certificate. The initials did not match those on the original death certificate for Hoxsey•s 56 father. This was how Hoxsey thought he would get around the fact that his father, who was touting a cancer treatment him• self, died of cancer. Dr. t.a One of the other things that I wanted to ask about related to the Krebiozen case, particularly your estimate of why it was that after the long, long trial in Chicago, and as a result of the trial in Chicago, the jury reached the verdict that Dr. Ivy and the Durovic brothers were not guilty in• criminal case of violating the law, when earlier it had been established that Krebio~en, chemically speaking, was a product that could in no way have any influence upon the course of cancer. Yes. \.te bad a very unfortunate jutye We started off with a panel of three hundred. When the judge announced 'that the , .•1 trial would take about three months, actually it ~ook nine, he gave those who felt that they could not sit at a long ' trial 1the opportunity to be excused. That one operation alone, reduced the jury panel down to about one hundred talis• men. In other vords, we lost two hundred prospective jurors, and these were probably our best jurorso S1 Dr. Y.1 The ones who would have had good Jobs and ••• That's right-•who felt that they couldn't spare three months. Those who felt that they could apare three months, you won• ' ' dered, you questioned what kind of people they were that the.y can spaTe three months; perhaps they were retired. But I think we lost our best people wben that oc:cun:ed. Now, you•ve got to r~cnember, too, that tha people in Cnicago nao 'been be• sieged and bombarded with propaganda •bout Krebiozen botb pro and con. I doubt thet there was any thinldns person. in Chicago who.--b&dn' t hea:cd of Kre biozen and who badn' t, by; this time, bad a~ idea of whether they felt 1t had any real merit or not. Surely, the people ln Chicago who b.ad cancer were very apt to wind up using th~ Krebiozen treatment because it wa$ home-based. And there were 4f!nougb doctors there wbo were using it. Yes, ~»se of the influence of Dr. Ivy. If Dr. Ivy had not been involved, there wouldn't have been any 1ssu,e. llut because of Ivy and the conft~nce he instilled, doctors frQm Chicago, 58 were, mostly at the insistence of their patient$ and their relatives, getting Krebiozen. Now, for each person getting Krebio~en, there are many, many perscn~ who know about it. Consequently, to me, it seemed a little bit strange that, we had jurymen who ultimately got on the jury who ptofessed not to have heard of Krebio•en and, therefore, they were unin• fluenced by the prop•ganda, and could decide this case with• out bias, and that they had formed no opinione Host ama&ing to lfN:lt was that there were persons on that jury who said that they had never heard of Krabiozeno I felt that either they were lying or that they must be.awfully ignorant. What. intelligent person would not know, at least know, about KreG biozen? Yet, there were persons on that jury whQ said that they had never heard of ite So, we did not have $U A•l jury, and we knew this~ We knew right from the staft that this was a very poor jury to decide this very important case$ Did yob really knm, very much about ·the background and the educational level of the jury -mbers1 No. We had their occupation listed, nothing more. But you've got to remember thiss that where the occupation indicated a 59 high degree of intelligence, like attorney, the defendants challenged them, made sure that any person with any education was uot on that jury. And they had a gr~at many challenges, because there were four different attorneys there, each re• presenting a different defendant, and ea~h attorney was en• titled to his full quota of challenges, giving them an enor• mous advantage over the government who bad only the number of challenges to which one attorney was entitledo·--·They had four times as many challenges. Anyone with intelligence• apparent intelligence by reason of the position he:ld, was ~utomatically dropped from the jury. So, this, too, contributed to lower the l•vel of the jury. Nowt that was one aspect. Yet, not• withstanding that, there were at least six persons on that jury vho were pers~aded by the government's case to the point where they were for conviction of all defendant~~ The~e were, however, five who were against conviction. Now, of those five 9 one, who tu-med out to be the foreman of the jury later, was a per.on whose wife bad had cancer, who bad heard of the Kre• biozeu treatment, and who hod considered using the Krebiozen treatment for his wife in the event that there was a recurrence of caucer of the breast. The breast had been amputated end, apparently, there was no recurrence, so be never was faced with the need in the two years between operation and jury service to use the Krebiozen. But he later admitted to newspape~ people 60 that he had considered taking his wife for Krebiozen in the event that there was any return of the cancer and that he at that time felt that Krebiozen had value. Yet, he sat on the Jury, and he had lied in the voir dire on the part of the judge as to whether be had heard of it or had any preconceived ideas. Now that was one. Another thing was, one of the members of the jury by the ne.me of Butkowski was an official of the Inter• national Meatcutters Union. tie was cbaracteri&ed by the jury people who were~ conviction as the "Hammer Man" on the jury. From the very start, with the very first government witness, thb man attacked the government to the othe-r jury people., Despite the ~ing of the judge with each recess that the jury was not to dbcuss the case among themselves nor were they to discuss the ease with enyone else, that they should• under no circumstances, permit anybody to talk with them, as soon as there was a recess, no matter who the government W"it ... ness was, Butkowski would attack.them as liars, egg heads, stupid. Thia International Mksatcutters Union, whe~e he was on . f," -~ the board of directors, and was one of the members of the exec- utive committee, and a high official, had taken a position publicly with respect to the Krebiozen case. As a matter of. fact, ovw-r union headquarters which he had to go into, every time he went to his office, was a big sign that saids "Kreb1oaen should be given a gove.cnment test." During the course of the &ii&! UJIIU d!IUUZWK C OWIMJWD.1 t 61 trial, there was a meeting of a local of this union in Peoria, Illinois. Ivy and Marko Durovic attended this meeting during the course of the trial. It was also attended by this jury man••Butkowski. Dr. y el During the course of the trial? Mr. Oo I During the course of the trial. Dr. Y,1 \.!hile it was in recess., Mr. G.1 It was over a weekend. Ivy and Marko addressed this local and this union leader was there. During the cours~ of the trial, on two occasions, every member of the jury was circularized with pro Krebiozen leaflets. Tbis circularization was by mail; the letters bore the return address of this union., Dr. Y.. s You have oo idea why the union took this position? 62 Mr. G.: Many unions did. I think the American Federation of Labor took a position which was pro-Krebiozen as did Senator Humphrey, as did Senators Douglas, Proxmire, Hart, Kefauver. They all took positions to get special treatment for Krebiozen from the Sec• retary of Health, Education and Welfare~ Was this out of respect for Ivy that Senator Douglas had and then the other senators out of respect for Senator Douglas? l would say so. It would be my guess. Now Senator Javits also was approached to take a similar stand, until one day his staff man called us on tee phone and wanted to know·1about this ··•··'ill petition tbat Senator Douglas was sending around to the othe.· members of the Senate, asking the Secretary of Health, Educa- tion and Welfare to set aside ::he requirements of the law as to Krebiozen and to pennit interstate shipment of Krebiozene He wante<f"fo knol1, "This is a little !rregulara 'wt{.i't are the facts?" We gave him the facts and Senator Javits withdrew., But prior to that he had gone along with Senator Douglas. Now during the deliberations of the jury, and this we got from the jury people• at the fir!t ballot, and almost throughout the J&&C 1 . itJ ca :m• u I& M 63 f: \•, deliberations, it was si:x:~for conviction and five for acquit.al, and one who said she'd go with the majority& She was lndif• ferent. Didn't care either way. Whichever way the majority went, she'd go. And that's the way this thing remained day after day. I think they were out for eight days when they apparently reached an agreement to get out of this impasse. This was. Saturday, the 29th of January, l believe, 1966. They agreed that they would acquit Ivy and Marko and convict Stefan Durovic, Dr. Phillips, the Kreblozen Research Foundation and Fromaek Laboratories on counts which they would decide after .... tvy•s and Marko Durovic's acquital. Now this "Hammer Man" insisted that before they deliberate further as to what they should convict Stefan Durovic and the others on, that they go in.and acquit these two people. this was done. When the jury came back to deliberate--this we got from those who were for eonviction••those who were for conviction discovered that they had been double•crossed-' This guy from the union said, "You misunderstood us. We haven't said that at all. We had no ! agreement to convict anybody." That W$S bis position, and they were stuck. Dr. Y.: They were hung then, at least for the time be~ng. ----- 64 Mr. G. r They were hung, yes. And all the time, they bad been asking the judge to let them go because they were h~ng up. The judge would say• "No, keep on deliberating; reach t, verdict; it's your respon• sibility. 11 Then, they came back, and found themselves in a posi• tion where they had let go some of these defE;ndautso When they saw the hopelessness of it, tney again told the judge, and agaln the judge told them to continue their deliberations. This was about the sixth or seventh tune that they appealed to the judge to declare a mistrial because of lack 0£ .agreement.. That was on Saturday when they found Ivy and Marko Durovic not guilty. On Su'.'lda;r, a woman fa the jury got sick. Now those for con• viction feel•"-.she was one for acquitalil••that she didn°t re.ally get sick; she feigned sickness., At any rate, they· took her out in an ambulance, an.i this chap from the union is reputed to have said, this is what ~u were told by the jury people, that "I.f she dies, this will be on your conscienceso You are tbe cause of ito" Thishhe told to those. who were for conviction. Dr• Y. t Because they kept her there so longe Mr. G.,: That's right. He tormented them further with the question: 65 "And how can you as Christians ever sit in a church again," or words to that effect. This is what we were informed when we spoke to some of those jury pecple who were for conviction. Well, as it turned out, she was back Monday. Tbat~was on Sun• day, she was back Monday, well. In the meantime, the shock of this made those for conviction feel that they bad to get out of this thing. They were going to make one last appeal to the judge that they were hung and that they should be let go. They did, that Monday morning, and that Monday the judge said, "No, go back.fl This was about the ninth day, maybe the tenth day, l don•t know. It was a long time. Well, they dirln 9 t go back in. They felt resentment; they threw in the sponge; to get out they voted for acquittal. As they were coming out of the jury cham• bers, one woman who felt very strongly for conviction, heard Butkowski s.ay to the foreman, ••• "Boy• I 1·ever thought we'd swing it all the way like we did.n And she told us that she felt like . slapping his face. Instead, she burst into tears and the accounts of the acquittal in the newspapers have it that ghe had tears streaming d,own her face. Well, she later told us what had oc ... curred. She beard this remark and this so infuriated her that she burst into tears, and she came into the Courtr-0om with tears streaming dow her cheeks. Now, this Mam.r~er Man, Butkowski ••• 66 Dr. Y.1 How do you spell the name? Mt'. Go I B U T K O W S K I. He bad been charged with contempt of court and he plead "not guilty" and the matter is awaiting triale (Butkowski was later convicted and given a three•year prison sentence.) Dr. Y.: On what grounds 7 Mr. G6 I On grounds that he obstructed justice., Dr. Y.,a Because he hadn't admitted earlier that he had bad some con~ nection with Krebiozenf Mr. G.: No. Because of his failure to comply with the requirements of the court, that he not discuss the case. 67 Dr. Y.s t' I see. Mr. G.s And that there he was ~own ih Springfield with some of these defendants during the trial. I see. Mr. G.s For that convention of the union local. That and the fact that be was constantly hammering away at the wit..~esses of the govern• ment when he w&s under court instructions not to discuss the case at all, right from the start~ And the fact that his union had taken a position on Krebiozen and there was that sign over beadquat"tet's, ; And this case still awaits tri~l? Yes. Now you ask how it is that this occurred? Well, this is how it occurred: Much of what I have told you here is public information,. 68 now. It was all reported in a series of articles in the lli Louis Post-Dispatcl:,., written by one of that newspaper•s ace report~rs, a fellow by the name of Collins, his full name slips me at the moment. But what I've just told you is public. And does he allege that ~here was anything behind the position of these pro~Krebiozen jury people? No. He doesn't. Of course, the whole thing :ls mighty unfo:r:tunate. He doesn • t allege that the Krebiozen forces got to and bribed the witnesses or anything ••• ? No. There is nothing like that alleged. What motivated But- i kowsld, 'I can•t say. The government was doomed from the start. Dr. Y.1 Now, this case differ$ f:tom the ti.oxsey case in that it was a jury trial. 69 No. In the first l-foxsey case, that is, the case involving the injunction in Texas, that was before Judge Atwell without jury. But the second trial, which involved a tremendous seizure of all of Hoxey's medications in Fot~ge, P1nnsylvania, was a jury trial. Dr. Y • 1 Y~s. I was thinking of the first Hoxsey cas~ in Texas. There you could appeal. Yes. Dr. Yo c Would it hav~ been possible to make the same kind of an appeal to a circuit court after a jury trial case? Mr. G. s' Only in a seizure case. But in a criminal case there is notappeal if the government loses. To reverse an acquittal would be do~ble jeopardy. 70 Dr. Y.: That's what I thought. Consequently, we simply had to accept the verdict. It's an unfor• tunate thing that the judge was so insistent upon the Jury return .. ing a verdict. Dr. Y.: You think it would have been better had he recognized the impasse and called it a hung jury and permitted, therefore, a new trial to have been broughtf One of the yury women, the one who had tears in her eyes, told the Assistant United States Attorney who handled this case and Mro Palmer, one of FDA's inspectors~ that she felt that this was a very poor jury and that the government could not prevail with .a i , jury of; this poor quality and that she was very anxious that the gove~nt have another chance to prove its casee She was going to hold out for a hung jury, but the way things developed, they were the weaker ones, she said, and they couldn't hold out in the face of the aggressive attacks~ They were sick. There was an epidemic of the grippe going around. They were not immuneo They 71 were imprisoned. They could go only between the courthouse and the hotel. They had had it. Dr. Y. s And this had gone on for nine months? Mr. G.: Nine dayse The trial had gone on for nine months. But the de• liberations were for nine days, and they were imprisoned in this room with a lot of antagonism built up, and the judge wouldn't cooperate with those who were for conviction. They just felt such resentment that they threw the sponge in and said, HThe heck with it." Dr. Y •: Of course, the judge didn't have to explain his position? He was hopeful that he could get a verdict and avoid another long triale Mr. G. a ! That's right. But it was no secret that he wanted a conviction. He was convinced beyond any question that this was one of the greatest frauds ever perpetrated upon the American public,. He was sorely disappointed in that jury. --------·---------~------------~------·----,----., ... . . . . . . ., .UA4..l!t:t:'.bU iill M I 72 Dr .. Y.: But somehow he didn't, at that point, couldn't he realize ~hat was happening in the jury? Mr" G.: He didn't recognize that it was hopeless for the government. He did not foresee that, if anything, instead of compromising in favor of the government, the compromise would be again~t the government. He didn't recognize thise And your feeling vas that your evidence was every bit as persua- sive as the evidence had been in the case connected with Hoxseye It was the strongest evidence ever put on in any case within my experience and the members of the United States Attorney's office assigned to the case have said the same thingo i Dr. Y.: It wasi::;,µot only the kind of medical evidence with respect to the cases of people who hadn't benefitted or hadn't been cured, but in this case, you bad fraud. 73 Mr. G. 1 We put on tremendously persuasive evidence of fraud., Absolutely irrefutable. Dr. Ye: Did this relate to such things as the number of ampules that they had bought compared with the amount of medicine that they asserted that they had 1 That's right. That was one thing. The money they made was another$ There were many aspects of fraud. Dr. Y.: Things of that sort. Mr. G. s They said they had enought so-called Krebiozen powder to make only two hltt\dred thousand ampules of the injectable sol~tion. That's all they had, and yet they bought well over a million ampules. I can't recall the exact figures, but it certainly was well over a million ampules and ~ • them. .Now where did the Krebiozen powder come from? And then, what was the substance Krebiozen? Their refusal to give us samples of the powder was suspicious., 74 Ulti~~tely they did give us a sample, and what did it turn out to be? Creatine fuonohydrate. 't"Seir purchase of horse meat was sus• picious. We know we can make creatine from horse meat. We've n1ade it. Why were they buying horse meat? They were supposed to have the blood. Krebiozen, they claimed, came from the blood of horses. In other words, your assumption there was that they were making it out of the horse meat and not out of this tedious, complicated process that they claimed they were making it out of, injecting $omething in the horses and then taking the bloodo Mr. G.. s The evidence is clear to us that they made nothingo But when they were pressured to give samples to the government, they had to give it something. They gave creatine which they made from horse meat .. But creating doesn't dissolve in mineral oilo··~We never found any i creatine in mineral oil. But we did ·find l•metbyl•hydantoin, a creatine derivatiXf, which does dissolve in mineral oil, if you add a little amyl alcohol, and we found the amyl alcohol in the amI>ules of Krebiozen. Now what is the significance of this? The tHgnificance is: they had given the government ereatine and they could expect the govemment to look for it in the mineral oil 75 Krebiozen powder was supposed to be dissolved in. They knew creatiue doesn't dissolve in mineral oil so they put this creatine derivative 1-methylbydantoin into the mineral oil instead of creatine. The amyl alcohol was added to increase the so~ubility of l•methylhydantoin. I'm sure they never imagined that the govetument would be able to discover and identify such small •mounts of 1-methylhydantoin and amyJ; alcohol 1-'n the mineral oil. They thought the 1-methylhydantoin would surely confound the government chemists and convince them that a substance Krebiozen did exist. And so, when we bad samples examined by our chem~sts, this unknown something was discovered which we established ultimately, in a beai:ttiful piece of research work, to be 1 ..methylhydantoin. We were able to prove that Promack Laboratories, that is the Duro~ vies, had a supply of 1-methylhydantoin. We knew they also had ereatine because the commercial laboratory which they hired to analyze cet"tain ,.·.- . :,oded samples of unkno~'D substances were given...--· creatine and l•methylhydantoin. The laboratory was told that the sample, wbich turned out to be creatine, was Krebioaen powdero I . This commercial laboratory reported to the Durovies that it was creatine monohyd~ate. Once the government discovered that the Krebiozen given to them was creatine in the powder form• or 1~ methylhydantoin in the mineral oil, there was no longer any need for Dr. Durovic to carry on bis pretense. Inmediately after that the Krebiozen solution again became pure mineral oil~ Prior 76 to their giving us the $ample of creatine the injectable liquid labeled Krebio~un was pure mineral oilo After they gave us a sample of the powder which we established to be creatine; they dissolved l•methylhydantoin and amyl alcohol in the mineral oil. After we discovered this, Krebiozen once again became just mineral oil. The only time it contained anything other than mineral oil was for a short period of time in 1963 when it contained the l•methylhydantoino Now as far es the FDA is concerned, and it convinced the United .Statea Attorney and the Justice Depa~tment of thi$, Krebiozen is nothing but mineral oil. It never was anything but mineral oil, and everything else were the props of a con man. As a matter of faet the United States Attorney, in his summation, said he was struck with the similarity between Krebiozen and the fairy tale of Andersen• "The Emperor's Clothingo" The government attorney read Ande't'sen•s fairy tale to the jury iu summation. The story starts off, "Two ;~oreighnrs who were swindlers came,.to the city of this kingdom." The government attorney told the jury that that's. exactlr what happened here. Two foreigners who were swindlers came to Chicago from abroad. They pretended to make.Krebioaeno They brought the pi-ops to suggest its manufacture• but Krebio~en was never made •. It was only mineral oil, and the Krebiozen cloth was just spun out of nothing. WLJILL&&li 77 And in connection with the fraud point, didn't you also have some evidence that there had been tampering with medical records? Mr. G.,1 Oh, yes. A person who had cancer of the bladder took Krebiozen, then went back to Argentina 't·1here he di"!.J, of ••• cancer of the bladder., •• in 1956. The Krebiozen Research Foundation records showed him as being alive and examined in 1959, had him again examinP.d in 1961 0 an.d claitrncl he was free of. cance::•• tb.anks, of course, to Krebioaeu. This false record was given to the Nattonal Cancer Institute as evidence of Krebitl'zen•s efficacy., Or .. Y.: And you checked with the death records? We went to Argen Una. ! Did you go? Mr. G.z No. I was supposed to go but the Krebiozen case came up and someone 78 else batted for me. Dr. Y.s l see. But, we actually went down there and we brought up the aist~r, two siste~$, who testified, and we got, of course, a certified copy of the death cet:t'ificate and bis medical records. His dstex testif!.ctl that be dfed in H56., Foundation carried him on their records as having been examined in •59 and •61. They may have felt "Well, who's going to go down to Argentina to check this?" We did. So that was oneo There were, oh, any number. We alleged two or three such falsifications of rEcords which we charged as being cr!tainal acts beca~se the false records were submitted to the National Cancer Institute. The one involving the fellow down in Argentina.•• the dea.th in Argentina, is one of them.. But there were many of them; any records which didn't jibe with the actual medical fact$. Dr. Y.: N\IW, one of the truly intriguing questions that underlies this whole episode, end it makes it the kind of episode that it 79 'became with the stature and a magnitude of its appeal 9 is unquesdonablf the fact that Dr. Ivy lent his reputation, which had been a very high reputation, to it. From your observation of the trial and your examination of all the records getting ready for the trial, did you reach ~ny judgment as to why this sort of thing occurred? Mr. Gl>t l did, yes. The testimony of Ivy an~ the facts of the case indicnted that Dr., Ivy embraced Krehiozen wit;h almost no know• ledge about it, with no knowledge about the promoters, the Durovf.cs. lte worked with a physician by the name of Kranno, Louis Krasno, and they conducted a study with this. They didn't know what it was; its composition was comple~e,\y hnr.nown, and yet, they embraced it without knowing its composition, ~nd they conducte.:! a study of the most superficial type on dogs and human beings., l-lo scientist in his right mind would accept either the type of stud:,- that was done or the res~lts as b.aving any validity., And yet, 1 on the be.sis of that absolutely insignificant work, they concluded that Krebiozen had tromendous merit and justified in• tensive study. Now, in March of 1951, Ivy announced to the world in a convening of physicians and members of the press at the Dr~ke Hotel in Chicago that he had studied Krebiosen and that it had sufficient merit to warrant further investigation by the 7 80 medical profession, and he presented to the medical profession a booklet with a chart showing the patients, identified only by initial, the disease, the treatment, and so on. It was an interesting tabulation.· Now during the trial, we tore that apart and showed that there were downright falsifications in that chart. One of the doctors, for infJtance, had written to Ivy and said, "You've completely distorted" (it wasn't Ivy's patient, but it was this other doctor's patient, whom Ivy was permitted to observe) ••• "You•ve completely distorted my medical facts en this nmr.. He didrt ~ t benefit; he g<,;-c worise." This was after the booklet was published. Ivy never retracted. There were~ number of patients who had died of cancer and were shown in this ct,,l"t as being alive and well. He knew- they had died, because one of those who bad died was Dr. Pick's wife, and Or. Pick was one of the doctors who was working with Ivy on this thing. Ivy knew Dr. Pick's wife ,was dead. Certainly, Or. Pick knew his wife was dead, and yet there they both were on the plat• form at the Drake Hotel not saying anything when they spoke of ' the results of thei1: study of Krebiozen. So you -turk me whether I drew any opinion or any conclusion about I>r. Ivy and what motivated him. My own personal feeling was this, that Dr. Ivy had reached a stage in bis life where he was about to retire on a very small pension. Here was a run who was active all his life and he apparently never made very much moneyJ after all, he was 81 for most of his life a college professor" Al though he• s an M.D., he was not a practising M.D. He had five sons, four of whom ha sent through medical school, and l don't think he was in a position to accumulate too much wealth in the course of his professional activity. He was now reaching a time in his life when he would have to consider retirement on a small pension. Durovik came along and, perh~fS there was a lot of wishful thinking o~ the part of lvy 9 he embraced this preparation, perhaps he had visions of a Nobel prize. Even as late as the trial in this Krebiozen case, Ivy sued the government, the United States Attorney, to keep this trial from being held. He svught an injunction to keep this trial from coming up. And among hi$ contentions was that if be were convicted, and he felt that there was a godd likelihood that he would be con• victed, he would probably be the only Hobel pri2e winne~ who ever spent time in jail. ! think that's rather interesting, in that.it suggests that that's maybe what be had in mind when he embrsced thiso He hGdn•t achieved that; he had achieved ; fame end respect, but not the Nobel pri~e. Maybe tais was on his mind. Maybe that's whyhhe embraced it. Here was his <;ppo,:t• unity. l don't know whether he made any money out of this .thing. The evidence at the trial showed thet he had deposited a sum approximately equal to his teke-home pay as a university profes• sor; I think what the evidence showed was twelve hundred dollars 82 a month, perhaps fourteen hundred dollars a month, each month, that would be o.aposited. And that was equivalent to his salary minus his deductions as his take-home pay. Nothing else went into this account for years, and then suddenly in 1957, a hundre~ and ninety thousand dollars went into this account, in~ eluding, of course, those fourteen hundred dollar cheeks. And then in another year, soon after that, there was a hundred and sixty-fou~ thousand dollars that went into his account. This was a lot of money, and this is in the evidence. Now, whether it incicates that he got paid from Krebiozen, I don•t know. We weren•t able to prove that. He denied it$ But the fact is that he had tremendous stock holdings. ~faybe he made it on t~e market. Nobody knows, but certainly he bad at least a quarter of a million dollar.s in stocks. This was in the evidence. tt ,111 came about by a question asked by the defense attorney when he hau Ivy on the stanao He asked Dre Ivy, after having portrayed him as a man of no great means, who was new retired aftP:r having devoted a lifetime on the campus, "Dr. Ivy, what do you live on?" And Dr. Ivy, in furtherance perhaps of this thesis of giving the im• I pression of being a poor man, said, "\,lell,. I have a small ,ens:t.on, and I contributed to this pension• and the state contributed to this pension, and then some income that we have f:rom our invested f;tvings." All of which gave the impression of being very, very smdl. I think the pension was around six. thousand dollars a year., 83 Well, that opened it up, and actually he had had twelve thousand dollars, I don't remember whether, it was twelve thousand or four .. teen thousand, in dividends from the stocka. He didn't mention1 ,l that. He says, "Return on the investments that we've been able to make from our savings." Dr. Y. z Now, on cross•ex:amination, they found out what the sum was. Hr. G. a Yes. It was twelve thousand dollars. Well, we had known thiso We had his income tax report; he knew we had his income tax re~ port. But whether he made any money out of the Krebiozen venture, I don't knowo I rather suspect that perhaps he had hopes when he embraced Krebiozen of obtaining recognition as a Nobel prize winner. Dr. Y.:i I have talked to people who have had the feeling that he was the sort of personality who, once he got involved in a thing like this, would become more hardened in bis defense of it rather than admitting perhaps that he bad made an initial mistake. 84 I think he is incapable of saying nt was wrong." I gathered that from his testimony. He was on the stand a long time, sub• jected to rigorous cross•examination. In my opinion, be turned out to be a deplorable witnesao It was sad. It made me sad to see a great man responding in the manner that he was responding to questions from the United States Attorneye Sol gathered that be was ve-ry stubboi-n and incapable of admitting error on his pert. What you bad gathered, I think is true, that the more eriticism heaped upon him that the stronger became bis detet"mination not to abandon Krebio&en0 There was another Chicago scientist whom I wanted to ask you about. He was a physiologist at the University of Chicago, Anton J. Carlson~ Now in the research that I've done, I have found that many times Professor Carlson served as a prosecution witnees for the Food and Drug Administration, sometimes in quackety cases, sometimes in other kinds of cases. While you ' were with the Litigation or Regulatory Compliance part of the Food and Drug Administration were you involved in any cases in which Professor Carlson was a witnessr:]j 85 Mr. G.: Not while I was with tha Division of Regulatory Management. , By then, Carlson had gotten sick. He'd had a heart attack, and he w•s considerably less available as a witness. I might say that Ivy was a protege of Carlson. He was a disciple of Carl• son and Carlson was very proud of him until Ivy embraced Krebiozen., Dr. Y. a I might say that a friend of mine, a medical school dean 9 who knew Carlson, once met him in his latter years, after he bad his heart attack, at a convention in Atlantic City, .so he told me, and he posed the question to Carlson as to what had happened to Ivy in connection with the Krebiozen situatione According to my friend, Carlson took his hands and clutched his chest and said, "Thank God, I have my trouble !:!!!.! instead of ~ • " and on the last phrase he moved his hands from hia chest to his head. i Mr. G.: I've heard that story, too. Dr. Y.s So that that's true that DT. Ivy was a student of Professor Carlson. 86 Yes. And Dr. Carlson tried very diligently to persuade Ivy to give up Krebioaen, which he felt was madness on Ivy's part. And some of Ivr,'s friends and colleagues banded together and tried to persuade Ivy to give it up. Later on, Ivy accused them of an insidious motive in that. He didn 9 t accept their efforts in. the spirit in which they made them, namely, to persuade him that this was. suicide for him. -.p-rofessional suicide for him to pursue this. But instead of accepting it, he resented it and ntta~k~d them later~ But coming oock to Cerlson, l <lid have occasion to be on a case in which Anton Carlson testified. I '>. had heard of Carlson. He had a great reputation as being the dean of physiologists in. this country, but I had never met him and I didn't know him. The case in which he and I both testi• - fied was a ease brought by the government against maple syrup which contained lead. The lead was picked up in the sap during the collection of the sap in those days, because of the use of receptacles to collect the sap which we~e made of an alloy of tin andi lead known as "template". Now if the sap is a little acid, the tin and lead would dissolve into the sap, and then when the sap is concentrated down to syrup, of course, the metal, the lead in the tin also concentrates down. And so most of the syrup whieh was packed in Vermont that year, and this was 1938, was contaminated with lead. We had seized a good part of Vermont's 87 output, practically ruined the industry up there, and there was ~ contest. The defense was th~t the syrup wa$ not goi~g to be shipped frOCl the state of Vermot,t to other states in the condi- tion in which it was at the time of seizure. It was going to be deleaded, put through a process wbere the lead would be precipi• tat.ad down, the product filte1:ed, and the product would be free of lead. This was their contention. ~-- At tho time i~ entered int!it'State couwerce. At the time it entered inte~state commerce, it had lead. You see, wherus Vermont ships out a trecnendous Ml()unt of maple syrup, labeled as Vermont maple syrup, only a small part of it ' is actually produced in Vermont. A good part of it is produced . f.u New York, Ohio, Pennsylvania, and shipped in bulk to Vermont, were t't•s blended and repackaged and shipped out as \'ennont, pure Vonnon~ Qaple:: syrup but actualljy, its 01:igin is Nev Yo1:k, Ohio, Pmmsyl vanL, other a.rQQls, other plaees. Some of it came from Canadc, you .11aid. 88 Mr. G.: Yes. Now••• are you familiar with this case? Dr. Y. a Not in detail about the ease, but a little about the situatione Mr. G.: Yes. Well. kJ I say, the farmers who were collecting the sa.p, were the persons who were responsible for the contamination •• o We bad the right to sei~e and we did, to be sure that any de• leading would be done under cut' supervision., It wouldr 't be left to them. This "Was before the days of voluntaty compliance. ('i\ndwe did maintain, we felt, that this was the way to do it. If you want to be sure, you seize it and then it•s done under your supervision. They pay the cost of supervision, then you kuow:t ., it's gone out without any lead. The lead was too seriouse N01~, Dr. Carlson was brought in to testify about the hazards of lead in any food product, even in minute amountso Dr. Y •: What was the name of the case? Do you remember? Mr., Go I It was United States versus so many drums of maple syrup. I can 89 give it to you if you want it, I mean, if you are interested. I can give you the title. Dr. y.: I can find it, I think, but being a seizure c.!lse, that was the way it was instead of, of course, the name of ••• Mr. G, l That•s right. It was a consolidated seizure. lt represented many carloads of ~ple sytup which came in fr.-:;:m thes? c ther states into Vermont. We seized them piecemeal as the cars came in, and we had all of them consolidated up there for trial. Now there was a curious incident that occured with me in connection with that. This seizure was being tried in Vermont which is the home of Vermont maple syrup, and the seizure was bd.ng x:ried in a small town, I think it was Barre, Ve1;mont 8 a very small town. The jury was composed of the farmers, for the most r,art, of Vermont, vho had a personal loyalty and pride in Vermont maple i~syrup, and the United States atto111e:v, :i:ecognizing, this, had instructed all witnesses not to talk to any stranger, because he might be a local sympathizer of the ~ple syrup peopleo He gave us• blanket order. He didn't want us to talk to anybody. "If you don't know them, don't talk to them." Well, I had testi• fied, and right after my testimony, a recess was called, and we 90 all went to this countryLhotel with a long porch and rockers. After luncb, we sat out there waiting for time to go back to court, and I sat down. Before very long• this fellow, vhom I sized up to be a local yokel came over. He was smoking a corn cob pipe. He was very dishevelled. His suit was unpressed; one cuff was turned down; and he sat next to me and, in an accent, said to me he bad heard my testimony and thought it was brillianto I said, "Thank you." And then he continued to talk about the case. Being mindful of what the United States attorney bad told me, I said, "I'm sorry, but I can't discuss this case with you." But that didn't deter this fellow. He just kept on talking about the cas~, and I said• "Now look, I can 8 t discuss it with you. I 1 m sorry. I wish you'd stop discussing the case. You can talk about anything you want to talk about but not about the C$Se." _ Still, be continued talking about the case, and I said, "Look, I'm under orders, I'm sorry. I hope I don't offend you., 11 And I got up and walked away. When we got back into court, the very next witness called was Dr. Anton J. Carlson. This local yokel w~lked down the aisle in the courtroom to take the stand 1 I and he was the great Dr. Anton J. Carlson. He enjoyed the joke enough that he hadn't tipped his hand to you. 91 Mr. G.1 No. He had not aaid anything. Dr. Y.: · Well,nnow, how was he as Q witness? Do you remember that? ;,Terl:'ifie. He spoke 1n a Swedish accent. lt isn't ".Jesus"; it's "Yesus." It isnit J'umpin Jiminy; it's \rumpin' Yiminy, but he was very articulate, very dramatic and he iopressed me tremendously. He was an excellent witness on the dangers of lead. Did you get any evidence from this case as to his skill in hand• ling the cross ... examination that came after he had given his testimony? Oh, be was one step agead of the defense attorney or rather the I claimant!s attorney. Always one step ahead of him. Dr. Carlson knew just what was coming. He knew just hov to parry the ques- tions, how to answer them, yet without giving the appearance of being flippant or insincere or anything else. Ha was very good. He was one of the most impressive witnesses I've ever had the 92 pleasure of listening to. Dr. Y.: I certainly gathered that from the cases that I have read, in• eluding a few instances of the way be was able to make a question on cross-examination turn out to be a point for the government rather than a point for the defense, by the way that he answered the question. He'd bf' a man t:hat l would h&te to have to cross-examine,. As I say, at the time I saw him• he was probably in his prime-~that was in 1938•-and full of confidence. I have seen many expert witri.esses,b,however, who were brilliant men. In that Hoxsey case, up in Portage, Pennsylvania, we had a brain surgeon from Mayo Clinic who testified for us, and a brain surgeon, you'd imagine, is a man who has nert@s of steele This man testified, and I later spoke to him, congratulated him, and told him w--hat a wonderful job he had done testifyingG He said, ''Did my nervous .. I ness show?tt ; I said; "Not parJ;Jcularly." He said, "Let me tell you, I've had operations where I've had to stand on my ffet and . operate for hours and hours and hoursG The fifteen minutes that I was on the stand was one of the most gruelling experiences I have ever had." lu&Ei&J!.i L &.&& L .§£&& &alE&&id&l J 93 Dr. Y.z Well, in a speech once, Billy Goodrich said that doctors fear the witness stand almost as much as lawyers fear the operating table, and I guess that's a good example .. Mr. G.a That's right. Dr. y.: An inspector, such as you were fot a number of years, and then even after you went into headquarters, you were also a witness, has al~ ways to be prepared to be a witness, and so this kind of problem of knowing your facts and then of being able to stand up against the kind of hammering that comes in cross-examination, is one of the basic requisites of a good inspector, isn't it? Mr. G. i -~1'~~~·! ~-:-:..-..~,."1- It certainly is. All cases are difficult to win. Never is the exp.ressi~n ••• ,"a chain is as st-rang as .its weakest. link" more applicable than to a court caseo You can have the most solid case in the world, but if there's one minor weakness, you '7fill lose your case. The in~pector must not make a mistake on the stand. A mistake can be fatal~ He's got to know his facts; he's got to be able to anticipate the cross-examination and have 94 the right answers. Not only must he speak. the truth, but he's got to give the impression that he is speaking the truth. So his demeanor hes to be impeccable. Little things affect the jury, the way the man knots his tie, for instanee. But if he in any way gives the impression of not telling the truth• no matter how sincere he is• no matter ho~ truthful, if he gives the impression of not telling the truth, his testimony is lost. So• he uot only must tell the truth, but he must tell it in a way that is believable. We prepare our witnesses very careful~ ly. We go over their testimony with them before they testify, We review their testimony but we don•t rehearse ite Lut we have to gooier their testimony with themc1 We try, at that time, to smooth out things, eliminate those elements which might work to their disadvantage when they take the stand. We have ln"itten booklets or brochures on the deportment of the witness in the courtroom, not only in the courtroom but anywhere around thfl courtroom. because you never know when you are exposed to a juryman. He's the one who is deciding the case, so you cannot take anything for granted. You've got to be on you~ ltest behavior at all ;times. I •ve seen this happen: where hor:eeplay or a wise., crack was made about the judge or about a juryman in an elevator during a lunch hour break, and there was the judge on the elevator at the time. You may not recognize the judge when he's out of his judicial robe. He may look like a different person. I have 95 seen this happen. Some witness made a comment about the judge, and there was the judge standing right next to himo The witness didn •. t know it. Now if this is done about a juryman, God help you if that juryman is there. So it•s little things like that that your case sometimes hinges on., Tha inspector has to be on his toes at all times, and on his best behavior, dressed couserv.. atively, and he must do all the things that are necessary to create an impreiasion of credibility. Dr. Y.: In connection with inspectors, you mentioned that one of the members of the team that was assembled to oversae these cases was a man who could get the evidence when other people had a hard time doing it. Now, that's the impression xou have among your colleagues at the Food and Drug Administ~~tion. It's the impression that you had r.s an inspector, as you were coming up, that you were very able at ferreting out hard•to•secure evidence, and you were certainly in some of the difficult areas, such as New York City. Do you remember any experiences that illustrate this point where you were workir 6 on a case that was very hard to crack and you managed to find some way through by some in- genious method? 96 Mr. G. s Well, first of all, it takes imagination, and a suspicious turn of mind, and persistence. Now, first, as to imagination. Let me give you two illustrations that I was involved in which point up the question. of imagination. I was once in a warehouse be-- tween Thanksgiving and Christmas, and some barrels came in while I was there, while {t,riwas on t~1e delivery platform. This was a cold storage warehouse. I was waiting for something else, l don• t reull what. An Armour Packing Company truck pulled up and a number of barrels were unloaded. And just out of curiosity, I aske<l the werehoase foremar., "What 1 s in these bar::e 1 s 1" He said, "Turkeys." At that point, imagination came into play. What in the world were turkeys coming into a warehouse for between T~anksgiving and Christmas. Turkeys should be going out of a warehouse between Thanksgiving and Christmas., My suspicions were aroused. You have to have a suspicious tum of mind to be a good inspector. I requested that the barrels be uncovered and I looked into them. The barrels contained decomposed and rat defiled turkeys the equal of which I never saw before end have never seen since. The meat was rat nibbled, with rodent excreta everywhere. There was actually a layer of rat excreta pe!lets in one of the barrels, together lfith rat-gnawed decomposed turkeys. The manager of Armour and Company was i.:ying to salvage them. He had pennitted them to go bad, and be brought them to the warehouse 97 for freezing. Now, he wasn't going to throw good money after bad by freeJting them unless he had some ulterior motive. He had trucked them from Fall River, Massachusetts, to Providence, Rhode Island. The next day the shipment was seized and the firm was prosecuted and convicted 1n time. Suspicion and imagination resulted in the interception of this adulterated food. Another instance: I passed by another warehouse in New York City, and out there in the street, awaiting garbage collection, were barrels of labels. The labels read: "Crab meat. Geisha crab meatn qr ,omething, "Product of Japano 11 At that time vhere was a strong anti feeling in this country about Japanese goods. "Let me see about this," I thought. So I went into the warehouse and, sure er.ough, there I found some people busily stripping off labels from cans of Japanese crab maat, and putting on another label, •1Product of the u. s. Se R.," The u. s. So Ro at that time was our ally; Japan, our foe. Tn~y fished for crab meat in the same waters, off Japan and Siberia, Vladivo- i stock, right there, so the waters are the same end it's the same crab meat. The Olmers of the crab lfteat couldn't sell it as a product of Japan and so relabeled the c~ns to falsely declare the country of otigin to be the u. s. s. R,. This, of course, was misbranding. It's not the most serious violation of the law, but it is a violation. 98 Dr. Y.: Your curiosity paid off. Didn't you have something to do in developing the Plantation Extract Corporation case? Mr. G.: It takes imagination and suspicion to spot a violation and then determination. You can't tak.J 11 no 11 for an answer. Now, the Plantation V::nilla ease is one il.1 point. It was the fiT~t war frauds case and it involved bribery of War and Navy Depart• ments officials. FDA inspectors bed gone into the Plantation Extract place time and again, on su~,pieion and on competitors 9 complaints becaJ ..,e Plantation undersold everybody in the vanilla extract business. Yet, when Plantation's vanilla extra.et was examined, it tested out just like normal vanilla extract, and the question that the industry wa,s raising was, "How can they sell it at these prices and make a profit?" Inspector after inspeeto~ visited Plantation•s plant and came out with nothing. Now, I went up there, and I just didn't accept any of their stodes. ~; just didn't believe what they said. I've got tot;; decide the 'facts on whtt l tnyself observe and what our laboratory tells me. And so when they showed me a product called "J.B." which was supposed to be oleo resin of vanilla, which could be used, that's a legal product, and they showed me invoices to show, "Here it is, oleo resin of vanilla," and it•s called "J.·B.,, I --·-- 99 wouldn't accept their word for it. I took samples of it, but I also took snmples of other. lots U!8.rked "J. B." One was oleo resin of vanilla, the other was oleo resin of St. John •s worto Oleo resin of vanilla is the resin of vanilla beans costing eleven dollars a pound; oleo resin of St. John's wort is the resins of a weed, St. John's wor~costing six cents a pound. And these resins were used for the vanilla resins. They are very much alike in appearance~and properties. Now everybody else bad gone out there and reported this "J.B." and accepted the invoices, you see. So that's it: persistence and not awallowing everything that's told you, especially where the industry saysz "How can they do id" Dr. Y.a This was a situation in which• by mixing some real vanilla extract with an extract of this oleo resin of St. John's wort, they got a product that tasted like vanilla extract and ••• Mr. C.: Well, it was a little bitter. So they added •ugar. But by the che~ical examinations that prevailed at tbe time that were used to test, it checked outo 100 Mr. G.1 Plantation's vanilla looked just like pure vanilla extract, and when tested in the laboratory it couldn't be distinguished from the genuine product. Ultimately we broke the case and several defendants went to jail for their fraudulent scheme. Now, we had an orange juice fraud in Houston, Texas where the analysis clearly showed it was watered. Cal-Tex case. We went in for an injunction on the basis of the laboratory test which showed the juice was watered. We lost. It was apparent that we couldn't win on the basis of ju~t labora- tory work. We had to have supplementary evidenceo How do we get it? Our New Orleans District wrote in to the Division of Regulatory Management and said, "What can we do?" "Can we use _/ a m~rket to. be introduced into the ecl 1il tere.nts for tracing pur• poses?" We said, •1No." They asked again, "Well, what can we do to break this racket?" Since the District was asking for advice, we studied the problem. Here is where imagination comes in. We knew we couldn't get anywhere by factory inspectionsa We tried that and found the fi:rm too clever for us to get any lUl evidence of watering. We told our New Orleans District, "See if you can't get a place to rent close enough to the factory so that you can observe what's going on in the factory yard every day." They were ,,ery fortunate to get an apartment directly to the rea-r of the yard. They paid for a monthfs rent and there they obse-rved the operations and they we~e able to make a clear cut case of adulteration by watering and us<e of cover- up adulterants. Tba t was where they were bringing :l.n the sugar• •• 1 Mr .. Q.. : That•s right. Once we got some leads by spying• you see, then Wf;l were able to follow through and get other leads. It was a spy job. The inspectors wetched that place day and night, and got the evidence through that mean$. They used field glasses. · They took photos and :1l<>V1es c,f what· they observed. It takas i.mrgination; it takes suspicion; it takes persistence; and often it takes ~rsuasiveness. Sometimes you t.e.lk your ,,~y in. You I disarm the guy. You play dumbt like a fox. You ~o disarm the guy that his guard goes do,m end you get your evidence .. IIIIIAC&t&:: t a x - - l u WI 'G 102 Dr. Y.: Because the law is such that you couldn't demand? No, we couldn't demand. Or, let us say, I am going to a bank •s part of our investigation, and I question an officer of the bank. Now the instinct of the banker is, "I've g?t to protect my client." If I wert?. l!I banker I ce~":ainly would protc~t my ¢lieut. I mean, there's a trust there. I wouldn't give auj: any infonnat.inn to a goverr,ment agent. But yet we are successful in getting information. How is it that we arc able to go into a bank and get the banker 9 s cooperation? Very often the records of a bank reveal very important evidence necessary for the proof of a crime. You could subpoena a bank's records if everyyou get to a grand Jury investigation, but how do you know whethe~ you•ve got a case sufficiently strong to present it to a rraud ju~y? You'd like to know whether the bank does have any evidence. A skillful, ,tactful, persuasive inspector will get cooperation t of the bank, whereas another man, going in for the same thing, may strike out completely and get nothing. So, it is true that one inspector goes to a plant and apparently sees nothing and hears nothing, and another inspector going to the same plQnt un• covers a very serious, perhaps even fraudulent, violation. It's the make-up of the inspector• his intelligence, his acfuity, his 103 persuasiveness, his articulateness, his knowledge of human behavior and how to get things out of a person& Dr. Y•: Another area where persuasiveness obviously is important, it seems to me, is within the Food and Prug Adminhttation at the time efforts are being made to determine allocation of resources, which always certainly has been for the Food and Drug Admfnistra• tion a very difficult task, sinee most of th~ tima it hasn't had enot,g,h resot,rces to do the kinds of tsskr1 the 14'\W.s assigned it to do. io one of the problems that l 've been interested in is the problem of decision-making within the agency. One part of that decision~IMking has been divvying up the resources among the different projects that have been set up for the year, and, I suppose, to some degree, this is determined by people sitting down and debating what are likely to be the key ptoblems of the biggest magnitude fer the year that lays ahead and so on. You say, you went to Washington while Dr. Dunbar was still Commissioner? Mr. G.: Yes, in June of 1946. Dr. Y.s And then Mr. Crawford followed him, and Mr. Larrick followed Mr. C~~ford. You, in your position of responsibility, had dealings 104 officially with them and were part of the decision-making process that went on about what the Food and Drug Administra• tion should be doing with its resources, &nd whether or not it should undert&ke a given kind of campaign, and so on. Would you mind talking for a 1i ttle while about these Ul€n as person• alities and as admlnistrators? Mr. G.: All three had tremendous savvy in Food and Drug enfcrceme;.;;e They hd a ke~n understaud:fnS; of cC1nsumer Df\eds: wh?t the consumer wanted in the way of protection•-they themselves, before becoming Commissioner, had had almost a lifetime of work in enforcement of the Food and Drug act and the Food, Drug and Cosmetic Act. They knew so well the reaction of industry; they could anticipate the reaction of industry; they knew where the difficulties would arise. I had a tremendous respect for all three of these men. l think that the public was very fortunate in having men vf their calibre heading up the Food i and Drug Administration. I think that the public got a terrific bargain in enforcement. We had a small staff$ Morale? l never saw morale as high iu any governmental agency, in any organization as it was in FDA. You would think that each man had a private stake, a business stake, in the organ!• zation. Nobody was taking any g~aft or bribes. It wasn't a lOS monetary stake. It just was that under their leadership,, FDA's rank and file took great pride in its work, and it was imbued with the feeling that the l·1w was to be given its utmost scope of protection. I have a tremendous respect for all three men. I think that 9 perhaps with the exception of the last few years of Larrick's career in FDA, for the most part the organization was a terrific organizationo Dr,. Y.a Right. Now, how did they diff~r in th~ir personalities~ in the way they went about their task of leadership? Mr. G.s Mr. Crawford was the idealist. He had very lofty ideals., I think, of the three he wa:s prob6bly the most consumer-conscious. He was the one who wanted us to extend the law as far as possible in order to give protection and to test out the law. Ho was of bh ' philosophy that if we won all of .our cases, then we Yere not giving the publie 'the full b-;nefit of law enforcement. We should lose ' some. That was his feeling. Dr. Y. r He had been the one who had had the most to do personally with the drafting of the 1938 law. 106 Mr. O.: That is right. He worked with Ole Salthe; who was an administra ... tive assistant to Senator Copeland, .and together they framed the Food, Drug and Cosmetic Act. As l say, he was the idealist, and yet, I know that he would criticiie employees of the Food and Drug Admini•tration in high positions who took the position that all violators were despicable characters. No. He felt tbtt the violator, despite his violations, deserved at least respect. And 1 know he passed some disparaging remarks in rny presence about men in high positions in the Food and Drug Administration would who cast disparaging remarks about a violator because he was a violator. But yet he was a vigorous enforcer. Now Dunbar was a very preetical, level-headed administrator .. He knew Congress; he knev how to deal with Congress; he had the confidence and re• spect of Congress. As I say 0 to me 9 what characterized Dunbar most, was his hard~headed practicality. He never let himself get off on fanciful flights. It was all dow•to•earth; every• thing. Now,'Larrick was a diplomat. He was more of the politician, i perhaps the placatoro I don't think he had the idealism of Crawford. He had a lot of the practicality of Dunbar. But Larrick was beset with a lot of problems-~tremendous problems which his predecessors didn't have. Organizational disputes arose within the organi2ation. There was r~organization that was instituted by Crawford which functioned beautifully while Crawford 107 was Commissioner and beautifully up to a time when Larrick was Commissioner. But then, conflicts arose in Larrick's later days within FDA. I don't know what would have happened if Crawford were still there at that time. He might have settled the problems of Food and Drug. But the conflicts which later arose were very detrimental to the morale of FDA personnel throughout FDA. Dr. Y.1 This was internal as well as all the pressures that arose outside. Mr. c;.1 Yes, this arose simultaneously with the external pressures, with Congress coming into FDA. It is certainly sad that these internal disputes arose. I think that Larrick was aware of them, but ha hoped that they would pass over. Larrick was a man of tremendous know-how, and he had the respect of industry. He ~ay have been somEwhat of A compromiser. l don't think there was anything inherently ·wrong in that, but apparently he was blind to what was happening~ in bis own organization. He either wouldn't believe it or he hoped that it would pass over. But he was, nevertheiess, a good administrator. Dr. Y•: One of the other aspects of your duties at Regulatory Management was to have certain liaison with certain of the Congressional 108 cormnittee. Is that not right? Mr. G.: Yes, that 1 4 right. The Kefauver cOfmlittee• as you know, around 1960, started to investigate the pricing of drugs to determine whether there weTe monopolistic practices in connection with nev drugs that had passed clearanc~ with FDA. And that brought FDA into the scope of Senator Kefauver•s investigatiQUs. Since the ln:rdngs that Kefauver was conducting were a quaai•judicial type of thing, it was Larrick's thought that the Division of Regulatory Management who liv'ld with eot;rt cases wou:.<t be thil most h•gical <.livlsion in FOQd and Drug to work with the committee.. And so all requests from the committees wer~ funneled through our Division, and we ha.d to provide the material and the information for the committees. Now thi~ was not always a pleasant thing, because often the com~ mittee would ask for information which the General Counsel•s office and perhaps the Secretary's office felt thould uot be given to the committee. The question that c•me up early in our dealings with the committee was, ~How much information from new l drug files ishould the committee. have?tt The Federal Food, Drug and Cosmetic Act prohibits too giviug to anyone of information ·which, as a trade secret, is entitled to protection, except to a court or to the Secretary of Heal th, Education and Welfare. This is what Congress bad written, and hera we had a 'senator 109 from Congress asking for information which fell squarely within the scope of that prohibition. Yet Congress wrote the prohibi• tion and Congress was now asking for information within the scope of that prohibition. The Senator felt that he should have such infonnation. However, the attorneys in the Food and Drug Admin• istretion and even the Secretary's office stated that the Senator couldn't bave it, because of the progibition. Indeed, I, in the'i/1; Division of Regulatory Management was caught in the middle. And this was rather an unsavory position to be in. l think this con• troversy over what may or may not be given to a Congressman or Ser..ato:r, that's in the new drug files• was responsible for the Food and Drug Administration acquiring the reputation up on the Hill of being obstructionist and recalcitrant. Now I recognized that, and I did everything that I could in my power to placate the committee membe-rs and I think, in time, we worked out a compromise which was satisfactory to them. Dr. t.a Did you do your dealing in this diplomatic mission with members of the staff or tr1ith Senato;- Kefauver himself? Mr. G.1 On one occasiQn t had a conversation with Senator Kefauver, but almost exclusively it was with members of the staff. Dr. Y.1 Was that Mr. Dixon? Mr. G. i Mr. Dixon ••• yes. He was chief of the staff. Yes, end I had som:::: dealings with him and John Blair, the economist, andGoodwin and Irene $ill and Dr. Wayles Brown and a number of others ••• Schaeffe~ ••• quite a number of others. On another occasion, the committee delved into possible nalfeasance on the part of Dr. Welch, who was the head of the Antibiotics Division at the time. And this was a rather unpleasant experience where we bad to provide not only to the committee but also later to the FB:t informe.f;ion c,nr.r;rning activities at the Division of Antibiotics, and Dr. Welch's activities, too. And then later on, we had other committees• we had the Fountaiu committee, we had the McClellan cotmnittee, and the Humphrey committee--we had much dealing with the Humphrey committee. It was my job to give to these cottmittee members the feeling that we were cooperating with them, end I think that by and large, our dealings with the committee were fruitful both to the FDA and ,the'committe~. My own ~eaction was that Kefauver was doing an ; important job in the investigation and that it was absolutely our duty to cooperate with him to the fullest to the extent that the law permitted. 111 Certainly. In connection with the Kefauver committee, reading the industry reaction both within the hearing and in publications, one gains the impression tha_t industry believed or sought to let the public think they believed that Kefauver was interested in building bis own political image for his own political future, rather than being genuinely sincere 11bout the kinds of problems involving drugs that he was investigating. From your association with the members of the staff and with the Senator• the time you talked wt.th him 3 cfo you believe that this image from bdustry was wrong or right? Oh,·· I think that Senator Kefauver was sincere., There was nothing ever in my observation of Senator Kefauver during the f,earings or in his statements to the Senate which would lead me to believe tha:; he Wa$n't sincere, but r•ranot going to be so naive as to say that he might not have had in addition to thia sincerity a desire to uplift h~s image and promote himself, and I would say the same thing·about S•nator Humphrey. But l think that all the staff people there were sincere. They were impatient with us; they wouldn't ~~•bk any hesitation on our part or apparent reluctance on our part to provide the information. They made great demands upon us which required a considerable allotment of manpower to 112 dig up the information, and sometimes we wondered whether we could, under the law, provide the com:n!ttee members with the information they were asking for. They were impatient whenever we questioned this. They acted like policemen, almost, in theit dealings with us and at tioos a little hith-handed. But l wouldn't aay that they we1re not sincere. Was the decbion with respect to what could be given to them •ndi-'11 what could not under the law, made at the Secreun:y's level? Mr. G. a Sometimes at the Secretar-1•s level; sometir::es at the Commissioner's level. And if it was cut and dried, it was even done at my level, where sc:,mething had already been d@cided and they simply- wanted information along the lines of 'he decision. Then, of cour$e, I fel :; free to give it to. them, but if it was new, it was either the Commissioner or the Secretary who decided whetner the infortr~tion should be ptovided. ; Dr. Y.1 But there w~, a kind of general policy line that the lawyeis tn the Secretary's office worked out, that you had to operate on. ib Yes. That's right. Was this a written document? Mr. c. s No. lt was perhaps in the form of an interview met!'ot"andum, tele• phone conversat-f.on memo, or it might have been a letter to the Senator in conner.tinn 'With an foquiry that he :nade. W,e dLl insist, for the most part, up~n written requests and this• too• was troublesome. The Secretary's office wanted a written record of these requests, and this generated, for a time, some rather hard feelings among soma of the congreesman. They felt this was an unreasonable request; they felt that time could be saved by picking up the phone and calling for the information11 I know in the case of the Humphrey committee that even though the request for a written request had been made to them, and for a time they did comply~ there would be a tendency for that committee• parti ... I cularly Cahn• Julius Cahi., to drift away from that requirement~ He would simply pick up the phone and put the request to me by phone. And after a while I thought, that where there was precedent and where it could be handled convenie11tly, I did. I felt they had an important function. 114. But you didn't have a document from the lawyers that said, "Such . 4nd such infonaatJon you can give whenaver it's asked for. And other kinds of information, you can't give without seeking pennis• sion.'l Mr. a. a No. I had no such document. But if it had been the decision of the Secretary's office that we may give them certain information with respect to a cettain drug in the new drug file, then I £el t and the Commissioner felt that in a similar situation involving another drug, we could give the same kind of information under Dr. Y.; So long as u certain breach iL the trade s11cret sanctity had been m,1.ee, up to that line then and subaeque..1tly, you felt you had a rig.ht to •go. Exactly. But you know, something peculiar happened when Fountain got to inv::.s dga.ting FDA. We had worked a compcomise out with the Kefauver committee enabling them to get certain information from the new drug file. And then Fountain came along and asked I i I I ! 115 for the same kind of information and, for some reason, which I will never understand, the Comrnissioner•s office said, ttNo!" Well, now the Fountain staff people knew that we had given information of this kind to the Kefauve~ committee. Thoy felt that we were discriminating against them. As a matter of fact, one of the against the Fountain committee. - staff members told me that he felt that we were discriminating Well, we got that ironed out and in time gave them tha same kind of information. But it•s a lapse like that, you see, that creates the hard fe4ling that did exist between the Fountain coimnittee and FDA. They genuinely felt that we were giving scoops to the Kefauver committee and were withholding information that the Fountain fommittee ought to have. But, after a wile, though, we got very friendly and l think we had a very harmonious relationship. Certainly. The 1962 Law was a very impoi-tati!:.:r::<lti~W~Ul:.t;t,het11.~at'lle from that particular set of hearings. The Kefauver hearings. Yes. Dr. Y.: Let me ask you a question about quackery which was certainly ona 116 of the most central of your interests. You worked hard; you won a multitude of cases; and yet the job roally never ended. It wasn't the kind of battle perhaps in which total victory was possible. Am I right about that, and if I am, what comments do you have to make about it? You certainly are. Well, first, it is ama~ing how the failings of human beings crop up when quackery is attacked ••• Emotion ••• 1•ve seen that in operation a thousand times. I 9 ve even seen it operating among people whom I know to be intelligent, educated, discriminating, knowledgeable, and awares Yet, when it comes to mattet's of health they react es emotionally, snd as blindly, and as without reasoning as any uneducated fourth grader. And this is a barrier to easy enforcement. Because I have seen cases time and again lost in court ••• good cases, important cases ••• lost in court because of the myopia and prejudice of a judge, or a juryman, who I acts in the.' same emotional· way. Dr. Y.: Are there other cases besides the Hoxsey Case and Judge Atwell that you could cite? 117 Hr. G. s Ob, yes, there are. It crops up all the time. Now Atwell took the position that a person certainly ought to know whether he's been benefitted. He ought to know wbat ails bim. After all, he's the man who has the ailment, and if he doesn't lnow what's wrong with him, who does? That was the way Judge Atwell viewed it but that's an unthinking way of looking at it. I don•t know what ails me when I feel ill; and I rely upon a physician who tells me what my ailment is and I accept his word. He may be wrong, but I ecceot his word. But under any circumstances, I'm the last one in the vorld who is qualitied to say what my ailment is. And yet, I have seen a number of judges who pursued the line that was taken by Judge Atwell, that the patient is the best judge of what he has, and the best judge of whether a drug is helping him. I do-n't have to tell you how much psychology and emotion enter into a man's appraisal of whether he is benefitted$ Certainly, scientifically, one can not accept as the final word what a patient says about bis condition and about how he is pro• gressing. A,nd yet judges will adopt the attitude that the patient himself is the best person to testify about his condition and have not only allowed such testimony, but have also been persuaded by it and ruled against the government~ Now in a criminal case, there is no appeal. Fortunately, in the Hoxsey Case, which waa a civil case, there was an appeal, and Judge Atwell 1 s misconceptions i&&&Z::zaaki&CJJJJSRQ!Ui£fa2£ZU&bil&iliWMUMi£1ZUb§l::XS )U!WE &! Sill&& I. ZUSJMMl&a 1L3 were sharply cxiticized by the Court of Appeals on what a lay witness can say .ibout his condition in his testimonye What are some of the other major quackery cases that you worked very hard building up to get to court in which the public tras rendered a diseervice when, for reason of this ~yopia either on the part of the judge or the jury, you lost them? We had a case in Oklahoma involving an arthritis p-reparation, end the testimony of the government was essenti2lly the testimony of experts plus a minor clinical study. The testimony of the de~ fe1,dant was primarily the testimony of satisfied users. The government's case from a scientific standpoint was overwhelming. The judge, Judge Chandler• now deceased, ruled against the govern .. ment, acquitting the defendant. It was a cri.::ni.r-,1! ~a13; t'!lc?r4 was no appeal. And in chambers, the judge said, "You cau•t accept the i word of an ~xpert." He had no confidence in the word of a physician. He had seen too many instances. in wbicb they were wrong. He pre- ferred to place his credence upon the persons who used the drug, that is, lay users. Dr. Y.. s What was the product? 119 Mr. G.: 'It was an arthritis pttperation. I can't recall the name of the preparation. But we know that arthritics will always get relief from a drug they 1 re trying for the first time, because of wishful thinking. The symptoms of arthritis al'e not unrelated to psycho- somatic elements, and if the patient is promised relief, he hopes for relief, and he will actually find some temporary relief in anything new, no mat.:er what it isl Sooner or later, he may be .. come disillusioned with the drug; but for the beginning at least he 1 tli ,atf.sfied with it, gives a testimonial, testifies about it, and the court is persuaded. Now the court should know better. Then again when it comes to matters of health; everybody seems to be an expert. In the Krebiozen casa, for instance, people tn all walks of life protested the ~overnment action. They disregarded what the government ~xperts said about Krebtozen and assumed the role of self-styled experts, declaring the government to be biased or the govemment had an ulterior motive. Tbey became the experts, organizing mass movements, to protest and obstruct the government investigation. Yet, they demand£d a government-sponsored test for Krebiozen. All kinds of people, without qualifications, were telling their fellow citizens that the country's top physicians were wrong, that the government was wrong, that the scientists were wrong. They declared they were right. Krebiozen was effective. 120 Dr. Y.: Quite a few members of Congress put bills into the hopper in support of Krebiozen? Mr. G.1 Right. And they acted as though they were the experts~~ In matters of health, it seems that, especially with a controversial product, everybody but the P-xport is the expert. And this is somet~ing that we seem to have a lot of trouble with everytime we investigate or plan action against a controversial quack remedy·, Dr• .Y.: Now, in counec tion with the tremendous scale of operation such as lloxsey•s became and such as Krebiozen became, we are better off, we became better off as a result of the passage of the Kefauver-Harris Law, than we had been before, as far Rs public policy is concerned, did we not? Mr. G.: Yes. Dr. Y • t Even though the criminal case which you discussed was lost. tmaa:azama a 1 a 121 Nonetheless, the regulations of the Kefauver Law permitted the· closing down of distribution of Krebiozan in interstate commerce. Mr. G. i Yeso With the Kefauver Law we were able to charge a violation of law which we weren't able to charge before. There are provisions of the law now which require, in the case of ne-w drugs, that.the drug be shown to be effective. Before the Kefauver amendment only safety bad to be shown for new drugs. Well• we couldn't initially do anything about Krebiozen when Krebioaen was::mothing but mineral oil. We couldn't show that it was unsafe. But when Kefauver's bill became law requiring the showing of efficacy, then we had Krebiozen lickcdo Dr. Y.a You even had them before, going into court on a problem of efficacy because ••• they themselves wouldn't agree to the kind of regulations that wore set up in connection with the testing that preceded a new drug application. Mr. G. I Yes. That's right. We could have gone after them under commercial• ization, that this distribution was not for the purpose of bona fide investigation but for commercialization, and they were commercializing the product. However, be that as it im.y, for one reason or another, FDA did not~ing until after the Kefauver-Harris Amclnd• ment went into effect. And I might sr.y this: that although we lost the case, the disclosures and the exposures of the trial convinced the medical profession throughout the world that Krebio2:en was nothing. Nothing at all. And Krebiozen is today practically off the market, even though the sponsors were not convicted. nr-. Y. 1 Is it your feeling that the stronger provisions of the Kefauver Law cdll really permit the Food and Drug Administ-ration to pre ... vent any remedy that makes the kinds of claims that were ,ade in the Hoxsey and Krebiozen coses from zooming to big-scale inter• state commerce? Mr. G. t It's t question of whether FDA will enforce the law. If they do, yes. The law is such now that ~e should never have another Hoxsey Gase or anot,er Krebioa:en case if the law will be enforced vigorously and promptly. If it's permitted to drag on, as it was in the Kre• biozen case ••• Krebiozen could have been stopped effectively under the Public Heal th Service Act, biologicals '{>rovisi.ons. This was Tepresented to be a biological, and as such, it had to be licensed. 123 If the law had been enforced, and an insistence upon licensing made, under penalty of law, Krebiozen would have either gone off the mark.et, or its aponsors would have complied. But, of course, they couldn't have complied. So it would have gone off the marketo Dr. Y.: What held up the efforts to b~ing Krebiozen to book? Mr. G.2 I thbk, fr.inkly, ·thare was too wuch p(,)lities involved., lthate to say this, but the government was intimidated by Senator Douglas and other serultors whom Ivy got to assist him. Krebiozen became a ~hot potato" and rather than challenge it and perhaps bite off more than it could chew, the Government preferred to let it roll on. Well, let's not rock the boat. Dr. Y • z Had you, in Regulatory Management, made the concrete suggestion, "Let's try •uch and such," ~nd then were turned down? Mr. G.: Well, no. Long ago, the Food and Drug Administration had beeu told by the Secretary, Ovata Culp Hobby, that Krebiozen is m:mac: u IS£ 12,.. unquestionably a biological, which, of course, was a false premise, because it wasn't enything, really; it was just mineral oil, and it was a food and drug product, and not a biological. We were told by Secretary Hobby that since Krebiozen is a biological, the Division of Biological Standards will handle ite It was a bio- logical by pretense only. The Division of Biological Standards did nothing and Food and Drug was told "It's Jot your baby." Initially, Ivy said, "lt's a biological." But then when he was told he has to have a license, and in order to be licensed under the biological act he had to show efficacy, he switched, and said "It's a hormone. lt is not a biological." And he submitted paper after paper to establish that this was a hormone and, there• fore, subject to the Food, Drug and Cosmetic Act, and he went so far as to file a new drug application for it as a hormone, which was never approved. But the Department of Health, Education and Welfare was not persuaded and since the Secretary had said, "This is a matter for the Public Health Service and not the Food and Drug Administration," FDA's hands were tied. Dr. Y.: So you gathered information, but you couldn • t go beyond that. Mr. G.: That•s right. Whenever anybody wrote, we told them, "This is a 125 matter for D. B. s., the Division of Biological Standards, and we are fon.•arding your letter to the Public Health Service• .the National Institutes of Health." And that's the way we routinely ... ., Right up to '63, this was the way we answered letters. Tens of thousands of them. We were derelict. FDA was derelict. We could have stopped this. Dr,, Y.t But~-0f course, Secretary Hobby went out long before that, but you just presumed that the same pblicy was •• ., Mr. G,,: Oh, yes. We were never told that Secretary Hobby's policy was changed. We had no evidence ds to the composition of Krebiozen until our 1963 analysis. However, we were forced into the case by Krebiozen supporters• insistence upon a government-sponsored clinical trial. Fell, finally, they goaded Boisfeu!llet Jones who was a special assistant to the Secretary on medical matters to the point where Boisfeuillet said, "Okay, boys, if you want the test, we•r~ going to give you a test. But, first, we•ve got to have certain information. We're asking FDA and DBS to go out there to Chicago and get that certain information." That's how FDA ultimately got into the Krebiozen picture and as you know our trip out to Chicago with DBS to get the information ultimately 126 led to the fraud indictments. According to John Minor who is a medico•legal officer in the Califomia state set-up, there is a good deal more quackery now, and still a more tremendous amount that is intrastate than is interstatee Did you find as you ~ere closing down one big operation after,another that there was a deliberate effort on the part of the quacks who were conte$ting to get into intrastate operation? Mr. G.: Yes. And some of them got into trouble. Lelord Kordel, as you know, has been in trouble with Food and Drug on a number of oc• casions. He's a health food lecturer. Now, initially, he,shipped his product in interstate commerce with labeling, and we proceeded to take action on tha to Then, ·,·:hen he was con vie ted of that, in an attempt to beat the law, be took off the labeling. He had no written, printed or graphic matter accompanying bis product which could misbrand his products. But, instead~ he would make speeches i about his pt:oducts.. Now the product; let us say, was p,;oduced in Chicago., When he went to Detroit, in advance of his trip to De ... troit, he would ship from Chicago whatever he thought he could sell in Detroit; and then we would give his lectures in Detroit 127 and he would extol the virtues of these products which has been shipped from Chicago. As you know, the courts have held that oral statements may serve to misbrand. Even though labeling is written, erinted o~ graehic matter accompanying the article, still there is a gimmick in the law which enables you to charge misbrand• ing if you make oral claim for a product, and the directions for use for the conditions that you are claU11ing the product to be effective for are not stated on the label. So he misbranded his products by these oral claims. Let•s say the product was simply Vitamin A, but in his .speeches he said Vitamin A was good for tt1he that or the other disease. You go to the label, and find there are no directions for use for these diseases which he says Vitamin A is, good for. The product then is misbranded for lack of directions for its use because the directions don't tell you how to use the product in treating the claimed disease. And in that way, through a squeeze play, we are able to prosecute himo .He. then realized that he had to do something mora drastic to get out from under the law, so he thought he would go completely intrastate. This is what he did. If he were going to Detroit to make a speech, he would set up an outfit in Detroit which manufactured the productse Now he got away with this for a while since this is purely intra• state; it is all produced in the state of Michigan end his speeches are made there. But then we got court decisions which held tba t• if any of the ingredients move in interstate commerce, even though iJAJiiiiilillLWffiJJ!J££tl kMJ!lhdb!i t ib@Ll@Mi££Li21!l!Si¥.M&M. - I www •. a 128 they are compounded into what might be regarded as a separate article, it is still the same article, says the court, and it has moved in interstate commerce. Lelord Kordel was recently convicted in Detroit in this attempt of his to circumvent the law by going intrastate. But you can•t go intrastate anymore, iftthe ingre• dients move interstate. Dr. Y.a So if he gets out of jail, he'll probably make his product within a atate with products that he ~igs out of the ground, Mr. c. a That would be the only way he could get out of it. But apropos your question, "Are they driven to an intrastate business?" The answer is, "Yes." But they've got to be ca~eful. It's difficult to be completely intrastate now. You've got to be sure that every• thing., •• · Dr. Y.: Presumably the box ••• Mr. G.1 Everyt2ing significent ••• not the box, no, the article. It 1 s the article. Now the article ••• the ingredient has to.be a sigg.ificant ingredient. For instance, let us say we have a mixture of ,IJ.llliCWD'.UiltUJMi4,it.#i44!1iii&M.4@!ffii!MW&LSJWJtkllMD£:Si£41MA a IS& t&JDaw;a11sn1 u ma : ua :a SSL£ 11•w1011 2& 129 amphetamine and pheuobarb in a tablet, and let us say, the e~ipient moved interstate, the starch. I don• t believe that we could hold that the article is starch. The articles, ampheta~ mine and phenobarb, they would have to move interstate. Dr. Yol So that there are limits to the way in which ~his kind of Mr. Crawford logic can be expanded. Mr. G.a Right~ Dr .. Y.s Not to the very periphery. As I understand it, the Food and Drug Administration~ has an organization in which there isn't so much of a central team to manage the cases from the center that you bad. There may be central managements for major national pro~ motions like the diet pills. Mr. G.1 There is still a Bureau of Regulatory Compliance. Dr. Y.a Right. 130 Mr. G.: But th,::y don't have this corps of experts. It doesn't exist anymore, and Pm just wondering whether FDA can mount a really tough case like they had consistently mounted in the past. As a matter of fact, since the abolition of the Division of Regulatory Manage~nt, the pace of the development of cases of national scope and importance has dropped into the cellar. There are now very few, whereas before, FDA was constantly coming out with big cases. Dr. Y.1 They also aren't working on cases, because of budgetary limita• tions, which are only threats to the pocketbook and not threats, as they say, to health. But I was wondeting, do you see any kind of hezards in this from the point of view of quackery closed-in-on breaking lose as it were in some way? Mr. G.: I think the Kefauver Law requiring the showing of efficacy for uew drugs will effectively curb new quackery, if the law's enforced.·~4 i . ·...,,q I must say that, because we could have curbed Krebiozen. We didn't. We l:J~t::it ·become a monstet'. We let it victimiz~tand ,kill many, many people for lack of adequate 5:reatment while they were experimenting with K-· biozen. And we did nothing about it. I can't say anything more than that we were derelict. Conceivablyp that kind of dereliction could occur again, but if the law• s enforced ••• Dr. Y• I As it was in Rand Anti-cancer Vaccine ease., Mr. G. a As it was in Rand, exactlye There's no reason why we should have another Krebiozen, or any b:i.g quackery outfit., Dr. Y.a Then it would be a matter of the smaller fry operatin 6 within the states. Mr. G.1 Yes. I would ~ay so., You could close in rapidly on a firm who 1 s selling a quack remedy under the New Drug provisions. The govern• ment doesn't have to show lack of efficacy. All it has to show is there's no showing of efficacy by them. It's the difference betwPen our having to show that the product is worthlesso The burden is upon them to show efficacy. 132 Dr. Y • s And that, of course, is an infinitely different thing; then they have a burden of the magnitude that you had when you h~d to show that there wasn't a single case that turned out rigi,t for them. Mr. G.1 That 0 s right. Dr. Y.s Well, you've been most kind to spend your afternoon today in talking about these questions that you've devoted such a long time to working on, and still are interested in and a~dve about, and t want to thank you very much, ~ilbert. Mr. G.: You are welcome, Harveys My pleasure. 133 Index American Federation of Labor, 62 American Medical Association, 12, 36 Armour Packing Company, 96-97 arthritis remedy, 118-19 Atwell, William, 35-39, 42-44, 69, 116-18 Baker, Norman, 14 Biological Standards, Division o~ 122-25 Blair, John, 11!3 BrandenburJ, Robert, 54 Breaux, Willard, 11, 15 Browne, Wayles, 110 Butkouski, 60-61, 63-68 Cahh, Julius, 113 Cain, John T., 6 Cal-Tex case, 100-101 Carlson, Anton J., 84-92 Chandler, Judge, 118 Collins, 68 crab, 97 Crawford, Charles w., 4-5, 103-107 1 129 Dixon, Paul Rand, 110 Douglas, Paul, 62, 123 Dunbar, Paul B., l, 103-106 Durkee, J.B., 42, 49 Durovic, Marko, 56-86 Durovic, Stefan, 56-86 Fishbein, Morris, 36 Fountain, Lawrence, 110, 114-15 Hearst publications, 36 Goldzhier, Max, 46 Goodrich, William, 39, 93 Goodwin, Mrs. Dorothy, 110 Granger, Gordon, 40 Gulledge, Inspector, 26 Harrell, o. Morris, 41 Hart, Philip, 62 Harvey, John L., 6-7 Hobby, Oveta Culp, 123-25 Hoxsey, Harry, 9-56, 68-69, 92, 116-18, 122 Humphrey, Hubert, 62, 110, 113 Ivy, Andrew, 56-86 Jackson Memorial Laboratories, 46 Javits, Jacob, 62 Jones, Boisfeuillet, 125 Kefauver, Estes, 62; 108-15, 120-22, 130 Kordel, Lelord, 15•16, 18, 126-28 Krasno, Louis, 79 Krebiozen, 2, 9, 56-86, 119•26, 130-31 &&WUU!@&4UWWJ!l1£ . :am:uw~&&i:Z..Jl'BltbWiiiiiiil 135 .. Larrick, George P., 103-107 Litigation, Division of, see Regulatory Compliance, Bureau of maple syrup, 86-91 McClellan, John, 110 McGuire, Joseph, 40 Minor, John, 126 Monfore, Kenneth E., 6 National Cancer Institute, 77 Pearson, James c., 6 Phillips, 63 Pick, Dr•, 80 Plantation Extract case, 9, 98-100 Post Office Department, 10-11 Proxmire, William, 62 quackery, 3-86, 115-32 Rand anti-cancer vaccine, 131 Regulatory Compl:f.ance, Bureau of, 2•56, 93-95, 100-103, 107-115 122, 129-32 Regulatory Management, Bureau of, see Regulatory Compliancei Bureau of Salthe, Ole, 106 Schaeffer, 110 Smart, Van w., 6 lli Louis Post-Di'U'!atch, 68 Till, Irene, 110 136 'turkeys, 96-9~;.. vanilla, 98-100 Welch, Henry, 110