-The paradigm dispute in medicine (H. L. Coulter)
– Harris l. coulter, ph.d.  april, 1997

johnson The paradigm dispute in medicine -  Krebiozen

Stage I: Emergence of the Minority Paradigm; Its Separation and Expulsion
 Krebiozen, a substance obtained from the blood of horses with a tumor of the jaw caused by actinomyces bovis, was discovered by the Serbian physician, Stevan Durovic, and brought to the United States in the late 1940s. There its cause was represented by the world-renowned, and indeed illustrious, physician and professor of medicine, Andrew Ivy. (3) Durovic was attracted to the American, however, primarily because of a prophetic article Ivy had published in 1947 stating that the body produces substances which control cancer and that the future of cancer research lay in isolating these substances.
 Krebiozen was apparently a type of immunologic treatment. The word itself comes from the Greek for “growth regulator,” and both Ivy and Durovic saw cancer as a disease caused by a deficiency of substances which control cellular growth. The actinomyces bovis was thought to activate the growth-restraining system in the horse and stimulate secretion of Krebiozen.
 Krebiozen may be identical with a substance isolated from animal tissue in 1955 and named “retine” by Albert Szent- Gyoergyi, the world-famous biochemist and Nobel Prize winner for his discovery of Vitamin C. Like Ivy and Durovic, St. Gyoergyi was never able to define it chemically, even though working on this problem for 20 years.
 In the late 1940s conventional medicine had no interest in the biochemical or immunologic treatment of cancer in view of fast ripening plans to introduce chemotherapy as the treatment of choice. Surgeons and radiologists had other equally valid reasons for disliking Krebiozen.
 In March, 1951, when initial treatment of a handful of patients showed marked improvement of their symptoms and pathology, Ivy urged that Krebiozen be investigated in a more systematic way. To his astonishment, his admittedly preliminary results were ferociously criticized, and essentially dismissed out of hand, by a “Status Report” authored by Paul L. Wermer, Secretary of the Committee on Research of the American Medical Association’s Council on Pharmacy and Chemistry and issued in October of the same year, just seven months after Ivy’s initial communication.
 This “Status Report” was the end of the story as far as the American Medical Association was concerned. The dispute over Krebiozen continued 27 more years (!!), until Ivy’s death in 1978, with many charges and countercharges, reports and counter-reports, lawsuits civil and criminal both by and against Ivy, legislative hearings by the Illinois General Assembly, etc., but at no time did the AMA disown this initial condemnation of Krebiozen. In 1964 the AMA’s Chief Investigator, Oliver Field-the same individual who in 1957 called homoeopathy an “obnoxious subversive cult”-was quoted as stating that Krebiozen was “pure quackery …We tested it in 1951 and showed it was no good.”
 The “Status Report” held that, of 100 patient records reviewed by an AMA committee, “ninety-eight patients were reported as failing to show objective evidence of improvement.” Hence, “these findings fail to confirm the beneficial effects reported by Ivy and Associates.” This was tantamount to calling Ivy’s data fraudulent. And Krebiozen, which was probably the best therapy for cancer at that time, went down in history as a classic example of medical quackery.
 Three years later Ivy produced his own “Report on Krebiozen: An Agent for the Treatment of Cancer: 1951- 1954,” a description of 550 cancer patients in the United States and 160 more in various other countries; Ivy claimed reduction in tumor size in 50 percent of the cases, disappearance of tumors in 3.5-4.0 percent of the cases, and other beneficial results as well. He emphasized that, of these cases, 20 percent were “terminal cases,” 78 percent were “advanced” cases, and only 1.6 percent were cases in the early stages of cancer.
 By 1964 Ivy and 3000 (!!) associated physicians had treated a total of 5000 cancer patients suffering from 35 types of tumors, 97 percent of them considered hopeless and the greater part of these cases accompanied by the necessary supporting documentation.
 These physicians reported:
 – an observable decrease in the size of the tumor for varied periods of time in from 20 to 70 percent of the patients, depending on the type of tumor;
 – reduction of pain in 33 to 74 percent of the patients, including some who did not know they were receiving Krebiozen;
 – clearing of the mind for varied periods of time in 49 to 72 percent of 68 patients who were comatose, semicomatose, or in a state of mental confusion because of brain tumor or brain metastases;
 – dramatic long-term improvement in about 12 percents of the patient;
 – survival of from 4 to 12 years in 151 patients whom physicians had declared terminal (giving them from a few days to a year of life).
 Perhaps the most striking case in this last category was Gary Cathcart-in 1951 an 11-year old boy with advanced cancer of the kidney. At initial diagnosis the tumor was the size of a grapefruit and could not be operated on, or even biopsied, for fear of a fatal hemorrhage. He was given 6 weeks to live. After an injection of Krebiozen (. 01 milligram-the normal adult dose), the tumor virtually disappeared. Then the Krebiozen was withheld for a couple of weeks, and the tumor grew again-to half its previous size. Krebiozen was given again, and the tumor disappeared completely. In 1954, however, it returned, and Cathcart was treated again with success. For the next ten years or so he took Krebiozen at regular intervals, and when he stopped, the tumor would start to grow again. In 1964 Gary Cathcart was a Rhodes Scholar in mathematics at Oxford, and still taking Krebiozen regularly.
 No objective reading of the Krebiozen record could lead to accepting the AMA’s word over Ivy’s. At the Illinois General Assembly hearings in 1953-1955 several of Ivy’s associates testified under oath about their successes treating cancer patients with Krebiozen. A number of physicians told a Denver Post reporter in 1964 that they had witnessed Krebiozen’s efficacy with their own eyes. In any case, it was scientifically impossible to evaluate a cancer treatment in such a short space of time. The inescapable conclusion is that the AMA “Status Report” was fraudulent-a cobbledtogether administrative measure designed to stop the Krebiozen bandwagon in its tracks and put an end to a serious threat to the majority paradigm in cancer therapy.
 This exercise illustrates a common problem with paradigm disputes. The representatives of the majority paradigm can make fraudulent statements because they have the benefit of the doubt in the public mind and largely control the channels of communication. The accepted view that medical disputes are technically complex is another reason for the public to leave their solution up to the experts.
 Today the US public is somewhat more sophisticated in matters medical, and it would be less easy for the medical establishment to attempt a totally fraudulent exercise, but in the 1950s Americans were far more trusting.
 Stages II and III: Ideological Warfare;
 Economic and Professional Coercion
 The “Status Report” failed to sink Krebiozen, as it ran up against the immense prestige of Ivy, who rapidly exposed it as bogus. In various publications and also in sworn testimony at the Illinois General Assembly’s Krebiozen Hearing, 1953- 1955, he pointed out that 24 of the AMA’s 100 cases had been contributed by a certain Dr. Henry Szujewski who, in fact, had not treated 23 of them at all. They had been treated by Ivy himself and a colleague. In a sworn affidavit Ivy said, “Dr. Szujewski reported that improvement occurred in only one patient. However, relief of pain or subjective improvement occurred for a period in 20 of the 24 patients, and objective improvement occurred in 18. ” Ivy also noted that the AMA had selected for its list 40 patients who were so close to death that they could receive only two doses of Krebiozen; 33 others received no more than 4 injections. How could Krebiozen be evaluated in patients on the brink of death? Ivy made other and equally damaging charges. Ten of the patients declared to be moribund in the AMA’s report showed up for the 1953-1955 Krebiozen Hearings. Seven were still alive and well as late as 1963-twelve years after treatment!
 At these Hearings Szujewski steadily refused to take the witness stand and testify under oath in his own defense.
 The continual parading of facts like these kept the AMA off balance for thirteen years and maintained Ivy’s status with the public and with a part of the medical profession.
 Perhaps because of the numerous objections raised to the “Status Report”
 the AMA and associated organizations produced several more studies;
 – the National Research Council late in 1951 reported it had reviewed 63 patients treated with Krebiozen and found “no evidence of any curative effect.”
 – the March 15, 1952, issue of the AMA Journal contained another official indictment of the drug (written by Szujewski).
 – In September, 1952, a review committee appointed by Dr. George Stoddard, President of the University of Illinois, and chaired by Warren Cole, M.D. , emeritus professor of surgery, published a study of 500 Krebiozen-treated patients whose case histories Ivy had submitted. This Stoddard-Cole Report is discussed below.
 All this time, of course, a propaganda war was being conducted against Ivy and Durovic.
 The attack on Ivy was bitter in the extreme. He was said to be senile and “off the beam,” an easy victim for the scheming Steven Durovic and his brother, Marko. He was accused of promoting a “quack cancer cure,” when his position from the first had only been that Krebiozen was sufficiently promising to deserve clinical testing; in fact, Ivy was careful never to call it a “cure” for cancer. Two weeks after the AMA’s “Status Report” Ivy was suspended from the Chicago Medical Society on the charge that Krebiozen was a “secret remedy.”
 Durovic and his brother, Yugoslav émigrés to Argentina, were described as “vicious aliens.” Steven was portrayed as a semieducated (he had been a professor of medicine in Belgrade) foreigner attempting to perpetrate a hoax on the American public. After a press conference in 1951 at which Ivy made his first announcement of the Krebiozen data, he was criticized for appealing to the lay public rather than to his professional peers-just like the homoeopaths in the 1840s and Benveniste in 1988.
 But Ivy’s demolition of the AMA’s case, and his steady stream of apparently cured patients, was having its impact on public opinion. So the AMA had to devise a technique for neutralizing his statistics.
 In this propaganda barrage the principal salvo was the “healing power of nature” argument, i.e. , that patients get well of themselves. But since this is not generally known to occur in cancer, a special effort had to be mounted to locate at least a few instances of this in the world literature. Warren Cole was deputized to rapidly amass information on the number of “spontaneous remissions” of cancer in the world literature. As he admitted in 1980, this was done to muster up information for the anti-Krebiozen campaign. Articles on “spontaneous remission,” and eventually the book by Cole and his associate, Spontaneous Regression of Cancer, were widely cited against Ivy.
 Cases like Gary Cathcart were blithely put down to “spontaneous remission,” even though this was statistically absurd. Cole found 176 examples of spontaneous regression in the whole world literature of cancer from 1900 to 1964, which came to an estimated 1:100,000 cases. (4) Since Ivy never had as many as 5000 cases under treatment, several spontaneous remissions in this small sample was statistically impossible. But the case was no longer being conducted according to the rules of science. Journalists, who in those days knew little about statistics, were happy to attribute to “spontaneous remission” the otherwise unfathomable Krebiozen cures, and the anti-Krebiozen forces maintained plausibility.
 Cole’s role in the Krebiozen affair was dishonorable in the extreme. A professor of surgery (the surgeons would have had the most to lose in income if Krebiozen had been accepted), he was a colleague of Ivy’s and supposedly a friend. But from the beginning he intrigued against him and eventually managed to be appointed chairman of the University of Illinois Committee which issued one of the many damaging reports on Krebiozen which appeared year after year and decade after decade (see below for discussion of the disreputable Stoddard-Cole Report).
 A second explanation of the Krebiozen cures was “previous therapy.” Since Gary Cathcart, for instance, had had radiation in 1951 at the time of original diagnosis, his thirteen years of survival (up to 1964) were rationalized as due to the original radiation. But for this very reason Ivy had withheld Krebiozen from time to time, until Cathcart’s tumor started growing again, thus negating the “previous treatment” argument.
 Ivy was accused of promoting a “secret remedy,” because the Durovic brothers could not determine the structural formula of Krebiozen and did not want to reveal the manufacturing details before getting patent protection. In 1951 they applied for a “product and process” patent, but this required proof of therapeutic efficacy, and a month earlier the AMA “Status Report” had roundly denied Krebiozen’s therapeutic value.
 The “secret remedy” charge resonated in the public mind and was picked up by journalists. Even though in 1960 the New York Post printed virtually all the manufacturing details of Krebiozen, the “secret remedy” charge continued to be invoked against physicians who presumed to prescribe Krebiozen. One such letter, issued in 1964, read: “The prescription or dispensing by a physician of Krebiozen or other secret medicines or remedial agents, of which he does not know the composition, is unethical under any circumstances.”
 In fact, no manufacturer of medicines reveals all details of the manufacturing process, and for obvious reasons. Patricia Spain Ward has commented on the “secret remedy” charge: “Neither side seemed to notice that most of the history of therapeutics belies the Cole Committee’s flat assertion that evaluation of efficacy depends on knowing the chemical and biological composition of a substance.” Penicillin and insulin, for instance, were used in medicine long before their structural formulas became known.
 A final criticism of Krebiozen related to the minute, virtually homoeopathic, size of the dose. Throughout the whole controversy, involving the treatment of 5000 patients and the release of a certain amount of Krebiozen for testing purposes, the sole source of the substance was the two grams which Durovic brought with him from Argentina in 1949. This represented the residue of bleeding 2000 horses. So 1000 horses yielded one gram of Krebiozen. The two grams were divided by Durovic into 200,000 doses, each dose representing 0.00001 gram (one hundred thousandth part of a gram), and this 0.01 milligram dissolved in light mineral oil was the dose for a cancer patient.
 From the very beginning, in the spring of 1951, a conspiratorial dimension was superimposed on the Krebiozen imbroglio, inflaming further a controversy already becoming superheated, when the AMA treasurer, a certain Josiah J. Moore, MD, attempted to purchase the US rights to Krebiozen from the Durovic brothers. Evidence to this effect was produced by witnesses testifying under oath at the Illinois Krebiozen Hearings. But, like Henry Szujewski, Moore himself refused to take the stand in his own defense where he could have been prosecuted for perjury.
 Instead, he ran out of the hearing room to deny the charges in statements to the press. Nor did he sue Ivy for allegations which, unless actually true, would have been libelous in the extreme. When asked why, Moore responded that he “wouldn’t get in the gutter” with Ivy and the Durovic brothers.
 The Krebiozen Hearings thus illustrate another tactic devised by the majority paradigm for its own defense. None of those accused by Ivy of conspiracy-especially Josiah J. Moore-were willing to testify under oath. Instead, their lawyers demanded (and received) the right to unlimited cross-examination. Off and on over a period of two years they called Ivy and the Durovic brothers repeatedly to the stand and rehashed the same materials over and over again, all the while promising to put Moore and his associates on the stand. But this was never done.
 The theory generally accepted by Ivy and his supporters was that Moore, frustrated by the refusal of the Durovic brothers to sell the Krebiozen rights to himself and his associates (several major drug companies were offering the Durovics millions of dollars for the rights at this time), induced the AMA to attack the Durovics and defame Ivy in order to weaken their bargaining position.
 A final technique used by the AMA against Krebiozen was the issuance of a report (the Stoddard-Cole Report) whose “Conclusion,” released to the public, differed entirely from the body of the report (kept confidential, allegedly because too technical for the public to understand). This technique is used in medical writing generally when the data developed are politically unacceptable, but the Stoddard-Cole Report carried it to amazing lengths. The Conclusion of this Report, issued in September, 1952, stated: “We have found no acceptable evidence that any malignant tumor has been cured.” But the confidential part of the Report states the opposite: “The clinical details of 15 cases were presented to the committee …Thirteen were presented in person. All of these cases showed subjective improvement of some type, such as relief of pain, reduction in size of tumor, or retardation of growth, and the possible disappearance of the tumor in one case. Judged by this presentation alone, Krebiozen would appear to have beneficial effects.” Again, the Conclusion states that the committee had been presented “with no histological evidence by Dr. Ivy that the material [i.e., Krebiozen] has produced degenerative or regressive changes in tumor cells.” But inside we find: “Microscopic slides were examined on nine patients, six of whom were included in the series of patients demonstrated to us June 29. We concurred in the diagnosis in all except one patient. In this patient we considered the slide (representing uterine scrapings) following Krebiozen therapy was negative for malignancy instead of positive, as reported to us. Accordingly, this difference in opinion does not reflect disadvantageously on Krebiozen therapy, but might reflect advantageously.” The Report is full of such inconsistencies. A journalist later (1964) commented that the language of the Stoddard-Cole Report was so “ambiguous that its interpretation even today remains a mystery.” A newspaper editor called the Conclusion the most “weasel-worded” two pages of medical writing ever produced.
 In later legislative hearings it was brought out that Warren Cole himself had single-handedly written the Conclusion of the Report, which was not seen by the other members of the Committee before its release to the press.
 By the time the body of the Report came to light, the Conclusion had been broadcast to the world, and few were interested in the discrepancies.
 How is the public to respond to this sort of flim-flam? There are at present no adequate procedures for dealing with major scientific dishonesty in the higher reaches of medicine. Warren Cole, who did so much to destroy Krebiozen, lived a lengthy and comfortable retirement at the University of Illinois.
 A peculiar point is that the committees and groups which criticized and condemned Krebiozen were not interested in actually interviewing patients. The AMA committee which issued the “Status Report” saw no patients and had no desire to do so. Its judgments were based only on written records. The Cole Committee did see some patients at Ivy’s insistence but was not interested enough to ask them questions. One who had been a terminal cancer patient prior to being treated with Krebiozen, later testified to an Illinois State Assembly committee:
 Well, Dr. Ivy informed the Cole Committee that they could ask me any questions they liked, but the Committee sat there for quite a while and looked at me but didn’t ask me anything. And after a while one of the doctors said: “We are mainly interested in the pain angle,” and then we sat there a little while longer and looked at one another, and then another doctor said. “How much morphine were you receiving at the time that you first took Krebiozen?” …Dr. Ivy informed the Cole Committee that they were free to examine me if they wished to, and none of them signified any interest in examining me.
 The NCI committee, which evaluated Krebiozen in 1963, also did not see any live patients.
 Nor, despite unending barrage of propaganda, was there any desire to actually test Krebiozen. When Ivy proposed in 1953 that a controlled trial of Krebiozen be conducted under the joint auspices of himself and the AMA, the latter organization refused. The reasons cited, upon this and other occasions, were: 1) unwillingness to test a “quack remedy,” 2) unwillingness to provide “quack medicine” with a “platform,” 3) and unwillingness to deprive patients of “effective treatment.”
 In all of this Ivy did not help his own cause, acting from first to last with extreme naiveté. He apparently never realized that he was in a political struggle but continued to operate by scientific rules. In demanding that Krebiozen be tested by the NCI, the AMA, or the American Cancer Society he insisted on the one concession the establishment could never make and thus played into their hands to his own destruction.
 Stage IV: Administrative and Judicial Coercion
 The FDA was brought into the Krebiozen controversy by virtue of the Kefauver-Harris Amendments to the Food and Drug Law, passed in 1962 and taking effect in June, 1963, which required proof of “efficacy” before a drug could be shipped in interstate commerce.
 The FDA, working with two milligrams of Krebiozen provided by Durovic, promptly undertook a chemical analysis and in September, 1963, announced that it was “almost entirely” creatine (a neutral organic substance found in muscle tissue).
 Five weeks later a screening committee of 24 cancer experts appointed by the National Cancer Institute reported that it had studied 504 case histories of Krebiozen-treated patients and found the drug of no value.
 Ivy’s response was that “almost entirely” creatine is not the same as “entirely,” that the Krebiozen ampules usually contained 20 percent creatine, and that in attempting to purify it further to help the FDA with its testing they had inadvertently increased the creatine content of the ampules.
 But what was clear to everyone, especially to Krebiozen’s enemies, was that the medicine was being used in truly infinitesimal doses.
 The analysis of Ivy’s 504 cases by the National Cancer Institute Committee is emblematic of how difficult it is to secure agreement in a paradigm dispute.
 The Committee used a technique which in political life is called “salami tactics,” slicing off one sliver at a time until nothing is left.
 Of the 504 cases, 216 were not even considered by the Committee because of what it called an “inadequate test situation”: 101 had taken other therapy at the time Krebiozen was administered, 50 had not had biopsies, 49 showed no residual cancer after the previous therapy, and for the remaining 16 the data were “inadequate.” What “inadequate” meant was not explained.
 That left 288 cases to evaluate. The Committee found no evidence of “significant regression” of tumor in 273. By “significant” the Committee meant tumor regression of more than 50 percent!! It disregarded cases in which tumor growth was arrested or in which the tumor size regressed from 1 to 49 percent.
 For 13 of the remaining 15 cases the committee expressed uncertainty because of “obscure conditions” which included inadequate documentation, doubt about measurements, and ignorance of the precise stage of the disease. So these were also thrown out.
 That left only two cases. One was Gary Cathcart, already described above. The committee described this case as “inconclusive” because of a lack of permanent microscopic slides and because his initial X-ray treatment might have been the cause of tumor regression.
 The final case, a Krebiozen patient whose stomach cancer disappeared completely and who had taken no other treatment was ascribed to “spontaneous remission.”
 Krebiozen’s backers asked how the NCI could find Krebiozen effective against cancer in view of the FDA’s statement that it was creatine. In other words, the NCI conclusion was foreordained.
 Unnamed officials of the National Cancer Institute were cited by Science in 1963 as betraying concern that the Institute was demanding more of Krebiozen than of the thousands of other anti-cancer agents regularly screened as part of the NCI’s Chemotherapy Program which had commenced in 1955.
 But the government thereupon declared the Krebiozen case closed.
 At this point Senator Paul Douglas of Illinois, a close friend of Ivy’s, undertook to force a test of Krebiozen by having the Congress adopt a law to that effect. His staff obtained test results from other laboratories negating the identification of Krebiozen with creatine. They observed that whenever a patient was treated with Krebiozen and some other therapy, any improvement was automatically assigned to the other therapy. The NCI committee did not interview a single Krebiozen-treated patient in person, did not hear testimony from a single physician of the 3000 who had used Krebiozen, and did not summon Ivy himself to appear.
 Douglas called the FDA findings “demonstrably false” and accused the agency of yielding to pressure by the AMA which, he said, was just trying to save face. He noted that the criteria applied to Krebiozen were ones which would be appropriate if the medicine was claimed to be “curative” in cancer, not for a medicine which was just supposed to be, in Ivy’s words, “beneficial in the treatment of many kinds of cancer.”
 It was by now obvious that the federal government-like the AMA and other private medical organizations-would under no circumstances organize a clinical trial of Krebiozen. At a time when the NCI was screening 14,000 substances every year for anti-cancer activity and putting 100 of these substances through clinical trials, it could muster up no interest in Krebiozen.
 The argument advanced was invariably that distracting patients with Krebiozen would prevent them from obtaining cancer therapy of proven value (surgery, radiation, and chemotherapy).
 In November the government brought suit against Ivy and Durovic for distributing Krebiozen in interstate commerce. They were indicted for failure to file proper applications with the FDA, for making false reports to the FDA, for falsifying sworn statements concerning records of treatment, for selling Krebiozen commercially instead of solely for investigational purposes, for selling Krebiozen to lay persons, for mislabeling the drug, for misstating that outcome of clinical trials, and for mislabeling Krebiozen as an effective cancer cure and thereby using the mails to defraud-in all, a total of 49 counts. Ivy himself was charged on 37 counts, with maximum possible penalties of $334,000 or 127 years in Federal prison.
 The trial began in April, 1965, and ran until January, 1966, longer than any preceding criminal action in a Chicago court. The defendants were eventually acquitted on all counts, although one member of the jury was later sentenced to three years in prison for bringing materials into the jury room and arguing with fellow-jurors in Ivy’s favor. 

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