Laetrile in Historical Perspective

James Harvey Young, Ph.D.
June 13, 2020

Laetrile’s history has been complex, tortuous, kaleidoscopic. Beginning inauspiciously like hundreds of other small-time anti-cancer schemes, Laetrile soared to a notorious pinnacle as the unorthodox brand-name health promotion generating the largest amount of public furor in the nation’s history. Numerous actors played roles in this perfervid drama. Laetrile’s history, first, may be placed within three successive periods which may be designated: the creation by the Krebs, the McNaughton ascendancy, the appeal to freedom. Then the Laetrile pattern may be compared with the pattern of earlier cancer unorthodoxies.

The Creation by the Krebs

Two men, each named Ernst T. Krebs, father and son, bring Laetrile to market and dominate its early years. Their backgrounds may prove instructive.

Ernst Krebs, Sr., born in 1876, son of a California pharmacist, himself worked as a pharmacist before attending the San Francisco College of Physicians and Surgeons [1,2]. He received his medical degree in 1903. Practicing in Nevada during the influenza pandemic of 1918, Dr. Krebs became persuaded that an old Indian remedy possessed great efficacy in combatting the flu. A rare species of parsley, Leptotoemia dissecta, Krebs wrote in a Nevada State Board of Health bulletin, had permitted the Washoe Indians to survive the epidemic without loss of life, whereas members of other tribes died in great numbers [3,4].

Krebs promptly commercialized his discovery. In San Francisco he set up the Balsamea Company to market a proprietary named Syrup Leptinol, recommended for use in epidemic influenza, bronchial asthma, whooping cough, pneumonia, and pulmonary tuberculosis [5]. A later version called Syrup Bal-Sa-Me-A, with rhubarb added, bore labeling which recounted how Leptotoemia had protected the Washoes and which promised users “miraculous results” [6]. “It strikes at the cause,” the circular read, “quickly checking germ action.” Such claims so disturbed Krebs’ fellow physicians that he resigned from medical societies and never rejoined [1]. Such claims also disturbed the Bureau of Chemistry of the Department of Agriculture, in charge of enforcing the Pure Food and Drugs Act of 1906. The Bureau had shipments of Krebs’ proprietary seized in Missouri, Illinois, and Oregon, terming its labeling false and fraudulent [5,6]. When no claimants appeared, courts condemned the medicines and ordered them destroyed. Dr. Krebs did not give up on his product. At the end of the 1950s a Syrup of Balsamea was still being sold, and Krebs’ promotion contained the suggestion that he had discovered the first antibiotic [7,8]. No longer an over-the-counter proprietary, Krebs now distributed Balsamea under the guise of an investigational prescription drug.

In the intervening years Dr. Krebs had continued to seek new therapeutic entities. Before 1951, when Laetrile surfaced surely in the public record, he had been involved with both cancer treatments and apricot kernels. Krebs had promoted an enzyme, chymotrypsin, as a cancer remedy, explaining its action by the same trophoblastic theory, borrowed from John Beard, a turn-of-the-century Edinburgh embryologist, that was to undergird later Laetrile promotion [9]. And in 1945 Krebs submitted a New Drug Application (NDA) for a drug called Allergenase, manufactured from the kernels of shelled apricot seeds, and claimed to be ”a systemic detoxicant” for treating all allergies, including arthritis, asthma, and “shingles.” [10,11] He had begun work on this drug, he said, in 1924. In due course Allergenase evolved into pangamic acid, otherwise known as Vitamin B-15.

Dr. Krebs told two tales about Laetrile’s origin. The earlier account ascribed a recent discovery date. The later account, furnished in a court affidavit signed by Dr. Krebs in 1965, provided a more remote origin. As of 1965, having a long history for Laetrile had become legally important, because of so-called “grandfather” clauses relating to drugs in both the 1938 Food, Drug, and Cosmetic Act and the 1962 Kefauver-Harris Amendments to that law. Drugs in use before critical dates escaped some aspects of regulation.

Some versions of the Laetrile legend traced the drug’s origin to Dr. Krebs’ researches in the 1920s aimed at making bootleg liquor palatable [12]. In his 1965 affidavit Krebs stated that he had first made an extract from apricot kernels in 1926, calling it Sarcarcinase, containing amygdalin, a chemical known for a century [13]. A later critic has denied that Sarcarcinase could have been Laetrile’s amygdalin-containing ancestor, because Sarcarcinase was a chloroform extract of apricot kernels, and the amygdalin would have gone down the drain with the discarded aqueous portion [14]. In any case, Dr. Krebs stated in his affidavit that sarcarcinase proved too toxic a drug when injected into rats. Steadily improving his extraction process, Krebs asserted, he achieved an ever higher level of amygdalin purity. In 1949 Krebs’ son slightly modified his father’s process and named the result Laetrile. This version of Laetrile’s origin became the standard canon among its promoters.

The earlier tale that Dr. Krebs had told about Laetrile’s beginning dated its birth to 1951. In an interview with Food and Drug Administration officials during December 1952, Dr. Krebs said that ten months before he had begun experimenting with a cyanogenetic glucoside which he had extracted from a mixture containing apricot pits [15]. He had tested it successfully on patients, he asserted, but had kept no records. Injected near the site of a cancerous lesion, Laetrile worked by liquefying the malignant growth through the release of cyanide.

Soon Dr. Krebs and his son presented a more elaborate explanation for Laetrile’s mode of action. The theory proved to be the same one which they had recently used to justify the presumed anti-cancer activity of an enzyme with which they had been experimenting.

Ernst Krebs, Jr., who coined the name Laetrile, had come home to California after peripatetic schooling. He did not have a Ph.D. from the University of Illinois, as he sometimes asserted, nor had he yet received his only claim to the doctorate, an honorary Doctor of Science degree from the American Christian College in Tulsa, Oklahoma [16]. According to California state investigators, Krebs had attended colleges in Mississippi, Tennessee, and California before receiving a bachelor of arts degree in 1942 from the University of Illinois. Also before going to Illinois, Krebs had spent three years as a medical student at Hahnemann Medical College in Philadelphia, the second of which was a repetition of the first year’s work. Krebs devoted two years, from 1943 to 1945, to graduate study of anatomy at the University of California, but was dismissed because of his pursuit of what was deemed unorthodoxy [17].

Krebs, Jr., continued his researches in collaboration with Dr. Charles Gurchot, a pharmacologist who also had left the university (18). The two had published a letter in Science, “Growth of Trophoblast in the Anterior Chamber of the Eye of the Rabbit” ([19] and now set up a foundation bearing Beard’s name to seek a cancer cure fitting his principles [18].

In 1950 Krebs-père and -fils published their own version of Beard’s trophoblastic or unitarian thesis [9]. All cancer, they asserted, is one, brought on when the normal trophoblast cell goes wrong. This cell, which in both sexes emerges from a very primitive cell, is best known for its role in securing the embryo to the uterine wall. This function, the Krebs stated, demands erosion, infiltration, and metastasizing. In becoming cancerous, trophoblasts do the same things, dangerously. Beard had said that some pancreatic enzymes attack trophoblasts. The Krebs and Gurchot had found an enzyme they believed to be specifically antithetical to malignant cells.

The 1950 article, seeing great promise in the enzyme chymotrypsin, did not mention Laetrile. At about the very same time, however—at least, according to Dr. Krebs’ 1952 account—Laetrile was born. And soon the Krebs presented a Beardian explanation for Laetrile’s mode of action. The Laetrile molecule, the theory held, when it reached the site of the cancer, was hydrolyzed by an enzyme, beta-glucosidase, releasing cancer-killing hydrogen cyanide [20,21]. This enzyme accumulated in cancerous areas in much greater quantity than it did in healthy cells, so the cyanide was released where it was needed. Moreover, normal cells were protected by another enzyme, rhodanese, which detoxified any cyanide that might be liberated in or stray to them. Cancerous cells lacked rhodanese. Thus Laetrile, according to its promoters’ theory, fulfilled a prime objective of the nascent field of cancer chemotherapy, specificity of action: it targeted damage to cancerous cells without injuring normal cells unduly.

Right from the start Laetrile became related to a number of separate but intertwining organizations, legally distinct but linked, at least so FDA officials came to believe, through Ernst Krebs, Jr., their “guiding light.” [8,22] The John Beard Memorial Foundation, the research unit, became Krebs, Sr.’s province. Krebs, Jr., personally supervised production in the Krebs’ Research Laboratories. The finished product then went to the Spicer-Gerhart Company in Pasadena which distributed Laetrile as an investigational drug. Some California general practitioners began to use it in treating patients with cancer, and requests for it came in from other states and from overseas. A New Jersey group of doctors, for example, used Laetrile. Their business manager, Glenn Kittler, upon hearing a tape recording of Krebs’ explanation of the trophoblastic theory, responded by opining that Krebs was “well on his way toward the Nobel Prize.” [22]

California cancer specialists were not so quickly persuaded. The Cancer Commission of the California Medical Association sought to secure some Laetrile from Krebs to permit a clinical trial under the direction of the Research Committee and the Tumor Board of the Los Angeles Hospital. While “anxious” to have clinical work commenced, Krebs, Jr., replied, he foresaw difficulties [23]. Especially he objected to tests made by physicians ignorant of trophoblastic theory. “Conducting work under these conditions,” he wrote, “is almost tantamount to attempting to conduct an orderly practical industrial implementation of nuclear fission with the cooperation of physicists who failed to accept the E=mc2 formula and were gravely in doubt about the atomic constitution of matter.” Unless a doctor of his own choosing could direct the experiment, Krebs would send no Laetrile. Such a stance recurred not infrequently in Laetrile’s future: an expressed desire, sometimes a demand, for trials, but heel-dragging about complying with the established parameters of scientific research, a denial that mainstream scientists could test Laetrile fairly. In Krebs’ metaphor from physics, be it noted, he baldly transposed orthodoxy and unorthodoxy.

With a supply of Laetrile secured from the Food and Drug Administration [24], the Cancer Commission of the California Medical Association sponsored at three cancer research centers controlled trials of Laetrile as a treatment for various cancers in mice [25]. None of the tests revealed that Laetrile had any effect on the course of the disease. The Commission also assembled as much information as it could about patients who had been treated with Laetrile—forty-four cases in all—and found no objective evidence that Laetrile alone exercised any control over cancer. The conclusion was based on examination of seventeen cancer sufferers still alive and on autopsies of nine of the nineteen patients who had died. Furthermore, the Commission disputed the explanation by the Krebs as to how Laetrile purportedly functioned. The molecule-cleaving enzyme which supposedly released hydrogen cyanide at the site of the cancer, held by the Krebs to be more abundant in cancerous than in normal cells, in fact, said the Commission, was not; normal cells contained more of the enzyme than did neoplastic tissue. In time scientists were to presume that, because of the extremely small concentrations of beta-glucosidase in human tissues, Laetrile administered parenterally would undergo scarcely any metabolic breakdown and would leave the body in the urine virtually intact [26].

Krebs, Jr., and the small coterie of Laetrile physicians dismissed the California Cancer Commission’s report. A newer improved version of Laetrile and new dosage levels, they said, invalidated the Commission’s distorted findings [22,27]. In any case, asserted one Laetrile doctor, no curative claims had ever been held out, only the promise of stopping the cancer’s growth and prolonging the patient’s life with diminished pain and greater comfort. Despite the denial, Dr. Krebs, Sr., had in fact been quoted in the press as saying that Laetrile wrought cures in forty percent of cancer patients and brought improvement to the remaining sixty percent [28].

Laetrile’s proponents no doubt welcomed controversy as a way of making their product better known. They had courted publicity. The Cancer Commission first heard about Laetrile through a barrage of inquiries from national magazines, news services, and the California press [25]. A Laetrile physician had given a list of his patients to a newspaper, inviting reporters to interview and photograph them. Krebs, Jr., worked hard at expanding the market for his investigational drug. Some insight into his zeal may be derived from what he wrote, some years later, to an entrepreneur hoping to market Laetrile under his own trade name in foreign areas:

… [T)he field of cancer chemotherapy is a law to itself. This jungle offers the greatest opportunity anywhere in commerce at this moment, but there are snakes in every bush. I believe . . .  it’s best to push hard, sell, don’t be backward about disaffecting a few, and establish . . . [Laetrile] right from the start as something precious that not even hospitals get for nothing.” [29]

In the same letter Krebs noted: “. . .  [O]ne can usually buy even the top medical investigators as one does sirloin steak—and at about the same price.”

In fact, reports suggesting Laetrile’s utility in cancer came not from the top but from a few clinicians overseas and several American general practitioners (26] American cancer experts dismissed the pro-Laetrile studies as purely anecdotal or so poorly designed as to lack validity. If the market grew for Laetrile during the 1950s, it was at a modest rate. Krebs, Jr., secured a British patent for the product, but it did not mention cancer [30].  He joined with Fred J. Hart, a promoter of therapeutic devices, in testifying against a California bill aimed at curbing cancer quackery, but the law passed anyway [31]. Another signal ominous for the Krebs appeared at the start of the new decade. In 1960 the Food and Drug Administration made its first seizure of an interstate shipment of Laetrile. That same year a decade of litigation had finally driven Harry Hoxsey from the field of cancer quackery [32]. His successor at the Dallas clinic, barred from using Hoxsey’s mix of botanicals, had ordered the lot of Laetrile which the FDA had seized [33].

The Food and Drug Administration had watched the Laetrile venture from its early days. The California Cancer Commission critique of 1953 raised the question of taking regulatory steps. After weighing the matter at the highest level, FDA opted for continuing close scrutiny of operations, not immediate action. Other projects held higher priority, and manpower was short. Laetrile was both small in size and difficult to combat. “. . . [T)his type of promotion, namely an article distributed as a new drug for investigational purposes but indirectly promoted for use in cancer, is hard to handle” (34] So concluded a headquarters memorandum. If Laetrile were directly offered as a cancer treatment in printed labeling, chances for controlling it through regulation would be “brighter.” Thus the Krebs’ cautious approach, depending mainly on word-of-mouth promotion instead of bold labeling claims, postponed trouble, probably at the expense of growth. The 1960 seizure signaled a change.

The first period of Laetrile’s history, during which the Krebs’ brand of amygdalin, shrewdly but cautiously promoted, made modest gains without encountering serious regulatory troubles, ended about 1963. By then both state and federal governments, the latter with powerful new weapons given it by the Kefauver-Harris law, had attacked in force. Public worry about drugs, cued by Senator Estes Kefauver’s hearings and the frightening thalidomide episode, which lay behind the Tennessee Senator’s law, had soared to new heights. Besieged by regulatory actions, the Krebs yielded real control over their enterprise to a Canadian citizen possessing capital, audacity, and a broader vision of Laetrile’s destiny.

The McNaughton Ascendancy

Andrew Robert Leslie McNaughton first met Ernst Krebs, Jr., so McNaughton testified, in a Miami drugstore in 1956 or 1957 [12]. Shortly before this, McNaughton had informally set up a foundation in Montreal, incorporated in 1958, to support researchers possessing unorthodox but possibly useful ideas who found it difficult to secure funds elsewhere. In 1960, after spending several weeks in the Krebs’ San Francisco laboratory, McNaughton Look some Laetrile back with him to Canada, persuaded several tobacco companies to contribute research funds, and, through his McNaughton Foundation, distributed Laetrile to a number of Quebec physicians as an investigational drug. In 1961 McNaughton founded Biozymes International Ltd., a manufacturing concern, which the next year began to produce Laetrile [36].

McNaughton came from a notable family and had enjoyed a glamorous if at times checkered career [36-38]. His father had headed Canada’s armed forces during World War II. The son had served as chief test pilot for the Royal Canadian Air Force. He had sold arms to Israel and had let Fidel Castro capture weapons which McNaughton had been commissioned to sell to Batista, the Cuban president, for use in suppressing Castro’s insurgency. In time McNaughton and his foundation became targets of a suit brought by the U.S. Securities and Exchange Commission, charging promotion and sale of unregulated securities, stock in Biozymes International-al. In 1973 a district court in California, not having received an answer to the complaint, rendered a default judgment of permanent injunction (39]

Besides launching his Laetrile enterprises in Canada, McNaughton undertook an initiative in the United States. Taking Krebs, Jr., and a pro-Laetrile. physician along, McNaughton went to Washington. Through the good offices of a New Jersey Congressman, he secured conferences with Health, Education and Welfare and Food and Drug Administration officials [40,41]. What would it take, the Laetrile party asked, to have a New Drug Application favorably considered? Krebs explained the rationale behind Laetrile’s purported action, indicating that dosage levels now were higher than those first used. No claims for cure of cancer would be made, only for palliation. While safety data seemed complete, evidence of effectiveness admittedly rested on clinical research outside the nation’s borders, although three United States clinical investigations were under way. In the granting of an NDA was only safety considered? Not, FDA officials replied, with drugs prescribed for life-threatening diseases. In such cases safety and efficacy could not be separated. An innocuous product which failed to help the patient would constitute a hazard when used in lieu of treatment that offered some promise of success. Without sound clinical evidence from recognized experts, the government men told Krebs and McNaughton, a New Drug Application could not be deemed complete.

In November 1961 the FDA charged Krebs and the John Beard Memorial Foundation with violating the law [42]. The case involved not Laetrile, but Krebs’ other major product, pangamic acid or Vitamin B-15. Krebs had shipped capsules of this new drug into Oregon and Florida without having an effective NDA, in the same way in which he was distributing Laetrile. Both the Foundation and its sole officer pleaded guilty to the charge, Krebs being fined $3,750 and sentenced to prison. Imprisonment was suspended when Krebs agreed to the terms of a three-year probation. One of those terms barred Krebs and his Foundation from manufacturing and distributing Laetrile until there should be an approved NDA.

The court shortly agreed to a modification of the probation order permitting Krebs to exhaust the supply of Laetrile on hand by shipping it without payment to the McNaughton Foundation in Montreal and to a few physicians in the United States so that experiments might continue [43,44]. Laetrile patients and their families had written pleading letters to the judge.

When the small reserve supply of Laetrile came to an end, interstate distribution supposedly would cease. NDAs submitted by both Krebs, Jr., and Krebs, Sr., fell short of meeting FDA’s standards for acceptance [45]. Krebs, Jr., and the John Beard Memorial Foundation obeyed the court’s ruling and stopped making Laetrile. But production and distribution did not stop. Krebs, Sr., and Krebs Laboratories, according to FDA records, picked up the task. And McNaughton’s Canadian venture quickened. He got some of his raw material for making Laetrile from England, Krebs, Jr., thought, and for one stage in the production process sent the drug into New Jersey [46].

Indeed, McNaughton increasingly made his powerful presence felt on the entire Laetrile scene. He strove, without success, to get the Damon Runyon Cancer Fund to evaluate Laetrile, reaping some headlines from the effort [47]. However, a vastly more successful publicity coup soon followed. The American Weekly, a Hearst publication, during March 1963 ran two articles presenting Laetrile in a most favorable light [48]. They were followed shortly by a paperback book from which they had been taken, Laetrile, Control for Cancer[2]. “The most important medical news of our time, “the cover promised, “First major breakthrough in the cancer mystery. The day is near when no one need die from cancer. LAETRILE, the revolutionary new anti-cancer drug . . . WILL BE TO CANCER WHAT INSULIN IS TO DIABETES.” Written by Glenn D. Kittler, who earlier had acclaimed Krebs, Jr., as Nobel Prize material, the book presented a highly dramatic version of Laetrile’s discovery and a most optimistic rendering of Krebs-sponsored clinical experience with the drug. To use the term “cures” for cancer Kittler considered “inaccurate. but he added: “The idea of a cancer control, on the other hand, is perfectly plausible. In the minds of an increasing number of leading scientists, the best control now available is Laetrile.” The book concluded by quoting Andrew McNaughton to the same effect. McNaughton contributed also the book’s foreword, to which he appended his Foundation’s Montreal address. Letters of inquiry sent to the Foundation received replies saying Laetrile might soon be available

from Canada and asking cancer sufferers to have their doctors write the Foundation [49]. Some United States citizens crossed the border to Montreal to get Laetrile injections [50].

While thus deeply involved in a publicity venture tremendously expanding Laetrile’s national visibility, McNaughton also worked away on other fronts. He sent Laetrile made in Canada to a foreign trade zone in San Francisco for trans-shipment to markets in the Far and Middle East [51]. And he continued to deal with the Krebs. Relations were sometimes tense, but McNaughton — at least in the judgment of observing food and drug officials — came to assume the upper hand [52]. In speaking of Laetrile, he often used the proprietary “we,” and he acted as if he were making the important decisions. When the probation stock of Laetrile ran out, it was McNaughton who went to Washington, this time alone, to see if he could pressure the FDA into letting him have more, arguing that he should not be penalized for the misdeeds of Ernst Krebs, Jr. [53]. FDA officials pointed out that Laetrile still did not have a completed NDA and that the new Kefauver law had stiffened standards for admitting new drugs to the market.

Legal difficulties, indeed, soon cast shadows across the publicity coup resulting from Kittler’s book. California, after holding hearings under its new law aimed at specious cancer treatments, banned Laetrile as a quack remedy [54,55]. The Canadian Food and Drug Directorate barred further distribution of Laetrile by the McNaughton Foundation on the grounds that its safety and efficacy had not been proved [56]. McNaughton, calling unconstitutional the law under which the Directorate had moved, sought in 1964 to enjoin the Directorate from enforcing it. But McNaughton lost in court. The next year the Food and Drug Administration strove to curb Dr. Krebs, Sr.’s small-scale but persistent shipment of Laetrile in interstate commerce. After protracted court action, he was enjoined, later cited for criminal contempt, and finally fined for violating his probation [57]. Dr. Krebs probably prescribed Laetrile for his patients through the remainder of his life, although he gave up manufacturing and distributing it, while maintaining the production of pangamic acid [58]. He died in 1970 from a fall on the stairs at the age of 94 [59,60].

In the meantime, Andrew McNaughton had moved to California. Both the Krebs, father and son, had been enjoined from dealing in Laetrile, and in Canada so had McNaughton himself. Using several corporate names, McNaughton continued the manufacture of Laetrile in San Francisco, then in Sausalito [38,61], and from his transplanted McNaughton Foundation he tried once more in 1970 to get FDA approval for experimental use of Laetrile on human subjects [62-64]. McNaughton’s submission of an IND, an Investigational New Drug application, a document required by the Kefauver-Harris Act before human trials could proceed, became a cause celebre. Upon receipt of the IND, the FDA routinely approved it, in accordance with then prevailing practice. A quick appraisal did not reveal in the application the kind of promising evidence from animal experimentation that would provide a reasonable basis for expecting anti-tumor activity in man. Eight days later the FDA wrote McNaughton that the IND could not be continued without more satisfactory data, and when no new information arrived before the deadline set in regulations, the FDA cancelled the application. Further information later submitted by McNaughton did not persuade Food and Drug officials to change their minds. Manufacturing controls and preclinical and clinical data all remained unsatisfactory.

Laetrile supporters reinterpreted these events into a tale of FDA’s perfidy. According to this version, FDA’s initial automatic acceptance of an IND until the evidence could be examined became instead a bona fide acceptance which the agency then reversed under pressure from the political moguls of the cancer research establishment [65,66]. A pro-Laetrile reporter predicted “a showdown” between the hidden forces of repressive orthodoxy and champions of alternate modalities [65].

A showdown did indeed occur. A varied constellation of circumstances had moved the Laetrile cause upward on the path of political power. Not only had Hoxsey’s star set through governmental action and exposure, so too had Krebiozen’s virtual demise arrived by 1966, thus creating a vacuum at the apex of cancer unorthodoxy ready for filling by a new contender. The publicity generated by Kittler’s book gave Laetrile a good boost toward the top. Moreover, McNaughton gained a recruit to his cause from the inner citadel of the cancer research establishment who was destined to play for Laetrile something like the role Andrew Ivy had played for Krebiozen. Dean Burk, who had received his Ph.D. in biochemistry from the University of California, had devoted a more than forty-year career to cancer investigation, with many honors along the way, and now was chief of the Cytochemistry Section of the National Cancer Institute [65,67]. In 1968 McNaughton had persuaded Burk to undertake research on Laetrile, and by the time two years later of FDA’s rejection of the McNaughton Foundation’s IND, Burk had become a fervent Laetrile champion, calling many of his contrary-minded governmental associates “scientifically immoral.” [65] Stepped-up Laetrile publicity focused the spotlight on Burk.

The scope of Laetrile publicity had also broadened because a new organization had sprung up to wave its banner and because an established league of unorthodox health promoters had taken up Laetrile’s cause. The new group, the International Association of Cancer Victims and Friends, was founded in 1963 by a San Diego schoolteacher, Cecile Pollack Hoffman [50,68]. She herself had turned to Laetrile with despair and hope. In 1959 she had sustained a radical mastectomy because of breast cancer, and three years later the spread of cancer led to further surgery. She learned of Laetrile when her husband saw a copy of Kittler’s book in an airport lobby. Cued by McNaughton’s foreword, Mrs. Hoffman journeyed to Montreal for Laetrile injections. She continued receiving them closer to home, by crossing the border to Tijuana, becoming the first Laetrile patient of a Mexican physician, Ernesto Contreras Rodriguez. Persuaded that Laetrile had saved her life, angry that this treatment was not legally available in the United States, Mrs. Hoffman established her International Association. Through print, meetings, and personal evangelism, the association castigated “out-of-date, outmoded, so-called ‘orthodox’ treatment” and vigorously espoused what Mrs. Hoffman termed “non-toxic, beneficial therapies,” especially Laetrile. Krebs, Jr., Contreras, and in time Dean Burk addressed IACVF assemblies [69-71]. The organization provided cancer sufferers with information on how to get to Tijuana. When Canada joined the United States in making Laetrile illegal, Dr. Contreras’ business boomed. Mrs. Hoffman died in 1969 of metastatic cancer, but her organization continued on [72].

Mrs. Hoffman’s emphasis upon “Freedom of Choice” in cancer treatment echoed the constantly reiterated dominant theme of another organization which had been established eight years before she founded the IACVF. The National Health Federation was founded in 1955 [73,74]. The moving spirit in its creation was Fred J. Hart, a California promoter of health devices who had just been enjoined by Food and Drug Administration initiative from distributing them in interstate commerce. Other NHF founding fathers also had encountered legal restraints, some spending time in jail, for false claims about devices, dietary wares, and so-called cancer treatments. One of Harry Hoxsey’s lawyers became the Federation’s first legal representative in Washington. The Federation developed into a powerful league linking the various segments of health unorthodoxy. They held up each other’s spirits and sought new converts at frequent meetings, developed skillful propaganda playing on public anxieties and frustrations, grew adept at pressure politics, mobilizing the faithful for letter-writing campaigns and confrontation lobbying. Hart and Krebs both testified against the California cancer law, and the Federation welcomed Laetrile supporters to its ranks and gave their cause strong support. Condemning overweening and bumbling bureaucracy for administering health laws to favor the medical establishment, the NHF pleaded for patient freedom of choice so that each ailing person might treat himself from amongst unorthodoxy’s abundant catalog of wares. The Federation journal pictured Washington and Lincoln on its cover over the caption, “They Too Fought for Liberty Against Great Odds.” These criticisms of governmental actions in the health field mounted amidst the growing broader disillusion with governmental policy resulting from the war in Vietnam.

The distorted Laetrile version of the FDA’s rejection of McNaughton’s IND received widespread coverage in the publications of unorthodoxy and in the sensationalist press [75]. A barrage of angry mail bombarded Washington. FDA’s police state tactics, charged one protester, “reduce[d] Hitler and Stalin to the status of small time hoodlums.” [76]

Mail deluged the Congress as well as the FDA [77]. The National Health Federation Bulletinhad explicitly urged this action [78]. Representative Lawrence H. Fountain, after committee hearings, brought pressure on Elliot Richardson, Secretary of Health, Education, and Welfare, to sponsor further evaluation of Laetrile’s efficacy [79]. The FDA checked its own internal judgment by soliciting external expert opinion. A panel of independent cancer specialists was assembled, which reviewed the data submitted in McNaughton’s application, heard face-to-face what McNaughton and Burk had to say, sought whatever new information Laetrile physicians like Contreras might have to offer, then concluded that the sum total of evidence did not warrant testing Laetrile on humans. Further rodent tests in recognized independent laboratories, the committee held, might be desirable. The Secretary considered the conclusions of FDA’s ad hoc committee valid [63,80]. National Cancer Institute tests on mice had offered no promise of Laetrile’s effectiveness, and no new NCI tests seemed worth undertaking. That Institute, however, the Secretary said, would recognize grant applications for further testing from qualified independent investigators. Secretary Richardson reported his judgments to Congressman Fountain who did not continue to press the issue. A bill introduced into the House by another member, to authorize research on and testing of non-toxic substances for the diagnosis, treatment, and prevention of cancer, made no headway [81].

Regulatory pressure on Laetrile promoters did not subside. In 1971 the state of California began a criminal case against Ernst Krebs, Jr., charging him with practicing medicine without a license and, aided by his brother Byron, an osteopathic physician, with distributing a prohibited drug [82-84] Two years later the brothers pleaded nolo contendereto violating the state cancer act’s taboo on Laetrile. The judge fined them and placed them on probation. The terms required them to obey all city, state, and federal laws, especially the cancer treatment provisions of the California code, and forbade Krebs, Jr., to practice medicine without a license. California took further legal steps as well. A case against Mary Whelchel sought to impede the turning wheels of an accelerating “underground railroad” which assembled cancer victims from all over the nation in a boarding house on the United States side of the border, then ran them across to Tijuana for Laetrile treatment in Dr. Contreras’ flourishing operation [84,85]. In 1971, Mrs. Whelchel was convicted of delivering an illegal compound for treating cancer, fined, and, as a term of her probation, was forbidden to transport anyone to Mexico. (It should be noted, however, that this conviction was set aside two years later.)

The Appeal to Freedom

Such relentless regulation coupled with scant success from the epistolary campaign in Washington sped changes already launched that remade Laetrile’s self-image, the explanation for its therapeutic action, indications for its use, the strategy and tactics of its promotion, even its very name. Andrew McNaughton remained commanding general but became an officer in exile. In 1974 his reputation in his Canadian homeland suffered a blow when a judge convicted him of conspiring fraudulently to affect the market price of a mining stock [86]. The United States, with Laetrile under attack on both state and federal levels, must have seemed increasingly hostile. McNaughton took up residence in Tijuana. The press credited his foundation with sponsoring both manufacturing and clinical facilities for Laetrile in the Mexican city [36], stations at the underground railroad’s terminus. The railroad began to run the other way, carrying smuggled Mexican Laetrile into the U.S.A. [87].

McNaughton thus continued, as a reporter put it, “more than any other man … the driving force behind the Laetrile movement.” [88] In this third period, however, McNaughton in exile gained powerful allies of great leader-ship potential in the United States. This chain of events began in 1972 when a California general practitioner, Dr. John A. Richardson, was arrested at his Albany clinic, charged with prescribing Laetrile in violation of the state’s anti-quackery law [89]. The dramatic arrest, filmed on television cameras, involved policemen with drawn guns and a thorough search of the premises. The physician spent a brief time in jail. A trial before a judge, finding Richardson guilty, was quashed on appeal. Two jury trials followed, both ending with jurors split [36,90] Eventually the California Board of Medical Quality Assurance revoked Dr. Richardson’s license to practice medicine on grounds of “Gross negligence and incompetence.” [91,92]

Richardson’s initial arrest upset some of his fellow members of the John Birch Society. Such dedicated disciples of freedom-from-government doctrine saw in Richardson’s plight a prime example of bureaucratic oppression. Led by Robert W. Bradford of Los Altos, a small group of ultraconservatives founded yet another organization to help Laetrile’s besieged prescribers [93]. Bradford was a nuclear technician on the Stanford University staff, working on the building of a linear accelerator for research in subatomic physics. Poised, articulate, skilled at organization, Bradford, aided by equally dedicated associates, quickly made a success of the new Committee for Freedom of Choice in Cancer Therapy [36,94,95]. In 1975 he gave up his Stanford job to devote full time to the Committee and to Laetrile. Ties with the nation’s already existing conservative network surely helped immensely in the speed with which the Committee established local branches. By 1977 Bradford claimed five hundred chapters with some 35,000 members.

The Committee and its allies focused upon freedom, making any governmental interference with a cancer sufferer’s right to take any remedy available seem a violation of the Constitution and the fundamental rights of man. Thus an atmosphere of high principle infused the zealous campaigning in Laetrile’s behalf. Laetrile’s opponents, in the Committee’s propaganda, constituted a selfish conspiracy of those involved in orthodox cancer research and therapy, futilely cutting, burning, and poisoning their victims, and rejecting hopeful treatments like Laetrile for fear of doing themselves out of their jobs. The Committee showed great ingenuity at making their message widely known. They employed meetings, films, pamphlets, paperback books, quickly triggered letter-writing campaigns, and the assembling of the faithful for legislative hearings. Full-time crusaders sought out cancer victims and urged Laetrile upon them and upon members of their families [96]. Counsel could be given as to how to get to Contreras’ clinic in Mexico or how to acquire Laetrile in the United States. Indeed, some Committee leaders, including President Bradford himself, allegedly at great personal profit, engaged in a conspiracy to smuggle Laetrile in from Mexico and, with much surreptitious ingenuity, distribute it within the United States. After a three-month trial in 1977, Bradford, Dr. Richardson, and others were convicted of this conspiracy; the Court of Appeals for the Ninth Circuit confirmed the convictions [97]. McNaughton, also indicted, pleaded guilty [87].

Laetrile in the 1970s assumed a different character from the chemotherapeutic Laetrile with which the Krebs began. In 1963, in a letter to the Food and Drug Administration, Dr. Krebs had asserted: “The cyanogenetic glucosides belong to the nutritional vitamins and should not be classified as drugs.” [98] Here appears the earliest reference encountered in the file to Laetrile’s future destiny. Already, Krebs, Jr., had committed himself, as part of his probation, not to distribute Laetrile as a drug. Perhaps both father and son had begun to wonder if legal restrictions might not be less stringent under the food sections of the law. Such a shift in Laetrile’s status would require a modification of the prevailing chemotherapeutic explanations of Laetrile’s mode of action. Shortly Krebs, Jr., published a pamphlet, not really retreating, but adding the suggestion that Laetrile could be characterized as a pro-vitamin for B-12. The pamphlet bore the title, “Cancer Is a Deficiency Disease.” [21]

As regulatory actions mounted, Krebs, Jr., in 1970 brought his pamphlet title to full flower. In an article in the Journal of Applied Nutrition he asserted that Laetrile and other “nitrolosides” made up a true vitamin which he denominated B-17 [99]. Vitamin B-17, he wrote, amounted to a cancer-protective factor. Moreover, Krebs asserted, in this “new vitamin . . . all of us are severely deficient.” Cancer could be cured by massive injections of the vitamin. Cancer could also be prevented by smaller quantities, made from de-fatted apricot kernels, regularly taken by mouth. Four years before the appearance of this article Dr. Krebs had begun to distribute an oral dosage form of Laetrile (100]. Now that form became popular, widely publicized by McNaughton, as co-therapy with injections of Laetrile in cancer treatment and, among perfectly healthy people, as a presumed preventive. Chewing unprocessed apricot kernels bought at health food stores also came into vogue.

If one were interested in Laetrile as a commercial venture, one might anticipate several advantages from this combination of new directions. Vitamin status for a product, one could argue and hope, might bring some immunity from actions under the drug provisions of both state and federal law. Moreover, the concept of cancer prevention would certainly elicit broad public interest, for of all threats, including war, Americans feared cancer most. Potential sales of a preventive could be enormous. And, if to the popular mind the word “cancer” bore ominous overtones, the word “vitamin” evoked glamorous reverberations of buoyant health (101]. Americans had mounted to a new plateau of concern about their health, accompanied by a wide variety of approaches toward do-it-yourself safeguarding, by no means all of them sound. Health food marketers, including National Health Federation members, both agitated the public’s concern about health and oversold the need for vitamin supplementation [102].

Nutritional scientists repeatedly denied that Laetrile fulfilled any of the criteria for a true vitamin [103-105]. “In short,” summed up a veteran vitamin researcher, Dr. Thomas H. Jukes, “nothing could be less like a vitamin than laetrile.” (106] Despite such criticism, Laetrile’s vendors continued to assert this claim. In testifying in 1977 before Senator Edward Kennedy’s Subcommittee on Health, Ernst Krebs, Jr., termed Laetrile “a scientific revolution as profound as the germ theory of disease . . . and the Copernican theory.” [107] What Vitamin C is to scurvy, niacin to pellagra, and Vitamin D to rickets, he suggested, Vitamin B-17 is to cancer. If every American took Laetrile regularly, Dr. Richardson told the subcommittee, “in 20 years cancer would be relegated to the dusty pages of history.”

To make amygdalin accessible for regular self-dosage by the American public, Laetrile’s sponsors displayed much marketing skill. In 1972 there appeared in California a consumer product bearing the trade name Seventeen. Just in front of the name on the carton came a picture of a bee. A McNaughton Foundation representative offered a reporter from a San Jose newspaper a chance to interview the noted cancer specialist, Dean Burk, who happened to be visiting the Bay area [108,109]. By this route Burk’s praise for the new food supplement found its way into the press. Bee-Seventeen, Burk said, contained three percent Laetrile, thirty percent protein, fifty percent unsaturated fats, with the remainder minerals. The powder was to be taken daily with juices or milk. Laetrile, Burk told the reporter, could both prevent and cure cancer, but no medical claims were being made on behalf of Bee-Seventeen. It was offered for sale solely as a food.

Such a ruse did not protect the product from action by the Food and Drug Administration. The manufacturers of Bee-Seventeen were enjoined from distributing what the court termed both an unapproved food additive and a misbranded drug [110]. Other amygdalin-containing products, like Aprikern, though devoid of therapeutic claims in their labeling, were also barred from the marketplace [111].

Laetrile’s champions not only propagated their vitamin gospel with aggressive vigor; they also took the offensive against their critics in other ways. Oppressed by federal food and drug law and by the California anti-quackery statute, the Laetrile coalition turned its attention to legislative chambers. Several efforts to repeal the efficacy provision in the California law failed [112]. In the national Congress, Laetrile supporters favored a bill introduced by Representative Steven D. Symms of Idaho which would have repealed the provision of the Kefauver-Harris Act requiring that new drugs be proved effective before being permitted on the market [113,114]. This bill gained some 140 co-sponsors in the House but made no progress toward enactment.

Laetrile’s major legislative push aimed at persuading state legislatures to pass laws legalizing the extract made from apricot kernels. Bills differed in substance from state to state, although most would at least permit physicians to prescribe Laetrile for patients certified as terminally ill of cancer [115]. Cancer specialists pointed to the great difficulty in achieving any satisfactory definition of the word “terminal.” [116] Alaska enacted the first such law in September 1976, and within two years sixteen other states had followed suit. Other legislatures pondered Laetrile bills and defeated them. The deliberative bodies in Indiana, Illinois, and Rhode Island enacted their measures over vetoes by the governors [117,118]. In New York, two years in succession the governor’s veto held.

The scenarios in the several states had much in common [119]. A cooperative assemblyman introduced a bill at the request of a constituent. In due course the health committee held hearings. The hearings, replete with drama, became newsworthy happenings, recorded by television cameras, widely reported in the press. In some states, orthodoxy and unorthodoxy got equal time in number of testifying witnesses. In other states, pro-Laetrile sentiment was dominant. In news coverage, unorthodoxy—the underdog, the challenger—received the greater play. Members of The Committee for Freedom of Choice in Cancer Therapy turned out in force. Wearing campaign buttons, they packed the galleries, intense, completely absorbed. Depending on the strictness of the rules imposed, Laetrile’s friends either shouted or murmured praise for pro-Laetrile testimony, and heaped imprecations, either loudly or sotto voce, upon spokesmen from the state medical society, nearby universities, the American Cancer Society, the Food and Drug Administration, who explicated Laetrile’s unproven status. The Laetrile lobby produced living testimonials claiming to demonstrate the contrary. After my operation—so the pattern went—my doctors gave me only a year to live, but I took Laetrile and here I am three years later, speaking before you legislators. The main thrust, however, of Laetrile spokesmen, often the national leaders of the movement, fell upon freedom of choice. State legislators had their own problems with the powerful federal presence, and might listen with sympathy to constituents blasting segments of the Washington bureaucracy. In any case, pleaded Laetrile witnesses in many states, only a little freedom was being sought, freedom for the dying, under a doctor’s direction, to try Laetrile as a last resort.

After the hearings came continued pressure upon legislators, through conversations and a massive deluge of mail. Occasionally, if the terms of initial bills seemed too broad for acceptance, successive versions would follow with ever weaker provisions, until skeptical assemblymen would consider the measure too innocuous to matter and could thus satisfy both their consciences and the demands of those who had sent in the preponderance of mail.

No matter how weak the laws enacted, each one, announced to the nation through growing media coverage, contributed to bandwagon psychology, giving the imprimatur of another state’s approval to Laetrile. To the ordinary citizen, sanction might equate with efficacy. Thus each new law enhancing Laetrile’s prestige made it seem like legitimate therapy to victims of cancer and their families, including those victims whose cancer had just been diagnosed. And each law, making a specific exemption of Laetrile, dealt a new blow to the theory behind the federal law, which many states had imitated, that promoters of new drugs must prove them efficacious and safe before they could be marketed. The Kefauver law, moreover, demanded a high standard for proving efficacy, the results of adequate and well-controlled studies, not random cases proclaiming benefit, whether presented in paperback book or in testimony at committee hearing.

The state laws, however, did not negate the national law, and Laetrile remained illegal in interstate commerce. It was reported that McNaughton, allied with Bradford in a new John Beard Research Institute in Palo Alto, hoped to set up plants to manufacture Laetrile and clinics to dispense it within states enacting favorable laws [120], although these projects did not move rapidly forward. And in Illinois at least, where legal use of Laetrile was hedged in with many restrictions, the pattern set by the law has not been much employed [121]. Rather, black market Laetrile has continued to be vended in the most dangerously careless way. A Chicago reporter told of buying Laetrile surreptitiously from a foot doctor downstate who asked no medical questions [122].

A second legal route for Laetrile prescribing, this one breaching the ban on interstate commerce, developed from action in the federal courts. As the Laetrile forces undertook a counter-offensive against regulation on the legislative front, so also did they on the judicial front. The key case in the campaign centered on Glen L. Rutherford, a manufacturer’s representative who lived in Conway Springs, Kansas [123]. Upon receiving a medical diagnosis that he suffered from a cancerous polyp, Rutherford refused radical surgery of the larger bowel. Instead he went to Dr. Contreras’ clinic in Tijuana. The physician in charge of Rutherford’s case later wrote a federal judge that Rutherford was treated with Laetrile and proteolytic enzymes, and then the remaining polyp was “cauterized.” [123] Cancer specialists indicate that the excision of a polyp of this type solves the problem in a high proportion of cancer cases [124].

Upon returning home, Rutherford sought to ensure himself of a continuing supply of Laetrile. He joined a law suit already begun, became the sole surviving plaintiff, and in 1975 won from the United States District Court in Oklahoma an injunction against federal regulators which permitted him and other terminally ill cancer patients to import from Mexico a limited amount of the drug for their personal use [123]. Judge Luther Bohanon insisted that each patient present a physician’s affidavit certifying to the stage of illness and specifying the quantity of Laetrile needed to be imported.

Upon appeal of the Rutherford case, the United States Court of Appeals for the Tenth Circuit upheld the injunction [125]. The court also instructed Judge Bohanon to require the Food and Drug Administration to develop an administrative record on two points contested in the case: whether or not Laetrile was a “new drug” as defined by law, and whether or not it was exempt from premarketing approval requirements by reason of being “grandfathered.” FDA complied. In its proceeding, the agency received four hundred written statements from friends and foes of Laetrile and held in May 1977 two days of public hearings in Kansas City [126]. Jammed with Laetrile supporters, these hearings had the emotional flavor of hearings in the states [105]. Cheers greeted pro-Laetrile speakers, boos and hisses their opponents. To one distinguished scientist present, “the affair appeared to be a confrontation between two cultures. One side was characterized by the voice of science—skeptical, analytical, orderly, but sometimes bluntly critical and uncompromising. The other side faced the situation with fervor, passion, conviction, revolt against logic, all emotionally expressed. They seemed to willfully reject distasteful facts.” [105]

Food and Drug Commissioner Donald Kennedy and his staff turned their court-appointed responsibility into a comprehensive review of Laetrile, as thorough, broad-gauged, and insightful an analysis of a highly promoted but unorthodox drug as could be found in the American literature [21]. Besides answering the court-posed issues—Laetrile had not been “grandfathered” under either the 1938 or 1962 law; experts did not consider it either safe or effective for its prescribed uses—the report discussed other significant matters relating to Laetrile. Laetrile’s composition and identity would be difficult to define, the report stated, because so many different chemical entities had appeared under that name in both the literature printed about and the products distributed as Laetrile. The Commissioner countered the various claims made for Laetrile’s effectiveness in cancer, disputing the shifting theories, remarking the inadequate anecdotal character of pro-Laetrile case reporting, and citing the lack of promise in  numerous well controlled animal studies that had been made by the National Cancer Institute and private cancer research centers. The few animal tests interpreted as favorable to Laetrile by Dean Burk and others, the report criticized directly, concluding that Laetrile had failed “to show any effect in the animal system.” The document found the nature of Laetrile’s appeal in the psychology of patients and their loved ones caught in the crushing cancer crisis. The “disparagement of conventional therapy,” the Commissioner stated, “a bulwark of the campaigns of Laetrile proponents, is perhaps the most morally reprehensible aspect of the pattern of the drug’s promotion.” This disparagement led sufferers away from proven remedies, that might offer some chance, to almost certain disaster. Even short delays could mean the difference between life and death.

Commissioner Kennedy met the “freedom of choice” argument head on. Congress had decided, he noted, “that the absolute freedom to choose an ineffective drug was properly surrendered in exchange for the freedom from the danger to each person’s health and well-being from the sale and use of worthless drugs.” In any case, the choice to use Laetrile, made in an atmosphere of double stress, compounded from fear of disease and from the zeal of Laetrile advocates, with seldom any “rational laying out of competing arguments,” can seldom be properly described as free.

The Commissioner’s conclusions and all their buttressing evidence did not persuade the Oklahoma judge. He ruled that Laetrile was exempt from the need for pre-market approval and forbade the Food and Drug Administration from interfering with its importation and transport in interstate commerce or with its use by licensed medical practitioners in treating cancer patients [127]. Again the FDA appealed.

When the Tenth Circuit considered FDA’s appeal of this new Rutherford decision, the judges cut back markedly on the District Court’s liberality toward Laetrile, but still authorized its use for a restricted segment of the population [128]. Ruling in July 1978, the appellate judges concluded that the law’s taboo against unsafe and ineffective drugs did not apply to people who were dying. Therefore, patients whose physicians would certify that they were terminally ill with cancer could legally import Laetrile—but only for intravenous injections, not in its oral form.

This last proviso revealed that the Court of Appeals was taking into account, as the District Court had not, evidence of amygdalin’s toxicity when taken by mouth. Evidence submitted to the Commissioner’s review, testimony given before Senator Kennedy’s subcommittee, and stories in the press cited severe poisonings and even deaths from the ingestion of Laetrile tablets and apricot kernels [21,129-132]. Enzymes in the gastrointestinal tract split the amygdalin molecule and released its cyanide.

The Tenth Circuit did not heed other evidence submitted to it with the FDA’s appeal, that the long-vaunted claims made in behalf of injectable Laetrile’s non-toxicity might not be completely true. Little research had been undertaken on Laetrile’s action when injected into the body. Some physicians began to report unfortunate consequences, surmising that many such adverse effects had earlier occurred but had been blamed not upon the treatment but upon the disease [133].

That the dying should be barred from the law’s protective mantle, Commissioner Kennedy deemed a “remarkable finding” indeed, and he urged an appeal of the Tenth Circuit’s opinion to the Supreme Court [134]. In August 1978 the Commissioner thought his hand strengthened when the Court of Appeals for the Seventh Circuit rendered an anti-Laetrile decision. In 1977 FDA had seized apricot kernels, partially processed kernels, and empty capsules intended for filling with Laetrile at perhaps the largest processing plant in the United States, a former dairy in Manitowoc, Wisconsin. Later the company, which had sold two million dollars worth of its illegal product, was enjoined from continuing its business [135]. On appeal, the Seventh Circuit ruled that Laetrile could properly be excluded from interstate commerce until it should be proven safe and effective [136]. In due course the Supreme Court could be expected to decide between the contrary opinions of the Tenth and Seventh Circuits [137].

Other con and pro decisions marked Laetrile’s increasingly litigious history. In California, the state’s effort to restrain Laetrile practitioners ran into a snag. A state appeals court called the California cancer law unconstitutional, ruling that the state had no power to deny doctors the right to use non-toxic unorthodox cancer treatments [138]. The state Supreme Court in 1978 granted a petition for review of this decision [139]. In Georgia, a jury exonerated one of the most notable personages in the ranks of Laetrile proponents. Larry P. McDonald, physician and member of the John Birch Society and of the United States Congress, had prescribed only Laetrile for a patient’s cancer [140]. When the man died, his family sued for malpractice. The jury decided not so, yet feeling sympathy for the widow decided that she should be reimbursed for the expense of her dead husband’s treatment.

The Food and Drug Administration continued seizing imports of Laetrile from Mexico and from Germany not protected by court-ordered physician affidavits swearing that the drug was intended for a particular patient who was terminally ill. Moreover, some samples offered for import turned out to be not amygdalin at all, but a dangerous fever reducer; other samples were contaminated with fungus [141,142]. Indeed, even the affidavit system itself, the FDA soon charged, had become a cloak for fraud (143]. Reporters visiting Tijuana observed stacks of presigned affidavits available for the asking to Laetrile purchasers [122]. Hitherto Laetrile smuggling, as revealed in the trial at which Dr. Richardson and Bradford had been convicted, had been an underground operation. Now, the government alleged in a seizure action, the druggist at a Baltimore pharmacy had manipulated the affidavit system for his own profit [144,145]. He had obtained affidavits from a physician and had filled them in for the maximum importable amount of Laetrile, using the names of cancer patients who had in fact ordered smaller quantities or none at all. The druggist had then sold the surplus to other patients, sometimes getting the authorized release and sometimes not. A judge upheld the validity of the seizure, but, pending a Supreme Court decision, would not order the seized Laetrile destroyed.

The extensive litigation and the legislative battles in the states made Laetrile an issue of national interest and debate. News magazines carried cover stories [37]. Television—including the program “60 Minutes” [146]—looked at Laetrile. The press kept tabulated track of contests in the states. Conservative columnists, most notably James J. Kilpatrick, attracted to the freedom-of-choice theme, repeatedly gave Laetrile users a prestigious boost [147]. The promoters intensified their own publicity. Paperback successors followed Kittler’s original success: G. Edward Griffin’s World Without Cancerin 1974 [148]; Mike Culbert’s Freedom from Cancer in 1976 [149]; John Richardson’s Laetrile Case Histories [90] and Robert Bradford’s Now That You Have Cancer in 1977 [150]. A majority of American citizens, according to a Louis Harris poll, thought decriminalization of Laetrile would be a good idea [151]. Some Laetrile leaders sounded smug at their success.

“Rest assured, gentlemen,” Bradford told Senator Kennedy’s subcommittee, “that the people demand Laetrile. And they are going to get it whether Big Brother wants it or not . . . . [W]e cannot expect that thousands of American cancer sufferers are going to wait for more long years, while the Federal Government fiddle-faddles through animal tests and more red tape.  Do we really want another American civil war?” [152]

So disturbed became the state of the mass mind that a segment of sober opinion, unbelievers in Laetrile’s efficacy, concluded that the speediest way to quiet public clamor would be to let Laetrile’s worthlessness be proved either by widespread use or in a series of well controlled clinical trials in humans conducted by investigators of unimpeachable integrity and skill. Some scientists, indeed, believe that any drug should be tested for which suggestive evidence exists, even hearsay, that the drug might be of benefit. To test Laetrile in humans would breach the prevailing system, which puts the burden of proof upon a new drug’s sponsor. Such a step, further, would fly in the face of the weight of animal evidence. The major pro-Laetrile animal experiments, announced in 1977 at a National Health Federation meeting by Harold W. Manner, a zoologist at Loyola University in Chicago [153,154], have received severe criticism on the grounds of inadequate methodology [155]. Human trials with Laetrile, therefore, posed grave ethical questions respecting patient rights and the value of expending limited resources available for testing in such a way [156]. But so dangerous seemed the consequences of the spirit behind the new Laetrile state laws that some commentators, both laymen and physicians, resorted to the forbidden fruit argument. The way to dampen “Laetrilomania,” suggested F. J. Ingelfinger, distinguished editor of the New England Journal of Medicine, might be to reduce the glamor derived from its illicit status by making it freely available, and then keeping accurate records of patient experience [157]. The editors of the New York Timestook a similar tolerant approach toward Laetrile distribution [158]. Charles G. Moertel of the Mayo Clinic favored a less extreme course: if Laetrile’s sponsors would not assume their legal obligations, then reputable scientists must undertake the task. “The only established means of proving a drug effective or ineffective, safe or unsafe, is by a properly designed, tightly controlled clinical trial.” [159]

Officials at the National Cancer Institute reluctantly reached the same conclusion. If such action had to come, FDA Commissioner Kennedy argued at Senator Kennedy’s hearing, at least all parties must agree on the specific chemical formula, among the many that had been posited and marketed, of the “Laetrile” to be tested [160]. Senator Kennedy labored diligently throughout the hearing and believed he had achieved a consensus on this point which included Laetrile’s promoters. Tests would weigh the merit of amygdalin [161].

After careful review of the situation, National Cancer Institute officials decided not to launch human trials immediately, but to undertake a retrospective study of patients who, according to their .physicians, might have benefited objectively from the use of Laetrile [162]. From the purportedly 70,000 patients in the United States who had been treated with Laetrile, the NCI hoped to get full enough records to permit analysis of two or three hundred cases. In quest of such records a much publicized appeal went forth to the more than 400,000 physicians and other health professionals in the nation. The director of the project sought to persuade the Laetrile inner ring of leadership to urge physicians active in Laetrile prescribing to submit case records [163].

In the end, however, only ninety-three cancer cases were submitted for evaluation, only twenty-two of them concerning patients who had been treated with Laetrile alone for whom the records were adequate for appraisal [164]. A panel of twelve cancer experts stated that under Laetrile treatment apparently seven of the patients had worsened, nine had remained the same, and six had responded favorably, two with complete and four with partial remissions. These conclusions, the reviewers granted, had to be taken with a grain of salt because of the possible “submission of incorrect clinical interpretations, falsified data and intentional or unintentional omission of data.” Nor had the review been designed to discover patients who had not responded to Laetrile. Nonetheless, more than two hundred physicians had volunteered evidence about more than a thousand patients who had shown no beneficial response.

After further review, the National Cancer Institute revived its earlier decision to undertake a clinical trial of amygdalin in some 150 to 300 terminal cancer patients. Dr. Arthur Upton, NCI director, announced the plan in September 1978, expressing hope that the outcome would resolve the debate over Laetrile “once and for all.” [165]

Such optimism seemed scarcely warranted. Laetrile proponents, while publicly appealing for testing, had been customarily reluctant or unable to provide complete data on patients for evaluation. The FDA’s request for clinical records to Dr. Contreras and to a German experimenter, Dr. Hans Nieper, had not brought in usable material. Nieper submitted no data at all, and Contreras’ case records, when evaluated by NCI scientists, showed no patient benefits ascribable to Laetrile [166]. Contreras, in fact, insisted to a reporter that employing his clinic for purposes of research would be unethical [167]. Nor had a whole succession of animal experiments, which to established cancer researchers offered no hint of Laetrile’s efficacy, satisfied Laetrile’s proponents, who sought to reinterpret a few such trials in a way favorable to their product [168].

From the beginning, indeed, as a basic premise, Laetrile’s supporters questioned the validity of experiments conducted by experimenters who did not share faith in the theories supporting Laetrile’s value. Pro-Laetrile physicians must direct the clinical trials, Krebs, Jr., had told the California Cancer Commission in 1952, or he would not provide Laetrile for experimentation [23]. In 1977 Krebs made essentially the same point: those inside and outside the Laetrile movement “do not necessarily speak the same language.” [107] Each dwells “in a different universe.” [60] Unless, a pro-Laetrile physician told the Kennedy subcommittee, the NCI study should be conducted “in the way that the proponents of Laetrile . . . are urging that it be done,” then “it will be an absolute sham.” [107] Robert Bradford echoed these sentiments: “the protocols that exist for orthodox therapy are not applicable, for the most part, to metabolic therapy and Laetrile.” [95] Traditional oncologists, for example, held that the removal or reduction in the size of a neoplasm measured the success of therapy, whereas espousers of Vitamin B-17, believing cancer to be a deficiency disease, considered the size of the lump irrelevant. “You do not and cannot expect to get results from laetrile treatment,” Bradford said at the Kansas City hearing, “unless you are a trained metabolic physician.” [169]

Commissioner Donald Kennedy wondered if some maneuvers by Laetrile’s promoters might not be intended for the purpose of disparaging test results adverse to the drug [160]. “[I)n sifting the strange mixture of nomenclature, alleged chemical identity, and proposed mechanism of action that comprises Laetrile’s record of the past twenty-five years,” Dr. Kennedy said, “one becomes gradually convinced that these uncertainties are not accidental. They provide an effective cover for the promoters, since failure to achieve a result can always be attributed to having used the wrong material and arguments against one hypothesis of action can always be met by embracing another.”

During the Vitamin B-17 period, the increasing stress upon “total metabolic therapy” marked another change in approach to the promotion of Laetrile. In treating cancer, according to the new doctrine, Laetrile alone could not be relied upon. While Vitamin B-17 held the indispensable place, it needed to be administered as part of a complex program involving a multitude of variables [150]. The other parts consisted of diet, exercise, rest, detoxification, minerals, enzymes, vitamins A, C, and E, and that other major Krebs’ promotion, Vitamin B-15 or pangamic acid. A patient might require “several dozen tablets every day.”

In Bradford’s book, Now That You Have Cancer, he likened the metabolic program to a crown containing nine jewels, with Laetrile “the crown jewel within that diadem.” [150] Such a “total approach,” combining an attack on the cancer, a bolstering of the body, and a positive mental attitude, metabolic physicians held, provided “the best chance to control cancer.” If the metabolic doctrine bolstered Laetrile with a host of attendant therapies, the system also expanded Laetrile’s prowess beyond cancer. In a book titled How You Can Beat the Killer Diseases, Harold W. Harper accorded Laetrile a role in preventing and treating a broad range of other ailments, including diabetes, emphysema, arthritis, and cardiovascular disease [170].

The diversified regimen of metabolic therapy certainly complicated the problem of evaluating in human trials Laetrile’s role as a possible therapeutic agent for cancer, and made second-guessing of results inevitable. Nonetheless, the National Cancer Institute’s Dr. Upton stated that, in devising the Institute’s experiments, he would “not rule out the possibility of looking at combinations” of Laetrile and high-potency vitamins [165]. Laetrile’s advocates greeted the NCI’ s retrospective review as ”Laetrile’ s biggest breakthrough,” because “from now on the myth as to the ‘officially’ observed lack of validity in Laetrile has been destroyed.” [171] Yet Bradford had told the Kansas City hearing that no “effective agreed upon protocol” for a study of cancer under metabolic therapy could be set up [169]. Whatever a NCI trial might show, disputations between advocates of orthodoxy and champions of unorthodoxy seemed certain to continue.

The Pattern of Cancer Unorthodoxies

Health quackery has flourished since that ancient day when, as Voltaire put it, the first knave met the first fool. Through most of American history, nourished by the Enlightenment concepts of the Revolutionary generation, the presence of quackery has been acknowledged but its status has been considered transitory. When medical science had expanded its horizons a little further, when the populace had received a little more schooling, when the Congress had enacted another protective law, then would quackery vanish, consigned to the museum of outmoded delusions. Certainly through the Progressive period at the beginning of our own century, such optimism sustained itself [172]. When the Pure Food and Drugs Act became law in 1906, the New York Times editorialized: “the purity and honesty of the . . . medicines of the people are guaranteed.” [173]

As the twentieth century has proceeded, despite enhanced medical science, more universal schooling, and a great increase in social legislation, observers have grown less confident about predicting quackery’s imminent demise. The course of events and the pathways of philosophy both have chilled such naive optimism. The doctrine of inevitable progress fell under the impact of a series of terrible wars. Faith in the inherent goodness of human nature, battered by new philosophical perspectives, crumbled under the revelations from the Nazi concentration camps. Belief in education as a panacea withered. Science-technology inventiveness did continue to produce wondrous products for mankind’s benefit but also devised nuclear weapons and polluted the environment. Modern industrial civilization struck many people as part of the cause for burgeoning unhappiness, Ernst Krebs, Jr., among them. At the Kansas City hearing, Krebs expressed abhorrence for “the horrible onslaught of technology blindly impinging upon the fragile flesh that contains our flame of life.” [60] Some disturbed souls sought to return to nature. Pressing upon this long developing crisis of confidence came Vietnam, an unpopular and unsuccessful war that put generations at each other’s throats, and Watergate, seeming proof of what some voices had long been crying, that blame for the discontents of civilization could be laid upon leadership.

Such an atmosphere induces irrational approaches to fundamental problems. The disillusioned, questing for new faith, are terribly vulnerable to false prophets. Distrust of established authorities encompasses all those who have traditionally sought to protect the public from charlatanry. The medical profession suffers suspicion, including the specialists within it concerned with cancer. In a behavioral survey sponsored by the Food and Drug Administration and other federal agencies, it was revealed that forty-two per-cent of American adults would not be persuaded by almost unanimous expert opinion that an unorthodox “cancer cure” held out false hope [101].

Cancer quackery in America goes back to the earliest days. In colonial times one purported cure consisted of alleged “Chinese Stones” vended by a self-styled Frenchman who hawked his wares from town to town [174]. At the beginning of this century, the first major case lost by the government under the 1906 law had aimed at suppressing Dr. Johnson’s Mild Combination Treatment for Cancer [175]. By mid-century unorthodox cancer promotions loomed largest among the illegal operations which regulatory agencies sought to control.

Basic to this circumstance were both the impact and the image of cancer in our society. With the decline of infectious diseases as a cause of death, due to sanitation, vaccines, and chemotherapy, cancer had risen to second place in the mortality lists. The 1900 death rate for malignant neoplasms was 64 per 100,000 deaths, the 1977 estimated rate 177 [176]. On the disease and death front, cancer had moved to the center of public attention. A sense of urgency led to an all-out attack, with billions of dollars appropriated by the Congress in imitation of the nation’s venture into outer space, in an effort to conquer cancer once and for all. But the enemy proved to be too complex for such a battle plan. Despite many advances, failure to fulfill the central promise brought new disillusionment [177].

Yet the image of cancer may be an even more important force for quackery than its factual circumstances. Heart deaths exceed cancer deaths, but no wave of cardiovascular cures has surfaced similar to those in the cancer field. That centuries ago cancer began to acquire a hostile and terrifying image may be deduced from the word “cancer” itself, derived from the Greek work for crab. The crawling spread of cancer, gradual but mainly relentless, whether external and observable or internal and secretive, through the centuries appeared to be, and indeed generally did amount to, a sentence of death. This image hangs on, a powerful force in men’s minds, a force not adequately revised by the victories orthodoxy increasingly has won. In our mythology, Susan Sontag has written, cancer has become a “cosmic disease: the emblem of all the destructive, alien powers to which the organism is host . . . [C]ancer is thought of as a disease of the contamination of the whole world.” [178] “As long as a particular disease is treated as an evil, invincible predator, not just a disease,” she states, “most people with cancer will indeed be demoralized by learning what disease they have.” And Sontag cites Karl Menninger to the effect that “the very word ‘cancer’ is said to kill some patients.” This deeply imbedded fear is constantly revivified in the lurid tracts and the camp meeting oratory of orthodoxy’s opponents.

Four major unorthodoxies have emerged in the United States during the last half century. First, a Detroit physician, William F. Koch, proclaimed his newly discovered Glyoxilide an anti-toxin for cancer. Each ampule, costing $25, Koch said, contained one part Glyoxilide to one trillion parts of water. Three thousand American health practitioners bought and administered the purported chemical, charging up to $300 per injection [179].

Second, a former coal miner, Harry Hoxsey, after treating external cancers with caustics here and there in Illinois, made his way to Dallas, Texas, where he set up a clinic for treating internal cancer. At its peak, the clinic had ten thousand patients on its books, charging each one a fixed four hundred dollar fee, prescribing a “pink medicine” and a “black medicine.” The former contained lactated pepsin and potassium iodide, the latter a botanical laxative in an extract of prickly ash bark, buckthorn bark, barberry root, licorice root, pokeweed, alfalfa, and red clover blossoms [32,179].

Third, two Yugoslavian brothers named Durovic brought from Argentina to the United States a whitish powder called Krebiozen, said to have come from the blood of horses which had been injected with a micro-organism responsible for “lumpy jaw” in cattle [179,180]. Their assertion that Krebiozen could cure cancer won the dogged allegiance of one of the nation’s leading cancer experts, Dr. Andrew Ivy of the University of Illinois. Thousands of physicians secured vials of this so-called investigational drug for eager patients, making a nine dollar “donation” for each ampule. In 1963 a team of FDA chemists, analyzing the only sample of Krebiozen ever secured from its sponsor, discovered it to be the common amino acid, creatin monohydrate. Simultaneous analyses of the Krebiozen distributed to physicians revealed it to be nothing but mineral oil.

The fourth major promotion has been that of Laetrile.

Laetrile possesses a more complex chronicle and a more varied cast of characters than those of Glyoxilide, Hoxsey’s botanicals, and Krebiozen, and has created greater public impact and gained more political power than did its three predecessors. Nonetheless, Laetrile impresses the historian as conforming to a ten-point profile of health quackery de-rived from a study of past quackish ventures [181].

Exploitation of Fear

Quacks have traditionally scared their victims with disturbing language, frightening pictures, and grim statistics, stressing pain and threat of death. A turn-of-the-century pamphlet described gruesomely how cancer ate away the sufferer’s nose, face, palate, and throat [182].

The modern promotional mode employs greater subtlety in playing on the morbid fear of cancer in our society. Laetrile agents try to reach patients when cancer has just been diagnosed and panic is high, and, like others before them, interpret orthodox therapies as essentially useless and more painful than the disease itself. One physician testifying in Kansas City told of a patient who, within a day of having lung cancer diagnosed, received Laetrile advertising in the mail [183]. “Cutting, burning, and poisoning” to characterize surgery, radiation, and chemotherapy have become a litany in Laetrile literature [184]. “Voodoo witchcraft” would do more good.

Promise of Painless Treatment and Good Results

“No knife or pain,” advertised a Chicago cancer quack in 1912, promising to cure breast cancer [185]. The history of cancer quackery reveals constant assurances of easy treatment and good results. In earlier days, sure cures were promised. More recently, prudence has dictated greater caution. By treating cancer with nothing more painful than injections of a non-toxic drug, according to a Laetrile tract, fifteen percent of patients with advanced metastasized cancer and eighty percent of those with early diagnosed cancer “will be saved.” [186] And Dr. Richardson evoked the vision of a cancerless nation in a mere two-score years, achieved by nothing more arduous than regular oral doses of Laetrile [107].

Claims of a Miraculous Scientific Breakthrough

Marvelous new discoveries are a dime a dozen in the literature of quack promotions. In earlier times the secret might be an herb brought back by a missionary from some primitive overseas tribe or pried loose by an explorer from an Indian medicine man [187]. Hoxsey attributed his botanical formula to the perception of his great-grandfather who noted the healing of the cancer on the leg of his horse which grazed in a pasture where the plants grew [32]. Recent “discoveries” have generally been said to derive from inspired research. The Durovics’ horse experiments in the Argentine furnish an example.

Laetrile’s heroic tale centers on the humble physician, Ernst Krebs, Sr., busy with his practice yet always seeking out drugs and vitamins to benefit mankind, and on his son, Krebs, Jr., inveterate researcher, who modified the cyanide-containing chemical his father had found in apricot kernels so that it could kill cancer cells but leave healthy cells unharmed [2]. To the audiences at the legion of Laetrile meetings before which Krebs, Jr., appears, he has become a figure of awe and veneration, acclaimed as a Pasteur and linked with the signers of the Declaration of Independence [188], a myth in his own time.

One Cause / One Therapeutic System

Quacks often win allegiance to their doctrines by promising to end confusion and doubt and to make complexity simple and comprehensible to the untutored mind. Disease, the quack says, has but one cause. Therefore, one treatment is all that is needed to fight it. In the nineteenth century Benjamin Brandreth blamed all illness on vitiation of the blood caused by constipation [189]. For a perfect panacea, therefore, try Brandreth’s cathartic pills. Later Samuel Hartman’s high-alcoholic Peruna promised only to cure catarrh, but Hartman defined catarrh to cover almost every symptom in the book [190].

A similar sweeping boldness has operated in the cancer realm. Reputable authorities now assert that there are as many different cancers as there are different common colds, over a hundred, with a broad range of causes. But for Koch all cancer came from a single toxin. For Hoxsey all cancer resulted from a disturbance in body chemistry. At the start, Laetrile’s sponsors rooted their explanation in the unitarian or trophoblastic theory, and more lately have denominated all cancer dietary deficiency disease. Initially Laetrile alone played the role of virtual specific. “Laetrile does not palliate,” Dr. Krebs wrote in an early pamphlet, “it acts chemically to kill the cancer cell selectively without injury to the normal tissues of the body.” [191] Recently Laetrile in its new guise of Vitamin B-17 has assumed central place in a therapeutic system, complex, but according to its proponents, integrated. Robert Bradford envisioned metabolic health centers as “the wave of the medical future,” replacing orthodoxy’s rugged and allegedly futile methods, and heralding the day “when the killer degenerative [disease) . . . of the civilized world would come to an end.” [150] In the same year Dr. John Richardson could posit use of Laetrile alone as a universal cancer preventive [107].

The implication of these futuristic claims is bold enough, in contrast with the restraint about Laetrile’s current effectiveness in public utterances. At the hearings held by the FDA in Kansas City and by Senator Kennedy’s subcommittee in Washington, Laetrile’s sponsors made the most modest of claims. The public record, however, and private conversations sometimes take on a different tone. Ernst Krebs, Jr. , could say in Kansas City, “We disclaim saving anyone’s life.” [60] But during a trial at which the state of California had charged Krebs with violating his probation, evidence indicated that his promises were not so circumscribed [192]. A widow testified that her husband, learning that he had lung cancer, had rejected the operation which his doctor had told him had a ninety percent chance of success. Instead, having heard Krebs on television, the man looked his name up in the telephone directory and asked his advice. Krebs told the inquirer that, if he relied on Laetrile, his chance of recovery would be one hundred percent. Krebs sent the man to Dr. Richardson. Nine months later the man was dead.

The Galileo Ploy

In response to criticism from the community of scientists, quackery has often brought into play the Galileo ploy. The unorthodox say the orthodox are wrong, just as earlier critics condemned pioneering explorers, inventors, and scientists. We are, the unorthodox assert, like Columbus, Jenner, and Pasteur—the list is long. We are today misunderstood by blind men but are destined to be heroes to future generations.

In 1951 at the trial of a woman who sold a so-called Radio Therapeutic Instrument, claiming it could cure cancer of the breast with rays beamed over great distances, her attorney trotted out Columbus, Harvey, and Semmelweiss in her defense [193]. Laetrile promoters have offered the same gambit. The text of a film strip, World Without Cancer, likened Krebs, Jr., to these three worthies, as well as to Galileo and the Wright brothers (184]. In praising Krebs before Senator Kennedy’s subcommittee, Robert Bradford admitted that Krebs had “only an honorary doctorate,” then added: “Are you aware, gentlemen, that Christopher Columbus never went to nautical school? Can we recall the shoddy credentials of Thomas Edison? Was Albert Einstein all that bright a student in school?” [95]

The Conspiracy Theory

Another time-tested response to criticism is the shouting of conspiracy. The scientific establishment doesn’t dare recognize the validity of my great discovery, the quack claims, for it will undermine their power and prestige and eliminate their jobs. So the establishment scientists conspire to suppress the wonderful new remedy.

Koch, Hoxsey, and the Krebiozen forces all resorted to the conspiracy theory, and so do the Laetrile supporters. Dr. Richardson sees the Rockefeller family at the center of the web, controlling pharmaceutical manufacturers and preventing them from developing drugs not made from oil [194]. The Rockefellers also control the American Cancer Society, a staunch foe of Laetrile. In this nightmare, the National Cancer Institute, the Food and Drug Administration, and organized medicine are likewise deemed members of the selfish conspiracy to suppress Laetrile.

Shifts to Adjust to Circumstances

Quackery has never felt obliged to retain a given posture if some change might offer greater prosperity or safety. In the nineteenth century a cold cure that wasn’t selling became a stomach remedy and reaped huge profits.

Laetrile’s history has been marked by many changes. When the Krebs’ version of amygdalin emerged, chemotherapy as a mode of treating cancer was new, public excitement about it high. The first pro-Laetrile paperback, Kittler’s Control for Cancer, grafted the apricot pit drug onto that interest, stressed Laetrile’s chemical nature, did not mention the word “vitamin.” [2] By the 1970s nature’s way toward health enjoyed great public favor, chemicals in cancer therapy had slipped some in popular prestige, and chemicals in the environment had come under grave suspicion. John Richardson’s Laetrile Case Histories blasted chemotherapy in cancer, denied explicitly that Laetrile was a “drug,” and concluded that control of cancer had been found “in nature.” [195] From drug to vitamin, from cure to palliative and preventive, from low dosage to high dosage level, the pattern of Laetrile’s postures has been kaleidoscopic. “The mere fact that there is a constantly changing set of theories as to why laetrile should be used or how it does work,” asserted the American Medical Association to the Kennedy subcommittee, “is sufficient to lead objective persons to question the validity of any of the theories put forth.” [196]

Reliance on Testimonials

Through history the testimonial has been a major weapon in the arsenal of quackery. When someone just like you and me says, with urgent sincerity, “I was cured,” the persuasive power ranks high. “Our experience of more than thirty years in the enforcement of the Food and Drug Act,” a former Commissioner once wrote, “has demonstrated that testimonials may be obtained for practically any article labeled as a treatment for practically any disease.” [197] But testimonials given in the first flush of hope prove sadly premature. Old newspapers contain instances of testimonials appearing in the same issues with the obituaries of the testators [198]. Modern science holds that drug efficacy can not be determined by individual instances, nor even by a series of such cases. Much more sophisticated scientific methods are required. As a matter of law, the Supreme Court has so ruled [199].

All major cancer unorthodoxies have relied heavily on testimonials. The despairing cancer victim hears or reads such success stories as part of an enthusiastic promotional presentation, one that resounds with a sense of conviction and with every evidence of sincere concern for the victim’s welfare. He is offered hope, told things he himself may do to take his own treatment into his own hands. His new painless therapy, his new diet, his sense of support from new acquaintances, his more cheerful expectations, do indeed enhance the way he feels. The placebo effect is powerful, if temporary, medicine. An injection of confidence may indeed give the patient a better appetite, let him gain weight, enhance the way he looks, improve the way he feels. If he has been suffering from the side effects of effective treatment, perhaps nausea and the loss of hair, a switch to unorthodoxy may end these unpleasant consequences. Under these circumstances both the patient and the doctor who is administering the unorthodox treatment may pen testimonials. If, as a result of previous or concomitant orthodox therapy, the patient’s health may indeed be improved, the testimonial may nonetheless give all the credit to unorthodoxy.

In preparing for legal action against Hoxsey’s enterprise, the Food and Drug Administration investigated the writers of all the testimonials which Hoxsey had printed in behalf of his internal cancer treatment [32]. Hoxsey’s claimed cures, the FDA was able to demonstrate in court, fell into three classes. Either the patients had never had cancer — and some cancers are extremely difficult to diagnose—although treated for it at Hoxsey’s Dallas clinic. Or they had been cured of cancer by proper orthodox treatment before or while consulting Hoxsey. Or they had had cancer and either still were afflicted despite Hoxsey’s treatment or else had died. This evidence substantiated the scientific inadequacy of anecdotal evidence, no matter how sincere the testimony. The same findings resulted from the National Cancer Institute’s evaluation of Dr. Contreras’ cases [166].

Further, one of the odd paradoxes relating to quackery is that failure seldom diminishes patient loyalty. The duped seem unable to realize deception has occurred. The quack has done such a good job of exuding sincerity and concern that the victim believes the false explanation that the specious remedy or routine would have healed had treatment only begun a little sooner. And the misery of the decline toward death had seemed, under the unorthodox regimen, less arduous than would otherwise have been the case [200].

Laetrile promotion has relied heavily on testimonial evidence, given by patients before legislative committees, compiled by Laetrile advocates between the covers of books. The scientific weakness of such an approach, as exemplified by Dr. John Richardson’s Laetrile Case Histories, receives stark underlining in the analysis of this volume presented in Commissioner Kennedy’s report to the Oklahoma court [21].

Distortion of the Idea of “Freedom”

Before food and drug laws were enacted, quacks waved the banner of “freedom” to smear criticism aimed at them by physicians and pharmacists. When drug laws came, quacks formed protest groups with high-sounding names, like the National League for Medical Freedom and the American Medical Liberty League [201]. “Freedom” is certainly one of the most treasured words in the American lexicon. As has been seen above, the manipulation of this word by unorthodox health promoters has constituted their major symbolic campaign during the last quarter century. Thus Laetrile’s loud appeal for “freedom of choice” in cancer therapy is nothing new. Pushed with vigor, however, by those with ultraconservative convictions about the governmental role in society, in a climate of opinion worried about over-regulation, Laetrile’s “freedom” pitch has persuaded more numerous converts to its cause than any previous unorthodoxy has succeeded in winning. The prevailing mythology of cancer, Susan Sontag has written, conjoins with “a simplistic view of the world that can turn paranoid.” “Perhaps,” she adds, “right-wing groups are the main organized support for quack cures like Laetrile because they also share a paranoid view of the world.” [178]

Such a direction for “freedom” leads toward the license of those ancient days, when “the toadstool millionaires,” operating without restraint, fleeced and often killed their victims. That is a fate from which seven decades of constructive legislation, beginning with the Pure Food and Drugs Act of 1906, has somewhat rescued the nation. Complex, modern, industrial, urbanized society, with standards of medical judgment far more precise than in the nineteenth century, can not afford to let the nation’s health concerns be governed by a distorted definition of that great symbol “freedom” which would return piratical anarchy to the realm of health.

Large Sums of Money Are Involved

It was Oliver Wendell Holmes who termed nineteenth century nostrum vendors “toadstool millionaires.” [202] They might not make a million, but money was their goal.

Laetrile is big business. Investigations by California authorities revealed what huge sums some of the Laetrile leaders had been putting in the bank [36,92]. Robert Bradford, according to an agent of the Food and Drug Bureau cited in the New York Times, had been taking in an estimated $150,000 to $200,000 a month in Laetrile sales. In slightly over two years, Dr. John Richardson had deposited some $2,800,000 in a single checking account [203].  The quantity of Laetrile that Judge Bohanon determined to be a six-month supply would have cost the user about $2,250 [204]. Estimating Laetrile users at 75,000, the mathematics mounts to millions.

Laetrile Within the Perspective of the Past

Fear of cancer, suspicion of government, a primitivistic retreat from complex civilization to “natural” ways, skillful organization, adept lobbying, and a shrewdness at borrowing time-tested techniques from quackery’s well-stocked past, such factors undergird the Laetrile movement. In the face of scientific evidence and informed advice, frightened people place vain hope in it.

What guide might the past provide as to Laetrile’s future? The other major cancer unorthodoxies of the twentieth century, Glyoxilide, Hoxsey’s botanicals, Krebiozen, have virtually disappeared within the United States, although they linger outside the nation’s borders, available to the desperate traveler. What brought Koch, Hoxsey, the Durovics and Ivy down from their peaks of prominence was a combination of vigorous regulatory action, sustained critique, and faddist fascination with still newer unorthodoxies.

Dr. William Koch underwent two very long trials in 1943 and 1946, charged with promoting misbranded and ineffective drugs [179]. The first ended with a hung jury, the second when a juror became ill. Koch gave up business and retired to Brazil. Against Harry Hoxsey, the Food and Drug Administration initiated numerous actions. Injunction proceedings begun in 1950 before a judge disposed in Hoxsey’s favor were finally won only after the case had twice reached the Supreme Court [32]. In 1957 an injunction closed Hoxsey’s satellite operation in Pennsylvania. Krebiozen came to a halt in interstate commerce when its sponsors withdrew a plan for the investigational use of the drug which they had submitted to the FDA [179,180]. This ban held, even though the government failed to convict the Durovics and Dr. Ivy in a nine-month criminal case decided in 1966 by a Chicago jury. Later, an investigation of jury tampering led to the conviction and jailing of one of the jurors. Thus regulatory action almost completely removed the unorthodox cancer treatments from interstate commerce, permitting their sponsors almost no elbow room for continuing promotion.

Not that unorthodoxy did not fight back. Hoxsey, for example, strove strenuously for political support, gaining favorable recognition from several United States Senators [32]. And he sought to establish and ally with organized support for his cancer clinic. In 1959 Hoxsey spoke at a naturopathic convention in Chicago, which also hearkened to the National Health Federation’s president, Fred J. Hart. At NHF membership rallies, Hart solicited funds to help Hoxsey carry on his contest with the FDA, and Hoxsey in turn gave royalties from his autobiography to help finance the NHF. Despite his efforts, Hoxsey did not develop an institutional base broad and strong enough to permit his unorthodox clinics to survive. Nor did the promoters of Glyoxilide or Krebiozen succeed with similar attempts.

Prior to Laetrile’s series of victories in the legislatures of seventeen states, the major political triumph achieved by the forces of unorthodoxy came in the national Congress with the enactment of the Vitamin Amendments of 1976 [102]. Led by the National Health Federation, promoters of nutritional products skillfully mobilized their followers into a powerful lobbying force. By securing the new law, the health food industry not only succeeded in thwarting the Food and Drug Administration’s attempt to tighten the stringency of regulation in this field, they won from Congress a curtailment of FDA’s authority below that which had been given the agency by Congress in the 1938 law.

This episode reveals that health unorthodoxy has the capability of mounting sufficient political power to win important victories. The obviously growing strength of nutritional unorthodoxy may well have played a role in Laetrile’s transmogrification into a “vitamin.” The National Health Federation has accepted and promoted Laetrile’s vitamin status. In 1977 the NHF made legalizing Laetrile its “No. 1 priority.” [205] It remains to be seen whether the millions of Americans who flirt with nutritional unorthodoxy will welcome an anti-cancer Vitamin B-17. Not all citizens who believe in extra vitamins as a sure road to extra pep may so readily accept vitamins in the treatment of cancer.

No previous cancer unorthodoxy ever approximated the institutional base which Laetrile achieved, resting on the International Association of Cancer Victims and Friends; the Cancer Control Society, formed by dissident members of the IACVF [206)] and particularly the Committee for Freedom of Choice in Cancer Therapy, whose motivation is as much political as therapeutic. The big question is whether this political base is firm enough to establish Laetrile in an institutionalized sense in our society, whatever else may happen. Indeed, it may be surmised that Laetrile’s boom has peaked and now is in decline. Reports about toxicity doubtless dampened public ardor. Laetrile bills before state legislatures did not fare so well during 1978 as in 1977 [115]. Future consideration and reconsideration may find state assemblymen looking more probingly past the freedom of choice argument at the scientific facts, following the example of Massachusetts [207]. Inquiries about Laetrile to the Food and Drug Administration have fallen off [208]. Media coverage has declined, despite such newsworthy events as the announcement of the National Cancer Institute’s proposed trials and the Tenth Circuit’s decision in the Rutherford case. Even should that decision stand, the legal use of Laetrile would be drastically curtailed from the level defined in Judge Bohanon’s decision, with oral dosage forms eliminated. The Supreme Court, in adjudicating between the Tenth and Seventh Circuits, may confirm the FDA’s authority to ban Laetrile completely from interstate commerce [209].

Even if Laetrile should follow Krebiozen and the others off center stage, this does not mean unorthodoxy’s demise. As long as cancers remain a grave problem and wear a fearful image, quackery threatens. Much disenchantment exists with scientific medicine. Cancer patients have felt rejected by some orthodox physicians who have seemed to lose interest in their cases when nothing more medically could be done. The unorthodox offer considerable psychological support. The quixotic state of public feelings about health conduces to strange enthusiasms and open sesame for charlatans. Despite such a hopeful development as the hospice movement [210], offering skilled and considerate support to the dying and their families, a gloomy prognosis is hard to avoid. The broader and more diffuse approach of metabolic therapy, in which Laetrile is now enveloped, may prove a more difficult regulatory problem to confront than combatting a single unproven entity.

A shrewd and seasoned observer, looking ahead, recently took a somber tone:

During the past decade, a change has taken place in public attitudes toward medical science. There has been an increasing acceptance of misinformation, as shown for example by the success of the laetrile and ‘health food’ movements. This acceptance has been aided by the media, especially television, which publicize sensational and erroneous statements. These are seldom rebutted. There is distrust of the ‘establishment,’ and a feeling that doctors are exploiting patients. I believe this trend is so well established, and so little challenged, that its impact will produce a decline of scientific medicine, and its replacement by quackery [211].

This article was originally presented at the symposium on politics, science, and cancer held at the 1979 annual meeting of the American Association for the Advancement of Science in Houston, Texas. Dr. Young was professor of history at Emory University.

References and Notes
  1. Report by Jack Forbragd and Kenneth B. Ewing of interview with Ernst T. Krebs, Sr., Dec. 11, 1962, San Francisco District File CF: 10 183, Krebs Laboratories, vol. 1, Food and Drug Administration Records (San Francisco).
  2. G.D. Kittler, Control for Cancer (Paperback Library, New York, 1963).
  3. Bull. Nev. State Bd. of Health, Jan. 1920, clipping, FDA report, Dec. 9, 1957, San Francisco District File, CF: 10 183, John Beard Memorial Foundation, vol. 4, FDA Recorqs (San Francisco).
  4. Nevada Appeal, Carson City, Nov. 14, 1957, clipping, ibid.
  5. Bureau of Chemistry, Department of Agriculture, Notices of Judgment 11193 (1923) and 12047 (1924).
  6. FDA D.N.J. 17066 (1930).
  7. S.B. Gilmore and J.B. Corson to San Francisco District, Apr. 1, 1958, San Francisco District File, CF: 10 183, John Beard Memorial Foundation, vol. 6, FDA Records (San Francisco).
  8. San Francisco District Summary and Recommendation for Prosecution, Oct. 20, 1960, ibid.
  9. E. Krebs, Jr., E. Krebs, Sr., and H. H. Beard, The Unitarian or Trophoblastic Thesis of Cancer (McNaughton Foundation, Montreal, 1950).
  10. Walter Van Winkle, Jr., to Ernst T. Krebs, May 7, 1945, [re NDA 5703), AF 26-731, vol. 1, FDA Records (Rockville).
  11. Edward V. O’Gara to San Francisco District, July 14, 1945, ibid.
  12. D. Rorvik, New West, Apr. 25, 1977, p. 51.
  13. Affidavit of Ernst T. Krebs, Sr., Apr. 28, 1965, FDA File on Labeling and Composition of Laetrile, FDA Records (Rockville).
  14. Statement of Eric E. Conn on Patent Specifications 13228, vol. M, item 424, FDA Administrative Record, Laetrile, Docket No. 77N-0048.
  15. Russell C. White and Donald L. Taylor to San Francisco District, Dec. 15, 1952, FDA File on Labeling and Composition of Laetrile, FDA Records (Rockville).
  16. Statement of Carol M. Hehmeyer, Banning of the Drug Laetrile from Interstate Commerce by FDA (95th Cong., 1st sess, Hearing before the Subcommittee on Health and Scientific Research of the Committee on Human Resources, U.S. Senate, July 12, 1977 [hereafter, Hearing before Kennedy subcommittee]), pp. 239-40.
  17. Ralph Weilerstein to San Francisco District, series of 1945 memoranda, AF 26-731, vol. 1, FDA Records (Rockville).
  18. Eugene Eno to San Francisco District, Sep. 13, 1950, San Francisco District File, CF: 10 183, John Beard Memorial Foundation, vol. 1, FDA Records (San Francisco.
  19. Science, 103, 25, (1946).
  20. E.T. Krebs, M.D., Laetrile (San Francisco, n.d.), in Laetrile file of exhibits, AF 26-731, Accession 88-73-6, box 50, FDA Records, Record Group 88, Washington National Records Center (Suitland, MD) (hereafter, WNRC).
  21. FDA, Laetrile, Commissioner’s Decision on Status, Fed.Reg. 42, 39773 (1977).
  22. Richard M. Stalvey to San Francisco District, Sep. 10, 1953, San Francisco District File, CF: 10 183, John Beard Memorial Foundation, vol. 1, FDA Records (San Francisco).
  23. Krebs, Jr., to Ian McDonald, Dec. 8, 1952, ibid.
  24. Memorandum of interview between Ralph Weilerstein and L. Henry Garland, Dec. 9, 1952, ibid.
  25. Cancer Commission of the California Medical Association, Calif. Med. 78, 320 (1953).
  26. R. T. Dorr and J. Paxinos, Ann. Internal Med. 89, 389 (1978).
  27. Memorandum of interview between Ralph Weilerstein and E.W. DeLong, Aug. 24, 1953, San Francisco District File, CF: 10 183, John Beard Memorial Foundation, vol. 1, FDA Records (San Francisco).
  28. San Francisco News, Mar. 24, 1953.
  29. Krebs, Jr., to Richard E. Sponholz, Mar. 28, 1961, in Laetrile file of exhibits, AF 26-731, Acc. 88-73-6, box 50, FDA Records, RG 88, WNRC.
  30. Patent Specification 788,855 (1958).
  31. San Francisco District Report, Dec. 9, 1957, San Francisco District File, CF: 10 183, John Beard Memorial Foundation, vol. 4, FDA Records (San Francisco).
  32. J. H. Young, The Medical Messiahs (Princeton University Press, Princeton, 1967), pp. 360-89.
  33. FDA D.D.N.J. 6543 (1960).
  34. M. L. Yakowitz to J. R. Cain, July 6, 1953, AF 26-731, vol. 1. FDA Records (Rockville).
  35. Deposition of Andrew R. L. McNaughton, June 2, 1964, The Canadian Laetrile (Anti-Cancer Drug) Case (Montreal, 1964), in Laetrile file of exhibits, AF 26-731, Acc. 88-73-6, box 50, FDA Records, RG 88, WNRC.
  36. New York Times, June 26, 1977.
  37. Newsweek June 27, 1977, pp. 48-56.
  38. The Financial Post, Toronto, Mar. 10, 1973.
  39. SEC v. Biozymes International Ltd., et al. U.S. District Court, Northern District of California, Civil Action No. C72-2217-SW, Apr. 27, 1973.
  40. Memorandum of interview at HEW by W. B. Rankin, Oct. 18, 1961, San Francisco District File, CF: 10 183, John Beard Memorial Foundation, vol. 4, FDA Records (San Francisco) .
  41. Memorandum of interview at FDA by Ralph G. Smith, Oct. 18, 1961, ibid.
  42. FDA D.D.N.J. 7062 (1962).
  43. Many documents dealing with the circumstances of Krebs’ probation are filed in San Francisco District File l- 412P, vols. 3 and 4, FDA Records (San Francisco).
  44. Krebs argued that his violation of the law had been technical, cued by his haste to beat the Russians in pangamic acid research, which, because oxygen utilization was involved, might help the United States triumph over the Soviet Union in the space race. Krebs to Robert M. Ensign, Sep. 18, 1963, ibid., vol. 4.
  45. Maurice P. Kerr to Chief Inspector, Dec. 9, 1963, San Francisco District File, CF: 10 183, Krebs Laboratories, vol. 1, FDA Records (San Francisco).
  46. Krebs to John A. Sprague, May 1, 1963, San Francisco District File l-412P, vol. 3, FDA Records (San Francisco).
  47. Gregory S. Stout to California State Board of Health, June 27, 1963, ibid., vol. 4.
  48. G. D. Kittler, “The Struggle,” American Weekly, Mar. 3 and 10, 1963.
  49. James Nakada to District Directors, May 1, 1963, San Francisco District File l-412P, vol. 3, FDA Records, (San Francisco).
  50. Interview with Cecile Pollack Hoffman by William P. Leckwold, Feb. 12, 1965, San Francisco District File, CF: 10 183, Krebs Laboratories, vol. 1, FDA Records (San Francisco).
  51. McKay McKinnon to Wallace Janssen, June 12, 1964, San Francisco District File l-412P, vol. 4, FDA Records, (San Francisco).
  52. Arthur Dickerman to William Goodrich, Jan. 25, 1963, ibid., vol. 3.
  53. Memorandum of interview with McNaughton by G. S. Goldhammer, Feb. 1, 1963, ibid.
  54. California Cancer Advisory Council, Report on the Treatment of Cancer with Beta-Cyanogenetic Gluosides (“Laetriles”) (1963), exhibit to affidavit of w. Sherwood Lawrence, Vol. F, item 183, FDA Administrative Record, Laetrile, Docket No. 77N-0048.
  55. San Francisco Examiner, June 6, 1963.
  56. FDA Report on Enforcement and Compliance, Aug. 1964, pp. 8-9.
  57. William C. Hill to K. F. Ernst, May 25, 1967, Krebs Injunction 508 File, vol. 2, FDA Records (San Francisco).
  58. San Francisco District Report, Sep. 22, 1969, San Francisco District File, CF: 10 183, Krebs Laboratories, vol. for 1969-71, FDA Records (San Francisco).
  59. San Francisco Chronicle, Jan. 27, 1970.
  60. Testimony of Ernst Krebs, Jr., vol. 0-1, FDA Administrative Record, Laetrile, Docket No. 77N-0048.
  61. Numerous documents during 19~9 and 1970 in San Francisco District File, CF: 10 183, Krebs Laboratories, FDA Records (San Francisco).
  62. FDA news release about NDA 6734, Sep. 1, 1971.
  63. HEW Secretary Elliot Richardson to Congressman Lawrence H. Fountain, Aug. 26, 1971, AF 26-731, vol. 12, FDA Records (Rockville).
  64. FDA letters to McNaughton Foundation, Apr. 20 and 28, 1970, ibid.
  65. Don C. Matchan in Alameda (CA) Times-Star, July 14, 1970.
  66. Dean Burk to Secretary Richardson, Mar. 23, 1971, AF 26- 731, vol. 12, FDA Records (Rockville).
  67. Dean Burk, in Who’s Who in America, 40th Edition, 1978-1979 (Marquis Who’s Who, Chicago, 1978), vol. 1, p. 470.
  68. C. P. Hoffman and E. N. Blaauw, If It Is True Cancer Can Be Controlled Why Isn’t It?, 1964 pamphlet, in San Francisco District File, CF: 10 183, Krebs Laboratories, vol. 1, FDA Records (San Francisco).
  69. James A. Crandall to Los Angeles District, July 12, 1965, ibid., vol. for 1965-68.
  70. John w. Holten to Los Angeles District, Aug. 23, 1965, ibid.
  71. Memorandum of telephone conversation between Gordon R.Wood and T. M. Rice, June 23, 1969, ibid., vol. for 1969-71.
  72. S. Barrett and G. Knight, eds., The Health Robbers (George F. Stickley, Philadelphia, 1976), p. 9.
  73. Ibid., pp. 189-201.
  74. Young, The Medical Messiahs, pp. 383-84, 400-401.
  75. Clippings from the National Health Federation Bulletin, Prevention, and National Enquirer, AF 26-731, vol. 11, FDA Records (Rockville).
  76. Walter Ermer to M. J. Ryan, Oct. 16, 1970, ibid.
  77. Numerous letters, ibid., vols. 11 and 12.
  78. NHF Bulletin, Sep. 1970, clipping, ibid., vol. 11.
  79. Fountain to Richardson, Mar. 16, 1971, ibid., vol. 12.
  80. FDA news release, Sep. 1, 1971, with attached Report of the Ad Hoc Committee of Oncology Consultants.
  81. H. R. 12092, introduced by John G. Schmitz, Dec. 7, 1971, Cong. Rec., 92nd Cong., 1st ses., p. 45120.
  82. People v. Ernst T. Krebs, Jr., Malvina Cassese, and Byron Krebs, San Francisco Municipal Court, Dept. 6, Docket No. G-14656 et al.
  83. Testimony of Carol M. Hehmeyer, Hearing before Kennedy subcommittee, pp. 226, 237.
  84. Resume of Laetrile cases, State of California, Health and Welfare Agency, Department of Health Services, various dates.
  85. People v. Mary Whelchel, San Diego Superior Court, Dept. 18, Docket CR 23718, Jan. 14 and 17, 1972; Feb. 13, 1974.
  86. Her Majesty the Queen v. Andrew R. L. McNaughton, Province of Quebec, District of Montreal, Court of Sessions of the Peace, No. 499-72, Judgment, Apr. 22, 1974.
  87. McNaughton pleaded guilty to a charge of conspiracy to facilitate the transportation of smuggled Laetrile. United States v. Andrew R. L. McNaughton, U.S. District Court, Southern District of California, No. 76-0448- Criminal, Judgment, Dec. 12, 1977.
  88. Newsday, Apr. 23, 1977.
  89. Unsigned memorandum for file, Mar. 10, 1972, AF 26-731, vol. 19, FDA Records (Rockville).
  90. J. A. Richardson and P. Griffin, Laetrile Case Histories (Bantam Books, New York, 1977), pp. 13-17, 71-73.
  91. California Board of Medical Quality Action Report, 10/1/ 76-12/30/76, John A. Richardson, M.D., Albany, Nov. 29, 1976.
  92. Testimony of Herbert B. Hoffman, Joseph Consentino, and Louis Castro, Hearing before Kennedy subcommittee, pp. 189-98.
  93. Robert W. Bradford to Dear Friend, The Committee for Freedom of Choice in Cancer Therapy brochure, [early 1973), in AF 26-731, vol. 22, FDA Records (Rockville).
  94. San Francisco Chronicle, Aug. 11, 1976.
  95. Statement of Robert W. Bradford, Hearing before Kennedy subcommittee, pp. 280-311.
  96. Affidavit of O.E. Kelly, vol. K, item 389, FDA Administrative Record, Laetrile, Docket No. 77N-0048.
  97. U.S. v. Bradford and U.S. v. Richardson, U.S. District Court, Southern District, California, 76-0448 Criminal, Judgment and Probation filed Dec. 12, 1977; U.S. v. Richardson, Bowman, Salaman, and Bradford, U.S. Court of Appeals, 9th Circuit, Nos. 77-2203, 77-204, 22-2262, and 77-2288, opinion filed Oct. 20, 1978.
  98. Ernst Krehs, Sr., to FDA, Apr. 18, 1963, San Francisco District File, CF: 10 183, John Beard Memorial Foundation, vol. 6, FDA Records (San Francisco).
  99. E.T. Krebs, Jr., Jnl. Applied Nutrition 22, 75 (1970).
  100. Frank D. Corum memorandum, Mar. 24, 1966, San Francisco District File 131-699B, FDA Records (San Francisco).
  101. National Analysts, Inc., A Study of Health Practices and Opinions (National Technical Information Service, Springfield, VA, 1972).
  102. H. Young, “The Agile Role of Food,” in Nutrition and Drug Interrelations, J.N. Hathcock and J. Coon, eds. (Academic Press, New York, 1978), pp. 1-18.
  103. M. Greenberg, West. J. Med., 122, 345 (1975).
  104. National Nutrition Consortium, Inc., Statement on Laetrile-Vitamin B 7, Dec. 21, 1976.
  105. H. Jukes, Nutrition Today 12, 12 (Sep.-Oct. 1977).
  106. Testimony of Thomas H. Jukes, vol. 0-1, FDA Administrative Record, Laetrile, Docket No. 77N-0048.
  107. Testimony of John A. Richardson, Robert Bradford, Ernst T. Krebs, Jr., and Bruce Halstead, Hearing before Kennedy subcommittee, pp. 272-74.
  108. Mercury, San Jose, Sep. 7, 1972.
  109. Merlyn Wurscher to San Francisco District, Oct. 19, 1972, San Francisco District File, CF: 10 183, Krebs Laboratories, vol. for 1972, FDA Records (San Francisco)
  110. FDA N.J.s 29 (Oct. 1975) and 31 (Nov. 1975).
  111. FDA N.J.s 32 and Inj. 660 (Apr. 1978).
  112. Sacramento Bee, June 24, 1978. On the California cancer quackery law, first enacted in 1959 and made permanent in 1969, see L. F. Saylor, Calif. Med. 112, 94 (1970).
  113. R. 12573, introduced by Steven D. Symms, Mar. 16, 1976, 94th Cong. 2nd ses., p. H2002.
  114. Symms interview, U.S.News and World Report, June 13, 1977, pp. 51-52.
  115. L. Nightingale and F. D. Arnold, Legal Aspects of Medicine 6, 31 (1978).
  116. Affidavit of Peter H. Wiernik, vol. H. item 200, FDA Administrative Record, Laetrile, Docket No. 77N-0048.
  117. New York Times, May 2, Aug. 16 and 25, 1977; June 7, 1978.
  118. Atlanta Journal and Constitution, Nov. 20, 1977.
  119. Based on author’s observations in one state and conversations with several observers in other states.
  120. Arizona Republic, Phoenix, June 20, 1977.
  121. Chicago Tribune, Aug. 27, 1978.
  122. Chicago Sun-Times, Mar. 5, 1978.
  123. Rutherford v. United States, 399 F. Supp. 1208 (W.D. Okla., 1975).
  124. Medical World News, June 28, 1976, pp. 17-20. Medical World News quotes Rutherford as saying that in Mexico surgeons “cauterized” the growth, and also quotes a Chicago pathologist as stating: “It is exceptionally rare for this type of tumor to metastasize. Local excision of the polyp virtually always cures the patient.”
  125. Rutherford v. United States, 542 F. 2d 1137 (10th Cir. 1976).
  126. FDA Administrative Record, Laetrile, Docket No. 77N- 0048.
  127. Rutherford v. United States, 438 F. Supp. 1287 (W. D., Okla. 1977).
  128. Rutherford v. United States, 10th Circuit opinion, text cited in United States v. Rutherford, Petition for a Writ of Certiorari, filed with the Supreme Court, Oct. 10, 1978.
  129. Statement of Joseph F. Ross, with exhibits, Hearing before Kennedy subcommittee, pp. 62-188.
  130. Medical World News, Jan. 9, 1978, pp. 16, 21.
  131. Charlotte (NC) Observer, Sep. 12, 1976.
  132. P. Lehmann, FDA Consumer 11, 10 (Oct. 1977).
  133. F. P. Smith et al., JAMA 238, 1361 (1977).
  134. FDA Talk Paper, July 12, 1978.
  135. United States v. Mosinee Corp., Inj. 789, FDA news release, May 16, 1977.
  136. FDA news release, Aug. 18, 1978.
  137. On June 18, 1979, a unanimous Supreme Court reversed the Tenth Circuit, holding that the safety and effectiveness standards in the law do apply to terminal patients. The high court did not address some issues which the district court had raised but the circuit court had not. United States v. Rutherford, No. 78-605.
  138. People v. Privitera, Court of Appeals, Fourth Appellate District, Division One, 4 Cr. No. 8323 (1977).
  139. The Supreme Court reversed the appellate course in this case. People v. Privitera, Supreme Court of the State of California, No. Crim. 20340 (1979), Sup., 153 Cal. Rptr. 431.
  140. Atlanta Constitution, Feb. 1-23, 1978, passim.
  141. FDA news release, Mar. 26, 1978.
  142. FDA Drug Bulletin, Nov.-Dec. 1977.
  143. United States v. Articles of Drug . . . Amigdalina Cyto Pharma De Mexico, S.A., Docket No. K77-1283, U.S. District Court for Maryland, filed Aug. 4, 1977, cited in Brief Amicus Curiae of the American Cancer Society, by Grace Powers Monaco, Mar. 8, 1979, in United States v. Rutherford, No. 78-605, in the Supreme Court of the United States, October Term, 1978.
  144. Medical World News, Sep. 5, 1977, p. 22.
  145. Interview with Eu9ene Pfeifer, Oct. 25, 1978.
  146. On Mar. 31, 1974.
  147. Atlanta Constitution, Aug. 21, 1975; Feb. 10, Apr. 1, May 13, 1976; Apr. 19, Dec. 8, 1977; Feb. 9, 1978.
  148. American Media, Westlake Village, CA,1974.
  149. ’76 Press, Seal Beach, CA, 1976.
  150. Choice Publications, Los Altos, CA, 1977.
  151. Cited in statement of Robert W. Bradford, Hearing before Kennedy subcommittee, p. 285.
  152. Ibid., pp. 272, 310.
  153. Los Angeles Times, Sep. 8, 1977.
  154. H.W. Manner, The Remission of Tumors with Laetrile Therapy (text of presentation to annual meeting, NHF, 1977) .
  155. Robert S.K. Young, Review of “The Remission of Tumors with Laetrile Therapy” (text of critique, 1977).
  156. M.B. Lipsett and J.C. Fletcher, N. Engl. J.  Med. 297, 1183 ( 1977) .
  157. J. Ingelfinger, N. Engl. J.  Med.. 296, 1167 (1977). After toxicity evidence concerning Laetrile had begun to mount, Ingelfinger told a reporter that he might not write the kind of editorial again that he had earlier written. Chicago Sun-Times, Mar. 8, 1978.
  158. New York Times, Feb. 11, 1977.
  159. G. Moertel, N. Engl. J.  Med.. 298, 218 (1978).
  160. Statement of Donald Kennedy, Hearing before Kennedy subcommittee, pp. 26-38.
  161. Hearing before Kennedy subcommittee, pp. 248-50, 295.
  162. Statement by Guy R. Newell, M.D., Deputy Director, National Cancer Institute, on Retrospective Evaluation of Laetrile Anticancer Activity in Man, Jan. 26, 1978.
  163. Neil M. Ellison, Report on a Doctors’ Workshop on Metabolic Therapy, Amygdalin, and Cancer–Newark, New Jersey, Feb. 4-5, 1978.
  164. M. Ellison, D. P. Byar and G. R. Newell, N. Engl. J. Med. 299, 549 (1978).
  165. Atlanta Constitution, Sep. 28, 1978. In December 1978 the NCI ‘ormally applied to the FDA for an IND to permit the clinical trials.
  166. Robert C. Wetherell, Jr., Status of Laetrile, Feb. 6, 1975, AF 26-731, vol. 31, FDA Records (Rockville).
  167. Newsday, Apr. 25, 1977.
  168. Dean Burk to Edward Kennedy, Nov. 16, 1977, and exhibits, Hearing before Kennedy subcommittee, pp. 384- 419.
  169. Testimony of Robert W. Bradford, vol. 0-2, FDA Administrative Record, Laetrile, Docket No. 77N-0048.
  170. D. Leff, Medical World News, May 1, 1978, pp. 43-51.
  171. Editorial, The Choice (Oct. 1978).
  172. J H. Young Cimarron Rev., No. 8, 31 (1969).
  173. New York Times, July 1, 1906.
  174. Pennsylvania Gaazette, Philadelphia, Oct. 17 and 31, 1745.
  175. Young, The Medical Messiahs, pp. 48-49.
  176. American Cancer Society, 1977 Cancer Fact & Figures (New York, 1976).
  177. Donald Kennedy, text of speech on “Cancer Politics,” Nov. 3, 1977.
  178. Susan Sontag, New York Review, Jan. 26, pp. 10-16; Feb. 9, pp. 27-29; and Feb. 23, 1978, pp. 29-33. These articles have been combined into a book, Illness as Metaphor (Farrar, Straus and Giroux, New York, 1978).
  179. W.F. Janssen, Analytical Chem., 50, 197A (1978).
  180. Young, The Medical Messiahs, pp. 401-402, 420.
  181. This pattern the author first explored in Newsday, May 1, 1978.
  182. American Medical Association, Nostrums and Quackery, 2nd ed. (AMA Press, Chicago, 1912), p. 56.
  183. Testimony of David T. Carr, vol. 0-1, FDA Administa¬tive Record, Laetrile, Docket No. 77N-0048.
  184. Edmund Griffin, World Without Cancer, transcript of sound track of documentary film, supplied by Food and Drug Administration.
  185. American Medical Association, Nostrums and Quackery, p. 39.
  186. Edmund Griffin, in Richardson, Laetrile Case Histories, p. 64.
  187. H. Young, The Toadstool Millionaires (Princeton University Press, Princeton, 1961), pp. 165-89.
  188. San Francisco Chronicle, Aug. 11, 1976.
  189. Young, Toadstool Millionaires, pp. 75-89.
  190. Ibid., pp. 220-21.
  191. Affidavit of W. Sherwood Lawrence, vol. F, item 183, FDA Administrative Record, Laetrile, Docket No. 77N- 0048.
  192. California v. Krebs and Cassese, San Francisco Municipal Court, No. G 14673 and G 14670, 1977.
  193. Young, The Medical Messiahs, pp. 239-57.
  194. Richardson, Laetrile Case Histories, pp. 97-102.
  195. Ibid., pp. xv, 4, 55-65.
  196. Statement of the American Medical Association, Hearing before Kennedy subcommittee, pp. 327-32.
  197. G. Campbell to Leland M. Ford, Mar. 4, 1941, Inter-state Office Seizure No. 16224-E File, FDA Records, RG 88, National Archives Bz an ch , WNRC.
  198. Arthur J. Cramp, Nostrums and Quackery and Pseudo-Medicine (AMA, Chicago, 1936), pp. 198-208.
  199. Weinburger v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609.
  200. An apparent example of this circumstance is revealed in a letter headed “Cancer and Oncologists versus Laetrile,” July 25, 1975, AF 26-731, vol. 30, FDA Records (Rockville).
  201. Cramp, Nostrums and Quackery and Pseudo-Medicine, pp. 218-21.
  202. W. Holmes, Medical Essays (Houghton Mifflin, Boston, 1891), p. 186.
  203. Richardson comments on these circumstances in Laetrile Case Histories, pp. 76-77.
  204. Order and Affidavit and Extension, filed May 10, 1977, by Judge Luther Bohanon, Rutherford v. United States. I have multiplied the quantity of tablets and injectable liquid authorized by the then current cost, one dollar a tablet and ten dollars for a 3g. ampule.
  205. Form letter from National Health Federation, [Dec. 1977), promoting “Fund to Stop Government Ban on Laetrile,” Decimal File 539,ILX, vol. 33, FDA Records (Rockville).
  206. A most useful sociological study of persons who attended a “Cancer Control Symposium” sponsored by a Michigan chapter of the Cancer Control Society appears in G. E. Markle, J.C. Petersen, and M.O. Wagenfeld, Soc. Sci. & Med., 12, 31 (1978).
  207. Boston Herald-American, May 19, 1978.
  208. Interview with Stuart L. Nightingale, Oct. 24, 1978.
  209. It has been suggested, however, that the right of privacy doctrine established by the Supreme Court in Griswold v. Connecticut, 381 u. S. 479 (1965), might provide grounds for a challenge of federal law restrictions on the consumer’s free choice of drugs. D. G. Rushing, UCLA Law Rev., 25, 577 (1978).
  210. Death Education devoted its double Spring/Summer 1978 issue to the Hospice movement.
  211. Thomas H. Jukes to author, Aug. 11, 1978.