The Medical Messiahs:
A Social History of Health Quackery
in Twentieth-Century America

Afterword

James Harvey Young, PhD

On a Saturday afternoon in June 1990, on a Chicago El train rumbling from Wrigley Field back to the Loop, a friendly, well-dressed woman handed another passenger a single sheet of paper crowded with suggested uses for aloe vera, plus three telephone numbers from which that botanical in its various processed forms might be ordered. As juice, gel, lotion, facial, shampoo, and activator, aloe vera, according to this simple document, could come to grips with over a hundred health problems, external and internal, from scalp sores to athlete's foot, from migraine headaches to intestinal flu.

From the earliest times, aloe has played a multiple role in medication, favored by Dioscorides and Galen [1]. The aloe vera variety was introduced at least as early as the sixteenth century to the Dutch West Indies, where it was grown on the island of Curacao. Official from the first edition of the United States Pharmacopeia, aloe was prescribed by physicians and was included in such popular patent medicines as Brandreth's Vegetable Universal Pills and Kickapoo Indian Sagwa [2]. Aloe may still be found in the 1990 edition of the United States Pharmacopeia Drug Information volume on Advice to the Patient, as one of two botanical laxative ingredients in an over-the-counter medicine called Nature's Remedy [3].

The vast variety of therapeutic values once ascribed to aloe in regular medicine, and still retained to a considerable extent in folk belief, has, under scientific scrutiny, shrunk to a bare minimum [4]. Internally, the dried latex (juice) of aloe has cathartic power. Externally, the fresh gel or mucilage (often confusingly called juice) may be of use in treating minor burns and bruises. Commercial fabrications, however, have not necessarily shown such dermatological benefits and, indeed, have been toxic to cultured cells on which tests have been made.

Scientific medicine would certainly give no credence to the implied claims on the Chicago handout that aloe vera would prove useful in treating arthritis, asthma, baldness, cancer of the skin, coronary thrombosis, diabetes, female problems, gallstones, glaucoma, psoriasis, and stomach ulcers. Passengers suffering from such severe ailments who yield to the El train soft-sell promotion and purchase aloe vera for their ills contribute to the nation's multibillion-dollar annual quackery toll.

Just how many billions quackery's bill amounts to can only be estimated. A quarter-century ago, despite the most intensive regulatory and educational campaign against health fraud in the nation's history, the figure approximated, according to an informed public official, "two or more billion" a year, and it was growing [5]. Hardly anyone, however, anticipated the rapidity of its expansion.

By 1984 a subcommittee of the Select Committee on Aging of the House of Representatives, chaired by Claude Pepper of Florida, concluded after a four-year staff study that quackery afflicting the elderly alone added up to "A $10 Billion Scandal." [6] For the population as a whole, testified Victor Herbert at a hearing held by the subcommittee, the annual sum was two-and-a-half times as great [7]. Early in 1990, other expert observers put the figure at $28 billion [8].

Dr. Herbert, a professor of medicine at the State University of New York Downstate Medical Center, a lawyer, and one of the nation's most dogged foes of quackery, had in his testimony broken down his $25 to $26 billion yearly health fraud total into its component parts [9]. Six billion dollars, he told the House subcommittee, went for "food supplement, pill, powder and potion quackery." About $3 billion each were expended for arthritis, cancer, and heart disease quackery. Several complex categories each accounted for $2 billion: (1) "quack diagnostic tests, such as specious computer questionnaires, hair analyses, cytotoxicity testing, kinesiology, iridology"; (2) "naturopathic, herbalist, occult healing and other cult quackery"; and (3) "clinical ecology, hypoglycemia, nontoxic, metabolic, and natural quackery." In the $1 billion range fell three more quack genres: (1) false treatment for Alzheimer's disease and mental illnesses; (2) "quackery-promoting literature"; and (3) diploma mills providing false credentials to those offering dubious regimens of treatment. Thus the terrain of quackery had become broader and more costly than ever and, Dr. Herbert charged, more adept at its ability to "maim and kill."

How to explain the two-decade boom in pseudomedicine? Why did the guarded optimism among fighters opposed to health fraud in the late 1960s dissipate, to be replaced by gloom in the mid-eighties? In part, currents in the broad environment were responsible. On a narrower front, the cohesion and vigor of antiquackery efforts diminished, while the energy, ingenuity, and collaborative efforts of those promoting unproven therapies expanded considerably.

As the century wore on, philosophical currents presented and the impact of events revealed human nature in a less optimistic way than when the century had begun [10]. Error was more firmly rooted than it once had seemed to be, less easily eradicated by that universal panacea, education. Progress, once deemed well-nigh inevitable, had slowed, if not reversed itself. Lookers toward the future "shifted their gaze from utopias to dystopias." [11] Many of the disillusioned, especially among the young, came to distrust reason and to flirt with wild varieties of unreason. Astrology soared, not as a pastime but for real: publishing houses minted millions from it; almost every campus had a peripheral course in reading the stars; in time its influence invaded the whitest houses in the land. Tarot cards, numerology, and palmistry flourished. Paperbacks on these themes were among the hottest-selling items in university bookstores from Cambridge to Berkeley [12]. A popular magazine announced: "Witches are surfacing everywhere." [13]

Vietnam and Watergate left a legacy of disillusionment with big government, including its regulatory function. Environmental alarms, especially with regard to nuclear energy, increased skepticism of big science, including government's scientific role [14]. An ironic expression of this perspective came in a 1979 commencement address by Kurt Vonnegut. "We would be a lot safer," the novelist told the graduates, "if the Government would take its money out of science and put it into astrology and reading Palms." [15]

The distrust harbored by citizens went beyond government. "There is virtually no one," columnist Erma Bombeck asserted, also in 1979, "who is beyond question or suspicion." [16] Scientists, Carl Sagan observed, had acquired a negative image in the public mind [17]. Physicians became more vulnerable to sometimes querulous suspicion. Following a television program in 1978 presenting the perspectives of the medical profession, hundreds of viewers wrote letters voicing a wide variety of complaints [18]. The year before, patient visits to orthodox physicians had declined by eleven percent [19].

Consumer literacy regarding medicine and science generally, critics charged, had seriously declined. Sagan considered the level of science education in the schools abysmal [20]. John Allen Paulos blamed widespread mathematical illiteracy for muddled judgments in many areas, not least in health [21]. "Today," complained a psychology professor, "we can go from kindergarten through graduate school without having to take a single course in the sort of logic, scientific methods and self-understanding which would help protect us from quackery." [22] John C. Burnham, tracking the theme of popular science and health through American history, compressed his sobering conclusion into his title, How Superstition Won and Science Lost [23].

Whatever their capacity for being confused, Americans had entered upon a period of great preoccupation with keeping fit. Taking control of one's own health, in a variety of ways, amounted to a public passion. "Running," Lewis Thomas wrote in one of his perceptive essays, "a good thing for its own sake, has acquired the medicinal value formerly attributed to rare herbs from Indonesia." [24] But beyond exaggerated expectations lay false advice and fraudulent products. A healthy attitude could be twisted into unhealthy buying. Taking charge of one's health could get distorted into handing that health into the custody of an unscrupulous marketer and paying dearly for the deception. Promoters of specious wares plugged into self-help psychology. A firm vending a fake vitamin, brought to court by the Food and Drug Administration, chose to simplify the confrontation in a publicity release by terming it "Self-help v. 'Doctor knows best,' " thus sneaking its specious product, condemned by scientific medicine, under a rubric invested with popular enthusiasm [25].

While the cultural climate became more hospitable to irrational ventures, both the criticism and the regulation of health quackery declined from the high plateau of intensity reached in the 1960s. The American Medical Association, dominant in the realm of nostrum fighting since early in the century, while not abandoning the role completely, in 1975 abolished its quackery committee and closed down its Department of Investigation [26]. The major joint educational campaign against quackery, sponsored by regulatory and voluntary health associations during the sixties, had no counterpart in the seventies. The interpretation of unorthodoxy in the popular media, print and electronic, shifted away from skepticism, often toward drum-beating support. One rare critic wondered if a great many of the self-help health books universally available were not a "Rx for Disaster." [27] David Leff described the science in the checkout-counter tabloid press as a "neo-medieval fantasy world of magic, mystery and miracle." [28] Even mainstream newspapers and magazines have been known to curb their critiques of quackery in order to avoid the threats of economic and legal reprisals [29]. Television and radio talk shows have often given promoters of unscientific health ideas and products a welcome warm enough to constitute endorsement [30]. Some television programs, indeed, have masqueraded as entertainment, even hiring out-of-work actors to serve as studio audience. In fact, however, these programs are nothing but half-hour or hour-long commercial pitches for obesity, baldness, and impotency "cures." [31]

Regulatory control of quackery also receded in the seventies. To make this point starkly was one of Claude Pepper's main goals in his 1984 subcommittee report and hearing [32]. The Postal Service, aided by a 1983 law increasing penalties on repeat offenders, had continued to perform with skill and diligence, although its enforcement officials could handle only a fraction of fraudulent promotions introduced into the mails. Otherwise, federal antiquackery efforts had become "minimal." The Food and Drug Administration spent only .001 percent of its budget combating health fraud. Although possessing an earlier proud record, the FDA:s current efforts, in the subcommittee's judgment, "resemble indifference and neglect." The Federal Trade Commission's role in seeking to restrain false advertising related to health also had shrunk to the extent that it had become "almost non-existent, . . . imperceptible." The Commission seemed "strangely paralyzed." Were the federal agencies doing a satisfactory job? "In a word, no." Nor were state and local antiquackery endeavors any more vigorous.

Government inaction, testified a former committee aide, had given a green light to quackery and the perception that "the law of the jungle" was legitimate; it was "open season to rip off the elderly." [33] Congressman Pepper agreed: the recent boom in quackery resulted from its "immense profitability and apparent absence of risk. [34]

The regulatory agencies could make a plausible case that their resources had not been adequate for the broad scope of the responsibilities assigned them by the Congress, and that quackery cases were complex, difficult, and expensive to investigate and litigate [35]. Food and Drug Commissioner Arthur Hull Hayes, Jr., for example, confessed in 1983 that the agency was "simply overmatched. . . . There are too many quacks, too skilled at the quick change of address and product name, for the cumbersome procedures of the FDA." The 1962 Kefauver-Harris Amendments had vastly increased the FDA's obligations for controlling prescription drugs and had prompted a retrospective review—begun in the early seventies and still under way—of over-the-counter medicines, to assure their safety, their efficacy, and the truthfulness of their label claims [36]. The results of this review would help curb quackery in the long run, but in the meantime it absorbed much agency time. So too did implementing the Medical Device Amendments that became law in 1976 [37].

As a result of its accumulating duties, the Food and Drug Administration had accorded quackery a lower priority [38]. Moreover, a modification of the way in which the FDA conducted its business made its control of quackery arguably less effective. Partly as a result of advice given the agency by two Citizens Advisory Committees, the FDA began to regulate more by education and less by litigation, becoming, as it were, more of a counseling agency helping legitimate industry untangle its complex problems, and less of a police force. Crises arose from industry's excessive zeal or unwitting accidents, and usually got settled without going to court. Recalls boomed; prosecutions plummeted.

For most of the FDA's mission, involving legitimate drugs, devices, and food additives, the highly scientific, collaborative, rarely litigious approach may well have been the most efficient and effective way. However, to protect the public from old-fashioned, bare-bones, hard-core quackery, as well as from new-fashioned, ingenious, ruthless, hard-core quackery, some critics both within and without the FDA came to believe, required the return to a greater reliance on criminal prosecutions. Victories in court, especially those imposing heavy fines and imprisonment, would cause other promoters with similar operations to stop or to modify their procedures. Court victories would also provide greater credibility to the FDA and others in carrying on expanded antiquackery educational campaigns. Such legal decisions would further help shield critics of quackery from nuisance libel suits.

With the ambient cultural climate favorable and regulators greatly preoccupied With other tasks, proprietors of questionable and specious health products increased the vigor and blatancy of their promotions. They met their would-be customers at all the old places. Health food stores boomed, and survey after survey around the country revealed the distorted, often dangerous, counsel offered by the clerks. After AIDS had been identified, for example, Dr. John H. Renner sent students to health food stores in Kansas City to ask if they had products that would help ward off that dread disease, and fifteen of sixteen managers said they did [39].. Many of the herbs for sale in such stores, even herbs with ancient reputations in folk tradition, posed grave hazards to health [40].

Pyramidal schemes for the vending of nutritional supplements to friends and neighbors, who would then be recruited as salespersons, resurfaced in an inflated way [41]. A newer form for face-to-face selling expanded: the alternative therapy convention, at which a wide variety of wares was displayed at booths, and occasional lectures were delivered to those in attendance. Typical was a cancer-nutrition convention held in Detroit in 1978, boosting such unorthodox modalities as reflexology, iridology, ionization, kinesiology, chelation, and transcutaneous nerve stimulation, plus a broad gamut of vitamin and mineral supplements [42]. Clinics, as will be seen below, also proliferated, both within the nation and outside its borders, a way of reducing or escaping regulatory attack.

Advertising ran rife in specialty catalogs, the magazines of unorthodoxy, and the scantily self-policed press, as well as over the airwaves. Cautious about claims, advertisers relied on getting their curative messages across in First Amendment-protected feature articles, often in the same journals in which the ads appeared [43]. Sometimes such stories were deliberately planted. in 1986 an officer and a former officer of General Nutrition, Inc., the largest chain of health food stores in the United States and Canada, pleaded guilty to misbranding a proprietary form of evening primrose oil by arranging newspaper and magazine stories and radio coverage that falsely praised the oil's value in preventing such serious diseases as arthritis, hypertension, and multiple sclerosis. This campaign was planned to coincide with company advertising [44].

Advertising became increasingly sophisticated, often composed by M.D.s and Ph.D.s and crafted with cleverness and skill, making pseudoscience sound like science [45]. The slickness of his advertising, suggested Wilbur J. Blechman, Jr., a longtime observer of arthritis quackery, was perhaps the quack's solitary scientific achievement [46].

Some advertising sent the reader to a health food store. Other advertising persuaded him or her to mail in money. Since use of the mails for ordering and delivering health wares that might transgress fraud statutes posed some degree of risk for promoters, they sought increasingly to dilute this hazard by resorting to such new inventions as the 800 long-distance number and commercial delivery systems. Other modern devices came into play: computers, banks of WATS-line telephones, customized lists for reaching special groups of likely customers, credit cards. "This is the new electronic midway," the attorney general of Maine wrote for Congressman Pepper's subcommittee. "Two-headed cows are easily ignored compared to the late night phone call to your home by an out-of-state caller who uncannily knows that you are an elderly person suffering from a medical ailment and who can convince you to invest large amounts of money for relief and magic lures." [47]

.The new techniques were used to preach and expand old gospels. The nutrition myth, so effective in the 1960s, retained its persuasive power [48]. Indeed, when A Study of Health Practices and Opinions, sponsored by seven federal agencies, appeared in 1972, it revealed that a large proportion of American adults engaged in self-treatment that could be characterized as "rampant empiricism," guided by no coherent body of theory, true or false—except in one signal respect [49]. When it came to self-treatment with vitamins and food supplements, consumers did adhere to a set of doctrines, and these bore a remarkable resemblance to the fake tenets of the nutrition myth. Three out of every four Americans believed that, no matter how nutritionally adequate their diet, using extra vitamins would imbue them with added pep.

Nutritional solutions to health problems developed into the dominant feature of unorthodoxy in the years that followed [50]. Modifications of diet and other lifestyle changes aimed at preventing and ameliorating serious degenerative diseases became an increasing concern of scientific medicine as the major infectious diseases came increasingly under control. As so often before, unorthodox medicine mirrored a theme of mainstream science, distorting it to suit its own promotional purposes. The preoccupations of many consumers made them unusually receptive to such carefully crafted promotions. For those seeking to keep fit by their own efforts, diet was a major mode of self-help. Especially for those desiring to keep thin for the sake of health and beauty, a compelling urge since early in the century and now at a new peak of intensity, promoters vended an incredible range of food supplements, drugs, devices, dietary regimens, and books of advice, promising an easier solution than cutting down on calories through self-restraint. The vitamin and mineral market kept booming, with predictions rosy for continuing growth [51]. In time, quackery related to the most dire of diseases, cancer and AIDS, came to encompass a nutritional component.

Critics continued to expose the fallacies and caution of the hazards in pseudonutrition: that consumers on a rounded diet did not need vitamin supplementation, that megadosing could not ward off dread diseases and might itself injure the body, that certain so-called vitamins were not vitamins at all, that some products sold for weight loss were worthless and others could kill, The warning words of scientific nutritionists, dietitians, consumerists, and regulators, however, were outweighed a thousand or more to one by the printed and oral verbiage of pitchmen. Consequently, as a witness asserted at the Pepper subcommittee hearing, "the biggest area of quackery right now is phony diet pills, phony diet cures," a number of which were on display in the hearing room [52].

The Food and Drug Administration had been concerned with the disordered state of the nutritional marketplace for a long time. In 1962 the agency had announced its intention to update the regulations for food supplements first put in place after the Food, Drug, and Cosmetic Act had been passed in 1938 [53]. This proposal led to marathon hearings that accumulated a record of 32,000 pages. In 1973 the FDA issued revised proposals that it hoped might ultimately rationalize the promotion of vitamins and supplements.

Charging to the attack came the health food industry, led by the National Health Federation, many of whose members would be forced to change drastically their promotional practices should the regulations go into effect. Flying furiously the flag of "medical freedom," NHF leaders stirred up their customers into a frightened and frenzied lobbying force of considerable numbers. This development was just what had worried Food and Drug Commissioner Alexander Schmidt the most.

"The opposition with which we are most concerned," Schmidt announced,

stems from the honest fears of many citizens. Some fear that FDA is going to make certain vitamin pills unavailable or, if available, then only by prescription and at higher cost. Others fear that FDA may infringe on their right to decide what they will eat. None of this is true. The single most important purpose and effect of the regulation is to require full and honest labeling and fair promotion of vitamin and mineral products as the basis for a more informed consumer choice [55].

The misguided customers of nutritional pseudoscience chose to believe their marketers rather than the regulators. Prodded by the NHF, thousands of common citizens expressed to members of the Congress their anger about the FDA's proposals and their support of a bill that had been introduced by Congressman Craig Hosmer, cosponsored by 150 other members of the House [56]. The bill, if it became law, would not only negate the FDAA's attempt to tighten controls, but would cut back the agency's authority to regulate vitamins and food supplements to a pre-1938 level.

In the three-year contest that followed, some two million NHF-generated letters flooded Congress. Some members said that the vitamin-control issue spurred more mail than Watergate [57]. Besides responding to such pressure from constituents, some congressmen were also no doubt voting their own convictions, beguiled by the constant reiteration of the nutrition myth. In 1974 a variant version of the first bill passed the Senate by a margin of 81 to 10 [58].

In the 94th Congress, during the nation's centennial year, a revised Senate version of the vitamin bill became attached as a rider to a "must" bill, the Health Research and Health Services Act. The House version passed without the rider, but the conference committee accepted it. Both houses then concurred, and President Gerald Ford quickly signed the bill into law [59].

Congress cannot be said to have given the issue serious consideration, as indicated by the devious parliamentary strategy. Moreover, the 94th Congress did not hold hearings on the bill, despite strong opposition to it by a wide spectrum of groups, including the American Society of Clinical Nutrition, the Committee on Nutrition of the American Academy of Pediatrics, the American Association of Retired Persons, Consumers Union, and Ralph Nader's associates [60]. A trade newsletter termed the course of events "one of the 'legislative miracles' in a lifetime." [61]

The 1976 amendment to the 1938 act represented the first retrogressive step in federal legislation respecting self-treatment wares since the initial Food and Drugs Act became law in 1906. The amendment, as the Food and Drug Administration viewed it, would bar the agency from "limiting the potency of vitamins and minerals in dietary supplements to nutritionally useful levels; classifying a vitamin or mineral preparation as a 'drug' because it exceeds a nutritionally rational and useful potency; requiring the presence in dietary supplements of nutritionally essential vitamins and minerals; [and] prohibiting the inclusion in dietary supplements of useless ingredients with no nutritional value." [62]

Toward the close of this legislative adventure, Commissioner Schmidt spoke of the then pending bill as "a charlatan's dream." [63] The law did indeed embolden the purveyors of food supplements and accelerated the trend toward moving unorthodox pills and potions from risky "drug" status into the presumably safer "food" category.

The National Health Federation lobbied strenuously for more forthright legislation to give consumers access to products regulators could otherwise deny them. Senator Steven D. Symms introduced such a bill into the 94th Congress. It would have repealed the requirement of proving to the FDA's satisfaction the efficacy of a drug for its indicated uses before a promoter could market it in interstate commerce [64]. This stipulation had been added to food and drug law by the Kefauver-Harris amendments of 1962. The bill did not pass, but others followed it, introduced by Senator Jesse Helms and by Congressman Lawrence McDonald, a physician and adviser to an NHF publication [65]. The NHF also pushed a "Foods are not Drugs" bill that would bar the FDA from taking actions against manufacturers or distributors of foods who made claims that their products would "prevent, cure, or mitigate disease." [66].

Sometimes the NHF sought to keep legislation from passing, or even from being considered. In connection with his hearing in 1984, Congressman Pepper introduced three bills to strengthen in various ways government's authority to control health fraud [67]. The NHF termed the proposals "lysenkoism," and, when they did not pass in that session, worked hard to persuade Pepper not to introduce them in the next. [68]. "NHF President Maureen Salaman," reported William T. Jarvis in the National Council Against Health Fraud Newsletter, "went so far as to buy a plane ticket on a flight with Mr. Pepper and arranging to have her seat assignment next to him and bent his ear all the way to his destination." [69] Probably sensing the futility of the effort, Pepper did not reintroduce his bills.

The National Health Federation promoted a number of crusades [70]. It fought the extension of fluoridation tooth and nail. It campaigned against state laws to license scientific nutritionists and to bar the untrained from using the designation. It took a stand against such established health measures as milk pasteurization and vaccination for smallpox and polio. It supported an expansive gamut of unorthodox health doctrines and practices in its publications, special mailings, and convention programs. It helped fund litigation involving persons whose causes it favored. For most of its members, Stephen Barrett concluded, "Nutrition is a religion, not a science." The NHF also sought to blame the nation's health ills on organized medicine and its conspiratorial allies. "The biggest and the most costly and the most dangerous quackery rampant in the United States today," NHF's legislative representative, Clinton Miller, charged at the Pepper subcommittee hearing, "is the medical quackery inside organized medicine as represented by the American Medical Association." [71]

The NHF and its allies in the nutritional products industry also counterattacked those who criticized their policies. William Jarvis, recipient of the NHF's initial "Health Bigot of the Year Award," told of a conversation with Clinton Miller in which the latter said, "There is nothing personal in all of this, but when you are the enemy, we have to clobber you." [72] Such blows included comparing Jarvis, Stephen Barrett, and Victor Herbert to Hitler, Goering, and Goebbels. Herbert told the Pepper subcommittee of an interview, appearing in an NHF publication, with Robert Atkins, formulator of a diet disparaged by scientific nutritionists [73]. Atkins had stated that Herbert "house[d] an evil spirit that needs to be exorcised." Soon thereafter Herbert had received death threats by mail and phone.

The NHF placed on its board of governors David T. Ajay, president of the National Nutritional Foods Association, a trade association of health food producers, distributors, and retailers [74]. In 1978 Ajay proclaimed "Operation Counterattack," a series of lawsuits against critics of the industry. The next year Ajay and two other distributors launched a libel suit for themselves and the NNFA against Elizabeth M. Whelan, executive director of the American Council of Science and Health, and Fredrick J. Stare, Emeritus Professor of Nutrition of the Harvard School of Public Health, both sharp critics of nutritional quackery [75]. None of the plaintiffs was mentioned in the publications at issue, and a judge eventually threw the case out of court. For the defendants it was a welcome, if time-consuming and costly, victory.

In the 1970s, the National Health Federation, with its aggressive leadership, more than a hundred local chapters, and 25,000 members, increased its influence by allying with the expanding ranks of the supporters of Laetrile, an unproven cancer remedy [76]. In the early days of the NHF, its founder, Fred J. Hart, had collaborated with Harry Hoxsey, then the most prominent figure in cancer unorthodoxy, who was locked in a struggle with the Food and Drug Administration he was to lose in 1960 [77]. Hart, during this period, testified against a bill being considered by the California legislature aimed at curbing cancer quackery [78] Another hostile witness was Ernst Krebs, Jr., codeveloper, with his father, of Laetrile. When the FDA forced Hoxsey to abandon his Dallas clinic, his successor began treating cancer patients with Laetrile [79]. The FDA made its first seizure of Laetrile at the clinic in 1960. A nurse who had long been on Hoxsey's staff carried his medications across the border to Mexico, where they are still prescribed for cancer [80]. That is true also of Laetrile, but before its almost complete exile Laetrile provoked "one of the most politicized medical disputes in American history." [81]

The Laetrile of commerce was amygdalin, a chemical first isolated from bitter almonds in 1830 by two French chemists, although the product Ernst Krebs, Jr., trademarked as Laetrile had a slightly different structure [82] The significant ingredient was cyanide, some six percent by weight [83], and by centering on this poison Krebs fashioned his first explanation as to how Laetrile combated cancer [84]. When the Laetrile molecule reaches the cancer site, Krebs argued, an enzyme especially abundant in cancerous areas splits the molecule, releasing hydrogen cyanide to kill the cancer. Another enzyme protects normal cells, detoxifying any cyanide that strays into them. Thus Laetrile purportedly fulfills a prime objective of cancer chemotherapy: specificity of action. An impressed business manager for a group of doctors opined that Krebs had made a major step toward receiving a Nobel Prize. Soon, however, cancer specialists were to deny Krebs's premise. The normal cells turn out to contain more of the molecule-cleaving enzyme than do neoplastic tissues. Indeed, Laetrile administered by injection undergoes scarcely any metabolic breakdown and is excreted virtually intact in the urine. Laetrile taken orally, however, can be split by ingredients in food, releasing its poison and placing the person at grave risk. Indeed, both Laetrile and apricot kernels from which it was made killed a number of people [85].

Under the management of the two Krebs, father and son, Laetrile developed modest sales but encountered increasing criticism from cancer scientists and the beginning of legal restraints from both California and federal regulators. Indeed, in time, the would-be Nobelist spent several months in jail [86].

A series of happenstances lofted Laetrile into the national limelight. As the Krebs pair faltered, a Canadian adventurer, Andrew R. L. McNaughton, took control of Laetrile's destinies. He trumpeted his discontent when he failed to secure an investigational New Drug exemption from the Food and Drug Administration, even though he had not submitted adequate evidence. He expanded his drum-beating, placing in the Hearst American Weekly articles penned by G. D. Kittler, the man who thought Krebs, Jr., should win a Nobel Prize. This admirer then published a paperback, promising that Laetrile would "be to cancer what insulin was to diabetes." [87] McNaughton gained a recruit from within the cancer research establishment, Dean Burk, who gave Laetrile a semblance of scientific legitimacy. McNaughton sought to escape rising regulatory pressures by establishing manufacturing and treatment facilities in Tijuana, to which American patients began to go and from which Laetrile was smuggled into the United States and distributed clandestinely.

To McNaughton's assistance came a growing network of institutional support. The first patient treated in Tijuana established the International Association of Cancer Victims and Friends to publicize Laetrile, help cancer victims get to Mexico, and fly the flag of medical freedom. This organization and another that seceded from it, the Cancer Control Society, had unusual success in bringing Laetrile's message to members of the middle class, including some with considerable education [88]. More important still for Laetrile's expansion of social and political influence was the arrest in 1972 of a California physician, John A. Richardson, for prescribing Laetrile in violation of the state's antiquackery law. Two trials ended with hung juries. The California Board of Medical Quality Assurance then stepped in and revoked Richardson's license on grounds of incompetence and gross negligence.

These events upset some of Richardson's fellow members of the John Birch Society. Such dedicated disciples of freedom-from-government doctrine saw in this physician's case a prime example of bureaucratic oppression. Led by Robert W. Bradford, a nuclear technician at Stanford University, Richardson's friends formed the Committee for Freedom of Choice in Cancer Therapy. By 1977 Bradford claimed five hundred chapters with some 35,000 members throughout the nation. Experienced in Birch battles against fluoridation and sex education, Committee members used a wide variety of tactics to condemn the community of cancer scientists, to castigate its allegedly futile therapeutic methods of cutting, burning, and poisoning, and to make any governmental interference with a cancer patient's right to use Laetrile or any other unorthodox treatment seem a violation of the Constitution and the fundamental rights of man.

Laetrile at this time, although still the same substance, had changed guises again. Ernst Krebs, Jr., while retaining much of his original theory as to Laetrile's mode of action, had converted cancer to a deficiency disease and transformed Laetrile from a chemotherapeutic drug to a vitamin, designated B-17. In addition to controlling cancer, B-17 could now prevent it. Nutritional scientists denied that Laetrile fulfilled any of the criteria for a true vitamin. "In short," summed up veteran vitamin researcher Thomas H. Jukes, "nothing could be less like a vitamin than laetrile." [89] Such criticism did not deter Laetrile enthusiasts. Krebs, Jr., testifying before Senator Edward Kennedy's Subcommittee on Health in 1977, termed Laetrile "a scientific revolution as profound as the germ theory of disease ... and the Copernican theory." What Vitamin C is to scurvy, niacin to pellagra, and Vitamin D to rickets, he asserted, Vitamin B-17 is to cancer [90]. If every American took Laetrile regularly, Dr. Richardson told the subcommittee, "in 20 years cancer would be relegated to the dusty pages of history."

Besides fighting a propaganda battle in the arena of public opinion, Laetrile's champions sought victories in legislatures and courts. The main legislative effort came in the states. Alaska passed the first law giving Laetrile special distribution status, and by the early 1980s half the states had enacted statutes, the terms varying from place to place. [91]. Members of the Committee for Freedom of Choice played a major lobbying role in the state campaigns.

The most significant judicial encounter began with patients who had returned from Laetrile clinics in Mexico and wanted to prevent the Food and Drug Administration from interfering with their imports of the amygdalin product for continuing treatment. The principal plaintiff who emerged was Glen L. Rutherford, a manufacturer's representative from Conway Springs, Kansas [92]. At the Tijuana clinic, he had been treated with Laetrile and enzymes, and an intestinal polyp had been cauterized. Cancer specialists believed that the excision of a polyp solved the problem in a high proportion of cases, but Rutherford wanted the reassurance of Laetrile. In 1975 he won this right from a federal judge in Oklahoma. Judge Luther Bohanon ruled that Rutherford and all other cancer patients as a class who secured physicians' affidavits designating them as terminally ill could import a limited amount of Laetrile in both injectable and oral forms for their personal use.

Considering the deliberate pace of the law during the process of appeals, that privilege stretched through a dozen years [93]. The Circuit Court, taking into account amygdalin's hazard when ingested by mouth, barred oral dosage forms. The Supreme Court ruled unanimously that the safety and efficacy standards of the law did indeed apply to terminal patients. Despite the Court's failure to address all other issues explicitly, "the tone of the opinion," commentators observed, "left no doubt as to the Supreme Court's determination to uphold the FDA ban on laetrile." [94] The Circuit Court so interpreted the decision and ordered judge Bohanon so to rule. He finally did so in 1987. The FDA then issued an Import Alert, stating that, as an unapproved drug, Laetrile under its various designations could not be brought into the country [95].

Along this extended judicial trail, the Food and Drug Administration was ordered to conduct administrative proceedings, and Commissioner Donald Kennedy and his staff turned this task into as thorough and insightful a review of a highly promoted unorthodox drug as could be found in the American literature [96]. The report countered the various claims made for Laetrile's effectiveness in cancer, disputing the shifting theories, remarking upon the inadequate anecdotal character of pro-Laetrile reporting, and citing the lack of promise in numerous well-controlled animal studies made at the National Cancer Institute and private cancer research centers. The report criticized as unpersuasive the few animal tests interpreted as favorable to Laetrile by Dean Burk and others. The commissioner found that Laetrile's appeal lay in the psychology of patients and their families caught in the crushing cancer crisis. The "disparagement of conventional therapy" by Laetrile advocates was "morally reprehensible," leading sufferers away from proven treatment.

Commissioner Kennedy further 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 the fear of disease and the zeal of Laetrile advocates, with seldom any "rational laying out of competing arguments," could not accurately be described as free.

The litigation and the legislative battles in the states made Laetrile an issue of national concern. News magazines carried cover stories, and high-ranked television programs looked at Laetrile [97]. Conservative columnists, most notably James J. Kilpatrick, attracted to the freedom of choice theme, gave Laetrile favorable attention [98]. The promoters intensified their own publicity with a series of paperback books [99]. The National Health Federation put leading Laetrile figures—including Andrew McNaughton and Glen Rutherford—on its board of governors and gave the Laetrile cause continuing support with publicity, financing, and legal aid [100]. A majority of Americans came to believe decriminalization of Laetrile would be a good idea [101]. Some Laetrile leaders sounded smug about their prospects [102].

"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. . . . We 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 redtape. Do we really want another American civil war?"

Laetrile advocates hoped that they might yet achieve the repeal of the effectiveness provision in the drug law [103]. During the 1980 presidential campaign, Ronald Reagan was quoted in an interview in the National Health Federation journal as favoring such action [104]. Richard Crout, director of the FDA's Bureau of Drugs, feared that this might happen and hoped that, if "the political heat" engendered by Laetrile pressure groups got too much for Congress, the members might choose a less extreme course, exempting Laetrile alone from the effectiveness requirement. That Dr. Crout should venture to discuss such a worst case possibility suggested its potential for happening.

As public sentiment favoring Laetrile mounted, and as tens of thousands of cancer patients forsook orthodox therapy to rely on Laetrile instead, a debate began within the scientific community. Should the established rules for testing new drugs be firmly adhered to, or, in Laetrile's case, should the rules be breached, with the government itself assuming the testing burden, or even, as the distinguished editor of the New England Journal of Medicine, F.J. Ingelfinger, suggested, should Laetrile be made freely available in the marketplace, with detailed records kept of its use?105 After great deliberation, the middle course was followed. The National Cancer Institute solicited case histories from physicians who had used Laetrile and, in the mass of unchecked data, found the minimal suggestive evidence to warrant proceeding with clinical trials 106]. The FDA doubted that the evidence was sufficient but recognized societal reasons for pushing forward to resolve the issue scientifically [107].

After consulting with Laetrile physicians, NCI scientists devised protocols that defined Laetrile as amygdalin and included a special diet and numerous vitamins in the regimen, according to then current Laetrile treatment practice [108]. The FDA gave the NCI an Investigational New Drug exemption, thus bringing the experiment under the law. Charles Moertel of the Mayo Clinic led the team of investigators at four cancer research hospitals. With the trials having months to run, Dr. Moertel surprised the scientific community and the nation when, on April 30, 1981, he made an initial report to the American Society of Clinical Oncology [109]. "Laetrile has been tested," he declared. "It is not effective." It did not relieve symptoms of cancer patients or extend their life span. In only one case was there a reduction of tumor size, but it proved temporary.

The fuller published report of the investigative team confirmed and amplified Dr. Moertel's announcement [110]. Laetrile had produced "no substantive benefit . . . in terms of cure, improvement, or stabilization of cancer, improvement of symptoms related to cancer, or extension of life span." indeed, "patients died rapidly." Oral dosages of amygdalin produced some evidence of cyanide toxicity. In sum, Laetrile failed to meet the FDA's safety and efficacy standards.

Laetrile leaders sought to deny the trial's validity. "The whole thing," charged Robert Bradford, "is a put-up deal to discredit Laetrile. It was a phony test." [111] Despite such disparagement, the failure of Laetrile in the National Cancer Institute clinical trials had considerable impact on public perception of the drug's efficacy. By this time, in any case, Laetrile's image had already gone into decline [112]. The Supreme Court had expressed its skepticism. The campaign for state laws had faltered, and some states had repealed laws earlier enacted [113]. Little Chad Green and actor Steve McQueen, headlined for awhile as successful Laetrile users, had died [114]. Interest in Laetrile did not vanish within the realm of cancer unorthodoxy, but it did diminish. In 1982, shortly after the final National Cancer Institute evaluation of Laetrile was published, Barrie Cassileth of the University of Pennsylvania Cancer Center wrote a short article in the New England journal of Medicine entitled "After Laetrile, What?" [115]

Replacing Laetrile, she explained, was an "unusual" mode, differing from past unorthodoxies and constituting "more of a challenge than did Laetrile or its predecessors." The regimens were multiple and varied, featuring "antimedicines" in the sense that diet patterns, detoxification, and mind control were central to therapy. What brought a certain unity out of complexity, Dr. Cassileth suggested, was theory. The new mode owed much to New Age philosophies and religions from the Far East, as well as to earlier unorthodox traditions that once had great vogue in an earlier America: homeopathic and naturopathic concepts, and the belief that intestinal putrefaction lay at the root of disease. Old cancer quackeries had been medications; the new mode stressed lifestyle changes, adjustments purportedly to restore life to more "natural" patterns. Patients could play an active role in their own healing. The wide scope of ideas fostered an expansive range of disease coverage. Not cancer alone, but other ills fell prey. Since lifestyle was chiefly involved, the new wave was largely beyond the control of licensing and regulatory agencies. Clinics were the customary treatment sites. One of unorthodoxy's zealous journalists had already paraded a series of cancer clinics in the pages of Penthouse [116].

Laetrile's promoters had already recognized advantages in the developing pattern of "total metabolic therapy" and had adopted it. In Robert Bradford's book, Now That You Have Cancer, he likened the new therapeutic approach to a crown containing nine jewels, with Vitamin B-17 "the crown jewel within that diadem." The other parts included diet, exercise, vitamins A, C, and E, and another false vitamin, B-15 or pangamic acid, that the Krebses had promoted vigorously. Such a total approach, Bradford insisted, provided "the best chance to control cancer." The complexity, it may be presumed, would seem to possess the merit of making Laetrile a less conspicuous regulatory target. To approximate this new expanded regimen surrounding Laetrile, the NCI research team had included the vitamins and enzymes in their protocols.

The 1984 report and hearing of Congressman Pepper's subcommittee unquestionably spurred increased attention to quackery on the part of regulatory agencies, the press, and the public. The tide and temper of concern, however, had already begun to turn. The reporting of events that blackened Laetrile's image played a part in this. So too did the appearance of several books surveying the field of quackery from a severely critical perspective. The Health Robbers, engineered by physician Stephen Barrett, had been published in 1976, followed by a revised edition four years later. Also issued in 1980 were Victor Herbert's Nutrition Cultism and a collection of hard-hitting articles from Consumer Reports entitled Health Quackery. Newspaper journalists also displayed a revived interest in investigating quackery's deceptions and hazards. An excellent example was a series by James DeBrosse, researched with the FDA's help and published, despite the threat of multiple lawsuits, by the St. Petersburg Times [117].

Speaking to the Pharmaceutical Advertising Council in 1982, FDA Commissioner Arthur Hull Hayes, Jr., cited Consumer Union's Health Quackery and admitted that his agency was doing "not much" about the problem [118]. Dr. Hayes—and later Congressman Pepper—might properly have given the FDA more credit for its campaign to restrain Laetrile. Hayes did believe that the agency "acted promptly" against "products that actually do or could harm users" but neglected those that deprived users of legitimate therapy and those posing hazard only to the purse. The overall task was too huge for the FDA alone; its staff power was woefully insufficient. The agency could afford only one or two prosecutions a year against the worst offenders and could "never hope to even stalemate the quacks with publicity." The regulatory agencies must cooperate. The Better Business Bureau might join with the medical and advertising professions to give quackery pitiless exposure.

A year later Commissioner Hayes congratulated the Pharmaceutical Advertising Council for acting on his cue and proposing plans for a joint public service campaign with the FDA, carried in a variety of media, focusing on quackery's flaws [119]. Internally, also, the FDA was rethinking its stance toward quackery, prompted by "concern and frustration" both at headquarters and in the field about the existing program [120]. This process was "agonizingly slow" because of conflicting opinions among agency personnel about what to do [121]. An effort at resolution occurred at a Policy Board Quackery Go-Away in March 1983, which determined to change the target name from "quackery" to "health fraud," arranged better internal coordination on health fraud matters, and agreed to allocate resources specifically for compliance in this field [122].

More activity did occur. A pilot program, "Tipped Off or Ripped Off," aimed at medical devices whose promotion grossly deceived the public, even though no threat to health was involved [123]. The promoter of such a device would be warned of his sins and, unless changes were made within a month, the agency would publicize them. This plan was expanded to drugs, and a new standing committee on health fraud could decide on seizures, injunctions, or prosecutions to halt promotions dangerous to health [124]. Simultaneously, warning letters would go to firms marketing similar products. A Drugs and Biologic Fraud Branch was established for coordinating activities, initiating actions, and providing support to other federal regulatory agencies [125] In the agency's A Plan for Action, issued in 1985 after Dr. Frank E. Young had become commissioner, health fraud became one of the FDAs top ten priorities, with the promise of "increased emphasis" on both enforcement and education [126].

The climate for enforcement, however, was not propitious in the 1980s. Tight budgets and antiregulatory sentiment restrained the bureaucrat's hand. Decisions of a type the FDA had hitherto made on its own now might be overruled by officials in the Department of Health and Human Services or the Office of Management and Budget [127]. Prosecutions relating to quackery remained few and far between, and critics kept complaining [128].

The arrival of a new, mysterious, frightening, infectious epidemic, when such contagions had been deemed on their way toward extinction, forced the Food and Drug Administration and other regulatory agencies into emergency action. "We stand nakedly in front of a very serious pandemic," stated the director-general of the World Health Organization, "as mortal as any pandemic has ever been."[129] Victims of acquired immunodeficiency syndrome, lacking approved medications that could cure or, for several years, even palliate their condition, turned desperately to rumored or fraudulently promoted treatments [130]. As gatekeeper for new medications, the FDA, when legitimate drugs seemed tardy in arriving, bore the brunt of AIDS activist organization wrath [131]. Many ordinary citizens, convinced the cause of AIDS was ubiquitous, panicked into purchasing falsely advertised "protective" devices.

Postal inspectors filed a complaint against an alleged air-purifying gadget called Viralaid—"The product of lightning harnessed for your use!"—to protect "bed linens, bath towels, even eating utensils." [132] The Environmental Protection Agency acted against antiseptics overpromising to safeguard home and office environments. 133 A plastic shield was vended to cover public telephones, to block the user from the breath and spit of previous mouths [134].

Of those stricken with AIDS, or fearing this fate, a great many entered "a jungle of truly questionable and quack products." [135] Dr. John Renner of Kansas City tabulated over three hundred quack schemes and guessed there might be thousands more [136]. Victor Herbert pointed to one significant trend: "Every cancer scam has become an AIDS scam." [137] Robert Bradford and Mike Culbert, with headquarters in San Francisco and a treatment center in Tijuana, now covered AIDS as well as cancer. 138 Garlic pills, enemas, and meditation formed part of the regimen, but its central element, Culbert told a television interviewer, was "live cell therapy, the embryonic cellular extracts from calves, although sheep, goats will do just as well." In the Bahamas, Dr. Lawrence Burton, a zoologist, dispensed a blood serum treatment for cancer that possessed the potential of taking Laetrile's place as an American social movement built upon an unorthodox therapy [139]. Burton added AIDS to cancer as a disease that he claimed could be treated effectively by his therapy. With sad irony, it was later demonstrated that some samples of the serum had become contaminated, as shown by the presence of antibodies to the AIDS-causing human immunodeficiency virus. The FDA barred Burton's product from importation.

As the viral destruction of immunity became established and widely announced to be the genesis of AIDS, safeguarding immunity became a central doctrine in unorthodox therapy [140]. The health food industry eagerly latched on to this approach, and a variety of products surged into the marketplace with explicit or guarded claims for preventing or combating AIDS. The FDA took action against over-the-counter and mail-order medications using the immunity pitch if AIDS was named or obviously implied in the name or labeling. The agency sent regulatory letters to makers of whey-concentrate colostrum with names like Stimulac, and sought to stop the promotion of Prevention Plus and Resist-AIDS tablets [141].

Another group of drugs presented the FDA with more difficult decisions. Unproven products, some made by American pharmaceutical firms, others derived from the science or folklore of foreign nations, had gained wide use in the guerrilla clinics of the AIDS underground [142]. A number of these drugs went into legitimate clinical trials, although too slowly to suit AIDS activists, a few to emerge with true therapeutic roles related to secondary afflictions to which AIDS patients were prone, others to prove ineffective or lethal.

Under the double pressure of the AIDS lobby and the Reagan administration's desire to reduce regulatory burdens, the FDA devised policies of earlier release for drugs showing some promise to treat life-threatening diseases [143]. Moreover, the agency did not interfere with individuals seeking the treatments dispensed at underground clinics, unless the marketers made illegal labeling claims [144]. The FDA further permitted people with AIDS to bring back from other countries, or to have mailed to them from abroad, limited supplies of any AIDS product that caught their fancy, except those on Import Alert.

The FDA's modifications of policy kept the agency in the middle of controversy, the changes seeming insufficient to the AIDS community, but to some health scientists threatening the integrity of the new drug introduction system and the control of quackery [145]. Commissioner Young gave a reporter this apologia for FDA policy: "I'd rather err on being compassionate. People with this dreaded disease have limited hope, and I don't want to rob them of it."[146]

With AIDS quackery as with other health fraud, FDA officials continued to assert that education had to play the leading role in the agency's counterattack. Its "big guns—regulatory actions and criminal prosecutions," would be fired off only occasionally, when the provocation seemed overwhelming [147].

Intensive effort went into the FDA's educational campaign [148]. Cooperating with the Council of Better Business Bureaus, the FDA sought to secure tighter screening of advertising by all branches of the media and urged direct marketers to check more carefully their product claims. In a variety of ways, the agency and its allies also sought to jolt the broad public into greater awareness of health fraud hazards. The joint effort with the Pharmaceutical Advertising Council put spots on television and radio and public service announcements in newspapers, magazines, and medical publications, all warning of quackery. A consumer brochure produced by the Council, the FDA, the FTC, and the Postal Service received massive circulation. The FDA undertook special programs to increase sensitivity about health fraud among physicians, nurses, pharmacists, and pharmaceutical manufacturers. An Information Exchange Network was inaugurated with the National Association of Consumer Administrators, and Health Fraud Surveillance Teams were begun with the Association of Food and Drug Officials, thus strengthening federal and state cooperation in detecting and planning attacks on fraudulent ventures.

FDA Consumer published numerous articles on the health fraud theme, and the agency issued press releases on newsworthy developments. The FDA's Consumer Affairs Officers stressed health fraud in their numerous meetings with members of the public. Special programs were targeted at groups deemed especially vulnerable: the elderly, Hispanic citizens, arthritis sufferers, and people with AIDS.

The National Health Fraud Conferences of the 1960s were revived. The first of the new series, sponsored by the FDA, the FTC, and the Postal Service, met in Washington in September 1985 [149] Congressman Claude Pepper, on his eighty-fifth birthday, came to bestow his blessing on the enterprise. Commissioner Young called health fraud "a disease, devouring, destroying and contagious," and quackery's most committed critics, among them Victor Herbert, Stephen Barrett, and Grace Powers Monaco, elaborated the grim details.

Regional conferences across the country and in Puerto Rico carried the message closer to the grass roots until the next National Health Fraud Conference, sponsored by the FDA and Trinity Lutheran Hospital, convened in Kansas City, Missouri, in March 1988 [150]. Those who assembled seemed to accept some basic assumptions: that quackery was too deeply entrenched to be destroyed, but much could be done "to minimize the negative impact . . . upon society."[151] There were hopeful signs: a recent "substantial increase," despite low budgets, in federal enforcement [152] and a considerable improvement in networking among quackery's foes. The current masks worn by the illegitimate were vividly described. Much time at the conference went into considering the practical aspects of combating health fraud: how to gather evidence during an investigation; how to write accurately about the problem; how to avoid legal difficulties; how to improve education in the schools.

Another National Health Fraud Conference would meet in Kansas City in September 1990. This time the Food and Drug Administration would not be among the four official sponsors, while the American Medical Association would resume its 1960s role. The theme of the conference, according to the preliminary announcement, would be "Quackery, Health Fraud, and Misinformation: A Pandora's Box." [153]

Quackery has always been Pandora's box, constantly reopened with hope, never releasing a genuine benefit, although sometimes the opener is fooled into believing so. The box has an infinite capacity. Old cheats like before-and-after pictures and the fake diagnostic test come out wrapped in new tinsel [153]. In one case, for a weight-loss scam, both pictures were taken on the same day of the same woman, the company president, who apparently donned a padded robe for "before" and a swimsuit for "after." In another instance, a Los Angeles lab claiming to test blood for allergies was itself put to the test. Federal investigators paid the required $350 fee, sending in blood from a vegetarian described as "overweight, irritable [and] constipated." The lab reported allergies to milk, blue cheese, and yogurt. The patient was a cow.

Pandora's box continues to be stuffed with a variety of brazen health deceptions beyond recounting, perhaps beyond reckoning. Despite increased efforts at education, the perennial proneness seems not to have diminished perceptibly. A national survey conducted by Louis Harris and Associates, which the FDA helped devise, found that more than a quarter of the American public reported using one or more questionable health care treatments [154]. At Kansas City, Deputy Commissioner Norris stated that the agency believed this figure "seriously underestimated the extent of the problem." [155] More than half of such users thought they had derived some benefit, certainly evidence of self-deception. The poor and sick seemed at special risk, but college education offered no protection against resort to questionable products.

Cancer quackery offers evidence of how both populist and elitist elements of the population have been preyed upon. James Patterson stressed the class nature of the phenomenon [156]. The poor have been vulnerable in both an economic and an educational sense, constituting a counterculture suspicious of expert knowledge, especially skeptical of orthodox medical opinion, trusting instead in folk tradition, home remedies, faith healing, and quackery. A survey conducted by Jon D. Miller of Northern Illinois University found that three-quarters of his respondents believed "there are good ways of treating sickness that medical science does not recognize." [157]

Remarks by Glen Rutherford at the Kansas City hearing on Laetrile conducted by the FDA catch the bitter feeling often expressed toward establishment medicine [158]. "You people in authority," the FDA's stubborn opponent said, "consider all the rest of us a bunch of dummies. . . . You set yourself up as God and Jesus Christ all rolled up into one. And we don't have any rights. . . . Patrick Henry said: 'Give me liberty, or give me death.' Glen Rutherford says, 'Let me choose the way I want to die. It is not your prerogative to tell me how. Only God can do that.'"

The educated also become seduced by cancer unorthodoxy. Revealing this truth again, Barrie Cassileth and her colleagues followed her terse answer to the question "After Laetrile, What?" with an empirical study, sampling the experience of patients in her Philadelphia region treated both in cancer centers and by unorthodox practitioners [159]. The researchers found that patients taking unorthodox treatment alone or in addition to conventional therapy tended to be better educated than those receiving only conventional treatment. The study reported that 54 percent of patients on conventional therapy also used unorthodox treatments, and that 40 percent of those so doing abandoned conventional care. Eight percent of the patients had received no conventional treatment at all. Perhaps the most surprising finding was that 60 percent of the dispensers of unorthodox treatment were physicians.

The principal unorthodoxies Cassileth and her associates discovered were those of the new wave, "metabolic therapy, diet therapies, megavitamins, mental imagery applied for anti-tumor effect, spiritual or faith healing, and 'immune' therapy." A "common perspective" gave unity to the diversity: "Cancer and other chronic illnesses tend to be viewed not as disease entities, but as symptoms of underlying dysfunction, disorder, or toxicity." As a consequence, therapy was aimed at enhancing the patient's physical and mental capacity to counteract what was deemed fundamentally wrong.

This pattern reveals that unorthodox cancer treatment had moved to a considerable degree under the "alternative" or holistic umbrella. From this position the foes of scientific medicine not only condemn the medical/regulatory establishment and lobby against it in legislative bodies, but they also frame a counter-paradigm that they seek to persuade the public is intellectually more valid and therapeutically more effective than the system of science. "One of the major successes of pseudoscientific thinking," William Jarvis has written, "has been tacit acceptance of the word 'alternatives' into current health jargon." [160] Holistic medicine," Clark Glymour and Douglas Stalker have argued, "is a pablum of common sense and nonsense offered by cranks and quacks and failed pedants who share an attachment to magic and an animosity toward reason. Too many people seem willing to swallow the rhetoric-even too many medical doctors-and the results will not be benign." [161] These two philosophers have edited a book in which scholarly specialists expose the illogic of major elements in the holistic movement [162].

As a sociologist has observed, "the fate of medical social movements is not determined by the soundness of their theories or the effectiveness of their therapies, but by their ability to mobilize political and social resources effectively." [163] The civil war that Robert Bradford predicted over Laetrile is now being waged fiercely on a broader front, and it is too soon to say whether science or antiscience will win. At the peak of the Laetrile movement, scientist Thomas Jukes, a dedicated foe of quackery, asserted that public acceptance of unorthodox health practices had become "so well established, and [is] so little challenged that its impact will produce a decline of scientific medicine and its replacement by quackery." [164] Despite a decade of counterattack on pseudomedicine by the revived legions of regulators and quackbusters, Dr. Jukes commented early in 1990, "Unfortunately, I see no reason to retract my pessimistic opinion." Whatever the odds, the intense contest continues for the allegiance of the people. Those dedicated to the cause of science and reason need to take a committed stand.

References

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  2. Charles W. Oleson, compiler, Secret Nostrums and Systems of Medicine (5th ed., Chicago, 1894), 18-19, 22.
  3. United States Pharmacopeial Convention, USP DI, vol. 2, Advice for the Patient (Rockville, 1990), 801.
  4. Varro E. Tyler, The Honest Herbal: A Sensible Guide to the Use of Herbs and Related Remedies (Philadelphia, 1982), 23-24; Varro E. Tyler to author, July 2, 1990.
  5. See above, 421-22.
  6. Quackery: A $10 Billion Scandal, A Report by the Chairman of the Subcommittee on Health and Long-Term Care of the Select Committee on Aging, House of Representatives (98th Cong., 2d sess., May 31, 1984). Hereafter, Quackery: A $10 Billion Scan" (Report).
  7. Quackery: A $10 Billion Scandal, Hearing before the Subcommittee on Health and Long-Tenn Care of the Select Committee on Aging, House of Representatives (98th Cong., 2d sess., 1984), 88-91. Hereafter, Quackery: A $10 Billion Scandal (Hearing).
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  10. In what follows I rely somewhat on two of my articles, "The Persistence of medical Quackery in America," American Scientist 10 (1972), 318-26, and "The Foolmaster Who Fooled Them," Yale Journal of Biology and Medicine 53 (1980), 555-56.
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  25. FoodScience Laboratories news release, November 30, 1979.
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  31. Ibid., 13 (May/June 1990), 4; Richard Cleland in 1988 National Health Fraud Conference Proceedings, 30.
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  34. Ibid., 2.
  35. Quackery: A $10 Billion Scandal (Report), 169.
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  41. Nutrition Forum 4 (February 1987), 15.
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  43. Young, "The Foolmaster Who Fooled Them," 564.
  44. FDA Talk Paper, November 7, 1986; NCAHF Newsletter 10 (January/February 1987), 2.
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  47. James Tierney testimony, Quackery: A $10 Billion Scandal (Hearing), 178; Richard Cleland in 1988 National Health Fraud Conference Proceedings, 88.
  48. See above, 350-54, 432.
  49. A Study of Health Practices and Opinions was conducted by National Analysts, Inc., and published by the National Technical Information Service of Springfield, Virginia. Its conclusions were summarized in J.W. Buchan, "America's Health: Fallacies, Beliefs, Practices." FDA Consumer 6 (October 1972) 4-10.
  50. Among the many works relevant to this paragraph are Stephen Barrett, "Diet Facts and Fads," and Victor Herbert, "The Health Huslers," in Barrett, The Health Robbers, 49-68, 173-83; Theodore Berland, Rating the Diets (New York, 1980); Editors of Consumer Reports Books, Health Quackery (Mt. Vernon, N.Y., 1980); Victor Herbert, Nutrition Cultism: Facts and Fictions (Philadelphia, 1980); Herbert and Barrett, Vitamins & "Health" Foods; Gilda Knight, "The Confused Crusaders," and Jean Mayer, "Weight Control and 'Diets': Facts and Fads," in Barrett and Knight, The Health Robbers, 47-59, 175-87; Hillel Schwartz, Never Satisfied: A Cultural History of Diets, Fantasies, and Fat (New York, 1986); Daniel Tatkon, The Great Vitaminn Hoax (New York, 1968); Elizabeth M. Whelan and Fredrick J. State, Panic in the Pantry: Food Facts, Fads, and Fallacies (New York, 1975); and the newsletter Nutrition Forum, Stephen Barrett, ed. Newsweek, April 30, 1990, and U.S. News and World Report, May 14, 1990, had cover stories on reducing.
  51. FDC Reports, April 16, 1984, T&G 7.
  52. Val J. Halamandaris testimony, Quackery: A $10 Billion Scandal (Hearing), 12.
  53. In the discussion of the background to the vitamin law of 1976 1 follow my treatment in American Self-Dosage Medicines, 46-50, and in "The Agile Role of Food: Some Historical Reflections," in John N. Hathcock and Julius Coon, eds., Nutrition and Drug Interrelations (New York, 1978), 13-16.
  54. For the origin of the National Health Federation, see above, 383-84, 392, 400-401, 431.
  55. FDA news release, August 1, 1973.
  56. H.R. 643, S. 2801, Congressional Record, 93rd Cong., lst sess., 53, 40936.
  57. Herbert and Barrett, Vitamins & "Health" Foods, 131-32.
  58. Cong. Record, 93rd Cong., 2d sess., 7455-56, 32376.
  59. Cong. Record, 94th Cong., 1st sess., 1785, 9262, 10023, 10839, 11086; 90 U.S. Stat., 410-13.
  60. Vitamin, Mineral, and Diet Supplements, Public Health and Environment Subcommittee of the Committee on Interstate and Foreign Commerce, House of Representatives, 93rd Cong., Ist sess., Committee print No. 11, 1973; Food Supplement Legislation, 1974, Hearings on S. 2801 and S. 3867, Health Subcommittee of the Committee on Labor and Public Welfare, U.S. Senate, 93rd Cong., 2d sess., 1974; C. E. Butterworth, Letter from American Society for Clinical Nutrition to members of Congress, July 8, 1975; M. A. Holliday, Letter from Committee on Nutrition, American Academy of Pediatrics, to members of Congress, June 19, 1975.
  61. FDC Reports, September 1, 1975, 5.
  62. Harold Hopkins, "Regulating Vitamins and Minerals," FDA Consumer 10 (July/August 1976), 10-11; FDA Talk Paper, 1976.
  63. Ibid.
  64. H.R. 12573, 94th Cong., 2d sess., 6564; Herbert and Barrett, Vitamins & "Health" Foods, 132. NHF legislative representative Clinton Miller presented his defense of such a bill at the Pepper subcommittee hearing. Quackery: A $10 Billion Scandal (Hearing), 112-13.
  65. S. 1683, Cong. Record, 95th Cong., Ist sess., 18628; Barrett, The Health Robbers, 254.
  66. NCAHF Newsletter Bulletin Board 8 (June 1985).
  67. H.R. 6049, 6050, 6051, 98th Cong., 2d sess., 21714; Food Chemical News, August 6, 1984, 49-50.
  68. NHF publication cited in NCAHF Newsletter Bulletin Board 8 (June 1985).
  69. NCAHF Newsletter 9 (March/April 1986), 3; NCAHF Newsletter Bulletin Board 8 (June and August 1985).
  70. Stephen Barrett has discussed the NHF program in chapters entitled "The Unhealthy Alliance" in Barrett and Knight, The Health Robbers, 189-201; Barrett, The Health Robbers, 244-56; Herbert and Barrett, Vitamins & "Health" Foods, 116-38 (quotation at 138); and in his The Unhealthy Alliance: Crusaders for "Health" Freedom (New York, 1988).
  71. Quackery: A $10 Billion Scandal (Hearing), 111.
  72. NCAHF Newsletter Bulletin Board 9 (January/February 1986).
  73. Quackery: A $10 Billion Scandal (Hearing), 91.
  74. Barrett, TheUnhealthy Alliance, 7.
  75. James Harvey Young and Robert S. Stitt, "Nutrition Quackery: Upholding the Right to Criticize," Food Technology 35 (December 1981), 42-46, 64.
  76. Gerald E. Markle and James C. Petersen, "Resolution of the Laetrile Controversy: Past Attempts and Future Prospects," in H. Tristram Englehardt and Arthur L. Caplan, eds., Scientific Controversies: Case Studies in the Resvlution and Closure of Disputes in Science and Technology (Cambridge, 1987), 326.
  77. See above, 383-88.
  78. San Francisco District Report, December 9, 1957, San Francisco District File, CF 10 183, John Beard Memorial Foundation, vol. 4, Food and Drug Administration Records (San Francisco).
  79. FDA Drug and Device Notice of judgment 6543 (1960).
  80. Ken Ausebel, "The Troubling Case of Harry Hoxsey," New Age journal, July/August 198, 43-49, 78-79, 86; James A. Lowell, "Hoxsey Treatment Still Available." Nutrition Forum 4 (December 1987) 89-91.
  81. James C. Petersen and Gerald E. Markle, "Expansion of Conflict in Cancer Controversies," in Louis Kriesberg, ed., Research in Social Movements, Conflict and Change (Greenwich, Conn., 1981), IV, 164.
  82. Food and Drug Administration, Laetrile: The Commissioner's Decision (Rockville, 1977), 4-10. Hereafter, FDA, Laetrile. This document is reprinted from the Federal Register, August 5, 1977.
  83. Herbert, Nutrition Cultism, 15-32.
  84. The narrative account of Laetrile is drawn principally from my chapter "Laetrile in Historical Perspective" in Gerald E. Markle and James C. Petersen, eds., Politics, Science, and Cancer: The Laetrile Phenomenon (Boulder, 1980), 11-60.
  85. Herbert, Nutrition Cultism, 23-32.
  86. San Francisco Chronicle, May 13, 1983.
  87. G.D, Kittler, Control for Cancer (New York, 1963).
  88. Gerald E. Markle, James C. Petersen, and Morton 0. Wagenfeld, "Notes from the Cancer Underground: Participation in the Laetrile Movement," Social Science and Medicine 12 (1978), 31-37; Morton 0. Wagenfeld, Yvonne M. Lissing, Gerald E. Markle, et al., "Notes from the Cancer Underground: Health Attitudes and Practices of Participants in the Laetrile Movement," Social Science and Medicine 13 (1979), 483-85.
  89. Thomas H. Jukes testimony, vol. 0-1, FDA Administrative Record, Laetrile, Docket No. 77N-0048; National Nutrition Consortium, Inc., Statement on Laetrile-Vitamin B-17, December 21, 1976; Jukes, "Laetrile, the Bogus 'Vitamin B17,'" in A. Neuberger and T. H. Jukes, Human Nutrition: Current Issues and Controversies (Lancashire, 1982), 233-41.
  90. Testimony of John A. Richardson, Robert W. Bradford, Ernst T. Krebs, Jr., and Bruce Halstead, Banning of the Drug Laetrile from Interstate Commerce by FDA, Hearing before the Subcommittee on Health and Scientific Research of the Committee on Human Resources, U.S. Senate, 95th Cong., Ist sess., 27274. Hereafter, Hearing before Kennedy Subcommittee.
  91. New York Times, May 2, August 16 and 25, 1977, June 7, 1978; Status Report of State Legislative Actions Regarding Laetrile, Public Health Service memorandurn, January 22, 1988.
  92. Rutherford vs. U.S., 399 F. Supp. 1208 (W. D. Oklahoma, 1975); Medical World News, June 28, 1976, 17-20.
  93. 542 F. 2d 1137 (10th Circuit Court, 1976); 424 Supp. 105 (W. D. Oklahoma, 1977); 429 Supp. 506 (W.D. Oklahoma, 1977); 442 U.S. 544 (1979); 616 F. 2d 455 (10th Circuit, 1980); 499 U.S. 937 (1980); FDA, "Laetrile Chronology"; Order No. CIV-75-0218-B, W. D. Oklahoma, March 21, 1987.
  94. Jonathan Brant and John Graceffa, "Ruthetford, Privitera, and Chad Green: Lactrile's Setbacks in the Courts," American Journal of Law and Medicine 6 (Spring 1980), 151-71.
  95. FDA Import Alert, 62-01 Revision, December 7, 1987.
  96. FDA, Laetrile.
  97. Newsweek, June 27, 1977; 60 Minutes, CBS, March 31, 1974.
  98. 98 Atlanta Constitution, August 21, 1975; February 10, April 1, May 13, 1976; April 19, December 8, 1977; February 9, 1978.
  99. G. Edward Griffin, World Without Cancer (Westlake Village, Calif, 1974); Mike Culbert, Freedom from Cancer (Seal Beach, Calif, 1976); John Richardson, Laetrile Case Histories (New York, 1977); Robert Bradford, Now That You Have Cancer (Los Altos, Calif., 1977).
  100. Barrett, The Unhealthy Alliance, 9, 11-12.
  101. Washington Post, June 27, 1977.
  102. Robert Bradford testimony, Hearing before Kennedy Subcommittee, 272, 310.
  103. H.R. 53, Cong. Record, 95th Cong., Ist sess., 127.
  104. Public Scrutiny, 3 (August 1980), 1; J. Richard Crout, "The Drug Regulatory System: Reflections and Predictions," Food Drug Cosmetic Law journal 36 (1981), 106-19.
  105. F.J. Ingelfinger, "Laetrilomania," New England Journal of Medicine 296 (1978), 1167-68.
  106. Neil M. Ellison, et a]., "Special Report on Laetrile: The NCI Laetrile Review," ibid., 299 (1978), 549-52.
  107. Food and Drug Administration and the 95th Congress (Rockville, 1978), 116-17.
  108. Charles G. Moertel, et al., "A Pharmacologic and Toxicological Study of Amygdalin," JAMA 245 (1981), 591-94; Moertel, et al., "A Clinical Trial of Amygdalin (Lactrile) in the Treatment of Human Cancer," New England Journal of Medicine 306 (1982), 201-6.
  109. Science News, May 9, 1981, 293-94.
  110. Moertel, et al., "A Clinical Trial ofAmygdalin."
  111. AtlantaJournal, May 1, 1981.
  112. Irving J. Lerner, "Lactrile: A Lesson in Cancer Quackery," CA 31 (1981), 91-95.
  113. Status Report of State Legislative Actions Regarding Laetrile, 1988 PHS memorandum.
  114. Corey H. Marco, "Why Chad Green Died in Mexico," Legal Aspects Of Medical Practice 7 (December 1979), 35-38; Quackery: A $10 Billion Scandal (Report), 152-53.
  115. Barrie R. Cassileth, "After Laetrile, What?" New England journal of Medicine 306 (1982), 1482-84.
  116. Gary Null, "Alternative Cancer Therapies," Penthouse, November 1979, 107-12, 212.
  117. St. Petersburg Times, July 29-August 1, 1984.
  118. Arthur Hull Hayes, Jr., "Remarks" to the Pharmaceutical Advertising Council, Inc., February 18, 1982.
  119. Hayes, "Remarks" to the Pharmaceutical Advertising Council, Inc., February 17, 1983.
  120. Associate Commissioner for Regulatory Affairs Joseph P. Hile to Policy Board, February 25, 1983.
  121. Arthur Hull Hayes, Jr., to author, August 26, 1982.
  122. Hayes to Policy Board, April 5, 1983; notes taken at FDA Policy Board Quackery Go-Away.
  123. FDA Talk Paper, December 9, 1983.
  124. Food Chemical News, December 5, 1983, 3-4; FDC Reports, December 19, 1983, 10.
  125. FDA Talk Paper, October 15, 1984.
  126. FDA, A Plan for Action (Rockville, July 1985).
  127. Food Chemical News, June 17, 1985, 10-12.
  128. Nutrition Forum 4 (August 1987), 55; Stephen Budiansky, "New Snake Oil, Old Pitch," U.S. News and World Report, December 8, 1986, 68-70.
  129. Halfden Mahler cited in Loretta McLaughlin, "AIDS: An Overview," in New England Journal of Public Policy 4 (Winter-Spring 1988), 15.
  130. In this discussion of AIDS quackery, I follow my paper, "AIDS and Deceptive Therapies," given at the American Association for the History of Medicine convention in Birmingham, April 28, 1989.
  131. Eloise Salholz, "Acting Up to Fight AIDS," Newsweek, June 8, 1988, 42.
  132. U.S. Postal Service memorandum, March 1985.
  133. Environmental Protection Agency memorandum, February 9, 1988.
  134. Angelo J. Aponte speech, Food and Drug Administration audiovisual tape of excerpts from lectures at the National Health Fraud Conference, Kansas City, March 1988.
  135. Angelo J. Aponte lecture, National Association of Consumer Agency Administrators convention, June 12, 1987.
  136. John Renner cited in Janny Scott and Lynn Simross, "AIDS: Underground Options," Los Angeles Times, August 16, 1987.
  137. FDA press release, April 4, 1988.
  138. MacNeil/Lehrer News Hour, PBS, November 6, 1985.
  139. Stuart L. Nightingale, "Immunoaugmentative Therapy," American Family Physician 34 (December 1986), 159-60; "Isolation of Human T-Lymphotropic Virus Type III/Lymphadenopathy-Associated Virus from Serum Protein Given to Cancer Patients—Bahamas," Centers for Disease Control, Morbidity and Mortality Weekly Report 34 (1985), 489-91; FDA Import Alert, August 6, 1986. The FDA's Nightingale had earlier answered the question "Could there be another Lactrile?" with a reluctant affirmative. "Laetrile: The Regulatory Challenge of an Unproven Remedy," Public Health Reports 99 (1984), 333-38.
  140. FDA Health Fraud Bulletin 11, "Immune System Products," August 17, 1987; Stephen Barrett, "Strengthening the Immune System—A Growing Fad," Nutrition Forum 3 (1986), 24.
  141. FDA Health Fraud Bulletin 9, "Colostrum Products," January 15, 1987; Don Colburn, "AIDS and Desperation," Washington Post Health, January 6, 1987.
  142. This subject was probed in Therapeutic Drugs for AIDS: Development, Testing, and Availability, Hearings before a Subcommittee of the Committee on Government Operations, House of Representatives, 100th Cong., 2d sess., April 28-29, 1988. Hereafter, April 1988 House Subcommittee Hearings.
  143. Federal Register 53 (October 21, 1988), 41516-24; Nancy Mattison, "The FDA's Treatment IND: Current Controversies," Pharmaceutical Medicine 3 (1988), 159-71.
  144. April 1988 House Subcommittee Hearings, 396.
  145. Ibid.; Mike King, "Ethics of FDA:s Faster Drug Approval Process Questioned," Atlanta Constitution, January 4, 1988; Erich Stephen Berger, "FDA:s AIDS 'Remedies': Misguided Compassion," Los Angeles Times, August 1, 1988, reprinted in Priorities, Winter 1989, 43-44; George J. Annas, "Faith (Healing), Hope and Charity at the FDA: The Politics of AIDS Drug Trials," Villanova Law Review 34 (1989), 771-97.
  146. Cited in Susan Okie, "AIDS Sufferers Buying Hope," Washington Post, April 3, 1988.
  147. Deputy Commissioner John Norris cited in Food Chemical News, March 21, 1988, 7-8.
  148. FDA Office of Consumer Affairs, "Health Fraud Activities Status Report," February 1987; ibid., 1989.
  149. Ibid.; Consumer Newsweekly, September 16, 1985.
  150. 1988 National Health Fraud Conference Proceedings.
  151. William Jarvis, ibid., 11.
  152. Victor Herbert, ibid., 31. FDA's greater regulatory activity also received comment in "FDA in Battle on Health Food Frauds," New York Times, June 1, 1989.
  153. NCAHF Newsletter, 9 (March/April 1986), 2; 8 (August 1985), 2.
  154. Louis Harris and Associates, "Executive Summary" of national health fraud survey, 1987; FDA, "Health Fraud Activities Status Report," 1989.
  155. 1988 National Health Fraud Conference Proceedings, 3.
    Patterson, The Dread Disease.
  156. San Francisco Chronicle, February 15, 1986, cited in NCAHF Newsletter, 10 (July/August 1987), 2. 15' Rutherford, vol. 11, 308, 315-16, FDA Administrative Hearing, Laetrile, Docket 77N-0048.
  157. Barrie L. Cassileth, et al., "Contemporary Unorthodox Treatments in Cancer Medicine: A Study of Patients, Treatments, and Practitioners," Annals of Internal Medicine 101 (1984), 105-12,
  158. California Medical Association, TheProfessional'sGuide to Health & Nutrition Fraud (San Francisco, 1987), 9.
  159. Clark Glymour and Douglas Stalker, "Engineers, Cranks, Physicians, Magicians," New England journal of Medicine 308 (1983), 960-64.
  160. Stalker and Glymour, Examining Holistic Medicine. See also Gerald E. Markle and James C. Petersen, "Social Context of the Laetrile Phenomenon," in Markle and Petersen, Politics, Science, and Cancer, 151-73; Loretta Kopelman and John Moskop, "The Holistic Health Movement: A Survey and Critique," Journal of Medicine and Philosophy 6 (1981), 209-35; Denise Hatfield, "The Holes in Holistic Medicine," ACSH News & Views 6 (November-December 1985), 12-13.
  161. Marcine J. Cohen, "Medical Social Movements in the United States (18201982): The Case of Osteopathy" (University of California, San Diego, dissertation, 1983), xii.
  162. Thomas H. Jukes to author, August 11, 1978, and March 13, 1990.
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