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

Chapter 19: Turmoil on the Drug Scene

James Harvey Young, PhD


"A . . . unique characteristic [of prescription drugs] is the difference between buyer and orderer; in the words of Chairman Kefauver, 'He who orders does not buy; and he who buys does not order.' . . . Hence in ethical drugs the ability of the ordinary consumer to protect himself against the monopoly element inherent in trademarks is nonexistent. The consumer is 'captive' to a degree not present in any other industry."

—Report of the Kefauver Subcommittee, 1961 [1]

"Americans are now paying the greatest price they have ever paid for worthless nostrums, ineffectual and potentially dangerous devices, treatments given by unqualified practitioners, food fads and unneeded diet supplements, and other alluring products or services that make misleading promises of cure or end to pain.

"It is incredible that a wealthy nation, priding itself on its enlightenment and its thirst for progress, should pay such a heavy penalty for ignorance or lack of adequate enforcement."

—Report of the Williams Subcommittee, 1965 [2]


To combat the menace of quackery, Secretary of Health, Education, and Welfare Abraham A. Ribicoff told the delegates to the 1961 Congress on Medical Quackery, his Department and the American Medical Association could cooperate wholeheartedly. "It is a well-known fact," he also said, "that we do not always agree on every subject-the AMA and myself." [3]

This remark brought a chuckle from Ribicoff's audience, well aware that the power struggle over Medicare, quiescent during the Eisenhower years, was, with John F. Kennedy's accession to the presidency, beginning to heat up. The President would shortly present to the Congress a wide-ranging plan of legislative and executive action to protect more adequately the consumer's interests, a plan in which the tighter control of drugs held high priority. A new period of reform was dawning in America, and central to the design of the New Frontier was improvement of the nation's health. The thrust of the Kennedy years would continue in Lyndon B. Johnson's striving toward the Great Society. "The Department of Health, Education, and Welfare," stated John W. Gardner, one of Ribicoff's successors, in 1966, "is a partner in a historic effort in health, an effort that will mean a more rewarding life for each individual in our society and for society as a whole. But the partnership will work only if all of the elements with which the Federal Government has allied itself enjoy continuing strength and vitality-and that includes state and local agencies, public and private hospitals, professional associations and private practitioners. All of them must play a creative and independent role/" [4]

Ways in which a partnership to curtail the hazards of pseudomedicine might enhance the public health had formed the agenda of the 1961 Congress on Quackery. But as the overall drug problem was coming to be viewed, quackery was only one of many serious issues which required attention. As to prescription medication, critics were charging, the chemotherapeutic revolution had produced a "therapeutic nightmare." [5]

Academic physicians initiated the criticism, and their somber judgments were picked up by lay journalists and Congressional committees. No one denied the tremendous benefits that a generation of new drugs had brought in saving lives, easing pain, reducing the population of mental hospitals. But the valuable new therapeutic agents had proved to be so powerful that, when improperly used, grave consequences, sometimes long delayed, ensued. Some patients, because of personal idiosyncrasies, could not take drugs others could use with safety and displayed dangerous, sometimes fatal, reactions. Some drugs had cumulative toxic effects. Other drugs, once effective, lost their value as germs mutated into new and resistant strains. Drug-induced ailments of various kinds became an increasingly urgent problem as the statistics of "therapeutic misadventure" mounted.

Some risk was inevitable in drug therapy, the critics said, a chance necessarily taken when striving to achieve a cure. But various developments had ballooned the risk beyond all need. Many practicing physicians must share in the blame. They sometimes prescribed drugs when none was needed. They used too potent and hazardous drugs for conditions which might be served by medicines less potent and hazardous. They tried out new therapeutic agents without adequately informing themselves about the potential dangers in their use. To be sure, the task of keeping up to date was well-nigh impossible for the average doctor. New drugs were marketed in such a bewildering array and in such numbers—some 400 a year—that had a doctor sought to read all the pertinent scientific literature, much of which, in any case, was published after the drugs became available for use, he would have had no time to see his patients. What bothered the academic critics most was that too many physicians did not resort to the most authentic sources to keep themselves informed. They relied too heavily on the promotional literature with which they were deluged by pharmaceutical manufacturers and on the counsel of these companies' traveling salesmen, called detailmen.

Drug manufacturers received sharper criticism than did doctors. To be sure, they were engaged in a highly competitive business with wares that rapidly became obsolete. Much of their expensive research seeking to find new agents of value went for nought, since most prospective medicines turned out to be ineffective or too toxic to market. Thus, when they found a drug that showed commercial promise, they wanted to cash in on it before another drug from another pharmaceutical house replaced it. Critics charged, indeed, that too little of the research budget of such companies went for basic research to seek genuinely needed new drugs and too much of the budget went for seeking minor modifications, which might be patentable, of competitors' drugs that had achieved outstanding commercial success. Critics also held that, in the rush to get drugs to the market, some pharmaceutical manufacturers did not engage in adequate testing programs, either in animals or in man, to establish as securely as was desirable the safety and efficacy of their new wares. Some of the clinical testing that took place, critics believed, smacked more of promotion than of science, being an effort to acquaint doctors with the product prior to its release for sale by the FDA.

New prescription drugs had as part of the labeling enclosed with each package a brochure, which the FDA had to approve, describing the therapeutic indications for the drug's use, informing about the proper dosage patterns, and also providing warnings and contraindications. But, since the drug went from the manufacturer to the pharmacist, many doctors did not see this brochure as a matter of course. A few companies mailed copies to physicians, but many did not. They did send, however, lavishly printed literature stressing the drug's merits but playing down, or omitting altogether, commentary on the risks. Nor did drug advertising in most medical periodicals provide a balanced picture of the good and bad. Some detailmen, it was discovered, had been instructed, even after a new and more vigorous warning had been required in a drug brochure by the FDA, to minimize the warning in their conversations with physicians. Pharmaceutical companies were also guilty, the critics said, of placing research papers in medical journals that fell far short of meeting sound scientific canons. And the companies sometimes went to elaborate lengths to plant stories of some soon-to-be-released drug in the popular press or in a family magazine, presumably with the hope that patients would bring pressure on their doctors to prescribe it.

Pharmaceutical companies, moreover, the more severe critics held, charged too high a price for drugs. Drug industry profits ranked highest among all American industries, and promotional costs were certainly near the top, needlessly high. Trade-name pharmaceuticals which were patented held the same price level for years, despite economies of production, and sometimes this occurred when there were several trade-name pharmaceuticals made by different companies useful for essentially the same therapeutic purposes—they all remained for a long span of time stable in price, a price virtually identical from brand to brand. Institutional buyers, such as governmental agencies, sometimes found that bids for contracts from several competing companies were identical; at other times, it seemed, bids revealed that companies could make profits from drug prices incredibly lower than those the individual consumer was required to pay.

Whatever the degree of validity in these various charges and they launched a great debate as the groups criticized sought to defend themselves—it was apparent that much was amiss. Instances of greed, deception, and inexcusable carelessness were definitely established. But basically the revelations during these years showed that old ways were not sufficient for a new day. All along the line, from the discovery and testing of new drugs to their promotion, prescribing, and use, a caution, a scientific sophistication, was demanded much beyond the level required in the era before the wonder drugs had appeared. The speed with which the chemotherapeutic revolution had remolded therapy, the complexity of the chemical and physiological problems involved, the optimism warranted by the new drugs' lifesaving potency which tended to becloud the sober later awareness of the risks had created the need for agonizing reappraisal. This reappraisal took place in full public view, for news of the dangers inherent in drug use came to concern the nation's people as earlier news of drug miracles had cheered them. What came to seem like guilt, from the perspective of the new criticism, had been in some measure an unawareness of the high level of scientific rigor required in the production and use of the new therapeutic agents.

While there had been some popular writing on this crucial theme earlier, and the Blatnik subcommittee had concerned itself with tranquilizing drugs, the hearings presided over by Senator Estes Kefauver, between December 1959 and September 1960, made headlines that turned prescription drug practices into a national issue. The Tennessee Senator introduced a strong remedial bill, but, despite the public concern his hearings had aroused, the bill, weakened by amendment, languished in the Senate Judiciary Committee. As prior to 1906 and 1938, it was to take a stupendous threat to the public health-this time, happily, a "might-have-been"—to ensure legislative action [6].

The Food and Drug Administration did not escape unscathed during the agonizing reappraisal. The Citizens Advisory Committee of 1955 had urged a marked improvement in the FDA's scientific competency, through increasing the stature and prestige of the professional staff inaugurating greater cooperation with other federal health agencies, and engaging in more research on the side effects of dangerous drugs. Other CAC suggestions aimed at helping industry by expediting the processing of new drug applications. Later critics wondered if the FDA had not helped business much too much at the expense of the drug-consuming public. In conformity with the general governmental climate during the Eisenhower years, relations between the regulators and the regulated had been generally cordial. In retrospect, from a more reformist perspective, this seemed a fault. Some FDA doctors, processing new drug applications, believed that industry representatives had exerted too great and constant pressure on them to rush the applications through, and thought also that their own administrative superiors had not shielded them adequately from such pressure. The entire agency, in its posture toward business, was brought under a cloud as a result of a revelation made by the Kefauver subcommittee. Following up a clue presented by John Lear in the Saturday Review, the subcommittee discovered that FDA's director of the Division of Antibiotics, Dr. Henry Welch, had engaged in an enterprise that certainly aroused the suspicion of conflict of interest. Dr. Welch had secured permission from his superiors to edit two journals in his field in exchange for an "honorarium." No one had raised the question as to what size this presumably modest sum might be. As it turned out, Dr. Welch had received, during a seven-year span, an amount exceeding $280,000. This income came mainly from a percentage on drug advertising carried in the journals and a percentage on reprints of journal articles bought by drug manufacturers for use in their promotion. Although scrutiny by a blue-ribbon committee selected by the National Academy of Sciences revealed no evidence that Welch's "honorarium" had influenced his official decisions in evaluating antibiotics, the Welch case obviously injured the FDAs prestige and made it easier to interpret the agency's relationships with business in a critical light [7].

The lack of sufficient scientific competence within the FDA received increasing criticism. A new Citizens Advisory Committee in 1962 rebuked the agency for having failed to follow up adequately suggestions for strengthening its scientific resources made by the earlier committee in 1955. Nor did scientists within the agency, medical and Congressional critics charged, carry the weight they should have in making key decisions. "The Food and Drug Administration," Senator Hubert H. Humphrey asserted, "has been looked upon as a 'police' department, rather than as an agency of scientists and other professionals with a broad variety of health-related skills." Drugs had been approved which the FDA admitted should not have been, because proof of their safety had not been adequately demonstrated. Drugs had been kept on the market long after accumulating evidence had shown their hazards. Perhaps if scientists had played a more decisive role in the decision-making, such contingencies would not have occurred. "The New Frontier," said Humphrey, had "yet to make its mark on . . . [the] 54-year-old effort" to regulate food and drugs. "The Food and Drug Administration should be upgraded. There should be some 'new blood,' some new endeavor, some new action, some new spirit." [8]

Humphrey's Congressional inquiry, which revealed some of the FDA's shortcomings in evaluating new drugs, had arisen, ironically enough, from one of the agency's great triumphs. The shrewdness and firmness of an FDA woman physician had kept the United States from sharing in a terrible medical disaster.

A drug with the generic name thalidomide had been marketed in West Germany in 1957, By 1960 its sales had skyrocketed and, through leasing arrangements between the manufacturer and foreign drug companies, thalidomide had become purchasable in Britain, Canada, Portugal, and other countries. Used as a sleeping tablet, sedative, and anti-emetic in pregnancy, thalidomide became renowned for a certain sort of safety: unlike most other sedatives, it did not, when taken intentionally or accidentally in large doses, cause death. In September 1960, after nearly two years of animal and clinical testing, an American drug company submitted to the FDA a new drug application to market thalidomide under the trade name Kevadon. So confident of quick approval was the company that it gathered key detailmen together the next month to send them forth on a major pre-clearance campaign of lining up hospital doctors for a final round of clinical trials. The purpose, in a minor way, was "confirmation" of thalidomide's already established usefulness, the salesmen were informed. "But the main purpose is to establish local studies whose results may be spread among hospital staff members. You can assure your doctors that they need not report results if they don't want to. . . ." In all, more than 1,200 investigators were given free samples, nearly 20,000 patients treated [9].

But in the FDA's Division of New Drugs, Dr. Frances O. Kelsey, who was given the application to process, did not believe that the evidence submitted by the company demonstrated beyond question the drug's safety. Despite a succession of letters, phone calls, and personal visits from company officials, she would not grant acceptance and asked for more data. Her precautionary hunch was confirmed by a doctor's letter to the editor in the British Medical Journal, wondering if thalidomide might not be responsible for four cases he had observed of peripheral neuritis, a deterioration of the nerves in the bands and feet. A similar discovery in West Germany led to the changing of thalidomide's status from over-the-counter to prescription sale. Dr. Kelsey wondered, if thalidomide produced such an ailment, might it not be hazardous to the unborn child?

About the time the American drug company was briefing its detailmen, two cases of phocomelia were presented by a German doctor to a pediatric convention. As an American physician later reported the episode, "Photographs and X-ray pictures showed that the long bones of the infants' arms had almost completely failed to grow; their arms were so short that their bands extended almost directly from their shoulders. Their legs were less affected but showed signs of a similar distortion of growth. Both infants were also marked by a large hemangioma (strawberry mark) extending from the forehead down the nose and across the upper lip; one of them was also found to have a duodenal stenosis, that is, a constriction of the beginning of the small intestine."" Phocomelia, a name derived from two Greek words meaning "seal" and "limb," had been so rare an affliction that most doctors had never encountered it during a lifetime of practice. But babies by the hundreds began to be born in Germany thus terribly malformed. By November 1961, a German physician suspected the culpable agent to be thalidomide taken during the first three months of pregnancy. Hearing a rumor of this widespread affliction, Dr. Helen B. Taussig, of the Johns Hopkins University pediatrics department, went to Germany immediately for an investigation on the spot and came home to spread the word through letter, public address, and print of thalidomide's horrifying potentiality. Dr. Kelsey went to Baltimore to learn first-hand from Dr. Taussig her disquieting intelligence. On March 8, 1962, the American drug company asked Dr. Kelsey that its new drug application be withdrawn.

Had Dr. Kelsey been less adamant and had Kevadon been released, some 10,000 deformed babies would have been born in the United States before the danger was known. That a smaller-scale disaster did not take place was remarkable, considering the widespread distribution of Kevadon by the American company to clinical "investigators." Much of the record-keeping by these doctors was non-existent or shoddy, and the FDA had a difficult task making sure that all supplies of the drug had been recalled or destroyed. As it was, only a few cases of phocomelia occurred in America, mostly from thalidomide secured abroad.

The story of Dr. Kelsey's determined opposition to the marketing of thalidomide was first publicly reported by Morton Mintz in the Washington Post in mid-July. This news story precipitated a tidal wave of national publicity and numerous editorials of gratitude for Dr. Kelsey's perceptive contribution to the American people. President Kennedy presented her with the Gold Medal Award for Distinguished Civilian Service. The thalidomide episode focused scientific attention on the problem of teratogenicity: could other drugs taken during pregnancy also make monsters of babies who would be born?

The episode also called into question anew, as during Senator Humphrey's hearings, the practices of drug companies in testing their drugs prior to marketing and the procedures by which the Food and Drug Administration evaluated drugs which they released for sale. The FDA issued new regulations seeking to control clinical testing sponsored by manufacturers prior to their submission of new drug applications. If the FDA had had such authority under the 1938 law, Senator Humphrey questioned, why, in view of the way thalidomide had been distributed for testing to so many doctors who could by no means be classified as "experts," had not the agency promulgated such regulations much earlier?

The thalidomide near-disaster, like the meat-packing scandals of 1906 and the sulfanilamide tragedy of 1937, forced the Congress to enact a major new protective law. The languishing bill was revived, its weakened clauses restrengthened, and on October 10, 1962, the Kefauver-Harris Drug Amendments passed both Houses of Congress unanimously. Although provisions dear to Senator Kefauver's heart aimed at reducing drug prices did not find their way into the law, the measure markedly improved the FDA's control over the marketing and promotion of prescription drugs. Henceforth the FDA must approve all plans for clinical testing, must be assured that clinical investigators were scientifically qualified to conduct the tests. An investigator was required to inform his patient that he was taking part in an experiment involving an investigational drug unless, in the doctor's judgment, this was not feasible or would not be in the patient's best interest. The new law also required that no new drug could be released to the market unless the manufacturer had submitted to the FDA substantial evidence that the drug was not only safe—the 1938 law had required this—but also efficacious for treating the ailments for which it was designed as therapy. Both during clinical trials and after marketing, drug companies were required to notify the FDA immediately—as they had not always done before—should they receive reports of any adverse effects caused by a drug. All drug manufacturers were required by the new law to operate according to good manufacturing procedures, and the scope of the FDA's factory inspection was enlarged in plants making prescription drugs. An effort failed to put into the law the same inspection rigor for plants making proprietary products. Pre-marketing certification by the FDA was expanded from five antibiotics to all of them. And prescription drug advertising, hitherto the Federal Trade Commission's prerogative, was brought within the jurisdiction of the FDA. Each advertisement was required henceforth to present truthfully a brief summary of known side effects and contraindications, as well as information about the drug's effectiveness [12].

As Food and Drug Administration officials sought to implement the new law, they did so in a goldfish bowl. Seven years before the public may have been largely unaware of the agency and its mission, but the Kefauver bearings, the thalidomide headlines, and the new law greatly enhanced the newsworthiness of the agency. In the years that followed, reporters and Congressional committees kept the FDA under constant and critical scrutiny [13].

Such was the broader drug scene within which the continuing contest with medical quackery took place. Amid all the testifying about prescription drug difficulties that preceded the 1962 law, Congressional committees occasionally beard the shortcomings of over-the-counter medication mentioned. Arthritis and Rheumatism Foundation spokesmen, for example, described for the Kefauver subcommittee the broad range of deceptive remedies offered for direct sale to arthritis sufferers. And the editorial director of Consumers Union, Mrs. Mildred Brady, expressed her sympathy with the doctor's dilemma. "We who listen hours a day," she said, "to the conflicting claims made by various brands of deodorants, cold remedies, toothpastes, hair dyes, headache remedies and laxatives—claims made frequently by the same companies who also promote and sell brand name prescription drugs to doctors—we television viewers and radio listeners cannot help but feel a sympathetic uneasiness for our physicians, subject as they are to.equally intensive and extravagant hard sell directed at them." [14]

The main thrust of the hearings, however, as of the law, aimed at abuses associated with prescription drugs. The new law, nonetheless, provided important weapons against quackery. The new proof-of-efficacy pre-marketing standard applied to all drugs, not just prescription products. No promoter could henceforth seek to sell direct to the lay public any new drug that had not met this rigorous provision without quickly facing a Food and Drug action he could not hope to win. Nor would it any longer be possible for a specious promotion to masquerade for years "under the guise of pre-marketing clinical trials, distributing medicine" in exchange for a "contribution" to help cover the firm's expenses, a contribution that might really include a large margin of profit. Now the promoter would have to present to the FDA his plan for clinical trials and must persuade the agency that his experts were properly qualified, or else stop distributing his wares in interstate commerce. On this rock were wrecked the hopes of Krebiozen, Proved by FDA scientists to be nothing more than mineral oil and creatine, a common laboratory chemical. A committee of 24 cancer experts, chosen by the National Cancer Institute, reported in 1963, after surveying the records of 504 patients treated with Krebiozen, that the drug was ineffective in treating cancer. The committee strongly recommended that no clinical trial was warranted. Dr. Durovic filed with the FDA a plan for the investigational use of Krebiozen, required by the Kefauver-Harris law. But a month later Durovic withdrew his plan. Thus he failed to meet the new law's standard and could no longer distribute Krebiozen as an investigational drug across state lines. This ban held, even though the government failed to convict Krebiozen's promoters in a criminal case decided by a Chicago jury in 1966 [15].

In a pioneering case under the Kefauver-Harris law, the Food and Drug Administration took successful action against another unproved cancer remedy, Mucorhicin. This substance, extracted from a mold grown on a mixture of wheat, salt, yeast, and water fermented in a pan, had neither been proved effective nor been produced under good manufacturing practices. So it too was barred from interstate commerce [16].

The 1938 law formed the legal basis for precedent-setting victories in the device and nutritional fields: the Micro-Dynameter and Vitasafe cases broadened the scope of the FDA's control over these critical areas. It began to appear as if the Food and Drug Administration, through the new law and accumulating judicial precedents, had gained enough legal authority to prevent the promotion of an unquestionably ineffective drug. aimed at the consumer market from growing to gigantic proportions, as had so often happened in the past [17]

A myriad of small and borderline deceptions, however, continued and were born anew: a Cincinnati promoter, for example, advertised that he could counteract the hazardous effect of thalidomide. Legal procedures still could drag. FDA resources, while expanding, hardly kept up with its growing obligations. Quackery practiced solely within the borders of the individual states remained immune to federal restraint. "In my experience," stated John W. Miner of California, the only prosecutor in the nation specializing in medicolegal crimes, "less than 10% of quackery cases could be filed in federal courts or reached by federal agencies." Speaking before the Third National Congress on Medical Quackery held in Chicago in 1966, Miner termed earlier estimates of quackery's financial toll too low. "An overall annual quackery take of two or more billion," be asserted, "would be a reasonable guess." Quackery "channels an amount equal or more to 2% of our national budget into the pockets of criminals." [18]

Other experts, seeking to balance regulatory gains and losses agreed that quackery had not diminished in size. Henry B. Montague, Chief Postal Inspector, thought fraudulent scheme still on the increase. Tle Arthritis Foundation, in 1966, raised its estimate of the annual sum spent by arthritics on misrepresented wares to a new high of $310 million. AMA headquarters, judging by letters of complaint received, considered cancer quackery the number one medical fraud, and the American Cancer Society issued its updated survey of the wide range of unproved remedies from whose appeals victims—or frightened self-diagnosers—of cancer might choose [19].

Thus, despite very real regulatory gains, quackery remained a major social problem, "a criminal activity as harmful as any in society" in John Miner's words, "but against which the law has done the least." And despite mounting campaigns to warn the public against the hazards of pseudo-medicine, many citizens of this "wealthy nation, priding itself on its enlightenment and its thirst for progress,' continued to hunt health in unenlightened ways. What was there about John Doe that made him such a perennial victim? [20]

References

  1. Administered Prices: Drugs, 87 Cong., I ses., Senate Rep. 448 (1961), 3.
  2. Frauds and Deceptions Affecting the Elderly, 89 Cong., I ses., Committee print of a report of the Subcommittee on Frauds and Misrepresentations Affecting the Elderly to the Special Committee on Aging, United States Senate (1965), 1.
  3. Proceedings, National Congress on Medical Quackery, 3.
  4. N.Y. Times, Mar. 16, 1962; Gardner, "The Creative Partnership for Health," Medical Tribune, June 22, 1966, 1, 11.
  5. Morton Mintz used The Therapeutic Nightmare as the title for his book critically surveying the period (Boston, 1965). The discussion below is derived mainly from two sets of Senate committee hearings, presided over by Senators Estes Kefauver and Hubert Humphrey respectively; the printed hearings contain not only the testimony of witnesses but also a rich assortment of documents taken from the files of pharmaceutical manufacturers and of the FDA, as well as a reprinting of articles from the press and many journals: Administered Prices: Hearings before the Subcommittee on Antitrust and Monopoly of the Committee on the Judiciary, United States Senate (86 Cong., I and 2 ses.), Parts 14 through 26 (1960-1961), cited below as Kefauver hearings; Interagency Coordination in Drug Research and Regulation: Hearings before the Subcommittee on Reorganization and International Organizations of the Committee on Government Operations, United States Senate (87 Cong., 2 ses., and 88 Cong., I ses.), Parts I through 4 (1963-1964), cit~d below as Humphrey hearings. See also the essays in Talalay, ed., Drugs in Our Society, and Louis Lasagna, The Doctor's Dilemmas (N.Y., 1962).
  6. False and Misleading Advertising (Prescription Tranquilizing Drugs). Hearings before a Subcommittee of the Committee on Government Operations, House of Representatives (85 Cong., 92 ses., 1958). An illuminating account of the Kefauver hearings and of the legislative history of the Kefauver bill, written from a position of sympathy with the Tennessee Senator's objectives, is Richard Harris, The Real Voice (N.Y., 1964).
  7. Pertinent excerpts from the 1955 Citizens Advisory Committee report and from a series of internal and external critiques of FDA during the years that followed are brought together in the Humphrey hearings, Part 2. Kefauver bearings, Parts 22 and 23, are concerned with the Welch case, John Lear, "The Certification of Antibiotics," Sat. Rev., 42 (Feb. 7, 1959), 43-48.
  8. Citizens Advisory Committee, Report to the Secretary of Health, Education, and Welfare on the Food & Drug Administration (Washington, 1962); excerpts in Humphrey hearings, Part 2, 428-47. Humphrey cited, ibid., 583, 588.
  9. Humphrey hearings, Parts I and 2, are concerned with the thalidomide case, and contain not only testimony but a vast assortment of documents, including reprinting of comment from magazines and the press. The William S. Merrell Co. document appears in Part 1, 259-70.
  10. Helen B. Taussig, "The Thalidomide Syndrome," Scientific American, 207 (Aug. 1962), 29-35, reprinted in the Humphrey hearings, Part 1, 108-14.
  11. July 15, 1962.
  12. 76 Stat. 780; Harris, The Real Voice, passim; George P. Larrick, "Appraising Drug Safety and Efficacy," Emory University Qtly., 21 (Summer 1965), 88-96.
  13. For an example of hearings, see Drug Safety: Hearings before a Subcommittee of the Committee on Government Operations, House of Representatives (88 Cong., 2 ses.), Parts I and 2 (1964).
  14. Kefauver hearings, Part 14, 7975-94; Part 21, 11536.
  15. George P. Larrick, "Changes in the Status of Proprietary Drugs under Federal Law, , mimeographed text of May 11, 1964, address; CA—A Cancer Jnl. for Clinicians, 13 (1963), 76-78; Dept. of HEW release, Oct. 16, 1963; Medical World News, Aug. 2, 1963, 41, and June 3, 1966, 25. Newsweek, 67 (Feb. 14, 1966), 65-66; American Cancer Society, Unproven Methods of Cancer Treatment, 62-64. An expert summary of the Krebiozen events, entitled "The Krebiozen Story; Is Cancer Quackery Dead?," was presented on Oct. 7, 1966, to the Third National Congress on Medical Quackery by Dr. James F. Holland of the Roswell Park Memorial institute of Buffalo, Papers, Third National Congress on Medical Quackery (Chicago, 1967), 48-59.
  16. Cal 11 (1961), 17-18; FDA release, Mar. 7, 1964.
  17. Micro-Dynameter: see ch. 11; Vitasafe: 226 Fed. Supp. 266 (1964); 235 Fed. Supp. 84 (1964); 345 Fed. (2d) 864 (1965); 382 U.S. 918 (1965).
  18. F&D Rev.2 47 (July 1963), 191; Miner, "The Costs of Quackery," mimeographed text of Oct. 8, 1966, address.
  19. Health Frauds and Quackery, Hearings before the Subcommittee on Frauds and Misrepresentations Affecting the Elderly of the Special committee on Aging, United States Senate (88 Cong,, 2 ses., 1964), Part 3, 286; Medical Tribune, July 23-24, 1966, 15; American Cancer Society, unproven Methods of cancer Treatment.
  20. Miner, "The Costs of Quackery"; Frauds and Deceptions Affecting the Elderly, 89 Cong., I ses. (1965), 1.

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