The Medical Messiahs:
A Social History of Health Quackery
in Twentieth-Century America
Chapter 12: The Chemotherapeutic Revolution
James Harvey Young, PhD
"When an untrue or misleading health claim is deliberately, fraudulently or pretentiously made for a food, drug, device or cosmetic, this is quackery. . . .
"It matters not whether the quackery is practiced by the witch doctor or the licensed medical practitioner; the Indian medicine man or the pharmacist; the proprietary drug manufacturer or the prescription drug manufacturer; . . . the health lecturer . . . [or] the doorstep diagnostician—It is still quackery."
—Dr. Kenneth L. Milstead, 1963 
The quarter century following the enactment of the Food, Drug, and Cosmetic Act of 1938 witnessed a revolution in the drugs which doctors prescribed for ailing patients. So vast was it in scope, so significant in repercussions, this revolution ranks as one of the major events in medical history. Its side effects for self-medication were bound to be enormous.
That same sulfanilamide, whose disastrous mixing with a poisonous solvent had led to the "new drug" provision in the 1938 law, heralded the day of miracle drugs. Sulfanilamide fulfilled the hope of Paul Ehrlich, early in the century, for a specific drug to combat bacterial infection. While important discoveries had been made—insulin for diabetes, the use of liver extract to treat pernicious anemia—efforts between 1915 and 1935 to duplicate the specificity of Ehrlich's pioneer antisyphilis drug had proved discouraging. The 1920's were "doldrum years" in chemotherapy. Many authorities spoke of the outlook as barren .
But sulfanilamide, with its amazing ability to conquer various staphylococcal and streptococcal infections, renewed hope. Franklin Roosevelt, Jr., desperately ill with a "strep" infection, was given the drug and quickly recovered. In the previous decade, Calvin Coolidge's son, under similar circumstances, had died. Hundreds of Americans, like young Roosevelt, survived previously fatal infections when treated with sulfanilamide, a product of German and French research. Other sulfonamides followed in the years ahead, drugs so effective that the original sulfa became obsolete .
With World War II came penicillin. In searching for drugs to combat infections in war wounds, British scientists turned back to the accidental discovery of Alexander Fleming in 1928. Fleming had observed that a common mold, contaminating his culture plate of staphylococcal germs, had killed the germs. But he had been unable to concentrate the beneficent lethal force exuded by the mold. In the early war years, Howard Walter Florey and his associates succeeded somewhat better. Growing the mold on broth in outmoded bedpans, they managed to isolate a very small quantity of penicillin for a clinical trial. In February 1941 a London policeman, gravely ill with an infection, was given the drug. He rallied remarkably, but the drug supply ran out. The patient relapsed and died. New supplies of penicillin, tediously prepared, proved, with children, the drug's lifesaving potency. Florey came to the United States, seeking help in getting penicillin mass-produced .
Major American pharmaceutical manufacturers were ready for this challenge. Their own growing research potential had been quickened by the demands of the 1938 law's "new drug" requirements. Research staffs were expanding to provide the safety data demanded by the Food and Drug Administration before it would permit a new drug to be marketed. Know-how was increasing with respect to synthetic techniques and production methods. Under governmental sponsorship, a crash program succeeded in making penicillin cheaply and in large quantities. From 29 pounds produced in 1943, the output expanded until sufficient supplies were available for the Normandy landings of the Allied invasion forces. During the war, as Austin Smith, a president of the Pharmaceutical Manufacturers Association later observed, the American pharmaceutical industry came of age .
In the postwar years penicillin, first isolated and then synthesized, was made by the hundreds of tons. Penicillin was followed by other antibiotics, by anti-malarials, synthetic vitamins, new and improved vaccines, steroid hormone-like compounds, antihistamines, tranquilizers, and other potent therapeutic agents. Dickinson W. Richards, a Nobel laureate, has summed up the impact of these new drugs on health: "the long way that we have come toward control of streptococcal, pneumococcal, even staphylococcal infections, of Gram-negative infections of many varieties, of syphilis, gonorrhea, tuberculosis, malaria, plague, yellow fever, cholera, typhus and typhoid, poliomyelitis and measles, towards the partial relief of arthritis, asthma, lupus, skin affections, nervous and mental diseases of many forms, and so on down the line. In addition, there are the new and most useful agents to control particular aspects of acute or chronic illness, such as the anticholinergic drugs in gastrointestinal diseases, and the antihypertensive drugs, and the remarkably effective new diuretics .
Life expectancy at birth in the United States had been 60 years in 1937, when sulfanilamide appeared. By 1956 it had risen to almost 70 between 1938 and 1950 as between 1921 and 1937. Infants, children, and young adults had benefited most. The death rate from childhood diseases had tumbled 90 per cent. Almost as dramatic were declines in the death rates for influenza-pneumonia and for infectious diseases. "How much value can we place on 3.2 million American lives?" asked Austin Smith rhetorically in 1959. "These are the lives that can be attributed in large part to the chemical revolution in medicine." 
Drugs discovered during this revolution dominated the market. Ninety per cent of the prescriptions written by doctors, noted the FDA Annual Report in 1956, called for drugs not commercially available when the new drug safety clearance required by the 1938 law went into effect. And the new drugs prescribed were curative "high-powered bullets" unlike the "old-fashioned shotgun medication to alleviate symptoms" which had dominated the prerevolutionary era. Of the thousands of drugs marketed in earlier times, only about a hundred, asserted a pharmacologist in 1928, were "by common consent deemed essential for treating the sick." Other authorities thought the basic list should be much more limited than that. In the new day, pharmaceutical manufacturers accelerated a trend already started, curtailing production of botanical medicines, to concentrate on the new and potent chemical agents. One firm, Smith Kline & French, for example, had marketed some 15,000 products during the 1920's; by the late 1950s their line contained fewer than 60 .
If drug entities were fewer, the total market was vastly expanded. The tendency toward therapeutic nihilism was reversed. With truly effective drugs, doctors prescribed—in time overprescribed—and pharmaceutical production boomed. In the early 1930's Americans spent less than $200,000,000 for prescription medication; by 1957 the sum had reached $2,000,000,000. Problems would arise in time to cast some shadows over the new miracle of prescription drugs, problems of prices and profits and promotion, problems of unexpected side effects and adverse reactions, problems of bacterial strains developing a resistance to drug action. But the chemotherapeutic revolution, with its unquestioned benefits for public health, had ushered in a new and irreversible age .
The double pressure of this revolution and the new and stricter law posed for proprietary manufacturers many crucial problems. Major proprietors, under constant urging from Proprietary Association officials, made such haste to bring their labeling within the bounds of legal rectitude that they won commendation from Food and Drug officials. Of 284 actions taken by FDA against proprietaries for human use in one seven-year span, only four belonged to Proprietary Association members. Commissioner Crawford, addressing the Association, was willing to grant that most violations "by honest and well-intentioned manufacturers" arose "from inadvertence, accident, or thoughtlessness." Relations were so friendly that FDA officials helped the Proprietary Association prepare an industrial film on the proper uses of self-medication .
But many proprietary formulas in wide use when the new law came into effect relied heavily on the same botanicals that were dropping from the pages of official pharmacopeial volumes and becoming outmoded in prescription medication as the drug revolution surged on. Nor did important segments of the proprietary industry expand research facilities to the same extent, in order to establish the efficacy of products on the market and to find new ones, that pharmaceutical manufacturers did. Prior to 1938, Frederick Cullen, the Proprietary Association's medical consultant, said, "true research was extremely spotty." The Association sought to encourage research, and conditions improved. But two decades later Cullen thought not all investigation was as thorough as might be, some of it aimed primarily at discovering data that might be used to counter criticism of therapeutic claims should this arise. The ratio of research cost to sales for drug products sold direct to consumers was only a third that for prescription pharmaceuticals. Critics outside the industry also were somewhat skeptical. Dr. Albert B. Holland, Jr., head of FDA's Division of Medicine, addressing the Association in 1958, posed for proprietors the frank question, "How many proprietary products are actually supported by good, sound scientific data?" His answer was not reassuring. Too many proprietaries, be judged, were still "not acceptable for advertising in first-rate medical journals." Too few "good papers on proprietaries" appeared in the medical literature. Holland urged an expansion of solid research, not the "all-too-common 'cookbook' paper for promotional purposes only." 
Thus there was some threat to traditional proprietaries because of inadequate scientific undergirding for their efficacy. Sometimes the threat was countered by changing the formula, while retaining the trade name, introducing new ingredients developed through research. Often, as in the early days of the new law, label claims were sharply restricted to avoid the "false and misleading" charge.,
Traditional proprietaries confronted other pressures during the chemotherapeutic revolution. Pharmaceutical manufacturers themselves began to enter the self-medication field. Not all of the new discoveries in their ever-expanding laboratories turned out to be drugs requiring the prescription legend. The 1938 law was "ambiguous" regarding the line between prescription and self-medication drugs. Food and Drug Administration policies restricted most medicines cleared through the "new drug" procedures—like the sulfonamide successors of sulfanilamide—to the doctor's prescription pad. But the FDA also insisted that, if a drug could be used safely by laymen when labeled with adequate directions, that drug should be released for self-medication sale. Many pharmaceutical companies marketed "over-the-counter" drugs, sometimes restricting their promotion to doctors and druggists, but increasingly advertising them, through the press, magazines, radio, and television, direct to the lay public .
Indeed, the distinction that had once existed between ethical drugs and proprietaries began to break down, both on scientific and corporate grounds. Prescription drugs as well as self-medication items could be "brand name specialties" and hence proprietary articles, each the exclusive property of a single manufacturer: by 1959, of the 409 drugs most prescribed in the nation 83 per cent were brand-name specialties and only 17 per cent generic-name drugs. For reasons both of the best utilization of research and of economic stability, large corporate complexes that marketed both prescription and self-medication drugs developed. A drug trade attorney sought to explain this trend .
"There was a time," James F. Hoge asserted, "when proprietary manufacturing was separated completely from the pharmaceutical; when one was east and the other west and when ne'er the twain would meet. Now the time has apparently come when manufacturing interests look to proprietary products for stability, for balance. Pharmaceutical products are, by their nature and in the circumstances of their use, more dramatic and spectacular. But likewise they are more liable to obsolescence; are more susceptible to new, quick and sensational discoveries; to revolutionary research developments." During years when pharmaceuticals "leveled off" in sales, the steady sale of proprietaries proved a decided financial asset. "The time is at hand," Hoge said, "when there is more than a meeting of the twain. There is actual merging. . . ." 
There were two avenues that merged to reach the same goal. Pharmaceutical companies launched proprietary remedies and acquired control of established proprietary firms. Proprietary companies began marketing prescription drugs and purchased pharmaceutical concerns. The result was the appearance of large and growing diversified firms, making and marketing drug products of all types—as well as cosmetics, toilet articles, egg dyes, and what not. Nor did merging stop at this point. Manufacturers whose major products had been razors, chemicals, liquor, petroleum, soap, sundries entered the drug field. A significant share of proprietary medicine sales, as time went on, fell to the lot of a handful of the large diversified producers. By 1956 five companies controlled over two-fifths of the American proprietary market .
This market was large, surpassing a billion dollars before the end of the 1950's. But proprietaries were not maintaining their proportionate share of the total drug market. Early in the century proprietaries outsold prescription drugs by over two to one, and by the eve of World War II sales of the two types were roughly even. After two decades of the chemotherapeutic revolution, however, the prescription drug market had become three times as large as that for proprietary drugs. Furthermore, over-the-counter pharmaceuticals were gaining business at a more rapid rate than were the old-line proprietaries. And proprietary sales were not keeping pace with increases in population or in consumer spending .
The role of legitimate self-medication had shrunk with the 1938 law. The bulk of the business was confined to the treatment of minor ailments. By 1954, as any peruser of newspaper ads or viewer of television commercials might have surmised, analgesics, mainly aspirin and compounds containing aspirin, led the proprietary market. Following in order, according to the Census of Manufactures, were laxatives, vitamins, cold and cough preparations, antacids and stomach remedies, antiseptics, liniments, and tonics .
Not that all was smooth sailing even here. Common symptoms, like headache, coughing, constipation, in some cases properly treatable with home medication, might also herald serious disease. An Atlanta chest specialist, checking medical textbooks, found 137 different causes for coughing. How was the ordinary citizen to know if his cough denoted a minor irritation or tuberculosis? Expert opinion was by no means unanimous as to just how much self-medication might be safe. Some medical specialists thought the zone should be drastically restricted; proprietors generally wanted it enlarged. The Food and Drug Administration came to insist that even the commonest remedies must bear label warnings against possible hazards. If pain persisted or recurred frequently, the consumer should consult a doctor. Laxatives should not be taken when abdominal pain was present, possibly indicating appendicitis. Antihistamines might cause drowsiness, and the user should avoid driving a car or operating machinery. Aspirin should be kept out of the reach of children .
Furthermore, even the most used and safest self-medication drugs might, through their promotion, become dangerous and illegal. To find the border between legitimate proprietaries and quackery was as hard at one extreme as to find the border between ethical drugs and proprietaries at the other. Proprietary Association spokesmen recognized the need "to draw lines between good and not-so-good self-medication products." "Part of our program," asserted the organization's executive vice-president, "should be . . . to make clear that intelligent, directed self-medication, with reliable products, made by reputable manufacturers, is in the public interest, whereas uncontrolled, unsound self-medication with quack products made by quack manufacturers is not." To draw this line, he readily admitted, would be "difficult." 
Fundamentally, quackery is what quackery does. Kenneth L. Milstead, a Food and Drug official, employed this concept in seeking to mark the border beyond which quackery lay .
"When," said Dr. Milstead, "an untrue or misleading health claim is deliberately, fraudulently or pretentiously made for a food, drug, device or cosmetic, this is quackery. . . .
"It matters not whether the quackery is practiced by the witch doctor or the licensed medical practitioner; the Indian medicine man or the pharmacist; the proprietary drug manufacturer or the prescription drug manufacturer; the health food manufacturer or the clerk in the health food store; the health lecturer, the self-styled nutritionist, the doorstep diagnostician, the fly-by-night operator or some of our most respected food, drug, device and cosmetic manufacturers—it is still quackery.
"It matters not which mask it wears—ignorance, superstition, fear, gullibility, folklore, myth, half-truth, or falsehood—it is still quackery.
"And, it matters not whether the article is harmless or whether it gives some psychosomatic relief; whether it is cheap or whether it has value for other purposes; whether it is produced by an obscure firm or whether it is produced by a 'reputable' firm—the promotion of it is still quackery."
The speech in which Dr. Milstead formulated this eloquent definition was delivered before a conference of pharmacists. During World War II, a few of the thousands of American pharmacists had engaged in shady practices—"quackery" as Milstead defined it—that eventually led to a revision in the 1938 law making it easier than it had been to draw the line between prescription and self-medication drugs. Word reached the Food and Drug Administration from a Navy base in Maine that the venereal disease program was encountering difficulty because some sailors were attempting to treat their gonorrhea by dosing themselves with sulfathiazole. One sailor in particular, buying the prescription drug easily at a waterfront pharmacy, had continued taking small amounts of sulfathiazole until his ailment had become sulfa-fast. Complications developed which put the sailor in the hospital for a long stretch of time. The drugstore, the FDA, found, was doing a land-office business in the illegal sale of sulfathiazole at a dime a tablet. Investigation revealed similar breaches of the law by druggists near military bases elsewhere in the country .
Suspicious that such, sales were being made by Sullivan's Pharmacy in Columbus, Georgia, two Food and Drug inspectors, on separate occasions, posed as would-be customers and, without prescriptions, sought to buy sulfathiazole. They were successful. The druggist in each case took a dozen tablets from a bottle, put them into a small box, and banded them to the inspector in exchange for his money. All that was written on the box was the name of the drug—and it was misspelled "SULFOTHIAZAL." When the district attorney hailed the druggist into court, Sullivan denied that he had broken the law. Both his buying of the drug, from an Atlanta branch of the manufacturer, and his selling of the drug, he argued, had been solely intrastate .
The district judge agreed with the government's contention that, though the transactions did take place within the state of Georgia, nonetheless the 1938 law applied. Congress had meant to preserve the integrity of labeling until it reached the ultimate consumer, else much of the protective power of the law might be denied. And sulfathiazole was too dangerous a drug for consumers to use to treat themselves. The bottle from which the druggist had taken the tablets bore not only the caution that the drug was for use "only by or on the prescription of a physician," but also the further warning that physicians "should familiarize themselves with the use of" sulfathiazole before administering it, because in some people the drug might cause "severe toxic reactions." Daily blood and urine examina tions were suggested to check on dangerous abnormalities that might develop—anemia, for example.
Sullivan appealed his case to the circuit court, and there the judges, taking a less flexible constitutional position, supported him. The law was not "plain enough," they ruled, "to make criminals of retail grocers and druggists" who had bought their wares within their state. Thus, pending a final verdict from the Supreme Court, the FDA's efforts to restrict over-the-counter sale of dangerous drugs lay in jeopardy. In January 1948, however, the Supreme Court, in a divided opinion, reversed the circuit court, ruling that action against Sullivan for his sale of sulfathiazole was within the law and constitutional. Even though the sale was intrastate, it came within the law's provision forbidding "the doing of any . . . act with respect to, a . . . drug . . . if such act is done while such article is being held for sale after such shipment in interstate commerce and results in such article being misbranded." The language of the law was broad and sweeping. It mattered not "how long after the [interstate] shipment the misbranding occurred" or "how many intrastate sales had intervened." The ultimate consumer must be protected.
Thus reassured by the highest tribunal in the land, the Food and Drug Administration accelerated its campaign against the sale of hazardous drugs without prescriptions. Other medicaments besides the sulfas fell into this category-thyroid extract, benzedrine sulfate, and various barbiturates among them .
But sales without prescriptions were not the only problem, In their investigations, Food and Drug inspectors had discovered another way in which prescription drugs were being abused. This was the indiscriminate, unauthorized refilling of prescriptions. Checking on drugstores suspected of illegal sales, inspectors were often told that, while this drug or that could not be sold without a prescription, once the pharmacist had a prescription on file, he could supply virtually an unlimited quantity of the drug in question. This happened most often with barbiturates .
These drugs, a product of the German chemical industry, had appeared on the market early in the century. Depressants of the central nervous system, they provided doctors with valuable therapeutic tools, useful for treating epilepsy, certain nervous conditions, and for bringing sleep to the distraught. But their potential for harm was also great. The 1938 law had placed them in the list of dangerous drugs and had required labeling their habit-forming potentialities. War and postwar stresses increased both their use and their misuse. Medical scientists took note of an increasing rate of barbiturate addiction, which in some ways was worse than narcotic addiction. Deaths from accidental overdosage and from suicide were rising. In 1948 drug manufacturers produced 24 sleeping pills for every man, woman, and child in the nation, a quantity far above legitimate needs. FDA inspectors, in their rounds, discovered tragic case histories. While most pharmacists practiced their profession responsibly, in some instances the source of the drug leading to tragedy was a prescription endlessly refilled .
A woman in a town in the Midwest, the mother of three children, was discovered, upon admission to a hospital, to be a barbiturate addict. A check on her source of supply revealed that she had had a prescription for 30 capsules refilled 16 times within three months. Another woman, who had been mildly afflicted with high blood pressure, was found dead in her bed. Investigation at the pharmacy named on her prescription showed that she had secured 23 refills for 20 barbiturate capsules during the preceding six months .
In Kansas City a woman's neighbors, noting accumulating milk bottles and newspapers, summoned the police. Breaking into the house, they found the woman's body on the floor, mutilated by rats. She had been dead about three days. Her estranged husband told the authorities she had become addicted to barbiturates. From smudges of finger marks knee-high on the wallpaper, it appeared that a great deal of the time she had been too heavily drugged to walk. The husband gave police the name of the California drugstore near their former home from which his wife had been buying her drugs. The mailbox contained a package notice, but so much time had elapsed the package had been returned to the sender. A Food and Drug inspector got the husband's sister to write the drugstore, saying the woman could not pick up the package and asking that it be mailed again. Shortly two bottles arrived, each containing 500 barbiturate capsules. Investigation revealed that five years previously the woman had secured a prescription for 15 capsules. The druggist had refilled the prescription 43 times for a total of 7,000 capsules. The doctor who had written the prescription was never consulted about refilling it .
As such disheartening instances mounted, the Food and Drug Administration decided to take action. A number of states had no laws regulating prescription refills, and in some of the states that did, enforcement was woefully inadequate. After the Sullivan decision, which was followed by an amendment to the 1938 law covering its main point, the FDA could move against illegal sales on the retail level with a greater feeling of security. In October 1948, speaking before the National Association of Retail Druggists, Commissioner Dunbar announced a new FDA policy. All prescription refills, he said, would henceforth be considered as illegal unless they had been specifically authorized by a physician. The question FDA officials had posed for themselves, agency spokesmen told various groups of pharmacists, was, "Is a prescription once filled still a bona fide prescription when presented for refilling without the doctor's knowledge and approval." The answer they had come to, after consulting the laws of various states and foreign nations, as well as scholarly works on prescription writing, was "No." An unauthorized refill meant that the pharmacist, not the physician, was doing the prescribing. This amounted to over-the-counter selling of prescription legend drugs .
While recognizing the hazards in unauthorized refills, organized pharmacy objected strenuously to the FDA's method of attacking the problem. Most prescription refills, pharmacy spokesmen argued, dealt with safe drugs, and refilling amounted to 40 per cent of the total prescription business. Legal control of pharmacy was traditionally a state instead of a national concern. To have the Food and Drug Administration enter so massively into the sacred physician-pharmacist-patient relationship seemed ominous. The answer to the unscrupulous minority should not be federal intervention, but more effective state laws and better education. So disturbed were pharmacists at the FDA's position, and legal actions initiated under it, that they sponsored a proposed law, introduced by a pharmacist member of the House of Representatives, which would exempt from the jurisdiction of the Food and Drug Administration all products dispensed upon prescription or prescription refill. The FDA naturally opposed this measure .
In the wake of this action, leaders of the National Association of Retail Druggists and FDA officials engaged in conversations looking toward a compromise. If a new law could ban only unsafe refilling, then the major part of the prescription business would continue unhampered by possible federal intrusion. But what was unsafe? The draft eventually presented to the Congress by Congressman Carl Durham and Senator Hubert Humphrey, pharmacists both, specified three categories of drug prescriptions which could not be refilled by pharmacists without specific authorization of the physician: drugs, like the barbiturates, which were habit-forming; new drugs released for marketing by the FDA with the stipulation they be limited to prescription sale; and other drugs to be designated by the FDA, after a hearing, which could be employed safely and effectively only under the supervision of a doctor .
The third category seemed of signal importance to Food and Drug officials, for, with respect to all drug products, it would permit the drawing of a sharp line between prescription and self-medication items. This line the 1938 law had not drawn, and regulatory efforts to mark it had not had much success. A "broad twilight zone" continued to exist. The problem was not only the over-the-counter sale of hazardous drugs. Drugs safe for use by laymen, even sodium bicarbonate, were being marketed as prescription items so that their vendors could avoid labeling them with adequate directions for lay use, counting on advertising claims to impress the consumer mind .
Food and Drug officials also were pleased to have the standard of effectiveness written into the draft law. They recognized that consumer safety lay not alone in a drug's inherent lack of toxicity. The circumstances under which a drug was used played a central role in safety. A non-toxic diuretic, used by a layman to reduce swelling in his ankles, might be extremely hazardous if the swelling was caused by heart or kidney disease. Such a diuretic, FDA's George Larrick told a Congressional committee, should not be permitted on the market for self-dosage. "We submit," Larrick asserted, "that it is just as important that a drug be effective in the hands of the person who acts as his own physician as that it be safe in the sense that it will not poison him." 
To many pharmacists, physicians, and drug makers, however, this section of the Durham-Humphrey bill seemed even more threatening than recent FDA administrative policies. These groups did not trust the Food and Drug Administration to draw the line, James Hoge and Charles Wesley Dunn explained the opposition of proprietary and pharmaceutical manufacturers. To give the FDA administrative authority to separate self-medication from prescription drugs, wrote Hoge, "introduced a plan for the regulation of the drug industry to an extent never heretofore proposed or contemplated." The administrative hearings, he thought, would prove to be "snares and delusions," The whole concept was Tugwellian and, if enacted, would "increasingly restrict the right of self-medication," something that Congress in 1938 had "stated was not to be restricted but made safe." An ominous clue had been forthcoming at the Congressional hearings. The Federal Security Administrator, while testifying, had been asked if there was any possibility that a prescription refill might be required for aspirin. He had said no, not as of the moment, although a future Administrator might put the issue up for hearing. Dunn likewise thought the proposed law portended "governmental control of the drug business and the medical profession, which can be used to socialize them in the most invidious sense; and it amounts to life-or-death control over non-prescription drugs." 
So Congress, yielding to these sentiments, removed from the bill the FDA's authority to decide, after administrative hearings, which were prescription and which non-prescription drugs. Instead, the Durham-Humphrey Act, passed in October 1951, contained an objective definition of prescription drugs. Included in this category was any drug intended for human use which "because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer such drug." Gone from the earlier bill was the word "effective," though something of its flavor lingered on. Dangerous drugs as so defined, as well as habit-forming drugs and new drugs clearing FDA procedures as prescription items, must bear the prescription legend and not be refilled by pharmacists without the specific authorization of physicians. The FDA might issue advisory lists, but the initiative still rested with manufacturers to decide whether or not their therapeutic wares fit the Durham-Humphrey definition. If disagreement arose between a manufacturer and the FDA, the issue could be settled in the courts .
Enforcing the Durham-Humphrey Act, in fact, did not prove placid. In seeking to apply the new statutory definition, the FDA, as always, moved in the midst of conflicting scientific opinions and divergent economic interests. In the main, the agency continued to act within its interpretation of the 1938 law: to provide as much self-medication as might be safe. But safety, as a result of the new amendment to the law, was a more sophisticated standard than before. Some drugs once thought safe for self-medication, experience had shown, proved not to be—sulfa in salves, for example—and the FDA returned them to the prescription legend. Demanding requirements were set for moving prescription drugs to over-the-counter status: thorough data on the length and extent of use, the nature of any side reactions encountered, evidence on differences in response to the medicine with respect to sex and age, acute and chronic toxicity studies, and much else. When ten pharmaceutical manufacturers petitioned to exempt hydrocortisone ointment from the prescription dispensing requirement, doctors and pharmacists opposed the move. Too much of this powerful drug, dermatologists testified, might get into the user's system, especially if he neglected to heed the label warnings and overused the ointment. Evidence was presented, through a public opinion study run for the American College of Apothecaries, that this indeed might happen. Two-thirds of the consumers interviewed showed lack of familiarity with label warnings on a dozen nationally advertised proprietaries. Persuaded by such evidence, the FDA forbade the change .
The Proprietary Association objected to the hydrocortisone ointment decision. "It seems," said Dr. Cullen, "the effect of this hearing is an attempt to present again at the federal level the issue of self-medication as it has not been raised since the enactment" of the 1938 law. If switches from prescription to over-the-counter status became increasingly difficult, noted a drug trade journal, the proprietary industry would "face a dubious future insofar as really new products, containing modern therapeutic ingredients" were concerned .
Some pharmacists sided with the Proprietary Association, seeing greater profits in a high volume of over-the-counter sales. But the majority of pharmacists favored releasing drugs from prescription status only slowly. The issue became involved in a long-standing dispute between pharmacists and proprietary manufacturers, the restrictive sales controversy. Arguing that many proprietary products posed hazards if used unwisely, pharmacists sought to confine their sale to drugstores. In this way the pharmacist, knowing his customers, could point to label warnings, caution against excessive purchases, and generally exercise some supervision over self-medication in the interests of public health. The proprietary industry, on the other hand, charged that the pharmacists' alleged solicitude for public health was specious and their desire to restrict sales to drugstores "simply a matter of private profit." Changes in marketing patterns were indeed increasing proprietary sales in groceries and supermarkets and decreasing sales in drugstores. Whatever the motivation, pharmacy groups undertook to change state pharmacy laws to stem this tide. The Proprietary Association, aided by drug wholesalers, grocery associations, and some pharmaceutical manufacturers, fought to defeat such laws and, where laws existed, to have them interpreted in the courts to their advantage. One concession the Proprietary Association was willing to make: to limit sales of medicines by non-drug outlets to those proprietaries promoted to the lay public, thus excluding over-the-counter pharmaceuticals promoted only to the health professions. But pharmacy organizations would not accept this compromise and fought state bills, sponsored by the Proprietary Association, that sought to enact this definition into law. Pharmacists hoped to ban from non-drug outlets all home medications that required warning labels under the law, and all medications listed in the Pharmacopeia or other official compendiums-including milk of magnesia and aspirin. The battle raged on, on the whole inconclusively, although with varying fortunes on various fronts. Nor has it ended. In place of the two-class division in medication set forth in the Durham-Humphrey Act, the American Pharmaceutical Association has recently been campaigning for a four-class structure, one group to consist of proprietaries needing such caution in their self-use that only a pharmacist personally should sell them .
The abuse which started events moving toward the Durham-Humphrey Act, the unauthorized refilling by some pharmacists of prescriptions for dangerous drugs, was quite satisfactorily resolved by that statute. But this did not end the illegal usage of barbiturates. Thrill-seekers and addicts sought these powerful hypnotics through other channels, and the bootleg black market boomed. Enough sleeping pills were produced in the year the Durham-Humphrey bill was passed, a doctor said, to put every person in the United States to sleep for 20 years. Half the capsules, he estimated, were used for non-medical purposes. A similar diversion from legitimate purposes occurred with the amphetamines, used by truck drivers, for example, to disguise tiredness. The misuse of these drugs, indeed, expanded into one of the nation's most serious social problems. An ever larger portion of the Food and Drug Administration's limited resources went into tracking down illegal sources of "bennies" and "goof balls." The work was not only time-consuming for FDA inspectors, but hazardous as well .
Greatly preoccupied by this emerging form of "quackery," the FDA could not devote so much attention to medical quackery of more traditional forms. Nor was traditional quackery in a moribund state, safely to be neglected. Quite the reverse: despite the more potent, really curative medicines available to doctors, quackery, with its false medicines, was growing. Indeed, paradox though it might be, the very success of the chemotherapeutic revolution contributed greatly to quackery's reinvigoration. Never before the exciting age of miracle drugs had so many people met so much publicity in such varied media about the field of health. In 1936, for example, the Saturday Evening Post had run two medical articles and had not mentioned a drug in its editorial columns during the whole year; in 1956 the Post published 36 articles on health, referring to 72 different drugs a total of 330 times. Each new therapeutic wonder, real or would-be, received full and exciting coverage in the press and magazines, on radio and television. "Readers are not just more medically conscious," a drug trade journal stated, "but more drug conscious too." Health was something that could be bought. As always, the average citizen had difficulty in analyzing the credentials of competing vendors .
"More and more," the FDA's director of public information said, "people believe in miracles, not only the real miracles of scientific achievement but also the fake miracles of promoters and charlatans." "Americans have come to believe," stated a president of the American Medical Association, "that science is capable of almost everything. Any glib salesman who has a white coat and calls himself a doctor can take a black box, a powder, a pill, or a liquid and set out to capitalize on it." 
So science and pseudo-science advanced hand in hand.
- Milstead, "Enforcement of Antiquackery Laws," Jnl. Amer. Pharmaceutical Assoc., ns 3 (Sep. 1963), 458.
- Shryock, The Development of Modem Medicine, 438-39.
- Donald G. Cooley, The Science Book of Modern Medicines (N.Y., 1963), 19-21.
- Ibid., 22-24.
- Ibid, 24; Robert A. Hardt, "A Pharmaceutical Manufacturer Looks at the Food and Drug Administration," Antibiotics and Chemotherapy, 6 (May 1956), 316-18; George P. Larrick, "Can We Rely on Modem Medicines?," mimeographed text of Mar. 15, 1957, address; Smith cited in FDC Reports, Dec. 19, 1960.
- Larrick, "Can We Rely on Modern Medicines?"; Richards, "A Clinician's View of Advances in Therapeutics," in Paul Talalay, ed., Drugs in Our Society (Baltimore, 1964), 31.
- Bureau of the Census Historical Statistics of the United States, Colonial Times to 1957 (Wash., 1960), 25; Public Health Service, Vital Statistics of the United States, 1950, 1 (Wash., 1954), 145; Smith cited in Newsweek, 54 (Dec. 7, 1959), 88.
- 1953 Annual Report of the U. S. Department of Health, Education, and Welfare (FDA), 200; Stieglitz, Chemistry in Medicine, 496; R.T. Stormont, "From Alchemy to Antibiotics," FDC Law Jnl., 11 (Feb. 1956), 98-99; Frank H. Wiley, "The Analysis of Drugs," ibid., 16 (Dec. 1961), 733-34; Mahoney, The Merchants of Life, 33, 35-36.
- Mary Ross, "Potions and Pills, The High Cost of Mystery," Survey, 67 (Jan. 1, 1932), 372; George Larrick before a House Committee, cited in FDC Law Jnl., 13 (Apr. 1958), 230. For information on some of the problems that arose, see the essays in Talalay, Drugs in Our Society, and see below, ch. 19.
- FDC Reports, Nov. 18, 19572 6; Charles W. Crawford, "Problems of Compliance and Enforcement under the Drug Law," mimeographed text of May 18, 1947, address; PI, 226 (Feb. 25, 1949); 227 (Apr. 22, 1949), 15. See ch. 9 for the early reaction of major proprietors to the 1938 law.
- Proprietary Association Executive News-Letter 482 (June 7, 1959); James F. Hoge, "Government Interest in the Drug Business," mimeographed address distributed with ibid., no. 59-21, May 29, 1959; FDC Reports, Apr. 14, 1945, white 6-7; Drug Trade News, 36 (Dec. 25, 1961), 27, 37; Holland, "Who Will Be First?," FDC Law Jnl., 13 (July 1958), 4 1-72.
- Larrick, "Pharmacy at the Crossroads," mimeographed text of Aug. 24, 1959, address; Robert L. Swain, "Our Self-Defeating Pharmacy Laws," FDC Law Jnl., 14 (Apr. 1959), 263-66; FDC Reports, Sep. 19, 1955, 13-41; Aug. 21, 1959, 18.
- Ibid., July 4, 1960, 17-18; Mahoney, 26.
- Hoge, "Government Interest in the Drug Business."
- JAMA, 112 (June 3, 1939), 2276-78; Drug Trade News, 33 (Mar. 10, 1958), 30; FDC Reports, Feb. 6, 1954, white 12; Jan. 2, 1956, 15; Aug. 12, 1957, 3; Aug. 26, 1957, 3, 17; Nov. 11, 1957, 22; Feb. 3, 1958, 20; Apr. 27, 1958, 24; June 16, 1958, 13; Aug. 18, 1958, 20; Sep. 15, 1958, 18; Mar. 2, 1959, 7; Aug. 17, 1959, 17; May 23, 1960, 9-10.
- Newsweek, 51 (June 16, 1958), 62; Hoge, "Government Interest in the Drug Business"; FDC Reports, Apr. 29, 1957, 1-8.
- Bureau of the Census, United States Census of Manufactures: 1954, ii, Industry Statistics, Part 1, General Survey and Major Groups 20 to 28 (Wash., 1957), 28C-10 through 28C-12.
- Andrew Sparks, "How Good Are Physical Checkups?" Atlanta Jnl. and Constitution Mag., Apr. 15, 1956, 26; N. E. Cook, "Our Mutual Problems," mimeographed text of Aug. 26, 1957, address; FDC Reports, Aug. 14, 1954, pink 2-3; FDA "Labeling Recommendations in the Interest of Children's Health," Mar. 18, 1957; FDA news release on label warnings, Mar. 25, 1960.
- Howard A. Prentice, cited in FDC Reports, May 22, 1961, 15.
- Milstead, "Enforcement of Antiquackery Laws," 458.
- Larrick, "The Federal Food, Drug, and Cosmetic Act and Pharmacy, 11 mimeographed text of June 13, 1950, address; 1944 Report of the Food and Drug Administration, 27-28.
- United States v. Sullivan, an Individual, Trading as Sullivan's Pharmacy, 67 Fed. Supp. 192 (1946), in Kleinfeld and Dunn, Federal Food, Drug, and Cosmetic Act, 1938-1949, 319-27; Jordan James Sullivan, Trading as Sullivan's Pharmacy v. United States, 161 Fed. (2d) 629 (1947), in ibid., 334-37; United States v. Sullivan, Trading as Sullivan's Pharmacy, 332 U. S. 689 (1948), in ibid., 350-58.
- 1948 Report of the Food and Drug Administration 556; 1949 Report, 25-26; Larrick, "Indiscriminate Sale of Dangerous and Habit-Forming Drugs," FDC Law Jnl., 5 (May 1950), 251-57.
- N.E. Cook, untitled text of mimeographed address given before District of Columbia Pharmaceutical Association, Nov. 15, 1950.
- Leonard P. Prusak, "Barbiturate Control by Legislation," FDC Law Jnl., 5 (Sep. 1950), 598-603; Stieglitz, 485-86, 491; Literary Digest, 97 (June 16, 1928), 65-66; PI, 164 (July 1933), 21; N.Y. Times, Dec. 16, 1951; 1949 Report of the Food and Drug Administration, 25-26.
- Cook, Nov. 15, 1950, address.
- Crawford, "The Federal Drug Law and the Druggist," mimeographed text of Oct. 18, 1950, address.
- Crawford, "The Federal Drug Law and the Druggist," FDC Law Jnl., 5 (Dec. 1950), 812-12; Walton M. Wheeler, Jr., "Prescription Refills," ibid., 5 (Nov. 1950), 746-54. The Miller Amendment became law June 24, 1948.
- Ibid, The Durham Bill was introduced into Congress Apr. 12, 1949.
- Ibid. The history of the Durham-Humphrey Act is traced in Richard J. Hopkins, "Medical Prescriptions and the Law: A Study of the Enactment of the Durham-Humphrey Amendment to the Federal Food, Drug, and Cosmetic Act" (Emory University: unpublished Master of Arts thesis, 1965).
- Testimony of Federal Security Administrator Oscar R. Ewing, Federal Food, Drug, and Cosmetic Act: Hearings before the Committee on Interstate and Foreign Commerce, House of Representatives, . . . on H. R. 3298 (82 Cong., I ses., 1951), 20. A Senate subcommittee also held hearings: To Amend Section 503 (b) of the Federal Food, Drug, and Cosmetic Act of 1938, As Amended: Hearings before the Subcommittee on Health of the Committee on Labor and Public Welfare, U. S. Senate, . . . on S. 1186 and H. R. 3298 (82 Cong., 1 ses., 1951). House Report 700 and Senate Report 946 issued from these hearings.
- Larrick, House Hearings, 94.
- Hoge, "The Durham-Humpbrey Bill," FDC Law Jnl., 6 (Feb. 1951), 135-41; Hoge, "Major Drug Law Problems," ibid., 6 (Dec. 1951), 933-35; Dunn, "The Durham-Humphrey Bill," ibid., 5 (Dec. 1950), 854-65; and their similar testimony at the hearings: House Hearings, 75-87 (Dunn), 191-206 (Hoge); Senate Hearings, 103-19 (Hoge); 148-52 (Hoge written statement); Ewing on aspirin, House Hearings, 38.
- 65 Stat. 648. Analysis of the law appears in Dunn, "The New Prescription Drug Law," FDC Law Jnl., 6 (Dec. 1951), 951-69, and in F&D Rev., 35 (1951), 227.
- Cook, "Over-the-Counter Sales and the Pharmacist," Antibiotics and Chemotherapy, 6 (May 1956), 315-16; FDC Reports, May 29, 1954, pink 2; Aug. 7, 1954, white 14; Aug. 14, 1954, pink 2-3; Nov. 13, 1954, 13-15; Sep. 10, 1956, 8; Dec. 17, 1956, 8-10; May 13, 1957, 11-14; FDA press release, Jan. 17, 1957.
- FDC Reports, Oct. 15, 1956, 9-10.
- William F. Weigel, "State Legislation Restricting the Sale of Drugs," FDC Law Jnl., 13 (Jan. 1958), 48-56; Sol A. Herzog, "The Advantages to the Public of Restricting the Sale of Drugs and Medicines to the Retail Drug Store under the Supervision of Registered Pharmacists," Amer. Jnl. Pharm., 126 (May 1954), 177-84; Drug Trade News, 29 (Oct. 25, 1954), 1; FDC Reports, Feb. 17, 1945, white 5; Mar. 13, 1954, white 14-15; Sep. 25, 1954, pink 1, 4, white 2; Nov. 2(, 1954, 11; May 30, 1955, 3; May 14, 1956, 16; Dec. 10, 1956, 9-10; May 18, 1959, 16-18; William S. Apple, "The Pharmacist and the Public Health," Emory University Qtly., 21 (Summer 1965), 118-21; Apple, "APhA Statement before House Subcommittee on Intergovernmental Relations," Jnl. Amer. Pharmaceutical Assoc., ns 4 (May 1964), 212-16, '119; Carl L. Vitalie, "Reclassification of Drugs: A New Look at a New Mea," Pharm USC (June 1965), 7, 36-37.
- Larrick, "The Food and Drug Administration's Battle against Unlicensed Merchandisers of Bootleg Drugs," mimeographed text of Oct. 19, 1955, address; Dr. Donald Dukelow, cited in Atlanta journal, Mar. 20, 1953. Much more thorough legislative controls over such dangerous drugs were passed by the Congress in 1965 and given to the FDA to administer.
- FDC Reports, Dec. 16, 1957, 7-10; Herbert Ratner, "Are Americans Overmedicated?," Saturday Rev., 45 (May 26, 1962), 8; Russell S. Boles, "When Medicine Makes the Headlines," ibid., 34 (May 19, 1951), 7; Wallace F. Janssen, "Quackery and the News," Public Health Reports, 74 (July 1959), 635-38.
- Ibid., 636; Dr. Louis M. Orr cited in Newsweek, 52 (July 7, 1958), 48-49.
This page was posted on January 30, 2002.