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

Chapter 3: A Decade of Enforcement

James Harvey Young, PhD


"Half success is the best that can be claimed for the Pure Food Law insofar as it affects nostrums. The reason is that we who fought to get the law passed aimed at the wrong side of the bottle. We should have attacked the advertisements in the newspapers. That is where the real damage is done."

—Samuel Hopkins Adams, 1915 [1]


The Cuforhedake Brane-Fude case was a dramatic victory but not an accurate harbinger of the fate of nostrum makers under the 1906 law. The nature of Harvey Wiley's interests, the shrewdness of proprietors, the decisions of judges, all joined to hold enforcement of the patent medicine provisions to a very modest level indeed.

Dr. Wiley's dominating passion was pure food, and it controlled his enforcement decisions as it had earlier influenced his crusading. Of the first 1,000 judgments rendered under the law, covering cases up to mid-1911, only 135 actions concerned proprietary medicines. Food adulteration, to the Bureau chief, constituted a greater threat to the public than patent medicines and, considering the limited personnel available, must be given top priority [2].

This policy meant no abatement in Wiley's hostility to quackery. Right from the start, he sought to make the law as effective an anti-nostrum weapon as he could. The job of regulation-making was imposed by the act upon the Secretaries of Agriculture, Commerce, and the Treasury, and these cabinet officers delegated the responsibility to three subordinates, Wiley serving as chairman. Announcing a tentative set of rules, the three-man commission held hearings in New York. Representatives of the food and drug industries came to question and to protest. The proposed regulations, in the words of one pharmacist, hit the drug trade with "the shock of a volcanic explosion." [3]

What bothered the proprietary manufacturers was the way in which the regulations stretched the law. The law did not precisely define "label"; the commission wanted "label" to include pamphlets packed in the carton. The law forbade a false statement with respect to place of manufacture; the commission insisted that the true place of manufacture be given. And so it went, even to the size of type required in labeling. Proceedings were "friendly and courteous," but there were tensions held in check. The main points of the commission's draft, accepted by the three cabinet secretaries, struck many in the drug trade as "so comprehensive as greatly to supplement the act." [4]

This sort of protest did not deter Wiley at all. He went even further in tightening the screws through interpretations of the regulations which he began to draft for the Secretary of Agriculture to promulgate. Intent on vigorous protection of the consumer, Wiley would sometimes brush aside the suggestion by his associates that some prospective step was not countenanced by the law. The chief would answer: "We must read it into the law!" [5]

At the same time, Wiley was interested in securing as much voluntary compliance as possible by informing the trade as to the law's provisions. There were deputations to consult with, speeches to deliver, correspondence to read and answer. Scores of letters flowed into the red-brick Bureau of Chemistry building, from the lawyers of major medicine concerns, from Congressmen in the interest of their constituents, from small-time proprietors themselves, begging for information. "I can't find out from any one what is what about the new law that takes effect," wrote a druggist who made a skin ointment, "and perhaps I will never know. . . . I am not looking for trouble and if your department will help me, will avoid it. The law is too complicated for poor devils to understand it." [6]

Wiley and Dr. Kebler, chief of the drug laboratory, responded patiently to the poor devils who sought help [7]. They assigned them guaranty numbers in return for a promise that their products were not adulterated or misbranded within the meaning of the law. This regulation was a way of absolving retail druggists of responsibility for wares on their shelves that might prove to be illegal." It should be distinctly understood, however," Wiley and Kebler warned proprietary manufacturers, "that the filing of a guaranty and the securing of a serial number does not in any way mean that the Government guarantees your products." The chief chemist and his aide advised against use of the word "cure" on labels, except in cases beyond medical dispute. "The term 'corn cure,'" Wiley observed drolly in one instance, "is in itself a misnomer, because it is not the corn that is ill and needs to be cured." They raised questions about the appropriateness of nostrum names. "You ask," a Kansas promoter responded, "what connection Mexican has to do with my [Barb Wire] Liniment. Nothing whatever only a name." [8]

Many proprietors wrote in that they were voluntarily modifying their labels, and some admitted to making changes in ingredients. The changes might be slight and they might be grudging, but they were detectable, "So far as I have gone," Samuel Hopkins Adams wrote to Wiley in 1907, "I find a general disposition to obey the law in the letter, though to evade it as far as possible in the spirit." "Our experience," Wiley answered, "is in accord with yours." [9]

One token of voluntary change was a marked reduction in the narcotic content of patent medicines, especially those marketed by large-scale manufacturers. The composition of Mrs. Winslow's Soothing Syrup, for example, a particular whipping boy of the nostrum muckrakers, was modified, first to cut down on the percentage of morphine present, then to eliminate it altogether. The Harrison Narcotic Act of 1914 accelerated this trend by placing a ceiling—considered low at the time—on the amount of such drugs which proprietaries could contain. The proportion of alcohol in patent medicines also declined after 1906, although voluntaryism was supported by pressure from the Commissioner of Internal Revenue, who taxed proprietors whose wares seemed to exist mainly to satisfy the thirsty in the ever-expanding prohibition territory. To avoid the tax, the makers of Hostetter's Bitters reduced their alcohol from 39 to 25 per cent and "decidedly" increased the amount of cinchona and serpentaria in their remedy. "The demand for these new Bitters," the president told the stockholders, "is entirely problematical." [10]

The "before" and "after" picture, that ancient promotional technique among nostrum proprietors, now furnished the cue for their opponents. Many famous American labels did not look the same after 1906 as they had looked before. A good deal of the change was voluntary, to avoid trouble with the law.

The labeling sections, noted a journal representing interests of the major proprietors, "caused some serious introspection . . . and many abuses which had crept into the business were remedied." Manufacturers, this journal explained, had made exaggerated claims through ignorance on the part of their medical or chemical advisers or through the excessive enthusiasm of their advertising or sales managers. Whatever the reasons, the situation required change, and change there was. Nostrum critics were not averse to reproducing for the consumer these "before" and "after" views, or to picturing side by side labels used on the same proprietaries prepared for sale in America and in England, where labeling restrictions were as yet not so severe. Piso's Cure for Consumption, for example, had become Piso's Remedy, A Medicine for Coughs and Colds [11].

Occasionally, when the letter of the law was violated, the government went to court, and it won the vast majority of cases. In one way the Brane-Fude case did prove to be a precedent: convictions did not bring imprisonment. If Wiley hoped that the Harper decision would establish a tradition of maximum fines for those proved guilty, he was destined to be disappointed. Only rarely were fines levied at the top figure, which was $200 for interstate violations. More often the sums assessed were very low, from $50 down to one cent. Only rarely did a company with an annual advertising budget of hundreds of thousands fall afoul of the law. Proprietary Association spokesmen asserted that some of these cases doubtlessly would have been won by the manufacturers, except that it was cheaper to plead guilty and pay a nominal fine than to go to all the trouble of a court trial [12]

Egregious violations by small-scale proprietors made up the bulk of criminal cases involving nostrums in the early years of the law. Numerous other headache "cures" besides Harper's fell under Dr. Wiley's ban. Campaigns were also conducted against broad-gauge tonics (one was Humbug Oil), male-weakness remedies (like Sporty Days Invigorator), . "cures" for cancer (including the radium-imitating Radol), alleged germicides, and "cures" for narcotic addiction. Some of this work was done in cooperation with the Post Office Department. Seldom did a proprietor see fit to offer the Bureau a serious contest in the courts. Pleas of "not guilty" were few and far between. Besides criminal action against the proprietor, the law gave federal district attorneys another type of legal action to bring on the basis of evidence provided by the Bureau of Chemistry. This was the seizure of the adulterated or misbranded article itself and a suit for its condemnation. In the early years of enforcement, few seizure actions were directed against proprietary remedies [13].

Success in these limited campaigns against the most dangerous types of nostrums prompted the Bureau of Chemistry to issue now and then an optimistic assertion. In 1910 Wiley reported that, as a result of cooperation between the Bureau and postal authorities, "the mail-order 'cancer-cure' business" had "to a very large extent, been suppressed in this country." Drug-addiction cures were also yielding to the pressure [14 ].

These advances in a limited sector of the patent medicine front, plus what improvement had been brought about by voluntary modifications in formulas and labels, were not the overwhelming victory which the more hopeful food and drug reformers had predicted when they rejoiced at the enactment of the law. Many manufacturers continued to defy its provisions, willfully or out of ignorance. New abuses, indeed, were arising, ironically enough out of the very circumstances of enforcement. Despite reiterated warnings, nostrum makers told their would-be customers that the phrase "Guaranteed under the Pure Food and Drugs Act"—really intended to protect retailers from the misdeeds of manufacturers—meant a governmental certification of healing potency. And, if this distortion was not bad enough, Wiley had to suffer the personal indignity of finding his warnings against the misuse of pain-killers distorted in advertisements in such a way as to make him sound like a testimonial-giver to their efficacy [15]. In 1911 a new blow fell, a blow which badly crippled the modest controls over remedy labeling which the law had seemed to contain. The Supreme Court ruled that the law's prohibition of false labeling did not apply to therapeutic claims.

The misbranding section of the law did not explicitly refer to curative promises. A food or drug article was misbranded, the law stated, "the package or label of which shall bear any statement, design, or device regarding such article, or the ingredients or substances contained therein which shall be false or misleading in any particular." Wiley and Kebler, in their initial regulations, had aimed this general clause directly at unwarranted assertions that promised relief or cure. At the time questions were raised about the Bureau's interpretation. In view of the differences of opinion prevailing over matters therapeutical, a drug editor suggested, "it will be interesting to know who is to be judge of the truth or falsity of the therapeutical claims which may be made." [16] Certainly among medical practitioners an ancient therapeutic debate had reached a new and bitter stage. In the American Medical Association's effort to improve standards, Association spokesmen were condemning the healing practices of various sects and cults [17]. These groups fought back with vigor, defending their therapies and opposing the AMA's effort to enforce therapeutic monopoly. While such a debate was going on, could Wiley and Kebler, perusing nostrum labels, find firm scientific grounds on which to approve or reject? They themselves took this for granted and, during the first years of the law, so did the trade. Many manufacturers toned down their therapeutic claims. Others did not, but when hauled into court admitted Wiley's view of the law's applicability by pleading gUilty [18].

Out in Kansas City an eclectic physician named Johnson decided on a different legal course. He had been vending an assortment of tablets and liquids as "Dr. Johnson's Mild Combination Treatment for Cancer." For this purpose, of course, the concoctions were worthless. Johnson fulfilled the law's requirements as to the accurate labeling of his ingredients. It was solely against his false curative promises that the government brought its suit. The medicine man's lawyers moved to quash the indictment, pleading that Congress had not intended the law to forbid such practices. When the case had run its course, the Supreme Court had agreed. Oliver Wendell Holmes delivered the decision, a tortuous exploration of grammatical construction that could find no proper link between the prohibition of false labeling and assertions of healing potency. Congress was not apt to legislate, Holmes argued, in the debatable realm of what could cure and what could not. This would "distort the uses of its constitutional power to establishing criteria in regions where opinions are far apart." [19]

Charles Evans Hughes wrote a vigorous dissent. His study of the grammar of the law revealed the connection Holmes could not see. He cited the act's legislative history to show that Congress had indeed intended a prohibition of therapeutic nonsense on nostrum labels. Even the makers of medicines had generally assumed the law to be so written, Hughes pointed out, since so many had promptly entered pleas of guilt. Holmes had "impressively described," the dissenting justice said, the conflict that did indeed exist between schools of medicine and the difficulty of legislating in such an uncertain area. "But granting the wide domain of opinion," he added, "and allowing the broadest range to the conflict of medical views, there still remains a field in which statements as to the curative properties are downright falsehoods and in no sense expressions of judgment. This field I believe this statute covers." This type of downright falsehood was what Johnson had placed on the labels of his cancer cure.

But Holmes had the majority with him. The decision, wrote an incensed George Creel, was "first aid to fraud and murder," leaving the nostrum provisions of the law with "as much bite as a canton flannel dog." Wiley was angry. Maybe Holmes understood his opinion, the chief chemist said. I don't. All I can make out is that it gives anyone the right to lie about drugs whenever he feels like it." Wiley preferred to stand with Hughes. "He disagreed," the chemist added bitterly, "probably, because he had not been on the bench long enough to know better." [20]

The decision in the Johnson case, said President Taft, meant that over 150 cases of the same type pending in the courts, "involving some of the rankest frauds by which the American people were ever deceived," would have to be dismissed. He urged the Congress promptly to pass a law to plug the hole. Holmes had made clear—and Hughes had agreed—that "any attempt to legislate against mere expressions of opinion would be abortive." Thus the new law should proscribe only "knowingly false misstatements of fact as to the effect of the preparations." Such a measure, the President was persuaded, would control "the greater part of the evil." [21]

Congressman Swagar Sherley of Kentucky introduced a bill, and it was passed by Congress "without any blare of trumpets." The amendment to the food and drug law declared an article misbranded "if its package or label shall bear or contain any statement, design, or device regarding the curative or therapeutic effect of such article or any of the ingredients or substances contained therein, which is false and fraudulent." [22]

In view of the Johnson decision, "false and fraudulent" was as strong a phrase as Congress could very well enact. But would proving fraud be such an impossible task as to offer quackery an open road? Congressman Sherley acknowledged this hazard: "very frequently," he said, the government would have difficulty "in convicting the guilty man." A fellow Congressman, James Covington of Maryland, foresaw no untoward danger. "The proof of intention in the criminal law," he said "does not mean the metaphysical reading of a man's mind. Specific proof of intent is not necessary; it may be established by evidence of attending facts and circumstances, and therefore the Government can easily show that a false statement on a label regarding a drug is one from which fraudulent intent may be implied. Conviction in all proper cases will be consequently comparatively sure." [23]

Wiley was less cheerful. The dangers Congressman Sherley saw as likely, Wiley viewed as certain. The word "fraudulent" in the amendment, he said, was a "joker" which would nullify the law's intent. Congress had "given the manufacturers of fake cure-alls another lease on life and enabled the roots of fraud and corruption to sink deeper into the soil of protective legislation-protective to vested interests, not to public welfare." But enforcing the Sherley Amendment was not to be Harvey Washington Wiley's responsibility. Five months before Taft signed the law, Wiley had resigned his post as chief of the Bureau of Chemistry. The decision had been, perhaps, impending since 1906. The talents required for crusading in behalf of a law are not the same talents required for enforcing it. The measure was a pioneering one, and weaknesses in drafting became apparent, especially a lack of clarity as to enforcement responsibilities. Wiley's categorical stand against food preservatives antagonized industries with great political power, and this power they brought to bear. President Roosevelt, becoming unsure of Wiley's science, created checks upon his single-banded action within the Bureau which hamstrung the chief chemist. Bitter internecine warfare developed which, in Taft's administration, led to a charge of malfeasance against Wiley. Although he was vindicated by the President, Wiley felt that Taft should then have proceeded to oust his enemies and restore his authority. This the President did not do. Embittered, tired of fruitless fighting, and anxious to increase his income because of his recent marriage, Wiley quit [24].

In the whole protracted struggle, patent medicines played almost no part at all. One of Wiley's opponents within the Department of Agriculture had chided the chemist for working up weak food cases when so many strong cases might be developed against vicious nostrums sold within "the shadow of the National Capitol." Granted that the complaint possessed some merit, it has all the earmarks of a blow aimed at embarrassing Wiley in the continuing battle. At any rate, the Johnson case had already been decided against the government in the District Court [25]

Although patent medicines were not a real issue in the fight, Wiley's resignation was an important factor in rekindling the anti-nostrum crusade. The controversial chemist had been much in the press during the contest with his enemies, especially since a Congressional committee had investigated the misconduct charge against him. Pure food advocates were outraged at this charge and tended to view Wiley's departure from government as, in effect, a firing. Widespread publicity about the law's main architect was accompanied by a revived attention to the various facets of the law, In this renewed public interest, patent medicines shared. The Johnson decision and the Sherley Amendment also helped direct attention to the theme. Concerned observers began to conclude, moreover, that truthful labeling—even if the Bureau of Chemistrv really had the will and the funds to secure it—was not enough. Granted there had been improvement. Granted—though this was uncertain—there might be more improvement under the Sherley law. The situation was still appalling. From the perspective of the medicine maker, as the National Druggist had predicted in 1906, the law had proved "not such a terrible thing after all." [26] From the viewpoint of the ardent reformer, therefore, something was needed.

In the renewal of patent medicine muckraking, the famous writer-editor team of Samuel Hopkins Adams and Norman Hapgood again took the lead. Now, however, they were not harnessed together as in 1905. Hapgood, having moved from Collier's to Harper's Weekly, got George Creel to write a series of hard-hitting attacks on the "Poisoners of Public Health." Adams aimed his shots mainly from the pages of Collier's and the New York Tribune. He also wrote a novel about the nostrum business. With a proprietor based on the old German who made Peruna and a plant modeled on the Swamp Root factory, The Clarion depicted details of nostrum production and promotion so critically as to bring anguished protests from real medicine makers. Adams' picture of the industry, charged the editor of the Proprietary Association's journal, was "as wide of the truth as anything ever set down in English," and Adams himself was "like a certain nasty breed of wooly dogs that delight to roll in filth and then sit down and rapturously smell themselves." [27]

Dr. Wiley himself became a muckraker. Upon resigning from the Bureau, he joined the staff of Good Housekeeping to keep its readers posted on the continuing food and drug crusade. Food still interested him most, but Wiley's column and correspondence contained frequent items of evidence to buttress his general thesis, asserted in the title of an article, "The Inherent 'No-Accountness' of Patent Medicines." [28]

Wiley was a doctor, and in the new assault, the main artillery was fired by physicians. The American Medical Association took the lead, making an increasing effort not only to inform its own members about the hazards of quackery, but also to reach the laity. At their 1915 meeting, the AMA's House of Delegates addressed a petition to President Woodrow Wilson and the Congress. Despite the law, the petition asserted, "fraudulent and deceitful practices" with respect to proprietary medicines still abounded. The President should recommend that Congress establish a commission to investigate the evils and make them widely known. The next year a deputation from the Association waited upon Wilson to reiterate the request. Despite improvements resulting from enforcement of the law, the doctors told him, the patent medicine "problem as it affects the people of the whole country has scarcely been touched." Wilson expressed his sympathy with the Association's objectives, but made no promises [29].

Physicians, journalists, and bureaucrats agreed that, despite the optimism with which it had been greeted and the integrity with which it had been enforced, the 1906 law had not eliminated quackery. There were some who argued that, quantitatively, the patent medicine evil was worse than it had been. "The passing of these sordid rascals [through the activity of the Bureau and the Post Office]," wrote Creel. . . ," made no more than a ripple on the surface of fraud. For every one that has been put out of business, a score has arisen to take the vacant places." In 1909 a President's commission had made the same point: "In spite of solemn protests and ostracism, the frightful list of . . . harmful . . . [secret and proprietary medicines] increases at the rate of about 200 a year." [30] The hope that an honest—though not fully revealing—label would warn an alert public away from danger had not been vindicated. Why not?

For one thing, the job was too big. There were too many patent medicines, too small a regulatory staff. "The Bureau," wrote Creel, "is in the position of one who tries to mop up water on the floor while the spigot is still turned on." Each case was costly to try, if contested, running from $30,000 to $50,000. Penalties were too light to serve as deterrents. Fines, small as they were, were often remitted. Although the law permitted one-year sentences for second offenders in interstate commerce, no one went to jail. Upon learning that a man had been sentenced to four months of hard labor for imitating a trademark, the Journal of the American Medical Association editorialized, "Some day, possibly, a court may be found that will consider the crimes of making drug fiends of young people, of poisoning babies with opium mixtures or of killing women with headache powders as more serious offenses than the counterfeiting of the label of a fraudulent 'patent medicine.' Apparently, that time is far off." [31]

Some forms of quackery, the critics pointed out, could not be moved against at all. The 1906 law defined "drug" in such a way that mechanical devices promoted as sure cures for dread diseases had a clear field. So did quack concoctions promising to put flesh on the skinny or take it off the fat. Face creams, hair dyes, and other cosmetic preparations, although they might pose serious hazards to health, could avoid conflict with the law if their proprietors resisted the urge to put therapeutic claims upon the labels. This state of affairs, Wiley's successor felt, was one of the "serious limitations" of the law [32].

The new Bureau chief, Carl L. Alsberg, also grieved that the law failed to include "any restriction whatever upon the use of many of the most virulent poisons in drugs." So long as the label announced the presence and proportion of the eleven dangerous drugs included in the law, things were legal. This list of poisons had been found to be woefully short. There were many others—Dr. Kebler compiled a list of 46—just as hazardous, which could be included in any quantity without a word of warning to the customer." [33]

More important, the general theory behind the labeling provisions seemed, after a decade's experience, not quite so sound as it had seemed in 1906. How many Americans, reading a proprietary label, would understand the hazardous meaning of "heroin, alpha or beta eucaine, chloroform, cannabis indica," or, at any rate, would know how large a dose of any one of these drugs might be ingested with safety? How many Americans, indeed, seeking out proprietary remedies, paid much heed to labels at all? Pharmacists testified that most customers asked for nostrums by name and carried them off with scarcely a glance at the cartons. Thus, asserted Creel, the law as it stood failed to safeguard "the large percentage of ignorant, careless or reckless purchasers." Not until "the public is afforded a protection that does not rest upon the initiative of the individual," he believed, would "the ultimate goal" be reached. This would require a flat prohibition of certain dangerous ingredients in remedies offered for public sale. It would likewise require control of nostrum advertising [34].

The very therapeutic claims on labels which the Sherley Amendment had forbidden, for the second time as it were, continued boldly in the advertising columns of much of the nation's press. The nostrum buyer who did not look at the label did not need to. He went into the drugstore with the promise of a cure "burned into" his mind from frequent rereading of patent medicine advertising. "Printer's ink," wrote Creel, "in the last analysis, is the net that catches the victims of quackery. . . . The Food and Drugs Act cannot be anything but a circling of Robin Hood's barn as long as the patent medicine liar has the daily press at his disposal." Samuel Hopkins Adams might not be quite so discouraged, but he concurred in the basic point. "Half success is the best that can be claimed for the Pure Food Law insofar as it affects nostrums," he wrote. "The reason is that we who fought to get the law passed aimed at the wrong side of the bottle. We should have attacked the advertisements in the newspapers. That is where the real damage is done." The same judgment was rendered by Kebler and his new chief, by Wiley and his old superior. "I believe," wrote ex-President Roosevelt, "that legislation could be framed to forbid such advertisements." [35]

At the time the Sherley Amendment was being considered, Congressman William Richardson of Alabama had introduced a bill that would have brought advertising under some restraint and tightened the control of drugs in a number of other ways. Kebler from within the Bureau and Wiley from without urged a House committee to support the legislation. Kebler displayed reams of advertising and scores of offending bottles, stark exhibits to demonstrate that the 1906 law needed toughening to cope with quackery. But spokesmen both for proprietary manufacturers and for the prescription drug industry condemned the measure. The committee did not report it back to the House [36].

The Proprietary Association was dead set against governmental control of advertising. Aware that there were excesses that needed curbing, the Association began to take steps to improve the standards of its members. This was one of several moves made in an effort to rehabilitate an organization that had been greatly demoralized by the events of 1906. In the month that the new food and drug law became effective, a drug periodical reported on the Association's moribund condition:

At present the proprietary association's meetings do not exhibit the old time éclat. The industry is being generally attacked by the independent magazine press, the retail trade is growing stronger in opposition to it, legislation restricting it and removing much of its secrecy is being enacted, and its influence is waning. Several of the manufacturers of so-called ,'ethical' goods have resigned from its membership, as have also some of the leading 'patent' medicine manufacturers. The meetings . . . are paid very little attention to by the other branches of the trade nowadays, and, as a rule, the sessions are secret [37].

From this rout there had been a slow rally. Proprietors found that by exercising a little diligence they could easily live with the new law. Brushes with the law were few, fines not unreasonable. Sales, instead of falling off, kept booming. In the decade between 1902 and 1912, the Association's president said, total production in the industry had increased 60 per cent. Census figures bore him out, with the future looming brighter still. And as the Bureau of Chemistry eliminated small fly-by-night promoters, the big proprietors got an in creased proportion of the total volume. By 1915, members of the Proprietary Association were producing some 80 per cent of American proprietaries sold. Proponents of the 1906 law "who hailed it as the 'end of the patent medicine business.," noted an industry spokesman, were "sorely disappointed. it was rather the beginning than the end." [38]

By 1913, members of the Proprietary Association felt enough at ease under governmental control to invite Lyman Kebler to address them. He urged the group to strengthen self-imposed restrictions on proprietary labeling and to develop its own code of ethics to cover advertising. Two years later the Association took steps to follow Kebler's advice. They sent a committee to confer with a special commission on proprietary medicines of the American Pharmaceutical Association. This commission, after long and diligent inquiry, had devised "Minimum Requirements with Which Proprietary Remedies Should Comply in Order to Render Them Safe for Direct Sale to the General Public," a set of standards which the parent body had formally approved. Out of the discussion between delegates of the two drug organizations came a somewhat revised version of the "Minimum Requirements," which was adopted by the Proprietary Association to govern its members. The law was to be obeyed. Narcotics for children and abortifacients were completely taboo. Narcotics in adult medicines should not exceed the Harrison Law ceiling. No other ingredient should be put in a medicine that would "endanger life or health if used in accordance with instructions accompanying the package." Alcohol should be kept at a minimum, no more than enough to keep the active ingredients in solution and to prevent freezing. "Statements [on the package] regarding therapeutic effects must neither be obviously unreasonable nor demonstrably false." As to advertising, the Proprietary Association rule was less stringent than the American Pharmaceutical Association standard, which recommended that advertising and labeling meet the same tests. The Proprietary Association version stated, "The preparation must not be advertised or recommended as a cure for diseases or conditions which are generally recognized as incurable by the simple administration of drugs." [39]

To enforce the requirements, a committee was created to scrutinize labeling—but evidently not to check advertising copy—used by members of the Association. By 1919 this committee could report that only 19 members had not yet met its approval on this score. A number of applicants for membership in the Association had been turned down [40].

The code of ethics was only one part of the Proprietary Association's effort at rehabilitation. It made a determined and successful attempt to increase its membership. It set up a journal, Standard Remedies, to keep its members alert to common problems and aware of dangers. In this magazine, the Association counterattacked its critics with a vigor and bitterness not seen since pre-law days. When Norman Hapgood began to publish George Creel's sharp attacks in Harper's Weekly, Standard Remedies saw the purpose as "To Raise H--L and Sell Newspapers." The American Medical Association, the medicine makers charged, used "Hun methods" and the ethics of "the journalistic prostitute" in its anti-proprietary campaign. When the House of Delegates petitioned for a national commission of inquiry, Standard Remedies termed the resolution "smug, . . . conceited. . . . impertinent," and inquired, "Is this a free country, or are we to be Russianized." [41]

Despite the weaknesses in the law as it applied to nostrums, despite the revival of muckraking and constant pressure from the medical profession, no new national legislation was enacted. The alertness of the Proprietary Association and its efforts at good behavior were no doubt in some part responsible. Two other factors also seem important. Food and drug legislation had been one aspect of the Progressive movement, and the Progressive movement, sustained for more than a decade, was on the wane. Then, too, with the European War, public attention began to shift from domestic to foreign affairs. No man better knew the need for a new law than Wiley's successor as chief of the Bureau of Chemistry, Carl L. Alsberg. No summary of the loopholes in the 1906 measure was more admirably succinct than that which Alsberg included in his 1917 annual report. Since no new law seemed forthcoming, however, Alsberg set out to enforce the Sherley Amendment as rigorously as he could [42].

Like Wiley, Alsberg was a scientist. His degrees—including the M.D.—were all from Columbia, and he had engaged in postgraduate study at several German universities, taught chemistry at Harvard, and worked as a biologist in the Bureau of Plant Industry before Taft elevated him to head the Bureau of Chemistry. Wiley, on the outside, thought one of his own aides should have been promoted to the post. "Doctor Alsberg," the ex-chief wrote, "appears to me to be a very promising kind of young man if he can just keep under the right influence." [43].

The two men made a striking contrast in appearance and temperament. Whereas Wiley was "big-faced, big framed, bald-headed, large limbed, deep voiced and pugnacious," wrote a reporter, the new chief was of medium height modestly dressed, possessed of plenty of hair and a black mustache, and imbued with the air of a man of leisure, imperturbable even under great pressure. When he walks, the newsman noted, no floorboards squeak [44].

Dr. Alsberg believed his objectives were bound to be different from Wiley's mission. "I hope to sink my personality in the work," he said several months after his appointment. "My predecessor was a man of great strength of character and in the work of attacking the food adulterators and starting the fight, he necessarily came into the limelight. If I can knock out the food fakers and get the bureau down to hard constructive work as well that is all I want to do. I have no desire to be known as a great personage, a fighting character or a man who has killed a dragon " [45]

To make the Sherley act rapidly effective, Alsberg transferred as many chemists as could be spared from other work to a crash program against nostrums. Hundreds of patent medicines were analyzed within a few months' time. In this campaign the first seizure to be contested in court involved a product long known to patent medicine customers and critics, 1 the Microbe Killer, that wondrous draught which had transformed an impoverished Texas gardener into a prosperous resident of New York. By now William Radam was dead, but his trademark lived on. Vended in stone jugs of three strengths, the Microbe Killer had lost none of its vaunted self-assurance. When the potent liquid was imbibed, the labeling said, Microbe Killer's healing gases were released by the heat of the stomach, from whence they went forth to disinfect the entire system, in the process curing headache and worms, measles and malaria, consumption and yellow fever, small pox and leprosy. The Microbe Killer was also effective preventive medication: added to drinking water, it acted as a safeguard against disease [46].

A carload lot of this preposterous proprietary had been shipped from the New York manufacturer to his agent in Minneapolis. Dr. Alsberg arranged for federal authorities to seize 539 wooden boxes and 322 pasteboard cartons of the stuff, worth at retail prices some $5,166, although government chemists estimated the cost of making it at $25.82.

When the Microbe Killer agent contested the seizure, Alsberg and his key aides went west to help with the trial. "We have several hundred cases like this," the bureau chief said, "and if we lose here I do not know just what we will do. . . . On it practically hangs our pure food and drug law." [47]

The case pitted medical science against testimonials from the untutored. No mixture that was essentially 99 per cent tap water and 1 per cent sulphuric acid, Dr. Alsberg told the jury, could cure the diseases mentioned. The greatest therapeutic action the Microbe Killer might possess would be as a mild laxative. And for many people it would irritate the stomach and upper intestine. "Then all your complaint. . . ," Alsberg was asked by the defense attorney, "is the inflammation which is caused by this medicine as it passes through the alimentary tract?"

"What we are complaining of is more than that," the bureau chief answered. "It is the fact that a man may be very sick and use this medicine until it is too late to use something else."

"Then it is the time he loses?"

"The time he loses may be sometimes the difference between life and death."

A District of Columbia bacteriologist testified. "I don't know of anything," he said, "in which sulphuric acid of that strength could be used as a therapeutic agent." Local physicians, one an old-timer who had practiced in Minneapolis for years, the other a University of Minnesota medical professor, supported the government's case.

The defense relied on testimony by satisfied users of the Microbe Killer. During a hearing in Washington that preceded the trial, an attorney for the manufacturer had told Alsberg about 47 bound volumes of letters in the company's possession, written by men and women grateful for their cures. To the witness stand in Minneapolis went a number of such champions: a woman who had vanquished cancer with five bottles of the Microbe Killer; a man who had rid himself of tuberculosis in three months; a woman who had knocked out her son's diphtheria in half a night. The Minneapolis agent was himself a devoted user. Twenty doctors had told him they could not help his throat trouble, he testified, but 20 to 30 gallons of the Microbe Killer, taken in the course of seven months, cured him completely. The most he had ever taken at one time, he said, was two whole bottles in one day.

Despite the earnestness of such testimony, the jury decided against the Microbe Killer. "If you believe," the judge had charged them, "that this remedy is so absolutely worthless, for example, for leprosy or for catarrh or for consumption or for diphtheria, that the manufacturer must have known that, then you would be justified in finding that the statements made with reference to these diseases upon the labels are false and fraudulent." So believing, the jury condemned the 539 boxes and 322 cartons of the Microbe Killer to destruction. "I favor," said the district attorney, "using an ax." [48]

Bolstered by a court decision indicating that fraud could be deduced from a nostrum's label, Alsberg accelerated his campaign against the most obnoxious patent medicines. Two years later the Supreme Court, with justice Hughes delivering the opinion, affirmed the constitutionality of the Sherley act. Eckman's Alterative, a "cure" for all throat and lung diseases, Hughes said, had been properly restrained by governmental action. Alsberg increased still more the pressure on quack labeling. To take charge of Sherley Amendment activity, he added to his staff a physician, M. W. Glover, from the Public Health Service. To give legal victories a greater impact for public education, the Bureau began to issue press notices. To prevent the distortion of the guaranty system, the guarantee of compliance was taken off the label, where the public could see it, and shifted to the bill of sale [49].

Dr. Glover sought and secured wide support from state and local food and drug officials in screening sources of sale for mislabeled nostrums. This help was crucial in the first major effort employing the seizure provisions of the law to drive hazardous patent medicines from the market. Worried by baby soothing syrups, the Bureau engaged in multiple seizures, taking legal action wherever the nostrums might be found. Some 123 lots of one brand, Sirop D'Anis Gauvin, were acted against from Maine out to Michigan and the dangerous medicine destroyed. Some makers of similar soothing syrups stopped their manufacture [50].

Most of Dr. Glover's work was aimed at remedies purporting to grapple with the uncontrollable diseases. "Our experience has taught us," he wrote, "that the appearance on the label of the name of a disease usually conveys to the user the impression that the preparation is all that he needs to get permanent relief from that trouble." Therefore more attention was given, in studying labels, to the names of diseases than to "associated wording." Those diseases about which there was no conflict of medical opinion, diseases which virtually all doctors would deem incurable, were those to which the Bureau was most alert. "We hold," Dr. Glover stated, "that a manufacturer of a medicine, when he tells people what diseases it is a treatment for, assumes a position of superior knowledge; of one who knows all about drugs and their relative value as therapeutic agents, and when he promises that a certain combination will do certain things, which it will not, that he is guilty of fraud." Untruthful statements, the Bureau held, "made with a reckless or wanton disregard as to whether they were true or false," thereby revealed their fraudulency [51].

Scores of vicious nostrums were driven from the market, or made to modify their labeling. Campaigns were pushed against throat and lung proprietaries of the Eckman's Alterative type, against kidney and liver remedies, against mineral waters sold with cure-all claims, against abortifacients and male rejuvenators. During the years of the first World War an old quack practice quickly rose to threatening proportions. After testing many medicinal products offered the Surgeon-General's Office for treating sick soldiers, the AMA's Council on Pharmacy and Chemistry asserted that "it would seem unbelievable that such a variety of fakes would be offered in earnest to the government." Many medicines equally unworthy, especially concoctions promising to cure venereal disease, were offered for direct sale to the troops. The Bureau of Chemistry set out in hot pursuit [52].

The result of the Bureau's anti-nostrum crusading, from the Microbe Killer decision into the early postwar years, amounted to a revolution. There was, in proprietary labeling, "a notable change for the better," in that flagrant and flat-footed claims to cure the dread diseases were markedly reduced. Fines for violation were generally higher than in the Wiley years.

But what was the effectiveness of the revolution in protecting the public against quackery? Not very great. Subtle and devious label claims, too vague for Sherley Amendment action, continued—indeed, increased. These claims the ordinary man could interpret, if he bothered to read them at all, as an echoing of the nostrum maker's completely unrestricted boasting in his advertising, whence the old categorical claims had migrated. Thus the Sherley Amendment was a useful but not a decisive weapon for combatting quackery. Suddenly it became an even weaker weapon than it had seemed to be [54].

References

  1. Harper's Wkly., 60 (1915), 155
  2. Anderson, The Health of a Nation, 197-259; James C. Munch andJames C. Munch, Jr., "Notices of Judgment—The First Thousand," Food Drug Cosmetic Law Jnl., 10 (1955), 219-42 [Hereafter cited as FDC Law Jnl.].
  3. Secy. of Agric. James Wilson to Wiley, July 24, 1906, Wiley Papers, box 60, Library of Congress; John Uri Lloyd, "The National Pure Food and Drug Act," reprint from Eclectic Medical Gleaner, May 1907, 5.
  4. Amer. Druggist, 49 (1906), 158, 173-78; Bull. Pharmacy, 20 (1906), 441-42; the regulations were reprinted in 59 Cong., 2 ses., Sen. Document 252.
  5. Fred B. Linton, "Federal Food and Drug Laws—Leaders Who Achieved Their Enactment and Enforcement," FDC Law Jnl., 4 (1949), 462.
  6. Amer. Druggist, 50 (1907), 35-37, 48-50; numerous letters in Incoming Corres. of the Bur. of Chem., RG 97, NA; the quote from Leopold Kusnick, Cincinnati, Dec. 6, 1906. Congressman W. C. Adamson inquired Dec. 21, 1906, about Horn of Salvation, made by a Newman, Ga., constituent.
  7. The Drug Laboratory was organized Mar. 1, 1903, and was renamed the Division of Drugs Jan. 1, 1908. Lyman F. Kebler, its chief, had come to the Bureau after a decade's experience as chief chemist at a Philadelphia pharmaceutical manufacturing concern. "Division of Drugs," ms. by Kebler in folder "Drug Lab" (243), Bur. of Chem., General Corres., 1909, RG 97, NA; Who's Who in America, 1914-1915, 285-86.
  8. Wiley to Indian Black Vegetable S. & R. Co., Dec. 26, 1906, and Wiley to Amer. Druggist Publishing Co., Dec. 21, 1906, from Letterbooks, General Corres., Bur. of Chem., RG 97, NA. Harry Leonard to James Wilson, Dec. 3, 1906, Incoming Corres., Bur. of Chem., RG 97, NA.
  9. For example, Erso Proprietary Co. to Secy. of Agric., received Dec. 29, 1906, and The Herpicide Co. to Bur. of Chem., Nov. 8, 1906, Incoming Corres., Bur. of Chem., RG 97, NA. Adams to Wiley, Mar. 26, 1907, and Wiley to Adams, Apr. 1, 1907, Gen. Corres., RG 97, NA.
  10. John P. Street, "The Patent Medicine Situation," Amer. Jnl. of Public Health, 7 (1917), 1037-38; Jnl. Amer. Pharmaceutical Assoc., 7 (1918), 71; Bull. Pharmacy, 22 (1908), 332-34, 444; President's reports, 1908 and 1909, Minute Book of the Hostetter Company, examined in the Hostetter Corporation archives, Pittsburgh, 1956.
  11. Standard Remedies, 4 (Jan. 1918), 8-10; N&Q, 1, 671-80; it, 101, 162.
  12. Reports of Bureau of Chemistry, 1907-1911; Munch, "Notices of Judgment—the First Thousand," 219-42; Hampton's Mag., 27 (1911), 393; Standard Remedies, 1 (Sep. 1915), 809.
  13. Reports of Bureau of Chemistry, 1907-1911; Munch, 219-42. On Post Office anti-quackery efforts see ch. 4 below.
  14. 1910 Report of Bureau of Chemistry, 19, 35.
  15. John Uri Lloyd to Wiley, Dec. 2, 1908, Wiley Papers, box 65, Library of Congress; typescript copy of Tarrant's Seltzer-Aperient poster in Falls Church Railway Car, ibid., box 60; Orangeine ad in Chicago Tribune, Feb. 17, 1907.
  16. Amer. Druggist, 49 (1906), 234.
  17. Burrow, AMA, 2-6, 33, 100-101, 317-18.
  18. Message from President Taft, Cong. Record, 62 Cong., I ses., 2380 (June 21, 1911).
  19. White and Gates, in Decisions of Courts in Cases under the Federal Food and Drugs Act, cite the District Court decision, 85-88, and the Supreme Court decision, including the dissent, 267-73.
  20. Harper's Wkly., 60 (Jan. 2, 1915), 60; Chicago Tribune, Dec. 9, 1911.
  21. Cong. Record, 62 Cong., 1 ses., 2379-80.
  22. Ibid., 11,322-23, 11,352, 11,744; the Amendment was passed Aug. 23 , 1912, ch. 352, 37 Stat. 416; Outlook, 101 (1912), 993. There had been a brief hearing: The Pure Food Law, Hearings before the Committee on Interstate and Foreign Commerce, House of Representatives, 62 Cong., 2 ses. (Wash., 1912).
  23. Ibid., 16; Cong. Record, 62 Cong., 1 ses., Appendix, 676.
  24. Wiley cited in Rural New Yorker, Sep. 14, 1912, clipping, Wiley Papers, box 236, Library of Congress; Wiley, "The Public Tricked Again," Good Housekeeping, 55 (1912) , 694. Wiley's account of his struggles is given in his The History of a Crime against the Food Law (Wash., 1929). An impartial and excellent appraisal is Oscar E. Anderson, Jr., "The Pure-Food Issue: A Republican Dilemma, 1906-1912," Amer. Hist. Rev., 61 (1956), 550-73, and the matter is treated at length in Anderson, The Health of a Nation, 197-258. See also Dupree, Science in the Federal Government, 179-80.
  25. George R. McCabe to Wiley, Jan. 29, 1910 (copy), Wiley Papers, box 200, Library of Congress; Anderson, The Health of a Nation, 233-34.
  26. 36 (1906), 210.
  27. Creel had eleven articles in Harper's Wkly., between Jan. 2 and Apr. 24, 1915. Adams published Colliers articles during 1912 and 1913 and the Tribune series was reprinted as Some of the Adams Articles on Fraudulent and Deceptive Advertising. Published in the New York Tribune during Nineteen-Fifteen and the First Half of Nineteen-Sixteen (N.Y., 1916). The Clarion (Boston, 1914); interview with Adams, Apr. 5, 1955; Standard Remedies, I (Mar. 1915), 7-10.
  28. Wiley's Good Housekeeping correspondence makes up boxes 163-173 of his Papers, Library of Congress; the magazine from late 1912 on contains his monthly contributions. "The Inherent 'No-Accountness"' article he wrote with Anne Lewis Pierce, 59 (1914), 384-92.
  29. JAMA, 65 (1915), 120, 122; 66 (1916), 974. On the AMA antiquackery campaign, see ch. 7 below.
  30. Harper's Wkly., 60 (1915), 5; William H. Baldwin, Reports of the President's Homes Commission, 60 Cong., 2 ses., Sen. Doc. 644 (1909), 246.
  31. Harper's Wkly., 60 (1915), 135-36; JAMA, 58 (1912), 706.
  32. 1917 Report of the Bureau of Chemistry, 16; Harper's Wkly., 60 1 915), 136.
  33. 1917 Report of the Bureau of Chemistry, 16; The Pure Food and Drugs Act, Hearings before the Committee on Interstate and Foreign Commerce, House of Representatives, 62 Cong., 2 ses. (Wash., 1912), 68.
  34. Harpers Wkly., 60 (1915), 112.
  35. Ibid., 136, 155, 158; 1917 Report of the Bureau of Chemistry, 14; Wiley, "The Public Tricked Again," Good Housekeeping, 55 (1912), 694; Roosevelt, "Applied Ethics in journalism," Outlook, 97 (1911), 807-809; Kehler cited in The Pure Food and Drugs Act, Hearings . . . 62 Cong., 2 ses., 81, 119.
  36. Ibid., passim; Cong. Record, 62 Cong., 1 ses., 2492, 2656; 2 ses., 12.
  37. Druggists' Circular, 51 (1907), 114.
  38. Standard Remedies, 1 (Mar. 1915), 26; 4 (Jan. 1918), 8-10; 5 (July 1919), 8-10; Bureau of the Census, 13th Census of the United States . . ., viii, Manufactures, 1909 (Wash., 1913), 40; Bureau of the Census, Census of Manufactures: 1927, The Drug Industries (Wash., 1929), 6; Leonard L. Minty, The Legal and Ethical Aspects of Quackery (London, 1932), 194.
  39. Standard Remedies, I (Dec. 1915), 17-18; 2 (May 1916), 11-12, 17-19; 5 (Apr. 1919), 30-31; 6 (Feb. 1920), 21-22; Jnl. Amer. Pharmaceutical Assoc., 2 (1913), 1469-71; 4 (1915), 1148-67; 5 (1916), 137489; 7 (1918), 67-76. The American Pharmaceutical Association "Minimum Requirements" are listed ibid., 4 (1915), 1165-66, and the Proprietary Association "Requirements for Membership," 5 (1916), 1374-75.
  40. Standard Remedies, 5 (Apr. 1919), 30-31.
  41. Ibid., 1 (Jan. 1915), 1, 5-6; (Apr. 1915), 7; (Aug. 1915), 3; 4 (Jan. 1918), 13; 5 (Jan. 1919), 13; (May 1919), 12-13; 6 (May 1920), 22; (Dec. 1920), 26. Standard Remedies began Jan. 1915 as the "baby" of the Proprietary Association. In May 1915 it was incorporated under private ownership, although intended to remain an organ of the major manufacturers of proprietary medicines. Until his death in 1934, Ervin F. Kemp, General Representative of the Proprietary Association since 1905, served as the editor. Ibid., I (Jan. 1915), 1; (May 1915), 3; 21 (Nov. 1934), 3.
  42. 1917 Report of the Bureau of C'hemistry, 14 -16.
  43. Alsberg discussed his background on the witness stand in the Radam's Microbe Killer trial. Transcript of testimony in Food and Drug Case 4910, Office of the Solicitor of the Dept. of Agric., Notice of judgment [NJ] 3004, RG 16, NA. Wiley to Albert B. Matthews, Apr. 11, 1913, Wiley Papers, box 112, Library of Congress. See also Fred B. Linton, "Federal Food and Drug Laws-Leaders Who Achieved Their Enactment and Enforcement," FDC Law Jnl., 5 (1950), 103-15.
  44. Minneapolis Journal, Oct. 12, 1913.
  45. Ibid.
  46. 1913 Report of the Bureau of Chemistry, 2. On the origins of the Microbe Killer, see Young, The Toadstool Millionaires, ch. 10. The discussion here is mainly based on the files of the Bureau of Chemistry (Interstate office Seizure File, Seizure No. 1628, F&D No. 4910, RG 88, NA) and of the Office of the Solicitor of the Dept. of Agric. (F&D 4910, RG 16, NA.) Satisfied user testimony is from Minneapolis Morning Tribune, Oct. 11, 1913. White and Gates, 511-19, cite Judge Willard's charge. In 1909, during Wile 's regime, a shipment of the Microbe Killer had been seized in Washington state and condemned without contest (Office of the Solicitor, F&D 603, NJ 205, RG 16, NA).
  47. Minneapolis Morning Tribune, Oct. 10, 1913.
  48. White and Gates, 517; Minneapolis Morning Tribune, Oct. 14, 1913.
  49. Munch, "Notices of judgment-Nos. 1001 to 5000," FDC Law Jnl., 11 (1956), 17-34; 1916 Report of the Bureau of Chemistry, 351. Press notices began in 1915, with a great many devoted to proprietaries through 1919; Press Notice file in, Food and Drug Administration. A 1915 press notice notes the change in the guaranty system. White and Gates give the Jan. 10, 1916 Supreme Court decision (239 U.S. 510) in the Eckman's Alterative case.
  50. Food and Drug Review, 4 (Aug. 1920), 16-18. This journal was begun as a restricted private organ of the Bureau of Chemistry to keep its staff, in Washington and in the district offices, as well as state food and drug personnel, posted on matters of concern. Hereafter cited as F&D Rev.
  51. M. W. Glover, "The Administration of the Sherley Amendment," F&D Rev. 4 (Oct. 1920), 17-19.
  52. Press Notice file, 1915-1920, FDA; Munch, "Notices of Judgment ­ Nos. 1001 to 5000," FDC Law Jnl., 11 (1956), 17-34; Munch, "Notices of judgment—Nos. 5001-15,000," ibid., 196-211; JAMA, 72 (1919), 1741; Reports of the Bureau of Chemistry, 1918-1921.
  53. F&D Rev., 7 (Jan. 1923), inside back cover; (Dec. 1923), 10; Munch, "Notices of judgment-Nos. 5001-15,000," 206.
  54. See ch. 5.
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