“This is the most important case that this [Food and Drug] Administration has ever had, and if we lose it we might just as well shut up the shop and go home.”
—P.M. Lowell, Acting Chief, Drug Control, 1929 
During 1922 in a federal district court in Concord, New Hampshire, the United States government suffered defeat in an action to condemn “Eleven Packages of B. & M. External Remedy.” Disappointed but not disheartened, officials charged with enforcing food and drug legislation set out forthwith on what was destined to be a ten-year campaign to turn the tables of justice 
B. & M. labeling flaunted the boldest of claims. The list of maladies it could cure ran on and on: pneumonia, laryngitis, bronchitis, pleurisy, la grippe, asthma, hay fever, catarrh, rheumatism, lumbago, neuralgia, neuritis, peritonitis, neurasthenia, locomotor ataxia, varicose veins, blood poisoning, autointoxication, sprains, scalds, burns, cancer, and tuberculosis—above all, tuberculosis. B. & M.’s career had begun, however, more humbly.
During the first decade of the century, a racetrack habitué named William McClellan, finding himself hard pressed for funds, marketed a liniment for horses. As to the source of his formula, McClellan later told different tales. Either it was brought from Ireland by his mother-in-law, a woman named Burns, or it was picked up from a Dr. Byrnes, who was either a doctor who played the horses or a doctor who treated them. Whatever its origin, the potent brew did not differ much from liniments long in use: its three main ingredients were turpentine, ammonia, and raw eggs. McClellan tinkered with the mixture some—the first of many modifications—adding small amounts of formaldehyde and the oils of mustard and wintergreen. The name of the liniment—destined, unlike the formula, to remain stable—derived its key letters from the Burns and McClellan initials.
Persuaded that the horse could not long hold out against the automobile, McClellan shrewdly shifted his appeal from beast to man. Pouring his excoriating concoction into small bottles, he began to peddle it around Boston for rubbing on sore muscles and aching joints. Among McClellan’s customers was a court reporter plagued with rheumatic fingers. One bottle of B. & M. let him get on with his shorthand and turned his interest to the liniment. Approaching the age of 70, Frank E. Rollins was seeking a business opportunity to occupy the years of his retirement. In his youth he had worked as bookkeeper for the Ayer remedy company, so he was not unfamiliar with the promotion of proprietaries. Trying out B. & M. on others members of his family, Rollins reached the conclusion—so, at least, he was to insist unswervingly—that McClellan had far underestimated the healing capacities of his liniment. Rollins’ grandniece, his sister-in-law, his daughter, all cruelly afflicted with tuberculosis, made miraculous recoveries. McClellan was pleased at the interest of the mild-mannered, round-faced, smiling court reporter, who had such good contacts in legal and religious circles. Rollins’ life savings would come in handy, too. For his part, Rollins saw retirement security in the formula owned by the rough and simple racetrack man. The two got together and in 1913 incorporated as the National Remedy Company.
The situation was, as a government investigator put it, “a case of Greek meeting Greek.”  Rollins was to win. Within a few years he had maneuvered McClellan out of his stock, and-continuing to teach a large Sunday School class the while Rollins had amplified B. & M.’s curative compass to include the whole gamut of major human ills. He had also gone to great pains to get physicians and sanatoriums to try his remedy on tubercular patients-he had even written to Washington urging that it be used in army hospitals during the war. These efforts to reach the medical profession proved largely futile. A village doctor or two succumbed. Political influence from Rollins’ court reporting days led to a test in one state hospital, but the results were not such as could be used in advertising. Much more successful was the effort to gather testimonials from laymen who had used the medicine. These Rollins reported in pamphlet and press. On them he based his rhapsodic promises.
“White Plague Conquered!!!” began one pamphlet. “The New Chemical Compound B. & M. External Remedy Has Won the Victory—Tubercular germs are entirely eradicated from the lungs, glands, or joints in four to twelve weeks . . . without any radical change in mode of life. The breadwinner need not abandon his employment. The housewife need not leave her cares to others. The student need not abandon his books. The expensive sanatorium treatment during months or years is no longer necessary. The looking forward into the grave, while dreading the approaching end, may now be only a nightmare banished forever.” 
Such deathless prose was bound sooner or later to come to the attention of the Bureau of Chemistry. Since Rollins’ interstate shipments were still on a mail-order basis, the Bureau’s Boston man talked with a Post Office inspector, who took the facts to the district attorney. Rollins a menace? That could hardly be. The attorney knew him well. He would try to get the cherubic ex-court reporter to tone down his advertising. But no change occurred.
In 1919 the Bureau had some shipments of B. & M. seized in New Hampshire. While the case was awaiting trial, the Boston health commissioner took action. Asserting that Rollins’ “false and misleading” advertising violated state law, the commissioner hailed B. & M.’s owner into court on an indictment of 35 counts. Rollins put two witnesses on the stand who swore that the liniment had cured them of consumption. The commissioner got their permission to have them examined by physicians on his staff and x-rayed at a city hospital. The results were sobering. Both witnesses still had tuberculosis, and one was so sick he soon would die. Another of Rollins’ satisfied users, on his way to testify how he had been cured of Bright’s disease, gangrene, and diabetes, collapsed while climbing the courthouse stairs and almost expired on the spot. To condemn B. & M. came distinguished physicians, including the chairman of the board governing the state’s hospitals for tubercular patients, who told of the liniment’s abysmal failure when it had been put to the test. When the verdict was rendered, Rollins won on 33 and lost on two counts. The judge, who was acquainted with the accused, assessed a fine of $10 and made guilt sound very much like innocence.
“I believe Mr. Rollins to be a man of the very highest type,” he said from the bench, “absolutely sincere, and having the utmost faith in the efficiency of his remedy. I think the testimony shows that he was actuated by altruistic motives rather than motives of personal gain.” 
In the Concord courtroom, a longer parade of men and women than in Boston praised B. & M. from the witness chair. Tuberculosis, pneumonia, rheumatic fever, blood poisoning, these and other ailments, they said, had been banished by the heroic liniment. A Boston minister-physician, David L. Martin, told of cures he had seen wrought. Rollins himself took the stand, beaming and benign, with a quarter-century of experience in court behind him. He made a most persuasive witness, telling of his hopes to heal mankind, his vain efforts to persuade physicians to adopt his remedy, the need, therefore, to market it himself.
The government relied on expert testimony. Concord doctors and a Harvard medical professor assured the jury that B. & M.’s ingredients, singly or in combination, could not possibly do what Rollins’ witnesses claimed. The whole thing was so medically ridiculous, it seemed pointless for government lawyers to check up on and counter the particular curative tales told by the 28 who testified. In an effort to dispel Rollins’ aura of humanitarianism, the government did put McClellan on the stand. It was a mistake. Life at the track had not trained him for the ordeal of cross-examination. He contradicted himself, admitted to telling Rollins lies, revealed his own cupidity.
The judge made it clear in his charge that the Sherley Amendment required for conviction fraudulent intent as well as false claim. The jury found against the government and for the 11 packages of Rollins’ medicine. Had McClellan instead of Rollins been on trial, one juror said, he would have found him guilty. But who could send that poor man to jail? (This, of course, was not a possibility, because conviction at the worst would have meant destruction of the seized medicine.) The juror had obviously been impressed by Rollins’ demeanor and by the plea of defense attorney Melvin Johnson, that the philanthropist be given the verdict as a birthday present. He had just reached the ripe old age of 72.
With more than septuagenarian vigor, Rollins turned his court triumph into publicity. “A jury of New Hampshire men good and true,” he announced in half-page advertisements, had found B. & M. to be “an efficient weapon.” The conclusion was clear. “Within a few months the awfully destructive enemy, tuberculosis[,] could be put to rout in the Old Granite State.”  The ads were supplemented by pamphlets summing up the testimony of Rollins’ satisfied customers at the trial. “Vindicated”—such was the title—was distributed across the nation. B. & M. sales boomed.
The loss of this case posed a serious threat to effective control of quackery. It seemed to suggest that the burden of proof for establishing a fraudulent state of mind might be a well-nigh insuperable obstacle. Reputable doctors could all agree that the impact of turpentine and ammonia on the bare chest, excoriating as it was, could still not penetrate through to reach tuberculosis in the lungs. That was no matter. Rollins posessed no conceivable background to give him insight into practice of medicine. That was no matter either. The experts could tell him his claims were ridiculous, as he had been advised before the trial when he visited the Bureau of Chemistry accompanied by his congressman. That was equally irrelevant. If Rollins—or any other nostrum maker—could convince a jury that he believed his remedy efficacious, the law would not interfere. This was the “joker” in the Sherley law.
What would it take to prove fraud in court? What lessons could be learned from the Concord defeat? These were significant questions for Food and Drug officials to ponder during the decade of the twenties.
Despite the spreading wave of B. & M., the patent medicine scene was vastly improved in one significant respect compared with the days preceding 1906. The giants of the proprietary industry found it good business to live within the law. Ever larger, as combinations continued in the favorable economic climate, the major concerns had never before been so respectable or so proud of respectability. “Many of us remember the days,” said Frank Blair, perennial president of the Proprietary Association, in 1928, “when the business was laughed at. Today it is a most substantial, firmly established, constantly growing industry.” Doctors of the present day were not like “barber surgeons and crude empirics” of a former age, asserted a Proprietary Association stalwart, and no more did major medicine makers resemble “street fakirs of the past.” The disrepute in which proprietary manufacturers had once been held by the financial community had largely dissipated. Ownership of many major proprietaries had passed from family hands into corporations with stocks traded on all the exchanges and owned by investors around the globe. Overseas sales had expanded too to the point that American proprietors were the largest exporters of packaged medicines in the world. The Department of Commerce itself urged them to be even more “aggressive.”‘
In this aura of respectability, the president of a trade association representing smaller remedy makers shared. “I am sure,” said H.E. Woodward of the United Medicine Manufacturers of America, “there is not a man nor a member of our association, nor, indeed, scarcely a package medicine manufacturer in the country, who does not regard his business as entirely honest and legitimate in every way and himself as a self-respecting citizen serving humanity in general quite as fully as does the manufacturer of cotton thread or washing machines.” 
Perhaps the insistent assertion of respectability might indicate secret doubts. Standard Remedies at least recognized “a need for concerted action by package remedy makers to remove, the reproach which the average man unconsciously fastens upon the term ‘patent medicine.'” It was nonetheless a token of how accustomed major proprietors had become to the fact of governmental regulation that in 1920 a drug journal could give the Proprietary Association major credit for having secured the enactment of the 1906 law .
Believing in that law, the big concerns sought to avoid trouble’ expense, and bad publicity by keeping their labeling within the law’s limits. The Proprietary Association, screening applications for membership, offering advice on labels, suggesting some restraints on advertising, played the major role. Blair was sure that the industry’s enhanced respectability was due almost entirely to the Association’s efforts. To keep aware of officialdom’s thinking about regulatory problems became, for manufacturers, a necessary task. Lawyers for trade associations and for individual proprietors moved to Washington and paid frequent calls at the Bureau of Chemistry offices. “The Proprietary Association,” asserted the editor of Standard Remedies, “if it had no other claim upon its members, would more than justify itself by its bureau contacts.” 
Bureau officials, for their part, desired the largest measure of compliance with the law that could be attained. They realized that voluntary cooperation from the regulated industries, if it could be secured and maintained, was quicker and less expensive than compliance wrung from recalcitrant offenders through legal action. Wiley had so asserted in his early annual reports, and his successors were to reiterate frequently that their purpose was primarily educational. “The food and drugs act,” said the acting chief in 1922, “is corrective rather than punitive.” Legal action would come only as a last resort, when suggestions and warnings had not been heeded. At the start of the twenties, proprietary attorneys could not get Bureau officials to pass on label claims before labels were glued to the bottles. But long experience in listening to nuances of conversations let the lawyers shrewdly guess at how far their clients might go and still be safe. Informal procedures expanded as the decade went by. Bureau officials became willing to discuss formulas and criticize labels before proprietors took their wares into the marketplace: in 1928-1929, 15,000 such letters of inquiry were received in a single year. An ever-expanding list of diseases and symptoms was made known to the trade: the mere mention on a label of appendicitis, Bright’s disease, cancer, diabetes, and so on through the alphabet to venereal disease, brought the threat of quick seizure without mercy. Public warnings predicted campaigns soon to start against specific labeling abuses, providing the wise proprietor with time to set his house in order. Other helpful counsel was given in press releases, speeches, conversations. Except for references to the dread diseases, label violations discovered by Food and Drug inspectors were called to the manufacturer’s attention, so that he might, if he chose, voluntarily undertake the needed change .
A Bureau drug officer, addressing the Proprietary Association in 1927, could express pleasure that the trade’s earlier “suspicion” of bureaucrats had disappeared. And in the journal that spoke for the Association, there was, during the twenties, more of exultation than of anguish. Bureau government might not be perfect, but it was not too onerous either. The names of Association members appeared in the Notices of judgment, by which actions under the law were publicized, hardly at all .
To be sure, there were the inevitable tensions between the regulated and the regulator. Manufacturers chafed under certain rulings decreed from Washington, two being especially upsetting during the decade. Piqued at proprietors who toned down the phraseology on their labels, only to make bold claims in advertising, Bureau officials developed a new interpretative device. When a medicine label bore some such vague and elastic phrase as “stomach troubles,” the therapeutic meaning which the manufacturer really intended to convey was determined by reading his advertising. Seizures were made on such a basis. This procedure, many proprietors believed, unduly stretched the law .
Even worse were multiple seizures. The threat that the government might initiate legal actions against a proprietor’s product at a dozen sites at once, according to Standard Remedies, provided the “one great abuse” that had arisen from the enforcement of the 1906 law. The practice was “monstrous.” It let the government “paralyze and destroy a business, no matter how reputable, no matter how old, no matter how great the investment, no matter how meritorious the preparation .
Bureau officials admitted the effectiveness of multiple seizures. That, indeed, was the indispensable value of this legal weapon. It provided the most certain method of quickly stopping the grossest frauds. And it was so used, being resorted to rarely and when the public threat was great. The attack by industry struck bureaucrats as ingenuous and unfair. “The fancied threat of multiple seizure,” said Walter Campbell, chief of the agency, “seems to have been set up as a straw man for the purpose of inspiring terror in the drug manufacturing industry and a zeal for a modification of the Federal food and drugs act which would practically amount to nullification as far as patent medicines are concerned.” Such ripper bills, which would have outlawed the multiple seizure weapon, were constantly before Congress. They failed to pass, and so did other bills of contrary intent, which would have strengthened regulation by expanding controls to cover nostrum advertising .
Campbell’s tiff with industry came at the end of 1929, when the public climate was beginning to change. For most of the prosperity decade, despite occasional strains, major proprietors and bureaucrats did business together politely. Campbell was key man in enforcement, as he had been, indeed, from the day that the law had gone into effect. Wiley had brought the young lawyer to Washington from the Kentucky Agricultural Experiment Station. His state boss had written a glowing recommendation: “He is the best inspector . . . we have yet had … [,] familiar with chemical terms, and … very easy with figures…. He is a thorough gentleman, he has a big fund of commonsense.” The chief chemist had been equally impressed. When Wiley resigned, Campbell stayed on to help Alsberg set up and adopt the “project” system, a method of priorities by which the Bureau’s limited resources could be concentrated on those abuses that seemed most threatening. Serving briefly as acting chief when Alsberg left, Campbell refused the full title since he believed a chemist should hold the post. He saw a conflict between the research and regulatory functions of the Bureau, believing that each could operate with greater success if administratively separate. This step was taken in 1927. The Food, Drug, and Insecticide Administration (three years later the “Insecticide” was deleted) was created with Campbell as chief. Into the new Administration came the old Bureau’s Drug Control Laboratory, created in 1923, with the surveillance of proprietaries as part of its task .
Dr. Wiley misread the abolition of the Bureau as a blow to law enforcement, one more proof of the cumulative “crime” that had destroyed the law he had worked so bard to secure. He had himself sought compliance through education, but during the 1920’s he thought his successors were carrying the process much too far. The pressure groups which ousted him, he felt, were calling the tune. Other critics, equally bitter, although not for reasons so personal, agreed with Wiley. They were convinced the consumer was being sacrificed to the forces of Big Business which had captured America, and namby-pamby enforcement of this particular law was but one case in point. “The control of foods and drugs in America,” so the authors of one book saw it, had been “characterized by inexcusable official indifference and negligence.” There had been shocking “administrative incompetence, shiftiness, and a preference for backstairs methods,” as well as “a progressive weakening of official activity and concern for the public health through the pressure of concealed commercial forces in close touch with food and drug administrators.” 
This criticism was much too harsh, but, truth to tell, the national political climate during the golden glow of prosperity made it impossible to be a crusader and a bureaucrat. Wiley’s successors, so many of them—like Campbell—chosen by him, were really not interested in being crusaders in any case, certainly not crusaders of the Wiley stamp. They agreed with Dr. Alsberg in having “no desire to be known as a great personage, a fighting character or a man who has killed a dragon.” What they sought for was personal anonymity in an esteemed agency. Campbell and his subordinates believed that “publicity for the service, rather than for any individual” was “the rational course to be followed for a business-like execution of the job.” Without a Wiley, with his flair for personal publicity, they were quick to admit, it was virtually impossible to get the agency on the front page and into public attention. This could mean lack of the kind of fervent support that led to adequate appropriations and remedial amendments. It could even mean a threat of retrogression. The ripper bills did not evoke a ripple of public interest. “We have no publicity value,” an administrator wrote. “Not since Wiley resigned have we had a headliner.” 
It was fortunate for Food and Drug officials—and for the American public—that the plan of compliance through education worked as well as it did. They were not equipped to tackle the enforcement problem in any other way. Business was in the saddle economically, politically, and mythically. In the prevailing mythology of prosperity, the businessman was not the suspicious character he had been in the decade when the food and drug law was enacted. Now a figure of popular veneration, he was engaged in ushering in a millennium of material comfort. No bureaucrat could treat such a noble figure too roughly. Whereas Henry Wallace, Sr., while Secretary of Agriculture, had been sympathetic with the agency, his successors were, in the phrase of one administrator, “men typical of the last half of the ‘Roaring Twenties.'” Appropriations were meager and staff was small. While the regulated industries kept expanding, the resources of the Bureau did not. At the end of the decade, the agency, taking into account inflation, was worse off than it had been in 1910. One estimate put the total annual appropriation at only one-third of one per cent of the retail sales of proprietary drugs alone. The fewer than a hundred inspectors could barely scan the field. To gain compliance by voluntary action not only took less precious time than going to court, it was much swifter. Court dockets were crowded with prohibition cases. Many district attorneys were reluctant to undertake food and drug cases, because the issues were so complicated and the fines so small .
The sanctity of business did not, even in the twenties, cloak the unmitigated fraud. Nobody liked the most unscrupulous of medical quacks, except themselves and their as-yet-undeceived patients. The large-scale manufacturers of packaged remedies wanted quacks eliminated both as competitors and discreditors, for they injured the good name of the trade. Eternal vigilance was necessary against nostrum vendors either completely ignorant or utterly unscrupulous. One operator might be put out of business, but another was right at hand to take his place—if not the first fellow with a new product. Walter Campbell was as aware as his collaborators in the Post Office Department of the hardy perennials. “Not infrequently,” he wrote, “firms are encountered which repeatedly violate the law, paying the fines imposed. . . . but apparently regarding these penalties as in the nature of a license fee for doing an illegitimate business.” 
The wartime contest against “cures” for venereal disease continued through the early postwar years, the Bureau also campaigning against such allied products as “lost manhood” remedies and abortifacients. The next project placed special emphasis on nostrums claiming to cure serious ailments, especially kidney disease. Then, after a nation-wide survey, came an attack upon purported radioactive drugs, some dangerous because they contained radioactive material, others deceptive because they did not .
Projects combining much pressure for voluntary improvement in labeling with some legal action sought to reduce excessive claims being made for cod liver oil preparations, for pyorrhea-curing toothpastes, and especially for so-called antiseptics. After a wide survey of the market, nearly half the soaps, douches, mouthwashes, and gargles analyzed were found to be “wholly ineffective” as germicides. Some even contained live bacteria. Virtually all the rest of the products exaggerated their germ-killing powers. Indeed, the survey revealed, few manufacturers had really ever tested the germicidal qualities of what they sold as antiseptics. The FDA, combining press releases and seizures, warred on this front for several years .
The routine enforcement of a prosperity decade could not meet the needs of a nation in depression. With competition sharpening in a declining market, promotional practices deteriorated in honesty and taste. The tempo of criticism increased. Business seemed not so sacrosanct as in the good years now gone by. A particular spur to public interest in drug matters was a Congressional investigation, undertaken because of scare stories about imported ergot. The long hearing made clear that the Food and Drug Administration did not have staff and funds to do an adequate job. The FDA itself, welcoming this revival of public concern, sought to enlarge it. Through press releases, radio programs, an openhanded welcome to writers, the agency sought to inculcate in consumers a read-the-label habit. At the same time the FDA made pointedly clear what the law would not permit it to do .
The new temper of the times emboldened regulatory officials to more vigorous enforcement. Congress, despite the depression, enlarged appropriations, and Campbell and his aides made good use of them. J.J. Durrett, who had taken charge of drug work in 1928, believed in tight controls over questionable practices. A Southerner with a Harvard medical degree, he pursued the anti-“antiseptic” campaign with added intensity and began a new one against malaria medicines short on quinine. Conversations between Durrett and proprietors became more formal, even chilly, than similar conversations in the pre-depression years. When the Proprietary Association’s general representative came by to make the complaint that the proprietary branch of the drug industry received more rigorous attention from the FDA than did manufacturers of prescription drugs, the results of the interview must have been dismaying. “I told Mr. Kemp,” Durrett wrote in a memorandum, “that I was very glad that he had called, that it had caused us to review our activities and we were inclined on first results to believe that his group was receiving by far the most lenient treatment and that we might have to revise our activities accordingly.” 
Dr. Durrett was particularly incensed at the way even the mightiest proprietors jumped on the epidemic bandwagon when a wave of influenza swept the country in late 1928 and 1929. The FDA acted quickly. It sent letters to hundreds of manufacturers and issued a trade notice warning against the temptation to label salves, gargles, and aspirins as preventives or treatments of influenza, la grippe, pneumonia, and related diseases. Proprietors laggard in complying were assailed by seizures, some 300 products suffering this fate during 1929. The Post Office Department helped out. Since the most direct appeal to the public came through advertising, some newspapers solicited ads against the flu from remedy makers—the FDA also besought the Federal Trade Commission for aid. “Out of that joint effort,” Durrett told the Proprietary Association, “had come probably what is a permanent working agreement between these regulatory governmental agencies .
The combination of Durrett and depression brought cries of protest from the drug industry. The doctor was personally arrogant, trade journals charged, and his medical views were wrong. A “therapeutic nihilist,” he and the FDA were “working toward a bureaucratic prohibition of drugs.” Carloads of antiseptics, chest rubs, antipyretics, and analgesics had been seized during the influenza ‘epidemic merely because manufacturers sought to tell the people how physicians treated the disease. “The drug industry is long-suffering,” an editorial complained. “It apparently is afflicted with some sort of inferiority complex. It has been law-ridden for ages, and it seemingly knows not how to get rid of its ‘old Man of the Sea.'” The law itself was all right. But the regulations under it, aimed at curtailing the use of medicines, were something quite different. “When will the drug trade . . . shake off its fear of over-zealous officials, become truly unified in its common cause and fight as it could fight, for its rights?” 
A fight was not far off. In the meantime, the FDA, in a spirit of new hopefulness, turned its attention to some unfinished business. Short, round, amiable Frank E. Rollins, the retired court reporter, was still flooding the country with his mixture of turpentine, ammonia, and raw eggs. A case prepared more carefully than for the New Hampshire trial, FDA officials reasoned, might rid the market of this tuberculosis “cure.” In December 1928 and January 1929 agents seized shipments of B. & M. from Maine to California, charging adulteration and misbranding. At the same time the most elaborate preparations were begun to build an air-tight case. Experts on tuberculosis were lined up to testify about the consensus of medical opinion. Other doctors began clinical trials, rubbing B. & M. on tubercular patients to observe how it affected them. Dr. Charles E. Holton of the FDA’s Boston station was ordered to track down what he could discover about every testimonial-giver ever used by Rollins in B. & M. advertising .
Three years went by before the issues were tried before a jury. The government’s enforcement officials were not the only parties to learn a lesson in New Hampshire. Rollins and his urbane lawyer, Melvin Johnson, realized that something more than an appearance of amiable innocence might be desirable. So, as testimonials continued to pile up, Rollins banded over inquiries and symptom-forms to the minister-physician, Dr. Martin, to handle. Rollins also hired a pharmacist, Benson Fenwick, to perform experiments, both laboratory and clinical, that could be cited in B. & M. pamphlets, copy for which both Martin and Fenwick approved. More than that, attorney Johnson went to New York to the Pease Laboratories, a private research center much patronized by manufacturers as a source Of medical studies to be cited in advertising. Johnson put B. & M. into Dr. Herbert D. Pease’s hands for tests. Science as well as empiricism could be a weapon in the fight against the government.
So too could legal maneuvering. Johnson wrote the Secretary of Agriculture reasserting the good faith of B. & M.’s maker, as newly attested by the thousands of research dollars he was expending. Let the government but state what claims might legally be made, Johnson declared, and Rollins would adopt them. At the same time Johnson sought an injunction against the Secretary to stop further seizures of B. & M. until a test case could be tried. The letter did no good, but the suit did. An appeal court decreed that the injunction must be issued, crippling the FDA’s use of multiple seizures in its effort to suppress nostrums.
On the eve of the trial in Baltimore, Rollins and Johnson backed out. Fenwick had erred in making a test, they said, and the label was wrong in stating the potency of B. & M. compared with carbolic acid. The government was welcome to destroy the bottles seized.
B. & M. was soon on the market again with labeling approved by Dr. Pease. He himself, indeed, had penned most of the text that went to the printer, and the new pamphlet showed the fruits of his research in picture, table, and text. “Tabulations of Results,” the heading on one exhibit read, “Showing the Number of Surviving Germs in (a) Circulating Infected Horse Serum and (b) Circulating Infected Beef Broth after Flowing from Animal Membranes with Undiluted B. & M. on the Opposite Side of the Same.”
What relevance, FDA officials wondered, reading the new circular, did Dr. Pease’s experiments have to Mr. Rollins’ claims? And what about the reappearance of the same old glowing testimonials, about which Dr. Holton had been finding some interesting, indeed, shocking, facts?
So the government seized more B. & M., and this time the company did not concede. The case came to trial in Baltimore during a scorching heat wave in late June 1932. Melvin Johnson, as he had done since 1920, headed Rollins’ defense. Dignified, able, authorized to practice up to the Supreme Court of the United States, university law professor, college trustee, chairman of a medical school board of visitors, Johnson had even been elected president of the B. & M. company. This fact embarrassed him, he said, and it had happened in his absence. Fighting the case for the government was a young district attorney named Simon Sobeloff. Funds had been set aside to employ special counsel, but the depression made it seem advisable to save the money. The year 1932 was one in which all federal employees sacrificed one month’s pay, and Sobeloff’s month was that of the B. & M. trial. Keen, quick, witty, indefatigable, Sobeloff outpointed the more experienced Johnson.
The B. & M. presentation at the trial aimed at persuading the jury that no one had been guilty of fraud. It could not be the saintly Rollins, who, through thick and thin, continued to believe in the efficacy of his remedy, even to the point that only grudgingly would he modify his claims at the insistent urging of his medical advisers. And why should he not have faith in B. & M.? In some empirical way, mysterious and unknown to science, the medicine wrought cures. There were all the early tales, so often recited in the pamphlets, that could be told again. More recent successes could be demonstrated by healthy people in the witness chair. Gibbs L. Baker, a Washington attorney, had been told by a doctor to go to a sanatorium. He had refused and had used B. & M. Now he was well. Russell Ricker of Philadelphia, who laid hardwood floors, had contracted tuberculosis. Life in the country, working in the mornings, resting in the afternoons—and B. & M.—had cured him. John Frank Havens of Morehead, Kentucky, full of despair, had left the sanatorium to die. But B. & M. had worked a miracle, and he had resumed his trade of butchering. There were many more to bless Rollins for their health and happiness.
Rollins himself bespoke his own faith. He told how doctors, most of them now dead, had used B. & M. with great success. One, on the staff of Harvard, would not now testify, he said, for fear of retribution from the medical profession. Rollins told of paying Fenwick, who had died the year before, more than $80,000 to conduct his valuable experiments, and he had paid Dr. Pease $15,000 more. He did not understand all that they told him, but he followed their advice.
Was B. & M. a general germicide? It could, Rollins believed, cure any germ disease in the body, except, perhaps, in the brain. The skull was too thick. How did it work? Rubbed on the body, Rollins said, B. & M. “penetrates to where the germs are, if enough is used to reach that far, and combines with the poisons of the germs, destroying the soreness. We can find the poisons on the outside that we know are inside and the discharge from the sores is the same as the sputum shows by an examination. The skin eruption will be exactly over the infection if the infection is local. But where the infection is all through the blood stream, the eruption will be generalized.” 
One doctor did come to Baltimore to speak for B. & M., the same Dr. Martin who had testified in Concord. He recited how he had used the remedy at Camp Oglethorpe during the war, and how it had kept 24 men from succumbing to the flu. Since then he had prescribed B. & M. with outstanding success for dozens of ailments, including numerous cases of blood poisoning. Rollins himself had had a bad case of ulcers and had heroically kept applying the liniment. The medicine cured him, drawing the ulcers right up through the skin. How did it work? “We render an antitoxin in the system,” Dr. Martin explained, “which gives Nature a chance to heal and throw off whatever germ is attacking the place.” 
Attorney Johnson, who had his own separate version of how B. & M. worked, pointed to Martin to show that medical thought was not united with respect to his client’s remedy. The consensus of medical opinion, in any case, was not necessarily right. By the consensus of medical opinion George Washington had been bled to death.
Such skepticism did not deter Sobeloff from seeking to persuade the jury that reputable modern medicine was of one mind regarding the utility of B. & M. Twenty-two doctors, of various medical specialties, spoke for the government side. Night after night until two in the morning they met in Sobeloff’s office working on the case. One by one, Sobeloff called them to testify. There was Eugene Maximilian Karl Geiling, Johns Hopkins’ brilliant pharmacologist, who walked to the stand with a suitcase in each hand. Why, the judge asked, did he have the suitcases? “I have brought my authorities,” replied Geiling in his Dutch accent . No medicine or combination of medicines, the authorities all agreed, could kill the tuberculosis germ in the human body. Certainly not the ingredients of B. & M. The harsh liniment could indeed blister the skin, but it could not penetrate into the body. Its use was mischievous in tuberculosis, because the discomfort of irritated skin prevented rest and the sharp ammonia fumes stimulated coughing. Rollins’ theory of germs coming out through blisters in the skin was absolute nonsense. “To me it appears as so stupid,” Dr. Geiling said, “just as if I . . . was to ask you gentlemen, ‘Close your eyes and you will see a green angel.” 
In this judgment the other physicians concurred. From leading medical schools and sanatoriums throughout the nation, America’s distinguished doctors came to call Rollins’ claims ridiculous.
Sobeloff did not stop this time, as had the attorney at Concord, with presenting the judgment of medical experts. Dr. Victor F. Cullen, superintendent of a state tubercular hospital in Maryland, told of using B. & M. on 22 patients. Not one had been helped, and some had lost rest from the blistering and coughing. The same disheartening results were reported by a Vanderbilt University professor who had tried out B. & M. on 25 patients in Tennessee. A veterinary from the Bureau of Animal Husbandry said he had duplicated one of Fenwick’s guinea pig tests, reported in B. & A literature, and found ,that the remedy did not prevent tuberculosis in the little animals. A technician who had helped Fenwick do his original ,experiment testified that the same had been true then. A Johns Hopkins physiologist asserted that Dr. Pease’s animal membrane test in no way simulated conditions in the human body.
Still other doctors were heard in Baltimore. They told of treating the men and women whom Rollins had cited in his pamphlets. In many instances, patients had never suffered from the illnesses from which, according to their testimonials, they had been delivered by B. & M. In other cases, patients had died from tuberculosis, so doctors testified and death certificates revealed, and Rollins had gone on using their letters thanking B. & M. for curing them. There was poor Mrs. Edith Merchant of Ashland, New Hampshire. At the Boston trial she bad lauded B. & M. Then a doctor had examined her and told her she was still afflicted. Mrs. Merchant’s praise remained in Rollins’ booklets, as did her promise to write inquirers about her case. This she persevered in doing, even on her deathbed. Rollins furnished her a desk, stationery, stamps, and, out of sympathy for her suffering and impoverishment, $1,141.10. Her letters, he once wrote her, were an important part of his advertising. When Mrs. Merchant died at last, her son sent the news to Rollins. The amiable proprietor replied, saying that it was important to his company to learn the cause of death. People attacking B. & M., he noted, would probably say that it was tuberculosis. Was it, perhaps, cancer of the rectum? “Yes, Mr. Rollins,” the son replied, “you have it right. It was cancer of the rectum. The cause of mother’s death.” 
Sobeloff introduced the death certificate which Dr. Holton had tracked down. Mrs. Merchant had died, it showed, from pulmonary and intestinal tuberculosis.
Mrs. Merchant’s was not the only example of conflict between testimonial and death certificate presented in court. Indeed, there were more than 60. Holton had gone around, Rollins complained, stealing epitaphs from tombstones. “Well, that may be extreme,” Sobeloff replied, “but do you blame the Department for looking for your customers in graveyards if you send them there ?” 
The government sought also to impeach the testimony of living witnesses. When the Kentucky butcher, John Frank Havens, stepped down, Sobeloff called Dr. Paul Turner to the stand. Havens had been less than candid, Dr. Turner said. He bad failed to state that after fleeing from the sanatorium to pursue self-treatment with B. & M., he had paid a return visit to the hospital. Dr. Turner had examined him and found that he was still sick. Havens had been given the gloomy report and warned that it was illegal for him to work, as he was doing, in a restaurant.
Dr. Turner’s appearance with Havens’ hospital records startled the defense. “I did not know until yesterday,” one of Rollins’ lawyers told the judge, “that Havens was going to testify.” “Evidently the district attorney did,” the judge replied . Sobeloff did not inform them how a woman in Washington, gossiping over the fence, had told her neighbor she was going to have guests from Kentucky, the man to appear in a food and drug case in Baltimore. The neighbor’s husband worked for the FDA. The B. & M. case, the Administration had earlier informed its branch offices, must take precedence over all other matters, and any leads sent down must be developed instantly. The backyard gossip had led promptly to Dr. Turner.
Havens could not have been too surprised when an examination by a Johns Hopkins physician brought out the sad truth that tuberculosis still held him in its grip. Other B. & M. witnesses did not have the same forewarning. The Washington lawyer and the Philadelphia carpenter learned to their dismay, as a doctor showed their x-ray plates to the jury, that B. & M. had failed them too. A French Canadian who had put his trust in Rollins’ remedy found out in open court that he was in the last stages of consumption and soon would die. He broke down and wept. The jury was much moved.
Nor did B. & M.’s scientists stand up well. The dead Fenwick was shown to have lost his job as hospital pharmacist because of a liquor scandal. His research for Rollins, government witnesses said, was worthless. Under Sobeloff’s relentless cross-examination, Dr. Martin revealed how remote were his views from those of modern medicine. He took Rollins’ pay and prescribed B. & M. for the gravest maladies after looking at mailed-in symptom-sheets filled out by laymen. When asked what he knew about the tetanus bacillus, Martin replied: “Well, I don’t know that they have isolated the particular germ. I was taught it was streptococcus.”  Dr. Pease, head of the large New York laboratories, sat through the presentation of the government’s case. Later he said he had not been hired to testify, but during the trial Johnson desired to put him on the stand. Pease was not to be found. Even a court subpoena could not stir him up. “I have no excuse to offer you,” Johnson told the jury, “. . . for his not being here, except that he walked out on us.” And the urbane attorney, pointing out that Rollins had paid Pease $15,000, pleaded with the jury to have sympathy for a saintly man whose scientist had “welched.” 
This appeal did not impress the twelve good men and true. They had heard Judge Calvin Chesnut charge them: “If . . . you find that the statements made by” Rollins and his allies “were made with knowledge of their falsity, or recklessly made without reasonable grounds for making them, in defiance of known authoritative information which was reasonably available to them and the failure on their part to make said reasonable inquiry, then you may find that they were acting in bad faith and fraudulently.”  The jury returned in an hour and 35 minutes to report that the makers of B. & M. had violated the Sherley Amendment and the seized bottles of the blistering liniment should be condemned.
After more than ten years of time and at a cost of more than $75,000, the Food and Drug Administration had cleaned up the labeling of a horse liniment sold as a tuberculosis cure . Immediately Walter Campbell sent out an order to seize misbranded B. & M. wherever it could be found. A criminal suit was launched against the corporation, to which, in time, its officers pleaded guilty. At $100 for each of twenty counts, the fine amounted to $2,000.
The B. & M. verdict furnished a much-needed tonic for FDA morale. The agency had recently lost major misbranding cases against Chi-Ches-ters Pills for female disorders and a bottled concoction called Lee’s Save the Baby . The B. & M. victory saved the agency’s officials from despair; they did not need to shut up shop; they could remain in business. Nonetheless, the unbelievable effort it had taken to win the B. & M. case was one more spadeful piled atop a growing mountain of proof that Dr. Wiley’s law was out of date and in need of drastic overhauling.
While the B. & M. trial was taking place in Baltimore, out in Chicago the Democrats were holding a quadrennial convention. Before many months had passed, a new regime and a new spirit were installed in Washington. With the New Deal came a new fight for a new law.
- Lowell to Dr. Bowman C. Crowell, Oct. 31, 1929, Food and Drug Case 23296 (NJ 18176), Office of the Solicitor, Dept. of Agric., RG 16, NA.
- The early history of B. & M. and litigation concerning it is compiled from the records of F&D Case 11492 (NJ 11671), office of the Solicitor, Dept. of Agric., RG 16, NA; Charles E. Holton, “B. & M. Case . . . Résumé of Field Investigation, 1929-1930,” in F&D Case 26900 (NJ 19651), ibid.; Boston Herald, Dec. 4, 1920; Concord Monitor, Dec. 15, 1922; B. & M. folder, Dept. of Investigation, AMA, Chicago; Boston Better Business Bureau Bulletin, Aug. 27, 1932; U.S. V. Eleven Packages of B. & M. External Remedy, charge to jury, in White and Gates, Decisions of Courts under the Federal Food and Drugs Act, 1059-70; Ruth deForest Lamb, American Chamber of Horrors (N.Y., 1936), 40-44; B. & M. pamphlets in author’s possession.
- Holton’s resumé.
- 1916 pamphlet, “B. & M. External Remedy.”
- Cited in 1930 pamphlet, “In the Interest of Maintaining Truth.”
- Manchester Leader, Mar. 7, 1923, clipping, AMA folder.
- George H. Simmons, in Foreword, N&Q, III, [iii]; Standard Remedies, 14 (Mar. 1927), 31; 15 (June 1928), 11-12; William H. Gove, President, Lydia E. Pinkham Medicine Co., to Chicago Tribune, Aug. 29, 1916, Pinkham folder, AMA; M. C. Bergin, Markets for Prepared Medicines (U.S. Bur. of Foreign and Domestic Commerce, Dept. of Commerce, Trade Promotion Series, No. 48: Wash., 1927). Standard Remedies during the decade was filled with information about export markets.
- N.Y. Times, Sep. 13, 1927.
- Standard Remedies, 6 (Aug. 1920), 5; Drugdom, cited in ibid., (Nov. 1920), 18.
- Standard Remedies, 8 (May 1922), 12; 11 (May 1925), 12; 15 (June 1928), 11-12; 19 (June 1932), 5.
- 1907 Report of the Bureau of Chemistry, 3-4; 1908 Report, 13; 1922 Report, 25. 1925 Report, 20; 1926 Report, 20; 1928 Report, 4-5; Standard Remedies, 8 (Oct. 1922), 16, 18, 24; (Nov. 1922), 8, 10, 12; 14 (May 1927), 46, 48; F&D Rev., 9 (May 1925), 13-17; 10 (Sep. 1926), 19-22; 13 (Dec. 1929), 416; Paul Dunbar, cited in Harvey W. Wiley, The History of a Crime against the Food Law (Wash., 1929), 375-76. The list of diseases and symptoms that could not be mentioned on labels had evolved by 1930 into the following (FDA Decimal file 530-.11 for 1930): appendicitis, Bright’s disease, cancer, diabetes, diphtheria, female pills (amenorrhea, dysmenorrhea, ovarian and uterine diseases, menstrual disorders, vaginal diseases-venereal), flu and synonyms, heart disease, high blood pressure or hypertension, kidney pills (other than “diuretic to the kidneys”), la grippe and synonyms, “lost manhood” restorers, malaria (except for remedies containing quinine or cinchona alkaloids in a sufficient dosage), pneumonia, pyorrhea, rheumatism (if this appeared in the name of the product), scrofula, tuberculosis, venereal diseases (except for recognized treatments).
- Alexander G. Murray, acting chief of the Drug Control Laboratory, Standard Remedies, 14 (May 1927), 46; ibid., 11 (May 1925), 12.
- Ibid., 8 (Apr. 1922), 5; Waldon Fawcett, “The Government’s Position on Control of Collateral Advertising,” ibid. (Sep. 1922), 20, 22, 24; Bur. of Chem. mimeographed “Information on Drugs,” cited in ibid., 12 (May 1926), 94-96.
- Standard Remedies, 10 (June 1924), 12; 13 (Nov. 1926), 13; 14 (May 1927), 22.
- Charles W. Crawford to Florence Kirlin, Apr. 9, 1935, “Correspondence on Legislation,” FDA Records, Office of Commissioner, Legislation, 1927-40, Bills-Regulations, box 12, RG 88, NA; Campbell, Press Notices, x, Nov. 8, 1929, Office of Information, Dept. of Agric. On various bills intended either to weaken or strengthen the law, see Standard Remedies, 10 (Mar. 1924), 11; 12 (May 1926), 20-21; (June 1926), 21; 16 (June 1929), 11; 18 (Mar. 1931), 4-6; 19 (Jan. 1932). 7-8; F&D Rev., 10 (Nov. 1926), 8-10; 13 (Feb. 1929), 86-87.
- R.M. Allen to Wiley, May 24, 1904, Bur. of Chem., Letters Received, RG 96, NA; Gustavus A. Weber, The Food, Drug and Insecticide Administration (Inst. for Govt. Research, Service Monograph No. 1950: Baltimore, 1928), 23-24, 33, 43-45, 62-63; Campbell, “The Project Plan Fundamental in Regulating Commerce in Food and Drugs,” F&D Rev., 5 (Nov. 1921), 1-2; 1928 Report of Food, Drug, and Insecticide Administration, 1; 1930 Report of Food and Drug Administration, 1; F&D Rev., 7 (Jan. 1923), 4. Chief of the Bureau of Chemistry during the mid-20’s was C. A. Browne.
- Wiley, The History of a Crime, 372-76; Arthur Kallet and F.J. Schlink, 100,000,000 Guinea Pigs (N,Y., 1933), 195-96. A judicious assessment of the risks inherent in close fraternizing between regulator and regulated is presented in E. Pendleton Herring, “The Balance of Social Forces in the Administration of the Pure Food and Drug Act,” Social Forces, 13 (1935), 358-66.
- Minneapolis Journal, Oct. 12, 1913; Crawford to David F. Cavers, Aug. 1, 1933, “Correspondence on Legislation!’; 1926 Report of Bureau of Chemistry, 19; T. Swann Harding, The Popular Practice of Fraud (N.Y., 1935), 273.
- James Harvey Young, “The Myth of Prosperity in the 1920’s,” Emory University Qtly., 13 (June 1957), 99-111; Crawford to Cavers, Oct. 6, 1934, “Correspondence on Legislation”; Kallet and Schlink, 254; Lauffer T. Hayes and Frank J. Ruff, “The Administration of the Federal Food and Drugs Act,” Law and Contemporary Problems, I (Dec. 1933), 24-25, 30. In the group of Notices of judgment numbered 5,001-10,000 (issued Jan. 1918-Mar. 1912), 1,765 Notices related to drug products and preparations; the number fell off to 691 in the 10,001-15,000 group (Mar. 1922-June 1927). Munch, “Notices of Judgment-Nos. 5001-15,000,” FDC Law Jnl., 11 (1956), 201,
- 1931 Report of Food and Drug Administration, 4.
- 1921, 1925, 1926 Reports of Bureau of Chemistry; Press Notices, 1, July 13, 1926, Office of Information, Dept. of Agric.
- 1928, 1929, 1931, and 1933 Reports of Food and Drug Administration; Press Notices, x, June 18, 1928, Aug. 12, 1929, Office of Information, Dept. of Agric.; F&D Rev., 10 (Sep. 1926), 11-14; (Dec. 1926), 3-7; 11 (June 1927), 22-23; (Aug. 1927), 27; 15 (1931), 86.
- N&Q, m, xii; Ralph W. Hower, The History of an Advertising Agency: N. W. Ayer & Son at Work, 1869-1949 (Revised ed., Cambridge, Mass., 1949), 147-50; Harding, 4, 186, 201-202; PI, 169 (Oct. 11, 1934), 63-64; 1930, 1931, and 1932 Reports of Food and Drug Administration; F&D Rev., 13 (Dec. 1929), 429.
- 1929 through 1932 Reports of Food and Drug Administration, Standard Remedies, 15 (June 1928), 40; 16 (Jan. 1929), 7-8; Press Notice, i, Jan. 3, 1929, Office of information, Dept. of Agric.; Durrett memorandum of interview with Ervin F. Kemp and Alexander G. Murray, Apr. 29, 1930, FDA Decimal file 530-11 for 1930.
- F&D Rev., 13′(July 1929), 231-38; Trade Notices, i, Jan. 16, 1929, Office of Information, Dept. of Agric.; R. W. Dunlap, Acting Secy., to Sen. Otis F. Glenn, Dec. 5, 1929, FDA Decimal file, 530-11 for 19299, 1929, 1930, and 1931 Reports of Food and Drug Administration; Lamb, 134-40, 316-17.
- Oil, Paint and Drug Reporter, May 13, 1929, and Druggists’ Circular, June 1929, cited in Standard Remedies, 16 (June 1929), 5-6 and 44-46; Drug and Cosmetic Industry, Nov. 1933, “Clippings on Food and Drug Legislation,” Scrapbooks, FDA Records, RG 88, NA.
- Information on the 1928-1932 campaign against B. & M. is from records of F&D Cases 23295 and 23296 (NJ 18176), Office of the Solicitor, Dept. of Agric., RG 16, NA; F&D Case 26900 (NJ 19651), ibid.; records of Interstate Office Seizure Case 5067 (NJ 19651), RG 88, NA; correspondence in Medical Remedies folder, General Corres. of the Secy. of A 1929, 1931, and 1932, RG 16, NA; Records of the District Courtst1cle U.S., Nos. 4666 and 4667, RG 21, Federal Record Center, Region 3, General Services Adm.; interview with Simon Sobeloff, July 13, 1956; United States v. 17 Bottles, Large Size, and 65 Bottles Small Size, of an Article of Drugs Labeled in Part “B. & M.,” 55 Fed’ (2d) 264 (DC. Md; 1932), reprinted in White and Gates, 1287-1322; Baltimore Sun, June 28-July 20, 1932; B. & M. folder, AMA; 1931 and 1932 Reports of Food and Drug Administration; JAMA, 99 (1932), 578-82; standard Remedies, 18 (Nov. 1931), 3-5. Very useful is the 94-page mimeographed “Summary of the Trial, U.S. of America vs. Certain Bottles of B. & M., F. E. Rollins Company, Claimant,” a copy of which is Med with Seizure Case 5067.
- Cited in “Summary of Trial,” 27.
- Ibid., 38.
- Sobeloff interview.
- “Summary of Trial,” 7.
- Cited in Lamb, 56.
- Ibid., 54.
- Sobeloff interview.
- “Summary of Trial,” 44.
- Lamb, 53.
- White and Gates, 1306.
- Crawford memorandum, Jan. 24, 1938, “Statements in Connection with F.D.C. Act Legislation,” Office of the Commissioner, FDA Records, RG 88, NA.
- F&D Case 30186 (NJ 22177), Office of the Solicitor, Dept. of Agric., RG 16, NA.
- White and Gates, 1240-61.
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