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

Chapter 1: Brane-Fude

James Harvey Young, PhD


"The lesson to be learned is that the law must be obeyed."
—Pharmaceutical Era, 1908 [1]


The first court trial under the Pure Food and Drugs Act [2], pitting the federal government against the maker of a remedy with the inspired and inspiring name of Cuforhedake BraneFude, got under way during February 1908. This was nearly twenty months after Theodore Roosevelt had signed the pioneering statute and more than thirteen months after the law's effective date.

In the meantime Harvey Washington Wiley, chief of the Bureau of Chemistry in the Department of Agriculture, had not been idle. Wiley, whose crusading zeal had been of central significance in the enactment of the law, was now charged with its enforcement. Recruiting a staff of scientists and inspectors took time. The task of regulation-making proved equally demanding. For such a complicated subject, the 1906 law was very short. General statements required elaboration with more specific meanings. Hearings, conferences, addresses, conversations, correspondence kept every hour busy. Since the passage of the law, wrote Wiley, "we have been absolutely flooded with work." [3]

At long last the Bureau, with staff and regulations ready, sought to determine which of the many violations of the law should be tackled first. They decided on a patent medicine case likely to make a significant precedent. To protect the public in its right of self-medication, the law forbade statements on the labels of proprietary remedies that were "false or misleading in any particular." Wiley and his aides chose a nostrum with several possible misbranding particulars: the percentage of a key ingredient, the nature of the exhortations to would-be purchasers, the very name itself, Cuforhedake Brane-Fude. The remedy, moreover, was manufactured within the District of Columbia. This had two advantages: busy Bureau officials could better participate in helping the district attorney's office to work up the case, and the law set heavier penalties for District than for interstate violations, In addition to all this, the manufacturer was not an ignorant nobody, but a trained pharmacist and a prominent citizen [4]

Robert N. Harper had begun making his headache remedy back in about 1888. He was then a student at the Philadelphia College of Pharmacy, at the same time gaining practical experience by working as a chemist for the pharmaceutical manufacturing firm, John Wyeth & Brother. Synthetic pain-killers and fever-reducers, derived from coal tar and imported from Germany, were still in the early exciting stages of their impact upon American medicine and pharmacy. In 1886 two German physicians, by sheer accident, because a young pharmacist erred in filling a prescription, had discovered that one such derivative, acetanilid, could bring down fever and deaden pain [5]. Their report was quickly confirmed, and the news crossed the Atlantic. Harper, running across this information, gave acetanilid the central role in a formula he concocted, tried out on himself and his friends, and then—as any ambitious citizen had a perfect right to do—put on the market. He called it Cephalgine. Upon graduating, Harper had transferred his base of operations to the nation's capital. A ready seller, Harper's mixture of acetanilid, antipyrine, caffeine, sodium and potassium bromide, and alcohol, continued to well after 1905, when he changed the name because of a possible trademark violation of which he had been unaware up to that point. By 1908, indeed, some two million bottles of the remedy had been sold. As Harper's market grew, so did his stature in the community. He was elected president of the Retail Drug Association. He served for several years as a Commissioner of Pharmacy for the District. He became head of a bank. He was chosen president of the Chamber of Commerce. A Virginia Democrat, Harper swung some political weight.

When the Pure Food and Drug)rs Act became law, Harper went by the office of the Bureau of Chemistry to ask how he should change his Cuforhedake Brane-Fude label. He was told the same thing that Wiley and Lyman Kebler, head of the Bureau's drug division, told all inquirers, that they could not give positive instructions on this point. It was up to the manufacturer to read the new law and make his labeling conform. Harper modified his label to show that his remedy contained 30 per cent alcohol and 16 grains of acetanilid (the law demanded that the proportion of these two ingredients be indicated) but otherwise left things the same.

These changes, Wiley and Kebler believed, were not enough. For one thing, analysis showed the percentage of alcohol to be not 30 but 24 per cent. For another, the descriptive matter on the label and in a pamphlet packed with each bottle contained statements that struck the Bureau officials as false and misleading. No such mixture of ingredients could truly claim that it was "a most wonderful, certain and harm less relief," or that it contained "no . . . poisonous ingredients of any kind." Extensive use of acetanilid might be fraught with hazard. One of the terrifying blasts aimed against patent medicines during the battle that led to the new law had been directed against headache mixtures loaded with acetanilid. Samuel Hopkins Adams in the pages of Collier's had printed a box enclosing the names and addresses of 22 victims, allegedly brought to death by acetanilid poisoning.6 Dr. Kebler and his aides, after combing medical literature and querying physicians, believed that there might be a great many more, in addition to numerous cases of chronic poisoning and habituation to the drug.' Thus acetanilid was deemed a major threat to the public health, and it was an act of misbranding when Harper assured the public that this remedy contained "no ... poisonous ingredient." Wiley was also persuaded that Harper's trade name was misleading. Cuforhedake certainly looked like an evasive spelling for headache cure. And none of the nostrum's ingredients was food for the brain.

Going to a Washington drugstore, a representative from the district attorney's office, acting in accordance with the procedures of the new law, seized some bottles of Cuforhedake Brane-Fude by a process of libel for condemnation. Later the Bureau gave the druggist a hearing. Harper showed up too. Wiley and Kebler explained their objections to the BraneFude labeling. Harper debated some of the criticisms, noted that he had recently made new modifications, and asserted that many users-including two Senators-had testified to the therapeutic value of his remedy. This defense did not persuade the Bureau of Chemistry officials. Convinced that they had a winning case, they submitted their evidence to the Department of justice. Not only was a civil action needed against the seized medicine itself, Wiley argued, but also a criminal action against its manufacturer. In January 1908 an information was filed against Harper in the Police Court of the District. A month later the case came to trial.

The proceedings presented a 16-day debate over the definition of terms [8]. Were Harper's key ingredients "poisons" or were they not? Could they be considered food for the brain? Was it proper to give to a drug which relieved a headache the name of "cure"? A handful of prosecution witnesses, especially Dr. Reid Hunt, a pharmacologist from the Hygienic Laboratory of the Marine Hospital Service, expounded on the dangerous nature of acetanilid and antipyrine. Too much acetanilid taken over too long a period, Dr. Hunt testified, could destroy up to four-fifths of the red blood cells. In cross-examination, the defense attorney slyly got the doctor to admit that little of his research had been done with people, most with rabbits, guinea pigs, and mice. Hunt and other government witnesses asserted that acetanilid benumbed the nerves rather than treating the basic ailments of which headaches were one symptom. It was inaccurate, therefore, to term acetanilid a headache cure.

Dr. Wiley himself took the stand. Alcohol, he said, might in small quantities furnish the body "a modicum of food." But alcohol provided no special nourishment for the brain, indeed, might do it serious injury.

"In what way, Doctor?" he was asked.

"It tends to harden all the cells with which it comes into contact," he answered, "and to coagulate their contents.

There was a simplicity, almost a casualness, about the prosecution case that suggests either inadequate preparation, perhaps from the pressure of other work, or, more likely, the feeling that Harper's misbranding was prima facie and needed little more than pointing out. The Harper defense which followed must have surprised Bureau of Chemistry officials, it was so massive, so vigorous, so telling.

The reason a government chemist found that Cuforhedake Brane-Fude contained 24 per cent of alcohol instead of the labeled 30 per cent, testified a chemistry professor from Georgetown University, was that he did not seem to realize that not absolute alcohol but commercial alcohol was used in the remedy's manufacture. The commercial grade, reckoned at 94.9 per cent pure, was the standard ingredient for proprietary remedies requiring alcohol. Not only was the Bureau of Chemistry careless, the defense insisted, its officials were too literal-minded in their definition of terms. Acetanilid was not a poison. The nation's leading authority on coal tar products came down from New York to say so. Virgil Coblentz, professor of pharmacy at Columbia University, had sat at the feet of the German professor who discovered acetanilid's medical properties.

"Professor," he was asked, "what is a lethal, or fatal dose, of acetanilid?"

"There is no such thing," he answered. Doses as large as an ounce—437.3 grains—had been taken without harmful results. A whole bottle of Cuforhedake Brane-Fude contained only 24 grains of acetanilid. Moreover, Coblentz added, whatever depressant effect the acetanilid might have was to some degree counteracted by the caffeine present in the mixture. Harper's formula was harmless. "The dosage is very, very moderate. . . ."

Presumed cases of acetanilid poisoning, the professor testified, were often caused by impurities not removed from the coal tar starting product during manufacture. Also, some people displayed an idiosyncrasy to acetanilid, but this was no reason to label the drug a poison. Some people developed a rash from eating strawberries.

Coblentz's statements were echoed by several Washington physicians, who stoutly denied that there was anything poisonous in Harper's formula. It was indeed, they testified, a mixture of ingredients very like ones they themselves often prescribed for patients. Pharmacists from the District were called to the stand to demonstrate the truth of this assertion. Bringing prescriptions which they had filled during the last year, the pharmacists showed that from 9 to 10 per cent of the total had been for formulas similar to that which Harper had been marketing, the acetanilid in the prescriptions varying from considerably less to a little more than in Cuforhedake Brane-Fude. In all their experience, the druggists added, they had never heard the Brane-Fude blamed for bringing harm to anyone.

In this judgment by the pharmacists the defense physicians concurred. The coal tar pain-killers were not only not harmful, they were a positive blessing. Their increasing use had cut down on reliance upon opium with all its attendant dangers. Moreover, the doctors argued, contrary to what government witnesses had said, acetanilid really "cured" a headache. To throw an impressive weight of evidence behind this definition of "cure," the defense put more than a score of satisfied customers on the witness stand, many of them prominent citizens of the District. One was an editor of the Washington Times, another an official of the National Baseball League. The United States Senators did not testify. But two of Harper's witnesses (like Dr. Wiley) worked for federal agencies-the Census Bureau and the ICC. The prosecuting attorney protested against this evidence: laymen could have no understanding of the effect of drugs upon their bodies. The judge, however, let them testify how they had suffered misery with headaches, had taken Cuforhedake Brane-Fude, and the headaches had vanished.

Harper himself was final witness in his own defense. Poised and confident, he recounted his autobiography and insisted that through 20 years and 2,000,000 bottles no word had reached him of any harmful effect upon any user of his remedy.

The judge charged the jury forthrightly. The prosecution need not prove all its points, he said, but merely one, for the law used the phrase "false or misleading in any particular." Unless there was a distinct kind of food that nourished the brain as distinct from a food that nourished the whole body, the judge stated, and unless Harper's Brane-Fude was such a food, then he must be found guilty. In evaluating the labeling, the jury must consider how statements would influence the average citizen. "This law was passed," the judge said, not to protect experts especially, not to protect scientific men who know the meaning and value of drugs, but for the purpose of protecting ordinary citizens, like the jury and like counsel. . ." [9]

One private observer guessed that the prosecution expected to be beaten. But the twelve ordinary citizens promptly found Harper guilty of misbranding his Cuforhedake Brane-Fude. There was some hint that they had reached their verdict on the "brain food" point alone, not going into the other issues, so hotly argued between prosecution and defense, as to acetanilid's alleged curative properties and poisonous character, a debate destined to rage on for many years [10].

Between the rendering of this verdict and the sentencing, the case of United States v. Harper took a dramatic turn. A message reached the prosecuting attorney that he should hurry to the White House. There he had an interview with Theodore Roosevelt. "It is your duty," the President told the lawyer, according to a newspaper account, "to make an example of this man, and show to the people of the country that the pure food law was enacted to protect them. He has been convicted after a fair and impartial trial, and you should use every argument in your power to convince the judge to impose a jail sentence. To a man of his wealth, a fine as the penalty ... would be little less than ridiculous." [11]

Some newspapers railed about violation of the separation of powers. Harper resigned his bank presidency. But the lawyer took the President's advice and urged the judge to send Harper to prison. "This is a new law," he argued. "To a certain extent the court is blazing the way. It now remains to be seen whether this law is to be enforced, so that every manufacturer, every druggist-not merely in the District of Columbia, but in the whole land-will know that they must obey this law, that was made for the benefit of the people of the United States. " [12]

Harper's attorney protested. "The request of the district attorney," he said, "is absolutely unprecedented in the annals of jurisprudence in this District, unless my friend is compelled to make this request by an influence which it is unnecessary for me to mention here."

The judge did not sentence Harper to jail. Prison was not necessary, he explained, for the medicine maker's reformation. Harper had changed his labeling after his medicine was seized, and he was not likely to err again. Nonetheless, the manufacturer had not been "an innocent, technical violator of the law, but knew what he was doing." So the judge fined Harper on one count the maximum money penalty under the law, $500, and added a fine of $200 on another count. He had made up his mind, the judge noted, immediately after the jury's verdict, and before "any controversy in the newspapers." Representatives of drug trade associations had attended the trial, the judge observed, for the purpose of reporting the proceedings all over the nation. News of the maximum fine, he hoped, would exercise a deterrent effect on potential violators of the law [13].

Harper was not unduly chastened. The well-wishing he had been receiving after his castigation by the President, he smilingly told a reporter, made him feel not at all in "the jail bird class." Wiley was not as elated as he might be. "I thought the judge was going to send him to jail," the chemist said later. Harper "had made two million on the product. He was fined $700 . . . and was just $1,999,300 ahead." Many reformers rejoiced that the first court trial under the law was at least a victory. Harper's "money, position, and influence," editorialized a drug magazine, "were unable to save him from the stigma of conviction. This phase of the suit and decision is very gratifying." "The lesson to be learned," another drug editor wrote, "is that the law must be obeyed." [14

References

  1. Editorial, 39 (Apr. 23, 1908), 513.
  2. Act of June 30, 1906, ch. 3915, 34 Stat. 768.
  3. Secy. of Agric. James Wilson to Wiley, July 24, 1906, Wiley Papers, box 60, Manuscripts Div., Library of Congress; 1907 Report of Bureau of Chemistry, 4 [this and subsequent Reports are cited from the reprinted versions in Food Law Institute Series, Federal Food, Drug, and Cosmetic Law, Administrative Reports, 1907-1949 (Chicago, 1651)]; Wiley to American Medical Association, Jan. 2, 1907, Letterbook, General Corres., Bur. of Chem., Record Group 97, National Archives. Hereafter RG and NA.
  4. The primary sources for this case are the records filed in Seizure No. 28, Record File Interstate Office, and Hearing No. 49, 1. S. 8751, RG 88, NA; Food and Drug Case 3, Office of the Solicitor of the Dept. of Agric., RG 16, NA; and the printed Notice of judgment 25, issued Nov. 25, 1908. Biographical information on Harper and data on the trial have also been found in the Oil, Paint and Drug Reporter, 73 (Feb. 3, 1908), 25-26; (Feb. 17), 9; (Feb. 24), 40-41; (Mar. 2), 28D, 29, 30; (Mar. 9), 9-10; (Mar. 16), 9, 16, 17, 40; (Mar. 23), 7-8, 28B; (Mar. 30), 8-9; (Apr. 6), 22; (Apr. 20), 15-16; the Wash. Herald, Mar. 17, 18, 19, Apr. 16, 1908; Wash. Post, Mar. 6, 13, 19, Apr. 16; Wash. Star, Mar. 16, 17; and in the Harper's Cuforhedake Brain Food folder, Dept. of Investigation, Amer. Medical Assoc., Chicago.
  5. Martin Gross, Acetanilid: A Critical Bibliographic Review (New Haven, 1946), 1-2.
  6. Collier's, 36 (Dec. 2, 1905), 16-18.
  7. L.F. Kebler, F.P. Morgan, and Philip Rupp presented the results of their study in The Harmful Effects of Acetanilid, Antipyrin and Phenacetin, Bulletin 126, Bur. of Chem., 1909, and in the less technical Harmfulness of Headache Mixtures, Farmers' Bulletin 377, Dept. of Agric., 1909. Gross offers a recent critique of this work, 58-103.
  8. The fullest account of the trial itself is in Oil, Paint and Drug Reporter, 73 (Feb. 3-Apr. 20, 1908, passim).
  9. Judge Kimball's charge is reprinted in Mastin G. White and Otis H. Gates, compilers, Decisions of Courts in Cases under the Federal Food and Drugs Act (Wash., 1934), 11-18.
  10. Oil, Paint and Drug Reporter, 73 (Mar. 16,1908), 9; (Mar. 23), 7. Early debate about acetanilid, as during the Harper trial, has been seen in retrospect as "a welter of polemics," with the critics unduly harsh and the proponents much too optimistic. Dispensatory of the U.S. (25th ed., 1955) 5. If the sinister reputation acetanilid had with Wiley and Kehler was too extreme, and based in some measure on erroneous judgments, time was to confirm some of the hazards and reveal others; this plus the development of safer analgesics was to bring the virtual displacement of acetanilid in painkillers sold direct to the American laity. Torald Sollmann, A Manual of Pharmacology (8th ed., Phila., 1957), 723, 728-30.
  11. Wash. Herald, Mar. 17, 1908. Roosevelt made his statement at the urging of officials of the Departments of Agriculture and justice. Oil, Paint and Drug Reporter, 73 (Mar. 23, 1908), 2813.
  12. Wash. Herald, Apr. 16, 1908.
  13. Ibid.
  14. Wash. Star, Mar. 17, 1908; [Decatur (Ill.) Herald, Jan. 21, 1913], clipping, Wiley Papers, box 237, Library of Congress (Wiley exaggerated Harper's income from the headache remedy); Midland Druggist, cited in Eclectic Medical Gleaner, Ds 4 (1908), 317; Pharm. Era, 39 (Apr. 23, 1908), 513. Harper initiated an appeal from his defeat, but later withdrew it, saying he felt confident of winning, but that victory would require a retrial under the same unsatisfactory conditions as had prevailed before. With label modified, Harper continued to vend his remedy. Druggists' Circular, 52 (Nov. 1908), 582; Oil, Paint and Drug Reporter, 73 (Apr. 6, 1908), 22.

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This page was posted on December 19, 2001.

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