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|The Medical Messiahs: Chapter 6, 20/11/2004|
|While Frank Rollins fought with the Food and Drug Administration over the fate of B. & M., a court contest equally decisive sought to determine the anti-nostrum powers of another federal agency. One contestant in this struggle was Edward Hayes, erstwhile promoter of male-weakness remedies, now vending Marmola, an obesity cure. Hayes' court opponent was the Federal Trade Commission.|
The critical court decision concerned Marmola . Back in 1907, at about the same time he was launching Man Medicine, Edward Hayes set up another company to vend his weight-reducing remedy.
Besides desiccated thyroid, Marmola contained laxatives and several other ingredients, relatively inert. But the formula did not remain fixed from year to year. In 1911 the amount of thyroid was cut because of its rising price. During the war, the laxative phenolphthalein, a German import, got scarce, so it was dropped and the amount of cascara—an American herbal laxative—was upped. In 1922 the thyroid in each Marmola tablet was reduced again, to half a grain, on the advice of the pharmaceutical manufacturer who compounded the tablets for Hayes .
If the formula varied, the main theme of Marmola advertising persevered without change. "Take Off the Fat Where It Shows," urged the headline on an early ad, under the picture of a huge-busted woman. "Famous Beauties Never Get Fat," assured another advertisement: grand ladies might indulge in a "lifelong loaf," drink liquor "not illiberally," and abandon "table restraint," all without risk of obesity-if they used Marmola. "Beneath Your Fat a Graceful Figure Dwells," cajoled another message .
The moderate market of the days of tbe Gibson girl became, in the twenties, a golden opportunity. Style decreed that men must be lithe and athletic, women slim to the point of emaciation, "There seems, indeed, to have come upon the women of America," wrote the editor of the Journal of the American Medical Association, "a veritable craze for reduction which has passed the bounds of normality and driven women and young girls to a type of self-mutilation impossible to explain on any other basis than the faddism of the mob." "Fabulous sums are spent for . . . anti-fat frauds," said Commissioner Humphrey, "since the female skeleton has become the fashion of this country," The first general NBBB bulletin dealt with this racket. Marmola told flaming youth and the would-be young about "The Pleasant Way to Banish Excess Fat" and presented the testimony of movie actress Constance Talmadge: "The demand for slender figures is so universal that movie stars must have them. Not only beauty, but good health and vitality argue against excess fat." The argument was persuasive. Marmola's sales climbed to the sum of $600,000 a year .
When his old nemesis, the Post Office Department called upon Hayes to show cause why a fraud order should not be issued against the Marmola Company, Hayes sent a lawyer to talk things over. The upshot was an affidavit signed early in 1927, in which Hayes swore that the company had "absolutely abandoned" its business and would "not resume it at any time in future." Nor did it. But Hayes immediately launched the Raladam Company—the name was composed by the girls in the office—which did no mail-order business, dealing only with wholesale and retail druggists and shipping Marmola only by express .
When an attack came from another quarter the next year, Hayes bad to stand and fight. The Federal Trade Commission challenged the Raladam Company's advertising. "People used to think that excess fat all came from over-eating or under-exercise," some ads had said, whereas "fat people, it was found, generally suffered from an under-active thyroid." These statements, the FTC complained, were wrong. So was the advice Marmola advertising offered to consumers. It was not a "scientific way" to reduce, the complaint alleged, to "simply take. . . four tablets daily , until weight comes down to normal ."
Dr. Kebler of the Food and Drug Administration testified that, at the most, only 5 per cent of the overweight owed their obesity to an under-active thyroid. Thus for 95 per cent of fat people, the use of desiccated thyroid, even carefully administered, would do no good. For many people, with various ailments, any extra thyroid was highly dangerous. For anybody, even the most healthy, too much thyroid posed a threat. The Marmola dosage, said Dr.
Kebler, was "very unwise." Another witness, Dr. William E. Clark of the Georgetown Medical School, painted a grim picture of the potential results of Marmola dosage for many people if continued over a period of time. "Rapid pulse" could develop, as well as "headache, nervousness, tremor, often bad diarrhea, weight loss, sweating, and often a toxic state." Prescribing the same amount of thyroid for each patient, a Northwestern University medical professor thought, was criminal. In addition to the thyroid danger, be said, Marmola posed a threat of creating the laxative habit-after the war phenolphthalein had been restored.
Other medical professors were similarly appalled at Marmola's hazards. But Hayes found six physicians—some of them medical professors and all members of their local medical societies—who took his side. Taken as directed, they asserted, Marmola was both effective and safe. The pharmacopeial dose of dried thyroid was, after all, a whole grain. And the Marmola label warned self-dosers to consult their doctors upon encountering "unusual conditions." Thyroid worked for their patients, the doctors said, when they prescribed it for obesity. One of them testified that be gave from 6 to 40 grains a day.
The average person, Hayes' medical witnesses insisted, could take Marmola safely for 60 to 90 days without medical supervision and attain the desired results.
Dr. Arthur Cramp, head of the American Medical Association's Bureau of Investigation and himself a witness against Marmola, was stunned to find established physicians arrayed for pay in favor of the thyroid remedy. "Here, then, is a sweet spectacle," Cramp wrote in a Journal editorial, "the American Medical Association attempting to protect the public against quack remedies, while individual members testify in behalf of exploiters of quack remedies!" Cramp published their names for all their professional colleagues to see. A spokesman for the proprietary industry thought the editorial an "outrageous attempt to influence testimony."
It was Cramp's side of the argument which seemed the more persuasive to the hearing examiner and, later, to the full Commission. In April 1929 an order was issued demanding that the Raladam Company stop advertising Marmola as a scientific, accurate, and harmless method for treating obesity. If Marmola was to be promoted for reducing weight, the order said, the company must include a statement that the remedy could not be taken with safety to physical health except upon the advice of a competent physician .
Hayes did not bow to the order and tone down Marmola advertising.
When the three judges had weighed the matter, they gave their judgment to Marmola, canceling out the Commission's order. Physicians had testified on both sides about Marmola's value. Words like "scientific" and "safety" were so flexible that they could properly be used in different ways by doctors of contrary views. Marmola's role lay not in the realm of fact but—shades of the McAnnulty decision—in the realm of opinion.
"The specific question . . . " said the court, "is whether this amount of thyroid taken in this way is so inherently and characteristically dangerous to the patient as to make that danger a fact, as distinguished from a reasonable scope of conflicting opinion." The answer must be negative on the basis of the FTC's own order, for the Commission would permit a citizen to take Marmola—if he got a doctor to supervise .
Despite the court's excursion into medical opinion, however, the real reason for the reversal had nothing at all to do with therapy. More basic, said the judges, was a "broader question of the jurisdiction of the Commission." The law forbade methods of competition that were unfair. If the Commission failed to demonstrate that competitors had been hurt, it had no case. That lack was obvious in the action against Marmola. The Commission had sought to show injury to the public, but had paid no explicit heed to any competitors. Might they be discovered by indirection? Possibly the medical profession, the court posited. "It cannot be seriously contended," the judges went on, destroying their own hypothesis, "that the act was intended to protect any profession against encroachment—the aid of the Commission might be as logically given to physicians and surgeons as against chiropractors, or to lawyers against incompetent will draftsmen." How, then, about competing nostrums "commercially exploited . . . for obesity?" Could they be considered competitors deserving protection? "It is fairly to be inferred," the court stated, "not only that these are on the same index expurgatorius
as Marmola, but that they are relatively disreputable. Again, it cannot be seriously contended that the machinery of the Commission was intended to give governmental aid to the protection of this kind of trade and commerce."
So, while the Commission appealed the decision to the Supreme Court, Marmola advertising reached a new level of audacity. "Obesity Frauds," a headline ran. "Time was when there was a great cry against obesity frauds," the text continued. "Methods either harmful or useless. That cry has led many to fear a method that is right and scientific. But now frauds are few. All things wrong or harmful are short-lived. Marmola prescription tablets have been sold for 24 years—millions of boxes of them—during all this furore of folly.... You can trust a help so time-tested, so endorsed."
The Supreme Court gave this time-tested weight-reducer a verbal blow—but also handed Marmola the victory. "If the necessity of protecting the public against dangerously misleading advertisements of a remedy sold in interstate commerce were all that is necessary to give the Commission jurisdiction," wrote justice Sutherland, "the order could not successfully be assailed. But this is not all." Competition must be demonstrated, and this task the Commission had failed to undertake .
|The Medical Messiahs: Chapter 9, 20/11/2004|
| of Marmola Prescription Tablets, 1943 |
With respect to one section of the law, 502(j), there was little that could be legally ambiguous: drugs were misbranded if "dangerous to health" when used as directed in the labeling. Within this danger zone were products against which the Food and Drug Administration had been impotent to act under the 1906 law. Now these hazards to health got top enforcement priority, "Our first search," Walter Campbell said, was for . . . containing dinitrophenol." But their manufacturers had heard the word. Although these deadly reducers had been abundant during the fight to secure the law, Campbell's inspectors could find none now. The agency turned to other obesity products containing dangerously potent drugs-including the dried thyroid nostrum named Marmola
Something of the massive effort required of the FDA in preparing a major case is illustrated by its contest with Marmola. During the Congressional hearings, this thyroid-extract reducing remedy had been mentioned as an egregious example of the dangerous drugs which the old law could not keep off the market. Other regulatory agencies had had their try, but obesity was not a disease within the purview of the FDA's labeling control. With the new law, Marmola was one of the first proprietaries against which the FDA began to develop evidence, and in several ways the case turned out to be significant .
Marmola promotion, in the wake of its 1931 Supreme Court victory over the Federal Trade Commission, had become especially cocky, its pamphlets referring disparagingly to "silly gossip about harmful ingredients." , The Commission's defeat in this case, indeed, became a key argument for giving control of drug advertising to the FDA. Seeking to reverse this major loss, the FTC issued in 1935 a new complaint against Marmola, this time making sure that injury to competitors as well as to consumers was amply demonstrated. In the hearing Edward Hayes once again defended the proprietary that had supported him so well for more than three decades, his testimony bolstered by that of a Detroit physician telling the tale of a lazy beagle. After chasing rabbits for half an hour, the doctor said, the hound fell to the ground exhausted. But on a diet of the thyroid glands of sheep, the beagle revived, two months later winning a blue ribbon in the Canadian trials. This and more human testimony did not save Hayes from a cease and desist order, issued in 1937. But Marmola appealed, and in the same month in 1941 that the Food and Drug Administration action went to trial, won another victory over the FTC, when a circuit court adjudged the cease and desist order void . Hayes could not know this cheering news, or appear as witness in the FDA trial. He had died in 1939 .
Marmola labeling had been somewhat toned down with the passage of the 1938 law, recommending its four tablets a day "only as a treatment for adult fat persons whose excess fatness is caused by bypothyroidism . . . but who are otherwise normal and healthy." But its main gospel was the same. Science had dispelled the old notion that "laziness or gluttony" were the sole reasons for excess weight. The "basic cause" was a "deficiency" in the body, which Marmola's half grain of desiccated thyroid would counteract. From person to person the speed of weight loss would vary, but "a moderate rate of reduction" was best.
There might be side effects, for all drugs could produce in some susceptible persons "unpleasant or harmful symptoms. If this occurred, the circular advised, stop taking Marmola until the symptoms disappeared, then resume with half the former dose. The labeling disavowed explicitly that it was diagnosing; only physicians could do that .
Believing Marmola dangerous and even its more cautious claims false and misleading, the FDA seized 62 packages that had been shipped from Detroit to LaCrosse, Wisconsin. To make its case in court, the FDA employed the opinions of expert scientists, a mail inquiry of physicians, evidence from clinical trials, and sad instances of women whose use of Marmola had brought disaster.
At the trial in Madison before a judge, 19 notable scientists—drawn from private practice and such institutions as the Mayo Clinic and the universities of Wisconsin, Michigan, and Chicago—challenged Marmola's basic theories, Obesity did not result, they said, from an underactive thyroid gland. Undue weight was gained simply by taking into the body more calories through food and drink than the body expended through work or the output of heat. Nor did the thyroid hormone, necessary to normal life, exert any direct effect upon the fat deposits of obesity, Indeed, some people with hypothyroidism—too small an output of the hormone—were very thin, and some with hyperthyroidism—too great an output were too fat. For the layman who was accumulating unnecessary pounds, therefore, to diagnose his own problem as hypothyroidism and start taking Marmola was ridiculous.
From person to person, the border of danger would differ, since the metabolic rates of individuals differed. No lay person could himself know when the amount of thyroid he was taking had reached point of threatening his physical reserves. These factors of safety in his kidneys, nerves, pancreas, blood vessels, and heart might reach severe depletion because of excessive thyroid while a person still looked healthy and felt fine. The Marmola dosage was enough, the medical scientists said, to activate latent diabetes, spur on borderline pellagra, precipitate incipient tuberculosis, cue a severe emotional disturbance, or bring on—especially in an overweight person—a heart attack. Even without these direst of results, the symptoms of hyperthyroidism were grim enough: vertigo, nausea, headache, nervousness, trembling, palpitation, labored breathing, menstrual suppression.
Ninety-eight per cent of some 2,000 members of the American College of Physicians who answered a mail inquiry arranged by the FDA believed that the indiscriminate use of two grains of thyroid a day—the recommended Marmola dosage—for a period of one to two months posed danger to health. Some of the government witnesses had sought to induce experimentally a carefully controlled byperthyroidism. A fifth of the patients in the experiment developed distressing, and sometimes hazardous, symptoms, with dosages of two daily grains of desiccated thyroid or less. In some cases injury resulted from dosages as low as one-fifth, or even one-tenth, a grain a day.
What had occurred in the clinic, under the most cautious controls, also took place within the large number of Marmola's customers, who used its thyroid extract in the random way customary among those practicing self-dosage. Six women, serving as government witnesses, gave from the stand their tragic testimony.
One Chicago woman of 24, growing up in an unhappy home, had weighed 165 pounds by the time she was 18. Called "Fatty' and subject to the crude jokes and ostracism of her schoolmates, she had sought to remedy her pligbt. Secretly purchasing Marmola, she used it according to directions, but without a very great restriction on her eating. Thus, although she began to vomit occasionally and developed dizziness, headaches, and muscular pains, she lost very little weight. After three months she decided on an even more rigorous regimen. Taking five Marmola tablets a day, she cut her breakfast to a cup of coffee and a piece of unbuttered toast, her lunch to a bottle of pop. She ate no supper at all.
Her spells of vomiting increased, and at last she began to lose weight rapidly. After seven months, when her stepmother discovered what she was doing and forbade further use of Marmola, the girl's weight was down to 90 or 95 pounds. Even without more thyroid extract, her weight continued to plummet, reaching a low of 50 pounds, and her unpleasant symptoms continued. At the time of her testimony in court, though having gotten her weight back up to 70 pounds, she still was very ill.
Marmola had its own medical experts who challenged the validity of the case made by the government's witnesses. Thyroid in the Marmola dosage was safe, they argued, and would cause no permanent damage. The symptoms of hyperthyroidism were admittedly unpleasant, they said, but transitory, and not too high a price to pay for the reduction of excess weight by people who lacked the will power to diet.
Besides defending its tablets, the Marmola company sought in its case to attack both the Food and Drug Administration and the new law the Administration was seeking to enforce. The agency was trying to use the law, a trial brief argued, to secure "bureaucratic" powers over the public's "inalienable right" of self-medication.
In any case, Marmola's promoters insisted, the 1938 act was unconstitutional. Its provisions were too uncertain and indefinite, permitting unwarranted search and seizure, and unlawfully delegating legislative powers to an agency within the executive branch.
Nor did be agree with the Marmola contention that the act, or the FDA's interpretation of the act, was aimed at the elimination of self-medication. The law "was enacted to make self-medication safer and more effective," he ruled, "and to require that drugs moving in interstate commerce be properly labeled so that their use as prescribed may not be dangerous to the health of the user." Marmola was not so labeled. "The substantial portion of the public, after reading the labeling . . . the judge said, "would conclude that Marmola is a safe and efficient remedy for obesity, which is not a fact." Testimony by the government witnesses had been most persuasive. In Marmola there was "an inherent and potential danger that may reasonably be expected to attend its use when one considers that it will be used by the strong, the weak, the old, the young, the well ' and the sick, without first having a physical examination or a diagnosis of their condition by a competent physician."
So 62 packages of Marmola, seized by the government, were condemned under the law. The circuit court in due course affirmed this decision, and the Supreme Court, by denying certiorari, let it stand. While the district judge was still weighing his judgment, the Supreme Court had already looked at Marmola advertising and found it bad.
Reversing the circuit court's decision in the Federal Trade Commission case, the highest court restored the Commission~s cease and desist order . Following up its part of this double victory, the Food and Drug Administration attacked Marmola throughout the country with multiple seizures .
Four years had elapsed between the initial seizure of Marmola and the Supreme Court's denial of certiorari ending the case.
|The Medical Messiahs: Chapter 4, 20/11/2004|
|Marmola was to be ten times the nostrum that Man Medicine had been .|
25 Stat. 873 (Mar. 2, 1889); N&Q, 11, 284-87; Kehler to A. J. Cramp, July 27, 1927, Marmola folder, Dept. of Investigation, American Medical Association.
|The Medical Messiahs: Chapter 10, 20/11/2004|
|Judge Patrick T. Stone—who had also presided over the Marmola trial—was not completely unmoved, but he remembered other unfortunates who had appeared in the courtroom during the trial.|