Elixir Sulfanilamide Tragedy: Calls for Improved Legislation

As FDA inspectors continued to collect outstanding bottles of Massengill's Elixir Sulfanilamide throughout the country, calls for legislation to ensure the safety of marketed drugs filled the nation's newspapers. Particularly troubling was the fact that the elixir could only be seized legally on the tenuous basis of misbranding—given that an "elixir" technically should include an alcohol solvent. If Massengill's product had been labeled a "solution," no seizure could have been effected by the federal agency.

In the press, the League of Women Voters specifically was highly critical of existing laws and chastised legislators for their historical ineptitude and disregard for public safety [1]:

For four years the league has been vainly urging on Congress adequate regulation of food, drug and cosmetic products. In the face of opposition of special interests, one measure of protection after another has been whittled away from pending bills. The bill that passed the Senate at its last session and was pending in the House had been shorn long since of original provisions that would have protected the public against the tragedies of this elixir.

The women's group referred to Senate bill 5 no. 2, a highly watered-down version of the originally proposed "Tugwell bill" and a revision of the original 1906 Pure Food and Drugs Act. In a November 7 editorial, Washington, DC, journalist Rodney Dutcher concurred that the original revisionist bill, introduced in 1933, had "long since been pulverized by lobbyists and congressional sympathizers." Those called out by Dutcher for the "final emasculation of such shreds of the Tugwell bill" were Senators Josiah Bailey (D-NC), Joel Clark (D-MO), and Arthur Vandenberg (R-MI) [2].

Morris Fishbein, Editor-in-Chief of the AMA's journal, described the series of missteps that led to the scores of elixir-related deaths. He extended blame from the Massengill Company to blindly prescribing physicians [3]:

Who should have made certain of the safety of the preparation if not the purveyor? In the cycle comes first the manufacturer who launched the preparation without proper precaution; second, the detail man who importuned physicians to use the product; third, the pharmacist who was willing to sell across the counter, either on request from the public or on physicians' prescriptions, toxic preparations of secret character, yet whose training is vaunted as a protection to the public. But most serious perhaps after the manufacturer are those physicians who will not heed the warnings concerning the use of proprietary, unstandardized, semisecret remedies.

Fishbein described the ambiguity of the term "elixir," the definition of which "has undergone some changes in the practice of pharmacy" through the use of solvents like glycerin, instead of alcohol. Furthermore, he claimed no legal definition of the term (probably to the FDA's consternation) and urged the US Pharmacopeial Revision Committee or "some group with legal power" to define the word in practice. Last Fishbein acknowledged, "Surely there has been no blacker picture of the inadequacy of our present food and drug laws or the lack of common scientific decency in drug manufacture than that illustrated by this tragic disaster" and likened the current FDA to a hunter stalking a tiger with a fly swatter.

Even industry groups recognized the need for a revision of law in the wake of so many deaths. Editors of the trade journal The Drug and Cosmetic Industry wondered, "Why a comparatively small manufacturer should, in ignorance or carelessness, believe that he alone had suddently discovered a proper answer to a problem which the entire industry was trying to solve is beyond comprehension," and concluded, "The only way in which the industry can properly protect itself against another accident of the same type is for [an] outside agency, such as the government, to have proper control over manufacturers and their products." [4].

Likewise, the Oil Paint and Drug Reporter found the sale of Massengill's Elixir Sulfanilamide "appalling for its evidence of ignorance or greed on the part of some who seek to be entrusted with ministration to the needs of the sick...Why a pharmaceutical manufacturer would use an industrial solvent of unknown pharmacologic activity in the making of a medicine for internal use is beyond comprehension." For the drug industry, the editors advised [5]:

Experimentation is as desirable in pharmacy as it is in medicine. Improved or more acceptable dosage forms of valuable drugs are helpful to the medical profession. It is an important function of [pharmaceutical] manufacturing to provide these. But experimentation with drugs in every connection should be scientific. Empirical trial and error is dangerous, especially when concerned with potent drugs of complex chemical composition and inestimable potential chemical reactivity.

And predictions were made [5]:

Juridical awards of damages for the losses of life will not satisfy the needs for protection of the public...It is inevitable that the "poison elixir" calamity will arouse public sentiment for speedy and closely tightening revision of the Food and Drugs Act [of 1906]. There will be no great difficulty in calling up a pending bill in the special session of Congress. It cannot be denied that revision of the law has been too long deferred. It must be realized that the delay had to be attended with the possibility of increasing demand for still more rigorous prohibitions.

It is to be expected that the public demand for protection will not be satisfied with making it possible to catch a poisonously adulterated drug in commerce, or with classifying the undisclosed presence of a dangerous ingredient as misbranding. The cry will be for formula disclosure and for factory inspection. The drug industry must expect attacks more severe than any it has known.

In its coverage of the national tragedy, Time also noted that the original, revised food and drug bill that had been up before Congress in its last session would have made Massengill liable to federal prosection. The magazine described Dr. Samuel Massengill, the company's chief, as a compounder of "veterinary medicines in a good-sized factory at Bristol, Tenn.," and cited an FDA source for the company's "total lack of testing facilities" [6].

Massengill's local paper, the Bristol Herald Courier took umbrage with the news magazine's critical, and very national, coverage of the recent events. In a pseudonymous opinion piece, the paper—while giving a passing nod to the tragedy of the deaths—defended the scope of Massengill's company and its reputable history [7]. The writer's tone forecasted the level of insular, public defense to be employed by Massengill.

It is deplorable, of course, that any deaths have occurred. But had there been many more deaths, and could they have been traced to the sulfanilamide elixir, the fact would not have warranted Time in publishing an article containing an intimation that the Massengill Drug Company is a small and irresponsible firm. The company is domiciled in a large group of modern buildings, it employs an army of men and women, and it has branch houses in New York, Kansas City, and San Francisco. And thousands of physicians and druggists all over the country will bear testimony to its responsibility.

The article in Time quoted a Federal agent as saying the Massengill Company lacks testing facilities and is careless in the manufacture of drugs. Not by practices of that kind did Dr. Massengill, who holds the degree of M. D., become one of the leading manufacturing pharmacists of the country. He has built up an enviable reputation over a period of forty years, by patient and persevering effort, by sound business judgment and capable management, by close personal attention to the affairs of his company, and by turning out honest products.

The Time article stated that Federal men "confiscated every last flask of the Massengill 'elixir' upon which they could lay their hands." That publication may not have known that with the first report of a death from sulfanilamide, which came from Oklahoma, Dr. Massengill deluged the Western Union office in Bristol with telegrams to his salesmen and others to take every ounce of the elixir off the market. Probably there were few flasks left for Federal men to confiscate.

This column has no means of knowing what constituted the lethal quality of elixir sulfanilamide. But six registered chemical pharmacists are employed in the Massengill laboratories here, and one is loath to believe that mistake has been made in the preparation of a formula or in the manufacture of a medicine by that company. All the evidence seems to be that the fatalities caused by sulfanilamide were due to the use of other medicine in connection with the elixir.

The article in Time did a grave injustice to Dr. Massengill. So far as known, the quality of a product manufactured by his company has now been called in question for the first time in the forty years of its existence. And our information is that if this product has been fatal in a few cases, it has been beneficial in many—though the fatal results are not, of course, offset by the beneficial effects. One unacquainted with Dr. Massengill and unfamiliar with the history of his company would gain a false impression of both from the Time publication. We say what we have said with a view to correcting, as far as possible, in injustice and the false impression.

1. Sulfanilamide elixir deaths bring demand for US curb. St. Louis Post-Dispatch. November 2, 1937.

2. Dutcher R. Sulfanilamide Elixir deaths. Anniston Star. November 7, 1937; p 4 cols 3, 4.

3. Fishbein M. Deaths following Elixir of Sulfanilamide-Massengill: III. J Am Med Assoc. 1937;109:1544-1545.

4. The deadly "elixir." Drug Cosmet Ind. 1937; 41:611, 614,  615, 619. In an interesting aside, the editors criticized the AMA for "throwing out its chest and trying to impress everone with a desirability of the association having full power over all drugs and how they shall be marketed. This is so despite the fact that the association has been unable to control its own members as is evidenced by the fact that physicians failed to follow the Council of the association and prescribed or dispensed this 'Elixir' even though it had not been accepted by the Council."

5. Pharmaceutical Tragedy. St. Louis Post-Dispatch. November 11, 1397; p 2C. (Editorial reprinted from the Oil, Paint and Drug Reporter.)

6. Fatal remedy. Time. November 1, 1937.

7. Old Timer. "Time" article is unfair to Massengill Company, one of leading drug manufacturers. Bristol Herald Courier. November 21, 1937; p 1 col 1.

Image of commemorative stamp honoring the 1906 Pure Food and Drugs Act from the FDA.