Elixir Sulfanilamide Tragedy: Calls for Improved Legislation (2)

In mid-November of 1937, the US Senate and House adopted resolutions* asking then Secretary of Agriculture Henry A. Wallace to report on the Elixir Sulfanilamide deaths [1]. Wallace's report, the content of which became widely publicized, was submitted to the Secretary of the Senate, Edwin A. Halsey, on November 25, Thanksgiving morning [2,3].

In his plain-speaking "Letter of Transmittal," Wallace revealed not only the extent of known elixir-related casualties in the United States (93 at the time), but unpacked, for the first time, the chronology of events that led to them. Details included the elixir recipe, the lack of testing before marketing, the wide distribution of elixir shipments, the evasive words of Massengill's first recall telegrams, and the FDA's yeoman efforts to confiscate the poisonous medicine—often in the face of considerable obstruction. And if this information did not sufficiently convey the impact of the tragedy, the full content of a letter written by the mother of elixir victim Joan Marlar to President Roosevelt was added:

Tulsa, Okla., November 8, 1937.

President Roosevelt:

Dear Sir: Two months ago I was happy and working taking care of my two little girls, Joan age 6 and Jean age 9. Our byword through the depression was that we had good health and each other. Joan thought her mother was right in everything, and it would have made your heart feed good last November to have seen her jumping and shouting as we listened to your re-election over the radio.

Tonight, Mr. Roosevelt, that little voice is stilled. The first time I ever had occasion to call in a doctor for her and she was given the Elixir of Sulfanilamide. Tonight our little home is bleak and full of despair. All that is left to us is the caring for of that little grave. Even the memory of her is mixed with sorrow for we can see her little body tossing to and fro and hear that little voice screaming with pain and it seems as though it would drive me insane. During her 9 days of illness as we sat by her bed only once did those little eyes lose their dull and unknowing look. Jean and I begged her to look and know us. A smile broke over her face and she laughed aloud with us and as quickly it vanished, never to smile and know us again.

Tonight, President Roosevelt, as you enjoy your little grandchildren of whom we read about, it is my plea that you will take steps to prevent such sales of drugs that will take little lives and leave such suffering behind and such a bleak outlook on the future as I have tonight.

Surely we can have laws governing doctors also who will give such a medicine, not knowing to what extent its danger, and then lying and stealing the prescription they wrote supposedly from a reliable drug store. I don't believe such a doctor has taken his oath in all sincerity. Our lives are not safe entrusted in the hands of such a doctor, for that was my experience to my sorrow.[**]

In my confidence in you I am writing you and hope that you can realize a little of what I am suffering and that you will take steps to prevent such in the future for I realize also there are other homes where hearts are broken such as mine.

It is easy for people to say "Try to think that she died that others might live." It is easier to say when it doesn't strike in your own home.

Enclosed is a picture of the baby I grieve for day and night.

Thanking you and
   Sincerely,

(Mrs.) Maise Nidiffer

Wallace further revealed that 25 seizures of the elixir had been made by federal agents on the basis of misbranding during interstate commerce. Many other lots were confiscated by state agents under state or municipal laws. (For instance, in New York City, a patent medicine could not be sold until the manufacturer had registered the product with the health department and gave details of its ingredients and indications [4].) Wallace assured the Congress (and the public), "Citations are already in preparation for issuance to the manufacturer, in accordance with established procedure, calling on him to show cause why the cases should not be referred to the Federal courts for criminal prosecution."***

The Secretary concluded by recommending the following measures to improve existing drug legislation:

1. License control of new drugs to insure that they will not be generally distributed until experimental and clinical tests have shown them to be safe for use.
2. Prohibition of drugs which are dangerous to health when administered in accordance with the manufacturer's directions for use.
3. Requirement that drug labels bear appropriate directions for use and warning against probable misuse.
4. Prohibition of secret remedies by requiring that labels disclose fully the composition of drugs. [Notably labels of exported US drugs provided this information, owing to foreign laws that required disclosure.]

Congress and the public now informed, the job of replying to Mrs. Nidiffer was left to FDA Chief Walter G. Campbell [5].

My dear Mrs. Nidiffer:

Your letter of November 8 was received and read at the White House and immediately referred to the Food and Drug Administration, which was even then trying by all means in its power to trace down every possible ounce of the poisonous Elixir Sulfanilamide. In sending your letter to me there was transmitted the President's request that your letter be answered.

Believe me when I say, Mrs. Nidiffer, that in the course of my thirty years in the Government service I have never had a more difficult assignment than the President's request to reply to you. Your letter was laid before me during the weeks that we were desperately following up outstanding lots of the Elixir. I have looked at the lovely smiling face of your little girl and I think I realize in some measure your unending sorrow at a needless sacrifice.

The President and the Department of Agriculture, and many enlightened legislators as well as representatives of the public, have been urging with the utmost earnestness for the past four years the passage of a food and drug law which will give more ample protection than our present statute. One of the first actions of both the House and the Senate when they convened for the present special session was to pass resolutions calling upon the Secretary of Agriculture for a report on the Elixir Sulfanilamide tragedy, together with recommendations for legislation which would prevent such catastrophies[sic] in the future. The Secretary's report was delivered to both Houses of Congress on Thanksgiving morning. Your letter was included as a part of the report in the belief that it would impress upon our national legislators, more forcibly than an official recital, the horror of this tragedy and the absolute necessity for national legislation which will make its repetition impossible.

I agree with you it should not have been necessary for your baby to die to arouse public sentiment to the point that proper legislation will be enacted. If it is enacted—and I sincerely believe that there are strong and good men in both the House and Senate who have resolved that laws will be passed which will make a repetition of this tragedy impossible—it may be of some small comfort to you to know that your letter has had a real influence in bringing about this result.

With the most sincere sympathy, I am

Sincerely yours,

W. G. Campbell 

* Senate resolution 194 of November 16, 1937, and House resolution 352 of November 18, 1937.

** According to FDA records, both the druggist at Tulsa's Getman Drug Store and the prescribing doctor, Logan A. Spann, attempted to obstruct the FDA's investigation in this case.

*** A particularly interesting notation made by the Secretary was that the fact that some drug manufacturers had considered making a solution of sulfanilamide in diethylene glycol but had abandoned the idea after learning of the solvent's potential toxicity.

1. The day in Washington. The New York Times. November 19, 1937; p 7.

2. Wallace HA. Report of the Secretary of Agriculture on the deaths due to Elixir-Sulfanilamide-Massengill. November 16, 1937.

3. 'Death drug' hunt covered 15 states. The New York Times. November 26, 1937; p 42.

4. FDA newspaper clippings. City has its own restrictions on sale of medical remedies. Herald Tribune. October 31, 1937.

5. FDA correspondence. Letter from W. G. Campbell to Mrs. Maise Nidiffer. November 30, 1937.

Photo of elixir victim Joan Marlar from Ballentine C. Taste of raspberries, taste of death: the 1937 Elixir Sulfanilamide incident. FDA Consumer. 1981;June:18-21.