Massengill's Elixir Sulfanilamide: The FDA Visits Bristol, Tennessee

After the FDA received word of the Tulsa deaths, the agency's chief medical officer, Theodore G. Klumpp, and Cincinnati inspector William T. Ford left immediately for the Massengill headquarters in Bristol [1]. There they found a worried-looking company president. Dr. Massengill offered his "full cooperation" to Klumpp and Ford, including access to his shipping records.* But in his defense, he claimed that he had done "all that was humanly possible" to retrieve the at-large bottles of his elixir. Some 1100 telegrams had been sent out from Bristol and the company's branches to consignees and Massengill's sales reps, asking for the return of the product. However, none conveyed the elixir's danger [2,3].

Sent Friday afternoon, October 15, to retail druggists and doctors who received shipments:

DO NOT USE ELIXIR SULFANILAMIDE SHIPPED RETURN OUR EXPENSE

Sent Friday afternoon, October 15, to wholesalers who received shipments:

DO NOT USE ELIXIR SULFANILAMIDE SHIPPED IF SOLD NOTIFY CUSTOMERS OUR EXPENSE RETURN STOCK

Sent October 16, to all salesmen:

ELIXIR SULFANILAMIDE DISCONTINUED STOP PICK UP AS RAPIDLY AS POSSIBLE ALL SOLD IN YOUR TERRITORY

Both Massengill and his head chemist, Harold Cole Watkins, who created Elixir Sulfanilamide, admitted to Klumpp and Ford that no toxicity tests (or specifically animal tests) had been performed before the product was shipped out. However, Massengill resisted the AMA's mounting evidence that diethylene glycol was responsible for the fatalities. Instead he suggested to the FDA agents that overuse of the antibiotic was to blame. "The drug sulfanilamid[e] had been so exploited by physicians and the press that everyone in the country was going wild with it and using it for everything and now the disastrous effects of it were coming out," Massengill explained. He postulated that the adverse effects of his product were caused by other drugs taken with Elixir Sulfanilamide [2].

Klumpp and Ford found Watkins particularly insensitive to the safety of drugs generally and that of his elixir specifically. The chemist described his previous compounding of a colloidal sulfur solution, which had caused the deaths of "a number of people." A flummoxed Klumpp wrote, "Mr. Watkins told about this event as if it were an ordinary incident in the business of making and marketing pharmaceuticals." Watkins also admitted to the imminent release of a cinchophen product, despite established evidence of the drug's liver toxicity. A disheartened Klumpp concluded from his Tennessee visit: "The expressed or implied attitude of certain drug manufacturers seems to be that drugs can be tested on the American public. If they fail to kill, or injure in such a way that the injury can be detected and traced to its source, the products have then met their trials successfully. The conclusion is unescapable that such drug manufacturers are perfectly willing to wait for reports of death or injury for information concerning the toxicity of their drugs" [2].

Since learning of the elixir-related deaths, the company had conducted its own tests of the product on guinea pigs and reported "favorable" results [4]. Watkins also boasted to Klumpp and Ford that he had taken a large swig of diethylene glycol without consequence. Klumpp doubted the chemist's claim; however, if true, the act was merely a "futile, heroic gesture" [2].

Inspector Ford retained the job of staying "indefinitely" in Bristol (at the Virginia Hotel) to oversee the recall of Elixir Sulfanilamide. Ford believed that it would be necessary to personally account for all seizures, so that he could "refrain from bringing pressure on the manufacturer to hasten return of such lots." FDA's district chiefs were instructed to advise Ford of all seizures and "informal" disposals (eg, flushing the bottle contents down a toilet) of Elixir Sulfanilamide [4].

To expedite the recall, Ford's first order of business was to cajole Massengill into sending out more explicit telegrams. Follow-up wires sent on October 19 to the company's branches and elixir consignees now included the phrase, "PRODUCT MAY BE DANGEROUS TO LIFE" [3]. But a particularly vexing issue was accounting for the more than 600 physician or salesman samples that had been distributed by the company. In a letter to the FDA's Central District Chief, J. O. Clarke, Ford expressed several days' worth of frustration in his attempt to get a list of company salesmen and a nod from "the old boy" Massengill on the text of the sample-recall wire [5]. 

Dear Mr. Clarke:—

Here is your list of salesmen out of Bristol + copy of wire.[**]

Had some job finding the old boy around town, and a worse one inducing him to send wires—guess he was trying to drown his troubles—and at least 2 sheets in the wind.

He was in no condition to supervise the sending of 61 telegrams. So yours truly did it for him, getting him to OK the charge to W[estern] U[nion].

Hostily

W. T. F. 

As told you over phone, will see Monday, when heads of that Dpt. get back to town, if they —ally know what they did with the 1 oz. physician samples. Each salesman (including all branches) got a 2 oz. case sample. 

* By the existing Food and Drugs Act of 1906, Massengill was not obligated to share his company's records with government inspectors (FDA correspondence. W. G. Campbell to George A. Denison, Jefferson County [AL] Board of Health. November 6, 1937).

** IMPERATIVE YOU TAKE UP IMMEDIATELY ANY CASE OF PHYSICIANS SAMPLES YOU MAY HAVE GIVEN TO PHYSICIANS OR ANYONE ELSE AND RETURN TO US (FDA correspondence. Letter from J. O. Clarke to Chief Administration. November 1, 1937.)

1. FDA correspondence. Letter from Theodore G. Klumpp to Perrin H. Long. November 1, 1937.

2. Klumpp TG. FDA report on Massengill Co. October 18, 1937. Cited in Young JH. Sulfanilamide and diethylene glycol. In: Parascandola J, Whorton JC, eds. Chemistry and Modern Society: Historical Essays in Honor of Aaron J. Ihde. Washington, DC: American Chemical Society; 1983:105-125.

3. FDA correspondence. Report from J. O. Clarke to Chief Administration. December 4, 1937.

4. FDA correspondence. Letter from Paul B. Dunbar to Chiefs of Districts. October 22, 1937.

5. FDA correspondence. Telegram from W. T. Ford to FDA, Chicago. October 20, 1937.

Image of Bristol, TN-VA, from Wikipedia. Reproduced under Creative Commons License.