Results tagged “Elixir of Sulfanilamide” from Pathophilia

Since 1937, there have been at least 8 episodes of fatal mass poisoning caused by the oral ingestion of diethylene glycol-tainted drug products; although none has occurred in the United States.

In the summer of 1969, 7 children (ages 6-31 months) died in the area of Cape Town, South Africa, after receiving one or both of 2 liquid sedatives (Pronap or Plaxim). The products were made by the same pharmaceutical firm, which had substituted diethylene glycol for propylene glycol (the latter being an FDA-approved solvent for drugs, cosmetics, and food). Attempted treatment included rehydration, correction of metabolic acidosis, peritoneal dialysis (in 2 cases), and life support.

In 1986, 14 inpatients in a Bombay (Mumbai) hospital died of acute renal failure after receiving in-house glycerin therapy. The glycerin—which contained 18.5% diethylene glycol, 51% polyethylene glycol, and 9% glycerin—was purchased by the hospital through intermediary brokers, who had bought the product on the cheap from an industrial producer in India. Treatment with sodium bicarbonate, various diuretics, and dialysis (in 12 cases) was unsuccessful.

Between June and September of 1990, 47 children died at a Nigerian teaching hospital after ingesting paracetamol syrup that was tainted with diethylene glycol. Treatment consisted of rehydration and correction of acidosis, but none underwent dialysis. All died within 2 weeks of admission. (In a related incident, 109 Nigerian children died the same year after consuming ethylene glycol-tainted cough syrup.)

Beginning in 1990, a significant rise in the incidence of unexplained renal failure in Bengalese children was believed to be due to the ingestion of various brands of paracetamol elixir that were tainted with diethylene glycol. At least 67, and as many as 272, children were affected. After the government banned the sale of paracetamol elixirs in December 1992, pediatric hospitalizations for unexplained renal failure dropped by 84%.

In 1992, 29 people in Argentina died of acute renal failure as a result of consuming diethylene glycol-tainted propolis syrup. A study of 15 adult victims revealed a "good correlation" between the amount of diethylene glycol ingested and the anion gap. Syrup samples contained 65% diethylene glycol (w/v), and victims took between 5 and 20 mL. Therefore, the lethal dose of diethylene glycol for adults was estimated at 0.014-0.170 mg/kg body weight.

An increase in the incidence of unexplained renal failure in Haiti led to the discovery of diethylene glycol-induced disease in 109 children (ages 1 month-13 years) from the fall of 1995 to July 1996. The ingestion of locally made acetaminophen syrups (Afebril and Valodon) was significantly associated with the condition. Analysis revealed that these formulations were made with diethylene glycol-contaminated glycerin, which had been imported from a Chinese manufacturer by way of Europe. The median concentration of diethylene glycol in the final products was 14.4% (range, 1.2%-19.6%). The median estimated dose of consumed diethylene glycol (n = 32) was 1.34 mL/kg (range, 0.22-4.42 mL/kg), but toxic doses were often less than 1 mL/kg. The death rate among the children who remained in Haiti was 98% (85 of 87*). Among the 11 children transported to the United States for treatment, 8 survived, and 7 recovered renal function.

In 1998, 36 Indian children developed acute renal failure after consuming a diethylene glycol-tainted cough syrup, which was produced by a company in Gurgaon; 33 of these children died despite undergoing peritoneal dialysis. How and when diethylene glycol entered the syrup was unknown at the time of the medical report.

In the fall of 2006, an investigation into cases of unexplained renal failure in Panama ultimately led to the discovery of more than 100 deaths due to the consumption of cough syrup made with Chinese-imported glycerin. The glycerin, which was sold to the Panamanian health service, was incorporated into 260,000 bottles of the medicine. In its investigation, the New York Times traced 46 barrels of imported glycerin stock, labeled as 99.5% pure but containing ~24% diethylene glycol, from a Panamanian port to the Taxing Glycerine Factory in the Yangtze Delta (by way of Barcelona). A Panamanian government report released last year concluded that at least 174 people were poisoned and 115 were killed (66% death rate) as a direct result of the contaminated syrup (Bogdanich W. Panama releases '06 report on poisoning. NYT, February 14, 2008).

*****************************************************************************

The toxicity of diethylene glycol is believed to be due to its metabolite, HEAA—which is produced by the enzymatic activity of ADH and ALDH. But how HEAA produces cellular dysfunction is unclear, according to Kraut et al. Like other alcohols, diethylene glycol is rapidly absorbed from the gut and has a low volume of distribution (0.5 L/kg). Animal studies indicate that 30%-50% of diethylene glycol is eliminated through the liver, and 50%-70% via the kidneys. Although toxic and lethal doses in humans have been estimated in some reports of mass poisoning, susceptibility to diethylene glycol appears to vary widely for reasons that remain unknown.

Animal studies also indicate that the administration of ADH and ALDH inhibitors (eg, fomepizole) may prevent the production of HEAA, and dialysis (with or without fomepizole) has been used successfully in patients with diethylene glycol poisoning. Dialysis is not only instituted for renal failure, but may remove diethylene glycol and its toxic metabolite.

ADH = alcohol dehydrogenase; ADLH = aldehyde dehydrogenase; HEAA = 2-hydroxyethoxyacetic acid.

* Follow-up was unavailable for 11 children.

Depicted chemical structure of diethylene glycol from Wikipedia.

January 10, 1939

: Three months after Dr. Samuel E. Massengill pleaded guilty to 174 counts of adulterating and misbranding Elixir Sulfanilamide, he was elected president of the Bristol Chamber of Commerce in a show of municipal confidence [1].

January 17, 1939: Former Massengill chemist and creator of Elixir Sulfanilamide, Harold Cole Watkins, 58, shot himself in the heart with a .38 caliber automatic pistol at 7:30 am in the kitchen of his Bristol home. Watkins had "retired" from the Massengill company 6 months earlier; the circumstances of his departure from the firm, whether voluntary or by request, were not clear. Although the death was reported a suicide, Watkins's wife claimed that the self-inflicted gunshot was accidental. In addition to his widow, Watkins was survived by 2 sons [2-4].

January 19, 1939: Massengill sales manager Gordon Fletcher reported that the company had paid out more than $500,000 in injury claims regarding Elixir Sulfanilamide [4].

April 14, 1939: In the District Court for the Northeastern Division of the Eastern District of Tennessee (at Greeneville), judge George C. Taylor* ordered Massengill to pay $8500** and court costs for the wrongful death of Earl L. Beard, who had died in a Tulsa hospital on October 16, 1937, after consuming Elixir Sulfanilamide. The suit was brought by the deceased's mother, Mrs. Norris T. Beard of Oklahoma City [5]. (The plaintiff, represented by Swingle and Hardin of Greeneville, originally filed the suit in September 1938 and asked for $50,000.)

April 19, 1939: A civil suit brought by the widow and heirs of John W. Gibbons of Mt. Olive, Mississippi, against Massengill was dismissed without prejudice in the same federal court. Gibbons, 71, had died October 9, 1937, after consuming 2.5 ounces of a 4-ounce elixir prescription, which had been written by his physician, Archie Calhoun. (The civil complaint, originally filed on October 1, 1938, asked for a total of $45,000 in damages and a jury trial.) The plaintiffs moved for a voluntary nonsuit, most likely on the basis of deposition testimony. One of the deceased's physicians testified that Gibbons had died of coronary thrombosis, which was believed to be independent of diethylene glycol toxicity. A treating urologist also suspected prostate cancer. The plaintiffs were required to pay court costs [5].

April 20, 1939: A civil complaint was filed against Massengill in the same federal court by Claire B. Williams, widow of Fred L. Williams, a Florida resident who had died October 12, 1937, after consuming probably 6 ounces of Elixir Sulfanilamide. The plaintiff, represented by Caldwell, Brown, and O'Dell of Bristol, Tennessee, demanded $10,000 and court costs. Three months later, the case was settled out of court for an undisclosed amount [5].

November 3, 1939: A civil complaint was filed against Massengill in the same federal court by Sylvia Cauley, who alleged the wrongful death of her husband, Emanuel Cauley. Cauley, a Florida resident, had died October 16, 1937, after consuming 5 ounces of Elixir Sulfanilamide. The plaintiff, also represented by Caldwell, Brown, and O'Dell, demanded $10,000 and court costs. Massengill defended the suit by arguing that the 1-year Tennessee statute of limitations applied, not the 2-year limit in Florida. Judge Taylor agreed, and the suit was dismissed in March of 1940. The plaintiff was ordered to pay court costs [6].

Also in November, Theodore Klumpp, Chief Medical Officer of the FDA, and Herbert Calvery published their report on the Elixir Sulfanilamide deaths, which included information from 353 persons who consumed the drug. Data were "sufficient" to conclude that Elixir Sulfanilamide was the primary cause of 105 deaths; although in "several" cases, concomitant illness may have contributed to mortality. The drug was most often prescribed for the treatment of gonorrhea (39% of deaths) or sore throat (23% of deaths). The average time of survival from the first elixir dose to death was 9.4 days (range, 2-22 days) [7].

The most common, initial symptoms were nausea and vomiting—symptoms which may have been life saving for some by prompting discontinuation of the drug. Headache was also frequently experienced. These symptoms were followed by a progressive decrease in urine output, which was often associated with considerable back, flank, and/or abdominal pain. Signs of uremic encephalopathy then emerged, leading to coma, convulsions, and death. In only a few cases were laboratory studies performed (eg, South Carolina case report).

The average elixir dose taken by the deceased, both children and adults, was somewhat higher than that taken by the 248 survivors, although there was considerably overlap in the range of doses taken by the 2 groups.

Group	Mean Dose, cc	Minimum Dose, cc	Maximum Dose, cc
Deceased
7 months-16 years    (n = 34)	52.7 ± 32.8	5	120
17-78 years    (n = 71)	98.6 ± 37.9	20	240
Survivors
1-14 years    (n = 48)	44.2 ± 30.2	3	105
≥15 years    (n = 200)	83.7 ± 57.5	1	240

March 8, 1940: A civil complaint was filed against Massengill in the District Court for the Northeastern Division of the Eastern District of Tennessee (at Greeneville) by the administrator for Pearl Locklair. Locklair died October 4, 1937, in Charleston, SC, after consuming an unknown quantity of Elixir Sulfanilamide. The plaintiffs asked for $35,000 in total damages. Massengill defended the complaint by arguing that the 1-year Tennessee statute of limitations applied, not the 6-year limit in South Carolina. Judge Taylor agreed, and the suit was dismissed on August 7, 1940. The plaintiff appealed to the US Court of Appeals for the Sixth Circuit [5,8].

January 9, 1942: The US Court of Appeals for the Sixth Circuit reversed the lower court's decision, and the wrongful death suit for Pearl Locklair was remanded for trial [8]. 

May 25, 1942: Massengill's petition to the US Supreme Court in the wrongful death suit for Pearl Locklair was denied [9].

September 2, 1942: In a settlement with the administrator for Pearl Locklair, Massengill agreed to pay $1500, plus $150 in expenses and court costs [5].

* The same judge who presided over the government's adulteration and misbranding case against Massengill. The Beard judgment was the result of a non-jury decision.

** $7500 for loss of support and other pecuniary loss and $1000 for pain and suffering.

1. Massengill heads Bristol chamber. Bristol Herald Courier. January 11, 1939; p 5, cols 1-3.

2. H. C. Watkins victim wound. Bristol News Bulletin. January 17, 1939; p 1, col 6.

3. Harold Cole Watkins victim of gunshot. Bristol Herald Courier. January 18, 1939; p 2, col 2.

4. Maker sulfanilamide formula is suicide. Greeneville Sun. January 19, 1939; p 1, col 6.

5. Greeneville, TN, court records; obtained from NARA. 

6. Cauley v S. E. Massengill Co. 35 F 371 (TN Dist 1940).

7. Klumpp TG, Calvary HO. The toxicity for human beings of diethylene glycol with sulfanilamide. South Med J. 1939;32:1105-1109.

8. Wilson v Massengill. 124 F2nd 666 (US App 1942).

9. Massengill v Wilson. 316 US 686; 62 S Ct 1274; 86 L Ed (US SC 1942).

In a way that only grand tragedy can instigate reform, the rising number of deaths due to Massengill's Elixir Sulfanilamide mobilized a formerly apathic press and public to demand revision of the 30-year-old Wiley statute. The principal House opponent of Copeland's first S. 5 bill, B. Carroll Reece (R-TN), was particularly stung by the fact that Massengill's company resided in his district, and reformists were only too happy to point out this fact.

But passage of S. 5, while facilitating the FDA's ability to seize bottles of Elixir Sulfanilamide, would not have prevented the disaster. The bill, unlike the original Tugwell measure (S. 1944), had no licensing provisions for new drugs entering the market, as the League of Women Voters was quick to note. This fact was verified by Representative Lea with Paul Dunbar of the FDA, and the California legislator requested an appropriate amendment to rectify the omission.

Copeland was way ahead; on December 1, he introduced S. 3073, which stated that any manufacturer who sought to market a new drug must submit the drug's components, testing records, an explanation of the manufacturing processes, labeling examples, and drug samples (if requested) to the Secretary of Agriculture. Five months later, the Senate passed S. 3073 unanimously, after a few minutes of half-hearted objections.

However, the old sticking point of the government's advertising purview remained, manifest in the Wheeler-Lea bill (S. 1077)—which was intended to expand the FTC's control over food, drug, and cosmetic advertising. After heated debate, the House had passed the measure in January of 1938, and the Senate had followed 2 months later. The bill was signed into law on March 21. The FDA was "apoplectic," given that the act not only stripped the agency of any marketing control over drugs but required proof of fraudulent intent after the fact (like the 1912 Sherley amendment).*

By the spring of 1938, Lea, after increasing pressure, finally brought S. 5 no. 2 out of House committee, but not before he had slipped in a section that allowed for numerous appeal reviews for alleged violators in any one of the 85 federal district courts. Lea's rationale was to provide a check on the Secretary of Agriculture's regulatory power, but reformists were having none of it. Consumer and national women's organizations were outraged and bombarded the President with pleas to intervene. FDR did so, although somewhat cryptically. Publicly he gave no indication that he would sign the Copeland-Chapman bill if Lea's appeal section was included; privately he informed the House committee of a forthcoming veto.

So in June, a legislative compromise was hammered out in conference: industry's appeals would be restricted by circumstance and court venue. And in a conciliatory mood, the conferees also accepted stronger language on the subjects of label disclosure, standard variations, and seizures. The conference report was quickly passed by the Senate and House, and FDR signed the new Food, Drug and Cosmetic Act on June 25, 1938—12 days after Massengill pleaded not guilty to federal charges of mislabeling and misbranding Elixir Sulfanilamide and 8 days after an exhausted Royal Copeland collapsed on the Senate floor and died later that evening. He was 69.

The Act that Copeland championed would become effective 1 year later.

* Regulation of prescription-drug advertising was finally transferred to the FDA after passage of the Kefauver-Harris Drug Amendments in 1962.

Chief source: Jackson Co. Food and Drug Legislation in the New Deal. Princeton, NJ: Princeton University Press; 1970.

In relentless pursuit of food and drug law reform, Copeland introduced a second version of S. 5 (S. 5 no. 2 or S. 5-1937) into the Senate in December 1936. A companion bill in the House, HR 300, was launched concurrently by Virgil Chapman. Important differences between the 2 bills rested in clauses defining seizure rules, drug-strength variations, and penalties for false advertising; but the main point of contention remained the FDA's proposed control over drug marketing. Industry—which was now becoming anxious for a federal law that would override the increasing tangle of state drug laws*—was evidently split on the point of advertising purview by the FDA and the FTC.

With the input of the FDA and the influence of the all-important women's groups (who had the backing of Eleanor Roosevelt), S. 5 no. 2 was strengthened in committee on the points of misbranding and seizures. The bill was passed by the upper chamber on March 9, 1937, and forwarded to the House, where the FTC had historically exerted its influence to retain advertising control.

The power struggle between the FDA and the FTC was further complicated by the simultaneous introduction of the Wheeler-Lea bill, which was drafted to expand the FTC's authority. The measure (S. 1077), spearheaded by Senator Burton Wheeler (D-MT) and Representative Clarence Lea (D-CA), was sent to the House after Senate passage on March 29, 1937. The timing meant that both the Copeland-Chapman bill and the Wheeler-Lea bill would be debated in House committee at the same time—in this case, mid-May of 1937. Political maneuvering between the Chapman and Lea camps would keep both measures in House limbo when Massengill's Elixir Sulfanilamide hit the market during the fall of 1937.

* From January 1935 to October 1936, 92 drug-related laws had passed in 39 states.

Chief source: Jackson Co. Food and Drug Legislation in the New Deal. Princeton, NJ: Princeton University Press; 1970.

In the summer of 1935, the House conducted hearings on Copeland's latest food and drug bill, S. 5. Chairing the hearings was Representative Virgil Chapman (D-KY), a lawyer and newcomer to food and drug reform. Chapman, however, was quick on the uptake. He rapidly grasped the thorny issues that impeded the passage of effective reform—particularly the conflict between the FTC and the FDA for advertising control. S. 5's best chance for passage, he concluded at the end of the hearings, lay in a quiet education campaign, until sufficient House support was confirmed.

In the meantime, Chapman held the bill in committee, where efforts were made to strengthen the drug variation and seizure clauses. But the chief question remained: Who would control drug advertising, the FTC or the FDA? The President offered little in the way of decisive input, and after 9 months, Campbell's agency ultimately lost its fight for purview over advertising.

On May 22, 1936, the House version of S. 5 was finally reported out of committee, with a minority dissent (led by Virgil Chapman) on the advertising section. In mid-June, this version of the bill was passed in the House, after which time Senate and House conferees met to hammer out a compromise on the amendments—and specifically, on the issue of advertising oversight. After considerable wrangling, the final bill stipulated that all health-related advertising would be regulated by the FDA; the FTC would oversee the marketing of food and cosmetics.

Although the Senate accepted the compromise, fierce opposition to the advertising agreement was led in the House by lawyers B. Carroll Reece (R-TN) and Samuel D. McReynolds (D-TN). Both men represented districts in East Tennessee, the home of influential FTC member Ewin L. Davis. Reece's district was also the headquarters of the S. E. Massengill Company, in Bristol.* Their arguments, which drew on FTC loyalty and fears of Tugwell, were persuasive; in the summer of 1936, the House killed S. 5 in an overwhelming vote.

* In November 1937, Massengill would deny any attempted influence on Reece regarding passage of a food and drug law: "I have never, directly or indirectly, opposed any proposed Food and Drug law. I never spoke to Hon. Carroll Reece, my congressman, about the one now pending, nor, to my knowledge, did any of my friends do so."

Chief source: Jackson Co. Food and Drug Legislation in the New Deal. Princeton, NJ: Princeton University Press; 1970.

Photograph of Virgil Chapman from the Biographical Directory of the US Congress.

Shortly after S. 2800 died in committee, Senator Copeland (newly reelected, no thanks to FDR) began drafting yet another food and drug bill, this time without the input of Tugwell or the FDA. In January 1935, Copeland introduced his new reform measure, S. 5, into the Senate. Concessions made to industry in this bill were even heavier than those in Copeland's previous drafts.

Requirements for drug labeling were considerably more lenient; formulas merely had to be filed with the Secretary of Agriculture, which would avert label disclosure. The list of diseases prohibited from advertising was shortened, and FDA seizures for misbranding were limited to 3 actions on a single product. Products that varied from the recognized Pharmacopeia standard were also permissible.

Once again, FDA leadership recognized Copeland's new draft as a general improvement on the 1906 law and a realistic compromise. S. 5, like its predecessors, also had the reluctant support of the all-important women's organizations and professional pharmaceutical groups. However, the AMA found the bill too weak. The more militant consumer groups were also unhappy with S. 5, as were proprietary drug manufacturers—whose Congressional lobbyists would become instrumental in the new bill's fate.

Public hearings in March of 1935 portended the early passage of S. 5, and the bill was reported out of committee on the 22nd, despite opposition efforts from Senators Josiah Bailey (D-NC) and Joel Bennett Clark (D-MO). The 2 senators' obstructive efforts were probably informed by their respective state's interests. North Carolina was the home of the Vick Chemical Company, maker of VapoRub; the Lambert Pharmaceutical Company, of Listerine fame, was located in Missouri.

On April 1, S. 5 came up for Senate debate, and Copeland expected a speedy vote. However, Bailey and Clark had other ideas. In an attempt to gain opposition support, the 2 senators extended the debate for 8 days, arguing for 1) modified definitions of "misbranding" and "adulteration" that would significantly undermine the FDA's right to seize products and 2) the FTC's continued control over advertising. The former argument was carried in a bill amendment that, to Copeland's frustration, was passed by the Senate on April 8.

The 2 sides now viewed this juncture of S. 5's journey through the Senate as a legislative flash point. To avoid further compromise on the bill, Copeland was ready to call for a vote; Bailey and Clark wanted to return the bill to committee to attack the advertising issue. To the relief of reformists, the tension was defused by procedural maneuvering on an unrelated bill, and S. 5 was placed in limbo back on the senatorial calendar—but at least it was safely out of the hands of a dickering committee.

A compromise on the Bailey amendment—instigated by FDR with Tugwell's influence—would be reached between Copeland and the opposition the following month. Multiple seizures of a product by the FDA would by allowed if there was "probable cause" that the product was "imminently dangerous." But the FDA and women's groups remained disheartened by the compromise, because the existing 1906 law stipulated no such restrictions. Nevertheless, these proponents of reform continued to support the passage of S. 5, while hoping to strengthen the seizure language before the bill became law.

On May 28, 1935, Copeland's S. 5 was brought to a vote and passed by the Senate. The bill was now at the mercy of the House.

Chief source: Jackson CO. Food and Drug Legislation in the New Deal. Princeton, NJ: Princeton University Press; 1970.

Photograph of Royal S. Copeland from the Biographical Directory of the US Congress.

Toward the end of 1933, Senator Royal Copeland realized that, if a new food and drug bill had any chance of passage, revisions would have to be made in response to the powerful opposition from trade groups. In February of 1934, Copeland introduced his second rewrite of S. 1944 (the notorious "Tugwell bill"), now called S. 2800, into the Senate.

This "sane, sensible, workable bill," as Copeland described it, provided 4 major concessions to industry, 3 of which directly affected drug manufacturers. First, full disclosure of ingredients would no longer be required on proprietary drug labels; instead, the manufacturer need list only specified components of his product. Second, publishers of false advertising would not be held legally liable; however, they would be required to identify those who produced the false copy to the Department of Agriculture. And in response to concerns that previous bills gave unrestricted regulatory power to the government, the revised bill also allowed for the creation of advisory boards to appeal alleged violations.

But as is the case with most compromises, no one was particularly happy with S. 2800. Trade groups, while appeased, to some extent, on the issue of advertising, predicted continued economic gloom with so much regulation of their business in the midst of the Great Depression. Tugwell himself, despite the fact that the revised bill still carried his name, was also unhappy with the concessions—to the point of publicly calling the bill "very disappointing" and losing interest altogether in its passage. This opinion was echoed by proponents of the original Tugwell bill, consumer lobbyists, who described the new measure as "emasculated" and a godsend to quacks.

The FDA's leadership, while harboring reservations about concessions in S. 2800, was still in favor of its passage. Chief Campbell was sufficiently pragmatic to understand that potentially unpleasant compromises would have to be made if food and drug reform were ever to become reality. The sentiment was generally shared by the AMA, which urged its members to support the bill's passage by contacting their congressmen. Influential women's groups also backed S. 2800, while continuing to lobby for the restoration of original components of the Tugwell bill.

Unfortunately Tugwell's sour opinion of S. 2800 would inform the President's apathy for its passage. And without FDR's leadership to champion the bill through Congress, S. 2800 died a death of indifference at the end of the 1934 Congressional session. FDR's coolness toward S. 2800 was likely political, given the ongoing friction between Senator Copeland and the Administration's New Dealers. And the President's ambivalence toward the bill probably had something to do with the FTC's struggle with the FDA over the control of advertising. In the President, the FTC found a sympathetic ear to its concerns for retaining its purview over advertising. In the coming years, contention between the 2 government groups over advertising control would become a major obstacle to legislative reform.

Chief source: Jackson CO. Food and Drug Legislation in the New Deal. Princeton, NJ: Princeton University Press; 1970.

Photograph of Royal S. Copeland from the Biographical Directory of the US Congress.

By 1933, serious shortcomings in the US Pure Food and Drug Act of 1906 (the so-called Wiley statute) were evident. First, the old law did not provide for the government regulation of cosmetics (relevant language was dropped from the proposed law in 1900). Second, the law did not adequately cover the regulation of patent medicines. Specifically the definition of dangerous drugs was outdated, given the pharmaceutical innovations of the early 20th century, such as the introduction of barbiturates. Third, language concerning the definition of food adulteration was vague and ambiguous; and fourth, the law provided no control over false advertising.**

Amendments to the 1906 act, such as the 1912 Sherley Amendment, attempted to rectify some of these shortcomings. Congress specifically enacted the amendment to supersede the 1911 Supreme Court decision in US v Johnson, which determined that drug "misbranding" only applied to statements regarding the product's identity and related properties (eg, its strength, purity, etc) and not to statements regarding the product's proposed curative powers (even claims as outrageous as curing cancer). The Sherley Amendment characterized the misbranding of drugs as statements that were both false and fraudulent. However, the wording of the law was unfortunate. The amendment required that the government prove fraudulent intent on the part of the manufacturer—a nearly impossible standard.

Public outcry, from both disinterested parties and dubiously motivated commercial sources*** (as well as muckraking journalists), against the inadequate oversight of food, drugs, and cosmetics led, in 1933, to Congressional hearings and an internal investigation of the Food and Drug Administration. And the FDA, headed by Kentucky lawyer Walter G. Campbell, was only too happy to concede deficiencies in the 1906 law. Perhaps the most important outcome of these events was the spark of interest created in Senator Royal S. Copeland (D-NY), a physician and former New York City health commissioner, to reform the old statute.

In the Spring of 1933, Senator Copeland became the Congressional backer of the so-called Tugwell bill, a measure initially drafted by Rexford G. Tugwell, then Assistant Secretary of Agriculture, with considerable input from the FDA's Campbell. Senate Bill 1944, as it was labeled, would no longer place the burden of proving the manufacturer's fraudulent intent on the government, and misbranding would be defined as any therapeutic claim on the label that was "contrary to general medical opinion." Palliative claims would be distinguished from those that promised cure, and drug manufacturers would have to disclose the ingredients of their products. The charge of adulteration would be applied to any product that was dangerous to health, when used according to the manufacturers directions. Last, provisions relating to drugs would also encompass medical devices.

Support for S. 1944 was mixed. Not surprisingly, most of the drug industry wanted the bill defeated and argued that the measure gave far too much discretionary power to the government. The response from the American Medical Association was curiously lukewarm and the influential Consumers' Research (a frequent critic of the FDA) labeled the bill as too weak. Support for the Tugwell bill was to be found, however, among women's groups—particularly the difficult-to-ignore League of Women Voters.

The FDA engaged in a concerted publicity campaign to promote S. 1944—through favorable press coverage, speaking engagements, the Department of Agricultures' "National Farm and Home Hour," posters, and the agency's notorious "Chamber of Horrors" exhibit. The exhibit was a popular, traveling display of the most worthless, fraudulent, and dangerous drug products on the US market, like Crazy Crystals, Koremlu (a thallium-containing depilatory cream), Marmola, and radioactive Radithor. However, these government-back efforts were ultimately stifled by charges that the FDA was violating the 1919 Deficiency Appropriation Act. The act prevented government agencies from lobbying their causes to Congress. Consequently organized opposition to S. 1944 gained steam, after the FDA's publicity campaign for reform was silenced. Toward the end of 1933, FDA Chief Campbell became convinced that Congressional compromise of the bill was inevitable.

* Not as boring as you think.

** And the Federal Trade Commission was hamstrung in its power to prosecute false advertising given the 1931 Supreme Court decision in the case of the FTC v Raladam Co.

*** Specifically chemist and crude-ergot peddler Howard Ambruster.

Chief source: Jackson, Charles O. Food and Drug Legislation in the New Deal. Princeton, NJ: Princeton University Press; 1970.

On October 3, 1938, Dr. Samuel E. Massengill, head of the S. E. Massengill Company of Bristol, Tennessee-Virginia, pleaded guilty in a federal court to 112 counts of adulteration or misbranding of Elixir Sulfanilamide [1]. The US District Attorney, James B. Frazier, recommended that the defendant be fined $150 for each count—a recommendation that the federal judge, George C. Taylor, accepted. Massengill was consequently fined a total of $16,800 (~$252,826 in 2009), the largest fine posed to date under the 1906 Pure Food and Drugs Act. No jail time was handed down.*

According to news reports, the doctor was required to pay one third of the fine immediately and the remainder within 30 days [2]. Judge Taylor also announced that Massengill would plead guilty to 62 counts of adulteration or misbranding that were pending in a Kansas City, Missouri, federal court [1]. The fine stemming from these charges would total $9300 [3].

The government had prepared for the testimony of "numerous world famous experts in physiology and toxicology" at the trial, but these witnesses were told not to appear, given Massengill's change in plea [1]. According to Massengill's General Counsel, Frank DeFriece, Massengill initially offered $100 per shipment, or $9000, in plea negotiations with the government [4]. DeFriece rationalized any plea bargaining and the avoidance of further litigation on the basis of "the welfare and best interests of the company."

Invoking the government's slim chances of conviction, additional negative publicity for the company, and the expense of continued litigation, DeFriece further defended his boss's decision—that is, as long as the government's fine wasn't too hefty.

Massengill and his advisors feel that in view of the very narrow grounds upon which the government has based its case its chances of conviction, or even of sustaining its indictment, are very slim, and about all that the government would get out of it would be the satisfaction of further advertising the calamity of Elixir Sulfanilamide to the nation. Even in this event it would be expensive litigation. And if the government obtains a compromise judgement and fixes a reasonable fine, it certainly wins its point, and the amount of the fine ought not to be a matter of so great importance. It is felt that, in view of the immense amount of money which has been expended in the adjustment of claims both valid and invalid which have been made against the Massengill Company on account of Elixir Sulfanilamide, the payment of any large fine would seriously cripple the future business of the Company, and unless it is the purpose of the government to make an effort to wipe out the Company entirely, it is impossible to find the reason for the infliction of so great a sum as a penalty.

Following the plea, Time magazine reported that the S. E. Massengill Company had expended more than $150,000 in the settlement of damage suits brought by survivors of elixir victims [5]. (By mid-1938, the company maintained that all claims, except for two, had been negotiated out of court and that only 2 civil suits had been filed. One of these had been settled [4].) 

Also according to company accounts, Frank DeFriece, Massengill's General Counsel and son-in-law, personally visited the close relatives of elixir victims and, often, their physicians in an effort to negotiate out-of-court settlements. During these extended road trips, DeFriece frequently avoided claimant's lawyers and county officials who had issued arrest warrants for Massengill and his top executives. DeFriece claimed to have made friends with most of the bereaved and relayed a story (as told by his son) of the welcome he received in the "deep South" from the brother, a gas station attendant, of one of the elixir victims [6].

A young man came out to serve them and, immediately upon seeing his customer, said something like, "By golly, it's you, Mr. DeFriece. I'm glad to see you." After introducing his wife, Frank DeFriece asked about the man's wife (by name!) and his children. In answering, the man gave some details on them and several other relatives and invited both of them to "come over for supper tonight—nothing special, you know. My wife will be glad to have you and meet the missus."

DeFriece reportedly declined the invitation.

* It's not clear that jail time was or could be considered in this case.

1. Bristol man submits to charge violating Pure Drug Law. Greeneville Sun. October 3, 1938; p 1, cols 6-8; p 6, cols 5,6.

2. Associated Press. Massengill fined total of $16,800. Bristol Herald Courier. October 4, 1938; p 9, col 6.

3. FDA correspondence. Letter from Theodore G. Klumpp to Mr. H. H. Smith. November 29, 1938.

4. Pully P. Masengill Brother Company and the S. E. Massengill Company, 1807-1971. Knoxville, Tenn.: Tennessee Valley Publishers; 1996. Appendix 7.

5. Massengill pays. Time. October 17, 1938.

6. Pully P. Masengill Brother Company and the S. E. Massengill Company, 1807-1971. Knoxville, Tenn.: Tennessee Valley Publishers; 1996. Appendix 5.

On September 7, 1938, attorneys for Samuel E. Massengill filed a demurrer, or formal objection, to each of the 166 charges of adulteration or misbranding of Elixir Sulfanilamide, which were filed in the Greeneville, Tennessee, federal court. The demurrer overtly capitalized on the inadequacies of the Pure Food and Drugs Act of 1906.

With respect to charges of adulteration, the government contended that the "purity" of Elixir Sulfanilamide "fell below the professed standard or quality under which it was sold." Specifically the product's name indicated that the antibiotic was dissolved in a nonpoisonous solvent, which was, in reality, poisonous. Massengill responded that the charges did not violate the Pure Food and Drugs Act, because "adulteration...is not anywhere so defined under said Act, nor by any interpretation thereof..." The doctor was evidently drawing on the Act's nonspecific definition of drug adulteration, which was described as differing "from the standard of strength, quality, or purity as determined by the test laid down in the United States Pharmacopoeia or National Formulary official at the time of investigation."

On the counts of misbranding, specifically with respect to the use of the name "Elixir Sulfanilamide," the government charged that Massengill had used the term "elixir" in a misleading fashion by failing to dissolve sulfanilamide in a nonpoisonous solvent. The doctor, however, rebutted that the Pure Food and Drugs Act did not specify such a definition for misbranding—an argument that could be floated with some merit. The Act defined a misbranded drug as one that was "an imitation of or offered for sale under the name of another article," or if the contents of an original package were replaced by other contents. The government, however, could cling to legislative wording that also defined misbranding as failing to label a product with "the quantity or proportion of any alcohol, cocaine, heroin, alpha or beta eucaine, chloroform, cannabis indica, chloral hydrate, or acetanilide, or any derivative or preparation of any such substances contained therein." Diethylene glycol could be loosely construed as an alcohol derivative (although this rebuttal was contrary to the basis for the FDA's seizure of Elixir Sulfanilamide).

Last, Massengill countered the government's charges of misbranding on the basis of the sticker pasted to the elixir bottle's stopper, which read "Quality Pharmaceuticals." Massengill argued that the words have "no reference to the contents of the bottle to which it was attached," and added, "It referred solely and alone to the S. E. Massengill Company as pharmacists, and is a sort of slogan."

The federal judge, George Caldwell Taylor, evidently agreed with Massengill's third argument and, on September 30, dismissed all of the government's charges, 54 in total, relating to the doctor's use of the "Quality Pharmaceuticals" sticker. The decision left 112 counts of adulteration or misbranding, concerning 56 interstate shipments of Elixir Sulfanilamide, for Massengill to defend at trial.

Massengill's partial victory in federal court was dampened by civil action brought in a Fresno, California, superior court on September 19. A $25,000 damages complaint was filed by Mr. and Mrs. Orvin C. Kutz, parents of the deceased 5-year-old Orvin Kutz, Jr., against Samuel E. Massengill, the manager of Massengill's San Francisco branch, the Fresno druggist who sold the elixir, and 2 drug wholesalers. Counsel for the Kutz parents included California Congressman Bertrand W. Gearhart.

Sources:

United States v Massengill (ED TN 1938).

Death elixir is basis for big damage action. Fresno Bee. September 20, 1938; p 1, col 8.

In late October 1937, gossip columnist Louella Parsons revealed that both Warner Brothers and film executive B. P. Schulberg were in preproduction stages for 2 separate films that would dramatize the "shocking elixir deaths" [1].

Warner Brothers had bought the rights to the muckracking novel of investigative journalist Samuel Hopkins Adams, The Clarion. The book, published in 1914, was an expose of the fraudulent advertising of patent medicines. Screenwriters would incorporate the recent elixir-related deaths into the film, Parsons reported, which was to star Dick Foran (The Petrified Forest) and newcomer Ann Sheridan as the "romantic leads." The working title for Schulberg's production was Permit to Kill, with Edward Arnold (Diamond Jim) in a starring role.

Although the New York Times reported later that the Warner Brothers film title was changed to One Hundred Million Suckers, with a screenplay by Larry Kimble and Ring Lardner, Jr., neither film appears to have made it to production [2].

The elixir-related deaths were conveyed in nonprint media through NBC's radio broadcast of The National Farm and Home Hour, which was produced by the US Department of Agriculture, and William Randolph Hearst's "News of the Day"* newsreel, which was shown contemporaneously in movie theaters [3,4]. While attending the cinema in Flushing, New York, a pleasantly surprised FDA chemist praised the well-conceived "dramatic presentation" and the "clear and distinct voice" of FDA chief Walter G. Campbell in a letter to the FDA's New York station. The chemist described the production's scenes from memory:

I. S. E. Massengill's plant.

II. Dr. Calhoun [of Mt. Olive, Mississippi] (?) one of the physicians that had prescribed the Elixir, and a nurse who had taken some of the Elixir but was still alive.

III. The laboratory of the American Medical Association at Chicago, showing a chemist working on a distillation apparatus and then holding in a graduate some of the distillate which was described as being the deadly ingredient.

IV. The same A.M.A. laboratory protraying[sic] a chemist using a Spectrographic apparatus.

V. Mr. Campbell's office door.

VI. Scene showing Mr. Campbell picking up a phone, and instructing all agents to immediately stop all other work and to concentrate on location the Elixir, to be seized wherever found. In this scene Mr. Campbell did the talking rather than the commentator.

* Released by Metro-Goldwyn-Mayer.

1. Parsons L. Ford will direct Haycox in new film for Sam Goldwyn. Modesto Bee and News-Herald. October 31, 1937.

2. Screen news here and in Hollywood. New York Times. March 18, 1938; p 23.

3. FDA correspondence. Letter from W. G. Campbell to Chief, Central District. January 31, 1938.

4. FDA correspondence. Letter from D. M. Walsh to Chief, New York Station. October 29, 1937.

Public domain screenshot of Ann Sheridan from Wikipedia.

Several weeks after Samuel E. Massengill pleaded not guilty to federal charges of adulteration and misbranding in the case of Elixir Sulfanilamide, the FDA received word of the company's possible defense [1]. A "confidential informant," who had obtained information from a pharmaceutical chemist and "close friend" of Dr. Massengill, told FDA Assistant Chief Paul B. Dunbar that the firm had acquired at least 660 affidavits from elixir customers who attested to their "entire satisfaction" with the product.

According to Dunbar's source, Massengill would contend that those who suffered elixir-related deaths used the medication "recklessly and in excess of the dosage recommended." When given under competent medical supervision in the advised amounts, the company would argue, the product caused no harm.

In addition, Massengill would attempt to show that sulfanilamide alone could have caused the deaths. A 15% mortality rate with the antibiotic, as quoted by the company, would compare favorably with the firm's calculated elixir-related death rate. The latter statistic would be acquired by dividing the estimated number of reported deaths, approximately 100, by the total number of cases of use per the company (660 + 100, or 760) for a death rate of 13%.

Dunbar also learned that Massengill was worth about $11 million (>$165 million in 2009) and had expended about 5% of his net worth (>$7 million) on the tragedy. Although Massengill regretted the deaths, he believed himself to be "blameless," the chemist reported. Moreover, Massengill and others in the Bristol area considered the doctor to be a public benefactor. Last, while admitting to be a friend of Massengill, the chemist had no respect for the elixir's creator, Harold Cole Watkins, who was described as "unreliable."

1. FDA correspondence. Letter from P. B. Dunbar to Drug Division. July 23, 1938.

At a closed federal hearing on January 12, 1938, in Cincinnati, attorneys for the S. E. Massengill Company denied that the firm's Elixir Sulfanilamide was adulterated or misbranded. Massengill's counsel Ruby D. Garrett of Kansas City and Robert Burrow of Bristol presented a written denial—which was forwarded to Washington, where a "prompt decision" was expected with respect to prosecution [1]. The federal hearing had been postponed twice to permit the company "to gather all the facts" before their presentation [2].

On February 17, the FDA's records concerning the interstate shipments of Elixir Sulfanilamide were forwarded to the Justice Department, along with recommendations for an expedited prosection [3,4]. FDA chief Walter G. Campbell wrote the following letter to then-Solicitor Mastin G. White, explaining the rationale for the charges against Samuel E. Massengill and his chief chemist, Harold Cole Watkins.

...The business of the firm is largely interstate so that Watkins had a responsibility in manufacturing the article to see that it complied with the Food and Drugs Act. The use of the article in various parts of the country resulted in the death of numerous patients because of the presence of a poisonous ingredient, diethylene glycol, used as a vehicle or solvent for the sulfanilamid[sic]. On the shipments from Kansas City, Samuel E. Massengill should be named as sole defendant. Although 5 of the 30 samples shipped from Kansas City bore code numbers of two batches made at Bristol, the remaining 25 samples were taken from Kansas City shipments representing a batch made at Kansas City with which Harold C. Watkins had no connection in the actual manufacture. It is accordingly felt that Watkins should not be included as a defendant on the Kansas City shipments.

[...]

The charges on which citation was issued are as follows:

Adulterated: Its purity falls below the professed standard or quality under which it was sold, namely, "Elixir Sulfanilamide", since the article is not an elixir of sulfanilamid but is a solution in a mixture of diethylene glycol and water.

Misbranded: (1) The statement on the label, "Elixir Sulfanilamide", is false and misleading as applied to an article containing sulfanilamid dissolved in diluted diethylene glycol.

(2) The statement on a sticker attached to the stopper of the bottle "Quality Pharmaceuticals" is false and misleading as applied to an article consisting of a solution of sulfanilamid in diluted diethylene glycol and labeled "Elixir Sulfanilamide."

To both the physician and pharmacist the term "elixir" when associated with the name of a drug means that the drug is dissolved in a palatable, aromatic, harmless solvent.

We will be in a position to adduce medical and pharmaceutical testimony to the effect that the term "Elixir Sulfanilamide" means a solution of the sulfanilamid, having the medicinal properties of sulfanilamid alone. We will be able to adduce clinical testimony that the principal effect of this product, "Elixir Sulfanilamide", when administered to patients, was due to the highly toxic ingredient, diethylene glycol; as a matter of fact, the use of this preparation resulted in nearly 100 deaths during the period in which the product was on the market. In other words, this article fell below the professed standard under which it was sold, that is, "Elixir Sulfanilamide", a solution having the therapeutic action of the drug sulfanilamide, in that its principal action was that of an acute poison.

The misbranding charges are practically restatements of the adulteration charge, and are based on the same considerations. We believe it highly important in presenting this case that the testimony of doctors whose patients actually died be introduced as conclusive evidence of the poisonous properties of the article. It is assumed that the allegations to be drawn on the basis of the charges of adulteration and misbranding mentioned will permit the introduction of evidence that the diethylene glycol present is a toxic ingredient and an acute poison. We suggest that the counts in the information be so framed as to permit the introduction of such evidence.

The large number of shipments involved in this case entailed numerous investigations to establish interstate shipment and identity of samples. Inevitable delays occurred, therefore, before citation[s] could be issued. Citation notices issued on December 8, 1937, setting December 20, 1937, as the date for the hearing. A postponement of the hearing was then requested by the defendant and granted by the Administration. Hearing was actually held on January 12, 1938, and since that time we have been actively engaged in preparing the case for transmission to you.

It is highly important that the further preparation of the case be expedited, first, because of the extensive public interest in this matter and, second, because of the gravity of the offense. In transmitting these records we wish to urge the importance of an early preparation of the information. The Food and Drug Administration is ready to cooperate with you to the fullest extent in expediting these cases.

Of note, the distributed elixir shipments from San Francisco (which resulted in one death, that of 5-year-old Orvin C. Kutz, Jr., of Fresno, California) and those from New York City were considered a continuation of the violations originating from the company's Bristol headquarters. Therefore, the FDA did not advise prosections against Massengill in these jurisdictions [5,6].

The compilation of witnesses for the prosecution would be assigned to Cincinnati-based FDA Inspector William T. Ford and the task of locating them to Inspector W. B. Simmons [7]. "Wherever possible," Campbell advised, "physicians who administered the Elixir and lost patients as a result will be used; first, as dealer witnesses; second, to testify to the medical concept of the term 'Elixir Sulfanilamide'; and third, as to the toxic character of the product." Campbell believed that most of these doctors would voluntarily testify on the basis of their duty as public servants. Those unwilling would be subpoenaed.

At least one former employee of the S. E. Massengill Company came forward to the FDA as a witness against the firm [8]. C. (possibly Clarence) Falstrom had worked from 1925 to 1933 in Massengill's Kansas City "laboratory," a word he placed in quotes in a letter to the FDA. Falstrom claimed that he "saw many abuses which were in violation of the laws." "They don't even have a registered pharmacist in Kansas City!" he declared and predicted, "You will see the day again when they violate the law." Falstrom went on to describe how the company prepared for on-site inspections:

When an inspector would call for samples they would have some all "fixed" for him so they passed OK. On one particular case they were told to discontinue selling a certain batch of Fl. Ext. Ergot. USP. This stock was hidden away for a time. When the inspector called for a sample of Ergot later they told him they were temporarily out of stock but this particular batch of Ergot was sold just the same. I would like to appear as a witness against them but I am afraid it would actually hurt me on future jobs.

Although intrigued by Falstrom's letter, Campbell believed that the former employee's testimony would not be particularly useful in the Elixir Sulfanilamide litigation, given that Falstrom had been terminated from the company at least 4 years before the incident. 

On March 11, The Kingsport Times reported that Massengill was preparing to contest a suit for more than $120,000 in a Greeneville, Tennessee, federal court regarding the death of Oklahoman Earl Lee Beard. Beard, 25, died 5 months earlier after consuming an unknown amount of an 8-ounce prescription for Elixir Sulfanilamide. The suit was brought by the victim's divorced mother, Mrs. Norris Beard [9].

On June 6 in Kansas City, a federal complaint by US District Attorney Maurice M. Milligan alleged that Massengill had violated the Pure Food and Drugs Act on 93 counts [10]. Five days later, US District Attorney James B. Frazier, Jr, confirmed to news sources that the government had instituted criminal charges against Massengill in the US Federal Court in Eastern District of Tennessee (Greenville). This complaint alleged violation of the Pure Food and Drugs Act on 166 counts, each relating to an interstate shipment of "mislabeled" and "misbranded" Elixir Sulfanilamide.* Frazier explained that the complaint, in this case, was equivalent to an indictment and had recommended that Massengill be placed under arrest, with a $25,000 bond.

Massengill's General Counsel and son-in-law, Frank DeFriece, stated that if the government prevailed in its cases against his boss, the doctor could be fined a total of $261,000 and sentenced to 261 years in prison [11]. "This ridiculous situation," DeFriece explained, "is made possible in a simple misdemeanor offense because [the] alleged offense is the second one."** DeFriece went on to predict the fallout from the federal prosecution, which he likened to "simple persecution."

So far as Massengill is personally concerned perhaps the Department [of Agriculture] figures he hasn't suffered enough, but there is another angle. Continuous gouging at the business will, of course, eventually kill it. When that is done it may be that Massengill's financial ruin would be pleasing to some, but to do it destroys the source of living for 350 families all over this country, and also destroys a substantial business in Tennessee-Virginia, of which the entire South may be justly proud. Is such animus fair to these people, who had absolutely nothing to do with it, and who are paying for houses and subsistence, all of which may be suddently wiped out!

On June 13, Dr. Massengill pleaded not guilty after being arraigned and posting bond in Bristol for his appearance at the September 19 term of the federal court in Greeneville [12].

Twelve days later, FDR signed into law the newly passed Food, Drug, and Cosmetic Act—legislation that was largely forged through a historically gridlocked Congress at the urging of an enraged public. The law specifically required manufacturers, like Massengill, to demonstrate the safety of any new drug to the FDA before its sale.

* Specifically the charge stated that the drug was sold as being suitable for human consumption when it was not.

** The first being related to Massengill's sale of understrength Tincture of Aconite.

1. Associated Press. Denial is issued on adulteration. Kingsport Times. January 12, 1938; p 1, col 6.

2. Associated Press. Deny adulteration of fatal Elixir of Sulfanilamide. Times Recorder (Ohio). January 13, 1938; p 1, col 8.

3. FDA correspondence. Letter from P. B. Dunbar to J. O. Clarke. February 24, 1938.

4. FDA correspondence. Letter from W. G. Campbell to Solicitor. February 17, 1938.

5. FDA correspondence. P. B. Dunbar to Chief, Eastern District. February 11, 1938.

6. FDA correspondence. W. G. Campbell to Chief, Western District. February 19, 1938.

7. FDA correspondence. W. G. Campbell to Chief, Central District. February 4, 1938.

8. FDA correspondence. W. G. Campbell to Chief, Central District. January 31, 1938. 

9. Massengill will face damage suit. Kingsport Times. March 11, 1938; p 3, col 2.

10. International News Service. US accuses maker of sulfanilamide. El Paso Herald-Post. June 3, 1938; p 1, col 4. According to Massengill's General Counsel, Frank DeFriece, a capias was issued for Massengill in Kansas City on information charging 95 shipments, with 3 counts per shipment. DeFriece also claimed that, because Massengill was a resident of Tennessee, the Kansas City court could not serve process on the defendant. See Pully P. Masengill Brothers Company and the S. E. Massengill Company, 1807-1971. Knoxville, Tenn.: Tennessee Valley Publishers; 1996: Appendix 7.

11. Pully P. Masengill Brothers Company and the S. E. Massengill Company, 1807-1971. Knoxville, Tenn.: Tennessee Valley Publishers; 1996: Appendix 7.

12. Massengill enters plea of not guilty. Greeneville Sun. June 14, 1938; p 1, col 5.

In December 1937, while continuing to "deny all liability and responsibility for deaths of persons whose relatives claim they took the sulfanilamide compound," the S. E. Massengill company distributed a lengthy question-and-answer statement to their "friends and customers" regarding Elixir Sulfanilamide. The statement, the firm claimed, was intended "to correct the false statements that have been circulated" about the product, with the following qualification: "For legal reasons, we cannot at this time give some information that we would like to give" [1].

Among the 29 questions posed and answered by the company were several concerning the inclusion of diethylene glycol in Elixir Sulfanilamide. Massengill defended the use of the substance on the basis of its solvency and, perhaps unbelievably, its relative lack of toxicity when compared with the common anti-freeze ingredient, ethylene glycol. While attempting to dissociate diethylene glycol from ethylene glycol, the company indicated, nevertheless, that the former substance, if ever used as an anti-freeze, "should not reflect unfavorably upon it"; both alcohol and glycerin had been used for the same purpose. Moreover, ethylene glycol was a solvent in hypodermic injections that had been approved by the AMA, the firm argued.*

Massengill then endorsed its control department, claiming, "[W]e have six graduate pharmaceutical chemists in our employ who spend their entire time in the control and testing of our products before they are placed on sale," and denied that Elixir Sulfanilamide was rushed into the marketplace. When the company asked itself, "Why did your tests not show any bad results?" it replied, "At this time we cannot say, but undoubtedly we will have the answer when it can be shown why many using the identical lots sold had most excellent results." Massengill proceeded to indicate that the reason for elixir-related fatalities may never be known:

Is your company making an effort to ascertain what did happen to cause the ill effects?
Yes, our own chemists are continually working on the problem, and we also have independent sources doing similar work. After working on the problem for several weeks, one body of scientists makes the statement: "It is probable that no chemist or pharmacologist will ever be able to determine exactly what happened," and added, "Theory and guess work on the part of all who are working on this problem is all that has developed at the present time." The latest report of another one of our connections is as follows: "We are making an effort to determine the exact cause of the present trouble, and shall keep you advised of the progress of the work as soon as it has advanced to the stage where any reasonable interpretation of the results obtained can be made."

Last, the company floated the idea that deaths due to the consumption of its Elixir Sulfanilamide were actually the result of adverse drug-drug interactions. The only known drug that could be safely taken with the antibiotic was sodium bicarbonate, Massengill claimed, and a number of drugs—saline cathartics, sulfates, analgesic coal-tar derivatives, and many laxatives—were either probably or definitely contraindicated with sulfanilamide.

* The company cited the 1935 edition of the AMA's New and Nonofficial Remedies, page 132, and the 1937 edition, page 116.

1. Pully P. Masengill Brother Company and the S. E. Massengill Company, 1897-1971. Knoxville, Tenn.: Tennessee Valley Publishers; 1996; Appendix 6.

By mid-December 1937, the S. E. Massengill Company had made out-of-court settlements in "about a dozen" cases of elixir-related deaths. Massengill's Kansas City attorney, Ruby D. Garrett, reported that the company intended to dispose of all claims that it regarded as justified before they could make it to court. He added that the company, which was solely owned by Dr. Massengill, had no insurance to cover death claims resulting from the use of its products. The firm's assets consisted solely of its drugs, some real estate, and its income-raising sales force, the attorney stated [1].

Garrett stressed that settlements would continue "purely on a basis of good faith," but that "we will continue to deny all liability and responsibility for deaths of persons whose relatives claim they took the sulfanilamide compound" [2]. However, he also stated that "a number" of claims were unjustified: some were presented by survivors whose relatives did not even consume Elixir Sulfanilamide; in other cases, the decedent would have died anyway, he proposed. Garrett provided an anecdotal example to the Tulsa Daily World:

Several doctors told me and my investigators that deaths had been attributed to sulfanilamide erroneously, due to the widespread publicity regarding the fatal cases...One woman took an elixir which she thought was sulfanilamide because she developed all the symptoms of sulfanilamide poisoning. Later it was found that she had taken a harmless cough medicine and she had recovered.

In no case, Garrett publicly declared, could Massengill's product be conclusively proved as the cause of death. Claimants would probably receive greater financial compensation by settling, he argued. Bad publicity from the elixir-related deaths would result in reduced income for the company, which would limit the firm's ability to pay off high-dollar court rulings.

The following elixir-related settlements were publicized in contemporary news reports:

Matilda Schroeder, widow of William M. Schroeder of St. Louis, received $2000 [3].

Thomas M. Hobson, father of 8-year-old Kathleen Hobson of Tulsa, received $1000 [4].

Mrs. Maise Nidiffer, mother of 6-year-old Joan Marlar of Tulsa, received $1250 [4].

The parents of 5-year-old George Nixon, of East St. Louis, received $1000 [1].

The parents of 4-year-old Maurice Slaughter, of East St. Louis, received $1000 [1].

The family of Alexander A. Brooks, 70, of East St. Louis, received $1000 [1].

Ellis Black, the husband of Gertrude L. Black, 38, of East St. Louis, received $1500 [1].

The family of Joseph L. Henry, 60, of East St. Louis, received $1500 [1].

In 2 unidentified cases in Mississippi, settlements were made for less than $300 each [5].

Addie Kyte, widow of 38-year-old William A. Kyte, of Knoxville, Tennessee, settled for an unknown amount [6].

Other claims against Massengill, which may or may not have been settled, are listed:

Mayme Welch Miller, wife of Charles W. Miller, 25, of Memphis, TN, asked for $50,000 in damages [7].

As a prelude to lawsuits, a Tulsa court appointed administrators in the cases of Millard O. Wakeford, father of 5-year-old Millard Wesley Wakeford ($6000 claim); George P. Sheehan, father of 6-year-old Michael S. Sheehan ($6000 claim); J. M. Sumner (of Leonard, OK), father of 2-year-old Robert "Bobby" Sumner ($6000 claim); and Mrs. Norris T. Beard (of Oklahoma City), mother of Earl L. Beard, 25 (undesignated amount) [8,9].

The wife of Willie Badger (25?) of Scotia, SC, was represented by a Hampton attorney, according to FDA letters [10,11].

The father of Edward (B. E.) Walker, Charles D. Walker of Enterprise, AL, was represented by a Montgomery attorney, according to FDA correspondence [12]. 

On December 15, 1937, simultaneous citations were issued in Kansas City, KS, Cincinnati, OH, and New York City for Massengill to appear before FDA officials on Monday, December 20, and show why the agency's information on the elixir-related deaths should not be turned over to the Justice Department. The citations covered 32, 52, and 4 instances of interstate shipments of Elixir Sulfanilamide in the respective cities [13].

N.B.: According to an online inflation calculator, $1000 in 1937 = $14,735.63.

1. FDA newspaper clippings. Five elixir death claims settled here. St. Louis Post-Dispatch. December 28, 1937.

2. FDA newspaper clippings. US agents push new drug inquiry. Tulsa Daily World. December 16, 1937.

3. FDA newspaper clippings. Drug firm paying on sulfanilamide elixir claims. St. Louis Post-Dispatch. December 10, 1937.

4. FDA newspaper clippings. Sulfanilamide maker pays. Kansas City Times. December 22, 1937.

5. FDA newspaper clippings. $2000 claim paid for elixir death of St. Louis man. Star-Times. December 10, 1937.

6. FDA correspondence. Letter from G. P. Larrick to Lindsay, Young & Atkins. March 4, 1938.

7. Associated Press. $50,000 is asked in 'elixir' death. Atlanta Constitution. November 13, 1937; p 9. Miller's widow filed suit against Massengill and the Memphis drug store that sold the elixir over the counter.

8. Two new moves in elixir suits. Tulsa Daily World. November 4, 1937.

9. Associated Press. Claims damages from medicine co. Ada Weekly News. November 2, 1937.

10. FDA correspondence. Letter from W. G. Campbell to Armstrong, Cranford, Barker and Bedford. December 14, 1937.

11. FDA correspondence. Letter from W. G. Campbell to George Warren. December 4, 1937.

12. FDA correspondence. Letter from P. B. Dunbar to Hill, Hill, Whiting & Rives. May 2, 1938.

13. FDA newspaper clippings. US agents push new drug inquiry. Tulsa Daily World. December 16, 1937.

Massengill's chief chemist and the creator of Elixir Sulfanilamide, Harold Cole Watkins, maintained (and perhaps informed) the defense of the product, a defense that was gaining at least local steam in November 1937. Writing to the publication Drug Trade News, Watkins claimed that his company had performed its own animal experiments after news of the first elixir-related deaths [1]. "We gave forty times the human dose of the elixir to pigs and they liked it," he wrote to the journal, "They had not, of course, been taking other medicines with it."

In addition to suggesting that the deaths were somehow due to adverse drug-drug combinations, Watkins floated the idea that some of the casualties were actually caused by sulfanilamide itself and not diethylene glycol. Patients may have overdosed on the elixir, or the product was taken in combination with epsom salts or other sulfates, he proposed. Watkins went on to conclude that "[t]he solvent itself [diethylene glycol] had nothing to do with the deaths," despite very recent experimental evidence (performed at the University of Chicago), which indicated the contrary.

Watkins also boasted that he had taken the elixir himself, without consequence, after the first public warning from the AMA: "On Monday [probably October 18] I started taking the elixir, one ounce a day, in two doses, and am still here and writing to you, though I have taken four ounces in four days. Federal men and our men saw me take it." (According to Theodore G. Klumpp, the FDA's chief medical officer, Watkins claimed that he had taken a large swig of diethylene glycol, when Klumpp and inspector Ford first arrived at the company's headquarters in Bristol, Tennessee. Klumpp wrote later that he doubted Watkins's claim [2].)

Stunningly enough, Watkins also cited the study by Haag and Ambrose, "Studies on the physiological effect of diethylene glycol," which was published earlier that year in the Journal of Pharmacology and Experimental Therapeutics [3]. Although the solvent was determined by the authors to be less deadly than ethylene glycol in rats, they nevertheless observed the lethality of the substance, when given intramuscularly, intravenously, or orally to experimental animals.

Watkins further attempted to bolster whatever specious argument he was weaving by noting that the AMA reported no apparent chemical reaction between diethylene glycol and sulfanilamide in its recent distillation experiments of the company's elixir. This finding was raised by the chemist, despite the fact that the AMA found pure diethylene glycol and Massengill's product to be equally deadly in animals, and that pure sulfanilamide in proportional doses was not.

Last, Watkins noted that the use of diethylene glycol—which was "manufactured exclusively by the Carbon and Carbide Chemicals corporation"—in consumer products was not without precedent. The substance had been advertised as preventing throat irritation in a "widely known brand of cigarettes."*

* The use of diethylene glycol as a humectant in cigarettes was promoted by a number of manufacturers, including Philip Morris, in the 1930s and later. For a discussion of cigarette-related health claims in marketing, see Garner MN, Brandt AM. The physician in US cigarette advertisements, 1930-1953. Am J Public Health. 2006;96:222-232. 

1. Details of deadliness of sulfanilamide revealed in comprehensive news story. The Amarillo Globe. November 17, 1937; p 7 cols 2-5.

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. Haag HB, Ambrose AM. Studies on the physiological effect of diethylene glycol. J Pharmacol Exp Ther. 1937;59:93-100.

The day after the Secretary of Agriculture, Henry A. Wallace, gave his report to the Senate on the Elixir Sulfanilamide deaths, Dr. Massengill claimed that the casualties attributed to his product were being exploited by the FDA in an effort to widen its powers [1,2]. On Saturday, November 27, both the Bristol Herald Courier and the Bristol News Bulletin printed Massengill's statement in full—a scattershot and head-spinning response that defended, among several things, the "elixir" label, the use of diethylene glycol, the "unpredictable effect" of his product, and his support of more stringent food and drug regulation.

I have never, directly or indirectly, opposed any proposed Food and Drug law. I never spoke to Hon. Carroll Reece, my congressman, about the one now pending, nor, to my knowledge, did any of my friends do so.[*] This proposed bill is not supposed to be aimed to any great extent at manufacturers of drugs for prescription use, but, chiefly, at the advertising of drugs sold to the public. It is to my personal interest that the laws governing the manufacture of drugs be made stringent. I has been evident from the first interview given out by the Food and Drug Administration that they hoped to use this deplorable occurrence to stampede Congress into giving them power they had, heretofore, refused.

The preparation we marketed was just as properly labeled "elixir" as many others of this class on the market and to which no objection has, heretofore, been made. There is no requirement that an "elixir" contain alcohol. The current National Formulary, a government standard, and one of the authorities under which we work, contains two formulas that do not contain alcohol as a part of the menstrum. One of them does not even contain aromatics.

The Elixir Sulfanilamide was not rushed on the market by us before it was tested. I am not defending the preparation, but the several hundred patients who took it with good result is evidence of the unpredictable effect. We had precedent for using a glycol as a solvent. We used the diethylene glycol, which is much less toxic than the ethylene glycol which is used as an anti-freeze mixture. The American Medication Association approved and published in their New and Nonofficial Remedies two formulas for intramuscular injection which contained ethylene glycol as the solvent. The doses recommended are 1-2 teaspoonful.

I am heartily in favor of the passage of the Food and Drug Act now pending in Congress.

One week later, the Sullivan-Johnson County Medical Society, representing 2 East Tennessee counties (which included the city of Bristol), adopted a resolution expressing its "sincere confidence in the integrity of Dr. S. E. Massengill and the products of The S. E. Massengill Company" [3]. The resolution stressed that Massengill's products were only supplied to the professions and not advertised to the "laity." The members of the medical society, which included Dr. Massengill, "deeply regret[ted] the unfortunate occurrence and the unfavorable publicity to which the S. E. Massengill Company has recently been subjected." The sympathetic paper concluded its front page coverage of the medical society's endorsement with the sentence, "Seventy-three 'known' deaths have been attributed to the preparation," placing "known" in quotation marks.

* Likely refers to Senate bill 5-1937, which was foundering in the House in the fall of 1937.

1. Massengill avers false statements made about elixir. Bristol Herald Courier. November 27, 1937; p 1.

2. Dr. Massengill in defense of sulfanilamide. Bristol News Bulletin. November 27, 1937; p 7 col 1.

3. Massengill and firm endorsed by doctors. Bristol Herald Courier. November 2, 1937; p 1.

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.

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.

A page providing the names and some details of all known (confirmed or possible) victims of Massengill's Elixir Sulfanilamide is now a permanent feature* of this blog (link in left-hand bar on main page). Any corrections, clarifications, or additions are urged and can be made by contacting barbara dot martin at bmartinmd dot com.

* Insofar as anything can be permanent on the web.

Alabama (10 confirmed, 2 possible)

"Baby" (Syble G.?) Singleton, of Eufaula died sometime in September. Was given 2-ounce salesman's sample by local physician.

John (Johney) C. Holloway, age unknown, of Clayton died September 24. Two prescriptions (for 6 and 4 ounces each) dispensed. Consumed unknown amount.

Anderson Crews (aka Cruce), possibly 63 years, of Headland died September 25. Three ounces dispensed on prescription.

Ewell Daughtrey (or Daughtry), possibly 32 years, of Clio died September 26 in Waycross, Georgia, hospital. Two ounces dispensed on prescription.

Ethel (or Ether or Ester) Colston, "adult," of Ariton died sometime in October after drinking about 8 tablespoons of elixir. In this case, the FDA reported the "complication of possible cerebral hemorrhage."

Edward Walker, "boy" (son of Charles Walker), died October 3 of Bright's disease in Dothan hospital. Was sold two 4-ounce prescriptions from Enterprise druggist, who attempted to conceal identity of purchaser from FDA.

Fannie Zeanah, age unknown, of Eufaula died October 13. Consumed some portion of 6-ounce prescription.

Ed (or Edd) Scott, age unknown, of Demopolis died October 14. Three-ounce prescription dispensed. FDA did not recover remaining elixir, because prescription bottle placed in casket.

Betty Joe Story, 2, of Arab died October 16 after drinking 1.5 ounces of 6-ounce prescription.

Alfred "Alf" McDade, age unknown, of Eufaula died October 17. Consumed some portion of 3.5-ounce prescription.

Possible

Martin Smith, age unknown, of Pisgah died sometime in October. Consumed some or all of 3-ounce prescription.

Rita Glendyne Mallon, "baby," of Mobile died October 10. Consumed some portion of 3-ounce prescription.

Arkansas (1 confirmed)

Ruth Jeanell Long, 7, of McCaskill died October 24 after consuming some or all of 2-ounce prescription. Treating physician probably attempted to deceive FDA inspectors about patient's identity. Post-exhumation autopsy findings consistent with diethylene glycol poisoning.

California (1 confirmed)

Orvin Kutz, Jr, 5 (son of Orvin, Sr, and Celia), of Fresno died of anuria and uremic encephalopathy October 20. Consumed 1 ounce of 2-ounce prescription, which was given for streptococcal sore throat and high fever.

Florida (2 confirmed, 1 possible)

Fred L. Williams, age unknown, of Jacksonville died October 12 after consuming probably all of 6-ounce prescription.

Emanuel Cauley, possibly 34, of Jacksonville died October 16 after consuming total of 5 ounces from 2 sequential 4-ounce prescriptions.

Possible

J. C. Donaldson, age and sex unknown, of Quincy died October 16 after consuming some portion of 2-ounce prescription. The FDA reported, "There is some question as to whether or not this patient died as a result of elixir poisoning."

Georgia (10 confirmed, 2 possible)

Jewell Fitts (male), 36, of Dahlonega died October 5 after receiving unknown amount (but probably 4 ounces) of elixir on prescription from the "extremely irascible" Dr. Samuel A. West.

Betty Louise Satterfield, age unknown, of Greensboro died October 6 after receiving 4-ounce prescription.

Luther N. Gillham (or Gilham), 29, of Porterdale died October 8 after received 4-ounce prescription. Prescribing physician initially tried to mislead investigating authorities by removing Gillham's prescription from dispensing druggist's records.

Herman Bolton, possibly 34, of Wadley died October 16 in Millen hospital. Bolton likely received 6 ounces of elixir over the counter from local druggist, who denied dispensing the medication.

Robert L. Fields, 68, of Aaron died October 17. Consumed some portion of 8-ounce prescription that was shared with neighbor and victim Lilly (or Lillie) Lyons. Prescription discovered after incomplete amount returned to Bristol by Metter pharmacist.

Leonard J. Dees, probably 22, of Milner died October 18 after consuming some portion of 6-ounce prescription; dispensed by Griffin pharmacist. 

Lilly (or Lillie) Lyons, 41, of Aaron died October 19. Shared prescription with fellow victim Robert L. Fields.

Robert L. Parks, 19, of Dahlonega died October 19. Received 4-ounce prescription from the "extremely irascible" Dr. Samuel A. West.

Seth L. Durden, age unknown, of Wadley died October 21. Eight ounces of elixir purchased over the counter from druggist in Swainsboro.

Will (William L.) Portwood, 34, of Swainsboro died October 26. Four ounces of elixir purchased over the counter from druggist in Swainsboro.

Possible

Arnette (or Anett) Lewis, sex and age unknown, of McDonough died October 6. Two-ounce prescription received directly from physician. FDA suspected that diethylene glycol poisoning was not cause of death in this case.

Mrs. Mark (Morning Catherine) Reynolds, 77, of Dublin died October 12. FDA suspected that diethylene glycol poisoning was not cause of death in this case.

Illinois (7 confirmed, 1 possible)

Hazel Mildred Fea, 23, of Granite City died October 10 at Barnes Hospital in St. Louis, Missouri. Consumed probably 2 ounces of 4-ounce prescription dispensed directly by hometown physician Philip M. Dale. 

J. D. Kimbrough (Jee D. Kimbrew), age unknown, of East St. Louis died October 15. Consumed about 2.5 ounces of 4-ounce prescription written by Dr. Henry H. Weathers. Elixir dispensed by Walter J. Daut Pharmacy.

Maurice (Edwin M.) Slaughter, 4 (son of Edwin and Helen), of East St. Louis died October 16 at St. Mary's Hospital (East St. Louis). Consumed probably "all but two doses" of 1-ounce prescription written by Dr. Henry H. Weathers for "inguinal adenitis." Elixir dispensed by Lincoln Pharmacy. 

George W. Nixon, 5 (son of Joseph and Mary), of East St. Louis died October 18 at St. Mary's Infirmary (St. Louis). Consumed about 0.6 ounces of 1.5-ounce prescription written by Dr. Henry H. Weathers for treatment of streptococcal sore throat. Elixir dispensed by Lincoln Pharmacy.

Joseph L. Henry, 60, of East St. Louis died October 18 at St. Mary's Hospital (St. Louis). Consumed all but 3 or 4 doses 4-ounce prescription written by Dr. Henry H. Weathers. Elixir dispensed by Lincoln Pharmacy.

Alexander A. Brooks, 70, of East St. Louis died October 21 at St. Mary's Hospital (East St. Louis). Took "about 5 doses" of 4-ounce prescription written by Dr. Henry H. Weathers. Elixir dispensed by Lincoln Pharmacy.

Gertrude Lee (Mrs. Ellis Z.) Black, 38, of East St. Louis died October 24 at Homer G. Phillips Hospital. Consumed 2 ounces of 4-ounce prescription written by Dr. Henry H. Weathers. Elixir dispensed by Walter J. Daut Pharmacy.

Possible

Bessie Lee Bosley, 53, of East St. Louis died October 8 at St. Mary's Hospital (East St. Louis) of streptococcal infection of the jaw and teeth. Consumed some portion of 4-ounce prescription written by Dr. Henry H. Weathers and dispensed by Walter J. Daut Pharmacy.

Mississippi (27 confirmed, 1 possible)

Elnora (Mrs. Robert) Perkins, age unknown, of Itta Bena died October 1. Consumed some portion of 4-ounce prescription.

Joe Hewitt, possibly 31, of Deasonville died October 4 after consuming an unknown portion of 2-ounce prescription dispensed by Dr. Homer E. Frizell.

Claiborne L. Anderson, 37, of Laurel died October 4 after taking 2.75 ounces of 6-ounce prescription written by physician Joe Green. Remainder of elixir held by widow for "possible legal use."

Albert Cole, 19, of Laurel died October 5 after consuming unknown amount of 6-ounce prescription written by physician Joe Green.

Hettie Young, 18, of Magee died October 5 after consuming unknown amount of 3-ounce prescription obtained at Magee General Hospital.

John W. Gibbons, 71, of Mt. Olive died October 9. Consumed about 2.5 ounces of 4-ounce prescription written by Mt. Olive physician Archie Calhoun and dispensed by Calhoun Drug Company.

Robert A. Boutwell, 27, of Ellisville died October 10. Consumed unknown amount of prescription written by Laurel physician Joe Green. Elixir bottle held by decedent's father for legal use.

Walter Bell, age unknown, of Benton died October 11 after consuming unknown amount dispensed by Dr. Homer E. Frizell.

William Cornell Howell ("negro"), possibly 36, of New Albany died October 14. Consumed 3 ounces of 4-ounce over-the-counter sale.

Edie (or Eddie) Sullivan, 49, of Magee died October 17. Consumed some portion of 4-ounce prescription obtained at Magee General Hospital.

Columbus Bryant, 34, died October 17 at John Gaston Hospital in Memphis, Tennessee. Prescription obtained directly from physician in Cary, Mississippi. Consumed some portion of 6-ounce prescription.

Otis Coulter, age unknown, of Mt. Olive died October 19. Received 4-ounce prescription and 4-ounce refill, both written by Mt. Olive physician Archive Calhoun and dispensed by Calhoun Drug Company.

James Monroe Vick, 53, of Ellisville died October 20 of "carcinoma of gallbladder and stomach," according to death certificate. Consumed unknown amount of prescription written by Laurel physician Joe Green.

Mrs. J. Edmond (Vala?) Penn, age unknown, of Mt. Olive died October 20 after consuming unknown amount of elixir. Prescription written by Mt. Olive physician Archie Calhoun and dispensed by Calhoun Drug Company.

Lorene (or Lorece or Lorenzo) Lewis, sex and age unknown, of Philadelphia died October 20. Consumed portion of 4-ounce prescription.

Reverend James Edward Byrd, 65, of Mt. Olive died October 21 in a Knoxville, Tennessee, hospital. Consumed unknown amount of 3-ounce prescription written by Mt. Olive physician Archie Calhoun and dispensed by Calhoun Drug Company.

Jerry Strickland, 3, of Burnsville died October 22. Consumed 1.75 ounces of 4-ounce prescription dispensed directly by physician on October 11.

Gussie Mae (or Jessie May) Grubbs ("negress"), age unknown, of Mt. Olive died between October 20 and 22. Consumed 3 ounces of 4-ounce prescription written by Mt. Olive physician Archie Calhoun and dispensed by Calhoun Drug Company.

Leffie Easterling ("negress"), age unknown, of Collins died between October 20 and 22. Consumed all of 4-ounce prescription written by Mt. Olive physician Archie Calhoun and dispensed by Calhoun Drug Company. 

Sallie Louise Brown ("negro"), age unknown, of Benton died October 24. Consumed about one third of 2-ounce prescription dispensed in Yazoo City for "severe strep sore throat" on October 13.

Emmett (or Eva or Era) Pickens, sex and age unknown, of Laurel died October 24 or 25. Consumed 1 ounce of 6-ounce prescription. Remainder was held by the prescribing physician, Joe Green, for "possible legal use."

Katie (or Katy) Stuckey (nee Meadows), about 38, of Collins died on an unknown date. Consumed 2.5 ounces of 4-ounce prescription, which was written by Mt. Olive physician Archie Calhoun and dispensed by Calhoun Drug Company. Empty elixir bottle left with husband.

Essie Davis, about 42, of Bentonia died on an unknown date. Consumed unknown amount of prescription written by Dr. James.

Henry G. Taylor, age unknown, of Bentonia died on an unknown date. Consumed 4.75 ounces of 6-ounce prescription written by Dr. James.

Franklin Jones, age unknown, of Bentonia died on an unknown date. Consumed 2.75 ounces of 4-ounce prescription written by Dr. James.

"Little" Martin Shelby, age unknown, of Bentonia died on an unknown date. Consumed 2.75 ounces of 8-ounce prescription written by Dr. James.

Steve Demus, about 27, of Bentonia died on an unknown date. Consumed unknown amount of prescription.

Possible

Julia Brown, age unknown, of Weathersby died on an unknown date. Consumed unknown amount from 2 prescriptions (3 and 6 ounces).

Missouri (1 confirmed)

William M. Schroeder, 50, of St. Louis died October 24 at Barnes Hospital in St. Louis. Consumed about 5 ounces of 6-ounce prescription dispensed directly by physician. Three days before death, Schroeder refused to release remaining elixir to FDA. Bottle retained by widow.

North Carolina (2 confirmed, 1 possible)

Charles "Charlie" Richardson, 24, of Nashville died October 17 at Rocky Mount Sanitarium. Consumed about 4 ounces of 8-ounce prescription dispensed directly by Dr. John H. Martin of Red Oak.

John Thomas Tanner, 59, of Rocky Mount died October 31 at Parkview Hospital. Consumed all of 4-ounce prescription dispensed directly by Dr. John H. Martin of Red Oak. 

Possible

Master Billy Lee Lindsey, 3, of Rocky Mount died October 12 at Parkview Hospital of "acute nephritis" and "acute streptococcic tonsillitis." One-ounce prescription dispensed. According to FDA, "There is some doubt that this death was due solely to Elixir Sulphanilamide."

Ohio (1 confirmed)

Jo Anne Cramer, 6, received 2-ounce sample from Copley physician for "mild case" of scarlet fever. Consumed some portion and died of "uremic poisoning" on October 17 at children's hospital in Akron.

Oklahoma (11 confirmed)

Robert "Bobbie" Sumner (or Summer), 2 (son of J. M. Sumner/Summer) of Leonard, died September 30 at his aunt's home in Tulsa. Consumed unknown quantity of 4-ounce prescription dispensed by Getman Drug Store for possible treatment of strep throat.

Mary Earline Watters, 11 months (daughter of Earl F. and Fern), died October 1 at St. John's Hospital in Tulsa. Consumed unknown quantity of 4-ounce prescription dispensed by Getman Drug Store for possible treatment of strep throat.

John "Jack" King, Jr, 8 (son of John and Katherine/Kathryn), died October 1 at St. John's Hospital (or 1207 E. 21st St.) in Tulsa. Consumed an unknown quantity of 3-ounce prescription dispensed by Lincoln Drug Store (originally obtained from Getman Drug Store) for treatment of possible strep throat. 

Millard Wesley Wakeford, 5 (son of Millard O. and Natalie), died October 4 at St. John's Hospital in Tulsa. Consumed unknown quantity of 4-ounce prescription dispensed by Getman Drug Store for treatment of strep throat.

Joan Marler, 6 (daughter of R. R. Marlar and Maise Nidiffer), died October 6 at Morningside Hospital in Tulsa. Consumed unknown quantity of 3-ounce prescription dispensed by Getman Drug Store for treatment of strep throat. 

Michael S. Sheehan, 6 (son of George and Helen), died October 6 at St. John's Hospital in Tulsa. Consumed unknown quantity of 4-ounce prescription dispensed by Getman Drug Store for treatment of strep throat. 

Kathleen E. Hobson, 8 (daughter of Thomas Marshall and Pearl), died October 9 at Morningside Hospital in Tulsa. Consumed 1.5 ounces of 4-ounce prescription. Balance "thrown out in the trash and burned by deceased's mother."

Glen F. Entler, 19 (son of Alfred B.), of Tuscola, Illinois, died October 9 in Tulsa while visiting his aunt and uncle. Consumed most of 6-ounce prescription. Remainder sent October 11 by prescribing Tulsa physician, Dr. Darwin B. Childs, to AMA in Chicago for analysis.

Charlene Mardell Canady, 4 (daughter of Charles K.), died October 12 at St. John's Hospital in Tulsa. Consumed 2 ounces of 3-ounce prescription dispensed for treatment of strep throat. Father retained portion in original bottle as evidence.

Earl L. Beard, 25, died October 16 in a Tulsa hospital. Consumed unknown quantity of 8-ounce prescription dispensed by Getman Drug Store.

Wilmer Morris, 18, of Osage, died October 27 at St. John's Hospital in Tulsa. Consumed about half of 4-ounce prescription dispensed by Cleveland drug vendor. In an attempt to conceal patient's identity, treating physician changed prescription records filed at drug store. 

South Carolina (9 confirmed)

Oscar Chisholm, 2, of Charleston died September 30 at Roper Hospital of "uremia from acute nephritis." Consumed unknown amount of 2-ounce prescription; dispensed September 24 for treatment of "sore throat."

Ella Blanche Washington, 3, of Charleston died September 30 at Roper Hospital of "uremia" and "acute nephritis." Consumed unknown quantity of 3-ounce prescription.

Pearl Locklair, 37, of Charleston died October 4 at Roper Hospital of "uremia." Consumed unknown quantity of 6-ounce prescription; dispensed September 24 for "retropharyngeal abscess."

Susie Mae DeLoach, 16, of Fairfax died October 7 in Brunson of "kidney suppression." Consumed unknown quantity of 2-3-ounce prescription for treatment of "streptococcus infection of leg." Prescribing doctor, Johnston Peeples of Estill, evasive about patient's identity with FDA.

James Stewart, 10, of Charleston died October 12 at Roper Hospital of "uremia from acute nephritis." Consumed unknown amount of 4-ounce prescription; dispensed October 2.

Ward St. John O'Brien, 39, of Charleston died October 13 at the Hospital & Training School. Consumed all of 4-ounce prescription between October 6 and 8.

Harry Terry, 34, of Estill died October 14 of "acute uremia" and "acute nephritis." Consumed 3 ounces of 4-ounce prescription; elixir originally obtained from Dr. Johnston Peeples.

John McDaniel (or J. J. McDanie), 35, of Luray died October 14. Consumed about 3 ounces of 4-ounce prescription. Treating doctor, Johnston Peeples of Estill, evasive about patient's identity with FDA. Elixir bottle found on top of patient's grave.

Willie Badger, age unknown, of Scotia died October 18. Consumed about 1.5 ounces of 4-ounce prescription. Treating doctor, Johnston Peeples of Estill, evasive about patient's identity with FDA. Prescription bottle found in weeds behind Badger's home. 

Tennessee (4 confirmed, 1 unlikely)

Horace Williams, age unknown, of Sevierville died October 12 after receiving 3-ounce prescription from local physician.

William E. Kyte ("colored"), 38, of Knoxville died October 17 at Knoxville General Hospital. Consumed unknown quantity of 4-ounce prescription.

Charles William Miller, 25, of Memphis died October 20 at Methodist Hospital. Consumed unknown quantity of 8-ounce over-the-counter purchase.

Charles Merideth, age unknown, of Cleveland died October 24. Consumed 2 ounces of 4-ounce prescription.

Unlikely

"Baby" Thompson, age unknown, of Jacksboro died October 17. Consumed unknown amount of 2-ounce prescription. According to FDA, "All evidence indicates that this patient did not die as a result of Elixir Sulphanilamide."

Texas (7 confirmed, 2 possible)

Johnie Fay Kay (girl), 12, of Hemphill died October 4 of "uremia" and "lobar pneumonia." Consumed about 6 tablespoons of elixir prescription.

William Taft Parker, 27, of Wichita Falls died October 10 of "uremia due to acute nephritis" at Bethania Hospital. Consumed 3.5 ounces of 6-ounce prescription.

Robert Montgomery Goode, 29, of Texas City died October 10 at John Sealy Hospital in Galveston of "acute toxic hemorrhagic nephritis" and "toxic hepatitis." Consumed 4 ounces of 6-ounce prescription.

Levi Kelly ("colored"), 19, of Highbank died October 12. Consumed all of 4-ounce prescription obtained in nearby Marlin from "negro" physician Allan L. Hunter. 

Alberta Yvonne Howell, 2 (daughter of Lee and Irene), of Ballinger died October 13 of "acute nephritis." Prescribed 2 ounces for "streptococcic sore throat."

Lois Jean Wilkins, 4, of Leona died October 16. Consumed about half of 4-ounce prescription obtained in Madisonville.

Mollie May Schmitton, 20, a student in Commerce, died October 20. Consumed little over half of 4-ounce prescription.

Possible

Lillie Maurye Howard, 5, of Goree died October 6 of "Vincent's angina" (trench mouth). Consumed about 2 ounces of 4-ounce prescription, which was also taken by 2-year-old sister without consequence.

"Baby" Rosas (possibly Margrita), age unknown, daughter of migrant cotton picker living in Tahoka box car. Died October 7 of pneumonia at Mercy Hospital in Slaton. Consumed about half of 1-ounce prescription. FDA concluded that elixir-induced death was questionable.

Virginia (2 confirmed)

Mrs. D. T. (Martha Agnes) Cairns, age unknown, of Petersburg died October 7. Consumed about 4 ounces of 6-ounce prescription dispensed by Dr. D. C. Mayes (of Church Road) on September 25.

Robert Harrison Mayes, age unknown (son of J. H. Mayes), of Church Road died October 17. Consumed 3 ounces; dispensed on prescription by Dr. D. C. Mayes on October 4.

West Virginia (2 confirmed)

William Irvin, 17, died at Beckley Hospital on October 11. Consumed probably 2 ounces of 3-ounce prescription dispensed by Dr. R. J. Howard.

Jonathan Walter Lyons, 35, died at Beckley Hospital on October 18. Consumed unknown quantity of prescription dispensed by Dr. R. J. Howard.

Primary sources:

FDA correspondence. Report from J. O. Clarke to P. B. Dunbar. November 17, 1937.

FDA correspondence. Report from J. O. Clarke to P. B. Dunbar. November 20, 1937.

Individual state death certificates, when available.

For any corrections, clarifications, or additions, please e-mail barbara dot martin at bmartinmd dot com.

In all, 31 states and Puerto Rico received a total of 633 shipments of Elixir Sulfanilamide, the majority of which were in pint bottles. The elixir was distributed coast to coast within the (then) 48 states and as far north as Harvey, North Dakota, and the upper peninsula of Michigan and as far south as San Juan, Puerto Rico (map). Shipment endpoints were frequently tiny settlements, far from any remotely beaten path—like Wink, Texas, Wedowee, Alabama, and Doe Hill, Virginia (the last of which doesn't even have a Wikipedia entry). During the last 2 weeks of October 1937, nearly all FDA inspectors in the field (239) had picked up, destroyed, or otherwise accounted for 228 gallons and 2 pints of elixir of the 240 gallons produced, including hundreds of salesmen's and physicians' samples [1].

Along the way, the FDA uncovered scores of deaths, many of which would otherwise have been misattributed to other causes or remained deliberately concealed, as demonstrated by numerous field reports. Deaths roughly paralleled the volume of elixir shipments to a geographic region. But deaths were also a function of the willingness of local physicians* to prescribe the new product and chance—given that the likelihood of death after diethylene glycol consumption proved to be about 25%.

A total of 11 gallons and 6 pints of elixir were dispensed on prescription or over the counter (OTC) throughout the United States. Approximately half of this volume was consumed, and the remainder was literally (not just figuratively) taken out of the hands of patients by FDA inspectors, when possible. The first death occurred as early as September 24, and the last victim died October 31.** At least 97 deaths were believed to be due to elixir ingestion; approximately 30% of these victims were children or infants. Another 10 deaths were associated with and possibly due to elixir consumption.

If the entire 240 gallons of distributed Elixir Sulfanilamide had been dispensed and consumed, an estimated 4000 people would have died.

State	Shipments	Prescription or OTC Consumed	Confirmed Deaths
Alabama	80	38	10
Arkansas	3	3	1
California	16	?	1
Colorado	1	0	0
Connecticut	1	?	0
Florida	18	5	2
Georgia	83	26	10
Illinois	38	68	7
Indiana	25	9	0
Iowa	2	0	0
Kansas	2	0	0
Kentucky	14	1	0
Louisiana	13	4	0
Maryland	3	1	0
Michigan	17	0	0
Minnesota	3	0	0
Mississippi	43	70	27
Missouri	17	1	1
New York	2	?	0
North Carolina	24	16	2
North Dakota	2	1	0
Ohio	15	3	1
Oklahoma	18	38	11
Oregon	1	0	0
Pennsylvania	7	?	0
Puerto Rico	1	0	0
South Carolina	12	19	9
Tennessee	45	23	4
Texas	106	33	7
Virginia	12	11	2
West Virginia	14	7	2
Wisconsin	2	0	0
Total	640	377	97

* For example, high-volume prescribers Dr. Archie Calhoun of Mt. Olive, MS, or Dr. Henry Weathers of East St. Louis, IL.

** John (Johney) C. Holloway of Clayton, AL, and John Thomas Tanner of Rocky Mount, NC, respectively. "Baby" Singleton of Eufaula died sometime in September; however, the date of death is currently unknown.

N.B.: Prescription data for CA, CT, NY, and PA are not presently complete. The total number of shipments exceeds 633, owing to occasional interstate shipping of stocks of elixir from pharmacy to pharmacy.

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

By popular demand,* a short (incomplete) history of the Massengill douche—which is the legacy of the S. E. Massengill Company of Bristol, Tennessee—is provided today (while attempting to conceal some of the fallout from the Elixir Sulfanilamide tragedy).

According to its 1936 product catalog, the S. E. Massengill Company offered a number of vaginal treatments:

• Aseptogill, 15%: an antiseptic and astringent suppository—composed of dermatol, zinc oxide, boric acid, bismuth oxyiodide, and thymol iodide—"[s]uggested for relaxed and morbid conditions of the vaginal tract, ulcerations of the cervix, etc."
• Ichthyol compound: an anodyne, antiphlogistic (ie, anti-inflammatory), antiseptic, and gonococcidal suppository—composed of 10% ichthyol and 1% protargol—"[s]uggested for allaying inflammatory conditions of the vaginal mucosa, specific infection, etc."
• Mercurochrome, 2%: a prophylactic and general antiseptic suppository, which does not "burn, irritate, or injure tissue," and is "[s]uggested for the treatment of specific infection of the female."
• Phe-mer-nite (phenylmercuric nitrate): a "powerful antiseptic, vaginal suppository which does not burn, irritate or injure the tissue" and is "[s]uggested as a general antiseptic in the treatment of various infections and inflammations of the uterus and appendages, gonorrhea, ulcerations and morbid conditions of the vaginal mucosa generally."
• Vaginal antiseptic: an "antiseptic, alterative and anodyne that is suggested as a local application for catarrhal vaginitis, inflammation of the uterus and appendages, gonorrhea, ulcerations, and morbid conditions of the vaginal mucosa generally." The active ingredient was apparently ichthyol, 10%.
• Several prophylactic suppositories

By 1940, some of these products were supplanted by Massengill Powder (an "acid vaginal douche") and Trimagill for vaginal infections. The powder (10 grams)—containing boric acid, ammonium alum, berberine salt, menthol isomers, thymol, eucalyptol, and methyl salicylate—was to be dissolved in a quart of warm water. The product was indicated as an "astringent, soothing vaginal douche." The catalog boasted, "Therapeutically, it can be used as an aid to the management of trichomonas, monilia, staphylococcus and streptococcus infections," and claimed, "Its clean, refreshing odor makes Massengill Powder acceptable to the most fastidious patient."

Trimagill, available in powder and as vaginal inserts, contained tartaric acid, citric acid, boric acid, dextrose, potassium bitartrate, potassium alum, and adhesives. Its indications and advantages were advertised as follows:

Trimagill is indicated for acidification of the vaginal tract in the treatment of Trichomonas vaginalis, Candida albicans (Monilia), Hemophilus vaginalis, and nonspecific leukorrhea. Trimagill is also recommended as a nonabsorbable agent following conization of the cervix to help eliminate postoperative sloughing and perineal odor, to absorb secretions and maintain an acid pH.

Trimagill provides a low pH environment in which pathogenic micro-organisms cannot survive or reproduce. Infectious organisms are destroyed by the prolonged acid condition. Trimagill's low pH favors the growth of the beneficial Doederlein bacilli and helps restore the normal vaginal flora following infections. Unlike antibiotics, Trimagill does not foster monilia overgrowth. Resistant strains cannot develop.

The catalog also claimed, "There are no known contraindications to Trimagill when applied as directed."

The vaginal products, but primarily Massengill's douche line, were somehow parlayed into a multimillion-dollar industry, which was dominated by the S. E. Massengill Company during the early 1960s. The well-known cringe- or eye-roll-inducing TV ads from that decade and beyond can be attributed (at least in part) to the now-defunct agencies of Lee Ramsdell and Company; Cargill, Wilson, & Acree (of Atlanta); and Dancer-Fitzgerald-Sample.** By 1970, Massengill reportedly spent more than $1 million to market its feminine-hygiene products (>$5 million in 2007 USD).  

In 1971, the UK-based Beecham acquired Massengill, including the company's consumer line. In 1989, SmithKline acquired Beecham, and Glaxo gobbled up SmithKline in 2000. Massengill's feminine-hygiene products survived the series of mergers, presumably owing to their popularity and substantial market equity in the brand name. The ingredients of today's Massengill Disposable Douche bear no resemblance to the original formulas; contemporary packaging emphasizes the inclusion of "natural" substances, like vinegar or baking soda.

Now, laying aside the "douche issue," the Elixir Sulfanilamide saga will continue. 

* Really for Raphe and Mary.

** Some of these ads can be found on YouTube.

California

The FDA's San Francisco station oversaw the confiscation of elixir that was distributed from the Massengill Company's branch, located at 240 Fourth Street. Of the nearly 30 gallons shipped from Bristol, more than 4 gallons, mostly in pint containers, had been distributed between September 23 to October 13 to a dozen pharmacies, several physicians offices, and one hospital. A few shipments went to nearby Oakland but most were dispersed to small towns scattered throughout the middle of the state. Two pints each were also sent to Meeker, Colorado, and Eugene, Oregon, thereby establishing interstate commerce of the product from Massengill's San Francisco warehouse. An initial inventory by the FDA revealed that only 2 pints had been returned as a result of the company's recall telegrams [1].

At the Livermore General Hospital, which had received 1 pint of elixir, only 1 patient had been given the medicine—the son of staff physician, Dr. William E. Judson. What follows is probably one of the most complete case reports by the FDA of the effects of Massengill's product and that of contemporary medical treatment [2].

This son, a student in the University of California and member of the football squad, came home from school on the ninth of October with a sore throat that was diagnosed by his father as of streptococcic origin. In order to be positive a smear was made of the throat on Sunday morning, the 10th, and analyses run for the elimination of diphtheria, which was found to be negative.

Upon diagnosis of a streptococcic throat condition Dr. Judson, who had had some previous experience with the Massengill Sulphanilamide ampules [intended for intramuscular administration] and with negative results, decided to administer the Elixir Sulphanilamide orally and a course of three teaspoons at 12:00, 4:00, and 8:00 P.M. in treatment was started at noon on October 10th. The midnight dosage was reduced to 2 teaspoonsful and on Monday a full course of treatment of two teaspoonsful each was inaugurated. On Monday night early the stomach rebelled and throughout Tuesday the patient was nauseated but did not vomit. He complained of his head, stating that it did not feel right and that his mind was not clear. The urine on Tuesday was quite scanty.

On Wednesday morning the patient was in an almost comatose condition and Dr. Judson became greatly alarmed because he could not account for these symptoms. He ordered a continuing treatment of hot packs with frequent hot drinks, continuing this treatment throughout Wednesday afternoon and Wednesday night. On Thursday the treatment began to yield satisfactory results and the alarming symptoms cleared up but even up to the time of my interview with Dr. Judson on October 22nd he states that the boy was still in a very weak condition, showing a continued lassitude and dullness. It was also stated that he had lost about 20-lbs. weight and because of the weakened condition was still out of school. Dr. Judson stated that the feeling of nausea continued for approximately one weeks time and that at times the son complained of severe pains in the joints.

Insofar as other medication was concerned Dr. Judson stated that on Thursday the patient was thoroughly purged with Pluto water and that for several days beginning about Thursday the 14th, administration of salicylates was made for the joint pains. No other medication was used. Dr. Judson states that he feels the son is now out of danger and on the road to recovery but he is still naturally somewhat worried because of the publicity that the Elixir has received in connection with the deaths of certain patients having been treated with it. Dr. Judson is firmly convinced in his own mind that the alarming symptoms developed by his son after the administration of this drug were directly brought on and caused by the treatment.

The only death due to Elixir Sulfanilamide in California occurred in Fresno. Five-year-old Orvin Kutz, Jr, (son of Orvin, Sr, and Cecilia) consumed a total of 1 ounce from a 2-ounce prescription. Initially Orvin's clinical condition, characterized by a streptococcal sore throat and high fever, improved rapidly with treatment, but within 12 hours, he repeatedly vomited and became listless. Ten days later he developed anuria with uremic encephalopathy and died October 20 [3,4]. On November 30, Orvin would have celebrated his sixth birthday. 

1. FDA correspondence. Letter from R. B. Bork to Chief, San Francisco Station. October 19, 1937.

2. FDA correspondence. Letter from R. B. Bork to Chief, San Francisco Station. October 26, 1937.

3. FDA correspondence. Letter from J. O. Clarke to P. B. Dunbar. November 20, 1937.

4. FDA correspondence. Letter from W. G. Campbell to Mrs. O. C. Kutz. May 25, 1938.

Photograph "Windmills and Golden Hills 2016" outside of Livermore, CA, by "CatDancing" at Flickr.

The FDA's St. Louis station oversaw confiscation of Massengill's Elixir Sulfanilamide in Arkansas, Illinois, and Missouri.

Arkansas

One pint each of Elixir Sulfanilamide was sent from Massengill's branch in Kansas City, Missouri, to 1 drug store each in the rural communities of Blevins, Ola, and Taylor. Only 3 prescriptions were written in the state, all of which were dispensed from the Blevins Drug Company [1].

When approached by the FDA inspector, the prescribing physician James E. Gentry (of McCaskill) identified one of his patients as "Jewell Long," an itinerant "negro" with gonorrhea. "Diligent investigation," however, revealed that Dr. Gentry's patient was, in fact, a young white girl, Ruth Jeanell Long, who was the daughter of a local farmer. Two ounces of the elixir had been prescribed for a streptococcal infection. Ruth Jeanell had last taken the medicine on October 16 and died October 24, 21 days after her seventh birthday.* The FDA concluded that Dr. Gentry probably tried to mislead the federal investigator [1,2].

In Arkansas, 3 wholly or partially consumed elixir prescriptions resulted in 1 death.

Illinois

A cumulative total of 7.5 gallons of Massengill's elixir, most of it sent from the company's Kansas City branch, were distributed in Illinois. Recipients included 16 physicians' offices and 22 drug vendors in 12 communities, the overwhelming majority of which which were in or clustered around East St. Louis. A total of 68 prescriptions were either wholly or partially consumed. The bulk of these prescriptions, 47 (or 70%), were dispensed by the Walter J. Daut Pharmacy (47) and the Lincoln Pharmacy (20), both in East St. Louis [1].

Except for 1 victim, Hazel Fea of Granite City, all the deceased were residents of East St. Louis and patients of Dr. Henry H. Weathers. The first of the 7 confirmed elixir-related deaths** occurred on October 10; the last, October 24 (38-year-old Gertrude L. Black). Among the elixir survivors in this region, a relatively high percentage complained of nausea, vomiting, or back pain during their treatment—which often prompted the discontinuation of the medication. This observation may explain the low fatality rate in Illinois, 10% (7 deaths among 68 prescriptions).

Missouri

A relatively small volume of elixir, 3.75 gallons, was distributed to 5 physicians and 12 drug vendors in 8 different communities, including St. Louis, where approximately 75% of the state's elixir stocks were shipped [1]. Only 1 prescription was dispensed.

Six ounces of elixir were given to William M. Schroeder, 50, of St. Louis, on October 14 by his physician, Dr. L. F. Murray, for an "infection." The physician had purchased 1 gallon of the product from the company's Kansas City branch the previous day. On October 16, Schroeder, a brewery employee, complained of nausea and pain, after taking a total of about 5 ounces. Dr. Murray advised his patient to stop the medication and proceed to the hospital, but Schroeder refused. During the FDA's statewide investigation, an inspector found the patient, ill at home on October 21, and attempted to confiscate the remaining ounce, but Schroeder refused to turn over the product, which he wanted for legal proceedings. Schroeder was taken to Barnes Hospital the following day, where he died on October 24. Schroeder's widow, Matilda, retained the remaining elixir. The couple had been married 4 months [1,4-7].  

* Findings consistent with diethylene glycol poisoning were confirmed by autopsy, after the body was exhumed for examination.

** Another elixir patient of Dr. Weathers, Bessie Lee Bosley, 53, died October 10 of "septicemia" and "infection of the neck" [1,3]. According to the FDA report, "Inspector visited the patient's sister who informed him that patient had infected teeth and her jaw was swollen and in very bad condition at time of death. The sister thought she died from the infection" [1].

1. FDA correspondence. Report from J. O. Clarke to P. B. Dunbar. November 17, 1937.

2. M'Caskill child is first reported victim in state. Hope Star. October 27, 1937; p 1 col 8, p 3 col 5.

3. Illinois death certificate 771.

4. Missouri death certificate 9912.

5. Most sulfanilamide elixir is recovered. St. Louis Post-Dispatch. October 26, 1937; p 10A, col 1.

6. Two more deaths here from Elixir of Sulfanilamide. St. Louis Post-Dispatch. October 25, 1937; p 3A, col 1.

7. FDA newspaper clippings. Elixir widow gets settlement. St. Louis Post-Dispatch. December 10, 1937. 

Photo of Eads Bridge connecting East St. Louis, IL, and St. Louis, MO, by "ca newsom" at Flickr.

Alabama

A total of 16 gallons of Elixir Sulfanilamide, nearly all of which were shipped from Bristol in pint bottles, found their way to 9 physicians' offices and 70 drug stores in 57 communities dispersed throughout the state. Before stocks could be confiscated by federal authorities, 37 prescriptions (including 2 for 1 individual) were either wholly or partially consumed. The consequences of 2 additional prescriptions dispensed in Eufaula could not be determined, despite local radio broadcasts that warned of the elixir's dangers and urged the return of prescriptions. Two over-the-counter purchases were also made in the state.

In addition to the 4 known Alabama deaths in Eufaula and Headland, which were reported nationally on October 23,* FDA officials discovered the following elixir-related casualties:

• In Clayton, 2 prescriptions (one for 6 ounces and another for 4 ounces) resulted in the death of John (or Johney) C. Holloway, age unknown, on September 24.
• In Clio, a 2-ounce prescription to Ewell Daughtrey, age unknown, resulted in her death on September 26 in Waycross, Georgia.
• In Ariton, Ethel Colston ("adult") drank about 8 tablespoons of her elixir prescription. She died sometime in October (exact date currently unknown). In this case, the FDA reported the "complication of possible cerebral hemorrhage."
• Martin Smith, age unknown, of Pisgah also died sometime in October after receiving a 3-ounce prescription; however, the FDA couldn't "prove" that his death was elixir induced.
• In Mobile, a partially consumed 3-ounce prescription resulted in the death of "baby" Glendyne Mallon on October 10.
• Another 3-ounce prescription was dispensed in Demopolis to Ed Scott, age unknown, who died October 14. The FDA did not recover any remaining elixir, because Scott's prescription bottle was placed in his casket.
• Two-year-old Betty Joe Story, of Arab, died October 16 after drinking some portion of a 6-ounce prescription for Elixir Sulfanilamide.

During the course of the investigation in Alabama, a "vicious deliberate lie" (as the FDA's J. O. Clarke characterized it) was discovered in Enterprise, where a local druggist reported selling 8 ounces of elixir over the counter to a "stranger." Persistent investigation by state and federal officials "failed to shake the story of this consignee," to determine the identity of the purchaser. Only later did the FDA discover that two 4-ounce bottles of elixir had been sold by the druggist for the treatment of Edward Walker. The boy died of acute nephritis on October 3 in a Dothan hospital, about 30 miles away. After his son's death, Charles Walker wrote the state's Public Health Service, stating that he suspected his son died of elixir poisoning. Mr. Walker submitted a portion of the elixir, which had, in fact, been purchased from the Enterprise druggist, to the FDA's New Orleans Station.

SENDING YOU PORTION DRUG I WANT ANALYZED. IT WAS PRESCRIBED FOR MY BOY. HE WAS TAKEN ACUTELY ILL AND DIED OF DISEASE DOCTORS DIAGNOSED ACUTE BRIGHTS.

A small sample of a reddish liquid was forwarded to the FDA's Baltimore laboratory for confirmatory analysis [1-4].

In Alabama, 37 elixir prescriptions (including 2 for 1 individual) and 1 over-the-counter purchase were associated with the deaths of 12 people (fatality rate, 32%).

Mississippi

Nearly 13 gallons of Massengill's elixir were distributed to 6 physicians' offices, 36 drug vendors, and 1 hospital in 36 communities [1]. A total of 70 prescriptions were written in the state. In 2 cases, 2 prescriptions (an original and a refill) were written for each of 2 patients, and 3 related children shared 1 prescription.

In addition to the publicized deaths in Mt. Olive (5), nearby Magee (2), Laurel/Ellisville (5), and Philadelphia (1),** the following elixir-related casualties were discovered in Mississippi during the course of the FDA's investigation and seizure. 

Also in Mt. Olive, the Calhoun Drug Company, which was run by the brother of the town's prescribing physician, Archie Calhoun, dispensed a total of 13 elixir prescriptions. Seven recipients died. Like Dr. Calhoun's previously named elixir victims, 2 individuals succumbed. John W. Gibbons, 71, died October 9, and Mrs. Katie Stuckey, 38(?), died sometime between October 5 and October 24. Both had consumed a little more than half of their 4-ounce prescriptions.

In Magee, 2 prescriptions were given to Julia Brown, age unknown, who died (like fellow residents Edie Sullivan and Hettie Young) as a consequence of diethylene glycol poisoning. The date of Brown's death is currently unknown.

In Itta Bena, 4 ounces of elixir were prescribed for Mrs. Robert (Elnore) Perkins, who died October 1 after consuming a portion of the medicine.

In New Albany, consumption of 3 ounces of a 4-ounce prescription resulted in the death of "negro" William Corneel Howell, age unknown, on October 14.

Six ounces of elixir, dispensed on prescription, to "negro" Columbus Bryant, 34, in Cary resulted in his death on October 17 at the John Gaston Hospital in Memphis, Tennessee [5]. Causes of death were "essential hypertension," "multiple cortical hemorrhage of both kidneys" (determined by autopsy), and "uremia."

In Corinth, 4 ounces of elixir were dispensed on prescription to 3-year-old Jerry Strickland on October 11. He drank a total of 1.75 ounces and died October 22.

Several communities in the state's delta county of Yazoo were affected by deaths due to Elixir Sulfanilamide.

In Yazoo City, a 2-ounce prescription was written for Sallie Louise Brown, age unknown, on October 13. She died 11 days later, after drinking less than 1 ounce of the elixir. 

Dr. Homer E. Frizell, who practiced in Deasonville and Vaughan, reported to the FDA inspector that he had dispensed 2-ounce prescriptions to "each of 3 or 4 colored patients." According to Dr. Frizell, the patients claimed that the medicine "made them sick," at which point he emptied out his elixir stock sometime before receiving Massengill's recall wire. The doctor also claimed that he did not know the names of his patients. Further investigation, however, revealed that Walter Bell, age unknown, of Benton was one recipient. He died October 11 after consuming nearly all of his prescription. Another patient was Joe Hewitt, 31(?), of Deasonville, who died of elixir poisoning on October 4. The amount of elixir that Hewitt had consumed was not determined. The FDA also discovered that Dr. Frizell had poured out the unused portion of Massengill's product "so as to refill [the bottle] with another medicine after ill effects began to show up."

In Bentonia, 9 prescriptions (for a total of 44 ounces) resulted in 5 deaths, the dates of which are currently unknown.

• Essie Davis: An unknown amount of a 6-ounce prescription was consumed.
• Henry G. Taylor: 4.75 ounces of a 6-ounce prescription were consumed.
• Franklin Jones: 2.75 ounces of a 4-ounce prescription were consumed.
• Little Martin Shelby: 2.75 ounces of an 8-ounce prescription were consumed.
• Steve Demus: An unknown amount of a 4-ounce prescription was consumed.

In Mississippi, 70 prescriptions for Elixir Sulfanilamide resulted in the deaths of 28 residents (fatality rate, 40%).  

* The previously reported deaths in Eufaula: a baby (possibly Syble G. Singleton), died in September (date unknown); Fannie Zeanah (age unknown), died October 13; and Alfred "Alf" McDade (age unknown), died October 17. In nearby Headland, Anderson Crews (or Cruce), 63, died September 25.

** In Philadelphia, the Davis Drug Company, which had received 1 pint of elixir from Bristol, returned a full 16 ounces to Massengill headquarters during the recall. Analysis, however, revealed that the returned product had been diluted with water. Investigation revealed that two 4-ounce prescriptions had been dispensed. One resulted in the death of Lorene Lewis.

1. FDA correspondence. Report from J. O. Clarke to P. B. Dunbar. November 17, 1937.

2. FDA correspondence. Telegram from G. P. Larrick to FDA, New Orleans Station. December 1, 1937.

3. FDA correspondence. Telegram from J. O. Clarke to FDA, Washington, DC. December 3, 1937.

4. FDA. Part III. Elixir Sulfanilamide Investigation.

5. Tennessee death certificate 3614.

Photo of warehouse in Eufaula, AL, by "Frankie 117" at Flickr.

"Somewhere in Yazoo County" by NatalieMaynor at Flickr.

The FDA's New Orleans Station, headed by E. C. Boudreaux, oversaw the confiscation of Massengill's elixir in Louisiana, Texas, Mississippi, and Alabama.

Louisiana

Fourteen pints (1.75 gallons) of elixir were shipped to 13 pharmacies in 9 communities, most of which were in the coastal region of the state [1]. The shipments contradicted an early claim on October 20, by the president of the Louisiana State Board of Health, that the state's "model pure food and drug law" of 1936 prevented any of Massengill's elixir from coming into the state [2]. Nevertheless, the sale of the elixir violated the new state law, which required the "submission of all new medical products to the board of health's chemists before it is offered for sale" [3].

Although 11 pints were seized by state or federal officials, before prescriptions could be written, 4 prescriptions were dispensed in late September [1]: 1 in Lafayette to an infant, and 3 in Westwego, also to children. All were partially or wholly consumed "with no ill effect."

On October 24, the Times Picayune-New Orleans States printed a feature article on one of the Westwego children who took the medicine, claiming "Boy Thrives on Death Elixir." A 1-ounce prescription was written for Ecton Terrebonne, Jr, 4, by Dr. Joseph J. Massony on September 29 for a "bad throat ailment." Ecton took the elixir for about 15 days, his mother reported, and improved [4].

"You see, towards the end of September, Ecton started off with a sore throat. Well, the doctor wanted to give him some pills but his throat was so sore that he couldn't swallow them. So he gave him this medicine in a bottle. It looked like when he gave him that he got better right away."

When informed that the medication was poisonous, Ecton's mother replied, "[I]t must have been that novena I said to St. Martha that saved my boy." Little Ecton was also afforded a "very strong constitution."

Texas

Four physicians' offices and 98 drug vendors in 70 different communities received a total of 16¾ gallons, almost all of which were dispersed in pint bottles. Before stocks could be confiscated or destroyed by state and federal officials, 33 prescriptions were either partially or wholly consumed [1].

1. In Hemphill, 1 of 5 prescriptions dispensed from the Post Office Drug Store resulted in the death of a girl, Johnie Faye Kay. The 12-year-old died October 4 of "uremia" and "lobar pneumonia," after taking about 6 tablespoons of Massengill's elixir [1,5].
2. In Wichita Falls, William Taft Parker, 27, died October 10 of "uremia due to acute nephritis," at Bethania Hospital. He had taken nearly half of his 6-ounce elixir prescription [1,6].
3. Robert Montgomery Goode, of coastal Texas City, also died October 10. The 29-year-old fishing pier operator passed away at John Sealy Hospital in Galveston. Causes of death were "acute toxic hemorrhagic nephritis" and "toxic hepatitis," after a 7-day course of progressive symptoms. Goode had taken 4 ounces of his 6-ounce elixir prescription [1,7,8].
4. The first nationally reported elixir-related death of a Texan was that of 19-year-old Levy Kelly. The "colored" Highbank farmer died on October 12 after consuming all of his 4-ounce prescription, which he obtained in nearby Marlin from "negro" physician Allan L. Hunter [1,9].
5. Two-year-old Alberta Yvonne Howell died in Ballinger of "acute nephritis" on October 13. Two ounces of Massengill's elixir were prescribed for a "streptococcic sore throat" [1,10].
6. In Madisonville, a 4-ounce prescription was dispensed for 4-year-old Lois Jean Wilkins of nearby Leona, who was suffering from a "sore throat." She died October 16 after taking half of the medication [1,11].
7. Mollie May Schmitton, 20, a student at the East Texas State Teachers College in Commerce, died October 20 after consuming a little over half of her 4-ounce elixir prescription [1,11].

Deaths associated with the consumption of Elixir Sulfanilamide in Texas but not believed to have been caused by the medication included that of Lillie Maurye Howard, age 5, of Goree. Lillie consumed about 2 ounces of a 4-ounce prescription, which was also intended for her 2-year-old sister. Lillie died October 6 of "Vincent's angina" (or trench mouth) with the contributing condition of a "blood stream infection." She exhibited no renal symptoms before her death, which would be expected with diethylene glycol poisoning. Lillie's younger sister consumed 4 ounces of Massengill's elixir for a streptococcal infection without ill effects [1,12].

In Tahoka, 1 ounce of Massengill's elixir was dispensed on prescription to "Baby" Rosas (possibly Margrita), the daughter of a migrant cotton picker. When the prescribing physician learned of the elixir's toxicity, he located the patient in her family's box-car home, where he recovered about one-half ounce of the elixir. Attempts to follow-up the child's condition were confounded by the itinerant nature of the family's existence; however, it was learned "in a round-about way" that the child developed pneumonia and was admitted to Mercy Hospital, about 20 miles away, in Slaton. She died there October 7. The FDA concluded that an elixir-induced death was questionable in this case [1,13].

Tracing elixir prescriptions to other migrant families posed more than the usual challenges to health officials. Also in Tahoka, a 2-ounce prescription was dispensed to a patient identified only as "Baby." When interviewed, the prescribing physician was finally able to recall that the infant was the child of a traveling cotton picker. After locating the parents, it was discovered that all of the prescription had been consumed. The infant remained alive on October 30 "but was sick with the disease for which it was being treated" [1].

In Munday, 3 ounces of Massengill's elixir were prescribed for a "Mexican baby." The names of the child or its parents, who were probably transient cotton pickers, were unknown to the prescribing physician and druggist. Calls made by authorities to the justice of the peace, the keeper of vital statistics, the mortuary, and the local priest were unfruitful; the child was never identified or located [1].

The complete confiscation of elixir in Texas was hindered by Massengill salesman B. H. Hensley, of San Antonio. Hensley had returned only 42 of 72 1-ounce physicians' samples and 3 of 4 2-ounce case samples to Massengill's Kansas City branch. The salesman claimed he had destroyed the remaining case sample and had consumed 3 1-ounce samples without adverse consequences. If true, the tally left 27 physicians' samples at large.

Both state and federal inspectors encountered "supreme difficulty" in dealing with Hensley, who refused to reveal where he had delivered the drug. For his defiance, Hensley was arrested. After spending a night in jail, Hensley pleaded guilty to "obstructing an officer in the performance of his duties" and was fined $25.00 (along with costs of $13.50). The reformed salesman then enabled inspectors to seize 12 elixir samples in Waco and 15 in San Antonio. In the process of running down the elixir, inspectors found bottles carelessly tossed in wastebaskets and slop jars. One sample each had been passed on to salesmen from Upjohn and Abbott [14,15,16]. None of Hensley's samples resulted in a death.

In Texas, 33 prescriptions for Elixir Sulfanilamide caused 7 confirmed deaths (fatality rate, 21%).

1. FDA correspondence. Report from J. O. Clarke to P. B. Dunbar. November 17, 1937.

2. FDA newspaper clippings. '36 law is barrier to fatal elixir. New Orleans Tribune. October 20, 1937.

3. FDA newspaper clippings. All poison drug on sale in this state traced by officers, seized. Times Picayune-New Orleans States. October 24, 1937.

4. FDA newspaper clippings. Schoenberg P. Westwego child given elixir has no bad effects. Times Picayune-New Orleans States. October 24, 1937.

5. Texas death certificate 52202.

6. Texas death certificate 52954.

7. Texas death certificate 50096.

8. Medicine is fatal to Texas City man. The Galveston Daily News. October 26, 1937; p 12 col 4.

9. Texas death certificate 49948.

10. Texas death certificate 52164.

11. Associated Press. No more Texas deaths expected. The Galveston Daily News. October 26, 1937; p 12 col 4.

12. Texas death certificate 51357.

13. Texas death index, 1903-2000 (certificate 51538).

14. FDA. Part II--Report on Elixir Sulfanilamide manufactured by S. E. Massengill Company, Bristol, Tenn.: disposition of physicians' and salesmen's samples.

15. FDA correspondence. Letter from G. P. Larrick to Samuel A. Lask. December 13, 1937.

16. S. A. elixir danger is removed. The San Antonio Light. October 28, 1937; p 1 col 3.

Photo at Our Lady of Prompt Succor in Westwego, LA, by G. J. Charlet, III, at Flickr.

Photo of Texas cotton field by "Big Grey Mare" at Flickr.

Tennessee

In Massengill's home state, 17½ gallons were distributed to 35 drug vendors and 10 doctors' offices in 25 communities. One gallon was shipped to the Fox Drug Company in Memphis, and another 4 establishments in Nashville received a cumulative total of 19 pints. The remaining elixir stocks were distributed mostly to roadside towns, along the Appalachian corridor. Curiously no elixir stocks were sent to drug stores or physicians' offices in Bristol, the company's headquarters [1].

In addition to gas-station attendant Charles W. Miller, 25, who died October 20 in Memphis of elixir poisoning, the FDA discovered that at least 3 other Tennessee residents succumbed* [1]:

• Horace Williams (age unknown), of Sevierville, died October 12 after receiving a 3-ounce prescription from his local physician.
• "Colored" butcher William E. Kyte, 38, died October 17 at Knoxville General Hospital after receiving a 4-ounce prescription. Kyte went to a Knoxville drug store on October 7 and asked "for some of that new medicine." The pharmacist advised Kyte to consult a physician, and Kyte obtained the following prescription from Dr. E. L. Lennon, whose office was located above the drug store: "4 Oz. Liquid Sulphanilamide — dose: 1 teaspoonful in a little water every four hours." On October 12, Kyte returned to Lennon's office, complaining of vomiting and stomach pain, whereupon the doctor advised Kyte to discontinue the medicine and wrote a different prescription, which "did not include" Elixir Sulfanilamide. Kyte died 5 days later of "terminal uremia" [2].
• Charles Merideth (age unknown), of Cleveland, died October 24 after receiving a 4-ounce prescription. He had consumed approximately 2 ounces.

Diverting from national coverage, the Bristol, Tennessee, newspapers couched stories of the elixir-related deaths in generalities and implicated sulfanilamide as the cause. On October 19, the Bristol News Bullein declared, "Strong Drug Is Recalled: Sulfanilamide Valuable But Not To Be Used Without Prescription Physician[sic]." Only the first 3 paragraphs of the widely distributed Associated Press story were printed by the paper, thereby deleting Morris Fishbein's warnings about diethylene glycol [3]. Two days later, the Bristol paper printed several abbreviated AP stories, which reported the deaths of Charles Miller in Memphis, the Reverend Byrd in Knoxville, and 2 other Mississippians, under the umbrella headline, "Sulfanilamide Deaths Rising" [4]. Again references to diethylene glycol were omitted, and the over-the-counter sale of elixir was "rapped."

One week after Fishbein publicly identified the toxic ingredient in Massengill's elixir, the Bristol Herald Courier, on October 26, implied that the cause of the deaths remained a mystery. The paper printed the brief article, "Key to Elixir Deaths Sought," on page 3 [5].

While federal and state authorities investigated over a score of deaths of users of a proprietary elixir of sulfanilamide, the American Medical Association, whose "Journal," in an article by Dr. Morris Fishbein, had previously warned doctors to exercise caution in the use of the new commercial drug, is continuing tests to determine the toxicity of the preparation. 

Although an unignorable presence in the city, Massengill's company, as the elixir manufacturer, was not identified by the Bristol press, despite the fact that Dr. Massengill expressed no culpability in the deaths to the AP on October 23 [6]. 

In Tennessee, a total of 20 prescriptions for Massengill's elixir were dispensed,** and 3 purchases were made over the counter (all from the Fox Drug Company in Memphis). As a consequence, 4 Tennesseans died (fatality rate, 17%).

Ohio

Along with Tennessee, the state of Ohio was the purview of the FDA's Cincinnati Station. A total of 17 pints of Elixir Sulfanilamide were distributed to 9 physicians, 4 drug vendors, and 1 hospital in 13 communities. However, only 3 prescriptions were written [1].

In Coldwater, 3 ounces were dispensed for a child with "bad coughing spells." On instruction from the prescribing physician, the patient's mother "destroyed" the remaining elixir, after the patient had consumed about 2 ounces.

In Middleport, 3 ounces were dispensed on prescription to an unnamed patient, who consumed the entire amount without ill effects.

In the farming township of Copley, Dr. Homer G. Long prescribed 2 ounces of elixir for 6-year-old Jo Anne Cramer, who had a "mild case" of scarlet fever. The FDA described the events leading to the prescription [1]:

Dr. Long had successfully treated a boy with the same condition with tablets of sulfanilamide. Massengill's salesman visited Dr. Long on October 7, and Dr. Long told him that he wished he had a liquid preparation of sulfanilamide, as Jo Ann Cramer, his patient, had difficulty swallowing tablets. The salesman gave him a 2 oz. sample, which was administered, 1 oz. on Oct. 9 with instructions to take a teaspoonful every four hours.

Jo Anne Cramer was admitted to the children's hospital in Akron on October 12. She became stuporous and died of "uremic poisoning" 5 days later—2 days before Dr. Long received Massengill's recall telegram [7,8]. The FDA confiscated the remainder of Dr. Long's elixir sample on October 22. Akron's Beacon Journal described the anguish of Jo Anne's mother [8].

Mrs. Cramer, mother of five children, was near collapse when she learned that the medicine which Jo Anne rebelled against was the cause of her death.

"She cried every time she had to take a dose of it," the mother sobbed. "She would say, 'Mamma, I hate that medicine, but if you say I must take it, I will.'

"I try to think that I gave it to her unknowingly, but that doesn't bring her back. She might still be alive if I hadn't made her take it.

"I keep thinking how she used to sit up in her bed with her teddy bear and make it squeak and call to me, Mamma, now it sounds just like it was saying Bob White, doesn't it?'"

In Ohio, 3 elixir prescriptions were dispensed, causing 1 death.

* "Baby" Thompson, of La Follette, died October 9 after receiving a 2-pounce prescription; however, per the FDA, "[A]ll evidence indicates that this patient did not die as a result of Elixir Sulphanildamide."

** One woman received an initial prescription and a refill prescription. She consumed a total of 11 ounces of Massengill's elixir and survived.

1. FDA correspondence. Report from J. O. Clarke to P. B. Dunbar. November 17, 1937.

2. FDA correspondence. Letter from P. B. Dunbar to Lindsay, Young & Atkins. January 7, 1938.

3. Associated Press. Strong drug is recalled: sulfanilamide valuable but not to be used without prescription physician. Bristol News Bulletin. October 19, 1937; p 1 col 8.

4. Associated Press. Sulfanilamide deaths rising: minister died at Knoxville, filling station attendant at Memphis. Bristol News Bulletin. October 21, 1937; p 1 col 6-7; p 2 col 3.

5. Key to elixir deaths sought. Bristol Herald Courier. October 26, 1937; p 3 col 4. 

6. Associated Press. Elixir Sulfanilamide manufacturer disclaims responsibility. St. Louis Post-Dispatch. October 24, 1937; p 9A.

7. Ohio death certificate 65583.

8. FDA newspaper clippings. Roundup of fatal remedy is too late to save child. Beacon Journal. October 26, 1937.

Photograph of East Tennessee roadside foliage, overgrown with kudzu, from Flickr.

Georgia

More than 21 gallons of Massengill's Elixir Sulfanilamide were distributed to 83 drug vendors or physicians in 60 different communities—most of them small towns scattered about the northwest part of the state or along the South Carolina border. Among these shipments, about 17½ gallons had been returned to the Massengill company headquarters in Bristol, Tennessee, before prescriptions were dispensed [1].

But in their "race against death," as declared by The Atlanta Constitution, state authorities and FDA inspectors learned that 28 prescriptions for Elixir Sulfanilamide had been written in Georgia. In addition, at least 3 individuals had obtained the elixir over the counter from their local druggists [1,2].

In Greensboro, about 70 miles east of Atlanta, investigators found that a 4-ounce prescription to Betty Louise Satterfield (age unknown) resulted in her death on October 6 [1,3].

In the cotton-mill town of Porterdale, a 4-ounce prescription for Elixir Sulfanilamide was dispensed to 29-year-old doffer, Luther Gillham. He died October 8. The prescribing physician, Dr. Loveless [probably Jackson C. Loveless] tried to mislead investigating authorities by removing Gillham's prescription from the dispensing druggist's records. "Becoming frightened," Loveless later returned the prescription to the store's file [1].

In the Piedmont town of Dahlonega, 70-year-old physician Samuel A. West, who had received at least 1 pint of Massengill's Elixir Sulfanilamide directly from Bristol, first refused to talk about the medicine with the visiting FDA inspector. However, "after much discussion," the "extremely irascible" Dr. West admitted to dispensing 4 ounces to 19-year-old Robert L. Parks, who died October 19. "It was impossible to obtain further information from Dr. West," the FDA reported of its first visit, but the agency learned later that Dr. West had also prescribed an unknown quantity of elixir (probably 4 ounces) to 36-year-old Jewell Fitts of Dahlonega, who had died October 5 [1,4].

During a second meeting, the FDA inspector discovered that Dr. West had also prescribed 4 ounces of the elixir to a man identified only as "Cochran." Although West stated that he did not know where Cochran lived, the doctor believed his patient worked in a saw mill several miles northwest of Dahlonega. West added that Cochran found Massengill's elixir "to be the best medicine he had ever taken." The FDA inspector finally located the right Cochran, Joe, who worked as a stone crusher about 10 miles "back in the mountains." He relayed a different story [4].

Cochran did not praise the medicine, stating that each dose he had taken almost killed him, causing dizziness, weakness and a terrible backache, but that it had not [affected] his kidneys. When he had consumed the 4 ounces he had gone to another physician, and he stated that that was his reason for misleading Dr. West as to the effect of the medicine.

In another Piedmont hamlet, Ellijay, the FDA discovered that a 3-ounce prescription for Massengill's Elixir Sulfanilamide had been dispensed to a "Mrs. Weeks," first name and residence unknown. Inquiries from the state and the FDA to the town's prescribing doctor yielded no further information. An ensuing investigation, which sent tongues wagging in the small mountain community, ultimately led to a log cabin in Cherrylog, about 8 miles further up in the hills. Once there, investigators found that the Weeks family had just moved "some distance" to a new location. With the help of a Cherrylog resident, Lula Weeks was finally discovered at her new cabin home, in "apparent good health." She stated that she stopped taking the medicine because it did not "do her any good." After a "long conversation" with the FDA inspector, Mrs. Weeks "suddenly recalled that when they had moved, they put a lot of bottles in an old black bag, and this bag which was in a corner of the hut, on being opened, disclosed the prescription" [5,6]. 

About 40 miles south of Atlanta, near Griffin, Leonard J. Dees (probably 22 years of age, from Milner in nearby Lamar County) consumed a few ounces of a 6-ounce elixir prescription. He died October 18. The remainder of the product was retained by attorneys for the deceased [1].

Approximately 60 miles northeast of Savannah, a pharmacist in Metter, who had received 1 gallon of elixir from Bristol, admitted to dispensing a 6-ounce prescription to a local woman; in this case, the elixir was determined to have caused no ill effects. However, FDA inspectors in Bristol reported that only 7 pints and 2 ounces had been returned to Massengill headquarters from the Metter pharmacy, leaving 8 ounces unaccounted for. Confronted with this information, the druggist then admitted to dispensing an 8-ounce prescription to 68-year-old farmer Robert L. Fields, of tiny Aaron, who died October 17. It was further discovered that Fields had shared his elixir prescription with neighbor Lilly (or Lillie) Lyons, 41, also of Aaron, who died 2 days after him [1].

Massengill's elixir was purchased without written prescriptions in Swainsboro, about 90 miles northeast of Savannah. Direct consumers Seth L. Durden (age unknown) and Will(iam) L. Portwood, 34, died on October 21 and 26, respectively. An over-the-counter purchase was also discovered in nearby Millen. The local druggist at Bell's Drug Store, who had received 1 gallon of elixir, returned only 7 pints and 10 ounces to Bristol. Persistent inquiries regarding the remaining 6 ounces led the FDA to the half-brother of the recently deceased Herman Bolton of Wadley. Bolton had died October 16 in a Millen hospital [1,7].

The half brother...stated that after [Herman's] death he had cleaned his car and found in it a half filled bottle containing a red liquid labeled "Bell's Drug Store" and with directions for taking, but...that no doctor's name or prescription number was on it. The prescription bottle was thrown into a rubbish pile and later searched for by 3 laborers, 2 boys and Bolton's brother for the whole afternoon. All of the children in the immediate vicinity were questioned and had seen none of it. The evidence is irrefutable that although Bell's Drug Store denies dispensing any Elix. Sulfanilamide, the death of Herman Bolton on Oct. 16 can be attributed to Elixir Sulfanilamide from Bell's Drug Store.

Other Georgia deaths associated with the consumption of Massengill's product included those of Arnette (or Anett) Lewis (age unknown) of McDonough, who died October 6, and 77-year-old Mrs. Mark (M. C.) Reynolds of Dublin, who died October 12. The FDA suspected, however, that the elixir was not the cause of death in these cases [1].

In Georgia, the whole or partial consumption of 26 prescriptions for Massengill's elixir resulted in 7 confirmed deaths. In addition, 3 other persons died after purchasing the medicine over the counter (fatality rate, 38%).

Florida

Nineteen pints of Elixir Sulfanilamide were shipped to 15 drug vendors and 2 doctors in 6 communities. All but one (Bay Harbor) were located in the far northern part of the state. A total of 7 pints were sent to Tallhassee, and Jacksonville received 4. Nearly 16 pints were destroyed by the state inspector or returned to Bristol, before prescriptions could be written [1].

Two prescriptions in Tallahassee, which were partially consumed, caused no ill effects. The FDA retrieved the remaining ounces from the patients.

In Jacksonville, 2 elixir prescriptions from the Gem Drug Store caused 2 deaths. Fred L. Williams (age unknown) probably consumed his entire 6-ounce prescription. He died October 12. Two sequential 4-ounce prescriptions were dispensed to Emanuel Cauley, 34(?), who died October 16. He had consumed 5 ounces of Elixir Sulfanilamide.

In Quincy, a 2-ounce prescription to J. C. Donaldson (sex and age unknown) may have led to the patient's death, also on October 16. However, the FDA reported, "There is some question as to whether or not this patient died as a result of elixir poisoning."

In Florida, 5 elixir prescriptions resulted in 2 confirmed deaths (fatality rate, 40%).

Puerto Rico

Six pints of Elixir Sulfanilamide were shipped on September 19 from Massengill's New York branch to a dealer in San Juan, Puerto Rico, Cesar A. Toro [7]. On October 23, Mr. Toro informed the New York branch, by letter, of the seizure of the elixir by Puerto Rico's Department of Health, before he could act on the company's recall telegram [8]. Toro also wrote of bad, local publicity: "I want to advise you also that one of the Broadcasting Stations in San Juan announced the news that a cable coming from Chicago reported more than 30 deaths caused by Elixir Sulfanilamide of the S. E. Massengill Co." 

On October 26, Massengill Company replied by letter:

Dear Mr. Toro:

Your very kind letter of October 23 has been received by us. We were sorry to hear that our trouble with Elixir Sulfanilamide has been broadcast in Puerto Rico. Probably if the proper authorities had gotten in touch with you before this was done they would have seen it was not necessary.

We know Dr. Massengill appreciates very much the letter which you wrote him.* We feel the same way here about the matter and all correspondence from our sales force carries the same tone.

It is our hopes[sic] that this matter will be cleared up very shortly, and we do not believe it is going to affect our business materially for any length of time.

You reported to us that the District Court of the United States in Puerto Rico had ordered your stock of Elixir Sulfanilamide be confiscated. We are wondering if the United States agents who took this off your hands paid you for the six pints you turned over to them. If not, please let us know so that we may leave a credit to your account.

You do not state in your letter whether or not you turned over to those people any samples of this preparation you might have had on hand. If you received any samples from this office, we would like for you to return them to us here immediately, or notify us that you did not receive them, or that they have been destroyed. In any case, we would like to hear from you as to their disposition.

We shall keep you informed in regard to Elixir Sulfanilamide as our home laboratory advises us.

Very truly yours,

The S. E. Massengill Company

* A separate letter was evidently written by Mr. Toro to Dr. Massengill, ostensibly expressing sympathy for him.

1. FDA correspondence. Report from J. O. Clarke to P. B. Dunbar. November 17, 1937.

2. 10 Georgians hunted in race to prevent elixir death. The Atlanta Constitution. October 24, 1937; p 1A.

3. State of Georgia. Indexes of Vital Records for Georgia: Deaths, 1919-1998. Georgia Health Department, Office of Vital Records, 1998.

4. FDA correspondence. G. P. Larrick to Chief, Central District. December 27, 1937.

5. FDA correspondence. J. J. McManus to FDA, Mr. Larrick. November 6, 1937.

6. FDA correspondence. J. J. McManus to FDA, Mr. Larrick. November 9, 1937.

6. Agents speed up drug hunt as Georgia reports 5 deaths. The Atlanta Constitution. October 26, 1937.

7. FDA correspondence. Memorandum from Charles Hyak. October 21, 1937.

8. FDA file correspondence. Letter from Cesar A. Toro to the S. E. Massengill Co, New York City. October 23, 1937.

Photograph of Georgia cabin by "billmcdavid" at Flickr.

North Carolina

More than 13 gallons of Massengill's Elixir Sulfanilamide, divided mostly in pint bottles, were distributed to 21 drug stores and 3 doctors in 14 different communities. FDA inspectors found that most recipients had returned their stocks to Massengill headquarters in response to the company's telegram requests, before any prescriptions were dispensed [1].

However, in the coastal plain city of Rocky Mount, 6 elixir prescriptions, including those for 3 children, were given out. One prescription was, in fact, dispensed by a physician for his 11-year-old daughter. One mother gave "a dose or two" of the elixir, which was intended for her 4-year-old son, to her 18-month-old child. All prescriptions were taken, most in their entirety (2-4 ounces), without obvious ill effect except for the infrequent report of headache and nausea [1,2].

Additional prescriptions for Massengill's elixir were written by Rocky Mount's Dr. E. [Earnest] M. Perry. FDA inspectors who were assigned to investigate the status of Dr. Perry's treated patients were stonewalled [1].

Dr. Perry claimed he did not know [the patients'] names or make any inquiries as to their identity. He stated he treats many patients for venereal diseases, that they pay cash, and that he keeps no record as to their names or addresses. Because of this unsatisfactory answer a telegram was sent [to] Dr. Perry by the [Atlanta FDA] Station urging him to locate his patients. A similar telegram was sent to the State Health Officer who later contacted [FDA] Inspector Grey, without results. Followup investigation was made by [FDA] Inspector Simms and Grey on November 7 in which all possible sources of information were thoroughly canvassed. Simms reports that, while Perry is a member of the A.M.A., his practice has all the appearance of quackery and he did not appear to be unduly concerned about his patients or worried about any possible publicity which might result if they died. He reiterated previous reports that he keeps no records of these patients and, even though the State law requires reports of venereal cases, he has made only one such case report since September 1st to the State Board of Health, and then only by number, which is permitted. Conferences with the State Board of Health officials were not productive.

Owing to persistent pressure from the state and the FDA, Dr. Perry finally admitted to giving out 4 elixir prescriptions, totalling 18 ounces, beginning in late September. The FDA inspector ultimately determined that 3 prescriptions were consumed without consequence. However, one patient, a 28-year-old school teacher, could not be traced. After canvassing the area that surrounded the woman's alleged home town, 60 miles from Rocky Mount, the inspector was left to conclude that the "school teacher" probably gave a fictitious name at the time of treatment. The mystery patient's status was never determined [1,2].

In nearby Red Oak, the patience of FDA inspectors was tested again, this time by the doddering Dr. J. [John] H. Martin, who had dispensed 8 ounces of the elixir to 24-year-old farmer Charles Richardson of Nashville, North Carolina. After taking 4 ounces, Richardson developed "acute urinary suppression" 2 days before his death, on October 17. Notably the farmer was diagnosed with "acute appendicitis," the symptoms of which were probably confused with elixir-induced abdominal or flank pain [1,3]. Dr. Martin had also dispensed 4 ounces of Massengill's elixir to 59-year-old logger John Thomas Tanner, who began experiencing symptoms of "acute glomerular nephritis" on October 18 [4]. Tanner died 13 days later at Parkview Hospital in Rocky Mount. FDA and state inspectors discovered that at least one other 4-ounce prescription had been dispensed by Dr. Martin. This time, investigation was thwarted not so much by willful resistance, but by apparent mental incapacity:

Repeated visits by [FDA] Inspector Grey to Dr. Martin failed to result in any information as to the patients who had taken the prescription dispensed, until one of the patients, J. T. Tanner, was taken to Parkview Hospital, Rocky Mount, in a dying condition. Even the State Board of Health officials had no satisfactory results from interviewing Martin. Further followup was made on November 7 by [FDA Inspectors] Simms and Grey who report that Martin is over 80 years old, very feeble, and in poor mental condition. His practice consists chiefly of venereal patients and there appears to be no hope of his recalling any of the patients, since he did not keep records of their names or addresses. He is also the local Registrant of births and deaths, and said there had been no recent deaths in his section, but many of his patients came from some distance, and check at the State Board of Health later in the month will be necessary.

A follow-up report indicated "no further progress" on Dr. Martin's patients and little hope of any fruitful developments, given the doctor's "advanced age and condition." Inspectors went so far as to interview the doctor's wife and son, hoping to gather any useful bit of information [1,2].*

Other elixir prescriptions in the state included one in the village of Chadbourn, in Waccamaw Souian territory. A 2-ounce elixir prescription was written for a Betty Hughes. The FDA learned she became nauseated after taking one-half ounce; the remainder of the prescription was duly confiscated [1]. In the Indian Woods township of Bertie County, approximately 1½ ounces of a 4-ounce prescription were consumed by a Linden Gillam. After "some difficulty," the patient was located by the FDA, and the rest of the elixir was seized [1]. On October 7, one-half ounce of elixir was also prescribed by Dr. J. P. Corbett of coastal Swansboro for a 2-month-old baby with ear abscesses and possible meningitis. The baby died of septicemia at Morehead City Hospital on October 8. It was determined later that none of the elixir had been given to the child [1,5,6].

In the state of North Carolina, at least 16 prescriptions were written for Massengill's elixir, and 2 related deaths were confirmed (fatality rate, 12.5%).**

South Carolina

Two doctors, 9 pharmacies, and 1 hospital training school received a cumulative volume of 11 gallons of Massengill's Elixir Sulfanilamide. Seven recipients were located in Charleston, and the remainder were in 5 small towns situated within the state's southern coastal plain. One physician, Alexander S. Blanchard of Williston, received 5 gallons of elixir, and another doctor, Johnston Peeples of Estill, received 1 gallon. Four prescriptions written by Dr. Blanchard, which were either wholly or partially consumed, caused no deaths. However, 7 prescriptions written by Dr. Peeples caused 4 deaths [1].

The deceased patients of Dr. Peeples:

• 16-year-old Susie Mae DeLoach: A 2-3-ounce prescription was dispensed in mid-September for a streptococcal leg infection. Deloach died October 7 in Brunson of "kidney suppression" [7].
• 34-year-old "laborer" Harry Terry died October 14 in Estill of "acute uremia" and "acute nephritis" after consuming 3 ounces of a 4-ounce elixir prescription [8].
• 35-year-old John McDaniel (or J. J. McDanie), of Luray, also died October 14, after taking about 3 ounces of a 4-ounce prescription [9]. 
• Willie Badger (age unknown) died October 18, after consuming about 1½ ounces of elixir. The bottle containing the remainder of Badger's 4-ounce prescription was recovered by FDA inspector M. O. Rentz in the weeds behind Badger's home in Scotia, on October 28 [10].

During his investigation to retrieve every last ounce of elixir in the state, Rentz found Dr. Peeples to be not entirely forthcoming [11].

[A] South Carolina doctor...told the inspector he had dispensed 1 pint 15 fluid ounces to three white patients and two Negroes whose names he did not reveal. He insisted that none of these patients had died. Information acquired by the inspector from other sources showed that the doctor had administered the elixir to seven patients, that three survived, that a white man, a white girl, and two Negro men had died. One of the fatal prescriptions was traced through neighborhood gossip describing the symptoms of the fatal illness of a Negro employee of a lumber mill [John McDaniel]. The inspector recognized the symptoms as characteristic of "elixir" poisoning, and through the mill superintendent found the victim's sister. She remembered that the doctor had given her brother some red medicine about October 2 or 3. She said that, in accordance with their custom, all medicines, glasses, spoons, etc., had been placed on the grave, which was about 1½ miles back in the fields. Accompanied by the Negroes, the inspector walked to the wooded knoll with its single mound of fresh earth on which lay several bottles, dishes, and spoons. One 4-ounce bottle contained about 1 ounce of the "elixir." It bore the weatherbeaten but legible prescription label of the doctor.

In Charleston, 7 prescriptions dispensed by McFalls Pharmacy led to 5 deaths [1,12]:

• 2-year-old Oscar Chisolm was admitted in a "stuporous state" to Charleston's Roper Hospital on September 30. A 2-ounce prescription for Massengill's elixir had been dispensed to the child 6 days earlier for a "sore throat." His blood urea nitrogen (BUN) was 105 mg/dL (normal, 8-23), and his creatinine level was 6 mg/dL (normal, 0.6-1.2). He died 13 hours after admission of "uremia from acute nephritis" [12,13].
• 3-year-old Ella Blanche Washington also died September 30 at Roper Hospital of "uremia" and "acute nephritis." She had received a 3-ounce prescription for the elixir [12,14].
• 37-year-old Pearl Locklair, wife and mother, was admitted to Roper Hospital on September 29 for a "retropharyngeal abscess or tumor." She had been given a 6-ounce prescription for the elixir 5 days earlier. During her hospitalization, she developed anuria and lapsed into a coma. On the day of her death, October 4, her BUN was 135 mg/dL, and her creatinine level was 19.2 mg/dL [12,15].
• On October 11, 10-year-old James Stewart was also admitted to Roper Hospital. He arrived in a "comatose state" and died 21 hours later of "uremia from acute nephritis." He had been ill for 11 days and had been given a 4-ounce prescription for Elixir Sulfanilamide on October 2. On the day of his death, October 12, his BUN was 165 mg/dL, and his creatinine level was 12.4 mg/dL [12,16].
• 39-year-old Ward St. John O'Brien, a cook, "developed dizziness, nausea, epigastric pain and vomiting" on about October 8. Two days later, he was anuric. On the day of his death, October 13, his BUN was 127 mg, and his creatinine level was 13.8 mg/dL. He died at Charleston's Hospital & Training School. It was determined postmortem, that O'Brien had consumed 4 ounces of elixir between October 6 and 8 [12,17]. 

After autopsies were performed on Chisolm, Locklair, and Stewart, "it became apparent to the staff members [of Roper Hospital] that something unusual had been encountered" [12]. While postmortem examinations were expedited, the local health authorities were warned of these possible cases of poisoning; although, it was apparently not known at the time that Chisolm, Locklair, and Stewart had all received prescriptions for Massengill's elixir. Roper physicians then learned that O'Brien, who died elsewhere, had been taking sulfanilamide, and an investigation to determine whether their deceased patients had received the same drug was initiated. Just at that moment, the news story broke of elixir-related deaths in Tulsa, and the common link among the cases was established.

In South Carolina, 19 elixir prescriptions resulted in 9 deaths (fatality rate, 47%). 

* It may have been the mileage, not the years--or Dr. Martin was trying to pull a fast one. The 1920 and 1930 censuses indicate that Dr. Martin was about 69 years of age in 1937.

** It should be noted that 3-year-old Billy Lindsay, of Nashville, died at Parkview Hospital in Rocky Mount on October 12, after consuming one ounce of Massengill's product. However, for some unwritten reason the FDA doubted that death, in this case, was due solely to the elixir. Lindsay's North Carolina death certificate lists the cause of death as "acute nephritis" with the contributory condition of "acute streptococcic tonsillitis." It was not reported who prescribed the elixir for Lindsay.

1. FDA correspondence. Report from J. O. Clarke to P. B. Dunbar. November 17, 1937.

2. FDA correspondence. Letter from J. J. McManus to Chief, Eastern District. November 16, 1937.

3. North Carolina death certificate 41392.

4. North Carolina death certificate 40310.

5. FDA correspondence. Letter from J. J. McManus to Chief, Eastern District. November 19, 1937.

6. North Carolina death certificate 32043.

7. South Carolina death certificate 15420.

8. South Carolina death certificate 19132.

9. South Carolina death certificate 19130.

10. FDA correspondence. W. G. Campbell to George Warren. December 4, 1937.

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

12. Lynch KM. Diethylene glycol poisoning in the human. S Med J. 1938;31:134-137.

13. South Carolina death certificate 13400.

14. South Carolina death certificate 13401.

15. South Carolina death certificate 14748.

16. South Carolina death certificate 14750.

17. South Carolina death certificate 14749.

In the East, state-by-state confiscations of Massengill's Elixir Sulfanilamide were coordinated through the FDA's Baltimore and Atlanta offices—and, in most cases, in conjunction with a state's health board authorities.

Maryland

Two drug stores and a physician received the elixir. In Salisbury, a Mr. Gordy of the Gordy Drug Company acknowledged his receipt of 3 pint bottles in late September from a local Massengill salesman, who claimed that the elixir "would appeal especially to children." From one of these bottles, 2 ounces were prescribed in early October by a local doctor (Albert W. Kitts) to a "small boy" for a "throat irritation." After rushing to the boy's house, investigators found that the patient had taken only one-half teaspoon. The boy's prescribing physician had ordered the medication to be discontinued, given the child's improvement. Most important, "there were no ill effects" from the elixir dose. Commenting on his investigation, the FDA inspector "found Mr. Gordy most cooperative and it is hoped that his firm will have no notoriety in the matter that might reflect on his business and his professional standing in the community" [1,2].

Two 1-pint bottles of elixir were shipped to a Dr. A. J. Fazenbaker in Westernport, Maryland, on September 13. "Crippled with arthritis," Dr. Fazenbaker learned of the new elixir at a bridge party, where a Massengill salesman advised him that "sulfanilamide in this form would not be objectionable and that it was a good way in which the preparation might be administered to children to whom tablets or pills are generally repulsive." Intending the elixir primarily for himself, Dr. Fazenbaker ordered the bottles; "but after receipt of the medicine forgot about it until he read accounts of deaths in the Washington, DC papers." A state inspector arrived at Fazenbaker's office to seize the elixir, just before the doctor found time to act on Massengill's recall telegram of October 19, which warned of the product's deadliness [1,3].

Virginia

Twelve shipments from Bristol, Tennessee, found their way to 3 physicians and 9 drug stores scattered throughout the state. In addition, 3 dozen physician samples were distributed by a local Massengill salesman. In many cases, Virginia physicians had already heard of the elixir's danger from their local pharmacists and had poured the medication down the drain [4]. However, a dispatched FDA investigator found one physician in tiny Mannboro, about 40 miles southwest of Richmond, who had given the elixir to 2 "small children" and an 18-year-old boy. The investigator discovered that all 3 prescriptions had been used up, or nearly so, without ill effect. But the teenager had noticed clouding of his urine on the third day of treatment [5]. 

A close call also occurred in the mining hamlet of Mineral, Virginia, where a physician dispensed 4 ounces of the elixir to a "large, healthy woman" for an ear infection. When the doctor received Massengill's recall telegram, he immediately visited the woman, on the pretense of a casual follow-up. He found her alive, but she had just taken the last 3 teaspoonfuls of the medication. The FDA inspector described the ensuing reaction: "The doctor attended her breathlessly in fear of the results. She became prostrate. To use her own words, '—was never so sick in [my] life.'" But by October 25, the woman had recovered completely, her health manifest in her ability to walk "to town several times" [6].

Two other Virginia citizens were not so fortunate. Dr. D. C. Mayes of Church Road, another small dot on the Virginia map, admitted to dispensing 6 elixir prescriptions; however, he assured the visiting FDA inspector that none of his patients had suffered any ill effects. Persistence from the inspector, nevertheless, revealed that 2 of Dr. Mayes's patients had died after taking the elixir: Mrs. D. T. (Martha Agnes) Cairns (age unknown) of Petersburg on October 7 and Robert Harrison Mayes* (age unknown) of Church Road on October 17 [1,7].

The determination of the FDA to retrieve Massengill's elixir is exemplified by the case of a 19-year-old woman, Bettie, who lived 20 miles outside of the already very rural town of Emporia. After driving over "muddy dirt roads," the assigned inspector found Bettie's home, where her stepmother and father were picking cotton in the field [8].

Bettie said she had taken all the medicine she had bought...and had thrown the bottle away. She was questioned closely about how much of the medicine she received and how much she took each day, etc., and she seemed to be trying to mislead me, or is in about the class of a moron. She claimed that she couldn't remember all about the medicine and just when she did get through taking it. I think she was really trying to keep me from knowing why she was taking the medicine. I explained to her that I was not investigating her...but was just interested in the medicine, but she still claimed she had taken all the medicine and had thrown the bottle down in the woods. Her parents didn't seem to know as much about the medicine as she knew.

I was afraid some of the medicine might still be on hand so I searched through the house for it and failing to find it I looked about the premises until dark trying to locate the empty bottle.

Bettie claimed that she had no unusual or ill effects from the medicine. She said as she remembered it now she did not even have any headaches or backache while she was taking the medicine. Very little reliance, however, could be put in her statements. Only one thing is sure and that is she is still very much alive.

The inspector discovered later that Bettie's prescribing doctor had already retrieved the elixir bottle from her home, when he learned of the product's danger.

In Virginia, 11 prescriptions for Massengill's elixir caused 2 deaths (fatality rate, 18%).

West Virginia

In 10 towns sprinkled throughout the state, 8 physicians and 5 drug stores received the product in 1- or 2-pint bottles. The FDA found that most had returned their shipments to Bristol on receipt of the company's recall telegram. However, one physician had written a 3-ounce prescription for a 13-year-old girl, who lived in the 1-intersection town of Eglon. The FDA inspector managed to retrieve the entire prescription [1,9].

In Beckley, a "colored" physician with a "large practice" among the town's African Americans, Dr. R. J. Howard, had received 2 pints of Massengill's elixir. However, on October 21, inspectors from the state health department and the FDA were told by Dr. Howard that he had "none on hand." Despite the doctor's denial, the inspectors searched his office and found the 2 bottles. One was empty, "except for a few drops"; the other held approximately 2 ounces. With this discovery, the doctor admitted that he had dispensed the medication for the treatment of gonorrhea, but he claimed that he had no record of the treated patients [10].

With repeated visits, the inspectors finally convinced Dr. Howard to give up the names of 5 treated patients on October 26. Their follow-up investigation revealed that 4 had consumed their 4-ounce prescriptions to no ill effect. Two ounces of a fifth prescription were confiscated from a patient's wife.

On October 25, the state's Charleston Gazette assured its readers that no fatalities had been reported in West Virginia [11]. Further evidence, however, would reveal that 2 of Dr. Howard's elixir patients, whose names were not given to the inspectors, died. On October 11, 17-year-old William Irvin succumbed to "acute nephritis" and "uremia" at Beckley Hospital.** He had consumed probably 1 ounce of Massengill's Elixir Sulfanilamide. On October 18, miner Jonathan Walter Lyons, 35, died of "uremia following acute pyelonephritis," also at Beckley Hospital.** It is not known how much elixir Lyons had taken [1,10].

In West Virginia, 2 of 7 patients who consumed Massengill's elixir were dead (fatality rate, 28%).  

* It's not known if there was a family relationship between Dr. Mayes and Robert Mayes.

** Death certificates were signed by Dr. D. C. Ashton of Beckley. 

1. FDA correspondence. Report from J. O. Clarke to P. B. Dunbar. November 17, 1937.

2. FDA correspondence. Letter from J. F. Earnshaw to Chief, Baltimore Station. October 21, 1937.

3. FDA correspondence. Letter from Chas. F. O'Neill to Chief, Baltimore Station. October 22, 1937.

4. FDA correspondence. Letter from McKay McKinnon, Jr., to Chief, Baltimore Station. October 25, 1937.

5. FDA correspondence. Letter from McKay McKinnon, Jr., to Chief, Baltimore Station. October 23, 1937.

6. FDA correspondence. Letter from K. F. McClure to Chief, Baltimore Station. October 25, 1937.

7. FDA correspondence. Letter from F. L. Wollard to FDA, Baltimore. November 24, 1937.

8. FDA correspondence. Letter from James C. Pearson to Chief, Baltimore Station. November 16, 1937.

9. FDA correspondence. Letter from J. C. Pearson to Chief, Baltimore Station. October 24, 1937.

10. FDA correspondence. Letter from Louis L. Judge to Chief, Baltimore Station. October 27, 1937.

11. Death dealing 'elixir' seized in W. Virginia. Charleston Gazette. October 25, 1937; p 1 col 1, p 2 col 7.

For previous installments of the Elixir Sulfanilamide disaster of 1937, see the following posts (in order):

The Beginning—Tulsa

The Beginning—Tulsa (2)

Inspiration, Formula, and Distribution

Early Investigation and Recall

East St. Louis and Mt. Olive Deaths

More Deaths in the Deep South

FDA Visits Bristol, Tennessee

 

The FDA's scramble to account for all of the bottles of Massengill's Elixir Sulfanilamide began as soon as district chief William H. Hartigan and inspector Walter E. Donaldson arrived in Tulsa, Oklahoma, on October 15. After meeting with the local medical society, the officers immediately set out to determine which of the city's druggists had the elixir in stock. With the help of FDA inspector Cramer at Massengill's Kansas City distribution center and data from the company's Bristol headquarters, Hartigan and Donaldson identified the Oklahoma druggists who had received the elixir. In addition to 8 pharmacies in Tulsa, shipments had been sent to 3 drug stores 100 miles away, in Oklahoma City. Bottles had also been shipped to 1 store each in the smaller communities of McAlester, Cleveland, Duncan, Skiatook, Enid, and Claremore [1,2].

Hartigan and Donaldson obtained permission to legally confiscate Massengill's elixir bottles through the US district attorney in Tulsa (Whit Mauzy), who granted seizure of the elixir on the basis of mislabeling. Druggists' stocks, when found, were returned to either Massengill's Kansas City branch or company headquarters, where they would be tallied by on-site FDA personnel. Although stocks were often directly handed over intact, Hartigan and Donaldson occasionally found themselves scrounging through a store's back-room trash in their attempt to account for every last ounce.

To track down elixir in consumers' hands, the inspectors had to review the prescription files of druggists, some of whom were not entirely cooperative. At Tulsa's Getman Drug Store, which had dispensed 24 elixir prescriptions (including those for 6 of the deceased), the FDA encountered "extreme difficulty" with the obstructive efforts of the druggist and a prescribing doctor. In Cleveland, Oklahoma, the local drug store and a prescribing physician "interposed every possible interference in attempting to trace subdistributions." The attending physician went so far as to change prescription records that had been filed by the drug store. The FDA ultimately determined that 18-year-old Wilmer Morris, from Osage, just across the Arkansas River, had received a 4-ounce elixir prescription from the Cleveland drug vendor. He consumed about half of it and died October 27—more than a week after the death of the last Tulsa victim, Earl Beard. [1,2].

In total, FDA agents found that 38 prescriptions had been dispensed for Massengill's product throughout Oklahoma. House-to-house visits in Tulsa and other affected communities revealed that most patients had consumed at least a portion of their elixir prescription without harm. But in one case, the FDA hit a brick wall. The agency discovered that a prescription had been written by an untraceable doctor for an unnamed individual who had been driving through Tulsa. The would-be victim was never found. In 2 cases, prescriptions were procured by drug salesmen from Squibb and Abbott—ostensibly out of curiosity and for competitive intelligence [1,2].

By the end of October, the FDA identified 11 elixir-related deaths in Oklahoma. The death rate in the state was 29%.

1. Root T. Frantic fight on death is heart-breaking job. The Kansas City Journal-Post. October 31, 1937.

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

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.

By Saturday, October 23, an understanding of the distribution of deaths due to Massengill's Elixir Sulfanilamide was emerging. The AMA's Morris Fishbein now confirmed the toll at 36.* Five citizens of another Mississippi community, about 10 miles from Mt. Olive, were dead [1,2,3]:

• Claiborne L. Anderson, 37, from Laurel died October 4 of "nephritis." He had consumed 2¾ ounces of the elixir.
• Albert Cole, 19, from Laurel died October 5 of "acute nephritis." The amount he consumed was unknown.
• Robert A. Boutwell, 27, from nearby Ellisville died October 10 of "nephritis." The amount he consumed was unknown.
• James Monroe Vick, 53, from Ellisville died October 20 of "carcinoma of gallbladder and stomach." The amount he consumed was unknown.
• Emmett (or possibly Era) Pickens, age unknown, of Laurel died October 24 of "complications." One ounce of elixir had been consumed.

Other elixir-related deaths in Mississippi were reported in Magee (Hettie Young, 18, died October 5) and Philadelphia (Lorene Lewis, age unknown, died October 20). A town along the southern border of Georgia and Alabama, Eufaula, counted 3 deaths: a baby (possibly Syble G. Singleton), who died in September (date unknown); Fannie Zeanah (age unknown), who died October 13; and Alfred McDade (age unknown), who died October 17. In nearby Headland, Alabama, Anderson Crews (or Cruce), 63, died September 25. And Texas confirmed 1 death: Levi (or Levy) Kelly, 19, died October 12 in Marlin [2,3]. An elixir-related death was also suspected in California.

Laurel physician Joe Green had prescribed Massengill's Elixir Sulfanilamide for the 5 patients who died in his hometown or in nearby Ellisville, Mississippi. In a lengthy statement to the local newspaper, he reserved final judgment on the cause of the deaths—possibly due, in part, to the influence of his local Massengill rep [2]:

It is more than possible that elixir of sulfanilamide played a part in the death of five patients...This drug was prescribed by me for some fourteen or fifteen people, all of whom were sick and some desperately sick. Five of the patients who took the elixir have died and it is more than possible that the drug played a part in their demise...Only a small amount of the elixir was taken and the people that died, with possibly one exception, had diseases that could prove fatal.

The other people who took it suffered no ill effects. One small baby about two years old had a rather large amount. Yet she suffered no ill effects and her family was highly pleased with the results obtained...Some five or six people were given the elixir 12 to 30 days ago and none suffered ill effects and are all right at the present time.

In a show of quaint transparency, Dr. Green added,

We want it strictly understood, and have so informed the families where there is a possibility that injury has been done, that my files are absolutely at their disposal. All records are just as they were written and are open to public officials as well as to the families.

Dr. Green, who had received samples of the elixir from his Massengill sales rep during a regular visit, was later informed that the elixir had been recalled. According to Green, the rep claimed that "up to the present time best chemists of the American Medical Association and the company were making a close and thorough investigation, but so far had not been able to determine what poison, if any, caused death of the alleged victims." The company also expected to visit every family "which felt that the drug had injured their relatives." For what it was worth, the local Massengill rep absolved doctors and druggists of any "ill effects" from the elixir [2].

Massengill's rep also had news of a telegram from the AMA, which reported "no chemical antidote for sulfanilamide poisoning [emphasis added]" [2].

In point of fact, the Massengill company had sent the following telegram to the AMA on October 20, asking for an antidote to its product [4]:

PLEASE WIRE COLLECT BY WESTERN UNION SUGGESTION FOR ANTIDOTE AND TREATMENT FOLLOWING ELIXIR SULFANILAMIDE

And the AMA responded in terse fashion [4]:

ANTIDOTE FOR ELIXIR SULFANILAMIDE-MASSENGILL NOT KNOWN TREATMENT PRESUMABLY SYMPTOMATIC

In an attempt to exonerate his company, Dr. Massengill issued his first public statement on October 23, regarding the "unfortunate elixir sulfanilamide affair" [5]. Massengill's apparent strategy was to implicate the toxicity of sulfanilamide, while avoiding the subject of diethylene glycol altogether.

My chemists and I deeply regret the fatal results, but there was no error in the manufacture of the product. We have been supplying legitimate professional demand and not once could have foreseen the unlooked for results. I do not feel that there was any responsibility on our part. The chemical sulfanilamide had been approved for use and had been use in large quantities in other forms, and now its many bad effects are developing.

Perhaps most of the unfair statements have been given out from two sources that are willing to capitalize on this tragic occurrence to further their certain ends.

Dr. Massengill declined to name the "two sources" to the Associated Press.

* One death reported by news sources in Hutchinson, Kansas, has not been found in government records or reports in from the AMA.

1. Associated Press. Sulfanilamide elixir deaths increase to 36. St. Louis Post-Dispatch. October 23, 1937; p 3A.

2. Elixir of Sulfanilamide may have played part in deaths of five, states local doctor. The Laurel Leader-Call. October 25, 1937; p 1, col 1, 2.

3. FDA correspondence. Report from J. O. Clarke to P. B. Dunbar. November 17, 1937.

4. Survey of deaths. J Am Med Assoc. 1937;109:1539. By telegraph, the AMA had solicited treatment recommendations for diethylene glycol poisoning from those few individuals (E. K. Marshall, Jr., W. F. von Oettingen, and P. J. Hanzlik) who had studied the toxic effects of the substance. They could only recommend trials of intravenous concentrated dextrose solutions.

5. Associated Press. Elixir Sulfanilamide manufacturer disclaims responsibility. St. Louis Post-Dispatch. October 24, 1937; p 9A.

For previous installments of the Elixir Sulfanilamide disaster, see the following posts (in order):

• The Beginning—Tulsa
• The Beginning—Tulsa (2)
• Inspiration, Formula, and Distribution
• Early Investigation and Recall

In addition to the now 10 known deaths* in Tulsa, Oklahoma, caused by the consumption of Massengill's Elixir Sulfanilamide, the AMA's Morris Fishbein confirmed 4 similar deaths in East St. Louis, Illinois, to news sources on October 19. And a fifth person was dying. A young St. Louis pathologist, Omer E. Hagebusch, had performed autopsies on the local victims and wrote of their deaths to Fishbein, with the idea that publication in the AMA's flagship journal was the most expeditious way to inform physicians of the new product's risk [1].

Four days earlier, 24-year-old J. D. (Jee) Kimbrough died at St. Mary's Hospital in East St. Louis, after taking a total of about 4 tablespoons of the elixir for a "sore throat" over the course of 5 days. Symptoms of poisoning, the hallmark of which was reduced urine production, began on the fifth day of treatment, and Kimbrough was hospitalized 2 days later, October 13. He died another 2 days after admission, with a diagnosis of "encephalitis" (a label possibly applied in the absence of recognizing uremic encephalopathy induced by the elixir's diethylene glycol). Four-year-old Morris Slaughter, son of Edwin and Helen, died at the same hospital the following day, October 16, after receiving a similar amount of Massengill's product for "inguinal adenitis," a gland infection. Symptoms of poisoning began 3 days after the first dose of medication [2,3,4].

On October 18, a child and an adult died across the Mississippi River, at St. Mary's Infirmary in St. Louis, after consuming (again) a few ounces of the elixir. Like Kimbrough and Slaughter, both had received prescriptions from the same physician. Five-year-old George Nixon, son of Joseph and Mary, hung on for 10 days after symptoms of elixir poisoning began. He was given the drug for a streptococcal sore throat. A railroad switchman, Joseph L. Henry, 60, died 6 days after stopping his prescription for prostatitis [2]. (The dying fifth person was most likely widower Alexander A. Brooks, 70, who took the medication for 4 days before symptoms of poisoning began. He lasted for another 9 days at St. Mary's Infirmary before succumbing.)**

The prescribing doctor, identified repeatedly in contemporary news sources as a "Negro" physician, Dr. Henry H. Weathers maintained an active practice in East St. Louis (either at 1341 Piggott Ave. or 1421 Kansas St.), where he served a population that was largely, if not exclusively, African American. Weathers was a graduate of Meharry Medical College in Nashville, Tennessee—the first medical school for African Americans in the US South—and had served on staff at the St. Louis Negro City Hospital, an open example of racially segregated healthcare in the United States at the time [3]. Weathers reported to the St. Louis Post-Dispatch that he began prescribing Massengill's elixir, distributed by the company's Missouri branch, on October 11. He also revealed that 3 other patients, to whom he had given prescriptions, were in serious condition [3].*** According to Hagebusch's case report, Weathers had prescribed the drug to about 30 people [1]. If true, the fatality rate associated with Massengill's product (so far) was approximately 20%—a rate consistent with animal studies performed at the University of Chicago.

The day that Nixon and Henry died, the chief of the FDA's St. Louis station, A. E. Lowe, reported initial findings of his local investigation, which was based on circulating rumors of the deaths. Astonishingly a representative of the city's medical association and the bureau of vital statistics knew of no deaths related to Massengill's elixir, despite the fact that Morris Fishbein had phoned the St. Louis Board of Health earlier in the day to inquire about the local rumors. Two agents of the Board specifically advised Lowe that "a careful review" of records dating back of October 1 revealed "nothing that could possibly be of value" [6].

Lowe's check of local drug distributors and chain stores showed that only one wholesaler had purchased Massengill's Elixir Sulfanilamide. On September 24, the Meyers Brothers Drug Company received 6 pint bottles of the product. However, when the company received Massengill's recall wire on October 15, it had only 1 bottle to return. The other 5 had been distributed to local drug stores, and Meyers Brothers advised the FDA that a search of the firm's records, to identify the stores that had received the elixir, would be a "tremendous job." It would be easier to locate the bottles by surveying the area's drug stores, the company advised. So while Massengill's reps were directed to search for the at-large product on foot, 2 FDA agents began sifting through the company's 20,000 sales slips [6].

These efforts would lead to the recovery of 2 bottles of the product in East St. Louis, Illinois—an important development, given that it established interstate commerce of Massengill's elixir from its Missouri branch. In addition, recovery efforts revealed that 1-pint elixir bottles, sold directly by Massengill's sales reps, were in circulation [4,6]. One local Massengill rep, after recovering a few bottles of elixir that he sold directly himself, advised FDA agents that the deaths, if due to the company's product, resulted from "oxidation" of the substance on contact with air. In an illogical attempt to bolster his argument, he added that adverse effects had only resulted when the drug was administered from 1-gallon containers and that "no illness has yet been traced to the pint bottles" [4].

Whether Massengill's rep came up with this explanation on his own or received it from company headquarters is unclear. Regardless, the argument was both scientific nonsense and false. In a statement to the Post-Dispatch, Dr. Weathers attempted to clarify where fault lay [7]: 

There has been an impression created that the error causing the East St. Louis deaths was made locally, either on my part or by the four East. St. Louis drug stores filling the prescription, so I wish to point out that the prescription was a legitimate one and that the error, if any, was made by the Kansas City pharmaceutical company which prepared the elixir. Sulfanilamide has been used extensively and successfully by physicians in other sections of the country. 

Nationwide misinformation and misunderstanding about Massengill's elixir and the cause of the related deaths in Tulsa and the St. Louis area remained among physicians, despite published explanations from Weathers and, most important, Fishbein. For instance, Ohio's health director, perhaps attempting to explain the apparent absence of deaths in his state, implied to the local press that only certain lots of the product were inadvertently contaminated [8].

However, given that diethylene glycol was an intended and major ingredient in Massengill's product, a local inquiry into recent, unexplained deaths in the St. Louis area was proceeding. Examined cases included 23-year-old manicurist Hazel Fea, who died of a "mystifying" case of acute nephritis on October 10 at Barnes Hospital. Investigation would reveal that, about 5 days earlier, Fea had consumed a total of 2 ounces of Massengill's elixir, which was prescribed for an "abdominal ailment." Fea had received the prescription directly from her physician, a Dr. Philip M. Dale of Granite City, Illinois, who had dispensed it from one of Massengill's 1-pint bottles [7]. Dr. Dale had also given the elixir to 3 other patients, including his wife, with "no ill effects" [9]. 

News of more deaths, including those in Massengill's home state, would undermine the explanations of those who tried to divert blame or allay public fear. On October 20, Charles W. Miller, a married 25-year-old gas station attendant from Memphis, Tennessee, died at Methodist Hospital after taking about 4 ounces of the elixir. The local paper described how Miller had obtained the product without a doctor's prescription [7,10,11].

Mr. Miller, friends of his family said, took the elixir to cure a venereal disease which he believed he had contracted. He sent a negro to the drug store with a note telling the druggist of his suspected ailment. The drug clerk prescribed the elixir of sulfanilamide. 

The following day (the same day that Alexander Brooks, of East St. Louis, died), a Baptist minister, 65-year-old James Edward Byrd died in a Knoxville, Tennessee, hospital after taking "13 doses" of the elixir. The reverend, a resident of a tiny town in southern Mississippi, Mt. Olive, had been traveling on clerical business when he became ill. He had received his prescription from his longtime friend and hometown physician, Dr. Archibald "Archie" Calhoun [12].

Calhoun, a seasoned doctor and highly respected Mt. Olive native, ran a busy, racially integrated practice out of a 2-room office above his brother's drug store. He began prescribing Massengill's liquid medication in mid-September, after receiving a sales call from a company rep; one of Calhoun's first patients was a visiting cousin, who took 4 ounces, without ill effect. Calhoun proceeded to prescribe Elixir Sulfanilamide for a dozen individuals, including his office nurse, Evelyn Sharbough. However, one of his patients died (probably Eddie Sullivan), and he couldn't figure out why.

When Calhoun received the company's October 19 telegram warning of the elixir's potential to kill, he "rode all night visiting every patient that I could remember prescribing to" [12,13]. But for half of them, it was too late. In addition to Reverend Byrd, the elixir's local victims were Eddie Sullivan, of nearby Magee, who died October 17; Otis Coulter, 36, who died October 19; Mrs. J. Edmond (Vala) Penn, who died in the early morning hours of October 20; and "two negroes," the Associated Press reported. The last 2 victims were Gussie Mae (or Jessie May) Grubbs and Leffie (or Linnie) Easterling, both Mt. Olive residents who most likely died on October 20 after consuming 3-4 ounces each.

In a public letter, Dr. Calhoun expressed his anguish at the fatalities and his role in them [14]:

Nobody but Almighty God and I can know what I have been through in these past few days. I have been familiar with death in the years since I received my M.D. from Tulane University School of Medicine with the rest of my class of 1911. Covington County has been my home. I have practiced here for years. Any doctor who has practiced more than a quarter of a century has seen his share of death.

But to realize that six human beings, all of them my patients, one of them my best friend, are dead because they took medicine that I prescribed for them innocently, and to realize that that medicine which I have used for years in such cases suddenly had become a deadly poison in its newest and most modern form, as recommended by a great and reputable pharmaceutical firm in Tennessee; well, that realization has given me such days and nights of mental and spiritual agony as I did not believe a human being could undergo and survive. I have spent hours on my knees, once I had done all any physician could do for his patients. I have known hours when death for me would be a welcome relief from this agony.

Thank God, the six remaining patients to whom I gave that medicine show no signs of dying as a result. It seems like a miracle to me. I have spent hours driving to see every one of them, white and Negro. I have checked and rechecked their condition several times a day. Why they are not dead like the first six who died, I do not understand. For some obscure physical reason, their bodies were able, apparently, to throw off the poisonous effects of the medicine.

It is miraculous to me. I do not understand it. But I am grateful to Almighty God. Those six deaths weigh heavily enough on my mind and heart. Six more! I shudder when I think of it as a possibility. To me those six yet living who took that elixir have been like six human beings standing under sentence of death ever since I got the warning from the pharmaceutical house that made and sold it, that it was poisonous in that form. I have lost track of how many miles I have driven, trying to counteract the results of the fatal mistake of the men who prepared that medicine.

I want to make it clear to the lay world that there is nothing poisonous or unfamiliar in sulfanilamide as a medicine in itself. It is invaluable in cases involving the urinary tract. I have used it for years. Hitherto it has come in two forms, a powder taken in capsules, and in tablets. I could not ever tell without checking my records how many hundreds of times I have prescribed it. But in capsule and tablet form it is very distasteful to many patients.

Within the past few weeks a representative of this big Tennessee pharmaceutical firm came to me with a liquid preparation of this drug, called Elixir Sulfanilamide, that was easier for patients to take than sulfanilamide in capsule or tablet form. He induced me to get it and administer it to my patients. The high standing of the firm he represented was all the recommendation their products needed. So I got some.

I am informed now that diethylene glycol, a solvent in the elixir, is responsible for its poisonous effect, its toxicity.

I had prescribed this elixir to 12 patients and they had taken it when I received a telegram from the pharmaceutical firm informing me that they had discovered its effect was deadly.

Imagine my feelings. My heart sank. I stood reading that telegram with cold sweat streaming down my forehead. Then I started out to warn all those 12 patients who had taken this elixir on my prescription, and to do all in my power to save their lives.

The Rev. J. E. Byrd, secretary of the Mississippi state Baptist Sunday school board, was one of them. He was my closest personal friend, as well as my patient. And he died at Knoxville, Tenn., where he was rushed in a vain effort to save his life. Then Mrs. J. E. Penn, Ed Sullivan and Otis Coulter died in the hospital at Magee, Miss., where they were taken. Then the two negresses, Jessie May Grubbs and Leffie Easterling died.

They died in agony. The effect of this poisonous elixir was violent nausea, and acute abdominal cramps, and complete cessation of the function of the kidneys.

Six dead because of medicine I had prescribed for them innocently! Six dead, who would have been living if I had prescribed for them the old, familiar sulfanilamide in its tablet or capsule form! One of them my closest friend on this earth, the Rev. Byrd.

But it was worse than that. There were six more human beings who had taken that elixir on my prescription, who were living yet, and who to me were living under sentence of death as surely as if jury and judge had convicted and sentenced them, and the gallows and the noose awaited. They had trusted me. I was their physician. They took the medicine I prescribed in complete confidence.

As I said at the beginning, nobody but Almighty God and I know what I have been through. Whenever I hear the words "living in hell" on this earth again, I know now what they mean. I have lived in a hell of fear for those human lives ever since I read that telegram from the pharmaceutical house.

But it seems as if a miracle had been vouchsafed those remaining six.

I checked again on every one of those remaining six cases today. In lay language, they seem "out of the woods." I believe that they are going to live, now, though I do not know why. Any doctor after a quarter of a century of practice can tell you of human beings who have refused obstinately to die; who have lived when as far as their physician could tell, they were condemned to death by causes beyond their physician's control. That is the case with these six who live yet. They seem on the road to recovery. They have been spared the death of agony that was the portion of the other six. I thank God on my knees for that.

But it seems to me that somebody should be responsible for the preparation of that elixir that brought an agonizing death to six innocent patients. 

The total number of known deaths caused by the consumption of Massengill's Elixir Sulfanilamide was now 23: 10 in Tulsa; 6 in the St. Louis area; 1 in Tennessee; and 6 from Mt. Olive, Mississippi.

* Millard Wesley Wakeford, 5; Joan Marler, 6; Michael S. Sheehan, 6; John "Jack" King (a child, age currently unknown); Mary Earline Waters/Watters, 10 months; Robert "Bobby" Sumner (a child, age currently unknown); Kathleen Hobson, 8; Glen F. Entler, 19; Charlene Mardell Canady, 4; and Earl L. Beard, 25.

** A retrospective comparison of autopsy findings from the East St. Louis victims with those from experimental animals given diethylene glycol at the University of Chicago, would reveal striking similarities [2]. On October 20, an autopsy on 2 guinea pigs in Tulsa, which died after being dosed with Elixir Sulfanilamide, also showed renal findings that were similar to those of the city's human victims [5].

*** One of these patients was likely housewife Gertrude Lee Black, 38, who died at Homer G. Phillips Hospital in St. Louis, Missouri, on October 24, 1937.

1. Hagebusch GE. Necropsies of four patients following administration of Elixir of Sulfanilamide-Massengill. J Am Med Assoc. 1937;109:1537-1539.

2. Geiling EMK, Cannon PR. Pathologic effects of Elixir of Sulfanilamide (diethylene glycol) poisoning: a clinical and experimental correlation--final report. J Am Med Assoc. 1937;111:919-926. According the case description for Alexander Brooks, he broke the first bottle of Massengill's elixir after consuming about 3 ounces. He then obtained a second bottle without consulting his physician (presumably Weathers). He took 1/2 ounce "from the second bottle at which time physician called."

3. Four deaths here among 13 laid to use of new drug. St. Louis Post-Dispatch. October 19, 1937; p 3A.

4. FDA correspondence. S. W. Ahlmann to Central District Chief. October 18, 1937.

5. Associated Press. Pigs used in new drug quiz: doctors perform autopsy, find clues in strange death investigation. Ada News Weekly. October 21, 1937; p 6 col 6.

6. FDA correspondence. A. E. Lowe to Central District Chief. October 18, 1937. See also FDA report Part I. Elixir Sulfanilamide Investigation. The FDA determined that Meyers Brothers sent 4 pints to East St. Louis (3 pharmacies) and 1 pint to a pharmacy in Lovejoy, IL.

7. Associated Press. New drug fatal to pastor and gas station operator. Kingsport Times. October 21, 1937.

8. Alleged fatal drug is widely in use here. The Lima News. October 21, 1937; p 4, col 5.

9. Death in elixir case to be probed: Granite City woman may have succumbed to poison drug dose. Globe-Democrat. October 21, 1937. [FDA files]

10. FDA correspondence. J. O. Clarke to P. B. Dunbar. November 17, 1937.

11. Poison 'elixir' kills Memphian who had druggist prescribe; medical society gives warning. The Commerical Appeal. October 21, 1937; p 1. 

12. Associated Press. Sulfanilamide elixir kills 6 in Mississippi. St. Louis Post-Dispatch. October 22, 1937; p 3A.

13. Toler K. Dr. A. S. Calhoun commended by Mt. Olive for candidness about lethal drug cases. News Commercial. October 29, 1937; p 1,2.

14. Calhoun AS. Doctor's story of deaths. New Orleans States. October 22, 1937. Dr. Calhoun's surviving patients were listed as Mrs. Frank Hamilton, 29; Velma Lucas, 21; Mrs. H. D. [or N. E.?] Booth, 60; Mrs. Baxter Pittman, 38; Lula Herring, 30; and Evelyn Sharbough. See Breazeale J. Elixir victim is laid to rest. New Orleans Item-Tribune. October 24, 1937.

The bottle contained...a reddish, somewhat viscous liquid, having an aromatic odor resembling raspberry and anise, a sweet taste, and resembling glycerin in general physical character.

———Journal of the American Medical Association, November 6, 1937

When the AMA learned of the Tulsa deaths and that diethylene glycol was a prominent ingredient in Massengill's Elixir Sulfanilamide, the organization immediately sought out the product for testing. In addition to receiving a 50-mL bottle (~1.7 fluid ounces) of the elixir from Tulsa physician Darwin B. Childs (which his patient, Glen Entler, had purchased from the city's Quaker Drug Company), the AMA obtained samples on the open market and a 1-gallon bottle directly from the Massengill company. Investigators at the AMA's chemical laboratory found the product to be "a reddish, somewhat viscous liquid, having an aromatic odor resembling raspberry and anise, a sweet taste, and resembling glycerin in general physical character" [1]. Distillation experiments confirmed the elixir to be a solution of approximately 40 grains (~2.6 g) of sulfanilamide per fluid ounce in a "menstrum" of about 72% diethylene glycol and about 16% water [1,2].

Although diethylene glycol was suspected to be the kidney-damaging substance in the Tulsa cases, it was not known if the solvent had any effect on the toxicity of sulfanilamide or vice versa. It was also not known if there had been any errors in Massengill's manufacturing process. The AMA's Morris Fishbein advised, "Indeed the possibilities are unlimited, since we are here concerned with a preparation not standardized by any reliable agency, semisecret in composition, and apparently hastily rushed into the market to meet an overenthusiastic reception of a new remedy [2]." But when the AMA's chemical laboratory tested the elixir's solid residue, they found sulfanilamide to be chemically intact—meaning that the diethylene glycol solvent had not affected the antibiotic [1]. Further tests also failed to reveal other potentially toxic substances, like lead, mercury, or arsenic.

Immediate experiments on rats, rabbits, and dogs at the University of Chicago showed effects that were strikingly similar to those seen in the Tulsa victims: death, always preceded by anuria, was observed in 20%-30% of animals that received either diethylene glycol alone, Massengill's elixir, or a synthetic version of the product (which had been mixed up by the AMA for experimental purposes). However, the authors noted the toxicity of the substance varied considerably among species and among individual animals. Most important, sulfanilamide, by itself, did not produce the same renal symptoms or death [3]. The experiments therefore confirmed the suspicion that chemically intact diethylene glycol in Massengill's preparation was the lethal ingredient and had not affected the toxicity of the antibiotic.

In conjunction with the arrival of FDA inspectors William H. Hartigan and Walter E. Donaldson on October 15, 1937, the Tulsa County Medical Society launched its own investigation of the deceased children who "had a peculiar kidney ailment, following sore throats" [4]. Despite the fact that there were rumors of similar deaths in the St. Louis area, there remained confusion as to why "the particular treatment would affect children in Tulsa and not...children or patients in other places where it [presumably sulfanilamide generally] has been used to much greater extent." To that end, cases of unexplained death in the area would be reexamined, and local tests of the elixir on guinea pigs were initiated [5].

Hartigan himself anticipated a cautious and perhaps protracted investigation in Tulsa, given his experience several years earlier with numerous cases of paralysis in Oklahoma City [5]. Consuming months, the investigation led to the discovery of Jamaica ginger, or "jake," that was adulterated with a neuropathy-inducing organophosphate. The jake, sold legally as a medicinal compound, was consumed enthusiastically for its alcohol content during the era of prohibition [6]. Hartigan's immediate job in Tulsa was to secure samples of Massengill's elixir for testing at the FDA's Baltimore laboratory. In the meantime, the president of the Tulsa Retail Druggists urged its members not to sell sulfanilamide without a prescription, and the sale of Massengill's elixir was to be discontinued entirely [4,7].

On Monday, October 18, 1937, Fishbein publicized the dangers of Massengill's elixir in an editorial released to the nation's newspapers and radio stations. Specifically he identified the death-causing ingredient: "It would appear that diethylene glycol rather than sulfanilamide was responsible since one of the patients [Glen Entler] had received [sulfanilamide] tablets over a period of two weeks without any bad effects and then developed the typical train of symptoms after taking the elixir...This tragic experience should be a final warning to physicians relative to the prescribing and administration of semi-secret, unstandardized preparations" [8]. Despite the understandable speed with which Fishbein acted to warn a vulnerable public, the finality of his report (and probably its chastising tone toward those who prescribed the elixir) was resented by Tulsa physicians. They still were waiting for an official AMA report on the analysis of local samples and, perhaps taking a cue from Hartigan, believed that a more complete investigation was necessary before judgment could be pronounced [9,10].

At present, Hartigan's boss, FDA Commissioner Walter G. Campbell was less emphatic than Fishbein about the cause of the Tulsa deaths. "We do not know as yet the explanation of the fatalities," he told the Associated Press. "It has been reported that the solvent, diethylene glycol, is probably the responsible agent. We know that there is something radically wrong" [11].

To initiate an investigation of all liquid sulfanilamide preparations on the US market, Campbell air-mailed the following letter to the agency's District Chiefs on October 18 [12].

The tragic results at Tulsa, Oklahoma, following the administration of sulfanilamide elixir made with diethylene glycol, indicate the necessity of immediate investigation of preparations of sulfanilamide already placed on the market by numerous pharmaceutical houses and coming into existence in new form almost daily.

For the present, it is suggested that this investigation be restricted to liquid preparations since these are more likely to undergo change than are the tablet and other solid preparations.

Because of the fact that Baltimore Station has already inaugurated a study of sulfanilamide preparations, such samples as are collected in the immediate future, may, if desired, be sent to that laboratory for examination. Each District, however, should promptly arrange for examinations of sulfanilamide preparations in one or more of its own laboratories.

Regardless of whether competing liquid products (if they existed*) posed the same risk as Massengill's product, an urgent and complete withdrawal of the proprietary elixir was imperative. Although the company had initiated its own recall by telegraph, Campbell initiated the FDA's oversight of what would become a massive and far-reaching process, ultimately drawing on nearly all of the agency's field force [13]. Federal seizure of the poisonous product, Campbell argued, would have to be rationalized on the basis of a "technical and trivial charge of misbranding," given the "present inadequate Federal law" [14]. Technically an elixir should contain alcohol, the FDA claimed; Massengill's product did not.

The FDA first targeted Massengill's distribution branches. On October 19, Campbell telegraphed San Francisco's FDA chief [13]:

MAKE INVESTIGATION MASSENGILLS SAN FRANCISCO BRANCH TO ASSURE NO DISTRIBUTIONS BEING MADE FROM THERE AND THAT OUTSTANDING STOCKS SO FAR AS POSSIBLE ARE BEING RECALLED PERIOD ANY STOCKS BEING DISTRIBUTED OR WHICH ARE NOT PROMPTLY WITHDRAWN FROM SALE REPORT FOR SEIZURE

Meanwhile, in Bristol, FDA agents Klumpp and Ford pushed Massengill to issue more explicit telegrams to all elixir consignees, given that the company's previous wires conveyed no sense of the product's toxicity or the emergency of situation. The follow-up telegrams, which were sent to all those listed as having received shipments from the company's headquarters or 1 of its 3 branches, now included the warning, "PRODUCT MAY BE DANGEROUS TO LIFE" [15].

The large job of taking Massengill's elixir out of the hands of consumers was forecasted by a quick inventory of product remaining at the company's Kansas City distribution center (which was the source of the elixir in Tulsa). FDA inspector Leo J. Cramer found a little more than 4 gallons left of the 40 gallons made there. In addition, the company's initial telegrams resulted in the return of 27 unopened pint bottles; 21 opened pint bottles, some of which contained as little as 4 ounces; and a 1-gallon bottle that was about 5/6 full. Optimistically the tally left approximately 30 gallons unaccounted for. After this disheartening inventory, the local production manager told the inspector "that if harmful effects had resulted from the use of Elixir Sulfanilamide...they were due either to improper dispensing or from the use of other drugs in connection with this product" [16].

At Massengill's San Francisco branch, the FDA's local chief inspector found that, of the nearly 30 gallons shipped from Bristol (in pints, gallons, or samples), more than 4 gallons of the elixir, mostly in pint containers, had been distributed regionally between September 23 to October 13. These were shipped to a dozen pharmacies, several physicians offices, and one hospital. Some shipments went to nearby Oakland, but most were dispersed to small towns scattered throughout the middle of California. Two pints each were shipped to Meeker, Colorado, and Eugene, Oregon. On the morning of October 19, only 2 1-pint bottles had been returned from drug stores [17,18].

Massengill's New York branch in Greenwich Village had sent out 21 pints of the approximately 8 1/2 gallons it received from Bristol. From September 19 to October 11, these pint bottles were shipped throughout New York, Connecticut, and Pennsylvania to a handful of physicians or druggists and 1 hospital.** In addition, several bottles were sent to a Massengill distributor in Puerto Rico, and 30 salesman samples had also been shipped. Although Massengill's branch manager, Athel W. Price, knew of the elixir recall, he claimed that did not know the reason until he was told by the visiting FDA inspectors [19].

When the FDA showed up on the afternoon of October 18 to the New York office, Price was initially cooperative; however, the following day, he put up considerable resistance to an on-site inspection for the remaining elixir. His stubbornness could only be broken by a telegram (GIVE GOVERNMENT AGENTS FULL INFORMATION DO NOT CONCEAL ANY FACT) and a phone call from the home office, but not before he tried the limited patience of New York City health inspectors—who, by this time, were also on the scene. As payback, the city agents confiscated, not only Price's remaining lots of elixir, but all of his other sulfanilamide products (tablets, capsules, and ampules). When Price asked the FDA inspector to intervene, the on-site agent declared that he could only honor the independence of the 2 regulatory bodies [19].

Back in Tulsa, physicians witnessed a small medical victory. Eight-year-old John T. "Jack" Voorhees was recovering after receiving a total of 2 ounces of Massengill's elixir for a sore throat. Like the other Tulsa victims, Voorhees experienced symptoms of nephritis but "did not pass into complete anuria." In news reports, doctors attributed his recovery to aggressive oral hydration—namely the consumption of 1 gallon of water and 2 quarts of fruit juice daily. Local reports also indicated that Tulsa's experimental guinea pigs were now "near death" after receiving the elixir [20].

And papers finally confirmed rumors of elixir-related deaths in the St. Louis area, after Fishbein officially announced the news. Without knowledge of the Tulsa deaths, a pathologist had sent the following case report to the AMA journal on October 19, with the "thought that this information should be in the hands of as many physicians as possible, and The Journal was the best means of accomplishing this end" [21].

In the last several days I have seen four deaths in patients using a product called "Elixir of Sulfanilamide" and sold by Massengill & Company.

These patients, all Negroes, were treated by a Dr. [H. H.] Weathers of East St. Louis, Ill. In all he has given the drug to about thirty people, but of the six people treated recently four are dead and have come to autopsy. One is expected to die at any time, and one may recover.

All have had similar symptoms: vomiting and diarrhea, subnormal temperatures, slow respiration, anuria, edema of the face, hands and feet, a progressive anemia and then death.

All four autopsies have shown the same findings; pulmonary edema, marked nephritis with hemorrhage into the cortex of the kidney, marked hemorrhage into the pericardium, mucosa of the stomach and duodenum and into the serous surfaces of lung and liver. The liver is pale, edematous and enlarged. Microscopic sections have not as yet been completed.

* Reports circulated that an identical product was being marketing by the Merrill Company of Cincinnati. (FDA correspondence. John L. Harvey to Western District Stations. October 20, 1937.)

** One shipment, to the Ira Shapiro Co. in New York City, was made on behalf of the Winthrop Chemical Co. Winthrop then sent Massengill's product to its Albany laboratories for analysis [19].

1. Schoeffel EW, Kreider HR, Peterson JB. Chemical examination of Elixir of Sulfanilamide-Massengill. J Am Med Assoc. 1937;109:1367.

2. Deaths following Elixir of Sulfanilamide-Massengill. J Am Med Assoc. 1937;109:1367.

3. Geiling EMK, Coon JM, Schoeffel EW. Preliminary report of toxicity studies on rats, rabbits, and dogs. J Am Med Assoc. 1937;109:1532-1536. These data were consistent with concurrent experiments conducted by the FDA's chief pharmacologist, Herbert O. Calvery. See also a final, follow-up report from the University of Chicago investigators: Geiling EMK, Cannon PR. Pathologic effects of Elixir of Sulfanilamide (diethylene glycol) poisoning: a clinical and experimental correlation--final report. J Am Med Assoc. 1938;111:919-926.

4. Probe started in deaths of Tulsa children. Tulsa Tribune. October 15, 1937; p 1 col 6.

5. Death answer may be late: Tulsa investigators are to be thorough. Tulsa Tribune. October 16, 1937; p 1 col 5.

6. Parascandola J. The Public Health Service and Jamaica ginger paralysis in the 1930s. Public Health Rep. 1995;110:361-363.

7. Manufacturers seek to recall drug shipments: Tulsa deaths bring editorial comment in medical men's journal. Tulsa Tribune. October 18, 1937; p 1 col 4, p 3 col 1.

8. Associated Press. Drug preparation blamed in deaths. New York Times. October 19, 1937; p 27.

9. Finality of AMA report resented: doctors here continue laboratory work with drug. Tulsa Daily World. October 19, 37.

10. Associated Press. Tulsa medical group acts. New York Times. October 19, 1937; p 27.

11. Associated Press. Shipments of fatal drug are seized by federal food body. Daily Capital News (Jefferson, Missouri). October 20, 1937; p 10 col 6.

12. FDA correspondence. Letter from W. G Campbell to Chiefs of Districts. October 18, 1937.

13. FDA correspondence. Telegram from W. G. Campbell to FDA, San Francisco, California. October 18, 1937.

14. Associated Press. Drug fatality case is traced to elixir. New York Times. October 20, 1937.

15. Wallace HA. Report of the Secretary of Agriculture on the deaths due to Elixir-Sulfanilamide-Massengill. November 16, 1937. The exact text of the telegram sent to all consignees listed as having received shipments of the elixir from the company's Kansas City, New York, and San Francisco branches: IMPERATIVE YOU TAKE UP IMMEDIATELY ALL ELIXIR SULFANILAMIDE YOU MAY HAVE DISPENSED. PRODUCT MAY BE DANGEROUS TO LIFE. RETURN OUR EXPENSE.

16. FDA correspondence. Letter from Leo J. Cramer to Central District Chief. October 18, 1937.

17. FDA correpondence. Telegram from W. G. Campbell to FDA, San Francisco. October 20, 1927.

18. FDA correspondence. Letter from R. B. Bork to San Francisco Chief. October 19, 1937.

19. FDA memorandum. Charles Hyak. October 21, 1937.

20. New deaths spur inquiry: four die in Illinois; Tulsa boy recovering. Tulsa Tribune. October 19, 1937; p 1 col 2, p 4 col 7.

21. Hagebusch GE. Necropsies of four patients following administration of Elixir of Sulfanilamide-Massengill. J Am Med Assoc. 1937;109:1537-1539.

[W]e are here concerned with a preparation not standardized by any reliable agency, semisecret in composition and apparently hastily rushed into the market to meet an overenthusiastic reception of a new remedy.

———Journal of the American Medical Association, October 23, 1937

In June 1937, drug salesmen for the S. E. Massengill Co. of Bristol, Tennessee, reported demand for a liquid preparation of the new, wildly popular antibiotic sulfanilamide [1], which was currently sold in capsule and tablet forms by several US pharmaceutical interests, including the Massengill company.

Only 5 years earlier, a corporate chemist for the German conglomerate I. G. Farben, Gerhard Domagk (left), had demonstrated the life-saving properties of a related compound, an azo dye trade-named Prontosil, in streptococcal-infected mice [2]. One year later, a German physician reported dramatic recovery of an infant with staphylcoccal septicemia after receiving Prontosil [3], and Domagk successfully used the agent on his own daughter, who was near death with streptococcal septicemia [4].

Then in 1935, French investigators showed that the active metabolite of the patented Prontosil was actually sulfanilamide—a compound that had been synthesized by an Austrian chemist more than 25 years earlier [5,6]. Consequently sulfanilamide was in the public domain and available for general production. Quick, follow-up studies of Prontosil and sulfanilamide by physicians in London and at Johns Hopkins established the equivalence of the 2 agents in human streptococcal infections [7,8].

But the real enthusiasm for sulfanilamide would be generated by a high-profile case study. Shortly before the Hopkins work was printed in the medical literature, news reports were buzzing with the recuperation of the American President's son, Franklin D. Roosevelt, Jr., from a serious throat and sinus infection. While hospitalized at the Massachusetts General Hospital in December 1936, the junior Roosevelt was treated with sulfanilamide tablets (branded as Prontylin by the Winthrop Chemical Co., NY) in a near last-ditch effort. The dramatic recovery of the President's son after treatment with the antibiotic was chronicled faithfully by Associated Press reports in the country's newspapers, including the New York Times [9].

Scientific endorsement and the glowing anecdoctal publicity for sulfaniladmide fueled widespread zeal for the drug among physicians and the American public. And zeal gave way to near fanaticism when medical studies described sulfanilamide's efficacy in cases of gonorrhea. News reports, overstating the medical findings, startled some readers by broadcasting that the drug was "the best thing ever for gonorrhea" and cured the veneral disease in 48 hours [10].

Soon the American market was flooded with several competitive brands of the antibiotic, including Prontosil (the original Farben drug), sulfanilamide, and several brand names for identical preparations. In May 1937, the AMA's Council on Pharmacy and Chemistry attempted to avert confusion by adopting "sulfanilamide" as the preferred nonproprietary term for the drug and stated, "It is regretted that certain firms in America are using proprietary names [for sulfanilamide]" [11].

Established in 1905, the Council's job was to determine standards for pharmaceutical manufacturing and advertising and to eradicate quackery [12]. In the absence of any federal legislation that required proof of safety, efficacy, or advertising claims for pharmaceutical products, the Council, in 1937, was the leading authority that reviewed and endorsed or dismissed commercial medicines that were submitted for inclusion in its widely read pharmacopoeia, New and Nonofficial Remedies. In July 1937, the Council published its "Examination of Certain American Brands of Sulfanilamide," which included assessments of products from the major American pharmaceutical firms Eli Lilly, Merck, Parke Davis, and E. R. Squibb & Sons [13]. The preparations were in powder, tablet, and injectable forms; no orally administered solution existed. The Council advised that the drug "has the apparent disadvantage of being relatively insoluble" and has a tendency to crystallize out of solution [11].

In the wake of continued enthusiasm for the drug, an editorial in the October 2nd issue of the AMA's journal—while acknowledging that the drug was "truly remarkable"—warned against its indiscriminate use [14]. Toxic reactions, including dermatitits, photosensitization of the skin, and hemoglobin abnormalities, had been reported. Specifically some cases of self-medication for venereal disease were associated with severe drug reactions, which necessitated hospitalization. (Although sulfanilamide was largely dispensed by means of prescription in the United States, no federal law in 1937 prevented pharmacists from providing the drug directly to the patient, on request.) The editorial warned, "Responsibility lies considerably with pharmacists who are willing to sell dangerous drugs to anybody over the counter."

In 1937, the S. E. Massengill Company introduced its own versions of sulfanilamide tablets and capsules for human consumption to the US market [15]. Originally a small family operation, the Bristol-based company began manufacturing nonproprietary pharmaceuticals for regional distribution at the end of the 19th century. Since 1916, the company had been led by one of its founding brothers, president Samuel E. Massengill, a proud and locally respected descendant of East Tennessee's original Massengill settlers and a 1899 medical graduate of the University of Nashville. 

Steady growth of Massengill's company during the early 20th century, from a 1-room laboratory to a 4-building plant on "spacious grounds" in the piedmont city of Bristol, eventually led to the establishment of a manufacturing and distribution branch in Kansas City, Missouri, and warehouses in New York City and San Francisco. Sales offices were also established in Hawaii and Puerto Rico. Massengill himself boasted that his company was "the largest pharmaceutical manufacturer for the entire South." At the end of 1936, net annual sales were recorded at more than $1.6 million (more than $24 million in 2007 USD) [16].  

The firm's 1936 catalog, which offered hundreds of tablets, capsules, elixirs, or ointments, reads like a drug compendium on the cusp of modern medicine. Products like antimony wine, mercurial ointment, and rhubarb elixir share index space with aspirin, novocaine, and phenobarbital. The catalog promised," Every step in the manufacture of our general line of pharmaceuticals is under the supervision of skilled workmen and strict chemical control, and the physician may rely upon our products for prompt and full therapeutic effect" [17].

In fact, the FDA had brought charges against the S. E. Massengill Company on 3 previous occasions, all during the 1930s. The cases, however, were not unusual in character or frequency given the nature of the pharmaceutical industry at the time. In 1 case, the company's Fluidextract of Colchicum, a gout treatment, was found to be overstrength; in another, the strenth of its Tincture of Aconite was determined to be below its stated concentration. Fines of $250 and $150, respectively, were paid by the company for these 2 infractions. In the third instance, the seizure of Massengill's Elixir Terpin Hydrate and Codeine, a steadfast cough suppressant, was based on charges of adulturation and misbranding. The case was successfully prosecuted in court [18]. 

Despite the fact that sulfonilamide was relatively insoluble in the typical pharmaceutical solvents, Massengill's head chemist, Harold Cole Watkins, was not deterred [1]. The son of a Maine newspaper publisher, Watkins had graduated from the University of Michigan in 1900 with a degree in pharmaceutical chemistry and thereafter had led an itinerant career in the drug industry. He performed laboratory work for Merck and was employed briefly in "various wholesale and pharmaceutical houses" [19]. US census records show that Watkins worked as a chemist in Spokane, Washington, in 1910, and in Brooklyn, New York, in 1920 (where he lived with his Norweigian wife, Marie, and their 4-year-old son, who was born in California). Census records from 1930 suggest that Watkins may have tried his luck at farming in the town of Benton in northeastern Pennsylvania (with Marie and their 2 sons). This brief career change may have had something to do with the fact that Watkins (as Watkins Laboratories) had been cited by the Solicitor of the Post Office Department on charges of fraud the previous year.  Records indicate that, on October 30, 1929, the chemist agreed to discontinue the promotion of a weight-loss medicine, which he had claimed produced a "perfect slenderness" and a "trim, youthful, athletic look" [1].

In any event, 5 years later, Watkins moved his family to the relatively cloistered city of Bristol to join the Massengill company as head chemist. He was 55. In the summer of 1937, he set out to find a liquid vehicle for sulfonilamide at the company and turned his attention to the glycols. He based this decision on their chemical similarity to glycerine, a commonly used solvent in liquid pharmaceuticals [19]. He soon discovered that he could dissolve as many as 75 grains of sulfanilamide in 1 fluid ounce of clear, odorless diethylene glycol. However, the resultant solution tended to separate on chilling, so he reduced the antibiotic concentration to 40 grains per fluid ounce and quickly settled on the following mass-quantity recipe for a stable product [1]:

Sulfanilamide, 58½ pounds
Elixir flavor, 1 gallon
Raspberry extract, 1 pint
Saccharine, soluble, 1 pound
Amaranth solution, 1-16, 1½ pints [a synethic, bright red, azo dye, which was presumably added to resemble the color of the patented Prontosil]
Caramel, 2 fluid ounces
Diethylene glycol, 60 gallons
Water q. s., 80 gallons

No animal or clinical tests were conducted by Watkins or the company at large to determine the toxicity of the individual ingredients or that of the combination. Any possible effects of diethylene glycol on sulfanilamide were also left to chance. The company's sole process for quality control consisted of checking the elixir for its appearance, flavor, and fragrance. The Acting Chief of FDA's Drug Division, Theodore Klumpp, bluntly described the company's elixir development: "[T]he only criteria of its safety and value as a medicine were that the ingredients were mixed, did not immediately explode, and the color, taste and smell of the product were satisfactory to their so-called control department" [20].

Watkins was evidently unaware that, for several years, the FDA had advised against the use of glycol solvents in foods, on the basis of limited safety data [21]. He was also presumably ignorant of 2 published reports, one in 1931 and one in early 1937, which described the lethality of diethylene glycol in experimental animals [22,23]. 

In late August, Watkins's formula for Massengill's Elixir Sulfanilamide was sent to the company's Kansas City branch in Missouri (208-214 W. 19th St.), where 40 gallons of the product were mixed in a large "stone jar" on September 20 [24,25]. Supplied instructions were remarkably simple: "Dissolve sulfanilamide in the diethylene glycol, add the other ingredients and mix" [25]. Sulfanilamide was obtained by the company from Ganes Chemical Works in New York, and diethylene glycol was purchased (at 23 cents per gallon) from Carbide & Chemical Corporation in West Virginia. No assay was made of the finished product, despite the fact that tests for sulfonilamide in blood and urine had been described several months earlier by pharmacologists at Johns Hopkins in the Journal of the AMA [18]. Another batch of 40 gallons was produced by Watkins himself at the company's Bristol plant, which began shipping the product to its San Francisco and New York branches on September 4 [1,26,27]. Two more batches of 80 gallons each were manufactured at Bristol; most of these batches also went into distribution.

Commercial lots from 1 pint to 1 gallon were shipped from Massengill's Bristol and Kansas City plants, as well as from its New York and San Francisco sales branches. In all, 633 shipments were made. The product label (example below) failed to list the product's ingredients, other than sulfanilamide. In addition, a total of 671 physicians' or salesmen's samples were sent from Bristol or Kansas City.* In time with the mass distribution, a promotional brochure for physicians announced, "Our research department has just released an Elixir Sulfanilamide...It is ideal for your patients who can take liquids—but little else. Also, it is not unpleasant to take, so is suitable for children" [28].

Both commercial and sample lots were distributed nationwide through October 15, 1937—the same day that Tulsa physicians telegraphed the AMA to convey their autopsy findings from 5 children who had consumed the elixir.

* The company employed approximately 200 salesmen.

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

2. Domagk G. Ein beitrag sur chemotherapie der bakteriellen infektionen. Deutsche Medizinische Wochenschraft. 1935;xx:250-253. Domagk's company, I. G. Farben, received a German patent for Prontosil on December 25, 1932. However, the patent was not published until January 1935, for reasons unclear. One month later, Domagk's landmark article was printed. The author offered clear credit to his company above the article's title ("Aus den Forschungslaboratorien der I. G. Fabenindustrie...") and little explanation for Prontosil's mechanism of antibacterial action, only writing that the agent possibly bolstered the immune system. For this work, Domagk would receive the Nobel Prize for Physiology or Medicine in 1939; however, he was prevented from accepting the prize at the time by the Nazi government.

3. Foerster R. Sepsis im anschluß an ausgedehnte periporitis: heilung durch streptozon. Zentralbl Haut Geschlechtskr Grenzgeb. 1933;45:549-550.

4. Dictionary of Scientific Biography. 1972:4:153-156.

5. Trefouel J, Trefouel J, Mitti F, Bovet D. Activite due p-aminophenylsulfamide sur les infections streptococciques expeimentales de la souris et du lapin. C R Seances Soc Biol Fil. 1935:120:756-760. English bacteriologist Ronald Hare—mistrusting German pharmaceutical development—argued that Domagk, in fact, knew in 1932 that the no-longer-patented sulfanilamide was the active ingredient in Prontosil. Hare further claimed that the intervening time between Domagk's initial experiments and his 1935 publication was sucked up by the creation and testing of a patentable analog of sulfanilamide (ie, Prontosil) for the interests of his company, I. G. Farben. (See Dowling HF. Fighting Infection: Conquests of the Twentieth Century. Cambridge, Mass.: Harvard University Press; 1977:108-124.)

6. Gelmo P. Uber sulfamide der p-amidobenzolsulfonsaure. J Praktische Chemie. 1908;77:369-382.

7. Colebrook L, Kenny M. Treatment of human peurperal infections, and of experimental infections in mice, with Prontosil. Lancet. 1936;June 6:1279-1286.

8. Long PH, Bliss EA. Para-amino-benzene-sulfonamide and its derivatives. J Am Med Assoc. 1937;108:32-37. For a contemporaneous history of the development of sulfanilamide and its introduction into the United States, see Long PH, Bliss EA. The historical aspects of sulfanilamide therapy. In: The Clinical and Experimental Use of Sulfanilamide, Sulfapyradine and Allied Compounds. New York, NY: MacMillan Company; 1939:1-13.

9. F D Roosevelt Jr is in Boston hospital; sinus attack calls mother to bedside. New York Times. Nov 27, 1936; Young Roosevelt better. New York Times. Nov 28, 1936; Mrs Roosevelt visits ill son. New York Times. Dec 11, 1936; Roosevelt operation delayed till Monday. New York Times. Dec 12, 1936; Young Roosevelt better. New York Times. Dec 13, 1936; President’s son still ill. New York Times. Dec 14, 1936; Franklin D Jr improving. New York Times. Dec 15, 1936; Young Roosevelt saved by new drug. New York Times. Dec 17, 1936.

10. Drug and Cosmetic Industry. July 1937.

11. Council on Pharmacy and Chemistry. Sulfonilamide and related compounds. J Am Med Assoc. 1937;108:1888-1890.

12. Smith A. The Council on Pharmcy and Chemistry and the Chemical Laboratory. In: Fishbein M, ed. A History of the American Medical Association, 1847 to 1947. Philadelphia, Pa.: W. B. Saunders Co. 1947:865-886. Note that the federal Food and Drugs Act of 1906, still in effect in 1937, merely required manufacturers to accurately label and brand medicinal products that were intended for interstate commerce.

13. The Chemical Laboratory. Examination of certain American brands of sulfanilamide. J Am Med Assoc. 1937;109:353-359.

14. Sulfonilamide--a warning [editorial]. J Am Med Assoc. 1937;109:1128.

15. Masengill Brothers Company and the S. E. Massengill Company, 1897-1971. Knoxville, Tenn.: Tennessee Valley Publishing; 1996.

16. Massengill, Samuel Evans. In: National Cyclopaedia of American Biography. Vol 34. New York City, NY: James T. White and Company; 1948; FDA records. Company assessment by Dun & Bradstreet, Inc. November 8, 1937.

17. Complete Catalog of the Products of the Laboratories of the S. E. Massengill Company. Bristol, Tenn.: King Printing Co.; 1936.

18. Citations of Notices of Judgment Under the Food and Drugs Act (23228 [1935], 27136 [1937], 24029 [1935]) and FDA correspondence (George Larrick to Central District Chief, November 21, 1934). In: Parascandola J, Whorton JC, eds. Chemistry and Modern Society: Historical Essays in Honor of Aaron J. Inde. Washington, DC: American Chemical Society; 1983:105-125.

19. Citations of FDA reports in Young JH. Sulfanilamide and diethylene glycol. In: Parascandola J, Whorton JC, eds. Chemistry and Modern Society: Historical Essays in Honor of Aaron J. Inde. Washington, DC: American Chemical Society; 1983:105-125. Young writes, "During the depression, Watkins had been idle some of the time, before joining Massengill."

20. FDA correspondence. Theodore O. Klumpp to Perrin H. Long. November 1, 1937. Klumpp also wrote, "It is also a sad but true fact that the chemist told me that they could not assay the sulfanilamid because there were no assay methods known. This might lead Doctor Marshall to wonder what he has been doing with his time all these months." Presumably Klumpp is referring to pharmacologist Eli Kennerly Marshall, PhD, of Johns Hopkins, who was lead author of "Para-aminobenzenesulfonamide: absorption and excretion--method of determination in urine and blood." The article, describing assays for sulfonamide, was printed several months earlier, in the March 20 issue of the Journal of the AMA (1937;108:953-956).

21. FDA correspondence. July 26, 1938.

22. von Oettingen WF, Jirouch EA. Pharmacology of ethylene glycol and some of its derivatives. J Pharmacol Exp Ther. 1931;42:355-372.

23. Haag HB, Ambrose AM. Studies on the physiological effect of diethylene glycol. J Pharmacol Exp Ther. 1937;59:93-100.

24. FDA correspondence: October 18, 1937, and Leo J. Cramer to Baltimore Station Chief. October 20, 1937. According to an FDA investigative report of the distribution of sulfanilamide (from FDA inspector Hugh F. Smyser, November 11, 1937, re interview with Otto B. May), the antibiotic was manufactured by heating acetanilid with chlorsulphonic acid, drowning in flake ice, and filtering in crocks. "The resulting paste is charged with ammonia, neutralized with sulfuric acid, filtered and charged with hydrochloric acid and neutralized with sodium hydroxide and filtered. Instead of recrystallizing twice as a matter of routine, the product is recrystallized from hot water repeatedly until two successive recrystallizations give a constant melting point. Three recrystallizations are the usual number."

25. FDA correspondence. Letter from Leo J. Cramer to Chief, Baltimore Station. October 21, 1937. The letter provides an inventory of samples sent from Massengill's Kansas City branch to the FDA's Baltimore laboratory for testing. 

26. FDA correspondence. W. G. Campbell to Central District Chief. November 12, 1937.

27. FDA memorandum. Charles Hyak. October 21, 1937.

28. Citation of Massengill brochure in Young JH. Sulfanilamide and diethylene glycol. In: Parascandola J, Whorton JC, eds. Chemistry and Modern Society: Historical Essays in Honor of Aaron J. Inde. Washington, DC: American Chemical Society; 1983:105-125. For Massengill's salesmen's talking points, see FDA correspondence. J. F. Earnshaw to Baltimore Station Chief. October 19, 1937.

Photo of Gerhard Domagk from nobelprize.org.

On Saturday, October 9, 1937, the following telegram was sent from the Springer Clinic in Tulsa, Oklahoma, to Dr. Morris Fishbein, editor of the Journal of the American Medical Association in Chicago [1].

ATTENTION IS CALLED TO AT LEAST SIX DEATHS IN TULSA FOLLOWING ADMINISTRATION OF ELIXIR OF SULFANILAMIDE SYMPTOMS OF ANURIA AND TOXIC DEGENERATION OF LIVER AND KIDNEYS

The necessary brevity of the clinic's wire understated the tragedy of the deaths. Five days earlier, a 5-year-old boy, Millard Wesley Wakeford, died in a Tulsa hospital (possibly Morningside Hospital or St. Joseph's), after receiving a 4-ounce prescription for the elixir [1,2]. Then the following night, a 6-year-old girl, Joan Marlar, died in hospital. She had received a 3-ounce prescription [1,3]. 

The deaths continued. Michael S. Sheehan, a 6-year-old boy, died October 6, and 8-year-old Kathleen E. Hobson died October 9. Both had received 4-ounce prescriptions for the elixir. Then a young man died Saturday, after taking Massengill's concoction: 19-year-old Glen F. Entler of Tuscola, Illinois, who had been visiting his aunt and uncle in the city [1,4].*

The deaths were not peaceful. Twenty-four hours after Entler had taken approximately 9 ounces of the elixir (about 260 cc), he developed symptoms of acute nephritis—nausea, vomiting, and intense flank pain. A day later he stopped producing urine altogether. (Dialysis for acute renal failure wouldn't be available for at least another decade.) He died 4 days after taking the last dose of medication [1]. Joan Marlar's mother described her daughter's anguish during the 9-day illness before her death. "[W]e 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"[5].

A pathologist in Tulsa, Dr. Ivo A. Nelson, had noticed the cluster of unusual nephritis cases and quickly suspected poisoning [6]. After dismissing the possibility of mercuric chloride toxicity, he interviewed the families and doctors of the victims and discovered, in all cases, that Massengill's elixir had been prescribed. In some cases, it was the only medication consumed by the deceased. 

After performing autopsies on 4 of the victims, Dr. Nelson "took his findings to his horrified associates in the Tulsa County Medical society, some of whom had prescribed the solution—notably child specialists" [6]. (Presumably Nelson presented his medical findings to the society on the evening of October 10, 1937, per Dr. James Stephenson's telegram to the AMA.)  

On October 12, the AMA determined by telegraph that Massengill's product contained a substantial amount of diethylene glycol, a known toxin. However, this information was too late for the parents of 4-year-old Charlene Canady of Tulsa, who had received the elixir for a sore throat. The girl died that day [1].

On Friday, October 15, Dr. Homer Ruprecht and Dr. Nelson telegraphed their autopsy findings on the Tulsa victims to the AMA. Eight out of 10 were now dead, and one was in critical condition. Astonishingly one patient had recovered. Urine production typically stopped within 2 days after patients received variable amounts (as little as one-half ounce) of the antibiotic elixir. Death occurred within 2-7 days after the onset of anuria. Gross postmortem findings revealed cortical necrosis of the kidneys, and microscopic examination showed a "consistent hydropic tubular nephrosis." No oxalate crystals were observed in the kidneys (as suggested by data conveyed by the AMA's Paul Leech). The telegram ended with, "Federal inspectors arrived today"[7].

In fact, the first word of the Tulsa deaths only came to the Food and Drug Administration the previous day. A New York physician "associated with a large drug manufacturing concern" had evidently telephoned the agency and repeated rumors, "presumably through professional or trade contacts, that fatalities had occurred at Tulsa" [5,8]. Immediately the agency telegraphed its Kansas City Office, and 2 agents, district chief William H. Hartigan and Walter E. Donaldson, "jumped into a motor car." They arrived in Tulsa, 250 miles away, the following morning and wired their findings to the FDA's Chicago office, which, in turn, wired Washington, DC [6,9].

TULSA COUNTY MEDICAL SOCIETY SUSPECTS DEATHS EIGHT CHILD STREPTOCOCCIC THROAT CASES ONE ADULT GONORRHEAL DUE ALIXIR[sic] SULFANILAMIDE MASSENGILLS SYMPTOMS ACUTE ANURIA STOP MEDICAL SOCIETY SUBMITTED SAMPLE TO AMERICAN MEDICAL ASSOCIATION STOP THREE SAMPLES ELIXIR COLLECTED TODAY FROM RETAIL DRUGGISTS WHO WITHHELD STOCKS FROM SALE ON REQUEST MEDICAL SOCIETY AIR EXPRESS-ED BALTIMORE STOP STLOUIS NOTIFIED VIA WESTERNUNION RUMOR HERE SIMILAR CIRCUMSTANCES STLOUIS WILL CONTINUE INVESTIGATION INCLUDING CLINICAL RECORDS UNTIL FURTHER NOTICE...MEDICAL ASSOCIATION REPORTS DIETHYLENE GLYCOL FOUND IN THEIR SAMPLE STOP CINCINNATI INSPECTOR WITH KLUMPP PROCEEDING BRISTOL FOR INVESTIGATION MASSENGILL STOP WILL FORWARD SAMPLES FINISHED PRODUCT AND ALL RAW MATERIAL BALTIMORE STOP HARTIGAN INSTRUCTED EMBARGO ALL WHOLESALE AND RETAIL LOTS IN TULSA STOP CINCINNATI TO REPORT ALL DISTRIBUTIONS THIS AND OTHER CODES PROBABLY CONTAINING DEITHYLENEGLYCOL AND ALL LOTS WILL BE EMBARGOED PENDING COMPLETE INVESTIGATION STOP BALTIMORE BEING ADVISED.

Most concerning was a rumor that similar cases had been observed in St. Louis, Missouri. Indeed, a pathologist in East St. Louis, Illinois, who was unaware of the Tulsa deaths, was preparing his necropsy report of 4 patients who had consumed the new antibiotic elixir [10]. And in addition to notifying its St. Louis office, the FDA was sending investigators (ie, Cincinnati inspector William T. Ford and the FDA's Acting Chief of its Drug Division, Theodore G. Klumpp, MD) to the Massengill company in Bristol, Tennessee.

For his part, Massengill was engaged in shrouded damage control. (The company had also learned of the Tulsa deaths in a complaint from the city's Getman Drug Store, which had dispensed several prescriptions for the elixir, including those to the deceased.) The day that FDA agents arrived in Tulsa, the Massengill company sent out more than 1000 telegrams nationwide [5]:

To its customers: DO NOT USE ELIXIR SULFANILAMIDE SHIPPED. RETURN OUR EXPENSE.

To its salesmen: ELIXIR SULFANILAMIDE DISCONTINUED. PICK UP AS RAPIDLY AS POSSIBLE ALL SOLD IN YOUR TERRITORY.

To "jobbers" (presumably wholesalers), druggists, and doctors who had received the product: HAVE WITHDRAWN PRODUCT ELIXIR SULFANILAMIDE. PLEASE RETURN UNUSED STOCKS IMMEDIATELY.

But within 24 hours, Massengill's elixir claimed its ninth Tulsa victim, Earl L. Beard, 26 years. He had received an 8-ounce prescription for the product and was ill for 2 days before requiring hospitalization [11,12,13,14].

* The sixth death at this time has not been deduced by this blog writer. It was likely one of 3 children: John "Jack" King; Robert "Bobby" Sumner; or 10-month-old Mary Earline Watters (or Waters). Each had received either a 3- or 4-ounce prescription for Massengill's Elixir Sulfanilamide.

1. FDA records. Correspondence from AMA Council, October 13, 1937.

2. Tulsa Daily World. October 6, 1937.

3. Tulsa Daily World. October 7, 1937.

4. Tulsa Daily World. October 10, 1937.

5. Wallace HA. Report of the Secretary of Agriculture on the deaths due to Elixir-Sulfanilamide-Massengill. November 16, 1937. The AMA also reported that it telegraphed the FDA on October 14, 1937, regarding the presence of diethylene glycol in Massengill's product. See footnote in Deaths due to Elixir of Sulfanilamide-Massengill. J Am Med Assoc. 1937;109:1985-1987.

6. Frantic fight on death is heart-breaking job. Kansas City J. October 31, 1937. According to the article, "precious days, hours, minutes were saved by" the work of Dr. Nelson.

7. Ruprecht HA, Nelson IA. Elixir of Sulfanilamide-Massengill: clinical and pathologic observations. J Am Med Assoc. 1937;109:1537.

8. FDA records. Letter from Perrin H. Long to FDA, October 15, 1937. The letter conveys information that rumors regarding the Elixir-Sulfanilamide deaths began spreading in the Tulsa community on October 7, 1937. A representative from Squibb and Sons and a representative from Winthrop Chemical Company reportedly called on several hospitals in the Tulsa area to obtain additional information. The reps discovered that all patients who were dead at the time, 5 children, were attended by the same pediatricians and were prescribed Massengill's product.

9. FDA records. Record of telegraph correspondence, October 16, 1937.

10. Hagebusch OE. Elixir of Sulfanilamide-Massengill: necropsies of four patients following administration of Elixir of Sulfanilamide-Massengill. J Am Med Assoc. 1937;109:1537-1539.

11. Tulsa Daily World. October 17, 1937.

12. Tulsa Tribune. October 17, 1937.

13. FDA records. November 20, 1937, correspondence.

14. Tulsa Tribune. October 17, 1937.

Picture of bottle of DEG-tainted Elixir Sulfanilamide from the FDA.

In 1937, more than 100 US citizens—many children—died after consuming Elixir Sulfanilamide, a raspberry-flavored antibiotic syrup manufactured by the S. E. Massengill Pharmaceutical Company of Bristol, Tennessee. The difficult-to-dissolve antibiotic was mixed with diethylene glycol (DEG), a known toxin, by the company's uninformed head chemist, Harold Cole Watkins. Watkins reportedly tested the elixir only for its appearance and palatability before its nationwide distribution. The catastrophic event led to the passage of the 1938 Federal Food, Drug, and Cosmetic Act.

In a series of posts (and perhaps what may be a very lengthy series), the Pathophilia blog will attempt to provide a chronology of this US pharmaceutical disaster, drawing on primary sources when available. The effort is intended to be a kind of memorial to those who died as a result of the catastrophe and an homage to those who attempted to avert further disaster. However, the reader's indulgence is requested for what may frequently resemble a patchwork construction: Because the series is a work in progress, newly discovered and rediscovered information, as it emerges, may need to be incorporated into existing posts for clarity, accuracy, and completeness. For those individuals whose family, friends, or colleagues were directly affected by the event, your input and corrections are urged.

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In the fall of 1937, the first reports of deaths that were suspected to be related to the S. E. Massengill Company's "Elixir Sulfanilamide" came from Homer A. Ruprecht, MD, of the Springer Clinic of Tulsa, Oklahoma, and James Stephenson, MD, president of the Tulsa County Medical Society. Their correspondence, by telegraph and letter, to the American Medical Association indicates the historical importance of the national association and its journal editor, Morris Fishbein, MD, as primary sources of medical and pharmaceutical guidance for physicians in the country (in contradistinction to the Food and Drug Administration or any other government agency, at the time). Specifically the AMA had formed the Council on Pharmacy and Chemistry in 1905, an organization created to examine the composition of industry-submitted pharmaceutical products for sale in the United States.

On Saturday, October 9, 1937, the following telegram was sent from the Springer Clinic in Tulsa to Dr. Fishbein in Chicago.

ATTENTION IS CALLED TO AT LEAST SIX DEATHS IN TULSA FOLLOWING ADMINISTRATION OF ELIXIR OF SULFANILAMIDE SYMPTOMS OF ANURIA AND TOXIC DEGENERATION OF LIVER AND KIDNEYS

In Dr. Fishbein's absence, Paul Nicholas Leech, PhD, Secretary of the AMA's Council on Pharmacy and Chemistry responded:

YOUR TELEGRAM WILL BE BROUGHT TO DR FISHBEINS ATTENTION ON HIS RETURN THURSDAY STOP IN MEANTIME WOULD APPRECIATE RECEIVING FULL DETAILS CONCERNING DEATHS IF THIS OFFICE CAN AID YOU FURTHER PLEASE ADVISE

The following day, Sunday, Dr. Stephenson telegraphed the AMA with a brief description of the deaths and asked for information regarding the contents of the elixir:

ELIXIR SULFANILAMIDE MASSENGILL THERAPY MANY CASES COMPLETE ANURIA WITH UREMIA TULSA COUNTY MEDICAL SOCIETY MEETS SUNDAY NIGHT DESIRE ALL POSSIBLE INFORMATION AT ONCE WIRE OR PHONE ME MY EXPENSE

Leech responded, indicating that the Council had not examined any such elixir:

NO PRODUCT MASSENGILL COMPANY ACCEPTED BY COUNCIL ON PHARMACY AND CHEMISTRY STOP SULFANILAMIDE IN ELIXIRS NOT RECOMMENDED STOP PHYSICIANS WOULD DO WELL TO USE ONLY ACCEPTED BRANDS AND DOSAGE FORMS STOP SEE EDITORIAL IN JOURNAL OCTOBER SECOND COMMA TEN ARTICLES IN JOURNAL SEPTEMBER TWENTY FIFTH AND COUNCIL REPORTS IN JOURNAL MAY TWENTY NINTH AND JULY THIRTY FIRST

The October 2nd editorial, referred to by Leech (Sulfanilamide—a warning. J Am Med Assoc. 1937;109:1128), advised of the potential toxicities of the wildly popular antibiotic—namely, dermatitis, photosensitization, granulocytopenia, and sulfhemoglobinemia—and the indiscriminate use of the product and its unvetted derivatives. These warnings were initially provided in reports to the journal and published in its September 25th issue. The Council on Pharmacy and Chemistry also submitted its review of the antibiotic, related compounds, and proprietary US formulations in the May and July issues of the journal (Sulfanilamide. J Am Med Assoc. 1937;108:1888-1890; New and nonofficial remedies: sulfanilamide. J Am Med Assoc. 1937;109:358-359). 

In a letter to the AMA, dated Monday, October 11, Dr. Ruprecht of the Springer Clinic further described the affected Tulsa patients and their symptoms:

Received your telegram in response to our wire regarding elixir of sulfanilamide. The details are as follows:

We have a list of ten patients who have received an elixir of sulfanilamide, all of which, so far as we have been able to determine, has been manufactured by the S. E. Massengill Company. Of these ten patients, four are living, two of whom have definitely recovered, and the other two will probably die. Eight of these patients were children and the drug was given because of an upper respiratory infection. The other two patients were young men and the drug was used for a gonorrheal infection. One of the latter two patients had received tablets of sulfanilamide over a period of two weeks without any bad effects and then changed doctors and the second doctor put him on the elixir of sulfanilamide and the typical train of symptoms followed shortly afterwards.

The onset is usually with nausea, vomiting, malaise, sometimes diarrhea, and then complete anuria. The N.P.N. [nonprotein nitrogen] urea nitrogen and creatinine rise rapidly. A fixed acid acidosis develops and death follows. Autopsy shows a marked accumulation of fluid in all the serous cavities and intense hydropic degeneration of the kidney tubules and a marked periferal[sic] type of liver necrosis.

We have asked Getman Drug Company of Tulsa to forward a sample of the material for analysis. Would appreciate any information which you can give me at the earliest opportunity.

In a separate letter, Dr. Darwin B. Childs of Tulsa indicated that he was providing a bottle of elixir to the AMA:

Under separate cover I am sending you a sample in the originally dispensed bottle, of "Elixir of Sulfanilamide".

This medicine was p