Ethics: February 2009 Archives

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.

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.

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.

• 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.

A nationwide recall has recovered more than 400 bottles of the product, and the Nigerian government has shut down the responsible company, Barewa Pharmaceuticals, in Lagos. Reuters also indicates that "a number of people involved in distributing [the product] have been arrested."

The AP writes that DEG entered the product when a Barewa official attempted to purchase propylene glycol, a "normal" ingredient in teething formula, from an unregistered chemical dealer on the slum fringes of Lagos. Historically DEG has been a cheap (and very toxic) substitute for glycerin in consumer products. The active ingredient in My Pikin is reported as paracetamol, aka acetaminophen.

Death due to the consumption of DEG is almost universally due to renal shutdown. For a list of previous incidents of DEG-contaminated consumer products, go here, and read ongoing posts about the 1937 Elixir Sulfanilamide disaster in the United States at this blog.

Photo of My Pikin Baby Teething Formula from Vanguard.

In a final act, Rod Blagojevich, the crazy ex-governor of Illinois, approved an increase in the state's Medicaid reimbursement rates to pediatricians who provide critical care services. Today's Chicago Tribune, which has the story (or at least some of it), reports that the governor's last-minute decision did not need a legislative nod. The percentage increase in Medicaid reimbursement was evidently not revealed by state officials.

Among the many charges in the federal complaint against Blagojevich—which led to his bizarre and unprecedented impeachment—is the allegation that he tried to squeeze the CEO of Children's Memorial Hospital in Chicago, Patrick Magoon, for a $50,000 contribution last November. In exchange, the governor would approve $8 million in state funds, as urged by a pediatric healthcare initiative, We Care for Illinois Kids, a coalition that promotes increased reimbursement rates for specialized pediatric care.

The coalition supports Illinois HB5331, which stipulates that physician fee rates for the All Kids Insurance Program (the state's Medicaid program for children) must increase to competitive levels. Currently pediatric specialists in Illinois received only 33 cents for every dollar spent on Medicaid patients, one of the lowest Medicaid reimbursement rates in the country. The Children's Hospital of Chicago is the state's largest provider of inpatient, outpatient, and physician Medicaid services.

Despite Blago's final attempt to increase pediatric Medicaid funding, which is to be reviewed by the current governor—the bland but, god willing, semi-ethical Pat Quinn—the funds are "nowhere near" enough, according to an involved lawmaker who was cited by the Trib.

This most recently developed theory of antivaccinationists proposes that simultaneous administration of multiple vaccines somehow affects (overwhelms, weakens, etc) a child's immune system, which in turn leads to some sort of neurologic effect that triggers autism. The big problem with this theory, as Gerber and Offit rightly note, is that there is no evidence that autism is an immune-mediated (or specifically autoimmune-mediated) disease.

Their counterarguments, with respect to vaccines:

• They do not overwhelm or weaken even a new infant's immune system—which, although immature, can generate "a vast array of protective responses."
• The total immunologic load of currently recommended vaccines (14) is actually much less than that of recommended vaccines administered in 1980 (7)—all thanks to advances in protein chemistry and DNA technology.
• Vaccines actually represent a tiny fraction of the immunologic challenges (eg, all those environmental antigens running around) that a child typically encounters.
• Vaccines don't "weaken" the immune system, as evidenced by the equivalent susceptibility to infections* among vaccinated and unvaccinated children.
• Last, there are no clinical data** to support the idea that spreading out or reducing the number of childhood vaccinations reduces the incidence of autism.

* Non-vaccine preventable.

** And for good reason, because such a study would be unethical.

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.

At present, WHO urges the following measures to stifle the spread of disease:

• Improve awareness of cholera prevention and treatment, particularly among residents in remote sections of the country.
• Increase the availability of oral rehydration salts and chlorine tablets within communities to enable a rapid response.
• Mobilize financial resources to pay Zimbabwe's healthcare workers, many of whom cannot pay for basic needs like transportation to work. WHO concludes, "This vacuum in availability of national health staff is a prime factor in the increasing number of cholera sufferers dying."
• Increase public access to nongovernmental organizations, like Médecins Sans Frontieres (aka Doctors Without Borders), which fill the current void in national services.
• Strengthen the "multisectoral" response of the United Nations, nongovernmental groups, donors, and the Zimbabwe government.

WHO's Assistant Director-General for the group's Health Action Crises Cluster, Dr. Eric Larouche advised, "Political differences need to be put aside, economic barriers overcome, health services in the country's periphery strengthened and community awareness to respond enhanced to save many more people from dying due to a disease that can be readily prevented and treated." Although the case fatality rate of Zimbabwe's epidemic has decreased slightly, reports WHO, it remains higher than 5%,* and the death rate at the community level is approximately 3 times higher than that in health facilities.

* The "acceptable" death rate is less than 1%. 

Map showing spread of cholera in Zimbabwe as of December 8, 2008, from Wikipedia.