Sulfa drugs held out the promise of being the wonder drugs of the 1930s: they cured bacterial infections such as pneumonia, blood poisoning, and meningitis. And so their use spread rapidly. Output of sulfa drugs in the United States in 1937—the first year of real commercial production—totaled about 350,000 pounds; by 1940, it had more than doubled. By 1942, it topped an estimated 10 million pounds.
Sulfanilamide, one of the first of the sulfa drugs, had been used safely for some time in tablet and powder form, but it was hard to swallow as a tablet and not especially palatable as an injection either. Children tended to balk at both.
In 1937, S. E. Massengill Co., a small drug formulator in Bristol, TN, sought to meet the demand for a drinkable liquid preparation. Harold Cole Watkins, Massengill's chief chemist, experimented and found that sulfanilamide would dissolve in diethylene glycol. The company control lab tested the mixture for flavor, appearance, and fragrance and found it satisfactory.
The concoction was called Elixir Sulfanilamide despite the lack of ethanol, an ingredient that was required for a preparation to receive the elixir designation. Immediately, the company compounded a quantity of the elixir and sent shipments--633 of them--all over the country. The presence of diethylene glycol was not divulged on the bottle labels. Furthermore, Massengill made no tests on its elixir before shipping from its plant in September.
One of the major points of delivery of the drug was Tulsa, OK. By early October, James Stephenson, the president of the Tulsa County Medical Society, had been notified that six local patients had unexpectedly died from renal failure after ingesting Elixir Sulfanilamide. In an October 11 telegraph to the American Medical Association, Dr. Stephenson requested the composition of the elixir. The AMA responded that they were unaware of any product from the Massengill Company and had never approved a liquid sulfanilamide preparation.
The AMA telegraphed Dr. Samual Evans Massengill, the firm's owner, requesting the composition of the elixir. Massengill released this proprietary information but urged that it be kept strictly confidential. He hypothesized that the deaths may have been caused by mixing the elixir with other drugs. Massengill and Watkins reluctantly admitted, however, that toxicity tests had not been done. To show confidence in his product, Watkins self-administered small amounts of diethylene glycol and elixir. No adverse effects were noted.
But the AMA laboratory had meantime isolated diethylene glycol as the toxic ingredient and immediately issued a warning, through newspapers and radio, that Elixir Sulfanilamide was toxic and deadly.
Walter Campbell, the chief of the Food & Drug Administration, assigned almost all of the bureau's 239 inspectors and chemists to the case, sending field agents immediately to the Massengill's headquarters in Bristol and to branch offices in Kansas City, New York, and San Francisco. They found that the firm had already learned of the poisonous effects of the liquid sulfanilamide and had sent telegrams to more than 1,000 salesmen, druggists, and doctors.
However, the telegrams merely requested the return of the product and failed to indicate the urgency of the situation or say that the drug was lethal. At FDA's insistence, the firm sent out a second wave of messages, worded more strongly: "Imperative you take up immediately all elixir sulfanilamide dispensed. Product may be dangerous to life. Return all stocks, our expense."
Dr. Massengill said: "My chemists and I deeply regret the fatal results, but there was no error in the manufacture of the product. We have been supplying a 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 firm's chemist apparently did not share this feeling; Harold Watkins committed suicide after learning of the effects of his latest concoction.
Through the dogged persistence of federal, state, and local health agencies and the effects of the AMA and the news media, most of the elixir was recovered. Of 240 gallons manufactured and distributed, 234 gallons and 1 pint were retrieved; the remainder was consumed and caused the deaths of more than 100 victims nationwide.
Under the U.S. food and drug law then in place, the government seized Massengill's deadly mixture only because it was misbranded; "elixir" implied that the solvent in the bottle was ethyl alcohol. Drug dispensers were required by law to label their products accurately but not to test them for safety. The company was fined $16,800 for its false label.
The lethal mixture, however, did encourage enactment of a much-strengthened food and drug law that was then pending in Congress. The Federal Food, Drug, and Cosmetics Act of 1938, which overhauled the law of 1906, stipulated that manufacturers must test any new drug for safety and report the results to the U.S. Food and Drug Administration. Some predicted that the new act would stifle research, but FDA historian Wallace Janssen says the reverse has been true: the research required by the law has stimulated medical progress.
sources: www.annals.org/cgi/content/full/122/6/456
http://pubs.acs.org/subscribe/journals/tcaw/10/i06/html/06chemch.html
www.fda.gov/AboutFDA/WhatWeDo/History/ProductRegulation/SulfanilamideDisaster/default.htm
Strauss's federal drug laws and examination review, by Steven Strauss, CRC Press, 2000
When I was born, I guess everybody just threw up their hands! The night I was born, Hobart went to visit with the neighbors, the Buckles family, across the street. According to Hobart, Mr. Gray Buckles said, “Well, It looks like the stork is visiting Oscar’s house again." Joe Bush, one of the Buckles’ relatives who was also visiting, responded: "Hell, that ain’t no stork! That’s a duck! The stork’s done worn its legs off!” So, I came into the world with laughter echoing on Carolina Hill.
---from ‘The Flavour of Home: A Southern Appalachian Family Remembers’ by Earlene Rather O’Dell
Earlene O’Dell, born in Bristol, TN, certainly wasn’t the first person in Appalachia to be exposed to the idea that the stork delivers babies. This myth can be found widely throughout US culture. In O’Dell’s case, it’s entirely possible that she could have encountered North America’s only native stork, the wood stork, as a child. The wood stork has a post-breeding summer range that extends from its Gulf Coast wetlands nest areas north to Arkansas, Tennessee, and North Carolina.
But the physical presence of wood storks hardly explains why ‘stork stories’ are so prevalent in areas of the US where wood storks never venture. The folk tales and beliefs that Appalachia’s German immigrants brought to their new home are a better place to look. The stork’s association with babies seems to have originated in northern Germany centuries ago.
In that country, white storks are known as “Adebar” which translates as “luck-bringer.” And apparently seed bringer, as well; even today pregnant German women are said to have been ‘bitten by the stork.’
Storks nesting on one's roof means good luck generally, and especially in the form of family happiness. The birds were actively encouraged to nest there. German nursery stories are full of references to the stork delivering babies down a chimney. By contrast, in rural Denmark, it means bad luck if a stork builds a nest on your roof; someone in the house will die before the end of the year.
One popular German stork tale revolves around the folk legend that the souls of unborn children live in watery areas such as marshes, wells, springs and ponds. Since storks visit such habitats frequently, they were believed to fetch babies’ souls and deliver them to their parents.White storks are highly migratory, leaving Europe for Africa in the fall. They return to central and northern Europe in late March or early April, and hence are regarded as a herald of spring.
They arrive just about nine months after Midsummer's Day, June 21, the summer solstice and the longest day of the year. This was a major festival in pagan Europe, a time for weddings and merrymaking well lubricated by fermented beverages.
(After the arrival of Christianity the feast continued to be celebrated as Saint John's Day; the modern association of June with weddings may also be related to this festival.) The return of storks just as the progeny resulting from summer revels put in their appearance would not have gone unnoted.
Furthermore, storks are monogamous, tend to return to and raise their annual offspring in the same nests, and seem to attach themselves to the same houses or villages year after year.
No surprise, then, that they’ve come to symbolize traditional human ideals of home, family, fertility, faithfulness and constancy.
Sources: The Flavour of Home: A Southern Appalachian Family Remembers, by Earlene Rather O’Dell, The Overmountain Press, 2000
Beacham's Guide to the Endangered Species of North America, by Walton Beacham et al., Thomson Gale, 2000
www.cafebabel.com/eng/article/24532/bun-in-the-oven.html
www.straightdope.com/columns/read/2144/why-are-storks-associated-with-babies
www.etymonline.com/index.php?term=stork
stork+myth Earlene+Rather+O’Dell.+Bristol+TN appalachia appalachia+history appalachian+history
