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see her little body tossing to and fro and hear that little voice screaming with pain and it seems as though it would drive me insane. ... It is my plea that you will take steps to prevent such sales of drugs that will take little lives and leave such suffering behind and such a bleak outlook on the future as I have tonight."
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A woman wrote to U.S. President
Roosevelt and described the death of her daughter: "The first time I ever had occasion to call in a doctor for and she was given Elixir of Sulfanilamide. All that is left to us is the caring for her little grave. Even the memory of her is mixed with sorrow for we can
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Congress responded to public outrage by passing the 1938 Food, Drug, and
Cosmetic Act, which required companies to perform animal safety tests on their proposed new drugs and submit the data to the FDA before being allowed to market their products. The Massengill Company paid a minimum fine under
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The owner of the company, when pressed to admit some measure of culpability, infamously answered, "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." Watkins, the chemist,
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occurred in 1930 and studies had been published in medical journals stating DEG could cause kidney damage or failure, its toxicity was not widely known prior to the incident.) Watkins simply mixed raspberry flavoring into the powdered drug and then dissolved the mixture in DEG.
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of 1914 banning the sale of some narcotic drugs, there was no federal regulatory control in the United States of
America for drugs until Congress enacted the 1938 Food, Drug, and Cosmetic Act in response to the elixir sulfanilamide poisonings.
97:, and called the preparation "Elixir Sulfanilamide". DEG is poisonous to humans and other mammals, but Harold Watkins, the company's chief pharmacist and chemist, was not aware of this. (Although the first case of a fatality from the related
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in the United States in 1937. It is believed to have killed more than 100 people. The public outcry caused by this incident and other similar disasters led to the passing of the 1938
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was not required by law, and
Massengill performed none; there were no regulations at the time requiring premarket safety testing of drugs.
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The company started selling and distributing the medication in
September 1937. By October 11, the
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assisted on a research project that verified that the DEG solvent was responsible for the fatal
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provisions of the 1906 Pure Food and Drugs Act, which prohibited labeling the preparation an "
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was notified, and an extensive search was conducted to recover the distributed medicine.
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Reputation and Power: Organizational Image and
Pharmaceutical Regulation at the FDA
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The clinical toxicology laboratory: contemporary practice of poisoning evaluation
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239:"Wallace Reveals How Federal Agents Traced Elixir to Halt Fatalities"
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received a report of several deaths caused by the medication. The
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Antibiotic preparation responsible for a mass poisoning in 1937
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Human subject research legislation in the United States
125:. At least 100 deaths were blamed on the medication.
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165:1985 Austrian diethylene glycol wine scandal
296:. Princeton: Princeton University Press.
387:United States federal health legislation
160:List of medicine contamination incidents
129:committed suicide while awaiting trial.
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367:Medical scandals in the United States
357:Health disasters in the United States
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53:, which significantly increased the
51:Federal Food, Drug, and Cosmetic Act
392:1937 disasters in the United States
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189:Ballentine, Carol (June 1981).
34:Bottles of elixir sulfanilamide
271:. Washington, DC: AACC Press.
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57:'s powers to regulate drugs.
18:Elixir Sulfanilamide disaster
352:Food and Drug Administration
320:Mihm, Stephen (2007-08-26).
115:Food and Drug Administration
111:American Medical Association
55:Food and Drug Administration
41:was an improperly prepared
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292:Carpenter, Daniel (2010).
265:Shaw, Leslie M. (2001).
191:"Sulfanilamide Disaster"
79:S. E. Massengill Company
382:Sulfonamide antibiotics
212:"Medicine: Post-Mortem"
372:Pharmaceuticals policy
67:Pure Food and Drug Act
43:sulfonamide antibiotic
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397:1937 health disasters
198:FDA Consumer Magazine
141:" if it contained no
119:Frances Oldham Kelsey
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39:Elixir sulfanilamide
324:. The Boston Globe.
247:. November 26, 1937
220:. December 20, 1937
244:The New York Times
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322:"A tragic lesson"
303:978-0-691-14180-0
87:diethylene glycol
45:that caused mass
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249:. Retrieved
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71:Harrison Act
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347:Drug safety
336:Categories
251:2009-07-20
224:2009-07-19
171:References
95:excipient
77:In 1937,
47:poisoning
149:See also
377:Poisons
143:ethanol
91:solvent
61:History
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139:elixir
85:using
194:(PDF)
298:ISBN
273:ISBN
217:Time
93:or
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