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ID: 1415906
User: 207.108.136.239
Article: Elixir sulfanilamide
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(History)
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Aside from the [[Pure Food and Drug Act]] of 1906 and the [[Harrison Act]] of 1914 banning the sale of some narcotic drugs, there was no federal regulatory control ensuring the safety of new drugs until Congress enacted the 1938 Food, Drug, and Cosmetic Act in response to the elixir sulfanilamide poisoning crisis.
 
Aside from the [[Pure Food and Drug Act]] of 1906 and the [[Harrison Act]] of 1914 banning the sale of some narcotic drugs, there was no federal regulatory control ensuring the safety of new drugs until Congress enacted the 1938 Food, Drug, and Cosmetic Act in response to the elixir sulfanilamide poisoning crisis.
   
In 1937, [[S. E. Massengill Company]], a pharmaceutical manufacturer, created a preparation of [[sulfanilamide]] using [[diethylene glycol]] (DEG) as a [[solvent]], and called the preparation "Elixir Sulfanilamide".<ref>{{cite news |first= |last= |authorlink= |coauthors= |title=Wallace Reveals How Federal Agents Traced Elixir to Halt Fatalities |url=http://select.nytimes.com/gst/abstract.html?res=F40C15F93B59177A93C4AB178AD95F438385F9 |quote=A graphic story of a race against death from "elixir sulfanilamide," carried on by the Food and Drug Administration in fifteen States from Virginia to California, a race not won until ninety-three persons had died after taking the lethal dose, was told by Secretary Wallace today in a report responding to Senate and House resolutions. |work=[[New York Times]] |date=November 26, 1937 |accessdate=2009-07-20 }}</ref> DEG is poisonous to humans, but Harold Watkins, the company's chief pharmacist and chemist, was not aware of this. (Though the first case of a fatality from ethylene glycol 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.)<ref name=FDA/><ref name="The clinical toxicology laboratory">{{cite book|last=Shaw|first=Leslie M.|title=The clinical toxicology laboratory : contemporary practice of poisoning evaluation|year=2001|publisher=AACC Press|location=Washington, DC|isbn=1890883530|url=http://books.google.com/books?id=pXvFGqz44pYC&pg=PA197&lpg=PA197&dq=ethylene+glycol+toxicity+1930&source=bl&ots=T0wT4wUAmp&sig=KwlnK_oWMJuwtUjMB05KM5lcrvc&hl=en&sa=X&ei=4GqQULL4BsHaqgHN7YG4BQ&ved=0CCcQ6AEwAQ#v=onepage&q=ethylene%20glycol%20toxicity%201930&f=false}}</ref> Watkins simply added raspberry flavoring to the sulfa drug which he had dissolved in DEG and the company then marketed the product. Although [[animal testing]] should have been routine in most drug company operations, Massengill performed none and there were no regulations requiring premarket safety testing of new drugs.
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In 1937, [[S. E. Massengill Company]], a pharmaceutical manufacturer, created a preparation of [[sulfanilamide]] using [[diethylene glycol]] (DEG) as a [[solvent]], and called the preparation "Elixir Sulfanilamide".<ref>{{cite news |first= |last= |authorlink= |coauthors= |title=Wallace Reveals How Federal Agents Traced Elixir to Halt Fatalities |url=http://select.nytimes.com/gst/abstract.html?res=F40C15F93B59177A93C4AB178AD95F438385F9 |quote=A graphic story of a race against death from "elixir sulfanilamide," carried on by the Food and Drug Administration in fifteen States from Virginia to California, a race not won until ninety-three persons had died after taking the lethal dose, was told by Secretary Wallace today in a report responding to Senate and House resolutions. |work=[[New York Times]] |date=November 26, 1937 |accessdate=2009-07-20 }}</ref> DEG is poisonous to humans, but Harold Watkins, the company's chief pharmacist and chemist, was not aware of this. (Though the first case of a fatality from ethylene glycol 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.)<ref name=FDA/><ref name="The clinical toxicology laboratory">{{cite book|last=Shaw|first=Leslie M.|title=The clinical toxicology laboratory : contemporary practice of poisoning evaluation|year=2001|publisher=AACC Press|location=Washington, DC|isbn=1890883530|url=http://books.google.com/books?id=pXvFGqz44pYC&pg=PA197&lpg=PA197&dq=ethylene+glycol+toxicity+1930&source=bl&ots=T0wT4wUAmp&sig=KwlnK_oWMJuwtUjMB05KM5lcrvc&hl=en&sa=X&ei=4GqQULL4BsHaqgHN7YG4BQ&ved=0CCcQ6AEwAQ#v=onepage&q=ethylene%20glycol%20toxicity%201930&f=false}}</ref> Watkins simply added raspberry flavoring to the sulfa drug which he had dissolved in DEG and the company then marketed the product. Although [[animal testing]] should have been routine in most drug company operations, Massengill performed none and there were no regulations requiring premarket safety testing of new drugs. SO they say!!!!!!!
   
 
The company started selling and distributing the medication in September 1937. By October 11, the [[American Medical Association]] received a report of several deaths caused by the medication. The [[Food and Drug Administration]] was notified, and an extensive search was conducted to recover the distributed medicine.<ref>{{cite book|last=Carpenter|first=Daniel|title=Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA|year=2010|publisher=Princeton University Press|location=Princeton|isbn=0-691-14180-0}}</ref> [[Frances Oldham Kelsey]] assisted on a research project that verified that the [[excipient]] DEG was responsible for the fatal [[adverse effect (medicine)|adverse effect]]s. At least 100 deaths were blamed on the medication.
 
The company started selling and distributing the medication in September 1937. By October 11, the [[American Medical Association]] received a report of several deaths caused by the medication. The [[Food and Drug Administration]] was notified, and an extensive search was conducted to recover the distributed medicine.<ref>{{cite book|last=Carpenter|first=Daniel|title=Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA|year=2010|publisher=Princeton University Press|location=Princeton|isbn=0-691-14180-0}}</ref> [[Frances Oldham Kelsey]] assisted on a research project that verified that the [[excipient]] DEG was responsible for the fatal [[adverse effect (medicine)|adverse effect]]s. At least 100 deaths were blamed on the medication.
Reason: ANN scored at 0.967242
Reporter Information
Reporter: Edwardo (anonymous)
Date: Wednesday, the 19th of August 2015 at 12:19:38 AM
Status: Reported
Friday, the 7th of August 2015 at 09:02:19 PM #100341
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Wednesday, the 19th of August 2015 at 12:19:38 AM #100716
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