BLG Week 2.docx - HISTORY BEHIND THE REGULATIONSWHY...

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HISTORY BEHIND THE REGULATIONS—WHY REGULATE? WHAT IS GCP? - Good clinical Practices (GCPs) re the accepted procedures for conducting clinical trails - GCP is defined as: an international ethical and scientific quality standard for - Designing - Conducting - Recording - Reporting trials that involve the participation of human subjects - Compliance with this standard provides public assurance that the rights, safety, and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible* REGULATIONS MILESTONES IN THE HISTORY OF DRUG DEVELOPMENT 1848 – DRUG IMPORTATION ACT - The first regulatory action - Congress enacted a law requiring the United States Customs Service - to stop the importing of adulterated drugs from outside the country. - It took another 50+ years for the next major piece of legislation to come about. 1862 – BUREAU OF CHEMISTRY - President Abraham Lincoln appointed Dr. Charles M. Wetherill, a chemist, to serve in the new Department of Agriculture. - Beginning of the Bureau of Chemistry, which in 1927 became the Food, Drug and Insecticide Administration. - Name changed to the food and drug administration (FDA) in 1930. 1906: FOOD AND DRUGS ACT - Signed by President Theodore Roosevelt - Before this Act: - No comprehensive statute regulating drugs - Standard medical practice - Purges - Blood letting - Few effective drugs on the market (opium, cocaine) - Products could be easily advertised and sold - Then came Dr. Wiley DR WILEY EXPERIMENT - POISON SQUAD STUDY - Harvey Washington Wiley was an American chemist known as the "Father of the FDA." - Wiley campaigned for reforms in food manufacturing and in food labeling. 1
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POISON SQUAD - Goal: trying some of the most commonly used food additives in order to determine their effects. - In 1883, Wiley took the position of chief chemist at the U.S. Department of Agriculture. He began his legendary "poison squad" investigations in 1902. - What was happening in the trials: - the members would eat steadily increasing amounts of each additive, - carefully tracking the impact that it had on their bodies. - They would stop when the members started to get sick. (headaches, NVD) - Who were these: - graduates of the civil service exam, - all were screened for "high moral character," - and all had reputations for "sobriety and reliability SAMPLE OF THE LETTER FROM ONE OF THE SQUAD MEMBERS 2
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1938: FOOD, DRUG, AND COSMETIC ACT - Major crisis-use of Elixir of Sulfanilamide - Tablet—a large one - Treat infections - Manufacturer wanted - Use in children - Too hard to swallow - Created a liquid by adding diethylene glycol (principle ingredient in antifreeze) - Tested for taste as a flavor was fine - Never tested for toxicity - Caused the deaths of so many mostly children - No regulations at the time NUREMBERG TRIALS - Nazi Germany conducted a series of medical experiments on Jews, POWs, Romani, and other persecuted groups.
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