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Notes from Sept. 23rd

by: Meghan Shah

Notes from Sept. 23rd HORT 3440

Meghan Shah
GPA 3.78

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About this Document

History of medicine: turn of the 19th century till today.
Herbs, Spices, and Medicinal Plants
James Affecter
Class Notes
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This 4 page Class Notes was uploaded by Meghan Shah on Friday October 14, 2016. The Class Notes belongs to HORT 3440 at University of Georgia taught by James Affecter in Fall 2016. Since its upload, it has received 2 views. For similar materials see Herbs, Spices, and Medicinal Plants in Biology/Anthropology at University of Georgia.

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Date Created: 10/14/16
Notes from Sept. 23  At the turn of the 19  century (late 1800s – early 1900s) … ○ Heroic medicine had been replaced by more scientific medicine that emphasized  the use of pharmaceutical drugs ○ Herbal medicines still had a strong following, led by practitioners belonging to the Eclectic School ○ Homeopathic medicine was practiced, and patent medicines were popular ○ There was very little government regulation of medicine and health care  Early 1900s: The American Medical Association Gains Momentum ○ American herbalists were holding their own at the turn of the century: 80,000  regulars,” 10,000 homeopaths, 8,000 eclectics, plus a few thousand other  alternative practitioners ○ AMA was dominant, but not in complete control of the healthcare landscape ○ In 1905, the Journal of the AMA announced it would start accepting  advertisements from pharmaceutical companies; revenues jumped  A Disarming Offer ○ In the early 1900s there were too many doctors, and (from the AMA’s  perspective) too much competition from Irregulars ○ “Irregulars” were welcomed to join regular medical societies as long as they gave up formal allegiance to competing schools and sects ○ Many accepted the offer, weakening the Irregular societies  The Strategic Importance of Medical Schools ○ Too many badly­trained doctors were graduating from too many low­grade  schools ○ 1902: The AMA formed a Council on Medical Education to address the problem ○ 1907: Counsel representatives begin visiting 160­plus schools throughout the  country, Regular and Irregular, and assigning them a number rating based on  entry requirements, lab and teaching facilities, faculty research, etc. ○ Obstacles: No power of enforcement, couldn’t claim to be impartial, project was  expensive  Carnegie Endowment and the Flexner Report ○ Carnegie Foundation for the Advancement of Teaching agreed to fund survey  and provide surveyor  ○ Abraham Flexner was an experienced educator, but not a physician ○ Conducted a 15­month survey of 168 North American medical schools ○ Flexner moved fast: “You don’t need to eat a whole sheep to know it’s tainted”  Two “Thumbs­Down” for American Medical Training ○ The Flexner Report, published in 1910, burst like a bombshell on the American  public ○ Provided lurid details about low standards, poor equipment, non­existent clinical  facilities  ○ “For 25 years there has been an enormous over­production of un­educated and  ill­trained medical practitioners” ○ Almost all Irregular schools, including Eclectics and others that stressed  medicinal plants, were strongly criticized  Flexner’s Principles for Modern Scientific Medical Training ○ Laboratory sciences are central to the curriculum (anatomy, pathology,  bacteriology) ○ Emphasis on pharmacology  ○ Botany no longer necessary; modern medicine “…need only concern itself with  the pharmaceutical side” ○ Focus was placed on disease rather than health, on cure rather than prevention  Impact of the Report: AMA firmly in control ○ 29 schools closed during the 4 years following the report ○ By 1920 there was only one Eclectic school left; it closed in 1938 ○ Total number of medical schools and their enrollment was cut in half by 1920 ○ Today no US medical school can operate without AMA approval   Food and Drug Legislation in the 20  century ○ Food and Drug Act of 1906: abolished patent medicine and meat­packing frauds  in response to public outcry ▪ Prohibited adulterated or mis­branded drugs; DID NOT address safety and  efficacy   FDA Given More Authority in Response to Two Drug Tragedies  ○ Issue: Elixir of Sulfanilamide in 1930s ▪ Federal response: 1938 Food, Drug, and Cosmetic Act; required that drugs  must be proven safe ○ Issue: Thalidomide deformities in the 1960s ▪ Federal response: 1962 Kefauver­Harris Amendments; drugs must be proven safe and effective ▪ Frances Oldham Kelsey  Pharmacists Show Herbs the Door, Health Food Stores Put out Welcome Mat ○ Acceptable evidence for efficacy and safety of herbal medicines as drugs didn’t  exist ○ Herbs migrated to health food stores and co­ops where they were sold as teas,  supplements, etc. ○ Labels limited to common names of plants, no claims of effectiveness  A Watershed Event for Herb Manufacturers and Consumers: 1994 Dietary  Supplement Health and Education Act (DSHEA) ○ Defines herbs as “dietary supplements,” not drugs ○ Prior approval by FDA not required (unlike with drugs) ○ Products are taken off market only after they have been proven toxic. (burden of  proof is on the FDA) ○ General structure and function claims are okay, specific reference to medical  benefits not allowed (manufacturer doesn’t have to prove efficacy) ○ Since the FDA doesn’t analyze the contents of supplements, the herbs you  purchase might… ▪ Not contain the correct species ▪ Contain higher or lower amounts of the active ingredient than indicated on  label ▪ Be contaminated with pesticides, other species, or pharmaceuticals  FDA finally published Good Manufacturing Practices (GMPs) in 2007 ○ 1994 DSHEA authorized FDA to produce GMPs for dietary supplements ○ Establishes rules for: handling, processing, labeling, and storing products ○ Includes quality control standards, record keeping, qualifications for technical  staff, handling customer complaints, etc. ○ Examples of GMP activities necessary for dietary supplement industry  compliance include: ▪ Employing qualified staff ▪ Having physical plants designed or built to protect against adulteration ▪ The use of appropriate equipment and utensils ▪ The use of master manufacturing and batch production records ▪ Employing quality control procedures  ▪ Holding and distributing dietary supplements and manufacturing materials in  ways that ensure that quality is not negatively affected ▪ Recording each product’s GMP­related complaints and retaining these  records for 1­2 years ○ Adverse Event Reporting  ▪ Federal legislation passed in 2006 requires supplement manufacturers to  report adverse events to the FDA ▪ In 2008, 604 adverse events had been reported, including at least 5 deaths  (anything from “isn’t working” to serious illness… and death apparently) ▪ 482,154 adverse event reports for prescription drugs in 2007  Independent Testing Programs to Verify the Quality of Herbal Products ○ – product reviews for consumers and voluntary certification  program for manufacturers ○ U.S. Pharmacopeia – verification programs for manufacturers who choose to  participate ○ Seeing the USP Verified Mark on a dietary supplement label indicates that the  product: ▪ Contains the ingredients listen on the label, in the declare potency and  amounts ▪ Does not contain harmful levels of specified contaminants ▪ Will break down and release into the body within a specified amount of time ▪ Has been made according to the current FDA Good Manufacturing Practices  using sanitary and well­controlled procedures  German Commission E ○ German government accepted standard of “reasonable certainty” ○ German equivalent of our FDA established a panel of experts to oversee use of  herbal medicines in Germany ○ Panel produced monograms on efficacy, side effects, precautions, medical  interactions, and dose ○ Led to much more widespread and more effective use of medicinal plants in  Europe than in US (things like Valerian)


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