Notes from Sept. 23rd
Notes from Sept. 23rd HORT 3440
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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Notes from Sept. 23 At the turn of the 19 century (late 1800s – early 1900s) … ○ Heroic medicine had been replaced by more scientific medicine that emphasized the use of pharmaceutical drugs ○ Herbal medicines still had a strong following, led by practitioners belonging to the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 ○ Consumerlab.com – 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)