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LAI531 Presentation
LAI531 Presentation
LAI531 Presentation
LAI531 Presentation
LAI531 Presentation
LAI531 Presentation
LAI531 Presentation
LAI531 Presentation
LAI531 Presentation
LAI531 Presentation
LAI531 Presentation
LAI531 Presentation
LAI531 Presentation
LAI531 Presentation
LAI531 Presentation
LAI531 Presentation
LAI531 Presentation
LAI531 Presentation
LAI531 Presentation
LAI531 Presentation
LAI531 Presentation
LAI531 Presentation
LAI531 Presentation
LAI531 Presentation
LAI531 Presentation
LAI531 Presentation
LAI531 Presentation
LAI531 Presentation
LAI531 Presentation
LAI531 Presentation
LAI531 Presentation
LAI531 Presentation
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LAI531 Presentation

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  1. <ul><li>50 Years of Thinking About Complimentary and Alternative Medicine Policy in America </li></ul>From Quacks and Nostrums to the WHCCAMP Thomas Donnelly - LAI 531 Science Policy Presentation
  2. First, some background...
  3. In the early 20th century, there was a proliferation of products claiming to treat any number of ailments or provide other health benefits. Caffeine, hah! Try radiation for a real pick-me-up!
  4. Thankfully, in 1938 congress passed the Federal Food, Drug, and Cosmetic Act which granted the US FDA the authority to regulate such products in order to protect American consumers.
  5. The Federal Food, Drug, and Cosmetic Act of 1938 <ul><li>Those medicines or devices which failed to meet scientific standards for safety could not be sold. </li></ul><ul><li>Later amendments to this Act included similar proof requirements for therapeutic claims as well. </li></ul>
  6. The Federal Food, Drug, and Cosmetic Act of 1938 <ul><li>The result was that what we now call complementary and alternative medicine (CAM) was as tightly regulated as scientific medicine. </li></ul><ul><li>Those making fraudulent therapeutic claims could be prosecuted by the federal government. </li></ul>
  7. 50 years ago in 1958, McGraw-Hill Book Co. produced an educational film for American high school students called Quacks and Nostrums detailing how the FDA then regulated CAM products.
  8. Quacks and Nostrums <ul><li>Explains the dangers of CAM. </li></ul><ul><li>Details the ways the US government protects citizens from these dangers. </li></ul><ul><li>Click h ere for a clip... </li></ul>
  9. The effect of an aggressive FDA during this era had far reaching consequences even outside of the regulation of commercially available CAM products. Popular interest in CAM also saw a steep decline.
  10. As evidence of this, by the 1950’s there was only one homeopathic college left in the country and by the early 70’s there were fewer than 100 practicing homeopathic doctors in the United States (down from an estimated 10,000 in 1900).
  11. In 1958 the President of the American Institute of Homeopathy declared that Homeopathy was “a fading institution.”
  12. But today, interest in Homeopathy has been reinvigorated and CAM products and services have become a a multi-million dollar industry.
  13.  
  14. So how did we get from there to where we are today...
  15. Amidst a popular resurgence of CAM in the 1980’s and 1990’s, congress passed the Dietary Supplement Health and Education Act, with disastrous effect. This significantly weakening the FDA’s ability to regulate related products.
  16. The Dietary Supplement Health and Education Act <ul><li>Framed by the CAM industry as “preserving the consumer's freedom to choose dietary supplements.” </li></ul><ul><li>Consumers were told that unless they urged their elected officials to act, the FDA would take away their right to buy vitamins. </li></ul><ul><li>Retailers were told that unless the act was passed, they would be forced out of business. </li></ul>
  17. The Dietary Supplement Health and Education Act <ul><li>Covers not just vitamins and minerals </li></ul><ul><li>Also covers herbs or other botanicals, amino acids, other dietary substances to supplement the diet by increasing dietary intake, and any concentrate, metabolite, constituent, extract, or combination of any such ingredients. </li></ul><ul><li>Even covers hormones, such as DHEA and melatonin as “supplements.” </li></ul>
  18. The Dietary Supplement Health and Education Act <ul><li>keeps the FDA from banning unproven supplement ingredients as &quot;unapproved food additives.&quot; </li></ul><ul><li>lets manufacturers not have to submit safety reports on their products </li></ul>
  19. The problem is that the burden of proof lies with the FDA. Even when the agency is able to act, how is it supposed to know which products contain [harmful ingredients], and who sells them? What is the agency supposed to tell people who may have consumed these herbs? Congress has put the FDA in the position of being able to act only after the fact and after substantial harm has already occurred. –David A. Kessler, MD., JD. Former FDA Commissioner
  20.  
  21. Products like this look a lot more legitimate than the paper bag of quack tea from the beginning of Quacks and Nostrums but by abiding by today’s regulations, even that could be sold as a “dietary supplement.”
  22. In 2000, White House Commission on Complementary and Alternative Medicine Policy (WHCCAMP) further promoted CAM.
  23. “ Congress and the Administration should consider enacting legislative and administrative incentives to stimulate private sector investment in CAM research on products that may not be patentable“ - The White House Commission on Complementary and Alternative Medicine Policy
  24. “ Congress and the Administration should consider enacting legislative and administrative incentives to stimulate private sector investment in CAM research on products that may not be patentable“ - The White House Commission on Complementary and Alternative Medicine Policy
  25. “ Congress and the Administration should consider enacting legislative and administrative incentives to stimulate private sector investment in CAM research on products that may not be patentable“ - The White House Commission on Complementary and Alternative Medicine Policy
  26. What?
  27. White House Commission on Complementary and Alternative Medicine Policy (WHCCAMP) <ul><li>Created by President Clinton to make &quot;legislative and administrative recommendations for assuring that public policy maximizes the benefits to Americans of complementary and alternative medicine.&quot; </li></ul><ul><li>The Commission recommended nearly universal adoption of CAM practices in related government agencies. </li></ul>
  28. White House Commission on Complementary and Alternative Medicine Policy (WHCCAMP) <ul><li>The Commission also recommended encouraging private and non-profit use of CAM practices through government incentive programs. </li></ul><ul><li>But interestingly enough... </li></ul>
  29. White House Commission on Complementary and Alternative Medicine Policy (WHCCAMP) <ul><li>Nearly all of the Commissioners were financially involved with or personally supportive of CAM remedies </li></ul><ul><li>No critics of CAM were appointed as Commissioners </li></ul>
  30. Conclusion <ul><li>In a span of only 50 years the US Government has moved from actively discouraging CAM practices to seemingly embracing them. </li></ul><ul><li>The change has been incremental but largely driven by private interests in a booming commercial market for CAM products and services. </li></ul>
  31. Conclusion <ul><li>CAM products and services are now more easily accessible than ever before. </li></ul><ul><li>Effective (and carefully worded) advertising has blurred the line between legitimate medicines and “dietary supplements” for many consumers. </li></ul>
  32. Conclusion <ul><li>Are American consumers more at risk today than they were in 1958? </li></ul><ul><li>Can scientific medicine push back? </li></ul>

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