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[object Object],From  Quacks and Nostrums  to the WHCCAMP Thomas Donnelly - LAI 531 Science Policy Presentation
First, some background...
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!
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.
The Federal Food, Drug, and Cosmetic Act of 1938 ,[object Object],[object Object]
The Federal Food, Drug, and Cosmetic Act of 1938 ,[object Object],[object Object]
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.
Quacks and Nostrums ,[object Object],[object Object],[object Object]
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.
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).
In 1958 the President of the American Institute of Homeopathy declared that Homeopathy was “a fading institution.”
But today, interest in Homeopathy has been reinvigorated and CAM products and services have become a a multi-million dollar industry.
 
So how did we get from there to where we are today...
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.
The Dietary Supplement  Health and Education Act ,[object Object],[object Object],[object Object]
The Dietary Supplement  Health and Education Act ,[object Object],[object Object],[object Object]
The Dietary Supplement  Health and Education Act ,[object Object],[object Object]
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
 
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.”
In 2000, White House Commission on Complementary and Alternative Medicine Policy (WHCCAMP) further promoted CAM.
“ 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
“ 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
“ 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
What?
White House Commission on  Complementary and Alternative Medicine Policy (WHCCAMP) ,[object Object],[object Object]
White House Commission on  Complementary and Alternative Medicine Policy (WHCCAMP) ,[object Object],[object Object]
White House Commission on  Complementary and Alternative Medicine Policy (WHCCAMP) ,[object Object],[object Object]
Conclusion ,[object Object],[object Object]
Conclusion ,[object Object],[object Object]
Conclusion ,[object Object],[object Object]

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LAI531 Presentation

  • 1.
  • 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.
  • 6.
  • 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.
  • 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.
  • 17.
  • 18.
  • 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.
  • 28.
  • 29.
  • 30.
  • 31.
  • 32.