1. Echinacea Not the Miracle Drug for Tomorrow Teresa Cantwell Issues of Science and Technology Nora Demers

2. The Issue  Today, there is not enough research done on nutraceuticals, such as Echinacea, to be readily available to the public.  Nutraceuticals  FDA  Echinacea

3. Nutraceuticals  What is it? Combination between pharmaceuticals and nutrition Combination between pharmaceuticals and nutrition “any substance that is a food or a part of a food and provides medical or health benefits, including the prevention and treatment of disease.” “any substance that is a food or a part of a food and provides medical or health benefits, including the prevention and treatment of disease.” American Nutraceutical Association American Nutraceutical Association American Nutraceutical Association American Nutraceutical Association

4. Popularity  This chart shows the demand for nutraceuticals in the United States (even without regulation)  According to American Chemistry American ChemistryAmerican Chemistry

5. The Food and Drug Administration  The FDA started in 1962 and it wasn’t until 1994 (Clinton Administration) that they started to address dietary supplements and nutracetucials.  The FDA places regulations on food and drugs for the U.S.  FDA FDA

6. Dietary Supplement Health and Education Act  1994 President Bill Clinton  FDA no longer has responsibility, the companies putting the drugs on the shelf are responsible for them  Problem: The public is unaware of the lack of FDA approval and is often mislead by the drug company’s marketing

7. Labeling  “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”  Although items are marketed as one thing, this statement is used as a disclaimer

8. How to get a drug passed through the FDA  Three step process costing approximatly $300 Million  This all depends on the type of drug up for application  For a general drug: Review Process Review ProcessReview Process

9. Echinacea  Purple Cone Flower- several different forms used within the medical field  E. purpurea, and Echinacea angustifolia are the most popular forms used for colds and immune systems  According to: American Family Physical American Family PhysicalAmerican Family Physical

10. History  Began with Native Americans using it for things such as colds, coughs, sore throats, infections, and veterinary needs.  1762- John Clayton learned about the herb and brought it back to Europe  The Herb flourished in the U.S., as well as in Europe (Germany) where the herb is still remains popular today.

11. History…  1887- Echinacea began its official use in the medical practice.  1930-The FDA releases information stating that there is no affect on the immune system from Echinacea: popularity decreases in the US, but remains in Europe still today.  2002- Studies show that retailers sold approximately $58 million in Echinacea products

12. Echinacea Today  Since the 1930 nothing has been done in the United States as far as research on Echinacea until today  Studies show now that the two most popular forms of Echinacea do nothing for a humans immune system  Studies also found that 483 people had bad reactions, 33 people were hospitalized, and one person who experienced a life threatening reaction Hurley, 2007 Hurley, 2007Hurley, 2007

13. Echinacea  Germany Studies found that: People with any kind of autoimmune disease should not be taking Echinacea. People with any kind of autoimmune disease should not be taking Echinacea. It is also found that there is not a standardized answer to Echinacea because there are so many types It is also found that there is not a standardized answer to Echinacea because there are so many types www.aafp.org/afp/20030101/77/html www.aafp.org/afp/20030101/77/html www.aafp.org/afp/20030101/77/html  Science Daily: “can trigger immunosuppressant, causing poor would healing and infection” – in regards to surgery “can trigger immunosuppressant, causing poor would healing and infection” – in regards to surgery http://www.sciencedaily.com/releases/2006/02/06021 4225847.htm http://www.sciencedaily.com/releases/2006/02/06021 4225847.htm http://www.sciencedaily.com/releases/2006/02/06021 4225847.htm http://www.sciencedaily.com/releases/2006/02/06021 4225847.htm

14. Negative Findings  The News-Press: “The federal government’s National Center for Complementary and Alternative medicine says scientific studies indicate that Echinacea doesn’t appear to prevent colds, nor does it shorten their duration.” “The federal government’s National Center for Complementary and Alternative medicine says scientific studies indicate that Echinacea doesn’t appear to prevent colds, nor does it shorten their duration.”

15. Who is Responsible?  Consumers? Not reading the labels Not reading the labels Not being informed Not being informed  FDA? Not taking responsibility Not taking responsibility  Drug Companies? Mis-marketing Mis-marketing Not informing the public Not informing the public

16. Video on Echinacea Echinacea

17. Solution  Everyone is responsible: I believe now that the best way to solve this issue is to make small changes everywhere: Consumers need to read the labels, as well as read up on drugs they are taking. Consumers need to read the labels, as well as read up on drugs they are taking. The FDA needs to create new regulations that puts these nutraceuticals in a new category. The FDA needs to create new regulations that puts these nutraceuticals in a new category. Drug Companies need to properly market their products. Drug Companies need to properly market their products.