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© John La Puma, MD Weight Loss Drugs and Dietary Supplements: Labeling, Marketing and Usage John La Puma, MD, FACP Santa Barbara Institute for Medical Nutrition & Healthy Weight http://drjohnlapuma.com
© John La Puma, MD Weight Loss Drugs and Dietary Supplements ,[object Object],[object Object],[object Object],[object Object],[object Object]
© John La Puma, MD Disclosures ,[object Object],[object Object],[object Object],[object Object]
© John La Puma, MD Conflict Notice Conflict notice: Dr. La Puma hosts "What's Cooking with ChefMD?" airing on Lifetime TV's "Health Corner" every Sunday at 930 a.m. EST/PST, 830 a.m. CST, since 2006.  He wrote and earns royalties from the New York Times bestseller "ChefMD's Big Book of Culinary Medicine" ( http://tinyurl.com/34h8pm ).  He co-authored and earns royalties from the Times Bestseller "RealAge Diet" and "Cooking the RealAge Way" with Dr. Michael Roizen, and contributed recipes to Dr Oz and Roizen's #1 "You the Owner's Manual."
© John La Puma, MD Disclaimer ,[object Object],[object Object],[object Object],[object Object]
© John La Puma, MD Scope of the Problem ,[object Object],[object Object],[object Object],[object Object]
7
© John La Puma, MD FDA Oversight: Drugs v. Supplements ,[object Object],[object Object],[object Object],[object Object],[object Object]
© John La Puma, MD FDA Oversight: Drugs v. Supplements ,[object Object],[object Object],[object Object],[object Object],[object Object]
© John La Puma, MD Two Essential Marketing Concepts Learned Intermediary Fair Balance
© John La Puma, MD Marketing R x  Weight Loss Drugs ,[object Object],[object Object],[object Object]
photo (c) John La Puma, MD
© John La Puma, MD Rx Medications Used, Studied or Promoted Off-Label for Weight Loss  ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
© John La Puma, MD Rx Medications Used, Studied or Promoted Off-Label for Weight Loss  2. Byetta (exentatide injection)...for diabetes control
Byetta ad, from 08.20.08 JAMA  (C) healthyskepticism.org  ,[object Object],15
© John La Puma, MD Improper Marketing? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
© John La Puma, MD Improper Marketing: Weight Loss Drugs ,[object Object],[object Object],[object Object],[object Object],[object Object]
© John La Puma, MD Sample Dietary Supplements for Weight Loss ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
21 Sample Dietary Supplement Structure and Function Claims Acceptable Unacceptable Maintains cardio function Protect against heart disease Promotes healthy cholesterol level Lowers cholesterol level Promotes healthy joints Reduces pain of arthritis Supports regularity, healthy intestinal flora Alleviates constipation; laxative Promotes urinary tract health Prevents urinary tract infections; improves urine flow in men over the age of 50; diuretic Supports the immune system Helps patients with reduced or compromised immune fxn Reduces stress and frustration  Helps cognitive functioning in the elderly Improves absentmindedness Herbal Prozac
© John La Puma, MD Dietary Supplements Quality Problems ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
© John La Puma, MD Dietary Supplements Quality Problems ,[object Object],[object Object],[object Object]
© John La Puma, MD Dietary Supplements Quality Problems Clinical Consequences with Spiking May have adverse effects *Phentermine, diethylpropion and phendimetrazine People with heart disease, high blood pressure, an overactive thyroid gland, or glaucoma should not use. *Sibutramine People with elevated blood pressure or at high risk for stroke should not take.
© John La Puma, MD More Dietary Supplements Quality Problems ,[object Object],[object Object],[object Object],[object Object],[object Object]
© John La Puma, MD Dietary Supplement Industry Response:  Fear, Loathing, and Concern  ,[object Object],[object Object],[object Object],[object Object],[object Object]
© John La Puma, MD Dietary Supplements: Deceptive Advertising ,[object Object],[object Object],[object Object],[object Object]
© John La Puma, MD Dietary Supplements: Deceptive Advertising ,[object Object],[object Object],[object Object]
© John La Puma, MD Industry Response to Dietary Supplements “Marketing Materials that Go Beyond the Label” ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
© John La Puma, MD Industry Response to DS “Marketing Materials that Go Beyond the Label” 4.  Why are all materials = to the label? 5.  The mandated required disclaimer protects free speech: "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."
© John La Puma, MD Two FTC Questions Asked,  Improper Marketing/Dietary Supplements ,[object Object],[object Object],[object Object]
© John La Puma, MD Two FTC Questions Asked,  Improper Marketing/Dietary Supplements ,[object Object],[object Object],[object Object],[object Object]
© John La Puma, MD
© John La Puma, MD Two FTC Questions Asked,  Improper Marketing/Dietary Supplements ,[object Object],[object Object],[object Object],[object Object],[object Object]
(c) nyc.gov 35
© John La Puma, MD Thank you for attending! John La Puma, MD, FACP Santa Barbara Institute for Medical Nutrition & Healthy Weight http://drjohnlapuma.com

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Weight Loss Drugs and Dietary Supplements: Labeling, Marketing and Usage

  • 1. © John La Puma, MD Weight Loss Drugs and Dietary Supplements: Labeling, Marketing and Usage John La Puma, MD, FACP Santa Barbara Institute for Medical Nutrition & Healthy Weight http://drjohnlapuma.com
  • 2.
  • 3.
  • 4. © John La Puma, MD Conflict Notice Conflict notice: Dr. La Puma hosts "What's Cooking with ChefMD?" airing on Lifetime TV's "Health Corner" every Sunday at 930 a.m. EST/PST, 830 a.m. CST, since 2006.  He wrote and earns royalties from the New York Times bestseller "ChefMD's Big Book of Culinary Medicine" ( http://tinyurl.com/34h8pm ).  He co-authored and earns royalties from the Times Bestseller "RealAge Diet" and "Cooking the RealAge Way" with Dr. Michael Roizen, and contributed recipes to Dr Oz and Roizen's #1 "You the Owner's Manual."
  • 5.
  • 6.
  • 7. 7
  • 8.
  • 9.
  • 10. © John La Puma, MD Two Essential Marketing Concepts Learned Intermediary Fair Balance
  • 11.
  • 12. photo (c) John La Puma, MD
  • 13.
  • 14. © John La Puma, MD Rx Medications Used, Studied or Promoted Off-Label for Weight Loss 2. Byetta (exentatide injection)...for diabetes control
  • 15.
  • 16.
  • 17.
  • 18.
  • 19. 21 Sample Dietary Supplement Structure and Function Claims Acceptable Unacceptable Maintains cardio function Protect against heart disease Promotes healthy cholesterol level Lowers cholesterol level Promotes healthy joints Reduces pain of arthritis Supports regularity, healthy intestinal flora Alleviates constipation; laxative Promotes urinary tract health Prevents urinary tract infections; improves urine flow in men over the age of 50; diuretic Supports the immune system Helps patients with reduced or compromised immune fxn Reduces stress and frustration Helps cognitive functioning in the elderly Improves absentmindedness Herbal Prozac
  • 20.
  • 21.
  • 22. © John La Puma, MD Dietary Supplements Quality Problems Clinical Consequences with Spiking May have adverse effects *Phentermine, diethylpropion and phendimetrazine People with heart disease, high blood pressure, an overactive thyroid gland, or glaucoma should not use. *Sibutramine People with elevated blood pressure or at high risk for stroke should not take.
  • 23.
  • 24.
  • 25.
  • 26.
  • 27.
  • 28. © John La Puma, MD Industry Response to DS “Marketing Materials that Go Beyond the Label” 4. Why are all materials = to the label? 5. The mandated required disclaimer protects free speech: "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."
  • 29.
  • 30.
  • 31. © John La Puma, MD
  • 32.
  • 34. © John La Puma, MD Thank you for attending! John La Puma, MD, FACP Santa Barbara Institute for Medical Nutrition & Healthy Weight http://drjohnlapuma.com