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

© 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
Scope of the Problem
Oversight: Dietary Supplements (DS) and Drugs
Improper Marketing/Drugs: FDA Questions
Improper Marketing/DS: FTC Questions
Further Resources

© John La Puma, MD Disclosures
Physician, Santa Barbara Institute for Medical Nutrition/Healthy Weight
Author
Royalties: RealAge Diet/Cooking the RealAge Way/ChefMD’s Big Book of Culinary Medicine
Partner: drjohnlapuma.com, chefmd.com, pediatricobesity.com, Chef Clinic

© 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
This presentation may discuss therapeutic products that have not been approved by the US FDA & off-label uses of approved products.
This information is not all-inclusive and is not meant to replace the diagnosis, advice, treatment, & judgment of medical or legal professionals.
Please verify all information and data and review updates before treating patients, employing any therapies, or recommending any drugs, herbs or supplements.
This information is (c) John La Puma, MD, Santa Barbara CA, 2010.

© John La Puma, MD Scope of the Problem
The World Health Organization (WHO) estimates by 2015, 1.5 billion overweight people.
Current health costs > $117 billion per year in the US alone.
Food, beverage and supplement weight management products
$3.64bn (2009 figures) in the US .

© John La Puma, MD FDA Oversight: Drugs v. Supplements
Drugs
Approval timeline: Years
Safety of formulation must be thoroughly tested prior to approval
Effectiveness must be proven
Purity is guaranteed

© John La Puma, MD FDA Oversight: Drugs v. Supplements
Supplements
Approval timeline: None
Manufacturer (not FDA) responsible for quality
Claims must be supported but evidence not submitted
Contamination seems common

© John La Puma, MD Marketing R x Weight Loss Drugs
Deceptive or Improper?
To identify whether marketing materials go beyond the label, a reasonable MD would need to have adequate information
...and most marketing materials present only one side of the story.

photo (c) John La Puma, MD

© John La Puma, MD Rx Medications Used, Studied or Promoted Off-Label for Weight Loss
1. Thyroid Hormone
Claim:
boost patient’s metabolism...even if normal thyroid.”
Caution:
xs means heart palpitations, bone loss; and can change warfarin dose
Labeling warns against use for obesity

Byetta ad, from 08.20.08 JAMA (C) healthyskepticism.org
c)
15

© John La Puma, MD Improper Marketing?
Why is this off-label promotion for weight loss?
Large type claim
Actual weight loss claim rejected in Australia, because there has not been “a properly designed weight loss study”
Fine print disclaimer is illegible , compared with large type claim
Picture of obese man reinforces the weight claim
80% of people glance at and do not read drug ads, and are likely to be misled... adapted from healthyskepticism.org

© John La Puma, MD Improper Marketing: Weight Loss Drugs
Off Label Use
Definition: different conditions, dosages, combinations, lengths of time than permitted
No governmental body has conducted a review of the effectiveness or safety of the drug for the off-label use
May be ineffective or detrimental
May actually require informed consent

© John La Puma, MD Sample Dietary Supplements for Weight Loss
Hoodia Gordonii (Trim-Fast™)
Glucomannan
Chitosan
Irvingio gabonensis
CLA
Acai Berries
Misc: Lipozene™ (Latin American Yam, Green Tea), Banatol™, Hydroxycut™

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
Spiking
69 products in 2009 FDA found to have undeclared active pharmaceutical ingredients
sibutramine
rimonabant
phenolphthalein
bumetanide

© John La Puma, MD Dietary Supplements Quality Problems
Spiking
As of January 21, 2010 fenproporex, fluoxetine, furosemide, phenytoin also found
To find the brands, go to fda.gov, search: “Tainted Weight Loss Products”

© 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
New Twist: Fake Alli Warning on 1.21.10
Sibutramine found in Alli capsules
in lab tests (3x/d vs 1x/d dosing)
Differences in packaging, lot, ink, capsule size, medication texture.
Office of Criminal Investigation: 800-551-3989

© John La Puma, MD Dietary Supplement Industry Response: Fear, Loathing, and Concern
Current good manufacturing practices (GMPs)
Expected to:
Maintain quality assurance standards
Reduce the risk of contamination.
But there is no standardization in many DS brands

© John La Puma, MD Dietary Supplements: Deceptive Advertising
Many examples. Here are two:
January 2007 FTC: $25m settlement from for deceptive advertising Xenadrine EFX, CortisSlim, Trimspa, One-A-Day WeightSmart.
December 2009: Marketers of “Chinese Diet Tea” and a diet patch to pay nearly $2 million to FTC: deceptive claims
e.g...

© John La Puma, MD Dietary Supplements: Deceptive Advertising
Claims
“ lose as much as six pounds a week by drinking one cup of the green tea after each meal to "neutralize the absorption of fattening foods.“
“ Bio-Slim Patch”..."repulsive, excess ugly fatty tissue will disappear at a spectacular rate due to the combination and synergy of these three natural ingredients."

© John La Puma, MD Industry Response to Dietary Supplements “Marketing Materials that Go Beyond the Label”
1. “Mere puffery”
i.e., Protected commercial speech
2 . Doesn’t Matter Financially
$50 billion industry can afford the fines
3 . Let the media censor the ads
Media ill-equipped to analyze/reject ads, especially with drop in ad spending

© 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
Two Key Questions:
1. Is the ad truthful and non-misleading?
2. Can the advertiser substantiate adequately its objective product claims? Before the ad is published?

1. Is the ad truthful and non-misleading?
Claims suggested=claims implied
Claims made also=claims inferred
e.g., Diet and exercise needed, so the prescription cannot do it alone

Can the advertiser substantiate adequately its objective product claims...before the ad is published?
“ Competent and reliable scientific evidence”
Anecdotal evidence inadequate
New Alli campaign (2010)
“ Survey shows mindless or emotional eating...” (vs. lose weight now!)

(c) nyc.gov 35

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

by John La Puma MD on Feb 11, 2010

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Weight Loss Drugs and Dietary Supplements: Labeling, Marketing and Usage — Presentation Transcript