© John La Puma, MD

Weight Loss Drugs and Dietary Supplements:

Labeling, Marketing and Usage

John La Puma, MD, FACPSanta Barbara Institute for Medical Nutrition &

Healthy Weighthttp://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

AuthorRoyalties: 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.

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© 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

Two Essential Marketing Concepts

Learned Intermediary

Fair Balance

© John La Puma, MD

Marketing Rx 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

© John La Puma, MD

Rx Medications Used, Studied or Promoted Off-Label for Weight Loss

2. Byetta (exentatide injection)...for diabetes control

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

• c)

© 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™

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Sample Dietary Supplement Structure and Function Claims

Acceptable UnacceptableMaintains 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 phendimetrazinePeople with heart disease, high blood pressure, an overactive thyroid gland, or glaucoma should not use.*SibutraminePeople 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 capsulesin 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 claimse.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?

© John La Puma, MD

Two FTC Questions Asked, Improper Marketing/Dietary Supplements

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

© John La Puma, MD

Two FTC Questions Asked, Improper Marketing/Dietary Supplements

2. 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!)

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(c) nyc.gov

© John La Puma, MD

Thank you for attending!

John La Puma, MD, FACPSanta Barbara Institute for Medical Nutrition &

Healthy Weighthttp://drjohnlapuma.com