Fad diets and the fda
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FAD DIETS and the FDA. Finding Factual Information About Today’s Top Health Trends Spencer S. Eccles Health Sciences Library. What is health?. Quality of life? A positive self-image? Conducting out daily lives in comfort? Energy to do the things we want to do?

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Fad diets and the fda

FAD DIETS and the FDA

Finding Factual Information About Today’s Top Health Trends

Spencer S. Eccles Health Sciences Library


What is health

What is health?

  • Quality of life?

  • A positive self-image?

  • Conducting out daily lives in comfort?

  • Energy to do the things we want to do?

  • The absence of pain and disease?


In pursuit of the appearance of health

In pursuit of the APPEARANCE of health

  • Body shape and proportion

  • Femininity/masculinity

  • Virility

  • Strength

  • Energy

  • Youth


The reality of health in the united states

The reality of health in the United states

  • Obesity

    • 60 million obese, 9 million severely obese. (AOA, 2005)

  • Cancer

    • Men: 1 in 2 lifetime probability of developing cancer

    • Women 1 in 3 lifetime probability of developing cancer

  • Mental Health

    • Eating disorders (~7 million girls/women)

  • Environmental Toxicity

  • Substance abuse


Fad diets and the fda

"Feeling good about the way they look is high on the list of priorities for many Americans."

ASAPS President Robert Bernard, MD, of White Plains, NY


Health trends

Health Trends

  • Today’s most popular health trends:

    • Fad Diets

      • 91% of women on a college campus, diet "often" or "always." (Kurth et al., 1995)

    • Elective plastic surgery

      • Up 20% from 2002-2003

        (American Society for Aesthetic Plastic Surgery)

    • Pharmaceuticals

      • People are increasingly relying on pills to fix their health problems


Fad diets and the fda

Would these health trends be so pervasive in society if the public had more factual information?


Health information for the public

Health Information for the Public

  • The role of the information professional:

    • What we can do:

      • Facilitate the discovery of quality, reliable information

      • Help people think critically about health information and their sources

      • Guide people to be more proactive in their own health care

    • What we can’t do

      • Make decisions for health consumers about their own health choices


Common sources of health information

Common Sources of health information

  • The Internet

  • Family and Friends

  • Physician/Health care provider

  • The medical literature

    • Language is difficult

    • Health consumers now have a wealth of medical information written for them


How do you check the reliability of information

How do you check the reliability of information?

Who runs this site?

Who pays for the site?

What is the purpose of the site?

Where does the information come from?

What is the basis of the information?

How is the information selected?

How current is the information?

How does the site choose links to other sites?

What information about you does the site collect, and why?

How does the site manage interactions with visitors?

10 Things to Know about Evaluating Medical Resources on the Web

(National Center for Complementary and Alternative Medicine)


Finding factual information

Finding Factual information

  • Dietary fads

    Sally Patrick

  • Pharmaceuticals and the FDA

    Nancy Lombardo


The fda fad diets

The FDA:FAD DIETS

Sally M. Patrick, M.L.S. Project Director

Utahealthnet

Spencer S. Eccles Health Sciences Library

University of Utah

Utah Library Association May 12, 2005


We re all confused

We’re All Confused!


My health my responsibility

My Health/My Responsibility

We are swimming in “beauty” media with little evidence-based promotion of health

  • http://www.MyPyramid.gov

    • US Dept of Agriculture’s most recent

      attempt to personalize nutrition


What is a fad diet

What is a Fad Diet?

  • Promises dramatic results

  • No long term success

  • Not balanced/unhealthy

  • Based on your insecurities

  • Much Marketing/Little Science

  • Go in and out of fashion


Some common fad diets

Some Common Fad Diets

  • Diet Type

    • Controlled Carbohydrates

      • Dr. Atkins’ New Diet Revolution

      • The Carbohydrate Addict’s Diet

      • Protein Power

      • Sugar Busters

      • The Zone


Some common fad diets1

Some Common Fad Diets

  • Diet Type

    • High Carbohydrate/Low Fat

      • Dr. Dean Ornish: Eat More, Weigh Less

      • The Good Carbohydrate Revolution

      • The Pritikin Principle

    • Controlled Portion Sizes

      • Dr. Shapiro’s Picture Perfect Weight Loss

      • Volumetrics Weight Control Plan


Some common fad diets2

Some Common Fad Diets

  • Diet Type

    • Food Combining

      • Fit for Life

      • Suzanne Somers’ Somerizing

    • Liquid Diets

      • Cambridge Diet

      • Slim-Fast


Some common fad diets3

Some Common Fad Diets

  • Diet Type

    • Diet Pills/Herbal Remedies

      • Dexatrim Natural

      • Hydroxycut

      • Metabolife 356

    • Other

      • Eat Right For Your Type: The Blood Type Diet

      • Macrobiotics

      • May Clinic Diet (not endorsed by the clinic)


If fad diets don t work why are they so popular

If fad diets don’t work, why are they so popular?

  • People willing to try anything to look/feel better regardless of true health

  • Promoters take advantage of get slim quick ethic with little effort required

  • Some do lose weight but cannot maintain-mostly water & lean muscle, not body fat-regain


Weight management good nutrition

Weight Management & Good Nutrition

  • Eat breakfast & don’t skip meals

  • Eat a variety of foods for daily nutrients

  • Limit daily intake of: saturated fat, cholesterol, sodium and sugar

  • Limit liquid calories-whole fruits rather than sugar enhanced juices

  • Watch portion size

  • Exercise on a regular basis-calories in>calories out

    • Aim for a more physically active lifestyle including 30-60 min./4-6 times per week


Resources for good nutrition

Resources for Good Nutrition…

  • Mayo Clinic/Healthy Living/Food & Nutrition

    http://www.mayoclinic.com/findinformation/conditioncenters/

    centers.cfm?objectid=000851DA-6222-1B37 8D7E80C8D77A0000

    Basics of healthy diets, food & health connection &

    tips for shopping & cooking


Resources for good nutrition1

Resources for Good Nutrition…

  • U.S. FDA-Center for Food Safety & Applied Nutrition

    http://www.cfsan.fda.gov/~dms/foodlab.html

    “How to Understand & Use the Nutrition Facts Label”


Resources for good nutrition2

Resources for Good Nutrition…

  • MedlinePlus - http://medlineplus.gov/

    Reliable nutrition/diet information for consumers

    Special resources for senior health


Resources for good nutrition3

Resources for Good Nutrition…

USDA National Agricultural Library/Food & Nutrition Information Center

http://www.nal.usda.gov/fnic/index.html

Educational materials, government reports, research papers and a consumer’s corner

Special resources for those who work with kids


Resources for good nutrition4

Resources for Good Nutrition…

  • American Heart Association/Diet & Nutrition

    http://www.americanheart.org/presenter.jhtml?identifier=1200010

    Healthy lifestyles, dietary recommendations and “Delicious Decisions”


Resources for good nutrition5

Resources for Good Nutrition…

  • USDA National Agricultural Library

    http://www.nutrition.gov

    Gateway to nutritional information and research from the federal government

    Includes information on dietary supplements, food allergy & safety, sports & exercise


Resources for good nutrition6

Resources for Good Nutrition…

  • American Academy of Family Physicians/Healthy Living/Food & Nutrition

    http://familydoctor.org/x5242.xml

    Easy to use and complete site for general nutrition, kids & nutrition, improving your nutrition


Resources for good nutrition7

Resources for Good Nutrition…

  • Public Citizen/Health Research Group/Food Information Center

    http://www.citizen.org/hrg/food/index.cfm

    National non-profit public interest organization

    Food information/Safety-dyes, irradiation, labeling, infant formula, etc


The power of the media

The Power of the Media


On television

On Television

  • Dr. 90210

  • Extreme makeover

  • I want a famous face

  • The Swan

  • Fear factor


In the magazines

In the magazines


Evaluating the fda s findings

Evaluating the FDA’s Findings

  • The GOOD

    • Multidisciplinary scientific oversight

      • Anesthesiologists, pathologists, epidemiologists, oncologists etc…

    • FDA studies claim to be all inclusive

      • All patient records are included, nothing (that we know of) is left out of their studies

  • The BAD

    • The FDA’s recommendations are confusing/ambiguous

    • Lack of consistency in recommendations

    • Information on the Web site is dated

  • The Ugly

    • Inamed and Mentor (Manufature wars) make it difficult to determine what the FDA’s position is


Drug approval and marketing

Drug Approval and Marketing

  • FDA Drug Approval Process

    • Center for Drug Evaluation and Research(CDER) http://www.fda.gov/cder/index.html

    • Evaluates all new drugs before they are sold

      • Prescription and over-the-counter

    • Ensures “that drugs are safe and effective”

    • “It is the responsibility of the company seeking to market a drug to test it and submit evidence that it is safe and effective.”


Fda approval

FDA Approval

New drug identified as potentially effective:

  • Laboratory studies

  • Animal testing

  • Clinical Trials

    • FDA guidelines and regulations for trials

    • Institutional Review Boards (IRB) – ensures trial safety

    • Ethical and scientific quality standards

  • Apply to FDA/CDER for approval

  • FDA Review


Fda approval1

FDA Approval

  • Clinical studies carefully examined

  • Input from advisory committees

  • Drug must be proven safe

  • Drug must prove effective for intended use

  • Benefits of drug must outweigh known risks


Fda approval2

FDA Approval

  • Potentially effective process

  • Clinical trials done by medical schools, academic health sciences centers, research centers

  • Advisory committees provided FDA with independent opinions, recommendations


Legislation

Legislation

  • 1980 – Bayh-Dole Act

    • Created uniform patent policy among many federal agencies funding research

    • Universities can retain ownership of inventions produced by federally funded research

    • Designed to speed the commercialization process, improve technology transfer

    • Drug companies can now use university researchers to do drug development, as well as drug trials


Legislation1

Legislation

  • 1980 – Bayh-Dole Act – continued

    • Transformed the perspective of academic medical centers

    • Became “partners” to industry with potential for financial gain

    • Faculty encouraged to patent their discoveries

    • University patents sold to drug companies bring financial rewards for publicly funded research

    • Drugs developed and tested at academic sites


Legislation2

Legislation

  • Hatch-Waxman Act – 1984

    • Extended the patent rights for brand-name drugs

    • Extended exclusive marketing rights

    • Effective patent rights increased from 8 to 14 years

    • Added billions to sales for drug companies


Fda approvals

FDA Approvals

  • Government-granted monopolies

    • FDA approval grants exclusive marketing rights

    • Patents prevent generics from infringing on market share

  • In 2002, FDA approved 78 drugs

    • Only 7 of these were classified as improvements over existing drugs

    • Other 71 simple variations of older formulas

    • New patent for old drug

    • Further exclusive marketing, more profit


Drug development costs

Drug Development Costs

  • Drugs are the fastest growing part of the nation’s health care bill

  • Biggest drug companies spend ~14% of budget on Research & Development (R & D)

  • Same drug companies spend ~31% on marketing

  • Big drug companies make more in profit than they spend on R & D


Drug development and testing

Drug Development and Testing

  • Much of the R & D done at universities with federal funding

  • Clinical trials funded by drug companies, carried out at universities

  • Schools and faculty engaged in clinical trials receiving payment from drug companies

  • Contracts may prevent dissemination of results

    • Unfavorable results not published

    • Sharing information with colleagues prohibited

  • Drug company consultants may sit on FDA advisory committees

    • Potential for conflict of interest


Where to find good information

Where to Find Good Information?

  • Not easy!

  • Critical evaluation of clinical trials

  • Research treatments using specific drugs

  • FDA process in revision

    • Communicate with your legislators

    • Encourage mandatory publication of drug studies


Drug safety information

Drug Safety Information

  • ClinicalTrials.gov

    • http://clinicaltrials.gov

    • Describes federally and privately supported clinical research in human volunteers

    • Information about a trial's purpose, who may participate, locations, sponsor of trial


Drug safety information1

Drug Safety Information

  • Clinical Alerts

    • http://www.nlm.nih.gov/databases/alerts/

    • Findings from NIH-funded clinical trials

    • Expedite findings that can “significantly affect morbidity and mortality”


Drug safety information2

Drug Safety Information

  • FDA'S CDER's Web site

    • http://www.fda.gov/cder/drug/

      • Information about all products regulated by CDER

    • http://www.fda.gov/cder/consumerinfo/

      • Information sheets on newly approved drugs

    • http://www.fda.gov/cder/audiences/acspage/

      • Rosters of members of FDA advisory committees


Drug safety information3

Drug Safety Information

  • PubMed – http://www.pubmed.gov/

    • Premiere biomedical information database

    • Scholarly reports of actual clinical trials

    • Reviews of drug therapies

    • Can be challenging for consumers


Drug safety information4

Drug Safety Information

  • MedlinePlus - http://medlineplus.gov/

    • Drug information for consumers

    • Alphabetical listing of drugs

    • Link to CDER warnings, recalls, and other drug information

    • Drug therapy information


Drug safety information5

Drug Safety Information

  • CenterWatch.com

    • http://www.centerwatch.com/

    • Information about clinical trials

    • New drug therapies, recent FDA approvals

    • Sponsored by publishing company


Drug safety information6

Drug Safety Information

  • Public Citizen Drug Information Center

    • http://www.citizen.org/hrg/drugs/

    • Publications, press releases and more

    • Sponsored by Public Citizen a nonprofit consumer advocacy organization representing consumer interests


Drug safety information7

Drug Safety Information

  • Prescription for Change

    • http://www.consumersunion.org/campaigns/prescription/

    • Newsroom – links to recent articles and Web sites on drug safety issues

    • Sponsored by Consumers Union, nonprofit publisher of Consumer Reports


Fad diets and the fda

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