FAD DIETS and the FDA

53
FAD DIETS and the FDA Finding Factual Information About Today’s Top Health Trends Spencer S. Eccles Health Sciences Library

description

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? - PowerPoint PPT Presentation

Transcript of FAD DIETS and the FDA

Page 1: 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

Page 2: FAD DIETS and the FDA

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?

Page 3: FAD DIETS and the FDA

In pursuit of the APPEARANCE of health

• Body shape and proportion• Femininity/masculinity• Virility• Strength• Energy• Youth

Page 4: FAD DIETS and the FDA

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

Page 5: 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

Page 6: FAD DIETS and the FDA

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

Page 7: FAD DIETS and the FDA

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

Page 8: FAD DIETS and the FDA

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

Page 9: FAD DIETS and the FDA

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

Page 10: FAD DIETS and the FDA

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)

Page 11: FAD DIETS and the FDA

Finding Factual information

• Dietary fadsSally Patrick

• Pharmaceuticals and the FDA Nancy Lombardo

Page 12: FAD DIETS and the FDA

The FDA:

FAD DIETS

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

Spencer S. Eccles Health Sciences LibraryUniversity of Utah

Utah Library Association May 12, 2005

Page 13: FAD DIETS and the FDA

We’re All Confused!

Page 14: FAD DIETS and the FDA

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

Page 15: FAD DIETS and the FDA

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

Page 16: FAD DIETS and the FDA

Some Common Fad Diets

• Diet Type– Controlled Carbohydrates

• Dr. Atkins’ New Diet Revolution• The Carbohydrate Addict’s Diet• Protein Power• Sugar Busters• The Zone

Page 17: FAD DIETS and the FDA

• 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 Diets

Page 18: FAD DIETS and the FDA

• Diet Type– Food Combining

• Fit for Life• Suzanne Somers’ Somerizing

– Liquid Diets• Cambridge Diet• Slim-Fast

Some Common Fad Diets

Page 19: FAD DIETS and the FDA

• 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)

Some Common Fad Diets

Page 20: FAD DIETS and the FDA

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

Page 21: FAD DIETS and the FDA

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

Page 22: FAD DIETS and the FDA

Resources for Good Nutrition…

• Mayo Clinic/Healthy Living/Food & Nutritionhttp://www.mayoclinic.com/findinformation/

conditioncenters/centers.cfm?objectid=000851DA-6222-1B37

8D7E80C8D77A0000Basics of healthy diets, food & health connection & tips for shopping & cooking

Page 23: FAD DIETS and the FDA

• 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 Nutrition…

Page 24: FAD DIETS and the FDA

• MedlinePlus - http://medlineplus.gov/Reliable nutrition/diet information for

consumersSpecial resources for senior health

Resources for Good Nutrition…

Page 25: FAD DIETS and the FDA

USDA National Agricultural Library/Food & Nutrition Information Centerhttp://www.nal.usda.gov/fnic/index.htmlEducational materials, government reports, research papers and a consumer’s cornerSpecial resources for those who work with kids

Resources for Good Nutrition…

Page 26: FAD DIETS and the FDA

• American Heart Association/Diet & Nutritionhttp://www.americanheart.org/presenter.jhtml?

identifier=1200010Healthy lifestyles, dietary recommendations and

“Delicious Decisions”

Resources for Good Nutrition…

Page 27: FAD DIETS and the FDA

• USDA National Agricultural Libraryhttp://www.nutrition.govGateway to nutritional information and research

from the federal governmentIncludes information on dietary supplements, food

allergy & safety, sports & exercise

Resources for Good Nutrition…

Page 28: FAD DIETS and the FDA

• American Academy of Family Physicians/Healthy Living/Food & Nutritionhttp://familydoctor.org/x5242.xmlEasy to use and complete site for general nutrition,

kids & nutrition, improving your nutrition

Resources for Good Nutrition…

Page 29: FAD DIETS and the FDA

• Public Citizen/Health Research Group/Food Information Centerhttp://www.citizen.org/hrg/food/index.cfmNational non-profit public interest organizationFood information/Safety-dyes, irradiation, labeling,

infant formula, etc

Resources for Good Nutrition…

Page 30: FAD DIETS and the FDA

The Power of the Media

Page 31: FAD DIETS and the FDA

On Television

• Dr. 90210• Extreme makeover• I want a famous face• The Swan• Fear factor

Page 32: FAD DIETS and the FDA

In the magazines

Page 33: FAD DIETS and the FDA

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

Page 34: FAD DIETS and the FDA

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.”

Page 35: FAD DIETS and the FDA

FDA Approval

New drug identified as potentially effective:1) Laboratory studies2) Animal testing3) Clinical Trials

a) FDA guidelines and regulations for trialsb) Institutional Review Boards (IRB) –

ensures trial safetyc) Ethical and scientific quality standards

4) Apply to FDA/CDER for approval5) FDA Review

Page 36: FAD DIETS and the FDA

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

Page 37: FAD DIETS and the FDA

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

Page 38: FAD DIETS and the FDA

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

Page 39: FAD DIETS and the FDA

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

Page 40: FAD DIETS and the FDA

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

Page 41: FAD DIETS and the FDA

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

Page 42: FAD DIETS and the FDA

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

Page 43: FAD DIETS and the FDA

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

Page 44: FAD DIETS and the FDA

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

Page 45: FAD DIETS and the FDA

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

Page 46: FAD DIETS and the FDA

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”

Page 47: FAD DIETS and the FDA

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

Page 48: FAD DIETS and the FDA

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

Page 49: FAD DIETS and the FDA

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

Page 50: FAD DIETS and the FDA

• CenterWatch.com– http://www.centerwatch.com/– Information about clinical trials– New drug therapies, recent FDA approvals– Sponsored by publishing company

Drug Safety Information

Page 51: FAD DIETS and the FDA

• 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 Information

Page 52: FAD DIETS and the FDA

• 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

Drug Safety Information

Page 53: FAD DIETS and the FDA

What do you think?