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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? – PowerPoint PPT presentation

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Title: FAD DIETS and the FDA


1
FAD DIETS and the FDA
  • Finding Factual Information About Todays Top
    Health Trends
  • Spencer S. Eccles Health Sciences Library

2
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?

3
In pursuit of the APPEARANCE of health
  • Body shape and proportion
  • Femininity/masculinity
  • Virility
  • Strength
  • Energy
  • Youth

4
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

5
"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
6
Health Trends
  • Todays 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

7
Would these health trends be so pervasive in
society if the public had more factual
information?
8
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 cant do
  • Make decisions for health consumers about their
    own health choices

9
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

10
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)

11
Finding Factual information
  • Dietary fads
  • Sally Patrick
  • Pharmaceuticals and the FDA
  • Nancy Lombardo

12
The FDAFAD 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

13
Were All Confused!
14
My Health/My Responsibility
  • We are swimming in beauty media with little
    evidence-based promotion of health
  • http//www.MyPyramid.gov
  • US Dept of Agricultures most recent
  • attempt to personalize nutrition

15
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

16
Some Common Fad Diets
  • Diet Type
  • Controlled Carbohydrates
  • Dr. Atkins New Diet Revolution
  • The Carbohydrate Addicts Diet
  • Protein Power
  • Sugar Busters
  • The Zone

17
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. Shapiros Picture Perfect Weight Loss
  • Volumetrics Weight Control Plan

18
Some Common Fad Diets
  • Diet Type
  • Food Combining
  • Fit for Life
  • Suzanne Somers Somerizing
  • Liquid Diets
  • Cambridge Diet
  • Slim-Fast

19
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)

20
If fad diets dont 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

21
Weight Management Good Nutrition
  • Eat breakfast dont 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 ingtcalories
    out
  • Aim for a more physically active lifestyle
    including 30-60 min./4-6 times per week

22
Resources for Good Nutrition
  • Mayo Clinic/Healthy Living/Food Nutrition
  • http//www.mayoclinic.com/findinformation/conditio
    ncenters/
  • centers.cfm?objectid000851DA-6222-1B37
    8D7E80C8D77A0000
  • Basics of healthy diets, food health
    connection
  • tips for shopping cooking

23
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

24
Resources for Good Nutrition
  • MedlinePlus - http//medlineplus.gov/
  • Reliable nutrition/diet information for consumers
  • Special resources for senior health

25
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 consumers corner
  • Special resources for those who work with kids

26
Resources for Good Nutrition
  • American Heart Association/Diet Nutrition
  • http//www.americanheart.org/presenter.jhtml?ident
    ifier1200010
  • Healthy lifestyles, dietary recommendations and
    Delicious Decisions

27
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

28
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

29
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

30
The Power of the Media
31
On Television
  • Dr. 90210
  • Extreme makeover
  • I want a famous face
  • The Swan
  • Fear factor

32
In the magazines
33
Evaluating the FDAs 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 FDAs 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 FDAs position is

34
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.

35
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

36
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

37
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

38
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

39
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

40
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

41
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

42
Drug Development Costs
  • Drugs are the fastest growing part of the
    nations 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

43
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

44
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

45
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

46
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

47
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

48
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

49
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

50
Drug Safety Information
  • CenterWatch.com
  • http//www.centerwatch.com/
  • Information about clinical trials
  • New drug therapies, recent FDA approvals
  • Sponsored by publishing company

51
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

52
Drug Safety Information
  • Prescription for Change
  • http//www.consumersunion.org/campaigns/prescripti
    on/
  • Newsroom links to recent articles and Web sites
    on drug safety issues
  • Sponsored by Consumers Union, nonprofit publisher
    of Consumer Reports

53
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