Fad Diets 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?

  • 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

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

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

 •   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?
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

• Dietary fads
  Sally Patrick


• Pharmaceuticals and the FDA
   Nancy Lombardo
          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!
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?

•   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

• Diet Type
  – Controlled Carbohydrates
    • Dr. Atkins’ New Diet Revolution
    • The Carbohydrate Addict’s Diet
    • Protein Power
    • Sugar Busters
    • The Zone
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 Diets

 • Diet Type
   – Food Combining
      • Fit for Life
      • Suzanne Somers’ Somerizing
   – Liquid Diets
      • Cambridge Diet
      • Slim-Fast
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?

• 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
• 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…

• 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
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
Nutrition…
 • MedlinePlus - http://medlineplus.gov/
   Reliable nutrition/diet information for consumers
   Special resources for senior health
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
Nutrition…
• American Heart Association/Diet & Nutrition
   http://www.americanheart.org/presenter.jhtml?identifier=
      1200010
   Healthy lifestyles, dietary recommendations and “Delicious
      Decisions”
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
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
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
On Television

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

• 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

New drug identified as potentially effective:
1) Laboratory studies
2) Animal testing
3) Clinical Trials
   a) FDA guidelines and regulations for trials
   b) Institutional Review Boards (IRB) – ensures
      trial safety
   c) Ethical and scientific quality standards
4) Apply to FDA/CDER for approval
5) FDA Review
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 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
• 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
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
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
• 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

• 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
• 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?
•   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

• 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 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 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 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 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 Information

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

• Prescription for Change
   – http://www.consumersunion.org/campaigns/pr
     escription/
   – Newsroom – links to recent articles and Web
     sites on drug safety issues
   – Sponsored by Consumers Union, nonprofit
     publisher of Consumer Reports
What do you think?