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Atkins, Augmentation and the FDA

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Title: PowerPoint Presentation Author: Valeri Craigle Last modified by: Valeri Craigle Created Date: 4/14/2005 4:40:05 PM Document presentation format – PowerPoint PPT presentation

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Title: Atkins, Augmentation and the FDA


1
Atkins, Augmentation and the FDA
  • Finding Factual Information About Todays Top
    Health Trends
  • Sally Patrick
  • Valeri Craigle
  • Nancy Lombardo
  • 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
  • Plastic Surgery/Elective Breast Augmentation
  • Valeri Craigle
  • Pharmaceuticals and the FDA
  • Nancy Lombardo

12
Atkins, Augmentation 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

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
Atkins, Augmentation the FDA Breast
Augmentation
  • Valeri Craigle, Project Coordinator
  • Neuro-Ophthalmology Virtual Education Library
    (NOVEL)
  • Spencer S. Eccles Health Sciences Library
  • University of Utah
  • Utah Library Association May 12, 2005

31
The Headlines
  • Breast implants dont cause serious illnesses,
    panel says (4/13/1999)
  • Dow Corning Corp. has offered 3.2 billion to
    settle silicone breast implant lawsuits
  • FDA approves saline breast implants (05/11/2000)
  • FDA study shows silicone breast implants rupture
    (05/18/2000)
  • FDA rejects silicone breast implant request
    (1/8/2004)
  • FDA to reconsider silicone implant ban (4/8/2005)
  • FDA panel recommends lifting implant ban
    (4/13/2005)

32
Breast augmentation in the US
  • Augmentation facts
  • Caucasian Women aged 19-34 have the highest rate
    of breast augmentation surgery
  • 150,208 augmentations last year
  • 54 of all augmentations in this age group
  • 51 have complications/follow up surgery (440,000
    women brought suit against Dow Corning in 1999)
  • 20-30 eventually have implants permanently
    removed
  • Third most performed cosmetic surgery in the US
  • Each year, numbers are up 8-10

33
Primary sources of information for this age group
  • Peers
  • Friends
  • Co-workers
  • Family members
  • The Internet
  • The media
  • Television
  • Magazines
  • Health Care Provider

34
The Power of the Media
35
On Television
  • Dr. 90210
  • Extreme makeover
  • I want a famous face
  • The Swan
  • Fear factor

36
In the magazines
37
A hypothetical Scenario
  • A young woman has several friends who are
    getting breast implants. She is starting to think
    she wants them too, but she has a lot of
    questions. She goes looking for information

38
She goes to the Web first
  • The first result in Google Implantinfo.com

39
The possible appeal of this site
  • Site designed by a peer (Nicole)
  • Attractive/well-organized design
  • Satisfaction survey! (94 satisifed)
    http//www.implantinfo.com/inforesources/implantsu
    rvey.pdf
  • Stories from women who have gone through it
  • Sponsors are Doctors

40
What are the dangers of this site?
  • Sponsors are Doctors (Plastic surgeons)
  • Information is dated
  • Information is not objective
  • The Information Resources and Research
    section contain selective information based on
    Nicoles biases

41
Ok, what does the Govt say?
  • The FDAs Breast implant Web site, Comsumer
    Handbook
  • http//www.fda.gov/cdrh/breastimplants/
  • Making an Informed Decision (Inamed!)
    Saline-Filled Breast Implant Surgery
    http//www.fda.gov/cdrh/breastimplants/labeling/in
    amed_patient_labeling_5900.html

42
FDAs list of possible complications
  • Asymmetry
  • Inflammation/irritation
  • Breast pain
  • Malposition/displacement
  • Breast tissue atrophy
  • Necrosis
  • Calcification/calcium deposits
  • Nipple/breast sensation changes
  • Capsular contracture
  • Palpability/visibility
  • Chest wall deformity
  • Ptosis
  • Delayed wound healing
  • Redness/bruising
  • Extrusion
  • Rupture/deflation
  • Galactorrhea
  • Scarring
  • Granuloma
  • Seroma
  • Hematoma
  • Unsatisfactory style/size
  • Iatrogenic injury/damage
  • Wrinkling/rippling
  • Infection, including Toxic Shock Syndrome

43
Other FDA findings
  • Reoperation is 20-26 at 5 years for augmentation
    patients (Mayo Clinic study)
  • Silicone rupture rate across studies is
  • 3-77 ???!!!
  • Connective tissue diseases and neurological
    disorders are reported by women who have
    implants, but no relationship can be proven

44
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

45
Trusted resources (MedlinePlus.org) Non-profit
  • The Implant Information Project of the National
    Research Center for Women Families
    http//www.breastimplantinfo.org/
  • National Cancer Institute Breast Implant study
    (only covers breast cancer and connective tissue
    disorder info http//www.cancer.gov/newscenter/si
    liconefactsheet
  • For teens Can I make my breasts larger?
    http//www.kidshealth.org/teen/expert/body/larger_
    breasts.html

46
With a grain of salt Sites sponsored by plastic
surgeons, or implant manufacturers
  • http//mentor4me.com
  • http//www.ebreastaug.com
  • http//www.breastimplants411.com/
  • http//www.inamed.com
  • http//inplantinfo.com

47
In General
  • Our young woman needs to know who is funding the
    studies and sponsoring the Web sites
  • Plastic surgeons
  • Implant manufacturers
  • Special interest groups
  • The government
  • Look beyond the headlines
  • NCI Study Finds No Long-Term Health Effects from
    Breast Implants
  • NCI Study Finds No Conclusive Evidence that
    Breast Implants Affect Development of Connective
    Tissue Disorders

48
Another consideration Cost
  • There is no definitive source of info on cost,
    but in general
  • Surgeons fee From 1,600 6,000
  • Price depends on the state she lives in
  • This price does not include anesthesia, hospital
    costs, or the implants themselves
  • Implant removal 20,000 (out of pocket)

49
Based on the information our young woman has
received from all of these sources, what can she
say she is certain about?
50
  • A LOT of women are getting breast
  • Many women are satisfied with their implants
  • Implants do NOT last a lifetime
  • The SAFETY of implants has not been proven or
    disproven
  • There are HEALTH RISKS associated with Breast
    augmentation
  • Insurance companies WILL NOT COVER elective
    augmention or elective removal of implants
  • Additional medical care will be required in the
    future

51
The moral of our story
  • She will have to weigh the risks and the benefits
    of elective breast augmentation. But at least she
    has the critical thinking skills and the facts on
    which to base her decision

52
Atkins, Augmentation the FDA Drug Safety
Whats up with the FDA and how can we find good
information?
Nancy Lombardo, M.L.S. Systems Librarian Spencer
S. Eccles Health Sciences Library University of
Utah Utah Library Association May 12, 2005
53
(No Transcript)
54
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.

55
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

56
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

57
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

58
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

59
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

60
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

61
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

62
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

63
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

64
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

65
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

66
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

67
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

68
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

69
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

70
Drug Safety Information
  • CenterWatch.com
  • http//www.centerwatch.com/
  • Information about clinical trials
  • New drug therapies, recent FDA approvals
  • Sponsored by publishing company

71
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

72
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

73
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