Download the PowerPoint - ULA -

Atkins, Augmentation
and the FDA
Finding Factual Information About
Today’s Top Health Trends
Sally Patrick
Valeri Craigle
Nancy Lombardo
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
• Plastic Surgery/Elective Breast
Augmentation
Valeri Craigle
• Pharmaceuticals and the FDA
Nancy Lombardo
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
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 maintainmostly water & lean muscle, not body fatregain
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
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
The Headlines
• Breast implants don’t 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)
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%
Primary sources of information
for this age group
• Peers
– Friends
– Co-workers
– Family members
• The Internet
• The media
– Television
– Magazines
• Health Care Provider
The Power of the Media
On Television
•
•
•
•
•
Dr. 90210
Extreme makeover
I want a famous face
The Swan
Fear factor
In the magazines
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
She goes to the Web first
–The first result in Google:
Implantinfo.com
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/impla
ntsurvey.pdf
• Stories from women who have gone through it
• Sponsors are Doctors
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 Nicole’s biases
Ok, what does the Gov’t say?
• The FDA’s Breast implant Web site, Comsumer
Handbook:
– http://www.fda.gov/cdrh/breastimplants/
• Making an Informed Decision (Inamed!): SalineFilled Breast Implant Surgery
http://www.fda.gov/cdrh/breastimplants/labeling
/inamed_patient_labeling_5900.html
FDA’s 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
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
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
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/siliconefactsh
eet
• For teens: Can I make my breasts larger?
http://www.kidshealth.org/teen/expert/body/larg
er_breasts.html
…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
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
Another consideration: Cost
• There is no definitive source of info on cost, but
in general:
– Surgeon’s 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)
Based on the information our
young woman has received
from all of these sources, what
can she say she is certain
about?
•
•
•
•
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
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
Atkins, Augmentation & the FDA:
Drug Safety
What’s 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
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?