Atkins, Augmentation and the FDA Finding Factual Information About Today’s Top Health Trends Sally Patrick Valeri Craigle Nancy Lombardo Spencer S. Eccles

Atkins, Augmentation and the FDA

Finding Factual Information About Today’s Top Health Trends

Sally PatrickValeri Craigle

Nancy LombardoSpencer 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 fadsSally 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 DirectorUtahealthnet

Spencer S. Eccles Health Sciences LibraryUniversity 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

http://www.mypyramid.gov/

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

• 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


• Diet Type– Food Combining

• Fit for Life• Suzanne Somers’ Somerizing

– Liquid Diets• Cambridge Diet• Slim-Fast


• 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 & Nutritionhttp://www.mayoclinic.com/findinformation/

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

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

• 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”


http://www.cfsan.fda.gov/~dms/foodlab.html











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

consumersSpecial resources for senior health


http://medlineplus.gov/

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


http://www.nal.usda.gov/fnic/index.html

• American Heart Association/Diet & Nutritionhttp://www.americanheart.org/presenter.jhtml?identifier=1200010Healthy lifestyles, dietary recommendations and

“Delicious Decisions”


http://www.americanheart.org/presenter.jhtml?identifier=1200010

http://www.americanheart.org/presenter.jhtml?identifier=1200010

• 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


http://www.nutrition.gov/

• 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


http://familydoctor.org/x5242.xml

• 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


http://www.citizen.org/hrg/food/index.cfm

Valeri Craigle, Project CoordinatorNeuro-Ophthalmology Virtual Education Library (NOVEL)




Breast Augmentation

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/implantsurvey.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!): Saline-Filled 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/siliconefactsheet

• For teens: Can I make my breasts larger? http://www.kidshealth.org/teen/expert/body/larger_breasts.html

…With a grain of saltSites 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

http://mentor4me.com/

http://www.breastimplants411.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 B

reast Implants

• NCI Study Finds No Conclusive Evidence that Breast Implants Affect Development of Connective Tissue Disorders

http://www.nlm.nih.gov/cgi/medlineplus/leavemedplus.pl?theURL=http%3A%2F%2Fwww%2Ecancer%2Egov%2Fnewscenter%2Fpressreleases%2FBreastImplantsO1Oct04

http://www.nlm.nih.gov/cgi/medlineplus/leavemedplus.pl?theURL=http%3A%2F%2Fwww%2Ecancer%2Egov%2Fnewscenter%2Fpressreleases%2FBreastImplantsO1Oct04

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

Nancy Lombardo, M.L.S. Systems Librarian




Drug Safety

What’s up with the FDAand how can we find good information?

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 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

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


• Clinical Alerts– http://www.nlm.nih.gov/databases/

alerts/– Findings from NIH-funded clinical trials– Expedite findings that can “significantly

affect morbidity and mortality”


• 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


• PubMed – http://www.pubmed.gov/– Premiere biomedical information database– Scholarly reports of actual clinical trials– Reviews of drug therapies– Can be challenging for consumers


• MedlinePlus - http://medlineplus.gov/– Drug information for consumers– Alphabetical listing of drugs– Link to CDER warnings, recalls, and other

drug information– Drug therapy information

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


• 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


• 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


What do you think?

Documents

Atkins, Augmentation and the FDA Finding Factual Information About Today’s Top Health Trends Sally Patrick Valeri Craigle Nancy Lombardo Spencer S. Eccles