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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? • 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?
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