Nutraceuticals vs. Pharmaceuticals: Safety Considerations

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Stuart P Richer, OD, PhD, FAAOChief, Optometry Section, DVA Medical CenterAssociate Professor, Family and Preventative Medicine, Rosalind Franklin University of Medicine & Science /

Chicago Medical SchoolNorth Chicago, Illinois 60064Stuart.Richer1@Med.VA.Gov

Vision Institute of Canada 24 October 2009

Therapeutic Eyecare

The therapeutic care of chronic disease should be and will be a major element of both patient care and revenue for the eyecare practice in the next decade.

J. James Thimons, OD, FAAO.May 2005.

Principles of Integrative Medicine

A partnership between patient and practitioner in the healing process Appropriate use of conventional and alternative methods to facilitate the body's innate healing response A philosophy that neither rejects conventional medicine nor accepts alternative therapies uncritically Use of natural, effective, less-invasive interventions whenever possible

Naturopath (ND)

First, do no harmEmploy the healing power of natureIdentify and Tx the causeTreat the whole personThe physician is a teacherPrevention is the best cureEstablish health and wellness

2004 2009

Expedient “Symptom” or Disease CareHighlights – Michael T Murray, ND

US is #1 in %GDP spent on health.We use 40 % of all worldwide medications.700,000 US physicians @ estimated $60,000 per year in marketing per physician.1992 average senior used 19.6 Rx / year.2005 average senior used 34.4 Rx / year.Simple measures:

Example - Vitamin C, D and Fish oil ignored.

What is Integrative Medicine?Integrative medicine is a healing-oriented medicine that takes account of the whole person (body, mind, and spirit), including all aspects of lifestyle. It emphasizes the therapeutic relationship and makes use of all appropriate therapies, both conventional and alternative. AKA: CAM (complimentary and alternative medicine).Integrative Optometry follows these same principles.

What is a Nutraceutical?Nutraceutical can be defined as, "a food (or part of a food)

that provides medical or health benefits, including the prevention and/or treatment of a disease."

However, the term nutraceutical as commonly used in marketing has no regulatory definition.

* “Prescription drugs are approved through the rigorous new drug application process (NDA). In contrast, dietary supplements are regulated as foods and the FDA must determine that a dietary supplement ingredient poses a "significant or unreasonable risk of illness or injury"•About $7 billion spent on vitamins & $31 Billion spent annually on dietary supplements, herbal foods and products.

RDA = Recommended Daily Allowance-”prevent 97% of deficiencies”RDI = Recommended Dietary Intake

* J Pharmacol Exp Ther. 2005 Apr 15; [Epub ahead of print]

Most Common Reasons For Visiting Doctors Office (Adults Over Age 45)

Coutesy Bill Sardi, Knowledge of Health Condition Alternatives NotesCough (bronchitis) Chewable zinc

Echinacea, propolis, Vitamin C (3000–15000 mg), licorice root, eucalyptus

Very effective and doesn’t cause drowsiness as drugs can

Colds Zinc, vitamin C, olive leaf, vitamin D, garlic

Sore throat (laryngitis) Same as above for colds Don’t forget to gargle with salt water

Wheezing (asthma) Vitamin C up to dose that causes loose stool then cut back 25%; vitamin B6, magnesium, coleus forskohlii, ginkgo biloba

Lower doses for prevention

Nasal sinus drainage (infection)

Zinc, steam inhalation, arabinogalactin, olive leaf extract

Allergy Vitamin C to point of loose stool then cut back 25%; quercetin, stinging nettle, Antronex, with Yakriton

Influenza Vitamin C to point of loose stool then reduce dosage 25%; vitamin D3 to 5000 IU 1–5 days for adults; zinc up to 50 mg (adults); astragalus 1–5 days for adults; Echinacea, goldenseal, oregano

Many senior Americans don’t develop sufficient antibodies after flu shots because of poor nutrition.

Heartburn HCL hydrochloric acid and pancreatic enzyme are secreted less with advancing age; replace with supplements; if symptoms persist try mastic gum, aloe vera

Heartburn drugs may cause osteoporosis due to loss of vitamin D and fatigue due to vitamin B12 depletion.

Chronic headache

Our first remedy is to thin the blood as increased viscosity is a primary cause in our experience; garlic oil, magnesium, fish oil, bromelain, turmeric, ginkgo, ginger, ginseng, cayenne pepper, feverfew, nattokinase

See a health professional if symptoms persist.

Is Diet Enough ?Bruce Ames, PhD

Percent Americans Consuming 100% of the RDA, Select Nutrients

64%

46%

70% 74% 72% 69%

0%

20%

40%

60%

80%

100%

120%

Vit. A Vit. C Vit. E Vit. B6 Zn CaVitamin / Mineral

% P

opul

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n

J Am J Am Coll Nutr 1994; 13:285-91Coll Nutr, 1994

“It is a distortion of priorities for much of the world's population to have an inadequate intake of vitamins or

minerals—at great cost to health—when a year's supply of a daily

multivitamin/mineral pill costs less than a few packs of cigarettes. The poor, in general, have the worst diets and have the most to gain from improving their

multivitamin and mineral supplementation and diet,” says Dr. Ames. [European Molecular Biology Organization) Journal (6, S20–S24,

2005]

RDAs needs to be updated to reflect new scientific studies

RDA for vitamin C was based on flawed data (half life of vitamin C was never calculated). Virtually all humans on the planet are vitamin C deficient.Vitamin D is not toxic at relatively high doses and major segments of the US population are suffering from diseases related to vitamin D deficiency (cancer, autoimmune disease, hypertension, bone loss). Fortification of foods with vitamin D would likely cause cancer rates to decline by as much as 30%. 40% of adults over age 50 experience signs of vitamin B12 deficiency (short-term memory loss, fatigue, nerve tingling) because of a decline in the production of stomach acid.

Drug Class Natural remedy

Antidepressants Folic acid, SAMe

Blood pressure drugs, immune suppressants, bone drugs

Vitamin D

Penicillin Garlic clove (crushed), oil of oregano

Hormone replacement, hair drugs Flaxseed meal, flax lignan pills

Sleeping pills Vitamin B12, melatonin

Cholesterol drugs, Vitamin C, vitamin D, resveratrol

Blood thinners Fish oil DHA, magnesium, vitamin E, garlic, resveratrol

Calcium blockers Magnesium, vitamin D, vitamin K, arginine

Beta blockers – slows heart rate ~8 beats per minute

Omega-3 fish oil – slows heart rate ~6 beats per minute

Stomach acid blockers (histamine blockers) Magnesium, quercetin

Anti-inflammatories, pain relievers, cortisone

Tart cherry, resveratrol, quercetin, SAMe

Anti-allergy anti-histamine Quercetin, vitamin C

Antivirals, vaccines Resveratrol, quercetin, vitamin D

KEEP IT SIMPLE

Examples of Basic economical $20 per month multivitamin –mineral (sufficiently potent)

and fish oil combination 1 each with breakfast / dinner

Basic multivitamin / mineral formulationsapprox $15 per month

NSI Basic Synergy v #3 Capsules BID

www.vitacost.com

LEF “Two per Day” 01215

www.lef.org

MedOp Whole Body50% DOSE

www.medop.com

www.vitacost.com24/7 Customer Service 1-800-381-0759

NSI 3005017240 Softgels

4 month supply

2 per day800 EPA400 DHA$22

Also 120 softgelsNSI #3001484

Increasing Rx Pharmaceutical & OTC Safety Concerns

• In 2007, Americans spent around $300 Billion on FDA approved prescription & OTC drugs• 700,000 ER visits for overdoses & allergic rxns each year • (2005) 15,000+ died from drug reactions compared to 5,519 people in 1998• fatalities linked to generic pain pills (oxycodone, fentanyl,

morphine & acetaminophen or Tylenol)• (2005) 89,482 serious side effects to the FDA• 2.5 X the 34,966 reported in 1998• More than half of all approved drugs (like Vioxx) produce serious side effects not detected prior to approval. [Journal American Medical Assn. 279: 1571-73, 1998] • only 3% of prescription medicines have been withdrawn from the American market for safety reasons over the last 20 years.'

Drug Induced- Nutrient Interactions(examples)

Chronic use of proton pump inhibitors for dyspepsia and gastroesophageal reflex disease (GERD) can induce vitamin B12 deficiency, which may cause secondary effects on optic nerve function.

Chronic or high dose acetaminophen use may induce glutathione deficiency, which accelerates cataract formation and yields myriad effects on ocular tissues.

Overuse of steroids, such as dexamethasone and prednisolone, can induce deficiencies of vitamins C and D, folic acid, zinc, potassium, magnesium and selenium.

COQ10 Depleters--- statins, beta blockers, metformin

Even OTC Pharmaceuticals can induce nutritional deficiencies which are often treated

with additional pharmaceuticals

Consumers Report

Nutritional and Fiscal cost of PharmaceuticalsDRUGS

2001: $120 Billion2006: $200 Billion estimate2008 $300 Billion

AVERAGE age 65 y/o4 medicationsGrowing % of healthcare budget with political aspects

“Prescription drugs have an intended effect on the body but they may be reducing vital nutrients in your cells causing all sorts of annoying and dangerous side effects. For example, cholesterol-lowering statin drugs mug you of Coenzyme Q10, which powers your heart beat and keeps you from becoming weak, or developing leg cramps. Estrogen-containing drugs mug you of certain nutrients, leaving you hypothyroid, depressed and tired. Diabetic medications mug a certain B vitamin that protects you from stroke & heart attack. There are hundreds of medications included as well as drug-food interactions (like grapefruit, oatmeal and cheese interactions that could harm you)... “

2008

Brand name Generic name Class Nutrients depleted

Aspirin Aspirin Pain reliever Vitamin C, folic acid, iron, potassium

Tylenol Acetaminophen Pain reliever Glutathione

Advil, Motrin Ibuprofen Pain reliever Folic acid

Lipitor Atorvastatin Cholesterol drug Coenzyme Q10

Tenormin Atenolol Beta blocker Coenzyme Q10

Zithromax Aizithromycin Antibiotic B vitamins

Furosemide Uroside, Uritol Diuretic, blood pressure Minerals, Vitamin B1, vitamin C, zinc

Amoxycillin Amoxil, Biomox, Trimox Antibiotic B vitamins, acidophilus, inositol, vitamin K

Hydrochlorothiazide Hydrodiuril, Esidrix Diuretic, blood pressure Minerals, Vitamin B1

Prilosec Omeprazole Heartburn drug Vitamin B12

Prevacid Lansoprazole Heartburn drug Vitamin B12

Zocor Simvastatin Cholesterol drug Coenzyme Q10

Cephalexin Keflex Antibiotic B vitamins, vitamin K

Glucophage Metformin Diabetic drug Folic acid, vitamin B12

Vioxx Rofecoxib Pain reliever Folic acid

Zestril Lisinopril Blood pressure Zinc

Prempro Estrogen-progesterone Hormone replacement Folic acid, magnesium, zinc, Vitamins C, B2, B6

Prednisone Deltasone, Orasone, Prednicen Anti-inflammatory Minerals, folic acid, vitamins C & D

Toprol XL, Lopressor Metoprolol Beta blcoker Coenzyme Q10

Pravachol Pravastatin Cholesterol Coenzyme Q10

Coumadin Warfarin Blood thinner Vitamin K

Cipro Ciprofloxacin Antibiotic B vitamins, acidophilus

Lanoxin Digoxin Heart drug Minerals, vitamin B1

Flonase, Flovent Flutacasone Asthma Minerals, folic acid, vitamins C & D, zinc

14 SuperFoods ® Spinach BlueberriesSardines CitrusTurkey Breast PumpkinBroccoli YogurtWalnuts OatsTomato LegumesSoy Green Tea

Daily sunlight and/or 1000 IU vitamin D daily also is very important for general health

Teach patients about food The FDA against the USDA

& 29 Cherry Marketers(Oct 2006)

“Eat 9 – 13 portions of

Fruits & Vegetables per

day”

“20 cherries reduces inflammation in a similar manner as aspirin or Cox-2 inhibiting drugs without the lethal side effects of gastric bleeding or vitamin depletion associated with these drugs” The molecules in cherries, called anthocyanins, work to reduce inflammation at ten times less dosage than aspirin. [Journal Natural Products 1999 Feb; 62(2): 294–6]

Warning letter threatening regulatory action if scientific “drug like” claims are not removed from the web.

Cherrios – 12 May 2009FDA questions General Mills' Cheerios marketingTriangle Business Journal - by Joey Peters Minneapolis/St. Paul Business JournalThe FDA told General Mills to stop promoting Cheerios, the country’s best-selling cereal, as a product that can lower cholesterol levels, reduce heart disease and reduce the risk of cancer. The agency said that claiming the cereal can lower cholesterol levels by 4 percent in six weeks amounts to marketing it as a drug and violates the federal Food, Drug and Cosmetic Act. In a prepared statement, General Mills (NYSE: GIS) said the complaint doesn’t question whether the cereal actually lowers cholesterol levelsand said the dispute is over language, not science.“The scientific body of evidence supporting the heart health claim was the basis for FDA’s approval of the heart health claim, and the clinical study supporting Cheerios’ cholesterol-lowering benefit is very strong,”. “We look forward to discussing this with FDA and to reaching a resolution.”Cheerios boxes say that two, one-and-a-half-cup servings of the cereal every day have been clinically proven to lower cholesterol. The message has been on the box for more than two years.

BRITAIN: Tea Council under fire

Sept 26, 2007 - The UK Tea Council has been criticized for exaggerating the benefits of tea and banned from making further claims about the drinks antioxidant potential after running a series of adverts.

The group came under fire after five people complained to the Advertising Standards Authority (ASA) about a media campaign which recommended drinking four cups a day as part of a healthy diet.

……despite the UK Tea Council (UKTC) submitting nearly 100 scientific studies backing up tea's health potential, the ASA said it had not seen evidence to "firmly substantiate" any health benefit in drinking four cups of tea per day and said the campaign "exaggerated" the health benefits.

…..under regulation (EC) No 1924/2006, which came into force in the UK from 1 July 2007, any food product claiming to have a health benefit must meet a list of European Commission approved wording and be supported by scientific evidence.

Patients need better nutrition and higher doses of vitamins as they age *Mal-absorption including gastric hypo-chlorhydria occurs with age, disease and use of acid blockers.As we age, the ubiquitin system (Nobel Prize 2004) becomes less efficient due to free radical attack and glycosylation.We have accumulated more free radical DNA hits with less efficient repair.We become increasingly cross-linked and rigid due to carbonyl and glycosylation end products.

* Vitamins for chronic disease prevention in adults: scientific review. (JAMA. 2002 Jun 19;287(23):3116-26.)

CODEX 2005

The international “harmonization” of foods including vitamin and mineral dosage in supplements. The FDA will abide unless it breaks US law. United Nations Codex Alimentarius Commission Several committeesCodex Committee on Nutrition and Foods for Special Dietary Uses (CCNSFDU).

The meetings are open to delegations from all over theworld and as well as non-governmental organizations such as the Council forResponsible Nutrition (CRN), the National Health Federation (NHF) and theAmerican Holistic Health Association (AHHA).

Review 145 (3) Issue 3/14/08

While the media creates “nutri-phobia”Adverse Reports

# of deaths

Multivitamins 2811 0Oral Contraceptives 9948 1Insulin 1686 8Diuretics 7710 10Cough & cold preps 97710 14Aspirin 5249 14Acetaminophen 28991 63Antidepressants 92675 255

Comparative Safety of Multivitamins Am J Emergency Med 20: 391-452, 2002

Taking an aspirin every day is nearly as risky as working as a firefighter.

For 50-y/o men, taking a daily aspirin (which many do to help prevent heart disease and strokes) increases the risk of death by the equivalent of 10.4 deaths per 100,000 men per year. Similar to the added risk that professional firefighters face. Firefighters have an added risk of 10.6 deaths per 100,000 people per year, compared to 3.9 for all occupations and 0.4 foroffice workers.In comparison, drugs that have been withdrawn from the market, such as the painkiller Vioxx and the multiple sclerosis drug Tysabri, increased the risk of death by 76 deaths per 100,000 people per year and 65 deaths per 100,000 people per year, respectively. Tysabri may be reintroduced to the market if the FDA deems it worth using despite the risks.Adverse drug events harm more than 1.5 million people and kill several thousand a year, costing at least $3.5 billion annually. (Institute of Medicine 2006)

Health Affairs, Vol. 26, No. 3, May/June 2007: 636-646

Anti-Dietary Supplement Propaganda Campaign

Witch hunt (definition): An investigation carried out ostensibly to uncover subversive activities but actually used to harass and undermine.

“often unsafe ?”

All 29,000 dietary supplement productsAmerican Association of Poison Control Centers data

600 US manufacturers1000 more products each yearUse in older patients: 44% in 1980; 55% by 1994, and 63% by 2000. In Europe, supplements like ginkgo biloba, kava kava, bilberry and even a citrus fruit extract for hemorrhoids, are all prescription drugs. 23 yrs of poison control center adverse events: 1.6 million adverse rxns & 230 deaths (approx 12 per year).

Most are ephedra diet productsGuilt by association in aging Americans ?

Supplement Manufacturers are now required By Law to notify the FDA of adverse events (not drug manufacturers)-Spanking the Wrong child ?

Government Sources on Herbs and Vitamins

National Library of Medicine Medline Plushttp://www.nim.nih.gov/medlineplus/druginformation.html

National Center Complementary / Alternative Medicine

http://ncam.nih.govOffice of Dietary Supplements

http://dietray-supplements.info.nih.govThe Center for Disease Control & Prevention

http://www.cdc.gov/nutrition/everyone/basics/vitamins

Certification Services

www.usp.orgwww.nsf.orgwww.informed-choice.orgwww.ConsumerLab.com

Herbs et al

Ginkgo biloba is associated with bleedingbut researchers could not reproduce these same side effects in animals or humans even at blood concentrations 100 times greater than the recommended dosage for ginkgo. (Phytomedicine 12:10-6 2005; Blood Coagulation Fibrinolysis 15: 303-09, 2004).

Glucosamine triggers a rise in blood sugar among healthy adults in two separate studies

Couldn’t reproduce this problem. (Osteoarthritis Cartilage 12: 506-11, 2004; Archives Internal Medicine163:1587-90, 2003).

USA Dietary Patterns (1890-2009)

High simple carbohydrate consumptionSoda -3.5 cans/day (only 25 % diet) - started in 1890White Flour Baked goods - started in 1890Potatoes - French Fries as #1 “vegetable”

Low Fruit & Vegetable (micronutrient/fiber) consumption20:1 imbalance W6:W3 fatty acids5-10 % calories from trans fatsGrain-fed & fattened cows, pigs, chickens -and stable, (perhaps slightly lower %) saturated fat consumptionProgressive increase in calories to 3700/capita in 1990s

(fast food , meal super-sizing and nocturnal 24/7 eating)

United States: The Revis family of North Carolina Food expenditure for one week: $341.98

Bhutan “Modern Nutrition” and Ocular DiseaseExcess Macronutrients & Low Micronutrients

Obesity and increased risk of CVD, HTN and +/- CANCERObesity and increased risk of AMD & CATARACT Obesity, Diabetes and increased risk of RETINOPATHYObesity and increased inflammation

Insufficient Nutritioninduced by average plant food consumption of only 3 servings/dayinduced by individual pharmaceuticals & poly pharmacyinduced by an RDA for ascorbic acid that is too lowinduced by recommendations to avoid fish – omega IIIinduced by recommendations to avoid sunlight – vitamin DInduced by mixed media messages and “nutri phobia”

Mal-nutrition examples-- TRANS fats from corn & vegetable oils -- high fructose corn syrup (methylglyoxal)-- aspartame-- MSG

History of USDA’s Food Guidance

1940s

1950s-1960s

1970s

1992

2005

Food for Young

Children

1916

Anatomy of www.MyPyramid.gov2005 for Americans (over age 2)

One Size Doesn’t Fit All

ActivityModerationPersonalizationProportionalityVarietyGradual Improvement

Age ; Gender ; Activity; 12 tailored diet plans

SupplementsCommon Misconceptions

Herbs/Vitamins are completely safeHerbs/Vitamins are ineffectiveMore is better – potential high dose issues

Vitamin EBeta CaroteneCalciumSeleniumOmega III

Reversible Minor Side effects

Diarrhea from vitamin CLoose stools from magnesiumFinger tingling from megadose Vitamin B6Flushing from niacinReversible discoloration of skin from B carotene

Subconjunctival Hemmorhage 10 Questions

ValSalva ?ConstipationVomitingCoughingStraining

ASA or Coumadin ?High Dose Vitamin E ?High Dose Fish Oil ?Ginkgo Biloba, Ginseng ?

Caution Required

Vitamin K with Coumadin ?Combining blood thinning agents

Coumadin, HeparinASAVitamin E (above 1100IU)Fish oil above 2 gramsGinkgo biloba, ginseng

Riboflavin above 10mg (photosensitizer)FE++ (iron)Herbal Steroids / Body Building Supplements

Discriminately READ Scientific StudiesTypes of Studies – don’t discount multiple

observations, but look at Power CalculationBias – “follow the $”* Absolute Risk - pay close attention to this oneRelative Risk – “ where’s the beef ”Odds Ratios - look for statistical significanceSignificance - is p = 0.06 worthy of our attention?Meta-analysis – was there selective inclusion ?

Bias is still possibleDo conclusions understate or overstate the data ?“Made in America” bias

Is academic medicine for sale ?“No, the current owner is very happy

with it”

1.Why are you prescribing this drug? 2.Are there older & safer less

expensive drugs ?3.Is a drug needed at all for this mild

case? Marcia Angell, MD former Chief Editor , NEJM "The Truth About the Drug Companies: How TheyDeceive Us and What to Do About It" (Random House, 2004).

How do we avoid “Disease Mongering” ?includes turning ordinary ailments into medical problems, seeing mild symptoms as serious, treating personal

problems as medical, seeing risks as diseases & framing prevalence estimates to maximize potential markets.

A recent report in the Columbia Journalism Review of the news media’s complicity in drug marketing http://www.cjr.org/issues/2005/4/lieberman.asp notes that noted medical journalists chose not to warn the American public of the potential dangers posed by Vioxx because pharmaceutical advertising is now a primary source of income for television and newspapers.

Selling sickness: the pharmaceutical industry and disease mongering: British Medical Journal, Volume 324: 886-91, April 13, 2002

Relative risk or “Sleight of Hand”(i.e. Headline “Cholesterol-lowering statin drugs lower the risk

for a heart attack by 30%”)A naïve reader would get the false impression that these drugs will result in 30 fewer heart attacks per 100 statin drug users Let’s say heart attacks occur among 3% of 1000 patients over 5 years -- that would amount to 30 heart attacks. A 30% relative risk reduction of 30 would be 9 less heart attacks (21 total over 5 years). That’s 2 heart attacks that were prevented every year among 1000 statin drug users, or just 0.2% difference (2/10ths of one percent) between users and non-users of statin drugs.Some 1,825,000 statin pills would be consumed to prevent 9 heart attacks –but not 9 lives saved. 4 statin drug trials 67 of 7065 (0.948%- 9/10ths of one-percent) statin drug users died

102 of 7054 (1.446% - nearly 1½ of one percent) who did not take the drug*An absolute difference of 0.498% (1/2 of one percent, absolute difference). [British Medical Journal 323: 1-5, 2000]

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Odds Ratios, Vitamin C studies HOPE (Heart Outcomes Prevention Evaluation) Vitamin E Meta analysis

JAMA 293:1338-47, 200519 studies, 135,000 people“400 IU increased risk of dying by 4%”What researchers claimed was that high-dose vitamin E increased the risk of heart failure by a whopping absolute 1% risk among people who took three drugs that induce heart failure (diuretics, statin drugs and beta blockers). The vitamin E got blamed for the problem & worse yet the researchers eliminated studies where there were no deaths and 2 studies with 2000 IU that showed a decrease!12% reduction in death in AREDS34% reduction in MIs & 49% reduction for high risk females over age 65 in the Womens Health Study, JAMA 294: 56-65, 2005

Safety: “Dose is the poison”

Safety of antioxidant vitamins and B carotene, Am J Clin Nutr 1995;62(suppl): 1510S-6S.Safety of antioxidant vitamins. Arch Intern Med 156: 925-35, 1996. Meta-analysis of 68 randomized trials, n=232,606 Goran Bjelakovic, MD, Copenhagen University Hospital in Denmark.JAMA. Feb 2007;297:842-857.

Meta-analysis of 68 randomized trials, n=232,606 Goran Bjelakovic, MD, Copenhagen University Hospital in Denmark.

JAMA. Feb 2007;297:842-857.

Trials/Agent Relative Risk of Mortality

95 % CI

All trials- all agents 1.02 0.98 - 1.06 nsLow Bias Trials-all agents

1.05 1.02 – 1.08

Beta carotene 1.07 1.02 – 1.11Vitamin A 1.16 1.10 – 1.24**Vitamin E 1.04 1.01 – 1.07

Relative Risk for All-Cause Mortality With Antioxidant Vitamins

Antioxidants & All Cause Mortality

Beta Carotene

High dose Vitamin A and Acutane® should be avoided by women who might become pregnant, patients with liver disease and those who drink heavily.

However vitamin A from B Carotene is produced on an “as needed” basis.

Consider the issue of competition with D, another fat soluble vitamin, when talking about the bone mineralization issue.

B Carotene Contraindication forSMOKERS

ATBC Trial18 % more lung cancers were diagnosed and 8 % more overall deaths occurred in participants taking 20 mg B carotene daily.

N Eng J Med 330:1029-35, 1994.

CARETAfter 4 years, there were 28 % more lung cancer deaths and 17 % more deaths in participants taking 30 mg B carotene daily.

N Eng J Med 334:1150-5, 1996.

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ß-Carotene - Intervention Studies

Slide: Helmut Sies,PhD University of Duesseldorf

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a) ß-Carotene

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b) Lycopene

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150

0.01 0.1 1 10

c) Lutein

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Carotenoid (nmol/ mg cellular protein)

Carotenoid (nmol/ mg cellular protein)Carotenoid (nmol/ mg cellular protein)

Carotenoids and UV-induced TBARS formationin skin fibroblasts

100 %= UV-induced TBARS-formation in controls without carotenoids: 1.4 ±0.2 nmol MDA/mg protein (n=14)

Eichler et al (2002) Photochem. Photobiol 75, 503-6.

Slide: Helmut Sies, University of Duesseldorf

CalciumHeartbeat, nerve conduction, hormone secretion, blood clotting & skeleton (osteoporosis 4x more common in females)Are Americans over-calcified ?Arterial plaques are 50% calcium but only 3% cholesterol.Unwanted soft tissue deposition.Not balanced by MagnesiumAortic valve calcification and decreased elasticity and rising systolic BPKidney stones Mitral valve defectsBruchs membrane calcifies with age

S Seeley, International J Cardiology, 1991;33:191-8

The predictive power of coronary artery CA++ scores

Among subjects whose coronary artery CA++ scorewas zero, the risk for any adverse coronary event was only about one-half of 1% (0.0044), or less than 1 in 200.

Those with a coronary CA++ score over 300, about 8.0% experienced an adverse event involving coronary arteries (0.0804), or about 8 in 100, an 18-fold difference (1800% !), over the 3.8 year period.

….For bone health, think about adding magnesium & boron (besides vitamin D) to

simple calcium supplementation

University of Auckland Study, Sept 2007CA++ link to heart attacks

N=1500 postmenopausal femalesPlacebo or 1000mg calcium to prevent osteoporosis over 5 years36 heart attacks for calcium users’22 heart attacks for placebos* 3 smaller international studies had similar results

200 ug Selenium & increased risk of DM IIN=1202; self report of DMNational Prevention of CA trialThe claim is that, after 7.7 years of use, a 200 microgram selenium supplement increased the risk for diabetes by 50%.A large long-term study reported in

1994 that the same dose of selenium resulted in a dramatic decline in cancer incidence Mechanism: There is animal data showing that selenium, which helps to produce an antioxidant enzyme called glutathione peroxidase, may trigger over-expression of this enzyme which could possibly increase the inability of insulin to enter cells (called insulin resistance).

Effects of Long-Term Selenium Supplementation on the Incidence of Type 2 Diabetes: A Randomized Trial.Annals of Internal Medicine: 21 August 2007, 147(4).

ABSOLUTE STATS

9.7%

6.5%

Flaws in this 10 yr post hoc study originally designed to look at cancer

The NP CA study was not designed to look at diabetes

Self-reporting of DMLimited data for analysis

No diet or medication dataIgnored + CA findings (1 sentence in article)

SE reduced deaths from prostate cancer by 63%. SE reduced deaths from colorectal cancer by 58%. SE reduced deaths from lung cancer by 46%.

ORGANS with FAT

BRAIN & RETINABREASTPROSTATE

Essential Fats for Thought and HealthIntelligence and breast feeding to 4 mo; 1st born and maternal DHA; visual acuityADHD Depression: USA vs. Japanese elderlyMental disorders i.e. schizophrenia/ 3 studiesAlcoholism- destroys DHAPostpartum depressionImpulsive violent behaviorType A vs. Type H (Hostility) and MIEczema and psoriasisRheumatoid ArthritisAMDDRY EYES

Omega 3 fatty acids

1. Diminish inflammatory tear components & meibomian glanddysfunction.

2. Augment the lipid component of the tear film (prevent evaporation).

3. Indirectly stimulate lacrimal tear secretion.

Is dry eye an indicator of systemic

essential fatty acid deficiency ?

IS THERE ANOTHER WAY TO TX DRY EYE ?

----or----

IF THE WHOLE HOUSE IS ON FIRE, WHY SEND THE FIRE DEPARTMENT ONLY TO THE BARN ?

Fish oil & Coagulation StatusWarfarin is an oral anticoagulant used to control and prevent thromboembolic disorders. The dose is adjusted to maintain

the patient's prothrombin time (PT) international normalized ratio (INR) within a recommended therapeutic range.

CASE REPORT Ann Pharmacother. 2004 Jan;38(1):50-2. Omega-3 fatty acids may lower thromboxane A(2) supplies within the platelet as well as decrease factor VII levels. Although controversial, this case report illustrates that fish oil can provide additive anticoagulant effects when given with warfarin. CONCLUSIONS: This case reveals a significant rise in INR (2.8 to 4.3) after the dose of concomitant fish oil was doubled (1 g to 2g) . Patients undergoing anticoagulation therapy with warfarin should be educated about and monitored for possible drug-herb interactions.

STUDY: J Thromb Thrombolysis. 1998 Jul;5(3):257-261.Effects of Marine Fish Oils on the Anticoagulation Status of Patients Receiving Chronic Warfarin Therapy….. “Fish oil supplementation in doses of 3-6 grams per day does not seem to create a statistically significant effect on the anticoagulation status of patients receiving chronic warfarin therapy”.

Current atrophic AMD interventionDecrease smokingAvoid obesity Exercise Avoid exposure to bright sunlight

(blueblockers-yellow tint)Increase plant food (spinach) consumption

Follow www. MyPyramid.Gov & SuperFoods Rx book by Steve Pratt, MD ………

1 egg every day is a good source of luteinAvoid or control hypertension.Avoid high Fe(II) intake; give blood 3x/year(Lutein based multivitamin/multimineral)Omega 3 fatty acidsA glass of red wine and blueberries.Soy (genistein), oranges, bananas & vitamin D against neovascularization (wet AMD)

Benefits of offering Ocular Nutritional Counseling

Solving the patient’s main problemEnhanced understanding of the patient’s overall healthBringing patients back to the office frequentlyBetter from you than the health food store clerkEnhanced reputation

Intellectual Morons

1. Admit they read only 4 journals 1. (i.e NEJM, AMA, Annals Inter Med, Lancet)

2. Don’t have time to research material that would improve a patient's care

3. Would be so obstinate and filled with so much self-importance they would allow a patient to die rather than try something that had strong clinical evidence of benefit without any complications