dr. stephen holt-dietary supplement dispensation

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    DIETARY SUPPLEMENT DISPENSATIONIN CLINICAL PRACTICE

    PRODUCT SELECTION, PROFITS, PITFALLS AND

    LEGALITIES

    Stephen Holt MD, LLD (Hon.) ChB., PhD, DNM,

    FRCP (C) , MRCP (UK), FACP, FACG, FACN,FACAM, OSJ

    Distinguished Professor of Medicine, NYCPM,Scientific Advisor, Natural Clinician LLC

    NATURAL CLINICIAN LLC.

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    DIETARY SUPPLEMENTS AS A

    PROFIT CENTER

    Declining revenue for cognitive activity inclinical practice

    Dietary supplement dispensaries are a

    major profit center Supplement sales promote return visits

    and precipitate spontaneous demandsfrom patients for disease prevention

    Margins on sales are high Supporting literature saves consultation

    time

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    ETHICS

    Physicians must not engage in selfreferral

    Private labels with physician identity

    are problematic

    State licensing authorities have mixed

    beliefs about supplement sales

    At law, dietary supplements are not to

    be used to prevent or treat any disease Medical practice should not be

    legislated

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    HISTORIC PERSPECTIVES

    Pharmacognosy: the study of

    natural products used in medicine

    Ancient discipline of medicalscience

    Pharmakon = drug, Gnosis =

    knowledge

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    CONCEPTS

    Natural medicine cannot integrate intogeneral medical practice without ascientific base.

    Botanicals or herbs are drugs and

    many drugs are botanicals or herbs, orsynthetic copies.

    Dietary supplement manufacturersexhibit widespread ignorance about

    pharmaceutical science. Hiding behind mythical and magical

    thinking is no longer acceptable inintegrative medicine.

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    CONCEPTS

    Some natural clinicians baulk at attemptsto explain the bioactivity of naturaltherapies within the framework of currentscientific knowledge.

    While sympathy exists for this position,our understanding of pharmacodynamiceffects of herbs, botanicals or nutrientsmust be based on scientific principle.

    Conversations about clinicalpharmacology among dietary supplementmanufacturers are rare and practicallynon-existent with their customer base.

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    DRUG OR NUTRACEUTICAL

    DISPOSITION If dietary supplements are to be used astherapeutic agents, there must be somerespect for basic pharmacologic concepts.

    The concepts are A, D, M and E. One may look critically at some dietary

    supplements by simply consideringfactors that influence absorption,

    distribution, metabolism and excretion ofchemical compounds [drugs ornutraceuticals].

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    ABSORPTION

    Absorption is a complex function of routeof delivery, chemical characteristics,processes of movement across

    absorption barriers and physiologicalevents such as gastric emptying, ormodified by presence of disease, age etc.

    Some nutraceuticals claim that they haveabsorption and bioavailability that cannotbe present, based on simple scientificprinciples.

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    ABSORPTION [examples]

    FISH OIL: Unstable in regularformulations, denatured by gastric acid,power is with EPA. Dosage requirements

    high, compliance issues, triplebioavailability with enteric coat.Standard fish oil products passe.

    SHARK CARTILAGE: solid or extract,enzymatic degradation of antiangiogenicproteins, buccal absorption a fairy tale,interesting facilitated absorption by aleaky gut.

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    DISTRIBUTION

    Drug distribution is often uneven:different tissue binding, different PH orpermeability of tissues.

    Example: Antioxidant Therapy: Idealantioxidant has lipophilic and hydrophilicprofiles and acts in a wide REDOX range.

    Single high dosage antioxidants have

    dangerous pro-oxidant effects. Most antioxidant supplements do not use

    the correct principles of formulation.

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    METABOLISM

    The process of chemical alteration ofdrugs in the body.

    A primary but not exclusive function of

    the liver. Inactive and active metabolites are

    produced, by synthetic or non-syntheticreactions.

    Example: Isoflavones: genistein/genistin,conjugation eg daidzein sulfate. Acomplicated story.

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    EXCRETION

    Elimination from the body, primarily bythe kidneys.

    A real concern exists with age related

    reduction in renal function andnutraceutical dosage adjustment.

    Some complex mechanisms exist egreabsorption transport mechanisms,

    tubular secretion and biliary excretionwith enterohepatic cycling.

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    DSHEA 1994

    Grassroots consumer lobby

    Defining a dietary supplement

    Section 3 : vitamins, minerals, herbs etc

    Safety : risk of illness or injury

    Section 5 : publications, balanced, not

    labels

    Labeling protocols : honest label ( section3)

    The enigma: not to be used

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    DSHEA- BASED MODEL

    WEAK SUPPORTINGDATA

    DIETARY SUPPLEMENT

    ?

    CREATE PLATFORM

    SELL WITH CLAIM

    PEER ACCEPTANCE

    SUCCESS FAILURE

    STRONG R & D

    PRODUCT AS A DIETARYSUPPLEMENT

    BODY STRUCTURE FUNCTIONCLAIM

    PEER ACCEPTANCE

    SELL (PHASE IV AND V)

    SUSTAINED

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    A PEEK INTO THE INDUSTRY

    The product of the month

    The evidence based formula

    Condition specific formulations CEO survey reveals scientific-

    based, new formulations are of

    major importance Who formulated the supplements

    you use in your practice?

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    KEY PUBLIC HEALTH

    INITIATIVES

    Lifestyle medicine combined with

    nutritional interventions have

    overshadowed allopathic approaches

    for many public health problems

    First line options for disease

    prevention are not rooted generally in

    drugs or surgery. Many factors have moved consumers

    of health care to the new paradigm of

    simple, gentle and more natural

    interventions

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    KEY PUBLIC HEALTH

    INITIATIVES

    Adult obesity

    Childhood obesity (A Dead-Loss

    Disorder) Cardiovascular health

    Cancer

    Arthritis Osteoporosis

    Etc

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    THE KEY PUBLIC HEALTH

    INITIATIVE

    The metabolic syndrome(SYNDROME X)

    A complex disorder rooted ingenetics, adverse lifestyle withprimary nutritional precipitation

    Defining Syndrome X

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    THE UNKNOWN EPIDEMIC

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    REDEFINING SYNDROME X

    Classic Definition: Obesity,Hypercholesterolemia, High Bloo

    Pressure, Linked by Insulin

    Resistance.

    Syndrome X, Y and Z.., an

    expanded definition incorporatinga novel unifying concept of

    common diseases

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    SUPER-SIZING AMERICA

    Americans exude

    complacency about

    their overweight

    status

    Obesity is part of a

    metabolic syndrome

    Syndrome X is

    under diagnosedand often mistreated

    by conventional

    medicine

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    UnrealisticUnrealistic

    weight lossweight lossexpectationexpectation

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    THE SAN BUSHMENTHE SAN BUSHMEN

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    Folklore useFolklore use Ethnobotanical factsEthnobotanical facts

    Whole plant/ plantWhole plant/ plantextractsextracts

    Steroidal glycosidesSteroidal glycosides

    Animal studiesAnimal studies

    Human studiesHuman studies

    PROPERTIES OFHOODIAPROPERTIES OFHOODIA

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