neverknwo
10/15/2004 5:33 PM
Report abusive post | UNO UPDATE: DSHEA (The UN PLAN to take away your vitamins and minerals and health cures.)
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Sent: Thursday, October 14, 2004 12:59 AM
Subject: DSHEA COMING UNDER MAJOR ATTACK FROM ASHP, ADA, AMA, ANA, PUBLIC
CITIZEN- OTHERS
link to www.godlikeproductions.com] alt=''>> IAHF Webmaster: Breaking News, Whats New, What to Do, USA, All Countries
>
> IAHF List: Many thanks for the heads up on this article to Josef
> Hasslberger from La Leva di Archimede
[link to www.laleva.cc] ,
an Italian
> health freedom organization allied with IAHF.
> link to www.godlikeproductions.com] alt=''>>
> As you can see from the article [below my comments], some huge
> pharmaceutical big guns are being trained on the American Dietary
> Supplement Health and Education Act. We must be vigilant to bills intended
> to scuttle DSHEA coming at us in the next Congress.
>
> It is not at all surprising that the Cartel would attempt an attack such
> as this on US soil concurrently to their International Assault via CODEX
> and the EU FSD.
>
> The price of freedom is eternal vigilance. Please mass forward this so
> more people will be aware of it.
>
> WHAT TO DO: link to www.godlikeproductions.com] alt=''>>
>
> For now, we must be vigilant to see if the Cartel introduces any
> legislation, but while waiting, we MUST take action against CODEX via the
> EMERGENCY SECTION at [link to www.iahf.com] and PLEASE donate to IAHF via
> 556 Boundary Bay Rd. Point Roberts WA 98281 or via paypal at
> [link to www.iahf.com] to help us get one more key person to the Codex
> meeting in Bonn on November 1 and also to get Candace and I to the
> Emergency Anti Codex Mtg in San Diego on November 19th.
>
> Please urge more people to sign up for the IAHF distribution list at
> [link to www.iahf.com] and urge them to get the Emergency Section materials
> in to every health food store in their area and to more vitamin companies.
> Please fully grasp that the supplement industry is being led to the cliff
> from within, so we MUST engage in this grass roots effort!!!
>
> Original article is here: [link to www.medscape.com]
>
>
> From American Journal of Health-System Pharmacy
>
> ASHP Statement on the Use of Dietary Supplements
> Posted 09/20/2004
>
>
> Position
>
> The American Society of Health-System Pharmacists (ASHP) believes that the
> widespread, indiscriminate use of dietary supplements presents substantial
> risks to public health and that pharmacists have an opportunity and a
> professional responsibility to reduce those risks. ASHP recognizes that
> patients may choose to use legally available dietary supplements, but
> believes that the decision to use substances that may be pharmacologically
> active should always be based on reliable information about their safety
> and efficacy. The current regulatory framework governing dietary
> supplements does not provide consumers or health care providers with
> sufficient information on safety and efficacy to make informed decisions.
> Furthermore, standards for product quality are currently inadequate. ASHP
> recognizes the concerns raised by the dietary supplement industry
> regarding regulating dietary supplements as nonprescription drugs because
> of the industry´s inability to patent product ingredients. !
> Still, ASHP urges Congress to amend the Dietary Supplement Health and
> Education Act of 1994 (DSHEA) to require that the Food and Drug
> Administration (FDA) develop a regulatory scheme to ensure that dietary
> supplements are safe and effective. ASHP believes that dietary
> supplements, at a minimum, should (1) receive FDA approval for evidence of
> safety and efficacy, (2) meet manufacturing standards for identity,
> strength, quality, purity, packaging, and labeling, and (3) undergo
> mandatory postmarketing reporting of adverse events, including drug
> interactions.
>
> ASHP strongly encourages in vitro and clinical studies of interactions
> between dietary supplements and medications. Because of the demonstrated
> risk of these interactions, ASHP discourages the concurrent use of dietary
> supplements and drug therapy, especially those therapies for which failure
> may have irreversible consequences (e.g., immunosuppressive therapy,
> cancer chemotherapy, treatment for human immunodeficiency virus infection,
> anticoagulation therapy, and hormonal contraceptive therapy).
>
> ASHP believes that the criteria used to evaluate dietary supplements for
> inclusion in health-system formularies should be as rigorous as those
> established for nonprescription drugs and that the self-administered use
> of dietary supplements during a health-system stay may increase risks to
> patients and liabilities to health care professionals and institutions.
>
> ASHP urges pharmacists and other health care practitioners to integrate
> awareness of dietary supplement use into everyday practice and encourages
> pharmacists to increase efforts to prevent interactions between dietary
> supplements and drugs. ASHP also supports the education of pharmacists and
> other health care practitioners in the taxonomy, formulation,
> pharmacology, and pharmacokinetics of dietary supplements and believes
> that such education should be required in college of pharmacy curricula.
>
>
> Background
>
> Dietary supplements are defined in DSHEA as products ´intended to
> supplement the diet´ that contain vitamins, minerals, herbs or other
> botanicals, amino acids; ´a dietary substance for use by man to supplement
> the diet by increasing the total daily intake´; or ´a concentrate,
> metabolite, constituent, extract, or combinations of these
> ingredients.´[1]
>
> Evidence of variability in dietary supplement content[2-8] has spurred
> efforts to standardize products. Current federal regulations regarding the
> manufacture of dietary supplements are not adequate.[9] Some manufacturers
> voluntarily follow good manufacturing practices (GMPs) devised by their
> own trade groups (e.g., the National Nutritional Foods Association GMP
> Certification Program[10]), and the U.S. Pharmacopeia (USP) has created
> voluntary standards for a handful of dietary supplements.[11]
> Manufacturers that wish to carry the ´USP approved´ seal on their product
> labels have to subject their products to testing by USP. The creation of
> these voluntary programs reflects a widespread concern, even on the part
> of dietary supplement manufacturers, that production processes must be
> regulated. Although FDA has had the authority to establish dietary
> supplement GMPs for almost a decade, it issued its first proposed rule on
> the topic in 2003.[12]
>
> DSHEA does not require FDA to review evidence of the efficacy or safety of
> dietary supplements, so manufacturers have no burden to prove that their
> products are effective or safe. Although dietary supplement labeling
> cannot claim activity in the treatment of a specific disease or condition,
> claims that suggest an effect on the ´structure or function of the body´
> are allowed.[1] For example, dietary supplements containing echinacea can
> be labeled as supporting immune health (as a ´function´) but cannot be
> labeled as preventing or ameliorating colds (treating a disease).
> Regardless of this distinction between function and treatment, consumers
> are bombarded by the lay press (and even some scientific literature) with
> what can only be described as specific-disease indications for dietary
> supplements (e.g., glucosamine for osteoarthritis, black cohosh for
> menopausal symptoms, and St. John´s wort for depression).
>
> The health claims allowed in dietary supplement labeling by current
> interpretation of DSHEA create further confusion for consumers. FDA´s
> attempt to hold these health claims to the same scientific standard
> required for conventional foods was struck down in Pearson v. Shalala, so
> FDA must permit dietary supplement labels to carry ´qualified´ health
> claims based on equivocal scientific evidence.[13]
>
> Although DSHEA does require that dietary supplements be safe, it does not
> require prospective testing to ensure safety. To remove a product from the
> market, FDA must prove that the product is unsafe. Under DSHEA, some
> dietary supplements that were banned from the U.S. market because of
> concerns about their safety have been allowed to return (e.g., sassafras
> tea, dehydroepiandrosterone). Demonstrably unsafe products have made their
> way onto the market, and fatal adverse reactions have been
> reported.[14,15]
>
> Establishing the safety record of dietary supplements has been complicated
> by the lack of systematically collected data about their adverse
> reactions. The MedWatch system has been used to a limited extent to report
> adverse events related to dietary supplement use, but, nine years after
> the passage of DSHEA, FDA is still developing an
> adverse-reaction-reporting system for dietary supplements. Despite the
> limited data, however, the number of case reports of interactions between
> dietary supplements and medications is growing.[16-21] The safety of
> dietary supplements for special populations (e.g., children, pregnant
> women, people with impaired organ or immunologic function) has also not
> been demonstrated.
>
>
>
>
> Dangers to Public Health
>
> It has been estimated that 40% of the U.S. population uses dietary
> supplements often and that almost twice as many have used at least 1 of
> the estimated 29,000 dietary supplements on the market.[22] Out-of-pocket
> expenditures on dietary supplements total approximately $18 billion
> annually.[23] Such widespread and indiscriminate use of dietary
> supplements presents five dangers to the public health:
>
> 1. Some dietary supplements are inherently unsafe when
> ingested orally (e.g., chaparral, ephedra, comfrey, tiractricol,
> aristolochic acid, pennyroyal).[24-28]
> 2.
> Lax regulation of dietary supplement manufacturing presents the risk of
> contamination or adulteration with harmful substances, including
> carcinogens,[29-32] and of dangerous variability in active ingredient
> content among products.[2-8]
> 3.
> The use of dietary supplements may compromise, delay, or supplant
> treatment with therapies of proven efficacy.[16-21,25]
> 4.
> Dietary supplements may present dangers to special populations (e.g.,
> children, pregnant women, patients undergoing surgery, patients with
> impaired organ or immunologic function).
> 5.
> Spending on dietary supplements represents an enormous health-related
> expenditure of unsubstantiated value.[33]
>
> Since the mid-19th century, the federal government has exercised its
> responsibility to protect Americans from hazardous or adulterated foods
> and medicines. ASHP believes that, with the passage and implementation of
> DSHEA, the federal government has abandoned its duty to create a
> regulatory scheme for dietary supplements that adequately protects the
> health of consumers. Under DSHEA, consumers and health care practitioners
> are not provided with the information they need to use dietary supplements
> safely. To reduce the dangers posed by the current regulatory framework,
> Congress should amend DSHEA to
>
> 1. Require that dietary supplements undergo FDA approval for
> evidence of safety and efficacy,
> 2.
> Mandate FDA-approved dietary supplement labeling that describes safe use
> in a clear, standardized format, including the potential for interaction
> with medications and cautions for special populations,
> 3.
> Require FDA to promulgate and enforce GMPs for dietary supplements,
> 4.
> Require that dietary supplements meet FDA-established standards for
> identity, strength, purity, and quality, and
> 5.
> Empower FDA to establish and maintain an adverse-event-reporting system
> specifically for dietary supplements, and require dietary supplement
> manufacturers to report suspected adverse reactions to FDA.
>
>
>
>
> Implications for Practice
>
> Although examples of persons rejecting potentially life-saving medical
> interventions in favor of alternative therapies can be found in the
> medical and lay press,[34] the presumption that most users of dietary
> supplements reject traditional treatments is unfounded. One survey found
> that most individuals who use alternative therapies for a specific symptom
> or disease are also receiving care and prescription medications from a
> physician or surgeon.[35] In a more recent nationwide survey, almost 20%
> of adults taking prescription drugs reported that they were taking at
> least one dietary supplement, not including vitamin or mineral
> supplements.[36]
>
> Pharmacists and other health care practitioners therefore have an
> opportunity to reduce the risks associated with dietary supplement use.
> Health care providers face unfamiliar challenges in this effort, however,
> because much of the information they typically use to establish
> pharmaceutical treatment regimens is lacking for dietary supplements.
> Product content is not standardized, therapeutic goals are vague, and
> evidence of efficacy and safety is absent or ambiguous. ASHP believes that
> pharmacists, as medication-use experts and accessible members of the
> health care team, are uniquely qualified and positioned to counsel
> patients using or considering the use of dietary supplements. Despite
> their professional responsibility to provide patients with sound advice,
> pharmacists (like other health care providers) are frustrated by the lack
> of reliable information about the safety and efficacy of dietary
> supplements. Pharmacists have shown that they can improve medication
> safety by ide!
> ntifying and preventing adverse drug events,[37] and they could play a
> similar role in preventing adverse events due to dietary supplement use if
> they had sound, evidence-based professional resources.
>
>
> Incorporate Awareness of Dietary Supplement Use Into Practice
>
> ASHP urges pharmacists and other health care practitioners to integrate
> awareness of dietary supplement use into everyday practice. ASHP believes
> that all health systems should have an institutional policy regarding the
> use of dietary supplements. Such policies should allow pharmacists and
> other health care practitioners to exercise their professional judgment
> and try to balance patient autonomy and institutional concerns.
>
> Patient Counseling
>
> Although most consumers of alternative therapies also take prescription
> medications,[35] one survey found that 72% of respondents who used
> alternative therapies did not report that use to their health care
> providers.[38] Pharmacists and other health care practitioners must
> therefore routinely inquire about a patient´s current or planned use of
> dietary supplements, providing examples so that patients understand what
> is meant (e.g, asking ´Do you use dietary supplements, such as St. John´s
> wort or gingko?´).[39] This information will allow pharmacists and other
> health care practitioners to counsel the patient about dietary supplement
> use and monitor for adverse reactions and drug interactions.
>
> When counseling patients about dietary supplements, the concept of caveat
> emptor (buyer beware) must be emphasized because the content and safety of
> dietary supplements are not well regulated. ASHP believes that all
> pharmacists, at a minimum, should be familiar with the pharmacology and
> pharmacokinetics of common dietary supplements that might contraindicate
> concurrent use with a therapeutic regimen (i.e., proven and potential
> pharmacokinetic and pharmacodynamic interactions with prescription and
> nonprescription medications) to the extent that sound evidence exists. To
> provide informed counsel to patients using or considering the use of
> dietary supplements, pharmacists further need to be familiar with the
> following:
>
> * The typical uses of common dietary supplements and the
> scientific literature regarding their efficacy and safety,
> *
> The proven and potential interactions between common dietary supplements
> and prescription and nonprescription medications,
> *
> The methods of therapeutic monitoring for common dietary supplements,
> including signs and symptoms of potential adverse effects and toxicities,
> *
> The proven and potential effects of certain disease states on supplement
> absorption, distribution, and elimination, and
> *
> The safety of using dietary supplements before or after surgery.
>
> Despite the shortcomings of the data on dietary supplements, the limited
> references on the topic that are available should be consulted.[40-45]
>
> Patients stabilized on a combination of a supplement and medication should
> be cautioned not to suddenly discontinue the use of either without first
> consulting with the prescriber. The potential for adverse effects from an
> interaction exists both when a dietary supplement is discontinued and when
> it is initiated.
>
> Dietary supplement sales have a very high potential for profit. Despite
> the expectation that pharmacies should receive a profit from the sale of
> products, professional ethics mandate that any recommendations or
> purchasing suggestions be made with the well-being of the customer or
> patient as the primary concern. Pharmacists should also review promotional
> and reference materials promulgated in or by their workplaces to ensure
> that these materials are evidence based and not misleading or deceptive.
> The scientific literature about the safety and efficacy of dietary
> supplements is updated continually. Pharmacists have a responsibility to
> continually monitor that literature and incorporate the evolving knowledge
> into their care for and advice to patients.
>
> Inclusion in Formularies
>
> ASHP believes that the criteria used to evaluate dietary supplements for
> inclusion in health-system formularies should be as rigorous as those
> established for prescription and nonprescription drugs. The Joint
> Commission on Accreditation of Healthcare Organizations (JCAHO) has
> recommended that medical staff weigh the patient care implications of
> dietary supplements with the same rigor applied to prescription and
> nonprescription medications,[46] and all JCAHO medication management
> standards apply to dietary supplements, as well as prescription and
> nonprescription drugs.[47] ASHP believes that the decision to include any
> product in a health-system formulary should be based on comparative data
> regarding efficacy, adverse effects, cost, and potential therapeutic
> advantages and deficiencies.[48] The lack of definitive evidence of
> efficacy and safety and the demonstrated variability in product content
> make most dietary supplements unsuitable for inclusion in health-system
> formularies!
> .[49] More research is needed to determine the relative effectiveness of
> dietary supplements and their safety for all patient populations,
> especially drug-supplement interactions.
>
> The shortcomings that make most dietary supplements unsuitable for
> inclusion in formularies also argue strongly against their use by patients
> via self-administration during a health-system stay. ASHP believes that
> the use of self-administered medications should be avoided to the extent
> possible[50] and that pharmacists should identify all drug products before
> their use.[51] There is currently no way to definitively determine the
> content of dietary supplements brought into health systems. In addition,
> discontinuing supplement use may be advisable as part of the diagnostic
> workup, and the possibility that supplement use may have contributed to
> hospitalization should be considered.
>
> If an institution decides, as a matter of patient autonomy, to allow the
> use of dietary supplements, such use should require a prescribed order for
> the specific dietary supplement in the patient medical record and
> pharmacist review and verification of the order. Health systems should be
> aware that the use of dietary supplements may expose patients to risks,
> and the health system and staff should take steps to reduce potential
> liability (e.g., require patients to sign a liability waiver for dietary
> supplement use) and decrease those risks.
>
>
> Conclusion
>
> Current regulation of the manufacture and labeling of dietary supplements
> fails to address substantial risks to the public health. As the activity
> of some dietary supplements has become apparent, so have their dangers and
> the shortcomings of the current regulatory framework. These laws and
> regulations should be revised, with the primary goal of providing
> consumers and health care practitioners with the information they need to
> use dietary supplements safely and effectively. In short, dietary
> supplements should be regulated in a manner that ensures that they are
> safe and effective. Pharmacists have an opportunity and a professional
> responsibility to reduce the risks presented by dietary supplement use.
>
> Acknowledgements
>
> David J. Kroll, Ph.D., is gratefully acknowledged for authoring the first
> draft of this statement. ASHP also acknowledges the following
> organizations and individuals for reviewing and commenting on drafts of
> the statement: American Dietetic Association (ADA); American Medical
> Association (AMA); American Nurses Association (ANA); National Consumers
> League; Public Citizen (PC); Ron Barnes, M.S.; Carol J. Bickford, Ph.D.,
> RN, BC (ANA); Lisa Boothby, Pharm.D.; Cindi Brennan, Pharm.D., M.H.A.;
> Sian Carr-Lopez, Pharm.D.; Steven Chen, Pharm.D.; Kevin J. Colgan, M.A.;
> David Copelan, Pharm.D.; Joseph Cranston, Ph.D. (AMA); Denise E. Daly,
> Pharm.D.; Peter A. G. M. De Smet, Pharm.D., Ph.D.; CAPT Joseph Deffenbaugh
> (USPHS, Ret.), M.P.H.; Kim H. DeRhodes; Paul Doering, M.S.; Deanna Dreher,
> Pharm.D.; Christine F. Edie, Pharm.D.; Steven Eggleston, Pharm.D.; Carla
> B. Frye, Pharm.D., BCPS, FASHP; Bill J. Gurley, Ph.D.; Guy Hasegawa,
> Pharm.D.; COL W. Mike Heath, M.B.A.; Roxanne Homar, Pharm.D.;!
> Marianne F. Ivey, Pharm.D., M.P.H., FASHP; Cherry Jackson, Pharm.D.; Roger
> Klotz; Cynthia L. LaCivita, Pharm.D.; Alan H. Mutnick, Pharm.D.; Brian M.
> Meyer, M.B.A.; Charlie Myers, Pharm.D.; Keith Olsen, Pharm.D.; Roland
> Patry, M.S.; Marjorie S. Phillips, M.S., FASHP; Steven C. Piscitelli,
> Pharm.D.; Darryl S. Rich, Pharm.D., M.B.A., FASHP; Larry D. Sasich,
> Pharm.D., M.P.H., FASHP (PC); Douglas Scheckelhoff, M.S.; Gayle N. Scott,
> Pharm.D., FASCP, BCPS, ELS, CGP; Kelly M. Shields, Pharm.D.; Susan C.
> Smolinske, Pharm.D., BCPS, DABAT; Sharm Steadman, Pharm.D., BCPS, FASHP,
> CDE; Gary Stein, Ph.D.; Jennifer Strickland, Pharm.D.; Cynthia Thompson,
> Ph.D., RD, FADA (ADA); Kasey K. Thompson, Pharm.D.; Candy Tsourounis,
> Pharm.D.; Sherry Umhoeffer, M.B.A.; Paul C. Walker, Pharm.D.; Dennis M.
> Williams, Pharm.D.; David R. Witmer, Pharm.D.; Raymond Woosley, Ph.D.; and
> William A. Zellmer, M.P.H.
> For Health Freedom,
> John C. Hammell, President
> International Advocates for Health Freedom
> 556 Boundary Bay Road
> Point Roberts, WA 98281-8702 USA
> [link to www.iahf.com]
> jham@iahf.com
> 800-333-2553 N.America
> 360-945-0352 World |
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