DSHEA COMING UNDER MAJOR ATTACK FROM ASHP, ADA, AMA, ANA, ETC.

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13 Oct 2004 23:54:01 -0000

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DSHEA COMING UNDER MAJOR ATTACK FROM ASHP, ADA, AMA, ANA,

PUBLIC CITIZEN- OTHERS

 

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 http://www.laleva.cc , an Italian

health freedom organization allied with IAHF.

 

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:

 

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 http://www.iahf.com and PLEASE donate to IAHF via

556 Boundary Bay Rd. Point Roberts WA 98281 or via paypal at

http://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

http://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: http://www.medscape.com/viewarticle/488945

 

 

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

identifying 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

http://www.iahf.com

jham

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360-945-0352 World