Homeopathy under attack

[freelynn]

Looks like the quackbusters are at it again.

Lynn Cremona

The policy committee listed below is part of the American Pharmacist
Association. If you know any pharmacists in the organization please
let them know that this recommendation is being considered. I just got this
notice from a friend and do not know exactly where it is in the process of
being presented or voted on.
June E. Riedlinger. R.Ph., Pharm.D.
Director, Center for Integrative Therapies in Pharmaceutical Care
Associate Professor of Clinical Pharmacy
Massachusetts College of Pharmacy and Health Sciences
179 Longwood Avenue, Boston, MA 02115-5895
Phone: 617-732-2232 Fax: 617-732-2236
2001 -2002 Policy Committee Report
Homeopathy
Recommendation:

The Committee recommends the Association adopt the following
statements:
1. APhA opposes the advocacy and/or sale of homeopathic products in
the absence of sufficient evidence from adequate, well-designed clinical
trials that demonstrate the safety and efficacy of these products.
2. APhA recognizes patient autonomy regarding the use of homeopathic
products. If patients choose to use homeopathic products, pharmacists
should educate them about
a) the potential problems associated with the use of homeopathic
products, and
b) the lack of scientific data supporting safety and efficacy.
3. APhA encourages revision of federal and state food, drug and
cosmetic laws to remove the Homeopathic Pharmacopeia of the United
States (HPUS) as an official compendium.

Summary of Committee Discussion:
a. The committee reviewed and discussed homeopathy, reviewing
background material from the APhA Academy of Pharmaceutical
Research and Science, including the material compiled in Attachment A.
b. The Association does not have specific policy on homeopathy. The
1997 policy on Complementary and Alternative Medicines (see "review of
existing policy" after this summary) was developed in the context of a broad
discussion of complementary and alternative medicine, with one component
of the discussion focusing on homeopathy. By contrast, this discussion
focused solely on homeopathy.
c. The practice of homeopathy is based on the belief that disease
symptoms can be cured by small doses of substances that produce similar
symptoms in healthy people. Homeopathic products are recognized and
regulated as
"drugs": the Federal Food, Drug and Cosmetic Act recognizes as official
those
products that comply with the Homeopathic Pharmacopeia of the United States
and its supplements.
d. The American Medical Association (AMA) has periodically reviewed
homeopathy and other alternative medicine approaches. Although many
journal articles, policy reports and letters to the editor have debated the
issue of homeopathy, the official AMA policy on homeopathy does not condemn
the practice.[27]
e. The committee was concerned about the lack of scientific data
supporting the use of homeopathic products. In contrast to medications
listed
in the United States Pharmaceopeia or approved by the Food and Drug
Administration, homeopathic products are not subject to rigorous
clinical trials
demonstrating safety and efficacy.
f. Many patients may not be aware of this difference, and assume
that a pharmacist recommendation to use these products indicates that the
products are subject to the same review as other medications. An implicit
endorsement exists when pharmacists sell these products, whether or not an
explicit recommendation exists. Some may argue that pharmacists who recommend
homeopathic remedies undermine the profession's claim as a drug therapy
expert.
g. Because of the lack of scientific data supporting the use of
these products, the committee proposes in the first statement that
pharmacists decrease patient confusion by not selling these products.
Compilation of additional safety and efficacy evidence could support sale
of these
products and subsequent revision of this policy (if adopted).
h. Such a statement does not prohibit pharmacists from selling
homeopathic products; it merely identifies problems with the products and
potential confusion created when these products are presented with other,
more
stringently regulated medications.
i. The committee also discussed consumer interest in using
homeopathic products, and the pharmacist's responsibility to discuss the
use of
these products and any interaction with other therapy. The second proposed
statement provides some guidance for these discussions, including
the difference between homeopathic products and other medications. This
may require the pharmacist to learn about these products, and APhA could
be instrumental in providing such education.
j. Recognition of the Homeopathic Pharmacopeia of the United States
(HPUS) as a compendium in the Federal Food, Drug and Cosmetic Act (FD&C Act)
may create the impression that homeopathic products are equivalent to other
therapies.
To combat this problem, the committee recommends the third statement,
focusing on changing applicable food and drug laws to remove the
HPUS recognition. Removal of the recognition as a compendium would remove
the definition of these products as "drugs" under the FD&C act.
k. The committee conducted a comprehensive review of existing APhA
policy related to homeopathy, and discussed the topic with the Policy
Review Committee. Existing policy statements are listed below, with the
recommendation from the Policy Review Committee. These recommendations
will be considered after the House completes action on the Policy
Committee Report, in Part II of the Policy Review Committee Report.

Review of Existing Policy
(Presentation in green designates a recommendation to rescind the
statement, highlighting designates a recommendation to archive the
statement as
historical, underlined sections designate a recommendation to update
the statement.) These recommendations of the Policy Review Committee
will be considered after the House completes action on the Policy Committee
Report. The committee recommends retaining the policy as written.
1997 Complementary and Alternative Medications
1. APhA shall support informed decision-making based upon the
professional judgment of pharmacists regarding the appropriateness of use
or the
sale of complementary and alternative medicines.
2. APhA shall assist pharmacists and pharmacy students in becoming
knowledgeable about complementary and alternative medications to
facilitate the counseling of patients regarding effectiveness, proper use,
indications, safety and possible interactions.
(JAPhA NS37(4): 459. July/August 1997)

The committee recommends rescinding the following policy.
1986 "Quack" Therapy
1. APhA encourages FDA and FTC to increase their efforts to
eliminate "quack products."
2. APhA encourages pharmacists not to stock any "quack products."
(Am Pharm NS26(6):420. June, 1986)
Attachment A APhA-APRS PRIORITY: A POLICY ON HOMEOPATHIC REMEDIES
SUMMARY
APhA does not have a policy on the use of homeopathic remedies.
Reference books on OTC and natural medicines endorsed by APhA span the
spectrum of praising homeopathy for use in conditions such as asthma,
epilepsy
and glaucoma (1), presenting the pros and cons of this alternative
medicine without making any recommendations on the appropriateness of its use
(2), and criticizing the use of homeopathic remedies (3). APhA-APRS is
concerned that member pharmacists are receiving a mixed message and
therefore could
be ill equipped to provide appropriate counseling to patients and other
healthcare
professionals on the legitimacy of the treatment. Although it is
unlikely that a patient would suffer from an adverse event from a formulation
that is so diluted as to contain little to no pharmacological activity,
the use of
a homeopathic remedy by a patient may delay the use of more appropriate
interventions. In addition, a pharmacist's recommendation of a homeopathic
remedy undermines the professions claim as a drug therapy expert. An
APhA-APRS objective in 2001/2002 is to develop a policy on the use
of homeopathic remedies.

BACKGROUND
The renewed interest in natural products by consumers and healthcare
practitioners, and the passage of the Dietary Supplement and Health
Education Act in 1994 have led to a large growth in the use of herbal
medicine. Many consumers and healthcare practitioners consider homeopathic
remedies to fall within this general class of herbal medicine since
approximately
60% of homeopathic ingredients are derived from plants (1). According to a
published survey homeopathic use in the U.S. increased from 0.7% in 1990 to
3.4% in 1997 (4). Plant derived dietary supplements and homeopathic
remedies differ
dramatically and it is critical that pharmacists understand these
scientific differences. Unlike botanical dietary supplements that are
developed
according to the same proven pharmacological approach that is used
for synthetic drugs, homeopathy was developed to be an alternative to
traditional medicine by a German physician in the early 1800's.
According to the
author of a recent text for pharmacists on nonprescription therapeutics,
homeopathy is founded on principals that are "so far removed from
traditional
medicine as to render them mutually exclusive" (5). The major principals
are:
1. The Law of Similars - the use of a medication that produces thesame
symptoms
that a patient is experiencing (e.g. using caffeine to treat insomnia).
Although vaccines
and allergy injections are based on using a substance to elicit an
immune response,
homeopathy carries the concept way beyond a scientific explanation,
especially when this principal is
considered together with the Law of Infinitesimals discussed below.
2. The Law of Infinitesimals - the more diluted the medication is,
the stronger it becomes. This flies in the face with the concept of a
dose response curve. "Low potency" remedies are typically considered to
be dilutions that are 12X or below. A 12X dilution means that the
sample is diluted 1:10 TWELVE times with a diluent. A 6X dilution would be a
one part per million dilution. Mid-potency remedies are between 12X and 30X.
"High potency" remedies are anything greater than 30X (2). Of critical
concern is that a substance that is above a 24X dilution would be beyond
Avogadro's number, meaning that there is no physical substance left in the
dilution (1), yet such a preparation is concerned to be highly potent. Of
concern
is that the authors who wrote the chapter on homeopathic remedies in APhA's
Handbook of Nonprescription Drugs state: "Higher potencies are more
likely to
produce aggravations and should not be used if the practitioner is unsure of
the remedy, if a non-expert is recommending the remedy, or if the patent
is using the remedy as a self-treatment without the aid of a homeopathic
practitioner"(2).
3. The Process of Succussion - medications are inert in their native
state. The diluted medication must be shaken to "potentize" or "dynamize"
the medication, releasing hidden healing forces. No commentary is needed
to elaborate on this concept!
Homeopathy has a long and interesting regulatory status in the U.S.
Abraham Lincoln reportedly responded to a petition to include homeopathic
medicines in the U.S. Army Dispensary with the words: "The application is
dismissed.

You cannot fertilize with flatus"(5). Although FDA regulates
homeopathic medications as drugs, manufacturers are not required to prove
that
the products are effective due to an exception in the Food, Drug and
Cosmetic Act of 1938. The Homeopathic Pharmacopoeia of the United States
(HPUS)
is the official compendium that defines the OTC or Rx status of homeopathic
remedies. The American Homeopathic Pharmaceutical Association and
the Homeopathic Academy of Naturopathic Physicians are active advocates.
Even though homeopathic remedies have been used for almost 200
years, proof of efficacy is still sought. Several meta-analysis of
placebo-controlled
trials have been published and the results are equivocal. Advocates of the
treatment point out that new paradigms and research methods are needed to
demonstrate efficacy. Opponents point out that the studies are flawed and
that there
is a very high placebo effect. What is clear is that a mechanism of
action is unknown and
that the principals of homeopathy are inconsistent with the fundamental
scientific
principals on which pharmacology and clinical pharmacy are based.

References
1. Natural Therapeutics Pocket Guide, 2000-2001, J. LaValle, D.
Krinsy, E. Hawkins, R. Pelton, N. Ashbrook, Lexi-Comp, pps 31-35. (note: APhA
seal is on the cover and the book is advertised as an APhA publication)
2. K. Grant and R. Herrier, "Homeopathic Remedies" in Handbook of
Nonprescription Drugs, 12th Edition, American Pharmaceutical
Association, 2000, pps 983-1005.
3. A. Peirce, The American Pharmaceutical Association Practical
Guide to Natural Medicines, the Stonesong Press, 1999, p. 2. (note: this book
has been dropped from the APhA Publications Catalog)
4. Eisenberg, E.M, et al. "Trends in alternative medicine use in the
United States, 1990-1997: results of a follow-up national survey, JAMA,
1998, 280:1569-1575.
5. W. S. Pray, Nonprescription Product Therapeutics, Lippincott
Williams & Wilkins, Philadelphia, 1999, pps 750-756.

[Soroush Ebrahimi]

Re Part g
If the Pharmacist is not a qualified Homoeopath, how can they recommend a
homoeopathic remedy?

Soroush

[Rosemary Hyde]

It seems as though it might be useful for someone from NASH, for example, to
contact counterparts at APhA and offer some education, since their basic
premise seems to be "we don't understand this so we'll try to get rid of
it." Is there someone on the list who would be able to suggest this to the
most appropriate NASH officers?

Rosemary C. Hyde, Ph.D.

[Nancy Siciliana]

Soroush wrote:
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