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American College of Physicians
Board of Regents
AGENDA
February 17-18, 1933
Philadelphia, PA
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,\, P.~MElUCAN
-$ C‘OILEGE OF
I: HUSICIANS
--.
American ,C=ol'nge
ofPhysicians ‘II)
Health Quacker-
The attached position paper entitled "HeaIth Quackery" is presented by
the Health and Public Policy Committee for Uoartd of Regents review and
approval.
At the first Board of Regents review of the r)aper-on June 26, 1987 it
was suggested that the paper, then called "tleaith Fraud," explore the
issues in a more detailed fashion and that +ecommendations for action
be offered.
The Health and Public Policy Committee and 'he Health Promotion
Subcommittee have struggled with the scope I).'the paper and have
concluded that the attached version with rei;ompendations and a resource
listing makes the most direct and effective presentation.
American Colkge of Physicians
-
l/17/89
Position Paper
Sunmary of Proce>L
Title:
Health Quackery
Responsible Subcommittee:
Health Promotion
Date Project Initiated:
December 12, 1985, by Clinical
Pharmacology Subcommittee
Authors:
Stuart L. Nightingale,
Lois Snyder
Outside Reviewers:
Victor Herbert, MD, JD, FACP
Eugene A. Hildreth, MD, FACP
Stephen Barret.t, MD
Legal Counsel
First HPPC Review:
December 2, 1086
Second HPPC Review:
March 25, 1987
First BOR Review:
June 26, 1987
Third HPPC Review:
February 2, l?B&
Fourth HPPC Review:
May 17, 19X!
Fifth HPPC Review and Approval:
December 15, 1988
Second BOR Review:
February 17, 1989
MD, FACP
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HEALTH QUACKER)
Draft Position Paper
of the
American College of Phys;cians
Health and Public Policy Committee
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20 January 1989
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00017 For purposes of this position statement, health quackery is defined as the
00018 promotion and commercialization of unproven and often dangerous health
Generally, its essential elements are deception
00019 products and procedures.
00020 and a primary concern with profit. The deception invariably includes
00021 omission of adverse information relating to efficacy or safety. This paper
00022 does not focus on the intentional unnecessary and inappropriate use of
00023 otherwise legitimate tests and therapies by some practitioners; this type of
00024 substandard care will be the subject of future papers.
Rather, the focus
00025 here is on clear-cut health quackery--those products and practices
00026 designated as such by authoritative, credible sources.
This paper does not
00027 attempt to deal with unproven remedies which are legitimately being
00028 investigated by qualified researchers.
Clearly, there are currently
00029 "unproven remedies" that will be demonstrated in the future to be safe and
But there are also "remedies" that clearly cannot be proven safe
00030 effective.
It is these "remedies" that the American College of
00031 and effective.
00032 Physicians highlights in this paper as deserving attention.
00033
00034 Health quackery is characterized by the following facts:
00035
Health quackery generally falls into three categories.
Direct health
00036 1)
00037 hazards are those products or procedures which pose a risk of direct harm
00038 -patient
including, for example, the employment of chelating agents in
00039 so-called "chelation therapy" for arteriosclerotic cardiovascular disease
00040 with resultant nephrotoxicity and death (1). This therapy has never been
Indirect health hazards are health frauds that do not
00041 proven efficacious.
00042 pose a direct health hazard when used as intended but may have a significant
00043 adverse impact because they cause patients to delay or forego appropriate
00044 care. Examples of these kinds of health quackery include a variety of
00045 unproven 'cancer cures" and a sobriety aid product purporting to counteract
Economic frauds include ineffective
00046 the effects of alcohol consumption.
00047 or worthless products or practices which cause nodetriment
to the user's
00048 health, but which are nonetheless significant because of their overall
00049 impact on the public's expenditures on health-related items. Examples
00050 include products falsely purporting to cause hair regrowth or increase
00051 mental or physical vigor, and electrical devices for exercise and waistline
00052 reduction.
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A Congressional inquiry in 1984 concluded that health fraud against one
of society's most vulnerable groups, the elderly, costs the U.S. public at
least $10 billion a year in expenditures for fraudulent products and
services.
One witness testified that health quackery, as a whole, is a $25
billion a year industry (2).
2)
A new and growing concern is the promotion of fraudulent products to
3)
Reliance on
individuals with AIDS and those who are HIV-antibody positive.
ineffective or dangerous health care measures and the resulting deferment of
appropriate health care has substantial economic and emotional costs in
addition to increasing morbidity and mortality.
It has become evident that the rapid development of effective therapies
4)
is paralleled by an increasing public interest in unorthodox or unproven
treatments.
The absence of a vocal, clear and coherent opposition of
medical professional organizations and individual physicians to health
quackery may be perceived by the public as tacit support of unorthodox
approaches.
For example, in a study of cancer patients' use of unorthodox
treatments, it was revealed that 75% of the patients informed their
physicians of such practices; 42% of those physicians were supportive or
neutral as regards such practices (3).
While medical science has produced major accomFflishments which have
5)
improved its capabilities immeasurably, practices which are unproven,
unorthodox and fraudulent flourish (4). Which patients are interested in
In a recent study of cancer patients, those who used
unorthodox therapy?
non-traditional treatments in addition to or in place of conventional
treatment did not match the stereotype of the poorly educated, end-stage
patient who had exhausted conventional treatment.
Instead, these cancer
patients were in the early stages of disease, frequently were asymptomatic
and were better educated than patients receiving conventional treatment only
(3). Physicians might, therefore, underestimate how many and what kind of
patients could be attracted to unproven treatments.
At least some of the appeal of unorthodox treatment may be due to the
use of relatively pleasant therapies that can be used in the home, easy
explanations of the cause of illness based on common experience, placebo
effects, and the charismatic personality of some of their promoters.
Patients leave behind what they believe are deficiencies in conventional
care for alternative treatments that promoters persuade them will fill in
the gaps.
The ingenuity, resourcefulness, and nationwide networking of the
6)
promoters of fraudulent products and services represent more of a challenge
Public agencies at the federal, state, and
than the public sector can meet.
local levels of government have responsibility for protecting the public
from health quackery, but they need help. The active involvement of others,
including the medical profession, in combatting health quackery through
informational and educational activities is, therefore, of major importance.
RECOMMENDATIOtiS
The American College of Physicians supports an informed and active
1)
Physicians and other health
opposition to fraudulent xreatment practices.
care professionals have a responsibility to become informed about general
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00108 and specific
issues in health quackery, and to disseminate this
00109 information.
Physicians must communicate to their patients in an
00110 understandable manner that efficacy and safety are crucial to all tests,
00111 prevention techniques, therapies or remedies. Physicians should welcome and
00112 be responsive to inquiries from patients concerning products and services
00113 patients have questions about. In responding to patient questions, the
00114 physician should focus on the medical merits and appropriateness, or lack
00115 thereof, of a particular practice or product; the physician should not
00116 defame the product or service provider while informing a patient on a
00117 particular issue. He or she should critique the therapy and compare it with
00118 the medically accepted treatment regimen, and pcint to the lack of journal
00119 articles and/or clinical trials for the practice in question.
00120
00121 2)
Physicians should elicit information from their patients concerning
00122 products and services the patient is currently or was once using.
00123 History-taking should include inquiry into the products and services (drugs,
00124 devices, diet therapy or other therapeutic regimens) being used, or used in
00125 the past by the patient. This information may assist in the diagnosis of
00126 disease or in the correction of a current practice, and may be valuable in
00127 the assessment of future treatment options.
00128
00129 3)
The College encourages physicians to be knowledgeable about health
00130 quackery, and will develop educational programs for ACP members, other
00131 physicians and the public to increase recognition of health quackery and
00132 encourage familiarity with programs and resources which combat it. This
00133 might include a public service video for communSty groups on how to identify
00134 health quackery, with examples of fraudulent credentials, diagnostic tests,
00135 therapies, and words and phrases that suggest the possibility of
00136 questionable practices, such "unorthodox" or "non-traditional" treatments,
00137 or "miracle cure." A listing of resources and supplemental reading
00138 materials is included in the appendix of this paper.
00139
The College will publish appropriate information in the ACP Observer
00140 4)
00141 concerning health frauds that have come to the attention of federal
00142 agencies, taking advantage of the FDA's offer to make such information and
00143 educational materials routinely available. Articles on general and specific
00144 health quackery subjects will be considered for publication in the Annals
00145 of Internal Medicine.
00146
The College encourages physicians to addre,;:;civic groups on health
00147 5)
00148 quackery issues and to assist the media in raising public awareness of the
FDA guidelines as
00149 lack of scientific evidence supporting these pmctices.
00150 well as evaluations of suspicious practices by the College's traditional
00151 resource for technology assessment, the Clinical Efficacy Assessment Project
00152 (CEAP), can be used to these ends. Physicians who make public statements
00153 about health quackery topics should be well-informed on the topic and
00154 should focus on the medical efficacy of the product or service, not the
00155 oromoter, manufacturer or "care qiver". The goal is to transmit scientific
00156 knowledge and thereby expose fraid, not to attack the motives of the
00157 proponents of these practices. Physicians should be conscious of the
00158 potential for defamation and other lawsuits and should consult legal counsel
00159 as necessary.
00160
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00161 6)
When doubt exists about a specific unproven product or procedure and
00162 its promotion or use is widespread, consideration will be given to an
00163 expeditious evaluation by the College's technology assessment
00164 process--CEAP--and the results will be disseminated to the appropriate
00165 authorities and audiences. Questions can also be referred to the College's
00166 Ethics Committee.
00167
00168 7)
Physicians and other health care professionals should report
00169 questionable health products and practices to the appropriate authorities.
00170 A comprehensive attack on health quackery requires the reporting of specific
00171 information about questionable health products and practices to municipal
00172 consumer protection agencies, State Attorney General Offices, the United
00173 States Postal Service (US Postal Service, Office of Consumer Affairs, 475
00174 L'Enfant Plaza West, SW, Washington, DC 20260), the Federal Trade
00175 Commission (Correspondence Branch, Room 692, FTC, Sixth and Pennsylvania
00176 Avenue, NW,Washington, DC 20580) or the Food and Drug Administration (FDA
00177 Health ~Fraud Staff, HFFu'-304,Center for Drug Evaluation and Research, 5600
00178 Fishers Lane, Rockville, MD 20857), as appropriate, Reporting will assist
00179 in the identification of fraudulent practices and allow for further
00180 investigation and enforcement measures.
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APPENDIX:
RESOURCES AND SUPPLEMENTAL
READING
1.
Ethics Manual.
American College of Physicians.
American College of Physicians; 1984.
Philadelphia,
PA:
2.
American Medical Association.
Ethical and Judicial Affairs.
Association; 1986.
3.
Barrett S, ed. The Health Robbers.
Stickley Company; 1980.
4.
The Professional's Guide to Health &
California Medical Association.
(Available from
Nutrition Fraud. San Francisco, CA: CMA, 1987.
CMA, Sutter Publications, P.O. Box 7690, San Francisco, CA
94120-7690).
5.
Department of Health and Human Services, "The Big Quack Attack:
Medical Devices," Publication No. (FDA) 84-4C22, Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857.
6.
The National Council Against Health Fraud, Tnc. Membership
Information, P.O. Box 1276, Loma Linda, CA 92354.
7.
The National Council Against Health Fraud, Inc. Resource Center, 2800
Main Street, St. Mary's Hospital, Kansas City, MO 64108.
Current Opinions of the Council on
American Medical
Chicago, IL:
Philadelphia:
George
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REFERENCES
Oliver LD. Acute renal failure following administration of
ethylenediamine tetraacetic acid (EDTA). Texas Medicine,
February 1984.
Herbert V. Testimony in: Quackery:
A $10 billion scandal.
Hearing: Subcommittee on Health and Long-Term Care of the Select
Committee on Aging, House of Representatives, 98th Congress, Second
A $10 billion
Session, May 31, 1984. Comn. Pub. No. 98-463, Quackery:
scandal. Washington, D.C.: U.S. Government Printing Office: 88-105,
A $10 billion scandal.
Report CO~TI.
131-133. See also: Quackery:
Pub. No. 98-435.
Cassileth BR, Lusk EJ, Strouse TB, Bodenheimer BB. Contemporary
Ann Inter Med.
1984;
unorthodox treatments in cancer medicine.
101: 105-112.
the medical community and
Holohan TV. Referral by default:
1987; 257: 1641-Z
JAMA.
unorthodox therapy.