Complementary and Alternative Medicine The Science and the

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Transcript Complementary and Alternative Medicine The Science and the

Complementary and
Alternative Medicine:
Science, Pseudoscience, and
Ethics
Martin Donohoe, MD, FACP
Karen Adams, MD, FACOG
Outline
What is CAM?
 Philosophies of CAM and “Western
medicine”
 Recognizing Quackery, Pseudoscience and
Bogus Discoveries
 Risks and Benefits of Herbal Remedies
 Why Herbs are Not Regulated
 Conclusions and Recommendations

What is CAM?
 Any
health care intervention not
offered by traditional “Western”
physicians
–E.g., chiropractic, massage,
acupuncture, homeopathy, distance
healing, therapeutic touch, Reiki
therapy, aromatherapy,
herbs/nutraceuticals
CAM
Some are recommended by physicians for
certain conditions or people:
– Chiropractic, massage, acupuncture,
aromatherapy
 Proven benefit – e.g., acupuncture for
certain types of chronic pain,
chemotherapy-induced nausea and
vomiting; guided imagery to reduce stress
of surgery in children and adults

No Such Thing as CAM

Good medicine
– Scientific
– Evidence-Based
– Quality Control
– Peer Reviewed
– Humanistic and Caring
No Such Thing as CAM

Bad Medicine
– Non-scientific
– Poor or No Quality Control
– Non-Peer Reviewed
– Impersonal, Uncaring
CAM is Not Unique
in Its Emphasis on:
 Humanistic
health care
 Empathy and Compassion
 Emphasis on healing the mind
and body / recognizing the
powerful links between the two
CAM is Not Unique
in Its Emphasis on:
 Care
involving family, friends,
religious practitioners
 Care emphasizing the “whole patient”
or the provider-patient relationship
CAM Versus Western Medicine
These attributes are the
characteristics of quality medicine and
public health, yet have been co-opted
by the CAM movement
Don’t get sCAMmed by CAM
 Some
CAM is without benefit,
some harmful
 Therefore, it is important to be
able to recognize quackery,
pseudoscience and bogus
discoveries
How Quackery Harms
Economic harm –individual costs
 Direct harm
– Medical – e.g., cyanide toxicity from
laetrile, electrolyte imbalances from
coffee enemas, quadriplegia from
cervical spine manipulations
– Psychological – e.g., unjustified guilt,
distortion of perspective

How Quackery Harms
Indirect harm:
– E.g., delay in seeking care
 Harm to Society:
– Perpetuates pseudoscience, puts other
contemporary and future patients at risk

Warning Signs of a Bogus Scientific
Discovery
The discoverer pitches the claim directly to
the media
 The discoverer says that a powerful
establishment is trying to suppress his/her
work
 The scientific effect involved is always at
the very limit of detection
 Evidence for a discovery is anecdotal

Warning Signs of a Bogus Scientific
Discovery
 The
discoverer says a belief is
credible because it has endured for
centuries
 The discoverer has worked in
isolation
 The discoverer must propose new
laws of nature to explain an
observation
Characteristics of Pseudoscience
Indifferent to facts
 Looks only for evidence supporting
hypothesis
 Indifferent to criteria of valid evidence
 Relies heavily on subjective validation
 Depends on arbitrary conventions of
human culture, rather than on unchanging
regularities of nature

Characteristics of Pseudoscience
Avoids putting its claims to meaningful
tests
 Often contradictory
 Deliberately creates mystery where none
exists, sometimes by omitting important
details
 Does not progress
 Attempts to persuade with rhetoric,
propaganda and misrepresentation

Characteristics of Pseudoscience
Appeals to false authority, emotion,
sentiment, or distrust of established facts
 Extraordinary claims and fantastic theories
 Often described by an invented vocabulary
of words with ambiguous meanings
 Relies on anachronistic thinking
 Appeals to vanity, fear, magical thinking or
desperation

Characteristics of Pseudoscience
Relies on anecdotes and testimonials
 Products often claim to be effective
against a wide range of unrelated diseases
 Quick, dramatic results promised for onetime therapies; frequent retreatments/maintenance treatments
required for ongoing therapies

–$
Characteristics of Pseudoscience
Disclaimers couched in pseudo-medical
jargon
 Claims that “Western Medicine” is
dangerous
 Practitioners advise, “Don’t trust your
doctor”

Characteristics of Pseudoscience
 Claims
of “no side effects”
 Products claimed to be “natural” –
usually are not
Misconceptions re Cancer
Cause
Anglos
Latinos
Sugar Substitutes
42%
58%
Bruises from trauma
34%
53%
Microwaves Ovens
23%
47%
Eating Pork
11%
31%
Eating Spicy Food
8%
15%
Breast Feeding
6%
14%
Antibiotics
12%
32%
Misconceptions re Cancer
Anglos
Death Sentence
26%
Latinos
(“fatalismo”)
46%
God’s Punishment
2%
7%
Largely Unpreventable
18%
26%
Uncomfortable to touch CA pt.
8%
13%
Perez-Stable.JAMA 1992;268:3219-3223.
Ban Dihydrogen Monoxide?
Iowa junior high school student science
fair project
 100 adults surveyed at State Fair

Would you sign a petition to ban
dihydrogen monoxide?
1. It can cause excessive sweating and vomiting
2. It is a major component in acid rain
3. It can cause severe burns in its gaseous state
4. It can kill you if accidentally inhaled
5. It contributes to erosion
6. It decreases effectiveness of automobile brakes
7. It has been found in tumors of terminal cancer
patients
Ban Dihydrogen Monoxide?

Results
– 90 – yes
– 8 – “Get away from me kid! I don’t sign
petitions.”
– 2 – “Are you kidding - that is water!”
One Reason Why Pseudoscientific
Beliefs are Common: Public
Education is in Disarray
U.S. Schools ranked lowest among
western nations, particularly in science
 ↓ funding, infrastructure decaying
 1/4 of U.S. Schools have no library
 1/4 of schools use textbooks from the
1980s or earlier

Herbal Remedies
 $17.8
billion on herbs and supplements in 2001
–$58 billion on pharmaceuticals
 12%
 E.g.,
use herbs in one year (vs. 2.5% in 1990)
between 1996 and 1998, 8% of normalweight women and 28% of obese women used
non-prescription weight loss products
Herbal Remedies - Disclaimer

More than ½ of current prescription and OTC
medications come from plant products
– Many herbs, in pure form, may be beneficial
– Studies poor, no incentives for industry to
rigorously investigate

Less than 0.5% of the world’s vanishing tropical
plant species have been investigated for their
medicinal qualities
What is All Natural?
 “Natural”
means eating a balanced
diet, favoring organic, local foods,
and protecting the environment
Gauging Risks Of Herbal
Remedies
 FDA:
Manufacturer may claim that the
product affects the structure or function of
the body, as long as there is no claim of
effectiveness for the prevention or
treatment of a specific disease, and
provided there is a disclaimer informing
the user that the FDA has not evaluated
the agents
 Multiple violations / near violations
Why Herbs Are Not Regulated
By The FDA
 1974:
(Senator William “Golden
Fleece Award”) Proxmire
Amendment:
-“Nutritional supplements are
not drugs”
Why Herbs Are Not Regulated
By The FDA
1994: Dietary Supplement Health and Education
Act
-supplements excluded from purity, composition,
effectiveness and safety review
-supported by Orrin Hatch (R-Utah), recipient of
$169,000 from pharm and nutraceutical ind. in
2000, more than any other Senator; Utah home
to more herbal/nutraceutical companies than
any other state
 Established Office of Dietary Supplements

FDA Oversight
 2100
 1100
scientists in 40 labs
investigators and inspectors
–Monitor and inspect 95,000 businesses
–Visit >15,000 facilities per year
–Collect 80,000 domestic and imported product
samples for label checks
Risks of Herbal Remedies
 Products
 Variable
–
–
–
–
–
unregulated/untested
collection
processing
storage
naming
purity
Risks of Herbal Remedies
 Adulterants
and contaminants include:
–Botanicals – e.g., digitalis, belladonna
–Microorganisms – Staph aureus, E coli,
Salmonella, Shigella, Pseudomonas
–Microbial toxins – aflatoxins, bacterial
endotoxins
–Pesticides
Risks of Herbal Remedies

Adulterants and contaminants include:
– Fumigation agents
– Toxic metals – lead, cadmium, mercury, arsenic
– Drugs – analgesics and anti-inflammatories,
corticosteroids, benzodiazepines, warfarin,
fenfluramine, sildenafil

1998: 32% of Asian patent medicines sold in the
US contained undeclared pharmaceuticals or
heavy metals
Risks of Herbal And
“Naturopathic” Remedies
 Est.
less than 1% of adverse reactions reported
to FDA (vs. 10% est. for prescription drugs)
 19,468
adverse events reports to poison control
centers in 1998, vs. 500 to FDA
 Potential
toxicities: cardiac, CNS, liver, kidney
High Risk Users of “Naturopathic”
Remedies
 Elderly,
infants
 Poor
pregnant and nursing women,
overall health status
 Chronic
users, prescription drug users
Risks of Herbal Remedies
 Dietary
supplements containing
ephedrine, caffeine
–HTN, MI, CVA, psychosis, seizures
 Chapparal,
germander, comfrey,
skullcap, sassafras
–Hepatotoxic, carcinogenic
Risks of Herbal and
“Naturopathic” Remedies
 GE-L-tryptophan
→ Eosinophilia Myalgia
Syndrome (1989): 5,000 in US affected, 37
deaths, 1500 permanently disabled
 Ephedra
- heart attacks, dysrhythmias, strokes
and seizures
 Garlic,
gingko, and ginseng – bleeding
 Ginseng
- hypoglycemia
Risks of Herbal and
“Naturopathic” Remedies
 Kava
and valerian - potentiation of
anesthetic effects
 St.
John’s wort - increased metabolism of
many drugs
–↓CyA effectiveness → transplant rejection
Conclusions
CAM is widespread: some may be useful
 Caveat emptor – know how to recognize
quackery and pseudoscience


Do not confuse or conflate CAM with
humanistic / integrative / whole person
care
Conclusions
 Traditional
medicine is not immune
from bad science, misleading
advertisements, excessive corporate
influence, corruption and support of
some therapies offering limited
benefit.
Conclusions

Medical education and training curricula
should include greater emphasis on
professionalism, ethics, the humanities,
public health, social justice,
communication skills, legal issues, and
cultural and religious understanding and
sensitivity
Conclusions

Visit lengths, which have become shorter
in the face of financial pressures, need to
be increased to allow more time for the
development of rapport between doctor
and patient, comprehensive screening,
accurate diagnosis, and patient counseling
and education
The National Center for CAM

Established 1998, 7 yrs. after its
predecessor (Office of Alternative
Medicine)
– Annual budget = $110 million/yr

Role of Iowa Senator Tom Harkin,
Chairman/Ranking Member of Labor,
Health and Human Services and Education
Subcommittees – “held entire NIH budget
hostage”
NCCAM
Board populated with discredited, fringe
practitioners
 Culture of fear among academics needing
funding and universities establishing
“Centers of Alternative Medicine” to not
anger NCCAM and Senator Harkin

Unethical NCCAM Studies

Fringe studies of discredited and highly
implausible techniques exploit patients
and deplete health care resources
– Homeopathy
– psychic healing
– therapeutic touch
Unethical NCCAM Studies
Dangerous studies with inadequate
informed consent forms
 E.g., decreased effectiveness of protease
inhibitors not mentioned

– St John’s Wort for HIV
– Garlic for hyperlipidemia due to HAART
treatment for HIV
NCCAM

After 10 years and $200 million, NCCAMsponsored research has not demonstrated
efficacy for any CAM method, nor has the
Center informed the public that any
method is useless or harmful
Reference

Adams KE, Cohen MH, Eisenberg DA,
Jonsen AR. Ethical considerations of
complementary and alternative medicine
in conventional medical settings. Annals of
Internal Medicine, October 2002; 137:660664.
Contact Information
Public Health and Social Justice
Website
http://www.phsj.org
[email protected]