Complementary and Alternative Medicine: Science, Pseudoscience, and Ethics Martin Donohoe, MD, FACP...
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Transcript of Complementary and Alternative Medicine: Science, Pseudoscience, and Ethics Martin Donohoe, MD, FACP...
Complementary and Complementary and Alternative Medicine:Alternative Medicine:
Science, Pseudoscience, and Science, Pseudoscience, and EthicsEthics
Martin Donohoe, MD, Martin Donohoe, MD, FACPFACP
Karen Adams, MD, FACOGKaren Adams, MD, FACOG
OutlineOutline
What is CAM?What is CAM? Philosophies of CAM and “Western Philosophies of CAM and “Western
medicine”medicine” Recognizing Quackery, Pseudoscience Recognizing Quackery, Pseudoscience
and Bogus Discoveriesand Bogus Discoveries Risks and Benefits of Herbal RemediesRisks and Benefits of Herbal Remedies Why Herbs are Not RegulatedWhy Herbs are Not Regulated Conclusions and RecommendationsConclusions and Recommendations
What is CAM?What is CAM?
Any health care intervention not Any health care intervention not offered by traditional “Western” offered by traditional “Western” physiciansphysicians– E.g., chiropractic, massage, E.g., chiropractic, massage,
acupuncture, homeopathy, acupuncture, homeopathy, distance healing, therapeutic distance healing, therapeutic touch, Reiki therapy, touch, Reiki therapy, aromatherapy, aromatherapy, herbs/nutraceuticalsherbs/nutraceuticals
CAMCAM
Some are recommended by physicians Some are recommended by physicians for certain conditions or people:for certain conditions or people:– Chiropractic, massage, acupuncture, Chiropractic, massage, acupuncture,
aromatherapyaromatherapy Proven benefit – e.g., acupuncture for Proven benefit – e.g., acupuncture for
certain types of chronic pain, certain types of chronic pain, chemotherapy-induced nausea and chemotherapy-induced nausea and vomiting; guided imagery to reduce vomiting; guided imagery to reduce stress of surgery in children and adultsstress of surgery in children and adults
No Such Thing as CAMNo Such Thing as CAM
Good medicineGood medicine– ScientificScientific– Evidence-BasedEvidence-Based– Quality ControlQuality Control– Peer ReviewedPeer Reviewed– Humanistic and CaringHumanistic and Caring
No Such Thing as CAMNo Such Thing as CAM
Bad MedicineBad Medicine– Non-scientificNon-scientific– Poor or No Quality ControlPoor or No Quality Control– Non-Peer ReviewedNon-Peer Reviewed– Impersonal, UncaringImpersonal, Uncaring
CAM is Not Unique CAM is Not Unique in Its Emphasis on:in Its Emphasis on:
Humanistic health careHumanistic health careEmpathy and CompassionEmpathy and CompassionEmphasis on healing the mind Emphasis on healing the mind
and body / recognizing the and body / recognizing the powerful links between the twopowerful links between the two
CAM is Not Unique CAM is Not Unique in Its Emphasis on:in Its Emphasis on:
Care involving family, friends, Care involving family, friends, religious practitionersreligious practitioners
Care emphasizing the “whole Care emphasizing the “whole patient” or the provider-patient patient” or the provider-patient relationshiprelationship
CAM Versus Western CAM Versus Western MedicineMedicine
These attributes are the These attributes are the characteristics of quality characteristics of quality medicine and public health, yet medicine and public health, yet have been co-opted by the CAM have been co-opted by the CAM movementmovement
Don’t get sCAMmed by CAMDon’t get sCAMmed by CAM
Some CAM is without benefit, Some CAM is without benefit, some harmfulsome harmful
Therefore, it is important to Therefore, it is important to be able to recognize be able to recognize quackery, pseudoscience and quackery, pseudoscience and bogus discoveriesbogus discoveries
How Quackery HarmsHow Quackery Harms
Economic harm –individual costsEconomic harm –individual costs Direct harmDirect harm
– Medical – e.g., cyanide toxicity from Medical – e.g., cyanide toxicity from laetrile, electrolyte imbalances from laetrile, electrolyte imbalances from coffee enemas, quadriplegia from coffee enemas, quadriplegia from cervical spine manipulationscervical spine manipulations
– Psychological – e.g., unjustified guilt, Psychological – e.g., unjustified guilt, distortion of perspectivedistortion of perspective
How Quackery HarmsHow Quackery Harms
Indirect harm:Indirect harm:– E.g., delay in seeking careE.g., delay in seeking care
Harm to Society:Harm to Society:– Perpetuates pseudoscience, puts Perpetuates pseudoscience, puts
other contemporary and future other contemporary and future patients at riskpatients at risk
Warning Signs of a Bogus Warning Signs of a Bogus Scientific DiscoveryScientific Discovery
The discoverer pitches the claim The discoverer pitches the claim directly to the mediadirectly to the media
The discoverer says that a powerful The discoverer says that a powerful establishment is trying to suppress establishment is trying to suppress his/her workhis/her work
The scientific effect involved is The scientific effect involved is always at the very limit of detectionalways at the very limit of detection
Evidence for a discovery is anecdotalEvidence for a discovery is anecdotal
Warning Signs of a Bogus Warning Signs of a Bogus Scientific DiscoveryScientific Discovery
The discoverer says a belief is The discoverer says a belief is credible because it has endured credible because it has endured for centuriesfor centuries
The discoverer has worked in The discoverer has worked in isolationisolation
The discoverer must propose new The discoverer must propose new laws of nature to explain an laws of nature to explain an observationobservation
Characteristics of Characteristics of PseudosciencePseudoscience
Indifferent to factsIndifferent to facts Looks only for evidence supporting Looks only for evidence supporting
hypothesishypothesis Indifferent to criteria of valid evidenceIndifferent to criteria of valid evidence Relies heavily on subjective validationRelies heavily on subjective validation Depends on arbitrary conventions of Depends on arbitrary conventions of
human culture, rather than on human culture, rather than on unchanging regularities of natureunchanging regularities of nature
Characteristics of Characteristics of PseudosciencePseudoscience
Avoids putting its claims to Avoids putting its claims to meaningful testsmeaningful tests
Often contradictoryOften contradictory Deliberately creates mystery where Deliberately creates mystery where
none exists, sometimes by omitting none exists, sometimes by omitting important detailsimportant details
Does not progressDoes not progress Attempts to persuade with rhetoric, Attempts to persuade with rhetoric,
propaganda and misrepresentationpropaganda and misrepresentation
Characteristics of Characteristics of PseudosciencePseudoscience
Appeals to false authority, emotion, Appeals to false authority, emotion, sentiment, or distrust of established factssentiment, or distrust of established facts
Extraordinary claims and fantastic theoriesExtraordinary claims and fantastic theories Often described by an invented vocabulary Often described by an invented vocabulary
of words with ambiguous meaningsof words with ambiguous meanings Relies on anachronistic thinkingRelies on anachronistic thinking Appeals to vanity, fear, magical thinking or Appeals to vanity, fear, magical thinking or
desperationdesperation
Characteristics of Characteristics of PseudosciencePseudoscience
Relies on anecdotes and testimonialsRelies on anecdotes and testimonials Products often claim to be effective Products often claim to be effective
against a wide range of unrelated against a wide range of unrelated diseasesdiseases
Quick, dramatic results promised for Quick, dramatic results promised for one-time therapies; frequent re-one-time therapies; frequent re-treatments/maintenance treatments treatments/maintenance treatments required for ongoing therapiesrequired for ongoing therapies– $$
Characteristics of Characteristics of PseudosciencePseudoscience
Disclaimers couched in pseudo-Disclaimers couched in pseudo-medical jargonmedical jargon
Claims that “Western Medicine” is Claims that “Western Medicine” is dangerousdangerous
Practitioners advise, “Don’t trust Practitioners advise, “Don’t trust your doctor”your doctor”
Characteristics of Characteristics of PseudosciencePseudoscience
Claims of “no side effects”Claims of “no side effects” Products claimed to be “natural” Products claimed to be “natural”
– usually are not– usually are not
Misconceptions re CancerMisconceptions 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 CancerMisconceptions re Cancer
Anglos Latinos (“fatalismo”)
Death Sentence 26% 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?Ban Dihydrogen Monoxide?
Iowa junior high school student Iowa junior high school student science fair projectscience fair project
100 adults surveyed at State Fair100 adults surveyed at State Fair
Would you sign a petition to Would you sign a petition to ban dihydrogen monoxide?ban dihydrogen monoxide?
1. It can cause excessive sweating and vomiting1. It can cause excessive sweating and vomiting
2. It is a major component in acid rain2. It is a major component in acid rain
3. It can cause severe burns in its gaseous state3. It can cause severe burns in its gaseous state
4. It can kill you if accidentally inhaled4. It can kill you if accidentally inhaled
5. It contributes to erosion5. It contributes to erosion
6. It decreases effectiveness of automobile brakes6. It decreases effectiveness of automobile brakes
7. It has been found in tumors of terminal cancer 7. It has been found in tumors of terminal cancer
patients patients
Ban Dihydrogen Monoxide?Ban Dihydrogen Monoxide?
ResultsResults– 90 – yes90 – yes– 8 – “Get away from me kid! I don’t 8 – “Get away from me kid! I don’t
sign petitions.”sign petitions.”– 2 – “Are you kidding - that is 2 – “Are you kidding - that is
water!”water!”
One Reason Why One Reason Why Pseudoscientific Beliefs are Pseudoscientific Beliefs are
Common: Public Education is in Common: Public Education is in DisarrayDisarray
U.S. Schools ranked lowest among U.S. Schools ranked lowest among western nations, particularly in western nations, particularly in sciencescience
↓ ↓ funding, infrastructure decayingfunding, infrastructure decaying 1/4 of U.S. Schools have no library1/4 of U.S. Schools have no library 1/4 of schools use textbooks from the 1/4 of schools use textbooks from the
1980s or earlier1980s or earlier
Geographic IgnoranceGeographic Ignorance
Percent of US teens unable to locate Percent of US teens unable to locate the following on a map:the following on a map:– United States – 11%United States – 11%– Pacific Ocean – 29%Pacific Ocean – 29%– Japan – 58%Japan – 58%– United Kingdom – 68%United Kingdom – 68%
Pseudoscientific BeliefsPseudoscientific Beliefs
Percentage of Americans who believe “at Percentage of Americans who believe “at least to some degree” in these least to some degree” in these “phenomena”“phenomena”
19761976 19971997 AstrologyAstrology 17%17% 37%37% UFOsUFOs 24%24% 30%30% ReincarnationReincarnation 9% 9% 25%25% Fortune-TellingFortune-Telling 4% 4% 14%14%
Ignorance/Pseudoscientific Ignorance/Pseudoscientific BeliefsBeliefs
Half of US citizens do not believe in Half of US citizens do not believe in evolution and do believe that evolution and do believe that humans and dinosaurs coexisted humans and dinosaurs coexisted (2007)(2007)– 40% think scientists still generally 40% think scientists still generally
disagree about evolutiondisagree about evolution– Only 12% of U.S. Protestant Only 12% of U.S. Protestant
pastors believe in evolutionpastors believe in evolution
Pseudoscientific BeliefsPseudoscientific Beliefs
37% believe places can be haunted 37% believe places can be haunted (2007)(2007)
25% believe in UFOs (2007)25% believe in UFOs (2007) 24% believe in astrology (2009)24% believe in astrology (2009) 16% believe that people with the “evil 16% believe that people with the “evil
eye” can cast curses or harmful spellseye” can cast curses or harmful spells 14% have consulted a psychic or 14% have consulted a psychic or
fortune teller (2009)fortune teller (2009)
Ignorance/Pseudoscientific Ignorance/Pseudoscientific BeliefsBeliefs
22% of Americans don’t know whether 22% of Americans don’t know whether an atomic bomb has ever been dropped an atomic bomb has ever been dropped (2000)(2000)
20% of Americans don’t know the earth 20% of Americans don’t know the earth revolves around the sun (1999)revolves around the sun (1999)
18% believe in Bigfoot and the Loch 18% believe in Bigfoot and the Loch Ness Monster (2007)Ness Monster (2007)
8% of men / 18% of women believe in 8% of men / 18% of women believe in astrology and fortune tellers (2007)astrology and fortune tellers (2007)
Ignorance/Pseudoscientific Ignorance/Pseudoscientific BeliefsBeliefs
Some states require instructors to Some states require instructors to teach “creation science,” “intelligent teach “creation science,” “intelligent design,” and “climate change design,” and “climate change skepticism”skepticism”– Despite politicians’ statements, 72% of Despite politicians’ statements, 72% of
Republicans believe global warming is Republicans believe global warming is occurring (92% of Democrats)occurring (92% of Democrats)
Herbal RemediesHerbal Remedies $17.8 billion on herbs and supplements in $17.8 billion on herbs and supplements in
20012001– $58 billion on pharmaceuticals$58 billion on pharmaceuticals
12% use herbs in one year (vs. 2.5% in 1990)12% use herbs in one year (vs. 2.5% in 1990)
E.g., between 1996 and 1998, 8% of normal-E.g., between 1996 and 1998, 8% of normal-weight women and 28% of obese women used weight women and 28% of obese women used non-prescription weight loss productsnon-prescription weight loss products
Herbal Remedies - Herbal Remedies - DisclaimerDisclaimer
More than ½ of current prescription and OTC More than ½ of current prescription and OTC medications come from plant productsmedications come from plant products– Many herbs, in pure form, may be Many herbs, in pure form, may be
beneficialbeneficial– Studies poor, no incentives for industry to Studies poor, no incentives for industry to
rigorously investigaterigorously investigate
Less than 0.5% of the world’s vanishing Less than 0.5% of the world’s vanishing tropical plant species have been tropical plant species have been investigated for their medicinal qualitiesinvestigated for their medicinal qualities
What is All Natural?What is All Natural?
““Natural” means eating a Natural” means eating a balanced diet, favoring organic, balanced diet, favoring organic, local foods, and protecting the local foods, and protecting the environmentenvironment
Gauging Risks Of Herbal Gauging Risks Of Herbal RemediesRemedies
FDA: Manufacturer may claim that FDA: Manufacturer may claim that the product affects the structure or the product affects the structure or function of the body, as long as there function of the body, as long as there is no claim of effectiveness for the is no claim of effectiveness for the prevention or treatment of a specific prevention or treatment of a specific disease, and provided there is a disease, and provided there is a disclaimer informing the user that the disclaimer informing the user that the FDA has not evaluated the agentsFDA has not evaluated the agents
Multiple violations / near violationsMultiple violations / near violations
Why Herbs Are Not Regulated Why Herbs Are Not Regulated By The FDABy The FDA
1974: (Senator William 1974: (Senator William “Golden Fleece Award”) “Golden Fleece Award”) Proxmire Amendment:Proxmire Amendment:
-“Nutritional supplements -“Nutritional supplements are not drugs”are not drugs”
Why Herbs Are Not Regulated Why Herbs Are Not Regulated By The FDABy The FDA
1994: Dietary Supplement Health and 1994: Dietary Supplement Health and Education Act Education Act -supplements excluded from purity, -supplements excluded from purity, composition, effectiveness and safety reviewcomposition, effectiveness and safety review-supported by Orrin Hatch (R-Utah), recipient -supported by Orrin Hatch (R-Utah), recipient of $169,000 from pharm and nutraceutical of $169,000 from pharm and nutraceutical ind. in 2000, more than any other Senator; ind. in 2000, more than any other Senator; Utah home to more herbal/nutraceutical Utah home to more herbal/nutraceutical companies than any other statecompanies than any other state
Established Office of Dietary SupplementsEstablished Office of Dietary Supplements
FDA OversightFDA Oversight
2100 scientists in 40 labs2100 scientists in 40 labs
1100 investigators and inspectors1100 investigators and inspectors– Monitor and inspect 95,000 businessesMonitor and inspect 95,000 businesses– Visit Visit >15,000 facilities per year>15,000 facilities per year– Collect 80,000 domestic and imported Collect 80,000 domestic and imported
product samples for label checksproduct samples for label checks
Risks of Herbal Risks of Herbal RemediesRemedies
Products unregulated/untestedProducts unregulated/untested
VariableVariable– collectioncollection– processingprocessing– storagestorage– namingnaming– puritypurity
Risks of Herbal RemediesRisks of Herbal Remedies
Adulterants and contaminants include:Adulterants and contaminants include:–Botanicals – e.g., digitalis, belladonnaBotanicals – e.g., digitalis, belladonna–Microorganisms – Staph aureus, E coli, Microorganisms – Staph aureus, E coli, Salmonella, Shigella, PseudomonasSalmonella, Shigella, Pseudomonas
–Microbial toxins – aflatoxins, bacterial Microbial toxins – aflatoxins, bacterial endotoxinsendotoxins
–PesticidesPesticides
Risks of Herbal RemediesRisks of Herbal Remedies
Adulterants and contaminants include:Adulterants and contaminants include:– Fumigation agentsFumigation agents– Toxic metals – lead, cadmium, mercury, Toxic metals – lead, cadmium, mercury,
arsenicarsenic– Drugs – analgesics and anti-inflammatories, Drugs – analgesics and anti-inflammatories,
corticosteroids, benzodiazepines, warfarin, corticosteroids, benzodiazepines, warfarin, fenfluramine, sildenafilfenfluramine, sildenafil
1998: 32% of Asian patent medicines sold 1998: 32% of Asian patent medicines sold in the US contained undeclared in the US contained undeclared pharmaceuticals or heavy metalspharmaceuticals or heavy metals
Risks of Herbal And Risks of Herbal And “Naturopathic” Remedies“Naturopathic” Remedies
Est. less than 1% of adverse reactions Est. less than 1% of adverse reactions reported to FDA (vs. 10% est. for prescription reported to FDA (vs. 10% est. for prescription drugs)drugs)
19,468 adverse events reports to poison 19,468 adverse events reports to poison control centers in 1998, vs. 500 to FDAcontrol centers in 1998, vs. 500 to FDA
Potential toxicities: cardiac, CNS, liver, kidneyPotential toxicities: cardiac, CNS, liver, kidney
High Risk Users of High Risk Users of “Naturopathic” Remedies“Naturopathic” Remedies
Elderly, pregnant and nursing Elderly, pregnant and nursing women, infantswomen, infants
Poor overall health statusPoor overall health status
Chronic users, prescription drug Chronic users, prescription drug usersusers
Risks of Herbal RemediesRisks of Herbal Remedies
Dietary supplements containing Dietary supplements containing ephedrine, caffeineephedrine, caffeine–HTN, MI, CVA, psychosis, HTN, MI, CVA, psychosis, seizuresseizures
Chapparal, germander, comfrey, Chapparal, germander, comfrey, skullcap, sassafrasskullcap, sassafras–Hepatotoxic, carcinogenicHepatotoxic, carcinogenic
Risks of Herbal and Risks of Herbal and “Naturopathic” Remedies“Naturopathic” Remedies
GE-L-tryptophan GE-L-tryptophan → Eosinophilia Myalgia → Eosinophilia Myalgia Syndrome (1989): 5,000 in US affected, 37 Syndrome (1989): 5,000 in US affected, 37 deaths, 1500 permanently disableddeaths, 1500 permanently disabled
Ephedra - heart attacks, dysrhythmias, Ephedra - heart attacks, dysrhythmias, strokes and seizuresstrokes and seizures
Garlic, gingko, and ginseng – bleedingGarlic, gingko, and ginseng – bleeding
Ginseng - hypoglycemiaGinseng - hypoglycemia
Risks of Herbal and Risks of Herbal and “Naturopathic” Remedies“Naturopathic” Remedies
Kava and valerian - potentiation of Kava and valerian - potentiation of anesthetic effects anesthetic effects
St. John’s wort - increased St. John’s wort - increased metabolism of many drugsmetabolism of many drugs– ↓↓CyA effectiveness → transplant CyA effectiveness → transplant
rejectionrejection
ConclusionsConclusions
CAM is widespread: some may be CAM is widespread: some may be useful useful
Caveat emptor – know how to Caveat emptor – know how to recognize quackery and recognize quackery and pseudosciencepseudoscience
Do not confuse or conflate CAM with Do not confuse or conflate CAM with humanistic / integrative / whole humanistic / integrative / whole person careperson care
ConclusionsConclusions
Traditional medicine is not Traditional medicine is not immune from bad science, immune from bad science, misleading advertisements, misleading advertisements, excessive corporate influence, excessive corporate influence, corruption and support of some corruption and support of some therapies offering limited benefit.therapies offering limited benefit.
ConclusionsConclusions
Medical education and training Medical education and training curricula should include greater curricula should include greater emphasis on professionalism, ethics, emphasis on professionalism, ethics, the humanities, public health, social the humanities, public health, social justice, communication skills, legal justice, communication skills, legal issues, cultural and religious issues, cultural and religious understanding and sensitivity, and understanding and sensitivity, and bedside teachingbedside teaching
ConclusionsConclusions
Visit lengths, which have become Visit lengths, which have become shorter in the face of financial shorter in the face of financial pressures, need to be increased to pressures, need to be increased to allow more time for the development allow more time for the development of rapport between doctor and of rapport between doctor and patient, comprehensive screening, patient, comprehensive screening, accurate diagnosis, and patient accurate diagnosis, and patient counseling and educationcounseling and education
The National Center for CAMThe National Center for CAM
Established 1998, 7 yrs. after its Established 1998, 7 yrs. after its predecessor (Office of Alternative predecessor (Office of Alternative Medicine)Medicine)– Annual budget = $110 million/yrAnnual budget = $110 million/yr
Role of Iowa Senator Tom Harkin, Role of Iowa Senator Tom Harkin, Chairman/Ranking Member of Labor, Chairman/Ranking Member of Labor, Health and Human Services and Health and Human Services and Education Subcommittees – “held Education Subcommittees – “held entire NIH budget hostage”entire NIH budget hostage”
NCCAMNCCAM
Board populated with discredited, Board populated with discredited, fringe practitionersfringe practitioners
Culture of fear among academics Culture of fear among academics needing funding and universities needing funding and universities establishing “Centers of Alternative establishing “Centers of Alternative Medicine” to not anger NCCAM and Medicine” to not anger NCCAM and Senator HarkinSenator Harkin
Unethical NCCAM StudiesUnethical NCCAM Studies
Fringe studies of discredited and Fringe studies of discredited and highly implausible techniques exploit highly implausible techniques exploit patients and deplete health care patients and deplete health care resourcesresources– HomeopathyHomeopathy– psychic healingpsychic healing– therapeutic touchtherapeutic touch
Unethical NCCAM StudiesUnethical NCCAM Studies
Dangerous studies with inadequate Dangerous studies with inadequate informed consent formsinformed consent forms
E.g., decreased effectiveness of E.g., decreased effectiveness of protease inhibitors not mentionedprotease inhibitors not mentioned– St John’s Wort for HIVSt John’s Wort for HIV– Garlic for hyperlipidemia due to HAART Garlic for hyperlipidemia due to HAART
treatment for HIVtreatment for HIV
NCCAMNCCAM
After 20 years and about $1.6 billion, After 20 years and about $1.6 billion, NCCAM-sponsored research has not NCCAM-sponsored research has not demonstrated efficacy for any CAM demonstrated efficacy for any CAM methodmethod
ReferenceReference
Adams KE, Cohen MH, Eisenberg DA, Adams KE, Cohen MH, Eisenberg DA, Jonsen AR. Ethical considerations of Jonsen AR. Ethical considerations of complementary and alternative complementary and alternative medicine in conventional medical medicine in conventional medical settings. Annals of Internal Medicine, settings. Annals of Internal Medicine, October 2002; 137:660-664.October 2002; 137:660-664.
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