Download - Complementary and Alternative Medicine: Science, Pseudoscience, and Ethics Martin Donohoe, MD, FACP Karen Adams, MD, FACOG

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


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


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


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– $$


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”


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)


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)


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


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


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


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.


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


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.

Contact InformationContact Information

Public Health and Social Justice Public Health and Social Justice WebsiteWebsite

http://[email protected]

Download - Complementary and Alternative Medicine: Science, Pseudoscience, and Ethics Martin Donohoe, MD, FACP Karen Adams, MD, FACOG

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