Complementary and Alternative Medicine: Science, Pseudoscience, and Ethics

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Complementary and Alternative MedicineScience,
Pseudoscience, and Ethics

• Martin Donohoe, MD, FACP
• Karen Adams, MD, FACOG

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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

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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

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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

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No Such Thing as CAM

• Good medicine
• Scientific
• Evidence-Based
• Quality Control
• Peer Reviewed
• Humanistic and Caring

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No Such Thing as CAM

• Bad Medicine
• Non-scientific
• Poor or No Quality Control
• Non-Peer Reviewed
• Impersonal, Uncaring

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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

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CAM is Not Unique in Its Emphasis on

• Care involving family, friends, religious
  practitioners
• Care emphasizing the whole patient or the
  provider-patient relationship

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CAM Versus Western Medicine

• These attributes are the characteristics of
  quality medicine and public health, yet have been
  co-opted by the CAM movement

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Dont 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

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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

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How Quackery Harms

• Indirect harm
• E.g., delay in seeking care
• Harm to Society
• Perpetuates pseudoscience, puts other
  contemporary and future patients at risk

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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

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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

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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

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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

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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

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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 one-time
  therapies frequent re-treatments/maintenance
  treatments required for ongoing therapies

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Characteristics of Pseudoscience

• Disclaimers couched in pseudo-medical jargon
• Claims that Western Medicine is dangerous
• Practitioners advise, Dont trust your doctor

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Characteristics of Pseudoscience

• Claims of no side effects
• Products claimed to be natural usually are not

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Misconceptions re Cancer
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Misconceptions re Cancer
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Ban Dihydrogen Monoxide?

• Iowa junior high school student science fair
  project
• 100 adults surveyed at State Fair

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Would you sign a petition to ban dihydrogen
monoxide?

• 1. It can cause excessive sweating and
  vomiting2. It is a major component in acid
  rain3. It can cause severe burns in its gaseous
  state4. It can kill you if accidentally
  inhaled5. It contributes to erosion6. It
  decreases effectiveness of automobile brakes7.
  It has been found in tumors of terminal cancer
  patients

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Ban Dihydrogen Monoxide?

• Results
• 90 yes
• 8 Get away from me kid! I dont sign
  petitions.
• 2 Are you kidding - that is water!

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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

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Herbal Remedies

• 17.8 billion on herbs and supplements in 2001
• 58 billion on pharmaceuticals
• 12 use herbs in one year (vs. 2.5 in 1990)
• E.g., between 1996 and 1998, 8 of normal-weight
  women and 28 of obese women used
  non-prescription weight loss products

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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 worlds vanishing tropical
  plant species have been investigated for their
  medicinal qualities

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What is All Natural?

• Natural means eating a balanced diet, favoring
  organic, local foods, and protecting the
  environment

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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

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Why Herbs Are Not Regulated By The FDA

• 1974 (Senator William Golden Fleece Award)
  Proxmire Amendment
• -Nutritional supplements are not drugs

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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

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FDA Oversight

• 2100 scientists in 40 labs
• 1100 investigators and inspectors
• Monitor and inspect 95,000 businesses
• Visit gt15,000 facilities per year
• Collect 80,000 domestic and imported product
  samples for label checks

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Risks of Herbal Remedies

• Products unregulated/untested
• Variable
• collection
• processing
• storage
• naming
• purity

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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

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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

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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

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High Risk Users of Naturopathic Remedies

• Elderly, pregnant and nursing women, infants
• Poor overall health status
• Chronic users, prescription drug users

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Risks of Herbal Remedies

• Dietary supplements containing ephedrine,
  caffeine
• HTN, MI, CVA, psychosis, seizures
• Chapparal, germander, comfrey, skullcap,
  sassafras
• Hepatotoxic, carcinogenic

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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

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Risks of Herbal and Naturopathic Remedies

• Kava and valerian - potentiation of anesthetic
  effects
• St. Johns wort - increased metabolism of many
  drugs
• ?CyA effectiveness ? transplant rejection

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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

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Conclusions

• Traditional medicine is not immune from bad
  science, misleading advertisements, excessive
  corporate influence, corruption and support of
  some therapies offering limited benefit.

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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

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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

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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

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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

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Unethical NCCAM Studies

• Fringe studies of discredited and highly
  implausible techniques exploit patients and
  deplete health care resources
• Homeopathy
• psychic healing
• therapeutic touch

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Unethical NCCAM Studies

• Dangerous studies with inadequate informed
  consent forms
• E.g., decreased effectiveness of protease
  inhibitors not mentioned
• St Johns Wort for HIV
• Garlic for hyperlipidemia due to HAART treatment
  for HIV

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NCCAM

• After 10 years and 200 million, NCCAM-sponsored
  research has not demonstrated efficacy for any
  CAM method, nor has the Center informed the
  public that any method is useless or harmful

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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 137660-664.

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Contact Information

• Public Health and Social Justice Website
• http//www.phsj.org
• martindonohoe_at_phsj.org