Complementary and Alternative Medicine: Science, Pseudoscience, and Ethics

1
Complementary and Alternative MedicineScience,
Pseudoscience, and Ethics

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

2
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

3
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

4
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

5
No Such Thing as CAM

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

6
No Such Thing as CAM

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

7
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

8
CAM is Not Unique in Its Emphasis on

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

9
CAM Versus Western Medicine

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

10
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

11
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

12
How Quackery Harms

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

13
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

14
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

15
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

16
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

17
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

18
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

19
Characteristics of Pseudoscience

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

20
Characteristics of Pseudoscience

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

21
Misconceptions re Cancer
22
Misconceptions re Cancer
23
Ban Dihydrogen Monoxide?

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

24
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

25
Ban Dihydrogen Monoxide?

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

26
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

27
Geographic Ignorance

• Percent of US teens unable to locate the
  following on a map
• United States 11
• Pacific Ocean 29
• Japan 58
• United Kingdom 68

28
Pseudoscientific Beliefs

• Percentage of Americans who believe at least to
  some degree in these phenomena
• 1976 1997
• Astrology 17 37
• UFOs 24 30
• Reincarnation 9 25
• Fortune-Telling 4 14

29
Ignorance/Pseudoscientific Beliefs

• Half of US citizens do not believe in evolution
  and do believe that humans and dinosaurs
  coexisted (2007)
• 40 think scientists still generally disagree
  about evolution

30
Pseudoscientific Beliefs

• 37 believe places can be haunted (2007)
• 25 believe in UFOs (2007)
• 24 believe in astrology (2009)
• 16 believe that people with the evil eye can
  cast curses or harmful spells
• 14 have consulted a psychic or fortune teller
  (2009)

31
Ignorance/Pseudoscientific Beliefs

• 22 of Americans dont know whether an atomic
  bomb has ever been dropped (2000)
• 20 of Americans dont know the earth revolves
  around the sun (1999)
• 18 believe in Bigfoot and the Loch Ness Monster
  (2007)
• 8 of men / 18 of women believe in astrology and
  fortune tellers (2007)

32
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

33
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

34
What is All Natural?

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

35
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

36
Why Herbs Are Not Regulated By The FDA

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

37
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

38
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

39
Risks of Herbal Remedies

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

40
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

41
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

42
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

43
High Risk Users of Naturopathic Remedies

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

44
Risks of Herbal Remedies

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

45
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

46
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

47
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

48
Conclusions

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

49
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

50
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

51
(No Transcript)
52
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

53
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

54
Unethical NCCAM Studies

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

55
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

56
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

57
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.

58
Contact Information

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