Complementary and Alternative Medicine The Science and the by 2EQ6aWQ

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									   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 one-
  time therapies; frequent re-
  treatments/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            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?

 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
         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%
       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%
   Ignorance/Pseudoscientific
            Beliefs
 Halfof US citizens do not believe in
 evolution and do believe that humans
 and dinosaurs coexisted (2007)
 –40% think scientists still generally
   disagree about evolution
      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)
    Ignorance/Pseudoscientific
             Beliefs
 22% of Americans don’t know whether an
  atomic bomb has ever been dropped
  (2000)
 20% of Americans don’t 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)
            Herbal Remedies
 $17.8billion on herbs and supplements in 2001
   –$58 billion on pharmaceuticals

 12%     use herbs in one year (vs. 2.5% in 1990)

      between 1996 and 1998, 8% of normal-
 E.g.,
 weight 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   scientists in 40 labs

 1100investigators 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   unregulated/untested

 Variable
  –   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

     less than 1% of adverse reactions reported
 Est.
 to FDA (vs. 10% est. for prescription drugs)

 19,468adverse events reports to poison control
 centers in 1998, vs. 500 to FDA

 Potential   toxicities: cardiac, CNS, liver, kidney
 High Risk Users of “Naturopathic”
            Remedies

       pregnant and nursing
 Elderly,
 women, infants

 Poor   overall health status

 Chronic    users, prescription drug users
  Risks of Herbal Remedies

        supplements containing
 Dietary
 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

 Kavaand valerian - potentiation of
 anesthetic effects

   John’s wort - increased metabolism of
 St.
 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
 Traditionalmedicine 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, 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
                 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; 137:660-
    664.
    Contact Information
Public Health and Social Justice
             Website

    http://www.phsj.org
   martindonohoe@phsj.org

								
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