Complementary and Alternative Medicine: Science, Pseudoscience, and Ethics

1. Complementary and Alternative Medicine:Science, 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. 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

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, “Don’t 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 don’t 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 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)

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 world’s 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 >15,000 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. John’s 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