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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 coopted 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 onetime therapies; frequent retreatments/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 Death Sentence 26% Latinos (“fatalismo”) 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” Astrology  UFOs  Reincarnation  Fortune-Telling  1976 17% 24% 9% 4% 1997 37% 30% 25% 14% 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 –Only 12% of U.S. Protestant pastors believe in 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)  Ignorance/Pseudoscientific Beliefs  Some states require instructors to teach “creation science,” “intelligent design,” and “climate change skepticism” – Despite politicians’ statements, 72% of Republicans believe global warming is occurring (92% of Democrats) Herbal Remedies  $17.8 billion on herbs and supplements in 2001 –$58 billion on pharmaceuticals  12%  E.g., use herbs in one year (vs. 2.5% in 1990) between 1996 and 1998, 8% of normalweight 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  1100 scientists in 40 labs 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 Risks of Herbal Remedies  Products  Variable – – – – – unregulated/untested 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  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 High Risk Users of “Naturopathic” Remedies  Elderly, pregnant and nursing women, infants  Poor overall health status  Chronic users, prescription drug users Risks of Herbal Remedies  Dietary supplements containing 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  Kava and valerian - potentiation of anesthetic effects  St. John’s wort - increased metabolism of 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  Traditional medicine 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, cultural and religious understanding and sensitivity, and bedside teaching 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 20 years and about $1.6 billion, NCCAM-sponsored research has not demonstrated efficacy for any CAM method 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; 137:660664. Contact Information Public Health and Social Justice Website http://www.phsj.org [email protected]