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 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 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, infants Poor pregnant and nursing women, 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, 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, NCCAMsponsored 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; 137:660664. Contact Information Public Health and Social Justice Website http://www.phsj.org martindonohoe@phsj.org