COMPLEMENTARY MEDICINE IN THE TREATMENT OF CANCER: ETHICAL ISSUES

1. COMPLEMENTARY MEDICINE IN THE TREATMENT OF CANCER: ETHICAL ISSUES Gordon Saxe, MD, PhD Assistant Professor of Medicine University of California San Diego Department of Family and Preventive Medicine

2. Presentation Overview • A personal story • Background cases • Overview of complementary and alternative medicine (CAM) • Guiding ethical principles • Cases for discussion

3. A Personal Story . . .

4. Background Cases

5. The Cases of PC-Spes • PC Spes – A Chinese herbal supplement, developed by biochemist and produced by BotanicLab, based on “integration of modern science and ancient Chinese herbal wisdom” • Widely used by prostate cancer patients until about 2 ½ years ago • Shown to have benefit in small clinical trial, with responses in 5/9 patients with advanced disease and mean 62% PSA reduction

6. The Cases of PC-Spes • Unusual side effects: breast enlargement, hot flashes, decreased libido • Average out of pocket expense > $600/month • Later determined to be contaminated by several pharmaceutical agents: DES, warfarin, and Xanax • FDA issued consumer warning in February 2002 and product removed from market by manufacturer shortly thereafter • Class action lawsuit initiated by patient groups

7. The Chad Green Case

8. The Chad Green Case • Chad was 2 ½ year old boy diagnosed with leukemia in 1977 • Parents were deeply religious couple who decided to use laetrile and metabolic therapy rather than chemotherapy

9. The Chad Green Case • Massachusetts quickly declared Chad a ward of the state, removed him from parents’ custody, and forced him to undergo chemotherapy • Parents battled state for over a year and regained physical, but not medical, custody

10. The Chad Green Case • Upon regaining custody, parents took Chad to Mexico for CAM therapy • Chad died suddenly in Mexico in late 1979. • Case was played out publicly on national TV

11. Overview of Complementary and Alternative Medicine

12. Definitions • Alternative medicine – Interventions that are neither taught widely in medical schools nor generally available in U.S. hospitals (Eisenberg) • Complementary medicine – Alternative approaches used as an adjunct to conventional medicine. • Integrative medicine – Suggests an eclectic approach which combines the best of conventional and alternative medicines.

13. Tenets of CAM • Healing comes from within. The body has the power to heal itself, often without drugs or surgery. Treatment aims to encourage self healing. • Holism: Find the root cause(s) of the problem and treats the whole person, not just the symptom. • Body, mind, and spirit are interconnected.

14. Extent of CAM Use • Over 40% of Americans used CAM in 1997 • Visits to CAM practitioners increased by almost 50% from 1990 (427 million visits) to 1997 (629 million), exceeding visits to PCP’s (386 million) in 1997. • Expenses for CAM services, $21.2 billion ($12.2 billion out-of-pocket), exceeded out-of-pocket expenses for all hospitalizations in 1997.

15. Extent of CAM Use • In 1992 Congress mandated establishment of Office of Alternative Medicine (now NCCAM) • Funding for NCCAM has increased year by year from about $2 million in 1992 to over $100 million in 2004. • More recently, the NCI has established its own CAM office, OCCAM

16. Demographics of CAM Use • Use of CAM higher among women (49%) than men (38%) • Lower among African-Americans (33%) than other racial groups (45%). • Higher rate of use in 35 – 49 age group (50%) than in older (39%) or younger (42%).

17. Demographics of CAM Use • CAM use higher among college-educated (51%) than in non – college educated (36%). • More common in those with income > $50,000 (48%) than in lower income (43%). • Use higher in the West (50%) than in rest of U.S. (42%).

18. Reasons for CAM Use by Cancer Patients • As alternative form of primary, adjunctive, or salvage treatment • Increase immunity • Manage side-effects or complications of disease and its treatment • Enhance overall quality of life

19. CAM Modalities Commonly Used By Cancer Patients • Alternative Medicine Systems • Traditional Chinese Medicine • Naturopathy • Homeopathy • Dietary Therapies • Macrobiotics • Gerson Therapy • Herbs • Megavitamins

20. CAM Modalities Commonly Used By Cancer Patients • Mind-Body Therapies • Meditation • Yoga and t’ai chi • Spiritual Healing • Body-based Therapies • Acupuncture • Chiropractic • Massage • Energy Therapies • Reiki • Therapeutic Touch

21. Guiding Ethical Principles

22. Guiding Ethical Principles • In 1970, Beauchamp and Childress developed a framework for clinicians to recognize and apply basic ethical principles.

23. Guiding Ethical Principles • Principlesincluded: • Autonomy: respecting the decision-making capacities of autonomous individuals • Nonmaleficence: avoiding the creation of intentional, needless harm or injury to the patient, either through acts of commission or omission

24. Guiding Ethical Principles • Principlesincluded: 3. Beneficence: Being of benefit to the patient, taking positive steps to prevent harm to and remove harm from the patient 4. Justice: Allocating benefits, risks, and costs fairly.

25. Cases for Discussion

26. Cases for Discussion • Case 1: • Patient is a 45 year old male, fair-skinned outdoors enthusiast who presents with 1 mm irregular, dark skin lesion on forehead. Lesion appears to his naturopath to be textbook melanoma. She recommends dermatology referral for surgical excision and biopsy. • He refuses any conventional therapy on basis of long-held spiritual and health beliefs, maintaining that he can heal the lesion through a combination of fasting and prayer.

27. Cases for Discussion • Case 1 – Questions: 1. What are the possible benefits and harms to the patient from treatment? From no treatment? 2. How should the patient be advised? What are the ethical and legal responsibilities of the naturopath? How might these differ from those of a physician?

28. Cases for Discussion • Case 2: • Patient is a 62 year old female, with a long history of depression, who has had recent rectal bleeding, fatigue, and unexplained weight loss. • Over the years, she has tried many pharmaceutical agents, such as Prozac, Paxil, and Elavil, but none have been both effective and tolerable in terms of side-effects. • Recently, she began using the herbal agent St. John’s wort to treat the depression and has been happier than in many years.

29. Cases for Discussion • Case 2 - Questions: 1. How should this patient be advised? 2. How might the physician balance the competing needs of beneficence and nonmaleficence in this case? 3. What responsibilities does this physician, or any physician, have to discuss their patients’ use of CAM?

30. Cases for Discussion • Case 3: • Patient is a 73 year old male who appears to be in relatively good health. However, routine lab tests show an elevated PSA level and DRE is abnormal. Patient undergoes prostate biopsy which reveals an apparently circumscribed Gleason 7 adenocarcinoma. • Urologist recommends prostatectomy radiation therapist suggests radiation therapy would also be acceptable. However, both agree that treatment is indicated.

31. Cases for Discussion • Case 3: • Patient prefers watchful waiting along with following macrobiotic diet. He’s worried about complications from surgery and radiation and that they could damage his immune system. • Both doctors express concern that if he waits too long, he may lose opportunity to cure disease before it spreads systemically. They also insist that he is “wasting his time with the diet” because there is no evidence that diet is a suitable alternative in his case.

32. Cases for Discussion • Case 3 – Questions: 1. Again, what are the possible benefits and harms to the patient from treatment? From no treatment? Did the urologist harm and radiation oncologist harm the patient by arguing against his use of the dietary approach? 2. How should the patient be advised?