COMPLEMENTARY MEDICINE IN THE TREATMENT OF CANCER: ETHICAL ISSUES - PowerPoint PPT Presentation

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

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

A Personal Story . . .

Background Cases

• 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

• 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

• 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

• 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

• 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

Overview of Complementary and Alternative Medicine

• 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.

• 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.

• 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.

• 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

• 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%).

• 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%).

• 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

• Alternative Medicine Systems
• Traditional Chinese Medicine
• Naturopathy
• Homeopathy
• Dietary Therapies
• Macrobiotics
• Gerson Therapy
• Herbs
• Megavitamins

• Mind-Body Therapies
• Meditation
• Yoga and t’ai chi
• Spiritual Healing
• Body-based Therapies
• Acupuncture
• Chiropractic
• Massage
• Energy Therapies
• Reiki
• Therapeutic Touch

Guiding Ethical Principles

• In 1970, Beauchamp and Childress developed a framework for clinicians to recognize and apply basic 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

• 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.

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.

• 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?

• 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.

• 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?

• 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.

• 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.

• 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?