Download Dietary Therapy of Prostate Cancer

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
Presentation Overview

A personal story

Background cases

Overview of complementary and alternative
medicine (CAM)

Guiding ethical principles

Cases for discussion
A Personal Story . . .
Background Cases
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
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
The Chad Green Case
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
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
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
Overview of Complementary and
Alternative Medicine
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.
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.
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.
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
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%).
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%).
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
CAM Modalities Commonly Used By
Cancer Patients

Alternative Medicine Systems
– Traditional Chinese Medicine
– Naturopathy
– Homeopathy

Dietary Therapies
– Macrobiotics
– Gerson Therapy

Herbs

Megavitamins
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
Guiding Ethical Principles
Guiding Ethical Principles

In 1970, Beauchamp and Childress developed a
framework for clinicians to recognize and apply
basic ethical principles.
Guiding Ethical Principles

Principles included:
1. Autonomy: respecting the decision-making
capacities of autonomous individuals
2. Nonmaleficence: avoiding the creation of
intentional, needless harm or injury to the patient,
either through acts of commission or omission
Guiding Ethical Principles

Principles included:
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
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 longheld spiritual and health beliefs, maintaining that he can
heal the lesion through a combination of fasting and
prayer.
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?
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 sideeffects.
– Recently, she began using the herbal agent St. John’s
wort to treat the depression and has been happier than in
many years.
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?
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.
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.
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?