Practical Medical Ethics
Goals of the Talk
A Brief Ethical History
Review the Principles
4 Ethical Boxes
2 Paradigm Cases of our time
E thics Pop Quiz
Which 2
H ipocrates & Aristotle
famous ancient
philosophers were also
physicians?
1
E
thics of Hippocratic Medicine
Harnessing the principals of nature as guide to healing
Be of benefit and do no harm
Asclepius
“Taught medicine for those who were healthy in their nature but were
suffering from a specific disease; he rid them of it…then ordered them to live
as usual…for those however, whose bodies were always in a state of inner
sickness he did not attempt to prescribe a regime to make their life a
prolonged misery…medicine was not intended for them and they should not
be treated even if they were richer than Midas.”
E
thics of JudeoJudeo-Christian Medicine
Healing comes from God through human means
Care for the poor, enemies, and strangers
“It is their need that cries out to you”
- Plato The Republic
Expansion of Medical Technology
Development of antibiotics 1930’s
Seattle’s “God Squad” 1962
Life Support (Karen Ann Quinlan) 1976
Artificial Organs (Barney Clarke) 1982
Societal Pressures
Civil Rights / Feminist Movements 1960’s
HIV Lobby 1990’s
Medical Scandals
Nazi Germany 1940’s
Nuremberg Code 1947
Declaration of Helsinki 1964
Belmont Report 1978
Establishment of 4 Principals
(Beauchamp and Childress) 1979
“A Reminder of What You Already Know”
A) Beneficence
B) NonNon-maleficence
C) Autonomy
D) Justice
Created the framework for determining ethical action
Tuskegee Report 1973
2
32%
16%
10%
y
ut
on
om
A
ic
i
ef
al
ef
ic
N
B
on
m
en
ity
6%
en
ce
Widely endorsed
37%
Beneficience
Nonmaleficience
Justice
Fidelity
Autonomy
e
Cross cultural
1.
2.
3.
4.
5.
st
ic
Ethical values not controversial
Fi
de
l
Framework for a wide variety of cases
Ju
Simple to remember (use?)
ie
nc
e
Usefulness of 4 Principals
A patient was given a dicloxicillin for a forearm cellulitis
despite having a clearly documented penicillin allergy in
the chart. He returned to the prescribing physician’s
office 3 days later with a cutaneous drug eruption. The
physician acknowledged and apologized for the error
and provided alternative therapy for the cellulitis. This
is an example of the practice of which ethical principle?
A patient was given a dicloxicillin for a forearm
cellulitis despite having a clearly documented penicillin
allergy in the chart
chart.. He returned to the prescribing
physician’s office 3 days later with a cutaneous drug
eruption.. The physician acknowledged and apologized
eruption
for the error and provided alternative therapy for the
cellulitis.. This is an example of the practice of which
cellulitis
ethical principle?
A) Beneficience
B) Nonmaleficience
C) Justice
D) Fidelity
COX-2 Inhibitors and CV
Outcomes
Patient is a 72 yo man with bilateral knee
DJD that has been treated with Vioxx for
the last 3 years with good relief. He had
a distant history of PUD and a previous
GI bleed that was positive for H. Pylori
infection-- (since treated). He arrived in
infection
your office saying he read in the New
York Times that his medication may
increase his risk for heart attack and
stroke. He wants your advice.
E) Autonomy
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NSAIDS were 16th leading cause of
death in US
VIOXX (Refocoxib)
• 1999- VIGOR (Vioxx GI Outcomes Trial)
– Refocoxib roughly 2/3 fewer GI ulcerations than
Naprosyn
– 5X increase in CV events…
– Barely mentioned in paper..
– Stated that effect due to cardio-protective naprosyn
– Topol and Colleagues suggest trials to evaluate in
accompanying editorial…..
http://www.md.ucl.ac.be/facm/facm--conferences.htm
http://www.md.ucl.ac.be/facm/facm
NSAID of Action
Biologic Plausibility Mechanism
Refocoxib-magnitude of risk
APPROVE Trial
MI/CVA rate
3.5% rofecoxib
?
Platelet
activation
?
Vascular
events!!!
1.9% placebo (P<0.001)
ARR=1.6
NNH= 62.5
Tens of millions of patients
using this medication…..
Topol, NEJM Volume 351:October 21, 2004 Number 17
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Timing is Everything…
“Dodge Ball Vioxx”
Cardiovascular Outcomes
FDA News
Sept 30th, 2004
FDA Issues Public Health Advisory on Vioxx as its
Manufacturer Voluntarily Withdraws the Product
Meta-analysis of
Metarandomised trials
comparing rofecoxib
with control
Juni et al. The Lancet,
Nov. 5, 2004
Merck knew in 2000 that there was an increased CV risk
Merck initially cited by FDA for acting responsibly in
this withdraw…
http://www.fda.gov/bbs/topics/news/2004/NEW01122.html
4 years before the withdraw
FDA Investigators estimate 27,000 excess MI and sudden cardiac death
could have been prevented…
Horton, R. The Lancet, published online Nov. 5, 2004
CLASS Study (?)
Gastrointestinal toxicity with celecoxib vs nonsteroidal anti-inflammatory
drugs for osteoarthritis and rheumatoid arthritis: the CLASS study: A
randomized controlled trial. Celecoxib Long-term Arthritis Safety Study.
Pharmacia Clinical Research and Development, 4901 Searle Pkwy, Bldg A3E,
Skokie, IL 60077, USA.
MAIN OUTCOME MEASURES: Incidence of prospectively defined symptomatic
upper GI ulcers and ulcer complications (bleeding, perforation, and obstruction)
and other adverse effects during the 6-month treatment period. RESULTS: For all
patients, the annualized incidence rates of upper GI ulcer complications alone and
combined with symptomatic ulcers for celecoxib vs NSAIDs were 0.76% vs
1.45% (P =.09) and 2. 08% vs 3.54% (P =.02), respectively.
CONCLUSIONS: In this study, celecoxib, at dosages greater than those indicated
clinically, was associated with a lower incidence of symptomatic ulcers (AT 6
MONTHS) and ulcer complications combined compared with NSAIDs at standard
dosages.
Issues brought forward
1- FDA is beholding to the drug industry
– 1992 Prescription Drug Fee Act
– $825 million from industry (’93-’01)
• 4.9 million to lobby FDA in ’03 alone
– Drug approval time decreased- 2714 months
• Drug recalls1.56%5.35%
– >50% of FDA expert panel members received
honoraria from Pharma..
JAMA. 2000;284:1247-1255
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Issues brought forward
2- Post-marketing surveillance
– FDA Medwatch
• depends upon voluntary reporting
• http://www.fda.gov/medwatch/
– Drug Manufacturers
• Less than half f/u studies promised initiated
• Fox guarding the henhouse..
Issues brought forward
• Direct marketing creates problems
– MERCK spends $100million/year
– We must figure out how to respond
Our fiduciary ETHICAL responsibility
–
–
–
–
refocoxib, cervistatin, troglitazone, rosiglitzone
Use medications with a “track record”
Report side effects to FDA
Company reps=salesmen
– $$ disincentive to report
– Be of benefit and do no harm..
Practical Bedside Ethics
Criticism of the Principles
•
•
•
•
Open to interpretation
Autonomy trumps all other principles
Justice trumped by the wallet biopsy
Hard to apply to at the bedside
Clinical Ethics
The 4 Box Method
Medical Indications Patient Preferences
Quality of Life
Contextual Features
- Al Jonson, Mark Siegler and William Winshade
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4 Ethical Boxes
Medical Indications
Patient Preferences
• Context of clinical discussion
Contextual Features
4 Ethical Boxes
Medical Indications
• Context of clinical discussion
• Dx, Tx options and goals
• Pathophysiology & Prognosis
• Easiest part for MD / RN
Quality of Life
•Intervention to improve, maintain or decrease
patients QOL?
• Patient’s & family’s perception
• Health care team’s perception
• Danger: Door Open for bias/prejudice
Medical Indications
• Context of clinical discussion
• Dx, Tx options and goals
• Pathophysiology & Prognosis
• Easiest part for MD / RN
• Dx, Tx options and goals
• Pathophysiology & Prognosis
• Easiest part for MD / RN
Quality of Life
4 Ethical Boxes
Patient Preferences
•What are the patient’s goals/values
• Adequate information/understanding
• Voluntary consent, coercion?
• Surrogate decision makers
• Nursing/SW/Chaplaincy can help!
Contextual Features
Quality of Life
Patient Preferences
•What are the patient’s goals/values
• Adequate information/understanding
• Voluntary consent, coercion?
• Surrogate decision makers
• Nursing/SW/Chaplaincy can help!
Contextual Features
4 Ethical Boxes
Medical Indications
• Context of clinical discussion
• Dx, Tx options and goals
• Pathophysiology & Prognosis
• Easiest part for MD / RN
Quality of Life
•Intervention to improve, control or decrease?
• Patient’s & family’s perception
• Health care team’s perception
• Danger: Door Open for bias/prejudice
Patient Preferences
•What are the patient’s goals/values
• Adequate information/understanding
• Voluntary consent, coercion?
• Surrogate decision makers
• Nursing/SW/Chaplaincy can help!
Contextual Features
• Describes “outside influences” on care
• Financial, social, cultural
• Danger: Guard against Prejudice
• Danger: Macro applied on micro scale
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Terri Schiavo
November 1984
Terri (nee Schindler) and Michael Schiavo are married.
February 25, 1990
Terri Schiavo suffers cardiac arrest, apparently caused by a potassium imbalance
and leading to brain damage due to lack of oxygen. She was taken to the Humana
Northside Hospital and was later given a percutaneous endoscopic gastrostomy
(PEG) to provide nutrition and hydration.
May 12, 1990
Terri Schiavo is discharged from the hospital and taken to the College Park skilled
care and rehabilitation facility.
Terri Schiavo
May 1998
Michael Schiavo petitions the court to authorize the removal of Terri
Schiavo’s PEG tube; the Schindlers oppose, saying that Terri would
want to remain alive. The court appoints Richard Pearse, Esq., to
serve as the second guardian for Terri Schiavo.
June 18, 1990
Court appoints Michael Schiavo as guardian; Terri Schiavo’s parents do not object.
December 20, 1998
Richard Pearse, Esq., issues his report in which he concluding that
Terri Schiavo is in a persistent vegetative state with no chance of
improvement and that Michael Schiavo’s decision-making may be
influenced by the potential to inherit the remainder of Terri Schiavo’s
estate.
September 1990
Terri Schiavo’s family brings her home, but three weeks later they return her to the
College Park facility because the family is “overwhelmed by Terri’s care needs.”
February 11, 2000
Judge Greer rules that Terri Schiavo would have chosen to have the
PEG tube removed, and therefore he orders it removed.
Terri Schaivo
Terri Schiavo
April 12, 2001
The Schindlers petition the Florida Supreme Court to stay the
removal of Terri Schiavo’s PEG tube.
April 18, 2001
The Florida Supreme Court chooses not to review the decision of
the 2nd DCA.
April 23, 2001
Justice Anthony M. Kennedy of the United States Supreme Court
refuses to stay the case for a review by that Court.
April 24, 2001
By order of trial court Judge Greer, and upon issuance of a 2nd
DCA mandate, Terri Schiavo’s PEG tube is removed, replaced
one week later on appeal
September 17, 2003
Judge Greer orders the removal of the PEG tube to take place on October 15,
2003.
October 20, 2003
The Florida House of Representatives passes a bill, “Terri’s Law,” that allows
the governor to issue a “one-time stay in certain cases.”
October 21, 2003
The Florida Senate passes the bill; Governor Bush issues an executive order
directing reinsertion of the PEG tube
March 20, 2004
Pope John Paul II addresses World Federation of Catholic Medical
Associations and Pontifical Academy for Life Congress on "LifeSustaining Treatments and Vegetative State: Scientific Advances and
Ethical Dilemmas."
September 23, 2004
Florida's Supreme Court, unanimously affirming the trial court order, declares
"Terri's Law" unconstitutional
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Terri Schaivo
January 24, 2005
The United States Supreme Court refused to review ruling overturning
“Terri’s Law” as unconstitutional.
March 17, 2005
For third time the PEG tube is removed
March 21, 2005
Shortly past 12:30 a.m., the U.S. House of Representatives votes 203-58 to
suspend its rules and pass S.686. President Bush signs it.
March 22, 2005
Federal District Court Judge Whittemore refuses to order re-insertion of the
PEG tube.
March 24, 2005
The U.S. Supreme Court refuses to hear the Schindlers’ case.
The Schiavo Case
3 Important Views
1- Medical/Ethical/Legal
2- Theological
3- Political
Application of 4 boxes
March 31, 2005- 9:05 AM- Terri Schiavo dies- 21 years after her accident
Post-Cardiac Arrest Rule
The Schiavo Case
1- Medical Indications
-what % of patients
survive cardiac arrest on TV?
• 225,000 patients have sudden cardiac death in US
• 50% arrive at hospital alive
– 80% are in post-arrest coma, 14% survive to discharge
– NEJM. 2001;334:1304-13
• 5 clinical signs predict poor outcome
absent corneal reflexes at 24 hours (LR, 12.9; 95% confidence
interval [CI], 2.0-68.7)
absent pupillary response at 24 hours (LR, 10.2; 95% CI, 1.848.6)
absent withdrawal response to pain at 24 hours (LR, 4.7; 95% CI,
2.2-9.8)
no motor response at 24 hours (LR, 4.9; 95% CI, 1.6-13.0)
no motor response at 72 hours (LR, 9.2; 95% CI, 2.1-49.4).
– Booth et al. JAMA. 2004;291:870-9
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Persistent vegetative state
Terri’s Medical Condition
•EEG Flatline
•Multiple Evaluations
•PVS
•14 years duration
Normal Head CT VS. Terri’s CT
The Schiavo Case
1- Medical Indications
- No chance for clinical improvement
2- Patient Preferences
Loss of cortical function with maintenance of brainstem
function-- eyes open unconsciousness with physiologic
function
sleep/wake cycles but no awareness of self or environment.
Neurology, 1989;39, 125125-126
Coma – profound unconsciousness caused by
disease, injury or sleep
• 210 patients with anoxic brain injury post arrest
• 134 (64%) died in the first week
• 27 (13%) were discharged to free living
• All but four improved by two weeks
- Levy, et al JAMA May 1985
Patient Preferences
• Competence – “A sufficiency of means for the
necessities of life”
– Legally is court determined
• Capacity – “The faculty for treating, experiencing
or appreciating”
Clinical judgment
Specific to making medical decisions
Medically “incapable” of decision
Terri did not have capacity
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Surrogate Decision Makers
Who chooses if no documentation exists?
Spouse, Adult Children, Parents,
Siblings, 2nd, 3rd
• Substituted judgment
Knowledge from the patient
Knowledge about patient
Patient’s best interest
Quality of Life
Futility
“Leaky, hence untrustworthy, in vain:
The Schiavo Case
1- Medical Indications
- No chance for improvement
2- Patient Preferences
-Legal Precedent with Husband
3- Quality of Life
Quantitative Futility
Likelihood that a medical intervention will achieve its desired
ends falls below a threshold considered minimal
1%-- but beware cost considerations
1%
failing of the desired effect through an intrinsic defect”
Focus is on intervention not patient, society or other factors
Qualitative Futility
Whenever a man suffers an ill which is too strong for the
means at the disposal of medicine, he surely must not even
expect that it can be overcome by medicine
Quality of outcome associated with an intervention falls well
below a threshold considered minimal
Value laden and threshold debatable
Hippocratic Writings
- Schneiderman
Schneiderman,, Jecker,
Jecker, and Jonson
Annals of Internal Medicine 112, 1990: 949949-954
Blue study drug example
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The Schiavo Case
1- Medical Indications
- No chance for improvement
2- Patient Preferences
-Legal Precedent with Husband
3- Quality of Life
- Interventions will not improve
4- Contextual Features
- Legal, Theological, Political
Theological
Pope John Paul II, March 2004
“The sick person in a vegetative state, awaiting
recovery or natural end, still has the right to
basic health care (nutrition, hydration,
cleanliness and warmth).
Administration of water and food, even in
artificial means, ..is natural, not a medical act.
…should be considered ordinary and
proportionate care.”
Legal- PVS statutes
• 1976- Karen Ann Quinlan- post OD
– NJ Supreme Court- “if there is no reasonable possibility
returning to a cognitive, sapient life,” life sustaining
treatment can be removed.
– Here asc with ventilators
– Began “living will” movement
• 1990- Nancy Cruzan- post MVA
– Cruzan vs. State of Mo.
– US Supreme Court- Tube feedings can be stopped if
surrogates produced “clear and convincing evidence”
that she would refuse.
– “no legal distinction between artificial food/fluids and
other interventions (ventilators).
Politics
• Then President Bush. "I urge all those who honor Terri
Schiavo to continue to work to build a culture of life,
where all Americans are welcomed and valued and
protected especially those who live at the mercy of
others.”..
• Florida's governor, Jeb Bush, "Her experience will
heighten awareness of the importance of families dealing
with end-of-life issues, and that is an incredible legacy."
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Lesson’s to be learned
•
•
•
•
Thank you for your attention
All Week!!
Apply the 4-Boxes
Encourage patients to discuss beforehand
Encourage living wills
Apply the rules of substitute judgment
– Shared decision making
– Involve experts with conflict
• Appreciate the opinions of others
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