HEW Final Report in 1972
• Concluded that the 40-year longitudinal study was
ethically unjustified
– Failed to obtain informed consent
– However, they did not expose the egregious fact of
deception: men were promised treatment and were
observed, despite availability of penicillin
Clinton issued formal apology in 1997
The Tuskegee Syphilis Study
11
Willowbrook
Institution for Mentally Retarded in NY with long waiting
list
• High prevalence of Hep B (almost 100%)
• Subjects injected with Hep B to assess antibody
response, and those whose parents gave consent
were admitted preferentially
• Patients kept in special quarters and supervised
• Hep B vaccine developed successfully.
Jewish Hospital
1963
22 terminally ill patients injected with live
cancer cells, so that spread or rejection
could be assessed at autopsy
Had given oral consent ot experiment, but
not told they wouyld be injected with
cancer
OC Trial
1971. Placebo controlled OC trial in 76
patients (placebo being a vaginal cream,
though participants not told less
effective)
Showed that OC were effective: 10 preg. In
placebo group.
Abortion not legally available
Most subjects were RC
Others
Prisoners offered early discharge if agreed
to irradiation of testicles.
Patients receiving radiotherapy were given
excessive doses to assess effect of
irradiation, (at request of Military)
Etc, etc, etc.
Conclusions
Were all these experimenters
monsters?
Task: is there an alternative scenario for
the Tuskegee study?
Medical Ethics
Truthful Disclosure
Medical Ethics
Truthful Disclosure
• “Being honest with the patient”
• Supported by moral principles:
Fidelity & Autonomy
• Need truthful facts
What if you are not been honest?
• Omitting a fact (success rate=10%)
or distorting information
• Therefore are DECEPTIVE
• Deception= to lie or omission of info
• “therapeutic privilege”
– If harm of disclosure outweighs harm of nondisclosure.
• Trend: Now is Absolute Honesty
• If you “mess up” - you inform the pt’/family
• Disclosure of medical mistakes:
• “If it can’t be fixed,why break it more?”
Reasons against Disclosure
• 1)Legal- fear against Law suit
• 2)Causes unnecessary distress
• 3)Decreased competency as viewed by
colleagues hence getting less referrals (i.e.
poor/unsuccessful post-op result)
• 4)Decrease in trust from patients
Reasons for Disclosure
1)Respect for autonomy-
Allows patient to:
*Decide whether they want to continue
seeing this Dr
*Remedy the mistake
*Opportunity to sue
*Honesty in physician/patient relationship
2)Legal risk of not disclosing
*Fear of patient finding out
3) Obligation to make changes to prevent
recurrence of mistakes.
• Eg. Phenol & LA ankle block.
• Phenol injected instead of local anaesthetic
• BK amputation
• Doctor reads cartridge,shown by nurse
• Label better
• Common practice= check name,dose,dates
• USA- 44,000-98,000 deaths per year 2ndary
to medical mistakes
Use of placebos
• A substance that is administered as a drug
but has no medicinal content, either given to
a patient for its reassuring or used in a
clinical trial of a real drug.
Use of placebos
• Psychological or biological effect?
1) Pain + placebo:
decrease in pain= 1st effect
• Do endogenous opiates(endorphins)
decrease pain?
• How to test?
Give opiate antagonists. So:
• 2) Pain + opiate antag^ + placebo:
No change in pain
Is it ethical to do this?
To have not told patient you are not giving
them real drug in this pain trial.
Types of placebo
1)Therapeutic
2) Diagnostic tool
3) Clinical research
Types of placebo
1)Therapeutic
• Pure- sugar pill. Very few
• Impure- Most common
Is a drug & will have an action but
not for pt’s symptoms
Problems: Deceiving them & therefore
violating informed consent & violating
fidelity (pt expects you to be honest)
Justification for therapeutic
placebo
• Patient insists on prescription
• Alternative is toxic
• High placebo response
Types of placebo cont...
2) Diagnostic tool
• Aids diagnosis
• eg. Pseudoseizures:
• attack resembles epileptic seizure but has
purely psychological causes. Lacks EEG
changes of epilepsy. Sometimes stopped
just by act of will.
• give patient placebo to control “seizure”.
• Helps rule out “fake” seizures
• 3) Clinical research
• Require informed consent eg. placebos used
in drug trials
• Continued monitoring needed
Truthful Disclosure- Unethical
Cases
• Stanley Milgram’s study on
Obedience
• 1961-1962
• Subjects= teachers
• Experiment to implement
punishment using shock.
• Wrong answers then shock
• Caused significant distress to
subjects
Case
“Don’t Tell Mother”
Withholding Information from a
Patient
The Case
• Lillian 84 y.o.
• Developed dysphagia
• Not concerned by sx (mild,”eats too fast”)
• Son concerned. Persuades medical eval^
• Workup: reveals mediastinal mass
impinging on esophagus
• Biopsy recommended
• If Ca- need immediate surgery(incl.
Laryngectomy & tracheostomy)to avoid
obstruction
• Radiotherapy & chemotherapy produce
palliation but not cure expected
• Even with rx obstruction likely but later
date
• Otherwise appears healthy. Severe hearing
loss
• Time & patience for explanations. Alert,
orientated & appears mentally intact.
• Apartment next to son & family
• Transport dependent on them
• Able to make decisions(daily living)
• Not asked many specific questions about
current situation (Dr’s relief)
• Son tells Dr not to tell mother diagnosis b/c
will not tolerate news nor disfiguring
operation
• Son reports hx of pt’s depression & takes
appearance as top priority
• Son argues her sx are mild & have not
progressed significantly over 2 years
• Tumor unusual & no radical rx need
perhaps
• Even if it is malignant son states, mother is
84yrs & may die of an unrelated cause so
this invasive plan of care is not appropriate.
1)How valid is the son’s argument that the
progress of his mother’s tumor eliminates the
need for an invasive care plan?
Progress of tumor has been slower than
expected; her sx have not progressed & no
loss of weight.
Incidence of cancer increases with age & only
a few specific malignancies are more
aggressive in older individuals. Majority in
the elderly population are less aggressive,
non-metastatic & less often the cause of
death.
• Any apparent reduction in cancer
aggressiveness may represent vulnerability
to higher prevalence of CVS or
cerebrovascular dz.
• Controversy over prognosis of CA among
very old in general remains unresolved.
• In any case, it is not possible to predict the
course of Lillian’s tumor.
Ethical & Legal Considerations
• 2) Should Lillian be told her diagnosis?
• Physician’s primary obligation is to the
patient-Lillian.
• The principle of truthful disclosure/selfdetermination
requires the physician to
disclose to patient all reasonable
information relevant to her condition and
treatment options so can make individually
appropriate decision.
• Info included upset Lillian but sensitive
approach to deliver news.
• Information upsetting is not justification to
withhold from pt.
• Physician in this case take time to
communicate if hearing impairment is a
barrier. Written explanations effective or
son assist in disclosure in the doctor’s
office.
• News not be delivered quickly. Gradual
process adopt & inform in a way
emotionally tolerated.
• Only way to confirm if Lillian wants
shielding from distressing info is to hear her
own thoughts thro dialogue.
• Statistics- Most people want to hear details
of their situation, even if info is burdensome
or devastating.
• Physicians should directly inquire to
particular preferences of individual pt’s
rather than presume.
• Lillian has right to decide whether wants
treatment. Can only decide if informed of
dx.
• Important to know if palliative approach or
more aggressive cure-orientated approaches
to her condition required
2)Could a decision be made to withhold
info from Lillian based on her son’s
warning about her emotional state?
• There are limited situations where justified.
• Physician may be excused from disclosing
info to pt where sufficient evidence that pt
is not psychiatrically or emotionally
equipped to consider the info or that
disclosure of info itself would pose serious
& immediate harm to pt.
• Eg. by inducing some physiologic response
such as a MI or prompting suicidal
behaviour
• Known as therapeutic exception to informed
consent process.
• In this limited scenario: benefit to be
achieved by disclosure is outweighed by the
harm induced from the disclosure itself.
• In this case: son believes info could harm
Lillian, perhaps causing deep depression.
Given the apparent closeness of his
relationship with mother, cannot lightly
dismiss his concerns.
10
• However, important to further explore
Lillian’s psychiatric hx, values & current
state of mind before concluding that son
was right.
• Even if therapeutic exception utilized here,
physician is not relieved of the obligation to
continually attempt to involve the pt in
decision process & prepare her for problems
that may arise.
3)Can it be concluded that Lillian has
delegated her decision-making authority
to her son?
• Clearly, son heavily involved in medical
decisions(started diagnostic path)
• The fact that a pt would rely on her son for
advice & support is natural & even
justifiable in view of their close
relationship.
• Not clear though is if Lillian wishes son to
take her place in decision making.
• If she wishes, then has right to make
delegation of authority.
• She could execute a health care power of
attorney or proxy, formalizing her decision
to have her son make medical decisions on
her behalf. Authority usually activated once
decisional capacity lost.
• The pattern in this case certainly suggests
Lillian;s son be authorized decision maker.
• Delegation of decisional authority clearly
established by physician. Not presumed.
• If pt has decisional capacity then physician
has no right to discuss pt’s medical care
with others unless the pt gives permission
for this (info is confidential)
• Physician ask directly whether she wants
son to be involved in the decision process &
to what extent, & whether she wants all or
part of info about her condition disclosed to
him.
• In this case: No conclusion of delegation
authority to son. Finally….
11
• The information he has conveyed could
well be highly pertinent; furthermore,
excluding him outright would alienate him
& might disrupt a therapeutic relationship
between physician & patient.
LOW YIELD: for those aiming for 100%
IMPORTANT
Legal definition of minor- In most states, any person under 18 years of age. All minors must be under the care of a competent adult (parent or guardian) unless they are "emancipated"--in the military, married or living independently with court permission. Property left to a minor must be handled by an adult until the minor becomes an adult under the laws of the state where he or she lives.
Emancipated minor- married, or in military, or have children, or independent- make their own decision.
-
You are at least 14 years old.
-
You willingly want to live separate and apart from your parents with the consent or acquiescence of your parents. (Your parents do not object to you living apart from them.)
-
You can manage your own finances.
Truthful disclosure- TUSEGEE CASE:
Low yield
Justification for therapeutic placebo-
Placebos can be physical (e.g., a manipulation), pharmacological (e.g., a pill) or psychological (e.g., a conversation). Double-blind and placebo-controlled trials have sometimes been the source of anxiety on the part of the public or of prospective participants, usually because an element of deception seems to be involved, or because patients who are allocated to the control group (which might, e.g., not receive a new treatment) may seem to be at an unfair disadvantage. Anxiety on both of these counts is quite understandable if certain conditions fail to be met when the trial is proposed.
The scientific justification for the use of placebo preparations is set out above. Their use is ethical if patients give consent in advance. However, there is "little evidence in general" that placebos had powerful clinical effects. The authors state "outside the setting of clinical trials, there is no justification for the use of placebos."
Rights and privileges.
• Next case of violation:
• Jehovah witness 11 y.o. girl
• Trauma patient- child unconscious
• Needs surgery & blood transfusion
• Mother refuses transfusion b/c of religion.
• Even if child will die, mother refuses rx
• Court rules- BEST INTEREST
• Therefore rx^ed the patient
Termination of Treatment
• Federal Law- Child Abuse Amendments
of 1984
• Includes regulations to ensure
appropriate medical therapy for
disabled infants
• Mandates life supporting/saving medical
treatment(LSMT)
• Exceptions= permanent
unconsciousness, futile rx imposing
excessive burdens
AMA’s position on seriously ill infants
• LSMT may be withheld if pain overrides
comfort or no experience of emotion
due to brain damage.
• Law & ethics state, if suffering & no joy
then “plug” can be pulled.
Research with Children
• FDA Modernization Act:
• Pediatric drug trials are mandated on all
drugs which are approved for adults
before they can be routinely used for
children.
• Federal regulations:
• Parental consent always
• Childs consent usually ( but if refuses
then not in trial)
The Case
A man was injured when his car was
rear-ended by another car. The other
car was being driven by a person
diagnosed with epilepsy.
The Case, continued
The patient diagnosed with epilepsy had
a seizure right before the collision,
causing him to lose control of his
automobile and crash into the car
ahead of him.
15
The Case, continued
The man in the first car sued the patient
and received a settlement award of
$100,000.
The Suit
After this settlement, the man also sued
the patient’s physician.
This suit claimed negligence by failing to
warn the patient not to drive while
under the influence of an anti-seizure
medication (Dilantin with
phenobarbital).
The Court
• The trial court dismissed the case.
• On appeal the court affirmed the
dismissal order.
• The case was dismissed based on
proximate cause.
What Do You Think?
• What does proximate cause mean?
• Who/what caused the accident?
• Was the physician directly responsible
for the accident?
Summary
• There was no evidence that the
accident had been proximately caused
by the physician’s failure to warn the
patient about taking the anti-seizure
medication.
• Contrary, evidence suggested the
accident was proximately caused by the
patient’s seizure.
Werner v. Varner, Stafford & Seaman, P.A., 659 So. 2d 1308 (Fla.
Dist. Ct. of App., Sept. 6, 1995).
Stages of life ? According to Erickson
Erickson theory deals with the ego part of Freud’s idea. He believed that if stages wasn’t managed well, it would result in malignancy (too much negativity, less positivity) and Maladaptation (too much positive, little negative).
Stage 1: Infant- 0 to 1 yr old
-
Trust vs Mistrust – (oral sensory stage)
Stage 2: Toddler - 2 to 3yrs
-
Autonomy vs shame and doubt
-
Regulaton of child’s behaviour e.g. Toilet training
-
If rewarded child develops sense of autonomy.
-
Impulsiveness, compulsiveness (everything must be done perfectly)
Stage 3: Pre school stage : 5 to 6
-
Initiative vs guilt
-
Ruthlessness (don’t care who they step on to achieve their goals)
-
Inhibition…too much guilt, too afraid to try, loose and to feel. In future, they could develop impotency and be frigid.
Stage 4: School age - 7 to 12
-
Industry vs Inferiority
-
Child competes with peers in development of intellectual, social and physical environment.
-
Sense of self accomplishment and confidence
-
Inferiority (too little success) leading to sexism, racisms etc..
Stage 5: Adolescent stage – 12 to 18yrs
-
Ego Identity vs Role confusion
-
Stage focuses on development of interpersonal relationships with peers
-
Becomes sexually intimate
Stage 6: Young adult – 20’s
-
Intimacy vs isolation
-
Achieves real intimacy with life partner as opposed to being isolated
Stage 7: Middle Adulthood - 20 to 50’s
-
Generativity vs self absorption
-
Provides for family
-
Can experience midlife crisis
Don’t bother with 8th stage
PREGNANCY,
Growth & Development
PREGNANCY
-
According to CDC national statistics, total pregnancy count in 2002 includes about 4 million live births, 1.3 million induced abortions and 1 million other causes of fetal losses. (miscarriages, stillbirths)
-
Cessation of sexual activity is required during last 4 weeks of pregnancy
-
Extramarital affairs are likely to be in third trimester due to reduction or cessation of sexual activity---- if that is the reason.
-
Spousal abuse occurs in 6% of women and is most likely to occur in first trimester. Increases risk for miscarriage, abortion and neonatal death.
-
Mood changes are very common in pregnancy due to biological factors and psychological factors
Teenage pregnancy
About 1 million teenage become pregnant each year
-
10% of all teenage girls
-
50% of all unwed mothers are teenagers
-
50% actually have the child
-
33% have elective abortions
-
About 17% have spontaneous abortion
-
About 33% of girls aged 15-19 have at least one unwanted pregnancy
-
Single mothers account for 70% of births to girls aged
15-19
Teenage pregnancy
CONSEQUENCES
FOR MOTHER:
LEADING CAUSE OF SCHOOL DROPOUT
HIGH RISK OF OBSTETRIC COMPLICATIONS
FOR CHILD:
NEONATAL DEATH AND PREMATURITY
LOWER LEVEL OF INTELLECTUAL FUNCTIONING
PROBLEMS OF SINGLE PARENT FAMILY
( DELINQUENCY, SUICIDE)
BIRTH RATE, INFANT MORTALITY AND CESAREAN
-
ABOUT 4 MILLION CHILDRENS ARE BORN EACH YEAR IN UNITED STATES
-
INFANT MORTALITY
-
RATES PER 1000 LIVE BIRTH ARE AS:
-
WHITES 6.0
-
BLACKS 14.3
-
HISPANICS 6.1-8.6
-
NATIVE AMERICANS 8.8
-
OVERALL 7.2
-
3 MAIN REASONS FOR INFANT MORTALITY:
-
BIRTH DEFECTS 24%
-
LOW BIRTH WIEGHT AND RDS 18%
-
SUDDEN INFANT DEATH SYNDROME 16%
-
AFRICAN AMERICANS HAVE HIGHEST RATE DUE TO LOW BIRTH WIEGHT AND INFECTIONS
-
SIDS IS SECOND MAIN CAUSE IN AF’S.
-
NATIVE AMERICANS HAVE HIGHEST SIDS RATES
-
SIDS RATES HAVE REDUCED SHARPLY BY:
-
HAVING INFANTS SLEEP ON THEIR BACK
-
AVOIDING INFANTS ON TOO SOFT OR FLUFFY SURFACE
-
MOTHER AVOIDING SMOKING DURING PREGNANCY
-
AVOID ALL SMOKING IN THE INFANTS HOUSEHOLD
CESAREAN BIRTH
-
NUMBER WAS INCREAED BETWEEN 1960 TO 1990 MAILY DUE TO FEAR OF MALPRACTICE DUE TO DEATH AND INJURY DURING VAGINAL DELIVERIES
-
CURRENTLY LEVELS OF CESAREAN BIRTHS ARE REDUCED TO 21% MAINLY DUE TO INCREASED AWARENESS OF SUGICAL COMPILCATIONS AND UNNECESSSARY SURGICAL PROCEDURE
MATERNAL DRUG ABUSE AND EFFECT
-
SMOKING------- LOW BIRTH WIEFHT AND WITHDRAWL AT BIRTH
-
CRACK COCAINE-----INCREASED IRRITIBILITY AND CRYING AND DECREASED DESIRE TO FOR A HUMAN CONTACT
-
FETAL ALCOHOL SYNDROME---- LEADING KNOWN CAUSE OF MENTAL RETARDATION(DOWN SYNDROME IS SECOND)
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