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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.

  1. You are at least 14 years old.

  2. 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.)

  3. 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%


  • KEY FACTS:

  • 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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