S1-2_Ryuichi Ida

Ethical Considerations in Health
Emergencies
– A Panorama of Ethical Considerations –
Ryuichi IDA
Senior Managing Director, JANU
(Former Chairperson, IBC, UNESCO; Professor emeritus, Kyoto University)
WMA’s Regional Expert Meeting in Pacific on the WMA Declaration of Helsinki
November 30, 2023 Hilton Tokyo Odaiba, Japan 1
Two Types of Health Emergencies
Epidemic : Pandemic
Ex. EVD; SARS, MARS, COVID-19
Disasters
Natural disasters
Earthquake, Tsunami, Typhoon(Hurricane, Cyclone) ,
Volcanic eruption, Meteorite impact
Fire
Warfare
Others
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Pandemic and Ethical Dilemmas
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Ebola Case
Conditions
Infection with a virus (first discovered in 1976 in DRC near the Ebola River)
Transmission through direct contact with :blood, body fluids, objects (syringes/needles),
infected primates (bats, apes, monkeys)
Burial of touching the dead body
High mortality : 50 – 90%
Countries/Areas
Insufficiency of literacy on disease and health as well as health care system
⇒ Standard care is not available : hospitals, HCWs, equipments, devices, drugs
Prevention of wide-spread affection
Existing methods : quarantine, movement and immigration control,
Existing methods are effective, if they are achieved in a complete manner.
Treatment
No existing drug or treatment registered or approved
ZMapp, Favipiravil, other = not approved as Ebola treatment
Is it permissible to use unregistered medical products for Ebola patient?
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Covid-19 Case
Conditions
Infection with a virus (Started in 2019)
Transmission through small liquid particles, aerosols and touching
surfaces or objects contaminated
Mortality differs among various mutant strains and among ages
Unknown at the beginning ⇒ Mutations precisely followed
Health care system perturbed = hospitals, HCWs, equipments, devices
because of lack of efficient drugs ⇒ Standard care is not available.
Prevention of wide spread affection
Existing methods : quarantine, movement and immigration control,
⇒Effective, if they are achieved in a complete manner
Vaccines : Nucleic acid vaccines(mRNA) & Vector vaccines
Treatment
ECMO
Several drugs now registered (Ex. Molnupiravir, Ensitrelvir, Nirmatrelvir) 5
General feature of Pandemics
“ Pandemics”
expansion of infected areas and peoples
to an extremely wide range
often occur in developing countries
Stages from outbreak to after-termination
* Appearance of symptoms ⇒ Contagion ⇒ Diagnosis
⇒ Pathogenesis ⇒ Treatment (unproven interventions)
* Prevention ⇒ Caution measures ⇒ Vaccination
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Prevention of the outbreak
1) Detection and Determination of the Pandemic
2) First Emergency Measures
3) Treatment of Existing Patients
4) Community environment
5) Prioritization of Health Care Workers
6) Movement of persons
7) Vaccination
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Ethical issues relevant to the pandemics
Ethical principles to be mitigated in the “Pandemics”
Expansion of infected areas and people to an extremely wide range
often occur in developing countries
Difficulties = Limitation of the Principles in Pandemics
Autonomy
⇔ Compulsory restrictive measures
The least harm, or the least infringement of the rights and interests
Informed consent
Confidentiality
Justice : Prioritization and Triage
Solidarity : Domestic Society＋International Cooperation 8
Ethical Dilemmas
Beneficence vs non-maleficence
Individual vs the common good
Procedural justice and Distributive justice
Integrity vs equity and compassion
Cost – Benefit consideration applicable?
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Limitation of Freedom of Movement
Beneficence/non-maleficence
Avoidance of infection of self vs Avoidance of infection of others
Individual vs Public (common good) = Public health vs Medicine (Individual medical treatment)
Compulsory restrictive measures
The least harm, or the least infringement of the rights and interests
Informed consent, but consent might be imperative or even ignored
Confidentiality may be an obstacle to grasping the whole situation
Freedom of self vs Limitation of movement
⇒ Individual benefit vs Common good/Public safety
Paternalism = Protection by the authority from harm
Cost vs Benefit
Life vs Freedom ⇒ “Calculation” or “Weighing” = Difficult decision
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Justice
Difficulties of achieving justice assured in normal life
Fairness of distribution of medical resources
Conventional situation ⇒ Contingency situation
⇒ Crisis situation
⇒Distributive justice
⇒Procedural Justice
“Global Justice”
Developed and developing countries
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Integrity vs Equity/Compassion(1)
Conditions of medical Research unachievable
⇒Eventual Use of unregistered intervention
Stages of research for trial
1)No evidence, no support use, but some reason to offer
2)Safe and effective in relevant animal models or repurposed
drugs
3) Safe and effective in animal models but unclear extrapolation
4)Safe and effective in relevant animal models
5)Phase I passed
6)Phase II passed
Research integrity vs “Compassionate use”
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Integrity vs Equity/Compassion(2)
1) We should not suppose the idea of altruism.
2) Idea of clinical equipoise should not be too much emphasized.
3) The supremacy of the placebo randomized trial as the most
valid source of experimental knowledge is being challenged by
the moral anxiety of using placebo in severe infectious
situation.
4) The concept of randomization and its consequences are
unlikely to be grasped by acutely suffered patients in the midst
of a pandemic.
5) Randomization might be felt as a tragic choice, amounting to
deliberately condemn half of their patients to possible harms,
or to withholding possible live saving benefits.
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Integrity vs Equity/Compassion(3)
– Elements in Research/Treatment –
1) Research during an epidemic is an ethical imperative:
2) Clinical equipoise is a moving target:
3) Risk of therapeutic misconception is very high.
4) “Compassionate” use may be misleading:
5) Informed consent remains the cornerstone of research:
6) Equitable distribution of scarce experimental treatments is challenging :
7) There is an ethical imperative
= data collection and sharing in real time
MEURI : Monitored emergency use of unregistered and experimental
Interventions (WHO)
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Disasters and Ethical Dilemmas
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Ethical Dilemmas (Pandemic and Disasters)
Beneficence vs non-maleficence
Individual vs the common good
Procedural justice and Distributive justice
Integrity vs equity and compassion
Cost – Benefit consideration applicable?
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Ethical Consideration
Difference from “Pandemic” situation
1) Infectious elements may be ignored or alleviated.
Everyone is affected. ⇒ No distinction among people.
2) Ethical dilemmas may be partly solved or ignored.
Freedom is hardly realized or protected for anyone affected.
3) Justice in regard to “life” is the most important.
⇒ Triage
4) Research elements are hardly on the level of treatment, but on the
level of the causes of disaster = Non-medical factors
5) “Urgency” is the most fundamental. (Same as in pandemic situations)
⇒ Research integrity vs Equitable use or “compassionate” use
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Conclusive remark
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Ethical Triangle in Emergency
It is almost to say that the result is the most important in
emergency situations, taking into account all the relevant
medical as well as ethical issues.
But, the truth is that the solution will be given through the
dialectics between public health and medical care in which
the research plays a decisive role.
Public health ⇔ Medical care
☝
Research
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Thank you!
Merci!
ありがとう
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