Download Learning Objective 6.4 - Global Health Training Centre

WHO Training Manual
Ethics in epidemics, emergencies and disasters:
Research, surveillance and patient care
Learning Objective 6.4
Identify issues of equity of access to
unproven treatments during research in
the course of emergency response
Outline
1. Introduction
2. Case study – filovirus hemorrhagic fever
3. Debate
4. Conclusion
L.O. 6.4
Time
(minutes)
0-15
(15 min)
16-30
(15 min)
31-45
(15 min)
46-60
(15 min)
Activity
Introduction
Reading
Debate
Summary
and
conclusion
What Resources Might Be Limited in a Public Health Emergency?
 Vaccines
 Medications to treat infected persons
 Life-sustaining medical technologies, such as ventilators
 Hospital beds, particularly in intensive care
 Laboratory capacity for diagnostic tests
 Access to medical specialists
 Infection control equipment
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Novel treatments in emergencies
 May develop novel treatments/vaccines in public
health emergencies, especially where epidemic is
sporadic
 Benefit sharing normally requires that portion of
benefit derived from collected data be returned to
those whose data were used
 But in emergencies, benefits may not be so
straightforward to distribute
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Situations of limited access to novel agents
 Physicians using professional privilege and acting as
gatekeepers
 Some patients unable/unwilling to enrol in research in
spite of feeling they have a legitimate claim to the
novel agent under investigation
 Physical bottlenecks e.g. limited manufacturing
capacity
 Novel treatments not yet broadly accessible but at
least relatively efficacious
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Avenues to increase accessibility
 Decrease regulatory restrictions
 Use alternative research designs
 Multiple the ‘treatments’ under investigation
 Appeal to compassionate use
 Eliminate physical bottlenecks
 Determine minimal dose
 Appeal to the Rule of Rescue
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Equity considerations
 Access limited to enrolled participants
 Risk bearing
 Conflicts of interest
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Case study
 Outbreaks of filovirus hemorrhagic fevers in central
and west Africa
 Tuffs A. (2009). Trial vaccine may have saved
Hamburg scientist from Ebola fever. British Medical
Journal, 388, b1223
L.O. 6.4
Case study small group discussions
 On what moral grounds was the Hamburg scientist offered
investigative treatment? Is this a case of compassionate use?
 Could ‘humanitarian’ reasons be put forward to justify the efforts of
shipping the post-exposure vaccine from Canada? If yes, could
reciprocity be one moral criterion (“The scientist made the sacrifice to
risk her life by choosing to research on a highly lethal agent. In return,
the community should make all effort to save her life in case of
accidental exposure”)
 When local health workers are exposed to needle stick injuries in the
course of an Ebola outbreak in Africa, should they be given the same
opportunities of a potentially life-saving treatment? Do the same moral
grounds apply (e.g., “Are they any less or more worthy of
reciprocity?”)?
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Case study small group discussions
 If the investigative treatment is made available during and
outbreak, should its use be restricted to the boundaries of
a defined clinical trial? Or on compassionate grounds, like
in the case of the Hamburg scientist?
 If a trial is the only acceptable solution, what should be the
design of the trial? For example: consecutive series with
historical comparisons, placebo controlled trial?
 Ultimately, who are the main or intended beneficiaries of
research on treatment for filovirus infection?
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Summary
 Alternative research designs may offer ways to deal
with equity of access to novel drugs in epidemics and
disasters
 May be technical or moral concerns with these
alternative designs e.g. informed consent where have
lack of knowledge regarding risks of novel agent
 Must consider who will be the intended beneficiaries
of research
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Sources
 Tuffs A. (2009). Trial vaccine may have saved
Hamburg scientist from Ebola fever. British Medical
Journal, 388, b1223
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Acknowledgements
Chapter authors
Calain, Philippe, Médecins Sans Frontières, Geneva,
Switzerland
Boulanger, Renaud F., Faculty of Medicine, McGill
University, Montréal, Québec, Canada
L.O. 6.4