Transcript 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
L.O. 6.4
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
L.O. 6.4
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
L.O. 6.4
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
L.O. 6.4
Equity considerations
 Access limited to enrolled participants
 Risk bearing
 Conflicts of interest
L.O. 6.4
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?”)?
L.O. 6.4
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?
L.O. 6.4
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
L.O. 6.4
Sources
 Tuffs A. (2009). Trial vaccine may have saved
Hamburg scientist from Ebola fever. British Medical
Journal, 388, b1223
L.O. 6.4
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