Learning Objective 6.4 Identify issues of equity of access to unproven treatments during - PowerPoint Presentation

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Learning Objective 6.4

Identify issues of equity of access to unproven treatments during research in the course of emergency response

WHO Training Manual

Ethics in

epidemics

, emergencies and

disasters

: Research, surveillance and patient care

OutlineIntroductionCase study – filovirus

hemorrhagic feverDebateConclusionTime (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 personsLife-sustaining medical technologies, such as ventilatorsHospital beds, particularly in intensive care

Laboratory capacity for diagnostic testsAccess to medical specialistsInfection control equipment

Novel treatments in emergenciesMay develop novel treatments/vaccines in public health emergencies, especially where epidemic is sporadicBenefit sharing normally requires that portion of benefit derived from collected data be returned to those whose data were usedBut in emergencies, benefits may not be so straightforward to distribute

Situations of limited access to novel agentsPhysicians using professional privilege and acting as gatekeepersSome patients unable/unwilling to enrol in research in spite of feeling they have a legitimate claim to the novel agent under investigationPhysical bottlenecks e.g. limited manufacturing capacity

Novel treatments not yet broadly accessible but at least relatively efficacious

Avenues to increase accessibilityDecrease regulatory restrictionsUse alternative research designsMultiple the ‘treatments’ under investigationAppeal to compassionate useEliminate physical bottlenecks

Determine minimal doseAppeal to the Rule of Rescue

Equity considerationsAccess limited to enrolled participantsRisk bearingConflicts of interest

Case studyOutbreaks of filovirus hemorrhagic fevers in central and west AfricaTuffs A. (2009). Trial vaccine may have saved Hamburg scientist from Ebola fever.

British Medical Journal, 388, b1223

Case study small group discussionsOn 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?”)?

Case study small group discussionsIf 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?

SummaryAlternative research designs may offer ways to deal with equity of access to novel drugs in epidemics and disastersMay be technical or moral concerns with these alternative designs e.g. informed consent where have lack of knowledge regarding risks of novel agentMust consider who will be the intended beneficiaries of research

SourcesTuffs A. (2009). Trial vaccine may have saved Hamburg scientist from Ebola fever. British Medical Journal, 388, b1223

AcknowledgementsChapter authorsCalain, Philippe, Médecins Sans Frontières, Geneva,

SwitzerlandBoulanger, Renaud F., Faculty of Medicine, McGill University, Montréal, Québec, Canada