Ethical Ebola

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  FULL TEXT ARTICLE Ethical considerations of experimental interventions in theEbola outbreak        ( http :// cdn . clinicalkey . com / rss / issue /01406736. xml )           Article in Press: Corrected Proof   Annette Rid MD and Ezekiel J Emanuel Ethical considerations of experimental interventions in the Ebola outbreak, Pages nunull, Copyright © 2014 Elsevier Ltd Background The outbreak of Ebola virus raging in west Africa is special in trespects. First, with more than 2100 infections and 1100 deathsit has already become the most severe and largest documenteEbola outbreak. It is also occurring in some of the world's leastdeveloped countries, and is therefore extremely complex toaddress. Second, experimental interventions that are still in thepreclinical trial phase—and hence untested in human beings— were first given to health-care workers from high-incomecountries, focusing extensive attention and controversy oninvestigational treatments and vaccines for Ebola. The rapidly evolving situation raises three fundamentalquestions: how much emphasis should the internationalcommunity place on experimental interventions in response tothe Ebola epidemic; what are the ethical considerations if experimental treatments or vaccines are deployed; and if any interventions prove safe and effective, how can they be mademore widely available? Prioritising the strengthening of health systems   1   2   3   45  The international community has both humanitarian duties of assistance and duties of global justice to address the Ebolaepidemic and its causes. Although the prospect of specificEbola treatments or vaccines is enticing, the current unproveninterventions should have a marginal role in the global responsFundamentally, this Ebola outbreak—and future ones—needfocus on strengthening of health systems and basicinfrastructure, rather than experimental treatments and vaccines.The major challenge of Ebola is containment—implementation isolation of suspected Ebola cases, infection control anduniversal precautions, contact tracing and monitoring,surveillance, and raised awareness in local communities andinternationally. Containment measures are not high-tech, bthey have a proven track record of controlling infectiousoutbreaks. Importantly, they require the basics of a functioniand trusted health system. For example, identification andisolation of suspected Ebola cases is impossible if basic healthcare is not offered to, and accessed by, all members of society.The most effective way to curb the Ebola epidemic is to adoptcontainment measures with a view to strengthen health systemand other infrastructure—eg, training and hiring of healthprofessionals, deployment of basic medical supplies such asgloves, community engagement, investment in clinics andhospitals, and ensuring prompt and safe burial.Improved health systems and infrastructure also have importacollateral health benefits. They not only help to prevent futuoutbreaks of Ebola and other diseases, but also improve the carfor many other diseases. Although Ebola's rapid spread and higrate of mortality capture our attention, the disease needs to beput into perspective. Cumulatively in the past four decades,Ebola has claimed less than 3000 lives. By contrast, thedeath toll in sub-Saharan Africa was 547   322 from diarrhoealdiseases and 222   767 from pneumococcal pneumonia in 2010alone; many of these deaths could have been preventedthrough access to basic health care, including cheap vaccines,and improved sanitation. Thus, strengthening of health systemand infrastructure will have positive externalities for healthpromotion after this epidemic subsides.  6   5   7   5   8   9   1   10   11  Furthermore, experimental Ebola treatments or vaccines areunlikely to have a decisive effect. The first issue is supply.Because the existing interventions are still in the earliest phaseof development, supply is extremely restricted. For example, th“handful of doses” of Zmapp (Mapp Biopharmaceutical, SanDiego, CA, USA)—a cocktail of antibodies aimed to treat Ebolahas already been exhausted. Further production is expected take months to produce a substantial amount. The second issue is that, irrespective of hope, we need to berealistic. The distance between preclinical promise and clinicaluse is vast and littered with failed compounds. Only 10% of nemolecular entities succeed from the point of preclinical candidaselection to commercial launch. Although promising in non-human primates, there is no reason to believe that theexperimental Ebola interventions will be more successful. Inother words, it is more likely than not that the interventions winot improve or save patients, and might even weaken them asthey battle a life-threatening disease. Ethical use of experimental interventions for Ebola  When thousands of people are confronted with a life-threatenidisease, and no specific therapies or preventive measures exist, can be ethically acceptable to assume greater risks and offerpatients unproven interventions. For example, patients withadvanced cancer who do not respond to established therapies aroutinely invited to participate in early-phase trials. Patients inthe early HIV/AIDS epidemic successfully campaigned for fast-track trials because they faced imminent death. Moreover,countries affected by Ebola want access to the investigationaldrugs. For instance, the Liberian Government requested Zmapfor some health workers. The Nigerian National EthicsCommittee clarified guidance for use of non-validatedtreatments, partly “for the rapid resolution of the currentemergency”. Additionally, a WHO panel—regrettably withourepresentation from the affected countries—stated in anannouncement that it is ethical to offer unproven interventions“in the particular circumstances of this outbreak, and providedcertain conditions are met”. 5   1213   14   15   16   1718  If experimental Ebola interventions are deployed in thisoutbreak, their use needs to comply with important ethicalprinciples. The first principle is that the interventions shouldonly be used in clinical trials, so that researchers can learn whether they work or not. At present, all investigational agentsare in the earliest phases of development, hence their risks andpotential benefits are largely unknown. Expansion of their use without additional testing would be irresponsible. Moreover, it would be wasteful to use the small amount of experimentalinterventions with no collection of systematic data about safety and efficacy.Consequently, these interventions should not be distributed forcompassionate use outside clinical trials—which might alsoundermine the feasibility of trials. If compassionate usenonetheless occurs, transparency is key and data about patientoutcomes should be collected and shared in full. Of concern, itappears that the existing stock of Zmapp has been used only focompassionate use, and details about patient outcomes are not(yet) readily available. To ensure that data from compassionateuse and clinical trials are rapidly integrated, a neutral body should oversee the use of experimental interventions during thiepidemic. When investigational drugs are used in this Ebola emergency,research ethics must be upheld to avoid exploitation of affectedindividuals and communities; the eight ethicalprinciples for research must be met ( panel (box1)  ). Althoughcompliance with all principles is necessary, three need specialattention. First, we agree with bioethicist Steven Joffe (personacommunication) that, to enhance social value and scientific validity, clinical trials should be randomised with participantsreceiving either experimental interventions with supportive caror supportive care and placebo. Randomisation and placebocontrols are the best means to control for confounding factorsand determine whether interventions work or whether patientshave recovered by chance. Panel Collaborative partnership ã Involve local communities and stakeholders inplanning, conducting, and overseeing of trials  19   20   21   22   23
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