Compassionate use of experimental drugs in the Ebola outbreak

Foláyan, Morẹ́nikẹ́ Oluwátóyìn; Brown, Brandon; Yakubu, Aminu; Peterson, Kristin; Haire, Bridget

doi:10.1016/s0140-6736(14)61605-6

Cited by 21 publications

(16 citation statements)

References 3 publications

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“…First, although the debate over the use of unproven interventions in the Ebola epidemic has focused on interventions at early stages of drug development (Folayan 2014;Rid and Emanuel 2014a;2014b), this overlooks some of the tough questions facing patients, physicians, health funders, and health systems when considering whether to provide already approved or otherwise available interventions. In theory, any physician could give a patient a limitless number of interventions.…”

Section: Two Ways the Issue Of Access To Unproven Interventions Arisesmentioning

confidence: 99%

“…In August 2014, an advisory panel to the World Health Organization (WHO) "concluded unanimously that it would be acceptable on both ethical and evidential grounds" to use unproven interventions that have been promising (in vitro and in animals) in clinical practice if certain conditions were met (World Health Organization 2014). Other commentators have agreed with the panel's assessment (Folayan 2014;Goodman 2014), going so far as to state that "the question of whether unproven treatments should be offered at all is now settled" (Folayan 2014). Since then, however, several commentators have argued that unproven interventions should not be offered outside of clinical trials (Hantel 2014;Joffe 2014;Upshur 2014), with some contending it would be "a serious mistake" to do so (Rid and Emanuel 2014b).…”

mentioning

confidence: 99%

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Examining the Ethics of Clinical Use of Unproven Interventions Outside of Clinical Trials During the Ebola Epidemic

Shah

Wendler

Danis

2015

The American Journal of Bioethics

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The recent Ebola outbreak in West Africa began in the spring of 2014 and has since caused the deaths of over 6,000 people. Since there are no approved treatments or prevention modalities specifically targeted at Ebola Virus Disease (EVD), debate has focused on whether unproven interventions should be offered to Ebola patients outside of clinical trials. Those engaged in the debate have responded rapidly to a complex and evolving crisis, however, and this debate has not provided much opportunity for in-depth analysis. Additionally, the existing literature on access to unproven therapies has focused on contexts like HIV/AIDS and oncology, which are very different than the Ebola epidemic. In this paper, we examine the ethical issues surrounding access to unproven therapies in the context of the recent Ebola outbreak to yield new insights about this controversial and unsettled issue. We argue first that, in this context, the interests of patients in obtaining access to unproven therapies are not fully aligned with the interests of their providers and drug developers. Second, we focus on the resource constraints facing providers, funders, and patients and conclude that they often counsel against the use of unproven interventions against EVD.

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Section: Two Ways the Issue Of Access To Unproven Interventions Arisesmentioning

confidence: 99%

mentioning

confidence: 99%

Examining the Ethics of Clinical Use of Unproven Interventions Outside of Clinical Trials During the Ebola Epidemic

Shah

Wendler

Danis

2015

The American Journal of Bioethics

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“…The probable success of the experimental drug ZMapp, used to treat two Americans who had contracted EVD in a West African country, made headline news. However, since this and similar drugs were not yet licensed or available for public use, the WHO convened a meeting of experts in ethics who discussed and then sanctioned the use of experimental drugs to treat EVD 17 18…”

Section: Non-maleficencementioning

confidence: 99%

Ethical challenges of containing Ebola: the Nigerian experience

Maduka

Odia

2015

J Med Ethics

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Responding effectively to an outbreak of disease often requires routine processes to be set aside in favour of unconventional approaches. Consequently, an emergency response situation usually generates ethical dilemmas. The emergence of the Ebola virus in the densely populated cities of Lagos and Port Harcourt in Nigeria brought bleak warnings of a rapidly expanding epidemic. However, these fears never materialised largely due to the swift reaction of emergency response and incident management organisations, and the WHO has now declared Nigeria free of Ebola. However, numerous ethical issues arose in relation to the response to the outbreak. This paper discusses some of these ethical challenges and the vital lessons learned. Ethical challenges relating to confidentiality, the dignity of persons, non-maleficence, stigma and the ethical obligations of health workers are examined. Interventions implemented to ensure that confidentiality and the dignity of persons improved and stigma was reduced, included community meetings, knowledge communication and the training of media personnel in the ethical reporting of Ebola issues. In addition, training in infection prevention and control helped to allay the fears of health workers. A potential disaster was also averted when the use of an experimental medicine was reconsidered. Other countries currently battling the epidemic can learn a lot from the Nigerian experience.

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“…The inequitable access to experimental therapy at the expense of local population had drawn public outrage 7. As we have argued elsewhere,8 preferential criterion other than medical indications for access to experimental therapies is problematic even within the local populations, as it can exacerbate existing inequalities. For an epidemic like Ebola where the infection affects all persons irrespective of professional status, it is important that the potentially derivable protective effects of the experimental therapies are not limited to those from particular professional backgrounds.…”

mentioning

confidence: 97%