Nancy Kass, ScD
This article was published online first at www.annals.org on 19 August 2014.
Disclosures: None. Forms can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M14-1864.
Requests for Single Reprints: Nancy Kass, ScD, Berman Institute of Bioethics, Johns Hopkins University, 1809 Ashland Avenue, Baltimore, MD 21205; e-mail, email@example.com.
Author Contributions:Conception and design: N. Kass.
Drafting of the article: N. Kass.
Critical revision of the article for important intellectual content: N. Kass.
Final approval of the article: N. Kass.
Kass N.; Ebola, Ethics, and Public Health: What Next?. Ann Intern Med. 2014;161:744-745. doi: 10.7326/M14-1864
Download citation file:
Published: Ann Intern Med. 2014;161(10):744-745.
Ebola virus disease has ignited some of our worst fears in a globalized world. The disease spreads quickly, with high mortality, and is crossing borders. More than half of infected persons have died (1). The confirmed cases include 2 Americans who have become the focus of public attention because of their heroism and for the extraordinary measures taken to ensure that they received optimum medical care.
With this attention, 3 ethics questions are being asked: Should the 2 Americans have been airlifted out of Liberia when others were not? Should they have been given a highly experimental treatment? And if treating them was appropriate, should the hundreds of Africans with Ebola also be treated?
Despite codes of ethics requiring physicians not to abandon sick patients (2), few health professionals would probably volunteer to care for patients with Ebola in West Africa today. Sound medical ethics is one thing, but traveling to help patients with an illness both highly contagious and usually fatal is what ethics calls “supererogatory'—above and beyond usual norms of good ethical conduct.
When a health care provider is willing to work amidst Ebola (or the severe acute respiratory syndrome or pandemic influenza), we, as a society, must fulfill our end of the bargain. It would be unconscionable to send physicians and nurses to Africa now without hazardous material suits, and it would be equally unconscionable not to assure them that, should they contract Ebola, they would be airlifted home to receive the best care available. It would clearly be better for persons in at-risk areas if they, too, had access to protective equipment and airlifts. The tragedy of people dying in Africa from this killer virus does not make our special treatment of the physicians and nurses who fly in to help them unfair.
The 2 American health care workers with Ebola were given a highly experimental treatment (3, 4) that was previously tested on monkeys and never before given to humans, not even in small clinical trials. Some ask whether it is ethical to give such treatment to humans, especially those whose judgment may be clouded by desperate circumstances. Yet, when a patient's chances of dying exceed the chances of surviving, when significant symptoms have set in, and when recipients are health care workers whose potential to understand risks is probably high, such a decision seems more reasonable. These 2 patients have had the visibility of few other cases of public health, medical care, or research investigations. As such, experts from the Centers for Disease Control and Prevention, U.S. Food and Drug Administration, and National Institutes of Health probably weighed in on the pros and cons of releasing the experimental serum, and through such collective deliberation of experts, some of the protections ordinarily provided to participants in research trials may have been realized.
Which leads to a final question: If it was reasonable to treat these 2 Americans, shouldn't the experimental treatment also be provided to the Africans? Callous as it may seem, the answer is no—or, at least, not yet. The threshold for determining that an individual patient receive access to a highly experimental drug on a compassionate-use basis (5) does, and should, differ from the threshold for rolling out a treatment program to an entire community, even one facing a life-threatening epidemic.
Drug testing requirements are designed to ensure that drugs are sufficiently safe and effective to be recommended to the public. No such evidence exists for these drugs. Moreover, U.S. researchers have been accused many times of exploitation (including of poor people in Africa) when testing new treatments during devastating public health outbreaks (6–8).
The visibility of the 2 treated Americans, however, has been a catalyst for debating whether, or under what circumstances, distribution of experimental drugs in Africa is warranted. The World Health Organization will convene a panel to address this question (9). In addition to considering the safety risks of untested treatments, the risk that they will be ineffective must also be considered. A top priority in this, and any, public health emergency is public health cooperation: The affected people must be willing to follow directions from international and local health authorities with regard to, for example, whether to assemble and how to handle the bodies of those who are sick or have died. What is at stake in a decision about using experimental treatments may be far greater than the risks to the individuals who take them.
Thus, risk and benefit must be evaluated expansively. A well-orchestrated public communications strategy must be a component of any rollout to reduce rumors and misconceptions (10). Any rollout must also proceed with caution. It should include small numbers of individuals and ones selected for their—or their families'—ability to provide meaningful informed consent. Starting with small numbers is itself a protection, as is an unwavering commitment to ongoing data collection. Ultimately, such data will be our best ethical guide.
The In the Clinic® slide sets are owned and copyrighted by the American College of Physicians (ACP). All text, graphics, trademarks, and other intellectual property incorporated into the slide sets remain the sole and exclusive property of the ACP. The slide sets may be used only by the person who downloads or purchases them and only for the purpose of presenting them during not-for-profit educational activities. Users may incorporate the entire slide set or selected individual slides into their own teaching presentations but may not alter the content of the slides in any way or remove the ACP copyright notice. Users may make print copies for use as hand-outs for the audience the user is personally addressing but may not otherwise reproduce or distribute the slides by any means or media, including but not limited to sending them as e-mail attachments, posting them on Internet or Intranet sites, publishing them in meeting proceedings, or making them available for sale or distribution in any unauthorized form, without the express written permission of the ACP. Unauthorized use of the In the Clinic slide sets will constitute copyright infringement.
Institute for Biomedical Ethics, University of Basel, Switzerland.
August 25, 2014
All health care workers should be treated equal for access to experimental drugs for Ebola
Paper by Nancy Kass teasing ethical questions around use of experimental drugs against Ebola for two American health care workers and whether such experimental treatments should be made available to all infected patients is a timely discussion on ethical debate generated by the current Ebola outbreak (1). She justified administration of highly experimental drug to two American health workers with two main arguments. First, health care workers such as these two Americans have shown tremendous courage and responsibility towards their patients in spite of major odds and significant risk to their own health while being at the forefront of fight against Ebola. Her second argument states that being health care providers, these two had knowledge and they fully understood the risks associated with accepting highly experimental drug and hence were able to give ‘informed consent’. One might argue that their ability to provide informed consent was at least partially compromised by their illness and awareness of impending death in absence of treatment, but for the sake of argument, lets accept that they were indeed capable of providing informed consent.I argue that the same two arguments should then also be applied to other local health care workers who are on the forefront of treating patients with Ebola in Western Africa. WHO report states that more than 240 health workers got infected and more than120 health care workers; mainly local doctors and nurses have died due to Ebola while carrying out their duties during this outbreak (2). Being locals, they were a resource, knowing the communities, understanding the grass root reality, speaking the local language and hence crucial to provide care to the patients. Many African countries already face major shortage of trained health care professionals (3). Death of these health care workers has further weakened the health care delivery system. If American health care professionals received the experimental drug for ‘supererogatory’ reasons, the local health care workers also qualify for the same unless supererogatory reasons require traveling to a foreign country to provide health care in dangerous situation. As far as argument about understanding risks associated with experimental drugs that have never been used in humans before, the health care professionals across borders and nationalities can be presumed to understand these unless we believe that this ability is dependent on nationality somehow.Thus, the local health force infected with Ebola should be considered for experimental therapy not only for the reasons of supererogatory actions and informed consent but to protect already weakened health work force in countries affected by Ebola outbreak. References(1) Kass N. Ebola, Ethics and Public Health: What next? Ann Intern Med. doi:10.7326/M14-1864.(2) World Health Organization. Unprecedented number of medical staff infected with Ebola. 25 Aug 2014. Accessed at http://www.who.int/mediacentre/news/ebola/25-august-2014/en/ on 25th August 2014.(3) Hongoro C, McPake B. How to bridge the gap in human resources for health. The Lancet 2004; 364 (9443): 1451-1456.
Infectious Disease, Ethics.
Results provided by:
Copyright © 2016 American College of Physicians. All Rights Reserved.
Print ISSN: 0003-4819 | Online ISSN: 1539-3704
Conditions of Use
This PDF is available to Subscribers Only