The WHO medical ethics panel convened Monday to discuss the ethics of using experimental treatments for Ebola in West African nations affected by the disease. I am relieved to note that this morning they released their unanimous recommendation: “it is ethical to offer unproven interventions with as yet unknown efficacy and adverse effects, as potential treatment or prevention.” There are, of course, the common caveats about ethical criteria guiding the interventions, but ultimately the recommendation has saved me from a tortured “WHO’s on first”-style commentary.[note]For other commentary on the committee composition, see Udo Schuklenk’s short, sweet, and to the point commentary; you can also read his reaction to their statement here.[/note] I’m sure we all appreciate that.
But just because the WHO recommendation follows what I’ve been arguing for the last 10-odd days doesn’t mean that the argument is actually over. In fact, as far as I can tell, it’s just getting worse, where worse should be interpreted to mean “even more people coming out of the woodwork to argue about ethics when they don’t have any familiarity with ethics.” Granted, Twitter is full of sample bias, but still. It is for this reason that I think it’s still important to post this statement on the ethics of providing unproven interventions that my husband (a real life bioethicist) and I worked on last week. We were side-tracked by needing to actually verify the science behind ZMapp, as well as the additional hands-throwing-up of hearing that ZMapp was provided for a Spanish priest after various US public officials stated there was none left to give.[note]After it was confirmed that the Spanish priest received ZMapp, also discussions about disparate treatment of people from the Developed vs Developing World.[note]Again, to clarify: This was finished on Saturday afternoon. Obviously, in that time frame, we have learned that a third Westerner was given ZMapp, it was released to two West African doctors, and WHO’s medical ethicspanel convened andâ€“pleasantlyâ€“reached the same conclusion we did. This is merely a more detailed argument for the release of unproven interventions.[/note] [Cross-posted at The Broken Spoke.]
Paternalism, Procedure, Precedent
The Ethics of Using Unproven Therapies in an Ebola Outbreak
A â€œsecret serum.â€ A vaccine. A cure. A miracle. With the announcement of the use of ZMapp to treat two Americans sick with the Ebola virus with apparently no ill effect, the hum and buzz on social media, commentary websites, and even the 24/7 news cycle, has become one of â€œshould the serum be given to Africa? Will it?â€ The question has dominated for more than a week, and become something that the World Health Organization feels it needs to address by convening a panel of medical ethics experts to offer an analysis of what should be done.
And the general question about untested cures/vaccines in the event of a disease pandemic is an important one; there are already guidelines for what kind of treatments can and will be made available during a flu pandemic, and it seems quite sensible that a guideline be developed for all potential pandemic pathogens. However, it isnâ€™t a question that is relevant in the current context, because we are already past that.
While people may be stating â€œshould the serum be made available?â€ thatâ€™s not the question being asked.
It isnâ€™t the question being asked, because we already know the answer: yes. In this last week, the serum has been made availableâ€”to Kent Brantly and Nancy Writebol. The pair of American health care workers have received the ZMapp serum, which, until this past week, had not been tested on any human subjects. We already know that the answer to whether or not the serum should be made available is â€œyesâ€â€“or at least, â€œyes, to people like us.â€[note] While some light debate may have questioned whether or not Brantly and Writebol had the ability to consent, there has never been a serious question here in the USA of not giving them the serum.[/note]
Instead, more specifically, the implicit (and at times very explicit) question being asked is: â€œshould the serum be made available to the West African countries suffering from the current Ebola outbreak?â€
Your instinctive response to this might be â€œyes! This is clearly a matter of equality and justice; the lives of those people suffering from Ebola in Sierra Leone, Guinea, Liberia, and Nigeria[note]Not â€œAfrica.â€[/note] are just as important as the Americans who were given the serum.â€ If so, good reader, then this essay is not addressed to you. After all, you have clearly reached the same conclusion we have: Why shouldnâ€™tâ€”assuming that Mapp can make good on its claims that it can manufacture sufficient quantities of their serumâ€”those who are suffering have care made available? There are risks, to be sure. But those risks were clearly outweighed by the urgency of the situation in which Brantly and Writebol found themselves, and in which hundreds (if not thousands) of people across the Atlantic find themselves now.
And why not? If it is in our power to help those suffering, we ought to do so. Justice and equality are traditions upon which civilizations are based. Adam Smith, better known for his â€œinvisible handâ€ of the market, believed that societies are only worthy when they are just. Peter Singer has argued that if we can help those in need at no cost to ourselves, we simply must do so. And Thomas Pogge has, for more then a decade now, argued that the historical injustices faced by countries who were preyed on by the West obligate those living today to assist in supporting the health systems of those countries, and bettering the lives of their citizens.
Indeed, the responses to â€œwhy not,â€ which attempt to justify not sharing a treatment already given to two people, has an uncomfortable relationship to the historical injustices that Pogge references. These objections, often made with good intentions, can be broadly broken down into three categories: paternalism; procedure; and precedent.
With paternalistic objections to proving experimental Ebola treatments to Western African nations in need, itâ€™s common to hear concern about corruption, ability to consent, or even a call-back to previous, unethical testing on vulnerable human subjects. Perhaps the most common of these is the belief that all governments in Africa are corrupt maws that inhale non-governmental organization money and aid to prop up an exclusive elite at the expense of the rest of the country. The history of corruption, from the power voids left by colonial government departures, to the actual problems created by colonialism (complete with unnatural country delineations) are broadly recognized and, importantly, well beyond the scope of a post arguing that it is ethical to allow these countries self-determination.
A more specific ethical concern is that people who are gravely ill are often viewed as being unable to give consent, let alone informed consent. Much of the current outbreak has occurred outside of city areas, in rural and remote areas of the affected countries. There are some valid questions about whether or not people can genuinely understand the risks and benefits of using a completely experimental vaccine if they donâ€™t have anything that easily maps onto the â€œbasic educationâ€ system common in the developed world. There is also the fact that when people are gravely ill, they may not be cognizant and aware enough to grant consent, or that their family is so desperate for a cure that they will do anything, regardless of risk.
Neither of these issues, though, means that it is impossible for infected patients or their families to made determinations about what kind of care they would like to receive. An aspect of receiving informed consent is to make sure risk and benefit is described in a way that makes sense and is understandable to the people making the choices; in this, the reverence for autonomy of the individual should be respected, rather than the paternalistic instincts of those in positions of power.
Informed consent also ties into specific and ugly histories involving pharmaceutical testing and African countries. There is a history of many countries in Africa, like Zimbabwe and South Africa, being exploited for AZT trials, experimental hormonal contraceptive, and other drugs and devices. These trials are frequently coercive, and have contributed to the legacy of black bodies being manipulated and violated for â€œthe benefit of all.â€
Fears about consent and testing on vulnerable populations are valid; no one is saying to parachute the ZMapp serum down in little chilled coolers for willy-nilly application. Merely that, given the history of testing on vulnerable people and exploiting the populations of African countries, rather than standing in a position of authority saying â€œlet us decide whether or not we will let you make your own decision,â€ the West should step aside and say â€œthis is your choice.â€
The difference here is stark: itâ€™s a matter of forcing an option vs. accepting that the choice is to be made by someone not you (where â€œyouâ€ is â€œthe Westâ€), and that these countries are full-fledged countries who have their own systems and own choices.
Others believe that there is an ethical issue in distributing the serum on a broad scale. Some people claim that the outbreak provides the perfect opportunity to conduct a large, randomized control trial (RCT)â€”the â€œgold standardâ€ of medical researchâ€”of ZMapp. Others believe that such a trial is impossible in the context of a pandemic, and we should thus hold off from making the drug available for lack of ability to monitor the drugâ€™s efficacy.
We believe both positions are false. By fetishizing the gold standard, weâ€”the USA and developed worldâ€”miss the point of our role as participants in solving this disease outbreak. Standards of evidence required for drug use are different from country to country, even in the developed world. They are also different in different contexts, and levels of urgency. An RCT would introduce an element of testing to treatment that, given what we know about the justified mistrust that people in developing nations have of the developed world and their experiments, would creating more tensions in countries wary of Western medical interventions. The potential of an RCT to backfire and jeopardize the provision of care makes it unwiseâ€”without changing our conclusion that assistance must be rendered.
But the lack of wisdom in conducting an RCT doesnâ€™t mean we should just throw up our hands and not assist. If the countries responsible for managing the outbreak thought it opportune, a large cohort study could be done where everyone who is able receives treatment, and the results are compared to the history of the virus over time. This might not allow researchers to control every factor, but it would go a long way to showing the efficacy of ZMapp the next time Ebola surfaces.
Talk of trials, however, misses the point of our role in participation in a more fundamental way. If you aid someone, you do so for their benefit on their terms. We donâ€™t want to mandate data collection â€œfor the good of West Africa.â€ We should ask the decision makers inside Guinea, Sierra Leone, Nigeria, and Liberia how we can best collect data with them, for them and their benefit as they see it.
The WHO has developed frameworks for this in other disease contexts, such as pandemic influenza.[note] World Health Organization. Pandemic influenza preparedness Framework for the sharing of influenza viruses and access to vaccines and other benefits. Geneva, 2011. http://www.who.int/influenza/resources/pip_framework/en/ Accessed 8 August 2014.[/note] While these need not define the scope of cooperation, the past can serve to guide deliberation on how best to assist. The WHOâ€™s policies, by virtue of being reached through international consensus, gives extra weight to the global nature of this cooperation.
The WHO can play an extra role in countering the paternalism of intervention by developed nations, while beginning the process to set a good precedent for future outbreaks. Jeremy Farrar, David Heynmann, and Peter Piot have argued that:
The [WHO] could assist African countries with developing rigorous protocols for the use and study of experimental approaches to treatment and prevention, while coordinating more traditional containment measures. As the only body with the necessary international authority, it must take on this greater leadership role.â€ [Our emphasis added.][note] Farrar J, Heymann D, Piot P. Experimental Medicine in a Time of Ebola. Published 6 August 2014: http://online.wsj.com/articles/experimental-medicine-and-african-ebola-1407258551 Accessed 7 August 2014.[/note]
The capacity of the WHO to provide oversight, while still enabling African countries to enact their own protocols and treatment plans, is our best chance to address concerns over oversight of the outbreak. There is no denying that this outbreak is international, and without proper management more countries could see cases of Ebola arise. An international body is better equipped to do this with legitimacy, and without paternalism, than any one country alone. The recent declaration by the WHO that the Ebola outbreak is a Public Health Emergency of International Concern, and their accompanying recommendations, is the perfect backdrop for this type of action.
Compassion, or Colonialism
We have to ask ourselves if we want to continue inflicting the wounds of colonialism on African nations. Insisting that Americans are a â€œspecial caseâ€ when it comes to a disease with a current CFR of 56% only underscores a persistent mistrust: that people in the West get better treatment and care, because those lives are valued more than the lives in developing parts of the world. This fear can be seen in previous Ebola outbreaks: During the 2000-2001 Ugandan outbreak of Sudan ebolavirus, an existing pervasive belief that Euro-Americans visit Central Africa to harvest body parts for profit was amplified by infectious disease control efforts, resulting in infected individuals and their family running and hiding from medical treatment, magnifying the extent of the outbreak. Many local people during the 2002 outbreak of Zaire ebolavirus in the border areas of Gabon and the Republic of Congo believed that Ebola was a disease invented by the French to eliminate African populations (allowing the French unfettered access to their lands and materials).[note] Hewlett BS, Hewlett BL. â€œEbola, Culture and Politics: The Anthropology of an Emerging Disease,â€ pp 57;77. Thomson Wadsworth; Belmont, California; 2008.[/note] Currently, people in Liberia are already asking why, if there is no cure for Ebola (the standard response on the ground), the Americans are being cured. [note] Farrar J, Heymann D, Piot P. Experimental Medicine in a Time of Ebola. Published 6 August 2014: http://online.wsj.com/articles/experimental-medicine-and-african-ebola-1407258551 Accessed 7 August 2014.[/note]
The choice to use the experimental vaccine was already made; that genie is well and truly out of the bottle. The question you have to ask yourself is this: can you live with supporting the idea that the lives of Brantly and Writebol are more important than the life of Shiekh Umarr Kahn, the only virologist in Sierra Leone? What about Dr. Samuel Brisbane, the chief medical officer of one of Liberiaâ€™s medical centers? How about the other approximately 800 people spread between Nigeria, Sierra Leone, Guinea, and Liberia, all of whom are certainly valued by the people within their lives.
Is this an appeal to emotion? Certainly. Sometimes decisions about what is moral, ethical, right, requires seeing the people youâ€™re talking about as people, rather than numbers and statistics on the other side of an ocean. But that emotion can and should build into our conception of ethics and justice. Returning to the legacy of Adam Smith, â€œthe relief of misery for its own sake is an impulse whose justification is a core intuitionâ€¦of any plausible theory of moral thought.â€[note] Campbell, T. â€œPoverty as a Violation of Human Rights: Inhumanity, or Injustice?â€ in Pogge, T., Freedom from Poverty as a Human Right: Who Owes What to the Very Poor? (Oxford, UK: Oxford University Press, 2007)[/note]
We know that Ebola is a disease of missing infrastructure, poverty, and minimal health care systems. No one is suggesting that these countries not be given the help that they are asking for, in containing the disease, in implementing public health strategies, or in having access to any experimental cures and vaccines available. No one denies that there are ethical issues at stake. Nor are we stating a belief that ZMappâ€“or Tekmira, or any other unproven interventionâ€“will stop the current outbreak. What we are advocating is merely that we, who have traditionally and unjustly held power over African nations, step back and accept our role as people to provide assistance, rather than determine it.
-Kelly Hills & Nicholas Evans