Ebola is named for a river in what’s now the Democratic Republic of the Congo, formerly Zaire. The viral disease, typically manifest by fever, vomiting, diarrhea, weakness and bleeding, carries a high fatality rate. Ebola belongs to a family of negative-strand RNA viruses called Filoviridae.
And I’ll say up-front, that I hope readers don’t mind my including a bit of science here, because that will be essential to my point, or question, on informed consent – and how impossible applying that medical ethics concept may be in managing such a rapid, devastating epidemic.
Like any doctor, I’ve been following news and medical reports on the recent Ebola outbreak. Last week, the World Health Organization (WHO) indicated that the current outbreak in west Africa may infect over 20,000 people, and put others at risk. The agency has suggested Ebola goes underreported. Already an unprecedented number of doctors, nurses and other health care workers have been infected.
To ignore this outbreak would be foolish. According to the latest update, dated August 28, the number of probable and confirmed cases from four countries (Guinea, Liberia, Nigeria and Sierra Leone) affected by the severe strain of Ebola is 3,069, with 1,552 deaths. Since that report was issued just three days ago, the WHO has confirmed a case in Senegal.
But some reassurance is in order, from the CDC and elsewhere. Ebola is not easily spread from one person to another. Rather, it rides in body fluids – blood, urine, saliva, feces, vomit, and semen. Good hygiene, taking care to avoid potentially infected water and minding what you touch and put in your mouth, should be preventive.
Among the challenges for health policy mavens and for people who teach medical ethics – and for doctors, nurses pharmacists and others who soon may be in a position to distribute drugs for Ebola, is the subject of informed consent. And that’s the problem here, as in most medical emergencies.
Broadly speaking, there are at least four types of Ebola treatment, three of which are experimental :
First, there’s ZMappTM – the so-called secret serum. This compound, described by the CDC as a mixture of three monoclonal antibodies, somehow manufactured in tobacco plants, has been given to a few Ebola patients and, in some, may have helped expedite their recovery. For the time being, the supply of this serum, provided by Mapp Biopharmaceuticals in San Diego, is gone.
Second are vaccines. These, of which there are several in the pipeline, have the potential to trigger protective immune response in healthy humans. The idea is to immunize people so they won’t get sick if exposed to Ebola. Some vaccines might also, in principle, lessen the degree of infection in people already infected. Last week, the NIH announced that it will soon begin testing of an experimental Ebola vaccine. The agent is being developed by
Third – and what might become available first, based on the comparative ease (and what should be lower cost) of manufacturing and distributing these kinds of drugs – are antiviral medications. Scientists design these compounds to interfere with how Ebola replicates and otherwise causes harm. One agent in this category, produced by
As considered here at Forbes by David Kroll, another type of antiviral drug to keep an eye on are nucleoside analogues (what an oncologist might call “chemotherapy”). These include the BioCryst compound BCX4430 that, as reported in Nature, appears to block Ebola infection in rodents and lessen the related Marburg virus in monkeys already infected.
The fourth kind of Ebola treatment is supportive care, as might be given to any person who is critically ill. This would include intravenous fluid, blood products and other treatments that can help keep a person alive while their body is challenged by the effects of severe diarrhea, bleeding and other consequences of disease.
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I’m boggled by the notion of informed consent in giving new and unknown drugs to humans in the setting of rapid, life-threatening infection . Vaccines, at least, are a standard way of bolstering an immune response and a familiar concept to many people. But those are oftentimes rejected, out of fear, in the face of science. How doctors might explain the use of an experimental RNA inhibitor seems impossible. The same goes for a chemo-like nucleoside analogue that has not yet been tried in humans.
There are, of course, exceptions to the general U.S. rules requiring informed consent for experimental interventions, such as when people receive treatment during emergencies. The Ebola outbreak may present an extreme case when doctors need to act, at a population-level, with sanction by careful and hopefully knowledgeable authorities, but in the absence of informed consent from individuals. For a large fraction of the population who may not know what, say, RNA interference means, obtaining informed consent may be a pipedream.
If we’re fortunate enough to find a drug that works, soon, treating Ebola will require trust that approximates a leap of faith (in medicine), and beneficence – that doctors will order and give these drugs because they think they’re more likely to help than harm those affected. Without that trust, we’ll be stuck, unable to give therapy to most people infected or at risk.
