Should Ebola patients in West Africa be given unproven treatments? How should clinicians decide which patients to treat, given the limited availability of some drugs? Should Ebola patients who are dying be given palliative care to relieve pain and suffering?
These are among the ethical questions addressed in a special issue of the American Journal of Bioethics, devoted to the many challenges involved in caring for patients with Ebola.
“Obviously, the Ebola crisis galvanized lots of different health care professionals and academics, but it was very important to the bioethics community,” David Magnus, PhD, director of the Stanford Center for Biomedical Ethics, told me. “From the very beginning, there were the usual public health ethics. But when the time came to give the scarce drug, ZMapp, to a small number of health care workers, there was a huge amount of controversy.”
“That also led to a major debate on the conduct of clinical trials and whether we should give unproven treatments to patients,” he said. “There’s a very big split in the biomedical ethics community.”
Magnus is editor-in-chief of the monthly journal, which is housed at Stanford. He said the special edition of the journal is particularly relevant now, given the recent launch by the NIH of a clinical trial involving ZMapp. The experimental drug, manufactured by a San Diego, Ca. company, was given to a very small number of clinicians in the United States who had been exposed to Ebola in West Africa.
In the journal, a group of ethicists led by New York University’s Arthur Caplan, PhD, argue that the gold standard in drug testing – the randomized, placebo-controlled trial – may not be the most practical and morally defensible approach in an emergency like the Ebola crisis.
A conventional trial is hard to justify, given that patients in the West were given the drug without any placebo controls; West Africans should be treated no differently. Nor can it be justified if the drug is compared against the usual standards of care in Africa, which may be ineffective and carry a high probability of death. That approach could just engender further mistrust in West African communities, they say. Rather, Caplan and his colleagues argue for an alternative approach – a side-by-side comparison of various experimental drugs to see which one is superior in helping rescue patients.
“Instituting alternative clinical trial designs can provide useful information for the elimination or selection of prospective therapies,” they write. “And that is what morally we owe those who are dying or at grave risk in environments where they have no other realistic means of survival.”
In a separate article, a team from the U.S. Food and Drug Administration strongly disagrees with this alternative approach, saying it could prove misleading and potentially harmful. One drug might be found to be superior to others, causing fewer deaths, but patients might still be better off without it. With no controls, it’s impossible to know.
“Caplan and colleagues’ approach puts patients at risk from exposure to investigational products while having little chance of providing interpretable efficacy and safety data – an approach that we believe is unethical,” the writers conclude.
The special issue of the journal will be available free to the public for the next month.
Previously: Ebola: This outbreak is different, Stanford physician shares his story of treating Ebola patients in Liberia and Ebola: A look at what happened and what can be done
Photo by European Commission DG ECHO