An ethics panel at the World Health Organization (WHO) has given a green light to treating Ebola patients with experimental drugs for the deadly virus. There had been “unanimous agreement among the experts that in the special circumstances of this Ebola outbreak it is ethical to offer unregistered treatments,” said Marie-Paule Kieny, assistant director-general of WHO, at a press conference today in Geneva, Switzerland.
“It is important that the committee affirmed the morality of compassionate use,” writes Arthur Caplan, a bioethicist at New York University in New York City, in an e-mail. “But there are huge ethical issues that still remain unaddressed and unanswered regarding experimental interventions.” Caplan is not a member of the WHO panel.
The 12-member panel had convened by telephone on Monday, as the largest Ebola outbreak on record rages on in West Africa. The virus has already sickened 1848 people and killed 1013 of them in Guinea, Liberia, Nigeria, and Sierra Leone, according to the latest numbers released by WHO. There are no vaccines or treatments against Ebola on the market. But researchers are developing several drugs, most of them backed by funding from the U.S. government and fueled by worries of bioterrorism.
Since the start of the outbreak, scientists have been discussing whether some of these candidate drugs could be used in West Africa. They were worried, however, that trying out these drugs in Africa would be seen as racist and could increase mistrust toward health care workers, already a problem in battling the outbreak. But after two U.S. health care workers fell ill in Liberia and received ZMapp, an experimental mix of monoclonal antibodies, the discussion took a turn. Some people began arguing that the drug should also be made available in Africa, where the majority of patients are dying.
The ethics panel, made up of researchers, ethicists, and patient safety advocates, reached consensus that under certain circumstances in this outbreak, “it is ethical to offer unproven interventions with as yet unknown efficacy and adverse effects, as potential treatment or prevention.“ They also concluded that “there is a moral obligation to collect and share all data generated, including from treatments provided for compassionate use“ and “a moral duty to evaluate these interventions (for treatment or prevention) in the best possible clincial trials under the circumstances."
Conducting clinical trials in the midst of the Ebola outbreak will be "challenging,“ writes Peter Smith, an epidemiologist at the London School of Hygiene & Tropical Medicine and one of the members of the ethics panel. But they are the best evidence for efficacy, he believes. “Clear explanations of the purposes of trials to those in the affected communities will be vital as well as obtaining informed consent from patients or their immediate relatives,“ he writes in an e-mail.
Many questions are still unanswered, Caplan says. For instance: who should weigh risks and benefits of a given therapy. “That cannot and should not be left to potential subjects,“ he writes. Other questions include who will pay for the unapproved drugs, who can give consent for using them, and how companies will be protected from liabilites should the drugs have harmful side effects.
Even more difficult is the question of how the limited amount of experimental drugs available should be distributed. According to several news stories, the last supplies of ZMapp have been sent to Liberia to treat two doctors there, and it will take months to produce more of the drug. Other experimental drugs are also available only in small quantities. When they are used, should health care workers be treated first, as some scientists have suggested? How should the supplies be distributed among countries?
“Much more ethical work needs to be done to create a sound infrastructure for compassionate use in humanitarian emergencies,“ Caplan writes. The ethics panel will meet in Geneva at the end of the month, Kieny said. Then, they will have to tackle at least some of these thorny questions.
*The Ebola Files: Given the current Ebola outbreak, unprecedented in terms of number of people killed and rapid geographic spread, Science and Science Translational Medicine have made a collection of research and news articles on the viral disease freely available to researchers and the general public.