Bioethics of Experimental Ebola Treatments

The administration of an experimental serum to two American healthcare workers treated for Ebola on US soil raises questions of safety, efficacy, access, and ethics.

By | August 7, 2014

WIKIMEDIA, PLOS BIOLOGYThe World Health Organization (WHO) yesterday (August 6) announced it is convening a panel of ethicists “to explore the use of experimental treatment in the ongoing Ebola outbreak in West Africa.”

“We are in an unusual situation in this outbreak. We have a disease with a high fatality rate without any proven treatment or vaccine,” Marie-Paule Kieny, assistant director-general at the WHO, said in a statement. “We need to ask the medical ethicists to give us guidance on what the responsible thing to do is.”

The recent administration of an experimental serum to two American healthcare workers who contracted Ebola in Liberia has sparked some outcry, and raised questions of whether and how soon the unapproved drug, which has not been through clinical trials, would be shipped to the center of the outbreak.

The serum, Mapp Biopharmaceutical’s ZMapp, is currently only available in limited quantities. Charles Arntzen from Arizona State University’s Biodesign Institute, who has collaborated with the firm, told The Washington Post he was pleased that government health officials opted to treat the two patients with a drug that no one knew for sure was safe or effective.

“The fact that somebody had the risk-taking mentality to actually do this just blows me away,” he said. “I’m just delighted . . . to me, it’s absolutely flabbergasting. But I love it. It restores my faith in government.”

Arntzen added that it would take time to scale up production of ZMapp to potentially meet the current need in West Africa. “Maybe they could do it in a month. If they were [already] planning on it, I’m sure they could produce 10,000 doses in a month,” he said.

Speaking with CNN, however, National Institute of Allergy and Infectious Diseases Director Anthony Fauci said that “it is not easy to make this serum . . . it really is going to be a supply problem.”

Mapp’s president, Larry Zeitlin, told The New York Times that his firm has been overwhelmed by recent events and is now “discussing with the FDA [US Food and Drug Administration] the right path to make the drug available to people as quickly and safely as possible.” CEO Kevin Whaley added that while Mapp “definitely would like to ramp up to have an impact on the Ebola epidemic,” his staff are “not decision makers on many of these issues. There are regulatory and legal issues that have to be addressed.”

The Wall Street Journal (WSJ) noted that, for the drug to be administered in Liberia—one of three countries at the epicenter of the ongoing outbreak—it would require approval by the country’s Ministry of Health Ethical Committee.

“Ultimately, the only way of discovering whether these new interventions are effective will be to test them in an Ebola epidemic,” Wellcome Trust Director Jeremy Farrar and his colleagues wrote in a WSJ editorial published this week (August 5).

Both patients treated with ZMapp appear to be doing well post-treatment. But was it the drug that potentially saved their lives? Or might it even have put them in additional danger? Without controlled clinical data, scientists are left scratching their heads.

“Fortunately, we are not striking out into completely uncharted waters,” G. Kevin Donovan, director of Georgetown University Medical Center’s Pellegrino Center for Clinical Bioethics said in a statement. “The issues to be raised will be reminiscent of those seen at the beginning of the HIV epidemic, but made more acute by the rapid and easy transmission of the Ebola virus and the rapid course it takes in the body.”

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Avatar of: Paul Stein

Paul Stein

Posts: 237

August 7, 2014

Marie-Paule Kieny started off her comment oh so right, but then continued oh so wrong.  In this case, forget the bioethicists.  Kieny should have said, "We need to tell the bioethicists that there is no other choice."

Avatar of: Lesley Weston

Lesley Weston

Posts: 3

August 8, 2014

All that's needed as far as ethics go is to ask each individual person who has ebola whether or not they want to take the risk of using this experimental treatment. Nearly all will choose to try it, and those people can be closely observed to see the effects. You can't do the normal type of trial with a placebo as control (that would indeed be seriously unethical), so your controls would be the few who chose not to have the serum. The difficulty in producing enough serum for everyone who needs it can be overcome by diverting resources (mice, for instance) from less urgent work until the crisis is over.

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