Posted on August 8, 2014

In Ebola Outbreak, Who Should Get Experimental Drug?

Andrew Pollack, New York Times, August 9, 2014

Some have said it is wrong that with hundreds of Africans dying from the outbreak of Ebola, extremely scarce supplies of an experimental drug went to two white American aid workers.

But what if the first doses of the drug–which had never been used in people and had not even finished the typical animal safety testing–had been given to African patients instead?

“It would have been the front-page screaming headline: ‘Africans used as guinea pigs for American drug company’s medicine,’ ” said Dr. Salim S. Abdool Karim, director of Caprisa, an AIDS research center in South Africa.

A history of controversy about drug testing in Africa is just one of the complexities facing public health authorities as they wrestle with whether and how to bring that drug and possibly other experimental ones to the countries afflicted with Ebola. Who should get such a scarce supply of medicine? Health workers? Children? The newly infected who are not yet as sick?

The World Health Organization is convening a meeting of ethicists early next week to discuss this sensitive and difficult dilemma. The United States government is also forming a group to consider the same issues, said Dr. Anthony S. Fauci, the director of the National Institute of Allergy and Infectious Diseases.

At least two of the countries affected by the Ebola outbreak, Liberia and Nigeria, have asked for the drug, according to a spokesman for the Centers for Disease Control and Prevention.

The debate about who should get the drug, which is called ZMapp, may be mainly academic in the short term, because there is virtually no supply left, Dr. Fauci said. By the time some modest supplies are available in a few months, the epidemic may have run its course.

Other experimental medicines might be available, but also probably in small amounts, like one from Tekmira Pharmaceuticals that has so far been tested only in healthy volunteers. Tekmira said Thursday that the Food and Drug Administration had determined that the drug was safe enough to be tried in infected patients.

ZMapp is reported to have helped the two aid workers, Dr. Kent Brantly and Nancy Writebol, who were initially treated in Liberia and are now at Emory University Hospital in Atlanta. But experts say it is too soon to conclude that it is truly effective.

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Dr. Arthur Caplan, head of the division of medical ethics at NYU Langone Medical Center, said priority should go to health care workers. Others say more recently infected patients would be more likely to be helped by the drug.

A senior F.D.A. official said priority might go to those who have access to other supportive care because they are most likely to benefit. But that could mean that the limited supplies might go to relatively privileged Africans.

This, of course, assumes that people will want the drug. That might not always be the case because of suspicions about health care in general and Western pharmaceutical companies in particular. Many patients stricken in the current outbreak are fleeing rather than going to clinics.

“There are just an awful lot of Africans who are afraid of the health care system right now,” said Dr. G. Kevin Donovan, director of the Pellegrino Center for Clinical Bioethics at Georgetown University Medical Center.

Northern Nigeria has a history of resisting the campaign to eradicate polio, for example, with rumors circulating that vaccinations are a plot to sterilize Muslim women. At least nine polio immunization workers were shot to death there in February 2013.

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