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Logistics, influence, price affect who gets experimental drugs

In Monrovia, Liberia, women from different religious groups prayed against the spread of the Ebola virus. An Ebola outbreak that has killed more than 700 people in West Africa is moving faster than efforts to control the disease.
In Monrovia, Liberia, women from different religious groups prayed against the spread of the Ebola virus. An Ebola outbreak that has killed more than 700 people in West Africa is moving faster than efforts to control the disease. AP

NEW YORK — What should happen if a massive viral outbreak appears out of nowhere and the only possible treatment is an untested drug? And who should receive it? The two American missionaries who contracted the almost-always-fatal virus in West Africa were given access to an experimental drug cocktail called ZMapp. It consists of immune-boosting monoclonal antibodies that were extracted from mice exposed to bits of Ebola DNA. Now in isolation at an Atlanta hospital, the patients appear to be doing well.

It's an opportunity the 900 Africans who've died so far never had. Is there a case to suspend ethical norms if lives might be saved by deploying an experimental drug?

The reasons for different treatment are partly about logistics, partly about economics and partly about a lack of any standard policy for giving out untested drugs in emergencies. Before this outbreak, ZMapp had only been tested on monkeys. But privileged humans were always going to be the first ones to try it. ZMapp requires a lot of refrigeration and careful handling, plus close monitoring by experienced doctors and scientists — better to try it at a big urban hospital than in rural West Africa, where no such infrastructure exists.

Even if the drug is cooled correctly, success in less than 20 monkeys tells us little about what will happen in a lot of humans who'd had the infection for more than two days. No one knows how much drug to give, how often, what other pre-existing medical conditions might influence its efficacy or even what route is best, be it IV, pill, syrup, or even surgically right into the liver.

But it's about more than logistics. Drugs based on monoclonal antibodies usually cost a lot — at least tens of thousands of dollars. This is obviously far more than poor people in poor nations can afford; and a tiny company won't enthusiastically give away its small supply for free. If they were going to donate drugs, it would likely be to people who would command a lot of press attention and, thus, investors and government money for further research,

The medical missionaries got the experimental drug because the evangelical Christian International Relief organization they work for, Samaritan's Purse, reached out to the CDC and the NIH to find out if there was any drug to give to them. They were referred to Mapp Pharmaceuticals and evidently struck some kind of deal to get the drug to their employees who were in Africa at the time. (Technically, African health ministries could make a similar request.) The FDA has little oversight over what goes on abroad, and the federal government has no program to consider appeals for use — much less payment — of experimental drugs that have only been tried on animals. Without an organization pushing, no one might have received access to any sort of treatment.

Even if logistical and economic obstacles could be surmounted, is there a case for giving Zmapp to Africans still dying from Ebola? Many Africans were infected more recently than the Americans now being treated, so they better fit the conditions in which the drug was tried in the monkey lab.

But there is no accepted set of rules for a sick person to request compassionate access to a drug that is experimental, expensive and in short supply. And access to experimental drugs remains a long shot full of risk. The dying may feel more cavalier about entering a drug experiment — the rewards could justify the risks — but a company may still withhold a drug from a willing volunteer for fear that it will fail and reduce investor interest or increase attention from malpractice attorneys.

This Ebola outbreak has taught us two things: that we need to act quickly to shut down emerging epidemics wherever they occur, and it is long past time to have a transparent public policy about what to do when not everyone gets a chance to live.

Arthur L Caplan is the director of the Division of Medical Ethics at NYU Langone Medical Center's Department of Population Health.

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