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, they 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. Mapp, the tiny, San Diego based pharmaceutical company that makes the drug stated two years ago: “When administered one hour after infection (with Ebola), all animals survived. … Two-thirds of the animals were protected even when the treatment, known as Zmapp, was administered 48 hours after infection.”
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.
And because of the drug’s experimental nature, it’s unclear that it should go to anyone else. Even if the drug is cooled correctly, success in a few monkeys (less than 20) 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. With an untested drug, there is always a chance you will kill the first human subject who might otherwise have lived. And the two Americans who got it in Africa had been infected for more than a week, making its efficacy completely unknown.
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 to pay; and a tiny company won’t enthusiastically give away its small supply of drug for free. It is likely that if they were going to donate drugs, it would be to people who would command a lot of press attention and, thus, investors and government money for further research — which is to say, not to poor Liberians, Nigerians or Guineans.
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.