Two Americans who contracted Ebola have been injected with a serum that hasn’t yet been tested in humans, CNN reports. Kent Brantly and Nancy Writebol got sick while volunteering at an Ebola clinic in Liberia. American officials recently evacuated Brantly from Africa to Atlanta, Georgia, for treatment, making him the first patient from this Ebola outbreak to enter the U.S. Writebol is supposed to fly in for treatment tomorrow. Before either of them left Africa, they received experimental injections made by a company called Mapp Biopharmaceutical.
Using an untested drug in this way is uncommon, but not unheard of. The U.S. Food and Drug Administration even has a special legal pathway to give patients access to experimental drugs, if their lives are in danger and they have no reasonable alternatives. Still, that legal pathway hasn’t been opened to the hundreds of people in West Africa infected with Ebola. Efforts to do the research to get Ebola vaccines and treatments to market—to take them from “experimental” to “FDA approved”—have been slowed by the disease’s rarity, Science magazine reported a couple of weeks ago.
Typically, a drug developer isn’t allowed to give experimental drugs to people until they’ve submitted a detailed study plan to the FDA for approval, plus data from experiments done in monkeys and mice. Even then, a “Phase I” human trial of a drug usually doesn’t measure whether a drug heals people, only whether its side effects are tolerable. After that, a drug has to make it through “Phase II” and “Phase III” trials before the FDA will allow a company to market it.
The treatment Brantly and Writebol received—at doses meant to cure them—has only been tested in mice and a few monkeys. You can see the results of one of those monkey trials here. Both volunteers responded well to the treatment, CNN reports.
Their cases fell under what the FDA calls its “Expanded Access” or “compassionate use” program. Expanded Access allows patients with life-threatening conditions to legally take experimental drugs (although there’s no guarantee a company will agree to sell an untested drug in this way). Federal researchers have talked extensively about using compassionate use to get promising Ebola treatments to West Africa, Science reported in July.
However, doctors on the ground say they’re already dealing with a lot of distrust and even violence from locals, who sometimes believe healthcare workers actually bring the disease to them. Throw rumors of an “untested injection” into the mix and, well, organizations such as Doctors Without Borders think it would be counterproductive.
The U.S. does plan to send at least 50 experts to West Africa to help doctors and hospitals there, the BBC reported this weekend. It sounds like they’ll be using the supportive treatments and containment techniques already proven to help with Ebola outbreaks.