It's too soon to give out Ebola drugs

Waiting on Ebola serum -- cold-hearted or good science?

Why would the United States decline to provide a serum that can cure Ebola to poor and desperate victims in several African nations where close to 1,000 people have died of the virus? Because it doesn't have such a serum.

What the U.S. does have are a number of possible treatments for Ebola that are in the experimental stages. Most were developed with the help of federal financing after 9/11; drug companies previously had little financial incentive to develop drugs for an illness that affected relatively few people, all of them in developing countries. But after the 2001 attacks, the government became interested in staving off possible bioterrorism.

Some of the treatments look very promising after early trials on animals. But it is not yet known whether any of them will cure or prevent the illness in humans, or even whether they are safe for humans to take. Nor is it known which among them would prove the most helpful.

As it happens, the experimental treatment that two American aid workers were given after being stricken with Ebola in Liberia was ZMapp, a cocktail of three monoclonal antibodies. Both patients, who are being cared for at Emory University Hospital, are improving, an outcome that has governments in the affected African countries as well as three highly regarded Ebola experts clamoring to have the serum released to the hundreds of people who are infected.

That would be premature. It's a big leap to assume that the two Americans were saved by the serum. About 45% of those afflicted in the West Africa epidemic have survived. The Americans may have been lucky, or they may have benefited from their access to far better medical care than most Africans get, or perhaps they can thank their own robust immune systems, a result of growing up with adequate food, clean water and other benefits of the developed world.

The decision to provide the two aid workers with the serum, though well intentioned, of course, has raised serious ethical and political questions. To many Africans, it looks as though rules were bent on behalf of a couple of white Americans, while the hundreds of infected people in Africa are receiving no special treatment. Given the high mortality rate of the disease, they demand to know, shouldn't the serum be available to all? Isn't an experimental treatment better than nothing?

There is no easy answer to this emotionally wrenching question. The chief argument for holding off on ZMapp's release — that it isn't known whether the drug will help or even whether it might harm the very people it is intended to save, and that safety trials must be completed before it is widely distributed — sounds cold-hearted, as though it is about following bureaucratic drug approval protocols rather than helping the dying. Yet the argument is a powerful one.

Perhaps the answer would be different if this epidemic carried the 90% mortality rate that Ebola has sometimes inflicted in the past. If the prognosis were a virtually terminal one, it would make sense to conclude that even a drug that might harm people is better than near-certain death. But that's not the case with this epidemic.

This is a decision that has to be made carefully and rationally, though without delay. Not because the world doesn't care about the lives of the victims but because it also cares about the lives of the thousands who might be infected in the future.

There are other promising Ebola treatments that are in Phase I safety trials; ZMapp hasn't reached that stage yet. It might make more sense, public health experts say, to make available the medications that are at least part of the way through safety testing.

One possible treatment, not yet in safety trials, is intended to prevent the disease in people who have been exposed to the virus; a version of it was given several years ago to a German researcher who had accidentally pricked herself with an Ebola-infected syringe. She did not become ill — though again, it's not known for certain whether her good fortune had anything to do with the experimental treatment. Still, if it is effective, many more lives might be saved by providing medication to prevent the disease rather than to treat those who are infected. That would give health workers a chance to get ahead of the epidemic instead of reacting to each new case.

Some medications may be more effective than others, but without random, controlled clinical trials, scientists may never learn which are which. Without trials, the United States or the World Health Organization might commit too early to the widespread use of a less useful treatment, or one that is far more expensive and thus would not reach as many people.

At the same time, it is our moral responsibility to look for ways to speed reasonably safe medications to those who need them. The U.S. Food and Drug Administration should approve expedited safety trials that take a month or so, instead of the six months that full Phase I trials require. It would take at least that long anyway for pharmaceutical companies to ramp up production from tiny batches intended for trials to thousands of doses to cover affected populations. Then the FDA should allow its existing "animal rule" to apply to Ebola drugs. The rule allows efficacy trials on two different kinds of animals to substitute for human trials — as long as safety tests have been done on healthy human volunteers — when randomized, controlled efficacy tests on humans aren't practical.

Even with pharmaceutical treatment, it would take a massive public health and education effort to bring the West Africa epidemic to a close any time soon, and at that point there will be time for fuller testing. But if anything, this epidemic teaches us that when it comes to developing lifesaving pharmaceuticals, we don't always have as much time as we think.

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