Ebola virus has landed several times in the United States and at least twice has spread to health care workers.
Given the terrible and extensive spread of Ebola in West Africa, more cases in travelers or health workers would not be surprising. Disease has spread in this manner since the times of plague, and sadly there will be more cases.
Despite the identification of Ebola and related viruses nearly 50 years ago, we doctors still don’t know the best therapies for people who have been infected. But with disease raging, we urgently need to learn the most effective ways to quickly treat critically ill people, not only to stem the tide of disease in the United States, but on behalf of the whole world.
In any epidemic, there are early cases and late cases. Let’s learn from the early cases so that if things get worse, we will have a better idea about what to do. Three years ago, cases of very severe E. coli infections began to appear in Germany.
By the time the epidemic was over, hundreds had become ill, and at least 50 people died. By studying this huge cluster of cases we could have learned much about which treatments were optimal; instead, the epidemic ended with us having learned nothing about how to treat the next outbreak.
Why? Because every doctor treated his or her patients according to their best individual judgment, given the information available to them. But judgment varies. Thus treatment varied and so did outcomes. Since so little was learned, when future E. coli outbreaks occur, we—and our patients—risk finding ourselves in the same sub-optimal position again. That’s where we are with Ebola.
There is a solution to this problem. Medical research has advanced greatly through controlled clinical trials: ill persons are randomized to receive one treatment or another, and then outcomes compared.
From such randomized clinical trials has come the knowledge that has improved chemotherapy for nearly all cancers, as well as treatments for HIV infections. The randomized clinical trial minimizes the bias of personal judgment and permits a head-to-head comparison of whether treatment A or B is better.
That’s what we need for Ebola, and for the next epidemic—whatever it is and whenever it comes, which it will. But regulatory processes are slow and essentially too time-consuming to be able to establish a randomized clinical trial in real time as an epidemic is unfolding. Thus, I have a modest proposal:
Our health authorities should pre-design a generic randomized clinical trial for acute infectious diseases. The trial design should be well-vetted, and blessed by the Centers for Disease Control and Prevention, the Food and Drug Administration, the National Institutes of Health, and appropriate ethics committees. When a possible outbreak appears on the horizon, the President, via the Surgeon General, would be empowered to call a public emergency, and the pre-approved generic trial would be launched.
All that would need to be decided at that point is what treatment should constitute A and what should be B. For nailing down treatment approaches, a panel of known experts—say in Ebola virus—should be convened to provide their best judgments. Thus when cases arrive, patients would be immediately offered the possibility of enrollment in the randomized clinical trial.
Since the treatment choices would be the best available, presumably few would refuse, and as data is gathered over time it would become clear which treatment is more effective, A or B. If it turns out to be B, the panel then asks: Is there a reasonable treatment C? The next trial would then compare B and C, and so on.
This approach would allow us to be continuously learning what works and what does not, and continuously improving treatment. Such a protocol would demonstrate an orderly approach to handling an epidemic, an approach that could be exported to other countries as well. And, of course, anticipation and order are important antidotes to fear.
Let’s start now, with Ebola, though rest assured that there will be another epidemic coming our way before too long. And another after that. Let’s prepare.
Martin J. Blaser M.D. is professor of medicine at NYU Langone Medical Center, a past president of the Infectious Diseases Society of America, and author of Missing Microbes. The opinions expressed in this commentary are his.