Public-health workers will contain the Ebola case—and any secondary spread—diagnosed in Dallas. But the decisive risk to the U.S. will emerge in a few months. If the virus continues to spread in West Africa at its current pace, much larger global outbreaks will become likely.
Should these outbreaks coincide with the cold-weather peak of the flu season—when symptoms of influenza can be confused for the early signs of Ebola—the health-care system’s ability to quarantine all the people with suspected Ebola infections, and test them in the required specially equipped labs, could be overwhelmed.
And if Ebola does decisively break out of West Africa, we may be unable to control the spread of the disease solely by conventional public-health tools of infection controls, tracking and tracing sick contacts, and isolating the ill. If this happens, we may face a global pandemic early next year.
For now, we must pin our hopes on drugs or vaccines that are still in early stages of development.
The good news is that there are a number of promising therapeutics that have already shown activity against Ebola, from an immune-based drug called ZMapp that was given to seven infected patients, to at least two vaccines that appear ready for large-scale testing. ZMapp showed remarkable efficacy in bolstering the immune system to directly attack the virus in monkey experiments and may also have helped several Ebola sufferers recover.
There are also drugs targeting cancer called “kinase inhibitors” that show potency against the Ebola virus. One advantage of drugs working at the host level—on the person not the virus—is that theoretically the drugs can still work even if the virus mutates. This is in contrast to a vaccine that relies on targeting certain markers on the virus surface that can change as Ebola mutates.
Yet too many public-health officials still believe that they can solve the crisis with tried-and-true methods to contain an outbreak that prioritize manpower over technology. Groups like the World Health Organization have been wrong at every turn in responding to the Ebola outbreak earlier this year. We can’t take the chance that they may again be miscalculating.
In light of the global threat there should be an intensive effort to find a therapeutic. It begins by establishing a regulatory process to evaluate and sanction the use of a new medical product. Political leaders, public-health officials and patients all need to participate to have some measure of confidence in a new drug or vaccine. Since Western companies are developing most of the drugs and vaccines, American and European regulators need to lead the effort.
The U.S. Food and Drug Administration and European Medicines Agency should establish a joint task force of drug reviewers to collaborate full time with companies on developing Ebola drugs. These two agencies already have agreements in place for the “joint review” of medical products.
After initial testing to determine a product’s safety and level of activity against Ebola, the most promising therapeutics need to be deployed into the field. We’re only going to learn whether drugs and vaccines work by getting real-world information. Conventional, randomized and double-blind clinical trials are not possible in the throes of an epidemic of a deadly pathogen. Given the urgency of the situation, we’re going to have to tolerate more uncertainty than usual.
There is a strong case for inverting the typical process—by doing the hard work of scaling the manufacture of the most promising drugs and vaccines and stockpiling them even while we figure out which ones are working. It may be too late to start large-scale production only after we’re done with more complete clinical testing. Manufacturing an initial half million doses of a vaccine for first responders, or many millions of doses of a drug, would probably cost less than $50 million per product, on average, depending on the kind of therapeutic. The investment spreads the risk and guards against mass-producing a single product only to find out later it was a dud.
Countries also need to agree on the standards for sanctioning an Ebola treatment. Here the WHO’s policy-making apparatus may play a useful role in convening nations. Since the products will be first used on a wide scale in West Africa, health leaders from those nations need to play a prominent role in reaching a decision on the standards. But history suggests they will also look to Western regulatory experts for guidance.
One standard might turn on whether a product has shown that it can be safely administered and is active at reducing the progression or transmission of the virus. This is different than the FDA’s “safe and effective” standard. Evidence of effectiveness that meets conventional standards may be unobtainable given the urgency, as well as the complexity, of running Ebola trials. Instead of the typical double-blind trial, patients treated with the newly certified therapeutics should be closely followed so we can see how well the products are working in the intermediate and longer term.
Finally, even while we focus on developing an Ebola remedy, we need to decide how it would be shared. Who would pay for the purchase of a successful drug or vaccine and who would assume liability for adverse events? Would international organizations buy the product at full price and then make it freely available? If so, would the U.S. or other contributing nations reserve doses for their citizens? Or would we send Africa all we have?
The U.S. has a national-security interest to treat the disease in Africa before it comes to America’s shores. On the other hand, the American people would not likely tolerate having an insufficient supply if there was an outbreak at home. None of these difficult questions are being addressed. They must be.
The U.S. dropped the ball on advancing a number of promising Ebola drugs and vaccines over the last decade. Medical countermeasures floundered for years in preclinical testing, largely because funding was sparse, and regulators applied conservative terms to how they wanted these medical products to be tested. In short, there was no sense of urgency. Now there should be.
The world’s poor response to Ebola in West Africa, its reliance on faulty estimates and false confidence, has turned an outbreak into an epidemic and made a pandemic possible. Public-health officials say a drug or vaccine is elusive, and won’t arrive in time to solve this crisis. They can’t know this to be true—and the crisis could be a lot worse than they are predicting. A crash effort to develop a therapeutic may be all the U.S.—and the world—has to bet on.