“If we had steak,” goes the old wheeze, “we could have steak and eggs for breakfast. If we had any eggs.”
To me, that’s what the World Health Organization (WHO) consultation on how to use novel Ebola vaccines and antivirals sounds like. An august group of experts spent 2 days discussing how the various experimental substances should be used, given that none — repeat, none — of the usual safety and efficacy studies have been done and that very little of the substances actually exists.
Briefly — and at the risk of doing injustice to the deliberations by ignoring the nuances — here’s a summary of what the consultation came up with:
- Tests using whole blood or sera from Ebola survivors can be done now, since there is a large pool of recovered patients. There is some evidence that this might work and it can be done safely despite the disarray of the health systems in the most affected countries.
- Two vaccine candidates are entering phase I clinical trials, in which they will have their safety tested in humans. They should go into efficacy trials in the affected countries as soon as their safety is established.
- Various other antivirals — antibody cocktails or small interfering RNAs — should go into safety/efficacy analyses in the affected regions whenever enough of them is available.
- And in all cases, frontline workers should form the test groups.
That to my admittedly cynical ears sounded like: “If the drugs were safe and effective, we would use them to treat healthcare workers … if we had any drugs.”
It’s fast. It’s risky. And it’s an “absolutely unprecedented” drug development program, commented Marie-Paule Kieny, PhD, an assistant director-general of the WHO, during a media briefing on the consultation.
Indeed it is.
If you want to test the efficacy of a drug against something, you have to do a trial among people at risk of that something. So that part makes sense — it was always going to be the case that these drugs would be tested during an Ebola outbreak.
And I guess it makes sense to rush them into trials as soon as possible because if you wait 6 months, this outbreak might be over. With any luck (and a lot of hard and dangerous work) it might be.
But I get a feeling that there’s some kind of “magic bullet” thinking going on, a restless hope for a simple answer.
The danger is that we will waste effort on substances that — in the best case — are innocuous. In the worst case, of course, they could prove harmful. You might recall that one HIV vaccine candidate sailed through early human trials until a phase III study showed it actually increased the risk of acquiring the virus.
There’s nothing say that won’t happen here. And imagine the reaction if it turned out that some miracle of modern medicine actually made things in West Africa worse.
But regardless of how the various studies come out, these drugs are unlikely to make a substantial difference in the Ebola caseload — there won’t be enough of them and they won’t be in time.
And their glittering prospect shouldn’t, as Oyewale Tomori, DVM, PhD, of Redeemer’s University in Redemption City, Nigeria put it during the media briefing, “detract from what’s needed to be done now.”
That is to say: finding and treating patients with aggressive supportive care, tracing and isolating contacts, and above all practicing good infection control.
“If we had done proper infection control in the first place, we wouldn’t be having the same problem we are having now,” he said.
The epidemic will continue to grow for the next weeks and months — not because there are no drugs — but because there is not the capacity on the ground to look after patients, to find and care for contacts, and to keep healthcare workers safe.
As WHO officials said last week, there aren’t enough doctors, nurses, beds, masks, gowns, trucks, ambulances … the list goes on. Name it, it’s needed.
If any of the work on investigational medicines interferes with getting those shortages remedied, it should not be done.