Drugs for Ebola – but will they work?

Colorized transmission electron micrograph (TEM) revealing some of the ultrastructural morphology displayed by an Ebola virus virion.  Photo credit: Frederick A. Murphy

Colorized transmission electron micrograph (TEM) revealing some of the ultrastructural morphology displayed by an Ebola virus vision. Photo credit: Frederick A. Murphy

Is a cure for Ebola getting to the people that need it?

News reports show that there may be a treatment – but the practical and moral issues around it are agonizing.

There are several drugs that may possibly treat the terrible disease, and some vaccines in the pipeline to try and prevent it. But as the World Health Organization said yesterday, “Some of these have shown promising results in the laboratory, but they have not yet been evaluated for safety and efficacy in human beings.”

One drug, Zmapp, has attracted a lot of attention, It was given to two Americans – who seem to be recovering – and a Roman Catholic priest in Madrid, who died. And Liberia will receive Zmapp, to treat people infected with Ebola, the Liberian government says.  But even for the two Americans who received the drug, it is not yet clear whether it was the drug that helped them recover, or whether their recovery to-date was due to other factors.

Zmapp “is a cocktail made up of three disease-fighting proteins that target a specific gene of an invading pathogen such as the Zaire ebolavirus strain and prevents it from entering a cell,” says the Globe and Mail, in a great explainer. “It is generated in tobacco plants that have been genetically engineered to produce the monoclonal antibodies.”

But the drug’s effects are uncertain – and no-one really knows if it will work.

Its side effects on humans are unknown. That’s in large part because it has not gone through the full clinical trial process for testing in humans that a drug would normally go through before approval for use. And to make things worse, the pharmaceutical company said its supply of the drug was exhausted. “Mapp and its partners are cooperating with appropriate government agencies to increase production as quickly as possible,” the company said.

This is an emergency, so the WHO convened a panel of medical experts, ethicists, and affected communities last week to discuss how best to respond.  That panel decided that it was OK to go ahead and use experimental drugs – even if the risks aren’t clear, it announced on Wednesday. “In the particular circumstances of this outbreak, and provided certain conditions are met, the panel reached consensus that it is ethical to offer unproven interventions with as yet unknown efficacy and adverse effects, as potential treatment or prevention.

But, they added, that isn’t a simple matter. “Ethical criteria must guide the provision of such interventions. These include transparency about all aspects of care, informed consent, freedom of choice, confidentiality, respect for the person, preservation of dignity and involvement of the community.”

“We find ourselves facing a dilemma,” said Marie Paule Kieny, a WHO assistant director-general, said. “Far too many lives are being lost right now.”

Those ethical dilemmas are already all too clear.

Doctors had a small supply of Zmapp, and faced the tough decision about whether to use it on the man who was running Libera’s anti-Ebola campaign, and had succumbed to the illness, the New York Times reported. “Would the drug… help the stricken doctor? Or would it perhaps harm or even kill one of the country’s most prominent physicians, a man considered a national hero, shattering the already fragile public trust in international efforts to contain the world’s worst Ebola outbreak?”

The treatment team made the agonizing decision not give the drug and the doctor, Sheik Umar Khan, died a few days later. Why? “doctors feared stoking the considerable suspicion of Western medical institutions in [Liberia], which was already making it harder to contain the outbreak,” said the NYT. Plus: Dr Khan already had high levels of the disease in his body, which made it less likely the drug would work.

What’s a fair way to distribute the drug?

“I don’t think that there could be any fair distribution of something which is available in such a small quantity,” Dr. Kieny of the WHO said.

Those who are sickest? The drug might not work. And how do you measure that? The “most deserving”? Who decides?

The drug company has been providing the drug at no cost, so this isn’t a question (yet) of economics, though it will be. In disease and drug development, the time it takes to develop a drug can be years; the time a patient has may be hours.

That doesn’t mean nothing can be done. Many organizations are working on the ground in Africa to help save lives. And governments are scrambling to pull together resources, people and money.

But it’s a race against time.