Zmapp to treat Liberian Ebola victims

The experimental drug Zmapp is to be used to treat Liberian Ebola victims, despite the fact that it has not yet been tested on humans.

Manufacturer Mapp Biopharmaceutical has supplied its entire stock free of charge to the country following a request from Liberia’s president Ellen Johnson Sirleaf.

The action opens up the wider question of the medical ethics of treating patients with drugs that have not undergone the usual rigorous testing in a public health crisis.

The World Health Organisation (WHO) convened an emergency meeting yesterday to discuss the ethics of using untested drugs and vaccines in response to a public health crisis. Currently there is no registered medicine or vaccine against the virus, but there are several experimental options under development.

Two infected health workers from Samaritan’s Purse treated with Zmapp have shown signs of improvement, but the situation has raised questions about whether medicine that has never been tested and shown to be safe in people should be used in the outbreak and, given the extremely limited amount of medicine available, if it is used, who should receive it.

“We are in an unusual situation in this outbreak. We have a disease with a high fatality rate without any proven treatment or vaccine,” explained Dr Marie-Paule Kieny, WHO Assistant Director-General. “We need to ask the medical ethicists to give us guidance on what the responsible thing to do is.”

Last week the WHO declared the Ebola outbreak in West Africa an international health emergency, reporting a death toll of 1,013 in the region.

Meanwhile, the US FDA has relaxed testing restrictions on another experimental treatment, TKM-Ebola, from Canadian company Tekmira Pharmaceuticals. In July the regulator placed a clinical hold on the drug, which was in a phase I trial, asking for more safety data. However, it has now re-graded the block to a partial clinical hold, which could allow it to be used on infected people.

Such action raises the prospect that other early-stage therapies could be used in the current outbreak, including Sarepta Therapeutics’ AVI-7537 and MediVector’s favipiravir.

Liberian officials are well aware of the risks of using an untested drug on Ebola victims, but as Information Minister Lewis Brown pointed out, “The alternative for not testing this is death, a certain death.”

Link

FDA relaxes restrictions on Ebola drug

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