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Ebola drugs can be tested on patients even if unproven, WHO says

08/12/2014 02:26 EDT | Updated 10/11/2014 05:59 EDT
Ebola outbreak patients in West Africa can ethically be treated with experimental treatments or vaccines that haven’t yet been tested on humans, the World Health Organization says.

The United Nations health agency said Tuesday that, as of Saturday, 1,013 people have died during the outbreak in Guinea, Liberia, Nigeria and Sierra Leone. Nearly 2,000 others are infected

The WHO also announced its panel of experts assessed the ethical implications of using experimental interventions and approved the idea with conditions. There is currently no registered drug to fight Ebola.

- MAP | The spread of the deadly Ebola virus

"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," the agency said in a statement.

"There was unanimous agreement that there is a moral duty to also evaluate these interventions [for treatment or prevention] in the best possible clinical trials under the circumstances in order to definitively prove their safety and efficacy or provide evidence to stop their utilization."

The death rate in the outbreak is estimated at about 50 per cent, according to the UN, which has added to the urgency to use experimental approaches to try to save lives.

But it’s unknown whether the experimental treatments or vaccines do in fact help fight Ebola or what the side-effects might be.

Marie-Paule Kieny, the WHO's assistant director general for health systems and innovation, acknowledged during a news conference that supplies are currently tight for ZMapp —  an experimental  drug made by U.S. biotech company Mapp Biopharmaceutical that was partly developed at Canada's National Microbiology Laboratory in Winnipeg.

ZMapp was given to two American health workers infected with Ebola in Liberia. It has been reported that a treatment course was obtained for an infected Spanish priest who was taken to Madrid for care. Hospital officials in Madrid declined to say whether the priest, Miguel Pajares, 75, had been treated with ZMapp, citing medical confidentiality rules, the New York Times reported.

Two more courses of ZMapp were reportedly heading Tuesday to Liberia to be used on two infected doctors — the first Africans to receive the experimental drug.

"There was a lot of discussion knowing, for example, whether health-care workers would have priorities based on the principle of reciprocity because they put their lives in danger," Kieny said. "There was some support to this, but on the other hand, there was also voices within the expert group who said, 'Well, wait a minute, … the people who are in this  community who are sick should also have priority."

The panel of ethicists included a University of Toronto professor, Dr. Ross Upshur, a representative of a patient advocacy group in the U.S., and others.

For now, efforts to contain Ebola focus on isolating cases, tracing their contacts and monitoring them for signs of infection, and following infection control practices for health-care workers.

Experimental drug options

The medical ethicists did not directly address who should get the limited drugs or how those decisions should be made, but said ethical criteria, such as transparency about informed consent and confidentiality, must guide the determinations.

The WHO plans to reconvene the panel, drawing in other experts as well, before the end of the month to work on more questions about the ethical use of available drugs and vaccines, and how to ensure that when they are used their efficacy is monitored.

As well as ZMapp, researchers and biotech companies are working on several other potential drugs, including B.C.'s Tekmira Pharmaceuticals, Biocryst Pharmaceuticals and Siga Technologies.

Researchers also plan to start a small clinical trial in humans of an experimental Ebola vaccine that was also partly developed at Canada’s National Microbiology Lab, the U.S. National Institute of Allergy and Infectious Diseases and GlaxoSmithKline, as soon as next month.

Other experimental vaccines are also in pre-clinical testing in cells or animal models.

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