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Untested Ebola therapies 'ethical'

Experimental therapies unproven as safe for human use can be offered to Ebola patients provided certain conditions are met, a World Health Organisation-convened panel has recommended in an effort to curtail the worst recorded outbreak of the disease.

West Africa is experiencing the most severe and complex outbreak of Ebola in history and if certain conditions are met - such as informed consent - it is ethical to offer "unproven" interventions, the panel of ethicists, medical experts and lay people concluded.

The panel said research efforts had been invested in developing drugs and vaccines for the disease over the past decade with some showing "promising" results in the laboratory, but they had not yet been evaluated for safety in human beings.

"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 UN health agency said in a statement.

"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."

The panel, which includes UK experts Professor Peter Smith - of the London School of Hygiene and Tropical Medicine and Professor Jeremy Farrar - director of the Wellcome Trust, added that there was a "moral duty" to evaluate interventions in the "best possible clinical trials under the circumstances".

The findings have been released amid growing demands for an experimental treatment to be made available to Africans amid a rising death toll from the disease which has been declared a public health emergency by WHO.

The virus has no known cure and causes symptoms including fever, vomiting, muscle pain and bleeding. It is spread by direct contact with bodily fluids like blood, sweat, urine, saliva and diarrhoea. Around 40% of those infected are surviving the current outbreak.

The outbreak has centred on Liberia, Sierra Leone, and Guinea.

So far 1,013 people have died and 1,848 suspected, probable or confirmed cases have been recorded. Nigeria, Africa's most populous country, has confirmed 10 cases.

Two American aid workers diagnosed with the disease while working in a hospital that treated Ebola patients and a Spanish priest, Father Miguel Pajares, all of whom were evacuated back to their home countries - are believed to have received the US-made experimental drug Zmapp. In spite of this, Fr Pajares died today in Madrid.

Professor Jonathan Ball, professor of molecular virology at the University of Nottingham, said the panel's findings did not come as a "huge surprise".

But he warned that using experimental therapies was not without risks, including that of generating "mistrust" among African countries.

"You certainly cannot say definitively that something which works and is safe in animals will work and be safe in humans; I think there is a risk," he said.

"However, when you weigh that against the fact that there is 60% chance that you will die of Ebola infection, you can understand how they reached the decision."

He said he was concerned too about how clinical trials could be conducted effectively in the current situation.

"I can absolutely understand why they have said they (the experimental therapies) can be used but it worries me that we might end up none the wiser at the end," he added.

Meanwhile an isolation unit with beds to treat two patients is on standby should anyone test positive for Ebola in the UK.

The high security unit at the Royal Free Hospital in Hampstead, north London, has two beds contained in airtight tents with their own air supplies and with built in suits for medical staff treating patients. The ward is sealed tight with automatic door locks and only a handful of specially trained doctors and nurses will be allowed to enter the unit.


From Belfast Telegraph