WHO backs use of experimental Ebola drugs in West Africa outbreak

[Buster's Uncle]

WHO backs use of experimental Ebola drugs in West Africa outbreak
Reuters
By Kate Kelland and Stephanie Nebehay  3 hours ago



A man has his temperature taken using an infrared digital laser thermometer at the Nnamdi Azikiwe International Airport in Abuja, August 11, 2014. REUTERS/Afolabi Sotunde



LONDON/GENEVA (Reuters) - It is ethical to offer unproven drugs or vaccines to people infected or at risk in West Africa's deadly Ebola outbreak, a World Health Organization panel of medical ethics experts ruled on Tuesday, but cautioned supplies will be limited.

The panel said any provision of experimental Ebola medicines would require "informed consent, freedom of choice, confidentiality, respect for the person, preservation of dignity and involvement of the community".

The drugs should also be properly tested in the best possible clinical trials, it said.

The West Africa Ebola virus epidemic - the world's largest and most deadly so far - has killed at least 1,013 of the more than 1,848 people it has infected in Guinea, Liberia, Sierra Leone and Nigeria. The WHO has declared it an international health emergency.

"Ebola outbreaks can be contained using available interventions like early detection and isolation, contact tracing and monitoring, and adherence to rigorous procedures of infection control," the panel said. "However, a specific treatment or vaccine would be a potent asset to counter the virus."



People sit near a poster with a government message against Ebola, at the health minister's office in Abidjan August 11, 2014. REUTERS/Luc Gnago


The ethics panel met to discuss whether various experimental drugs and vaccines being developed for Ebola might be used in the outbreak, despite not having been fully tested or licensed.

"A number of interventions have been through the laboratory and animal study phases of development," it said in a statement issued by the WHO.

It said it was likely that so-called "first in man" trials - the first tests of a drug in humans - would be conducted over the next two to four months, but cautioned that even after that and if the trials proved successful, supplies would be limited.

"It is ... likely that the number of doses available for further study and/or deployment from end 2014 onwards will remain insufficient to meet demand," the statement said.

The ethics meeting was called after experimental Ebola drug ZMapp, made by U.S. biotech company Mapp Biopharmaceutical, was given to two American health workers infected with Ebola in Liberia.



World Health Organization (WHO) Director-General Margaret Chan addresses the media after a two-day meeting of its emergency committee on Ebola, in Geneva August 8, 2014. REUTERS/Pierre Albouy


DRUGS SCARCE

The scarce experimental drug, of which a WHO spokeswoman said only 12 doses had been made, was due to be given to two Liberian doctors after U.S. authorities approved its export, Monrovia's information minister said on Tuesday. This would be the first time the treatment has been used on Africans.

A 75-year-old priest in Spain who also received ZMapp has since died. He contracted Ebola in Liberia.

"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 panel's statement said.

There are no licensed treatments or vaccines for Ebola. As well as Mapp, several other biotech companies and research teams have been working on potential drugs.

Companies with possible treatments include Tekmira Pharmaceuticals, Biocryst Pharmaceuticals and Siga Technologies.

GlaxoSmithKline and U.S. scientists at the National Institute of Allergy and Infectious Diseases hope to start a clinical trial of an experimental Ebola vaccine as soon as next month, after promising test results in primates.

It would normally take many years to move such a vaccine through three phases of clinical testing but some officials have suggested emergency procedures could be put in place to make it available in 2015, assuming it works in the early test phase.

Another experimental vaccine from Johnson & Johnson's Crucell unit should enter Phase I clinical trials in late 2015 or early 2016, while Profectus Biosciences is also working with U.S. scientists on another pre-clinical vaccine.

(Additional reporting by Ben Hirschler, writing by Kate Kelland; Editing by Janet Lawrence)


http://news.yahoo.com/backs-experimental-ebola-drugs-west-africa-outbreak-094434259.html

[Buster's Uncle]

WHO backs use of experimental Ebola drugs in West Africa epidemic
Reuters
By Kate Kelland and Stephanie Nebehay  2 hours ago



A man has his temperature taken using an infrared digital laser thermometer at the Nnamdi Azikiwe International Airport in Abuja, August 11, 2014. REUTERS/Afolabi Sotunde



LONDON/GENEVA (Reuters) - People infected in the West Africa Ebola outbreak can be offered untested drugs, the World Health Organization said on Tuesday, but scarce supplies raise questions about who gets priority in the epidemic of the virus, which has no proven treatment.

Liberia said it planned to treat two infected doctors with an unproven Ebola medicine called ZMapp, the first Africans to receive the drug, while a Spanish priest, who the Health Ministry in Madrid said had also been given ZMapp, died.

The West Africa Ebola virus epidemic - the world's largest and deadliest so far - has killed at least 1,013 people in Guinea, Liberia, Sierra Leone and Nigeria. The WHO has declared it an international health emergency and predicts the epidemic will continue for months.

There are no licensed treatments or vaccines for Ebola, but several biotech companies and research teams have been working on potential drugs. Some in West Africa took to social media to express their lack of hope of being offered those treatments.

"There was unanimous agreement among the experts that in the special circumstances of this Ebola outbreak it is ethical to offer unregistered interventions as potential treatments or prevention," the WHO's assistant director general Marie-Paule Kieny said after an ethics panel published its guidance.



Liberian soldiers check people travelling in Bomi County August 11, 2014. REUTERS/Stringer


The WHO-convened panel of medical ethicists said several potential drugs had passed the laboratory and animal study phases of development, and should now be fast-tracked into clinical trials as well as being made available for compassionate use.

"If these treatments can save lives - as the animal studies suggest - should we not use them to save lives, as far too many lives are being lost right now?" Kieny said.


ZMAPP HOPES

The WHO ethics meeting was called after experimental Ebola drug ZMapp, made by U.S. biotech company Mapp Biopharmaceutical, was given to two American aid workers infected with Ebola in Liberia.

The two U.S. aid workers have shown some signs of improvements since being given the drug, and Kieny said she had heard reports that the treatment had had a swift and dramatic effect in these patients.



A man washes his hands as a preventive measure against Ebola in Abidjan August 11, 2014. REUTERS/Luc Gnago


Only around 10 to 12 doses had been made of the experimental drug, according to the WHO. Liberia was preparing to treat the two Liberian doctors with ZMapp after U.S. authorities approved its export.

A 75-year-old priest in Spain, who the Health Ministry said was also being treated with ZMapp, died in hospital in Madrid on Tuesday. He contracted Ebola in Liberia while working for a non-governmental organization.

Ben Neuman, a virologist at Britain's University of Reading, said the WHO panel's decision was welcome.

"The humanitarian case for treatment in a disease as deadly as Ebola is very clear cut. If I had Ebola, I would be looking for any treatment available, even if it was only at an experimental stage," he said.

The epidemic in West Africa, one of the world's poorest regions where crumbling healthcare systems are unable to cope, has also raised the issue of who should been given priority for any drug that might become available for compassionate use.



People sit near a poster with a government message against Ebola, at the health minister's office in Abidjan August 11, 2014. REUTERS/Luc Gnago


On Twitter, users in the region created the #GiveUsTheSerum hashtag to voice their frustration at the failure to provide experimental medicines to people on the continent.

The WHO's ethics panel said it was likely the first tests of these drugs in humans would be conducted over the next two to four months, but cautioned that even after that and if the trials proved successful, supplies would be limited.

"It is ... likely that the number of doses available for further study and/or deployment from end 2014 onwards will remain insufficient to meet demand," the statement said.

Companies with possible treatments include Tekmira Pharmaceuticals, Biocryst Pharmaceuticals and Siga Technologies.

GlaxoSmithKline and U.S. scientists at the National Institute of Allergy and Infectious Diseases hope to start a clinical trial of an experimental Ebola vaccine as soon as next month, after promising test results in primates. [ID:nL4N0QH4ZR]

Another experimental vaccine from Johnson & Johnson's Crucell unit should enter Phase I clinical trials in late 2015 or early 2016, while Profectus Biosciences is also working with U.S. scientists on another preclinical vaccine.

The WHO has said the epidemic will likely continue for months as the region's healthcare systems struggle to cope and has appealed urgently for funding and emergency medical staff.

Ivory Coast, the economic powerhouse of French-speaking West Africa, on Monday banned air travelers from the three countries worst-hit by the Ebola outbreak and ordered its flagship carrier Air Cote d'Ivoire to cease flights to and from them.

Ivory Coast has not registered any cases but is seen as vulnerable given its shared borders with Guinea and Liberia.

Rwanda's Health Ministry said the country's first suspected case of Ebola, a German medical student who had spent time in Liberia, had tested negative.

(Additional reporting by Ben Hirschler in London, Clair MacDougall in Monrovia, Daniel Flynn in Dakar, Teresa Larraz in Madrid and Jenny Clover in Kigali; Writing by Kate Kelland; Editing by Raissa Kasolowsky)


http://news.yahoo.com/backs-experimental-ebola-drugs-west-africa-epidemic-162913954--finance.html

[Buster's Uncle]

WHO hopes for more Ebola drug doses, vaccine progress by end of year
Reuters
By Ben Hirschler  2 hours ago



LONDON (Reuters) - World Health Organization experts fighting the world's worst outbreak of Ebola hope for improved supplies of experimental treatments and progress with a vaccine by the end of the year.

That may come too late to put an end to the current epidemic, which is more likely to be stopped by standard infection control measures, but it offers hope for the next inevitable outbreak.

After ruling on Tuesday that it is ethical to offer unproven Ebola drugs to people infected or at risk in West Africa, the challenge is to secure enough doses to make a difference in an outbreak that has already claimed more than 1,000 lives.

An experimental drug called ZMapp from U.S. firm Mapp Biopharmaceutical appears to have had "a dramatic and very rapid effect" in the case of two U.S. doctors, WHO assistant director-general Marie-Paule Kieny told reporters.

However, the scant supplies of this drug are now effectively exhausted, after Liberia secured doses for two of its doctors. Spain's Health Ministry said a 75-year-old Spanish priest, the only other person known to have been given ZMapp, had died.

One of the deadliest diseases known to man, Ebola kills the vast majority of those infected. Its symptoms include internal and external bleeding, diarrhea and vomiting.

Other drugs are also at an early stage of development, including a treatment from Tekmira Pharmaceuticals that was cleared last week by U.S. regulators for testing in infected patients.

None of these, however, is available in the quantities needed to make a dent in the West African epidemic - even if they work as well as hoped.

Still, the WHO is optimistic supplies can be ramped up by around the turn of the year, although the number of doses available will likely still remain insufficient to meet demand.

The United Nations agency also believes a vaccine can be fast-tracked for use in those most at risk, such as healthcare workers caring for patients, laboratory technicians and people burying the dead.

Kieny said two vaccine candidates were set to enter clinical trials in the coming weeks and there could be enough early-stage data to consider their emergency use by the end of 2014.

"We could have enough information, very preliminary, but maybe enough information on their safety in humans by the end of the year," she said. "There is a way to fast-track clinical trials."

The two vaccines due to enter the first phase of human testing have been developed by GlaxoSmithKline and Profectus Biosciences.


MARKET FAILURE

Normally, it takes many years to test a new drug or vaccine and determine it is safe for use, so the bar will be lowered significantly in the case of Ebola. That worries some experts.

"So far these therapies have been tested only in a handful of monkeys," said Kevin Donovan, director of the Center for Clinical Bioethics and a professor of pediatrics at Georgetown University, speaking on a panel convened on Tuesday by the O’Neill Institute for National and Global Health Law.

"We don’t know what harm they will do over the long term or even the short term. We owe it to the Ebola victims, current and potential, to get this right."

The decision to support the use of unproven treatments reflects the deadly nature of the disease and the need to close the research gap left by the pharmaceutical industry's failure to tackle a neglected tropical disease found in poor countries.

"The fact that there is currently no registered drug for Ebola is a market failure," Kieny said. "If it hadn't been for the investment of a few governments into the development of these drugs and vaccines, we would be nowhere."

There has been an outbreak of Ebola every few years since the virus was first discovered nearly 40 years ago in the forests of central Africa.

But it is only in the past 10 years or so that researchers - prompted in part by the perceived bioterror threat posed by Ebola - have started to look seriously at the disease, generating the current range of potential drugs and vaccines.

(Additional reporting by Kate Kelland, Stephanie Nebehay and Toni Clarke; editing by David Clarke)


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