Untested Ebola drugs can be used in Africa
pharmafile | August 13, 2014 | News story | Research and Development, Sales and Marketing | Africa, Biocryst Pharmaceuticals, Ebola, Siga Technologies, Tekmira Pharmaceuticals, WHO, world health organization, zmapp
The World Health Organization will allow untested treatments for Ebola to be used in West Africa as the death toll from the virus passes the 1,000 mark.
The WHO’s panel of medical ethicists said several experimental drugs had passed the laboratory and animal study phases of development, and should be fast-tracked into clinical trials and made available for compassionate use.
Liberia, where the outbreak has been most prolific, says it now plans to treat two infected doctors with an unproven Ebola medicine called ZMapp, manufactured by San Diego-based Mapp. The FDA says it has approved its exportation to the country.
The drug has so far only been used in pre-clinical testing, and thus not on any human test subjects, making its efficacy and safety relatively unknown. The treatment mixes three antibodies engineered to recognise Ebola and bind to infected cells, so the immune system can kill them.
The medicine has already been given to two US aid workers who are still both infected with the disease. It was also given to a Spanish priest, the first European to be infected with the virus, but he died in a Madrid hospital yesterday.
The two Americans are said to be improving, but there is no way to know whether the drug helped, or if they are getting better on their own, as others have.
Health workers believe that around 40% of those infected with Ebola are surviving the current outbreak – the virus can have up to a 90% fatality rate, so the outbreak is not as deadly as first feared.
But the scarcity of ZMapp has raised questions about who gets priority access to treatment.
Twitter users in West Africa, where Ebola is killing around 60% of patients who become infected, have created the #GiveUsTheSerum hashtag as fear around the virus spreads.
Many in Africa also fear the health workers themselves, who they believe are bringing the virus to the country, making treatment difficult.
This is coupled with a long-held suspicion from Africans around Western pharmaceutical companies coming to the continent to test experimental drugs on the populous – it is for this reason that a WHO ethics committee had to decide whether using ZMapp in Liberia was the right course of action.
Speaking to the media this morning the Canadian health minister Rona Ambrose says that Canada would also donate 800 to 1,000 doses of an experimental Ebola vaccine developed in its government laboratory.
“Our government is committed to doing everything we can to support our international partners, including providing staff to assist with the outbreak response, funding and access to our experimental vaccine,” Ambrose says in a statement.
Canada owns a small quantity of the vaccine but would need four to six months to make a large quantity.
Companies with other possible treatments include Tekmira Pharmaceuticals, Biocryst Pharmaceuticals and Siga Technologies.
GlaxoSmithKline and American 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.
Another experimental vaccine from Johnson & Johnson should enter Phase I trials in late 2015 or early 2016, while Profectus Biosciences is also working with US scientists on another pre-clinical vaccine.
But all of these will take years to develop via the normal route of clinical testing, so will most likely not be used during the current outbreak.
R&D of Ebola drugs and vaccines is not a major driver for pharma, given the low rates of revenue it would receive for it, along with the difficulty of creating a treatment.
Rising death toll
The WHO says in a statement today that it believes 1,013 people had died so far and 1,848 suspected, probable or confirmed cases of the disease had been recorded.
WHO and other health workers on the ground have said that any treatments are welcomed, but add that it is key those infected with the virus get help as soon as possible, as early treatment improves outcomes and reduces the risk of further infection.
The virus, which is not airborne but rather passed via contact of bodily fluid, can cause fatal haemorrhaging.
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