An ethics committee organized by the World Health Organization (WHO) broke ground today when he said that the use of drugs or experimental vaccines not approved in the current Ebola outbreak is ethical assuming a set of criteria is met. There is a big problem, though: No experimental therapies and vaccines seems to be available in sufficient quantities to treat thousands in need. One of the issues to be discussed is how to fairly allocate scarce resources, the group said in a statement
Therefore another debate is preparing for some scientists and officials of public health: . What to try existing drugs that have been approved for other diseases but that could benefit patients and Ebola?
proposalsSeveral researchers have floated to try such drugs. An idea to try using statins and other, cheap widely used drugs created a "firestorm" this weekend after an op-ed piece project discuss the plan (which was submitted to The New York Times today) was distributed to some 80 researchers from around the world, said Thomas Geisbert, Ebola researcher at the University of Texas Medical Branch in Galveston.
Geisbert is squarely opposed to the idea because he said there was not enough evidence that the drugs would do any good. "I am very, very worried about it," he said.
But David Fedson, a retired pharmaceutical executive living in France who wrote the article in collaboration with Steven Opal of Brown University, said there are enough reasons to believe that some statins and other drugs such as ACE inhibitors and angiotensin receptor blockers can save lives and should be tried. Fedson said nearly 30 scientists, including the most prominent, have agreed to co-sign the article.
in the view of Fedson, Ebola problem is not so much infection . the virus itself but a runaway immune response that also occurs in bacterial infection called sepsis statins and other drugs can mitigate this immune reaction; a trial in 2012 patients with sepsis showed that atorvastatin reduced the risk of progression to severe sepsis 83%. He says he wrote to the Assistant Director-General Marie-Paule Kieny about the idea; she replied in a detailed letter from the reserves of the agency, he said. Article op-ed is another attempt to get the issue on the international agenda.
But Geisbert think it's a terrible idea. Researchers should be able to show that any therapy taken to Africa has at least prevented death in monkeys, he said, and drugs that Fedson promote and Opal did not meet this criterion. "I understand that people want good, and we all want to do something," said Geisbert. "But I saw so many things that looked promising and did not work in rodents, or has worked in rodents, but does not protect monkeys. ... We do not just have to enter anything on the back burner "that is approved by the US Food and Drug Administration (FDA) for certain uses.
compounds that modify the immune response could actually make a worse Ebola infection, Geisbert warns. And if drugs used in Africa today are ineffective, which could push the Ebola drug prospects as a whole, says Stephan Becker, a scientist at the University of Ebola Marburg in Germany. (Another veteran researcher Ebola Marburg, Hans-Dieter Klenk, said he signed the letter, though.)
Fedson said many scientists studying filoviruses like Ebola yet to catch the idea to treat the immune response. "All they can think about is hammering the virus," he said. (Fedson also lobbied for years for statins and other immunomodulatory agents accepted as a potential treatment during influenza pandemics.)
other scientists are trying to attract the attention of existing drugs as well. Eleanor Fish, a researcher at the University of Toronto in Canada, hopes to convince WHO and Médecins Sans Frontières benefits of Infergen use a synthetic interferon which she studied and has been widely used to treat hepatitis C and other diseases. Pharmunion BSV development, the Ukrainian company that makes it, offered to ship 60,000 bottles in Africa for free she said
fish has long studied the great antiviral properties of interferon α, and in 03, she used the patients infected with another virus outbreak, SARS;. a document it published in the Journal of the American Medical Association said it appeared to help. In an email she sent to officials at Médecins Sans Frontières and WHO yesterday, Fish cited two papers by researchers from the Canadian Public Health Agency, which suggest that it may help monkeys to survive an otherwise lethal dose of Ebola virus.
, but in these studies, interferon delivered by adenovirus was used in combination with a cocktail of monoclonal antibodies. Geisbert said mixing efficiency may be due to antibodies; previous studies that he and others have conducted found no effects on the Ebola virus to interferon itself, he said. The fish agrees there is no published evidence that interferon by itself can save monkeys.
Daniel Getts, scientific director of the Pharma Court in Chicago, Illinois, said he wrote the WHO suggest the use of nanoparticles Modifying Immune his company, designed to reduce tissue damage by immune cells called monocytes link. The agency rejected the idea; "They are only interested in therapies with primates data," he said.
Some researchers also see promising in two modulators selective estrogen receptor approved by the FDA one of them is used for treating breast cancer which have been shown to inhibit in vitro Ebola infection and in a mouse model in a 2013 document science Translational Medicine .
Fish said she realizes she is not alone in trying to attract the attention of the agency. "I guess people are probably down trees with all kinds of garlic therapies and who knows what," she said. While the WHO has the time and resources to consider all ideas unclear ; at a conference press on August 8, Director General Margaret Chan said his organization is "extremely tense" as is MSF WHO media office did not respond to emails from to. today Science Insider on the subject.
the epidemic shows no sign of slowing down. today, WHO reported that there were 1,848 cases up now and 1013 deaths, the actual figures almost certainly exceed that tally because some patients do not seek medical care
* Ebola files :. given the current Ebola epidemic, without precedent in terms of number of people killed and the rapid geographic spread, science and science Translational Medicine made a collection of research articles and news on the viral disease available for researchers and the general public.
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