MSF aims to start drug trials in Ebola clinics next month

By Daniel Flynn DAKAR (Reuters) - The medical charity Medecins Sans Frontieres (MSF) intends to start trials of experimental Ebola drugs in its treatment centers in West Africa next month, as it steps up measures to tackle the worst outbreak of the disease on record. Bertrand Draguez, medical director of MSF Belgium, said academics and the World Health Organization (WHO) were currently assessing which drugs to include in the tests. Meanwhile, a team of experts in West Africa was assessing which treatments should be tested in which MSF clinic, he said. Ebola is known to have killed more than 4,500 people in Liberia, Sierra Leone and Guinea. But with at least half the cases going unreported and with an estimated 70 percent fatality rate, the true toll may be more than 12,000, aid workers say. With cases also recorded in the United States and Spain, the outbreak has prompted pharmaceutical companies to fast-track trials of drugs to treat Ebola and vaccines to stop its spread. The WHO said on Tuesday that tens of thousands of people in West Africa should begin getting experimental Ebola vaccines by January, chief among them drugs from GlaxoSmithKline and NewLink Genetics. Successful vaccines would prevent people from getting Ebola. The MSF trials will test treatments for people who already have the disease. "It is the first time MSF will be involved in experimental research," Draguez said. "But it's an unprecedented outbreak and all actors need to be flexible ... We are one of the few providing care to patients and to do these trials you need patients." Draguez said priority would be given to pharmaceuticals that are already available - so called 'off-label' drugs that were approved for use on other diseases but that may have a beneficial effect on Ebola. "To start the trials, I hope we are talking about weeks," Draguez said. "I hope it will be around the end of November." TURN NO ONE DOWN Draguez said MSF wanted to avoid having to turn down any patient who wanted to be involved in the trials because of the lack of availability of drugs. He said that while there were good supplies of Avigan, or favipiravir, originally developed by Japan's Fujifilm to treat flu, and Chimerix's Brincidofovir, the ZMapp treatment developed by Mapp Biopharmaceutical was scarcer. A fourth treatment, TKM-Ebola, is being developed by Tekmira. Before trials start, MSF will send a team to meet with community leaders to seek their approval. Local resistance dogged early efforts to tackle the outbreak after it was detected in March deep in the forests of southeastern Guinea. MSF staff will also seek individual consent from patients. Draguez said MSF staff would monitor the results themselves, given the high-risk conditions inside Ebola treatment units. The trials are likely to be spread over MSF's six centers in the three countries, with each site testing different drugs. Exact timing will depend on expected patient numbers, to avoid overburdening staff and disturbing the quality of care. Some of the procedures of clinical trials will have to be abandoned, Draguez said. MSF wants to avoid committing staff to heavy monitoring of patients, including blood samples. "For us, it is also not acceptable to have a placebo, because we don't want patients asking 'why not me and why this person?'" Instead of randomized testing, Draguez said patients would be accepted for the trials sequentially as they arrived at clinics, with women and children included. "MSF retains the right to veto this and say we will not go for this trial," Draguez said. (This version has been refiled to fix typo in first paragraph) (Reporting by Daniel Flynn; Editing by Larry King)