[ti:Experimental Ebola Treatments Bypassing Usual Regulatory Hurdles] [ar:Anna Matteo] [al:Health Report] [by:www.51voa.com] [00:00.00]From VOA Learning English, this is the Health Report. [00:05.19]Researchers are hurrying to develop [00:08.54]effective treatments and vaccines for Ebola. [00:12.43]The disease has killed more than 4,500 people. [00:17.45]Most of the victims lived in one of three [00:21.51]West African countries - [00:23.62]Guinea, Liberia or Sierra Leone. [00:27.26]In the United States, [00:29.26]the government's process for approving new drugs [00:32.70]can often take years. [00:34.99]But treatments for Ebola are moving quickly [00:39.29]through the approval process. [00:40.99]Before US government officials approve a new drug, [00:45.81]researchers must perform detailed scientific tests, [00:50.86]what are called clinical trials. [00:53.60]The tests must be done on humanbeings [00:57.58]to show that the experimental treatment [01:00.71]is both safe and effective. [01:03.71]These drug trials usually involve thousands of people [01:08.60]and can take many years to complete. [01:11.73]But there are exceptions. [01:14.58]Thomas Geisbert is a microbiologist [01:18.47]at the University of Texas medical branch in Galveston. [01:22.71]He says the U.S. Food and Drug Administration [01:26.05]can make an exception through [01:28.74]what he calls its "animal rule." [01:31.19]This enables researchers to get fast approval [01:35.68]when faced with a deadly disease like the Ebola virus. [01:40.07]Mr Geisbert helped develop [01:43.69]what is known as the VSV Ebola vaccine, [01:47.39]this vaccine recently moved to human clinical trials [01:51.83]at the Walter Reed Army Institute of Research in Maryland. [01:56.41]The tests involve 20 healthy volunteers. [02:00.55]Mr Geisbert says that the animal rule [02:04.84]requires only that scientists demonstrate [02:08.57]that a treatment is effective [02:10.57]in an animal model of human disease. [02:14.05]This time, he says, [02:15.79]the human model of disease was monkeys. [02:19.14]"In conjunction with that, [02:20.98]you do a conventional phase one trial. [02:23.83]That¡¯s just a study [02:24.87]where you put a vaccine or treatment [02:26.41]into a healthy human volunteer [02:29.66]just to make sure that you know in normal, [02:32.15]healthy people that your vaccine or drug [02:34.14]does not cause any disease or serious adverse event," Geisbert said. [02:37.23]Another experimental drug called zMapp [02:41.02]went straight from the laboratory to Ebola patients. [02:45.05]The Food and Drug Administration also bypassed human safety trials [02:51.49]to treat a handful of patients in the United States. [02:55.96]Many researchers are hard at work [02:59.46]to develop effective treatments and vaccines for Ebola. [03:04.39]Canadian researchers made the VSV vaccine, [03:08.38]which is now being tested in Maryland. [03:11.52]The British drug company GlaxoSmithKline [03:15.65]has made another promising but experimental vaccine. [03:20.09]The safety of that vaccine is currently being tested in Mali. [03:25.43]The West African nation shares a border with Guinea, [03:30.07]where the virus has infected many people. [03:33.00]As of now, no Ebola cases have been reported in Mali. [03:38.58]Researchers say, the promising vaccine [03:42.93]will move into a more advanced human testing [03:46.47]early next year. [03:47.87]They will use these tests to show [03:51.11]if the vaccine is safe for human use.