Voice of America October 15, 2014
Experimental Ebola treatments are moving with lightning speed through a regulatory process that, for most drugs, can take years. The urgency of the lethal epidemic in three West African countries — Guinea, Liberia and Sierra Leone — means a number of promising treatments are bypassing the usual hurdles toward approval. Before a new drug gets the green light from U.S. regulators, researchers are required to conduct in-depth clinical trials on people to demonstrate the experimental compound is both safe and effective. Drug trials typically involve thousands of people and can take many years to complete. The U.S. Food and Drug Administration’s so-called “animal rule,” however, allows researchers to gain expedited approval when faced with a deadly pathogen like Ebola, according to UTMB’s Thomas Geisbert. Geisbert helped develop what’s known as the VSV Ebola vaccine, which this week moved to human clinical trials in 20 healthy volunteers at Walter Reed Army Institute of Research in Maryland. The animal rule, according to Geisbert, requires only that scientists demonstrate that a compound is effective in an animal model of human disease, in this case monkeys.