Ethicists to mull using untested drugs for Ebola patients

The World Health Organization is convening a panel of medical ethicists this week to discuss the knotty issues surrounding the use of unapproved and untested drugs in treating victims of the widening Ebola virus outbreak in Africa.

The ethicists will consider questions raised by the recent extraordinary treatment of two infected U.S. healthcare workers in Liberia who were given the drug ZMapp, produced by San Diego-based Mapp Biopharmaceutical. The drug has not been approved by the Food and Drug Administration and has not even been tested in humans for safety. The two patients are still alive, even though Ebola kills most victims.

Some experts say it’s a bad idea to administer the drug without adequate testing because it will hurt scientists’ ability to determine whether it’s safe and effective. But pressure is mounting. The Nigerian government has asked the Centers for Disease Control and Prevention for access to ZMapp.

“We are in an unusual situation in this outbreak,” said Marie-Paule Kieny, assistant director-general of the WHO, which does not regulate drugs but provides guidance when public health emergencies arise. “We have a disease with a high fatality rate without any proven treatment or vaccine. We need to ask the medical ethicists to give us guidance on what the responsible thing to do is.”

ZMapp is one of three experimental Ebola drugs being considered for use in Africa as the virus continues to spread. Last week, the FDA eased its hold on clinical testing of the Ebola drug treatment TKM-Ebola, made by Canada-based Tekmira Pharmaceuticals Corp., to allow for studies on infected human patients.