ZMapp has not been approved for human use, and has not even gone through the clinical trial process, which is standard to prove the safety and efficacy of a medication. The process by which the medication was made available to Brantly and Writebol is highly unusual. It may have fallen under the U.S. Food and Drug Administration’s “compassionate use” regulation, which allows access to investigational drugs outside clinical trials.
Getting approval for compassionate use is often long and laborious, but in the case of Brantly and Writebol, they received the medication within seven to 10 days of their exposure to the Ebola virus.
On July 30, the Defense Threat Reduction Agency, an arm of the military responsible for any chemical, biological, radiological, nuclear and high-yield explosive threats, allotted additional funding to MAPP Biopharmaceutical due to “promising results.”
Frankly, I’d prefer that these poor people had died, rather than being given special exemption from the deadly regulatory hoops the rest of us have to jump through.