by: J.S. Blumenthal-Barby
Yesterday I was contacted by the L.A. Times to answer a simple question: Should we give people access to the experimental Ebola drug, ZMapp?
The Drug and Clinical Trial Phases
So, I did a little digging to try to find out some more details about the drug. From what I could find in published news reports, the drug was developed by Mapp Biopharmaceutical Inc., with support from the NIH and the Defense Threat Reduction Agency. It has been tested on 8 monkeys. 4 of them were given the treatment 24 hours after being infected and all 4 survived. The other 4 were given the treatment 48 hours of being infected and 4 of those survived. One monkey was not treated and died. Ebola has a morality rate of 50-90%. From what I could gather, the drug had not been tested on any human yet. In research ethics lingo, it had not even gone through Phase 1 trials (to test safety and toxicity), let alone Phase 2 (to test efficacy) or Phase 3 (further, RCT, testing of safety and efficacy) trials.
Access and Compassionate Use
Under what justification could we give people access to an experimental drug that has not even been tested for safety in humans? The ready justification is a “compassionate use” exception. From the FDA website: “Expanded access, sometimes called “compassionate use,” is the use of an investigational drug outside of a clinical trial to treat a patient with a serious or immediately life-threatening disease or condition who has no comparable or satisfactory alternative treatment options. FDA regulations allow access to investigational drugs for treatment purposes on a case-by-case basis for an individual patient, or for intermediate-size groups of patients with similar treatment needs who otherwise do not qualify to participate in a clinical trial.
The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.