Via The Globe and Mail, an op-ed by Jim Lavery, managing director of the Ethical, Social and Cultural Program for Global Health at St. Michael's Hospital in Toronto: Ebola drugs and ethics: When need dictates action. Excerpt:
In truth, it is unlikely that any new drugs will have a big impact on the current outbreak. The main ethical obligation is to safeguard the affected populations by ensuring the best possible public health containment effort.
Even so, while the public health response gathers strength, we should behave as though ZMapp and TKM Ebola might save lives. But any serious effort to provide these experimental treatments to African patients must satisfy a daunting set of conditions:
1. A consortium of experts to iron out technical and logistical details, including financing, manufacturing capacity and standards, and delivery plans;
2. Ideally, the WHO would assume some role as a governing authority for the initiative;
3. From the start, there must be meaningful partnerships and collaboration, not only with the affected countries’ governments and their ministries of health, but with the local communities bearing the brunt of the outbreak;
4. A carefully crafted research plan to ensure that we learn as much as possible and can make valid scientific conclusions that will benefit future patients;
5. Provisions for careful monitoring to identify any negative effects quickly (if the experimental treatments saved some people but made things worse for others, it could actually increase the mortality rate for the outbreak);
6. Despite the incredibly difficult circumstances, patients would have to understand that they were receiving an experimental treatment and consent to the injection.
We have stringent rules for drug testing and research ethics for a reason. But there are also circumstances in which it is not appropriate for humanitarian action to be blocked by regulatory procedure. This is one of them.