Jim Lavery is managing director of the Ethical, Social and Cultural Program for Global Health at St. Michael’s Hospital.
When it came to light that Mapp Biopharmaceuticals Inc. of San Diego had a product in development that was designed to hold the Ebola virus in check and limit its destructive activity, it upset the consistent storyline for dozens of Ebola outbreaks since its discovery in the 1970s: Up to 90 per cent of those infected die, there are no treatments or vaccines, and little cause for hope.
ZMapp, as the new product is called, is not a cure. It acts more like a sump-pump to limit flood damage in your basement until the storm is past. But it is a glimmer of hope in an otherwise bleak situation.
In a plot line that could have been penned in a Hollywood studio, two American humanitarian aid workers were flown from the heart of the outbreak in Liberia to Atlanta. Both received an infusion of ZMapp. The World Health Organization and the world’s media quickly questioned whether it was right that these Americans, alone, should receive ZMapp, while hundreds of Africans infected with Ebola can do nothing more than suffer and wait to see if they beat the odds. The questioning intensified when reports emerged that an infected Spanish priest had also received ZMapp after being evacuated from Liberia to Spain, where he later died.
But is it true that “Ebola patients in West Africa are to be denied experimental drugs used in the U.S.,” as a recent headline in The Guardian newspaper proclaimed? Compassion requires that we not turn our backs on African patients, but we must not fall prey to simplistic arguments.
When news of ZMapp broke, and before it was administered to the Americans, I would have advised against its widespread distribution to infected Africans. ZMapp had never been given to a human being and therefore there was no human evidence of either benefit or safety. ZMapp is also not an easy product to make, handle and administer.
More importantly, I was concerned that offering ZMapp would inevitably fuel unrealistic hopes around the world. People in low- and middle-income countries have had their hopes dashed too many times in the past by grand gestures from rich countries. It is utterly disrespectful to offer people hope without the means and the will to follow through.
But when the two Americans were given ZMapp it was a game-changer for me ethically. There is no way to know whether ZMapp had anything to do with their survival, but the ethical dilemma springs to life here because we can’t simply presume that it didn’t. And, as if to prove the point that real ethical challenges are rarely simple, it has now come to light that Tekmira Pharmaceuticals Corp. of Burnaby, B.C., has received approval from the U.S. Food and Drug Administration to move its anti-Ebola drug, TKM Ebola, beyond safety testing in healthy people to tests in patients with the disease.
What should happen next?
On Aug. 12, the WHO posted a preliminary summary of the recommendations of an expert panel convened in Geneva. Predictably, and appropriately, in my view, the panel advised that “it is ethical to offer unproven interventions with as yet unknown efficacy and adverse effects, as potential treatment or prevention.”
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.
Jim Lavery is an associate professor in the Dalla Lana School of Public Health, University of Toronto