Posted on August 7, 2014 at 12:08 AM
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. They also permit expanded access for large groups of patients who do not have other treatment options available, once more is known about the safety and potential effectiveness of a drug from ongoing or completed clinical trials.”
Two additional ethical questions arise at this point. One is prioritization for that access and the second is the obligations of the drug company that manufactures this drug.
Prioritization and Guidelines
Why did the two Americans in Africa get access to the drug rather than any one of the 1,600 West Africans infected with the Ebola virus? How was that decision made? One hopes that it was on the basis of sound moral reasoning and not just biased affinity for Americans by Americans. A Utilitarian would certainly make decisions based on efficacy—and one might argue that the treatment was more likely to be effective on the Americans given the medical infrastructure and support those two patients would have here the U.S. relative to patients in hospitals in Africa. But Utilitarians have one view of justice (or the right thing to do). A certain sort of Egalitarian might push for a different one: equality of opportunity—or at lest, no causes of inequality that are arbitrary (such as what country one happens to live in). But one common ground that we can all (many) agree on is procedural guidelines for how these decisions are made and how these conversations should go. Norm Daniels has articulated some: the publicity condition (of decisions and rationales), the relevance condition (appeal to reasons and principles accepted by most people who are stakeholders), the appeals condition (mechanism for challenge), and enforcement (external oversight to make sure this process is happening). Similarly, moral political philosopher Gerald Cohen called for an “Interpersonal Test” that could serve as a justification of the policy in question to any member of society—we need to be able to fulfill a demand for justification since we live in a “justificatory community” (Cohen’s Rescuing Justice and Equality, Chapter 1).
Obligations of the Drug Company
A final issue that I will briefly comment on is the obligations of the drug company (in this case Mapp Biopharmaceutical Inc.). My understanding is that they had only produced 3 doses. They made those available. Presumably under a compassionate use request. Were they obligated to do that? Are they obligated to mass produce and do more? Legally, and from a regulatory standpoint, they are obligated to move through the phases of testing appropriately. But ethically, might this be a case of easy rescue? I have no idea how much work or man power it takes to produce this drug, but generally many people think that if we could easily prevent another person’s death or suffering then we ought to do so. And if I am in a special position to do that, then all the more so. Now again, there are costs…perhaps this would take too much company energy and they would have to abandon other important work that would also do good…then there are additional reasons not to do it in addition to the fact that it is not so easy.
Of course, if we decide access is justified and work out supply or prioritization issues, there will be additional complexities with consent, especially with avoiding the therapeutic misconception. But consent concerns are among the lesser of the worries here….