It didn’t matter to me – I was in it for the science. –GLaDOS.
Science provides us knowledge. But—for most—science and the knowledge it brings isn’t the only or most important thing out there. Modern biomedical ethics is built upon, among other seminal statements, the Declaration of Helsinki, which states that:
While the primary purpose of medical research is to generate new knowledge, this goal can never take precedence over the rights and interests of individual research subjects.
That’s one of the reasons it was so concerning to stumble across a new article on Scientia Salon, brainchild of CUNY Professor of Philosophy Massimo Pigliucci, in which it was argued that anyone who wants to receive an experimental treatment for the Ebola virus must enroll in a placebo-controlled, randomized clinical trial. The author, evolutionary biologist Joanna Monti-Masel, claims that
The unethical behavior here…is not doing an experiment, but doing an experiment without using a control group. There should be no compassionate use exceptions. Everybody who wants these treatments should have to enter a randomized trial to have a chance of getting them.
…At least five patients have received a potentially effective treatment, but nobody has yet been assigned to a control group. This is the ethical travesty, and it needs to stop.
For those catching up, the Ebola outbreak that is believed to have started in December of 2013 has infected 1,975 people, and killed 1,069. Last week, the WHO declared that the outbreak constituted an Public Health Emergency of International Concern; this week, a WHO ethics advisory committee released a statement approving the use of unregistered interventions for Ebola. Kelly Hills and I have written on the ethics of latter part here.
Monti-Masel, however, thinks that the WHO is acting unethically by allowing for “compassionate use,” which the WHO is defining here as access to an unapproved drug outside of a clinical trial. Rather, she argues, anyone who wants access to these new drugs must be part of a clinical trial.
And not just any trial. Monti-Masel believes that the only way we ought to collect data about these experimental interventions is by setting up a double-blind, randomized clinical trial in the middle of an epidemic in West Africa. That is, we offer those suffering from Ebola—which is primarily killing vulnerable members of the nations of Sierra Leone, Guinea, Liberia, and Nigeria—something, which may or may not be a drug that may or may not work, or might be a sugar pill. We don’t tell them which one it is, because we won’t know which it was until after the fact. We then determine who gets better, and which ones get worse. And if that isn’t what the patient wants, then they get nothing.
Science for the sake of science
It is worth noting, first up, that Monti-Masel is reacting to a hypothetical storm in a nonexistent teacup. Aside from the WHO ethics committee’s general recommendations that data collection is necessary, but must be collected and shared ethically and equitably, there’s nothing else to suggest what types of data collection, and study design, might be permissible. Moving immediately to the need for control groups and randomized trials presumes a lot about the WHO’s mild statement, and jumps the gun on a lot of serious ethics that has to happen before—and has to involve the countries that are actually in the middle of this outbreak.
But more importantly, Monti-Masel fetishizes data collection above and beyond any other consideration. The main benefits she cites is the power of the studies that could be achieved through a randomized trial. All other concerns are secondary, it seems, to the possibility of doing accurate—not good—science.
But that’s wrongheaded; more, it is paternalistic and racist—to say nothing of deeply myopic—to presume that the central purpose of these interventions ought to be to collect data. Collecting data is necessary; collecting data is good. But the ways in which collect that data, and the quality of data we should aim for, must be subject to the central aim of these interventions: “to try to save the lives of patients and to curb the epidemic.”
Requiring participation in a randomized, placebo-controlled clinical trial in order to access these drugs is deeply paternalistic. It presumes that the priorities defined by Monti-Masel’s hypothetical study are not only the best for the scientist, but the best for everyone. It doesn’t even consider that the people of a country embroiled in an Ebola epidemic might not want to participate in a placebo-controlled trial. Indeed, Monti-Masel claims that compassionate use outside of a clinical trial would be “an ethical travesty” because it would give us lower quality data for lack of a suitable (placebo) control group.
That reduces the patient to a mere data point. Considering the lengthy history of drug testing in African countries that leave the communities in which they are tested worse off, it is not hard to detect the racism implicit in such an extreme study design. History is rife with contributions “to the legacy of black bodies being manipulated and violated for ‘the benefit of all.’” To be ethical, research—even in small samples such as must occur with the limited experimental agents present for this outbreak of Ebola—must take into account practices that respect the agency and priorities of the participant. People are not simply data points; vulnerable populations are not simply a convenient supply of test subjects.
Finally, advocating placebo controls simply misses the ethical forest for the trees. Monti-Masel claims:
One final concern is that many Africans are suspicious of Western doctors and experiments, and that their fears will keep them away. That’s fine, at least for now. That’s what the ethical principle of autonomy is about, crystallized in the notion of informed consent.
Rather, we should simply let those prospective patients know that if they want a chance at accessing an intervention, they have to enroll. If not, they are just out of luck—a move that is, as already discussed, paternalistic and racist. This doesn’t concern Monti-Masel, however:
Plenty of infected Africans will probably refuse to take part in the trial. That’s okay, because we don’t have enough treatments to go around anyway.
This completely misses the point of the “suspicion of Western doctors” about which people are concerned. To know why, ask this question instead: what happens when it becomes clear that Western doctors are only offering the hope of drugs if you’ll sign up to their trials? In an outbreak in which people are already avoiding reporting cases, or hiding loved ones that are infected with the virus; for a disease that, historically, has generated mistrust in Western interventions; what does Monti-Masel think the impact of a placebo-controlled trial will be for the outbreak as a whole? I know there are no RCTs on that topic, but any student of history would be able to tell you that things will go downhill fast. Trust is a vital element in a public health intervention. Jeopardizing that trust in the name of a small trial values the data above the lives of everyone in the outbreak.
This is a disappointing article in Scientia Salon. The submission itself is problematic; the comments are horrific. One hopes that in the future the site will look closely at submissions, in light of the enthusiastic endorsement of enforced autopsies that has resulted from this post. There is power in the platform, and in the middle of an outbreak this is not a productive contribution.
Doing better means asking, not telling
Hills and I have already argued, at length, about the ethics of distributing these drugs. We’ve advocated that those “who have traditionally and unjustly held power over African nations, step back and accept our role as people to provide assistance, rather than determine it.” It isn’t surprising that Monti-Masel’s reply has struck the worst possible chord.
Moreover, there is still good science that we should be doing, in partnership with the countries that are the site of this outbreak. Giving up the fetish of the placebo control group doesn’t mean giving up on trials, or good research. It just recognizes that certain kinds of study are unethical to pursue in the context of a dangerous disease outbreak, among a vulnerable population that are prone to exploitation by Western powers.
At the end of the day, we want science to be commensurate with other important values. Making science—one type of science—the be-all and end-all of our ethical considerations takes the very important role of knowledge in promoting human health, wealth, and security, and perverts it. We do not want to be like GLaDOS, the super-intelligent, passive aggressive antagonist of the Portal franchise.
Our motto should never be:
I’ve experiments to run,
There is research to be done;
On the people who are still alive.