The Ebola outbreak in West Africa was first reported in March 2014. In the nearly two years that followed, more than 11,000 people infected with the virus died. Many spent their last excruciating days far from their families in makeshift medical units run by the international humanitarian group, Médecins sans frontières (MSF).
Queen’s University philosophy professor Udo Schuklenk spent several weeks visiting these units at MSF’s request. Schuklenk, who regularly advises governments and NGOs on ethics in health policy, was there to help doctors create a strategy around giving patients experimental drugs.
“They had access to unapproved drugs, but they had no ethics framework for giving them out,” he says. Schuklenk is the Ontario Research Chair in Bioethics, funded by an endowment from the government of Ontario.
At the time, medical researchers from around the world were asking MSF for access to its patients so they could enrol them in clinical trials for testing experimental drugs. As Schuklenk knew, there were serious ethical tradeoffs involved.
Clinical trials generally require large numbers of participants. Giving patients access to experimental drugs regardless of trial participation can mean not enough volunteers to run a study. But insisting desperate patients enrol in order to receive experimental treatment amounts to coercion and violates a basic standard of medical research: that participants are true volunteers.
Also, trials involve randomly assigning patients to one of two groups—the one receiving the experimental drug, or the one receiving either a placebo or a known unsuccessful drug. It’s only by comparing the outcome of each group that researchers can assess the effectiveness of their experimental drug, and develop potentially life-saving treatments.
The risk is that gravely ill trial participants can be randomly assigned placebos, or a known unsuccessful treatment, and die. “One of the biggest problems MSF had was that patients had no education and so couldn’t give informed consent to trials,” says Schuklenk. “Also, it wasn’t clear who could give consent on your behalf. Families were far away in their villages and probably didn’t understand (the implications) and authorities were not to be trusted.”
Schuklenk helped MSF doctors weigh the pros and cons, and then recommended they give patients experimental drugs without requiring them to take part in trials. But even had he recommended otherwise, medical researchers would have had little opportunity to assess their treatments. The average risk of death amongst those infected with the virus in West Africa was more than 50 per cent. The illness worked quickly, killing most potential study participants in short order. By the time researchers developed drugs that were ready to be tested on patients, there weren’t enough infected people to run a robust study.
Schuklenk developed his thinking on the ethics surrounding clinical trials during the height of the AIDS epidemic in the 1980s. “I’m a gay man and I grew up in that time. People my age who had AIDS died pretty shitty deaths,” he says.
Many AIDS patients in that era reported feeling pressured to enrol in clinical trials in order to receive unproven drugs. Medical researchers didn’t create the problem, says Schuklenk, but they did exploit it.
“A lot has changed since those days,” he says. “In Canada, we now have programs that provide patients access to experimental drugs, provided companies will part with those drugs.”
While Schuklenk makes the case for the moral right of gravely ill patients to access experimental drugs regardless of their participation in trials, he points out that the clinical trials process did eventually yield effective drugs for HIV, the virus that causes AIDS. In fact, he argues people have an obligation to participate in clinical research.
“But if you are most certainly going to die, this is probably one of the last decisions you’ll make and I’m not taking that away from you,” he says.