Challenge Trials Are a Poor Substitute for an Effective Pandemic Response

Jessica Flanigan defends the use of challenge trials for COVID-19. These trials would expose volunteers to the virus in order to hasten (better) vaccines and therapeutics. Flanigan emphasizes the huge amount of good such trials can do—they can save lives and end our lockdowns sooner. But she also says we should allow people to volunteer for such trials because it would be objectionably paternalistic to disallow this, given the benefits of such participation for them and for society more broadly.

I want to take issue with Flanigan’s claim that challenge trials would do a huge amount of good. The benefits of such trials are much smaller than Flanigan makes out. She writes: “As people die of COVID-19, it may look like they are dying from a deadly respiratory disease, but they are actually dying because of a failed policy response.” By a failed policy response, she is referring mainly to “excessive caution” in medical testing and trials. She concludes her piece with the following: “It is heartbreaking that more than half a million Americans have died of COVID-19, due largely to the needless delays associated with administrative incompetence and excessive caution.”

This is highly misleading. It is indeed heartbreaking that so many Americans have died of COVID-19, but it is unfair to attribute this to a lack of challenge trials. So many Americans have died of COVID-19 because the U.S. government has failed to properly protect its citizens, with adequate PPE and effective testing, contact-tracing, and strict lockdowns. If the U.S. government had followed the advice of leading experts, as governments in Australia, New Zealand, Taiwan, and others have done, hundreds of thousands fewer Americans would have died. The fault here lies not with medical, but with political, conservatism.

Some defend the actions of the U.S. government on the grounds that lockdowns destroy economies. But lockdowns are only part of the correct policy response to COVID-19. Equally important are adequate PPE, testing, and contact tracing. In any case, economies do not surge back while the virus is still rampant. Too many people are scared to return to shops and work. Strict, targeted lockdowns, accompanied by PPE, testing, and contact tracing, are a much better way of reviving economies. They do so by bringing case numbers to such a low level it becomes safe to open up again. As evidence of this, look again at the experience of Australia, New Zealand, and others.

It might be objected that it is far easier for island nations like Australia and New Zealand to suppress the virus using these measures. This is debatable. But even if it is true, the United States could still have saved hundreds of thousands of lives by implementing these measures more effectively and sooner. Mask mandates alone would likely have achieved this.

Consider, next, Flanigan’s claim that participation in challenge trials is actually in the best interests of some people in society, since many run a high risk of catching it anyway. But if this is true, it is true only (again) because governments have failed to properly protect these people. COVID-19, while highly infectious, is not as infectious as some had feared. It can be suppressed and controlled (as, again, the experience of countries like Australia and New Zealand bear out). If the U.S. government had acted swiftly and effectively, then people’s chances of catching the virus would be so low that it would not be in anybody’s best interests to take part in such trials. We should not allow people we have needlessly endangered to take part in something that could kill them, on the grounds that they are already endangered. Instead, we should be ensuring that people are not endangered in the first place, something which is eminently possible when it comes to this virus.

What about allowing people to volunteer for such trials who haven’t been especially endangered—say, effective altruists who have not had to physically work during this time? Flanigan says it is “disrespectful” or “paternalistic” to disallow such people from participation. She compares it to disallowing people to be essential workers right now, or to go rock climbing for fun. But there seem to me big differences here. We should allow essential workers to go to work right now because they are essential. Now more than ever we need doctors, nurses, police, food workers, and other essential workers. There is no alternative here. But we do not need people to take part in challenge trials. There is an alternative: follow the advice of experts, lockdown properly, and test vaccines in the normal way.

By letting effective altruists volunteer, we are still allowing some people to endanger themselves because we have failed to protect our citizens. This is bad for these incredibly noble volunteers, who would increase their risk of serious illness, but it is also extremely bad for the rest of us, as it lets us off the hook for not taking actions we should have taken. This encourages moral complacency and makes it more likely that in future crises we will again fail to take important steps to avoid catastrophe. The main reason for not allowing these people to volunteer for challenge trials is not out of a concern for them, but out of the need to ensure that in future times we do not take the easy way out by allowing some citizens to take big personal risks because we aren’t doing easy things (like wearing masks, physical distancing, and getting tested).

What about rock climbing? Well, by allowing people to go rock climbing, we are not letting anybody off the hook (if you’ll excuse the pun). People do not want to go rock climbing only because we have needlessly and culpably failed to protect some people in our society. They want to go because they find it enjoyable.

Are there any circumstances in which challenge trials could be okay for COVID-19? Yes. If there were no other way of developing a vaccine, then such trials would be permissible. Elsewhere, I have argued that if the United States were to properly lock down, test, contact trace, and the rest, and so brought case numbers so low that vaccines could not be tested in the normal way, then we could permissibly do challenge trials.

If the current batch of vaccines succeed in reducing case numbers to such a low level that we cannot test newer and potentially much better vaccines in the normal way, then we might be justified in conducting challenge trials. This would be—and here is the key point—because we wouldn’t be doing so only because we’d failed to properly protect some of our citizens.

One final point. Flanigan says that “racial justice and equity” speak in favor of allowing such trials. She writes: “Restrictions on challenge trials undermine racial and economic justice because low-income communities and communities of color are disproportionately harmed by the spread of COVID-19 and Black households are also disproportionately harmed by lockdowns too. For this reason, policies that impose further delays in vaccine development undermine racial and economic justice.”

It is true that low-income communities and communities of color are disproportionately harmed by the spread of COVID-19 and by lockdowns. But again, the fault here lies not with a lack of challenge trials, but with the grossly inadequate public policy response of the U.S. government. Had the United States put in place the measures I’ve mentioned repeatedly in this essay, and properly assisted those in lockdowns, these communities would not be suffering so greatly.

In any case, by calling for permission for already endangered members of the community to participate in challenge trials, Flanigan and other advocates of such trials are effectively calling to allow many disadvantaged Americans to be guinea pigs for the rest of us. This is not the right way to protect such people or groups. Good public policy is.

To sum up, my key point in this essay has been that so long as we are failing to take easy and proven measures to control this virus, we should not be allowing people to endanger themselves in such trials. Appeals to freedom of choice simply won’t cut it. This is because by conducting such trials, we endanger not only these individuals, but our whole society (its moral fabric), by making it less likely that we will take the sort of relatively easy measures prescribed by experts to avoid future crises.

Also from this issue

Lead Essay

  • Jessica Flanigan says much of the suffering of the past year might have been avoided had vaccines been available earlier, and this could have been the case in a culture and regulatory environment that supported and welcomed human challenge trials. Flanigan argues that bureaucratic foot-dragging and excessive caution on these matters have been some of the most serious contributors to the severity of the pandemic, and that ethicists and researchers should bear this in mind for the future.

Response Essays

  • Ben Bramble argues that challenge trials would be less of a help against COVID-19 than we may suspect. He adds that the real lost opportunity for the United States in the last year was that the United States never acquired sufficient personal protective equipment and failed to implement contact tracing and a strict, nationwide lockdown. If such measures were in place, the pandemic might have been kept at bay, but the fact that they were not implemented does not warrant turning humans into guinea pigs.

  • Charles Weijer says that it’s impractical, unethical, and simply dangerous to expose healthy volunteers to the virus that causes COVID-19. Promises of faster vaccines and greater knowledge about the virus are illusory because the necessary safety measures and experimental protocols can’t even be considered, much less designed, in the absence of good data. This makes human challenge trials fundamentally unworkable.