Would you allow scientists
to expose you to the novel Coronavirus
if it would speed up vaccine development?
Nearly 40,000 people from
more than 160 countries
have signed up to express interest in doing just that.
As the world waits for the results of traditional vaccine trials,
in which participants come into contact
with the virus naturally,
human challenge trials would deliberately expose a much smaller sample of young, healthy volunteers,
potentially cutting the
study time by several months.
But this approach is controversial among some public health officials and bioethicists,
because it would allow participants to put their own health at risk, without a foolproof rescue therapy.
And this debate relates to a longstanding divide over whether people in low risk groups
should be allowed to jeopardize their own health to save the lives of others, and even get paid for doing so.
To save one day, you know to me, ethically, that's a no brainer.
Josh Morrison is a 34 year old former corporate lawyer, who founded the nonprofit 1 Day Sooner
to advocate for human challenge trials.
If this approach speeds up
the availability of a vaccine, even by a single day,
Morrison argues it's worth pursuing.
If you're moving the calendar forward by a day, we think that about 4500 lives around the world
is a reasonable starting point.
And that obviously doesn't include things like, the economic activity, or the secondary consequences
on the kids who go back to school,
and the other illnesses that
people who are dying of those
because hospitals are
not able to treat them.
Morrison got involved
with challenge trials
through his work trying to
solve the kidney shortage.
He founded the nonprofit WaitList Zero
after donating a kidney himself to a stranger in 2011.
When the Coronavirus pandemic started,
Morrison recognized the parallels between challenge trials and kidney donations.
They're both ways for healthy volunteers to accept a small amount of risk
to save the lives of the more vulnerable.
It's definitely a thing with real risks. At the same time, we let people do things that are uncertain all the time,
and a lot of people say the risks to healthcare workers during the Coronavirus,
were uncertain, and still to some extent are uncertain.
To the best of our knowledge with available data, those risks are gonna be lower than
other risks we let people take.
Like childbirth, for example, or kidney donation.
It's not just a matter of, well we think the
benefits exceed the risks,
and it's also not just a matter of, well it's the person's own choice.
I think it's, I think that you need to hit both of those bars.
But Dr. Anthony Fauci of The White House Coronavirus Task Force indicated in July that the government
has no plans to encourage or move forward
with its own challenge studies
since the current infection rate in the U.S. is high enough to conduct traditional trials quickly.
Morrison says this view is shortsighted,
since challenge studies could still speed the development of multiple second generation vaccines,
that would be safer, more effective, and easier to distribute around the world than the first ones approved.
He also thinks U.S. officials shouldn't be counting on high infection rates to continue.
As an American, I think it would be a shame to just assume that people are gonna keep getting infected
at the rate they're getting infected now,
and that we can't accomplish what the rest of the developed world has accomplished.
So I think that saying, oh, well, we don't need challenge studies because
we're pretty sure there's gonna be a lot of transmission,
and a lot of people in America are gonna get sick and die.
I think that seems misguided.
Better to have it and not need it, than need it and not have it.
Conducting a challenge trial also requires FDA approval, but an official at the agency said in July
that this approach could
cause quote ethical heartburn,
because if something bad happens, you don't have a perfect fix for it.
Economists are accustomed to thinking about trade offs, it appears that at least
some parts of the ethics community, they are not.
Dr. Alvin Roth is a Stanford economist who studies repugnant transactions,
or exchanges that many people don't think others should be allowed to make.
He's one of fifteen Nobeloriate's who signed an open letter published by One Day Sooner,
urging the National Institutes of Health to prepare for challenge trials.
Roth analogizes allowing well informed individuals to get infected with the coronavirus
to letting firefighters run
into a burning building.
If you just wait 'til it burns itself out, you put lots of people at risk.
And so we pay firemen, to take additional risk, to go into the building.
He points out that traditional vaccine trials carry their own risks.
Unlike in challenge trials,
participants don't have the benefit of constant medical evaluation and first rate care.
And in a normal trial, thousands of participants get a placebo, meaning they can both get infected,
and infect other people.
They may even engage in riskier behaviors if they think they've been vaccinated.
Challenge trials, particularly when there are multiple vaccines to be tested,
you could have the different vaccines be the conditions of the experiment.
Instead of saying, some people get the vaccine, and some people don't.
You could say, some people get vaccine A, and some people get vaccine B.
Roth received his Nobel Prize in 2012, in part for his work applying market principles to kidney donations.
It's illegal to pay donors in the U.S., so he came up with way of encouraging them without direct compensation.
By using Roth's insights, policymakers were able to increase living donations by around 20%,
but tens of thousands of people still die each year in the U.S. due to the kidney shortage,
and Roth says that paying donors could save many more lives.
Though some fear that with this approach, poor or desperate people would be taken advantage of.
We pay people to become firemen,
who would not become firemen if we didn't pay them.
We should think about how to be appropriately grateful,
so that we're not exploiting the people who give us these things we need.
I don't think we feel that we're exploiting our fire fighters.
Public service is something we do compensate people for, and we do wanna treat people well.
And I think that is the commonality between kidney donation and being a challenge volunteer,
is this idea of public service,
where a lot of people see this idea of compensation, and they think that it's inherently exploitative,
and that it's treating people as lesser.
But it's actually the other way around.
With the world on hold waiting for results, thousands dying every day,
and hundreds of millions at risk of injury or poverty from the global pandemic.
Researchers at Oxford University, who were the first to enter traditional human trials with a vaccine,
have had trouble recruiting enough participants who are likely to become infected,
as the natural virus transmission rate in the U.K. has fallen.
They are currently racing to prepare a protocol for challenge trials
that can pass muster with Oxford's ethical review board,
with the aim of beginning
them by the end of the year.
I'm confident it will be approved, yes.
In the U.S., Reuters reported in mid August that partly due to the public pressure applied by 1 Day Sooner,
government scientists were
just starting to prepare
a protocol for challenge trials, two months after the NIH first said it would start that process.
But the agency still has not committed to moving forward with challenge trials.
And private efforts to develop a vaccine are following the government's lead.
It's certainly ethical to move forward, and allow people like myself and the other people
who work at 1 Day Sooner, who want to take this risk and make the sacrifice to be able to do so.
