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The Ethics Of Coronavirus Vaccine Trials In Developing Countries

SACHA PFEIFFER, HOST:

Now we're going to turn our attention to an ethical debate emerging as researchers rush to develop a COVID-19 vaccine. Large-scale vaccine trials have begun in several places around the world. Oxford University is leading research in a number of countries, including the U.S., Brazil, India and South Africa. Some of them have already begun. And this week in South Africa, demonstrators burned facemasks and questioned whether the vaccine trials would use poor and vulnerable people as guinea pigs.

My next guest has written extensively about ethical questions surrounding the testing of new drugs and vaccines in the developing world and on minority populations here in the U.S. Harriet Washington is a medical ethicist and author of the book "Medical Apartheid."

Harriet Washington, thanks for making time to talk with us.

HARRIET WASHINGTON: Thank you, Sacha.

PFEIFFER: Could you first lay out for us the rules for conducting vaccine trials in humans? So what guidelines to researchers have to follow, and do they vary by country?

WASHINGTON: Well, they do indeed vary by country. There are certain types of research that don't take place in this country, that are frowned upon here, that are allowed in the developing world. In this country, placebo studies are frowned upon. That is, if you have a really serious disorder, something that can be fatal or disabling, and there's a treatment for it, the trial has to be designed to include that treatment so that nobody ends up getting no treatment for the disease.

In the developing world, you have to get the standard of care that's available to you in that country. In many of these countries, the standard of care is nothing. So it effectively means that trials that would not be permitted here or that at least would undergo a greater ethical furor here can be legally conducted in the developing world.

PFEIFFER: Some of the protesters in South Africa brought up the ugly history of medical trials in Africa. Some of those caused great harm to people who took part of them. Do you think it's reasonable for the protesters to be suspicious today?

WASHINGTON: I think it's only due diligence to be suspicious. And we're not only talking about ancient history. There have been some rather - relatively recent developments that have shown a great abrogation of ethics - you know, complete abandonment of ethical principles.

In particular, during apartheid, there was an entire branch of government devoted to what the doctors who ran it called the war against anti-apartheid people. One of their stated goals - openly stated - was to develop contraceptives that could be administered surreptitiously to Black people and render them infertile without their knowledge.

PFEIFFER: A eugenics kind of approach.

WASHINGTON: Yeah - worse than eugenics. This was more. This was also administration of agents that were harmful to people - you know, poisons. They distributed T-shirts in the homelands - to which Blacks were relegated - that had been infused with poison. All this came out in Truth and Reconciliation trials. If I lived in South Africa, I'd be quite wary, too.

PFEIFFER: We mentioned that vaccine trials are also happening in Brazil, which has been hard-hit by the coronavirus. And I read something that was really interesting to me. It said that some Brazilians say they appreciate the opportunity to be involved in vaccine trials because they think they could benefit from it - maybe get a vaccine sooner or cheaper.

I don't think they all share the view, but I wonder, are they right to think that there are tradeoffs? We take risks by doing this, but maybe in the end, we'll get more vaccine, or we'll get an inexpensive or free vaccine, is that could be the gamble they take.

WASHINGTON: Often, vaccine trials in the developing world - elsewhere too, but mostly in the developing world - they're often justified or promoted with the idea that the people in that country have a high rate of the disease that you're trying to cure. And, of course, it sounds quite noble, and sometimes I'm sure it is noble.

But other times, this rationale rings hollow when you see what happens because it elides the distinction between treatment and research. Research by definition does not guarantee safety or efficacy. It may work. It may not. It may be helpful. It could just as easily be harmful. That's why we're conducting the research. We just don't know.

So you can't present it as an unalloyed benefit. People there are still taking a risk. And in my opinion, they often are taking a higher risk. What happens when drugs are tested, found be efficacious and safe and then go on the market? These people who have been subjects are usually barred from the drug. It's priced beyond their ability to pay it. So if the drug works, will they have access to it afterwards? Typically, the answer is no.

PFEIFFER: What's your major piece of advice for how we make sure that people around the world equally benefit from vaccine trials but are also not experimented on? How do we do this the best way?

WASHINGTON: These are Western universities, pharmaceutical companies, institutions, and so Western oversight is necessary. The FDA and other groups should be providing oversight. They should be checking documents, making sure there's informed consent, making sure that everything happens as it should happen. When you're not doing that, you're leaving the field wide-open for abuse.

The other thing that we really need to do is to reform patent law. We should not be demanding high prices of people in developing countries who have a relatively low income. They've actually made it possible for us to have these medications. The subjects took the risks, the doctors and health care workers there conducted the studies, all at a very low price, all cheaper and more quickly than they can do it in the U.S. To me, that means that we're in their debt.

PFEIFFER: Harriet Washington is author of "Medical Apartheid: The Dark History Of Medical Experimentation On Black Americans From Colonial Times To The Present." And she's a lecturer in bioethics at Columbia University.

Thank you for talking with us.

WASHINGTON: Thank you, Sacha.

(SOUNDBITE OF NYM'S "WE WERE NEVER THERE") Transcript provided by NPR, Copyright NPR.

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