We look at the history of clinical vaccine trials and exploitation of vulnerable people in the U.S. and India, which recently surpassed Brazil as the country with the second most infections worldwide. Kaushik Sunder Rajan, an anthropologist at the University of Chicago, says there is a documented history of “ethical lapses” and lack of accountability in vaccine studies in India. “The critical issue here is not whether vaccines are good or bad, but … even more, I would suggest what is at stake is a democratic public health,” he notes.
AMY GOODMAN: This is Democracy Now! The Quarantine Report. I’m Amy Goodman, with Nermeen Shaikh, as we continue to look at medical experimentation and also how COVID-19 vaccine trials are unfolding globally. On Wednesday, India reported nearly 96,000 new COVID cases, a new daily record, just two days after it surpassed Brazil as the country second hardest hit by the virus, after the United States. This comes as the Indian company enlisted to manufacture a billion doses of AstraZeneca’s experimental COVID-19 vaccine is pushing ahead with its own clinical trial, even as safety concerns led the British drugmaker to halt its tests this week.
For more, we are also joined by Kaushik Sunder Rajan, professor of anthropology at the University of Chicago, author of the book Pharmocracy: Value, Politics, and Knowledge in Global Biomedicine. And we’re still joined by Harriet Washington, the medical ethicist, author of Medical Apartheid: The Dark History of Medical Experimentation on Black Americans from Colonial Times to the Present.
Before we are also talking to Professor Rajan, Harriet Washington, you mentioned Pfizer in Nigeria. It’s a notorious 1996 drug experiment that Pfizer conducted on sick children in Nigeria, when researchers selected 200 children at an epidemic hospital for an experimental trial. About a hundred of the kids were given an untested oral version of the antibiotic Trovan. Researchers did not obtain signed consent forms. Medical personnel said Pfizer did not tell their parents their children were getting the experimental drug. Eleven children died. Others suffered disabling injuries, including deafness, muteness, paralysis, brain damage, loss of sight, slurred speech. After an 11-year legal battle, Pfizer paid compensation to four families. About 10 years ago, we spoke to Musikilu Mojeed, a Nigerian journalist who worked on this story for the NEXT newspaper in Lagos. He described what Pfizer did in Nigeria.
MUSIKILU MOJEED: Pfizer just went in, you know, briefly, and there was so much confusion in Nigeria. Nigeria needed help. There was this epidemic. The country just needed help from wherever, you know. And Pfizer came on a humanitarian ground. Nigeria accepted. And at the time, we had military dictatorship. Things were so bad. There was no order in the country. There was no proper procedures whenever following most of the things that happened at the time. So, really, at the time, Nigerians were grateful to Pfizer, and we never knew, until it broke out in the press several years later, and Nigerians were really, really outraged.
AMY GOODMAN: That’s Musikilu Mojeed, a Nigerian journalist who worked on this issue. Medical apartheid, global, I guess you could say. Tell us further about why you think this is such a critical experiment for us to understand today.
HARRIET WASHINGTON: Well, it’s actually one of many. Research design in the developing world is supposed to be governed by the same laws as the U.S. Researchers are supposed to adhere to U.S. law. The problem is, there’s little or no oversight. We only take researchers’ word that they are conforming and making sure there’s informed consent. And abuses such as happened in Kano, Nigeria, show us that sometimes people lie. A doctor admitted having deceitfully claimed that there had been the certification that was required. They forged the form after the research was already conducted. And so, abuses abound because there’s very little oversight and because there’s a different attitude toward people in the developing world.
I think the best illustration of that in regard to coronavirus-19 is what happened in April, when two French doctors suggested, quite openly, that trials, that were ethically troubled because they were placebo trials, falling out of favor in the West, be brought to Africa instead, where there were abundance of subjects who had no medical care and would grasp at whatever straw was offered them, and it could be conducted on people like prostitutes. So, this kind of — there was a lot of outrage over their statements, but what they were saying is something I have seen stated in medical journals repeatedly. They’re not the only ones saying this. And more to the point, they’re not the only one doing it. The research conducted in the developing world often dispenses with informed consent. A variety of excuses are offered for it. And sometimes researchers are not honest about what they have done.
NERMEEN SHAIKH: Professor Kaushik Sunder Rajan, if you could comment on what Harriet has just said, and talk about some of your concerns with clinical trials being held among vulnerable populations, not just here in the U.S., but around the world, including India, where you’ve studied them?
KAUSHIK SUNDER RAJAN: Sure, Nermeen. And thanks for having me on. It’s a pleasure to be on the show.
So, you know, it’s ironic. Nine years ago almost exactly to this day, you may recall that Michele Bachmann was on a tirade against the HPV vaccine in the Republican primary. And Bachmann’s anti-vaccine position was roundly and correctly condemned by scientists and the public health community. And it highlighted — but at the very same time, a major scandal was erupting around some experimental demonstration studies of the HPV vaccine in India. So this highlighted the fact that they are good reasons to be concerned about clinical trials in vaccines, but they’re not Michelle Bachmann’s reasons.
So I want to start by saying here that the critical issue is not whether vaccines are good or bad, but, as you’ve already talked about, some of the ethical issues surrounding their production, their distribution and rollout. But even more, I would suggest what is at stake is a democratic public health, because if we think about something like the HPV vaccine studies in India, the key question was about accountability: Who is held accountable by whom and how?
These studies were demonstration studies on the vaccine being conducted prior to the rollout of the vaccine as part of India’s national immunization program. And in the process, seven girls who belonged to Indigenous populations, who were on the study, died. Now, it was never established that the girls died because of the vaccine or because of the studies, and it’s quite possible that there was no correlation. However, commissions of inquiry set up after the study showed substantial procedural violations had occurred, including failure to obtain adequate consent for the studies from the parents of the girls. There were multiple institutional entities involved in the studies, both Indian state institutions but also U.S. not-for-profits, including the Gates Foundation-funded Program for Appropriate Technology in Health, or PATH.
And for me, the critical issue here is, of course, that there were ethical lapses — that is serious. But it was also that no one was held accountable, in spite of sustained civil society advocacy and media attention. And some of this is because these clinical studies are so extensively brokered, with so many different kinds of public and private entities insourcing and outsourcing both the science and the ethics, that responsibility becomes almost a kind of shell game. So it’s very hard, unless there’s gross intentional fraud, to say this is this entity’s fault.
But the other part of it is that when the studies erupted in scandal, PATH didn’t show up. They issued vehement defenses of their action in Western public health journals and to colleagues here, but civil society and community health advocates in India never got the answers that they were demanding. And that, more than anything else, is the lingering ground for anger, which is that you can’t have a genuinely public health without genuine public accountability.
NERMEEN SHAIKH: And, Professor Sunder Rajan, also if you could talk about the question of access? The people who participate in clinical trials for these vaccines are not necessarily those who first get the vaccine once one is approved.
KAUSHIK SUNDER RAJAN: Yes, I think that’s potentially true. And I think that if we’re thinking about COVID, for instance, questions of manufacturing scale-up, distributive justice, rollout, supply chain — all of these are going to be nightmarishly complicated logistical questions.
But I think you’re raising a more fundamental point, which is that a pandemic or a disease, or a response to a disease, a vaccine, is never just a biological problem. It’s always inherently a social problem. And a vaccine solves the biological part of that problem, but unless it’s allied to democratically accountable, socially inclusive mechanisms of distribution and access, there are always going to be problems. And we can speculate upon what that might mean in relation to COVID, but what I want to suggest is that there’s, of course, a critical issue of an essential artifact being produced that needs to be made equitably accessible.
But I think that the question here might be even broader than that, right? So, we have a situation at this moment where early, optimistic estimations for how long a COVID vaccine would take suggested 18 months to two years, and even that would have been remarkable. But there’s been such an unprecedented amount of research being done globally on COVID towards both therapeutic and vaccine development, that I have biologist friends who are telling me that it’s not unreasonable to expect a successful vaccine by the end of the year. And then there is a question of whether and how that would be made equitably accessible.
But I think there’s also a question beyond that of social infrastructures, right? Because what we’re dealing with is — I mean, you had mentioned vulnerable populations. I would prefer to say “underserved” populations. “Vulnerability” suggests an inherent weakness in the population. “Underserved” suggests that populations have been failed. The South Side of Chicago is not vulnerable, it’s underserved. And so, the question of what kinds of social infrastructure are required to ensure access to underserved populations, I think, is an essential one.
AMY GOODMAN: And, Harriet Washington, as we wrap up, what can instill public trust at this point? And the issue of patents? The U.S., for example — and this is true around the world — has put billions into these vaccines. Who gets the patent? And that means who gets the profit. Shouldn’t this be made available free to all?
HARRIET WASHINGTON: The patent system is what separates the people of the developing world from the medications that they have proved to be safe and efficacious. We rely upon them to help us test our medications. A good proportion of research is now done in the developing world by U.S. researchers and U.S. companies. And yet, when the drugs are developed, the people there do not have access to them because they’re priced beyond their ability to pay. Companies can do that because of U.S. patent law. And I argued in my book Deadly Monopolies that U.S. patent law need to be changed. It should not govern the distribution of medication. It’s what’s responsible for the high prices and the lack of availability to people who need it most.
I do also want to say something I think is really important in terms of domestic issues. And that is that we are framing this conversation erroneously. We’re talking about the need to recruit more and more people of color. The figures given by Dr. Fauci, 27%? African Americans represent 13.3% of people in the country. So, Fauci is suggesting that twice our representation should be in these vaccine trials. Why? Unfortunately, this is a subtle form of blaming the victim. By hanging the success of vaccine design on African Americans and Hispanic people, we’re imparting responsibility that is not fair, because, in reality, their fear, their reticence to engage in vaccine design is not the problem. The problem is the untrustworthiness of the U.S. healthcare system. We have to address both things. We can’t just talk about African American and Hispanic behavior and not talk about a healthcare system that is creating a situation where logical people have a rational fear of participating in vaccine — [inaudible]
AMY GOODMAN: We have to leave it there. I want to thank you, Harriet Washington, for joining us, author of Medical Apartheid, and Kaushik Sunder Rajan, professor of anthropology at University of Chicago. I’m Amy Goodman, with Nermeen Shaikh. Stay safe.