I mentioned yesterday in my post about anti-vaccine arguments that there seemed to be suspicions on social media platforms about vaccine testing in Africa. I’ve been looking around for more of that, and finding plenty of it. I’ve also heard from a colleague with some pertinent thoughts about how these things get going, and I think it’s worth addressing all this in a separate post.
First off, it is all to easy to realize where the suspicions about using Africa (and Africans) as a test bed come from. You can start with the Tuskegee syphilis experiment, an inhuman project that has stained biomedical research ever since. Yes, for forty years health authorities deliberately left black men in Alabama untreated to watch what happened as they slowly developed tertiary syphilis, all the time being told that they were receiving free care from the government. The male subjects were observed as they slowly died of the disease, while their wives contracted it from them and (in some cases) their children were born with it. Over the years, several people who became aware of the study expressed ethical concerns, only to be brushed aside. If you’re imagining a few amoral ringleaders operating in secret, though, prepare to be even more disillusioned: the study (including its design of leaving the men untreated and not informing them that they had syphilis) was endorsed by Robert Moton, head of the Tuskegee Institute (who died in 1940). Local physicians participated in the evaluation of the subjects. And the local chapters of the American Medical Association and the National Medical Association (the latter historically representing African-American physicians) actually both expressed support for the study’s continuation in the mid-1960s in a CDC report. (Both groups have since had internal examinations, often acrimonious, of their roles in the affair). No, like many other indefensible acts, this one had plenty of people who were willing to go along with it. As the world knows, the whistle was finally blown for good in 1972 and the study was halted amid a huge and totally justified outcry.
There’s a large secondary literature of attempts to judge just how much harm the Tuskegee experiment did for attitudes about medical research among the African-American population, and the answers vary widely. But how could it have not done damage? The details have been out for almost fifty years now, and while some people may have forgotten about it (or by this point perhaps never even heard of the study), many others will have learned about it so long ago that it’s part of their mental worldview. As it should be, honestly, along with the many other examples of what human beings are capable of when they decide to stop treating others as human beings themselves. Just in the biomedical field you have the Nazi experiments on concentration camp inmates and the Japanese experiments on prisoners of war and occupied civilian populations that come immediately to mind. We – that’s “we humans” – are capable of terrible things, and every time someone comes up with such ideas they always seem to be able to find people willing to help carry them out, too. Never forget this.
There are more recent events that bring on suspicion about drug trials in Africa, unfortunately. Many will have heard of a meningitis epidemic in Nigeria’s Kano state in the mid-1990s, and a Pfizer study of their antibiotic trovafloxacin that violated ethical guidelines. The patients (children, and their parents) were not adequately informed of the risks, and it turned out that an ethics-board approval from Nigerian authorities was back-dated by as much as a year. There were accusations of mis-dosing, inappropriate treatment, and more, and Pfizer’s own responses to this over the years did not do them credit, either, The legal battles have been long and convoluted and Pfizer has been paying out compensation to victims since 2011. This affair has been cited as one of the factors for the difficulties in getting full polio vaccination complete in Nigeria and other countries, and thus has done real and continuing harm even beyond the original victims.
The Current Epidemic
I feel that I need to lead with the bad stuff, because it’s real and it has to be taken into account. But now let’s look at what’s going on with the coronavirus pandemic. As far as I can tell, this news is what has set off the latest arguing in social media. It’s about the first coronavirus vaccine trials in Africa, which are being conducted with the Oxford/AstraZeneca vaccine by the University of Witwatersrand. What seems to have happened is that many took the headline to mean that this was the first vaccine trial anywhere, and that an African population was being used as the initial test subjects. Thus the uproar.
But that’s not the case. The Oxford vaccine itself first entered human trials with over a thousand people in Oxford, Southampton, London, and Bristol, England. Requirements were that participants be 18 to 55 years old, in good health, had not tested positive for the coronavirus, nor had participated in any other trials against the disease. The next phase of the study began in May, recruiting over 10,000 volunteers around the country in a wider range of age groups. Why, then, are they also testing in South Africa? Because it’s in the Southern Hemisphere, where winter is coming on, for one thing. And for another, Oxford (like all the other groups developing these vaccines) is having to go to the locations where the epidemic is spreading. That’s why they’ve also announced a 2,000-patient trial in Brazil. If you want good statistics on whether your vaccine protects people from infection, your best shot is in a population where the likelihood of such infection is higher. No one is going to go to New Zealand to test a coronavirus vaccine, for example, although it looks like you’d do well to dose in Houston or Phoenix right now.
You will find similar things with those other vaccines. Not one of them has been tested in Africa so far – the Oxford/AZ trial is the first. Moderna started human trials in March in Washington state, and here’s an interview with one of the first people to get it (in Seattle). Their Phase II trial (600 people) was cleared in early May to run in Seattle, Bethesda, and Decatur, GA, and their Phase III will enroll 30,000 people at sites all around the US (and likely in other countries as well). There are several vaccine efforts that are taking place entirely in China, with no enrollments outside the country. Pfizer and BioNTech started their first dosing in Germany in April, and have started dosing patients in the US in New York, Maryland, Rochester and Cincinnati. Novavax has started its Phase I in Australia, and its Phase II will take place at locations around the US. Imperial College has dosed their candidate vaccine in London just a few days ago. Curevac is starting trials in Germany and Belgium. Inovio has announced testing in China and South Korea, and Genexine has started their vaccine in South Korea as well (although as both go forward, they will surely have to move to other locations). J&J is starting in July in the US and in Belgium. And so on. There are many other candidates heading into trials later this year, and none of them have announced plans for work in any African country so far. There is absolutely no pattern whatsoever of Africa being used as a test bed for these new therapies.
And there is no pattern of African-American patients here in the US being used as such, either. In fact, the worries are about low enrollment in that community, and you’ll see from that article that a big part of the problem (naturally enough) is mistrust about medical research founded in the Tuskegee experiment. That’s the frustrating part: as we go on, we’re going to need data on these vaccine candidates from as wide a range of people as we can possibly get – ages, gender, ancestry, pre-existing medical conditions, other drugs being taken, all of it. The response of human beings to disease (and to disease treatment) varies across a huge complicated landscape of genetic, social, and environmental factors – many of them interacting with each other – and the only way to evaluate something like a coronavirus vaccine (which could well be rolled out to billions of people) is to test it as broadly as possible. The African-American population is clearly being hit hard by this pandemic – I hope that some of the legacy of fear and mistrust can be overcome as we all try to work our way out of it.