John le Carré’s 2001 thriller The Constant Gardner recounts the murder of an activist who knows too much about an unethical medical study being conducted in Kenya by a German company. Mr Le Carré has said that the wrongdoings of his fictional drug group are “as tame as a holiday postcard” compared with what really goes on.
In 2011, Pfizer, a US pharmaceutical company, set aside $35m to pay the families of Nigerian children who had died or were severely harmed during a 1996 trial of a meningitis drug, Trovan. Pfizer argued that meningitis, not its medicine, had caused the deaths and injuries. But the case, by no means the first of its kind, raised serious questions about the design of the trial and the manner in which it had been ethically approved.
There are thorny moral questions about testing medicines anywhere. Perhaps the drug being studied has rare but severe side effects that only emerge in large-scale trials. Perhaps it works exceptionally well, leaving those on placebo suffering unnecessarily.
There is also an element of “tornado chasing”. You go where the disease is. That is particularly true with vaccines, since scientists cannot establish efficacy in an environment where an illness is not circulating. This is one reason that the Oxford university coronavirus vaccine being developed with AstraZeneca is being tested in Brazil and South Africa, as well as in the UK.
Whatever ethical issues exist in rich countries are amplified in poor ones, where people may not know their rights, where regulatory authorities might be weaker and where there is often a history of exploitation and racism. Yet, such concerns notwithstanding, poor countries should be conducting more clinical trials not fewer.
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The fact is that only a tiny fraction of global medical research takes place in developing countries. According to a paper in Nature, of the 2,000 Covid-19 clinical trials registered around the world, more than 90 per cent are in wealthy countries, with China and India accounting for the bulk of the rest. Poor countries in Africa, Asia and Latin America barely get a look in.
Why should it matter where trials take place? From the perspective of poorer countries, perhaps it is better if medicines, including the Covid-19 vaccine, are tested in rich nations before being rolled out elsewhere.
This is wrong for several reasons. First, it is important to test medicines in specific populations. Responses to the same treatment vary according to many factors, including genetic. A rotavirus vaccine against diarrhoea was found to be 90 per cent effective in a western setting, 70 per cent in South Africa and only 40 per cent in Malawi, according to Shabir Madhi, professor of vaccinology at the University of Witwatersrand, which is leading the South Africa Covid-19 vaccine trial.
Health authorities need access to population-specific data. Moreover, if medicines are tested in rich countries, it can take years for them to get to poor ones. Some life-saving vaccines have taken two decades to make it to the developing world.
Conducting clinical trials is also a route to medical expertise. Clinical trials are complex affairs, involving strict protocols, meticulous data collection and high-standard medical care. In diseases such as malaria, tuberculosis and HIV, many African nations have built up world-class capabilities and networks through conducting clinical trials. In the Democratic Republic of Congo, Jean-Jacques Muyembe, a microbiologist and Ebola expert, helped oversee clinical trials that contributed to the approval of an Ebola vaccine and discovery of a treatment.
Networks of experts built up to combat Ebola, as well as malaria, HIV and tuberculosis, help explain the rapid and effective response of many African governments to Covid-19. Vietnam’s experience with Sars laid the groundwork for its impressive coronavirus strategy, with not a single death yet recorded.
There is understandable suspicion that testing in developing countries means exploiting poor people for pharmaceutical company profit. That is why clinical trials should never be carried out in countries where the resulting medicine, if licensed, is unavailable at affordable prices. If the Covid-19 vaccine being tested in South Africa proves both safe and effective, South Africans must be among the first to benefit.
In addition, regulatory authorities must be sufficiently robust to ensure that clinical trials are carried out to the same ethical standards as in rich countries. That requires building up precisely the sort of medical expertise that ensures science is marshalled for the benefit of the poor as well as the rich.
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