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“Unethical clinical trial is increasingly unlikely in Africa”

The Weekly Cross: Sub-Saharan Africa is often perceived as a privileged field for hazardous medical experiences. According to you, this is not the case. How to explain this distortion?

Fred Eboko: The perception of sub-Saharan Africa is out of step with reality. The image of a fragile continent, where you can do anything and everything, is maintained. At the beginning of April, two French scientists discussed on television to test the BCG vaccine against the coronavirus in Africa, implying that there was nothing to lose with such an experiment because the continent has neither masks no possibilities for resuscitation…

→ READ. Africa sharpens its weapons against the Covid-19

These representations are due to a poor knowledge of Africa, to the deep contempt of some but also to slippages in clinical trials that have marked the memory.

Do you have an example?

F. E. : One of the most shocking mistakes in recent years has been the trial of Tenofovir, an antiretroviral against AIDS. It was tested in the years 2004-2005, in Nigeria and Cameroon in particular. The associative mobilization in Africa, in Europe, as well as a report on French public television, led to its interruption. The prostitutes, on whom Tenofovir was tested because they are among the most exposed populations, had given supposedly informed consent.

An ethical problem persisted: it was a trial with two arms, molecule against placebo. However, the idea of ​​a placebo was unknown to prostitutes and the use of condoms became optional in their eyes. This raises a question: are some populations too vulnerable to be included in trials? A strict protocol must be applied, which includes good information and support by associations.

You mention civil society. Is it not playing an increasing role as a safeguard?

F. E. : Today, it is very difficult to conduct a clinical trial without ethical and deontological considerations in Africa because of the ethics committees, in the majority of countries, the international dimension of many trials and the great sensitivity of associations. Especially in certain countries like Burkina Faso, where civil society is very mobilized.

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However, Burkina is following suit. There is an equalization from the top of collective mobilizations. But if these have made it possible to stop slippages, they need explanations on these tests and biomedical research. These are pointed subjects, which require to approach the data cold. Otherwise, the idea that Africa is a target of trials is spreading, while it welcomes only a minority: 7% of the world total in 2017!

What does this marginal place hold?

F. E. : For two reasons. The first is that, as a general rule, clinical trials in Africa only cover pathologies which also concern the rest of the world. Endemic diseases, such as trypanosomiasis (sleeping sickness), have been the subject of very few trials until recently.

For the pharmaceutical laboratories, which are the source of a large part of the trials, there is a market imperative. The number of patients likely to be treated, due to the lack of investment from States and international partners, is too low to make the investment profitable.

The other reason is logistics. A test requires high standards: technical platform, close monitoring of people, laboratory analysis capacities, etc. Only a few countries, such as Egypt and South Africa, meet these standards.

Is it for these reasons that malaria persists in Africa, where more than 90% of cases are concentrated?

F. E. : Its persistence is not only due to the fact that it is endemic. There is a very strong link with ecosystems. In the western countries where it has existed, malaria has been eradicated by spatial planning and not by therapeutic means.

→ READ. In Burundi, malaria strikes one in two inhabitants

Clearly, the marshes have been drained. It should also be remembered that progress has been made against malaria. Mortality has dropped since the early 2000s. Vaccine research mobilizes a large number of researchers in the north and south.

What are the consequences of few clinical trials?

F. E. : First, a lack of public support for the trial protocols. They see the face of others there. Then, the low participation of Africa in scientific discoveries. However, the action of a network such as the “neglected diseases medicines initiative” (Drugs for Neglected Diseases Initiative (DNDI), NDLR) shows that Africa has brilliant researchers and practitioners!

It is not as integrated as it wishes with world research, for lack of means and political will. This nourishes a feeling of lack of recognition, which deepens a deep wound.

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