Clinical trials: when science recruits its linings in Africa or among the poor

While it is a question on LCI of verifying a molecule in Africa before making good use of it compared to Covid-19 or that the protocol of Professor Raoult is questioned, back on the history of clinical trials: when progress medical was bombing bodies of little importance.

Treat or punish, why choose?

The idea did not shock this microbiologist because it is commonplace: the delocalization of clinical trials, especially in Africa, and / or on prostitutes, is at the bottom of an ordinary practice of medical research. But it struck many spectators because it embeds a whole string of representations that come not only from the history of medicine but also from social history and colonial history. Because the history of clinical trials is the history of a power relationship, and more precisely of a deeply unequal relationship. For a long time, scientific progress has been based on this inequality. In many ways, this is still true.

The example of prostitutes (those who “do not protect themselves”), taken by the doctor on LCI, does not come from nowhere: in the history of clinical medicine, many experiments have been carried out on sex workers . And often, coercively. Their marginality from society was often a factor in this in the 19th century, at a time when medical experimentation was stabilizing. However, these women were not outside the law: neither the very first French penal code (which we owe to the revolutionaries, in 1791), nor that of 1810 (which will remain in force until 1994), will not prohibit prostitution , which moreover is also practiced in an ordinary way by the women of popular classes, married or not. But even if we called it “the fifth quarter”, that is to say, the one who puts butter in the spinach and often saves the household from misery, the practice is stigmatized by the authorities despite what the historian Clyde Plumauzille will call “silent decriminalization”. And it is from this stigma, and also because they can spread diseases, that we will regularly decide to test them on remedies.

At the end of the 1820s, for example, we decided to create a dispensary specially for them, managed by the doctors of the Police Prefecture, who force girls, prostitutes, official or not (we say “submissive” or “rebellious”) , to seek treatment. From 1836, in Paris, submissive girls (those who have declared themselves) who think they are affected by venereal diseases like syphilis no longer have the right to present themselves in any other hospital, and are solely in the infirmary built on the sides of Saint-Lazare prison. A prison-hospital where, by the way, doctors can also dismiss all the others, as soon as they are deemed too turbulent, remind historians Claire Barillé and Sandie Servais in their contribution to the collective book Impossibles Victims, Impossibles Culprits.

A little taste of mercury in the herbal tea

It is within this repressive framework that therapeutic trials on prostitutes, on whom we test, for example, different dosages of mercury, are becoming widespread. Are they aware of the risk inherent in the experiments? In his formidable genealogy of clinical trials and experimental medicine, Les Corps vils, published in 2008 at La Découverte, the philosopher Grégoire Chamayou said that a real sedition had taken place, between these Parisian walls where care and control overlapped : prostitutes had discovered that some of them, who were administered a simple placebo and not the mercury treatment, could also be cured. Response from the health administration: a bitter drink was invented enough to give the placebo the taste of mercury, and thus make them believe that they were all in the same boat.

Because consent to clinical trials is an invention much later than practice. This is the whole meaning of the term “vile body”, which translates a central Latin phrase in the history of medical jargon: “fiat experimentum in corpore vili”, which explicitly recalls that historically, we first tested drugs on these “bodies of little importance” – but without always asking their opinion. In the same book, Chamayou recalls that, for a long time, we will make ourselves bear on the poorest, as on prostitutes, the risk of trials, since after all, it is their whole way of life that would expose them to death :

The doctor will not bear responsibility for a risk that poverty would have put them in any case.

Does this damn uninhibited relationship to the administration of risk on the most modest seem barely believable? We understand it better if we have two things in mind. First, that the first tests on the tortured and the condemned have long been practiced. Thus, it was very common to see doctors crane at the foot of the scaffold in search of barely dead bodies, ready for experimentation. Science taking off, soon the bodies of the condemned will be made available, during their lifetime. First and foremost, those condemned to death, but also convicts, on whom we will test for example at the convict of Rochefort, in Charente-Maritime, various remedies that we still hesitated to administer to sailors. These bodies are still alive, but deprived of their social status, and it is since this decline that they have been made available for research. They basically become profitable for medicine whatever the cost, because they no longer have any social value.

Right of war or right to … heal?

But it must also be borne in mind that the hospitals of the 19th century are not the ones we know today, but first places of reception, hospices, dedicated to the needy. Thus also arises the idea that the poor, whose care but also burial, represent a burden for the community, can well repay their debt to society by subjecting their bodies to various tests deemed necessary . Immoral? The debate will take place on the scale of all Europe, from the 18th century, and will involve, in the fold of the Enlightenment, as well the French Encyclopedists as Emmanuel Kant. The controversy thus swells, as we discover the principle of vaccination which involves inoculating the disease in certain bodies as a test. Kant will reply, for example, that one has no right to risk the life of one part of the population so that the other lives. But many Enlightenment philosophers believe that the progress of science takes precedence, and Grégoire Chamayou finally compares the legitimization of experiments to a “right to war”, when a political power raises an army en masse to save a country.

For a long time, these bodies, thought to be of lower social value, thus act as “liners”, to use the very eloquent image developed by Grégoire Chamayou in his book. Then the idea that the patient’s informed consent is necessary settles in year after year. If the guinea pig is willing, the trials must still be viable. However, the end of the 19th century was also the time when medical research became sophisticated and rationalized, with the generalization of statistics, and of measures which became systematized in tests (we say in particular “metrology”). So-called “evidence medicine” was born, and it involves large-scale testing … and therefore, bodies. The colonial conquest will compensate for the lack of bodies on this scale, and provide a new category of “liners”. It is in this story that the doctor’s reaction to LCI is rooted: today, trials are still carried out in large numbers in developing countries, and in particular in Africa.

African linings

In 2015, 658 trials were carried out in Africa, including 280 in Egypt – which, against all odds, would take the place of El Dorado precisely because its health infrastructures and its universities are rather more developed there. On the spot, we are no longer at the gigantic colonial camps, where the new colonial administration had large-scale tests carried out in subordinate regions, which today correspond to Senegal or Cameroon. These countries are now independent. But their health policy remains closely linked to the old colonial powers, or to their pharmaceutical industries. If carried out correctly, that is to say that the populations have a real therapeutic benefit, this research is essential to give access to whole countries to crucial treatments. This is why, for example, a researcher sounded the alert in Le Monde, April 3, when none of the 359 clinical trials recorded today on earth for research on Covid-19 treatments. had started again in Africa. But still it is necessary that this research takes place in the rules of art. Because, despite a birth as late as it is laborious, ethical standards exist today.

The scale goes back to the Nuremberg trial in 1946, after which it will be understood that the research must be supervised so that nothing more resembles what may have been practiced in the Nazi camps. In the following two years, a first skeleton of an ethical charter took shape, which resulted, six years later, in what would remain as the “Declaration of Helsinki”.

The Declaration of Helsinki dates from 1964, and it is the very first text that frames the tests. A founding text, which recognizes the need for human experimentation “for the progress of science and for the good of suffering humanity”, and which distinguishes, for example, experiments carried out at the bedside of the patient, tests on a non-patient, in order to broaden scientific knowledge. The idea of ​​the guinea pig’s consent appears black on white. But it is still only a charter of good practices: no constraint in the Declaration of Helsinki or in the texts which will emerge in the process, and which specify for example that the person on whom one experiments must have an interest. In fact, it is up to countries to seize it to transform these great moral principles into law. It will take 24 years in all for France to come there: the medical profession and the jurists are divided, and a non-negligible part of them is far from being won over by the idea of ​​endorsing the experiment for good. on human subjects.

1988, and the very first French law

But in 1983, the creation of the National Ethics Committee, which will take a stand in favor of trials, seems to have accelerated the timetable: the very first bill on therapeutic trials in France was debated in 1985 in the National Assembly. The blocking of the text in the political field shows clearly all the controversial load which surrounds the question of the therapeutic experimentation, in France, in the 1980s. It is finally after a call to order from the Council of State that will be passed the very first law on tests: named after the parliamentarians who wear it, it will be the Huriet-Sérusclat law, which came into force on December 20, 1988. It contains in particular the principle that those on whom tests are practiced, which ‘have no direct therapeutic benefit, because they are not sick, can be compensated – but not others. And also that trials are only possible for a whole category of people on the express condition that they have an interest in their health: this concerns for example minors, or vulnerable adults like prisoners and patients in a situation of ’emergency.

A quarter of a century later, many NGOs report that clinical trials have exploded in Africa. Even MSF is now carrying out tests on African soil: the NGO’s first tests on Ebola date back to 2014, but as early as the 1990s, there are traces of malaria-related tests in the archives of Médecins Sans Frontières, for example this explanation:

Faced with the lack of data, Doctors Without Borders (MSF) has set up clinical studies to measure the effectiveness of antimalarials and to adapt treatments within its missions. Between 1996 and 2004, more than 12,000 patients were included in 43 studies in 18 countries in Asia and Africa.

As here, it is sometimes a question of testing, on site, specific pathologies, which would prevail in certain countries, and not in others. But not always. It also happens that a pharmaceutical company delocalizes its experimentation because it is sometimes up to five times cheaper to conduct trials in an African country than in Europe. And also because the Huriet-Sérusclat law does not oblige manufacturers who outsource their tests, even when it is a question of French laboratories? And that we would take a lot of liberties in the tropics with regard to these ethical principles which were so late in France? It is caricatural, and often downright wrong, to imagine that we would do anything in this new far west of therapeutic innovation. Protocols exist, which show that ethics have not simply disappeared somewhere above the Strait of Gibraltar. And in 1981, an international text, remained as “the Manila Declaration”, had supplemented that of Helsinki, specifying the conditions of clinical trials in developing countries.

North-South asymmetry

Despite everything, the North-South test report remains marked by a strong asymmetry. Several scandals, some of which have resulted in legal proceedings, show that many protocols can turn out to be more lax once the tests are carried out abroad. For example, for everything concerning the benefit of treatments: when we see the price of marketing many molecules, or even the diseases for which we are testing, we can sometimes doubt that the balance of benefits and risks is always favorable to the populations which lend themselves to the tests. Jean-Philippe Chippaux is a doctor and research director at IRD, the Research Institute for Development. In an illuminating work dating from 2004, and available here, this field researcher, who has worked for a long time since Dakar, concluded that there was an urgent need for “Africans to appropriate the concept of clinical trial for meet their specific public health needs ”. On this occasion, he recalled the infinitely political dimension of clinical trials. This was true in the 18th century when, at the foot of the scaffold, science bombarded the bodies of the tortured, brought back to the rank of object. But it’s still true now that it’s health geopolitics:

The clinical trial appears to be an essential instrument for health independence. Because, beyond this appropriation, the purpose of the practice of clinical trials in African countries is indeed to generate a local capacity allowing to decide, carry out, monitor and operate clinical research independently. This requires technical competence and political, therefore financial, research and health mastery.

The therapeutic trial as an emancipation rather than a double punishment? The idea has something reassuring as the reading of Grégoire Chamayou’s genealogy, Les Corps vils, is edifying. But it makes the question of consent of the test subjects even more decisive. However, from this point of view, it is an understatement to say that the guarantees are not equivalent depending on whether the test takes place on French soil or, for example, in Cameroon. An HIV trial took place there between 2004 and 2005, which specifically targeted 400 prostitutes. Subject of the test at the time: an antiviral named “Tenofovir”, which will be marketed in France from February 2002. But before it was put on the market, it had to be tested. Act-up had revealed that, not only, Cameroonian women who were part of the placebo cohort were insufficiently protected. But that, moreover, they were very numerous among all those involved in the Gilead laboratory study, to have signed in the belief that they were going to be administered a vaccine. And for good reason: the written protocol, to which they had been given stealthy access, was in English. However, for the most part, these women were illiterate, and above all, French-speaking.

The consent of these women was therefore not real. Their situation seems all the more asymmetrical than in France, on the contrary, many candidates for clinical trials must on the contrary fully apply. Unlike the work on blood donation, there are few sociological studies on therapeutic trials. But there is an exciting work, signed by the political scientist Olivier Filleule. For a study day in 2015 (which will give rise to the collective work Recruitment-engagement in clinical trials in prevention, under the supervision of Mathilde Couderc and Caroline Ollivier-Yaniv, also online and free access here), the researcher, an engagement specialist, sifted through the motivation letters sent by 4,259 candidates, between 1991 and 2001, for HIV vaccine trials. He sought to understand not only who proposed to participate in such unpaid trials (and why), but also who was selected.

And we take the measure, by reading Olivier Filleule, how much a protocol in good and due form, here in France, involves not only information to the line of volunteers, to whom we will clearly expose the costs of the engagement or the risks incurred. But also a sorting of the motivations of the candidates, whom the promoters of the tests warn for example of the “illusory character of rewards which can be hoped for”. We thus discover through the sieve of his investigation that a certain number of candidates, especially on the men’s side, placed a lot of hope in the idea that they could have a privileged partnership with researchers for the benefit of science . Not sure that was what these two doctors heard on LCI in early April, against the backdrop of the Covid 19 epidemic.

Clarification on 8/04/2020 at 9:30: the controversial television sequence took place on the set of LCI and not on BFM as briefly indicated by error.

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