key: cord-274307-kl0uvrbw
authors: Bordet, Régis
title: Is the drug a scientific, social or political object?
date: 2020-05-23
journal: Therapie
DOI: 10.1016/j.therap.2020.05.012
sha: 
doc_id: 274307
cord_uid: kl0uvrbw

nan

Randomized controlled trials are based on two principles: comparison and comparability. These two principles allow dispensing first with the natural evolution of the disease, particularly in infectious diseases, and second the placebo effect, which can now be corroborated by brain imaging studies. Without respect for these two principles, it is impossible to establish the role of the drug in the clinical effects observed when testing a new pharmacological approach. Paradoxically, the methodological rigour inherent to controlled trials and the role of the pharmaceutical industry in promoting these trials have ended up bringing discredit to this approach, which is, however, the best method for establishing the proven effect of a drug, in part of the population. The craze that has arisen for the distribution of hydroxychloroquine, based on a very preliminary study and the analysis of a cohort without a comparator group, was, from this point of view, very emblematic of the fact that belief can quickly replace scientific demonstration. This is not new and already exists for alternative therapeutic methods that refuse to fall under the caudine forks (so named in reference to the battle at the end of which the romans had to submit to the samnites) of clinical trial methodology. This attitude has, however, taken an emotional and claiming side in the context of the anxiety and fear generated by the Covid-19 pandemic and its lethal risk.

Empiricism seems to be trying to take again a top position over the rational approach, which some consider too dogmatic, especially in critical situations. Is it necessary, because it is urgent, to abandon all the scientific principles of clinical trials that have previously led to undeniable therapeutic progress? Undoubtedly not, which does not mean that the experimental design of the trials should not be adapted, in an approach reminiscent of Charles Peirce and William James theorising pragmatism as a third way transcending the empiricism/rationalism opposition. For more than thirty years, French medical pharmacologists and therapists have been contributing to an international movement of methodological diversification through a think tank (called "Ateliers de Giens") bringing together the academic, industrial and institutional worlds. Pragmatic trials, adaptive trials using the Bayesian approach, studies with external comparators, trials on small samples, taking into account secondary assessment criteria and the use of biomarkers are all methodological innovations that aim to make the framework of controlled trials more flexible in order to speed up or improve the evaluation of drugs, without abandoning the major and basic principle of comparison [1, 2] . The media outburst against methodology rightly clashes with the convictions of the vast majority of health professionals, who have perhaps not sufficiently integrated the fact that drugs, which they consider above all as a scientific object that is their prerogative, have also become an issue that the social body has taken up.

It is above all through the drug risk and its often-mediatized affairs that society has integrated drugs as a social fact [3] . The so-called "Mediator" affair has had a major impact on populations, in this case the French one, with the realization that drugs can be also dangerous, even in the long term. The front pages of newspapers and magazines devoted to medicines and their risks have been booming, like the questions addressed to the Regional Pharmacovigilance Centres. The development of social networks has had an amplifying effect on the emergence of medicines as a social issue, by bringing it out of the circle of health professionals, previously considered as the only "knowers". Some years ago, several episodes of reporting adverse drug reactions linked to changes in thyroid hormone formulation have emerged as a viral relay on social networks. Social demand may lead regulatory agencies to re-evaluate positions that were initially scientifically based, or to speed up market entry. Recently, the film "120 beats per minute" recalled the interactions, sometimes violent, between patient associations, pharmaceutical industry and regulatory agencies in order to bypass the usual marketing rules, in view of the mortality caused by HIV. This is reminiscent of what we are experiencing today with molecules reputed to be potentially effective against SARS-Cov-2, recalling what we have previously seen with other products, such as baclofen in alcohol use disorders.

While society may request answers from public authorities and healthcare professionals regarding the risks/benefits balance of drugs, social facts may also influence the medical use or diversion of medicines, or even investment in their development. The cult of thinness, advocated year-round in all magazines, was undoubtedly the main factor that triggered the misuse of the Mediator, replacing dexfenfluramine, which, a few years earlier, had been withdrawn from the market because of its valvular risk. Our modern societies, based on the over-emphasis on performance, generate a diversion of drugs, particularly psychotropic ones, for the purpose of cognitive doping. However, anxiety induced by loss of social bearings or by suffering at work linked to the search for profitability at all costs explains the over-consumption of psychotropic tranquillizers or antidepressants. The social context may therefore explain the emergence of a pattern of use or an increase in the prescribing or consumption of a particular drug, which then escapes rational, evidence-based use, necessitating regulatory measures to control prescribing or dispensing. The current health crisis has highlighted the immediate link between the announcement of preliminary or hypothetical results on the efficacy of a particular drug against coronavirus and its dispensing, and often consumption, outside of any regulatory framework.

Taking into account the social dimension of the drug reveals, however, a contradiction in the demand of the social body, which has been amplified during the health crisis. On the one hand, there is an expectation for information that has been scientifically validated by health professionals. In the space of one month, the Pharmacovid site [4] set up on 21 March was consulted nearly 300,000 times, with many questions asked by The current health crisis may be leading to a turning point, with drugs becoming a political football. It is first of all an object in the international political games, because it is clear that States have lost their sovereignty over the production of medicines, which, like other manufactured products, has become one of the goods of globalized capitalism. The current crisis, however, has made us aware that drugs are above all a common good, since they affect one of the essential elements for humanity, namely health. If tomorrow a vaccine or treatment against coronavirus is found, will we witness a war between states to control supply, as happened with masks? Will the world balance between states be altered? Will the ability to control drug policy in all its aspects (innovation, rapid assessment, production) become a diplomatic weapon or even a propaganda tool for external or internal propaganda? Because drugs have also become a domestic political issue, as we have seen with chloroquine and hydroxychloroquine, with partisan confrontations or positions taken without scientific basis by a head of state announcing his belief in the interest of chloroquine, in a country that was the first to create a regulatory agency. The balance between political power and regulatory agencies may be shifting, as shown by the announcement by the President of the United States of America, in person, of the authorisation of an antiviral by the FDA, developed by an American company, even though the results of clinical trials are still contradictory. It is the same with a nationalist attitude for the priority delivery of vaccine.

Will drug policy tomorrow become a subject of electoral debate, on a par with fiscal or educational policy, and an argument for economic nationalism? How can we reconcile this irruption in the public or political debate and the maintenance of a sufficient level of expertise to avoid falling into the populism we know in other fields, with its share of false or truncated information?

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