what is the urgency against the scientific method worth?

The argument of the crisis situation, the pandemic, the accumulating deaths, the emergency in short, is often brandished by those who defend sporadic non-compliance with the methodological rules of clinical trials. But what is it worth? By what premises is it supported? Details in this article.

More worn than an old Monopoly and as protective as a totem ofimmunity : the argument of the urgency of the pandemic. It is brandished every time we dare to question the methodology of the studies carried out to date on chloroquine, to take just this example that everyone is thinking about. Even if we have already detailed in two previous articles, on the one hand the absolute need for quality clinical trials even in times of crisis, on the other the need to wait for multicenter randomized clinical trials, We will briefly return to the premises which support the argument of urgency. This is to see if it can really be brandished all the time without arguing. This article is directly inspired by two papers (which we advise you to read), one appeared in the review Science signed by two bioethicists, Alex John London and Jonathan Kimmelman and the other, on the site Medium published by three specialists in the philosophy of medicine, Juliette Ferry-Danini, Cédric Paternotte and Maël Lemoine.

What is this conclusion based on?

1re premise : " Since the pandemic can potentially last a very short time, it's best to do with what you think you know, via preliminary studies in order to act, instead of doing studies that will give us results later, when thethunderstorm will be passed. "

Why is this argument problematic?

To use a formula from the article by Medium which illustrates this perfectly, in medicine it is not uncommon, with preliminary results, to confuse buoys with concrete blocks. Even when a drug passes the obstacle course of the marketing authorization, sometimes, pharmacovigilance brings up risks greater than the benefits that we had not anticipated. Even very well done studies leave room for uncertainty. Because they cannot grasp the complex reality.

However, if the latter cannot completely remove uncertainty (no science can do that), they reduce it considerably unlike experiments with a low quality design. In addition, do a lot of small independent studies without worries coordination is the best way to generate false leads. The consequences of these false leads can be serious: monopolization of time and resources, inability to detect the weak clinical benefits of a therapy and lead to preference treatment that would cripple medical research. Reports of compassionate treatment use also amplify this phenomenon. It was the case with a paper about Remdesivir in the New England Medical Journal. Finally, the duration of the pandemic is unknown and a health policy cannot be based on the highly uncertain assumption that it will not last.

2e premise: " Make clinical tests conflicts with the obligations of care of clinicians, medical ethics in short. "

Why is this argument problematic?

We must grieve for the doctor who would take knowledge out of the pocket of his white coat. A doctor, however competent he may be, is based, in caring for his patients, on the data acquired from science. It is also a fundamental point of the freedom to prescribe that transcribed article 8 of the medical code of ethics. For a treatment to be generalized, it is necessary to go beyond what ethicists call clinical equipoise. Basically, when a treatment is in clinical equipoise, this means that it is not known whether it brings more benefits in a given indication than other treatments or than usual care without specific treatment.

The randomized trials are therefore necessary in that they eliminate the least effective treatments and make it possible to respond well to the exploration-exploitation dilemma (knowing when to stop clinical exploration and when we move on to practical exploitation concerning treatment) even if new study design, based on Bayesian statistics, Allow us to answer them even better. Recall that the doctor's first duty is not to harm his patient, a Latin formula better known as " Primum Non Nocere ». That is why waiting, even if it is difficult, frustrating because our intuition tells us that a treatment will work, is essential. Because our intuition is often wrong. And that the health of individuals does not lend itself at all to Pascal's wager.

3e premise: " Researchers who sponsor trials have the right to do whatever they want with the design of their trials. "

Why is this argument problematic?

Research never works in a vacuum. It is a whole scientific world, a whole community, which is influenced by publications and rigorous arguments. The ethics and policy of medical research aim to use appropriate regulations and guidelines to align research conducted with the public interest. The knowledge produced by such research allows caregivers, among other things, to be able to discharge their moral responsibility. Thanks to robust and reliable knowledge, all actors around the world can make the right clinical choices, allocate their resources where necessary and therefore save lives. Doing what you want in your corner is not recommended, in any case, not in medical science, even less during a pandemic.

Medical research in a pandemic

So you have to go out Hollywood fantasy the researcher alone against everyone who would necessarily be right. Yes, intuitions are important in science. But what distinguishes science from belief or conviction is the fact of detaching oneself from one's intuition in order to submit it to reality.

We must absolutely avoid dispersing our efforts. There is a need for standardization inherent in the evaluation of a hypothesis, especially when we want to quickly generate knowledge. We can discuss the relevance of the evaluation methods and criteria, but once several players have agreed, we must stick to it, at the risk of scattering, of having scattered, incomparable results between them.

It is the role of governments and health agencies to maximize this standardization. To accurately inform our doctors in the field, we need to conduct many diverse, varied, but rigorous tests in order to detect which treatment (s) has (s) the best risk-benefit balance. Above all, you must be able to present your data to convince the scientific community, and validate its results. No one is immune from making mistakes or being carried away by the enthusiasm of their hypothesis: scientists remain humans.

In addition, what must be remembered is that for effective field medicine in times of pandemic, we need rigorous, coordinated and coercive research. Without these ingredients, we are wasting our time and more or less flouting medical ethics.

This will also interest you

Chloroquine and COVID19: what to think about it? Chloroquine has aroused enthusiasm among the population after the careless communications of a Marseillaise research team. However, care must be taken. The entire scientific community criticizes and calls for restraint in the interpretation of the results of this study.

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