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Clouds are gathering around Raoult and his treatment against Covid 19… To date, only one random trial (with draw) has been published. The Prescrire review concludes in detail: no proven efficacy, but many more undesirable consequences (30%, compared to 9% in the control group). And now the Council of the Order of Physicians is threatening him with an immediate suspension of his activities!
The Council published on April 23 a press release which, without citing it by name, seriously questions the behavior of Professor Raoult. The title of the press release sets the general tone: “Illegal clinical research protocols: the Order firmly recalls the rules in force”. The result is hardly more eloquent. Recalling that “it would be inadmissible in this {epidemic} context to raise false hopes of cure”, the Order officially referred to the Medicines Agency “these protocols which are outside the legislation in force”.
A barely veiled threat concludes this press release: “The endangerment of the sick, if it appears that it could be caused by treatments that are not scientifically validated, could justify referral to the Director General of the ARS {Regional Health Center of the Agency} to request the immediate suspension of the activity of these doctors ”.
Why this seizure of the Medicines Agency (ANSM)? The Order of Physicians here probably refers to the work of Pr Raoult, presented “in preview” to Emmanuel Macron, during his trip to Marseille on April 9. Because this work was the subject of a request for clarification from the ANSM ten days ago, and is still awaiting a response from Pr Raoult…
However, the ANSM’s request was simple, at least in appearance: that Professor Raoult provide proof that the results in question are part of an “observational” study and not “interventional”.
I see some at the bottom of the class who give up and, I admit, the distinction deserves an explanation. It’s a bit technical, but hold on, it’s worth it!
A study is said to be “observational” when its object is “usual” treatment. It is said to be “interventional” when it is an “experimental” treatment. Basically, in the first case, we give a known drug to patients we know well, and in the second, we are new, we try things “without a net”.
There is nothing trivial about this nuance, especially from a legal point of view. For an observational study, the legal framework is quite flexible, it suffices to obtain the agreement of the CPP (committee for the protection of persons) of its creation. For an interventional study, on the other hand, the framework is much stricter: the protocol must be clearly explained to patients, the risks must be carefully weighed and the study must first receive approval from the ANSM.
What did Professor Raoult do? Its first trial, on a very small number of patients, was indeed submitted to the approval of the ANSM as “interventional”. On the other hand, that of April 9 was declared “observational”. With this argument: Study No. 1 having “demonstrated” according to Professor Raoult the effectiveness of the treatment, that of April 9 would be nothing other than confirmation – on a larger scale – of the first.
A questionable reasoning to say the least … And which could cause him great trouble if the ANSM did not follow him. Because a clinical trial that does not comply with official procedures, this can go up to a year in prison and a fine of 15,000 euros.
In this case, this famous “observational” study that Professor Raoult presented to Emmanuel Macron involved 1,061 patients. According to his manager, the results would be excellent: almost 92% of patients healed in ten days, nearly 5% of patients healed “late” and less than 5% of “patients with complications”. In short, it is a “safe and effective treatment” according to Didier Raoult.
But when we look more closely at the details of the study, the reality is less bright. The “complications” in question are 31 patients hospitalized for more than ten days, 10 transferred to intensive care and 5 deaths. Big “complications” indeed…
Furthermore, Professor Raoult did not compare the results on patients with or without treatment – what specialists call “study with a control group”. Knowing that healing occurs spontaneously in 85 to 90% of cases, it is therefore impossible to say whether the solution advocated by Didier Raoult does better, finally, nothing or less than nothing.
Even more embarrassing, the study suffers from an impressive number of biases. Judge for yourself: Professor Raoult tested more than 3,000 people, but only retained 1,061 in the end. Why ? How? ‘Or’ What ? “Or what ? On what criteria? Mystery. Also, in 95% of cases, the 1061 suffered only from mild forms of Covid – while in most other studies, it was more like 80%. The proportion of women (53%) does not correspond to the epidemiological reality of Covidosis, which mainly affects men. Finally, the average age of patients (43 years!) Is extraordinarily low, since
