Hydroxychloroquine, Raoult, Discovery, Recovery, Lancet, Veran, HCSP over the last few weeks these words are pronounced multiple times each day, trays television to social networks, fueling the discussions, and dividing the camps. Difficult to see clearly in the puzzle of information with opinions and decisions that can sometimes seem incomprehensible to the French citizen, each seeking a piece of the puzzle. The minister of Health Olivier Veran has therefore taken the decision to suspend clinical trials in French and the use of HCQ in France on the basis of an article published in the Lancet, then that Discovery, Solidarity, and Recovery showed that there was no concern for the safety of hospitalized patients treated with HCQ. Why he made the decision so quickly, causing the wrath of the president Macron ?
The results erroneous or even fraudulent study published in the Lancet on may 22, proven implicitly by the clinical trial Discovery in the way of a missing piece of a puzzle.
The 22 last may, the journal “the Lancet” published the results of an observational study carried out on more than 95 000 patients Covid19 and hospitalized, distributed in many countries on all continents and have received various medical treatments.
This study showing, on a few 15, 000 patients, at best, inefficiency of Hydroxychloroquine (HCQ) – alone or in combination with an antibiotic “macrolide” – and at the worst the net hazard, WHO followed in particular by the French government, has very promptly discouraged the use of the HCQ and has stopped the inclusion of new patients in the ongoing clinical trials on this treatment.
In the following days, the results were very surprising, even astonishing, as well as glaring inconsistencies in the study published on 22 may by 4 authors – Mandeep Mehra, interviewed by FranceSoir, Sapan S. Desai, Amit Patel and Franck Ruschitzka – have provoked strong reactions, including that 180 doctors/scientists have signed up to a forum to ask a number of explanations, additional information and the raw data that led to these results. The authors of this study, on which we will return later, do not shine by their transparency by not responding – or so little – to the expectations and the legitimate questions raised by these scientists. The company surgisphere that has made the collection of data is quite dubious.
However, without even waiting for any answers of these 4 authors, we can have the certainty that the results of this study, conducted between December 2019 and April 2020, are at best erroneous and at worst fraudulent on the ineffectiveness and dangerousness of the HCQ…
For information or reminder, the clinical trial european Discovery, driven by the Inserm aims to assess since more than 2 months, by means of tests, randomized, 4-treatment, or ” arm ” – in which the HCQ ( Only without the association with an antibiotic ) on hospitalized patients.
This clinical trial european Discovery had to include 3 to 200 patients, but since the 22nd of march, less than 760 patients were included, of which more than 750 in France.
To this day, and despite promising results of the French government to, first of all at the end of April, and then for the may 14, none of the results of the clinical trial Discovery has been published by the Inserm.
In contrast, the may 7, Inserm and by the voice of the Pr Florence Ader, lead investigator of the trial Discovery, we learned that a committee, the DSMB, data safety monitoring board – ” an international group of people, different expertise, but extremely high, at which the data are transmitted “, was going to issue an opinion on the treatment outcomes of the clinical trial Discovery.
Extracts from the press point of the Inserm on may 7 :
“The data are analysed at regular intervals by an independent committee (DSMB) as inclusions. Next week, the DSMB of the trial meets to analyze the data collected from the 22 march. At the end of this meeting, as mentioned by the president of the Republic, the independent committee will produce a synthesis that will conclude either :
In the case of a positive signal or negative, of the changes of the study will be considered in consultation with SOLIDARITY “.
What notice has so been released on may 14, by the DSMB ?
Neither drum nor trumpet, nor sirens, Inserm announced this conclusion in a press conference terse :
In the clear, as confirmed on 15 may to one of our colleagues, following a question raised on the trial Discovery :
Another source close to the trial Discovery confirms : “The recommendation [the DSMB] is to continue the study without modification”.
The opinion issued by the DSMB on may 14, therefore, is the confirmation that neither the efficacy nor the inefficacy of the treatment with the HCQ of patients in the hospital are reported when the clinical trial began on 22 march.
Even more important…and highly reassuring, the opinion issued by the DSMB, therefore, is the confirmation of the non-dangerousness of the treatment with the HCQ of patients in the hospital because if this treatment proved to be dangerous and had caused the death of patients as the study published may 22 in The Lancet indicates, clinical trial Discovery on the HCQ – and the clinical trial Solidarity of the WHO at the same time – would have been halted immediately and with a great deal of communication of the WHO and the French government.
Also, on 14 may, the WHO and many governments were aware of the opinion of the DSMB.
However, the knowledge of this notice does not impede the decisions of the WHO and in particular of the French government in the days that followed the publication of the may 22 in The Lancet, a retrospective study based on medical records shared from several countries on all the continents, and analysed by tools of Artificial Intelligence.
These decisions of the World Health Organization and the French government are not only completely incomprehensible, but particularly suspicious because they disapproved of the clinical trials that were presented to us – Discovery and Solidarity, with strength in communication, such as scientific trials of the most rigorous and are the only ones able to scientifically demonstrate the benefits or not of such or such a treatment and in this case that of the HCQ.
In consequence, it is essential that the WHO and the French government to justify publicly the disavowal of the clinical trials, Discovery and Solidarity that they have themselves promoted and justified the reasons that led to their decisions on the HCQ following the publication of the study may 22 in The Lancet.
Also note that the 24 may, the committee of monitoring of the trial data Recovery did not see any valid reason to suspend the recruitment for security reasons and recommended that the trial continue recruitment without interruption. “Test of RECOVERY is currently the largest randomized controlled trial of HCQ for COVID-19, but is not yet large enough to detect (or exclude) the effects of treatment moderate, but significant.”
Notes and references
Supported and reviewed by the citizens ‘ group
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31180-6/fulltext
https://www.liberation.fr/checknews/2020/05/15/ou-en-est-l-essai-therapeutique-discovery_1788158
https://www.recoverytrial.net/files/professional-downloads/recovery_noticetoinvestigators_2020-05-24_1422.pdf
Inserm – Start of the clinical trial against the COVID-19 – video-march 23, 2020
Author(s): Xavier Azalbert and Eric Gyssler for FranceSoir
