Tribune of the Pr Dominique Baudon, chief physician and inspector of the health Service of the armies, Commander of the National Order of Merit, Officer of the order of the Legion of honour and Knight of the academic Palms. He is also a specialist in medical Biology and a former professor in Epidemiology and tropical public Health.
The goal that I have in this forum is to analyze the criticisms made of the Pr Raoult and his team on the treatment protocol used in the management of the Covid 19. Too often the media, but also some “scientists” criticize without really knowing. (Ultracrépidarianisme). I also think that the results have not always been well defended, even by those who were favourable to it.
In order to conduct a critical analysis of the treatment Protocol, it is necessary to know precisely this protocol, the target population that benefits from the Treatment, the side effects of the drugs used. It must also include a minimum of scientific terms, in particular, what are the mortality and lethality. At the end of this forum I have given a list of indicators referenced in the text with their mode of calculation, with the sources for obtaining these data ; I have also given some definitions to the understanding of the text.
The target population for the treatment.
He is sick with clinical signs suggestive of Covid 19, without serious complications, thus not requiring immediate hospitalization. It is not a matter of subjects detected without symptoms known as ” asymptomatic carriers “.
They have been suspected of the disease by a doctor who directed them to the IHU Marseille (Hospital Institute University Marseille Mediterranean Infection), for diagnosis and biological treatment. Sometimes, the patients are rendered themselves to the IHU for screening biological.
I call this population
The therapeutic protocol
It is well-known : it is the association ” Hydroxychloroquine with azithromycin “
The dosage in the protocol of the Pr Raoult was at the maximum of 6 g of hydroxychloroquine in 10 days associated with 1,25 g of azithromycin 6 days (minimum 3 days of treatment) ; the treatment was tailored to each patient according to his clinical situation.
The taking into account of the side effects of Hydroxychloroquine.
They are well known and have been controlled at the doses used in the protocol. The rhythm disorders were particularly sought after (Ekg initial and control), and research of serum potassium. I have worked as a physician and researcher in intertropical Africa for 20 years ; I have conducted numerous studies on Malaria and I have treated many patients of african or expatriate.
Until the 1990s, the effective treatment was chloroquine (Nivaquine) for the simple shapes, and for the more serious forms of quinine.
The dosage used for the treatment of a access of malaria was chloroquine at a total dose of 2.4 g in three days. (Chloroquine is no longer used in the treatment of malaria in intertropical Africa for more than 30 years because the malaria parasite is resistant to chloroquine)
What have shown the studies
With this protocol, the portage viral, once the diagnosis of the Covid 19 focused (PCR +), ranged from 5 to 10 Days. Chinese studies and other have shown that this port is usually 15 to 20 days, sometimes even longer in subjects with pauci-symptomatic ; it is now admitted, and should be considered as a reference. There are two positive consequences to the use of this protocol : one for the sick, which heals more quickly, the other for the public, because the subject is contagious for a shorter time. There has been no cardiac disorder.
Nothing else has been demonstrated. The Pr Raoult has never spoken of a “miracle drug” ;
(Ref.: www.mediterranee-infection.com/covid-19)
At June 30, in France the number of cases PCR+ reported by the health authorities was 197 885 with 29734 death (ref. www.santepubliquefrance), is a lethality, apparent 15 %. Of course we can’t compare these two different populations.
The three main criticisms
On the Effectiveness of the treatment : What has been said and written to by media and scientists : “In any case, 98 % of patients recover spontaneously, and the mortality rate of the Covid 19 is 0.5 %, the rate which would have been obtained in the studies of the Pr Raoult”. These two statements are false.
What is probably true is that 98 % of infected persons recover spontaneously : but this includes not only patients confirmed PCR+, but also of suspected cases that have not been detected, and especially asymptomatic carriers. I estimated more accurately than approximately 95 % of those infected have not developed the disease (*4).
The following statement is false : ” The mortality rate of the Covid 19 is 0.5 %, a rate obtained in the studies of the Pr Raoult”. I quote from the open letter of a University professor, Hospital Practitioner, signed ” Sigaps “, member of the Think Tank Lisa, published the 02-06-2020 : “The problem here is that the natural mortality of the Covid-19 has been estimated according to a mathematical modeling hardly debatable to 0.53 % [0.3 ; 0.9] in France, the period of confinement. In other words, you get a rate of mortality equivalent to (and not lower) than expected. No difference. What do you think ? “
There is a confusion in the rate of mortality in these patients (lethality apparent*1), and the natural mortality rate in the infected individuals (case-fatality real *2)
I’ve estimated the case fatality actual to date to 0.77 % (number of deaths among the hiv-infected subjects) (*4) ; probably it is this lethality that “Sigaps” refers to.
Toxicity : Yes toxicity exists in function of the dosage data. The doses used and precautions are taken conventional in prescribing medication, the risk of side effects is almost zero.
On the methodology : “there was no comparison group “, however, I validerai however the protocol. Here’s the reasons :
It is a study of “observational ” (*5), the sick (early) presenting to the IHU for a possible diagnosis of the Covid 19. All earlier studies had shown that the portage viral was of the order of 15 to 20 days. For me, these are the results of these studies, which represent the ” control group “, the reference for the comparison. By demonstrating that, with treatment, the portage was only 5 to 10 days, why do a control group in this circumstance of an emergency. The control group would have been necessary if at the beginning we did not know the length of the portage and viral.
This question I have often been asked and I am amazed by the lack of response.
And yet, it is evident and this aligns with my point from the beginning. Hospitalists see patients at the stage of complications, the doctors at the stage of beginning. Each person has their role.
My main criticism of the media and some scientists.
Thus, in all the published research on the effectiveness of hydroxychloroquine, regardless of the terms of use of this product, (associations or not with other products – variable doses – studies conducted only in a hospital setting), if the study did not show efficacy, the conclusion was drawn that the protocol of the Pr Raoult was ineffective !!
To show sometimes the bad faith of the few journalists, I would like to inform you of the remarks made on June 6 by a journalist from a news channel (I will mention neither the one nor the other) wanting to demonstrate, and I quote ” that is available on the toxicity of hydroxychloroquine, the Pr Raoult says everything and its opposite “. The demonstration was based on two interviews, one in French explaining that the hydroxychloroquine dose data in its protocol was not toxic, and another in English saying that the hydroxychloroquine to be very large dose could be toxic ; there are, of course, there’s no contradiction, but the viewer is not necessarily informed on the subject, can believe this reporter.
I wanted to give my opinion, only on this protocol. The behavior of the Pr Raoult, his statements must not interfere with the results obtained.
Sources, calculations and definitions
Sources : Public Health France – South China Morning Post (https://www.scmp.com)-www.mediterranee-infection-www.covidminute.com (G. Zagury and C. Gabay)-(Ref. Johns Hopkins university —https://coronavirus.jhu.edu/map.html)
Some figures and definitions
Situation of the Covid 19, to June 25, 2020 in France
- Number of cases of Covid 19 confirmed patients, PCR+) = 19 885 (Incidence since the beginning of the epidemic),
Number of cases per million inhabitants= 29 536 cases/1M (197 885/67 M) - Number of deaths by Covid 19 = 29 734 (specific mortality by the Covid 19)
Number of fatalities per million Inh.= 443,8/1M
Text references *
Lethality : this is a percentage of deaths among cases
(*1) Lethality apparent (or case fatality rate (CFR) in English = Number of deaths among the patients who were PCR + =15 % (29734/197 885)
Lethality apparent Protocol Pr Raoult = Number of deaths among the patients who were PCR + =0,54 % (18/3342)
(Please note that we do not have precise figures on the number of topics that are not sick, but being consistently tested PCR + ; we can not calculate the case fatality rate in this population)
(*2) Lethality in the real world (infection fatality rate) = Number of deaths among the hiv-infected subjects = 0,77 % (0,0077)
(*3) Estimation of the number of people infected by the virus. According to the Institut Pasteur Paris, 5,7 % of the French population would have been infected, a total of 3 819 000 hiv-infected subjects
(The hiv-infected subjects represents the sum of the subjects, asymptomatic carriers are not detected, subjects not patients, PCR+ at screening, and subjects patients confirmed PCR+)
(*4) Estimated percentage of hiv-infected subjects who have not developed the disease (natural cure) : number of subjects with spontaneous healing = 3621 115 (3819000-infected subjects -197 885 patients PCR+), or nearly 95 % of hiv-infected subjects. (29 734/3,8 million)
(*5) Studies observational
In epidemiology and statistics, an observational study draws inferences about the possible effect of a treatment on the participants, where the assignment of participants to a treatment group versus a control group is not the responsibility of the investigator.
In some cases, observational studies are the most appropriate methodology ( the condition studied is rare, the emergency.)…
Author(s): Pr Dominique Baudon for FranceSoir
