The first action influencing the decision to purchase hydroxychloroquine takes place on January 13, 2020 with the classification of hydroxychloroquine on list II of poisonous substances. Until now, the drug was over-the-counter, now it can only be obtained with a prescription.
It was stated that this decision could not be imputed to the Minister of Health at the time regarding a procedure initiated in 2018 by the Sanofi laboratory, manufacturer of Nivaquine® and Plaquénil specialties. It is claimed that Sanofi wished to obtain an alignment of the statutes of this two specialties with regard to their delivery (with or without prescription). Sanofi’s interest in requiring such a modification leaves room for doubt.
Indeed, this position does not stand up to the reading of certain official documents.
Following a notification by the Japanese authorities in 2015-2016 of a potential genotoxic effect of primaquine during pregnancy and in the hypothesis of a class effect for molecules derived from it, Sanofi proceeded a review of the medical literature and of its pharmacovigilance database for chloroquine (Nivaquine®). The laboratory then submitted a request for modification of the SPC for the “fertility / pregnancy / breastfeeding” section to the ANSM working group in meeting of June 21, 2018. The ANSM refused the modification of the Summary of Product Characteristics. (RCP) aiming to be more reassuring considering that there is not enough data.
A second similar request was made a few months later by Sanofi for hydroxychloroquine (Plaquénil®) and studied by the ANSM working group at the meeting of 1is October 2018. While the laboratory intended to demonstrate that the medicinal product had no significant genotoxic effect, the ANSM recommended modifying the SPC to advise against the use of hydroxychloroquine during pregnancy, which was not previously for this molecule.
Also, in reality, Sanofi requested a modification of a section of the SPC in that it advised against the use of chloroquine or hydroxychloroquine during pregnancy.
Contrary to what has been said, Sanofi has never requested the alignment of the status of hydroxychloroquine with that of chloroquine as regards the need for a prescription for the delivery of said drug.
In addition, the Minister’s explanation reveals some inconsistencies about this procedure. She affirms that the classification of a drug on list II of poisonous substances is a banal procedure which “happens every day” and that she would therefore have followed the opinion of November 12, 2019 of ANSES, the result of a procedure launched in 2018, taking an order 2 months later.
However, ANSES is not the body which evaluates the toxicity of the molecule concerned. ANSES is only consulted, in a purely administrative manner, before each entry on a list to check if this has no consequences on veterinary medicinal products. ANSES has issued approximately 3 to 4 opinions per year on the classification or downgrading of a drug on list II of poisonous substances since 2013. Lists I and II of poisonous substances are subject to modifications 5 to 6 times per year.
Therefore, the procedure was not initiated by Sanofi and the opinion of ANSES is anything but decisive in this decision of classification in List II.
In addition, this presentation frees itself from part of the history of the anti-hydroxychloroquine war that does not date from Covid-19.
As early as 2004, several in vitro tests on human cells and in vivo on animals demonstrated the efficacy of chloroquine on coronaviruses, in 2005 on the SARS coronavirus. The search had ceased with the outright disappearance of SARS.
No more at the time than in 2020, Sanofi, the holder of the originator, has not stepped up to defend the effectiveness of the old drug. And for good reason, it has fallen into the public domain and is now manufactured by many laboratories manufacturing generics.
But, above all, Sanofi had entered the SARS vaccine race, a much more financially promising path since the vaccine had to be patented. Moreover, Sanofi announced that it would develop an anti-Covid-19 vaccine based on the one prepared for SARS.
Finally, the synchronicity of the classification on list II alerts even if the classification procedure had been launched a few months previously. In fact, on January 9, 2020, the WHO announces that the origin of atypical pneumonia is a coronavirus. However, at this date, it is known that hydroxychloroquine has demonstrated its effectiveness on coronaviruses in in-vitro tests on human cells. Strange coincidence, 4 days later, the minister takes her decree.
Did the former Minister of Health not say everything? And ministers who give vague answers to the commission of inquiry
This October 15, the home of Agnès Buzin, Edouard Philippe, Olivier Véran, as well as Jérome Salomon were searched and their computers confiscated as part of a judicial investigation opened by the Court of Justice of the Republic on the management of the covid-19 crisis. Their respective statements during hearings by the parliamentary commission of inquiry lacked details and did not convince many observers. The former Prime Minister Edouard Philippe declaring about the masks to have declared their uselessness because “doctors told him“. The current Minister of Health has many contradictions and the latter has just been questioned by Renaud Muselier, president of the PACA region about the ANSM’s decision to refuse an RTU (temporary recommendation for use) to hydroxychloroquin, a highly politicized drug which therefore does not seem to be the subject of fair considerations.
Recall that in her policy for managing the covid-19 crisis, Agnès Buzyn had decided to classify hydroxychloroquine on list II of poisonous substances, on January 13, 2020 thus resulting in the end of the free sale of hydroxychloroquine a few dozen years after this free sale authorization. In addition, this makes this drug subject to medical prescription. During her hearing by the parliamentary commission of inquiry on June 30, 2020, Agnès Buzyn declared that the ANSM “must have received reports of accidents caused by hydroxychloroquine”. Candice Vacle in an article wonders: ” in short, Mrs Buzin can explain in part, but not in full, the administrative procedure which led to hydroxychloroquine being classified on list II of poisonous substances. And question that the fact that Mrs. Buzyn “Is clearly not at all interested in knowing why the ANSM asked him to classify hydroxychloroquine on list II of poisonous substances. It also did not verify the opinion of ANSES. Does she have blind faith in ANSM and ANSES? Yet “the error” is human and the Lancetgate (under the ministry of O. Véran) should have encouraged him to doubt the functioning of French health institutions. What is the point of being a minister if it is to obey the requests of his subordinates (ANSM) without verifying the merits of their requests? “
During her parliamentary hearing, Ms. Buzyn concluded her speech on her decision to classify hydroxychloroquine on list II of poisonous substances with this sentence: “I have seen conspiracy theories circulating about this decree, but it was issued on January 12. At this date, there are fifty cases in China, and one death … ”. She forgets to say that covid-19 has been officially identified since December 2019 in China; that on January 5, 2020, the WHO publish its first epidemic outbreak newsletter dedicated to covid-19; and that on January 10, 2020, the WHO publishes a set of guidance regarding covid-19. His argument therefore does not hold water.
In her article Candice Vacle concludes: before the parliamentarians, Ms. Buzyn, did not therefore explain the merits of her decision to classify hydroxychloroquine on List II of poisonous substances. She explains that she ignores the founding reason for her decision. Is this a good reason for its decision to put hydroxychloroquine on List II of poisonous substances to be reconsidered? The assumption of a genotoxic risk of hydroxychloroquine should be considered. Does this assumption still make sense in light of new scientific studies?
Consequently, the procedure for classifying hydroxychloroquine in list II raises questions and needs to be verified. The documents are however not accessible to the public.