No, the health authorities did not try to “bury” hydroxychloroquine before the pandemic



Has the National Agency for Food, Environmental and Occupational Health Safety (ANSES) tried “to bury hydroxychloroquine” – this antimalarial whose ineffectiveness against Covid-19 has been demonstrated – , and this even before the start of the pandemic? This is in any case what accuses him of several publications shared on social networks and widely relayed to the anti-vaccination and covid-skeptic community in recent days.

These publications, visible on Twitter, are based on an ANSES opinion dated 8 October 2019. In the latter, the director of the structure, Roger Genet, is requested by the National Agency for Drug Safety (ANSM) to give its opinion on the need, or not, to classify hydroxychloroquine-based drugs among ” list II of poisonous substances ”, so that it is no longer available in self-service, but under medical prescription.

If many Internet users, taken aback by the timing of this decision, shouted a set-up, the decision of the two agencies has no connection with the coronavirus. We take stock.

FAKE OFF

The ANSM decree proposal and the ANSES opinion are both available on the latter’s website, which is moreover requested only when “the substances, preparations or medicaments […] are used in veterinary medicine ‘, in accordance with
public health code. Once the decision has been validated, it is up to the Minister of Health, Agnès Buzyn at the time, to sign the decree defining the new classification of the substance in question.

Regarding hydroxychloroquine and its classification among list II of poisonous substances, it results from the desire of the ANSM to standardize the prescribing conditions of chloroquine (then distributed under prescription) and hydroxychloroquine (then free of charge). service).

“In 2018, the Sanofi laboratories submitted to the ANSM a request to update the information available in the leaflet and in the summary of product characteristics (SPC) of its chloroquine (Nivaquine) and hydroxychloroquine-based drugs. (Plaquenil). This request resulted in a complete review of the marketing authorization files (AMM) for these drugs by the ANSM ”, explained the ANSM press service to 20 minutes. “Following this review, it was notably decided to harmonize the prescription and dispensing conditions between these two drugs, given that they belong to the same therapeutic class and that they have common indications. “

In his proposed decree, the ANSM indicates that chloroquine is known for its genotoxic potential (which can compromise the physical or functional integrity of the genome), and that the same risk for hydroxychloroquine, despite the lack of data, “cannot be excluded” . The latter, notes the agency, should therefore “not be used during pregnancy unless the clinical situation justifies the continuation of treatment in view of the potential risks incurred for the mother and the fetus”.

Since hydroxychloroquine is likely to cause, “directly or indirectly”, a health hazard, the ANSM has therefore decided to make the distribution of drugs based on this molecule subject to compulsory medical prescription with possible renewal, unless the prescriber is prohibited. A proposal followed by Agnès Buzyn, who signed the decree January 13, 2020, a few weeks before the first cases of Covid-19 in France.





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