There is no question of widely authorizing hydroxychloroquine in France against Covid-19: the Medicines Agency (ANSM) has refused Pr Didier Raoult a more extensive use of this molecule, which has still not demonstrated its effectiveness. efficiency.
"
We cannot respond favorably to the request for RTU (temporary recommendation for use, Editor's note) for hydroxychloroquine in the management of Covid-19 disease
", indicates the ANSM in an information point. online on its website Friday 23 October.
"
To date, the available data, which are very heterogeneous and uneven, do not allow us to predict a benefit from hydroxychloroquine, alone or in combination, for the treatment or prevention of Covid-19 disease
", -she.
Hydroxychloroquine is marketed in France by the Sanofi laboratory under the name Plaquenil, but for other diseases such as rheumatism or certain lupus.
The prescription by a doctor of a drug outside the indications provided for by the marketing authorization (MA) must be done "
on a case-by-case basis
", by informing the patient of the risks incurred and of non-reimbursement, and the the words "
outside the Marketing Authorization
" must appear on the prescription.
The temporary recommendation for use (RTU), which gives access to reimbursement, aims for a massive prescription outside the Marketing Authorization, beyond the prescription on a case-by-case basis.
Hence the request from the Institut hospitalo-universitaire (IHU) Méditerranée Infection, headed by Didier Raoult, who has a large number of patients.
A "
double standard
", reacted Didier Raoult on Twitter after this refusal, accusing the ANSM of promoting the antiviral remdesivir (Gilead) to the detriment of hydroxychloroquine.
"
Scientific consensus
"
Veklury, trademark of remdesivir, received a conditional authorization to market in Europe at the beginning of July for severe forms of Covid-19 and it benefits in France from a temporary cohort authorization for use (ATU), another procedure allowing certain categories of patients to use drugs not yet placed on the market.
Published studies show that it may reduce the length of hospital stays for patients, but that it has little or no effect on mortality.
The ANSM also publishes an eight-page letter sent to the Marseille microbiologist, in response to his request.
She traces the history of uses and trials in the world of this drug that the director of the IHU of Marseille defends tooth and nail to treat Covid-19, stressing that they have not demonstrated its effectiveness.
"
In conclusion, when we take stock of the studies published (...) since the report of the High Council for Public Health (HCSP) of 23 July, no data has been identified to provide in question the conclusions of this report, not in favor of the use of hydroxychloroquine alone or in combination with azithromycin (an antibiotic, editor's note), in treatment or in prevention,
”writes the drug gendarme.
The ANSM also mentions “
international therapeutic recommendations reflecting a scientific consensus
” going in the same direction.
It also notes that in his letter requesting the development of a temporary recommendation for use, dated August 3, Professor Raoult cites hydroxychloroquine "
without specifying the envisaged modalities of its use (in terms of target population, administration schedule, potential association with azithromycin)
”and that he has also“
sent publications by email, not all of which are validated by a review committee
”.
The health agency specifies that "
this position could be revised
" if it was provided with new convincing clinical studies.
This decision may be the subject of an appeal for annulment before the Council of State within two months of receipt.
Plaquenil sales exploded in March-early April, before dropping drastically.
Its off-label prescription had been banned in town and reserved only for hospitals, especially for clinical trials.
This ban has since been lifted.
Its consumption is now roughly equivalent, in town and in hospitals, to that of the previous year, excluding Covid.
