The French official agency for medications, that depends directly on France’s Health Minister Véran, has refused to temporary use approval for hydroxychloroquine to the Marseille University Hospital, headed by Professor Didier Raoult.
OCT 26 UPDATE
French ministry of health hinders HCQ procurement, according to what Professor Raoult heard from SANOFI, which supplies the drug. We cannot treat all the patients who present, we will have to start triage, says Prof. Raoult.
Prof. Raoult also stresses that, while HCQ is being repressed, the European Union bought for over 1 billion euros of Remdesivir, days before the WHO SOLIDARITY clinical trial confirmed, once again, it was ineffective both for reducing mortality or hospital stay duration. French hospitals are told they can get Remdesivir if they want, but not hydroxychloroquine.
Use automatic translation towards English by youtube if need be.
According to the October 23 communiqué, “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. In this context and in view of the available safety data showing increased risks, in particular cardiovascular risks, it cannot be assumed that hydroxychloroquine has a favorable risk / benefit ratio regardless of its context of use.”
The agency thereby rejects the validity of the several studies conducted by IHU Marseille, on thousands of patients, having demonstrated reduced mortality and reduced need for hospitalization (most patients were treated as outpatients).
This is the next chapter in the battle between Health Minister Olivier Véran and IHU-Marseille Professeur Didier Raoult. Minister Véran had already used the fraudulent Lancet publication by Mehra et al to further restrict the use of hydroxychloroquine in France.
Professor Raoult reacted by deploring the situation and stressing that the same agency is promoting Remdesivir, a medication proven by the WHO Solidarity clinical trials to be of no benefit for COVID-19.
Renaud Muselier, the President of the South Region, and President of the Regions of France, and former Minister, reacted to the news, stressing the decision was in direct contradiction with the very principles of medicine and emphasized that medical doctors should be allowed to prescribe, in the best interest of their patients.
There will certainly be further developments. Professor Raoult is one of the pioneers of early treatment for COVID-19. He achieved case fatality rates for his patients around 0.5% (see bottom of graph below). France achieved record case fatality rates, reaching 19.6% on May 26, and now declining with the sharp increase in testing, including of asymptomatic cases.
See IHU results at: https://www.mediterranee-infection.com/covid-19/
TRANSLATION OF COMMMUNIQUÉ (google)
ANSM publishes its decision on the request for an RTU for hydroxychloroquine in the management of Covid-19 disease – Point d’Information
We have received a request for a Temporary Use Recommendation (RTU) for hydroxychloroquine in the management of Covid-19 disease, from the IHU in Marseille. In order to assess this request, we relied on the numerous recent studies published on the efficacy and safety of hydroxychloroquine, as well as on the latest recommendations of the High Council of Public Health (HCSP) of July 23, 2020.
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. In this context and in view of the available safety data showing increased risks, in particular cardiovascular risks, it cannot be assumed that hydroxychloroquine has a favorable risk / benefit ratio regardless of its context of use.
Therefore we cannot respond favorably to the RTU request for hydroxychloroquine in the management of Covid-19 disease.
This decision is also in line with the vast majority of international treatment recommendations. It may be revised at any time, especially if new results from clinical studies modify the findings made to date.