The sanitary crisis can’t be used as an excuse for ignoring the rules regarding proper evaluation and authorization of medicines : efficacy has to be rigorously demonstrated in methodologically sound studies and a favorable benefit risk ratio has to be established. This is the number one rule when it comes to appropriate use of medicines.
French National Agency for Safety of Medicines (Agence nationale de sécurité des médicaments, ANSM) has just granted emergency use authorization (Autorisation d’utilisation d’urgence, ATU) to Eli Lilly’s mAb bamlanivimab for COVID 19 as an early treatment for patients at increased risk for developing severe disease. This ATU program addresses 80+ and immune compromised patients
However phase 2 clinical data do not allow to establish efficacy of this drug in this indication.
In addition it specifically binds to the area of Spike harboring mutations of #SARSCoV2 VOC : 20H / 501Y.V2 (South Africa) and 20J / 501Y.V3. (Brazil), which may render it ineffective against those strains.
Finally, on February 27, 2021, the protocol for the ATU warned that “The use of bamlanivimab can promote the selection of de novo resistance mutations”.
Despite these shortcomings and limitations, coupled with a questionable practical feasibility conferring a high risk of overwhelming hospitals,
government has ordered a stock of the expensive drug (2,000 euros per vial) with « urgent DGS (Direction générale de la santé) » instructions for its use.
Citizen4Science, a non-profit citizen association advocating for the importance of maintaining scientific integrity, stands up against this Temporary use authorization (ATU) and expresses deep concerns at what it considers to be unacceptable.
a non-profit citizen association advocating for the importance of maintaining scientific integrity, stands up against this Temporary Use Authorization (ATU) and expresses deep concerns at what it considers to be unacceptable.
We are concerned about the interference of politics or other industrial interests in science and drug approval process, which we are combating.
This ATU does not protect interests of patients who will receive this expensive treatment with no proven efficacy – possibly instead of vaccine shots – which also happens to be associated with elevated risk of selection of de novo resistance mutations (as specified by the ATU itself!)
In 2020 we faced the issue of HCQ presented as a miracle cure and used around the world. HCQ – used despite lack of proven benefit against covid – turned out to be not only ineffective but dangerous. However it has been authorized by some countries based on non scientific grounds.
Remdesivir has been granted European approval without proven efficacy, while various products in the USA have been authorised despite insufficient evidence to support the use of these treatments.
France had so far escaped political interference in regulatory approval processes.
Campaigns of disinformation based on scientific populism and conspiracy theories are raging and Citizens are distancing themselves from science/rationality and vaccine hesitancy. We consider this unjustified ATU dangerous for patients and healthcare system.
It can only promote anti science.
Even more appalling considering all the efforts made by science advocates – Citizen4Science included – involved in this fight for 1y to educate the public on the importance of rigorous, well conducted clinical trials to assess efficacy and safety of drugs before granting approval.
Citizen4Science calls on th French government and health authorities and suggests that this ATU be suspended until data proving the efficacy of bamlanivimab as a monotherapy or in combination with other monoclonal antibodies are released and properly assessed
As a last resort, we trust practitioners in the field who will know how to promote appropriate use of drugs.
More information on Citizen4Science (RNA W751258960) on the website of the association:
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Fabienne Pinson, president to Citizen4Science