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The ANSM’s position on the lack of conclusive data on the efficacy of Spasfon

This is how the December 18 email begins. Ironically, the ANSM subsequently sidestepped the issue. It should be noted that the ANSM provided a generic response here and did not address my letter in detail. The issues of sexism and evidence-based medicine were thus ignored. Nor was there any mention of the indication for painful periods or other specific questions. Three points seem important to me:

1. The email seems to confirm my hypothesis that the ANSM bases its assessment of a drug’s risk-benefit ratio solely on its safety.

Indeed, the email begins by addressing the safety of phloroglucinol, then ignores the question of its actual usefulness. The ANSM writes that “the safety of phloroglucinol has been monitored for several years, with a significant decline in prescriptions” (note: unless I am mistaken, I have not observed this decline in prescriptions in the OpenMedic data) and immediately continues with “the benefit-risk balance of phloroglucinol hydrate/trimethylphloroglucinol for the aforementioned indications remains favorable to date.” The question of the drug’s efficacy or usefulness is thus not addressed, not even in the context of pregnancy, for which safety is then discussed at length.

3. On several occasions, the ANSM states that there is no new data that would call into question the drug’s efficacy or our understanding of it.

One might wonder why the ANSM pretends to ignore the two negative systematic reviews regarding Spasfon. The ANSM also pretends to ignore that there is absolutely no data at all for several of Spasfon’s indication – not even old data! The ANSM is therefore waiting for published data that would call into question… older studies that do not meet current scientific standards anyway, or studies that… do not exist. To illustrate the problem, it’s a bit as if the ANSM were an institution tasked with ensuring that Santa Claus exists and were to say, “We have not received any evidence that Santa Claus does not exist, so Santa Claus exists. Don’t worry, Santa Claus is harmless.”

In my book Pilules roses, I described the health authorities’ attitude as “apathic” regarding the issue of phloroglucinol’s efficacy. This apathy appears to be epistemologically accepted by the ANSM.

The ANSM and the European Medicines Agency (EMA) are passing the buck back and forth

On the platform Ma Dada, I had requested access to the latest PSUSA for Spasfon (“periodic safety update report single assessments”). In its December 18 email, the ANSM stated that following the most recent PSUR (“periodic safety update”) on phloroglucinol in 2022, the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee recommended maintaining the drug’s marketing authorization (MA). In its response on the Ma Dada website, the ANSM provided a different answer, simply stating that the EMA was “likely” to have the requested documents. In August 2024, the EMA had denied my request for access to documentation on Spasfon or phloroglucinol. For now, the two institutions are passing the buck back and forth, so it is impossible to determine on what basis the EMA based its 2022 decision (I have since followed up with the EMA). The European platform of the HMA (https://mri.cts-mrp.eu/portal/) (Head of Medical Agencies, or CAM in French, an organization that brings together the health authorities of member countries)—to which the EMA had referred me at the time—does not provide any documentation on Spasfon.