The following blog post was subsequently published in Prescrire forum: Ferry-Danini, J. (2025). Evaluation Du Phloroglucinol (Spasfon) : Des Pr´ecisions Sur La Position de l’ANSM. Prescrire Rubrique Forum, 501.
In late December 2024, I finally received responses to my letters from the ANSM. I first received an email response on December 18 to the letter I had sent several times—both in hard copy and by email. The full text of this response is included at the end of this post. I then received a response via the Ma Dada online platform on December 23, which you can view here.
The ANSM’s position on the lack of conclusive data on the efficacy of Spasfon
“You are asking us about whether this drug should remain on the French market, given its age and various publications that reportedly highlight the lack of data and randomized controlled clinical trials on phloroglucinol (…)”
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.
This philosophy, assessing a drug’s safety without considering its efficacy, seems absurd to me (one cannot weigh the benefits against the risks if there are no benefits) and contrary to the ANSM’s missions as defined by the Public Health Code. According to Article L5311-1, “The Agency shall evaluate the benefits and risks associated with the use of health products intended for human use (…). It shall monitor the risks associated with these products and conduct re-evaluations of the benefits and risks” (emphasis added). This also seems to me to raise a question of moral legitimacy: the government controls access to medications because it is considered better equipped to weed out useless and dangerous drugs. If this is not the case, then what legitimacy can be attributed to this control?
2. In one section, the ANSM discusses the antispasmodic properties of Spasfon:
“As you indicate in your letter, the antispasmodic properties of phloroglucinol were established based on pharmacological studies available at the time the drug was marketed. These studies are therefore outdated, but to date, no new data calling these properties into question have been brought to the attention of the ANSM.”
This is a rather significant admission on the part of the ANSM. The ANSM considers phloroglucinol to be an “antispasmodic” solely on the basis of research from the 1960s, which falls far short of current scientific standards. It is a rather serious methodological problem to fail to recognize that up-to-date scientific standards must be applied when evaluating drugs.
Does this passage mean that the ANSM is confirming that the assessment of Spasfon’s efficacy is also based solely on these older data? The ANSM refers to “antispasmodic properties.” This is unclear. The ANSM seems to be carefully avoiding discussing directly the question of efficacy.
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.
The agency writes that “no signals that could call the risk-benefit balance into question have been reported,” and that “no new data calling these properties into question have been brought to the attention of the ANSM.”
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.
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