Baclofen user takes French ANSM to court

 The French society for safety in medicines decided unilaterally to reduce the permissible dosage of baclofen to 80 mg last year.  It advised doctors and pharmacists not to issue prescriptions for high dose baclofen because, it said, there was evidence of hospital admissions and suicides or attempts by users of high dose baclofen.  This resulted in many not getting adequate dosage and poses a real threat to the lives of many who need treatment at the right level for their illness.   The wife of one baclofen user has now file an appeal against the ANSM, yesterday. Here is a report from AUBES on the case so far:

Recours de l’épouse de Thomas Maës Martin contre l’ ANSM (the wife of Appeal of Thomas Martin Maes against the ANSM) 

GOOD NEWS (fingers crossed): The appeals were filed Wednesday and Thursday before the Council of State.

In summary, the use argue:

– the serious and immediate threat to the position of the applicant and public health (40 000 persons concerned)
– the existence of a triple procedural including the obligation to make an assessment of the risk-benefit ratio before changing RTU
– a manifest error of assessment of risk would have regard to scientific data acquired in science,
– a manifest error of assessment of the benefit-risk ratio;
and ask:
– the immediate suspension of the modification of the RTU and the return to the formulation of March 2017
– the injunction under penalty of publication of the terms of this ruling on the front page of the website ANSM and the Ministry of Health,
– the injunction under penalty of dispatch to all hospitals and private practitioners, general practitioners, specialists, pharmacists with a letter informing them of the return to the old RTU.
The particular parts produced:
– Briefs, articles and scientific studies (BACLAD, BACLOVILLE, BEH, CRPG)
– Medical certificates and prescriptions with a prescription containing 16 refusal to issue pharmacies
– Newsletter of the College of Pharmacists
– Letter ANSM healthcare professionals
– Testimonials
– Press the SFA
– Petition
– Tribune BLADE Association
– Clippings
– Press the Health Minister Marisol Touraine
– Tribune twelve universities (12 Professors of Medicine)
– Open letter from members of the CSST
– Interdepartmental Report of May 2017 on the real life studies

We will be fixed within thirty days. Thank you to those of you who contributed to the development of this file by their testimonies.

The team BLADES

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