Meeting at the Ministry - Subjects: Meningioma operation, patients, etc.
The AMAVEA association was received on May 21 by the Ministry of Health. Many points have been discussed such as the need to operate meningioma, pharmacovigilence for molecules behind meningiomas, compensation for victims.
Amavea is an association, one of the main objectives of which is to provide support to people who develop meningiomas following the taking of molecules such as Androcur, Lotényl and Luteran. Today, the link between these drugs and the appearance of these tumors is well established. Taking this problem into account in the decision to practice the operation of a meningioma is one of our main concerns. Indeed, they can regress when you stop treatment.
This meeting with the Ministry of Health was essential for the association in order to discuss this particular point.
Participants
The following people were present in Reunion:
Céline Perruchon, Director of the Branch Products of Health and Quality of Practices and Care at the Directorate General of Health.
Frédéric Seval, Director of the Division Rights of Users, Legal and Ethical Affairs at the DGS.
Emmanuelle Huet-Mignaton, president of the AMAVEA association.
Maitre Charles Jospeh-Oudin, lawyer, advisor to the association.
Maitre Guillaume BRUNEAU-Queirex, lawyer and advisor to the association.
Five other people from the DGS, doctors and pharmacists, also attended Reunion.
This meeting was obtained with the support of Olivier Veran deputy LREM and neurologist at the Grenoble University Hospital.
Presentation of the AMAVEA association
The AMAVEA association was presented, with its history and its goals, as described in the statutes.
I presented my personal story succinctly by putting it in parallel with those of women whose association has been able to have the testimony for several months. The goal was also to put into perspective the word "Benin" used by the minister for the meningiomas with regard to the stories that we have experienced and that we still live in relation to these tumors.
It has been specified that for the moment, we talk a lot about Androcur , but that we will soon talk about Luteran and Lotényl , and possibly other progestins.
MENINGIOME operation: patient management
The central point of this problem is the fact that the operation of a meningioma or many is sometimes possibly not necessary.
Indeed, neurosurgeons have not all realized that a meningioma could interrupt its growth when the Androcur or progestins stop. Information in this sense seems essential. But the contacts that the association has had with the learned companies of neurosurgery are not very satisfactory.
Apart from a few very receptive neurosurgeons who are therefore already aware through congresses of this problem. It therefore appears to us clearly that it is up to the health authorities to set up this information.
Pharmacovigilance
The association has noted a malfunction in certain pharmacovigilance centers (CRPV) from the start. Professor Froelich, a neurosurgeon who is initiative of past and undergoing studies, has made a specific questionnaire to be able to have a quality epidemiological and statistical approach. Unfortunately, some centers do not play the game of this questionnaire.
Perhaps the lack of means is responsible for it. We insisted that studies (all studies, those of Pr Frouelich but also others) are done correctly. They will thus be able to allow a better understanding of the problem, and therefore a better monitoring of patients.
Information to patients by the ANSM
The recall of patients who took Androcur is a good thing. The association supports this procedure. But there remains a problem. The duration of recall over 24 slippery months is far too short and the "shooting window" very insufficient. What about women who have not taken Androcur for years but who take another treatment (Luteran, Lotényl, or other)?
If meningiomas have been created by Androcur, they continue to grow. In this case, the operation of a meningioma may be necessary when it could be avoided. We were answered by M Segal that he was going to be legally studied the possibility of blowing up this "lock" of the 24 slippery months.
We also noticed that our mail sent to the ANSM in February, to request all the documents held by the ANSM concerning cyproterone acetate, did not reach their entirety. Those we currently have are only public documents for the most part, without much interest for the work of lawyers.
Compensation for victims
This subject is of particular interest to lawyers. Me Charles Joseph-Oudin has around 70 “Androcur patients” files. He needs to know what the State intends to take charge or not as well as the terms of this care. He asked for a centralized expertise system, which does not seem to be on the agenda.
On the other hand, a guide of the expert will be done by the CNamed ( National Commission for Medical Accidents ) which will make it possible to coordinate expertise, to determine the causal link and define the consequences.
The CCIs ( conciliation and compensation commissions of medical accidents ) remain competent. It is quite technical, which is why the association needs a lawyer. He knows serial drug accidents and helps us find out without letting ourselves fall asleep.
Lawyers asked to have the list of experts to check their impartiality.
In this sense, the association will be invited on June 18 to a meeting in order to define the practical terms concerning expertise and compensation.
Conclusion
This meeting was very positive, with very attentive and respectful doctors and pharmacists. To come and come to come to advance these files.
Emmanuelle
Meeting at the Ministry - Subjects: Meningioma operation, patients, etc.
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