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Otter

The French position, fighting back

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Otter

The latest position in France is that some anti-baclofen alcoholic "experts" are trying to publish reports of failures on baclofen or side effects which have made people stop taking it. I've been sent an email and link where anyone can post positive results of baclofen use to help counter this opposition to the use of the medication. I have no idea what is behind this. My worry is that it may be an anti-generic action on the part of a drug company.There are now several who are wanting to get patents on their own version of alcohol treatment using different levels of baclofen and perhaps other drugs, but I don't entirely understand the situation in France.  If you do follow the instructions, please amend the final part of the testimonial so that it reads a bit better. I have left it as a "googlized" translation so it doesn't come out very well in English.  Here is the email I received.

 

H ello, 

An attempted manipulation public as an appeal for witnesses has been posted on the website of Hello Doctor.

They want to steer clear of the debate by seeking witnesses having stop baclofen due to adverse effects.

This is even more serious than Marina Carrère d'Encausse was and perhaps still in a relationship with Philippe Batel, long recognized alcohologist Allo Doctor and notoriously hostile to baclofen.

The journalist neutrality of this issue is clearly challenging.

So we ask you to testify in mass on the link below.

You will need register or log in to read this content

We suggest you start by describing the troublesome side effects you met (if there was) and then finish on profits that finally swept away.

We also ask you to finish your testimony with this sentence: "I am aware of the emotional ties or have joined Mrs Carrere d'Encausse and Dr Phillipe Batel, a long time your appointed alcohologist

and notoriously hostile to baclofen. As a result, your journalistic neutrality in this call to witness, very oriented so that the scientific debate is raging, seems to be questioned. "

 

IMPORTANT: 

Pécisez, if you like, in this testimony on the site of Hello Doctor you wish to remain anonymous. 

Do not forget to make a screenshot of your testimony before sending. Then we pass it here. We anonymiserons recess. 

In the current context, we must not let the free field to a public service broadcast widely watched to maintain fear around our treatment! 

Thank you mobilize you

Edited by Otter

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Otter

It would be very helpful to have anyone who can spare the time, write in and set out how they have been helped by baclofen to this site: You will need register or log in to read this content

They are looking for international contribution to show that high dose baclofen has been used around the world.  

This is a very sad situation, that in the home of Olivier Ameisen, there are cynical doctors who would deny patients already using baclofen at high doses, access to their medication.  This could result in their deaths through alcoholism.  The decision to limit use to 80 mg a day means that the government won't pay for prescriptions above that amount so many people won't be able to afford the treatment.  It will also mean that doctors will not want to go beyond that level because they are being scared off from doing so by what is essentially false evidence about the risks of using baclofen at higher doses. 

 

 

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Otter

The French government appears to have intervened in the court case over high dose baclofen and referred it to the Council of State which is a body which advises the government on legal issues and acts as the supreme court in France in relation to administrative issues. 

The French baclofen users group is now asking for testimonials of baclofen uses.  You can fill one out in English.  I received this notification a few days ago.

Here is the site with the forms: You will need register or log in to read this content4

They are looking for as much support as they can get.  

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Molly78

Otter, the website translates but the the forms stay stubbornly in French! Right click brings up "translate to English" but then won't let you!  Expect there is a clever way round it?

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Baclofenman
21 hours ago, Molly78 said:

Otter, the website translates but the the forms stay stubbornly in French! Right click brings up "translate to English" but then won't let you!  Expect there is a clever way round it?

Chrome will not translate a pdf, certainly not in stock browser form

Open the PDF

Right click on PDF

Select Ctrl and A

Right click anywhere on highlighted text and COPY

Open You will need register or log in to read this content in a new tab

Left click in left hand translate box

Right click and PASTE into left hand box

I would not recommend a "free pdf translation tool". Nothing is free Molls and you will probably end up with a load of crap on your computer you would not want!

You can then copy and paste the translation to a word document, if you so desire

Regards

 

Bacman

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Otter

I've heard from Aubes and they would like testimonials in English.  

Association AUBES <temoignages@baclofene.fr>

16 Mar (7 days ago)

to me

French

English

   

View original message

Don't automatically translate for: French

Dear David, so we take the testimony in English! No problem! Rather, it shows that baclofen is also prescribed elsewhere. 

Yours

Marion 

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Molly78

It's not giving me ctrl+A as an option.

What about just sending them free text about your experience? 

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Molly78

Ah, it's OK, I am trying to translate the wrong document - the one for  the prescribing doctor to fill in!  The one for the patient virtually is free text, & even I can understand the bit of French on it!

Job done, I will fill it in.

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Otter

Here's the latest.   You will need register or log in to read this content

The decision to reduce the maximum dose for baclofen in alcoholism treatment went before the French Council of State on 17 February 2018.  The hearing considered whether there should be an immediate reinstatement of the previous recommendation for treatment which allowed for high dose baclofen.  The Council decided not to increase the limit set by the ANSM, the French medicine safety board, and left it at 80mg per day.  However, the Council did not make a decision on the merits and will leave that until public hearings have taken place in the summer of 2018 or later at which the Council has promised that "tout let monde", all the world will be heard.

in the meantime there will be committee hearings of the CSST, a European committee of experts who will review the data from studies. It appears from the article that they will ask questions of the Alpadir laboratory who conducted studies into the efficacy of baclofen and found it helped abstinence but no more than placebo.  The study used volunteers who, I believe, had already stopped drinking by engaging in rehab counselling leading to criticisms of its methods.

I would urge everyone to submit testimonials and notify as many people as possible about this development.  

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Otter

I've been looking into what the role of the French ANSM is.  It was set up to exercise "pharmacovigilence".  On the face of it, this is a body which is supposed to examine new drugs and set limits on their use.  In the case of high dose baclofen, they simply rolled back the dosage to a maximum of 80 mg.  Having looked at the WHO directives on pharmacovigilence, this doesn't seem to be what they are supposed to be doing.  They should be trying to advance medical treatment for public health reasons and extending the use of new drugs. In underdeveloped countries where medical treatments are new, there is a lack of understandinding of how they are used and poor delivery and supervision.  By coordinating efforts a pharmacovigilence body should help to make the use of these drugs more successful.  It seems strange that the French ANSM would simply look at one study and conclude that everyone should be restricted to a maximum limit which might not help a lot of people.  Many people use the drug successfully and with good results, over a long period.  

Many of the studies I have seen coming out of France study a set of baclofen users for a short period of time. One study compared their success to other who had been in residential rehab and had come out of it abstaining. The baclofen group were also abstainers.  Baclofen is not a drug used to promote abstinence primarily.  Rehab has a poor long term record for abstention so both groups, having been through rehab performed the same, over the short term. But, that's where the study ends.  What happens over a longer period, say 7 or eight years?  And, what resources are in place to assist baclofen users in the community or in hospitals?   Those are the sorts of questions the ANSM should be looking at.

 

My experience with baclofen is that there is, in the UK, no role played by public health authorities at all in the use of the drug. Hospitals kick you out the door if you present as an alcoholic.  Doctors still won't prescribe and those few that do will treat it as though it is a pain killer which you can take yourself and the problem should "clear up".  How does any of this fit in with a public health policy which is progressive and based on good science?  The French government has said that everyone will be heard.  I hope so and I hope they review the role of the ANSM in this as a body which needs to exercise it's powers in a way that promotes public health and safeguards the treatment of individuals who benefit from baclofen at whatever dosage they need.  We shall see.  

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Otter

It seems that the French have decided to allow the use of baclofen in the treatment of alcoholism.  After hearing from baclofen users and supporters the scientific commission set up to consider the issue decided that baclofen treatment needs to continue.  Here is a report of the recommendations of the commission, I've underscored the important passages:

"Following the filing of a marketing authorization application filed by the Ethypharm laboratory concerning the specialty Baclocur® (baclofen in the treatment of alcohol-dependence) following the modified RTU which limited to 80 mg / day the maximum dosage of baclofen in this indication, the CSST (Temporary Special Scientific Committee) mandated by the ANSM had delivered a negative opinion on the benefit / risk of this treatment because of various signals of concern regarding the safety of use of this drug especially high doses.

The concern of the patients concerned, their entourage and caregivers was therefore major because this opinion could lead to the refusal of the AMM, the termination of the RTU and thus the withdrawal of baclofen in this indication! An unbelievable new episode in the already (too) animated saga of baclofen.

However, following the mobilization of patient associations, prescribers and professional federations and aware that baclofen met a real expectation and that the problem posed a real societal dimension beyond the conventional evaluation of a drug, the Director General of the ANSM decided for the first time to create and convene a "Joint Ad Hoc Committee", bringing together members of the three regular commissions of the ANSM to give an opinion on the evaluation of the use of baclofen in the treatment alcohol-dependent patients.

YES to baclofen!

This commission, chaired by Professor Nicolas Authier, met on 03 and 04 July, the day of 03/07 being devoted to the hearing of stakeholders, associations of patients, prescribers involved, learned societies, professional federations of which the Addiction Federation represented by Drs. Aram Kavciyan and Xavier Aknine (under MG Addiction). These hearings and the rich debates that followed allowed this commission, despite the CSST's opinion, to decide in favor of the use of baclofen in alcohol-dependent patients and therefore against the withdrawal of this drug. in this indication.

NO to the AMM "Baclocur", in the state

On the other hand, the Commission is against the marketing authorization application proposed by the Ethypharm laboratory. Unlike a RTU for which a mere presumption of effectiveness may be sufficient, a marketing authorization requires that the benefit / risk ratio be established, which, in the opinion of the Commission, was not the case solely with regard to elements produced in the dossier submitted by the laboratory.

YES to a refurbished prescription setting:

Following the hearings and the latest international data, the Commission proposes that the use of baclofen may continue, in particular under the following conditions:

in the indication of alcohol use disorders after failure of available therapies with the objective of reducing alcohol consumption to a low-risk consumption level;

prescription by any doctor up to the dosage of 80 mg / day. Beyond this dosage, specialized multidisciplinary management should be systematically proposed, given an increase in the frequency of serious undesirable effects with increasing doses;

no contraindication in case of associated psychiatric disorders but need guidance for advice or follow-up to a psychiatrist;

the prescription of baclofen must be associated with psychotherapeutic and / or psychocorporeal and / or social, systematic management;

the prescription of baclofen must be accompanied by a booklet for monitoring and promoting the proper use of baclofen.

 

Advances

In the end and despite the negative opinion concerning the AMM dossier for "Baclocur ®  " , the Commission is calling for the continued use of the baclofen indication in alcohol use disorders and even proposes to make the possibilities more flexible. prescribing the current RTU by no longer limiting them to 80 mg / day and not retaining the contraindications for psychiatric disorders proposed for example in the laboratory file . Lastly, it recalls the need for a global approach, not exclusively for medicine, to deal with such a complex problem.

A consensus on baclofen, is it possible?

Faced with this health problem of such a large scale and the difficulties of specialized access in certain territories, the Addiction Federation had for its part proposed a greater involvement of primary care medicine on the basis of ad hoc training. and strengthened links with addictology structures, reserving specialized intervention for complex cases regardless of a dose threshold. Similarly, the use of a specialized device beyond the dose threshold of 80 mg / day can only be done in compliance with the therapeutic alliance created with the patient.

Nevertheless, it welcomes the real progress achieved by this important work of consultation, especially as the convergent positions of all the professional organizations, including the Addiction Federation, helped to influence the debates in order to better meet patients' expectations. . It is now up to the ANSM to make a decision, we do not doubt that it is part of the dynamic consensual thus launched!" 

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Edited by Otter
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Molly78

It's a shame the prescription of bac has to be associated with all the psychotherapeutic/psychosocial stuff, since it is a stand alone treatment as many of us can testify. Still, it's progress & yes, good news!

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