August 16th 2014 (with an update on June 1st 2015)
Baclofen, a promising new indication for an existing drug, not yet sufficiently available to patients in the Netherlands.
Request and background information
The Stichting voor Alcoholverslavingszorg (SA) is a foundation that has been set up to help alcohol addicts by treating them with baclofen (and possibly other drugs) in combination with psychological support. The foundation believes they have found a unique treatment strategy that is new to the Netherlands. This strategy has not been adopted by regular healthcare services, making it inaccessible to a large group of alcohol addicts.
The SA aimed to make up for this deficiency by setting up a low-threshold clinic where alcohol addicts could be given baclofen as a first-line treatment option. The SA intended to start in Amsterdam, but hoped to expand its services to other parts of the country. The SA asked Cinderella for help in developing and promoting this new important indication for baclofen.
Baclofen is a muscle relaxant that is registered for the treatment of painful muscle cramps in diseases such as MS. It has been on the market for this indication for many years and is no longer protected by patent.
The effectiveness of high-dose baclofen in suppressing alcoholism was discovered by Olivier Ameisen, a New York-based French cardiologist who suffered from severe alcohol dependence. After many years of failed treatment programmes, during which he tried everything medicine had to offer, he discovered a publication describing how rats dependent on alcohol could be completely cured by treatment with baclofen. He then started experimenting with this drug on himself and experienced something that he had not felt during any of the other treatment programmes: the craving for alcohol − the reason for his relapses − disappeared completely. During other treatment programmes this craving was still present in the background and constant efforts were required to stay off the alcohol. He also discovered that baclofen was effective in suppressing his intense anxiety attacks, which he considered to be the cause of his alcoholism.
In 2004 he published his own case report in a medical journal, in the hope that his method would promote clinical research into baclofen. Several studies comparing baclofen with placebo were indeed carried out but their results were conflicting. Dr. Ameisen believed that dosage levels were too low, but doctors were reluctant to use higher doses for fear of possible dangerous side effects. They were not persuaded by Dr. Ameisen’s argument that patients with muscle cramps given high doses of baclofen suffered no such side effects. It was not until 2008 with the appearance of his best-selling book “Le Dernier Verre” (English version entitled “The end of my addiction”), in which he argued strongly in favour of more research with higher doses, that further interest was aroused. For example, the University of Amsterdam subsequently received a donation of half a million euros to initiate a clinical trial into baclofen. The donor, who initially wished to remain anonymous, said that he made the donation after reading Dr. Ameisen’s book.
The book has resulted in calls to action from alcoholics all over the world requesting treatment with baclofen. In France, official sales have increased by 20% over two years. If doctors refuse to prescribe the drug off-label, many people in France decide to treat themselves −after all, baclofen is readily available via the internet at affordable prices. However, the medical profession considers it irresponsible for people to take baclofen without professional supervision and the French drug regulatory agency is currently facing a major dilemma. If it approves the drug before more rigorous research has been done and there are problems then they will be accused of laxity; while if they continue to refuse, the large group of baclofen proponents will accuse them of holding back a potential wonderdrug. A further consideration is that complying with all the requirements of such clinical research into addiction is likely to be difficult and costly, costs that in this case will not be covered by the pharmaceutical industry. Meanwhile – in early 2013 – the ANSM (formerly AFSSAPS) abandoned his objections and baclofen may be prescribed by every physician in France.
What Cinderella has done
At an introductory meeting in July 2011, the proposers from the SA presented an action plan for this project. Cinderella recommended making a number of changes to this plan and putting the main points into a summary. This summary could then be presented to a number of prominent addiction experts to find out whether they would be interested in collaborating with this initiative.
The SA subsequently persuaded the Dutch Trimbos Institute to help them organize a seminar for the main players in addiction treatment in the Netherlands with either experience or interest in baclofen. The aim of the meeting was to bring together current experiences with baclofen and to develop a strategy regarding the further possibilities of using this drug to treat alcohol addiction.
This meeting took place on 28 February 2012. There was a useful exchange of expertise and much discussion of the design of the Amsterdam study, scheduled to start in June 2012 with high-dose baclofen and led by the University of Amsterdam and Solutions drug rehabilitation clinic. (A report of this meeting can be found below under ‘Additional information’.)
The meeting has provided sufficient information and recommendations for the SA to further develop its plans.
In January 2014 the preparations for the clinic were so advanced that it could be started as soon as the necessary start-up capital was brought together. Cinderella contributed to it with a bridging loan. In mid-August 2014, the outpatient clinic in Amsterdam started, but was forced to close down as early as December due to a lack of funds. Unfortunately, it proved impossible to conclude the necessary contracts with the health insurers. Treatments were therefore not refunded in full. The insurers also refused compensation of 75% of the costs, despite being obligated to do so under section 13 of the Dutch Healthcare Insurance Act (Zorgverzekeringswet).
All insurers imposed purchasing conditions relating to the results (i.e. turnover) of previous years, with which a new institution – by definition – cannot comply. The way in which the rejection was formulated by the insurer DWS is typical:
Non-contracted mental health care institutions only qualify for a contract in 2015 if the turnover regarding those insured by DSW is at least €25,000. To verify this, we look at the accounting period from 1 January 2013 to 31 December 2013. In this period you should have submitted at least €25,000 in diagnosis-treatment combinations relating to mental health care and primary health care, for at least ten policyholders. In addition, these diagnosis-treatment combinations must have been remunerated by us to you/our policyholders for the care that you provided. If your turnover is below the amount stated above and/or you have treated fewer than ten policyholders, you do not qualify for an agreement, or not yet.
The health care insurers have thus created a stalemate, rendering innovation in health care impossible.
Comments from Cinderella
The Amsterdam clinic’s initiative was not only innovative because of the introduction of baclofen, but also because of the possibility for outpatient treatment, the low-threshold approach and provision of e-coaching. Located opposite Amsterdam Central Station, the clinic was easily accessible to people from all over the country. The outpatients’ clinic was also opened in the evenings and on Saturdays, meaning absenteeism from work could be avoided. In addition to these advantages for clients, the costs for treatment were low, thanks to the chosen form (i.e. outpatient) and the fact that the SA is a non-profit organisation.
It is clear that health care insurers set little store by a new, more client-friendly and cheaper approach to treating a common disorder that causes severe damage to health and one that creates much social misery.
* CASE REPORT COMPLETE AND PROLONGED SUPPRESSION OF SYMPTOMS AND CONSEQUENCES OF ALCOHOL-DEPENDENCE USING HIGH-DOSE BACLOFEN: A SELF-CASE REPORT OF A PHYSICIAN, by OLIVIER AMEISEN, Alcohol & Alcoholism Vol. 40, No. 2, pp. 147–150, 2005
* De Kruistocht van een Ex-Alcoholist. Medisch Contact 64 no. 45 | 25 November 2009 | p. 1905
* ALCOHOL-DEPENDENCE: THE CURRENT FRENCH CRAZE FOR BACLOFEN by B. Rolland et al. Addiction, 107, 848–850
* Read here the report on the Trimbos meeting (in Dutch language) February 28th 2012.
The SA would very much like to hear from doctors or financial backers interested in collaborating with this initiative.