Baclofen: a new drug used to treat alcoholism
There are 120 alcohol-related deaths a day in France, and two and a half million each year in the world. The figures speak for themselves in terms of describing the damage alcohol can do. Could this disease, the causes of which are now known (genetic, biological and social), be treated effectively by a new, ground-breaking molecule called Baclofen?
A clinical trial on Baclofen will begin on 20 May 2012. “Finally!” according to doctors and specialists at addiction services who have been waiting for years to evaluate the tolerance and effectiveness of this treatment for alcoholism. After different warnings issued regarding its use without market authorisation (MA), the French Agency for the Safety of Health Products (Afssaps) now recognises the benefits this molecule has for certain patients and authorises the prescription of Baclofen on a case by case basis by health professionals experienced in treating and managing dependency on alcohol.
Baclofen: Up to 58% effectiveness
A preliminary study* led by French medics has shown the effectiveness of Baclofen in strong doses in combatting alcoholism. The medicine has only been in existence for 50 years. It is usually prescribed as a treatment for involuntary muscular spasms with underlying neurological causes (in multiple sclerosis for example). After one year of treatment with Baclofen, 80% of 132 patients who were prescribed the drug became tee-total (78), or were moderate drinkers (28). Considering patients who disappeared from view as “failures” as they could not be evaluated fully, the ultimate success rate was 58%.
The drugs currently used in clinical treatments are naltrexone and acamprosate as well as more general addiction management (psychotherapy) and the success rate for this treatment is only 30% (cured after one year). However, don’t get excited too quickly warns Dr. Philippe Batel, a psychiatrist and head of addiction services at the Beaujon Hospital: “We need to wait for the safety of Baclofen to be established. After a scandal like the Mediator diabetes drug in France, it would be absurd not to take into account any possible side-effects.”
Baclofen: a medicine prescribed without market authorisation
The story behind this discovery is based on self-experimentation. Professor Olivier Ameisen, professor of medicine and cardiology practising in France and New York, became an alcoholic and was cured by self-prescribing Baclofen in gradually increased doses up to 400 mg per day. The result was a total indifference to alcohol, with the previously unthinkable possibility of having the occasional glass of wine without launching into an infernal spiral of addiction. An experience corroborated by the testimony of many different sufferers who were prescribed the drug by thousands of doctors in France, despite the absence of market authorisation (MA) in this case. The phenomenon began in November 2008, following the publication of Professor Olivier Ameisen’s book, despite the restrictions.
Baclofen: The side effects at the heart of the controversy
“Today, 60% of prescriptions in paediatrics are made without market authorisation along with 70% of prescriptions in cardiology”, Professor Ameisen complains. “This drug does not cause dependency like tranquillisers or sleeping tablets (benzodiazepine-BZD) and no related deaths have been reported in the world”, he drives his message home. And this is exactly where the problem lies. It is not the effectiveness of this drug which is causing controversy among specialists but the physiological tolerance we have for it when taken in strong doses. Doctors Philippe Batel and Michel Lejoyeux, president of the French Society of Alcoholism (SFA), among others, question the side-effects of this medication. Drowsiness, dizziness, memory trouble, impaired motor coordination, hair loss, cardiac problems and dislocation have been associated especially with strong doses and ongoing treatment. “Out of 50 patients to whom I prescribed this drug, half experienced crippling side effects when taking 90mg doses”, Dr. Batel states. Side effects are classed as benign and disappear rapidly however, according to Dr. Bernard Joussaume, president of the French Association of Baclofen Approval and Usage (AUBES).
In June 2011 and despite the anger and determination of the experts who defend the use of this drug, Afsapps in France called for doctors to exercise extreme caution: “Little data exists about the safety of using Baclofen in doses higher than those which have received market authorisation, when combined with alcohol or other medication in patients with a dependency on alcohol. In fact, higher dosage can provoke psychological problems leading to comas, mental confusion, hallucinations, convulsions or respiratory depression.” But on 23 April 2012, Afsapps confirmed new data showing “the clinical benefits in certain patients suffering from alcoholism”, and also stated that the prescription of Baclofen could be envisaged only on a “case by case basis, prescribed and supervised by practitioners experienced in treating alcohol dependency...Whether or not these were psychiatrists, addiction experts, alcohol therapists or general practitioners, ideally in a multidisciplinary manner.” This “tentative” authorisation of Baclofen, pending the implementation of a temporary set of recommendations under the Act of 29 December 2011, is accompanied by continuing active observation of the side effects of this molecule. To date, “the data produced by pharmacovigilance is very limited but does not call the development of this kind of treatment into question.”
A clinical trial comprising of 320 patients should begin at the end of May 2012. The initial results will be known two to three years from now. This will be an important step in putting an end to the controversy. Currently, no laboratory has looked into beginning development of this drug.
“Abstinence and ‘Low-Risk’ Consumption 1 Year after the Initiation of High-Dose Baclofen: A Retrospective Study among ‘High-Risk’ Drinkers.” Laurent Rigal, Constance Alexandre-Dubroeucq, Renaud de Beaurepaire, Claire Le Jeunne and Philippe Jaury, Alcohol and Alcoholism, 19 March 2012.
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