- After years of controversy over baclofen, a drug used for ten years to treat alcoholism, the marketing of Baclocur was authorized on Monday in France.
- It was suspended two days later, after a collective appeal which considers that the dose recommended by the drug agency is clearly insufficient.
- The ANSM has just announced that it is going to appeal to the Conseil d'Etat in cassation against this suspension.
This is called a quick flip-flop. While Monday, Baclocur, based on baclofen, was authorized in France to treat alcoholism, Wednesday evening, this authorization was suspended by the courts, adding yet another chapter to the battle over baclofen in France. 20 Minutes takes stock of this new episode.
Monday yes, Wednesday no
Monday June 15, the marketing of Baclocur, from the Etypharm laboratory, was therefore authorized. Any good news for all those who are battling their addiction to alcohol? This is not everyone's opinion. Indeed, the Baclohelp collective, which helps alcohol-dependent people on baclofen, obtained the suspension of this marketing authorization (MA) on Wednesday evening by a decision of the administrative court of Cergy-Pontoise.
What is Baclocur?
It is a drug based on baclofen, the subject of controversy for years in France. Basically, this molecule is a muscle relaxant. But its use has gradually been diverted to the treatment of alcoholism. This alternative use exploded in 2008 with the publication of the book The Last Glass by cardiologist Olivier Ameisen, himself concerned by alcohol addiction.
"He discovered a study on mice on baclofen and decided to be his own mouse, testing doses up to 280 mg per day and it worked, says Thomas Maës Martin, founder of the Baclohelp collective. He became indifferent to alcohol, which was new to addiction. There are drugs that disgust you, that make you want to vomit, while with this treatment, you can drink without the addiction coming back. He tried to publish articles, without success, so he wrote a book. This is how he became known. It is really a drug that has imposed itself from the bottom up. "
Seeing this prescription increase, the drug gendarme seized the issue. Since 2014, baclofen was authorized in the treatment of alcoholism thanks to a temporary recommendation for use (RTU), for three years and renewable. Then, in October 2018, the drug agency (ANSM) granted Baclocur a marketing authorization (MA), making it the only baclofen drug authorized against alcoholism. The decision came into effect on Monday. But the ANSM had set two conditions: a maximum dose of 80 mg / day and a prescription only after failure of other treatments.
Treatment of alcohol dependence - From June 15, the drug Baclocur will be marketed:
↪️ RTU for other specialties based on # baclofen in this indication ends on this date
▶ ️ Prescriber guide: https: // t .co / 9DHtFMXmOi pic.twitter.com/2InNrhucu0
Why did the collective attack this marketing?
It is rather rare to see an association of patients refuse to market a treatment to fight against their disease ... The problem is the dosage. Some patients, the sickest, need 300 mg per day. "Three-quarters need doses greater than 80 mg per day, and on average, it's 185 mg, insists the founder of the collective. The peculiarity of this molecule is that the effective dose can vary considerably depending on the patient. »Why did the ANSM limit it to 80 mg? A joint Cnam-ANSM-Inserm study from 2017 estimated that "this muscle relaxant [...] has high undesirable effects when it is taken in large doses", recalls the ANSM, contacted by 20 Minutes . "This study is based on baclofen health insurance reimbursement data between 2009 and 2015. It concludes that there were more hospitalizations and deaths among baclofen patients than among those who were treated with drugs. without this molecule, says Thomas Maës Martin. However, we could not verify whether the patients who had taken baclofen were alcoholic or not. Many specialists have criticized this statistical nonsense. "He refers to another study," which shows that baclofen is a safe, effective and not dangerous drug up to 300 mg if taken under normal conditions, that is to say three times 100 g per day. The interest of the ANSM is to protect themselves, since the scandal of the Picks, it promotes zero risk taking. "
Second problem in his eyes: impose Baclocur and remove the RTU of the two other baclofen drugs, Zentiva and Lioresal. "This is the heresy of the situation: the ANSM requires patients to buy only this drug, which is the most expensive," he regrets.
Finally, by limiting the dosage to 80 mg, we limit reimbursements, according to the group. Of course, the doctor still has the option of prescribing a drug outside of the Marketing Authorization (at a higher dose than recommended by the ANSM). But “even if the patients would have found a doctor who agreed to take this responsibility, pharmacies were entitled to refuse this dosage, nuance Thomas Maës Martin. Most importantly, they would only be reimbursed up to 80 mg. However, it is an expensive drug. For 300 mg / day, this equals 160 euros per month. A significant budget for alcoholics who are often at risk. This suspension especially changes things for those who have a strong addiction. We are not allowed to select people based on the severity of their illness! If we told diabetics that we were only going to reimburse a quarter of the insulin, that would make us scream ... ”With a risk, recalled for the time being by the group, the ANSM, the justice system and the addictologists: should not abruptly stop treatment, at the risk of having dramatic withdrawal effects.
What does it change for patients?
With the suspension of the marketing of Baclocur, we return to the previous situation: Baclocur and other baclofen-based drugs can again be prescribed to alcoholic patients, without legal obligation of dose limit, explained the court in a communicated. "People who were treated with this device will continue to be treated and if their clinical condition requires it, to receive doses above 80 mg", continues the founder of the group.
What will happen next?
A judge must rule on the merits. “In general, when an interim measure suspends a decision, it is because the judge will undoubtedly cancel or modify the decision, suggests Thomas Maës Martin. He could ask the agency to modify the MA by increasing this limit by 80 mg. "
The ANSM has just announced that it is going to appeal to the Conseil d'Etat in cassation against this suspension decision. With the hope that Baclocur can return to commercialization, and therefore that more patients can hear about it and be treated with this molecule.
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