This Friday, 12 alcohol addiction specialists denounce in a press release “the remote-controlled and superficial work” of the expert committee commissioned by the Medicines Agency which recently judged the effectiveness of baclofen “clinically insufficient” in the treatment of alcohol dependence.
The controversy surrounding baclofen continues:th April 24, un expert committee appointed by the French Medicines Agency judged the efficacy of the drug to be “clinically insufficient” in the treatment of alcohol dependence. the committee felt that this muscle relaxer exhibited “a potentially increased risk of developing serious adverse events (including death, editor’s note), particularly at high doses “ and that this could lead “to consider that the benefit-risk ratio is negative”.
A “remote-controlled and superficial” work
This Friday, 12 alcohol addiction specialists jointly denounce in a press release “ce remote-controlled and superficial work “which according to them,” once again discredits the French drug agency “.
“Composed of experts, none of whom are in fact specialists in alcohol addiction”, the committee commissioned by the Medicines Agency “quickly carried out its mission without hearing those who dispute with solid scientific arguments and more of a decade of professional practice, the risk assessment implemented by the CNAMTS, ANSM and Inserm, believes the group. This assessment was carried out from massive unreliable medico-administrative data without clinical relevance. , and according to a methodology which does not allow in any case to conclude to any causal relationship “.
A job “riddled with errors”
Experts say the committee “did not take into account all of the literature on the subject “ to correctly assess the effectiveness of baclofen in the treatment of alcohol addiction, when the latter would be “generally favorable”.
“Above all, the elements communicated in the opinion of the CSST about the randomized double-blind clinical studies of baclofen against placebo Alpadir and Bacloville are riddled with errors, whether in terms of efficacy or safety data. To name just the grossest errors regarding tolerance, deaths in the baclofen group were not attributed to treatment by the study’s independent scientific committee, and in Alpadir there was more serious side effects in the placebo group than in the baclofen group “.
Scientists therefore consider the work of the commissioned committee to be “superficial”. He “once again discredits the French drug agency, which, in this case as in others, is distinguished by its scientific lightness, its manipulations, its casualness with regard to the equitable and contradictory search for the truth , his arrogance towards specialists in the field, his contempt for words and the interests of patients “.
Baclofen, the controversy
Prescribed as treatment against alcoholism since 2014 as part of a temporary recommendation for use (RTU), the National Medicines Safety Agency (ANSM) published a study co-conducted by the National Health Insurance Fund ( CNAM) and Inserm, concluding that the level of safety of the drug was “worrying” when it was used in high doses in alcoholics. In the process, the ANSM had reduced the prescription dose to 80 mg per day, against 300 mg previously “given the increased risk of hospitalization and death”.
But a year ago, the Ethypharm laboratory applied for a marketing authorization (MA) in order to market baclofen in the treatment of alcoholism officially and definitively. The study of the committee commissioned by the Medicines Agency was the first step in the process.
The signatories of the press release are :
The controversy surrounding baclofen continues:th April 24, un expert committee appointed by the French Medicines Agency judged the efficacy of the drug to be “clinically insufficient” in the treatment of alcohol dependence. the committee felt that this muscle relaxer exhibited “a potentially increased risk of developing serious adverse events (including death, editor’s note), particularly at high doses “ and that this could lead “to consider that the benefit-risk ratio is negative”.
A “remote-controlled and superficial” work
This Friday, 12 alcohol addiction specialists jointly denounce in a press release “ce remote-controlled and superficial work “which according to them,” once again discredits the French drug agency “.
“Composed of experts, none of whom are in fact specialists in alcohol addiction”, the committee commissioned by the Medicines Agency “quickly carried out its mission without hearing those who dispute with solid scientific arguments and more of a decade of professional practice, the risk assessment implemented by the CNAMTS, ANSM and Inserm, believes the group. This assessment was carried out from massive unreliable medico-administrative data without clinical relevance. , and according to a methodology which does not allow in any case to conclude to any causal relationship “.
A job “riddled with errors”
Experts say the committee “did not take into account all of the literature on the subject “ to correctly assess the effectiveness of baclofen in the treatment of alcohol addiction, when the latter would be “generally favorable”.
“Above all, the elements communicated in the opinion of the CSST about the randomized double-blind clinical studies of baclofen against placebo Alpadir and Bacloville are riddled with errors, whether in terms of efficacy or safety data. To name just the grossest errors regarding tolerance, deaths in the baclofen group were not attributed to treatment by the study’s independent scientific committee, and in Alpadir there was more serious side effects in the placebo group than in the baclofen group “.
Scientists therefore consider the work of the commissioned committee to be “superficial”. He “once again discredits the French drug agency, which, in this case as in others, is distinguished by its scientific lightness, its manipulations, its casualness with regard to the equitable and contradictory search for the truth , his arrogance towards specialists in the field, his contempt for words and the interests of patients “.
Baclofen, the controversy
Prescribed as treatment against alcoholism since 2014 as part of a temporary recommendation for use (RTU), the National Medicines Safety Agency (ANSM) published a study co-conducted by the National Health Insurance Fund ( CNAM) and Inserm, concluding that the level of safety of the drug was “worrying” when it was used in high doses in alcoholics. In the process, the ANSM had reduced the prescription dose to 80 mg per day, against 300 mg previously “given the increased risk of hospitalization and death”.
But a year ago, the Ethypharm laboratory applied for a marketing authorization (MA) in order to market baclofen in the treatment of alcoholism officially and definitively. The study of the committee commissioned by the Medicines Agency was the first step in the process.
The signatories of the press release are :
Renaud de BEAUREPAIRE, psychiatrist, head of staff at Paul-Guiraud hospital, Villejuif
Amine BENYAMINA, professor of psychiatry and addictology at the University of Paris-Sud
Samuel BLAISE, president of the Olivier-Ameisen association
Pascal GACHE, addictologist, Geneva
Bernard GRANGER, professor of psychiatry at the University of Paris Descartes
Sylvie IMBERT, president of the Baclofène association
Philippe JAURY, professor of general medicine at Paris Descartes University
Bernard JOUSSAUME, president of the Aubes association
Patrick de LA SELLE, president of the Baclofen Addiction Network
Jean-Roger LE GALL, member of the National Academy of Medicine
Thomas MAES-BARON, head of the Baclohelp collective
Didier SICARD, professor emeritus of internal medicine at the University of Paris Descartes, honorary president of the National Consultative Ethics Committee
.