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Licensed alcohol treatment drug is ‘not effective’
A drug to treat alcohol dependency was authorised for use in the UK despite “weak” evidence of its efficiency, researchers in Scotland have discovered.
Scientists are questioning the effectiveness of alcohol drug Nalmefene
Nalmefene was licensed for use in Europe in 2013 and went on to be recommended by the National Institute for Health and Care Excellence (NICE).
However, scientists at the University of Stirling in Scotland uncovered flaws in the clinical trials and how they were analysed.
The university claimed the method used to conduct the trials made it impossible to determine how much the drug, marketed as Selincro, helped reduce alcohol consumption in patients who were addicted to alcohol.
Its researchers looked at the published studies used for European licensing and the decision by NICE to approve the drug, but found any evidence of its effectiveness was “weak”.
On average, patients could possibly reduce their consumption by around one drink a day.
Dr Niamh Fitzgerald, a pharmacist and lecturer in alcohol studies at the university, said, as reported by the BBC: “It’s vitally important that we know that prescribed drugs are effective in treating the intended problem.
“In this case, we found problems with the registration, design, analysis and reporting of these clinical trials which did not prevent the drug being licensed or recommended for use.
“We believe this creates a difficulty for doctors trying to treat alcohol dependence and throws up critical questions for regulators around why a drug was licensed without a bank of high quality, reliable evidence.”