Two years ago, French regulators made a surprising decision, overruling one of their own expert committees to approve a controversial drug for combating alcoholism. But the move has triggered an increasingly heated debate over a key clinical trial, which critics argue raises troubling questions about transparency, as well as the extent to which patient groups may have influenced the regulator.
At issue is a drug called baclofen, a decades-old treatment for muscle spasms that is increasingly used in France on an off-label basis to help people control their drinking. In an attempt to appease patients, French regulators temporarily authorized off-label use in 2014, while awaiting the results of two clinical trials. But one of these studies took five years to be published and has proven problematic.