The French government blames Bial and Biotrial for a clinical trial that went wrong
One person died and five others were hospitalized after taking the experimental drug
The companies get a month to create an action plan or face suspension
The French Health Ministry has found fault with the two companies that were part of a French drug trial that went wrong in January, killing one person and hospitalizing five others.
The ministry released a report Monday from its ongoing investigation.
The five previously healthy volunteers who were hospitalized have since been released. They were among 128 volunteers who took an experimental painkiller created by Bial, a Portuguese pharmaceutical company.
The drug was meant to treat anxiety and motor disorders by targeting the endogenous cannabinoid system, a part of the body that helps manage pain. It was given under the supervision of doctors at a private medical center in Rennes, Brittany, in a trial run by the French company, Biotrial.
The investigation found that the conditions in which the trial was authorized by French authorities were within regulations; however, Bial and Biotrial were at fault “on several counts,” including how much of the drug they gave the volunteers and how long it took them to inform the government about the problems. They also failed to properly inform the other volunteers, the report said.
The early-stage drug trial, also known as a Phase I study, has been suspended.
Authorities will give the companies a month to create an action plan to guarantee that there won’t be any future problems, or else they face a threat of suspension.
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An independent authority will continue to investigate the health records of the volunteers and will relay that information to the European Commission.
The French ministry asked regional authorities in the country to inspect every center that is authorized to lead clinical trials to ensure that they are up to drug trial standards.
The report also made clear that there may be a separate judicial inquiry.