Physical Wellness
Wrong Medical Trials in France Leave Six People Extremely Ill
The clinical trial of an experimental drug in France went horribly wrong that killed one person and hospitalized the other five. However, after publically acknowledging the tragic incident on 15th January, lack of official explanation has left many clueless as to what would have happened.
"The French authorities have not been very rapid nor transparent in their response," says Catherine Hill, a specialist in clinical-trial design and a former member of the scientific advisory board of France's National Agency for Medicines and Health Products Safety (ANSM). She also added that the French investigation with regards to other medical accidents have often been obscure, as reported by Nature.
This was the first of its kind human trial in its Phase-1 to test the safety of the drug in healthy people. Bial, the Portuguese company responsible for the production of this drug aimed at treating anxiety, motor disorders that are linked to Parkinson's Disease and also chronic pain in people with cancer. The trial was conducted by a French contract-research company, Biotrial, in its Rennes facility.
"It's too early to know what went wrong in France," said Dr. Ben Goldacre, a fellow at the University of Oxford and cofounder of Alltrials.net, which advocates for disclosure of clinical research. "But it's really important that we do everything we can to address the known risks around Phase 1 trials," including greater public disclosure of the trials and their results.
According to STAT, most medical research institutes in the United States openly violate the federal law that requires the clinical trial, analyzing effectiveness and safety of the clinical drugs, results to be reported. However, Phase 1 trials are exempt from any disclosure rules, even though sponsors can provide results if they want to, voluntarily.
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