French clinical trial tragedy did not check all data
pharmafile | December 23, 2016 | News story | Medical Communications | Bial
There have been new revelations regarding the fatal French clinical trial that occurred in January of this year. Nature reports that in a conference call the company behind the trial, Portuguese company, Bial, did not use pharmacodynamics (PD) data regarding how the drug was acting upon patients who received a low dose before increasing the dose.
Helena Gama, head of Bial’s pharmacovigilance and drug safety office, commented upon the lack of analysis of PD data that: “The evaluation before starting a new drug escalation is based on safety evaluation and pharmacokinetic data. We did not have any profile that precluded the path to the further dosage.”
Many experts that were approached to comment stated that increasing dosage of the drug without PD data was the equivalent of ‘flying blind’. It is widely considered to be best practice to use the data, though there was no legal obligation for the company to do so.
The trial led to the death of one person, caused long-lasting neurological damage to four people and short-term neurological issues with ten others. Bial is yet to release full data concerning the trial despite significant pressure from the scientific community.
The clinical trial was the first experiment of the drug, BIA 10-2474, in humans, after having been tested on mice, dogs, monkeys and rats. The drug was meant to be a potential treatment for anxiety and motor disorders associated with Parkinson’s disease. The action of the drug was an inhibitor of the enzyme fatty acid amide hydrolase. This particular compound was known to be unselective and the risk of higher doses was therefore increased.
Ben Hargreaves
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