The investigators and inspectors “are trying to understand… what could have happened and how it could have resulted in such a tragic situation”, he said. The activity was held on a clinic in France headed by the research company Biotrial according to The Guardian.
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French prosecutors have launched a manslaughter investigation into the unusual case, which shined a spotlight on the practice of testing drugs on paid, healthy human volunteers. For the test, 90 participants were given different level dosages of the medication, while the rest got a placebo.
Of the six hospitalized, the ages range from 28 to 49. They started taking the drug on 7 January.
In Phase II, drugs are tried on patients who have medical conditions. Earlier reports suggested that the drug contained cannabinoids, an active ingredient found in cannabis plants, but the minister said it did not contain the drug or any derivatives of it.
Bial released a statement explaining that the new drug is a molecule that treats pain.
Clinical trials are the key to getting that data – and without volunteers to take part in the trials, there would be no new treatments for serious diseases such as cancer, multiple sclerosis and arthritis.
The Portuguese drug agency said that the new drug “is not being used in ant clinical trials in Portugal”.
In its defense, Portuguese drug producer Bial, which commissioned the study, said in a statement Friday that 108 healthy individuals had taken part in trials and had “no moderate or serious reactions”. Specifically, they will look for any missteps taken by the doctors who administered the trial. The risks are low but there must still be a leap of faith when they are tried in people for the first time.
The trial was in phase 1, in which healthy volunteers take the medication so its safety and pharmacological profile can be assessed.
Three separate investigations are under way to try and find out what went wrong. She urged calm, saying that no drug now on the market was implicated in the failed trial.
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Every year, thousands of volunteers, often students looking to make extra money, take part in such trials. According to department head Pierre-Gilles Edan, the man was admitted with acute symptoms similar to stroke and was later declared brain dead.
