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| French drug trial leaves one brain dead and five critically ill | French drug trial leaves one brain dead and five critically ill |
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| One person is brain dead and five others are seriously ill after taking part in a drug trial for Portuguese pharmaceutical firm Bial at a clinic in north-west France. | |
| The French health ministry said the six male patients had been in good health until taking the oral medication. It did not say what the new medicine was intended to be used for. | |
| The health minister, Marisol Touraine, said on Friday the six had been taking part in a “trial of an oral medication being developed by a European laboratory” in Rennes, Brittany. The patients were admitted to hospital at the beginning of this week. It was not immediately clear whether the six were among a larger group of volunteers involved in the tests or what dose they had been given. | The health minister, Marisol Touraine, said on Friday the six had been taking part in a “trial of an oral medication being developed by a European laboratory” in Rennes, Brittany. The patients were admitted to hospital at the beginning of this week. It was not immediately clear whether the six were among a larger group of volunteers involved in the tests or what dose they had been given. |
| The ministry said the test was carried out by the Biotrial clinic for Bial, which “specialised in carrying out clinical trials”. | |
| The trial was intended to test for side-effects of the new drug. All trials on the drug at the clinic have been suspended and the French state prosecutor has opened an inquiry. | The trial was intended to test for side-effects of the new drug. All trials on the drug at the clinic have been suspended and the French state prosecutor has opened an inquiry. |
| Touraine said the drug was meant to act on the body’s endocannabinoid system, which deals with pain. Earlier reports had 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. | |
| The study was a phase one clinical trial, in which healthy volunteers take the medication to “evaluate the safety of its use, tolerance and pharmacological profile of the molecule”, Touraine said. She is travelling to Rennes where she will give a press conference on Friday afternoon. | The study was a phase one clinical trial, in which healthy volunteers take the medication to “evaluate the safety of its use, tolerance and pharmacological profile of the molecule”, Touraine said. She is travelling to Rennes where she will give a press conference on Friday afternoon. |
| Medical trials typically have three phases to assess a new drug or device for safety and effectiveness. Phase one entails a small group of volunteers, and focuses only on safety. Phase two and three are progressively larger trials to assess the drug’s effectiveness, although safety remains paramount. | Medical trials typically have three phases to assess a new drug or device for safety and effectiveness. Phase one entails a small group of volunteers, and focuses only on safety. Phase two and three are progressively larger trials to assess the drug’s effectiveness, although safety remains paramount. |
| Every year thousands of volunteers, often students looking to make extra money, take part in such trials. Mishaps are relatively rare, but in 2006 six men were treated for organ failure in London after taking part in a clinical trial into a drug developed to fight auto-immune disease and leukaemia. | Every year thousands of volunteers, often students looking to make extra money, take part in such trials. Mishaps are relatively rare, but in 2006 six men were treated for organ failure in London after taking part in a clinical trial into a drug developed to fight auto-immune disease and leukaemia. |
| The men now apparently have a higher risk of cancer and autoimmune diseases tied to their exposure to the experimental drug. | The men now apparently have a higher risk of cancer and autoimmune diseases tied to their exposure to the experimental drug. |
| Dr Ben Whalley, a neuropharmacology professor at Britain’s University of Reading, said standardised regulations for clinical trials are “largely the same” throughout Europe. | Dr Ben Whalley, a neuropharmacology professor at Britain’s University of Reading, said standardised regulations for clinical trials are “largely the same” throughout Europe. |
| “However, like any safeguard, these minimise risk rather than abolish it,” Whalley said in a statement. “There is an inherent risk in exposing people to any new compound.” | “However, like any safeguard, these minimise risk rather than abolish it,” Whalley said in a statement. “There is an inherent risk in exposing people to any new compound.” |
| Agence France-Presse contributed to this story | Agence France-Presse contributed to this story |