Wake up call, seriously! Lesson for India which is one of the most preferred countries for conducting clinical trials with quicker approvals and better (lesser?) monetary compensation to (ill-advised and ill/nil-informed) volunteers!
French drug trial leaves one brain dead and five critically ill
90 people total took some dosage of experimental drug being tested for Portuguese pharmaceutical company Bial
French health minister Marisol Touraine discusses the ‘very serious accident’
Angelique Chrisafis in Paris
Friday 15 January 2016 16.49 GMT Last modified on Friday 15 January 2016 17.20 GMT
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 aged 28 to 49 had been in good health until taking the oral medication.
The volunteers are all men aged 28 to 49, French health minister Marisol Touraine said. They started taking the drug on 7 January. One person started feeling ill on Sunday and the other five afterwards. The brain dead volunteer was admitted to hospital in Rennes on Monday. Other patients went in on Wednesday and Thursday.
Pierre-Gilles Edan, head of the neurology department at the Rennes hospital, said that aside from the man who was brain dead, three others were suffering a “handicap that could be irreversible” and another also had neurological problems. The sixth volunteer had no symptoms but was being monitored.
In total, 90 people have taken part in the trial and taken some dosage of the drug, Touraine said, adding that others had taken a placebo. All trials on the drug have been suspended and all volunteers who have taken part in the trial are being called back.
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.
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.
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.
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.
“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.
http://www.theguardian.com/world/20...al-one-person-in-coma-and-five-critically-ill
French drug trial leaves one brain dead and five critically ill
90 people total took some dosage of experimental drug being tested for Portuguese pharmaceutical company Bial
French health minister Marisol Touraine discusses the ‘very serious accident’
Angelique Chrisafis in Paris
Friday 15 January 2016 16.49 GMT Last modified on Friday 15 January 2016 17.20 GMT
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 aged 28 to 49 had been in good health until taking the oral medication.
The volunteers are all men aged 28 to 49, French health minister Marisol Touraine said. They started taking the drug on 7 January. One person started feeling ill on Sunday and the other five afterwards. The brain dead volunteer was admitted to hospital in Rennes on Monday. Other patients went in on Wednesday and Thursday.
Pierre-Gilles Edan, head of the neurology department at the Rennes hospital, said that aside from the man who was brain dead, three others were suffering a “handicap that could be irreversible” and another also had neurological problems. The sixth volunteer had no symptoms but was being monitored.
In total, 90 people have taken part in the trial and taken some dosage of the drug, Touraine said, adding that others had taken a placebo. All trials on the drug have been suspended and all volunteers who have taken part in the trial are being called back.
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.
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.
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.
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.
“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.
http://www.theguardian.com/world/20...al-one-person-in-coma-and-five-critically-ill
