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| Version 3 | Version 4 |
|---|---|
| Expert drug trial safety advice | Expert drug trial safety advice |
| (20 minutes later) | |
| Experts investigating the drug trial which almost killed six young volunteers have made 22 recommendations on how to avoid such mistakes again. | Experts investigating the drug trial which almost killed six young volunteers have made 22 recommendations on how to avoid such mistakes again. |
| The group, set up by the health secretary, says some drugs may be best given to people who are already ill. | The group, set up by the health secretary, says some drugs may be best given to people who are already ill. |
| Also, doctors should have safety assessment training and an expert group should advise the government's drug regulatory body, the report said. | Also, doctors should have safety assessment training and an expert group should advise the government's drug regulatory body, the report said. |
| But it added trials could only be judged on a "case by case" basis. | But it added trials could only be judged on a "case by case" basis. |
| Victims of the TGN 1214 trial, which took place at Northwick Park Hospital in north London last March, welcomed the recommendations but called for an independent enquiry into their case. | |
| The experimental drug they took was designed to treat multiple sclerosis, leukaemia and arthritis. | |
| Catastrophic consequences | Catastrophic consequences |
| Its makers, German biotech company TeGenero, thought it would subtly "re-tune" the immune system. | Its makers, German biotech company TeGenero, thought it would subtly "re-tune" the immune system. |
| But instead it sent the immune system into overdrive with catastrophic consequences. | But instead it sent the immune system into overdrive with catastrophic consequences. |
| All six men who were given the drug suffered multiple organ failure. | All six men who were given the drug suffered multiple organ failure. |
| The worst affected, Ryan Wilson, had to have fingers and toes amputated. | The worst affected, Ryan Wilson, had to have fingers and toes amputated. |
| The wellbeing of volunteers must always come first Professor Gordon Duff, lead author of the report | The wellbeing of volunteers must always come first Professor Gordon Duff, lead author of the report |
| The expert scientific group, led by Professor Gordon Duff, took into account the events at Northwick Park when making its recommendations. | |
| The Duff report emphasises the need to collect safety information from unpublished clinical studies. | |
| And medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), should also have access to additional advice from independent specialist experts, it says. | |
| Whitewash | |
| The MHRA has been accused of being too lax in its decision to approve the TGN 1412 trial. | |
| The volunteers are launching a multi-million pound damages claim against Parexel, the research company that conducted the trial at. | The volunteers are launching a multi-million pound damages claim against Parexel, the research company that conducted the trial at. |
| Martyn Day, the solicitor for four of the six victims, said: "The report has done a good job at looking at the lessons to be learnt but it does nothing in terms of helping my clients understand the detail of exactly what happened and what went wrong." | Martyn Day, the solicitor for four of the six victims, said: "The report has done a good job at looking at the lessons to be learnt but it does nothing in terms of helping my clients understand the detail of exactly what happened and what went wrong." |
| Professor Duff said: "The alarming outcome of the TGN 1412 trial was unprecedented in the history of clinical trials, and we want to record our sympathy for all the trial volunteers. | Professor Duff said: "The alarming outcome of the TGN 1412 trial was unprecedented in the history of clinical trials, and we want to record our sympathy for all the trial volunteers. |
| "Hearing about their experiences was valuable in making our recommendations, and we are grateful to the volunteers who were able to talk to us. | "Hearing about their experiences was valuable in making our recommendations, and we are grateful to the volunteers who were able to talk to us. |
| "The wellbeing of volunteers must always come first. | "The wellbeing of volunteers must always come first. |
| "We believe our recommendations would safeguard this in the future." | "We believe our recommendations would safeguard this in the future." |