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Last Updated: Thursday, 7 December 2006, 11:13 GMT
Expert drug trial safety advice
Lab worker
The rules will affect how future drug trials are run

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 report also said an expert group should be set up to advise the government's drug regulatory body.

But those who took part in the London-based trial said the report was the latest in a series of whitewashes.

The victims would like an independent inquiry into what went wrong at the drugs research unit at Northwick Park Hospital in north London last March.

The experimental drug they took, called TGN 1412, was designed to treat multiple sclerosis, leukaemia and arthritis.

Catastrophic consequences

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.

The wellbeing of volunteers must always come first
Professor Gordon Duff, lead author of the report

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 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The Duff report emphasises the need to collect safety information from unpublished clinical studies.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.

Martyn Day, the solicitor for four of the six victims, said his clients were "very disappointed" with the report.

The finger of blame has been pointed at no-one
Martyn Day, solicitor for four of the six victims

He said: "They feel it is simply the latest in a series of whitewashes.

"Despite four reports from the regulator, the MHRA, and now Professor Duff, the finger of blame has been pointed at no-one.

"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."

Ann Alexander, who is representing the other two men affected in the trial, called for a more far reaching independent enquiry to be instigated.

She said today's report as "not having the wide remit needed to allow the full story to be heard, and all the lessons to be learnt."

Dr David Glover , an independent consultant in pharmaceuticals and biotechnology, said: "It is very regrettable that there has been no independent investigation of the MHRA and its processes that led to the disastrous clinical trial going ahead."

Professor Duff said: "The alarming outcome of the TGN 1412 trial was unprecedented in the history of clinical trials.

"We are grateful to the volunteers who were able to talk to us.

"The wellbeing of volunteers must always come first. We believe our recommendations would safeguard this in the future."

Health Minister Andy Burnham said the government would give the recommendations full consideration.


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