MHRA OFF THE HOOK... AGAIN!!!!!

Drug trials recommendations due


Experts investigating the drug trial which almost killed six young volunteers will present final recommendations to government today. The group, set up by the health secretary, is expected to say drug trial rules should be tightened to prevent future tragedies.

The worst affected of the men given the experimental drug TGN 1412 in March had to have fingers and toes amputated.

The drug 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.

All six men who were given the drug suffered multiple organ failure.

The volunteers are launching a multi-million pound damages claim against Parexel, the research company that conducted the trial at Northwick Park Hospital in north London.

A preliminary report by the expert scientific group, led by Professor Gordon Duff, recommends the initial drug dose should be given to just one person - which was not the case in the London trial.

And it recommended drugs which affect the immune system, like the monoclonal antibody TGN1412, may be best given to people who are already ill.

Checks and measures

The preliminary report also called for more dialogue between the drug developer and regulator when dealing with high risk drugs, and better international sharing of data on serious adverse reactions.

Although the report is likely to be welcomed, experts are concerned there has been no independent enquiry into the role of the drugs regulator, the MHRA, who authorised the trial.

Some say there was enough worrying scientific evidence about the drug being tested to have predicted the adverse reaction but the MHRA failed to pick them up.

Dr David Glover, an independent consultant to industry who gave evidence to the group investigating what went wrong, said: "The report has not investigated how and why the regulator approved this trial when there were many questions that could have been asked."
Martin Day, a lawyer who represents two of those involved in the botched trial, said his clients hoped there would be investigations into the details of what went wrong in their case.