The Elephant Man Horror Threatens Human Drug Trials; EXPERTS ADMIT THEY ARE BAFFLED BY CASE WHICH LEFT SIX FIGHTING FOR LIFE

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Byline: JENNY HOPE;MICHAEL SEAMARK

HUMAN drug trials were under threat last night after a Government safety watchdog admitted it was baffled by the 'Elephant Man' case.

Emergency measures have been introduced after an urgent investigation failed to discover why six volunteers injected with TGN 1412 were left clinging to life.

Foul play and human error have been ruled out. There was no apparent contamination of the drug or mistakes in last month's trial at the privately-run Parexel research unit in a London hospital.

Yet, despite a dose 500 times lower than that given to monkeys, when injected for the first time into human guinea pigs it provoked an 'unpredicted' reaction.

The Medicines and Healthcare Products Regulatory Agency report into the ill-fated trial of the drug - developed by German company TeGenero - concluded that the most likely cause of the adverse reaction was an 'unpredicted biological action of the drug in humans'.

An expert group has now been formed to examine the issue and will report to Health Secretary Patricia Hewitt in the next three months.

Meanwhile, the MHRA will seek expert advice before authorising any more firstinman trials of drugs such as TGN 1412.

But Ann Alexander, the solicitor representing the two most seriously affected victims, condemned the MHRA report as 'totally inadequate.' She called for an independent inquiry into the conduct of the trial on the drug designed to treat leukaemia, rheumatoid arthritis and multiple sclerosis.

She plans to make her concerns about the MHRA known to the Health Secretary and the Commons Health Select Committee and complained of too much secrecy surrounding pre-clinical testing.

She said: 'How long did it last, what animals were involved, what were the effects, and had these trials been completed? My clients and the general public are entitled to answers to these questions.'

Martyn Day, the solicitor representing the four other men, said he had serious concerns that the MHRA was 'regulating itself' after authorising the trial.

The fact that TGN 1412 was a 'novel' drug had not been explained to them, he said. 'If it had been explained that it was so new, then there's not the slightest chance that one of them would have gone through with the test. …