Drug calamity probe draws blank

The world of medical research has been thrown into chaos after an inquiry into a drug trial that went wrong concluded the problems had occurred because of an unexpected pharmacological reaction in humans.

The trial of the drug, TG1412, carried out in a private testing facility at Northwick Park Hospital, London, last month, left six human volunteers in intensive care fighting for their lives.

All six had severe reactions within minutes of taking the drug, including fever, swelling and vomiting.

The inquiry by the Medicines and Healthcare Products Regulatory Agency (MHRA), which is responsible for drug safety in Britain, found there was no human error involved in the manufacture, preparation or dose of the drug.

The solicitor for the two most seriously affected victims yesterday dismissed the findings as "totally inadequate" and accused the MHRA of a "lack of transparency".

Ann Alexander said the authority had failed to give details of the pre-clinical trials, about which there was conflicting information, and had failed to publish the protocol for the trial.

The shadow Health Secretary, Andrew Lansley, criticised the way the MHRA was "scrutinising its own actions".

He said: "It is only right that an independent group is established to scrutinise the decisions which gave rise to the original clinical trial authorisation."

The interim inquiry findings will cast a pall over the development and testing of all drugs with a novel biological action in Britain.

The MHRA announced a review of drug testing and said no further trials of novel compounds targeted at the immune system would be authorised without external advice from experts.

The conclusion means that despite the stringent safety measures already in place which require new drugs to be tested in the laboratory, on human tissues and in animals for several years, they can still produce powerful effects in humans that cannot be predicted.

Experts said they feared the impact on the future of drug testing.

Professor Geoff Hale, of the Therapeutic Antibody Centre at Oxford University, said: "I am worried that this will make it even more difficult for hospitals and charities and academics - the non-commercial sector - to do drug development."

TG1412, made by the German company TeGenero, was being developed as a treatment for immune disorders such as leukaemia, rheumatoid arthritis and multiple sclerosis.

Although it was given to the six human volunteers in a dose 500 times lower than that previously used on monkeys without ill effects, the drug triggered a life-threatening immune response in the volunteers.

The tests were run by United States-based company Parexel.

The six volunteers, all men aged 19 to 40, were taken to Northwick Park Hospital within hours of the start of the trial on March 13. Three weeks later one remains in hospital and the other five have been discharged. All are improving, the hospital says.

Professor Kent Woods, the chief executive of the MHRA, said the outcome raised important questions about pre-clinical testing of products of this kind.


Drug trial disaster

What went wrong?
Six men, including a New Zealander, were left fighting for their lives in intensive care after a London drug trial produced unexpected and severe reactions.

What caused it?
No one knows. An official investigation found the drug triggered a life-threatening response in humans, even though it had been tested on monkeys at doses 500 times higher with no ill effects.

What happens now?
Safety standards may have to be tightened further. Experts worry that this will make drug research even more difficult.

- INDEPENDENT