Drug trial disaster will discourage future volunteers

Apr 6 2006

According to the British government agency responsible for medical safety, the Medicines and Healthcare Products Regulatory Agency (MHRA), no evidence has been found to suggest there were any problems with the manufacturing of a drug which left six volunteers seriously ill.

The six volunteers, all healthy men aged 19 to 40, were taken to Northwick Park Hospital, London, within hours of the start of the trial on 13 March.

Three weeks later one remains in hospital and the other five have been discharged.

All, according to the hospital, are improving.

The trial of the drug, TG1412, has thrown the world of medical research into chaos since it left six human volunteers in intensive care fighting for their lives.

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

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

The tests were run by a U.S.-based company Parexel.

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

The inquiry by the 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.

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

The authority had apparently 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 British Shadow Health Secretary, Andrew Lansley, has also criticised the way the MHRA has scrutinised its own actions and says an independent group needs to be established to examine the decisions which gave rise to the original clinical trial authorisation.

Some experts are concerned that the disastrous trial will make it even more difficult to recruit volunteers to take part in drug trials, thus impeding the development of new treatments.

Health Secretary Patricia Hewitt had now agreed to form a group of international experts to examine the case further.