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Errors made in March drug trial fiasco

25th May 2006

There were a number of administrative errors and inconsistencies in a drug trial that left six men severely ill in March, a health watchdog has said.

On March 13th of this year six previously healthy men were issued with the drug TGN1412, designed to treat arthritis, leukaemia and multiple sclerosis, but within minutes they experienced a severe volatile reaction and multiple organ failures.

Although none of the volunteers lost their lives because of the trial, two men are yet to fully recover.

In its final report on the TGN1412 drug trial, the Medicines and Healthcare products Regulatory Agency (MHRA) revealed that good clinical practice was not carried out by trial-organiser Parexel, although it ruled that the volunteers' serious reaction was due to an "unpredicted biological action of the drug in humans".

Professor Kent Woods, chief executive of the MHRA, explained that while errors were made, they did not relate to the administration of development of the drug itself by manufacturers TeGenero.

However, Professor Woods did criticise Parexel for failing "to complete the full medical background of a trial subject in writing" and not putting in place a system for 24-hour medical cover in the event of severe reactions to the drug.

The MHRA report also hit out at the company for not ensuring personnel had received sufficient training and experience.