Watchdog hits out after hospital drug trial disaster

THE British Government’s drug watchdog yesterday criticised the firm behind a disastrous drug trial which left six men seriously ill.

Research firm Parexel failed to follow some correct procedures and made errors over contracts and patient records, Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) said in its final report into the incident earlier this year.

But, it said, the adverse reaction in the men was most likely down to an “unpredicted biological action of the drug in humans”. The MHRA reached the same conclusion in its interim report.

All six previously healthy men suffered multiple organ failure after being given TGN1412 in March. The drug is designed to treat arthritis, leukaemia and multiple sclerosis.

The report said Parexel, based at Northwick Park Hospital in London, “failed to complete the full medical background of a trial subject in writing”.

The placebo volunteers were also allowed to leave the premises “before appropriate checks were undertaken to confirm that they were the two subjects that had received the placebo”, it added.

There was also no “formal system” in place for 24-hour medical cover and no contract in place between manufacturer TeGenero and Parexel, although one was subsequently issued, it said.

Tests confirmed the drug had not been contaminated.

Four of the men taken ill have received unconditional interim payments of £10,000 (€14,600).

One of the men, 20-year-old Ryan Wilson, from Highbury, north London, remains in Northwick Park Hospital.

It has been reported that he fears his feet and hands may have to be amputated.

A TeGenero statement said: “We will continue to work to establish exactly what happened and will support ongoing efforts to make future trials as safe as they can be.”