Drug trial men showing signs of improvement

BRITAIN: Four men involved in a disastrous drug trial have regained consciousness, doctors said yesterday.

BRITAIN: Four men involved in a disastrous drug trial have regained consciousness, doctors said yesterday.

Two others were still critically ill and under sedation but showing early signs of responding to treatment.

Dr Ganesh Suntharalingam, clinical director of intensive care at Northwich Park hospital in north London, said: "Some of them have made noticeable progress in response to our treatment and we have been able to reduce the amount of organ support required.

"However, it is early days and they will clearly need continued specialist observation for some considerable time."

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Dr Suntharalingam said an advisory panel was meeting regularly and developing a more detailed understanding of what happened to the previously healthy men, who fell ill on Monday after taking part in a trial for the drug TGN1412. The medical research company responsible for the drug trial insisted it had followed correct procedures.

Herman Scholtz, head of Parexel International Clinical Pharmacology, said he was encouraged that the condition of some of the patients had started to improve and remained in close contact with the hospital.

"An initial review at the site to date has shown that best practices were followed and all of the appropriate policies and procedures were adhered to. Furthermore, we commend the staff for their swift reactions with the volunteers when the adverse reaction occurred. This type of reaction is extremely rare, and is a very unusual event," said Dr Scholtz. "Our thoughts are with the patients and their families."

A relative of Ryan Wilson, one of the two men who remain in a critical condition, said he could be in a coma for up to a year.

Ann Alexander, solicitor for one of the men, said it was not yet known whether the violent reaction was due to a fault in production, contamination, or an inherent problem with the drug itself. The drug is made by TeGenero, a pharmaceutical company based in Germany.

Chief scientific officer of TeGenero Thomas Hanke said the drug had been tested on rabbits and monkeys with no "drug-related adverse events".

Labour MP Barry Gardiner warned against speculating about what had gone wrong before the Medicines and Healthcare products Regulatory Agency (MHRA) finished its inquiry. It had not yet been established that there had been a mistake, he said.