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Six taken ill after drug trials

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BBC News
March 15, 2006

Six men remain in intensive care after being taken ill during a clinical drugs trial in north-west London.

The healthy volunteers were testing an anti-inflammatory drug at a research unit based at Northwick Park Hospital when they suffered a reaction.

Relatives are with the patients, who suffered multiple organ failure. Two men are said to be critically ill.

An investigation has begun at the unit, run by Parexel, which said it followed recommended guidelines in its trial.

Our immediate priority has been to ensure that no further patients are harmed
Kent Woods

The men were being paid to take part in the early stages of a trial for the drug to treat conditions such as rheumatoid arthritis and leukaemia until they were taken ill on Monday within hours of taking it.

Eight volunteers were involved, but two were given a placebo at the unit, which is on Northwick Park Hospital's grounds, but is run independently.

The hospital's intensive care director Ganesh Suntharalingam said the patients were admitted very quickly and were receiving "close monitoring and appropriate treatment".

A Northwick Park Hospital spokesman said two are in a critical condition, while the other four are "serious but stable".

'Exhaustive investigation'

The Medicines and Healthcare products Regulatory Agency (MHRA) immediately withdrew authorisation for the trial. An international warning has also gone out, to prevent it being tested abroad.

Its inspectors will visit the research unit and it is in contact with the local strategic health authority, the Department of Health and police about the cases.

Such an adverse drug reaction occurs extremely rarely
Herman Scholtz

Chief executive officer Professor Kent Woods said: "Our immediate priority has been to ensure that no further patients are harmed.

"We will now undertake an exhaustive investigation to determine the cause and ensure all appropriate actions are taken."

It had approved the trial and the drug had already been tested on animals and in a laboratory. Volunteers are paid up to £150 a day to take part in clinical trials, though the fee can vary depending on the amount of discomfort involved.

Parexel, which was running the trial, said it had followed guidelines and such cases were extremely rare.

Professor Herman Scholtz, from Parexel, said the clinical research organisation had followed regulatory, medical and clinical research guidelines during the study.

He said: "When the adverse drug reaction occurred, the Parexel clinical pharmacology medical team responded swiftly to stop the study procedures immediately."

He added: "Such an adverse drug reaction occurs extremely rarely and this is an unfortunate and unusual situation.

"Since our unit is located within the hospital, we have immediate access to world-class medical care and we did everything possible to get the patients treated as quickly as possible."


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