Six taken ill after drug trials
(http://news.bbc.co.uk/1/hi/england/london/4807042.stm )
The six are being treated at Northwick Park hospital
Six men are fighting for their lives after falling ill during a clinical drugs trial in north-west London.
They suffered a bad reaction to an anti-inflammatory drug being tested at a research unit and were rushed to Northwick Park Hospital on Monday.
Relatives are with the patients, who suffered multiple organ failure. Some cases are said to be life-threatening.
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 MHRA
The men were volunteers in the early stages of a trial for the drug to treat conditions such as rheumatoid arthritis and leukaemia, and were taken ill within hours of taking it.
Eight men had taken part, 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, but all were in a serious condition. He said they were receiving "close monitoring and appropriate treatment".
BBC London correspondent Tim Donovan said some cases were believed to be life-threatening.
'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
Parexel
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 more testing in a laboratory.
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." |
