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15/03/2006
Six men hospitalised after drug trial
Six men are in intensive care after falling ill during trials of a new anti-inflammatory drug.
Eight healthy male volunteers participated in the trial of TGN 1412 - a drug manufactured by German company TeGenero AG to treat conditions such as leukaemia and chronic inflammatory conditions - at a facility in the grounds of Northwick Park Hospital, London.
However, on Monday, six men had to be admitted to intensive care after suffering a serious reaction to the drug. The two other volunteers, who had been given a placebo, were not affected. No one else, other than the six men, were given the drug.
Two of the men are in a critical condition, while the other four are described as being in a serious condition, but are showing signs of improvement. All the men, who have suffered multiple organ failures, remain in intensive care.
A police investigation into the drug trial has now been launched.
Myfawny Marshall, whose boyfriend is one of the men in a critical condition, told BBC News that the 28-year-old's face was so puffed after taking the drug that he resembled the Elephant Man. Ms Marshall told the BBC: "This is a drug that they have never tested on humans before so they don't know what they are dealing with."
The Medicines and Healthcare Products Regulatory Agency immediately suspended the trial of the drug after the men were taken ill. Chief Executive 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."
Paraxel, the company which was running the trial, said that it had followed guidelines and stressed that such reactions to drugs were extremely rare. Professor Herman Scholtz from Paraxel said: "When the adverse drug reaction occurred, the Paraxel clinical pharmacology medical team responded swiftly to stop the study procedures immediately."
TeGenero Chief Executive Dr Benedikte Hatz said: "These events were completely unexpected and do not reflect the results we obtained from initial laboratory studies which enabled us to progress investigations into human volunteers."
The eight men are understood to have been paid £2,000 each to participate in the trial of the drug, which had already been tested on animals and in a laboratory.
(KMcA/GB)
Eight healthy male volunteers participated in the trial of TGN 1412 - a drug manufactured by German company TeGenero AG to treat conditions such as leukaemia and chronic inflammatory conditions - at a facility in the grounds of Northwick Park Hospital, London.
However, on Monday, six men had to be admitted to intensive care after suffering a serious reaction to the drug. The two other volunteers, who had been given a placebo, were not affected. No one else, other than the six men, were given the drug.
Two of the men are in a critical condition, while the other four are described as being in a serious condition, but are showing signs of improvement. All the men, who have suffered multiple organ failures, remain in intensive care.
A police investigation into the drug trial has now been launched.
Myfawny Marshall, whose boyfriend is one of the men in a critical condition, told BBC News that the 28-year-old's face was so puffed after taking the drug that he resembled the Elephant Man. Ms Marshall told the BBC: "This is a drug that they have never tested on humans before so they don't know what they are dealing with."
The Medicines and Healthcare Products Regulatory Agency immediately suspended the trial of the drug after the men were taken ill. Chief Executive 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."
Paraxel, the company which was running the trial, said that it had followed guidelines and stressed that such reactions to drugs were extremely rare. Professor Herman Scholtz from Paraxel said: "When the adverse drug reaction occurred, the Paraxel clinical pharmacology medical team responded swiftly to stop the study procedures immediately."
TeGenero Chief Executive Dr Benedikte Hatz said: "These events were completely unexpected and do not reflect the results we obtained from initial laboratory studies which enabled us to progress investigations into human volunteers."
The eight men are understood to have been paid £2,000 each to participate in the trial of the drug, which had already been tested on animals and in a laboratory.
(KMcA/GB)
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19 April 2006
Drug trial victims offered £5,000
Six volunteers who participated in a drug trial which left them seriously ill have been offered interim payments of £5,000 if they agree not to sue. Lawyers for four of the six men said that the manufacturer of the drug, TeGenero, had agreed to pay the men compensation on the condition that they accepted a “no-fault” procedure.
Drug trial victims offered £5,000
Six volunteers who participated in a drug trial which left them seriously ill have been offered interim payments of £5,000 if they agree not to sue. Lawyers for four of the six men said that the manufacturer of the drug, TeGenero, had agreed to pay the men compensation on the condition that they accepted a “no-fault” procedure.
20 March 2006
Company admits trial drug caused side effects in monkeys
The drug which has left six men seriously ill in hospital during a trial caused glands in two monkeys to swell during earlier tests, it has been revealed. However, TeGenero, the German company that manufactured the TGN1412 drug, said that the symptoms shown by the monkeys differed from those suffered by the men during the trial last week.
Company admits trial drug caused side effects in monkeys
The drug which has left six men seriously ill in hospital during a trial caused glands in two monkeys to swell during earlier tests, it has been revealed. However, TeGenero, the German company that manufactured the TGN1412 drug, said that the symptoms shown by the monkeys differed from those suffered by the men during the trial last week.
16 March 2006
Drug trial men remain seriously ill
Two volunteers who fell ill after participating in the trial of a new drug remain in a critical condition. Six men fell ill after participating in the trial of anti-inflammatory drug TGN 1412 at a research unit at the Northwick Park Hospital on Monday. Four of the men are now understood to be improving, although they are still seriously ill.
Drug trial men remain seriously ill
Two volunteers who fell ill after participating in the trial of a new drug remain in a critical condition. Six men fell ill after participating in the trial of anti-inflammatory drug TGN 1412 at a research unit at the Northwick Park Hospital on Monday. Four of the men are now understood to be improving, although they are still seriously ill.
31 March 2006
Drug trial man says brain 'on fire'
One of the six men who became seriously ill following a drug trial has given an interview, saying how he felt like his brain was "on fire" after taking the drug.
Drug trial man says brain 'on fire'
One of the six men who became seriously ill following a drug trial has given an interview, saying how he felt like his brain was "on fire" after taking the drug.
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