Bunny
15-03-2006, 08:52 PM
BBC NEWS
Two drug trial men critically ill
Two men remain critically ill and four others are in a serious condition after suffering a violent reaction while taking part in a clinical drugs trial.
All are still in intensive care in Northwick Park Hospital, north-west London, after falling ill on Monday.
Myfanwy Marshall told BBC News her boyfriend's body was badly swollen and she had been told he could die.
Relatives are said to be unhappy with the information given from the firm behind the anti-inflammatory drug.
After two meetings with pharmaceutical company TeGenero AG, which manufactures the drug and Parexel, which ran the trial, the families had been given "mixed messages", it was claimed.
Lawyer Ann Alexander, representing one of the critically ill men, added: "There are real problems that need to be investigated very quickly."
It was the first time the drug TBN1412, designed to treat conditions such as rheumatoid arthritis and leukaemia, had been tested on humans.
But within hours of taking it on Monday, the six young volunteers had to be admitted to intensive care - a further two had been given a placebo.
Ms Marshall, 35, whose boyfriend is critically ill, said the normally healthy 28-year-old's face was so puffed, he "looks like the Elephant Man".
She said he was completely lifeless, unable even to move an eyelid.
"They just keep saying he's very, very sick and we are doing all we can," she added.
"They are saying he could be lying there in six months. He needs a miracle, those were their words, he needs a miracle."
Ganesh Suntharalingham, the hospital's clinical director of intensive care, said they were continuing to treat the "inflammatory disorder" with treatment aimed at the immune system.
He said the families and friends of the volunteers were clearly concerned and distressed and the hospital would do all it could to help them.
TeGenero AG says there was nothing to indicate the reaction in previous laboratory tests and the events were "completely unexpected".
Its chief scientific officer Thomas Hanke said: "Our first concern right now is for the patients and families and that they get all treatment possible.
"We are confident with the excellent treatment at this hospital and have made ourselves available to answer any questions from the doctor about the drug."
An investigation at the private research unit on the hospital's grounds has begun.
American company Parexel, which runs the unit, said it followed recommended guidelines in its trial and got the patients treated as quickly as possible.
UK watchdog the Medicines and Healthcare products Regulatory Agency (MHRA) has sent its inspectors to the site and put out an international warning.
Professor Kent Woods, from the MHRA, said they would be looking at whether the reaction was caused by a manufacturing problem, contamination, a dosing error or whether it was some "completely unanticipated side effect of the drug in humans".
The Medical Research Council said that while it was "an unfortunate and extremely rare event", such clinical trials were essential for the development of new and better treatments.
Health secretary Patricia Hewitt said: "It is a shocking event and obviously our thoughts are with those young people and with their families."
Have you taken part in a drug trial? How did you find the experience? Would you consider taking part in one? Have you conducted a drug trial? Send us your comments and experiences.
Story from BBC NEWS:
http://news.bbc.co.uk/go/pr/fr/-/1/hi/england/london/4808836.stm
Published: 2006/03/15 18:33:19 GMT
© BBC MMVI
so does this go to prove that drug test on animals don't prove that they will work on humans ?
Two drug trial men critically ill
Two men remain critically ill and four others are in a serious condition after suffering a violent reaction while taking part in a clinical drugs trial.
All are still in intensive care in Northwick Park Hospital, north-west London, after falling ill on Monday.
Myfanwy Marshall told BBC News her boyfriend's body was badly swollen and she had been told he could die.
Relatives are said to be unhappy with the information given from the firm behind the anti-inflammatory drug.
After two meetings with pharmaceutical company TeGenero AG, which manufactures the drug and Parexel, which ran the trial, the families had been given "mixed messages", it was claimed.
Lawyer Ann Alexander, representing one of the critically ill men, added: "There are real problems that need to be investigated very quickly."
It was the first time the drug TBN1412, designed to treat conditions such as rheumatoid arthritis and leukaemia, had been tested on humans.
But within hours of taking it on Monday, the six young volunteers had to be admitted to intensive care - a further two had been given a placebo.
Ms Marshall, 35, whose boyfriend is critically ill, said the normally healthy 28-year-old's face was so puffed, he "looks like the Elephant Man".
She said he was completely lifeless, unable even to move an eyelid.
"They just keep saying he's very, very sick and we are doing all we can," she added.
"They are saying he could be lying there in six months. He needs a miracle, those were their words, he needs a miracle."
Ganesh Suntharalingham, the hospital's clinical director of intensive care, said they were continuing to treat the "inflammatory disorder" with treatment aimed at the immune system.
He said the families and friends of the volunteers were clearly concerned and distressed and the hospital would do all it could to help them.
TeGenero AG says there was nothing to indicate the reaction in previous laboratory tests and the events were "completely unexpected".
Its chief scientific officer Thomas Hanke said: "Our first concern right now is for the patients and families and that they get all treatment possible.
"We are confident with the excellent treatment at this hospital and have made ourselves available to answer any questions from the doctor about the drug."
An investigation at the private research unit on the hospital's grounds has begun.
American company Parexel, which runs the unit, said it followed recommended guidelines in its trial and got the patients treated as quickly as possible.
UK watchdog the Medicines and Healthcare products Regulatory Agency (MHRA) has sent its inspectors to the site and put out an international warning.
Professor Kent Woods, from the MHRA, said they would be looking at whether the reaction was caused by a manufacturing problem, contamination, a dosing error or whether it was some "completely unanticipated side effect of the drug in humans".
The Medical Research Council said that while it was "an unfortunate and extremely rare event", such clinical trials were essential for the development of new and better treatments.
Health secretary Patricia Hewitt said: "It is a shocking event and obviously our thoughts are with those young people and with their families."
Have you taken part in a drug trial? How did you find the experience? Would you consider taking part in one? Have you conducted a drug trial? Send us your comments and experiences.
Story from BBC NEWS:
http://news.bbc.co.uk/go/pr/fr/-/1/hi/england/london/4808836.stm
Published: 2006/03/15 18:33:19 GMT
© BBC MMVI
so does this go to prove that drug test on animals don't prove that they will work on humans ?