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article link: http://www.thesun.co.uk/article/0,,2-2006120434,00.html
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link: http://www.telegraph.co.uk/news/main...portaltop.html
By NICK PARKER,
EMMA MORTON and
JACQUI THORNTON
A VOLUNTEER who escaped the drug test disaster told last night how he saw six healthy young men turn into wailing wrecks within minutes. Human guinea pig Raste Khan ? who did not know he had been given a harmless placebo in the test ? said it was like a horror film unfolding before his eyes.
The 23-year-old TV technician added: The test ward turned into a living hell minutes after we were injected. The men went down like dominoes. First they began tearing their shirts off complaining of fever, then some screamed out that their heads felt like they were about to explode.
After that they started fainting, vomiting and writhing around in their beds. It was terrifying because I kept expecting it to happen to me at any moment. But I felt fine and didn?t know why. An Asian guy next to me started screaming and his breathing went haywire as though he was having a terrible panic attack. They put an oxygen mask on him but he kept tearing it off, shouting ?Doctor, doctor, please help me!? He started convulsing, shouting that he was getting shooting pains in his back.
Last night two of the victims were still fighting for life in Northwick Park Hospital, North West London, while the other four were listed as ?seriously ill?.
The head of trainee plumber Ryan Wilson, 21, is three times its normal size and his limbs are purple. Doctors said his chances of survival were slim. Another victim, a 28-year-old Asian man, was said to ?look like The Elephant Man?.
A frantic global race to find a ?cure? was launched yesterday. The patients? blood was being filtered every HOUR in a bid to remove any possible toxins. And homicide cops from Scotland Yard were drafted in to probe whether any negligence or deliberate tampering with the drugs was involved.
The six affected were among eight volunteers taking part in clinical trials for the American Parexel research company. Two were given placebos for comparison purposes. The others were injected with a new drug called TGN 1412, being tested for German firm TeGenero.
It is an anti-inflammatory agent makers hoped would become a lucrative treatment for rheumatism, leukaemia and multiple sclerosis. The drug has passed tests on animals but Monday?s session at the hospital was the first time it had been tried on humans.
The trial group was made up of one Englishman ? Ryan ? four Asian Brits, two Australians and a South African. They were each being paid ?2,000 plus ?30 a time for 11 follow-up checks. Raste, of Roehampton, South West London, said: ?We all turned up on Sunday and slept on what looked like a private ward before being given the drugs in the morning. We had needles inserted in both arms with valve devices so they could inject drugs and take blood for tests.?
Raste said four men in smart suits, who he assumed were from the drug company, mingled with nurses and kept tabs on the test. But they ?made themselves scarce? as it all went wrong and the victims were rushed into intensive care. The girlfriend of the unnamed 28-year-old, who runs a London bar, told last night how he had taken part in trials before.
And he volunteered for the one at Northwick Park, a complex which also includes St Mark?s Hospital, ?to help mankind?. Myfanwy Marshall, 35, described him as ?completely gorgeous, really buoyant, oozing with charm and really muscly.? But last night he had changed beyond recognition.
The girlfriend, who saw him in hospital, said: ?He was completely lifeless, like a shell. ?He can?t even move his eyelids. This machine is pumping out his lungs and his face is puffed out like The Elephant Man. A day ago he was fine and now they are saying he could die at any moment.? She added: ?The doctors say they are in the dark because they don?t know the drug or what it can do. They don?t know what they are dealing with.?
Parexel yesterday sent blood samples from the victims to the US for urgent tests. And TeGenero flew in 20 German doctors from its HQ in Wurzburg to see the patients. Britain?s watchdog body the Medicines and Healthcare products Regulatory Agency sent out alerts to counterparts in Europe. The homicide cops are liaising with health chiefs to ascertain if any crime has been committed.
A senior source said: ?Should any of the volunteers die, this could become a manslaughter inquiry or ? at the very worst ? murder.?
TeGenero?s chief scientific officer Thomas Hanke said: ?The investigation must proceed quickly into these shocking developments in the testing of a new medicine, which showed no signs of any safety problems in previous testing.?
Victims will be able to sue despite signing consent forms if medics did not act reasonably, lawyers said.
EMMA MORTON and
JACQUI THORNTON
A VOLUNTEER who escaped the drug test disaster told last night how he saw six healthy young men turn into wailing wrecks within minutes. Human guinea pig Raste Khan ? who did not know he had been given a harmless placebo in the test ? said it was like a horror film unfolding before his eyes.
The 23-year-old TV technician added: The test ward turned into a living hell minutes after we were injected. The men went down like dominoes. First they began tearing their shirts off complaining of fever, then some screamed out that their heads felt like they were about to explode.
After that they started fainting, vomiting and writhing around in their beds. It was terrifying because I kept expecting it to happen to me at any moment. But I felt fine and didn?t know why. An Asian guy next to me started screaming and his breathing went haywire as though he was having a terrible panic attack. They put an oxygen mask on him but he kept tearing it off, shouting ?Doctor, doctor, please help me!? He started convulsing, shouting that he was getting shooting pains in his back.
Last night two of the victims were still fighting for life in Northwick Park Hospital, North West London, while the other four were listed as ?seriously ill?.
The head of trainee plumber Ryan Wilson, 21, is three times its normal size and his limbs are purple. Doctors said his chances of survival were slim. Another victim, a 28-year-old Asian man, was said to ?look like The Elephant Man?.
A frantic global race to find a ?cure? was launched yesterday. The patients? blood was being filtered every HOUR in a bid to remove any possible toxins. And homicide cops from Scotland Yard were drafted in to probe whether any negligence or deliberate tampering with the drugs was involved.
The six affected were among eight volunteers taking part in clinical trials for the American Parexel research company. Two were given placebos for comparison purposes. The others were injected with a new drug called TGN 1412, being tested for German firm TeGenero.
It is an anti-inflammatory agent makers hoped would become a lucrative treatment for rheumatism, leukaemia and multiple sclerosis. The drug has passed tests on animals but Monday?s session at the hospital was the first time it had been tried on humans.
The trial group was made up of one Englishman ? Ryan ? four Asian Brits, two Australians and a South African. They were each being paid ?2,000 plus ?30 a time for 11 follow-up checks. Raste, of Roehampton, South West London, said: ?We all turned up on Sunday and slept on what looked like a private ward before being given the drugs in the morning. We had needles inserted in both arms with valve devices so they could inject drugs and take blood for tests.?
Raste said four men in smart suits, who he assumed were from the drug company, mingled with nurses and kept tabs on the test. But they ?made themselves scarce? as it all went wrong and the victims were rushed into intensive care. The girlfriend of the unnamed 28-year-old, who runs a London bar, told last night how he had taken part in trials before.
And he volunteered for the one at Northwick Park, a complex which also includes St Mark?s Hospital, ?to help mankind?. Myfanwy Marshall, 35, described him as ?completely gorgeous, really buoyant, oozing with charm and really muscly.? But last night he had changed beyond recognition.
The girlfriend, who saw him in hospital, said: ?He was completely lifeless, like a shell. ?He can?t even move his eyelids. This machine is pumping out his lungs and his face is puffed out like The Elephant Man. A day ago he was fine and now they are saying he could die at any moment.? She added: ?The doctors say they are in the dark because they don?t know the drug or what it can do. They don?t know what they are dealing with.?
Parexel yesterday sent blood samples from the victims to the US for urgent tests. And TeGenero flew in 20 German doctors from its HQ in Wurzburg to see the patients. Britain?s watchdog body the Medicines and Healthcare products Regulatory Agency sent out alerts to counterparts in Europe. The homicide cops are liaising with health chiefs to ascertain if any crime has been committed.
A senior source said: ?Should any of the volunteers die, this could become a manslaughter inquiry or ? at the very worst ? murder.?
TeGenero?s chief scientific officer Thomas Hanke said: ?The investigation must proceed quickly into these shocking developments in the testing of a new medicine, which showed no signs of any safety problems in previous testing.?
Victims will be able to sue despite signing consent forms if medics did not act reasonably, lawyers said.
link: http://www.telegraph.co.uk/news/main...portaltop.html
Drug test subject 'looks like elephant man' says girlfriend
(Filed: 15/03/2006)
The girlfriend of a man fighting for life after taking part in a pharmaceuticals trial has said the drugs he was given have left him looking "like the Elephant Man". Myfanwy Marshall, 35, said her boyfriend, a 28-year-old British man who had taken part in drug trials before without adverse side effects, felt ill 80 or 90 minutes after being given the drug on Monday.
He is now in the intensive care unit at at Northwick Park hospital in north-west London. Five other men were also admitted to the intensive care unit at Northwick Park from an independent medical research unit on the hospital campus after taking part in the trial.
They had reacted badly to the drug, which is to treat chronic inflammatory conditions and leukaemia. Miss Marshall said of her boyfriend: "He is like a shell of who he is and this machine is pumping out his lungs. "His chest is puffed out. He is already a big kind of guy but his face is out here, like Elephant Man, it's completely puffed.
She added: "They haven't got a cure. This is not leukaemia. This is a drug they have never tested on humans before so they don't know what they are dealing with. It's completely messed up their vital organs."
(Filed: 15/03/2006)
The girlfriend of a man fighting for life after taking part in a pharmaceuticals trial has said the drugs he was given have left him looking "like the Elephant Man". Myfanwy Marshall, 35, said her boyfriend, a 28-year-old British man who had taken part in drug trials before without adverse side effects, felt ill 80 or 90 minutes after being given the drug on Monday.
He is now in the intensive care unit at at Northwick Park hospital in north-west London. Five other men were also admitted to the intensive care unit at Northwick Park from an independent medical research unit on the hospital campus after taking part in the trial.
They had reacted badly to the drug, which is to treat chronic inflammatory conditions and leukaemia. Miss Marshall said of her boyfriend: "He is like a shell of who he is and this machine is pumping out his lungs. "His chest is puffed out. He is already a big kind of guy but his face is out here, like Elephant Man, it's completely puffed.
She added: "They haven't got a cure. This is not leukaemia. This is a drug they have never tested on humans before so they don't know what they are dealing with. It's completely messed up their vital organs."
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