BRITAIN: The girlfriend of a young man who is gravely ill in west London after taking part in the clinical trial for Parexel International said last night that doctors were warning he needed a miracle to survive.
The families of six ill men who acted as human guinea pigs for a new anti-inflammatory drug remained at their bedsides in the intensive-care unit at Northwick Park hospital, west London, as doctors battled the potentially life-threatening side-effects of the medication.
Four days ago, the men, all healthy and aged between 18 and 40, were injected with doses of the drug at the Parexel unit in the hospital as part of a trial for which they received £2,000 (€2,895). They had taken time out from their lives as students, barmen and office workers to join the trial after reading an advertisement for volunteers to test a new leukaemia drug on the Parexel website.
Each had signed a 16-page contract, which said the drug, named on the contract as RWJ676070, had been tested previously on mice, rats and dogs. The contract stated the side effects in mice and rats included "increased urine volume, decreased faeces, redness of the skin". In dogs the drug had caused an "increased heart rate and decreased blood pressure".
But last night two of the men were gravely ill, the other four were seriously ill and doctors at the hospital were struggling to deal with the devastating symptoms of the untested drug.
In the intensive-care unit, relatives sat huddled around each bed where the victims lay with tubes protruding from their swollen bodies. Outside some clutched mobile phones as they explained, in tears, to relatives and friends what had happened.
Myfanwy Marshall (35) said her 28-year-old boyfriend was beyond recognition, puffed out like the "elephant man".
"They are saying he could be lying there in six months," she said. "He needs a miracle; those were their words, he needs a miracle. In there is a man completely lifeless. You know, I can't even get anything, an eyelid movement, a squeeze out of his hand. He is like a shell of who he is. It needs every machine in there to keep him alive."
Ms Marshall said doctors were talking to scientists in America and Germany who had worked on the development of the drug.
She said her boyfriend, who had taken part in the trial on a "whim", had felt nauseous and complained of a headache within 80 minutes of receiving the injection at 8am on Monday. He was taken to the intensive-care unit and 12 hours later, she said, other volunteers were "dropping like flies". At 3am on Tuesday she was called by the hospital and rushed to his bedside.
"We think that the drugs company has taken six young, healthy, fit men and injected them with a lethal poison," said Ms Marshall. "These men are now fighting for their lives."
She added: "The doctors say they are in the dark, they don't know what happened. The drugs company were extremely worried and told us they felt guilty. We've been told by the doctors that they are just keeping the men alive, just keeping them ticking."
Ganesh Suntharalingam, clinical director of intensive care, said: "We are continuing to treat the inflammatory disorder triggered by the drug and the resulting effects. We have given some treatment aimed at the immune system and the patients are continuing to receive a whole range of treatments that the critical-care service offers."
At lunchtime, distraught relatives were invited to a meeting at the hospital with the German drug company TeGenero and Parexel, which was carrying out the tests on its behalf.
One student who volunteered for the trial to help pay off his debts described how he had pulled out. Tom Edwards (21) went to the Parexel unit three weeks ago to be presented with a 16-page contract.
"Something told me to be suspicious about it even though I did not know why I should. It just seemed a bit haphazard," he said.