Special report: Drug trial fiasco
Two men worst hit by German firm's drugs trial may remain in coma for a year. By Steve Bloomfield
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Your support makes all the difference.Two of the six men seriously ill after a disastrous drugs trial last week have been taken off organ support after responding to treatment. Doctors at the Northwick Park Hospital in London, where the trial took place, yesterday confirmed that the condition of two other patients had also improved. They were both "fully conscious and chatting with their relatives", a hospital statement said.
But the remaining two men, 21-year-old Ryan Wilson and 28-year-old Mohammed Abdullah, are still critically ill. Mr Wilson's family have been told that the two men could be in a coma for a year.
The first phase of human testing of the anti-inflammatory drug TGN1412 went horrifically wrong within minutes of being administered to the six volunteers on Monday morning. All six suffered multiple organ failure.
A further two human guinea pigs were given a placebo. One, Raste Khan, described how the room where all eight men were being analysed quickly turned into a "vomiting bath". "People were fainting and coming back to consciousness," he said.
The father of Mr Abdullah said yesterday that his son asked him to pray for him before he went into hospital. But Mohammed Abdullah did not tell his father, Ahmed, why he was going in. "He said he was going to have a small operation and asked me to pray for him," Mr Abdullah said from his home in Egypt. "I did not imagine it would come to this. One of his friends phoned me on Tuesday to say he was in a very serious condition."
The family of Ryan Wilson fear that he may be in a coma for up to a year. His sister-in-law, Jo Brown, said: "The only sign of life Ryan has shown in three days is when his brother William kissed him and a tear rolled down his cheek. Now we're being told that Ryan might be in a coma for six to 12 months. He can't even breathe on his own."
All eight men were believed to have been paid £2,000 after responding to an advert calling for volunteers. Myfanwy Marshall, understood to be the girlfriend of Mr Abdullah, said he had taken part in the trial because he needed to pay some bills.
"He saw the ad. He told me it was for a leukaemia drug. He'd taken part in trials before and been fine. I didn't want him to do it, but he said he was helping mankind, helping scientific knowledge." When Ms Marshall saw her boyfriend in hospital she said he looked like "the Elephant Man" - the 19th-century patient Joseph Merrick treated as a freak because of his deformed and swollen head.
The drug, developed by the German firm TeGenero, is designed to treat conditions such as rheumatoid arthritis, leukaemia and multiple sclerosis. Initial research into the medicine started in 1997 and it has been in development since 2000.
TeGenero apologised to the victims' families, and the company's chief scientific officer, Thomas Hanke, said the drug was tested on rabbits and monkeys with no "drug-related adverse events". The trial was carried out by a US-based firm called Paraxel. The medical research company insisted it had followed correct procedures. In a statement on the company's website, Dr Herman Scholtz, head of Paraxel, said: "An initial review at the site has shown that best practices were followed."
An inquiry into the trial has been launched by the Medicines and Healthcare products Regulatory Agency. Officers from Scotland Yard are in contact with the inquiry team and have not ruled out criminal charges.
Dr Ganesh Suntharalingam, director of intensive care at the hospital, said an advisory panel was meeting regularly and developing a more detailed understanding of what had happened to the previously healthy men.
Bizarrely, medical groups are reporting a huge surge in the number of volunteers keen to take part in drug trials. Private companies who carry out clinical trials of drugs said they were experiencing a sharp rise in the number of calls from would-be volunteers. The Medical Research Council had been concerned that the plight of the six men would put off potential volunteers. Instead, it appears as if the four-figure payments on offer to willing guinea pigs has attracted hundreds of people prepared to take the risk.
All new drugs have to pass three phases of human testing before they can be licensed. In the first phase, healthy volunteers are given the drug so that researchers can test for any potential side effects. Last week's test was the first phase for TGN1412.
Countdown To Coma: How a routine drug trial went horribly wrong
In just a few hours last Monday, six healthy young men hoping to make some extra money by testing drug treatments at Northwick Park Hospital in London collapsed as their immune systems went haywire. This is how eventsunfolded.
The eight volunteers - all healthy men in their twenties - go to bed at the hospital, having spent Sunday evening relaxing together, discussing how they will spend the £2,000 they will each get.
After they have slept for nearly six hours, the men are woken up. They have their blood pressure and heart rates tested. Everything appears to be completely fine.
Final preparations for the injections of the drug, TGN1412, begin. The men are each due to have five shots.
Medical staff begin injecting the men with TGN1412. Two of the eight men - Nick Whybrew, 29, and 23-year-old Raste Khan - are given placebos. The other six receive doses of the drug.
The first volunteer starts to shake violently. He takes his top off and begins rubbing his head, complaining that he is "burning up".
All of the men who have not received placebos are shaking, vomiting and writhing in agony. Many are slipping in and out of consciousness.
Nurses are passing round large black bin liners for the volunteers to vomit in. Some are having breathing difficulties. Staff have begun alerting next of kin.
Ryan Wilson, later identified as one of the two worst affected, begs doctors to put him to sleep because he is in so much pain. His family later say that the 21-year-old's head has swollen to three times its normal size.
Mr Khan and Mr Whybrew have returned to the hospital, after being sent away for lunch.
Two of the less seriously ill men are seen eating in the hospital's canteen. They are on intravenous drips and in wheelchairs. One of them loses consciousness.
Britain's drug safety watchdog, the Medicines and Healthcare products Regulation Agency, says all trials of the drug have been halted.
It emerges that the German firm responsible for the drug, TeGenero, had never tested its products on humans before.
Four of the men regain consciousness. The other two are in critical condition and under sedation.
Doctors say that all six are showing signs of improvement, although two remain in critical condition.
Jonathan Thompson
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