Human Guinea Pigs for Dangerous Drugs!
Victims
tearing at shirts
'It was like a scene from hell' ... shocked trial
volunteer Raste Khan outside hospital yesterday
UK Sun |
March 16, 2006
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.
END
Drug trial doctor reveals 'unique' symptoms
London Daily Mail | March 16, 2006
by MICHAEL SEAMAR
The doctor battling to save the lives of six men who took part in a drug trial said today he's never dealt with a case like this before, describing the set of symptoms as 'unique'.
The men suffered inflammation which had subsequently affected other parts of their body, including their internal organs.
Dr Ganesh Suntharalingam, clinical director of intensive care at Northwick Park Hospital in north west London, said: "We have seen some aspects of it. Some of the features such as the need for a large amount of fluid and unstable organs are things that happen with other disorders but the exact sequence of what's happening here is unique.
"No-one has had this agent before and no-one has had this reaction before but some aspects are familiar to us."
Dr Suntharalingam said it was too early to say whether the men would make a full recovery but some were showing signs of recovery.
"There is an inflammatory process going on that seems to have been triggered by something. That process started to affect other parts of the body so we have two jobs to do, one is to try to treat the inflammation and the other is to deal with the consequences of it.
"We do not know exactly what triggered the reaction," he said.
Dr Suntharalingam said the men were now being treated with anti-inflammatory drugs such as steroids but he was unable to say why some of the men had begun to recover while two remained critically ill.
"We do not know if it is genetic or if it is to do with individual responses," he said.
Dr Suntharalingam refused to comment on reports that one patient's head had swollen to three times its normal size but said: "This sort of condition does require fluid and that does cause swelling.
"That swelling does go away on recovery but it's very distressing for the families to see. It is one aspect of intensive care that gets better as the patients get better."
But he said it was far too early to say whether that would be the case.
Meanwhile, horrific stories have emerged of the drugs trial on human guinea pigs which went disastrously wrong.
The girlfriend of one victim emerged from an intensive care unit where he is fighting for his life saying he had been transformed from a handsome young man into Elephant Man.
Myfanwy Marshall said: "He was a young, fit, healthy, gorgeous-looking guy. Now his face is bloated, just like Elephant Man. He needs a miracle, those were their words, he needs a miracle."
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Another victim's head has apparently swollen to three times its normal size. The names of the volunteers have not been officially released but the second victim has emerged as Ryan Wilson, a 21-year-old student.
A volunteer taking part in the trial who was given a placebo and therefore escaped the effects described the appalling scene on the ward.
Raste Khan, 23, a television technician, said: "The test ward turned into 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 going 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 I didn't know why."
Six volunteers suffered catastrophic reactions to trials of the new drug, TGN1412, at Northwick Park Hospital in Harrow, North-West London.
They were the first people in the world to test the drug, being developed by the German pharmaceutical firm, TeGenero, and designed to treat chronic inflammatory conditions and leukaemia. They were paid £2,000 each.
Four are in a serious condition but showing signs of improvement. Two remain critical.
The full test group was made up of four British Asians, two Australians, a South African and one Englishman, Mr Wilson.
The trial began on Monday in a unit on the hospital campus run by the private American research company, Parexel.
All the men signed a consent form, but the tragedy could lead to compensation claims running into hundreds of thousands of pounds.
It could also deal a hammer blow to the drug-testing industry, which often relies on hard-up students volunteering as guinea pigs.
The Department of Health and Scotland Yard are investigating.
Miss Marshall, 35, a TV producer, said doctors were in the dark about how to treat the men.
"They haven't got a cure," she said. "This is a drug they have never tested on humans before so they don't know what they are dealing with."
Describing the moment she walked into the intensive care unit to see her partner, a 28-year-old bar manager from London, she said: "I nearly fainted. He is dark and gorgeous. Twenty-eight, almost twenty-nine, a muscley, hunky guy but here he looked like a 45-year-old man who had had a cardiac arrest.
"His blood is being pumped in and out. His lungs, his heart and his kidneys are being supported. They have basically killed him within a day with a lethal injection.
"He had a tube in his nose, a tube going into his mouth and a hole in his neck. There were tubes in his hands and something in his groin.
'It's like some nightmare movie'
"The doctors have said he could die at any moment. It's like some nightmare movie. My beautiful, lovely, gorgeous boyfriend is going to be dead without these machines.
"We've been told by doctors that they are just keeping the men alive, just keeping them ticking."
Ann Alexander, solicitor for the 28-year-old victim, explained what happened.
The men arrived at Parexel's 36-bed unit on Monday. They underwent tests to ensure they were fit and were given the drug at 8am, by injection, she believes.
They began suffering from headaches and nausea within 90 minutes. The headaches became severe and within 12 hours all the men had collapsed.
"The four men who are seriously ill I am told are sitting up and talking. My client is sedated, critically ill and on a life support machine," she said.
"The family are very scared about it and the prognosis is unclear. They are concerned about the lack of consistency in answers they are receiving from the drug company."
She said they had had two meetings with the drug company. "In the first they were told the drug had been tested previously on monkeys and dogs and that one dog had died.
"The next time they asked the same question they were told the drug had been tested on monkeys and rabbits. We need to get to the bottom of it."
The researchers are thought to have taken the unusual step of adjusting the dosage according to each volunteer's weight. This may explain why some of the participants are now more ill than others.
Miss Marshall said: "One of the mothers and I think that our two boys have had an overdose. They are big bulky guys and I think the drugs company gave them more than they gave to anyone else."
She said her boyfriend joined the trial on impulse for financial reasons after his wallet had been stolen and he had bills to pay.
When she protested about him joining the programme he replied: "I am helping mankind."
She said: "He is so full of life, he is this buoyant, bubbly, charismatic star, oozing charisma. Everyone adores him.
"In there is a man completely lifeless. You know, I can't even get anything, an eyelid movement, a squeeze of his hand. He is like a shell." She said he was 'athletic, healthy and full of life,' adding: "That's why they picked him or people like him."
He had no idea he was putting his life at risk by volunteering. "There was nothing on the form saying, "this could kill you, sign here"."
Thomas Hanke, chief scientific officer of TeGenero, said last night that the company had apologised to the families. "They were shocked, devastated. We deeply understand that they are. We are devastated at these shocking developments."
Dr Hanke, speaking at the hospital, was unable to say whether the men had suffered permanent damage but said there had been no adverse side effects previously in testing of the drug, which began in 1997.
When asked whether animals had died during testing, he said: "There has been no issue on the safety of the drug on animals. This is not relevant. The drug has not been tested on dogs or rats. It was tested on other mammals."
In a statement from Parexel's Boston headquarters, the company said: "These events were completely unexpected and do not reflect the results we obtained from initial laboratory studies."
One man told how he escaped the catastrophe because of nagging doubts.
Tom Edwards, 21, from Oxford, said: "It is not really like me to turn down big money for lying on my back but I was not comfortable with doing it.
"Something told me to be suspicious about it even though I did not know why. It seemed a bit haphazard."
END
Drug trial ignored guideline on safety
London
Times | March 16, 2006
By Nigel Hawkes
DRUG trials that left six healthy volunteers fighting for their lives did not conform to best medical practice, The Times has been told.
Senior doctors expressed concern that all six were given the same dose of the experimental drug TGN1412 at the same time. According to the standard medical text, trials of this sort should avoid giving all the doses simultaneously. The Textbook of Pharmaceutical Medicine specifically gives warning that such practices can be “very difficult to manage” and “put subjects at unnecessary risk”.
Last night the Medical and Healthcare Products Regulatory Agency was urgently investigating what went wrong in the the trials, as families kept up a vigil at the patients bedsides. It is trying to determine whether it was a fault in production, contamination or more likely an intrinsic problem with the drug itself.
“They haven’t got a cure,” said Myfanwy Marshall, whose boyfriend fell ill 90 minutes after taking the drug. “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.”
There was confusion last night about whether the drug had been tested successfully on animals before the tests on human volunteers.
“They [the drugs company] said there was an oversensitivity in monkeys,” Ms Marshall said. She went on to say that in the tests a “dog and some animals had died . . . so they reduced the amount to humans”.
Thomas Hanke, chief scientific officer of TeGenero, last night refused at a press conference to say whether animals had died during earlier tests. “There has been no issue on the safety of the drug on animals. This is not relevant,” he said. He said the drug had been tested on mammals but not dogs or rats.
He said that the company had apologised to relatives of the six ill volunteers. “We are devastated at these shocking developments which we were not anticipating. The investigation must proceed as quickly as possible (into) the testing of a new medicine which showed no signs of any safety problems in previous testing.”
Lawyers have been instructed on behalf of at least one of the victims. All six remained in care at Northwick Park Hospital, northwest London. Two were said to be in critical condition and the other four were serious, but showing signs of improvement. Relatives met doctors and staff from the two companies involved — the German biotech company, TeGenero, and Parexel, the contract company that was conducting the trial.
The trial protocol had been agreed with the MHPRA and was carried out “according to strict ethical and regulatory requirements”, according to Parexel.
The MHPRA yesterday refused to give precise details, citing commercial confidentiality, and questions to Parexel went unanswered. But TeGenero confirmed that all six volunteers had been given scaled doses of the drug according to their body weight. The tragedy, experts said, should result in a review into the way future trial are carried out.
Professor Sheila Bird, from the Medical Research Council’s Biostatistics Unit at Cambridge, said: “It is very unusual to have a tragedy in one volunteer in a trial like this, far less to have all six involved. ”
That could have been avoided, she said, if at the start only one of the volunteers had been given the drug.
All were healthy young men who had volunteered for the first human trials of a new arthritis drug, developed in Germany.
Professor Bird, citing the recommendations made in The Textbook of Pharmaceutical Medicine, a standard work on the subject. suggested that the trial would have been better to test two or three volunteers on day one, before other volunteers were given their dose.
However, Chris Springall of Covance Clinical Research, a company based in Yorkshire that carries out drug trials, said that the practice by which the whole group was given a dose at the same time was normal in the industry. But it was not considered risky because side-effects were so extremely rare.
“I've been in this business 20 years and I've never known anything of this nature before,” he said.
END
