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Old 03-15-2006, 11:50 AM   #1 (permalink)
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Clinical trial goes wrong

Six men remain in intensive care after they were taken ill during a clinical drugs test in north-west London.
The healthy volunteers had been given an anti-inflammatory drug at a private research unit based at Northwick Park Hospital when they suffered a reaction.
Myfanwy Marshall told BBC News her boyfriend's body was badly swollen and his organs were failing.
An investigation has begun at the unit, run by Parexel, which said it followed recommended guidelines in its trial.
The young men were being paid to take part in the early stages of a trial for the drug TGN1412 which is designed to treat conditions such as rheumatoid arthritis and leukaemia. But within hours of taking it on Monday, six volunteers had to be admitted to intensive care - a further two had been given a placebo.

Northwick Park Hospital's intensive care director Ganesh Suntharalingam said two were in a critical condition, and the other four were serious but showing some signs of improvement.
He added his team had been doing everything possible in this "unique set of circumstances".
"The drug, which is untested and therefore unused by doctors, has caused an inflammatory response which affects some organs of the body," he said.
Ms Marshall, 35, whose boyfriend is critically ill, said the normally healthy 28-year-old barman's face was so puffed, he "looks like the Elephant Man".
She said: "His friends cannot even face seeing him. I have to stay there because I'm looking beyond all the wires and the puffiness. "This is not leukaemia, this is not pneumonia, this is not something they know how to deal with."

The Medicines and Healthcare products Regulatory Agency (MHRA) immediately withdrew authorisation for the trial and an international warning was sent out to prevent the drug from being tested abroad.
MHRA inspectors have visited the independent research unit and are in talks with the local strategic health authority, the Department of Health and police about the cases.
Its chief executive Professor Kent Woods said: "Our immediate priority has been to ensure that no further patients are harmed.
"We will now undertake an exhaustive investigation to determine the cause and ensure all appropriate actions are taken."
It had approved the trial and the drug had already been tested on animals.
Volunteers are paid up to £150 a day to take part in clinical trials.

'Swift response'
Parexel, which was running the trial, said it had followed guidelines and such cases were extremely rare.
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.
Professor Herman Scholtz, from Parexel, said: "When the adverse drug reaction occurred, the Parexel clinical pharmacology medical team responded swiftly to stop the study procedures immediately.
"Such an adverse drug reaction occurs extremely rarely and this is an unfortunate and unusual situation. We did everything possible to get the patients treated as quickly as possible."
TeGenero, the Germany-based manufacturers of the drug, said the events were completely unexpected and did not reflect results from initial laboratory studies. Health secretary Patricia Hewitt said: "It is a shocking event and obviously our thoughts are with those young people and with their families."
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Old 03-15-2006, 01:17 PM   #2 (permalink)
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six volunteers had to be admitted to intensive care - a further two had been given a placebo.
lucky day.....now they know who drew the long straws
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Old 03-16-2006, 05:09 AM   #3 (permalink)
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UPDATE:

A drugs company says it has apologised to the families of two critically ill men and four others in a serious condition after a clinical drugs trial.

All are still in intensive care in Northwick Park Hospital, north-west London, after falling ill on Monday.
TeGenero, which manufactures the anti-inflammatory drug, described the reactions as "shocking developments".
Scotland Yard said officers are talking to the Medicines and Healthcare products Regulatory Agency and doctors. On Thursday morning, a hospital spokesman said there had been no change in the men's clinical condition overnight.

It was the first time the drug TGN1412, designed to treat conditions such as rheumatoid arthritis and leukaemia, had been tested on humans.
Within hours of taking it on Monday, the six young volunteers had to be admitted to intensive care.
They "went down like dominoes", according to Raste Khan, 23, one of two trial volunteers who escaped unscathed after being given a placebo.
He told the Sun newspaper: "They began tearing their shirts off complaining of fever, then some screamed out that their heads felt like they were going to explode. "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."


Guidelines followed
The Medicines and Healthcare products Regulatory Agency is 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".
Myfanwy 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".
"They just keep saying he's very, very sick and we are doing all we can," she added.
The hospital says it is continuing to treat the men's "inflammatory disorder" and would do all it could to support the families.
American company Parexel, which ran the trial, said it had followed recommended guidelines.

'Mixed messages'
And TeGenero said the new medicine had showed no signs of problems in earlier tests.
Chief scientific officer Thomas Hanke added the company's first concern now was making sure the patients got the best treatment possible and to support the families.
He said: "They were shocked, devastated. We deeply understand that they are. We are devastated at these shocking developments which we were not anticipating."
But the families said they had been given "mixed messages" during two meetings with the companies. A Metropolitan Police spokeswoman said it was "more than likely" officers had visited the hospital, adding that police were keeping a close eye on the case.
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Old 03-28-2006, 11:03 AM   #4 (permalink)
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UPDATE:

Two of the six men left seriously ill after taking part in a drugs trial have been allowed home. Doctors at Northwick Park Hospital, in north-west London, said they had responded very well to their treatment and made an "excellent recovery".
One man remains critically ill while the other three are continuing to make progress, it was said.
All six volunteers had a rapid inflammatory response to the drug TGN1412 at a research unit.
A statement from the hospital said the two men will regularly visit the hospital as out-patients for check-ups and tests.
The man still in a critical condition has made "good improvement" over the past week, it said.
Martyn Day, of Leigh Day and Co solicitors, who is representing four of the men, said: "Our clients are pleased to be recovering but are very anxious about their futures at this time.
"We are looking for an early meeting with the drug companies to ensure that financially our clients can get their lives back in order as speedily as possible without recourse to the courts."
Medical research firm Parexel, which carried out the tests, insists its staff followed correct procedures.
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Old 03-28-2006, 11:15 AM   #5 (permalink)
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I'll bet there are a few people updating resumes right now...
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Old 03-29-2006, 05:08 AM   #6 (permalink)
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I'll bet there are a few people updating resumes right now...
I bet the cost of a student to experiment on has just doubled
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Old 03-29-2006, 09:30 AM   #7 (permalink)
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I used to take part in a lot of drug studies in my younger days.

Nothing happend to me, and I'm still OK. Just look at the sort of people I mix with on this forum, I must be OK.
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Old 03-29-2006, 10:34 AM   #8 (permalink)
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Originally Posted by pdulfo
I used to take part in a lot of drug studies in my younger days.
Nothing happend to me, and I'm still OK. Just look at the sort of people I mix with on this forum, I must be OK.
Something tells me there was a lot of 'unofficial' drug testing going on several different places.
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Old 03-29-2006, 11:15 AM   #9 (permalink)
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Originally Posted by rwhite
Something tells me there was a lot of 'unofficial' drug testing going on several different places.
I think you can start with every university town but I think those drugs have already been well tested.
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Old 03-31-2006, 07:45 AM   #10 (permalink)
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Drug trial man's 'brain on fire'

One of six men who fell seriously ill after taking part in a drug trial has told reporters that he felt like his brain was "on fire".
Student Nav Modi, 24, speaking for the first time, said the experience was a "terrible nightmare".
He said: "I felt my head swelling up like an elephant's -I thought my eyeballs were going to pop out."
Mr Modi and the other volunteers had an inflammatory response to the drug TGN1412.
They had been given the drug, created by German pharmaceutical company TeGenero by medical research company Parexel.
The previously healthy men had volunteered to test the medication, which was designed to treat rheumatoid arthritis, leukaemia and multiple sclerosis.

'Intense pain'
Mr Modi, of Forest Gate, East London, told reporters that he was gripped by pain just an hour after the drug was given to him and the other men.
"I was suddenly gripped by a pain I can barely begin to describe."
Despite screaming to a doctor, he said he was told to "lie down" and brought a paracetamol tablet - which he vomited back up within five minutes.
Mr Modi said: "Then somehow the pain got even worse with the pressure in my head so intense it was like a truck had been parked on it."
The pain then moved to his back.
He said: "I felt even worse than before and I was conscious of bucking and writhing in the bed as they tried to get an oxygen mask on me.
"It felt like a terrible nightmare."
He said he took part in the trial at London's Northwick Park Hospital to earn £2,000 to pay for a new laptop.
The latest statement from Northwick Park Hospital, issued on Wednesday, said two of the six men had been allowed home after responding "very well" to treatment.
One man is still in a critical condition while the other three continue to make a good recovery.

I don't know about all of you but find this whole thing
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