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OfflineCptnGarden
fuck this site
Registered: 05/13/04
Posts: 11,945
Last seen: 14 years, 9 months
Sickening 'storms' in drug trials
    #5963830 - 08/14/06 07:27 PM (17 years, 5 months ago)

from here


Tuesday August 15, 2006


Six men, including a New Zealander, who became seriously ill while testing an experimental drug had an immune system overreaction known as a cytokine storm, the doctors who cared for them say.

All six men have recovered and the incident appears to have been an unforeseeable consequence of taking the drug, designed to treat chronic inflammatory conditions and leukaemia, said Dr Ganesh Suntharalingam and colleagues at Northwick Park Hospital in northwest London.

Their case can help doctors understand what happens when the immune system overreacts in such a way - which may well happen in future clinical trials, the doctors wrote in the New England Journal of Medicine.

New Zealander David Oakley spoke about the catastrophic trial 10 days ago. His head swelled to Elephant Man proportions and although he made a partial recovery, he is now battling cancer.

The men became ill shortly after they were given infusions of a protein engineered to affect immune system cells.

They were paid volunteers in a study being run by US drug research company Parexel International on behalf of TeGenero, which has since filed for insolvency.

Eight men took part in the trial. Six got the drug and two got a dummy infusion.

Within 90 minutes, the six men who got the drug reported headaches, shivers, nausea, diarrhoea and lower back pain.

When one patient became so ill he had to be put on a ventilator, the doctors decided to put the other five into intensive care just in case. Their blood pressures all plunged and their organs began to fail.

The doctors described a dramatic two weeks during which the previously healthy men developed symptoms that looked like a serious infection known as sepsis, with difficulty breathing.

The doctors struggled to keep the men going as they tried to figure out what had gone wrong. It took weeks to stabilise the patients and to lead them to slow recovery.

Tests of their blood shows they had a cytokine storm - a sudden over-release of immune system inflammatory chemicals.

The over-response of the immune system can kill, and has been described in patients with bird flu.

The researchers found no manufacturing errors or contamination in the drug.

New England Journal of Medicine editor Dr Jeffrey M. Drazen added in a commentary: "As long as we continue to manipulate biology in new ways, we probably cannot prevent all such events from occurring. We must do what we can to minimise risk, but the future health of the world population demands that we not let adverse events put an end to medical progress."

Journal editor DrParexel has not accepted any liability, although a $30,000 interim payment has been made to each of the six men by its insurers. The six victims are reportedly seeking damages of $15 million each.


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OfflineMustNotBe
HPPDer
Male User Gallery

Registered: 01/27/06
Posts: 930
Last seen: 1 year, 8 months
Re: Sickening 'storms' in drug trials [Re: CptnGarden]
    #5965428 - 08/15/06 08:46 AM (17 years, 5 months ago)

and they deserve some money


--------------------
Junkies United we stand , Devided we're sick as fuck.
-                  -                -
"Hallucinations are something heroin users are not at all accustomed to," said Const. Conor King, Victoria police drug expert. "They react like you or I would react if we took Aspirin and all of a sudden the TV got up and started walking across the room."
-                  -                -
Make drugs legal, or alcohol and tobacco illegal. Either way it's more fair.


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Offlinededjam
Electro Penguin
Male

Folding@home Statistics
Registered: 12/14/05
Posts: 2,139
Loc: Moralton, Statesota
Last seen: 12 years, 8 months
Re: Sickening 'storms' in drug trials [Re: MustNotBe]
    #5965889 - 08/15/06 11:51 AM (17 years, 5 months ago)

Quote:

MustNotBe said:
and they deserve some money




I disagree. They in no way are deserving of 15 million dollars. 100,000 might be good enough.

They took part in a drug trial. Drug trials have risks, and people are made well aware of these risks before they are accepted. This was an unforseeable problem, and there was no malicious intent. It is awful they went through this, but thats life.


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OfflineHix
Animal Mother
Male

Registered: 02/20/06
Posts: 299
Last seen: 16 years, 3 months
Re: Sickening 'storms' in drug trials [Re: dedjam]
    #5965971 - 08/15/06 12:17 PM (17 years, 5 months ago)

yeah fuck that shit, i'd never partake in that, unless it was research of DMT or people trying to find out about these "groundbreaking mystical experiences" with mushrooms a month ago.


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Invisibletruekimbo2
Cya later, friends.
Male User Gallery

Registered: 12/08/02
Posts: 9,234
Loc: ny Flag
Re: Sickening 'storms' in drug trials [Re: Hix]
    #5968578 - 08/16/06 03:23 AM (17 years, 5 months ago)

wtf? you're telling me this drug didn't also have terribly adverse effects in animals? and they didn't start with micro-doses to see if there would be terribly negative reactions?

i mean i don't know the whole story, but sounds like there was defintely some negligence involved.


--------------------
You can check the last post in my journal for contact info.


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