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    Friday, March 17, 2006

    Nature's Laws: Something went horribly wrong with this drug trial:

    "The gentleman on my left said, 'I've got really bad headache pains.' He said he was hot and then he started hyper-ventilating.

    "Then they tried to calm him down and then he passed out and came back to consciousness, he vomited and then they got a big bin liner from somewhere for him to vomit in," he said.

    Then he described how another volunteer became unwell and said he could not control himself and needed the toilet.

    "Everything was unplugged from him, he stood up, took several steps and he fainted. He was quite a big guy, it took quite a few nurses to help him up."

    Earlier, Mr Khan had told the Sun newspaper: "Some screamed out that their heads felt like they were going to explode."

    Clinical Director of Intensive care Ganesh Suntharalingham at Northwick Park Hospital said: "Of the six patients admitted to critical care, the four who are seriously unwell are continuing to show signs of improvement but it is still early days.

    "The other two men remain critical and it could be a while until they show significant change."

    There were eight study participants. The drug was TGN1412, a drug that is to target B-cell chronic lymphocytic leukemia. According to the company, the drug does two things. It enhances the body's ability to use its own immune system to fight the leukemia cells, and it enhances the self-destruction of leukemia cells. The company calls it a "superagonist" of T-cells, a type of white blood cell whose job it is to destroy infected and defective cells. Normally, T-cells only activate when they bind to a specific antigen on the suspect cell. The "superagonist" activates the T-cells without the need for an antigen. What happens when the T-cells are activated? Well, some of them are killer cells, which means they destroy the cells around them. Makes one wonder about the sudden, violent reactions to the drug in the volunteers. Perhaps those T-cells normally need antigens to activate for a reason - to make sure they only target cells that need to be eliminated. Nature has its rules, and they must be obeyed.

    Derek Lowe has much more, as does Black Triangle.

    posted by Sydney on 3/17/2006 08:15:00 PM 2 comments


    My own take on this whole debacle was that I couldn't believe they did this trial on volunteers from the U.K. Everyone I've ever known from the U.K. (including my British husband and several Welsh family members)has got what I'd call "dodgy immunity". My family members of U.K. descent all had colitis and/or inflammatory arthritis. My husband is allergic to every type of grass, tree, pollen, etc. and has severe symptoms year-round which are only barely controlled with multiple meds.

    I don't know if it's HLA-B27 or something else inherited, but my own take on it is that many in the U.K. have got "excitable" immune systems.

    By Anonymous Ice Scribe, at 1:02 PM  

    Disregard above comment--I just found out that the sickest guy is of Egyptian descent. So it's not dodgy Brit immunity after all...

    By Anonymous Ice Scribe, at 5:02 PM  

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