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Thursday, April 27, 2006

Biotech Drug Disaster Underlies Danger of GE Pharma Crops

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A drug trial catastrophe reflects upon the
secretive open field testing of pharm crops

This week saw the report of a drug trial that led to catastrophic injury to human volunteers. Six volunteers were injured , one of whom, may face up to a year or more of coma. The drug being tested (TGN 1412) was a recombinant humanized monoclonal antibody being developed to treat
diseases including leukemia and arthritis. The tests of the drug were being undertaken in Britain by a German biotechnology company (TeGenero).. The six young men participating in the drug trial were healthy volunteers paid a small fee to participate in the experiment(1,2,3,4). The Mab and its properties were described in a paper published in 2003, The drug is described as a superagonist (a super activator) of T-cells. The drug is expected to lead to development of
T-cell stimulatory drugs (5). T-cells are - a small lymphocyte developed in the thymus; they orchestrate the immune system's response to infected or malignant cells. The drug trial went wrong after a single relatively high dose led to over stimulation of the immune system leading to
inflammation and organ destruction.

Presently 18 Mab drugs have been approved by the US FDA. There are over 355 Mab drugs in clinical development. The drugs approved currently are mainly for cancer treatment and control of the immune system with a single anti-viral Mab. The approvals have been received by both
traditional pharmaceutical corporations and by biotechnology companies of relatively recent origin (6). Problems associated with the development of Mab drugs are widely recognized. A drug approved for treating multiple sclerosis (MS) was associated with several deaths from
brain infections. The drug was believed to block immune cell migration to the brain allowing virus infection. That drug has been voluntarily suspended for further study. The problem associated with up-regulating the immune system include inflammation of the eye, skin, gut, pituitary gland along with cases of hepatitis and loss of skin pigmentation(7). A humanized Mab used to treat colon cancer caused 17% of the cancer patients to experience adverse immune events . However, the initiation of adverse events could be detected by preliminary low level treatment and those patients could be removed from further treatment prior to the onset of severe adverse events(8). In the German human study in Britain a single high dose of Mab was reportedly used leading to adverse immune response (inflammation and organ failure) in all of those treated. In that experiment animal studies had been done but those experiments alone
are not sufficient to pinpoint all of the many problems associated with Mabs drug therapy. Adverse effects of the drug at low levels in one or two human subjects should have been studied before the whole group was exposed to high levels of the drug.

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