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[SANET-MG] a drug trial horror and pharm crops



March 17, 2006

Prof. Joe Cummins

A drug trial horror should alert the world to 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 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). Monoclonal antibodies are originally isolated from rodent cell culture then humanized (humanized means altering gene sequences to resemble those of human antibodies) using genetic engineering. The six young men participating in the drug trial were healthy volunteers paid a small fee to participate in the experiment.

Humanized monoclonal antibodies (Mabs) are being studied to treat a number of disease conditions including cancer and to protect against pregnancy. The clinical trials of Mabs have been fraught with adverse reactions that may be ameliorated by humanizing the Mabs but many instances the humanized Mabs may cause adverse immune responses. For example, 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. 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. It may very well be that the experimenters and those approving the experiment may be found guilty of neglect but , at any rate, a truly independent review of the experiment is essential.

One focus of research on Mabs has been the production of Mabs and humanized Mabs using crop plants. At least 25 field test releases of genetically modified (GM) crops acknowledged to be production of antibody but actual genes have been deemed confidential business information (CBI). The crops modified have been maize and soybean and the testers included Prodigene , Monsanto and Agracetus. The field releases have been done in Hawaii, Nebraska, Wisconsin, Iowa, Indiana Minnesota, Puerto Rico, Texas and other states. Of course other crops and Mabs may have been tested as well but designated pharmaceutical products CBI. The actual locations of such tests are deemed CBI and no effort has been made to notify by-standers and neighbors of the tests. People may be exposed to Mabs from modified crops by pollen, dust debris from leaves, stems and flowers along with polluted surface and groundwater. Once the Mab genes escape to fertilize neighboring crops they will likely be fixed in that population and persist in a Hardy-Wienberg equilibrium within the food crop.

Numerous publications review Mabs and humanized Mabs in crop plants. Such Mabs are to be used in treating HIV using vaginal application of Mabs, for treating herpes, for cancer treatment, for immuno-contraception and for diagnosis. However, Mab and humanized Mab production can be achieved without endangering the public by using plant cell culture. Exposure of humans without their knowledge or consent in secretive open field trials threatens the health , even the life, of those people. Such secretive field trials should not be allowed. The location and nature of current and previous field trials should be revealed to the public. Such revelations may explain an array of mysterious maladies for which there has been no previous explanation.

I will follow this brief article with a fully referenced article. However, it seems worthwhile to provide the information for discussion at this time.



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