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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
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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