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[SANET-MG] transgenic maize with monoclonal antibodies grown in France
A recent court decision in France enforced the secrecy of tests or
production of GM crops such as those described below. In a sense, the
courts seem to conspire with corporations to injure or kill people with
exposures that the people have not been allowed to have knowledge of.The
court appears to believe that people should not be allowed fair
compensations for their injury.
Transgenic Maize with Monoclonal Antibodies Grown in France
Prof. Joe Cummins, Dr. Mae-Wan Ho and Prof. Peter Saunders from the
Institute of Science in Society say this amounts to an illegal massive
clinical trial of monoclonal antibodies known to cause severe side
effects including death (Warnings on FDA Approved Monoclonal Antibody
Drugs, SiS30). They call for banning transgenic crops producing
pharmaceuticals and the withdrawal of EU funding for such projects.
French company granted permit to grow vaccine maize crops
We were astonished to discover that maize modified with human genes for
producing monoclonal antibodies had been approved for commercial
planting in France, as stated by the French company Meristem
Therapeutics on its website [1]: “MERISTEM® has successfully expressed
in transgenic corn several recombinant monomeric IgA sequences derived
from tumor specific IgG for a partner. One of these recombinant
plant-made monomeric Ig A 1 has been produced and GLP-purified at the
gram-scale…Our partner has showed [sic] that IgA s produced in corn have
interesting biological activity such as lung, breast and pancreatic
cancer tumor regression in animal models…In April 2005, MERISTEM was
granted their first authorization for field production of these
antibodies.”
A large number of monoclonal antibodies (mABs) for treating diseases are
being developed, eight of these, for treating cancers, are among those
approved by the United Stated Food and Drug Administration (FDA). All of
the approved cancer therapy mABs are associated with severe side
effects, frequently resulting in death [2]. One mAB tested in London
recently hit the headlines for weeks, as it made all six healthy
volunteers violently ill [3] (London Drug Trial Catastrophe – Collapse
of Science and Ethics, SiS30).
Producing mAbs in maize is bound to contaminate our food supply with the
mABs as well as the human or humanized genes coding for the antibodies.
Yet transgenic crops with these drugs are being tested in secret
locations [4] (Drug Trial Catastrophe & Safety of Secretly Tested Pharm
Crops, SiS30) and unsuspecting members of the public are exposed without
their knowledge or consent.
Cancer vaccines are tested and used for preventing or treating cancers.
The mABs are employed as therapeutic vaccines to treat developed
cancers, and despite their toxic side effects, can provide control of
cancers that are not too far advanced [5, 6]. Both prophylactic and
therapeutic cancer vaccines have been produced in plants, all too often
in food crops.
EU funds major programme in transgenic vaccines and antibodies in crops
plants
The European Union (EU) has promoted and funded a major programme to
produce vaccines and therapeutic antibodies in crop plants such as
maize. Officially, the first clinical trials are targeted for 2009, but
may start well before that date [7, 8].
Using food crops for prophylactic and therapeutic vaccines is a very
risky undertaking. The synthetic transgenes incorporated into food crops
are approximations of the original genes, frequently resulting in
proteins with altered amino acid sequences and with sugars added to the
protein (glycosylation patterns) totally different from those in the
original mammalian cells [9]. Apart from the intended and unintended
side effects of the vaccines on human subjects, the glycosylation
pattern of a protein is an important determinant of its immunological
activity. The scientific community has been rudely reminded of that
recently when tests were carried out on a transgenic pea [10]
(Transgenic Pea that Made Mice Ill, SiS29). A previously harmless bean
protein transferred to pea acquired new glycosylation patterns,
provoking dangerous inflammation of the lungs and general food
sensitivities.
Mass clinical trial without informed consent
Growing transgenic crops producing pharmaceuticals in secret locations
amounts to conducting mass clinical trials without informed consent,
thereby contravening the current EU directive 2001/20/EC [11] on
clinical trials of medical products, which sets out the requirement for
informed consent and product identification and labelling. In the case
of the transgenic maize, the use of male sterility traits or
de-tasselling is not sufficient to protect the public. People and
animals will be exposed to plant material in the form of dust and
debris; and the grain and corn kernels will escape as volunteers to
spread the transgenes. Diseased or decaying transgenic cobs or plant
residues will release vaccines and transgenes to contaminate surface and
groundwater.
It is imperative that those potentially exposed to transgenic vaccines
or other transgenic pharmaceuticals should be informed of the locations
and the full nature of crops grown commercially or field tested, both
currently and at any time previously. People who suffer adverse health
or other impacts from exposure to the transgenic plants must be given
appropriate compensation.
Meanwhile, we propose that all EU funding should be withdrawn from
projects using crop plants for transgenic vaccines and other
pharmaceuticals, and an immediate ban should be imposed on all further
environmental releases of such crops. We have time and again pointed out
that the production of transgenic pharmaceuticals should only be allowed
in plant/animal tissue culture under strictly contained conditions.
Please circulate this paper widely, forward it to your MEPs and relevant
regulatory bodies in the European Parliament and European Commission
References
1. Meristem Therapeutics Monoclonal antibodies, accessed 26 July 2006,
http://www.meristem-therapeutics.com/rubrique.php3?id_rubrique=39
2. Cummins J. Warnings on FDA approved monoclonal antibody drugs.
Science in Society 2006, 30, 46-7, http://www.i-sis.org.uk/isisnews.php
3. Ho MW and Cummins J. London drug trial catastrophe – collapse of
science and ethics. Science in Society 2006, 30, 41-43,
http://www.i-sis.org.uk/isisnews.php
4. Cummins J and Ho MW. Drug trial catastrophe and safety of secretly
tested pharm crops. Science in Society 2006,30, 50,
http://www.i-sis.org.uk/isisnews.php
5. Sobol RE. The rationale for prophylactic cancer vaccines and need for
a paradigm shift. Cancer Gene Ther. 2006, 13(8), 725-31.
6. Lollini P, Cavallo,F, Nanni,P. and Frni,G. Vaccines for tumour
prevention. Nature Reviews Cancer 2006, 6, 204-16
7. Drug Researcher EU backs crop biomanufacturing effort 2006
http://www.drugresearcher.com/news/printNewsBis.asp?id=53559
8. The European Union Framework 6 Pharma–Planta Consortium Molecular
farming for new drugs and vaccines EMBO reports 2005, 6,593-600
9. Cummins J. Pharm crops for vaccines and therapeutic antibodies
Science in Society 2004, 24, 22-23, http://www.i-sis.org.uk/isisnews.php
10. Ho MW. Transgenic pea that made mice ill. Science in Society 2006,
29, 28-29, http://www.i-sis.org.uk/isisnews.php
11. DIRECTIVE 2001/20/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 4 April 2001on the approximation of the laws, regulations and
administrative provisions of the Member States relating to the
implementation of good clinical practice in the conduct of clinical
trials on medicinal products for human use L 121/34 EN Official Journal
of the European Communities 1.5.2001
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