ISIS Press Release 27/07/06
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 since 2005, 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 [3-4]
(London Drug Trial Catastrophe – Collapse
of Science and Ethics, Post Mortem on the TGN1412 Disaster
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 [5] (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 [6, 7]. 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 [8, 9].
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 [10]. 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 [11] (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 [12] 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.
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. Saunders PT. Post mortem on the TGN1412 disaster. Science
in Society 2006, 30, 44-47. http://www.i-sis.org.uk/isisnews.php
5. 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
6. Sobol RE. The rationale for prophylactic cancer vaccines and need for a
paradigm shift. Cancer Gene Ther. 2006, 13(8), 725-31.
7. Lollini P, Cavallo,F, Nanni,P. and Frni,G. Vaccines for tumour prevention.
Nature Reviews Cancer 2006, 6, 204-16
8. Drug Researcher EU backs crop biomanufacturing effort 2006 http://www.drugresearcher.com/news/printNewsBis.asp?id=53559
9. The European Union Framework 6 Pharma–Planta Consortium Molecular farming
for new drugs and vaccines EMBO reports 2005, 6,593-600
10. Cummins J. Pharm crops for vaccines and therapeutic antibodies Science
in Society 2004, 24, 22-23. http://www.i-sis.org.uk/isisnews.php
11. Ho MW. Transgenic pea that made mice ill. Science
in Society 2006, 29, 28-29. http://www.i-sis.org.uk/isisnews.php
12. 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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