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 : “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 . 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  (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 . 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  (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  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.
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
The Institute of Science in Society