Genetically Modified Biopharmaceutical Crops Grown in Open Fields Threatening Genetic Pollution of Food Crops.

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"The doctor of the future will give no medicine, but will interest his patients in the care of the human frame, in diet and in the cause and prevention of disease."
- Thomas Edison

"Monsanto should not have to vouchsafe the safety of biotech food," said Phil Angell, Monsanto's director of corporate communications. "Our interest is in selling as much of it as possible. Assuring its safety is the FDA's job." 
- New York Times, October 25, 1998

"What the FDA is doing and what the public thinks it's doing are as different as night and day." - Dr. Herbert Ley, Former FDA Commissioner

"Production of the biopharmaceutical crops in confined greenhouses was deemed un-economic even though such production provides the barest essentials for isolating the pharm crops from contaminating our food crops as well as the atmosphere and groundwater."
- Prof. Joe Cummins

The US Food and Drug Administration (FDA) published a proposal on 24 November 2004 to allow experimental GM crops grown on "test" sites to legally enter the food chain. The proposal is open for comment until 24 January 2005.

Why not modify non-food plants to produce the drugs? Why risk contamination of food crops?

 

 

 


Cartoon source http://www.naturalnews.com/020279_pharmas_drug_side_effects.html

 

 

The Institute of

Science in Society

Science Society Sustainability http://www.i-sis.org.uk

General Enquiries sam@i-sis.org.uk Website/Mailing List press-release@i-sis.org.uk ISIS Director m.w.ho@i- sis.org.uk

Letter to the California

Department of Food and

Agriculture

 

April 3, 2004
Secretary of Food and Agriculture
A.G. Kawamura
California Department of Food and Agriculture
Division of Plant Health and Pest Prevention Services
1220 N Street, Room A-316
Sacramento, California 95814
attn:Stephen Brown, Special Assistant
Email: sbrown@cdfa.ca.gov

April 3, 2004
Governor Arnold Schwarzenegger
Governor's Office
State Capitol Building
Sacramento, CA 95814
Phone: 916-445- 2841
Fax: 916-445-4633
governor@governor.ca.go v


Re: Biopharmaceutical rice in California

Dear Secretary Kawamura:

Greg Massa, an organic rice producer from California reported, "Well, they did it. The California Rice Commission let down their growers, ignored public comment, and approved Ventria Biosciences' protocol for the introduction of genetically modified, pharmaceutical rice to California." And, "The worst part is that they approved this protocol with a special "emergency" petition, so that the California Secretary of Agriculture has only 10 days to decide on the issue, rather than the standard 4 months. This was to allow Ventria to plant the rice this year. This "emergency" may completely eliminate the public's ability to comment on the decision."

There is a very disturbing side to the above development. Normally, commercial production is preceded by USDA/APHIS approving a petition to deregulate the crop in question. There does not appear to be any recorded decision to deregulate the crop published at this time, and a retroactive deregulation would not normally be considered legal. Along with the USDA/APHIS's deregulation, FDA must provide review and support for the commercial production and marketing, but no FDA action has been made public up to now. Finally, human lysozyme has been patented as a plant incorporated protectant, and thus the rice should have been evaluated by EPA as well as FDA and USDA/APHIS. None of these evaluations, which normally take years, have been made available to the public as normally required. Therefore, the rush to authorize spring planting this year seems to say that US federal law will be ignored, or else that federal bureaucrats have promised a quick, perfunctory evaluation, which is illegal, to say the least.

Biopharmaceutical rice modified with human genes for the proteins lactoferrin and lysozyme is presented as if the product were as safe as mother's milk. But the modified rice does not contain the native human genes and proteins. Instead, it contains synthetic copies of the native genes that are modified for high level production in plants. This involves changes in codons and amino acids as well as in the sugar molecules added to the final protein. The products are essentially untested for potential allergenicity and toxicity to humans, livestock and wild life. At any rate, prudence dictates that food crops modified with pharmaceutical products should be grown only in isolated and controlled greenhouses.

We are enclosing a special report on the hazards of the transgenic rice and other pharm crops for your attention.

In conclusion, once released, the modified rice cannot be recalled, and its polluting effects may persist for generations to come.

Yours sincerely,

Prof. Joe Cummins
Dr. Mae-Wan Ho
Institute of Science in Society http://www.i- sis.org.uk/
And
Independent Science Panel http://www.indsp.org/


December 17 2003
Prof. Joe Cummins
e-mail: jcummins@uwo.ca
 

 

Pharm Crops Near You?


In 2002, Greenpeace disclosed the location of a site in Northern California where rice plants modified with the human genes lactoferrin and lysozyme were being tested [1]. Lactoferrin acts against bacterial pathogens by preventing them from taking up iron needed for their growth, while lysozyme breaks down the cell wall material of the bacterial pathogens. The biopharmaceutical rice-crop was being tested by a California biotechnology company, Applied Phytologics [1,2].

The Greenpeace disclosure created an avalanche of concern from the public and from both conventional and organic rice farmers fearing that contamination of their crops would lead to economic disaster.

Washington State University field-tested barley altered with human genes for lactoferrin, lysozyme, antitrypsin and antithrombin [3] without any comment from the public even though this posed an obvious threat to both conventional and organic beer production and animal feed, not to mention the hazards to health.

Maize modified with human lactoferrin was field-tested by Biochem SA company and by Meristem Therapeutics company in France [4], again with no comment from the public even though such tests threaten both conventional and organic maize production in Europe.

Most of the field-testing of genetically modified (GM) biopharmaceutical crops appears to have been carried out in the United States (US), France and Canada. US completed 315 such tests between 1991 and 2002, including GM maize, rice, soya and Tobacco Mosaic Virus. The majority of tests were done in Nebraska, Hawaii, Wisconsin and Puerto Rico [5]. Canada completed 53 field tests of pharm crops between 1995 and 2003 [6] while France completed 24 such field tests between 1995 and 1998 [4]. In the US and Canada, field trials of pharm crops are veiled in secrecy under the "confidential business information (CBI)" designation, which hides the details of the gene-constructs as well as the exact locations of the field tests. Thus, people living near the field trials have no means of relating any illness or discomfort experienced from exposure to polluted plant debris or pollen, or to contaminated ground or surface water escaping from the test sites.

The GM rice pharm-crop, like other crops that produce pharmaceuticals in seed, has a gene construct that includes the human genes for the biopharmaceutical protein driven by a seed-specific promoter, and the protein is expressed with a fusion polypeptide (the signal peptide) that causes the fusion protein to accumulate in a cell compartment such as a vacuole or seed endosperm [7]. Human lactoferrin produced in plants has been described in a US patent granted in 2003 [8]. Human lysozyme incorporated in plants was patented in 1994 as a biopesticide to protect plants against fungal and animal pests [9], and its localization to the endosperm of transgenic rice has been reported more recently[10,11].

Expression of human milk proteins in plants was discussed by nutrition experts who said such products should be tested in rats and then in human volunteers [12]; but they have totally ignored the problem of inadvertent exposure to the products by consuming crops contaminated by the product resulting from the inevitable, "accidental" spread of pollen or seed. Chickens were fed GM rice with human lysozyme and lactoferrin, and the rice was reported to have antibiotic- like properties [13].

Lactoferrin participates in the regulation of immune functions and controls pathogens by binding iron required for bacterial growth. Lactoferrin has been implicated in asthma with fatal consequences [14]. Lactoferrin variants have been associated with localized juvenile periodontitis [15]. It has been suggested that milk lactoferrin possesses allergenic sites [6]. Lactoferrin is a protein modified by glycosylation, a modification that contributes to enzyme activity and to allergenicity of the protein. Human lactoferrin was found to be glycosylated differently from the human transgene protein produced in tobacco [17]. The different patterns of glycosylation observed in human and the tobacco transgene product should not be considered insignificant until full studies of allergenicity of the transgenic protein are completed.

Chicken egg lysozyme is a well- known potent food allergen [18] while human
lysozyme is clearly not allergenic. Like lactoferrin, lysozyyme is a glycosylated enzyme and variants of human lysozyme have been characterized [19]. The glycosylation patterns of the transgenic enzyme produced in plants appear to have been neglected even though that pattern will influence allergenicity of the product. Clearly, both transgenic lactoferrin and transgenic lysozyme are potentially hazardous to human health, and such concerns should be made clear to those exposed at or near the field-test sites.

Transgenic rice crops may spread pollen or seed to adjacent fields thus contaminating those crops. Rice is known to be somewhat self fertilizing, but clearly capable of spreading both pollen and seeds to nearby fields. Studies on gene flow between commercial rice and weedy red rice [20, 21] suggest that transgenes may spread to non- transgenic rice. Once established, the transgenes may be difficult if not impossible to eliminate. Organic and conventional rice producers have a legitimate concern over the secrecy surrounding the field testing of the transgenic rice.

Transgenic glufosinate resistant rice (Liberty Link) was de-regulated in the US during 1999, the Animal Plant Food Inspection Service (APHIS) of US Department of Agriculture (USDA) thought that the transgenic rice would not pollinate weedy red rice, and even if it did, the weed could be eliminated using herbicides other than glufosinate [22]. I have outlined the concerns over the threat of transgenic rice to organic and conventional producers and the probable instability of transgenic rice due to somaclonal variability some years ago [23].

Recently, recombinant biopharmaceutical production in transgenic crops has been actively promoted, in spite of incidents of contamination of food production uncovered during field tests of such crops [24,25]. Production of the biopharmaceutical crops in confined greenhouses was deemed un-economic even though such production provides the barest essentials for isolating the pharm crops from contaminating our food crops as well as the atmosphere and groundwater.

Transgenic crops producing human milk proteins are promoted because "mother's" milk is presumed safe for all, but the transgenic "mother's milk" proteins are far from identical to the real thing. Furthermore, the transgenic milk-protein crops will soon be followed by anticoagulants, human growth hormone, antibodies and a range of other biopharmaceutical products all potentially significantly different from the original products. The biopharmaceutical dam may soon burst leaving the human population with an array of hidden non-prescribed medications in their food, plus a host of side-effects to boot.

References

  1. Greenpeace Press Release "Crop producing human proteins found growing in open field test" 2001 http://www.greenpeaceusa.org/media/press_releases/01_09_06text.htm
     
  2. Wilson K. Crop producing human protein found growing in open field test. Synthesis/Regeneration 2002 http://www.greens.org/s-r/28/28-26.html
     
  3. APHIS field test permits for bio-pharm crops. Washington State University, 2001 Barley
    http://www.colostate.edu/program s/lifesciences/TransgenicCrops/pharmpermits.html
     
  4. France, "Total number of summary notifications circulated" 2003
    http://biotec h.jrc.it/deliberate/FR.asp
     
  5. Freese,B. "Manufacturing drugs and chemical crops :biopharming poses new threats to consumers, farmers, food companies and the environment" Friends of the Earth Genetically Engineered Food Alert 2002, pp1-98.
     
  6. Canadian Food Inspection Agency, "confined field trials Canada pharmaceutical " 2003 http://www.inspection.gc.ca/english/plaveg/bio/tries se.shtml
     
  7. Lemaux P, Cho M and Buchanan B. "Production of protein in plant seeds" 2003 US Patent 6,642,437 pp 1-48.
     
  8. Legrand D, Salmon D, Spik G, Gruber V, Bournat P and Bertrand M. Recombinant lactoferrin, methods of production from plants and use. 2003 US Patent 6,569,831 pp 1-39.
     
  9. Hain R. and Stenzel K. Use of lysozyme gene structure in plants to increase resistance. 1994 US Patent 5,349,122 pp 1-24.
     
  10. Yang D, Guo F, Haung N and Watkins S. Expression and localization of human lysozyme in the endosperm of transgenic rice. Planta 2003, 216, 597-603.
     
  11. Huang J, Nandi S, Wu L, Yalda1D, Bartley G, Rodriguez R., Lonnerda B and Huang N. Expression of natural antimicrobial human lysozyme in rice grains. Transgenic Research 2002 11, 229"39.
     
  12. Lonnerdal B. Expression of human milk protein in plants. Journal of the American College of Nutrition 2002,, 18s- 221s
     
  13. Humphrey B, Huang N and Klasing K. Rice expressing lactoferrin and lysozyme has antibiotic like properties when fed to chicks. J. Nutr. 2002, 132, 1214-18.
     
  14. Tsokos M. and Paulsen E. Expression of pulmonary lactoferrin in sudden onset and slow onset asthma with fatal outcome. Virchows Arch. 2002, 441, 494-99.
     
  15. Velliyagounder K, Kaplan J, Furgang D, Legarda D, Diamond G, Parkin R. and Fine D. One of two human lactoferrin variants exhibits increased antibacterial and transcriptional activation activities and is associated with localized juvenile periodontitis. Infect Immun. 2003, 71, 6141-7.
     
  16. Sharma S, Kumar P, Betzel C. and Singh T. Structure and function of proteins involved in milk allergies. J Chromatogr B Biomed Sci Appl. 2001, 756, 183-7.
     
  17. Samyn-Petit B, Wajda Dubos J, Chirat F, Coddeville B, Demaizieres G, Farrer S, Slomianny M, Theisen M and Delannoy P. Comparative analysis of the site-specific N-glycosylation of human lactoferrin produced in maize and tobacco plants" 2003 European Journal of Biochemistry 2003, 270, 3235-42.
     
  18. Yoshinori Y and Zhang J. Comparative studies on antigenicity and allergenicity of native and denatured egg white proteins. J. Agric. Food Chem. 2002, 50 , 2679-83.
     
  19. Melcher R, Hillebrand A, Bahr U, Schroder B, Karas M and Hasilik A. Glycosylation- site-selective synthesis of N-acetyl-lactosamine repeats in bis-glycosylated human lysozyme. Biochem. J. 2000, 348, 507-15.
     
  20. Newswise "Gene flow patterns may give clues to managing promiscuous plants" 2002 pp1-2 http://www.newswise.com/p/articles/view/?id=GENEFLOW.UAR
     
  21. Song Z, Lu B, Zhu Y and Chen J. Pollen competition between cultivated and wild rice species. New Phyologist 2002, 153, 289-96.
     
  22. APHIS "determination of non-regulated status for glufosinate tolerant rice"
    1999 pp1-25 http://www.aphis.usda.gov/brs/aphisdocs/98_32901p.pdf
  23. Cummins J. Liberty Link rice: Herbicide tolerant rice for the masses. 2001 pp1-4
    http://www.amberwaves.org/web_articles/joecummins.html
     
  24. Ma J, Drake P and Christou P. The production of recombinant pharmaceutical proteins in plants. Nature Reviews of Genetics 2003, 4, 794-806.
     
  25. Peterson R. and Arntzen C. On risk and plant based biopharmaceutical. Trends in Biotechnology 2004, in press doi:10.1016/j.tibtech.2003.11.007

This article can be found on the I-SIS website at http://www.i-sis.org.uk/
 
If you like this original article from the Institute of Science in Society, and would like to continue receiving articles of this calibre, please consider making a donation or purchase on our website. ISIS is an independent, not-for-profit organisation dedicated to providing critical public information on cutting edge science, and to promoting social accountability and ecological sustainability in science.
 
 
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World Watch Magazine: May/June 2004

wwm 173 A California-based biotechnology company has been growing experimental fields of rice engineered with human genes to produce two proteins found naturally in human breast milk. According to the May/June issue of World Watch magazine, these test plots present significant risks to the environment, to people, and to the California rice industry.

In "Silent Winter," Claire Hope Cummings describes how state and federal regulators are failing to address the unprecedented agricultural, legal, environmental, economic, and ethical questions posed by newly created organisms.

Also in World Watch, Hilary French, director of the Globalization and Governance Project at Worldwatch, writes of her travels in Kenya where she visited a variety of grassroots development projects. Her tour demonstrated how international efforts to cooperate on the environment and sustainable development can add up to real on-the-ground preservation of delicate ecosystems and poverty reduction.

 

***

 
 

The Institute of

Science in Society

Science Society Sustainability http://www.i-sis.org.uk

General Enquiries sam@i-sis.org.uk Website/Mailing List press-release@i-sis.org.uk ISIS Director m.w.ho@i- sis.org.uk
 

ISIS Press Release 26/05/04

Pharm Crop Products In US


Market

Prof. Joe Cummins discovers that dangerous GM pharmaceutical crops have been produced and marketed in the United States for at least two years, unbeknownst to the public, via a gaping loophole in the regulatory process.

A fully referenced version of this article is posted on ISIS members' website. Details here.

There has been a great deal of public opposition recently to the testing of rice genetically modified to produce the human proteins lysozyme and lactoferrin in the United States. So far, those tests have been stalled (see SiS 22).

But, Sigma-Aldrich, a US chemical company, has been marketing the biopharmaceutical products trypsin, avidin and beta-glucuronidase (GUS) processed from transgenic maize, for at least two years. Meanwhile, Prodigene Corporation and Sigma-Aldrich are marketing aprotinin (AproliZean) from maize and from a transgenic tobacco.

Trypsin is a digestive enzyme used extensively in research, to treat disease and in food processing. The product TrypZean is marketed as an animal free product, and is produced jointly by Sigma-Aldrich and Prodigene (the company fined for contaminating food crops with biopharmaceuticals in the United States last year).

The development of genetically modified (GM) food crops generally follows a certain pattern in the United States: First, controlled field tests are undertaken for a number of seasons. Then, the proponent applies for deregulation of the GM crop following reviews by the Animal Plant Health Service (APHIS) of the Department of Agriculture (USDA), the Food and Drug Administration (FDA) and by the Environmental Protection Agency (EPA) if the GM crop includes a plant incorporated bio-pesticide. Upon completion of the process, the GM crop is deemed to be deregulated and can be grown without monitoring.

However, none of the biopharmaceutical-producing GM crops appears to have gone through the usual regulatory process. Instead they appeared to have progressed from field-testing to marketing without the benefit of final regulatory approval, with apparently full cooperation of the FDA and USDA (the agriculture department has proprietary interest in some of the biopharmaceuticals). The biopharmaceuticals have proceeded to the market via the backdoor, thanks to a loophole in the regulation of field tests.

According to the Pew Initiative on Food and Biotechnology, "current APHIS regulations do allow the commercialization of a GE [genetically engineered] crop without a prior affirmative approval by the agency and without public notice. Developers are not required to file a petition for non-regulated status before they produce a plant commercially. It is possible for developers to grow plants at a commercial scale under notification or field trial permits, even if the plants might pose some identifiable environmental or human health risk".

Crop production facilities are permitted as "field tests", but locations of such facilities are designated "confidential business information" and are not disclosed to people living nearby, even though the genes and products of such sites can easily contaminate crops, ground water and surface water. There seems to be no direct way to find out where the production facilities are, except via producers and government regulators.

The US government seems committed to going ahead with a procedure that bypasses public input and scrutiny, and which if, when disclosed, will threaten the marketability of US food exports. In contrast, the Canadian Food Inspection Service maintains that "plant products of test sites cannot be marketed", even though numerous plant biopharmaceutical products have been tested.

The regulation of plant- derived biopharmaceuticals was reviewed by the FDA in 2000; and by the Pew Initiative in 2004. Only the Pew report came to grips with the practice of marketing virtually untested products commercialized without public input.

As indicated earlier, test plot permits for crops producing biopharmaceutical proteins are usually designated confidential business information so that the nature of the products is hidden from the public as well as the location of the test sites. APHIS does, however, record the crop and the state in which the modified crop is tested. Between 2003 and 2004, Prodigene had test plots in Nebraska, Texas, Iowa and Missouri.

Production of the commercial biopharmaceuticals was, for the most part, achieved using maize, even though it is a food crop of fundamental importance and should not have been used to produce biopharmaceuticals, especially when the products are by no means benign for humans and animals exposed to them.

Trypsin is an enzyme produced in the pancreas to digest proteins. It is extensively used in laboratory applications, in wound treatment and to treat diabetes. It is also used in food processing and often put into infant formulations to aid in digestion. The plant-produced product is desirable because it is free of prions and animal viruses.

According to the safety data sheets provided by trypsin manufacturers, the product is capable of causing allergy - it is a skin, eye and respiratory irritant and may be a mutagen.

Avidin is a protein found in birds' eggs. It functions to bind the vitamin biotin, which is required for many insect pests. The pests are inactivated by the absence of the necessary vitamin. Transgenic maize modified for avidin production is resistant to storage insect pests.

A case study done by the Friends of the Earth turned up substantial evidence that the protein avidin caused dangerous biotin deficiency in humans and animals, leading to immune deficiency and growth retardation. Even marginal biotin deficiency is linked to birth defects in mice and in humans.

Aprotinin is a protease inhibitor normally prepared from the pancreas and lung of cows. Recombinant aprotinin produced in plants is currently marketed. Bill Freese of Friends of the Earth reviewed the problem of allergy and pancreatic disease associated with this product.

Aprotinin is also listed as a reproductive hazard. There is serious danger to those exposed to aprotinin after having had a previous exposure. For example, a two-year old child suffered severe anaphylactic shock (a life-threatening allergic reaction characterized by swelling of body tissues including the throat, difficulty in breathing, and a sudden fall in blood pressure) after a test dose of aprotinin. Fatal anaphylaxis followed aprotinin exposure in a local application of fibrin glue. A similar application led to an immediate skin reaction following re-exposure to fibrin sealant.

Secret field testing of plant-based recombinant aprotinin could result in severe or fatal anaphylaxis, either in a brief exposure in the maize field of someone previously treated during surgery, or exposure of someone exposed to the maize field followed by treatment during surgery.

The final commercial recombinant protein in maize is beta-glucuronidiase (GUS). The gene is used in a wide range of experimental situations but does not appear to have therapeutic importance. It has been observed that formula milk for infants had a low content of GUS while mother's milk had elevated GUS.

Elevated GUS has been implicated in bilirubinaemia (jaundice) of breast-fed infants and breast-fed infants of diabetic mothers. GUS is used extensively as a marker, believed to have little effect on the phenotype of the test organism. However, GUS was found to enhance the feeding activity in the peach aphid, suggesting that the marker may not be entirely without effect on the organism.

In conclusion, the secretive production of dangerous pharmaceuticals in food crops is a truly disturbing development. The sale of such products without transparent public approval is adding insult on injury, reinforcing the public perception that the regulatory authorities are putting corporate profit far above public safety.


This article can be found on the I-SIS website at http://www.i-sis.org.uk/GMBIM.php
 
If you like this original article from the Institute of Science in Society, and would like to continue receiving articles of this calibre, please consider making a donation or purchase on our website. ISIS is an independent, not-for- profit organisation dedicated to providing critical public information on cutting edge science, and to promoting social accountability and ecological sustainability in science.
 
 
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The Institute of Science in Society, PO Box 32097, London NW1 OXR
telephone: [44 20 8643 0681]   [44 20 7383 3376]   [44 20 7272 5636]

General Enquiries sam@i-sis.org.uk - Website/Mailing List press-release@i-sis.org.uk - ISIS Director m.w.ho@i- sis.org.uk

MATERIAL IN THIS EMAIL MAY BE REPRODUCED IN ANY FORM WITHOUT PERMISSION, ON CONDITION THAT IT IS ACCREDITED ACCORDINGLY AND CONTAINS A LINK TO http://www.i-sis.org.uk/

 

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The Institute of

Science in Society

Science Society Sustainability http://www.i-sis.org.uk

General Enquiries sam@i-sis.org.uk Website/Mailing List press-release@i-sis.org.uk ISIS Director m.w.ho@i- sis.org.uk
 

ISIS Press Release 31/08/04

Pharm Crops for Vaccines

and Therapeutic Antibodies

Prof. Joe Cummins warns of special health impacts of vaccine and antibodies in pharm crops

The extensive references to this article are posted on ISIS members' website. Details here.

Reckless disregard of known risks

The European Union (EU) recently announced a major program to produce plant-based vaccines and therapeutic antibodies [1], despite the risks that came to public attention two years ago [2]. The crops plants currently used to produce vaccines include tobacco, maize, potato, tomato, rice and alfalfa. In spite of the threat to the food supply, maize is a favorite crop for vaccine production because the transgenic protein can be concentrated in the kernels. In general, field-test releases of crop plants modified for vaccine production have been undertaken with little regard for the health and environmental consequences of contaminating food crop with the vaccine genes.

Risks of vaccine proteins and antibodies

Vaccines are made using antigen proteins from disease organisms such as viruses or bacteria to elicit production of antibodies following injection into the blood stream or ingestion with food. Plant-based vaccines are mainly produced from synthetic transgenes whose DNA code words have been altered for maximal activity in a crop plant [3]. Apart from vaccines, antibodies are also produced in plants for treating both animal and plant diseases. These antibodies are effective, but plagued by the powerful immune response to the antibodies themselves following repeated exposure.

Plant-based vaccines are mainly geared towards mucosal immunization following oral intake. Oral vaccines may elicit oral tolerance on repetitive exposure. Oral tolerance is the animal's defence against antigens in food. Thus, after repeated exposure to an oral antigen, the mucosal immune system ceases to view the antigen as such, leaving the animal susceptible to the pathogen for which the vaccine is supposed to protect against [4]. The problem of oral tolerance has been mentioned in at least one review of plant-based vaccines [5]. Oral tolerance has been used to treat autoimmune disease such as diabetes by feeding patients with plants producing an antigen eliciting the autoimmune response [6]. Oral tolerance to pathogens is one main threat from the contamination of our food supply with vaccine genes, whereas therapeutic antibodies threaten a direct immune response; these two impacts are seldom discussed by promoters of plant genetic modification or by science journals reporting the studies.

Risks from synthetic genes and viral vectors

Edible plant-based vaccines have been produced with synthetic nuclear genes, synthetic chloroplast genes or plant viruses modified with synthetic genes. These synthetic genes are completely unknown and untested for toxicities. The nuclear transgenes frequently failed to produce sufficient protein to evoke an oral immune response, while chloroplast transgenes tended to provide adequate protein levels. (Chloroplasts allow insertion of multiple transgene copies, with less problem of gene-silencing than nuclear transgene insertions). Chloroplast transformations produced antigens at high levels, up to 25% of total soluble protein while nuclear inserts generally produced less than 1% total soluble protein. The endosperm localization of nuclear gene products can boost antigen levels to 10% of protein in maize kernels [7].

Numerous plant viruses modified with vaccine antigens have been released in field tests. Such viruses can produce vaccine antigen up to10% total soluble protein in the infected plant but 1% is most frequent [8]. Little consideration has been given to containment of these GM viruses in field tests. They can be spread by sucking insects, plant wounding or by wind-blown plant debris. A recent study shows that plant viruses may be spread by wind, either in water droplets from the plant surface or by abrasive contact between plant leaves [9].

Box 1 provides a list of 30 human and animal diseases for which plant-based vaccines have been created. It is worth mentioning that about half of the transgenic vaccines on the list were produced using plant viruses as vectors, including tobacco mosaic virus, cowpea mosaic virus, alfalfa mosaic virus, potato virus X, plum pox poty virus and tomato bushy stunt virus. The virus constructions are productive but pose special long-term risks associated with the release of the virus to the environment and predictable viral recombination to produce novel disease agents. Little effort has been made to monitor these hazardous experiments.

Box 1

Plant-based vaccines [8]

Disease agents Species protected
1. Enterotoxigenic strains of E. coli humans & farmed animals
2. Vibrio cholerae/ Cholera toxin B subunit humans
3. Enteropathogenic E. coli/ Pilus structural subunit A humans
4. Vibrio cholerae/ Cholera toxin B subunit, rotavirus humans
5. Enterotoxigenic strains of E. coli humans
6. Hepatitis B virus/ Surface antigen humans
7. Hepatitis C virus/ Hypervariable region 1 of envelope protein 2 fused to cholera toxin humans
8. Norwalk virus &Rotavirus humans
9. Measles/ Haemagglutinin protein humans
10. HIV-1/ Peptide of gp41 protein humans
11. HIV-1/ V3 loop of gp120 protein humans
12. HIV-1/ Peptide of transmembrane protein gp41 humans
13. HIV-1/ Nucleocapsid protein p24 humans
14. Cytomegalovirus/ Glycoprotein B humans
15. Rhinovirus type 14/ Peptide of VP1 protein humans
16. Respiratory syncytial virus/ Peptides of G protein humans
17. Staphylococcus aureus/ D2 peptide of bronectin-binding protein FnBP humans
18. Pseudomonas aeruginosa/ Peptides of outer-membrane humans
19. Protein F Plasmodium falciparum (malaria) & Peptides of circumsporozoite protein humans
20. Human papillomavirus type 16/ E7 oncoprotein humans
21. Bacillus anthracis/ Protective antigen humans
22. Rabies virus/ Glycoprotein humans, domestic & wild animals
23. Foot-and-mouth disease virus/ Structural protein VP1 farmed animals
24. Transmissible gastroenteritis virus/ Glycoprotein pigs
25. Bovine group A rotavirus/ Major capsid protein VP6 cattle
26. Mannheimia haemolytica (bovine pneumonia teurellosis)/ Leukotoxin fused to green fluorescent protein cattle
27. Mink enteritis virus/ Peptide of capsid protein VP2 mink, dogs & cats
28. Rabbit haemorrhagic disease virus/ Structural protein VP60 rabbits
29. Rabbit haemorrhagic disease virus rabbits
30. Canine arvovirus/ Peptide of capsid protein VP2 dogs

Numerous plant based therapeutic antibodies for treating human, animal and plant diseases have been created and released in field tests. The antibodies are made from synthetic antibody genes and they are also greatly influenced by the pattern of glycosylation (sugar modification of protein) produced in the plant [10]. Further examples of plant-based antibodies include mice monoclonal antibodies that confer resistance to a herbicide by binding to it, thus inactivating the herbicide [11]. The antibody-bound herbicide was inactivated but not destroyed, and its ultimate fate is unknown; presumably it would be consumed with the transgenic crop. Kholer and Milstein discovered a method for preparing monoclonal antibodies in 1975 [12]. That discovery has made an exceptional contribution to the development of clinical analytical technology and to therapy, but that application has not fulfilled the expectation of a "magic bullet" for treating disease because the antibodies provoked a strong immune response if applied repeatedly.

Risks from cancer and HIV vaccines

In the reviews mentioned previously, numerous plant-based vaccines for treating infectious diseases have been described [7,8]. I shall now focus on cancer vaccines and vaccines against human immunodeficiency virus (HIV). A vaccine against a colorectal cancer was produced in tobacco plants [13], as was a vaccine for treating non-Hodgkins lymphoma [14]. A vaccine against the papilloma virus oncogene product causing human cervical cancer was produced using a potato virus-X vector carrying an antigen of the viral oncogene-encoded protein [15]. These cancer vaccines are an important effort to control cancer, but careless environmental release of the vaccines in crop plants could greatly increase people's susceptibility to specific cancers through the development of oral tolerance.

The Gag gene from Simian Immunodeficiency virus (SIV) a surrogate for HIV, was used to transform potato [16]. In that experiment, the native SIV gene was used rather than a plant enhanced synthetic copy. Failure to alter the genetic code to the form most active in plants may explain the relatively low production of Gag protein. In another experiment, the coat protein of alfalfa mosaic virus was modified to express antigenic peptides for rabies virus and HIV. Antibodies against rabies and HIV were expressed in mice immunized with the antigenic peptides [17]. Simian- human immunodeficiency virus (SHIV) tat gene was fused to the cholera toxin subunit gene and the combination was used to transform potato and the fusion protein was found suitable for mucosal immunization [18]. In none of the above publications was the potential danger of the horizontal spread and recombination of the virus genes discussed.

A number of technical enhancements have been attempted to enhance the vaccine antigen production in plants. Codon usage enhancement has been mentioned [3]. Various combinations of promoters and enhancers were used to boost expression of a gene from rabbit hemorrhagic virus in potato [19]. The potato patatin promoter proved more effective than the CaMV or the ubiquitin promoter. Ricin B, a lectin sub-unit of the deadly poison ricin, has been proposed as a delivery adjuvant for mucosal vaccines [20]. At least as far as the published information is concerned, plant-based vaccines and antibodies are far from ready for major commercial production. Production of plant-based vaccines in primary food crops such as maize and rice is extremely unwise on environmental and health grounds, but a recent publication indicates that maize, at least, is still promoted by crop plant vaccine promoters [21].

Regulators must put the brakes on firmly now

In conclusion, there has been extensive creation and field tests of plant-based vaccines and therapeutic antibodies, with little care given to the environmental and health consequences of the field releases. The major accidental exposures of the public that have come to light have done little to dampen the accelerating pace of development and testing, most of which are taking place in secret away from public scrutiny.

We are heading towards a monumental poisoning of our primary food supply, unless the regulators put the brakes on firmly now.


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Geiger Counter
Geiger Counter


The GQ GMC-320-Plus digital Geiger Counter is the latest model developed by GQ Electronics LLC, USA.

As an enhanced version of GMC-300E plus, it has larger internal flash memory to facilitate data processing capability. It also has temperature sensor & electronic gyroscope, LCD contrast control, front LED indicator, analog data port output, new graphic type.

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The device uses USB port for communication and power. The internal battery can be charged via wall adapter or car adapter. Using the adapters, continuous data monitoring is possible and no worry about batteries charge or any data loss. The main board has a real time clock for time related data logging purposes.

The USB port communicates with GQ GMC-320 Plus Soft Geiger Counter software and GQ Geiger Counter Data Viewer software. For professional data logging, a more advanced version, may be purchased at low cost from GQ.

 

 
Trifield EMF Meter from Sper Scientific

    • Measures extremely low frequency (ELF) electromagnetic fields from electrical power lines and transmission equipment, appliances, computer, HVAC, audio/video, and other electrical equipment

 

In 1904 there was very little cancer. Now there is an abundance of cancer. What has changed? Can this be reversed? If you have cancer or do not want to get cancer the information you and your family need is on this web site.

 

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