Press Notice from GM Free Cymru. 4th March 2007
Monsanto GM potatoes which are classified as pesticides in America were fed to Russian hospital patients in 1998 in a bizarre feeding trial.
The information is contained in comprehensive Report from the Institute of Nutrition of the Russian Academy of Medical Sciences, suppressed by Monsanto and the Russian authorities for 8 years but now available thanks to the determination of Greenpeace Russia. The Report (1) is now translated into English. In 1998 the Institute, with the full cooperation of Monsanto, conducted a trial in which Bt potatoes were fed to patients with different diseases in a Moscow clinic (2). The feeding continued for 3 weeks, and according to the Institute no negative effects were found. In other words, nobody got even more ill, or died, as far as the research team was aware.
On the basis of the human feeding study, and other studies involving mice and rats (3), the Institute of Nutrition concluded that "the studied types of potatoes can be used in human nourishment for the conduct of further epidemiological studies", i.e. during the study of the clinical picture of diseases and their distribution among the human population. These conclusions have been heavily criticized by three independent reviewers on the basis that they do not accord with the data in the Report (3).
The potatoes used in the study were Monsanto GM NewLeaf potatoes bred in 1988 -1995 from the Russet Burbank variety to be resistant to the Colorado Beetle. The GM event was registered as 082, and the potatoes are included in the Bt group of GM crops. It is probable that the variety code is NL10-RBK. The potatoes also contain an antibiotic resistance marker gene (4), and they are male sterile. The potatoes were deregulated in the USA in 1998/1999, without any feeding studies being required. Even earlier, in 1996, Monsanto started to introduce the potatoes into Russia and Georgia, and probably into many other countries with lax approval regimes as well. Partly on the basis of the 1998 feeding trials, consent was duly given in 2000 by the Russian regulators for the GM potatoes to be grown and marketed for human consumption. However, the NewLeaf GM potato was a failure. It was nutritionally inferior to traditional Russian potato varieties; and it proved to give poor yields and to be susceptible to disease in European environments. Monsanto also knew (on the basis of this study and others) that it was dangerous. The company pulled out of GM potato development in the USA and Europe in 2002 (5), but nonetheless cynically continued to work with the Russian authorities to develop a further GM (Bt) potato variety called Elizabeth (6). This variety is now approved for human consumption in Russia.
GM plants that are engineered to be resistant to the Colorado Beetle and other insects through the insertion of the Cry3A and NPTII genes are referred to as Bt varieties, and they act as powerful insecticides. All parts of the GM plant are toxic, and that is why the plants are classified as pesticides which come under the control of the Environmental Protection Agency in the United States (7). Many GM-Bt varieties, including cotton, maize and potatoes, have been found to be more dangerous than other GM varieties (8). In 2004 twelve cattle in Hesse, Germany, died after being fed on Syngenta's Bt176 maize; thousands of sheep and goats have died in India after feeding on the foliage of Bt cotton plants; and many non-target organisms are killed on the leaves, in the leaf litter and among the roots of Bt plants in field conditions (9). In addition, there are well recorded instances of human beings affected -- and sometimes killed -- by Bt crops, including workers in Bt cotton fields in India and the Philippines (10).
Another Bt variety, namely Bt10 maize, was at the centre of an international scandal in 2005 when it was discovered that at least 185,000 tonnes of contaminated maize from the United States had entered the food chain after being grown "accidentally" among other maize crops. It was later revealed that the Bt maize had never been tested, characterized, or approved for either animal feed or human food use (11). There is now no way of measuring what damage the contamination might have done to human or animal health -- which is of course exactly what the biotechnology industry intended. And it is certainly true that because of the erratic and even shambolic consent system in the US and Canada, many thousands of consumers have eaten GM New Leaf potatoes (prior to 2001) without any health testing whatsoever.
Commenting on the revelations about the human feeding trials, Dr Brian John, for GM Free Cymru, said: "We find it incredible that Monsanto should have allowed these feeding trials, using sick people in hospital, to go ahead, given that all GM-Bt plants are toxic and given that Bt potatoes are more toxic than any other commercialized GM food product. It is unforgivable that pesticides -- for that is what Bt potatoes are -- should be fed to patients who probably had no idea what they were being asked to eat. These trials would never have been allowed in the USA or in Europe. But nothing surprises us any longer about Monsanto, which has been playing fast and loose with public health for decades (12)."
Following an examination of the Russian report, Prof Malcolm Hooper (13) said: "I find it amazing that given the widespread evidence of the known toxicity of these potatoes any human trials have been allowed at all. The use of the vulnerable and the weak in our society as experimental animals is unethical and must be resisted by anyone concerned for the future of humanity."
Dr Michael Antoniou (14) said: "There is no logic whatsoever about this study, especially given the fact that such a diverse group of subjects was chosen. The "desired medical outcome" they were after was obviously "no adverse effects". This was an irresponsible trial to carry out and totally unethical, especially when already ill subjects were enrolled. These people truly were guinea-pigs." (15)
ENDS Contact: Dr Brian John Tel: 01239-820470
NOTES AND REFERENCES
(1) Medical-biological investigations of transgenic potatoes, resistant to the Colorado beetle (under agreement with Monsanto Co.) Russian Academy of Medical Sciences, Institute of Nutrition Moscow, 1998. Signed off by VA Tutelian, Deputy Director. Chapter 7. Clinical observation on patients with different diseases (pp 47 - 57) Full Report 62 pp, not including raw data.
(2) Information from the translated version of the Report: In the contents list / list of research participants for the Clinical trials, 27 people are listed as being collaborators involved in the work -- physicians, junior doctors, nurses, laboratory assistants, catering staff, cooks, specialists in diet and heart pathology, technicians, and the director of the medical biology laboratory at the Clinic. There is no doubt that this was a very serious and carefully planned study, backed up by a Monsanto “Agreement on Medical Biological Studies of Genetically Modified Russet Burbank Newleaf Potatoes Resistant to Colorado Beetle to Assess Their Safety for Human Nutrition and Sanitary Certification in the RF”. The clinical trial took place over 3 weeks in 1998, at the medicinal nutrition clinic of the Institute of Nutrition, Russian Academy of Medical Science (RAMS). The feeding trials involved 8 men and 12 women with different diseases including hypertonic disease, ischemic heart disease, and hyperlipoproteinemia (type 2 hereditary genesis). The patients were not obese. Of the 20 patients, 10 were in the control group fed with normal potatoes (Monsanto Russet Burbank or RB); and the other 10 were in the experimental group fed with GM-RB potatoes. All of the patients were Volunteers, but we do not know as yet what they were told or how they were chosen. The patients were on a 3-week hypo-sodium anti-atherosclerosis diet A1, and were fed 400g potatoes (per day) which were included in the first course (soup) and in the second or main course of meals. At the beginning and end of the trial patients were assessed, using clinical, biochemical, immunological, enzyme and instrumental methods. The intention was to identify any effects specifically relating to the consumption of GM potatoes. Patients were also asked to fill in a questionnaire. According to the Report, no significant differences were found between the two groups of patients. There were no tests relating to the survival or fragmentation of transgenic DNA in the bodies of the patients.
(3) A commentary on the rat feeding study by Dr Irina Ermakova is here: http://www.gmfreecymru.org/ The Russian Institute of Pharmacology Review is here: http://www.gmfreecymru.org/pivotal_papers/Vilar_opinion.pdf The review by Dr Arpad Pusztai is here: http://www.gmfreecymru.org/pivotal_papers/arpad.htm All three reviews suggest that the study was inadequate in many respects, but that there were real signs of toxic damage to organs in the GM feeding group. http://www.gmfreecymru.org/news/Press_Notice16Feb2007.htm It is extraordinary that in spite of the findings of the animal studies, the human feeding trials went ahead in the full knowledge that the "volunteer" patients would be subjected to considerable risk.
(4) <http://www.agbios.com/dbase.php?action=ShowProd&data=RBMT21-129% 2C+RBMT21-350%2C+RBMT22-082&frmat=LONG> http://www.naturemark.com/ Two New Leaf varieties were given approval for cultivation in Russia in April 2002 -- NL10-RBK and NL10-SUP As a Bt variety, the GM-RB potato is classified as a pesticide
(7) http://www.plant.uoguelph.ca/research/homepages/eclark/safety.htm http://www.cathnews.com/news/409/doc/15colgm2.doc http://www.natural-law.ca/genetic/geindex.html http://www.epa.gov/oscpmont/sap/meetings/2000/october/ brad3_enviroassessment.pdf http://www.epa.gov/pesticides/biopesticides/pips/bt_brad.htm http://www.biotech-info.net/seeds.html
(9) Cows ate GM maize and died (BT176) http://www.i-sis.org.uk/CAGMMAD.php 25% death rate among sheep which grazed on Bt cotton plants in India: http://www.gmwatch.org/archive2.asp?arcid=6499 http://www.gmwatch.org/archive2.asp?arcid=6494 http://www.deh.gov.au/settlements/publications/biotechnology/gm- cotton/summary.html
(10) Note also the effects on human health arising from contact with Bt varieties: http://www.i-sis.org.uk/full/MILTBTFull.php http://www.gmwatch.org/archive2.asp?arcid=6472http://www.i-sis.org.uk/ Bt11.php NB The work of the Norwegian scientist Terje Traavik and his colleagues. "Filipino islanders blame GM crop for mystery sickness. Monsanto denies scientist's claim that maize may have caused 100 villagers to fall ill" John Aglionby in Kalyong, southern Philippines, The Guardian, Wednesday 3 March 3, 2004 http:// www.guardian.co.uk/gmdebate/Story/0,2763,1160789,00.html Allergic reactions and cattle deaths 2005 attributable to Bt cotton in India (Madhya Pradesh): <http://news.webindia123.com/news/showdetails.asp?id=170692&cat=Health> Possible Human Health Hazards of Genetically Engineered Bt Crops Comments on the human health and product characterization sections of EPA's Bt Plant-Pesticides Biopesticides Registration Action Document By Michael Hansen, Ph.D. Consumer Policy Institute/Consumers Union Presented to the EPA Science Advisory Panel Arlington, VA, October 20, 2000 http://www.organicconsumers.org/ge/btcomments.cfm http://www.gmwatch.org/archive2.asp?arcid=7219 <http://www.biosafety-info.net/article.php? aid=413&PHPSESSID=9ead902ad24879cf9111558dbeecfea1> Genetic Engineering and Omitted health research: Prof Terje Traavik and Prof Jack Heinemann, 12 pp
(11) "I have confirmed with FDA that “BT10 never went through an FDA consultation process.” Therefore, it was never reviewed for unintended human health effects, at least not by the U.S." Doug Gurian-Sherman, Ph.D., Senior Scientist, Center for Food Safety, 660 Pennsylvania Avenue, Suite 302, Washington, D.C. 20003
(12) "..... GM has no detrimental effect either on the environment or on human health." Tony Coombes, Monsanto Deputy Chairman UK, in a letter to the Western Mail, Tuesday, 13th February 2007. That is a lie. "Monsanto should not have to vouchsafe the safety of biotech food. Our interest is in selling as much of it as possible. Assuring its safety is the FDA's job." - Phil Angell, Monsanto's director of corporate communications, quoted in the York Times, October 25, 1998 http://www.monsanto.com/biotech-gmo/asp/quickFacts.asp. The table entitled: Quick Facts on Biotechnology and Crop Production contains this extraordinary and patently untrue statement: "Reliably documented human or animal safety issues - zero." That is another lie.
(13) Malcolm Hooper Ph.D.,B.Pharm.,C.Chem.,MRIC Emeritus Professor of Medicinal Chemistry University of Sunderland
(14) Dr Michael Antoniou, Reader in Molecular Genetics, Division of Medical and Molecular Genetics, Guy’s, King’s & St Thomas’ School of Medicine in London. His area of expertise is chromatin domains, gene organisation and regulation of gene expression.
(15) In a further bizarre twist to this episode, we have discovered that in 2003 Monsanto strongly criticised the "Newcastle Feeding Trial" of 2002 on the basis that it used people who were ill, rather than using fit and healthy volunteers! http://www.fwi.co.uk/article.asp?con=10826&sec=2&hier=66 But the corporation is well used to facing in all directions at the same time. http://www.voteyeson27.com/monsanto.htm