REVEALED -- WHY MONSANTO SUPPRESSED GM MAIZE FEEDING STUDY
Independent analysis of data uncovers evidence of scientific fraud
Press Notice from GM Free Cymru Date: 14th March 2007
It has been revealed today (13 March 2007), at a Paris Press Conference (1), that the Monsanto GM maize referred to as MON863 caused serious damage to the liver and kidneys of rats which consumed it during feeding trials. This is the first time in the world that a study on the health risks of a GM maize authorized for consumption shows signs of hepatorenal toxicity (2). The study is published today in the peer-reviewed journal "Archives of Environmental Contamination and Toxicology".
The study, completed at CRIIGEN (Caen, France), contains an examination of the raw data on MON863 feeding experiments initially suppressed by Monsanto but later obtained in 2005 after a Court action in Germany. Prior to that court action, Monsanto had refused public access to the data on the spurious grounds of "commercial confidentiality", although it had been widely leaked that the feeding studies showed statistically significant negative health effects on animals fed with the GM maize (3).
The GM maize in question produces a new insecticide called “modified Cry3Bb1” which has the capacity to kill the coleopteran insect Diabrotica virgifera. The plant also contains a gene coding for antibiotic resistance. (There are many other commercial GM varieties which produce new insecticides, and many others which are herbicide- tolerant or herbicide-resistant. Almost all of these new varieties have been heavily criticized by independent scientists on the grounds that their safety has never been fully established.) In America the variety is classified as a pesticide since every cell is toxic to insects. In spite of widespread concern and protests from the scientific community and consumer organizations, MON863 was given formal approval by the EC on 8th August 2005.
The new study (4) involved a new and rigorous statistical analysis of all the raw data in the 1130 page document, concentrating on the blood and urine analyses of the test animals. The French researchers claim that the Monsanto statistics were not detailed enough and that their protocols were questionable. Real damage to test animals was therefore masked by the analytical methods chosen -- and there can be little doubt that Monsanto knew this. Upon detailed analysis, the French team uncovered an increase of up to 40% in blood triglycerides in females, and a more than 30% decrease in urine phosphorus and sodium in males, specifically linked to the GM diet. The reasons for these changes are unclear, but they may provide clues to the deaths of many animals which have consumed Bt feed in other animal experiments (5).
Professor Seralini said: "These revelations are profoundly disturbing from a health point of view. They are certainly sufficient to require new and more carefully conducted feeding studies and an immediate ban from human or animal consumption of GM maize MON 863 and all its hybrids. This maize cannot now be considered safe to eat. We are now calling urgently for a moratorium on other approved GMOs while the efficacy of current health testing methods is reassessed."
Speaking for GM Free Cymru, Dr Brian John said: "Now we know why Monsanto wanted so desperately to keep this animal feeding study out of the public domain. There is scientific fraud here, and this must now be apparent to all of us, including the regulatory bodies. Goodness knows how many other studies showing real harm to animals fed on GM crops and foods have simply been hidden away from independent scrutiny. We support Professor Seralini's call for an immediate moratorium on ALL GM varieties, approved or unapproved, while the regulators put into place the robust and independent health testing methods that we have been calling for since 2001. There can now be no further doubt that GM crops and foods are damaging to health."
ENDS
Contact: Brian John GM Free Cymru tel: 01239-820470
NOTES
(1) From the Independent Committee for Research and Information on Genetic Modification: Corinne LEPAGE, Présidente du CRIIGEN (Comité de Recherche et d’Information Indépendantes sur le Génie Génétique) vous convie à une conférence de presse le mardi 13 Mars 2007 à 17h30 sur le thème : « OGM : de nouvelles révélations » En présence du Professeur Gilles-Eric SERALINI, des Docteurs Dominique CELLIER et Joël SPIROUX de VENDOMOIS du Conseil Scientifique du CRIIGEN (www.criigen.org) Au Pain Quotidien 18 rue des Archives 75004 Paris Métro: Hôtel de Ville Merci de confirmer votre présence auprès de Céline ALONZO par téléphone au 06 03 53 19 07 ou par mail calonzo@free.fr
Un cas grave : un maïs OGM autorisé est impropre à la consommation Pour la première fois au monde, une étude des risques sur la santé d’un maïs transgénique autorisé à la consommation montre des signes de toxicité hépatique et rénale. Des exigences et recommandations seront formulées.
(2) The article, entitled "New analysis of a rat feeding study with a genetically modified corn reveals signs of hepatorenal toxicity" is by Gilles-Eric Séralini, Dominique Cellier], and Joël Spiroux de Vendomois. It is published on line (www.springerlink.com/content/ 1432-0703) by the American journal Archives of Environmental Contamination and Toxicology. It will be printed in April.
(3) The peer review of the MON863 feeding study by Dr Arpad Pusztai was subject to a gagging order imposed by Monsanto as a condition for the report to be examined. Dr Pusztai also revealed statistically significant differences between the "GM-fed" group of rats and the control, group. See these items: http://www.gmfreecymru.org/news/Press_Notice31May2005.htm http://www.gmfreecymru.org/pivotal_papers/monsanto.htm
(4) From CRIIGEN press release: Animal feed made from MON863 maize was given to rats in a laboratory over a period of 13 weeks. The associated tests on the GM-fed group and control groups were the longest and most detailed ones involving mammals which have consumed this plant, and they were used in support of its authorization throughout the world. These tests were controversial from the outset in France, and in 2003 they provoked a disagreement between experts, in particular in the French CGB (Commission du Génie Biomoléculaire). CRIIGEN (the Committee for Indepent Research and Information on Genetic Engineering) was concerned about possible scientific fraud, and asked the GM regulatory authorities for sight of of the raw data. These data were kept confidential until Greenpeace Germany won a Court verdict against Monsanto; this forced the company to make public the blood and urine analyses of rats fed with MON863 during the 3 month feeding trials.
The data are contained within more than 1130 pages of tables of numbers and calculations. A group from CRIIGEN comprising Prof. Gilles-Eric Séralini (researcher on pesticides and governmental expert on GMOs, University of Caen), Dr. Dominique Cellier (biostatistician, University of Rouen), and Dr. Joël Spiroux de Vendomois (physician and specialist on environmental health), has now performed a re-evaluation of these data. The work has been done quite independently of Monsanto or any other GMO producer.
The effects of the GM maize on animal weight variations were not studied by the Monsanto scientists. In 2006 the company published certain studies based on the feeding trials , but the scientists did not analyse animal weight or urine data. The statistics were not detailed enough and their protocols were questionable. Upon detailed analysis, the data are now shown to reveal an increase of up to 40% in blood triglycerides in females, and a more than 30% decrease in urine phosphorus and sodium in males, specifically linked to the GM diet. However, these effects were not picked up by the regulatory authorities including EFSA, and they did not request any repeat or prolongation of these experiments.
(5) http://www.gmfreecymru.org/news/Press_Notice16Feb2007.htm http://www.gmfreecymru.org/pivotal_papers/ermakova.htm http://www.gmfreecymru.org/pivotal_papers/toxic.htm
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See also Greenpeace breaking news story:
http://www.yubanet.com/artman/publish/article_52782.shtml
and briefing paper:
http://www.greenpeace.org/international/press/reports/ gp_briefing_seralini_study