Monsanto's genetically modified maize MON863, which has been authorized for planting and sale in Europe, was shown by a scientific study to cause liver and kidney toxicity in rats during feeding trials. The study had initially been suppressed by Monsanto but became available to researchers in 2005 after a Court action in Germany.
GM Free Ireland says the results of examination of the study were revealed at a Paris Press Conference and that this is the first time that a study on the health risks of a GM maize authorized for consumption shows signs of hepatorenal toxicity. The "New analysis of a rat feeding study with a genetically modified corn reveals signs of hepatorenal toxicity" is authored by Gilles-Eric Seralini, Dominique Cellier and Joel Spiroux de Vendomois and will be published in the peer-reviewed journal "Archives of Environmental Contamination and Toxicology", which is due to be printed in April.
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.
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 - the Monsanto GM potato study and the Ermakova study that found a high death rate in the offspring of rats fed genetically engineered soy died, as well as the BT gene's toxic effects found in GM varieties containing it.
With reference to the results of the MON863 BT maize study, Professor Seralini says:
"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 adds:
"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."
CRIIGEN, the French Committee for Independent Research and Information on Genetic Engineering, provides more details on their review of the study data:
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 Genie Biomoleculaire). CRIIGEN 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 provide raw data on 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 Seralini (researcher on pesticides and governmental expert on GMOs, University of Caen), Dr. Dominique Cellier (biostatistician, University of Rouen), and Dr. Joel 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.
This goes to show that approvals of genetically modified crops are a somewhat slipshod affair, favoring the multinational corporations such as Monsanto, which have patented and produce the seeds and stand to profit handsomely, while human and animal health from consumption of the GM cereals, vegetables and fruits seems less of a concern.
The French daily Le Monde has an article on the new finding. Greanpeace demands that the approval for Monsanto's GE maize be withdrawn...