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...
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STRONG SUSPICIONS OF TOXICITY IN A GMO MAIZE
Le Monde, March 14 2007. By Stephane Foucart.
Allowed to go on the market in France and Europe, MON 863, a transgenic corn invented by Monsanto, has been at the center of a controversy over its innocuousness for over two years (April 23rd, 2004, Le Monde). These debates could resume after the March 13th publication in "Archives of Environmental Contamination and Toxicology" of a study suggesting this genetically modified organism (GMO) is toxic to the liver and kidneys.
According to this work, consumption of MON 863 corn disturbs numerous biological parameters in rats to a greater or lesser extent: weight of the kidneys, weight of the liver, the level of reticulocytes (new red blood cells), the level of triglycerides, etc. Urinary chemistry is also changed, with reductions in excreted sodium and phosphorus going as high as 35 percent. The effects vary with the sex of the animals. "Female rats exhibit an increase in blood fat and sugar levels, and an increase in body weight - all associated with greater hepatic sensitivity," says Mr. Seralini, principal author of this study and, moreover, president of the Research Committee for Independent Research and Information on Genetic Engineering (Criigen). "Among males, the impact is opposite, with a drop in body and kidney weights."
The authors of this work used data drawn from an experiment sponsored by Monsanto, which bore on the study of 400 rats for 90 days. The statistical treatment applied to these data by the experts of the agrochemical firm was published in August 2005, by "Food and Chemical Toxicology." That work brought to light significant variations in biological parameters between animals fed MON 863 and those fed with its isogene - the same plant variety without the genetic modification.
Monsanto researchers, for their part, had concluded that those disparities were within the frame of the natural variability of the measured parameters. The effects produced by the GMO were therefore not considered pathological. As for the "natural variability," it had been established by measuring the same series of data on rats fed with other varieties of non-GMO corn, with different nutritional values from MON 863 and its isogene.
The raw experimental data - over a thousand pages - were kept confidential by the agrochemical firm until Greenpeace obtained an order for its publication in spring 2005 from the Appeals Court of Munster (Germany).
Criigen was thus able to examine the data in detail and to apply a new statistical treatment to them. According to Mr. Seralini, that, notably, consisted of extracting from the raw data the most significant effects specifically imputable to GMO absorption.
"Of the 58 parameters measured by Monsanto," the researcher details, "all those that were altered concern kidney or liver functioning." He continued, "furthermore, Monsanto had deemed that, because the males and the females responded differently, there was no reason for worry." He added, "Yet, the liver, for example, is an organ that reacts differently as a function of sex." In the same way, the fact that the measured biological response was not always in exact correlation with the dose of GMO received was interpreted by the company's experts as proof that the transgenic corn being tested was not the cause. Mr. Seralini contests that principle: "When the disturbances are hormonal, for example, the impact may not be proportional to the dose."
Toxicologist Gerard Pascal, a member, like Mr. Seralini, of the Committee on Bio-molecular Engineering, deems certain that Criigen's conclusions are erroneous. "I reject the analysis of the animals' weight curves, conducted without taking their feeding into account," says Mr. Pascal. "But I agree that the biological responses may vary between males and females and with the principle that the effects of a GMO corn must be compared with its isogene only and not take into account effects produced by other corn varieties."
According to Mr. Pascal, the lack of direct correlation between the GMO doses received and the impacts observed on the hepatic parameters disqualifies the conclusions about liver toxicity. Significant differences with respect to "kidney weight" and "urinary sodium, phosphorus, and potassium" suggest a renal impact. "However," Mr. Pascal recalls, "at my request, the CGB pressed for investigations of the kidneys and had not found any definitive evidence of toxicity" (December 15th, 2004, Le Monde). "The variations in the levels of reticulocytes and eosinophiles (white blood cells) remain," adds M. Pascal. "I don't know how to interpret that, but those are parameters that move around a lot in experiments." As far as Mr. Pascal is concerned, the information developed by Criigen is not of a nature to call into question the favorable opinions delivered with respect to MON 863. "All that is nothing but a personal interpretation," adds the toxicologist.
Criigen's work has been financed by Carrefour and Greenpeace, but, as Mr. Seralini explains, "Unfortunately, today there is no public budget for conducting this type of research." A situation all the more harmful, according to Mr. Seralini, in that, "the whole toxicological study ought to be redone, controlling for hormonal dosages" and, above all, the tests should be continued well beyond 90 days and on species other than the rat to reach a definitive conclusion.
[Translation: French language correspondent Leslie Thatcher]
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Greenpeace is demanding that the approval of the maize and other high-risk genetically modified products be reviewed
NEW STUDY REVEALS SIGNS OF TOXICITY OF GE MAIZE APPROVED FOR HUMAN CONSUMPTION
Greenpeace demands immediate withdrawal of high-risk GE products
Greenpeace International press release, Mar 13 2007
Laboratory rats, fed with a genetically engineered (GE) maize produced by Monsanto, have shown signs of toxicity in kidney and liver, according to a new study.(1) This is the first time that a GE product which has been cleared for use as food for humans and animals has shown signs of toxic effects on internal organs.
The study, published today in the journal "Archives of Environmental Contamination and Toxicology", analysed results of safety tests submitted by Monsanto to the European Commission when the company was seeking authorisation to market its GE Maize variety MON863 in the EU. (2)
The data shows that MON863 has significant health risks associated with it; nonetheless, the European Commission granted licences to market the maize for consumption by both humans and animals. (3)
The incriminating evidence was obtained by Greenpeace following a court case (4), and passed on for evaluation by a team of experts headed by Professor Gilles Eric Seralini, a governmental expert in genetic engineering technology from the University of Caen. (5)
In a joint press conference with Greenpeace at Berlin, Professor SEralini said, "Monsanto's analyses do not stand up to rigorous scrutiny " to begin with, their statistical protocols are highly questionable. Worse, the company failed to run a sufficient analysis of the differences in animal weight. Crucial data from urine tests were concealed in the company's own publications."
Greenpeace is demanding the complete and immediate withdrawal of Monsanto's MON 863 maize from the global market and is calling upon governments to undertake an urgent reassessment of all other authorised GE products and a strict review of current testing methods.
"This is the final nail in the coffin for the credibility of the current authorisation system for GE products. Once it's known that a system designed to protect human and animal health has approved a high-risk product despite clear evidence of its dangers, we need to start "strip-searching" all GE products on the market, and immediately abort this flawed approval procedure," said Christophe Then, Genetic Engineer campaigner, Greenpeace International.
The data in question has been the subject of fierce debate since 2003, when significant changes were identified in the blood of tested animals fed on MON863. MON863 was approved by the European Commission, in spite of opposition by a majority of EU member states, who raised concerns over the safety of the maize. Professor Seralini's analysis now scientifically confirms these concerns.
As the study states, "with the present data, it cannot be concluded that GM corn MON863 is a safe product." And yet, MON863 has been authorised for markets in Australia, Canada, China, Japan, Mexico, the Phillipines, and USA, besides the EU.
"This is an international emergency alert, requiring a global response," concluded Then, "Only a complete withdrawal from all markets will curtail the possible damage."
1. The article is published online (http://www.springerlink.com/content/02648wu132m07804/) by the American journal Archives of Environmental Contamination and Toxicology; it will be printed in May. A copy can be faxed on request. A Greenpeace briefing on the study is available at:
2. The tested GE maize named MON 863 produces a new insecticide called "modified Cry3Bb1" able to kill a pest insect in the soil (Diabrotica virgifera). This GE maize also contains a gene coding for antibiotic resistance.
3. The European Commission granted a license for MON 863 to be used in feed in August 2005, and subsequently approved it for human consumption in January 2006.
4. For details, please refer to the Greenpeace paper: "The MON863 case -a chronicle of systematic deception"
5. The analysis team was headed by Professor Seralini from the University of Caen and included experts from the French independent scientific organisation CRI IGEN.