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The first observation that we were able to make was that there is a good general concordance between our data and the results of Monsanto as presented in their original confidential reports, in particular on the proportion of statistically significant observations. However, the methodology we employed revealed different effects, which completely changed the interpretation of the experimental results. For instance, the sex differences are fully taken into account in our study, which contrasts with the first published comments of these data [, , ]. We evaluated and took note of differences in the reaction of male and female rats to the GM maize test diets based on accepted and now classical knowledge of endocrinology [], embryology [, ], physiology [, ], enzymology or hepatology [] demonstrating sex-specific physio-pathological effects. Indeed, our present results fully confirmed the sex-specific distribution of effects on kidney and liver parameters for all rats in all three studies analyzed here. An identical effect in both sexes would have been exceptional, like with strong or acute toxicity. This is obviously not the case here. In addition, we considered equally important effects that were neither time nor dose related, even if we detailed these when observed in the results. The proof for a linear dose dependency, as requested by Doull and coll. [] to determine the significance of effects, is impossible with only two feeding points with no prior standardization. Furthermore, a metabolic reaction either physiological or pathological is not necessarily linear in its response [, ]. Again, this does not invalidate a description of effects appearing at the higher GM feed doses.

Even if the significant differences are around 5% of all comparisons for each GM corn, we believe that they either constitute a very good possibility to represent signs of toxicity, or at the very least should be considered as sufficiently strong evidence to justify a repeat of the experiments incorporating longer feeding times, for several reasons. Firstly, the arguments of Hammond and coll. [, , ] from Monsanto and Doull and co-workers [] cannot demonstrate that the statistically significant GM-feed linked differences are not physiologically relevant []. Secondly, very few GM-feed effects appear only at the low dose or after the shortest (5 week) feeding period; 8.6% for NK 603, 6.6% for MON 810, 14.7% for MON 863 (Tables , , and ref. []). Thirdly, the marked sex difference effects observed for the GM maize feeding groups, in several instances, are found for physiological markers in all rats. Therefore, there is little probability that these effects were a random, chance occurrence. Fourthly, our stringent statistical tools allowed differentiation of GM-feed impacts from differences arising from variation in the composition of other reference diet. This is the first time that such an analysis has been conducted. Fifthly, there is a lack of cancer, hormonal or hepatic functional marker measurements (for example, oncogene expression, sex steroid hormone levels, cytochrome P450 levels), that could have provided explanatory insight into the results. The lack of availability of this type of data may be of benefit to those that doubt the current observations provide evidence of potential signs of toxicity. Sixthly, the physiological and biochemical parameters found to be disrupted in these feeding studies frequently provide a coherent, GM-specific picture of events, which corresponds and is in support of the generally admitted concept held by industry and regulators that GM crops and food should be considered on a case by case basis. Seventhly, several double-framed outcomes encompass all dietary effects only after the 3 month period of feeding. Last but not least, the most marked and most numerous effects are on organs involved in detoxification like the kidney and liver, usually reached after a diet-linked toxicity.

For instance in the NK 603 study statistically significant strong urine ionic disturbances and kidney markers imply renal leakage. This includes creatinine (increased urinary clearance), together with its diminution in the blood, and the decrease in urea nitrogen. Blood creatinine reduction has in some cases been found to be associated with muscle problems. It is therefore perhaps of note that the heart, as a very representative muscle organ was affected in the GM feeding groups. The possibility of renal porosity as evidenced by these data may be due to the presence of residues of Roundup herbicide, that are present in GM crop varieties such as the NK 603 maize investigated here. We have previously demonstrated that glyphosate-based herbicides such as Roundup are highly toxic at very low concentrations to human embryonic kidney cells [], inducing a decrease in viability, noticeably via inhibition of mitochondrial succinate dehydrogenase.