SECTION TWO : THE RESULTS
What is the magnitude of the difference in mortality of the controls compared to the historical norm?
Each experiment having its own conditions, the historical norm is too large to be a relevant comparator. The controls are in the average normal life, and our differences are compared to the controls of the experiment.
How do you explain the absence of manifestation of biochemical disturbances in the males?
On the opposite, there are many. However, all the results are not presented in the study, it was impossible because of their number. There is always a time difference between biochemical disturbances, the firsts to appear, and pathological lesions that we observe in both sexes. In the males the pathological lesions were earlier and larger than in the females and these lesions are the most noticed.
The same differences can be found in all treatments, how do you know that your controls are not the abnormal ones? Or that it is not due to luck?
Our controls correspond to the values observed in the species. Pathological findings have logical explanations for all treatments, they are consistent and numerous enough to not be related to chance; extensive statistics at the biochemical level are consistent and show it. Our in vitro studies are consistent.
How can you be sure that such a little depletion in ferulic and caffeic acids also explains a wide range of pathologies?
There are for us understandable indicators of the changes in the metabolism of the maize that could have happened, the very interesting logical tracks from the scientific literature and our work, they in no way exclude the action of other metabolites toxic due to the GMO and that is why we are asking for funding for analysis in proteomics, transcriptomics, in order to know the events' mechanistic key details.
Do you have any interesting results for the doses of Roundup in the tissues, microbiology and transgene dosing?
Yes we have results that must be completed that give us very interesting leads that will be published later. Several publications are planned after this preliminary work.
Why use the threshold of 17.5 * 17.5 mm in males and 20 * 20 mm in females to
Because it is the threshold size at which more than 95% of tumors are non-regressive.
What is the basis for determining the pathogenicity criteria used in Table 2? What classification do you use?
By differential elimination of the smallest gaps.
Have you measured glyphosate residues in the NK603 or the dry food?
Yes we checked its use and the presence of all pesticides. Values were below regulatory thresholds. The limits of quantification in the different matrices are different.
You indicate an effect on oxidative stress in rats due to your treatments, are the oxidative stress markers disrupted?
Yes for the cytochromes in the liver, and the GST for instance.
Have the maize been sprayed with other pesticides? Have you found other residues?
Yes, normally, they were not organic crops that we could test thereafter. There are no pesticides above the threshold of quantification in food.
SECTION THREE : DISCUSSION
Are the results that you find in this study corresponding to disturbances found in the subchronic tests reanalyzed previously in your publications, that Monsanto sub-interpreted?
Yes, there are signs of hepatorenal toxicity that were published previously after only 90 days of treatment, which are reported as pathologies firmly in our long-term experience.
Do you think that these pathologies may be transferable to humans?
Very generally, yes, but not all. In fact, any signs of toxicity in rats must be taken into account for the prohibition of a product. For 50 years the studies are performed in rat or human cells for products that are not tested in humans (where they test only drugs, not GMOs, nor pesticides nor chemicals). And for drugs, tests on rats or 2-3 mammals precede any clinical trial. If they show serious effects, humans are not treated then. Hormonal disturbances are certainly relevant for women to contribute to breast tumors and hepatorenal effects were found in vitro on human cells.
Why do you quote Zhang et al. 2012 as a reference? This reference concerns on no account GMOs.
One hypothesis is that new micro RNA produced by GMOs may interfere with the metabolism. We could not leave it untold, but we have other explanatory hypotheses.
How do you explain that the reported effects are not found in the human populations? Nobody has ever noticed an increase in breast cancer in the populations exposed to Roundup?
There is an explosion in the number of breast tumors that are not explained by epidemiological studies. We remind you that GMOs not being labeled, the GMO consumption in the U.S. is not listed, nor for the use of Roundup all around the world. The impact of Roundup and its GMOs add to the multitude of xenobiotics present in the environment and in the blood of populations exposed.
It is recommended to experiment on 50 rats for a statutory study on carcinogenesis. What value to bring to your results on 10 rats?
We studied 200 rats, 10 rats/group. Statutory biochemical studies are recommended by the OECD on 10 rats per group minimum.
No statutory study which allowed the authorization of GMOs had more than 10 rats measured per group.
We therefore made the most robust tests in the world, especially as we were examining the long term.
We could not anticipate the results of the tumors, but we observed and recorded them in this study, what was normal, it is not the study of specific carcinogenesis effects with 50 rats/group that would not have allowed to observe the hepatorenal effects and others.
Are the concentrations of ferulic acid found correspond to those indicated in the experiment of Monsanto?
Monsanto has unfortunately not measured the concentrations of hepato-renal and mammo-protective acids directly in the diet, but only once ferulic acid in maize and GMO control.
You say that 76% of the parameters are perturbed in the kidney, in what does that show toxicity? I do not understand this method.
We record all parameters disturbed compared to controls and compare them to the number of parameters related to renal activity over the set of all parameters. We have 48% of renal parameters amongst all measured parameters, yet 76% of the disturbed ones are markers of renal activity! Any doctor would panic for a patient in this case. Distribution cannot be due to chance. (This figure was 42% in one of our previous publications, of disturbed parameters, for 24.9% measured in the male kidney and for a quarterly consumption on average of 19 GMO, testing regulations). The kidney is 1.5 times more affected than other organs.
Roundup increases lifespan in males? Isn't this the best indicator of the safety of this herbicide? This increase is even dose-dependent. Strangely you do not talk about it, why?
We leave you this misinterpretation! Treated males were sicker than controls in all cases, even if in one case out of 6 treatments (3 males + 3 females) there was no extra mortality at any dose before average life expectancy. These rats lose weight however (discussed in another publication) and this can give them some resistance.
Have you compared your results with those of the Japanese study of Sakamoto or another? Contrary to what you say you're not the first to study the safety of one GMO for 2 years.
Yes. None has been as comprehensive as ours, and none is on the maize NK 603 beyond 3 months.
Why did you choose Sprague Dawley rats?
This is the most common model in these studies, the best known.
You've done the study in a GLP environment, is the study GLP? Doesn't the fact that it is not undermine it?
There was no standard protocol for this type of very long study with GMO, we establish it while improving it. This is a world first. Thus there could not be any pre-established standard for this type of test. In addition, this research is a protocol where we added analysis along, biochemical and microscopic to understand what was happening. Now it may serve as an example to establish standards for GLP for GMO, much more serious than what the health agencies do today who do work neither scientifically nor honestly. However, we did that in a GLP lab environment, of course.
Produced by the team of Prof. Séralini.