Therefore, the biological interpretations become crucial after a global statistical consensus. Two possible issues here: either a demonstration of innocuousness (Monsanto et al.'s opinion), or disturbing disruptions that should be followed by longer tests before approvals (in our opinion).
There are at least two arguments used by EFSA 15
and Monsanto et al. in general, to reject our study 2
. First, they said that our data were only presented in percentages and not in absolute values. On the contrary, we indeed published absolute values to give an idea of the crude effects for MON 810, NK 603 [2
, pp 724-5] and MON 863 [1
, p 600]. However, it does not change the results in any way. Secondly, the parameter values in our studies are compared to the controls and references (boxes and double boxes in the tables), contrary to what was claimed in EFSA's official opinion.
In addition, biological interpretations strongly diverge between us and Monsanto et al., on several key-points. We have previously developed this debate, at least in part, in two reviews 5, 10
, and suggested improvements in regulatory tests: relative to transparency, length, with a duration corresponding to the lifespan of animals (2 years for the rat in laboratory for instance, as is done for some pesticides and drugs). It has become essential to organize counter-evaluation.
EFSA and other national official committees have accepted to recommend the commercial release and consumption of these GMOs, based on Monsanto's own tests and interpretation. The main differences between their biological conclusions and ours, following statistical differences in biochemical and organ parameters, are listed below:
a) For the record, we would like to state that besides the controversy on the shortcomings of the protocol design outlined above, any early sign of difference should be collected in a table to get a global picture of the animal physiology after GMO consumption. It is really impossible within 90 days, with a single experiment worldwide and such a small number of rats, to get a consistent toxicological picture, as requested by Monsanto et al., and to consider the disturbing signs they indicate. This is a major point, because we are concerned by possible chronic pathologies.
Some effects may not be of major amplitude as yet; however, some are. For instance, the increase of the hearts' weight by 11% in males for NK603, or 40% increase in plasmatic triglycerides in females eating MON 863 (together with a pre-diabetic profile), could be considered as enough to trigger a moratorium. As a matter of fact, Monsanto did not repeat their studies or made them take place over a longer period of time. They even routinely prevent independent reproducibility by refusing to supply the material needed 12
and by blocking access to confidential data, as they did by bringing the case before the Court of Appeal in Germany 1
(however, they lost the case).
b) The statistical differences are often considered by Monsanto et al. between the GM-treated groups and the so-called “historical standards of the species” which are undefined, as the also undefined “normal range”. This approach makes it possible for them to consider larger variations as normal, for subjective reasons. The differences have to be considered first with the closest control group. It is only afterwards that it might be possible to compare it with experimental reference groups (Monsanto et al. did that first) receiving a non-equivalent regimen (for instance where salts or sugars are concerned). For the record, we wish to underline that the reference groups are still too numerous in comparison to the treated rats.
c) The significant effects are taken into account by Monsanto et al. only when they are similar in both sexes. This is not acceptable, since by the current knowledge 5
chronic pathologies, as well as the endocrine disturbances or some cancers, are usually sex-related and not proportional to the carcinogen dose taken over a short period of time. The data specificity of the parameters changing and depending on sex has just been admitted in Monsanto's answer to our study (16
, p. 12).
d) For Monsanto et al., the absence of dose-dependent effects is a reason to overlook the significant differences. This is also unacceptable, simply because, for instance, the potential endocrine disrupting antagonistic actions need to be taken into account 17
. Moreover, it has to be underlined that dose-dependency cannot be studied only with the two-dose study presented to the authorities by Monsanto (11 and 33% of GMO in the diet).
e) Since anatomo-pathological lesions or plasmatic biochemical disruptions could arise long after the beginning of a treatment, it is not necessary to establish correlations between these statistical differences and histopathological findings (overall within three months) to conclude on a disturbing sign, despite what Monsanto et al are claiming. In addition, histological slides and embedded organs are the property of the company, and were not double-checked by official committees or independent authors. We ask for an official counter-analysis, in particular of the male kidneys in these studies, that concentrate more than 43% of all disrupted parameters in a meta-analysis of all published data on commercialized GMOs 10
We already know that during the MON 863 study, Monsanto highlighted anatomic signs of “chronic progressive nephropathy” on GM-fed male rats' kidneys. However, Monsanto did not see these signs as being noteworthy due to the fact that, according to them, they were well known to occur in old Sprague-Dawley rats. This explanation was then publicly repeated by the president of the CGB, the French evaluation committee for the GMO in question. But these rats were only 5 months old, and still quite young at the end of the experiment. Oddly enough, these anatomo-pathological signs on kidneys were not noticed during the studies on MON 810 and NK603 maize. Yet the rats were the same age and from the same strain.
f) The chemical composition of food/feed is an important indication. However all insecticide toxins/herbicide residues/unintended or unknown metabolites (due for instance to insertional mutagenesis or new metabolites) are not assessed; thus the substantial equivalence with non GM products is not a proof of innocuousness.
g) A bias for biological interpretations could also be seen in the fact that the regulatory toxicological tests were presented and commented for the authorities only by the companies developing industrial products, and this has been the case, for at least the last fifty years. Few studies have been conducted by independent groups such as Malatesta et al. 17-21
who found ultrastructural alterations of hepatic cells of mice that had eaten Roundup- tolerant GMOs. Finamore's study, which focused on an insecticide-producing variety, suggested gut and peripheral immune response to GM crop ingestion 22
. No industry-funded studies suggest potential side effects of GMO consumption. It is a well-known problem; for instance in the bisphenol A controversy, the meta-analysis of all studies performed showed that none of the industry-funded studies showed adverse effects of bisphenol A, whereas 90% of government funded ones showed hazards at various levels and various doses 23
A proposition for studies conducted independently from companies to tackle this issue has been made to the Council of European Ministers by some of us 24