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Wednesday, October 03, 2012

GMO statistics Part 16. The internally contradictory falsely-significant results of CRIIGEN


There are standard tests to prevent false-discoveries using multiple stats comparisons. Results that fail these tests are not significant, except tor French homeopathic research organisation CRIIGEN.
Text below selected from
A Comparison of the Effects of Three GM Corn Varieties on Mammalian Health
Joël Spiroux de Vendômois, François Roullier, Dominique Cellier and Gilles-Eric Séralini
International Journal of Biological Sciences 2009; 5(7):706-726

Methods
 To perform multiple pairwise comparisons, we used the False Discovery Rate approach (FDR, [9]) to calculate adjusted p-values, in order to limit the rate of false positives to 5%. We preferred Benjamini and Yekutieli's method [10] rather than that of Benjamini and Hochberg [11] as the parameters under investigation are not independent...
Results...
3.2. MON 810
Feeding of MON 810 resulted in 11/15 significant effects in females (Table 2, crude means with SEM; Annex Table G), which again highlights sex-differential effects.

[Data were presented in Table 2. Differences between MON 810-fed rats and controls.]

The sex-dependency for the measured parameters in liver and kidney is observed for all rats Annex Fig. A & Fig. B). The significant GM-maize linked effects are generally detected either after 14 weeks of consumption or at a high GM feed dose in the diet. Parameters affected relate to: blood cells, adrenal gland and kidney weights, an increase in blood urea nitrogen and higher spleen weight. Significantly disturbed parameters in males are concentrated in liver function at the 33% GM-maize feeding level in the diet, with a slight diminution in general serum albumin production. All disturbances are less than 20% and p-values are significant but greater than 1% (Table 2, starred values). However, p-values adjusted for FDR are not significant....

3.3. MON 863
We have already described our evaluation of the MON 863 rat feeding studies [5]. Sex-dependency is well marked in this case also for the spreading of all parameters in liver and kidney (Annex Fig. C & Fig. D). The 34 significant GM-linked effects are equally distributed among males (16) and females (18). This contrasts with what is observed with NK 603 and MON 810. Nevertheless, 9/16 (56%) of males show statistically significant differences in kidney compared to 4/18 females. However, although kidney parameters represent only 37.5% of all measurements, these data show a male-specific effect in kidney function. This trend is somewhat opposite to what is seen in liver parameters where males showed significant effects in 5/16 cases whereas the rate is 9/18 in females. Male rats also appear more sensitive to kidney disturbances at the higher GM feeding dose (11 effects at 33% versus 5 at 11%).
Additional statistically significant differences include (i) a serum glucose and triglyceride increase (up to 40%) in females versus controls, together with a higher liver (7%) and overall body (3.7%) weight, (ii) elevated creatinine, blood urea nitrogen and urine chloride excretion in females, but greater variation in male kidney function (creatinine, and in urine sodium, potassium and phosphorus), (iii) up to a significant kidney weight decrease (7%) with a noticeable chronic nephropathy in males [18], (iv) a decrease (3.3%) in male body weights and (v) some liver function differences in males (albumin, globulin, as in females, plus alanine aminotransferase), although none of the FDR-adjusted p-values are significant...

Discussion
...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. [18, 26, 27] from Monsanto and Doull and co-workers [4] cannot demonstrate that the statistically significant GM-feed linked differences are not physiologically relevant [2]. 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 1, 2, and ref. [5]). 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.


Pundit's reaction.

First time?. I hope so.


Update 
Nov 28 2013 Elsevier Announces Seralini 2012 Article Retraction from Journal Food and Chemical Toxicology

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