Roundup has already been strongly indicated as an agent impacting
Amphibian populations. Now we have a clear indication of damaging
toxicity in mammalian populations. Our immediate take home has to be
that application of roundup needs to be tightly managed. Complete
rejection is the best option if it happens to be practical, otherwise
minimize its use as much as possible.
I do not have any sense here that the GMO corn is going any of the
damage and this is something that needs to be also checked using the
same protocol. In fairness, it should not. GMO may well use alien
DNA, but we consume alien DNA as a matter of course and it will need
a remarkable lapse in judgment to have a problem.
However Roundup is quite another matter and to discover this result
in rat tests so late in the day tells me that testing has been
deliberately gamed for years. Roundup has been with us for half a
century.
I often wondered what my father read into the Roundup label when he
took it back in the early sixties.
Shocking findings
in new GMO study: Rats fed lifetime of GM corn grow horrifying
tumors, 70% of females die early
Wednesday, September
19, 2012
by Mike Adams,
Learn more:
(NaturalNews) Eating
genetically modified corn (GM corn) and consuming trace levels of
Monsanto's Roundup chemical fertilizer caused rats to develop
horrifying tumors, widespread organ damage, and premature death.
That's the conclusion of a shocking new study that looked at
the long-term effects of consuming Monsanto's genetically
modified corn.
The study has been deemed "the most thorough research ever published into the health effects of GM food crops and the herbicide Roundup on rats." News of the horrifying findings is spreading like wildfire across the internet, with even the mainstream media seemingly in shock over the photos of rats with multiple grotesque tumors... tumors so large the rats even had difficulty breathing in some cases. GMOs may be the new thalidomide.
"Monsanto Roundup weedkiller and GM maize implicated in 'shocking' new cancer study" wrote The Grocery, a popular UK publication. (http://www.thegrocer.co.uk/topics/technology-and-supply-chain/monsant...)
It reported, "Scientists found that rats exposed to even the smallest amounts, developed mammary tumors and severe liver and kidney damage as early as four months in males, and seven months for females."
The Daily Mail reported, "Fresh row over GM foods as French study claims rats fed the controversial crops suffered tumors." (http://www.dailymail.co.uk/sciencetech/article-2205509/Fresh-fears-GM...)
It goes on to say: "The animals on the GM diet suffered mammary tumors, as well as severe liver and kidney damage. The researchers said 50 percent of males and 70 percent of females died prematurely, compared with only 30 percent and 20 percent in the control group."
The study, led by Gilles-Eric Seralini of the University of Caen, was the first ever study to examine the long-term (lifetime) effects of eating GMOs. You may find yourself thinking it is absolutely astonishing that no such studies were ever conducted before GM corn was approved for widespread use by the USDA and FDA, but such is the power of corporate lobbying and corporate greed.
The study was published in The Food & Chemical Toxicology Journal and was just presented at a news conference in London.
Findings from the
study
Here are some of the
shocking findings from the study:
• Up to 50% of males and 70% of females suffered premature death.
• Rats that drank trace amounts of Roundup (at levels legally allowed in the water supply) had a 200% to 300% increase in large tumors.
• Rats fed GM corn and traces of Roundup suffered severe organ damage including liver damage and kidney damage.
• The study fed these rats NK603, the Monsanto variety of GM corn that's grown across North America and widely fed to animals and humans. This is the same corn that's in your corn-based breakfast cereal, corn tortillas and corn snack chips.
The Daily Mail is reporting on some of the reaction to the findings:
France's Jose Bove, vice-chairman of the European Parliament's commission for agriculture and known as a fierce opponent of GM, called for an immediate suspension of all EU cultivation and import authorisations of GM crops. 'This study finally shows we are right and that it is urgent to quickly review all GMO evaluation processes,' he said in a statement. 'National and European food security agencies must carry out new studies financed by public funding to guarantee healthy food for European consumers.' (http://www.dailymail.co.uk/sciencetech/article-2205509/Fresh-fears-GM...)
Read the study
abstract
The study is entitled,
"A Comparison of the Effects of Three GM Corn Varieties on
Mammalian Health." Read the abstract here:
That abstract include this text. Note: "hepatorenal toxicity" means toxic to the liver.
Our analysis clearly reveals for the 3 GMOs new side effects linked with GM maize consumption, which were sex- and often dose-dependent. Effects were mostly associated with the kidney and liver, the dietary detoxifying organs, although different between the 3 GMOs. Other effects were also noticed in the heart, adrenal glands, spleen and haematopoietic system. We conclude that these data highlight signs of hepatorenal toxicity, possibly due to the new pesticides specific to each GM corn. In addition, unintended direct or indirect metabolic consequences of the genetic modification cannot be excluded.
Here are some quotes from the researchers:
"This research shows an extraordinary number of tumors developing earlier and more aggressively - particularly in female animals. I am shocked by the extreme negative health impacts." - Dr Michael Antoniou, molecular biologist, King's College London.
"We can expect that the consumption of GM maize and the herbicide Roundup, impacts seriously on human health." - Dr Antoniou.
"This is the first time that a long-term animal feeding trial has examined the impact of feeding GM corn or the herbicide Roundup, or a combination of both and the results are extremely serious. In the male rats, there was liver and kidney disorders, including tumors and even more worryingly, in the female rats, there were mammary tumors at a level which is extremely concerning; up to 80 percent of the female rats had mammary tumors by the end of the trial." - Patrick Holden, Director, Sustainable Food Trust.
Learn more:
Research Paper
A Comparison of the
Effects of Three GM Corn Varieties on Mammalian Health
Joël Spiroux de
Vendômois1, François
Roullier1, Dominique Cellier1,2, Gilles-Eric Séralini1,3
1. CRIIGEN, 40 rue
Monceau, 75008 Paris, France
2. University of
Rouen LITIS EA 4108, 76821 Mont-Saint-Aignan, France
3. University of
Caen, Institute of Biology, Risk Pole CNRS, EA 2608, 14032 Caen,
France
We present for the
first time a comparative analysis of blood and organ system data from
trials with rats fed three main commercialized genetically modified
(GM) maize (NK 603, MON 810, MON 863), which are present in food and
feed in the world. NK 603 has been modified to be tolerant to the
broad spectrum herbicide Roundup and thus contains residues of this
formulation. MON 810 and MON 863 are engineered to synthesize two
different Bt toxins used as insecticides. Approximately 60 different
biochemical parameters were classified per organ and measured in
serum and urine after 5 and 14 weeks of feeding. GM maize-fed rats
were compared first to their respective isogenic or parental non-GM
equivalent control groups. This was followed by comparison to six
reference groups, which had consumed various other non-GM maize
varieties. We applied nonparametric methods, including multiple
pairwise comparisons with a False Discovery Rate approach. Principal
Component Analysis allowed the investigation of scattering of
different factors (sex, weeks of feeding, diet, dose and group). Our
analysis clearly reveals for the 3 GMOs new side effects linked with
GM maize consumption, which were sex- and often dose-dependent.
Effects were mostly associated with the kidney and liver, the dietary
detoxifying organs, although different between the 3 GMOs. Other
effects were also noticed in the heart, adrenal glands, spleen and
haematopoietic system. We conclude that these data highlight signs of
hepatorenal toxicity, possibly due to the new pesticides specific to
each GM corn. In addition, unintended direct or indirect metabolic
consequences of the genetic modification cannot be excluded.
Keywords: GMO,
toxicity, GM corn, rat, NK 603, MON 810, MON 863
There is a world-wide
debate concerning the safety and regulatory approval process of
genetically modified (GM) crops and foods [1, 2]. In order to
scientifically address this issue, it is necessary to have access to
toxicological tests, preferably on mammals, performed over the
longest time-scales involving detailed blood and organ system
analyses. Furthermore, these tests should, if possible, be in
accordance with OECD guidelines. Unfortunately, this has been a
challenge since usually these are regulatory tests performed
confidentially by industry prior to commercialization of their GM
crops, pesticides, drugs or chemicals. As a result, it is more
instructive to investigate the available data that allows comparisons
of several GMOs consumptions on health effects. This will allow the
most appropriate statistical analyses to be performed in order to
avoid possible false positive as well as false negative results. The
physiological criteria used to either accept or reject any GM
significant effect as relevant should be made clear. Here we discuss
sex-related, temporal, linear and non-linear dose effects which are
often involved in the establishment of chronic and endocrine
diseases.
We investigated three
different GM corn namely NK 603, MON 810 and MON 863, which were fed
to rats for 90 days. The raw data have been obtained by European
governments and made publically available for scrutiny and
counter-evaluation. These studies constitute a model to investigate
possible subchronic toxicological effects of these GM cereals in
mammals and humans. These are the longest in vivo tests
performed with mammals consuming these GMOs. The animals were
monitored for numerous blood and organ parameters. One corn (NK 603)
has been genetically engineered to tolerate the broad spectrum
herbicide Roundup and thus contains residues of this formulation. The
two other types of GM maize studied produce two different new
insecticides namely modified versions of Cry1Ab (MON 810) and Cry3Bb1
(MON 863) Bacillus thuringiensis-derived proteins. Therefore,
all these three GM maize contain novel pesticide residues that will
be present in food and feed. As a result, the potential effects on
physiological parameters, due either to the recognized mutagenic
effects of the GM transformation process or to the presence of the
above mentioned novel pesticides within these plants can be evaluated
in animal feeding studies.
The three animal
feeding studies were conducted in two different laboratories and at
two different dates; at Monsanto (Missouri, USA) for NK 603 and MON
810 (June 7, 2000) and at Covance Laboratories Inc. (Virginia, USA)
for MON 863 (March 14, 2001) on behalf of Monsanto. The young adult
male and female rats, approximately 4-6 week-old, were of the
Sprague-Dawley albino strain Crl:CD(SD)IGS BR®, (obtained from
Charles River Laboratories Inc., NY, USA). The animals (400 per GMO;
200 for each sex) were randomized for similar body weight
distribution. In fact, there were only two treated groups for each
sex (20 animals each consuming specific GM maize feed). Only 10 rats
were measured per group for blood and urine parameters and served as
the basis for the major statistical analyses conducted. In addition,
the investigators claimed that OECD guidelines and standards were
followed. For each type of GM maize, only two feeding doses were
tested per sex. This consisted of either 11 or 33% GM maize in an
otherwise equivalent equilibrated diet; that is when the diet
contained only 11% GM maize, the difference was made up by adding 22%
non-GM maize (varieties not indicated). There were also two
comparative control groups fed diets containing similar quantities of
the closest isogenic or parental maize variety. Furthermore, groups
of animals were also fed with diets containing one of six other
normal (non-GM) reference maize lines; the same lines for the NK 603
and MON 810 tests, but different types for the MON 863 trials. We
note that these unrelated, different non-GM maize types were not
shown to be substantially equivalent to the GMOs. The quantity of
some sugars, ions, salts, and pesticide residues, do in fact differ
from line to line, for example in the non-GM reference groups. This
not only introduced unnecessary sources of variability but also
increased considerably the number of rats fed a normal non-GM diet
(320) compared to the GM-fed groups (80) per transformation event,
which considerably unbalances the experimental design. A group
consisting of the same number of animals fed a mixture of these test
diets would have been a better and more appropriate control. In
addition, no data is shown to demonstrate that the diets fed to the
control and reference groups were indeed free of GM feed.
The raw biochemical
data, necessary to allow a statistical re-evaluation, should be made
publically available according to European Union Directive CE/2001/18
but unfortunately this is not always the case in practice. On this
occasion, the data we required for this analysis were obtained either
through court actions (lost by Monsanto) to obtain the MON 863
feeding study material (June 2005), or by courtesy of governments or
Greenpeace lawyers. We thank the Swedish Board of Agriculture, May
30, 2006 for making public the NK 603 data upon request from
Greenpeace Denmark and lawyers from Greenpeace Germany, November 8,
2006 for MON 810 material. This allowed us to conduct for the first
time a precise and direct side-by-side comparison of these data from
the three feeding trials with these GMOs.
Approximately 80
different biochemical and weight parameters, including crude and
relative measures (Table A, Annexes), were evaluated in serum
and urine after 5 and 14 weeks of feeding. We classified these per
organ (markers by site of synthesis or regulation). These organs
weighed at the end of the experimental period, along with the whole
body were: adrenal glands, brain, gonads, heart, kidneys, liver, and
spleen. In addition, some parameters measured were related to bone
marrow (blood cells) and pancreas (glucose) function. Unfortunately,
some important measurements serving as markers for liver function
were not conducted for technical or unknown reasons. This included
gamma glutamyl transferase after 90 days feeding, cholesterol and
triglyceride levels in the NK 603 and MON 810 trials, and cytochrome
P450 family members in all cases. In addition, important sex
difference markers were also ignored such as blood sex or pituitary
hormone levels. Furthermore, it is well known and present in OECD
guidelines that measurements should be conducted for at least 3
different experimental points to study dose- or time-related effects.
Contrastingly and for reasons that are not stated, in all three
studies for all three GMOs, only 2 doses and periods of feeding were
measured, which makes it difficult to evaluate dose and cumulative
effects. We have in a first instance indicated lacking values for
different parameters (Annexes, Tables B, C, D).
The most fundamental
point to bear in mind from the outset is that a sample size of 10 for
biochemical parameters measured two times in 90 days is largely
insufficient to ensure an acceptable degree of power to the
statistical analysis performed and presented by Monsanto. For
example, concerning the statistical power in a t test at 5%, with the
comparison of 2 samples of 10 rats, there is 44% chance to miss a
significant effect of 1 standard deviation (SD; power 56%). In this
case to have a power of 80% would necessitate a sample size of 17
rats. Therefore, the statistical power is insufficient in these
studies to allow an a priori dismissal of all significant
effects. Indeed, this is true overall with the amplitude of the
effects that can usually be observed within three months, in the case
of usual chronic toxicity appearing after one year of treatment.
Hence, the lack of rejection of the null hypothesis at 5% does not
mean that this hypothesis is true. Thus, the assessment of
statistical power is absolutely necessary to understand the
undetectable size effect; the statistical power depends on the sample
and effect size, and the level of the test. This is exemplified when
Monsanto performed one-way analysis of variance (ANOVA) calculations
at 5% with a sample size of 10 animals for 10 groups. In this case
the probability of not detecting a medium size effect [3] (0.5 SD for
a t test for instance) is about 70% (power of the test 30%). However,
the fact is that within 90 days, a chronic toxicity has a maximum
chance of giving rise to a medium rather than large size effects. The
disturbance of parameters at the beginning of a disease is generally
less important than at its end or as time progresses. Therefore, the
protocol has to be drastically improved at this level, and as a
result we consider that based on the analysis as presented by
Monsanto that it fails to demonstrate that the consumption of these
GM maize feeds was indeed safe as claimed. Any sign of toxicity
should be taken into consideration to justify the prolongation of the
experiment, or, if this is not possible, to reassess the statistical
analysis, and to propose a scientifically valid physiological
interpretation of any findings relating to disturbed functional
parameters on a per organ basis. This was the ultimate objective of
this investigation.
In reality, in their
report containing the raw data and statistical analysis, Monsanto did
not apply in any case their chosen and described statistical methods.
Only parametric tests (one-way ANOVA under homoscedasticity
hypothesis and Student t tests on contrasts) were employed. Moreover,
to select significant results, they only contrasted the data sets
from the 33% GM maize feeding groups (for NK 603 and MON 810) with
all reference groups. Moreover, their biological interpretation of
statistically significant results differs from case to case. In
particular, sex differences were frequently used to reject
pathological significance, despite the fact that this was without
measuring effects on sex hormone levels. They also used the lack of
linear dose-related effects, which is almost inevitable given that
only two feeding doses were measured, to declare the diet as safe, as
proposed for MON 863 GM maize [4]. In the MON 863 experiments, the
authors still failed to apply their declared methodology, which was
slightly different. The ANOVA and contrast analysis (33% GM feeding
dose versus controls) were in this case the determining criteria for
evaluation of statistical significance, but only if the mean of the
33% GM feeding group was outside the range of the mean of the
reference cohorts. All this increases noticeably the risks of false
negative results.
Consequently, based on
the clear inadequacy of the statistical power used to refute toxic
effects (for instance the unquestionable large size effects in this
study), knowing also that billions of people and animals can consume
these products prior to the performance of appropriate in
vivo safety evaluation, we applied an appropriate,
experimentally validated statistical analytical methodology [5],
elements of which are described below.
We first repeated the
same statistical analysis as conducted by Monsanto to verify
descriptive statistics (sample size, means, and standard deviation)
and ANOVA per sex, per variable and for each of the three GMO. For
all that, the normality of the residues was tested using the Shapiro
test and the homoscedasticity (homogeneity of the variances) using
the Bartlett test. In the case where the Shapiro and Bartlett tests
were non significant (*p > 0.05 and **p > 0.01, respectively)
we performed an ANOVA [6, 7], and in the case of
heteroscedasticity the approximate Welch method was used. In the case
where the Shapiro test was significant, we performed the
Kruskal-Wallis rank sum test [7, 8].
We then analyzed the
effects of the GM maize varieties on each sex and each diet by
pairwise comparisons of the parameters of GM-fed rats versus control
groups, and subsequently to the unrelated non-GM maize reference
groups. The statistical differences between reference and control
groups were calculated in order to study the effects of the different
normal diets per se (due to differences in salts, sugars,
minerals, vitamins, pesticides, etc composition), and indicated by
contrast to Monsanto's work (see legend Table 1). In order to
select the appropriate two-tailed comparison test [7], we again
studied first normality (Shapiro test) and variance equality (F
test). According to the results, we performed the adapted test; that
is, an unpaired t test, a Welch corrected t test or a Mann-Whitney
test (which is generally more appropriate with a sample size of 10).
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. In
addition, after centering and scaling the data, Principal Components
Analysis (PCA, [12]) was performed in order to study the scattering
of the different factors (sex, period, diet, dose and group).
Finally, we established per group for each rat and by parameter the
representations and paired tests corresponding to the temporal
changes between the two feeding periods.
We used the R language
[7] version 2.5 for all statistical computations [13] with the
appropriate package: pwr package for power studies, the
bioconductor's multtest package for FDR [14-15] and the ADE4 package
[16, 17] for multivariate analysis.
We have previously
reported indications of toxicity in rats fed with MON 863 GM maize
for 90 days [5]. However, these signs of toxicity alone do not
constitute proof of adverse health effects. We have therefore
extended our initial analysis on the MON 863 feeding data by
collectively compiling the significant differences observed in the
physiological and biochemical parameters measured in feeding trials
of rats with each of the three GM maize varieties MON 863, MON 810
and NK 603 (Tables 1, 2; Annex Table E). When we then
initially compare all p-values in our calculations with those of
Monsanto (significant and non significant differences, Annex
Table E), we obtain ratios of 432/452 (NK 603), 435/450 (MON
810) and 442/470 (MON 863). By employing our statistical methods even
if we reached a concordance with Monsanto's results (Annex TableE),
the level of precision of the main effects and their interpretation
are highly different. Therefore, we then progressed to consider only
relative differences over 5% (Tables 1 and 2).
We first evaluated the
results for the NK 603 feeding trials. The observations shown in
Table 1 with relative differences versus controls reveal
that of 23 significantly different effects that are supposed to be
due to this GM maize, 18 are in males (raw means with SEM; Annex
Table F). The repartition of effects is thus sex-dependent. In
addition, in general liver (Fig. 1) and kidney (Fig. 2)
parameters in all rats are sex differentially expressed. This is
evident not only in the experiments involving NK 603, independently
of the treatment at week 14, but also at week 5 (data not shown), but
similarly observed in the MON 810 and MON 863 feeding tests (Annex
Fig. A- Fig. D).
Males are clearly more
sensitive than female animals to show physiological disturbances when
fed NK 603. This is not observed for all three GM maize varieties.
Moreover, most effects appear to be dose-dependent since 83% of male
effects emerge only at the 33% feeding level (15/18), the highest GM
maize concentration in the diet (Table1). The maximal mean
differences are observed in male kidney parameters.
Urine phosphorus, for
instance, is importantly disturbed in a dose-dependent manner and at
both 5 and 14 week periods of feeding and hence reproducible over
time. The significant effect at this level does not appear to be a
false positive result (week 5, 33%, adjusted p<0 .003=".003" 14="14" 33="33" according="according" adjusted="adjusted" all="all" also="also" and="and" benjamini="benjamini" calculated="calculated" comparable="comparable" considering="considering" differences="differences" fdr="fdr" for="for" i="i" independent.="independent." lymphocyte="lymphocyte" males="males" neutrophil="neutrophil" not="not" obtained="obtained" p="p" parameters="parameters" relative="relative" results="results" that="that" to="to" week="week" were="were" yekutieli="yekutieli">
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