Roundup has already been strongly indicated as an agent impactingAmphibian populations. Now we have a clear indication of damagingtoxicity in mammalian populations. Our immediate take home has to bethat application of roundup needs to be tightly managed. Completerejection is the best option if it happens to be practical, otherwiseminimize its use as much as possible.
I do not have any sense here that the GMO corn is going any of thedamage and this is something that needs to be also checked using thesame protocol. In fairness, it should not. GMO may well use alienDNA, but we consume alien DNA as a matter of course and it will needa remarkable lapse in judgment to have a problem.
However Roundup is quite another matter and to discover this resultin rat tests so late in the day tells me that testing has beendeliberately gamed for years. Roundup has been with us for half acentury.
I often wondered what my father read into the Roundup label when hetook it back in the early sixties.
Shocking findingsin new GMO study: Rats fed lifetime of GM corn grow horrifyingtumors, 70% of females die early
Wednesday, September19, 2012
by MikeAdams,
Learn more: http://www.naturalnews.com/037249_GMO_study_cancer_tumors_organ_damage.html#ixzz26wQwGJvR
(NaturalNews) Eatinggenetically modified corn (GM corn) and consuming trace levels ofMonsanto's Roundup chemical fertilizer caused rats to develophorrifying tumors, widespread organ damage, and premature death.That's the conclusion of a shocking new study that looked atthe long-term effects of consuming Monsanto's geneticallymodified corn.
The study hasbeen deemed "the most thorough research ever published into thehealth effects of GM food crops and the herbicide Roundup on rats."News of the horrifying findings is spreading like wildfire across theinternet, with even the mainstream media seemingly in shock over thephotos of rats with multiple grotesque tumors... tumors so large therats even had difficulty breathing in some cases. GMOs may bethe new thalidomide.
"MonsantoRoundup weedkiller and GM maize implicated in 'shocking' new cancerstudy" wrote The Grocery, a popular UK publication.(http://www.thegrocer.co.uk/topics/technology-and-supply-chain/monsant...)
Itreported, "Scientists found that rats exposed to even thesmallest amounts, developed mammary tumors and severe liver andkidney damage as early as four months in males, and seven monthsfor females."
The Daily Mail reported, "Freshrow over GM foods as French study claims rats fed the controversialcrops suffered tumors."(http://www.dailymail.co.uk/sciencetech/article-2205509/Fresh-fears-GM...)
It goes on tosay: "The animals on the GM diet suffered mammary tumors, aswell as severe liver and kidney damage. The researchers said 50percent of males and 70 percent of females died prematurely,compared with only 30 percent and 20 percent in the control group."
The study, ledby Gilles-Eric Seralini of the University of Caen, was the firstever study to examine the long-term (lifetime) effects of eatingGMOs. You may find yourself thinking it is absolutely astonishingthat no such studies were ever conducted before GM corn was approvedfor widespread use by the USDA and FDA, but such is the power ofcorporate lobbying and corporate greed.
The study waspublished in The Food & Chemical Toxicology Journal andwas just presented at a news conference in London.
Findings from thestudy
Here are some of theshocking findings from the study:
• Up to 50%of males and 70% of females suffered premature death.
• Rats thatdrank trace amounts of Roundup (at levels legally allowed in thewater supply) had a 200% to 300% increase in large tumors.
• Rats fedGM corn and traces of Roundup suffered severe organdamage including liver damage and kidney damage.
• The studyfed these rats NK603, the Monsanto variety of GM corn that'sgrown across North America and widely fed to animals and humans. Thisis the same corn that's in your corn-based breakfast cereal, corntortillas and corn snack chips.
The DailyMail is reporting on some of the reaction to the findings:
France's JoseBove, vice-chairman of the European Parliament's commission foragriculture and known as a fierce opponent of GM, called for animmediate suspension of all EU cultivation and import authorisationsof GM crops. 'This study finally shows we are right and that it isurgent to quickly review all GMO evaluation processes,' he said in astatement. 'National and European food security agencies must carryout new studies financed by public funding to guarantee healthy foodfor Europeanconsumers.' (http://www.dailymail.co.uk/sciencetech/article-2205509/Fresh-fears-GM...)
Read the studyabstract
The study is entitled,"A Comparison of the Effects of Three GM Corn Varieties onMammalian Health." Read the abstract here:
http://www.biolsci.org/v05p0706.htm
That abstractinclude this text. Note: "hepatorenal toxicity" means toxicto the liver.
Our analysisclearly reveals for the 3 GMOs new side effects linked with GM maizeconsumption, which were sex- and often dose-dependent. Effects weremostly associated with the kidney and liver, the dietary detoxifyingorgans, although different between the 3 GMOs. Other effects werealso noticed in the heart, adrenal glands, spleen and haematopoieticsystem. We conclude that these data highlight signs of hepatorenaltoxicity, possibly due to the new pesticides specific to each GMcorn. In addition, unintended direct or indirect metabolicconsequences of the genetic modification cannot be excluded.
Here are somequotes from the researchers:
"Thisresearch shows an extraordinary number of tumors developing earlierand more aggressively - particularly in female animals. I am shockedby the extreme negative health impacts." - Dr Michael Antoniou,molecular biologist, King's College London.
"We canexpect that the consumption of GM maize and the herbicide Roundup,impacts seriously on human health." - Dr Antoniou.
"This isthe first time that a long-term animal feeding trial has examined theimpact of feeding GM corn or the herbicide Roundup, or a combinationof both and the results are extremely serious. In the male rats,there was liver and kidney disorders, including tumors and even moreworryingly, in the female rats, there were mammary tumors at a levelwhich is extremely concerning; up to 80 percent of the female ratshad mammary tumors by the end of the trial." - Patrick Holden,Director, Sustainable Food Trust.
Learn more:
http://www.naturalnews.com/037249_GMO_study_cancer_tumors_organ_damage.html#ixzz26wQVcsxX
Int J Biol Sci 2009; 5(7):706-726. doi:10.7150/ijbs.5.706
Research Paper
A Comparison of theEffects of Three GM Corn Varieties on Mammalian Health
Joël Spiroux deVendômois1, FrançoisRoullier1, Dominique Cellier1,2, Gilles-Eric Séralini1,3
- 1. CRIIGEN, 40 rue Monceau, 75008 Paris, France2. University of Rouen LITIS EA 4108, 76821 Mont-Saint-Aignan, France3. University of Caen, Institute of Biology, Risk Pole CNRS, EA 2608, 14032 Caen, France
Abstract
We present for thefirst time a comparative analysis of blood and organ system data fromtrials with rats fed three main commercialized genetically modified(GM) maize (NK 603, MON 810, MON 863), which are present in food andfeed in the world. NK 603 has been modified to be tolerant to thebroad spectrum herbicide Roundup and thus contains residues of thisformulation. MON 810 and MON 863 are engineered to synthesize twodifferent Bt toxins used as insecticides. Approximately 60 differentbiochemical parameters were classified per organ and measured inserum and urine after 5 and 14 weeks of feeding. GM maize-fed ratswere compared first to their respective isogenic or parental non-GMequivalent control groups. This was followed by comparison to sixreference groups, which had consumed various other non-GM maizevarieties. We applied nonparametric methods, including multiplepairwise comparisons with a False Discovery Rate approach. PrincipalComponent Analysis allowed the investigation of scattering ofdifferent factors (sex, weeks of feeding, diet, dose and group). Ouranalysis clearly reveals for the 3 GMOs new side effects linked withGM maize consumption, which were sex- and often dose-dependent.Effects were mostly associated with the kidney and liver, the dietarydetoxifying organs, although different between the 3 GMOs. Othereffects were also noticed in the heart, adrenal glands, spleen andhaematopoietic system. We conclude that these data highlight signs ofhepatorenal toxicity, possibly due to the new pesticides specific toeach GM corn. In addition, unintended direct or indirect metabolicconsequences of the genetic modification cannot be excluded.
Keywords: GMO,toxicity, GM corn, rat, NK 603, MON 810, MON 863
There is a world-widedebate concerning the safety and regulatory approval process ofgenetically modified (GM) crops and foods [1, 2]. In order toscientifically address this issue, it is necessary to have access totoxicological tests, preferably on mammals, performed over thelongest time-scales involving detailed blood and organ systemanalyses. Furthermore, these tests should, if possible, be inaccordance with OECD guidelines. Unfortunately, this has been achallenge since usually these are regulatory tests performedconfidentially by industry prior to commercialization of their GMcrops, pesticides, drugs or chemicals. As a result, it is moreinstructive to investigate the available data that allows comparisonsof several GMOs consumptions on health effects. This will allow themost appropriate statistical analyses to be performed in order toavoid possible false positive as well as false negative results. Thephysiological criteria used to either accept or reject any GMsignificant effect as relevant should be made clear. Here we discusssex-related, temporal, linear and non-linear dose effects which areoften involved in the establishment of chronic and endocrinediseases.
We investigated threedifferent GM corn namely NK 603, MON 810 and MON 863, which were fedto rats for 90 days. The raw data have been obtained by Europeangovernments and made publically available for scrutiny andcounter-evaluation. These studies constitute a model to investigatepossible subchronic toxicological effects of these GM cereals inmammals and humans. These are the longest in vivo testsperformed with mammals consuming these GMOs. The animals weremonitored for numerous blood and organ parameters. One corn (NK 603)has been genetically engineered to tolerate the broad spectrumherbicide Roundup and thus contains residues of this formulation. Thetwo other types of GM maize studied produce two different newinsecticides 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 willbe present in food and feed. As a result, the potential effects onphysiological parameters, due either to the recognized mutageniceffects of the GM transformation process or to the presence of theabove mentioned novel pesticides within these plants can be evaluatedin animal feeding studies.
2.1.Experimental design
The three animalfeeding studies were conducted in two different laboratories and attwo different dates; at Monsanto (Missouri, USA) for NK 603 and MON810 (June 7, 2000) and at Covance Laboratories Inc. (Virginia, USA)for MON 863 (March 14, 2001) on behalf of Monsanto. The young adultmale and female rats, approximately 4-6 week-old, were of theSprague-Dawley albino strain Crl:CD(SD)IGS BR®, (obtained fromCharles River Laboratories Inc., NY, USA). The animals (400 per GMO;200 for each sex) were randomized for similar body weightdistribution. In fact, there were only two treated groups for eachsex (20 animals each consuming specific GM maize feed). Only 10 ratswere measured per group for blood and urine parameters and served asthe basis for the major statistical analyses conducted. In addition,the investigators claimed that OECD guidelines and standards werefollowed. For each type of GM maize, only two feeding doses weretested per sex. This consisted of either 11 or 33% GM maize in anotherwise equivalent equilibrated diet; that is when the dietcontained only 11% GM maize, the difference was made up by adding 22%non-GM maize (varieties not indicated). There were also twocomparative control groups fed diets containing similar quantities ofthe closest isogenic or parental maize variety. Furthermore, groupsof animals were also fed with diets containing one of six othernormal (non-GM) reference maize lines; the same lines for the NK 603and MON 810 tests, but different types for the MON 863 trials. Wenote that these unrelated, different non-GM maize types were notshown to be substantially equivalent to the GMOs. The quantity ofsome sugars, ions, salts, and pesticide residues, do in fact differfrom line to line, for example in the non-GM reference groups. Thisnot only introduced unnecessary sources of variability but alsoincreased 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 groupconsisting of the same number of animals fed a mixture of these testdiets would have been a better and more appropriate control. Inaddition, no data is shown to demonstrate that the diets fed to thecontrol and reference groups were indeed free of GM feed.
2.2.Data collection
The raw biochemicaldata, necessary to allow a statistical re-evaluation, should be madepublically available according to European Union Directive CE/2001/18but unfortunately this is not always the case in practice. On thisoccasion, the data we required for this analysis were obtained eitherthrough court actions (lost by Monsanto) to obtain the MON 863feeding study material (June 2005), or by courtesy of governments orGreenpeace lawyers. We thank the Swedish Board of Agriculture, May30, 2006 for making public the NK 603 data upon request fromGreenpeace Denmark and lawyers from Greenpeace Germany, November 8,2006 for MON 810 material. This allowed us to conduct for the firsttime a precise and direct side-by-side comparison of these data fromthe three feeding trials with these GMOs.
Approximately 80different biochemical and weight parameters, including crude andrelative measures (Table A, Annexes), were evaluated in serumand urine after 5 and 14 weeks of feeding. We classified these perorgan (markers by site of synthesis or regulation). These organsweighed at the end of the experimental period, along with the wholebody were: adrenal glands, brain, gonads, heart, kidneys, liver, andspleen. In addition, some parameters measured were related to bonemarrow (blood cells) and pancreas (glucose) function. Unfortunately,some important measurements serving as markers for liver functionwere not conducted for technical or unknown reasons. This includedgamma glutamyl transferase after 90 days feeding, cholesterol andtriglyceride levels in the NK 603 and MON 810 trials, and cytochromeP450 family members in all cases. In addition, important sexdifference markers were also ignored such as blood sex or pituitaryhormone levels. Furthermore, it is well known and present in OECDguidelines that measurements should be conducted for at least 3different experimental points to study dose- or time-related effects.Contrastingly and for reasons that are not stated, in all threestudies for all three GMOs, only 2 doses and periods of feeding weremeasured, which makes it difficult to evaluate dose and cumulativeeffects. We have in a first instance indicated lacking values fordifferent parameters (Annexes, Tables B, C, D).
2.3.Statistical power related to the experimental design
The most fundamentalpoint to bear in mind from the outset is that a sample size of 10 forbiochemical parameters measured two times in 90 days is largelyinsufficient to ensure an acceptable degree of power to thestatistical analysis performed and presented by Monsanto. Forexample, concerning the statistical power in a t test at 5%, with thecomparison of 2 samples of 10 rats, there is 44% chance to miss asignificant effect of 1 standard deviation (SD; power 56%). In thiscase to have a power of 80% would necessitate a sample size of 17rats. Therefore, the statistical power is insufficient in thesestudies to allow an a priori dismissal of all significanteffects. Indeed, this is true overall with the amplitude of theeffects that can usually be observed within three months, in the caseof usual chronic toxicity appearing after one year of treatment.Hence, the lack of rejection of the null hypothesis at 5% does notmean that this hypothesis is true. Thus, the assessment ofstatistical power is absolutely necessary to understand theundetectable size effect; the statistical power depends on the sampleand effect size, and the level of the test. This is exemplified whenMonsanto performed one-way analysis of variance (ANOVA) calculationsat 5% with a sample size of 10 animals for 10 groups. In this casethe probability of not detecting a medium size effect [3] (0.5 SD fora 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 maximumchance of giving rise to a medium rather than large size effects. Thedisturbance of parameters at the beginning of a disease is generallyless important than at its end or as time progresses. Therefore, theprotocol has to be drastically improved at this level, and as aresult we consider that based on the analysis as presented byMonsanto that it fails to demonstrate that the consumption of theseGM maize feeds was indeed safe as claimed. Any sign of toxicityshould be taken into consideration to justify the prolongation of theexperiment, or, if this is not possible, to reassess the statisticalanalysis, and to propose a scientifically valid physiologicalinterpretation of any findings relating to disturbed functionalparameters on a per organ basis. This was the ultimate objective ofthis investigation.
In reality, in theirreport containing the raw data and statistical analysis, Monsanto didnot apply in any case their chosen and described statistical methods.Only parametric tests (one-way ANOVA under homoscedasticityhypothesis and Student t tests on contrasts) were employed. Moreover,to select significant results, they only contrasted the data setsfrom the 33% GM maize feeding groups (for NK 603 and MON 810) withall reference groups. Moreover, their biological interpretation ofstatistically significant results differs from case to case. Inparticular, sex differences were frequently used to rejectpathological significance, despite the fact that this was withoutmeasuring effects on sex hormone levels. They also used the lack oflinear dose-related effects, which is almost inevitable given thatonly two feeding doses were measured, to declare the diet as safe, asproposed for MON 863 GM maize [4]. In the MON 863 experiments, theauthors still failed to apply their declared methodology, which wasslightly different. The ANOVA and contrast analysis (33% GM feedingdose versus controls) were in this case the determining criteria forevaluation of statistical significance, but only if the mean of the33% GM feeding group was outside the range of the mean of thereference cohorts. All this increases noticeably the risks of falsenegative results.
Consequently, based onthe clear inadequacy of the statistical power used to refute toxiceffects (for instance the unquestionable large size effects in thisstudy), knowing also that billions of people and animals can consumethese products prior to the performance of appropriate invivo safety evaluation, we applied an appropriate,experimentally validated statistical analytical methodology [5],elements of which are described below.
2.4.Statistical methods employed
We first repeated thesame statistical analysis as conducted by Monsanto to verifydescriptive statistics (sample size, means, and standard deviation)and ANOVA per sex, per variable and for each of the three GMO. Forall that, the normality of the residues was tested using the Shapirotest and the homoscedasticity (homogeneity of the variances) usingthe Bartlett test. In the case where the Shapiro and Bartlett testswere non significant (*p > 0.05 and **p > 0.01, respectively)we performed an ANOVA [6, 7], and in the case ofheteroscedasticity the approximate Welch method was used. In the casewhere the Shapiro test was significant, we performed theKruskal-Wallis rank sum test [7, 8].
We then analyzed theeffects of the GM maize varieties on each sex and each diet bypairwise comparisons of the parameters of GM-fed rats versus controlgroups, and subsequently to the unrelated non-GM maize referencegroups. The statistical differences between reference and controlgroups were calculated in order to study the effects of the differentnormal diets per se (due to differences in salts, sugars,minerals, vitamins, pesticides, etc composition), and indicated bycontrast to Monsanto's work (see legend Table 1). In order toselect the appropriate two-tailed comparison test [7], we againstudied first normality (Shapiro test) and variance equality (Ftest). According to the results, we performed the adapted test; thatis, an unpaired t test, a Welch corrected t test or a Mann-Whitneytest (which is generally more appropriate with a sample size of 10).To perform multiple pairwise comparisons, we used the False DiscoveryRate approach (FDR, [9]) to calculate adjusted p-values, in order tolimit the rate of false positives to 5%. We preferred Benjamini andYekutieli's method [10] rather than that of Benjamini and Hochberg[11] as the parameters under investigation are not independent. Inaddition, after centering and scaling the data, Principal ComponentsAnalysis (PCA, [12]) was performed in order to study the scatteringof the different factors (sex, period, diet, dose and group).Finally, we established per group for each rat and by parameter therepresentations and paired tests corresponding to the temporalchanges between the two feeding periods.
We used the R language[7] version 2.5 for all statistical computations [13] with theappropriate package: pwr package for power studies, thebioconductor's multtest package for FDR [14-15] and the ADE4 package[16, 17] for multivariate analysis.
We have previouslyreported indications of toxicity in rats fed with MON 863 GM maizefor 90 days [5]. However, these signs of toxicity alone do notconstitute proof of adverse health effects. We have thereforeextended our initial analysis on the MON 863 feeding data bycollectively compiling the significant differences observed in thephysiological and biochemical parameters measured in feeding trialsof rats with each of the three GM maize varieties MON 863, MON 810and NK 603 (Tables 1, 2; Annex Table E). When we theninitially compare all p-values in our calculations with those ofMonsanto (significant and non significant differences, AnnexTable E), we obtain ratios of 432/452 (NK 603), 435/450 (MON810) and 442/470 (MON 863). By employing our statistical methods evenif we reached a concordance with Monsanto's results (Annex TableE),the level of precision of the main effects and their interpretationare highly different. Therefore, we then progressed to consider onlyrelative differences over 5% (Tables 1 and 2).
3.1.NK 603
We first evaluated theresults for the NK 603 feeding trials. The observations shown inTable 1 with relative differences versus controls revealthat of 23 significantly different effects that are supposed to bedue to this GM maize, 18 are in males (raw means with SEM; AnnexTable F). The repartition of effects is thus sex-dependent. Inaddition, in general liver (Fig. 1) and kidney (Fig. 2)parameters in all rats are sex differentially expressed. This isevident not only in the experiments involving NK 603, independentlyof the treatment at week 14, but also at week 5 (data not shown), butsimilarly observed in the MON 810 and MON 863 feeding tests (AnnexFig. A- Fig. D).
Males are clearly moresensitive than female animals to show physiological disturbances whenfed NK 603. This is not observed for all three GM maize varieties.Moreover, most effects appear to be dose-dependent since 83% of maleeffects emerge only at the 33% feeding level (15/18), the highest GMmaize concentration in the diet (Table1). The maximal meandifferences are observed in male kidney parameters.
Urine phosphorus, forinstance, is importantly disturbed in a dose-dependent manner and atboth 5 and 14 week periods of feeding and hence reproducible overtime. The significant effect at this level does not appear to be afalse 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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