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GM maize linked to tumours? Maybe not

Gert van der Hoek

In Memoriam - Editor, Senior Moderator
GM maize linked to tumours

September 19, 2012

A KIND of genetically-modified maize has been linked to tumours in rats.

A team of French researchers found that rats fed for a year on GMO maize NK 603 (of which Monsanto owns the patent) were two or three times more likely to develop tumours than ones fed ordinary maize.

At the end of their lives, aged two, 50-80% of female rats had tumours, compared to 30% of ones eating non-GM food.

Tumours also tended to develop earlier in their lives than in the other animals, especially in males.

The scientist leading the study, Prof Gilles-Eric S?ralini of the Universit? de Caen, said: ?After less than a year of different GMO maize menus there was carnage among our rats to a degree I had not imagined.?

From just the fourth month tumours were found in two male rats that soon grew to measure a quarter of their body weight, he said.
The results give reason to think there may be risks for humans, Prof S?ralini believes.

He has an anti-GMO book coming out next week called Tous Cobayes! (We?re all guinea pigs), and a documentary has been made based on it.

The results are published in an American journal, Food and Chemical Toxicology.

Le Nouvel Observateur, which was the first to publicise the results in France, under the headline ?Yes, GMOs are poisons!?, predicted the findings would be a ?bomb? for the GM foods industry.

The Connexion

Original source:

4424449.jpg


EXCLUSIF. Oui, les OGM sont des poisons !

Cr?? le 18-09-2012 ? 00h19 - Mis ? jour le 19-09-2012 ? 10h53Par Guillaume Malaurie

Des chercheurs fran?ais ont ?tudi? secr?tement, pendant deux ans, 200 rats nourris au ma?s transg?nique. Tumeurs, pathologies lourdes? une h?catombe. Et une bombe pour l'industrie OGM.

Le Nouvel Observateur

Also see: Corn: New Worries About an Old Favorite
 
Re: GM maize linked to tumours

Re: GM maize linked to tumours

A two-year study apparently yields different results compared to the standard 90-days study?


Fresh fears over GM foods as French study claims rats fed the controversial crops suffered tumours

French team claim bestselling brand caused tumours and multiple organ damage

Leading scientists have questioned the study and its results


19 september 2012

Rats fed a lifelong diet of one of the bestselling strains of genetically modified corn suffered tumours and multiple organ damage, according to a French study published today.

The report is set to reignite the debate over whether GM crops are safe.
However, some scientists have questioned its results.

In an unusual move, the research group behind the research did not allow reporters to seek outside comment on their paper before its publication in the peer-reviewed journal Food and Chemical Toxicology.

Gilles-Eric Seralini of the University of Caen and colleagues said rats fed on a diet containing NK603 - a seed variety from crop giant Monsanto made tolerant to dousings of the bestselling weedkiller Roundup - or given water containing Roundup at levels permitted in the United States died earlier than those on a standard diet.
The animals on the GM diet suffered mammary tumours, 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.
Seralini was part of a team that flagged previous safety concerns based on a shorter rat study in a scientific paper published in December 2009 but this takes things a step further by tracking the animals throughout their two-year lifespan.

Alan Boobis, Professor of Biochemical Pharmacology, Imperial College London, said: 'Some of the effects are presented in a way that makes it difficult to evaluate their significance.

'For example, there does not appear to be a statistical analysis of the mammary tumours.

'These occur quite often in untreated animals.

Mark Tester, Research Professor, Australian Centre for Plant Functional Genomics, University of Adelaide, said: 'The first thing that leaps to my mind is why has nothing emerged from epidemiological studies in the countries where so much GM has been in the food chain for so long?

More: Daily Mail
 
Re: GM maize linked to tumours

Re: GM maize linked to tumours

"Long-term studies necessary: people eat throughout their lives ?"

19 september 2012

Een update from het French newspaper Le Nouvel Observateur: a part of the interview with researcher Gilles-Eric Séralini which will be published tomorrow.

The most important aspect of his research does seem to be the length: 2 years instead of the apparently usual 90 days. "People eat throughout their lives," he says.

Séralini thinks it is scandalous the European Health Authorities never have required long-term studies to asses the risks of GM food .


Le grand scandale, celui dont je ne me remets pas, c’est que les agences sanitaires n’ont jamais exigé des industriels une étude de toxicité de longue durée.

Pourtant, lorsque 450 millions d’Européens consomment des produits alimentaires à base d’OGM (et sans toujours le savoir), ils le font tout au long de leur vie.

More: Le Nouvel Observateur
 
Re: GM maize linked to tumours

Re: GM maize linked to tumours

Available online 19 September 2012

Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize

Abstract
The health effects of a Roundup-tolerant genetically modified maize (from 11% in the diet), cultivated with or without Roundup, and Roundup alone (from 0.1 ppb in water), were studied 2 years in rats. In females, all treated groups died 2?3 times more than controls, and more rapidly. This difference was visible in 3 male groups fed GMOs.

All results were hormone and sex dependent, and the pathological profiles were comparable. Females developed large mammary tumors almost always more often than and before controls, the pituitary was the second most disabled organ; the sex hormonal balance was modified by GMO and Roundup treatments. In treated males, liver congestions and necrosis were 2.5?5.5 times higher.

This pathology was confirmed by optic and transmission electron microscopy. Marked and severe kidney nephropathies were also generally 1.3?2.3 greater. Males presented 4 times more large palpable tumors than controls which occurred up to 600 days earlier. Biochemistry data confirmed very significant kidney chronic deficiencies; for all treatments and both sexes, 76% of the altered parameters were kidney related.

These results can be explained by the non linear endocrine-disrupting effects of Roundup, but also by the overexpression of the transgene in the GMO and its metabolic consequences.

Highlights
► A Roundup-tolerant maize and Roundup provoked chronic hormone and sex dependent pathologies. ► Female mortality was 2?3 times increased mostly due to large mammary tumors and disabled pituitary. ► Males had liver congestions, necrosis, severe kidney nephropathies and large palpable tumors.

► This may be due to an endocrine disruption linked to Roundup and a new metabolism due to the transgene. ► GMOs and formulated pesticides must be evaluated by long term studies to measure toxic effects..

Food and Chemical Toxicology
 
Re: GM maize linked to tumours

Re: GM maize linked to tumours

Why I think the Seralini GM feeding trial is bogus

Andrew Kniss September 19th, 2012

If you?re following the news about the French GM maize feeding trial, you?ve probably heard: (A) we need to pull GMO crops off the market immediately; or (B) that the study is flawed and is basically meaningless. I guess I find myself leaning toward the second group on this one. Here is why I think the recent GM corn feeding trial by Saralini (Seralini et al. 2012. Food and Chemical Toxicology) is bogus. Just for full discosure, I?m not in any way an expert on animal feeding studies. But I know something about statistics and probability (in most cases, just enough to be dangerous). I would invite anyone who sees errors in my logic from either an animal science, toxicology, or statistics standpoint to please let me know in the comments.

.........................

But if we compare the life span of rats with the life span of humans, the concept of ?long term? is not at all similar. And this is where I think the Seralini study falls apart. It boils down to the fact that this study lasted for 2 years, and used Sprague-Dawley rats. To those of us who don?t do rat studies, 2 years probably seems like a reasonable ?long term? duration for a study (it did to me at first glance). However, it seems that for the specific line of rats they chose (Sprague-Dawley), 2 years may be an exceptionally long time.

.........................

But here?s the important part: Simply by chance, if we draw 10 rats from a population in which 72% get tumors after 2 years, we have anywhere from 5 (?t2″) to 10 (?t1″) rats in a treatment group that will develop tumors. Simply due to chance; not due to treatments. If I did not know about this predisposition for developing tumors in Sprague-Dawley rats, and I were comparing these treatment groups, I might be inclined to say that there is indeed a difference between treatment 1 and treatment 2. Only 5 animals developed tumors in treatment 1, and all 10 animals developed tumors treatment 2; that seems pretty convincing. But again, in this case, it was purely due to chance.

So my conclusion is that this study is flawed due to the choice of Sprague-Dawley rats, and the duration (2 years) for which the study was conducted. Sprague-Dawley rats appear to have a high probability of health problems after 2 years. And when there is a high probability of health problems, there is a high probability that just by chance you will find differences between treatments, especially if your sample size for each treatment is only 10 individuals.

More: Control Freaks
 
Re: GM maize linked to tumours

Re: GM maize linked to tumours

The latest GMO study raises more questions than it answers

By Tom Laskawy

It?s been hard to avoid hearing about the recent study [PDF] linking GMO corn and pesticide (Roundup) exposure to tumor growth and early death in rats. Most major news organizations have picked it up, including The New York Times, the Washington Post, the Chicago Tribune, NPR, and the LA Times.

And that?s why this latest study is important. It?s not that it ?proves? GMOs are harmful to humans. It?s that a single study like this one can represent the only lifetime study of the effects of eating GMOs.

The fact that the study found anything different between the groups fed GMO corn and the control group demands further research. Yes, the results could be due to poor research design or simply ?bad luck? for those rats. But the only way to know is to perform more research.

You?d think that scientists and our government would respond to this study by encouraging other scientists to replicate Seralini?s findings, if for no other reason than this study?s suggestion that GMO crops may not be ?substantially equivalent? to other crops. Had Seralini fed rats various strains of conventional hybrid corn, no one would expect the kinds of results he found. The question is why he found what he found. It may have had nothing to do with the corn. But it would be nice if scientists agreed that we should find out.

I?m deeply disappointed in the failure of imagination that I?m seeing from mainstream scientists, in particular the easy dismissal of a study that raises questions about GMO safety. Unlike many of the industrial products that surround us (and permeate us), GMOs are still novel by historical standard.

My disappointment with the scientific community and my concern over the results of this study arises not because I know that GMOs are harmful to our health. On the contrary, it?s exactly because I don?t know. And I don?t think I?m the only one who would like to find out.

Full article: Gristorg
 
Re: GM maize linked to tumours

Re: GM maize linked to tumours

Comment:

Apparently this study has serious flaws, so everybody is telling me.

OK.

However some elements used in it, could be worthwile to use in followup studies:

- use Roundup "from the bottle" in stead of glyphosate;

- also test animals who ate gen corn / soya and also drank water with "safe" levels of Roundup;

- perform a longterm study, in stead of the usual 90-days study.


As far as I know, studies with these elements hardly have been done.

They should have been done already, IMHO.



 
Re: GM maize linked to tumours

Re: GM maize linked to tumours

Comment:

Apparently this study has serious flaws, so everybody is telling me.

OK.

However some elements used in it, could be worthwile to use in followup studies:

- use Roundup "from the bottle" in stead of glyphosate;

- also test animals who ate gen corn / soya and also drank water with "safe" levels of Roundup;

- perform a longterm study, in stead of the usual 90-days study.


As far as I know, studies with these elements hardly have been done.

They should have been done already, IMHO.





I agree.
 
Re: GM maize linked to tumours

Re: GM maize linked to tumours

19 September 2012

Expert reaction to GM maize causing tumours in rats


A toxicology study in Food and Chemical Toxicology into the health impact of a GM tolerant maize crop and the herbicide Roundup suggested lab rats developed mammary tumours and were more likely to die prematurely.


Prof Maurice Moloney, Institute Director and Chief Executive , Rothamsted Research, said:

"Although this paper has been published in a peer?reviewed journal with an IF of about 3, there are anomalies throughout the paper that normally should have been corrected or resolved through the peer-review process. For a paper with such potentially important findings, it would have been more satisfying to have seen something with a more conventional statistical analysis. A comparison of each measured parameter, which took into account the variance throughout the experiment, which would have been revealed using a multiple range test, would have provided better evidence for the concluding remarks and the abstract. Figure 1 does not provide any data from the controls and their variance is unreported here. Table 2 reports different numbers of individuals used for the controls than the treatments. In all cases the controls have used less individuals than used in the treatments. The data in Table 2 do not show confidence intervals or provide evidence of significant differences between all the treatments and the controls. The lack of a dose response effect is argued by the authors to be indicative of a ?threshold? effect. This is an extrapolation of their findings and could only be determined by intermediate dosing. The photographs are very graphic, but do not include a control. Sprague-Dawley rats frequently develop mammary tumours in well-fed controls. Are we to conclude from this that no controls developed tumours? Numerically, we cannot tell, because they are absent also from Figure 2. We are performing a more detailed analysis of the statistics in relation to the conclusions, but for the present it is fair to point out that normally a referee would insist on showing the control data and its variance in such a study."

Prof David Spiegelhalter, Winton Professor of the Public Understanding Of Risk, University of Cambridge, said:

"In my opinion, the methods, stats and reporting of results are all well below the standard I would expect in a rigorous study ? to be honest I am surprised it was accepted for publication.

?All the comparisons are made with the ?untreated? control group, which only comprised 10 rats of each sex, the majority of which also developed tumours. Superficially they appear to have performed better than most of the treated groups (although the highest dose GMO and Roundup male groups also fared well), but there is no proper statistical analysis, and the numbers are so low they do not amount to substantial evidence. I would be unwilling to accept these results unless they were replicated properly."

Dr Wendy Harwood, senior scientist, John Innes Centre, said:

"The full data set has not been made available, but the findings do not contradict previous findings that genetic modification itself is a neutral technology, with no inherent health or environmental risks.

"We have to ask whether a diet with this level of maize is normal for rats. Another control with an alternative diet should have been included.

"Ten rats per group is a small number. For example, is the death of three out of ten controls compared to five out of ten males in the treated group statistically significant?

"The data from the control group fed non-GM maize is not included in the main figures making it very difficult to interpret the results.

"Without access to the full data, we can only say that these results cannot be interpreted as showing that GM technology itself is dangerous. However they do indicate possible concerns over long-term exposure to Roundup that require further study."

Further comments from other scientists:

"Other issues that have come up:


? ?All data cannot be shown in one report and the most relevant are described here? ? this is a quote from the paper.
? Small sample size
? Maize was minimum 11% of the diet ? not balanced
? No non-maize control?
? No results given for non-gm maize
? For nearly 20 years, billions of animals in the EU have been fed soy products produced from genetically modified soybean, mainly from Latin America. No problems have been reported by the hundreds of thousands of farmers, officials, vets and so on.
? The same journal publishes a paper showing no adverse health effects in rats of consuming gm maize (though this is a shorter 90-day study)
? Statistical significance vs relative frequencies.
? We also have to ask why the rats were kept alive for so long ? for humane reasons this study would not have been given approval in the UK.
? In Fig.2, I assume the bars with a zero is for the non-maize control. Those bars don?t looks significantly different from the bars indicating 11, 22, and 33% of GM maize in the diet? Have the authors done stats on their data?"


Prof Anthony Trewavas, Professor of Cell Biology, University of Edinburgh, said:

"The control group is inadequate to make any deduction. Only 10 rodents so far as I can see and some of these develop tumours. Until you know the degree of variation in 90 or 180 (divided into groups of ten) control rodents these results are of no value.

"These figures for normal appearance of tumours in these rodent lines are surely available and using a line which is very susceptible to tumours can easily bias any result. To be frank it looks like random variation to me in a rodent line likely to develop tumours anyway."

Prof Ottoline Leyser, Associate Director of the Sainsbury Laboratory, University of Cambridge, said:

"Like most of the GM debate, this work has very little to do with GM. The authors of the paper do not suggest that the effects are caused by genetic modification. They describe effects of the roundup herbicide itself and effects that they attribute to the activity of the enzyme introduced into the roundup resistant maize. There is good evidence that introducing genes in to crops using GM techniques results in fewer changes to the crops than introducing them using conventional breeding.

"This is unfortunately rather a subtle point and is somewhat tangential to the immediate issue."

Prof Tom Sanders, Head of the Nutritional Sciences Research Division, King?s College London, said:

"Most toxicology studies are terminated at normal lifespan i.e. 2 years. Immortality is not an alternative.

"No food intake data is provided or growth data. This strain of rat is very prone to mammary tumours particularly when food intake is not restricted.


"There is a lack of information on the composition of the diet. One concern is whether there were mycotoxins in the maize meal because of improper storage. Zearalanone is a well know phytoestrogen produced by filamentous fungi that grow on maize.

"The statistical methods are unconventional, there is no clearly defined data analysis plan and probabilities are not adjusted for multiple comparisons."

Prof Mark Tester, Research Professor, Australian Centre for Plant Functional Genomics, University of Adelaide, said:

"The first thing that leaps to my mind is why has nothing emerged from epidemiological studies in the countries where so much GM has been in the food chain for so long? If the effects are as big as purported, and if the work really is relevant to humans, why aren?t the North Americans dropping like flies?! GM has been in the food chain for over a decade over there ? and longevity continues to increase inexorably!

"And if the effects are as big as claimed, why have none of the previous 100+ plus studies by reputable scientists, in refereed journals, noticed anything at all?

"Finally, of course, this was a study of one event with one gene. To then extrapolate to all genetically modified crops is absurd. Even if it eventuates that there is an issue with this one event, or even this one gene, there is no reason at all for other genes introduced using GM to carry the same burden of risk. GM is an adaptation of a natural process that occurs all the time all over the planet ? it is ?only? a technology, a technique. It is how it is used that is more important. Generalisations about the risk of the technology per se are absurd."

Prof Alan Boobis, Professor of Biochemical Pharmacology, Imperial College London, said:

"Some of the effects are presented in a way that makes it difficult to evaluate their significance. For example, there does not appear to be a statistical analysis of the mammary tumours. These occur quite often in untreated animals. One would usually also take into account the historical controls in the testing lab, in reaching a conclusion. The pesticide itself has been subject to long term studies in rodents by others."

?Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize? by Seralini et al., published in Food and Chemical Toxicology on Wednesday 19th September.

To contact the above please contact the Science Media Centre on 020 7670 2980

Note for editors

The Science Media Centre (SMC) is an independent venture working to promote voices, stories and views from the scientific community to the news media when science is in the headlines. Over 50 sponsors including scientific institutions, media groups, corporate organisations and individuals fund the Centre, with donations capped at 5% of the running costs to preserve its independence. The team at the Centre is guided by a respected Scientific Panel and Board of Advisors. This press release contains the personal opinions of those acknowledged; which represent neither the views of the SMC nor any other organisation unless specifically stated.

For more details see our website www.sciencemediacentre.org, please e-mail the Science Media Centre with your comments.
http://www.sciencemediacentre.org/pages/press_releases/12-09-19_gm_maize_rats_tumours.htm
 
Re: GM maize linked to tumours? Maybe not

I have changed the thread title to reflect the general disagreement with the conclusions made in the study.
 
Re: GM maize linked to tumours? Maybe not

EFSA publishes initial review on GM maize and herbicide study

Press Release

4 October 2012

The European Food Safety Authority has concluded that a recent paper raising concerns about the potential toxicity of genetically modified (GM) maize NK603 and of a herbicide containing glyphosate is of insufficient scientific quality to be considered as valid for risk assessment.

EFSA?s initial review found that the design, reporting and analysis of the study, as outlined in the paper, are inadequate. To enable the fullest understanding of the study the Authority has invited authors S?ralini et al to share key additional information.


Main findings of Initial Review

The task force, whose members were drawn from the Authority?s GMO, pesticide and scientific assessment units, has outlined a list of issues about the paper that would need to be resolved before it could be viewed as well-conducted and properly-reported study.

The strain of rat used in the two-year study is prone to developing tumours during their life expectancy of approximately two years. This means the observed frequency of tumours is influenced by the natural incidence of tumours typical of this strain, regardless of any treatment. This is neither taken into account nor discussed by the authors.

The authors split the rats into 10 treatment sets but established only one control group. This meant there was no appropriate control for four sets ? some 40% of the animals - all of whom were fed GM maize treated or not treated with a herbicide containing glyphosate.

The paper has not complied with internationally-recognised standard methods ? known as protocols - for setting up and carrying out experiments. Many of these procedures are developed by the OECD (Organisation for Economic Cooperation and Development).

For a study of this type, the relevant OECD guideline specifies the need for a minimum of 50 rats per treatment group. S?ralini et al used only 10 rodents per treatment set. The low number of animals used is insufficient to distinguish between the incidence of tumours due to chance rather than specific treatment effects.

The authors have not stated any objectives, which are the questions a study is designed to answer. Research objectives define crucial factors such as the study design, correct sample size, and the statistical methods used to analyse data - all of which have a direct impact on the reliability of findings.
No information is given about the composition of the food given to the rats, how it was stored or details of harmful substances ? such as mycotoxins ? that it might have contained.

It is not possible to properly evaluate the exposure of the rats to the herbicide as intake is not clearly reported. The authors report only the application rate of the herbicide used to spray the plants and the concentration added to the rats? drinking water but report no details about the volume of the feed or water consumed.

The paper does not employ a commonly-used statistical analysis method nor does it state if the method was specified prior to starting the study. The validity of the method used is queried and there are questions over the reporting of tumour incidence. Important data, such as a summary of drop outs and an estimation of unbiased treatment effects have not been included in the paper.

Many endpoints ? what is measured in the study ? have not been reported in the paper. This includes relevant information on lesions, other than tumours, that were observed. EFSA has called on the authors to report all endpoints in the name of openness and transparency.

Read more,: EFSA
 
Re: GM maize linked to tumours? Maybe not

machinetranslation

October 22, 2012

GM maize: HCB refutes the findings of Séralini and wants another study

PARIS - The High Council of Biotechnologies (HCB) Monday refuted the conclusions of controversial Professor Gilles-Eric Seralini [regarding the] toxicity of GM maize produced by Monsanto, but also recommended an independent long-term review of the corn.

HCB considers that there is no causal relationship between the observed events and the consumption of maize NK603, treated or not with Roundup. The experimental apparatus used is unsuitable for the study objectives, estimates the High Council, mandated by the government.

Findings from the deleterious effects of NK603 maize consumption are not supported by the analysis of the results presented in article, published in the journal Food and Chemical Toxicology 19 September, continues the HCB. It therefore considers that this Article shall not affect the findings of previous evaluations of this GMO.

The High Council will nevertheless address the concerns of society and recommends a long-term study, and contradictory or independent business under the government about the safety of NK603 maize.

More : Romandie

thanks to Makoto
 
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