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Ãâó http://weedcontrolfreaks.com/2015/03/glyphosate-and-cancer-what-does-the-data-say/

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Scientists react to republished Séralini GMO maize rat study
June 24, 2014 | Genetic Literacy Project

https://www.geneticliteracyproject.org/2014/06/24/scientists-react-to-republished-seralini-maize-rat-study/

Scientists around the world react as a controversial animal study on genetically modified (GM) corn and glyphosate-based herbicide that had been published and then retracted has been republished in expanded form in another academic journal.

The study, ¡°Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize¡± by a group of French scientists led by Gilles-Eric Séralini, claims that a Monsanto herbicide-tolerant GM corn and RoundUp, Monsanto¡¯s brand name for the herbicide, caused severe diseases and tumor growths in rats. It was republished today in the open-access journal Environmental Sciences Europe (SpringerOpen).

The study was originally published in Food and Chemical Toxicology (Elsevier) in September 2012. It met strong criticism from the scientific community almost immediately, with concerns ranging from the validity of the findings to the proper use of animals in the study. In November 2013, Food and Chemical Toxicology retracted the study.

In the previous publication, Séralini and colleagues faced immense pressure from the scientific community to release the raw data collected for the study. They did not do so then, but in the study¡¯s current republication and expanded revision, the raw data has been made available.

Here, the GLP posts a collection of the responses from scientists worldwide to the study and raw data release. We will post more reactions—critical and in support of the findings–as they become available.

David Spiegelhalter, Winton professor of the public understanding of risk at the University of Cambridge, said:

The article still does not appear to have had proper statistical refereeing, and the methods and reporting are obscure. The claimed effects show no dose-response, and so the conclusions rest entirely on a comparison with ten control rats of each sex. This is inadequate.

The study needs replicating by a truly independent laboratory using appropriate sample sizes. I agree with the authors that this whole area would benefit from greater transparency of data and improved experimental and statistical methods.

Joe N. Perry, quantitative ecologist and visiting professor of biometry at the University of Greenwich, said:

This paper appears to be based on the same data as Séralini¡¯s previous 2012 paper, with no real new information and only minor rephrasing and a few new references. Therefore, I doubt whether my conclusions would differ from those of the vast majority of independent members of the scientific community, who concluded in 2012 that there was insufficient evidence to justify the claims of CRIIGEN and Giles-Eric Séralini. However, I do welcome Séralini¡¯s promise to publish his raw data and my hope is that all organisations involved in GM risk assessment will, wherever possible in the future, publish in full their raw data in the spirit of full transparency and openness.

Marcel Kuntz, biologist, director of research at Centre National de la Recherche Scientifique (CNRS, France) and professor at University of Grenoble-Alpes, said:

The authors reach essentially the same conclusions that were already refuted and they don¡¯t take into account the fundamental criticisms addressed to them.

Looking specifically at the tumors:  The breed of rats used is subject to spontaneous tumor development. To identify a statistically reliable increase in tumors in a group of rats requires a large number of individuals. This re-publication is still deficient on this point.

These tumors were the most spectacular element of the media operation conducted by the authors. It should be noted that they showed photographs of three rats: a rat that used the GMO NK603, another that drank Roundup and a third absorbed both. Unlike the most basic scientific approach, no control rats (which didn¡¯t eat GMO or drink herbicide) were shown. These control rats are still not shown in the re-publication.

Disclosure statement for Marcel Kuntz:

My only income comes from my employers mentioned above (and marginally the copyright of my books). I have no current contract with a private company, or as an individual, nor to my laboratory. My current scientific work is basic research, unrelated to the marketing of a variety of plant (GM or not). I don¡¯t hold any patents, nor collect, nor received income as an inventor of a patent held by others. I do not identify any change in this situation in the foreseeable future.

Tom Sanders, professor of nutrition and dietetics at the King¡¯s College London School of Medicine, said:

Republishing data that was faulty in the first place in study design and analysis does not provide redemption. Furthermore, it is now possible to publish almost anything in Open Access journals!

Séralini did not follow conventional methods for assessing animal toxicity and made most of the measurements at the end of life. When a very large number of measurements are made, statistically significant differences will occur play of chance.

The figures of an animal with a large tumour serve no scientific purpose. There are numerous omissions of probabilities which could lead the less critical reader to infer differences that are not statistically significant.

Bruce Chassy, professor emeritus of food safety and nutritional sciences from the Department of Food Science and Nutrition at the University of Illinois, Urbana-Champaign, said:

The original Séralini paper was rejected for many reasons. Perhaps the most important of these was that the design of the study and the described methods for data collection were fatally flawed in a number of ways. No amount of rewriting or excuses for faults can make the data whole again. When the data are faulty, the experiment must be repeated with proper design and methods.

Food and Chemical Toxicology and Elsevier have acted poorly throughout this affair. It is difficult for experts to understand why Food and Chemical Toxicology published the paper since it is exceedingly challenging to find an expert peer-reviewer who cannot find numerous flaws in the paper. The journal then consumed more than a year to retract the paper.

Among the several reasons for retraction that Food and Chemical Toxicology failed to cite was the unethical use of animals in experiments which the Committee on Publication Ethics states is a reason for retraction.

Séralini now states that the research was not a cancer study. If that is true, then there was no reason not to euthanize animals when tumors were first detectable. There was nothing to gain or learn. This is unethical treatment of animals.

Christopher Preston, lecturer in the School of Agriculture, Food and Wine at the University of Adelaide said:

The sample sizes are too small, and there are too many treatments and not enough controls. The wrong breed of rat is used. As it is prone to high numbers of tumours, there is going to be a lot of noise and not enough statistical power. There is no dose response, i.e. they were just measuring noise. There are ethical issues with the treatment of the rats.

My guess at why Séralini has pulled out of the (EU) repeat is because other scientists want to do the trial correctly. Séralini knows he can find something to spin if it is done his way because the likelihood of one of the 9 treatments being different to the control is quite high.

Wayne Parrot, professor of crop science at the University of Georgia Institute of Plant Breeding, Genetics & Genomics, and Department of Crop & Soil Sciences, said:

Séralini to this day fails to say what about modification would cause cancer. It is as if a magical carcinogenic aura was imposed on the GMO. Looking at rat studies with a real carcinogen (Aristolochia herbs), the onset of tumors in a dose-dependent matter is rapid, and reaches 100% by 16 weeks. Séralini is not even in the ballpark.

Andrew Bartholomaeus, adjunct professor of toxicology and pharmacy at the School of Pharmacy, University of Canberra, and Therapeutic Research Unit, School of Medicine, University of Queensland said:

This paper is largely a re-publication of the original article published and subsequently retracted by Food & Chemical Toxicology due to concerns around the scientific quality of the study and its interpretation, with some amendments that qualitatively address some of the criticisms of the original.

The science of the original publication was carefully assessed by food regulatory agencies, including the European Food Safety Agency (EFSA) and Food Standards Australia NZ (FSANZ). EFSA concluded that the design analysis and reporting is of insufficient scientific quality to be relevant in the safety assessment process.

The damming criticisms of the European Society of Toxicologic Pathology (ESTP), the peak body for experts in the diagnosis and interpretation of animal pathology findings, remain most relevant. ESTP concluded that the interpretation of findings included such basic errors that they would ¡°be considered as a disqualifying mistake at an examination for pathologists¡± and stated they were ¡°shocked by the whole body photographs of animals bearing very large tumors¡¦ which should have been euthanized¡¦.much earlier¡¦¡¦.as the authors only illustrate that Sprague Dawley rats develop mammary tumors..(which are) common background lesions¡± in this strain of animal.

From a toxicological or food safety perspective the conclusions ANZ and international food regulatory agencies and peak scientific bodies suggest that the paper has insufficient scientific merit even to be considered controversial or provocative and will likely to be essentially irrelevant to the mainstream scientific community. None of the changes alter these fundamental criticisms.

In short the paper is likely to raise little more than a yawn amongst the mainstream toxicology and food regulatory communities. As an exercise in media management however the republication and associated commentary and media management such as the embargoes and limited access, reflects a masterful flair for publicity generation.

Unfortunately such studies, and the associated publicity, may lead to more serious public health consequences than those purported to be found in the studies themselves, as illustrated by the vandalism of field trials of Golden Rice in the Philippines, a crop being developed to alleviate the chronic disease and premature death of some of the worlds most desperate and disadvantaged children, suffering chronic vitamin A deficiency.

Declaration of interests for Andrew Bartholomaeus:

I have no direct financial interest in commercial biotechnology activities, either currently or at any time in the past. Before retiring I was the Branch head for the Risk assessment Branch of FSANZ, and prior to that the chief toxicologist for the prescription medicines branch of the TGA. I currently consult, primarily to Government, on science policy and practice in regulation and perform human health risk assessments for various areas of government.  I have also collaborated with ILSI (free of charge) to deliver workshops on biotechnology risk assessment for regulators around the world and to publish papers on this topic.

Ian Musgrave, senior lecturer in the Faculty of Medicine, School of Medicine Sciences, within the Discipline of Pharmacology at the University of Adelaide, said:

A French research study that claimed that rats fed a diet which contained a Roundup-tolerant genetically modified maize died more frequently and earlier over the two year study than control groups was retracted last year after widespread criticism of its methodology and interpretation. It has now been republished. However, the major flaws in this study still remain.

1)      The wrong controls were used – there should have been a non-GMO control for each level of GMO corn (i.e. there should have been an 11 per cent control for the 11 per cent GMO corn, a 22 per cent control for the 22 per cent GMO corn and 33 per cent standard corn for the 33 per cent GMO corn. As energy content, carbohydrate load and other components of the corn may affect tumour formation, this is a fundamental flaw which invalidates any conclusions.

2)      There is no dose response. For a substance to be an attributable cause of cancer, being exposed to more of the substance should result in more cases of cancer this just does not happen in this study.

3)      Furthermore, there is no consistent response to any of the measured outcomes that would even hint at a real adverse effect. The GMO corn had no effect on the number of tumours – Roundup even decreased the number of tumours in male rats, as did the combination of roundup and GMO corn in male rats (there was no consistent effect in female rats). High levels of GMO corn and high levels of roundup both reduced spontaneous mortality and pushed back the onset of death in male rats.

This shows that all we are seeing in these results is due to random variation in a poorly controlled experiment. It does not show that GMO corn, or roundup, even at concentrations that no human would ever be exposed to through diet, have no effect on cancer or mortality.

Thomas Lumley, professor from the Department of Statistics, University of Auckland, said:

I do not think the republication of the Séralini paper and the responses to critics answer any of the statistical concerns I had with the original paper. The main point of the response over sample size is to argue that some standard toxicological studies also use small sample sizes, which may be true but would not be relevant.

Although I do not find it convincing, I am pleased that the study is being republished. While I think it would have been reasonable to reject the paper initially, I was uncomfortable with a retraction that was not based on any new information or any accusation of wrongdoing, and said so at the time.

Since the responses to critics claim that much of the opposition is a smear campaign by people funded by Monsanto and the GM crop industry, I think it is appropriate to point out that I have never received funding from Monsanto or any company involved in GM crop technology.

Robert Wager, technician and faculty member in the Biology Department at Vancouver Island University, said:

There are two main issues with the data I think need explanation by Séralini. First, the basic rule of toxicology is the dose makes the poison. Everything can be toxic if the dose is high enough. Therefore all proper toxicology studies show dose response curves (the higher the dose, the greater the effect). None of the data in the Séralini paper show dose response curves.

The second point and probably more important point is the use of inappropriate strain of rats. Sprague-Dawley is a strain of rat that spontaneously generates tumors. For this reason they are extensively used in cancer research. One of the main criticisms of the original 2012 paper was the omission of the control rat data and photos. The re-release again does not show the control rats.

It is very clear that review of the science literature show the conclusions of Séralini et al. are not supported by the vast majority of publications in this area.

Disclosure statement for Robert Wager

I have no financial connection with any biotech company. I have never received any personal pay from any biotech company, nor does my institute receive/administer and grants from biotech companies. I have serious difference of opinion on GMO¡¯s with Séralini et al. but have no connection to him or his institute. I am an academic who hates the impact pseudo-science is having on public policy and that is my only motivation.

Alan McHughen, plant biotechnologist and geneticist at the College of Natural and Agricultural Sciences, University of California, Riverside, said:

The number of rats used was too small to detect a meaningful difference in treatments. In this ¡®new¡¯ study, the number of rats remains the same, too small to yield meaningful results. To illustrate for those not familiar, it¡¯s as if Séralini tossed a coin two times, and the coin came up ¡®heads¡¯ both times. With this result, Séralini is trying to convince us that he has a magic coin that only comes up ¡®heads¡¯.

The strain of rats used (Sprague-Dawley) was inappropriate for this type of two-year long study, as these rats have a natural predisposition to form tumors, regardless of the treatment. Séralini has not and can not justify this fatal error in experimental design

Séralini now asserts that he follows all European ethical guidelines for animal care. But he still shows rats with massive tumors, and the European ethical standards requires rats be euthanized when tumors reach 4 mm diameter. Clearly the rats in the photos have tumors larger than 4 mm, about the size of a small pea.

There¡¯s no dose response. In toxicity or carcinogenicity studies, increasing the dose of an actual toxin or carcinogen leads to greater effect. But Séralini¡¯s data do not show such dose effects, and Séralini still does not properly explain why.

In short, the ¡®new¡¯ paper will have the same impact as the original, retracted paper, because the original data were useless, and there is no new data. The methodology was faulty then, and, as there is no new methodology, it remains faulty now.

When the results of an experiment fail to reflect what we observe in the real world, the scientist knows the experimental design or interpretation must be wrong and tries to correct it. But Séralini insists his experiments and interpretations are fine; it¡¯s reality that¡¯s wrong.

Disclosure statement for Alan McHughen:

I am happy to advise that I am a public sector academic scientist serving the public interest, and as such, my research program is funded entirely from public sources; I do not accept private funds. As a result, I have no research connection to either Mr Séralini (or his coauthors), or CRIIGEN, or Monsanto.

Cami Ryan, professional affiliate with the Department of Bioresource Policy, Business and Economics at the College of Agriculture and Bioresources, University of Saskatchewan, said:

First, and most importantly, this is the same poorly designed scientific study that has been widely discredited by health and food safety agencies all over the world when it was published in 2012 (and subsequently retracted in 2013) by Food and Chemical Toxicology. Sample sizes and controls are still a problem (there are well-articulated OECD guidelines on this) and there are several holes in terms of interpretation of data.

If Séralini¡¯s goal here was the pursuit of good, quality science, he would have accepted the original retraction, paid mind to the broader criticisms that he received from subject-matter scientific experts and organizations and executed a new study (using an appropriate methodology) before attempting to publish again. Quality science is published in quality journals. If Séralini was really onto something here, it most certainly would have been taken up by more reputable academic journals such as Nature or Science.

Disclosure statement from Cami Ryan:

My current work is funded through various entities including not-for-profit grower groups and organizations as well as Genome Canada¡¯s Genome Prairie/GELS program. No conflict.

Peter Dearden, associate professor and director of Genetics Otago, Laboratory for Evolution and Development at the University of Otago, said:

The republication of the Séralini study raises a number of important issues to do with the scientific process. It must be noted that the paper being published is identical to the first one, which was initially attacked on methodological bases.

The paper is being republished because the authors feel it was unfairly retracted from Food and Chemical Toxicology. I think that the problem here is the controversial nature of the original paper.

This was a publication that gave some interesting results, but that needed to be replicated with larger numbers of rats in the experiment and, perhaps, a more statistically robust analysis. The paper was, in my mind, inconclusive, but pointed a direction in which future research could go.

After much public discussion the paper was withdrawn by the journal against the wishes of the authors. This is unusual. Even more unusual is the notice of retraction that states that the study was inconclusive, but there was no flaw or fraud in the original paper. Inconclusive data is no reason to retract a peer-reviewed and published paper.

The republication of this paper, and the rebuttals presented, have not changed my opinion. I am not convinced that the original paper indicates any danger of genetically modified food. I do think, however, that this research needs to be continued.

I am also convinced that retracting the original paper in this unusual way has not served the scientific process well. All good science is a debate, and one that should be held publically in published journals. Only through open publication, replication and exchange of scientific data can we use science effectively.

Controversial studies should not be buried because of public argument. They should be investigated, repeated, and new data published to either disprove or support the original findings. Only then do we get a clear and robust argument.

Jack Heinemann, professor of molecular biology and genetics at the University of Canterbury New Zealand, said:

The first publication of these results revealed some of the viciousness that can be unleashed on researchers presenting uncomfortable findings. I applaud Environmental Sciences Europe for submitting the work to yet another round of rigorous blind peer review and then bravely standing by the process and the recommendations of its reviewers, especially after witnessing the events surrounding the first publication.

This study has arguably prevailed through the most comprehensive and independent review process to which any scientific study on GMOs has ever been subjected.

The work provides important new knowledge that must be taken into account by the community that evaluates and reports upon the risks of genetically modified organisms, indeed upon all sources of pesticide in our food and feed chains. In time these findings must be verified by repetition or challenged by superior experimentation. In my view, nothing constructive for risk assessment or promotion of GM biotechnology has been achieved by attempting to expunge these data from the public record.

Michael Antoniou, head of nuclear biology group at King¡¯s College London, said:

Few studies would survive such intensive scrutiny by fellow scientists. The republication of the study after three expert reviews is a testament to its rigour, as well as to the integrity of the researchers.

If anyone still doubts the quality of this study, they should simply read the republished paper. The science speaks for itself.

If even then they refuse to accept the results, they should launch their own research study on these two toxic products that have now been in the human food and animal feed chain for many years.



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The Industry Funding Behind Anti-GMO Activist Gilles-Éric Séralini
By Genetic Literacy ... | June 19th 2015 08:00 AM | 7 comments | Print | E-mail | Track Comments
    
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Gilles-Éric Séralini is a French scientist who has been a professor of molecular biology at the University of Caen since 1991. Known for his research concluding that genetically modified food is unsafe for human consumption, his latest publication, scheduled for release in PLOS ONE on June 18, 2015–¡°Laboratory Rodent Diets Contain Toxic Levels of Environmental Contaminants: Implications for Regulatory Tests¡±– maintains that all safety studies of pesticides and genetically modified foods are ¡°invalid¡± because, the researchers claim, the dried feeds used as control diets for lab animals are ¡°contaminated¡± by GMOs, pesticides, heavy metals and other substances.

Funding for PLOS ONE Study and other Séralini Research

Funding for this study and much of Séralini¡¯s previous research comes directly from one of the US organic industry¡¯s leading figures Anthony Rodale–chairman emeritus of Rodale¡¯s Organic and founder of the Rodale Institute, a 501c3 that bills itself as ¡°advocating for policies that support farmers, and educating consumers about how going organic is the healthiest option for people and the planet.¡± Rodale works closely with former Patrick Holden, former director of the UK Soil Association, which calls itself a ¡°charity campaigning for planet-friendly organic practices¡± and ¡°healthy, humane and sustainable food, farming and land use.¡±.

They two provide money via a U.S. NGO known as the Sustainable Food Alliance (SFA) to overseas organic and anti-GMO groups, including scientists such as Séralini, without having to make the grants public. About US$2 million appears to have gone from this NGO to research for ¡°herbicide¡± and ¡°toxic evaluations¡± between 2011-2013. Seralini¡¯s research group acknowledged support from SFA in the PLOS ONE article. Séralini has previously received funding from Greenpeace, which financed a 2007 study that claimed that GM corn caused health problems in rats. The study was reviewed by the European Food Safety Authority, which concluded that all of the statistical anomalies cited by the study group were attributable to ¡°normal biological variation.¡±

Sources of funding listed for his current study:

CRIIGEN
JMG Foundation (formerly the Goldsmith Foundation, led by ecology environmental activist Ben Goldsmith)
Lea Nature, an organic and natural products company
Foundations Charles Léopold Mayer for the Progress of Humankind
Nature Vivante, an ecological trade association
Malongo, a fair trade, organic coffee company
Denis Gouchard, a natural living foundation
The Sustainable Food Alliance,a non-profit organization run by Rodale Organic¡¯s Anthony Rodale whose mission is ¡°To educate the public about the positive health and environmental benefits of organic food and farming.¡± Board members include: Patrick Holden, Owsley Brown, Clair Peters and Ed Baldrige.
Career
Séralini was born August 23, 1960 in Annaba, Algeria, then known as Bône. He is president and chairman of the board of CRIIGEN (Committee of Independent Research and Information. He has published multiple studies alleging health risks associated with plant biotechnology which have been called flawed and biased by various regulatory and academic groups.

Professor of Molecular Biology at the University of Caen, Laboratory of Biochemistry and Molecular Biology, I.B.F.A., Esplanade de la Paix, 14032 Caen Cedex, France. Séralini studied in Nice and became a Doctor in biochemistry and molecular biology at the University of Montpellier in 1987. He left then for North America to carry out fundamental research for four years, at the University of Western Ontario and Laval University Medical Center, doing research on corticosteroid-binding globulin. Qualified to supervise research, he passed, at the age of 30, the French national competitive exam for University Professors.

Séralini chose to focus on the interface of cancer research and endocrinology at the University of Caen, where he was appointed professor in June 1991, a position he has held ever since. He wrote about 100 scientific articles and conference papers for international specialist symposiums, and a number of lectures with a nation-wide impact, he assumes several roles in the Commissions of the University of Caen, where he leads a research team associated to CNRS (French National Centre for Scientific Research) and INRA.¡±

Research at CRIIGEN (Committee of Independent Research and Information on Genetic Engineering

Under the auspices of CRIIGEN, Séralini has published multiple studies claiming health risks associated with GMOs and the glyphosate-based herbicide Roundup on human cells and the enzyme aromatase in vitro, as well as rat testicular cells. His in vitro research has concluded that Roundup (the formulation with adjuvants, not just glyphosate) is toxic to cells in a dish, as well as that it is an endocrine disruptor.

In 2013, the Séralini lab published a study in the Journal of Applied Toxicology that examined the effects of Cry1ab and Cry1ac insecticidal Bt toxins, as well as their effects in conjunction with Roundup, on HEK cells

In his most controversial research, in 2012, Séralini et al published a study in the journal Food and Chemical Toxicology (Volume 50, Issue 11, November 2012, pages 4221-4231) titled ¡°Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize¡±. Here is the original abstract of the Food and Chemical Toxicology paper.

This study informed the banning of genetically modified foods by the Kenyan government in November 2012[2]. On November 28, 2013, however, the journal[3] retracted the article due to strong criticism from the scientific community about the way the study was conducted. The editor, A. Wallace Hayes, wrote that he retracted the paper because it was ¡°inconclusive,¡± claiming that this was consistent with Committee on Publication Ethics (COPE) guidelines, although others disagreed.

On June 24, 2014, the retracted study, in expanded form was republished with the tile ¡°Republished study: long-term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize¡± in an obscure open source journal, Environmental Sciences Europe—where Seralini had published before. [For an analysis of the study, click here] The journal, part of SpringerOpen, is too young to have an official Impact Factor (IF). Using the same calculation, however, the journal would have an IF of .55. That would place it about 190th out of the 210 journals in the ¡°environmental sciences¡± category at Thomson Scientific. (For comparison, Food and Chemical Toxicology has an IF of just above 3, and a ranking of 27th.)

This study is almost identical to the prior study, with some minor but important differences. Séralini claimed in a press release that the republished study was peer reviewed but that is not accurate, according to the publishing journal¡¯s editor made to Nature magazine. ¡°We were Springer Publishing¡¯s first open access journal on the environment, and are a platform for discussion on science and regulation at a European and regional level.¡±

ESEU conducted no scientific peer review, said editor Henner Hollert, ¡°because this had already been conducted by Food and Chemical Toxicology, and had concluded there had been no fraud nor misrepresentation.¡± The role of the three reviewers hired by ESEU was to check that there had been no change in the scientific content of the paper, Hollert added.

As before, the study claimed that rats fed a diet containing NK603—a seed variety made tolerant to the spraying of glyphosate (Monsanto¡¯s Roundup herbicide)—died earlier than those on a standard diet. The Séralini team reported that 50 percent of males and 70 percent of females died prematurely, compared with only 30 percent and 20 percent in the control group. The number of rats used in the study was too small to draw statistically meaningful conclusions.

The study team also selected a breed of rat to use in the experiments in which 80 percent routinely develop cancers, further obscuring the results. Some of the rats fed GM corn outlived the control group, further confusing the picture. The newly-released study, as the first version, did not include any pictures of the control rats. Critical scientists say that is most likely because the type of rat used is tumor prone and would almost certainly show numerous tumors after two years of life; including pictures of control rats with tumors would further undermine Séralini¡¯s claims that the cancer was caused by the corn or glyphosate.

In 2014, Séralini et al. published a study in BioMed Research International claiming that pesticides were more toxic than regulatory bodies had previously thought. The study prompted Ralf Reski, one of the editors of the journal in which it was published, to resign. Reski said, ¡°I do not want to be connected to a journal that provides [Séralini] a forum for such kind of agitation.¡±

Séralini Affair

What became known as the Séralini Affair began in September 2012, and involved the publication of an experiment conducted by a group led by Séralini involving the feeding of of Monsanto¡¯s Round-Up-resistant NK603 maize (called corn in North America) and the herbicide Round-Up to rats, over the rats¡¯ two-year lifespan.

Séralini had required that journalists, in order to receive a copy of the paper prior to the press conference, sign a confidentiality agreement prohibiting them from contacting other researchers for comment before the press conference. During the press conference, Séralini also announced he was releasing a book and a documentary film on the research. The press conference received extensive coverage in the media.

In the paper and in the press conference, Séralini claimed that the results showed that Round-Up-resistant maize and Round-Up are toxic. The abstract indicates: ¡°The health effects of a Roundup-tolerant genetically modified maize (from 11% in the diet), cultivated with or without Roundup, and Round-Up 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.¡±

The study used 200 Sprague-Dawley rats, 100 male and 100 female, and divided them into twenty groups with 10 rats each; ten experimental conditions were tested on male rats and separately on female rats for two years.

Other long-term studies, which were publicly funded, have uncovered no health issues. The Japanese Department of Environmental Health and Toxicology released a 52-week feeding study of GM soybeans in 2007, finding ¡°no apparent adverse effect in rats.¡± In 2012, a team of scientists at the University of Nottingham School of Biosciences released a review of 12 long-term studies (up to two years) and 12 multi-generational studies (up to 5 generations) of GM foods in the same journal that published the Seralini paper, concluding there is no evidence of health hazards.¡±

The release of the book and movie in conjunction with the scientific paper, and the requirement that journalists sign a confidentiality agreement, were also criticized and negatively peer reviewed.

Scientific evaluation
As summarized on Wikipedia, the study was widely criticized. The London-based Science Media Centre, which assists reporters when major science news breaks, posted an entire page of criticisms,Scientists claimed that Séralini¡¯s conclusions were impossible to justify given the experimental design – the small sample size together with the length of the study together with the known high incidence of tumors in the species of rats used.

The paper was also challenged by numerous food standards agencies. Many claimed that the conclusions were impossible to justify given the statistical power of the study. Sprague-Dawley rats have a lifespan of about two years and have a high tendency to get cancer over their lifespan (one study found that over eighty percent of males and over seventy percent of females got cancer under normal conditions).

The Séralini experiment lasted the normal lifespan of these rats, and the longer the experiment went, the more statistical ¡°noise¡± there was – the more rats get cancer naturally, regardless of what was done to them. For the experiment to have adequate statistical power, all the groups – control groups and test groups – would have to number at least 65 rats per group in order to sort out any experimentally caused cancers from cancers that would occur normally – but the Séralini study had only ten per group.

OECD (Organisation for Economic Cooperation and Development) guidelines recommends 20 rats for chemical-toxicity studies, and 50 rats for carcinogenicity studies. In addition, if the survival of the rats is less than 50% at 104 weeks (which is likely given the Sprague-Dawley rats used in the study) the recommended number of rats is 65.

Dr. Francis Nang¡¯ayo of the African Agricultural and Technology Foundation[4] criticized the study for having used rats that were susceptible to cancer. ¡°In science, the sample size for a study of such a magnitude should be at least 50 yet Seralini used only ten rats which to me greatly compromise the findings,¡± added Mr. Nang¡¯ayo.

King¡¯s College London Professor Tom Sanders wrote that since Sprague-Dawley rats are susceptible to mammary tumors when food intake is not restricted, data should have been provided about how much food the rats were fed (as well as the presence of fungus in the feed, another confounder). Sanders also wrote of this study, ¡°The statistical methods are unconventional ¡¦ and it would appear the authors have gone on a statistical fishing trip.¡±

The Washington Post quoted food activist and GMO critic Marion Nestle, the Paulette Goddard professor in the Department of Nutrition, Food Studies and Public Health at New York University: ¡°¡®[I] can¡¯t figure it out yet¡¦.It¡¯s weirdly complicated and unclear on key issues: what the controls were fed, relative rates of tumors, why no dose relationship, what the mechanism might be. I can¡¯t think of a biological reason why GMO corn should do this¡¦..So even though I strongly support labeling, I¡¯m skeptical of this study.'¡±

University of Calgary Professor Maurice Moloney, among others, wondered why there were so many pictures in the study, and in sympathetic news reports about it, of treated rats with horrific tumors, but no pictures of the rats in the control group.

Many national food safety and regulatory agencies reviewed the paper and condemned it. The German Federal Institute for Risk Assessment VP Reiner Wittkowski said in a statement, ¡°The study shows both shortcomings in study design and in the presentation of the collected data. This means that the conclusions drawn by the authors are not supported by the available data.¡±

A joint report by three Canadian regulatory agencies also ¡°identified significant shortcomings in the study design, implementation and reporting.¡± Similar conclusions were reached by the French HCB and the National Agency for Food Safety, the Vlaams Instituut voor Biotechnologie, the Technical University of Denmark, Food Standards Australia New Zealand, the Brazilian National Technical Commission on Biosafety, and the European Food Safety Authority (EFSA). The conclusions of the EFSA evaluation were:

The study as reported by Séralini et al. was found to be inadequately designed, analysed and reported¡¦The study as described by Séralini et al. does not allow giving weight to their results and conclusions as published. Conclusions cannot be drawn on the difference in tumour incidence between treatment groups on the basis of the design, the analysis and the results as reported. Taking into consideration Member States¡¯ assessments and the authors¡¯ answer to critics, EFSA finds that the study as reported by Séralini et al. is of insufficient scientific quality for safety assessments.

The European Federation of Biotechnology lobby, which counts Monsanto and other GM firms among its members, called for the paper to be retracted, calling its publication a ¡°dangerous failure of the peer-review system.¡±

Six French national academies (of Agriculture, Medecine, Pharmacy, Science, Technology and Veterinarians) issued a joint statement – ¡°an extremely rare event in French science¡±– condemning the study and the journal that published it. The joint statement dismissed the study as ¡®a scientific non-event¡¯.

The Food and Chemical Toxicology journal, an Elsevier imprint, has a full peer review process, and at least three scientists were needed to endorse the Seralini article prior to publication. The journal in question published a statement in their November 2012 issue, that ¡°the Editors have encouraged those people with concerns to write formally to the Editor-in-Chief, so that their views can be publicly aired.¡±

In March 2013, the same journal that published the Seralini study, published a letter from Erio Barale-Thomas, Principal Scientist of Johnson&Johnson Pharmaceutical Research and Development and the President of the Conseil d¡¯Administration of The Société Française de Pathologie Toxicologique (SFPT, French Society of Toxicologic Pathology. SFPT is ¡°a non governmental/non profit organization formed by veterinarians, physicians, pharmacists and biologists specialized in veterinary and toxicologic pathology.

The letter criticized the Seralini study on several fronts, and concluded: ¡°However, given this study presents serious deficiencies in the protocol, the procedures and the interpretation of the results, the SFPT cannot support any of the scientific claims drawn by the authors, and any relevance for human risk assessment. This letter presents the consensus scientific opinion of the Conseil d¡¯Administration of the SFPT.¡±

As a result of the publication of the Séralini paper, the Belgian Federal Minister of Public Health asked the Belgian Biosafety Advisory Council (BBAC) to evaluate the paper. The BBAC was asked to ¡°inform the Minister whether this paper (i) contains new scientific information with regard to risks for human health of GM maize NK603 and (ii) whether this information triggers a revision of the current authorisation for commercialisation for food and feed use of this GM maize in the European Union (EU). Responding to the two point mandate, the BBAC committee, whose members are drawn from the Belgian biotech Professoriat, pointed out that ¡°the long duration of this study is a positive aspect since most of the toxicity studies on GMOs are performed on shorter periods,¡± and concluded:

¡°Given the shortcomings identified by the experts regarding the experimental design, the statistical analysis, the interpretation of the results, the redaction of the article and the presentation of the results, the Biosafety Advisory Council concludes that this study does not contain new scientifically relevant elements that may lead to reconsider immediately the current authorisation for food and feed use of GM maize NK603. Considering the issues raised by the study (i.e. long term assessment), the Biosafety Advisory Council proposes EFSA urgently to study in depth the relevance of the actual guidelines and procedures. It can find inspiration in the GRACE project to find useful information and new concerted ideas.¡±

Support for Séralini paper
According to Wikipedia, Séralini defended the study design, the interpretation of the results, and manner and content of the publication. Support for the study came from ENSSER (European Network of Scientists for Social and Environmental Responsibility), of which CRIIGEN, the institute that Seralini founded and that funded the study, is a member.

A study funded by and conducted in consultation with ENSSER also found that EFSA applied double standards. An open letter in support of Seralini¡¯s article, signed by about 300 scientists, doctors, scholars and activists, was published in Independent Science News, a project of the Bioscience Resource Project, both of which oppose GM crops.

The German research group Testbiotech, which opposes GMOs and which believes that regulators have been captured by the biotech industry, posted a report critical of the EFSA¡¯s reaction to the study as not applying the same standards to studies submitted by industry as it did to Seralini¡¯s study.

A statement opposing the controversy, and especially the attacks on Seralini, was published in the newspaper Le Monde and was signed by 140 French scientists; the letter said: ¡°We are deeply shocked by the image of our community that this controversy gives citizens. Many of the threats to our planet have been revealed by scientists isolated and confirmed by many studies coming from the scientific community.

In this case, it would be more efficient to implement research on the health and environmental risks of GMOs and pesticides, improve toxicological protocols used for placing on the market and finance a variety of researchers in this domain¡¦.¡±

Reaction in the media
The press conference led to wide coverage in the media, which ¡°energized opponents of GM food, especially in Europe¡±. Le Nouvel Observateur covered the press conference in a story called, ¡°Yes, GMOs are poisons!¡±.

As Jon Entine put it in Forbes, ¡°Seralini¡¯s research is anomalous. Previous peer-reviewed rat feeding studies using the same products (NK603 and Roundup) have not found any negative food safety impacts.

Andrew Revkin dubbed it another instance of ¡°single-study syndrome¡±, and contended that the study was in support of an ¡°agenda¡±.

Henry I. Miller, writing for Forbes, said of the study that ¡°the investigators have refused to release all the data from the experiment, which constitutes scientific misconduct.¡± Séralini responded by saying, ¡°¡¦that he won¡¯t make any data available to the EFSA and the BfR until the EFSA makes public all the data under-pinning its 2003 approval of NK603 maize for human consumption and animal feed.¡±

The Guardian¡¯s Environmental Blog stated that the study linking GM maize to cancer ¡°must be taken seriously by regulators¡± and that although it ¡°attracted a torrent of abuse¡±, ¡°it cannot be swept under the carpet¡±. It noted that CRIIGEN funded the research although it did not report the source of the funds from organic interests and Greenpeace, which are vocal in opposition to genetic modification, and reported Séralini¡¯s response: namely, that studies in support of GM food are usually funded by ¡°corporates or by pro-biotech institutions¡±.

GMO-Seralini
The Seralini research claims are officially promoted via a website run and managed by U.K. organic exporter, Sustainable Pulse publisher and anti-GMO activist Henry Rowlands.[5]

Advocacy
Funding
Séralini¡¯s research campaign (reported to be more than 5 million Euros was funded in part with more than 3.2 million Euros by French organic food giants Auchan and Carrefour.[6] A million euros were also donated by the the Fondation pour le progrès de l¡¯homme (FPH – Foundation for the Progress of Humankind), a foundation with a reputation for generosity towards an assortment of anti-GMO groups. Séralini¡¯s work is also funded by the activist group Greenpeace.

Publicity for the release of his GMO rat feeding study claims was coordinated by the Sustainable Food Trust (SFT) lead by former UK organic industry Soil Association executive director Patrick Holden. A PR agency called Greenhouse PR managed the events, with media releases, sample tweets etc. and a press release telling media that ¡°for pictures of the rats contact Greenhouse PR¡± (this page has since been removed from the Sustainable Food Trust website).

Greenhouse PR also helped Sustainable Food Trust leverage Patrick Holden¡¯s close relationship with the Prince of Wales to try to secure positive media coverage for Séralini¡¯s controversial GMO corn study. Its website says: ¡°Greenhouse helped organise a series of events hosted by Patrick Holden at Highgrove Farm, home of the Prince of Wales. Events were attended by leading industry opinion formers and key media and included off-the-record debates on issues related to the future of food and farming, followed by a guided tour of the farm.

To raise awareness of GM on behalf of the SFT, Greenhouse also launched peer-reviewed scientific research into the impact of GM feed on the health of rats, accompanied by an educational website calling for more regulation and research.¡±[7] Former SFT staffer Henry Rowlands, now an organic marketing exporter and publisher, hosts and maintains the GMO-Seralini official websites. Seralini is linked to a company called Sevene Pharma, where he is a consultant. The company sells homeopathic remedies. He is also reportedly linked to the ¡®Invitation to Life¡¯ cult.




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