seralini bak
12/15
==
wikipedia 819
Republication
In June 2014, the original study was republished with the addition of the entire data set, in the journal Environmental Sciences Europe.[91][92] The entire data set was published because of requests from the national regulatory bodies CFIA, EFSA, FSANZ, ANSES and BfR.[93]
The editor said that the paper was republished without further scientific peer review, "because this had already been conducted by Food and Chemical Toxicology, and had concluded there had been no fraud nor misrepresentation."[92] The republication renewed the controversy, but now with additional controversy over the behavior of the editors of both journals.[94]
In July 2015, the International Agency for Research on Cancer published a monograph on glyphosate, which contained an evaluation of the Séralini paper as republished in June 2014 and the conclusion, that the study "was inadequate for evaluation because the number of animals per group was small, the histopathological description of tumours was poor, and incidences of tumours for individual animals were not provided."[95]
https://allianceforscience.cornell.edu/blog/2018/06/european-studies-disprove-seralinis-gmo-maize-tumor-claims/
june 2018
Three European studies have disproved Gilles-Éric Séralini’s widely circulated claims that genetically modified maize (corn) induces tumors in rats.
Séralini, a professor at the University of Caen, published his sensational claims in Food and Chemical Toxicology in September 2012, and used them to call for long-term GMO feeding studies. Though the publication later retracted his study, anti-GMO groups have continued to circulate Séralini’s conclusions in a bid to stoke fears about the safety of GM foods.
Now three studies — GRACE and G-TwYST, funded by the European Union, and GMO90+ in France — have refuted Séralini’s main conclusions about the toxicity of herbicide-tolerant (Roundup Ready) maize. The research — conducted to address concerns raised by the Seralini study and provide the EU with guidance on the need for long-term studies — identified no potential risk from the product.
“European consumers must be informed of the results of these studies, [which] should reassure them on the quality for their health of genetically modified plants authorized for commercialization and on the European evaluation procedure, already the most rigorous in the world,” theFrench Association of Plant Biotechnology (AFBV) stated. “In addition, these new studies contradict Seralini’s proposal on the need to carry out long-term studies.”
The EU requires applicants to conduct a 90-day feeding assessment study on whole GMO food/feed before it can be placed on the market. The original assessment conducted for herbicide-tolerant maize identified no potential risk to humans.
“The G-TwYST (GM Plant Two Year Safety Testing) data from 90-day and long-term rodent feeding studies did not identify potential risks as well, and therefore support the results from the initial analyses,” according to the study’s conclusions and recommendation’s document, which was presented at an[UNNAMED?] April 29, 2018 conference in Bratislava, Slovaki.
“It was concluded that there were no adverse effects related to the administration of the GM maize NK603 cultivated with or without Roundup,” the report stated.
The research included a combined chronic toxicity and carcinogenicity study, and “no toxicologically relevant effects related to the GM maize NK603 or the GM maize NK603 treated with Roundup were observed,” the report stated.
The GRACE (GMO Risk Assessment and Communication of Evidence) study conducted two 90-day feeding trials on rats using two different varieties of maize genetically modified to resist insect pests and tolerate glyphosate. “The results showed that the two GM maize varieties tested did not trigger any negative effects in the trial animals,” according to a report on the findings.
Additionally, data showed the GM maize did not affect the immune functions tested in both of the 90-day studies.
The GRACE study was published in Archives of Toxicology.
The GMO90+ study also assessed the Bt maize, using a 180-day feeding trial, and found no negative effects on the rodents.
In addition to addressing concerns raised by the Séralini study, the research was intended to provide the EU with guidance whether it’s necessary to conduct a two-year carcinogenicity feeding trial on rats with whole food/feed. “The necessity to perform a feeding trial with whole food/feed should be carefully evaluated given the high number of animals needed,” the G-TwYST report concluded.
Due to the controversial nature of the research, “substantial efforts were made to ensure stakeholder engagement, transparency and data accessibility,” the G-TwYST report stated. “These included stakeholder engagement in both project plans and results; making available draft research plans and preliminary research results (all data produced) for stakeholder scrutiny; a procedure for discussing, systematically considering and responding to all stakeholder comments as well as tracking how the comments were considered in the project; detailed documentation and transparency of all steps; open access publications, and an open access repository for raw data to be available following academic publication of the results. The approach received high praising from the majority of stakeholder participants.”
The report further noted: “These challenges and the considerable resources and efforts needed do not suggest this approach to be used on a routine basis. Yet, in case of highly contested scientific-technical issues and polarized views, the approach remains an interesting option to improve the quality and social robustness of research.”
The results from the experiments are now published on envision.com.
==
https://gmwatch.org/en/news/latest-news/18310-eu-funded-rat-feeding-studies-do-not-refute-seralini-study
9/18
Pro-GMO lobby groups have been caught misrepresenting EU studies to claim they "disprove" the findings of harm in the Séralini study
Two pro-GMO lobby groups, the Alliance for Science and the AFBV (l’Association Française des Biotechnologies Végétales) in France, are frantically busy trying to spin the results of EU-funded rat feeding studies with GM crops. These groups claim that the EU studies' findings disprove the findings of the Séralini study that the GM maize NK603 and the glyphosate-based Roundup herbicide it is engineered to tolerate caused adverse health impacts in rats. The Alliance's headline was "European studies disprove Séralini’s GMO maize tumor claims", while the AFBV's was "Three studies disprove the results of the Séralini study on GM maize".
The AFBV declared that the EU studies "refute the main conclusions drawn from the Séralini studies [sic.] on the toxicity of the analyzed GMO maize: no potential risk has been identified. In addition, these new studies contradict Séralini's proposal on the need to carry out long-term studies."
The lobbying efforts concern the EU-funded feeding study programmes known as GRACE and G-TwYST, as well as the GMO90+ study arranged by the French government.
However, both lobby groups are making false statements and misleading claims, with the apparent aim of pulling the wool over the eyes of the public and regulators.
The studies
The three EU research programmes mentioned in the AFBV press release are known as G-TwYST, GRACE, and GMO90+. These inter-related programmes include the following rat feeding studies:
* G-TwYST – 90-day subchronic and 2-year combined chronic toxicity and carcinogenicity studies on Roundup-tolerant GM maize NK603
* GRACE – 90-day and 1-year studies on Bt maize MON810
* GMO90+ – 6-month (180 days) studies on MON810 and NK603 maize, looking at biomarkers of health effects.
The holes in the GMO lobby's arguments
Below is a rundown of the gaping holes in the pro-GMO lobbyists' arguments. To the shame of science, the lobbyists are being supported in their misrepresentations and falsehoods by the researchers themselves.
1. Lobbyists are passing judgement on a study before it's published
The AFBV and the Alliance for Science are passing judgement on the findings of the G-TwYST 2-year carcinogenicity experiment on GM NK603 maize before they have been published in a peer-reviewed journal. We don't yet know if this study uncovered any real or potential risks that are being downplayed by the lobbyists and potentially even the researchers themselves.
All that is publicly known about the results of G-TwYST 2-year experiment is what was said at a press conference. Without supplying any detail, the researchers claimed that the results of this experiment and the shorter 90-day one on the same GMO "did not identify potential risks" from NK603 maize.
The public would be well advised to take this claim with a pinch of salt until the full results are published. Several EU-funded studies on GMO health effects have been misrepresented and lied about in order to pretend that GMOs are safe. The truth about the findings of these studies is not to be found in press conferences or summaries but deep within the detail of the published study.
As an example, we need look no further than the 90-day GRACE study invoked by the AFBV as proof of GMO safety. In this instance, the researchers themselves appeared to be chiefly responsible for the deception. They claimed that no adverse effects were seen in the GM-fed animals. But closer examination of the published study revealed that the rats fed MON810 maize showed a decrease in total serum protein concentration and pancreas weight and an increase in blood glucose levels, even at the lowest dose.
Surprisingly, the authors did not discuss these changes in conjunction, in spite of the well-known role of the pancreas in the regulation of blood glucose levels. Instead the discussion remained silent on the statistically significant and dose-dependent decrease of the relative pancreas weight and dismissed the significant increase in blood glucose because it was seen only in males of Trial A, conducted with one line of MON810 maize. However, the pancreas weight was not only decreased in males of Trial A, but also in males of Trial B, conducted with a second line of GM maize, although this change was not statistically significant. In the experiment as a whole, no "safe" level for this GM maize was found. Nonetheless the researchers dismissed all these findings as not toxicologically relevant, without a valid scientific justification.
In another historical example, a previous series of EU-funded 90-day rat feeding studies on GM rice was claimed by an EU Commissioner and various pro-GMO lobbyists to provide evidence of GMO food safety. But a close reading of the published studies revealed that all found changes in the GM-fed animals, which in some cases were statistically significant. The changes, including differences in organ weights and immune responses, were almost certainly adverse. None of the studies was able to conclude on the safety of the GM food tested, let alone of GM foods in general.
It seems that the pro-GMO lobbyists were banking on the assumption that people wouldn't actually read the studies but would just believe the soundbites they supplied in press releases, summaries, and quotes to the press.
False claims of "no effect" in a GMO feeding study are easier to get away with if they are made before the study appears in print, as no one can check if the claims are true.
This brings us to a revealing double standard in operation regarding GMO safety studies. It appears that it is a cardinal scientific sin to go public with such claims prior to peer-reviewed publication – but only if the message is that the GMO causes harm. If the message is that the GMO is safe, there's no problem with jumping the gun and going public with claims before the study has been published.
For example, in the 1990s, Dr Arpad Pusztai was condemned by the pro-GMO scientific establishment for going public with his study findings of adverse health effects in rats fed GMO potatoes before the data were peer-reviewed and published. But the same standard does not seem to apply to the G-TwYST researchers. They have not been challenged for announcing their non-peer-reviewed conclusions that the GMOs they tested were safe. Instead they claimed the moral high ground by suggesting that their approach exemplified "stakeholder engagement" and "transparency".
Why would the G-TwYST researchers agree to go public before their results are properly published and universally available, if it were not to collude in the attempt to spin them to the advantage of the pro-GMO lobby? Such a motivation would explain why they interpreted their study findings at their press conference to challenge the EU requirement for animal feeding studies on GMOs to be carried out prior to commercialisation. This theme has been enthusiastically taken up by pro-GMO lobbyists: the AFBV claimed that the results of the EU studies contradict Séralini's demand for long-term studies on GMOs; and the Julius Kühn-Institut, a federal research institution of the German Ministry of Agriculture, recommendedthat in light of the study results, the EU animal feeding trial requirement should be discontinued.
Indeed, people involved in the GRACE and G-TwYST studies have conflicts of interest with the agricultural GMO industry. The GRACE project coordinator isJoachim Schiemann, who is also the director of the biotechnology department at the Julius Kühn-Institut. According to a Testbiotech report, Schiemann is at the centre of a network of industry agencies and international organisations with strong ties to the GMO industry, which systematically influence research and federal agencies.
2. Lobbyists are comparing apples to oranges
The EU-funded studies are very different from the Séralini study in design and methodology and are therefore not comparable.
The Séralini study was a two-year general toxicology study investigating the effects of Roundup-tolerant GM maize and its associated herbicide, Roundup, tested together and alone. The effects of Roundup were not tested in any of the EU studies (see also point 3 below).
The main finding of the Séralini experiment was that a very low dose of Roundup herbicide, lower than that allowed in drinking water in the EU, caused liver and kidney damage. The liver damage finding was later confirmed by separate experiments at a different institution, using "omics" molecular profiling techniques. The results showed that the rats dosed with this so-called "safe" level of Roundup suffered from non-alcoholic fatty liver disease.
The two GRACE studies tested a different type of GM maize than Séralini – MON810 Bt insecticidal maize, as against NK603 Roundup-tolerant maize in the Séralini study. At 90 days and 1 year in duration, the GRACE studies wereshorterand thus not able to detect long-term effects of the type found in the Séralini study.
The 2-year G-TwYST study was as long as the Séralini study but had a narrowly focused and different aim: to assess carcinogenicity. However, unlike the Séralini study, it did not measure the chronological development of tumours into cancer. In addition, its study of general toxicology (with urine and regular blood tests) did not exceed one year, as compared with 2 years in the Séralini study.
As for the GMO90+ study, despite the implementation of "omics" techniques, it was limited to 6 months and addressed a different question.
Crucially, the GRACE studies and the G-TwYST studies used a different strain of rat than Séralini – the Wistar as opposed to the Sprague-Dawley. Their sensitivity is different, especially with regard to mammary tumours such as fibroadenomas, which were observed to increase in some treatment groups in the Séralini study.
The Sprague-Dawley strain is recommended by the US Toxicology Program for carcinogenicity studies and is a standard strain used in industry carcinogenicity studies performed for regulatory purposes. Monsanto used it in many of its carcinogenicity studies on glyphosate (the active ingredient of Roundup), as well as in its 90-day study on NK603 maize.
Therefore in their published study, the EU researchers should justify why they chose to use a potentially less sensitive strain.
Due to all these factors, the EU studies are in no way comparable to the Séralini study and thus are not able to "disprove" his findings.
3. The GMO maize tested in the EU studies is not representative of what's being grown and eaten
According to an analysis by Testbiotech, the maize cultivated in Canada and used for the G-TwYST carcinogenicity study is not representative of NK603 that has been grown under real farming conditions. The maize was only sprayed once with glyphosate with a dosage of 1.35 kg/hectare about one month after sowing. As the feed analysis shows, the residues from spraying with glyphosate were present at a very low level, below 0.5 mg/kg. Under real farming conditions, glyphosate-tolerant maize is often sprayed with Roundup more than once and with higher dosages per hectare. The application of Roundup can influence the level of residues and the composition of biologically active substances in the plants. Therefore this particular maize cultivation is not relevant for assessing the potential adverse health effects triggered by consumption of NK603 maize as it is usually grown.
4. Long-term effects of Roundup were not examined in the EU studies
The important shortcoming of the EU studies on GMOs is that the pesticide component of the Séralini study – measuring the long-term effects of Roundup herbicide – was not included in any of these studies. Séralini's experiment remains the only feeding study to have evaluated the effects of long-term consumption of low, realistic doses of a pesticide in its commercial formulation. These results remain in the scientific literature and have never been refuted.
Once again, in the wake of the EU studies, pro-GMO lobbyists are trying to divert the debate about the serious public health risks of a product that regularly contaminates our food supply and environment – and our bodies.
Séralini's attackers not credible sources
The AFBV's latest desperate attacks on the Séralini study are not surprising, given its record. The AFBV and its then president Marc Fellous previously resorted to personal attacks on Séralini after failing to argue the case against his study on a scientific basis. They were subsequently found guilty of libel in a lawsuit brought by Séraliniand his research group at the University of Caen together with CRIIGEN, the French research institute with which Séralini is affiliated.
Fellous presents himself as an independent scientist but in the court case it was revealed that he owns patents through a company based in Israel. This company in turn sells patents to corporations such as Aventis.
According to a press release from Séralini and the University of Caen, several members of the AFBV participated in the French commission for the evaluation of agricultural GMOs and thus would have approved GM crops as safe. So in effect, in attacking the Séralini study, they are defending their own previous opinions on GMOs.
As for the Alliance for Science, it purports to be a science-based organisation but presents only one side of the GMO debate – the pro-GMO side. It made an unsubstantiated claim to the BBC that an experimental GM plant, Bt brinjal (eggplant) had been a 90% success in Bangladesh. When challenged, it could not produce any evidence for the claim.
Stacy Malkan of the transparency group US Right to Know has accused the Alliance of abandoning scientific objectivity and instead operating as a "a global hub for the promotion of GM crops and food" and a "public relations arm for the agrichemical industry".
In contrast to the unscientific approach of these two lobby groups, GMWatch will await the full publication of the G-TwYST results before giving its opinion on what they say about the risks of the GM foods tested.
Report: Claire Robinson
nestle provides:
by Claire Robinson and Jonathan Latham, PhD
Richard Smith, former editor of the British Medical Journal, has jested that instead of scientific peer review, its rival The Lancet had a system of throwing a pile of papers down the stairs and publishing those that reached the bottom. On another occasion, Smith was challenged to publish an issue of the BMJ exclusively comprising papers that had failed peer review and see if anybody noticed. He replied, “How do you know I haven’t already done it?”
As Smith’s stories show, journal editors have a lot of power in science – power that provides opportunities for abuse. The life science industry knows this, and has increasingly moved to influence and control science publishing.
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RICHARD E GOODMAN, UNIVERSITY OF NEBRASKA
The strategy, often with the willing cooperation of publishers, is effective and sometimes blatant. In 2009, the scientific publishing giant Elsevier was found to have invented an entire medical journal, complete with editorial board, in order to publish papers promoting the products of the pharmaceutical manufacturer Merck. Merck provided the papers, Elsevier published them, and doctors read them, unaware that the Australasian Journal of Bone and Joint Medicine was simply a stuffed dummy.
Fast forward to September 2012, when the scientific journal Food and Chemical Toxicology (FCT) published a study that caused an international storm (Séralini,et al. 2012). The study, led by Prof Gilles-Eric Séralini of the University of Caen, France, suggested a Monsanto genetically modified (GM) maize, and the Roundup herbicide it is grown with, pose serious health risks. The two-year feeding study found that rats fed both suffered severe organ damage and increased rates of tumors and premature death. Both the herbicide (Roundup) and the GM maize are Monsanto products. Corinne Lepage, France’s former environment minister, called the study “a bomb”.
Subsequently, an orchestrated campaign was launched to discredit the study in the media and persuade the journal to retract it. Many of those who wrote letters to FCT(which is published by Elsevier) had conflicts of interest with the GM industry and its lobby groups, though these were not publicly disclosed.
The journal did not retract the study (editor’s note: later they did). But just a few months later, in early 2013 the FCT editorial board acquired a new “Associate Editor for biotechnology”, Richard E. Goodman. This was a new position, seemingly established especially for Goodman in the wake of the “Séralini affair”.
Richard E. Goodman is professor at the Food Allergy Research and Resource Program, University of Nebraska. But he is also a former Monsanto employee, who worked for the company between 1997 and 2004. While at Monsanto he assessed the allergenicity of the company’s GM crops and published papers on its behalf on allergenicity and safety issues relating to GM food (Goodman and Leach 2004).
Goodman had no documented connection to the journal until February 2013. His fast-tracked appointment, directly onto the upper editorial board raises urgent questions. Does Monsanto now effectively decide which papers on biotechnology are published in FCT? And is this part of an attempt by Monsanto and the life science industry to seize control of science?
To equate one journal with “science” may seem like an exaggeration. But peer-reviewed publication, in the minds of most scientists, is science. Once a paper is published in an academic journal it enters the canon and stands with the discovery of plate tectonics or the structure of DNA. All other research, no matter how groundbreaking or true, is irrelevant. As a scientist once scathingly said of the “commercially confidential” industry safety data that underpin approvals of chemicals and GM foods, “If it isn’t published, it doesn’t exist.”
Goodman’s ILSI links
The industry affiliations of FCT’s new gatekeeper for biotechnology are not restricted to having worked directly for Monsanto. Goodman has an active:{ and }
:{ involvement with the}::{ International Life Sciences Institute (ILSI)}::{. ILSI is funded by the multinational GM and agrochemical companies, including Monsanto. It develops industry-friendly risk assessment methods for GM foods and chemical food contaminants and inserts them into government regulations.}:
ILSI describes itself as a public interest non-profit but its infiltration of regulatory agencies and influence on risk assessment policy has become highly controversial in North America and Europe. In 2005 US-based non-profits and trade unions wrote to the World Health Organization (WHO) protesting against ILSI’s influence on international health standards protecting food and water supplies. As a result, the WHO barred ILSI from taking part in WHO activities setting safety standards, because of its funding sources. And in Europe in 2012, Diana Banati, then head of the management board at the European Food Safety Authority (EFSA), had to resign over her undisclosed long-standing involvement with ILSI (Robinson et al. 2013).
Goodman’s appointment to FCT is surprising also for the fact that the journal already has expertise in GM food safety. Of the four senior editors, José L. Domingo is a professor of toxicology and environmental health and author of two comprehensive reviews of GM food safety studies (Domingo 2007; Domingo and Bordonaba 2011). Both reviews expressed skepticism of the thesis that GMOs are safe. Consequently, it is far from clear why FCT needs an “associate editor for biotechnology”, but it is clear why Monsanto would have an interest in ensuring that the “Séralini affair” is never repeated.
Editing the scientific record: The case of Paul Christou
FCT is not the only academic journal that appears to have been captured by commercial interests. After the initial campaign failed to getFCT to retract the Séralini study, the journal Transgenic Research published a heavy-handed critique of the study and of the researchers themselves (Arjo et al., 2013). The lead author of that critique was Paul Christou.
Christou and co-authors castigated the editor of FCT for publishing the study, calling it “a clear and egregious breach of the standards of scientific publishing”. They insisted that the journal editor retract the study “based on its clearly flawed data, its breaches of ethical standards, and the strong evidence for scientific misconduct and abuse of the peer-review process”. “Even a full retraction of the Séralini article” wrote Christou, “will not cleanse the Internet of the inflammatory images of tumorous rats.”
The same writers further implied that the Séralini study was “fraudulent”, that the researchers failed to analyse the data objectively, and that the treatment of the experimental animals was inhumane.
This is not the first time Christou has attacked scientific findings that have raised doubts about GM crops. In 2001 Ignacio Chapela and David Quist of the University of California, Berkeley, reported in the journal Nature that indigenous Mexican maize varieties had become contaminated with GM genes (Quist and Chapela, 2001). This issue was, and remains, highly controversial since Mexico is the genetic centre of origin for maize. In an exact parallel with the Séralini study, an internet campaign was waged against Chapela and Quist demanding that the journal retract the study. Then Christou, just as he was later to do with the Séralini study, attacked Chapela and Quist’s paper in an article in Transgenic Research. The title said it all: “No credible scientific evidence is presented to support claims that transgenic DNA was introgressed into traditional maize landraces in Oaxaca, Mexico” (Christou, 2002).
Responding to the campaign, Nature editor Philip Campbell asked Chapela and Quist for more data, which they provided, and arranged another round of peer review. Only one reviewer in the final group of three supported retraction, and no one had presented any data or analysis that contradicted Chapela and Quist’s main finding. Nevertheless, Nature asserted, “The evidence available is not sufficient to justify the publication of the original paper”. Some subsequent investigations, testing different samples, reported finding GM genes in native landraces of Mexican corn (Pineyro-Nelson et al. 2009), while others did not (Ortiz-Garcia et al. 2005).
Paul Christou, in contrast, probably did not have much trouble getting either of his critiques published in Transgenic Research. He is the journal’s editor-in-chief. And, like Goodman, Christou is connected to Monsanto. Monsanto bought the GM seed company Agracetus (Christou’s former employer) and Monsanto now holds patents for the production of GM crops on which Christou is named as the inventor. It is normal practice to declare inventor status on patents as a competing interest in scientific articles, but Christou did not disclose either conflict of interest – his editorship of the journal or his patent inventor status – in his critique of the Séralini study.
The Ermakova affair: Preemptive editing of the scientific record
Not only can journal editors prevent the publication of research showing problems with GM crops in their own journals – they can effectively prevent publication elsewhere. In 2007, the leading academic journal Nature Biotechnology featured an extraordinary attack on the work of Russian scientist, Irina Ermakova (Marshall, 2007). Her laboratory research had found decreased weight gain, increased mortality, and decreased fertility in rats fed GM Roundup-tolerant soy over several generations (Ermakova, 2006; Ermakova, 2009).
The editor of Nature Biotechnology, Andrew Marshall, contacted Ermakova, inviting her to answer questions about her findings, which she had only presented at conferences. He told her it was “an opportunity to present your own findings and conclusions in your own words, rather than a critique from one side”. Ermakova agreed.
The process that followed was as deceptive as it was irregular. The editor sentErmakova a set of questions about her research, which she answered. In due course she was sent a proof of what she thought was to be ‘her’ article, with her byline as author.
However, the article that was finally published was very different. Ermakova’s byline had been removed and Marshall’s substituted. Each of Ermakova’s answers to the questions was followed by a lengthy critique by four pro-GM scientists (Marshall, 2007). The proof sent to Ermakova, now revealed as a ‘dummy proof’, had not included these critical comments. Consequently, she was denied the chance to address them in the same issue of the journal. And in the final article the editor had preserved the critics’ references but removed many of Ermakova’s, with the effect that her statements appeared unsubstantiated.
Nature Biotechnology’s treatment of Ermakova attracted condemnation from many scientists. It was also strongly criticized in somemedia outlets. Harvey Marcovitch, former editor of a scientific journal and now director of the Committee on Publication Ethics (COPE), which sets ethical standards for academic journals, commented, “This is a type of publication which I have never encountered.” He said that while reading it he was struck by “some surprising things”. He was unwilling to speculate as to what exactly happened: “Either the editor was trying out a new form of experimentation, in which not everything went according to plan, or there was indeed a conspiracy or whatever one wants to call it.”
Dr Brian John of the Wales-based campaign group GM-Free Cymru was more blunt, calling the process “tabloid academic publishing involving deception, lies, duplicity and editorial malpractice”.
Amid the uproar, editor Marshall released his email correspondence with Ermakova on the internet. It showed that far from his having “solicited” the comments from the critics, as he had originally claimed, the four pro-GM scientists had themselves approached the journal proposing their “critique”, and even though none of them are toxicologists, Marshall had agreed. The self-selected critics judged Ermakova’s research – which they had never even seen in its complete form – “demonstrably flawed”.
Nature Biotechnology also failed to fully disclose the conflicts of interest of Ermakova’s critics. Bruce Chassy was lead author on two influential ILSI publications, which defined weak risk assessment methodologies for GM crops that were later inserted into the guidelines of the European Food Safety Authority (EFSA). Vivian Moses was chairman of CropGen, a GM industry lobby group with Monsanto among its funders. L. Val Giddings, an industry consultant, was described in the article as formerly of the Biotechnology Industry Organization (BIO). Nature Biotechnology omitted to say that Giddings occupied a senior position at BIO – vice president for food and agriculture– and that BIO’s funders include the GM crop companies, Monsanto, Dow and DuPont. The last of the four critics, Alan McHughen, developed a GM flax called Triffid that in 2009 was found to have contaminated flax supplies coming into Europe from Canada. If these interests had been disclosed, readers might have judged the criticism of Ermakova differently.
Open source scientific publishing?
These examples show that the threat to scientific publishing from industry influence is real. The avenues for researchers to publish critical views in science are already few. This is especially true for the high-impact journals that the media notices and that therefore influence public discourse. Equally problematic is that few scientific institutions will support researchers whose findings contradict industry viewpoints, as Chapela found out when UC Berkeley tried to deny him tenure following the controversial maize study. Even fewer funding sources will give to such researchers. Consequently almost all funding of biosafety research finds its way into the hands of researchers with industry ties.
This directly affects the quality of the science produced. A recent literature review found that most studies concluding that GM foods are as safe as non-GM counterparts were performed by the developer companies or their associates (Domingo and Bordonaba, 2011). It is no coincidence that Norway, a country without an agricultural industry lobby, hosts the only publicly funded institute in the world with a mission to conduct research on the environmental, health and social consequences of genetic engineering.
There are in principle ways within the existing system to mitigate or neutralize the influence of industry on the ability of scientists to publish independent and critical research. The first is transparency in publishing. Journal editors should adopt the COPE guidelines and publish all conflicts of interest among staff and editors.
Also in line with COPE’s stipulation, peer reviewers should be selected to avoid conflicts of interest. If this proves impossible due to the spread of patents and industry research funding, then care must be taken to select a balanced panel representing a plurality of views.FCT is a member of COPE, but does not publish information on editors’ conflicts of interest, and its appointment of Goodman over Domingo shows that it does not seek to avoid them.
There may in fact be a need to critically examine the entire concept of peer review. The limitations of all types of expert opinion – whether that of an individual expert or of an expert panel – are recognized in the field of evidence-based medicine. To address this problem, bodies such as the non-profit Cochrane Collaboration have developed systematic and transparent methodologies to review and evaluate data on the effectiveness of different medical interventions. The aim is to enable healthcare practitioners to make well-informed clinical decisions. The reviewing criteria are transparently set out in advance, so there is less scope for bias in evaluations of studies. When disagreements do occur, it is easy to pinpoint the reason and resolve the problem. Cochrane also implements rulesto prevent conflicts of interest among its reviewers and editorial board.
The Cochrane approach is widely respected and the lessons learned in evidence-based medicine about conflicts of interest and resisting industry pressure are being applied to other fields, such as hazardous environmental exposures (Woodruff et al., 2011). There is no reason why scientific journals, including those publishing GMO research, cannot use similar methods to evaluate papers, so that less discretion is given to experts with conflicts of interest.
Implementing such policies presumes strong support among the scientific community for independent science. But this support may not exist outside of medical research.
FCT took on Goodman, a former Monsanto employee and well-known supporter of industry viewpoints, immediately following the publication of a controversial paper that was critical of Monsanto’s principal products. In doing so, FCT senior management bypassed the normal scientific editorial culture of gradual promotion from within.
Meanwhile, two other prominent academic journals have served as platforms for their editors to generate unsubstantiated and unscientific abuse without any repercussions for their editorial positions. Marshall remains editor of Nature Biotechnology. The fact that journal editors get away with such behavior suggests that support for independent research among scientists is generally lacking and that accountability within the scientific publishing world barely exists.
It seems unlikely that scientific journals will address unaided the defects in scientific publishing at FCT and elsewhere. To do so would require confronting the fundamental problem that academic science now largely makes its money from exploiting conflicts of interest. This has become the underlying business model of science. Universities offer ‘independent’ advice to governments while taking corporate money for ‘research’. Corporations offer that money to universities, not for the knowledge it generates, but primarily for the influence it buys.
These same incentives are reinforced at the personal level as well. Individual scientists occupy taxpayer-funded academic positions while benefitting from patents, stocks and industry consultancies. If journals and government agencies took action to eliminate conflicts of interest, the corporate money for science would dry up, because industry-funded scientists would lose influence.
But if scientific journals do not find a way to level the playing field for critical studies, the few scientists who are still able to carry out independent public interest research may need to find an alternative publishing model: public peer review, or ‘open-source science’. Such online collaborative approaches could even revitalize scientific publishing.
Unless radical reform is achieved, peer-reviewed publication, which many hold to be the defining characteristic of science, will have undergone a remarkable inversion. From its origin as a safeguard of quality and independence, it will have become a tool through which one vision, that of corporate science, came to assert ultimate control. Richard Goodman, FCT’s new Associate Editor for biotechnology, now has the opportunity to throw down the stairs only those papers marked “industry approved”.
Note: Click here to see a response from scientists to the attacks on Séralini
Postcript: FCT has now retracted (Nov 28 2013) the Séralini study. The editors’ letter is at the bottom of this link.
Post-postscript (Feb 25 2015): Food and Chemical Toxicology has expelled Richard Goodman and demoted Wallace Hayes, apparently because of numerous complaints.
References
Arjo G, et al. (2013). Plurality of opinion, scientific discourse and pseudoscience: an in depth analysis of the Séralini et al. study claiming that Roundup Ready corn or the herbicide Roundup cause cancer in rats. Transgenic Research 22: 2 255-267
Christou P (2002). No credible scientific evidence is presented to support claims that transgenic DNA was introgressed into traditional maize landraces in Oaxaca, Mexico. Transgenic Research 11: iii–v
Domingo JL (2007). Toxicity studies of genetically modified plants: a review of the published literature. Crit Rev Food Sci Nutr 47(8): 721-733
Domingo JL and JG Bordonaba (2011). A literature review on the safety assessment of genetically modified plants. Environ Int 37: 734–742.
Ermakova I (2006). Genetically modified soy leads to the decrease of weight and high mortality of rat pups of the first generation. Preliminary studies. Ecosinform. 2006;1:4–9.
Ermakova I (2009). [Influence of soy with gene EPSPS CP4 on the physiological state and reproductive function of rats in the first two generations] [Russian text]. Contemporary Problems in Science and Education 5:15–20.
Marshall A (2007). GM soybeans and health safety – a controversy reexamined. Nat Biotechnol 25: 981–987.
Ortiz-Garcia S, et al. (2005). Absence of detectable transgenes in local landraces of maize in Oaxaca, Mexico. Proceedings of the National Academy of Sciences 102: 18242.
Pineyro-Nelson A, et al. (2009). Transgenes in Mexican maize: molecular evidence and methodological considerations for GMO detection in landrace populations. Mol Ecol 18(4): 750-761.
Quist D and IH Chapela (2001). Transgenic DNA introgressed into traditional maize landraces in Oaxaca, Mexico. Nature 414(6863): 541-543.
Robinson, C, et al. (2013). Conflicts of interest at the European Food Safety Authority erode public confidence. J Epidemiol Community Health.doi:10.1136/jech-2012-202185.
Séralini GE, et al. (2012). Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize. Food and Chemical Toxicology 50(11): 4221-4231.
Woodruff TJ, et al. (2011). An evidence-based medicine methodology to bridge the gap between clinical and environmental health sciences. Health Aff (Millwood) 30(5): 931-937.
==
wapo
Lifestyle
French scientists question safety of GM corn
By Tim Carman September 19, 2012
The twoyear, peerreviewed study, allegedly the first to look at the longterm effects of genetically engineered corn
on animals, was published today in the Food and Chemical Toxicology journal. It was backed by the Committee of
Research and Independent Information on Genetic Engineering (CRIIGEN), a French nonprofit known for its
opposition to GM foods.
In a telephone conference call with U.S. reporters on Wednesday afternoon, GillesEric Seralini, a biologist at
Caen University and the study’s lead author, noted that GM animal studies typically conclude after three months,
likely because companies behind genetically modified foods don’t want to know the longterm consequences of their
products.
“After four months” Seralini said about his own longterm study on 200 rats, “the tumors began.”
“After one year, there was a . . . high increase in the number of tumors,” continued Seralini, who is also the president
of CRIIGEN’s scientific board. He said that most of the female rats had two or three tumors.
Tom Helscher, director of corporate affairs for Monsanto, sent a statement that noted more than a 100 peerreviewed
animal studies have confirmed the safety of biotech crops, but added that the company would review the
French study ”thoroughly, as we do all studies that relate to our products and technologies.”
Helscher also pointed out that Seralini and his colleagues have made similarly faulty conclusions in the past, notably
in 2007 when they analyzed a previously published 90day animal study about Monsanto maize. The European Food
Safety Authority, which reviewed the paper at the request of the European Union, found no merit in Seralini’s
report, concluding:
“EFSA considers that the paper does not present a sound scientific justification in order to question the safety of
[Monsanto] maize.”
Monsanto may have been rather restrained in its response, but other critics were not.
“[I] can’t figure it out yet,” said Marion Nestle, the Paulette Goddard professor in the Department of Nutrition,
Food Studies and Public Health at New York University. “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,” Nestle told All We Can Eat, “I’m skeptical of this study.”
The Londonbased Science Media Centre, which assists reporters when major science news breaks, provided a whole
Web page of criticisms from scientists, researchers and professors. Mark Tester, a research professor for the
Australian Centre for Plant Functional Genomics at the University of Adelaide told Science Media Centre:
“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!”
Seralini deflected many of the study’s criticisms during the conference call on Wednesday, claiming that by necessity
the study couldn’t include every scrap of data the scientists recorded. The study’s 200 rats — 100 females, 100 males
— were divided into groups of 10 based on their gender, including two control groups that were given plain water
and a standard diet that included a nonGM maize.
Six groups (three male, three female) were fed a diet supplemented with Monsanto GM maize in increasing
percentages (11 percent, 22 percent and 33 percent), all of their feed corn treated with the Roundup weedkiller. Six
other groups were fed in the same increasing percentages of maize, but theirs was not sprayed with Roundup. The
final six groups ate the control feed but were given water spiked with different amounts of Roundup, some reflecting
the level found in regular tap water.
The female rats appeared to be particularly sensitive to the diets spiked with GM corn, whether with or without
Roundup applied, and water spiked with Roundup.
“In females, all treated groups died 2–3 times more than controls, and more rapidly,” the study reported. Overall,
50 percent of the males and 70 percent of the females on the GM diet died prematurely, compared to 30 and 20
respectively in the control group. Interestingly enough, the rats that consumed a diet with higher percentages of GM
corn apparently did not get as sick as those with lower doses.
The study sent shock waves through California, where voters will decide in November whether to pass Proposition
37, which will require labeling on all genetically modified foods. The Right to Know campaign immediately latched
onto the study’s findings in its lobbying efforts to pass the ballot initiative. The No on 37 campaign issued its own
statement on the study.
:{
}:
Meanwhile, the Food and Drug Administration, which oversees GM plants in the food system, remained neutral on
the report. “We will be in a better position to respond after we have more data and have had time to review the
paper,” said Shelly L. Burgess, a spokeswoman for the agency.
According to the USDA’s Economic Research Service, an estimated 90 percent of the corn grown in the United States
is genetically modified.
Those are the kind of numbers that seem to get Seralini’s blood boiling. “You don’t even have [GM] labeling in the
States, and you are very late in this thinking,” he told reporters on the conference call. “Ithink the world has to
change if we really want to have secure food.”
Further reading:
* The full study as published in Food and Chemical Toxicology (PDF)
Tim Carman serves as the full-time writer for the Post's Food section and as the $20 Diner
==
edit war?
https://en.wikipedia.org/wiki/Talk:S%C3%A9ralini_affair
==
slate?
When Good Intentions Go Bad
Two studies—one on genetically modified corn and one on climate change—demonstrate how scare tactics can backfire.
By Bjørn Lomborg
Campaigners on important but complex issues, annoyed by the length of time required for public deliberations, often react by exaggerating their claims, hoping to push a single solution to the forefront of public debate. But, however well-intentioned, scaring the public into a predetermined solution often backfires: When people eventually realize that they have been misled, they lose confidence and interest.
Last month, there were two examples of this in a single week. First, French researcher Gilles-Eric Séralini attempted to fuel public opposition to genetically modified foods by showing the public how GM corn, with and without the pesticide Roundup, caused huge tumors and early death in 200 rats that had consumed it over two years
Supplying an abundance of pictures of rats with tumors the size of ping-pong balls, Séralini certainly captured the public’s attention. France’s health, ecology, and agriculture ministers promised a prompt investigation and threatened to ban imports of Monsanto’s GM corn to the European Union. Russia actually did block imports of Monsanto corn.
But Séralini’s research posed many problematic issues. For starters, the Sprague-Dawley strain of rats that he used is naturally prone to tumors. Studies of Sprague-Dawley rats show that 88 percent to 96 percent of those that *serve as experimental controls* develop tumors before they reach two years of age. But the public saw only pictures of tumorous rats that had consumed GM corn and Roundup. If the public had seen the similarly grotesque tumors that grow on untreated rats, officials most likely would not have acted so hastily. https://www.jstage.jst.go.jp/article/expanim/50/2/50_2_99/_article japanese co study?
Séralini used only 20 rats as a control group to be fed ordinary corn with no Roundup. Of these, five died within two years, which is unusual, because studies of thousands of untreated Sprague-Dawley rats show that about half should have died in that period. Using his low death rate as a base, Séralini claimed—with no statistical analysis—that the higher death rate (just below 40 percent) for the remaining 180 rats fed with GM corn and Roundup was suspicious.
Moreover, Séralini’s results contradict the latest meta-study of 24 long-term studies (up to two years and five generations), which found that the data do “not suggest any health hazards” and display “no statistically significant differences” between GM and conventional food.
Oddly, Séralini permitted access to his paper to only a select group of reporters and demanded that they sign a confidentiality agreement preventing them from interviewing other experts about the research before publication. But, while the first round of articles read like press releases, the scientific community has since spoken out forcefully. The European Food Safety Authority, for example, has now concluded that the “design, reporting, and analysis of the study, as outlined in the paper, are inadequate.”
The study was partly funded by CRIIGEN, a group that campaigns against biotechnology. CRIIGEN’s scientific board is headed by none other than Séralini, who has also just released a book and a documentary decrying GM food.
This debacle matters because many GM crops provide tangible benefits for people and the environment. They enable farmers to produce higher yields with fewer inputs (such as pesticides), so that more food can be produced from existing farmland. That, in turn, implies less human encroachment into natural ecosystems, enabling greater biodiversity. But, of course, Séralini’s pictures of cancer-addled rats munching GM corn have instead been burned into the public imagination.
The Séralini fiasco was only a week old when, the Climate Vulnerability Forum, a group of countries led by Bangladesh, launched the second edition of its Global Vulnerability Monitor. Headlines about the launch were truly alarming: Over the next 18 years, global warming would kill 100 million people and cost the economy upwards of $6.7 trillion annually.
These public messages were highly misleading and clearly intended to shock and disturb. The vast majority of deaths discussed in the report did not actually result from global warming. Outdoor air pollution—caused by fossil-fuel combustion, not by global warming—contributed to 30 percent of all deaths cited in the study. And 60 percent of the total deaths reflect the burning of biomass (such as animal dung and crop residues) for cooking and heating, which has no relation to either fossil fuels or global warming.
In total, the study exaggerated more than 12-fold the number of deaths that could possibly be attributed to climate change, and it more than quadrupled the potential economic costs, simply to grab attention. But it will be used as a cudgel by those who claim that electric cars or solar panels – technologies that will make only a marginal contribution, given their huge incremental costs – are the solution to climate change.
The technologies that can really make a difference quickly and at lower cost are scrubbers that clean smokestack emissions, catalytic converters that reduce tailpipe emissions, and many others. By focusing purely on cutting CO2, we neglect to help many more people, much faster, and less expensively.
When scare tactics replace scientific debate, whether about GM crops or climate change, nothing good can come of it. We all deserve better.
This article was originally published by Project Syndicate. For more from Project Syndicate, visit their Web site, and follow them on Twitter or Facebook.
Bjørn Lomborg is an adjunct professor at the Copenhagen Business School and directs the Copenhagen Consensus Center. He is the author of *The Skeptical Environmentalist*, Cool It, and most recently *How Much Have Global Problems Cost the World?*
12/15 bak
somewhat late: see entine, gmonsanto tag
Volume 50, Issue 11, November 2012, Pages 4221-4231
RETRACTED: Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize
Author links open the overlay panel. Numbers correspond to the affiliation list which can be exposed by using the show more link.
Gilles-Eric Séralini :{a:(style="box-sizing:inherit;position:relative;vertical-align:baseline;top:-0.5em"):}:, ⁎, criigen@unicaen.fr, Emilie Clair :{a:(style="box-sizing:inherit;position:relative;vertical-align:baseline;top:-0.5em"):}:, Robin Mesnage :{a:(style="box-sizing:inherit;position:relative;vertical-align:baseline;top:-0.5em"):}:, Steeve Gress :{a:(style="box-sizing:inherit;position:relative;vertical-align:baseline;top:-0.5em"):}:, Nicolas Defarge :{a:(style="box-sizing:inherit;position:relative;vertical-align:baseline;top:-0.5em"):}:, Manuela Malatesta :{b:(style="box-sizing:inherit;position:relative;vertical-align:baseline;top:-0.5em"):}:, Didier Hennequin :{c:(style="box-sizing:inherit;position:relative;vertical-align:baseline;top:-0.5em"):}:, Joël Spiroux de Vendômois :{a:(style="box-sizing:inherit;position:relative;vertical-align:baseline;top:-0.5em"):}:
Under a Creative Commons license
Referred to by
- G.E. Séralini, R. Mesnage, N. Defarge, J. Spiroux de Vendômois
Conclusiveness of toxicity data and double standards
Food and Chemical Toxicology, Volume 69, July 2014, Pages 357-359
- A. Rosanoff
Food and Chemical Toxicology, Volume 65, March 2014, Page 389
- Marcel Roberfroid
Food and Chemical Toxicology, Volume 65, March 2014, Page 390
- Brian John
Food and Chemical Toxicology, Volume 65, March 2014, Page 391
- Kevin Folta
Food and Chemical Toxicology, Volume 65, March 2014, Page 392
- Donald D. Dunklee
Food and Chemical Toxicology, Volume 65, March 2014, Page 393
- Gilles-Eric Séralini, Emilie Clair, Robin Mesnage, Steeve Gress, Nicolas Defarge, Manuela Malatesta, Didier Hennequin, Joël Spiroux de Vendômois
Food and Chemical Toxicology, Volume 63, January 2014, Page 244
- Lúcia de Souza, Leila Macedo Oda
Food and Chemical Toxicology, Volume 53, March 2013, Page 440
- Peter Langridge
Food and Chemical Toxicology, Volume 53, March 2013, Page 441
- Jack A. Heinemann
Food and Chemical Toxicology, Volume 53, March 2013, Page 442
- Dung Le Tien, Ham Le Huy
Food and Chemical Toxicology, Volume 53, March 2013, Pages 443-444
- Colin Berry
Food and Chemical Toxicology, Volume 53, March 2013, Pages 445-446
- Anthony Trewavas
Food and Chemical Toxicology, Volume 53, March 2013, Page 449
- Dale Sanders, Sophien Kamoun, Bella Williams, Michael Festing
Food and Chemical Toxicology, Volume 53, March 2013, Pages 450-453
Food and Chemical Toxicology, Volume 53, March 2013, Pages 455-456
- Mark Tester
Food and Chemical Toxicology, Volume 53, March 2013, Page 457
- Louis Ollivier
Food and Chemical Toxicology, Volume 53, March 2013, Page 458
- Frederic Schorsch
Serious inadequacies regarding the pathology data presented in the paper by Séralini et al. (2012)
Food and Chemical Toxicology, Volume 53, March 2013, Pages 465-466
- David Tribe
Food and Chemical Toxicology, Volume 53, March 2013, Pages 467-472
- Erio Barale-Thomas
Food and Chemical Toxicology, Volume 53, March 2013, Pages 473-474
Open Access
This article has been retracted: please see Elsevier Policy on Article Withdrawal (http://www.elsevier.com/locate/withdrawalpolicy).
The journal Food and Chemical Toxicology retracts the article “Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize,” which was published in this journal in November 2012. This retraction comes after a thorough and time-consuming analysis of the published article and the data it reports, along with an investigation into the peer-review behind the article. The Editor in-Chief deferred making any public statements regarding this article until this investigation was complete, and the authors were notified of the findings.
Very shortly after the publication of this article, the journal received Letters to the Editor expressing concerns about the validity of the findings it described, the proper use of animals, and even allegations of fraud. Many of these letters called upon the editors of the journal to retract the paper. According to the journal’s standard practice, these letters, as well as the letters in support of the findings, were published along with a response from the authors.:{1:(style="box-sizing:inherit;position:relative;vertical-align:baseline;top:-0.5em"):}:, Due to the nature of the concerns raised about this paper, the Editor-in-Chief examined all aspects of the peer review process and requested permission from the corresponding author to review the raw data. The request to view raw data is not often made; however, it is in accordance with the journal’s policy that authors of submitted manuscripts must be willing to provide the original data if so requested.:{2:(style="box-sizing:inherit;position:relative;vertical-align:baseline;top:-0.5em"):}: The corresponding author agreed and supplied all material that was requested by the Editor-in-Chief. The Editor-in-Chief wishes to acknowledge the co-operation of the corresponding author in this matter, and commends him for his commitment to the scientific process.
Unequivocally, the Editor-in-Chief found no evidence of fraud or intentional misrepresentation of the data. However, there is a legitimate cause for concern regarding both the number of animals in each study group and the particular strain selected. The low number of animals had been identified as a cause for concern during the initial review process, but the peer review decision ultimately weighed that the work still had merit despite this limitation. A more in-depth look at the raw data revealed that no definitive conclusions can be reached with this small sample size regarding the role of either NK603 or glyphosate in regards to overall mortality or tumor incidence. Given the known high incidence of tumors in the Sprague–Dawley rat, normal variability cannot be excluded as the cause of the higher mortality and incidence observed in the treated groups.
Ultimately, the results presented (while not incorrect) are inconclusive, and therefore do not reach the threshold of publication for Food and Chemical Toxicology. The peer review process is not perfect, but it does work. The journal is committed to getting the peer-review process right, and at times, expediency might be sacrificed for being as thorough as possible. The time-consuming nature is, at times, required in fairness to both the authors and readers. Likewise, the Letters to the Editor, both pro and con, serve as a post-publication peer-review. The back and forth between the readers and the author has a useful and valuable place in our scientific dialog.
The Editor-in-Chief again commends the corresponding author for his willingness and openness in participating in this dialog. The retraction is only on the inconclusiveness of this one paper. The journal’s editorial policy will continue to review all manuscripts no matter how controversial they may be. The editorial board will continue to use this case as a reminder to be as diligent as possible in the peer review process.
==
http://www.scienceforthepublic.org/assets/154/STHV%20GMO%20ILLUSORY%20CONSENSUS.pdf
...
denied that he threatened the editor. Lachmann was an author of the Royal Society’s 1998 highly favorable report on GMOs. A widely reported story line goes as follows: in 1999, Lachmann tried to persuade the editor of The Lancet not to publish A´ rpa´d Pusztai’s research on the adverse effects of GM potatoes on rats on the grounds that it was not sound science. The Lancet’s editor, Richard Horton, received what he described as an aggressive phone call from Lachmann. Dr. Horton said he was called at his office in central London on the morning of Wednesday October 13, two days before the Lancet published the paper by Pusztai. Dr. Horton, editor of The Lancet since 1995, said the phone call began in a ‘‘very aggressive manner.’’ He said he was called ‘‘immoral’’ and accused of publishing Dr. Pusztai’s paper, which he ‘‘knew to be untrue.’’ Toward the end of the call, Dr. Horton said the caller told him that if he published the Pusztai paper, it would ‘‘have implications for his personal position’’ as editor. The Lancet is owned by Reed Elsevier, one of Europe’s largest scientific publishing houses (Flynn and Gillard 1999). Lachmann’s own account of the Pusztai affair can be found in Panic Nation (2005). He categorically denies making the threat to Richard Horton. When The Lancet received the manuscript from Ewen and Pusztai, it was sent to six referees, whereas the usual peer review has two to three referees. Five of the six referees recommended the paper for publication, while one referee was strongly against publication. In addition, that referee transgressed a long-standing norm of the journal to keep reviews to the editor confidential by disclosing his negative review to the press. The Lancet published the article despite the pressures to do otherwise. The attacks against Pusztai were unrelenting. He and Ewen responded to a number of his critics in The Lancet (Ewen and Pusztai 1999b). Pusztai left Rowett and periodically has commented on the incident. To this date, no one has made an effort to replicate his study. The episode left Pusztai’s otherwise distinguished career in shambles. The Se´ralini Case The second most highly publicized study was led by Gilles-Eric Se´ralini, a professor of molecular biology at the University of Caen in Normandy, France. He is the founder and president of the scientific advisory board of the nonprofit Committee of Research and Independent Information on Genetic Engineering (CRIIGEN), an association that was in the public record. Funding from CRIIGEN was acknowledged in Se´ralini’s papers. In 2009, Se´ralini and eight other authors published a paper in the International Journal of Biological Sciences that discussed the relevant criteria Krimsky 19 Downloaded from sth.sagepub.com at The New School on August 7, 2015 that should be used to evaluate GMOs. Their paper raised questions about what regulatory agencies use to undertake risk assessments involving mammalian feeding experiments of GMOs (Se´ralini et al. 2009). By that time Monsanto had been undertaking short-term tests (ninety days) on certain GMO food products. The authors considered the current criteria to be fostering false negative results because of sample size and statistical design. Referring to some experiments that found adverse effects from GMOs the authors stated, ‘‘These GM-linked effects are then considered as signs of toxicity in the ninety-days, not proofs of toxicity’’ (Se´ralini et al. 2009, 442). The authors proposed....
The fifth scientific review was published by the European Food Safety
Association (EFSA 2014). Like many agency reviews, it typically is prepared
by a scientific panel and has many scientific reviewers commenting
on drafts before it is released. ‘‘The EFSA GMO panel concludes that the
proposed uses of MON 87769 soybean oil in foods will not result in intakes
4 Science, Technology, & Human Values
Downloaded from sth.sagepub.com at The New School on August 7, 2015
of stearidonic acid (SDA) with diverse effects and that the other changes in
the dietary fatty acid pattern are unlikely to have negative nutritional consequences
for humans. The EFSA GMO panel notes that the quantitative
dietary estimates described here would have to be revisited if the oil produced
by the soybean MON 87769 were to be extensively used in food
products not considered in this assessment, for example as dietary supplements
or to modify animal feed products.’’
...
The second paper was a published commentary that focused on conflicts of interest of those criticizing Se´ralini’s papers (Se´ralini et al. 2014). The authors note that a new assistant editor of biotechnology joined the journal Food and Chemical Toxicology after Se´ralini’s article was published and that this assistant editor previously worked for Monsanto for seven years. The authors interpret the decision to retract their paper a little over a year after it was appropriately refereed grew out of the role of the new assistant editor who had a conflict of interest as a former employee of Monsanto. A third paper discussed the conflicts of interest at the European Food Safety Authority (EFSA), a weak counterpart to the US FDA since it issues advisories to members of the European Union. According to its website, ‘‘The European Food Safety Authority (EFSA) [an independent European agency funded by the EU budget that operates separately from the European Commission, European Parliament and EU Member States] is the keystone of European Union (EU) risk assessment regarding food and feed safety ... . EFSA provides independent scientific advice and clear communication on existing and emerging risks’’ (EFSA). The agency reviewed the Se´ralini et al. publication and published the results in the EFSA Journal in 2012. EFSA found the study to be ‘‘inadequately designed, analysed’’ and discounted Se´ralini’s response to critics concluding that the study is of ‘‘insufficient scientific quality for safety assessments.’’
:{
}:
Robinson et al. (2013) argued that the EFSA has been rife with conflicts of interest. For example, the chair of EFSA’s management board had a longstanding relationship with the industry funded International Life Sciences Institute (ILSI). They claim that in 2010 more than half of the EFSA experts on the GMO panel had financial conflicts of interest. The agency had been cited by the Ombudsman for failing to manage conflicts of interest and Krimsky 25 Downloaded from sth.sagepub.com at The New School on August 7, 2015 despite changes still has not distanced itself from ILSI and thus does not represent an independent review of Se´ralini’s work. Among the points raised by Robinson et al. is that when differences are found between GMOs and non-GMO counterparts, several authors, including those funded by industry, dismiss the findings as being within the normal range of variation and are not biologically relevant. ‘‘An EFSA opinion allows industry to define biological relevance on a case-by-case basis’’ (Robinson et al. 2013, 2).
Conclusion
I began this article with the testimonials from respected scientists that there is literally no scientific controversy over the health effects of GMOs. My investigation into the scientific literature tells another story. I found twenty-six animal feeding studies that have shown adverse effects or animal health uncertainties (Table 2). The eight review articles were mixed in their assessment of the health effects of GMOs (Table 1). The analysis of how two respected scientists were treated so poorly by the scientific community over their peer-reviewed work raises questions about likely political and ideological influences in the science. I could find no comparable case in the history of science where someone’s published and peer-reviewed work was retracted because it was not definitive. Comparable works that found GMOs equivalent to their non-GMO parental strain were not retracted for the same reason since they too were not definitive. It has been argued that the weight of evidence is favorable to the hypothesis that the current family of commercialized GMOs is safe to humans and animals because there is a preponderance of articles establishing that point. In risk assessment, the number of studies that reveal a risk can be more significant than a larger number of studies that do not. Imagine a hundred flights to test a new aircraft. Ninety-five prove safe. Five flights produce electrical problems, failed landing gear, and a wing collapse. Does one just negate the five flights and go with the weight of evidence? Those five flights are very significant, perhaps because the aircraft was pushed beyond standard flight operations but within its design limits. When there is a controversy about the risk of a consumer product, instead of denying the existence of certain studies, the negative results should be replicated to see if they hold up to rigorous testing.
This point was made by the 300 scientists who signed a joint statement that was published in Environmental Sciences Europe. The statement ‘‘does not assert that GMOs are unsafe or safe. Rather the statement concludes that the scarcity and
26 Science, Technology, & Human Values Downloaded from sth.sagepub.com at The New School on August 7, 2015
contradictory nature of the scientific evidence published to date prevents conclusive claims of safety, or lack of safety, of GMOs’’ (Hilbeck et al. 2015, 1). David Schubert, professor at the Salk Institute, summarized the state of affairs of the GMO controversy as follows: ‘‘To me, the only reasonable solution is to require that all GM plant products be tested for long-term toxicity and carcinogenicity before being brought to market’’ (2002, 969). Until the twenty-six studies, or at least the best of them, are replicated and shown to be false positives, we have an obligation to treat these studies with respect and concern. My results have broad implications for the study of scientific and medical controversies, whether climate change, endocrine disruptors, statins, or mercury preservatives in vaccines. STS scholarship is best accomplished when it approaches a controversial issue systemically and includes a deep analysis of the primary science, a review of the function of professional societies, an analysis of the peer review process of journals, a study of the political climate and its impact on science and on federal regulatory agencies which set policy, the media’s role in shaping public understanding or misunderstanding, and the role that financial interests play in scientific risk analysis. All of these factors are brought into play in the GMO debate, about which I have argued that the putative consensus about the inherent safety of transgenic crops is premature.
==
Sheldon Krimsky is no stranger to the evolution of genetic testing and manipulation. In fact, he's authored and co-authored dozens of books on a range of topics including industrial genetics, hormone mimickers, corrupt biomedical research and why the public needs a "Genetic Bill of Rights."
Krimsky, a professor of Urban and Environmental Policy and Planning at Tufts University in Massachusetts, has dedicated his career to analyzing the relationship between agricultural biotechnology and the environment.
His latest book entitled, The GMO Deception: What You Need to Know about the Food, Corporations, and Government Agencies Putting Our Families and Our Environment at Risk, discusses genetically engineered foods and the long-term effects that they have on people's health and the environment.
A preview of his book on Amazon discusses his reaction to his college biology professor's allegation that "science is science," a statement that Krimsky highly disagrees with. "Today, my response would be 'not quite,'" wrote the author.
Krimsky is head of the Council for Responsible Genetics, a public interest group that "fosters public debate about the social, ethical and environmental implications of genetic technologies," according the group's website.
His expertise includes links between science, technology, ethics, values and public policy. Recently, Krimsky spoke with The Boston Globe's Karen Weintraub about his new book.
Weintraub quickly began questioning Krimsky about his apparent "anti-GMO position," asking whether or not he's truly opposed to them or just skeptical.
Krimsky cleverly rebutted by explaining that one of the core values of science is "organized skepticism," and the only way to truly test science is by being skeptical, exploring every possible fault until the skepticism disappears.
When Krimsky addressed the U.S. Food and Drug Administration's (FDA) failure to test the safety of GMOs, instead working a backward approach asking industry to report problems after they have occurred, Weintraub asked if he disagrees with that approach.
"You cannot predict what's going to happen to an organism if you put in a foreign gene. It could interfere with other genes, it could over-express some things and under-express other things. You cannot make predictions without testing them," explained Krimsky.
Weintraub responded by questioning whether or not a company can control where a gene goes or what it does after insertion.
"Genes do more than one thing. If you think of the genome as an ecosystem rather than a Lego system, it gives you a different idea of what the possibilities are. We have to test in order to understand what the foreign gene is going to do to the organism," said Krimsky.
He explained the difference between cross-pollination and genetic engineering, clarifying that hybrid crops come from the same species, while GM crops involve inserting genes from a completely different species and placing them into a plant genome.
Unsatisfied, the interviewer began referencing industry studies that regard GMOs as safe and no different from ordinary crops. Scientists that question the corporate narrative are often "vilified," replied Krimsky, and not all studies have proven GMOs to be safe.
Krimsky discussed the criticism that French scientists received after publishing research which found GMOs to cause "severe adverse health effects" in mice, including the development of mammary tumors and organ damage.
After calling the French study "unrealistic," Weintraub asked, "So this one negative finding carries more weight than dozens of positive ones?"
"Whenever you're looking at the risk of a product, a single negative result is more important than 99 positive results, especially when a substantial number of those positive results are funded by the agribusiness industry. We've had products on the market for 50 years: PCBs, asbestos, tobacco, DDT. Early on people said they were safe," answered Krimsky.
Weintraub wrapped up the interview by asking if anything would convince Krimsky that GMOs are safe.
"I would feel convinced if there were independent studies asking the right questions and seeking experiments looking for the most vulnerable cases," he replied.
A reprint of the interview by GMWatch corrected a few of Weintraub's points, including that there was nothing "unrealistic" about Seralini's long-term safety study on GM maize NK603 and Roundup.
Secondly, regarding Weintraub's comment about one negative study carrying more weight than dozens of positive ones, GMWatch points out that there are no other long-term safety studies on GM corn.
Additional sources:
http://www.councilforresponsiblegenetics.org
http://www.motherearthnews.com
http://science.naturalnews.com
Learn more: http://www.naturalnews.com/046689_GMOs_biomedical_research_Krimsky.html#ixzz3lY4dZM2L
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OPINION6/24/2014 @ 10:24AM 4,749 views
Profile of Gilles-Éric Séralini, Author Of Republished Retracted GMO Corn Rat Study
[note: this is clone (shorter) of JLP site: ]
Gilles-Éric Séralini has republished his retracted study of herbicide resistant GMO maize and glyphosate in an obscure European open source journal. The Genetic Literacy Project’s Jon Entine offers a detailed factual profile of the embattled French molecular biologist (along with a compilation of reactions from scientists from around the world).
Gilles-Éric Séralini (born August 23, 1960 in Annaba, Algeria, then known as Bône) is a French scientist who has been a professor of molecular biology at the University of Caen since 1991. He is best known for publishing research concluding that genetically modified food is unsafe for human consumption. 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.
Séralini Career
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 email: gilles-eric.seralini arobase unicaen.fr 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.
Food and Chemical Toxicology, Volume 50, Issue 11, November 2012, Pages 4221-4231
Gilles-Eric Séralini, Emilie Clair, Robin Mesnage, Steeve Gress, Nicolas Defarge, Manuela Malatesta, Didier Hennequin, Joël Spiroux de Vendômois
Since the publication of the above paper by Séralini et al., the Editors and the Publisher of Food and Chemical Toxicologyhave received many questions from members of the Scientific community.
In the light of these comments, the Editors and Publisher wish to make clear that the normal thorough peer review process was applied to the Seralini et al. paper. The paper was published after being objectively and anonymously peer reviewed, with a series of revisions made by the authors and the corrected paper then accepted by the Editor.
Post-publication members of the scientific community have challenged the paper, citing serious concerns about the study design, data presentation and related issues.
In responding to these criticisms, the Editors have encouraged those people with concerns to write formally to the Editor-in-Chief, so that that their views can be publicly aired. These letters and a response from Seralini et al. will shortly be published in the Journal.
Separately, the Editors and the Publisher, Elsevier, will be considering these criticisms. We are continually reviewing our peer review processes to ensure that the journal accepts the right papers with the appropriate levels of rigor and attention to detail. If we conclude that changes need to be made to the peer review process, that will be communicated openly to readers of the journal.
Food and Chemical Toxicologydeals with issues that are often controversial and where there are strong views held both within and beyond science. Preserving editorial independence and a robust peer review system in this process is obviously crucial. Here as elsewhere, Elsevier, as publisher of Food and Chemical Toxicology, both helps to facilitate the peer review process and upholds the principle of independent editorial decision making. ]
"inconclusive: http:/**/retractionwatch.**com/2013/11/28/controversial-seralini-gmo-rats-paper-to-be-retracted/ ...Unequivocally, the Editor-in-Chief found no evidence of fraud or intentional misrepresentation of the data. However, there is legitimate cause for concern regarding both the number of animals in each study group and the particular strain selected....
On June 24, 2014, the retracted study, in expanded form, this time including the data, 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 has published before. 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 [it was previously?] but that is not accurate, according to the publishing journal’s editor made to Nature magazine.[kai?] “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.” [note no cite] ESEUconducted 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.”[http://news.sciencemag.org/environment/2014/02/pesticide-study-sparks-backlash
53% pvt $: https://www.plant-biotech.net/members/CV_Reski_BE_2014.pdf
kai K is glp author? http://www.geneticliteracyproject.org/author/kai-kupferschmidt/
SCIENCEINSIDER
Breaking news and analysis from the world of science policy
Pesticide Study Sparks Backlash http://news.sciencemag.org/environment/2014/02/pesticide-study-sparks-backlash only www ref to ralf?]
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 unconven
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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 Observateurcovered 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 a
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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.
Books
- Séralini, Gilles-Éric (2004). *Ces OGM Qui Changent Le Monde*. Flammarion Publishing. ISBN 2080800620.
- Séralini, Gilles-Éric (2006). *Après Nous le Déluge?*. Flammarion
Criticisms
Seralini’s claims and tactics have been heavily criticized by the regulatory, academic and science watchdog communities. Examples include:
- CRIIGEN evaluation, by David Tribe, GMO Pundit, December 2012.
- Genetically modified corn and cancer – what does the evidence really say?, by Ashley Ng, The Converation, September 2012.
- 700 Researchers Call On Gilles-Eric Seralini To Release GMO Test Data, Science 2.0, October 2012.
- Being Gilles-Eric Seralini: Inside the mind of the anti-GM movement – See more at: http://www.geneticliteracyproject.org/2013/06/10/being-gilles-eric-seralini-inside-the-mind-of-the-anti-gm-movement/#sthash.RVnii37e.dpuf, by Jon Entine, Genetic Literacy, June 2013.
- Scientists smell a rat in fraudulent study, by Bruce Chassy & Henry Miller, Forbes Magazine, September 2012.
- Anti-GM corn study reconsidered: Seralini finally responds to torrent of criticism, AEI, November 2012.
- Seralini paper influence Kenya ban of GMO imports, by Emily Willingham, Forbes Magazine, December 2012.
- Seralini GMO rats & Cancer, Tech ‘N You, 2013.
- Why I think the Seralini GM feeding trial is bogus, by Andrew Kniss, Control Freaks, September 2012.
- Anti-GMO Scientist Gilles-Eric Seralini, Activist Jeffrey Smith Withdraw from Food Biotech Debate, by Jon Entine, Forbes Magazine, May 2013
- Seralini anti-Monsanto study was so poorly conducted it harms the anti-GMO movement, The Daily Paul, September 2012.
- The Seralini Rule, Skeptico, June 2013. Excerpt: “I have a new rule for debating anti-GMO people: If you favorably cite the 2012 Séralini rats fed on Roundup ready maize study, you just lost the argument…”
- March Against Monsanto, The Progressive Contrarian, May 2013. Excerpt: “I mentioned Seralini and Smith were frauds who refuse to publicly debate scientists who want to challenge them…”
- Science says GMOs are safe, Skeptical Raptor, June 2013. Excerpt: “But be forewarned, if it is junk science, I will call it junk science, like Gilles-Eric Séralini et al.’s paper about GMO corn causing cancer. Except it was poorly designed, utilized bad statistics, and really provided no evidence whatsoever for anything except that Séralini is an incompetent scientist…”
- Was Seralini GMO study designed to generate negative outcome, Storify, October 2012.
References
- 1 Gilles Eric Séralini – President of the Scientific Board – Molecular Biology Professor, by HH, CRIIGEN website, November 12, 2008.
- 2 http://gantdaily.com/2013/11/27/is-africa-ready-for-genetically-modified-foods/
- 3 http://www.journals.elsevier.com/food-and-chemical-toxicology/news/journal-statement/
- 4 http://mobile.nation.co.ke/business/Study-on-GMOs-withdrawn/-/1950106/2093496/-/format/xhtml/-/lt3pkm/-/index.html
- 5 http://gmoseralini.org/en/
- 6 http://gmopundit.blogspot.com/2012/09/auchan-and-carrefour-financed-criigen.html
- 7 http://greenhousepr.co.uk/clients/about/sustainable-food-trust/
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The Ecologist [1] / By Oliver Tickell [2]
Major Study: Monsanto GMO Corn Can Cause Damage to Liver and Kidneys, and Severe Hormonal Disruption
July 9, 2014 |
A scientific study that identified serious health impacts on rats fed on 'Roundup ready' GMO maize has been republished following its controversial retraction under strong commercial pressure. Now regulators must respond and review GMO and agro-chemical licenses, and licensing procedures.
A highly controversial paper by Prof Gilles-Eric Séralini and colleagues has been republished after a stringent peer review process.
The chronic toxicity study [3] examines the health impacts on rats of eating a commercialized genetically modified (GM) maize, Monsanto's NK603 glyphosate-based herbicide Roundup.
The original study, published in Food and Chemical Toxicology (FCT) in September 2012, found severe liver and kidney damage and hormonal disturbances in rats fed the GM maize and low levels of Roundup that are below those permitted in drinking water in the EU.
However it was retracted by the editor-in-chief of the Journal in November 2013 after a sustained campaign [4] of criticism and defamation by pro-GMO scientists.
Toxic effects were found from the GM maize tested alone, as well as from Roundup tested alone and together with the maize. Additional unexpected findings were higher rates of large tumours and mortality in most treatment groups.
Criticisms addressed in the new version
Now the study has been republished [5] by Environmental Sciences Europe. The republished version contains extra material addressing criticisms of the original publication.
The raw data underlying the study's findings are also published - unlike the raw data for the industry studies that underlie regulatory approvals of Roundup, which are kept secret. However, the new paper presents the same results as before and the conclusions are unchanged.
The republication restores the study to the peer-reviewed literature so that it can be consulted and built upon by other scientists.
The republished study is accompanied by a separate commentary by Prof Séralini's team [6] (also published on The Ecologist [7]) describing the lobbying efforts of GMO crop supporters to force the editor of FCT to retract the original publication.
The authors explain that the retraction was "a historic example of conflicts of interest in the scientific assessments of products commercialized worldwide."
"We also show that the decision to retract cannot be rationalized on any discernible scientific or ethical grounds. Censorship of research into health risks undermines the value and the credibility of science; thus, we republish our paper."
Paper subjected to extraordinary scrutiny and peer review
Claire Robinson, editor of GMOSeralini.org [8], commented: "This study has now successfully passed no less than three rounds of rigorous peer review."
First the paper was peer reviewed for its initial publication in Food and Chemical Toxicology, and according to the authors [9] it passed with only minor revisions.
The second review involved a non-transparent examination of Prof Séralini's raw data by a secret panel of unnamed persons organized by the editor-in-chief of FCT, A. Wallace Hayes, in response to criticisms of the study by pro-GMO scientists.
In a letter to Prof Séralini, Hayes admitted [10] that the anonymous reviewers found nothing incorrect about the results, but argued that the tumour and mortality observations in the paper were "inconclusive", and this justified his decision to retract the study:
"A more in-depth look at the raw data revealed that no definitive conclusions can be reached with this small sample size regarding the role of either NK603 or glyphosate in regards to overall mortality or tumor incidence.Given the known high incidence of tumors in the Sprague-Dawley rat, normal variability cannot be excluded as the cause of the higher mortality and incidence observed in the treated groups."
"The rationale given for the retraction was widely criticized by scientists [11] as an act of censorship and a bow to the interests of the GMO industry", says Robinson.
"Some scientists pointed out that numerous published scientific papers contain inconclusive findings, including Monsanto's own short (90-day) study on the same GM maize, and have not been retracted. The retraction was even condemned by a former member [12] of the editorial board of FCT."
Now the study has passed a third peer review arranged by the journal that is republishing the study, Environmental Sciences Europe.[JE denies?]
Let the critics carry out their own studies
Dr Michael Antoniou, a molecular geneticist based in London, commented, "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."
Dr Jack A Heinemann, Professor of Molecular Biology and Genetics, University of Canterbury New Zealand, said: "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."
'Significant biochemical disturbances and physiological failures'
The study examines the health effects on rats of eating Roundup-tolerant NK603 genetically modified (GM) maize (from 11% in the diet), cultivated with or without Roundup application, and Roundup alone (from 0.1 ppb of the full pesticide containing glyphosate and adjuvants) in drinking water. It found:
- "Biochemical analyses confirmed very significant chronic kidney deficiencies, for all treatments and both sexes; 76% of the altered parameters were kidney-related.
- "In treated males, liver congestions and necrosis were 2.5 to 5.5 times higher. Marked and severe nephropathies were also generally 1.3 to 2.3 times greater.
- "In females, all treatment groups showed a two- to threefold increase in mortality, and deaths were earlier.
- "This difference was also evident in three male groups fed with GM maize.
- "All results were hormone- and sex-dependent, and the pathological profiles were comparable.
- "Females developed large mammary tumors more frequently and before controls;
- "the pituitary was the second most disabled organ;
- "the sex hormonal balance was modified by consumption of GM maize and Roundup treatments.
- "Males presented up to four times more large palpable tumors starting 600 days earlier than in the control group, in which only one tumor was noted.
- "These results may be explained by not only the non-linear endocrine-disrupting effects of Roundup but also by the overexpression of the EPSPS transgene or other mutational effects in the GM maize and their metabolic consequences.
- "Our findings imply that long-term (2 year) feeding trials need to be conducted to thoroughly evaluate the safety of GM foods and pesticides in their full commercial formulations."
The paper concludes: "Taken together, the significant biochemical disturbances and physiological failures documented in this work reveal the pathological effects of these GMO and R treatments in both sexes, with different amplitudes.
"They also show that the conclusion of the Monsanto authors [13] that the initial indications of organ toxicity found in their 90-day experiment were not 'biologically meaningful' is not justifiable.
"We propose that agricultural edible GMOs and complete pesticide formulations must be evaluated thoroughly in long-term studies to measure their potential toxic effects."
Regulators must take these results seriously
Dr Heinemann commented: "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."
According to Patrick Holden, Chief Executive of the Sustainable Food Trust [14] (SFT) the study highlights the inadequacy of current safety testing:
"The most obvious deficiency relates to the fact that the current approval process is based on animal feeding trials of only 90 days, a totally inadequate duration when one considers that chronic diseases in animals and humans do not usually manifest until mid-life."
A second deficiency, he added, relates to the newly emerging science of epigenetics - which demonstrates that endocrine systems can be seriously disrupted by the presence of chemical residues at concentrations as low as a few parts per billion.
"This turns on its head the logic of an approval process based on MRL (maximum residue levels), since it is becoming increasingly apparent that these chemicals have patterns of non-linear response."
An 'urgent review' of pesticide licensing is needed
Given these concerns, said Holden, "there is a strong case for an urgent review of the regulatory process for licensing both the herbicide Roundup and the neonicotinoid class of insecticides. A fundamental review of the entire process for licensing agricultural chemicals is required to ensure that in future the public interest is better served."
Professor Pete Myers, Chief Executive of Environmental Health Sciences and scientific advisor to the SFT points out that only "the tiniest fraction of agricultural chemicals" have been studied for health effects by independent scientists:
"Over the last two-decades there has been a revolution in environmental health sciences that suggests the proportion of diseases attributable to chemical exposures is far bigger and more significant than previously understood.
"The tools we have available to us to say what is safe and not safe are deeply flawed. They are not based on two decades of development in the fields of endocrine disruption and epigenetics, but instead on tests developed in the 1950s.
"They do not reflect the complexity of mixtures, or the way in which chemicals interact."
See more stories tagged with:
gmo [16],
maize [17]
Source URL: http://www.alternet.org/food/major-study-demonstrates-monsanto-gmo-corn-product-can-cause-damage-liver-and-kidneys-and
Links:
[1] http://www.theecologist.org/
[2] http://www.alternet.org/authors/oliver-tickell
[3] http://sustainablepulse.us5.list-manage.com/track/click?u=96b2dcb7821c7b93f09376626&id=f44b24ebe5&e=e92fbf61bb
[4] http://www.spinwatch.org/index.php/issues/science/item/164-smelling-a-corporate-rat
[5] http://www.enveurope.com/content/26/1/14
[6] http://www.enveurope.com/content/26/1/13
[7] http://www.theecologist.org/blogs_and_comments/commentators/2452325/biosafety_and_the_seralini_affair_scientific_and_regulatory_reform_are_essential.html
[8] http://www.GMOSeralini.org/
[9] http://retractionwatch.com/2014/01/16/journal-editor-defends-retraction-of-gmo-rats-study-while-authors-reveal-some-of-papers-history/
[10] http://www.gmwatch.org/files/Letter_AWHayes_GES.pdf
[11] http://www.utsandiego.com/news/2014/jan/08/science-food-health/
[12] http://www.sciencedirect.com/science/article/pii/S0278691514000039
[13] http://www.enveurope.com/pubmed/15110110
[14] http://www.sustainablefoodtrust.org/
[15] mailto:corrections@alternet.org?Subject=Typo on Major Study: Monsanto GMO Corn Can Cause Damage to Liver and Kidneys, and Severe Hormonal Disruption
[16] http://www.alternet.org/tags/gmo
[17] http://www.alternet.org/tags/maize
[18] http://www.alternet.org/%2Bnew_src%2B
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http://www.spinwatch.org/index.php/issues/science/item/164-smelling-a-corporate-rat
Tuesday, 11 December 2012 21:17
Smelling a corporate rat
new study suggesting a Monsanto GM maize and the company's Roundup herbicide may pose serious health risks has been widely attacked, not just by scientists and commentators but also by scientific bodies and regulators. Here, Jonathan Matthews of GMWatch looks at the role of industry-linked scientists and lobbyists in a campaign aimed at getting the paper retracted. You can alsodownload this article as a PDF.
At the end of November Reuters ran the headline Science Journal Urged to Retract Monsanto GM Study and New Scientist also reported the growing pressure for retraction. These articles marked the latest stage in a campaign that kicked off the moment the study was published in mid-September, when researchers led by Prof. Gilles-Eric Seralini at the University of Caen in France announced their findings of serious health problems in rats that had been fed a Monsanto maize genetically engineered to be resistant to the company's herbicide Roundup, as well as in rats just fed low doses of the herbicide itself. In both cases the rats fed with the GM maize and/or minute amounts of the herbicide in water were several times more likely to develop lethal tumours and suffer severe liver and kidney damage when compared to the controls.
Science Media Centre spearheads the attack
Although the publication of the results of the long-term feeding trial in Food and Chemical Toxicology made front page news in France, it got a very different reception in the English-speaking world. This was thanks to the rapid rebuttal efforts of the London-based Science Media Centre (SMC), which almost as soon as the study was published began spoon-feeding journalists with ready-made quotes from scientists savaging the study.
The SMC's director Fiona Fox was subsequently reported as saying that she took pride in the fact that the SMC's "emphatic thumbs down had largely been acknowledged throughout UK newsrooms: apart from the Mail, only the Daily Telegraph and the Financial Times covered the story in their print editions – and both used quotes supplied by the Science Media Centre.” She added that several television news programmes had also rejected the story after reading the quotes
The SMC's quotes were pumped out internationally via its clones, like the Australian Science Media Centre, with like-minded local experts layered on the top. The quotes were also circulated to the media by Monsanto and other GM lobby groups. As a result, the quotes ended up in a lot of media coverage worldwide. One even popped up in the New York Times along with the scathing comments of Bruce M. Chassy, professor emeritus of food science at the University of Illinois.
Retraction campaign kicks in
Another key player in whipping up hostility to the paper was the American business magazine Forbes. In the ten days following the study's release, Forbes published no less than six separate attack pieces targeting not just the research but also the researchers. The first two pieces drew extensively on the quotes from the Science Media Centre and ran with them, but the Forbes piece that grabbed the most attention, particularly on social media, was one that kicked off with a headline that labelled the paper a fraud. The article went on to accuse Prof. Seralini not just of "gross scientific misconduct" but also of having "a long and sordid history" of "activism". The article concluded by bluntly telling the editors of Food and Chemical Toxicology that the only "honorable course of action for the journal would be to retract the paper immediately".
The retraction campaign was by then well under way. An :{online petition:(style="background-color:#ffff66;"):}:was up and running, demanding in the name of "the scientific community" that Seralini hand over all his raw data. The petition was aggressively promoted via social media, often with the implication that the researchers had something to hide. The assertion that the study was "fraudulent" obviously played well into this campaign, which culminated in the Reuters and New Scientist pieces reporting the retraction calls. Both these articles reported on the petition, as well as containing lacerating comments from two UK scientists – comments once again provided by the Science Media Centre.
One of the published comments – from Prof. Maurice Moloney – said it was "appalling" that such a study should ever have been published in a respected journal. And a researcher from the UK's John Innes Centre demanded to know whether it was not "time for Food and Chemical Toxicology to retract the manuscript?" The only other scientist quoted claimed the publication of the paper was more than just "a dangerous case of failure of the peer-review system." It represented a threat to not just the credibility of the journal but "the scientific method overall". This apocalyptic claim was backed up by the news that hundreds of outraged scientists had signed the online petition.
Who's behind the retraction petition?
Writing in The Guardianat the end of September, John Vidal described the attacks already raining down on Seralini and his team as "a triumph for the scientific and corporate establishment which has used similar tactics to crush other scientists". These included, Vidal said, "Arpad Pusztai of the Rowett Institute in Scotland, who was sacked after his research suggested GM potatoes damaged the stomach lining and immune system of rats, and David Quist and Ignacio Chapela", who studied the flow of genes from illegally planted GM maize to Mexican indigenous maize.
The vociferous attacks on Quist and Chapela resulted in the apparent retraction of their paper by the journal Nature,even thoughsuch a move was not supported by the majority of its reviewersand subsequent research confirmed the paper’s main finding. But, as the French journalist Benjamin Sourice has pointed out, the simplest way to definitively discredit a study and nullify its impact is to pressurise the journal that published it to retract it from its list of publications.
In the case of Quist and Chapela, an investigation that I undertook with the journalist and author Andy Rowell of Spinwatch revealed how the campaign of retraction had been carefully orchestrated from the start by Monsanto's PR people.It used proxies to whip up feeling against the lead author by branding Dr Chapela an "activist" rather than a scientist and by maintaining his findings were bogus and arrived at through collusion with environmental NGOs. Our research, which was widely reported in both print and broadcast media, suggested that at the heart of that retraction campaign sat Monsanto's former chief internet strategist and director of corporate communications. Jay Byrne had gone on to found his own internet PR company v-Fluence, based like Monsanto in the corporation's home town of St Louis.
Although Byrne appeared to be the campaign's chief architect, its principal conduit was the lobby group AgBioWorld, overseen by the GM scientist CS Prakash. The "ipetition"on Seralini contains no information as to who sponsored it, but its first signatory is CS Prakash. Prakash also seems to have set up an earlier more primitive version of the petition, which clearly identifies him as its sponsor.
Some time after GMWatch flagged upthe likely role of Prakash and AgBioWorld in the ipetition, the organisation acknowledged its authorship in a press releasewhich asserted that "the petitioning scientists are calling on the publishing journal editors to retract the Seralini study" if he failed to give in to their demand that he hand over all his data.
The AgBioWorld press release contained a quote by Bruce Chassy, who was also the first signatory of the earlier Seralini petition. Chassy was alsothe co-author of the Forbes pieceaccusing Seralini of fraud.
The article's other author was Henry Miller, a darling of the rightwing press who operates out of the Hoover Institution, among other industry backed lobby groups. Miller, like Chassy, has long been associated with Prakash's AgBioWorld. Miller recently co-authoredanother vitriolic piece on GM for Forbes, denouncing the "fear profiteers" of the anti-GM "protest industry". Miller's co-author on that occasion was none other than former Monsanto PR boss Jay Byrne of v-Fluence. Tellingly, Michael Pollan, the renowned New York Times food writer and professor of journalism at the UC Berkeley Graduate School of Journalism, described the piece by Byrne and Miller as a breathtaking example of "the Big Lie".
Byrne hasn't published any media pieces on Seralini. But it is apparent from Byrne's Twitter account that he was almost solely preoccupied with discrediting the Seralini study from the day of its publication for about the next month. Byrne describes himself on Twitter as v-Fluence CEO and as "Contributing author, Let Them Eat Precaution", a book on GM edited by Jon Entine. Entine, as it happens, is the author of probably more articles to date attacking Seralini than any other commentator.
Agribiz apologist
Entine's book emerged out of an American Enterprise Instituteconference overseen by Entine at which Byrne was an invited speaker. And Byrne's v-Fluence turns up again in company with Entine at another AEI conference he oversaw – this one attacking corporate social responsibility (CSR). According to Business Ethics: "A second AEI conference featured AEI fellow Jon Entine – a long-time critic of SRI [socially responsible investing] – and Sarah Fuhrmann of v-Fluence Interactive Public Relations. Several v-Fluence employees are ex-public affairs staffers for Monsanto – where they honed skills fighting CSR initiatives that targeted genetically modified foods."
Entine hasn't just worked with Byrne and v-Fluence, but has also done paid work for Byrne's company. In a piece about Entine by the food and farming commentator Tom Philpott, The Making of an Agribusiness Apologist, Entine denies being a hired gun for Syngenta in his work defending pesticides and downplays the fact that his company (ESG MediaMetrics) lists Monsanto as a client. This is how he explains it: "Nine years ago, I did a $2000 research project for v-Fluence, a social media company formed by former Monsanto executives. That's the entirety of my Monsanto relationship." Presumably Entine lists Monsanto and not Jay Byrne's firm as his company's paymasterbecause he recognises that what he does for v-Fluence he's really doing for Monsanto.
Entine's first attack on Seralini came out on Forbes within 24 hours of the paper's publication. His second piecea few days later contained further attacks, not just on Seralini, whom he accused of steadfastly refusing to share his raw data, but on almost anyone who attempted to defend the study. Entine also published a third more recent article which focuses particularly on letters to Food and Chemical Toxicology requesting Seralini's paper be retracted. In this he notes, "More than two dozen scientists from around the world co-signed a stinging rebuke of the Seralini study, concluding: 'We appeal to you to subject the paper to rigorous re-review by appropriate experts and promptly retract it if it fails to meet widely held scientific standards of design and analysis, as we believe it fails to do.'"
The letterEntine is referring to was signed by, among others, CS Prakash, Henry Miller and Bruce Chassy. Several of the other signatories also have connections to AgBioWorld. Entine's book on GM, incidentally, also has contributions from CS Prakash and his AgBioWorld co-founder, Greg Conko of the Competitive Enterprise Institute.
Cancer-prone rat
Another signatory of this joint letter to Food and Chemical Toxicology is Prof. Anthony Trewavas. Trewavas was also one of the experts quoted by the SMCin their media releasethat had such an impact on the reporting of the Seralini study.
In his SMC comments, which ended up being quoted in well over 20 different publicationsworldwide, Trewavas accuses the researchers of using a cancer-prone rat and claims: "[A] line [of rats] which is very susceptible to tumours can easily bias any result." This line of argument was also developed for the SMC by another expert, Maurice Moloney who says Sprague-Dawley rats frequently develop mammary tumours
It is this cancer-prone rat claim, which Trewavas and Moloney first set running, that more than any other underpins the Chassy-Miller allegation of fraud. The suggestion is that the study was deliberately designed to generate tumours, i.e. that Seralini and his team intentionally chose the Sprague-Dawley rat for their research in order to produce exactly the result they wanted - cancer!
But although variants on this claim have been widely reported, there are a number of problems with it. Not only is this line of rats the same one that Monsanto used for the study that underlies the regulatory approval of this GM maize (NK603), but Sprague-Dawley rats have also been used repeatedly in toxicology and carcinogenesis trials, including long-term ones. They were even used in industry’s own two-year research studies submitted to regulators to support the regulatory approval of glyphosate – the active ingredient in Monsanto's Roundup, one of the two substances that Seralini's team were researching.
And the fact that this strain of rat has a 30%-plus tendency to “spontaneous” cancers across its lifetime actually means it a good model for humans, who have a similar susceptibility to the disease. What's more, even allowing for the Sprague-Dawley rats having a tendency to spontaneous tumours, Seralini's team found the rats fed on either the GM maize or the herbicide suffered an increase in the number of tumours and they had an earlier onset when compared to those in the control group. The researchers also took account of the spontaneous tumour issue by comparing their results to the rates of similar types of tumour in other published studies using the same strain of rat.
This is not say that the Seralini study does not have its shortcomings. It's true that the study had fewer rats than are recommended for cancer studies, but Seralini did not set out to look for tumours. His study was a chronic toxicity one that unexpectedly found striking evidence of increased tumours in the treated rats. Given this finding, the onus should now be on Monsanto to fund a full-scale carcinogenicity study using larger groups of rats to prove that its products are safe – something it has so far failed to do.
Angelika Hilbeck of the Swiss Federal Institute of Technology (ETH Zurich) describes the "wrong rat" argument first put forward by Trewavas and Moloney as "absurd". Hilbeck says, "Seralini chose the same strain of rat as Monsanto. Do we really think that a substance should be tested on an animal that is not sensitive to it? With these defamations they wanted to distract us from the fact that Seralini used the same methodology as Monsanto. Because if you take Seralini seriously as a researcher, you have to take seriously his study and the comparison with Monsanto's study. That would put into question Monsanto's study and hence the approval of GM maize."
Double standards used to condemn studies showing risk
In fact, many of the charges that have been made against the Seralini study could be levelled against the studies that have been used to approve GM crops, which are less detailed than Seralini's and typically shorter-term. This is why a report by the European Network of Scientists for Social and Environmental Responsibility (ENSSER) concluded that a careful comparison of the Seralini rat feeding trial with Monsanto trials shows that if the Seralini experiments are considered insufficient to demonstrate harm, then those carried out by Monsanto cannot prove safety. This is because, whatever its limitations, Seralini's study was conducted to generally higher scientific standards than the studies underlying GM food approvals.
ENSSER highlights the double standards whereby studies on GM crops like Seralini's that show adverse effects are subjected to obsessive yet often poorly justified criticism of their experimental and statistical methods, while those like Monsanto's that claim safety are taken at face value. In this way risk is assessed in an asymmetrical fashion so that the burden of proof is not on the biotech industry to provide adequate evidence of the safety of its products, but is on public researchers like Seralini to prove harm beyond any doubt.Other experts have echoed the charge of double standards, including around 140 French scientists who, in a public statement published in Le Monde, declared that it was contrary to scientific ethics to damn an experimental protocol when it gave results that were not wanted, while accepting it when it gave results that were.
These double standards can also be seen in the ipetition demanding that Seralini hand over all of his raw data to his critics. Those championing the petition have no history of demanding from Monsanto full public disclosure of all the raw data underlying its studies supporting safety (the industry studies on glyphosate, for example, are kept secret under 'commercial confidentiality' agreements between industry and regulators). This is why Seralini has said he will undertake full disclosure when the same level of disclosure takes place for all the studies underlying GM food approvals, so that like can be compared with like.
Public science and private interests
One of the early UK signatories of the ipetition, as well as a co-signatory, like Prof. Trewavas, of the letter to Food and Chemical Toxicology from Prakash, Chassy and Miller, is Prof. Chris Leaver. Leaver, like Trewavas, is a GM scientist. He is also a former advisor to the Science Media Centre and a former consultant to the GM/agrochemical giant Syngenta. Since 1984 Prof. Leaver has also beenon the Governing Councilof the UK's leading public plant biotechinstitute, the John Innes Centre – something else he has in common with Prof. Trewavas, who was also for several years on the JIC's Governing Council.
The JIC has been a key player in the criticism of Seralini. This is apparent as soon as you look at the SMC's three media releases on the study. The first quoted eight experts including a senior scientist at the JIC and a former member of its Governing Council (Trewavas). The secondquoted just one expert, Cathie Martin of the JIC. The thirdquoted five experts, of which three, including Cathie Martin, were from the JIC.
What makes this predominance particularly revealing is that the scientists in question are not experts on toxicology or animal studies. Their expertise is in plant genetics and GM. What's more, the JIC and its Sainsbury Laboratory have had tens of millions of pounds in investment from GM giants like Syngenta. In fact, they are so dependent on the public acceptance of GM that a previous acting director of the JICconfided to his local paperthat any major slowdown or halt in the development of GM crops "would be very, very serious for us".
These vested interests are personal as well as institutional. Cathie Martin, for instance, says in her JIC profile, "I am inventor on seven patents and I recently co-founded a spin-out company (Norfolk Plant Sciences) with Professor Jonathan Jones FRS, to bring the benefits of plant biotechnology to Europe and the US." Jones, who is quoted along with Martin in one of the SMC releases, co-founded another biotech firm, Mendel Biotechnology, which has Monsanto as its "most important customer and collaborator".
The failure of Jones, who is also an advisor to Mendel Biotechnology, to be more explicit about his industry links, has generated controversy. Yet journalists are given no indication of these kind of conflicts of interest by the SMC's releases, as the journalist Joanna Blythman has noted: "The SMC introduced these experts to the media solely by listing the universities and public institutions that employ them, failing to give the full flavour of their interests." And the problem goes much wider than the JIC, as Blythman notes with regard to the experts quoted in the SMC's first media release: "seven out of eight are either evangelical advocates of GM food, or have received funding from, or worked with, prominent biotech corporations."
Take, for instance, the very first expert quoted by the SMC, Prof. Maurice Moloney. This year, the SMC has featured Moloney in no fewer than four different media releases on GM. They typically identify him only as "Institute Director and Chief Executive, Rothamsted Research", which is an independent charitable agricultural research centre. What journalists aren't told is that Moloney is so enamoured of GM that he drives around in a Porsche with a GMO number plate, and has a CV to match. He is the inventor on more than 300 patents and his GM research underpins one of Monsanto's main GM crops. He has also founded his own GM company in which the GM giant Dow AgroScience was an investor. The fact that Prof. Moloney's career and business interests have long been centered around GM is not something the SMC seems to think journalists need to know.
Letters to journal fail to disclose conflicts of interest
This pattern of significant but undisclosed conflicts of interest is relevant to not only the majority of the SMC's experts but also to many of Seralini's other critics, including those responsible for the twenty or so letters published by Food and Chemical Toxicology in response to Seralini's paper. Some of the letter writers are, in fact, exactly the same people that the SMC quotes. They are also often to be found amongstthe earliest signatories of the AgBioWorld ipetition. Maurice Moloney, for example, not only turns up twice in the SMC's media rebuttals of Seralini, but comes in at no. 11 on the list of ipetition signatories, and he wrote a letter to the journal.
Another letter writer demanding retraction is Prof. Mark Tester. Like Moloney and the JIC, Tester is a firm favourite with the SMC, featuring in three of this year's SMC's media releasesand in many more over the years. He was already a favoured expert a decade ago when the SMC wasaccused of orchestrating a spin campaign to discredit a BBC drama on GM crops. The University of Adelaide staff directory broadens out Prof. Tester's academic profile in a way the SMC never has: "His commercial acumen is clear from his establishment of private companies and successful interactions with multinational companies such as Monsanto, Syngenta, Bayer and Pioneer-DuPont."
Many other letter writers also have undisclosed industry links. Take, for instance, Martina Newell-McGloughlin. She identifies herselfas the director of the International Biotechnology Program at the University of California/Davis, but fails to mention that the Program is funded by the likes of Monsanto, Syngenta, DuPont and Bayer. Another letter writer and a colleague at UC Davis, Kent Bradford, has consulted for Monsanto. Lucia de Souzawrote to the journalwith Leila Macedo Oda on behalf of ANBio – the Brazilian Biosafety Association, without mentioning that ANBio's funders include Monsanto, Bayer, and DuPont.
Then there are the letter writers who fail to mention their previous employers, like Andrew Cockburn, Monsanto's former director of scientific affairs (Europe and Africa); L. Val Giddings, former Vice President of the Biotechnology Industry Organisation; and Sivramiah (Shanthu) Shantharam, former Syngenta man and until recently head of the biotech industry's main lobby group in India.
Even letter writers who at first glance seem like they must be entirely independent of the biotech industry can turn out to have links. Take, for instance, Erio Barale-Thomas, one of the few toxicologists to criticize the Seralini paper in the journal. Barale-Thomas, who says he writes on behalf of the Administrative Council of the French Society of Toxicological Pathology, takes Seralini to task for his failure to declare a conflict of interest in his paper, namely that Seralini is president of CRIIGEN, an independent research group with concerns about GM, which contributed funding to the research. Yet CRIIGEN's contribution to funding the study was declared in the paper, while Barale-Thomas does not disclose in his letter his own biotech interests. He is not only principal scientist at Janssen Biotech, but immediately prior to that he worked for the GM crop and agrochemical giant Bayer CropScience (1998-2003).
Another French scientist among the letter writers is Prof. Marc Fellous, whose declared connections are academic posts in the sphere of human genetics. What he doesn't mention is that he heads up the French Association of Plant Biotechnology, which lobbies for GM crops and has been so aggressive in its attacks on Seralini that last year he successfully sued Fellous for defamation.
Science or ideology?
Another letter writer is the pathologist Sir Colin Berry. Like Trewavas, Berry is an advisor to the Scientific Alliance, an organization which campaigns on environmental issues, particularly climate change, energy policy and agriculture. It is pro-GM, pro-nuclear and sceptical about climate change. Its director, Martin Livermore, runs an agri-food PR consultancy, prior to which he did PR for the GM giant DuPont. The Alliance was established by the lobby firm Foresight Communication with money from right-wing business interests.
Trewavas is one of only a couple of scientists who not only signed onto the Prakash, Chassy, Miller letter but also sent their own letter of complaint to the journal. Trewavas concludes it like this: "this paper and this journal have dealt the value of evidence-based knowledge a serious blow and it can only be rectified if the paper is withdrawn by the authors with an apology for misleading the public and the scientific community alike… Ideology and politics must be kept out of scientific study or we all suffer."
It is revealing that critics like Berry and Trewavas claim to champion an evidence-based approach while operating out of lobby groups that attack the scientific consensus on issues like climate change. Berry, incidentally, is also a shareholder in the company that owns the aggressively libertarian online magazine Spiked, which also promotes climate scepticism.Fiona Fox, the director of the Science Media Centre, was a long-time affiliate of the anti-environmental LM network that are behind Spiked.
The network around AgBioWorld also contains people with similar attitudes on environmental issues. These include Henry Miller, who co-wrote the article accusing Seralini of fraud, and AgBioWorld's co-founder Greg Conko of the Exxon-fundedCompetitive Enterprise Institute, which specializes in denialist "straight talk on global warming."
Given this, it is ironic that AgBioWorld's Seralini petition was set up in the name of "the scientific community." Similarly, Maurice Moloney says in his letterto Food and Chemical Toxicology that he thinks he can speak "for the vast majority of the biological sciences community." But as we have seen, Moloney and many of the other letter writers link to a narrow and heavily commercialised sector of the biological sciences, albeit one with powerful backers. And some in this community have links to extremist lobby groups more concerned with ideology than evidence.
Peeling the GM onion
Identifying the real forces behind the front-men and carefully selected experts of "the scientific community" can be like peeling back the layers of an onion. Take Anthony Trewavas, the scientist who first helped get the cancer-prone rat claim into circulation. In 2001 Prof. Trewavas was named in the High Court in London as the source of a letter published in a Scottish newspaper that made libelous claims against GM critics (Greenpeace wins damages over professor's "unfounded" allegations). Trewavas subsequently denied being the author of the libel letter published under his name, though he did admit circulating the material, which he said he had got from AgBioWorld. He said it had been written by a "lady in London" but "she" later turned out to bea front for the same Monsanto PR people who covertly directed the campaign that resulted in Nature's apparent retraction of Chapela's GM maize paper.
Trewavas, a long-time associate of Prakash and AgBioWorld, also played a notable role in that campaign. In that case, Trewavas encouraged people to demand Chapela be fired by the University of California, Berkeley, unless he handed over his maize samples for checking: "We should be asking Berkeley to request Chapela to release his samples so that they at least can be checked... Refusal to do so should then be used to request Berkeley to relinquish Chapella's [sic] position." Such calls to arms against Chapela were mostly posted on the AgBioWorld listserv. This use of the listserv eventually enabled Monsanto's covert orchestration of the campaign to be exposed.
The attack dog in the night-time
Interestingly, as the attacks on Prof. Seralini and his paper spread across both mainstream and social media, AgBioWorld's listserv went missing. In the two months following the publication of Seralini's paper, not a single bulletin went out on the listserv that played such a pivotal role in achieving retraction of the Mexican maize paper.
AgBioWorld's sudden silence calls to mind a famous exchange in The Memoirs of Sherlock Holmes:
Detective: "Is there any other point to which you would wish to draw my attention?"
Holmes: "To the curious incident of the dog in the night-time."
Detective: "The dog did nothing in the night-time."
Holmes: "That was the curious incident."
With Seralini, it's the curious silence of Monsanto's attack dog that suggests that this time the covert PR war is being conducted by other means.
If the silence of AgBioWorld's listserv is suggestive, so too is the attempt to silenceGMWatch. Within days of the publication of the Seralini paper, our website came under major DDOS (Distributed Denial of Service) attacks. The contours of the attacks followed the peaks of the controversy, with the two biggest and most debilitating attacks coinciding with days on which the major rebuttals of Seralini's paper were published. The GMWatch website had by then become a clearing house for rapid responses in English to the attacks on Seralini. We have no proof as to who was behind the attacks – that's hard to establish with DDOS. But oddly enough, an article in the Guardian about the retraction campaign against Quist and Chapela noted, "Just before the [Mexican maize] paper in Nature was publicly challenged, the server hosting the accounts used by its authors was disabled by a particularly effective attack which crippled their capacity to fight back."
More than a decade later history seems to be repeating itself in the covert war over GM crops.
Jonathan Matthews is the founder and director of GMWatch and has written numerous articles on the politics and spin around GM crops. He's a contributing author toThinker, Faker, Spinner, Spy: Corporate PR and the Assault on Democracy,eds Dinan and Miller (Pluto Press). Additional research: Claire Robinson, co-editor, GMWatch.
*Spinwatch plans to publish a separate piece looking at some of the study's European critics, including science academies and the European Food Safety Authority.
http://en.wikipedia.org/wiki/S%C3%A9ralini_affair
The Séralini affair began in September 2012, and involved the publication of an experiment conducted by a group led by Gilles-Éric Séralini. The experiments involved feeding Monsanto's RoundUp-resistant NK603maize (called corn in North America) and the herbicide RoundUp to rats, over the rats' two-year lifespan.[1]
Séralini had required that journalists, in order to receive a copy of the paper prior to the press conference, sign a confidentiality agreement that prohibited them from contacting other researchers for comment before the press conference. During the press conference, Séralini also announced that 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 Roundup-resistant maize and RoundUp are toxic.
The conclusions that Séralini drew from the experiments were widely criticized, as was the design of the experiments.[2][3] 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, namely Sprague-Dawley rats. The paper was also refuted by food standards agencies.[4] Other long term studies, which were publicly funded, have uncovered no health issues.[3][4] 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.[2]
In November 2013, Food and Chemical Toxicology, the journal that published the 2012 paper, announced that it was retracting the paper, after the authors refused to withdraw it.[5] The article was republished in June 2014 in the journal Environmental Sciences Europe, without further peer-review.
Contents
- 1 Background
- 2 2012 study and release
- 3 Scientific evaluation
- 4 Reaction by public and government officials
- 5 Reaction in the media
- 6 Criticism of the way the study was publicized
- 7 Retraction and response
- 8 Republication
- 9 References
Background
Gilles-Eric Séralini is a professor of molecular biology at the University of Caen in France, and is founder and president of the scientific advisory board of the Committee of Research and Independent Information on Genetic Engineering (CRIIGEN), which is known for being opposed to genetically modified food.[6][7][8] Séralini founded CRIIGEN because he judged that studies on the safety of GMOs are inadequate, and questioned their scientific evaluation.[6]
In 2004, Monsanto sought approval in Europe to introduce a rootworm resistant (MON863) maize, which led to controversy over acceptance by regulatory bodies of industry-funded toxicity studies and over the design of those studies. Séralini, who was on the committee that reviewed MON863 for the French government,[9] was a major figure in those controversies and continues to be a critic of toxicity study design.[10]
In 2004, the GMO Panel of the European Food Safety Authority recommended the authorisation of MON863.[11] Its report described the data that Monsanto provided, and referenced changes in some blood cell parameters and in kidney weights of rats that were tested.[11] Because of concerns in general but specifically referencing these changes, Greenpeace sued for release of the rat feeding studies that Monsanto had provided. Monsanto fought against the suit in order to protect its trade secrets.[12] In June 2005 a German court ordered the release of the original study.[12][13] With the full study in hand, critics of GM foods, including Séralini, pointed to differences in kidney size and blood composition found in this study, suggesting that the observed differences, as well as the design of the studies, raised questions about the regulatory concept of substantial equivalence.[14]
Previous Séralini papers and reactions to them
Prior to 2012, Séralini had published other peer-reviewed papers which concluded that there were health risks to genetically modified foods. However, some members of the scientific community and food safety authorities had questioned whether Séralini's data were sufficient to support his conclusions.
In 2007, Séralini and two other authors from University of Caen and the University of Rouen published a study of these data, funded by Greenpeace.[15][16][17] The study concluded that MON 863 caused numerous health problems in rats, including weight changes, triglyceride level increases in females, changes in urine composition in males, and reduced function or organ damage in the liver, kidney, adrenal glands, heart, andhaematopoietic system.[15] The study concluded that evaluating MON 863 safety required experiments longer than 90 days, as chronic organ problems are rarely evident within such a short amount of time.[15]Greenpeace cited the study in a press release, in which it said that MON 863 should be completely recalled from the global market and called for a strict review of current testing methods.[18]
The paper prompted the European Food Safety Authority (EFSA) to reexamine the MON 863 safety data. This included asking EU countries for any new data about the strain and new opinions on the original Monsanto toxicity study, and a technical meeting with the authors of the 2007 CRIIGEN paper. The EFSA concluded that all blood chemistry and organ weight values fell within the normal range of values for control animals[19] and that the paper used incorrect statistical methods.[20] These conclusions were reported by Markos Kyprianou (European Commissioner for Health and Consumer Policy) to the European Parliament on 9 July 2010.[21] The French Commission du Génie Biomoléculaire (AFBV) also reached critical conclusions.[22] Food Standards Australia New Zealand also reviewed the 2007 Séralini study and concluded that "...all of the statistical differences between rats fed MON 863 corn and control rats are attributable to normal biological variation."[23][24]
In 2009, the Séralini lab published another study, which re-analyzed the toxicity data for NK603 (glyphosate resistant), MON 810, and MON 863 strains.[25] The data included three rat feeding studies published by Monsanto scientists on MON 810 (Bt corn).[26][27][28] This study concluded that the three crops caused liver, kidney, and heart damage in the rats.[25]
The EFSA reviewed the 2009 Séralini paper and concluded that the authors' claims were not supported by the data in their paper, that many of their fundamental statistical criticisms of the 2007 paper also applied to the 2009 paper, and that there was no new information that would change the EFSA's conclusions that the three GM maize types were safe for human and animal health, and for the environment.[29] The French High Council of Biotechnologies Scientific Committee[30] (HCB) also reviewed the Séralini 2009 study and concluded that it "..presents no admissible scientific element likely to ascribe any haematological, hepatic or renal toxicity to the three re-analysed GMOs."[31] The HCB also questioned the authors' independence, noting that, in 2010, the Séralini web page still showed a 2008 Austrian anti-GM article which had been previously withdrawn by the authors themselves as flawed. Food Standards Australia New Zealand concluded that the results from the 2009 Séralini study were due to chance alone.[32]
In 2010, Séralini sued University of Paris VII Professor Marc Fellous, president of the French Association of Plant Biotechnology, and the Association, for libel, on the grounds that they had unjustly criticized his scientific ability, and on the grounds that they had criticized the science as invalid because it was funded by Greenpeace. The judge ruled that because Séralini was able to show that Fellous and other critics had financial ties to the agricultural biotechnology industry, their charge about the Greenpeace funding was defamatory; the judge refused to rule on the scientific grounds. Fellous was fined 1000 euros and Séralini was awarded a symbolic 1 euro in damages, and court costs.[33]
A 2011 review by the Séralini lab, which used 19 published animal feeding studies, as well as data from several animal feeding studies submitted for regulatory approval, continued to find that GM food had liver and kidney effects that were sex and dose dependent, and advocated for longer and more elaborate toxicology tests for regulatory approval.[10]
2012 study and release
On 19 September 2012, Séralini and his colleagues published a paper titled "Long-term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize" in the journal Food and Chemical Toxicology. The published research, which cost €3.2 million to perform,[34] was funded and run with CRIIGEN, and comprised a two-year study of the effect of Monsanto's genetically modified maize NK603, engineered to be resistant to the herbicide RoundUp, on rats.[35]
The abstract indicates: "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." 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.[1]
Séralini held a press conference on the day the study was released that also included an announcement of the release of a book and film about the study; selected journalists were given access to the paper prior to the press conference, and each writer was required to sign a confidentiality agreement that prevented them from discussing the paper with other scientists before the embargo expired. The agreement included a penalty for non-compliance: “A refund of the cost of the study of several million euros would be considered damages if the premature disclosure questioned the release of the study.”[35] In contrast, embargo guidelines by journals such as Nature do allow journalists to disclose the contents of upcoming papers to other scientists in order to comment.[36]
Scientific evaluation
The study has been criticized by various regulatory authorities and scientists.
Many claimed that Séralini's 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).[37][38][39] The Séralini experiment lasted the normal lifespan of these rats, and the longer the experiment goes, the more statistical "noise" there is – the more rats get cancer naturally, regardless of what you do to them. So for the experiment to have adequate statistical power, all the groups – control groups and test groups – would have to include at least 65 rats per group in order to sort out any experimentally caused cancers from cancers that would occur anyway – but the Séralini study had only ten per group.[35] OECD (Organisation for Economic Cooperation and Development) guidelines recommend 20 rats for chemical-toxicity studies, and 50 rats for carcinogenicity studies.[40]:5–6 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.[35][38][39]
King's College London Professor Tom Sanders[41] 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."[42]
The Washington Post quoted Marion Nestle, the Paulette Goddard professor in the Department of Nutrition, Food Studies and Public Health at New York University and food safety advocate: "'[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.'"[43] University of Calgary Professor Maurice Moloney, among others, went on record wondering 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.[44]
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."[45] A joint report by three Canadian regulatory agencies also "identified significant shortcomings in the study design, implementation and reporting."[46] Similar conclusions were reached by the French HCB[30] and the National Agency for Food Safety,[47] the Vlaams Instituut voor Biotechnologie,[48] the Technical University of Denmark,[49] Food Standards Australia New Zealand,[50] the Brazilian National Technical Commission on Biosafety,[51] and theEuropean Food Safety Authority (EFSA).[40] 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.[40]
The European Federation of Biotechnology lobby, which counts Monsanto and other GM firms among its members,[52] called for the paper to be retracted, calling its publication a "dangerous failure of the peer-review system."[35] Six French national academies (of Agriculture, Medicine, Pharmacy, Science, Technology and Veterinarians[53]) issued a joint statement – "an extremely rare event in French science"[54] – condemning the study and the journal that published it.[53] The joint statement dismissed the study as 'a scientific non-event'.[54] 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,[1] 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[55] from Erio Barale-Thomas,[56] 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[57]). SFPT is "a non governmental/non profit organization formed by veterinarians, physicians, pharmacists and biologists specialized in veterinary and toxicologic pathology. Its aim is to promote knowledge in pathology, toxicology and laboratory animal sciences for safety studies of drugs, chemicals and food products, and the role of the pathologist in the study design and data interpretation."[55] 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."[55]
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)."[58] Responding to the two point mandate, the BBAC committee, whose members are drawn from the Belgian biotech Professoriat,[58] 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 that:
"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[59] to find useful information and new concerted ideas."[58]:9
Responses
Séralini and supporters have defended the study design, the interpretation of the results, and manner and content of the publication.[60][61] They maintain a website about their views.[62]
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.[63][64] A study funded by and conducted in consultation with ENSSER also found that EFSA applied double standards.[65] An open letter in support of Seralini's article, signed by about 130 scientists, scholars, and activists, was published in Independent Science News, a project of the Bioscience Resource Project, both of which oppose GM crops.[66]
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.[67][68]
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...."[69]
Reaction by public and government officials
At the time of the initial release, French Prime Minister Jean-Marc Ayrault said that, if the results are confirmed, the government would press for a Europe-wide ban on the maize and The European Commission instructed the independent European Food Safety Agency (EFSA) in Parma, Italy, to assess the study.[70] In late September 2012, the government of Russia temporarily suspended importing genetically-modified corn as a result of the study[71] and in November 2012, the government of Kenya banned all GM crops.[72]
Reaction in the media
The press conference led to wide coverage in the media, which "energized opponents of GM food, especially in Europe".[70] Le Nouvel Observateur covered the press conference in a story called, "Yes, GMOs are poisons!".[73]
As Jon Entine put it at 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. 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, concluding there is no evidence of health hazards."[74] Andrew Revkin dubbed it another instance of "single-study syndrome", and contended that the study was in support of an "agenda".[75]
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."[76] 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."[35]
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". They also noted CRIIGEN's funding of the research and reported Séralini's response: namely, that studies in support of GM food are usually funded by "corporates or by pro-biotech institutions".[34] Proponents of California's GM labeling referendum, Proposition 37, hailed the study.[77]
Criticism of the way the study was publicized
The method by which the Séralini team publicized their 2012 paper was widely criticized. The original Agence France-Presse story noted: "Breaking with a long tradition in scientific journalism, the authors allowed a selected group of reporters to have access to the paper, provided they signed confidentiality agreements that prevented them from consulting other experts about the research before publication."[78] The confidentiality agreement contained a severe penalty for breaching the agreement: "A refund of the cost of the study of several million euros would be considered damages if the premature disclosure questioned the release of the study."[35] An editorial at the prestigious scientific journal, Nature, noted: "With such strong claims and the predictably large effect they will have on public opinion, researchers should take care how they present their findings to the public and the media. They should spell out their results clearly; emphasize the limitations and caveats; and make it clear that the data still need to be assessed, and replicated, by the scientific community. That didn't happen. The paper was promoted in a public-relations offensive, with a related book and film set for release this week. Furthermore, journalists wishing to report the research had to sign confidentiality agreements that prevented them from contacting other scientists for comment on the paper until after the embargo had expired. Some, to their credit, refused, or accepted and then revisited the story critically once their hands were no longer tied by these outrageous restrictions. The result was the exclusion of critical comment in many of the breaking stories — the ones that most people will remember."[79][80][81] National Public Radio's program, On the Media, discussed the way the paper was released to the media on 28 September 2012, with Carl Zimmer, a science journalist, who was especially critical of science journalists who allowed themselves to be manipulated, as well as criticizing the Séralini lab.[82] Zimmer had earlier posted on his blog at Discover magazine, "This is a rancid, corrupt way to report about science."[83] Cosmos Magazine's Elizabeth Finkel, wrote, "...a clause barring the gathering of independent opinions is extraordinary. What it meant was that Séralini’s story, when it broke, got to prance unfettered in the media limelight before second opinions could dull its shine. By the time the storm of criticism blew in, the media limelight had moved on."[84] The ethics committee of the French National Centre for Scientific Research (CNRS) also criticized the public-relations offensive as "inappropriate for a high-quality and objective scientific debate, and reminded researchers working on controversial topics of the need to report results responsibly to the public."[35]
Retraction and response
In November 2013, Elsevier, the publishing company for Food and Chemical Toxicology, the journal that published the 2012 paper, announced that the journal was retracting the paper, after the authors refused to withdraw it.[5][85] The editors of the journal concluded that, after an in-depth look at the raw data of the study, no definitive conclusions can be reached regarding the role of either NK603 or glyphosate in overall mortality or tumor rates, given the known high incidence of tumors in Sprague-Dawley rats and the small sample size. Normal variance could not be excluded as the cause of the results.[5][86] Séralini and his supporters strongly objected to the retraction,[85][87][88] and Séralini himself threatened to sue Food and Chemical Toxicology.[89] In January 2014, an online petition calling for the Séralini study be reinstated was posted by a group of Séralini's supporters from the Bioscience Resource Project.[90]
Republication
In June 2014, the original study that had first been published two years earlier was republished in the journal Environmental Sciences Europe.[91][92] The editor of Environmental Science Europe said that the paper was republished without further peer review, "because this had already been conducted by Food and Chemical Toxicology, and had concluded there had been no fraud nor misrepresentation".[92] Like the original study in Food and Chemical Toxicology, this new study faced considerable criticism from some scientists, some of whom had also criticized the study when it had been published in 2012. For instance, ecologist Joe Perry noted that the Environmental Sciences Europe study "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."[93]
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- ^ :{Jump up to::(style="top:-99999px;clip:rect(1px 1px 1px 1px);overflow:hidden;-webkit-user-select:none;position:absolute !important;padding:0px !important;border:0px !important;height:1px !important;width:1px !important"):}:^a b(http://en.wikipedia.org/wiki/S%C3%A9ralini_affair#cite_ref-Elsevier2013_5-1) c(http://en.wikipedia.org/wiki/S%C3%A9ralini_affair#cite_ref-Elsevier2013_5-2) "Elsevier Announces Article Retraction from Journal Food and Chemical Toxicology". Elsevier. Retrieved 2013-11-29.
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- :{Jump up:(style="top:-99999px;clip:rect(1px 1px 1px 1px);overflow:hidden;-webkit-user-select:none;position:absolute !important;padding:0px !important;border:0px !important;height:1px !important;width:1px !important"):}:^ Carman, Tim (September 19, 2012). "French scientists question safety of GM corn". Washington Post. Retrieved May 20, 2013.
- :{Jump up:(style="top:-99999px;clip:rect(1px 1px 1px 1px);overflow:hidden;-webkit-user-select:none;position:absolute !important;padding:0px !important;border:0px !important;height:1px !important;width:1px !important"):}:^ "French study finds tumours in rats fed GM corn". Reuters. September 19, 2012. Retrieved May 20, 2013.
- :{Jump up:(style="top:-99999px;clip:rect(1px 1px 1px 1px);overflow:hidden;-webkit-user-select:none;position:absolute !important;padding:0px !important;border:0px !important;height:1px !important;width:1px !important"):}:^ Seralini bio on CRIIGEN
- ^ :{Jump up to::(style="top:-99999px;clip:rect(1px 1px 1px 1px);overflow:hidden;-webkit-user-select:none;position:absolute !important;padding:0px !important;border:0px !important;height:1px !important;width:1px !important"):}:^a b(http://en.wikipedia.org/wiki/S%C3%A9ralini_affair#cite_ref-Seralini2011_10-1) Séralini, Gilles-Eric; Mesnage, Robin; Clair, Emilie; Gress, Steeve; De Vendômois, Joël; Cellier, Dominique (2011). "Genetically modified crops safety assessments: Present limits and possible improvements". Environmental Sciences Europe 23: 10. doi:10.1186/2190-4715-23-10.[non-primary ^source needed]
- ^ :{Jump up to::(style="top:-99999px;clip:rect(1px 1px 1px 1px);overflow:hidden;-webkit-user-select:none;position:absolute !important;padding:0px !important;border:0px !important;height:1px !important;width:1px !important"):}:^a b(http://en.wikipedia.org/wiki/S%C3%A9ralini_affair#cite_ref-EFSA2004-MON863_11-1) EFSA Panel on Genetically Modified Organisms (2004). "Opinion of the Scientific Panel on genetically modified organisms [GMO] on a request from the Commission related to the safety of foods and food ingredients derived from insect-protected genetically modified maize MON 863 and MON 863 x MON 810, for which a request for placing on the market was submitted under Article 4 of the Novel Food Regulation (EC) No 258/97 by Monsanto". The EFSA Journal 50: 1–25. doi:10.2903/j.efsa.2004.50.
- ^ :{Jump up to::(style="top:-99999px;clip:rect(1px 1px 1px 1px);overflow:hidden;-webkit-user-select:none;position:absolute !important;padding:0px !important;border:0px !important;height:1px !important;width:1px !important"):}:^a b(http://en.wikipedia.org/wiki/S%C3%A9ralini_affair#cite_ref-NoSecrets_12-1) MON863 maize: Court orders disclosure of all documents: No secrets in safety matters
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- ^ :{Jump up to::(style="top:-99999px;clip:rect(1px 1px 1px 1px);overflow:hidden;-webkit-user-select:none;position:absolute !important;padding:0px !important;border:0px !important;height:1px !important;width:1px !important"):}:^a b(http://en.wikipedia.org/wiki/S%C3%A9ralini_affair#cite_ref-Seralini2007_15-1) c(http://en.wikipedia.org/wiki/S%C3%A9ralini_affair#cite_ref-Seralini2007_15-2) Séralini, Gilles-Eric; Cellier, Dominique; De Vendomois, Joël Spiroux (2007). "New Analysis of a Rat Feeding Study with a Genetically Modified Maize Reveals Signs of Hepatorenal Toxicity". Archives of Environmental Contamination and Toxicology 52 (4): 596–602. doi:10.1007/s00244-006-0149-5.PMID 17356802.
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- ^ :{Jump up to::(style="top:-99999px;clip:rect(1px 1px 1px 1px);overflow:hidden;-webkit-user-select:none;position:absolute !important;padding:0px !important;border:0px !important;height:1px !important;width:1px !important"):}:^a b(http://en.wikipedia.org/wiki/S%C3%A9ralini_affair#cite_ref-huntingdon_sprague_dawley_data_38-1) "Mortality and In-Life Patterns in Sprague-Dawley". Huntingdon Life Sciences. Retrieved 26 October 2012.
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- ^ :{Jump up to::(style="top:-99999px;clip:rect(1px 1px 1px 1px);overflow:hidden;-webkit-user-select:none;position:absolute !important;padding:0px !important;border:0px !important;height:1px !important;width:1px !important"):}:^a b(http://en.wikipedia.org/wiki/S%C3%A9ralini_affair#cite_ref-EFSA_40-1) c(http://en.wikipedia.org/wiki/S%C3%A9ralini_affair#cite_ref-EFSA_40-2) European Food Safety Authority (2012). "Final review of the Séralini et al. (2012a) publication on a 2-year rodent feeding study with glyphosate formulations and GM maize NK603 as published online on 19 September 2012 in Food and Chemical Toxicology". EFSA Journal 10 (11): 2986.doi:10.2903/j.efsa.2012.2910. Lay summary – EFSA (4 October 2012).
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- :{Jump up:(style="top:-99999px;clip:rect(1px 1px 1px 1px);overflow:hidden;-webkit-user-select:none;position:absolute !important;padding:0px !important;border:0px !important;height:1px !important;width:1px !important"):}:^ Séralini, Gilles-Eric; Mesnage, Robin; Defarge, Nicolas; Gress, Steeve; Hennequin, Didier; Clair, Emilie; Malatesta, Manuela; De Vendômois, Joël Spiroux (2013). "Answers to critics: Why there is a long term toxicity due to a Roundup-tolerant genetically modified maize and to a Roundup herbicide". Food and Chemical Toxicology 53: 476–83. doi:10.1016/j.fct.2012.11.007. PMID 23146697.
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- :{Jump up:(style="top:-99999px;clip:rect(1px 1px 1px 1px);overflow:hidden;-webkit-user-select:none;position:absolute !important;padding:0px !important;border:0px !important;height:1px !important;width:1px !important"):}:^ European Network of Scientists for Social and Environmental Responsibility (ENSSER) (2012).Questionable biosafety of GMOs, double standards and, once again, a "shooting-the-messenger" style debate
- :{Jump up:(style="top:-99999px;clip:rect(1px 1px 1px 1px);overflow:hidden;-webkit-user-select:none;position:absolute !important;padding:0px !important;border:0px !important;height:1px !important;width:1px !important"):}:^ Hartmut Meyer and Angelika Hilbeck. Rat feeding studies with genetically modified maize – a comparative evaluation of applied methods and risk assessment standards Environmental Sciences Europe 2013, 25:33
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- ^ :{Jump up to::(style="top:-99999px;clip:rect(1px 1px 1px 1px);overflow:hidden;-webkit-user-select:none;position:absolute !important;padding:0px !important;border:0px !important;height:1px !important;width:1px !important"):}:^a b(http://en.wikipedia.org/wiki/S%C3%A9ralini_affair#cite_ref-Furor_70-1) Declan Butler for Nature News. September 25, 2012 Rat study sparks GM furore
- :{Jump up:(style="top:-99999px;clip:rect(1px 1px 1px 1px);overflow:hidden;-webkit-user-select:none;position:absolute !important;padding:0px !important;border:0px !important;height:1px !important;width:1px !important"):}:^ Staff, Phys.org. September 26, 2012 Russia suspends Monsanto corn imports
- :{Jump up:(style="top:-99999px;clip:rect(1px 1px 1px 1px);overflow:hidden;-webkit-user-select:none;position:absolute !important;padding:0px !important;border:0px !important;height:1px !important;width:1px !important"):}:^ Emily Willingham for Forbes. December 9, 2012. Seralini Paper Influences Kenya Ban of GMO Imports
- :{Jump up:(style="top:-99999px;clip:rect(1px 1px 1px 1px);overflow:hidden;-webkit-user-select:none;position:absolute !important;padding:0px !important;border:0px !important;height:1px !important;width:1px !important"):}:^ "EXCLUSIF. Oui, les OGM sont des poisons ! – Le Nouvel Observateur". Tempsreel.nouvelobs.com. Retrieved 2013-08-20.
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- :{Jump up:(style="top:-99999px;clip:rect(1px 1px 1px 1px);overflow:hidden;-webkit-user-select:none;position:absolute !important;padding:0px !important;border:0px !important;height:1px !important;width:1px !important"):}:^ Miller, Henry I. "Scientists Smell A Rat In Fraudulent Genetic Engineering Study". Forbes.
- :{Jump up:(style="top:-99999px;clip:rect(1px 1px 1px 1px);overflow:hidden;-webkit-user-select:none;position:absolute !important;padding:0px !important;border:0px !important;height:1px !important;width:1px !important"):}:^ Staff, Right to Know.Posts tagged Seralini
- :{Jump up:(style="top:-99999px;clip:rect(1px 1px 1px 1px);overflow:hidden;-webkit-user-select:none;position:absolute !important;padding:0px !important;border:0px !important;height:1px !important;width:1px !important"):}:^ Thomas Lumley for Stats Chat website. 20 September 2012 Roundup scare
- :{Jump up:(style="top:-99999px;clip:rect(1px 1px 1px 1px);overflow:hidden;-webkit-user-select:none;position:absolute !important;padding:0px !important;border:0px !important;height:1px !important;width:1px !important"):}:^ "Poison postures". Nature 489 (7417): 474. September 2012. doi:10.1038/489474a. PMID 23025010.
- :{Jump up:(style="top:-99999px;clip:rect(1px 1px 1px 1px);overflow:hidden;-webkit-user-select:none;position:absolute !important;padding:0px !important;border:0px !important;height:1px !important;width:1px !important"):}:^ Séralini, Gilles-Eric (2012). Tous Cobayes !: OGM, pesticides et produits chimiques. Editions Flammarion.ISBN 978-2-08-126236-2.
- :{Jump up:(style="top:-99999px;clip:rect(1px 1px 1px 1px);overflow:hidden;-webkit-user-select:none;position:absolute !important;padding:0px !important;border:0px !important;height:1px !important;width:1px !important"):}:^ "Tous cobayes? (2012) – IMDb". IMDB. IMDB.com.
- :{Jump up:(style="top:-99999px;clip:rect(1px 1px 1px 1px);overflow:hidden;-webkit-user-select:none;position:absolute !important;padding:0px !important;border:0px !important;height:1px !important;width:1px !important"):}:^ On the Media Radio Show, 2012 Sep 28 Manipulating Science Reporting
- :{Jump up:(style="top:-99999px;clip:rect(1px 1px 1px 1px);overflow:hidden;-webkit-user-select:none;position:absolute !important;padding:0px !important;border:0px !important;height:1px !important;width:1px !important"):}:^ Carl Zimmer on Discovery Magazine blog, The Loom. 21 September 2012 From Darwinius to GMOs: Journalists Should Not Let Themselves Be Played
- :{Jump up:(style="top:-99999px;clip:rect(1px 1px 1px 1px);overflow:hidden;-webkit-user-select:none;position:absolute !important;padding:0px !important;border:0px !important;height:1px !important;width:1px !important"):}:^ GM Corn and Cancer: the Seralini Affair
- ^ :{Jump up to::(style="top:-99999px;clip:rect(1px 1px 1px 1px);overflow:hidden;-webkit-user-select:none;position:absolute !important;padding:0px !important;border:0px !important;height:1px !important;width:1px !important"):}:^a b(http://en.wikipedia.org/wiki/S%C3%A9ralini_affair#cite_ref-Casassus_85-1) Barbara Casassus for Nature News. November 28, 2013 Study linking GM maize to rat tumours is retracted: Publisher withdraws paper over authors' objections, citing weak evidence
- :{Jump up:(style="top:-99999px;clip:rect(1px 1px 1px 1px);overflow:hidden;-webkit-user-select:none;position:absolute !important;padding:0px !important;border:0px !important;height:1px !important;width:1px !important"):}:^ Elsevier press release. December 10, 2013 Food and Chemical Toxicology Editor-in-Chief, A. Wallace Hayes, Publishes Response to Letters to the Editors
- :{Jump up:(style="top:-99999px;clip:rect(1px 1px 1px 1px);overflow:hidden;-webkit-user-select:none;position:absolute !important;padding:0px !important;border:0px !important;height:1px !important;width:1px !important"):}:^ Michael Hiltzik for the Los Angeles Times. November 29, 2013 Notorious anti-GMO study is retracted – creating more controversy
- :{Jump up:(style="top:-99999px;clip:rect(1px 1px 1px 1px);overflow:hidden;-webkit-user-select:none;position:absolute !important;padding:0px !important;border:0px !important;height:1px !important;width:1px !important"):}:^ Portier, Christopher J.; Goldman, Lynn R.; Goldstein, Bernard D. (1 February 2014). "Inconclusive Findings: Now You See Them, Now You Don’t!". Environmental Health Perspectives 122 (2): A36–A36.doi:10.1289/ehp.1408106.
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- :{Jump up:(style="top:-99999px;clip:rect(1px 1px 1px 1px);overflow:hidden;-webkit-user-select:none;position:absolute !important;padding:0px !important;border:0px !important;height:1px !important;width:1px !important"):}:^ http://endsciencecensorship.org/en/page/Statement
- :{Jump up:(style="top:-99999px;clip:rect(1px 1px 1px 1px);overflow:hidden;-webkit-user-select:none;position:absolute !important;padding:0px !important;border:0px !important;height:1px !important;width:1px !important"):}:^ Séralini, Gilles-Eric; Clair, Emilie; Mesnage, Robin; Gress, Steeve; Defarge, Nicolas; Malatesta, Manuela; Hennequin, Didier; de Vendômois, Joël. "Republished study: long-term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize". Environmental Sciences Europe 26 (1): 14.doi:10.1186/s12302-014-0014-5.
- ^ :{Jump up to::(style="top:-99999px;clip:rect(1px 1px 1px 1px);overflow:hidden;-webkit-user-select:none;position:absolute !important;padding:0px !important;border:0px !important;height:1px !important;width:1px !important"):}:^a b(http://en.wikipedia.org/wiki/S%C3%A9ralini_affair#cite_ref-Casassus2_92-1) Casassus, Barbara (26 June 2014). "Paper claiming GM link with tumours republished". Nature. Retrieved 26 June 2014.
- :{Jump up:(style="top:-99999px;clip:rect(1px 1px 1px 1px);overflow:hidden;-webkit-user-select:none;position:absolute !important;padding:0px !important;border:0px !important;height:1px !important;width:1px !important"):}:^ Grens, Kerry (24 June 2014). "Retracted GMO Study Republished". The Scientist. Retrieved 24 June 2014.
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note talk has same edit war as __?
Kingofaces43 : I'm an entomologist who works with various agricultural pests, emerald ash borer, etc. I deal a bit in research dealing with toxicology (mainly effects of insecticides on pests and beneficial insects), ecology, and biological control. With that I normally frequent agricultural and entomological related topics. As a scientist, I'm especially interested in how scientific findings reach and are interpreted by the general public. With that, my main interest on Wikipedia is seeing that scientific articles match up with the published literature and are appropriately summarized for general readers. With COI in mind, I don't edit on specific topics that I research directly. That means that while I may edit an emerald ash borer page, I won't be editing content pertaining to my research topics specifically (or citing my own studies for that instance).
I also follow guidelines for concise and accurate writing when editing. If it seems like I have removed content, it is very likely the exact same content was summarized earlier in the article and was redundant, or a couple deleted sentences could easy be summarized in one. This is to improve the general readability of articles that sometimes get too verbose for general reading. Feel free to leave a message on my talk page if you have any question about edits or articles I'm working on.
Jytdog : lays it all out: http://en.wikipedia.org/wiki/User:Jytdog
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http://en.wikipedia.org/wiki/Talk:S%C3%A9ralini_affair
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entine orig post on GLP (not all posted on forbes?)
-Éric Séralini (born August 23, 1960 in Annaba, Algeria, then known as Bône) is a French scientist who has been a professor of molecular biology at the University of Caen since 1991. He is best known for publishing research concluding that genetically modified food is unsafe for human consumption. 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.
Career
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 email: gilles-eric.seralini arobase unicaen.fr 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.” ESEUconducted 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 Observateurcovered 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 activistHenry 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.
Books
- Séralini, Gilles-Éric (2004). *Ces OGM Qui Changent Le Monde*. Flammarion Publishing. ISBN 2080800620.
- Séralini, Gilles-Éric (2006). *Après Nous le Déluge?*. Flammarion Publishing. ISBN 2082105490.
Criticisms
Seralini’s claims and tactics have been heavily criticized by the regulatory, academic and science watchdog communities. Examples include:
- CRIIGEN evaluation, by David Tribe, GMO Pundit, December 2012.
- Genetically modified corn and cancer – what does the evidence really say?, by Ashley Ng, The Converation, September 2012.
- 700 Researchers Call On Gilles-Eric Seralini To Release GMO Test Data, Science 2.0, October 2012.
- Being Gilles-Eric Seralini: Inside the mind of the anti-GM movement – See more at: http://www.geneticliteracyproject.org/2013/06/10/being-gilles-eric-seralini-inside-the-mind-of-the-anti-gm-movement/#sthash.RVnii37e.dpuf, by Jon Entine, Genetic Literacy, June 2013.
- Scientists smell a rat in fraudulent study, by Bruce Chassy & Henry Miller, Forbes Magazine, September 2012.
- Anti-GM corn study reconsidered: Seralini finally responds to torrent of criticism, AEI, November 2012.
- Seralini paper influence Kenya ban of GMO imports, by Emily Willingham, Forbes Magazine, December 2012.
- Seralini GMO rats & Cancer, Tech ‘N You, 2013.
- Why I think the Seralini GM feeding trial is bogus, by Andrew Kniss, Control Freaks, September 2012.
- Anti-GMO Scientist Gilles-Eric Seralini, Activist Jeffrey Smith Withdraw from Food Biotech Debate, by Jon Entine, Forbes Magazine, May 2013
- Seralini anti-Monsanto study was so poorly conducted it harms the anti-GMO movement, The Daily Paul, September 2012.
- The Seralini Rule, Skeptico, June 2013. Excerpt: “I have a new rule for debating anti-GMO people: If you favorably cite the 2012 Séralini rats fed on Roundup ready maize study, you just lost the argument…”
- March Against Monsanto, The Progressive Contrarian, May 2013. Excerpt: “I mentioned Seralini and Smith were frauds who refuse to publicly debate scientists who want to challenge them…”
- Science says GMOs are safe, Skeptical Raptor, June 2013. Excerpt: “But be forewarned, if it is junk science, I will call it junk science, like Gilles-Eric Séralini et al.’s paper about GMO corn causing cancer. Except it was poorly designed, utilized bad statistics, and really provided no evidence whatsoever for anything except that Séralini is an incompetent scientist…”
- Was Seralini GMO study designed to generate negative outcome, Storify, October 2012.
References
- 1 Gilles Eric Séralini – President of the Scientific Board – Molecular Biology Professor, by HH, CRIIGEN website, November 12, 2008.
- 2 http://gantdaily.com/2013/11/27/is-africa-ready-for-genetically-modified-foods/
- 3 http://www.journals.elsevier.com/food-and-chemical-toxicology/news/journal-statement/
- 4 http://mobile.nation.co.ke/business/Study-on-GMOs-withdrawn/-/1950106/2093496/-/format/xhtml/-/lt3pkm/-/index.html
- 5 http://gmoseralini.org/en/
- 6 http://gmopundit.blogspot.com/2012/09/auchan-and-carrefour-financed-criigen.html
- 7 http://greenhousepr.co.uk/clients/about/sustainable-food-trust/
http://topinfopost.com/2014/02/04/scientists-support-retraction-of-the-seralini-gmo-study-the-petition-to-reinstate-it-is-misleading-and-contradictory
sustainable pulse? bs?
The Seralini study that is memorialized by those pictures of rats with huge tumors now has a petition online calling for reinstatement of the retraction by Elsevier’s Food and Chemical Toxicology journal. And there is an article written around the petition claiming that experts are up in arms, calling for reinstatement. This petition web site is registered to Henry Rowlands, who claims to be director of Sustainable Pulse, a site dedicated to anti-GMO activism. Mr. Rowlands, who lives in Bulgaria, lists his profession as Media Production.
The petition misleads with statements bordering on outright lies.For instance:
“While critics of Séralini’s study claim that the Sprague-Dawley is an unusually tumour-prone strain of rat, in fact it is about as prone to developing tumours as humans living in industrialized countries.” (All of these were copied Feb 3, 2014)
The Sprague Dawley rat develops tumors at very high rates when allowed to eat an unrestricted diet without exposure to carcinogens. Those rates range from 45% (male) and 70% (female) on up to 95%. It is true that the overall human lifetime rate of cancer in the general population is 45% for males (a rough 1 in 2 risk) and 38% for females ( a rough 1 in 3 risk) but that is while exposed to carcinogens. Smoking, for instance, raises risk of lung cancer by 10-20 times. When various known risk factors are removed, total cancer risk drops by as much as half or more, as seen in Seventh Day Adventists. So while the Sprague-Dawley rat is a useful model, representing it to laymen as if those rats replicated normal human cancer is essentially lying. It’s just not true.
Another misleading petition claim:
This is like saying, “My article is the first and only article covering George Clooney white-water rafting on the American River.” News flash. George Clooney likes white-water rafting even though there is no article on George Clooney on the American River. Similarly, the Seralini paper failed to mention other similar studies which have relevance,including a major review by Snell, et al in the exact journal in which this paper appeared. Making the above claim gives a layman (and a scientist who doesn’t bother to spend hours on it) the impression that Seralini and friends broke new ground nobody had looked at before. Reality is, this study came late. It makes representations that contradict all the previous evidence. If you want to do that, fine. But you better have serious evidence.
What evidence against Seralini was around before he was published?
The petition makes much of how the Seralini paper wasn’t about cancer but presented toxicity and there were other toxicity effects in pathology. No. The Seralini paper presented tumors and various elements of pathology as evidence of toxicity, and specifically the toxicity of GMOs. The petition says so.
The petition contradicts itself. First, it says:
Then it says:
Then it flips back again:
Pardon me. What? That is, in terms of logic, just gibberish. Make up your mind Henry. Is the study inconclusive, or did the study show what it claims? Or were you hired by Seralini?
The petition claims that the review process that led to retraction was not transparent. Rubbish. The review process was open in the journal, visible in letters to the editor – many of them. Many of those letters are linked to below in the appendix to this article. They are devastating.
While the review process for retraction was as open as it could be, Seralini wasn’t. Seralini still refuses to share his raw data with other scientists. He sent something to Elsevier when the editor of the journal requested it. But that hasn’t been released for general consumption. I can only presume that Seralini instructed Elsevier not to do so. You figure that out.
So what is wrong with Seralini’s paper? It has that picture of rats with huge tumors! What did Seralini do wrong?!
1. Seralini, et al skated the edge of Elsevier’s policy which says that scientists will make all data available. Sure, not everyone does. I’ve even gotten a review back that complained that it was crazy to expect a reviewer to go through hundreds of pages of supplemental data. Summaries have their place. But when other scientists ask to see your stuff? Not letting them see it is beyond uncool. That’s like the cold fusion guy who responded to questions by refusing to share his data. For that alone Elsevier had grounds to retract the paper. Yes, Seralini did supply it when the journal asked for it. If he hadn’t that would have been grounds for retraction right there. But don’t you think it is curious that his data has not been shared openly. Why not?
2. Seralini, et al, failed to disclose a big conflict of interest. The major funder of the study was CRIIGEN.org. This is a web site registered to Gilles-Eric Seralini himself. He is the apparent founder of the organization. Perusal of the site shows that it has an anti-GMO agenda. Certainly, there are private foundations that fund such research, and that is fine. But getting funded by the organization that you started and appear to run? Getting funded by that organization when it has a clearly biased position on what you are studying? That’s like a lawyer failing to mention that he is being paid by your opponent. That’s like failing to mention that your study was funded by Monsanto and you are CEO of Monsanto – but in reverse. And it is a violation of Elsevier policy on conflict of interest.
3. Seralini, et al, violated laboratory standards on animal cruelty. Allowing tumors to get that large and ulcerated is not considered ethical. Based on what is reported in the article it probably violated French law. There is no reason to allow animals with tumors to go on so long without euthanasia. You have the same data whether you euthanize them or not. There are only two plausible reasons to not euthanize the animals that are apparent: A.) Seralini, et al, wanted to produce a photo that would go viral and place it in a scientific publication. It has. Good for him – if his job was in advertising. B.) Seralini, et al, hoped for organ failures to occur secondary to the tumors or due to aging, in order to skew their results. Either way, that’s not science. That’s propaganda. Minor cleverness, but not science.
4.The histopathology was so poor it appears to be incompetent. At least 11 serious types of errors were obvious in the article and some specific. For instance, in specific, it named a tumor two different things, and incorrectly attributed the tumor. That incorrect analysis was made much of, and yet in reality it simply proved there is no relationship. (Read the linked criticism for more depth.) The article does not make clear who did the pathology. The pathology is not clearly laid out, but scientifically useless pictures of animals and tumors are shown. This is a very serious problem for the article since the core of it is pathology. So why?
I’ve done a bit of pathology myself. (And I was pressured to say that results showed X when they didn’t. Cost me, big time, when I didn’t bend – lost a job over it. Professors can be very nasty people, and some put agreement with them above truth.) Usually slides are kept, and photos of the slides, and there is often excess material left in lab freezers. Sure, sometimes, if samples are small, you have to use it all. But that would not be the case in this study. And yes, his lab can say, “Oh, we disposed of it.” But, put this problem together with the others and you may see a pattern emerging.
5. Apparently, Seralini, et al, are incompetent at statistics. The small number of animals per group, even with the poor to incompetent pathology work, shows nothing meaningful. A different critique than the above link says:
Yet another critique nails it. Take a look at the table in the link.
6.Seralini has produced rubbish studies before.
Etcetera. There’s more. But this is more than enough.
Seralini’s group caused needless pain and suffering to animals and proved nothing at all. The study’s results are no more significant than random numbers selected from a phone book. Actually, this paper is less meaningful than random numbers because the numbers in the study were produced by work that in its most charitable analysis is slipshod or incompetent. To me, it reeks. There is absolutely no reason to be sympathetic to Seralini over this. None.
Are there reasons to be concerned about specific GMOs? Yes. There are.UCS goes a bit farther than I do, but I agree that the way GMOs have been used in agriculture promotes problematic approaches to farming.
The existence of Roundup Ready crops has resulted in near eradication of milkweed from much of the midwest. So there is a connection between Roundup (glyphosate) and monarch butterflies.
There is the possibility that Bt corn may affect monarch butterfly life cycle or reproduction. But so far, levels of Bt from corn plants does not appear to be high enough to matter. The PNAS study showing Bt pollen could kill monarch larvae was not supported by work in the field, since that variety of corn with high Bt levels was not planted much and those that are don’t kill larvae.
Using more and more herbicides on fields because crops can tolerate them creates ecological problems of sustainability. But I am greatly troubled by the way that organizations like Greenpeace have attacked any and all GMO agriculture, from beta-carotene rice (golden rice) to FlavrSavr tomatoes. That has frozen out creation of orange trees that won’t get citrus greening. We know how to stop it. That’s not a question. Plant immune systems use RNAi (interfering RNA) to control disease. But the RNAi gene has to be in the plant. We could do that, but then the tree is a GMO, even though it has no effect at all on anything except the disease. That’s crazy.
Scientists in general don’t have any problem blowing the whistle when it’s needed. But garbage science like Seralini has put out don’t help. In fact, they do the opposite, because when you cry wolf and you faked it, that undermines it for the time when it really does matter.
Appendix: List of published scientific criticism of Seralini, et al.
The single most complete criticism published is probably that of Sanders, Kamoun, Williams and Festing. Together with the critique of Erio Barale-Thomas, the criticism is devastating. Any reputable scientist would withdraw the paper on the basis of either set of criticisms.
Kevin Folta **Letter to the Editor** Food and Chemical Toxicology, Available online 3 January 2014, PDF (165 K)
Lúcia de Souza, Leila Macedo Oda **Letter to the editor** Food and Chemical Toxicology,Volume 53, March 2013, Page 440PDF (131 K)
Peter Langridge **Letter to the editor** Food and Chemical Toxicology, Volume 53, March 2013, Page 441PDF (123 K)
Dung Le Tien, Ham Le Huy **Comments on “Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize”** Food and Chemical Toxicology,Volume 53, March 2013, Pages 443-444PDF (140 K)
Colin Berry **Letter to the editor** Food and Chemical Toxicology, Volume 53, March 2013,Pages 445-446PDF (127 K)
Anthony Trewavas **Letter to the editor** Food and Chemical Toxicology, Volume 53,March 2013, Page 449PDF (131 K)
Dale Sanders, Sophien Kamoun, Bella Williams, Michael Festing **Letter to the editor**Food and Chemical Toxicology, Volume 53, March 2013, Pages 450-453PDF (152 K)
**Letter to the editor** Food and Chemical Toxicology, Volume 53, March 2013, Pages 455-456PDF (133 K)
Mark Tester **Letter to the Editor** Food and Chemical Toxicology, Volume 53, March 2013, Page 457PDF (124 K)
Louis Ollivier **A Comment on “Séralini, G.-E., et al., Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize. Food Chem. Toxicol. (2012),” http://dx.doi.org/10.1016/j.fct.2012.08.005** Food and Chemical Toxicology,Volume 53, March 2013, Page 458PDF (134 K)
Frederic Schorsch **Serious inadequacies regarding the pathology data presented in the paper by Séralini et al. (2012)** Food and Chemical Toxicology, Volume 53, March 2013, Pages 465-466PDF (142 K)
David Tribe **Letter to the editor** Food and Chemical Toxicology, Volume 53, March 2013,Pages 467-472PDF (178 K)
Erio Barale-Thomas **Letter to the editor** Food and Chemical Toxicology, Volume 53,March 2013, Pages 473-474PDF (145 K)
Author Bio:
Brian Hanley has a range of papers in biosciences, economics, and policy and publications on terrorism through West Point. He obtained his PhD in microbiology with honors from UC Davis, has a bachelors degree in computer science, is a multiple entrepreneur and guest lectured for years to the MBA program at Santa Clara University.He is the author of the book, Radiation – Exposure and Its Treatment, available onAmazon.
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National Academy of Sciences (NAS) is embarking on acomprehensive study of genetically engineered (GE) crops. It will examine the historic development of agricultural biotechnology, assess the “purported” benefits and negatives of GE crops, review food and environmental safety issues, and explore where the technology may be headed.
What is prompting such a deep dive into a thorny thicket? This:
Consumers in the United States and abroad get conflicting information about GE crops. Proponents tout the benefits while opponents emphasize the risks. There is a need for an independent, objective study that examines what has been learned about GE crops, assesses whether initial concerns and promises were realized since their introduction, and investigates new concerns and recent claims.
It so happens that the first public meeting for this study will be held today and tomorrow. More on this in a minute.
First, let’s review essential findings on crop biotechnology and related food safety concerns from the past decade.
In 2004, an NAS report declared:
To date, more than 98 million acres of genetically modified crops have been grown worldwide. No evidence of human health problems associated with these ingredients of these crops or resulting food products have been identified.
(As of last year, that cumulative total stood at 4 billion acres.)
In 2008, a paper published in the UK’s Royal Society of Medicine noted:
Foods derived from GM crops have been consumed by hundreds of millions of people across the world for more than 15 years, with no reported ill effects (or legal cases related to human health), despite many of the consumers comring from that most litigious of countries, the USA.
In 2010, the European Union declared:
The main conclusion to be drawn from the efforts of more than 130 research projects, covering a period of more than 25 years of research, and involving more than 500 independent research groups, is that that biotechnology, and in particular, GMOs, are no more risky than e.g. conventional plant breeding technologies.
Finally, the World Health Organization (WHO) states:
GM foods currently available on the international market have passed safety assessments and are not likely to present risks for human health. In addition, no effects on human health have been shown as a result of the consumption of such foods by the general population in the countries where they have been approved.
I know, I know, all these scientific institutions, professional societies and health bodies are bought off by Monsanto.
Seriously, back to the NAS study now underway. Remember, the justification for it is that “the public gets conflicting information about GE crops.” Yet, as I showed above, there is nothing ambiguous about the safety of GMOs. This is not to say that agricultural biotechnology doesn’t warrant strict regulation, monitoring, and continued testing. But let’s be clear: Thus far, nothing in the global food supply derived from genetically modified crops has been found harmful to public health.
So where is “conflicting information” coming from? Unfortunately, much skewed information on GMOs comes from thought leaders, advocacy journalists, and public interest groups, as I discussed in this 2012 *Slate* piece. And it will be on display at this week’s NAS public meeting. For a virtual who’s who of cranks, pseudoscientists and ideologues–the worker bees and stars on the anti-GMO circuit–will be appearing before the committee (Reputable scientists and science communicators will also be represented.) I don’t have time to run through them all, but two notorious individuals (who should be familiar to anyone vaguely familiar with the GMO discourse) are giving their presentations back to back on Tuesday: Jeffrey Smith and Gilles-Éric Séralini.
Smith is the author of two self-published books on GMOs– Seeds of Deception and Genetic Roulette.He appears to have no scientific credentials. I’ve discussed Smith several times in this space, including here. He’s made two appearances on the Dr. Oz show. One of them was a segment called, “GMO Foods: Are They Dangerous to Your Health?” As Michael Specter recounts in The New Yorker:
Oz was not subtle. “You’re probably eating them right now and don’t even know,” he began, darkly invoking “the brave new world of food. Are they safe?” Oz then introduced Jeffrey Smith, the author of “Genetic Roulette,” who says that engineered foods may cause many serious diseases, including colitis, asthma, and cancer. Smith has also made a film version of the book; Oz, for the sake of full disclosure, noted that “my wife, Lisa, was a narrator in Jeffrey’s film.” He added that no scientists were willing to share the stage with Smith. “So today we are doing something we have never done before,” Oz said. “After Jeffrey makes his points, he has to leave the stage before we can speak with the scientists in favor of genetically modified foods.” Other than to say that Smith was controversial, Oz did not indicate why no scientists would appear with him.
But Smith is just a fear-mongering messenger indulged by the likes of Dr. Oz. Séralini is a French researcher who published adeeply flawed (and ultimately retracted) study on GMO corn-fed rats and manipulated the media’s initial coverage of it. (This is the zombie paper that will not die.) Having Séralini give expert testimony at a scientific panel on GMOs is like having Andrew Wakefield present evidence at a similar panel on vaccine safety.
But hey, if the goal of the NAS committee is to discern nonsense from actual facts on genetically modified crops, then I suppose it is helpful to hear straight from the sources who have most succeeded in distorting the science of biotechnology and confusing the public about GMOs.
CATEGORIZED UNDER: AGRICULTURE, BIOTECHNOLOGY, GMOS, SCIENCE
MORE ABOUT: AGRICULTURE, BIOTECHNOLOGY, FOOD SECURITY, GILLES-ÉRIC SÉRALINI, GMOS,JEFFREY SMITH, NATIONAL ACADEMY OF SCIENCES
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