GM Free Cymru

Re-publication of retracted Seralini study

Date Added to website 25th June 2014

[GM-free Cymru welcomes the re-publication of this important study, which was retracted last year from FCT Journal following a coordinated and vicious campaign of vilification and dafamation directed at Prof Gilles-Eric Seralini and his fellow researchers by the assembled ranks of the GM industry and its acolytes. The paper's only fault was that it found that a GM crop and the Roundup that goes with it damaged the health of rats in a long-term feeding experiment. Instead of accepting that the paper -- however conclusive or inconclusive it light have been -- merited detailed consideration and a review of the GMO safety assessments conducted in the past, the GM industry and the regulators demonstrated that they all live in a state of permanent denial relating to the effects of GMOs and Roundup / glyphosate herbicide. They have, of course, all declared in the past that NK603 and Roundup are perfectly safe, and they were not going to change their minds or demonstrate their own incompetence by accepting the Seralini study as valid. There will, of course, be another furore now that the paper is "on the record" again -- and already snide remarks are appearing about the lowly academic status of the open-access journal selected. Let those who criticise go away and repeat or improve the Seralini experiment, and then let's see who has the last laugh. The problem is that public health is no laughing matter.]

CRIIGEN Press release:
Republication of Professor SÚralini's study: Time to be responsible
Paris, 24 June 2014
The 2012 study on the chronic toxicity of Roundup herbicide and the genetically modified Roundup-tolerant maize NK603 by Professor Gilles-Eric SÚralini and colleagues has been republished by the Springer group, with open access to its raw data. Now there will be a few embarrassing questions for the authorities.
After two years of controversy and pressure that led to the retraction of the study in November 2013, which was first published in 2012 by the Food and Chemical Toxicology (Elsevier group) journal, the research team of Professor SÚralini has announced that they have republished the study in the Journal "Environmental Sciences Europe", published by the Springer Group.
By republishing their study with some new data which are available online, the team of Professor SÚralini confirms that the world's best-selling pesticide, Roundup, causes severe liver and kidney deficiencies and hormonal disturbances, such as mammary tumours, at low environmentally relevant levels. Similar effects were observed from the chronic consumption of Roundup-tolerant GM maize. This is due to residues of Roundup and to the specific genetic modification of this maize. The formulations of Roundup, as well as Roundup-tolerant GMOs, should therefore be considered endocrine (hormone) disruptors and should be re-evaluated for safety by the health authorities.
Winfried Schr÷der, editor of the journal Environmental Sciences Europe of the Springer Group, stated: "We want to enable a rational discussion about the study of SÚralini et al. (Food Chem Toxicol 2012, 50:4221-4231) by republishing it. This methodological competition is the energy necessary for any scientific progress. The sole purpose is to enable some scientific transparency and on this basis, a discussion that does not try to hide, but focuses on these needed methodological controversies."
The research team of Prof SÚralini made the choice of an open access publication in a peer-reviewed journal, which arranged the third peer-reviewed assessment of the study. The researchers have published online the raw data of the study with free access for the entire scientific community - something that the industry has always refused to do, claiming commercial confidentiality or intellectual property restrictions.
Dr JoŰl Spiroux de Vend˘mois, medical doctor and President of CRIIGEN says, "Pesticides such as Roundup and agricultural GMOs cannot be ignored in the explanation of the epidemic of environmental pathologies". In addition, he emphasizes "the deficiency of the regulatory assessment of pesticides and GMOs, which endangers public health."
CRIIGEN is asking for free access to toxicological studies which have authorised the placing on the market of different formulations of Roundup, the free access to raw data on the toxicological urine and blood analyses for all products, and urges the legal authorities to undertake further public research, with a commitment to placing its findings in the public domain, regarding the possible toxicological and endocrine disrupting effects of GMOs and Roundup, as other pesticides, using long-term exposure periods to ensure a real protection of the public health.
Contact: presse@criigen.info Tel: +33 2 31 56 56 84 / +33 7 60 45 56 77
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Republication of the SÚralini study: Science speaks for itself
GMOSeralini.org welcomes the republication of the chronic toxicity study on the glyphosate-based herbicide Roundup and a commercialized GM maize, Monsanto's NK603, led by Prof Gilles-Eric SÚralini. The new publication and a commentary by the authors are available here:
http://www.enveurope.com/content/26/1/14
http://www.enveurope.com/content/26/1/13
--- --- Republication of the SÚralini study: Science speaks for itself Press release GMOSeralini.org, 24 June 2014
http://www.gmoseralini.org/republication-seralini-study-science-speaks/
GMOSeralini.org welcomes the news of the republication of the chronic toxicity study on the glyphosate-based herbicide Roundup and a commercialized genetically modified (GM) maize, Monsanto's NK603, led by Prof Gilles-Eric SÚralini. The republication restores the study to the peer-reviewed literature so that it can be consulted and built upon by other scientists.
The study 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. 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.
The study was first published in Food and Chemical Toxicology (FCT) in September 2012[1] but was retracted by the editor-in-chief in November 2013 after a sustained campaign of criticism and defamation by pro-GMO scientists.[2]
Now the study has been republished 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 republished study is accompanied by a separate commentary by Prof SÚralini's team describing the lobbying efforts of GMO crop supporters to force the editor of FCT to retract the original publication.
GMOSeralini.org editor Claire Robinson commented: "This study has now successfully passed no less than three rounds of rigorous peer review.
The first was for the initial publication of the study in Food and Chemical Toxicology. It passed with only minor revisions, according to the authors.[3]
The second review took months. It involved a non-transparent examination of Prof SÚralini'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.[4,5]
In a letter to Prof SÚralini, Hayes admitted that the anonymous reviewers found nothing 'incorrect' about the results presented. However, Hayes pointed to what he said was the 'inconclusive' nature of some aspects of the paper, namely the tumour and mortality observations, to justify his decision to retract the study.[6]
The rationale given for the retraction was widely criticized by scientists as an act of censorship and a bow to the interests of the GMO industry.[7,8] 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.[9] The retraction was even condemned by a former member of the editorial board of FCT.[10]
Now the study has passed a third peer review arranged by the journal that is republishing the study, Environmental Sciences Europe.
Comments from scientists
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, called the republication "an important demonstration of the resilience of the scientific community". Dr Heinemann continued, "The first publication of these results revealed some of the viciousness that can be unleashed on researchers presenting uncomfortable findings. I applaud Environmental Sciences Europe for submitting the work to yet another round of rigorous blind peer review and then bravely standing by the process and the recommendations of its reviewers, especially after witnessing the events surrounding the first publication.
This study has arguably prevailed through the most comprehensive and independent review process to which any scientific study on GMOs has ever been subjected.
The work provides important new knowledge that must be taken into account by the community that evaluates and reports upon the risks of genetically modified organisms, indeed upon all sources of pesticide in our food and feed chains. In time these findings must be verified by repetition or challenged by superior experimentation. In my view, nothing constructive for risk assessment or promotion of GM biotechnology has been achieved by attempting to expunge these data from the public record."
ENDS
Contact Claire Robinson: claire@clairejr.com
Notes


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Gene Ethics Media Release - June 25, 2014
Seralini Roundup & GM maize toxicity study re-published today
The long term Seralini experiments which found rats are harmed by Roundup and GM maize has been vindicated. It is republished today in the Journal "Environmental Sciences Europe", published by the Springer Group
"Today's republication of the Seralini study is a vindication of sound independent science, the scientific method and the system of scientific publication," says Gene Ethics Director Bob Phelps.
"The editors of the Food and Chemical Toxicology journal retracted the peer-reviewed study under extreme duress from a coterie of corporate interests and their scientific lackeys.
"But the grounds for retraction were nonsense as they did not conform with the agreed rules for retractions and erased the validity of all scientific peer-review processes.
"In trying to justify his retraction, the Editor of Food and Chemical Toxicology wrote:
"A careful and time-consuming analysis found that the data were inconclusive, and therefore the conclusions described in the article were unreliable. Accordingly, the article was retracted."
"But the findings of all published and peer-reviewed papers are inconclusive as they must open to review and refutation. If not, they would not be the products of scientific inquiry which is always a work in progress," says Phelps.
"Seralini's team and their methodology were found to be honest and sound. If they had been faulty, that would have been good grounds for the retraction.
"Seralini found that GM maize and residues of the Roundup herbicide sprayed on the crop were toxic to the laboratory rats and their findings are now validated by this republication in a very reputable journal.
"The onus of proof for the safety and efficacy of GM crops and foods should rest with the GM industry but Seralini paper's results show up the flaws in corporate research.
"Their smaller sample sizes, shorter 90 day duration, and lack of independence also cast doubt on the validity of GM crop and food approvals which rely mostly on corporate data.
"It's now clear that some varieties of GM foods and toxic chemical residues harm experimental animals and probably us too and this should be grounds for reviewing these product approvals.
"We call on our governments to remove GM foods and toxic chemical residues from the human food supply," Mr Phelps concludes.
More comment: 0449 769 066
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ENSSER PRESS RELEASE
RE-PUBLICATION of the SÚralini et al. study on the "Long-term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize"
ENSSER welcomes the re-publication of the data from the long-term rat feeding study with herbicide-tolerant NK603 maize and the associated Roundup herbicide plus the publication of the raw data by the researchers of Professor SÚralini's group[1]. This study follows up on the Monsanto study submitted to the European regulator in support of its safety declaration for commercial approval. The study used the same type of rats as used by Monsanto. They were fed with Roundup-tolerant NK603 genetically modified (GM) maize (11% of the diet), cultivated with or without the application of Roundup together with Roundup alone (0.1 ppb of the full pesticide containing glyphosate and adjuvants) in drinking water for 2 years. EFSA accepts rat-feeding studies that are terminated after only 90 days, which constitutes a fraction of the entire lifespan of rats and, thus, addresses only short-term toxicity. SÚralini and colleagues extended this period to a full lifespan in order to study chronic long term effects.
The most significant results of the extended study by SÚralini and colleagues are signs of toxicity for all treatments GM maize sprayed and unsprayed with Roundup- and Roundup-only treatments. Most of these signs occurred after 90 days. Biochemical analyses confirmed chronic kidney problems for all the treatments, for both sexes and also a higher number of severe liver problems. In females, all treatment groups showed a two- to threefold increase in mortality, and deaths occurred 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. Last but not least, females developed large mammary tumors more frequently and earlier than the controls; the pituitary was the second most disabled organ; the sex hormonal balance was modified by consumption of GM maize and Roundup treatments. These data are worrying and call for follow-up studies designed to further consolidate whether these signs of toxicity are indeed proof of toxicity. These data must be contextualized with recently published data by other independent researchers in South America and Europe, releasing data that require us to re-consider previous toxicity evaluations of Roundup and Glyphosate[2].
When originally published in the Elsevier journal Food and Chemical Toxicology (FCT) in September 2012, a global campaign was launched within days by the GM industry and their associated scientists, and their sole aim was to 'shoot the messenger' hoping that the data will thus be invalidated. In an accompanying comment piece, now also being published, the team of SÚralini and colleagues put the events that followed publication of their report on record. Here, they also address "conflicts of interest, confidentiality and censorship in health risk assessment" which ultimately resulted in the retraction of the paper over a year later after an ex-Monsanto employee was installed as associate editor[3]. The retraction was accompanied by a statement of the editor-in-chief Hayes asserting that there was no fraud, no misconduct or anything else wrong with the SÚralini study other than the supposed 'inconclusiveness' of the data in the eyes of an shadowy group of scientists assembled for an undisclosed post-publication re-evaluation. This unprecedented move by FCT was challenged and has now been corrected.
Scientific progress is only possible if research is conducted in an open fashion and research data is subjected to fair and critical (preferably transparent) peer-review and is subsequently put on record by being published in the scientific literature allowing then for a discourse of that research data and its various interpretations. While this holds true for all fields of science, it is a fundamental prerequisite for scientific progress when it comes to data that is relevant to environmental and human health. While scientific technological interventions have generated great benefits for human societies and contributed significantly to human progress, history has also shown over and over again, that research that lacks rigour regarding the safety and long term consequences of these technological interventions has caused massive suffering and destruction of environmental and human health. This has cancelled out many or all of their earlier benefits in a manner that could have been avoided if the initial research had been more rigorous.
This attempt to censor inconvenient research data and suppress critical scientific discourse should have no place in the 21st century world. We face a convergence of massive environmental and social problems that put the collective well-being of humanity at risk. This is in many ways the result of the premature and injudicious release of technological interventions without proper safety evaluation for long term consequences. Solving these converging crises will fundamentally hinge on a critical scientific discourse and collective reflection. We need a debate about the various trajectories for progress. This should be informed by rigorous and independent (i.e. technology- disinterested) assessment of technology risks from various perspectives.
Lucas Wirl, Coordinator ENSSER
Email: lwirl@ensser.org
Mobile: 0049 (0) 176 6410 3500
Phone: 0049 (0) 30 2065 4857
For further information please view: www.criigen.org / www.ensser.org
[1] http://www.sciencedirect.com/science/article/pii/S0278691513008090
[2] Paganelli A, Gnazzo V, Acosta H, Lopez SL and Carrasco AD. Glyphosate-based herbicides produce teratogenic effects on vertebrates by impairing retinoic acid signalling. Chem Res Toxicol, August 9. http://pubs.acs.org/doi/abs/10.1021/tx1001749
http://www.gmoevidence.com/wp-content/uploads/2013/09/Glyphosat-D%C3%A4nemark.pdf
[3] http://www.gmwatch.org/files/Letter_AWHayes_GES.pdf