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SCIENCE & RISK ASSESSMENT: Journal retraction of SÚralini study is illicit, unscientific, and unethical



                                  PART 1


------------------------------- GENET-news -------------------------------

TITLE:   JOURNAL RETRACTION OF SéRALINI STUDY IS ILLICIT, UNSCIENTIFIC, AND UNETHICAL

SOURCE:  GMWatch

AUTHOR:  Claire Robinson

URL:     http://www.gmwatch.org/index.php/news/archive/2013/15184-journal-retraction-of-seralini-study-is-illicit-unscientific-and-unethical

DATE:    02.12.2013

SUMMARY: "The editor of the journal Food and Chemical Toxicology (FCT), Dr A. Wallace Hayes, has decided to retract the study by the team of Prof Gilles-Eric Séralini, which found that rats fed a Monsanto genetically modified (GM) maize NK603 and tiny amounts of the Roundup herbicide it is grown with suffered severe toxic effects, including kidney and liver damage and increased rates of tumours and mortality."

----- archive: http://www.genet-info.org/information-services.html -----


JOURNAL RETRACTION OF SéRALINI STUDY IS ILLICIT, UNSCIENTIFIC, AND UNETHICAL

The editor of the journal Food and Chemical Toxicology (FCT), Dr A. Wallace Hayes, has decided to retract the study by the team of Prof Gilles-Eric Séralini, which found that rats fed a Monsanto genetically modified (GM) maize NK603 and tiny amounts of the Roundup herbicide it is grown with suffered severe toxic effects, including kidney and liver damage and increased rates of tumours and mortality.[1]

GMWatch believes FCT?s retraction of Prof Séralini?s paper to be illicit, unscientific, and unethical. It violates the guidelines for retractions in scientific publishing set out by the Committee on Publication Ethics (COPE),[2] of which FCT is a member.[3] 

COPE guidelines state that the only grounds for a journal to retract a paper are:

    Clear evidence that the findings are unreliable due to misconduct (eg data fabrication) or honest error

    Plagiarism or redundant publication

    Unethical research.

Prof Séralini?s paper does not meet any of these criteria and Hayes admits as much. In his letter informing Prof Séralini of his decision [link here], Hayes concedes that an examination of Prof Séralini?s raw data showed ?no evidence of fraud or intentional misrepresentation of the data? and nothing ?incorrect? about the data.

Hayes states that the retraction is solely based on the ?inconclusive? nature of the findings on tumours and mortality, given the relatively low number of rats used and the choice of rat strain, which Hayes says naturally has a ?high incidence of tumours?.

Crucially, however, inconclusiveness of findings is not a valid ground for retraction. Numerous published scientific papers contain inconclusive findings, which are often mixed in with findings that can be presented with more certainty. It is for future researchers to build on the findings and refine scientific understanding of any uncertainties.

It is important that scientists do not overstate their findings or draw conclusions that are not justified by the data, but Prof Séralini?s paper does not do this. Because Prof Séralini?s study was a chronic toxicity study and not a full-scale carcinogenicity study, which normally requires larger numbers of rats, he conservatively did not do a statistical analysis of the tumours and mortality findings. Instead he simply reported them, without drawing definitive conclusions. This is in line with the OECD chronic toxicity protocol, which requires that any ?lesions? (including tumours) observed are recorded.[4] 

The criticisms of the low number of rats and choice of rat strain have been addressed by Prof Séralini?s team in a comprehensive response to critics that was published in FCT,[5] as well as by independent scientists writing in support of the study.[6] 

Experts in statistics writing in support of the study have pointed out that large numbers of animals are only required in safety studies to avoid false negative error, where a toxic effect exists but is missed because too few animals are used. In the case of Séralini?s study, this was not an issue. The toxic effects of the test substances were so pronounced (there was a ?large effect size?) that smaller numbers of animals were sufficient for statistical significance.[7,8,9]    

Regarding the Sprague-Dawley strain of rat that was used, all strains of rodents develop spontaneous tumours with age, as do humans. The fact that there is a low level of spontaneous tumour occurrence in the control group in Séralini?s study mimics the human condition. For this and other reasons, most toxicology studies use this strain of rat.

Hayes fails to address these responses and arguments in support of the study, raising questions about the expertise, balance, and objectivity of his anonymous review panel. In addition, the legitimate peer reviewers had previously considered these aspects of Séralini?s study and nevertheless decided that ?the work still had merit? and should be published.

In a highly irregular process, Hayes now contradicts the outcome of the peer review and editorial process and decides to retract the paper over a year after it was published. His decision is not made on the basis of new data, but on a secret and non-transparent review by unnamed persons, who evidently do not feel able to stand behind their decision publicly or disclose any conflicts of interest they may have.

Hayes? decision will tarnish the reputation of FCT and will increase public mistrust of science in general and genetically modified foods in particular.

The Goodman factor

Hayes? decision to retract the paper follows FCT?s appointment of Richard E. Goodman, a former Monsanto scientist and an affiliate of the GMO industry-funded group, the International Life Sciences Institute, to the specially created post of associate editor for biotechnology at the journal, early this year.[10]

Goodman?s appointment in turn followed an orchestrated campaign by GMO supporters to persuade FCT to retract the study. Some critics even accused Prof Séralini of fraud, without presenting any evidence. Many of the critics had undeclared conflicts of interest with the GMO industry.[11] 

After Goodman was installed, FCT withdrew a separate study by Brazilian researchers that also raised questions about GM crop safety. The study showed that Bt insecticidal toxins similar to those engineered into GM Bt crops were not broken down in digestion, as is claimed by the industry and regulators, but had toxic effects on the blood of mice. The Brazilian paper, like Prof Séralini?s, had been peer-reviewed and published by FCT prior to Goodman?s arrival. After Goodman?s arrival, the paper was withdrawn without explanation from FCT[12] ? only to be immediately published in another journal.[13]

There is no proof that Goodman was responsible for the retraction of Prof Séralini?s study. But his appointment, coming so soon after the ?Séralini affair?, along with FCT?s failure to list the interests of its editors, raises questions about corporate influence on the editorial board at the journal.

Notes

1. 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.

2. http://publicationethics.org/files/retraction%20guidelines.pdf

3. http://publicationethics.org/members/food-and-chemical-toxicology

4. Organisation for Economic Cooperation and Development (OECD) (2009). OECD guideline no. 452 for the testing of chemicals: Chronic toxicity studies: Adopted 7 September 2009. http://bit.ly/LxJT1Z

5. Séralini GE et al (2013). Answers to critics: Why there is a long term toxicity due to NK603 Roundup-tolerant genetically modified maize and to a Roundup herbicide. Food and Chemical Toxicology 53: 461-468. http://www.ncbi.nlm.nih.gov/pubmed/23146697

6. http://gmoSéralini.org/faq-items/what-was-the-reaction-to-the-study-2/

7. Deheuvels P. Étude de Séralini sur les OGM: Pourquoi sa méthodologie est statistiquement bonne [Seralini study on GMOs: Why the methodology is statistically sound]. Le Nouvel Observateur. 9 October 2012. http://bit.ly/RtPivG

8. Saunders P. Excess cancers and deaths with GM feed: The stats stand up. Science in Society. 16 October 2012. http://www.i-sis.org.uk/Excess_cancers_and_deaths_from_GM_feed_stats_stand_up.php

9. Deheuvels P. L?étude de Séralini sur les OGM, pomme de discorde à l?Académie des sciences [The Seralini GMO study - A bone of contention at the Academy of Sciences]. Le Nouvel Observateur. 19 October 2012. http://leplus.nouvelobs.com/contribution/661194-l-etude-de-seralini-sur-les-ogm-pomme-de-discorde-a-l-academie-des-sciences.html

10. http://www.independentsciencenews.org/science-media/the-goodman-affair-monsanto-targets-the-heart-of-science/

11. http://www.spinwatch.org/index.php/issues/science/item/164-smelling-a-corporate-rat

12. Mezzomo BP et al (2012). WITHDRAWN: Effects of oral administration of Bacillus thuringiensis as spore-crystal strains Cry1Aa, Cry1Ab, Cry1Ac or Cry2Aa on hematologic and genotoxic endpoints of Swiss albino mice. Food Chem Toxicol. http://www.ncbi.nlm.nih.gov/pubmed/23146696

13. Mezzomo BP et al. (2013). Hematotoxicity of Bacillus thuringiensis as spore-crystal strains Cry1Aa, Cry1Ab, Cry1Ac or Cry2Aa in Swiss albino mice. J Hematol Thromb Dis 1(1).





                                  PART 2

------------------------------- GENET-news -------------------------------

TITLE:   SéRALINI: PAPER TYING RAT CANCER TO HERBICIDE IS RETRACTED

SOURCE:  New York Times

AUTHOR:  Andrew Pollack

URL:     http://www.nytimes.com/2013/11/29/health/paper-tying-rat-cancer-to-herbicide-is-retracted.html?ref=andrewpollack&_r=2&;

DATE:    02.12.2013

SUMMARY: "A food safety journal has decided to retract a paper that seemed to show that genetically modified corn and the herbicide Roundup can cause cancer and premature death in rats. "

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SéRALINI: PAPER TYING RAT CANCER TO HERBICIDE IS RETRACTED

A food safety journal has decided to retract a paper that seemed to show that genetically modified corn and the herbicide Roundup can cause cancer and premature death in rats.

The editor of the journal, Food and Chemical Toxicology, said in a letter to the paper?s main author that the study?s results, while not incorrect or fraudulent, were ?inconclusive, and therefore do not reach the threshold of publication.?

The paper, published 14 months ago, has been cited by opponents of biotech foods and proponents of labeling such foods. But it has been vociferously criticized as flawed, sensationalistic and possibly even fraudulent by many scientists, some allied with the biotechnology industry. The main author of the study, Gilles-Eric Séralini, of the University of Caen in France, had done other studies challenging the safety of genetically engineered foods, some of which had also been questioned.

In his letter to Dr. Séralini, A. Wallace Hayes, the editor in chief of the journal, said that ?unequivocally? he had found ?no evidence of fraud or intentional misrepresentation of the data.?

He said that Dr. Séralini had cooperated in providing his raw data to a review panel formed by the journal.

However, Dr. Hayes said there was ?legitimate cause for concern? that the number of rats in each arm of the study was too small and that the strain of rat used was prone to cancer. That made it difficult to rule out that the results were not explained by ?normal variability,? he said.

The letter was posted on the website of GMWatch, a British organization that opposes genetically engineered crops. GMWatch called the journal?s action ?illicit, unscientific and unethical,? saying that inconclusive data was not sufficient grounds for a retraction.

Dr. Hayes, while confirming he wrote the letter, referred questions to an executive at Elsevier, the publisher of the journal.

An email to that executive received an automatic reply saying she was away for Thanksgiving.

The study followed 200 rats for two years, essentially their entire lives. They were divided into 10 groups, each with 10 males and 10 females. Some groups were fed different amounts of a Monsanto corn genetically engineered to resist the herbicide Roundup, also known as glyphosate.

Some of the corn had been sprayed in the field with Roundup and some not. Some other groups were fed different doses of glyphosate in drinking water.

The rats that ate either the corn or the glyphosate tended to have more tumors and die earlier than the 20 rats in the control group, which were fed nonengineered corn and plain water.

The study passed the peer review process of the journal, which is considered one of the leading publications in toxicology. But many letters to the journal then criticized the study, as did food safety authorities in Europe.

Dr. Séralini and some other scientists had defended the paper in letters to the journal. They said the same strain of rats was used by Monsanto in its 90-day feeding study that led to European approval of the corn.

They also said that even though the rats had a high natural rate of cancer, what mattered was the difference in tumor incidence between the rats fed the corn or herbicide and the controls. 



                                  PART 3

------------------------------- GENET-news -------------------------------

TITLE:   SERALINI GMO RAT STUDY SET TO BE WITHDRAWN, SAYS JOURNAL

SOURCE:  Food Navigator

AUTHOR:  Nathan Gray

URL:     http://www.foodnavigator.com/Science-Nutrition/Journal-set-to-retract-Seralini-GM-rat-cancer-study

DATE:    02.12.2013

SUMMARY: "The research first hit the headlines last year when Gilles Seralini his colleagues published their findings in the journal Food and Chemical Toxicology. The study, along with graphic images of tumour ridden rats released by the authors, attainted global media coverage with suggestions that long term exposure to even relatively low levels of Monsanto?s herbicide Roundup and the genetically modified  NK603 resistant maize crop could result in a ?greatly increased risk of tumours? and premature death ."

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SERALINI GMO RAT STUDY SET TO BE WITHDRAWN, SAYS JOURNAL

The research first hit the headlines last year when Gilles Seralini his colleagues published their findings in the journal Food and Chemical Toxicology. The study, along with graphic images of tumour ridden rats released by the authors, attainted global media coverage with suggestions that long term exposure to even relatively low levels of Monsanto?s herbicide Roundup and the genetically modified  NK603 resistant maize crop could result in a ?greatly increased risk of tumours? and premature death .

Now, however, A. Wallace Hayes the editor of Food and Chemical Toxicology has sent Seralini a letter saying that the paper will be retracted if he does not agree to withdraw it.

In a letter to Dr Seralini dated the 19th November, Hayes asserts that the journal board had completed a 'thorough examination' of the data provided to them by the researcher and had expressed many concerns about the quality of the data, and ultimately recommended that the article should be withdrawn.

"I have been trying to get in touch with you to discuss the specific reasons behind this recommendation," wrote Hayes. "If you do not agree to withdraw the article, it will be retracted."

The letter also notes that very shortly after the publication of the study, the journal received many letters to the editor expressing concerns about the validity of the findings it described, the proper use of animals, "and even allegations of fraud."

"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," the letter continues.

The right thing to do ... but too late?

Within weeks of its appearance in the peer-reviewed journal, more than 700 scientists had signed an online petition calling on Seralini to release all the data from his research , while the European Food Safety Authority (EFSA) issued a statement  concuding the research was of ?insufficient scientific quality to be considered valid.' EFSA added that the research had serious defects in design and methodology and did not meet acceptable scientific standards.

Commenting on the decision to withdraw the study, Professor Cathie Martin, group leader at the John Innes Centre, UK said that the major flaws in the paper make its retraction the right thing to do. While David Spiegelhalter, Winton Professor of the Public Understanding of Risk at the University of Cambridge, said: "It was clear from even a superficial reading that this paper was not fit for publication, and in this instance the peer review process did not work properly."

"At least this has now been remedied and the journal has recognised that no conclusions can be drawn from this study, so I suppose it is better late than never," he added. "Sadly the withdrawal of this paper will not generate the publicity garnered by its initial publication."



                                  PART 4

------------------------------- GENET-news -------------------------------

TITLE:   ELSEVIER ANNOUNCES ARTICLE RETRACTION FROM JOURNAL FOOD AND CHEMICAL TOXICOLOGY

SOURCE:  PR Newswire UK

AUTHOR:  

URL:     http://www.prnewswire.co.uk/news-releases/elsevier-announces-article-retraction-from-journal-food-and-chemical-toxicology-233754961.html

DATE:    02.12.2013

SUMMARY: "Elsevier announces that the article "Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize," by Gilles Eric Séralini et al. has been retracted by the journal Food and Chemical Toxicology."

----- archive: http://www.genet-info.org/information-services.html -----


ELSEVIER ANNOUNCES ARTICLE RETRACTION FROM JOURNAL FOOD AND CHEMICAL TOXICOLOGY

"Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize," by Gilles Eric Séralini et al. has been retracted by the journal Food and Chemical Toxicology

Elsevier announces that the article "Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize," by Gilles Eric Séralini et al. has been retracted by the journal Food and Chemical Toxicology.

The journal has issued the following retraction statement:

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] 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] 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.  

--------------------------------------------------

1. Please see Food and Chemical Toxicology, 53 (1), pp. 440-483, for all Letters to the Editor and the response.

2. http://www.elsevier.com/journals/food-and-chemical-toxicology/0278-6915/guide-for-authors#8101 [http://www.elsevier.com/journals/food-and-chemical-toxicology/0278-6915/guide-for-authors ]

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.