A heavily criticized study of the effects of genetically modified maize and the Roundup herbicide on rats is being retracted — one way or another.

The paper — by Gilles Seralini and colleagues — was published in Food and Chemical Toxicology last year. There have been calls for retraction since then, along with other criticism and a lengthy exchange of letters in the journal. Meanwhile, the paper has been cited 28 times, according to Thomson Scientific’s Web of Knowledge, and the French National Assembly (their lower house of Parliament) held a long hearing on the paper last year, with Seralini and other scientists testifying.

Now, as reported in the French media, the editor of the journal, A. Wallace Hayes, has sent Seralini a letter saying that the paper will be retracted if Seralini does not agree to withdraw it.

Here’s most of the November 19 letter, including Hayes’ proposed retraction notice:

The panel had many concerns about the quality of the data, and ultimately recommended that the article should be withdrawn.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. If you do not agree to withdraw the article, it will be retracted, and the following statement will be published it its place: The journal Food and Chemical Toxicology retracts the article “Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize,”1 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. 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. 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 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 a fair, thorough, and timely peer-review process; sometimes expediency might be sacrificed in order to be 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.

Seralini — whom, as we note, tried to get reporters to sign a non-disclosure agreement when the study was first being released, a move Ivan called an outrageous abuse of the embargo system designed to turn reporters into stenographers — rejected Hayes’ findings, according to Le Figaro. And GMWatch called Hayes’ decision “illicit, unscientific, and unethical.”

There’s a lot to chew on here:

Our read is that Hayes is basically saying that while the paper doesn’t meet the usual criteria for retraction, it should never have been published in the first place. This will likely be quite controversial, and it will be interesting to see how the scientific community reacts. Based on comments here at Retraction Watch, many scientists say that retraction should be reserved for fraud and serious error. Does that hold for a paper that many criticized as deeply flawed — and which challenged GMOs, whose use is supported by many scientists? Hayes is also saying that expedience is never an excuse for rushing a paper through peer review, no matter how controversial the subject. (Contrast Hayes’ comments with those by the editor of another Elsevier journal, Cell, earlier this year: “It is a misrepresentation to equate slow peer review with thoroughness or rigor or to use timely peer review as a justification for sloppiness in manuscript preparation.”) Post-publication peer-review — something we’ve championed for a while — is really important.

Update, 11:15 a.m. Eastern, 11/29/13: Here is Seralini et al’s response to Hayes’ letter. It begins:

We, authors of the paper published in FCT more than one year ago on the effects of Roundup and a Roundup-tolerant GMO (Séralini et al., 2012), and having answered to critics in the same journal (Séralini et al., 2013), do not accept as scientifically sound the debate on the fact that these papers are inconclusive because of the rat strain or the number of rats used. We maintain our conclusions. We already published some answers to the same critics in your Journal, which have not been answered (Séralini et al., 2013).

CRIIGEN also posted this press release:

The international journal Food and Chemical Toxicology (FCT) has requested the retractation of our study published more than one year ago (ref) on the long term toxicity of the herbicide Roundup, and of a GM maize tolerant to it. After the analysis of all our raw data, the chief editor signs that there is no fraud nor incorrect data, nor intentional misinterpretation. However, he writes that the data are inconclusive, because of the rat strain and the number of animals used. These critics are unacceptable for us, they have already been answered in a debate published one year ago by the same journal (Séralini & 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 Chem. Tox. 53:461-468). They were promoted by the Monsanto Company in the press, when simultaneously one its directors penetrated the FCT editorial office to be in charge of biotech papers, after our publication. The retractation would not be authorized by the international ethical norms accepted by FCT (called COPE), because there is no error nor fraud. By contrast, a short Monsanto study was published in the same journal to prove the safety of their product contains errors or frauds, and is not the subject of a controversy. It was done with the same strain and number of rats, but its comparators are false because the feed for the control rats is contaminated by GMOs, at doses comparable to the treated rats. This is linked to the very high number of animals requested for the carcinogenesis studies. These double subjective criteria are not admissible and endanger science and public health. We request to FCT the retractation of the Monsanto study on the same GMO, which has been used for its authorization. If FCT persists in its decision to retract our own study, CRIIGEN would attack with lawyers, including in the USA, to require financial compensation for the huge damages to our group. We question the european authorities to re-rexamine the studies used to authorize GMOs and pesticides, because the GMO and other contaminants presence in control feed as well as in the reference or historical data invalidate these studies.

Hat tips: Martin Pigeon, Keith Kloor

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