We, the undersigned international scientists and experts, condemn the retraction by Dr. A. Wallace Hayes, the editor-in-chief of the scientific journal Food and Chemical Toxicology (FCT), of the pioneering 2012 study by GE Séralini on a genetically modified maize and its associated pesticide, Roundup.
Dr Hayes, FCT, and the journal’s publisher, Elsevier, must reinstate the Séralini study and provide a full public apology to Professor Séralini and his team.
The Study’s Findings
Séralini and colleagues’ chronic toxicity rat feeding study is the first and only long-term investigation of the effects of this particular type of GM maize (called NK603) and low levels of the herbicide Roundup, which the maize is engineered to tolerate during cultivation.
The study found severe organ damage, particularly to the liver, kidneys and pituitary gland, in rats fed the GM maize and/or low levels of Roundup in their diet. Additional unexpected observations were higher rates of large palpable tumors and mortality in most treatment groups.
Retraction Decision Reached in Non-transparent Process
The decision to retract the paper was reached through a nontransparent, second review process involving a panel of unnamed persons of unknown professional competence and with undisclosed potential conflicts of interest. The decision was announced over a year after the paper had passed through the original peer review process and was published.
Retraction Violates Norms of Scientific Publishing
According to the Committee on Publication Ethics (COPE), of which FCT is a member, retraction of a paper is reserved for cases of "unreliable" findings due to misconduct or honest error, redundant publication or plagiarism, and unethical research.
However, none of these criteria apply to the Séralini paper, as Dr Hayes conceded in a letter to Professor Séralini. Dr Hayes stated that an examination of Professor Séralini’s raw data had revealed "no evidence of fraud or intentional misrepresentation" and results presented were "not incorrect".
Dr Hayes added that the retraction was solely based on the “inconclusive” nature of the tumors and mortality outcomes, based on the relatively low number of animals and the strain of rat used. Dr Hayes later wrote in a statement: “No definitive conclusions could be drawn from the inconclusive data.”
However, lack of definitive conclusions is not valid grounds for retraction. Retraction on these grounds appears to be unprecedented in the history of scientific publishing.
Retracting a Whole Paper on Grounds of Inconclusiveness of Some of its Findings is Unjustified
According to widely accepted norms, Séralini’s study did not use sufficient numbers of animals for a carcinogenicity study. Therefore the questions raised by the observations of tumors and mortality can only be resolved by replicating and extending the study with larger numbers of animals, as suggested by Séralini’s team in their "Answers to critics," also published in FCT.
However, contrary to how it is presented by critics, Séralini’s study is not a flawed carcinogenicity study. It was designed as a chronic toxicity investigation, as the authors state in the title and introduction to their paper. The study generated statistically significant findings of organ damage and biochemical disturbances in treatment groups. These toxicity findings form the most important aspect of the study and are solidly based. They have important implications for public health.
Dr Hayes conceded in his statement that "the number of animals used may have been sufficient to reach conclusions regarding oral toxicity". Yet he has retracted the entire paper on the basis of the alleged inconclusive nature of some of its findings, namely the tumor and mortality rates.
He has not offered any explanation of why the toxicity findings, as well as the tumors and mortality observations, should be erased from the scientific record. We contend that they must remain in the scientific literature to inform further studies.
FCT Editor Defends Decision by Misrepresenting the Paper
On December 10, 2013, Dr Hayes defended his decision to retract the study in a published statement. In this statement, Dr Hayes appeared to contradict his previous statement in his letter to Prof. Séralini that the results were "not incorrect." He now maintained that the retraction was in line with the COPE guidelines, since the Séralini paper was an example of unreliable findings due to "honest error." Dr Hayes wrote:
"The data are inconclusive, therefore the claim (i.e., conclusion) that Roundup Ready maize NK603 and/or the Roundup herbicide have a link to cancer is unreliable… it is the entire paper, with the claim that there is a definitive link between GMO and cancer that is being retracted."
However, this is a misrepresentation of Séralini’s paper. The authors do not claim that the GM maize NK603 and/or Roundup herbicide have a "definitive link" to "cancer." Moreover, the authors specify in their introduction that the study is not a carcinogenicity study.
Instead, the authors simply observe and record the rates and timing of tumors (which are not, by definition, synonymous with "cancer") in the various groups of animals. This is in line with the international norm of the OECD chronic toxicity guideline 452, which requires that in a chronic toxicity study, all "lesions" (which would include tumors) are noted.
Dr Hayes does not specifically identify any unjustified or "definitive" claims in the paper. If he is able to identify any such claims, then, under COPE guidelines, this would justify requesting the authors to publish a correction or clarification. It would not justify retraction of the paper.
Conclusive Findings are Rare in Science
The notion that a pioneering study must produce conclusive results is incompatible with the way in which scientific progress occurs. Retrospectively applying a previously unknown standard of mandatory conclusiveness to all scientific papers would decimate the existing scientific literature, discourage innovative research, and impede understanding of complex issues.
In his letter to Prof Séralini, Dr Hayes states that the results of the study, because of their inconclusive nature, "do not reach the threshold of publication for Food and Chemical Toxicology." It is now incumbent on Dr Hayes to prove that all other studies published in FCT reach a higher standard of conclusiveness, or to retract them, also. Alternatively, Dr Hayes must reinstate the Séralini paper and apologize for its retraction.
Retraction Compromises Scientific Integrity and Could Put Public Health at Risk
Scientific uncertainties are only clarified by further research. Removing Séralini’s paper from the scientific record in this apparently unprecedented manner is antithetical to scientific progress. It also sends an unmistakable message to other researchers exploring the potential risks of GM crops and their associated pesticides: to the effect that their scientific research may not be funded or published, that their professional and personal reputations could be attacked, and that their careers could be ruined.
Moreover, erasing the evidence provided by the Séralini study could potentially put at risk the health of people, livestock, and the environment.
The retraction of the Séralini paper sets a dangerous precedent. Retrospectively applying previously unstated criteria to this paper alone, and doing so more than a year after publication, appears to be an act of scientific censorship. It runs counter to the interests of science, scientists, and the public at large.
Dr Hayes, FCT, and Elsevier must reinstate the Séralini study and provide a full public apology to Professor Séralini and his team.
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