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Séralini affair

The Séralini affair was the controversy surrounding the publication, retraction, and republication of a journal article by French molecular biologist Gilles-Éric Séralini. First published by Food and Chemical Toxicology in September 2012, the article presented a two-year feeding study in rats, and reported an increase in tumors among rats fed genetically modified corn and the herbicide RoundUp. Scientists and regulatory agencies subsequently concluded that the study's design was flawed and its findings unsubstantiated. A chief criticism was that each part of the study had too few rats to obtain statistically useful data, particularly because the strain of rat used, Sprague Dawley, develops tumors at a high rate over its lifetime.

Background
Séralini, a professor of molecular biology at the University of Caen, is president of the scientific advisory board of the Committee of Research and Independent Information on Genetic Engineering (CRIIGEN), which opposes genetically modified food (GM food). Séralini co-founded CRIIGEN in 1999 because he judged that studies on GM food safety were inadequate. Before 2012, Séralini had published other peer-reviewed papers that concluded there were health risks to GM foods. In 2007 he and two others published a Greenpeace-funded study (Séralini 2007). It concluded that MON 863, a corn rootworm-resistant Bt corn developed by Monsanto, caused 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 and haematopoietic system. The French Commission du Génie Biomoléculaire (AFBV) also criticized the study's conclusions. In 2009, the Séralini lab published another study (Séralini 2009), which re-analyzed toxicity data for NK 603 (glyphosate resistant), MON 810 and MON 863 strains. The data included three rat-feeding studies published by Monsanto scientists on MON 810. This study concluded that the three crops caused liver, kidney and heart damage in the rats. The French Haut Conseil des biotechnologies (High Council of Biotechnologies Scientific Committee or HCB) reviewed Séralini 2009 and concluded that it "presents no admissible scientific element likely to ascribe any haematological, hepatic or renal toxicity to the three re-analysed GMOs." The HCB questioned the authors' independence, noting that, in 2010, the "body to which the authors belong" displayed material from a 2008 Austrian anti-GM study, the results of which had been acknowledged as mistaken by the study's authors. Food Standards Australia New Zealand concluded that the results of Séralini 2009 were due to chance alone. In 2010, Séralini sued Marc Fellous, president of the French Association of Plant Biotechnology, for libel, after Fellous criticized Séralini's research, in part because it was funded by Greenpeace. The judge ruled that the charge about the funding was defamatory. Fellous was fined €1000; Séralini was awarded a symbolic €1 in damages. A 2011 article by the Séralini lab that reviewed 19 published animal-feeding studies, as well as data from animal-feeding studies submitted for regulatory approval, concluded 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. Séralini's research was funded primarily by three organizations: the Sustainable Food Alliance (an organic food industry group), Greenpeace, and Sevene Pharma (a French manufacturer of homeopathic "remedies"). == 2012 study ==
2012 study
Study background On 19 September 2012, the journal Food and Chemical Toxicology published a peer-reviewed paper entitled "Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize." The paper's abstract stated: "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." Publication strategy Séralini held a press conference on the day the study was released in which he "promoted the cancer results as the study's major finding." Selected journalists were given early access to the paper on condition they sign a confidentiality agreement, which meant they were unable to confer with other scientists before the embargo expired. The ethics committee of the French National Centre for Scientific Research wrote that Séralini's public relations approach was "inappropriate for a high-quality and objective scientific debate." Cosmos Magazine Elizabeth Finkel said that the confidentiality clause had allowed Séralini's story to "prance unfettered" before second opinions arrived. == Reception ==
Reception
Scientific evaluation The study was criticized by various regulatory authorities and scientists. With few exceptions, the scientific community dismissed the study and called for a more rigorous peer-review system in scientific journals. Many said 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 risk of cancer over their lifespan (one study concluded that over eighty percent of males and over seventy percent of females developed cancer under normal conditions). The Séralini study had only ten per group. 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.'" Likewise, Dan Charles, writing for NPR, noted that in the study, rats that ate 33% GM food developed fewer tumors than did those who ate 11% GM food, suggesting the absence of a dose response. University of Calgary Professor Maurice Moloney publicly wondered why the paper contained so many pictures of treated rats with horrific tumors, but no pictures of control group rats. Many national food safety and regulatory agencies condemned the paper. 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 EFSA. EFSA concluded: 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. called for the paper to be retracted, calling its publication a "dangerous failure of the peer-review system." – condemning the study and the journal that published it. The joint statement dismissed the study as 'a scientific non-event'. 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. 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." The BBAC committee, whose members are drawn from the Belgian biotech Professoriat, to find useful information and new concerted ideas." A 2015 reanalysis of multiple animal studies found that Seralini chose to forgo statistical tests in the main conclusions of the study. Using Seralini's published numerical data, the review found no significant effects on animal health after analysis with statistical tests. The finding that "in females, all the treated groups died 2–3 times more than controls" was not statistically significant. The highest mortality was observed for the group of female rats fed 22% genetically modified maize. This difference was not statistically significant. Seralini also originally claimed males in groups fed 22% and 33% genetically modified maize had three times lower mortality than controls, but this was also not statistically significant. The findings of liver necrosis and mammary tumors were also not significant. A 2017 study found that since it was retracted, Seralini et al. (2012) had been cited 60 times after it was retracted, and that more of these citations were negative (39%) than were positive (26%). Responses to criticism Séralini and supporters defended the study design, the interpretation of the results, and manner and content of the publication. Support for the study came from the European Network of Scientists for Social and Environmental Responsibility (ENSSER), of which CRIIGEN is a member. A subsequent study published in 2013 by ENSSER concluded that EFSA (European Food Safety Authority) applied double standards in evaluation of feeding studies, criticized EFSA's applied criteria. Séralini responded to criticisms of his methodology (and specifically a lack of difference between rodent groups at higher doses) with a July 2015 paper in PLOS ONE claiming that all laboratory rodent diets are contaminated with "dangerous" levels of GMOs. This has been strongly criticised by numerous experts, for example, Tamara Galloway said that the study "speculates beyond the evidence presented in this paper". Other Séralini supporters criticized the retraction of the study, concluding the response was a product of industry-driven campaign and regard this as a concerning example of industry interference in the scientific process. 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 EFSA in Parma, Italy, to assess the study. and in November 2012, Kenya banned all GM crops. In 2022, Kenya reversed the ban in its entirety. Media The press conference led to widespread negative media coverage for GM food, especially in Europe. Jon Entine in Forbes stated, "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." Andrew Revkin wrote in a blog the study was another instance of "single-study syndrome", and that the study was in support of an "agenda". Henry I. Miller, in an opinion piece for Forbes, said "[Seralini] has crossed the line from merely performing and reporting flawed experiments to committing gross scientific misconduct and attempting fraud." 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." Proponents of California's GM labeling referendum, Proposition 37, hailed the study. A statement about the controversy, and especially the attacks on Seralini, was published in Le Monde, signed by 140 French scientists; the letter said: Lawsuit In 2012 Séralini sued the editor of Marianne and journalist Jean-Claude Jaillet for defamation after they accused him of fraud. The High Court of Paris ruled in Seralini's favor in 2015. The court said that the fraud allegation had first been made by Henry I. Miller in Forbes. The journalist was fined a total of 3,500 euros, while the editor was fined twice that amount because of past convictions. == Retraction ==
Retraction
In November 2013, Elsevier announced that FCT was retracting the paper, after the authors refused to withdraw it. The journal's editors concluded that while there was "no evidence of fraud or intentional misrepresentation of the data", the results were inconclusive and "[did] not reach the threshold of publication for Food and Chemical Toxicology". After an in-depth look at the study's raw data, no definitive conclusions could be reached regarding the role of either NK603 or glyphosate in overall mortality or tumor rates, given the 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. and Séralini himself threatened to sue FCT. A bioethicist with the NIH examined the case and wrote in the Journal of Agricultural and Environmental Ethics that articles should not be retracted for inconclusiveness, but that retraction due to flaws in study design or due to ethical violations may be appropriate, and that republication of retracted papers should occur only after additional peer review. On 1 August 2017, as part of a lawsuit against Monsanto, documents were released showing, among other things, that the editor-in-chief, Wallace Hayes, had once had a contractual relationship with Monsanto. Hayes said in an interview that he did not have a contract with Monsanto when he retracted Séralini's paper, and that his decision to retract it was not influenced by Monsanto at all. == Republication ==
Republication
In June 2014, the original study was republished with the addition of the entire data set, in the journal Environmental Sciences Europe. The entire data set was published because of requests from the national regulatory bodies CFIA, EFSA, FSANZ, ANSES and BfR. 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." 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." ==See also==
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