Séralini affair
[n 1] At the press conference, Séralini emphasized the study's potential cancer implications, and photographs from the article of treated rats with large tumors were widely circulated by the media.
[6] Following widespread criticism by scientists, Food and Chemical Toxicology retracted the paper in November 2013 after the authors refused to withdraw it.
[1] In June 2014 an amended version of the article was republished in Environmental Sciences Europe,[8] and the raw data were made public.
[12][13] 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.
[12] The European Food Safety Authority (EFSA) concluded that all blood chemistry and organ weight values fell within the normal range for control animals, and that the paper had used incorrect statistical methods.
[25] 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.
[27][28] 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.
[citation needed][32][33] 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.
[n 3] The press conference and publication occurred weeks before the vote on California Proposition 37, which called for labeling genetically modified food.
[37] Cosmos Magazine's Elizabeth Finkel said that the confidentiality clause had allowed Seralini's story to "prance unfettered" before second opinions arrived.
The longer an experiment continues, the more rats get cancer naturally, that makes it harder to separate statistical "noise" from the hypothetical signal.
"[44] 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.
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.
The journal published a statement in their November 2012 issue, that "the Editors have encouraged those people with concerns to write formally to the Editor-in-Chief, so that their views can be publicly aired."
"[61] The BBAC committee, whose members are drawn from the Belgian biotech Professoriat,[61] pointed out that "the long duration of this study is a positive aspect since most of the toxicity studies on GMOs are performed on shorter periods," and concluded that: "Given the shortcomings identified by the experts regarding the experimental design, the statistical analysis, the interpretation of the results, the redaction of the article and the presentation of the results, the Biosafety Advisory Council concludes that this study does not contain new scientifically relevant elements that may lead to reconsider immediately the current authorisation for food and feed use of GM maize NK603.
Using Seralini's published numerical data, the review found no significant effects on animal health after analysis with statistical tests.
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.
[75] 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.
[76] 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.
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."
[82] 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.
"[3] The Guardian's Environmental Blog stated that the study linking GM maize to cancer "must be taken seriously by regulators" and that although it "attracted a torrent of abuse", "it cannot be swept under the carpet".
[84][85] A statement about the controversy, and especially the attacks on Seralini, was published in Le Monde, signed by 140 French scientists; the letter said: "...the protocol followed in this study presents problems that are subject to debate within the scientific community.
We think our community should remember past mistakes..."[86]In 2012 Séralini sued the editor of Marianne and journalist Jean-Claude Jaillet for defamation after they accused him of fraud.
[7][89] 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".
In our analysis, his conclusions cannot be claimed from the data presented in this article.Séralini and his supporters strongly objected to the retraction,[89][90][91] and Séralini himself threatened to sue FCT.
[8][95] The entire data set was published because of requests from the national regulatory bodies CFIA, EFSA, FSANZ, ANSES and BfR.
[96] 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.
[97] 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.
