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.
The publicity surrounding the initial publication of the article also attracted criticism, with science writer Declan Butler calling it "a tightly orchestrated media offensive". As part of a news embargo, Séralini required journalists to sign an unusual confidentiality agreement in exchange for advance access to the article, prohibiting them from conferring with other scientists before the press conference announcing publication. 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. The French Society of Toxicologic Pathology pointed out that, because such tumors are commonly found in older rats, the inclusion in the article of those images from treated rats, without also showing control rats, was misleading. Séralini also released a book and documentary film about the study in conjunction with the press conference.
Following widespread criticism by scientists, Food and Chemical Toxicology retracted the paper in November 2013 after the authors refused to withdraw it. The editor-in-chief said that the article was retracted because its data were inconclusive and its conclusions unreliable. In June 2014 an amended version of the article was republished in Environmental Sciences Europe, and the raw data were made public. According to writer Nathanael Johnson, not all of the raw data were, in fact, released. The journal did not conduct any further peer review; reviewers checked only that the scientific content of the paper had not changed.
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."Gilles Eric Séralini" and "Committee for Independent Research and Information on Genetic Engineering" , CRIIGEN.
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 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."Statement of the Scientific Panel on Genetically Modified Organisms on the analysis of data from a 90-day rat feeding study with MON 863 maize", EFSA, adopted 25 June 2007.Les experts européens innocentent un OGM, Le Figaro, 13 July 2007. The French Commission du Génie Biomoléculaire (AFBV) also criticized the study's conclusions., report prepared for the French Prime Minister by the Centre d'Analyse Strategique, 20 July 2007. Retrieved 31 May 2013
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 EFSA concluded that the authors' claims were not supported by their data, that many of the statistical criticisms of Séralini 2007 applied to Séralini 2009, and that the study included no new information that would change the EFSA's conclusions. 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.Olivier, Vincent. "OGM: deux chercheurs au tribunal" ("GM: two researchers in court"), L'Express, 19 January 2011 (English translation).
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.
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 two-year toxicity study, which cost €3.2 million, was conducted at the University of Caen by Séralini and seven colleagues. It had been funded by and run with the collaboration of CRIIGEN.
The study used 100 male and 100 female Sprague Dawley rats, divided into twenty groups with 10 rats in each. One male and one female group were each fed one of the following 10 test diets (also referred to in the study as "treatments"):
Three diets were composed of a mix of standard laboratory rat food and genetically modified corn (NK603) in proportions of 11 percent, 22 percent, and 33 percent
Three similar diets, in the same proportions, but with NK603 corn which had been treated in the field with Roundup.
Three diets consisted of a mix of standard laboratory rat food and 33% non-GMO corn, each accompanied with differing concentrations of Roundup in their drinking water
One diet consisted of a mix of standard laboratory rat food and 33% non-GMO corn, without contaminated drinking water. This served as the "control" diet.
All of the rats were allowed free access to food and water."A scientific analysis of the rat study conducted by Gilles Eric Séralini et al." , Vlaams Interuniversitair Instituut voor Biotechnologie, 19 January 2013.
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." At the press conference he also announced the release of a book and film about the study. 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. In contrast, embargo guidelines by journals such as Nature allow reporters to check their stories with independent experts.
Séralini's approach was widely criticized. A Nature editorial called it "a public-relations offensive." The result of the confidentiality agreement, the journal said, was that critical commentary was absent from the first round of stories, the ones most likely to be remembered. The press conference and publication occurred weeks before the vote on California Proposition 37, which called for labeling genetically modified food. The study was cited by supporters of the proposition.
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." Science journalist Carl Zimmer criticized the science journalists who participated.On the Media Radio Show, 2012 Sep 28 Manipulating Science Reporting Cosmos Magazine Elizabeth Finkel said that the confidentiality clause had allowed Séralini's story to "prance unfettered" before second opinions arrived.GM Corn and Cancer: the Seralini Affair
Reception
Scientific evaluation The study was criticized by various regulatory authorities and scientists. With few exceptions, the scientific community questioned the study and the peer-review process that allowed it to have been published.
Many said that Séralini's conclusions were impossible to justify due to experimental design issues or lack of 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 experiment covered the normal lifespan of these rats. The longer an experiment continues, the more rats get cancer naturally, that makes it harder to separate statistical "noise" from the hypothetical signal. For the study to achieve such separation (statistical power), each control and test group would have to include sufficiently many subjects. Organisation for Economic Co-operation and Development (OECD) guidelines recommend 20 rats for chemical-toxicity studies, and 50 rats for carcinogenicity studies. In addition, if the survival of the rats is less than 50% at 104 weeks (which is likely for Sprague-Dawley rats) the recommended number of rats is 65. The Séralini study had only ten per group.
Tom Sanders from King's College London noted a lack of data on amount of food given, and on growth rates, further noting that rats are susceptible to mammary tumors when food intake is not restricted. Sanders said, "The statistical methods are unconventional ... and it would appear the authors have gone on a statistical fishing trip."Ben Hirschler and Kate Kelland. Reuters. 20 September 2012 Study on Monsanto GM corn concerns draws skepticism