{"id":163567,"date":"2010-01-10T16:00:00","date_gmt":"2010-01-10T21:00:00","guid":{"rendered":"tag:blogger.com,1999:blog-18884161.post-7437521496536263156"},"modified":"2010-02-08T17:00:41","modified_gmt":"2010-02-08T22:00:41","slug":"gmo-statistics-part-5-fsanz-say-non-validated-statistical-dredging-doesnt-mean-much","status":"publish","type":"post","link":"https:\/\/mereja.media\/index\/163567","title":{"rendered":"GMO statistics Part 5. FSANZ say non-validated statistical dredging doesn’t mean much"},"content":{"rendered":"

FSANZ response to Seralini et al.(2009), A comparison of the Effects of Three GM Corn Varieties on Mammalian Health,Int. J. Biol. Sci. 5(7): 706-726
<\/a><\/p>\n

Reports in the media refer to a newly published paper in the International Journal of Biological Sciences(December 2009) by S\u00e9ralini and colleagues in which the authors claim to have identified adverse effects in rats fed GM corn using statistical analysis. Whereas a similar paper published in 2007 focused on MON863 corn, this paper applies the same statistical methodology<\/span><\/strong> to data from separate feeding studies for GM corn lines MON863, MON810 and NK603.<\/p>\n

RESPONSE
\u2022 In their latest paper, S\u00e9ralini and colleagues again use a statistical analysis approach to interpret data from animal toxicity studies. On this occasion, they apply their methodology to separate feeding studies in rats with GM corn lines MON863, MON810 and NK603, and claim that their analysis has identified “new side effects linked with GM maize consumption, which were sex- and often dose-dependent”.<\/p>\n

\u2022The authors claim that their results show “signs of toxicity” mostly associated with the kidney and liver, although other effects were reported to have been identified in heart, adrenal glands, spleen and haematopoietic system. Based on their reported findings, the authors argue strongly that longer-term (up to 2 years) feeding experiments are necessary in at least three animal species for in vivo safety evaluation of GM foods.<\/p>\n

\u2022In response to S\u00e9ralini\u2019s 2007 paper, an expert scientific panel dismissed similar claims made by these authors. FSANZ also independently investigated the material presented in the paper and concluded that the incidence of statistically significant differences in animals fed GM corn (MON863) is entirely consistent with normal background variability.
<\/span><\/strong>
\u2022In their most recent paper, S\u00e9ralini and colleagues reject the consensus view and instead propose a cause-and-effect link between the findings and the new pesticides (herbicide or insecticide) specific to each GM corn, or associate the results with unintended effects arising from the genetic modification process itself. The authors do not offer any plausible scientific explanations for their hypothesis, nor do they consider the lack of concordance of the statistics with other investigative processes used in the studies such as pathology, histopathology and histochemistry.<\/p>\n

\u2022S\u00e9ralini and colleagues have distorted the toxicological significance of their results by placing undue emphasis on the statistical treatment of data, and failing to take other relevant factors into account. Reliance solely on statistics to determine treatment related effects in such studies is not indicative of a robust toxicological analysis. There is no corroborating evidence that would lead independently to the conclusion that there were effects of toxicological significance. FSANZ remains confident that the changes reported in these studies are neither sex- nor dose-related and are primarily due to chance alone.
<\/strong><\/span>Background
S\u00e9ralini and colleagues have now published several papers reporting on feeding studies with GM foods. In June 2009, S\u00e9ralini and colleagues repeated claims made in an earlier article (S\u00e9ralini et al., 2007) that a statistical re-analysis of the toxicity data originally reported by Hammond et al., 2006 provided evidence of hepato renal effects in rats fed GM maize for three months. No new data were presented in the article. Instead, the authors commented on a published report by an expert panel (Doullet al., 2007) that discussed the risk assessment conducted by S\u00e9ralini et al. 2007. For reasons not stated, the authors did not address the numerous deficiencies of their statistical re-analysis that had been reported by several international regulatory agencies (FSANZ 2007; EFSA 2007a; EFSA 2007b; Monod 2007).<\/strong><\/span> Instead, they chose to focus on the issues raised in a later published report by Doullet al., 2007. In the absence of new data and the failure of the authors to acknowledge that the interpretation of toxicity studies does not only involve statistics but requires the need for biological context, FSANZ is of the opinion that the recent article from S\u00e9ralini et al. provides no grounds to revise its previous conclusions on the safety of food derived from MON 863 corn. The FSANZ assessment concluded that food derived from MON 863 corn is as safe and wholesome as food derived from other commercial corn varieties.<\/p>\n

References<\/strong>
Doull J, Gaylor D, Greim HA, Lovell DP, Lynch B, Munro IC. Report of an expert panel on the reanalysis by S\u00e9ralini et al. (2007) of a 90-day study conducted by Monsanto in support of the safety of a genetically modified corn variety (MON 863).Food Chem Toxicol2007;45:2073-2085.
European Food Safety Authority (EFSA) (2007a). 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. Adopted 25 June 2007. http:\/\/www.efsa.europa.eu\/cs\/BlobServer\/Statement\/GMO_statement_MON863.pdf?ssbinary=true<\/a>
European Food Safety Authority (EFSA) (2007b). EFSA review of statistical analyses conducted for the assessment of the MON 863 90-day rat feeding study. 28 June 2007. http:\/\/www.efsa.europa.eu\/cs\/BlobServer\/Scientific_Document\/sc_rep_efsa_stat_review,0.pdf?ssbinary=true<\/a>
FSANZ. Review of the report by S\u00e9ralini et al., (2007): “New analysis of a rat feeding study with a genetically modified maize reveals signs of hepatorenal toxicity”. Food Standards Australia New Zealand July 2007. http:\/\/www.foodstandards.gov.au\/_srcfiles\/Review_of_Report_by_Seralini_et_al_July_2007.doc
Hammond B, Lemen J, Dudek R, Ward D, Jiang C, Nemeth M, Burns J. Results of a 90-day safety assurance study with rats fed grain from corn rootworm-protected corn.Food Chem Toxicol 2006;44:147-160.
Monod H., 2007. Exp\u00e9rience sur rats men\u00e9e par Monsanto en 2001-2002 avec certains r\u00e9gimes comportant du ma\u00efs g\u00e9n\u00e9tiquement modifi\u00e9: analyse statistique des courbes d\u2019\u00e9volution du poids. Study conducted upon request of the CGB (Commission du G\u00e9nie Mol\u00e9culaire, France).
http:\/\/www.ogm.gouv.fr\/experimentations\/evaluation_scientifique\/cgb\/autres_avis\/Avis_CGB_MON%20863_15juin2007.pdf<\/a>
S\u00e9ralini G-E, Cellier D, de Vendomois JS. New analysis of a rat feeding study with genetically modified maize reveals signs of hepatorenal toxicity.Arch Environ Contam Toxicol 2007;52:596-602.
S\u00e9ralini G-E, de Vendomois JS, Cellier D, Sultan C, Buiatti M, Gallagher L, Antoniou M, Dronamraju KR. How subchronic and chronic health effects can be neglected for GMOs, pesticides or chemicals.Int J Biol Sci 2009;5:438-443.
Spiroux de Vendomois J, Roullier F, Cellier D and S\u00e9ralini G-E, A Comparison of the Effects of Three GM Corn Varieties on Mammalian Health.Int J Biol Sci2009;5(7):706-726.<\/p>\n

See also<\/p>\n

GMO Statistics Part 4<\/a>
GMO Statistics Part 7 (EFSA Opinion)<\/a>
Discover Magazine blog<\/a><\/p>\n

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FSANZ response to Seralini et al.(2009), A comparison of the Effects of Three GM Corn Varieties on Mammalian Health,Int. J. Biol. Sci. 5(7): 706-726 Reports in the media refer to a newly published paper in the International Journal of Biological Sciences(December 2009) by S\u00e9ralini and colleagues in which the authors claim to have identified adverse […]<\/p>\n","protected":false},"author":710,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[7],"tags":[],"class_list":["post-163567","post","type-post","status-publish","format-standard","hentry","category-news"],"_links":{"self":[{"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/posts\/163567","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/users\/710"}],"replies":[{"embeddable":true,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/comments?post=163567"}],"version-history":[{"count":0,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/posts\/163567\/revisions"}],"wp:attachment":[{"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/media?parent=163567"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/categories?post=163567"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/tags?post=163567"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}