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1 Background
Main article: Gilles-ric Sralini
2
concluded that the authors claims were not supported
by their data, that many of the statistical criticisms of
Sralini 2007 applied to Sralini 2009, and that the
study included no new information that would change
the EFSAs conclusions.[19] The French Haut Conseil des
biotechnologies (High Council of Biotechnologies Scientic Committee or HCB) reviewed Sralini 2009 and concluded that it presents no admissible scientic 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 studys
authors.[20] Food Standards Australia New Zealand concluded that the results of Sralini 2009 were due to chance
alone.[21]
3 RECEPTION
The papers abstract stated: In females, all treated groups
died 23 times more than controls, and more rapidly.
This dierence was visible in 3 male groups fed GMOs.
All results were hormone and sex dependent, and the
pathological proles were comparable.
3.1
Scientic evaluation
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.[5] The letter criticized the Seralini study on several fronts, and concluded:
However, given this study presents serious deciencies
in the protocol, the procedures and the interpretation of
the results, the SFPT cannot support any of the scientic
claims drawn by the authors, and any relevance for human risk assessment. This letter presents the consensus
scientic opinion of the Conseil dAdministration of the
SFPT.[5]
The Belgian Federal Minister of Public Health asked the
Belgian Biosafety Advisory Council (BBAC) to evaluate
the paper. The BBAC was asked to inform the Minister whether this paper (i) contains new scientic information with regard to risks for human health of GM maize
NK603 and (ii) whether this information triggers a revision of the current authorisation for commercialisation
for food and feed use of this GM maize in the European
Union (EU).[56] The BBAC committee, whose members are drawn from the Belgian biotech Professoriat,[56]
pointed out that the long duration of this study is a pos-
3 RECEPTION
itive aspect since most of the toxicity studies on GMOs higher doses) with a July 2015 paper in PLOS ONE claimare performed on shorter periods, and concluded that:
ing that all laboratory rodent diets are contaminated with
dangerous levels of GMOs.[67] This has been strongly
Given the shortcomings identied by the
criticised by numerous experts,[68] for example, Tamara
experts regarding the experimental design, the
Galloway said that the study speculates beyond the evistatistical analysis, the interpretation of the redence presented in this paper.[69]
sults, the redaction of the article and the preOther Sralini supporters criticized the retraction of the
sentation of the results, the Biosafety Advisory
study, concluding the response was a product of industryCouncil concludes that this study does not condriven campaign and regard this as a concerning example
tain new scientically relevant elements that
of industry interference in the scientic process.[70]
may lead to reconsider immediately the current authorisation for food and feed use of GM
maize NK603. Considering the issues raised
3.3 Ocials
by the study (i.e. long term assessment), the
Biosafety Advisory Council proposes EFSA
At the time of the initial release, French Prime Minister
urgently to study in depth the relevance of the
Jean-Marc Ayrault said that, if the results are conrmed,
actual guidelines and procedures. It can nd inthe government would press for a Europe-wide ban on
spiration in the GRACE project[57] to nd usethe maize and The European Commission instructed the
ful information and new concerted ideas.[56]:9
EFSA in Parma, Italy, to assess the study.[71] In late
September 2012, Russia temporarily suspended importThe study was also criticized by the European Society of ing GM corn as a result of the study[72] and in November
Toxicologic Pathology, which expressed shock at the way 2012, Kenya banned all GM crops.[73]
the rats in the study were treated and questioned whether
the study was legal to perform under European law.[58]
A 2015 reanalysis of multiple animal studies found that
Seralini chose to forgo statistical tests in the main conclusions of the study. Using Seralinis published numerical data, the review found no signicant eects on animal health after analysis with statistical tests. The nding that in females, all the treated groups died 23 times
more than controls was not statistically signicant. The
highest mortality was observed for the group of female
rats fed 22% genetically modied maize. This dierence
was not statistically signicant. Seralini also originally
claimed males in groups fed 22% and 33% genetically
modied maize had three times lower mortality controls,
but this was also not statistically signicant. The ndings of liver necrosis and mammary tumors were also not
signicant.[59]
3.4 Media
The press conference led to widespread negative media
coverage for GM food, especially in Europe.[71] Le Nouvel Observateur covered the press conference in a story
called, Yes, GMOs are poisons!".[74]
Jon Entine in Forbes stated, Seralinis 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 52week feeding study of GM soybeans in 2007, nding no
apparent adverse eect 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
3.2 Responses to criticism
health hazards.[75] Andrew Revkin wrote in a blog the
study was another instance of single-study syndrome,
Sralini and supporters defended the study design, the in[76]
terpretation of the results, and manner and content of the and that the study was in support of an agenda.
publication.[60][61][62] Support for the study came from Henry I. Miller, in an opinion piece for Forbes, said "[Serthe European Network of Scientists for Social and En- alini] has crossed the line from merely performing and revironmental Responsibility (ENSSER), of which CRI- porting awed experiments to committing gross scientic
IGEN is a member.[63][64] A subsequent study published misconduct and attempting fraud.[77] Sralini responded
in 2013 by ENSSER concluded that EFSA (European by saying, "...that he won't make any data available to the
Food Safety Authority) applied double standards in eval- EFSA and the BfR until the EFSA makes public all the
uation of feeding studies, criticized EFSAs applied data under-pinning its 2003 approval of NK603 maize for
criteria.[65] An open letter in support of Seralinis arti- human consumption and animal feed.[3]
cle, signed by about 130 scientists, scholars, and activists, The Guardian's Environmental Blog stated that the study
was published in Independent Science News, a project of linking GM maize to cancer must be taken seriously
the Bioscience Resource Project.[66]
by regulators and that although it attracted a torrent of
Sralini responded to criticisms of his methodology (and abuse, it cannot be swept under the carpet. They also
specically a lack of dierence between rodent groups at noted CRIIGENs funding of the research and reported
5
Sralinis response: namely, that studies in support of GM
food are usually funded by corporates or by pro-biotech
institutions.[25] Proponents of Californias GM labeling
referendum, Proposition 37, hailed the study.[78][79]
further scientic peer review, because this had already been conducted by Food and Chemical Toxicology, and had concluded there had been no fraud nor
misrepresentation.[87] The republication renewed the
over the
A statement about the controversy, and especially the at- controversy, but now with additional controversy
[88]
behavior
of
the
editors
of
both
journals.
tacks on Seralini, was published in Le Monde, signed by
140 French scientists; the letter said: "...the protocol fol- In July 2015, the International Agency for Research on
lowed in this study presents defects that are subject to Cancer published a monograph on glyphosate, which condebate within the scientic community.... We are deeply tained an evaluation of the Sralini paper as republished
shocked by the image of our community that this contro- in June 2014 and the conclusion, that the study was inadversy gives citizens. The risk expertise to human health equate for evaluation because the number of animals per
or the environment is a dicult activity which is fac- group was small, the histopathological description of tuing many uncertainties Many of the threats to our planet mours was poor, and incidences of tumours for individual
have been revealed by scientists isolated and conrmed animals were not provided.[89]
by many studies coming from the scientic community.
In this case, it would be more ecient to implement research on the health and environmental risks of GMOs 6 See also
and pesticides, improve toxicological protocols used for
placing on the market and nance a variety of researchers
Pusztai aair
in this domain....[80]
3.5
Lawsuit
Retraction
7 Notes
[1] Agence France-Presse, September 20, 2012: Breaking
with a long tradition in scientic journalism, the authors
allowed a selected group of reporters to have access to
the paper, provided they signed condentiality agreements
that prevented them from consulting other experts about
the research before publication.[4]
[2] Nature Geoscience editorial, December 2011: Giving the
media advance notice of upcoming papers and full access
to them several days before publication allows reporters
time to research a story, and ask independent experts to
comment on the full peer-reviewed paper.[29]
[3] Nature, September 2012: With such strong claims and
the predictably large eect they will have on public opinion, researchers should take care how they present their
ndings to the public and the media. They should spell out
their results clearly; emphasize the limitations and caveats;
and make it clear that the data still need to be assessed, and
replicated, by the scientic community. That didn't happen. The paper was promoted in a public-relations oensive, with a related book and lm set for release this week.
Furthermore, journalists wishing to report the research
had to sign condentiality agreements that prevented them
from contacting other scientists for comment on the paper
until after the embargo had expired. Some, to their credit,
refused, or accepted and then revisited the story critically
once their hands were no longer tied by these outrageous
restrictions. The result was the exclusion of critical comment in many of the breaking stories the ones that most
people will remember.[30]
Republication
8 References
traction.
Food Chem.
Toxicol.
65: 3945.
doi:10.1016/j.fct.2014.01.006. PMID 24407018.
[2] Cassasus, Barbara (25 June 2014). Paper claiming GM link with tumours republished.
Nature.
doi:10.1038/nature.2014.15463.
[3] Butler, Declan (10 October 2012). Hyped GM maize
study faces growing scrutiny. Nature 490 (7419): 158.
doi:10.1038/490158a. PMID 23060167.
[4] France orders probe after rat study links genetically modied corn to cancer. Agence France-Presse. 20 September 2012.
[5] Barale-Thomas, Erio (2013).
Letter to the editor.
Food and Chemical Toxicology 53: 4734.
doi:10.1016/j.fct.2012.10.041. PMID 23165156.
[6] Elsevier Announces Article Retraction from Journal
Food and Chemical Toxicology. Elsevier. 28 November 2013.
[7] Gilles Eric Sralini and Committee for Independent
Research and Information on Genetic Engineering, CRIIGEN.
[8] Carman, Tim (19 September 2012). French scientists
question safety of GM corn. The Washington Post.
[9] Sralini, Gilles-Eric; Cellier, Dominique; De Vendomois,
Jol Spiroux (2007). New Analysis of a Rat Feeding Study with a Genetically Modied Maize Reveals
Signs of Hepatorenal Toxicity. Archives of Environmental Contamination and Toxicology 52 (4): 596602.
doi:10.1007/s00244-006-0149-5. PMID 17356802.
[10] GM maize MON863: French scientists doubt safety.
GMO Compass. 16 March 2007. Retrieved 11 November 2010.
[11] Statement of the Scientic Panel on Genetically Modied Organisms on the analysis of data from a 90-day rat
feeding study with MON 863 maize, EFSA, adopted 25
June 2007.
[12] European Food Safety Authority (2007). EFSA review of statistical analyses conducted for the assessment of the MON 863 90-day rat feeding study.
doi:10.2903/j.efsa.2007.19r.
[13] Les experts europens innocentent un OGM, Le Figaro,
13 July 2007.
REFERENCES
[27] Sralini, Gilles-Eric (2012). Tous Cobayes !: OGM, pesticides et produits chimiques. Editions Flammarion. ISBN
978-2-08-126236-2.
[45] Sta (22 October 2012) French panel rejects study linking
GM corn to cancer Agence France Presse. Retrieved 23
October 2012
[46] Sta (8 October 2012) VIB concludes that Sralini study
is not substantiated VIB Life Sciences Research Institute,
Belgium. Retrieved 14 October 2012
[47] Sta (October 2012) The Technical University of Denmark National Food Institutes assessment of a new longterm trial with genetically modied maize NK603 and
spray Roundup (In Danish) Technical University of Denmark, Danish National Food Institute, Rertrieved 23 October 2012
[48] Response to Sralini paper on the long term toxicity
of a Roundup herbicide and a Roundup-tolerant genetically modied maize. FSANZ website. October 2012.
Archived from the original on 20 October 2012. Retrieved 13 November 2013.
[49] Ministry of Science Technology and Innovation : Considered Opinion (PDF). Cibiogem.gob.mx. Retrieved
2013-08-20.
[50] Devos Y, Aguilera J, Diveki Z, Gomes A, Liu Y, Paoletti C et al. (2014) EFSAs scientic activities and
achievements on the risk assessment of genetically modied organisms (GMOs) during its rst decade of existence: looking back and ahead. Transgenic Res 23 (1):125, see pg 15. doi:10.1007/s11248-013-9741-4 PMID
23963741
[51] EFB (2013) Members
[52] Avis des Acadmies nationales dAgriculture, de
Mdecine, de Pharmacie, des Sciences, des Technologies, et Vtrinaire sur la publication rcente de G.E.
Sralini et al. sur la toxicit dun OGM Communiqu de
presse 19 octobre 2012
[53] Six French academies dismiss study linking GM corn to
cancer (Update 2)", Agence France-Presse, October 19,
2012.
[54] Erio Barale-Thomas linked in page
[55] webpage of the Socit Franaise de Pathologie Toxicologique
[56] Bioveiligheidsraad Conseil de Bioscurit (Belgian
Biosafety Advisory Council) (2012). Advice of the
Belgian Biosafety Advisory Council on the article by
Sralini et al., 2012 on toxicity of GM maize NK603
[57] GRACE project. grace-fp7.eu.
[58] Bartholomaeus, A; Parrott, W; Bondy, G; Walker, K; ILSI
International Food Biotechnology Committee Task Force
on Use of Mammalian Toxicology Studies in Safety Assessment of GM, Foods (November 2013). The use of
whole food animal studies in the safety assessment of genetically modied crops: limitations and recommendations.. Critical Reviews in Toxicology. 43 Suppl 2: 124.
doi:10.3109/10408444.2013.842955. PMID 24164514.
REFERENCES
[74] Malaurie,
Guillaume (September 20,
2012).
EXCLUSIF. Oui, les OGM sont des poisons !
Le Nouvel Observateur. Tempsreel.nouvelobs.com.
[75] Entine, Jon (30 September 2012). Does the Seralini
Corn Study Fiasco Mark a Turning Point in the Debate
Over GM Food?". Forbes.com. Retrieved 11 May 2013.
[76] Andrew
C.
Revkin
Single-Study
Syndrome
and the G.M.O. Food Fight September 20,
2012,dotearth.blogs.nytimes
[77] Miller, Henry I. (25 September 2012). Scientists Smell
A Rat In Fraudulent Genetic Engineering Study (opinion). Forbes.
[78] Sta, Right to Know.Posts tagged Seralini
[79] Pollack, Andrew (20 September 2012). Foes of Modied Corn Find Support in a Study. New York Times.
Retrieved 15 November 2014.
[80] Andalo C, Chercheuse AHS, Atlan A, Auclair D, Austerlitz F, Barot S. Science et conscience English translation
via Google Translate: Science and conscience. Le Monde.
14 November 2012.
[81] Elise Ferret (27 November 2015). Le professeur GillesEric Sralini remporte le procs en diamation face
Marianne. France 3, Basse-Normandie (France Tlvisions). Retrieved 1 December 2015.
[82] Barbara Casassus for Nature News. November 28, 2013
Study linking GM maize to rat tumours is retracted: Publisher withdraws paper over authors objections, citing
weak evidence
[83] Michael Hiltzik for the Los Angeles Times. November 29,
2013 Notorious anti-GMO study is retracted creating
more controversy
[84] Portier, Christopher J.; Goldman, Lynn R.; Goldstein,
Bernard D. (1 February 2014). Inconclusive Findings: Now You See Them, Now You Dont!". Environmental Health Perspectives 122 (2): A36A36.
doi:10.1289/ehp.1408106.
[85] Entine, Jon (29 November 2013). Sralini Threatens
Lawsuit In Wake Of Retraction Of Infamous GMO Cancer Rat Study. Forbes. Retrieved 19 February 2014.
[86] Sralini, Gilles-Eric; Clair, Emilie; Mesnage, Robin;
Gress, Steeve; Defarge, Nicolas; Malatesta, Manuela;
Hennequin, Didier; de Vendmois, Jol. Republished
study: long-term toxicity of a Roundup herbicide and a
Roundup-tolerant genetically modied maize. Environmental Sciences Europe 26 (1): 14. doi:10.1186/s12302014-0014-5.
[87] Casassus, Barbara (26 June 2014). Paper claiming GM
link with tumours republished. Nature. Retrieved 26
June 2014.
[88] Science Media Centre. June 25th, 2014. Controversial
GM study republished experts respond
[89] IARC monograph on glyphosate, p. 35, right column
External links
Sralini, Gilles-Eric; Clair, Emilie; Mesnage,
Robin; Gress, Steeve; Defarge, Nicolas; Malatesta,
Manuela; Hennequin, Didier; De Vendmois, Jol
Spiroux (2012). Long term toxicity of a Roundup
herbicide and a Roundup-tolerant genetically modied maize. Food and Chemical Toxicology 50 (11):
422131. doi:10.1016/j.fct.2012.08.005. PMID
22999595. (Retracted)
Gilles-Eric Sralini, Emilie Clair, Robin Mesnage,
Steeve Gress, Nicolas Defarge, Manuela Malatesta,
Didier Hennequin and Jol Spiroux de Vendmois
(2014). Republished study: long-term toxicity of a
Roundup herbicide and a Roundup-tolerant genetically modied maize. Environmental Sciences Europe 26: 14. doi:10.1186/s12302-014-0014-5. (as
republished)
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10.2
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10.3
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