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Seralini and Science: an Open Letter

October 2, 2012 Biotechnology, Commentaries, Health 47 Comments

(Authors listed below) (Traduction Francaise)
A new paper by the French group of Gilles-Eric Seralini describes harmful effects on rats fed diets containing genetically modified maize (variety NK603), with and without the herbicide Roundup, as well as Roundup alone. This peer-reviewed study (Seralini et al., 2012), has been criticized by some scientists whose views have been widely reported in the popular press (Carmen, 2012; Mestel, 2012; Revkin, 2012; Worstall, 2012).  Seralini et al. (2012) extends the work of other studies demonstrating toxicity and/or endocrine-based impacts of Roundup (Gaivão et al., 2012; Kelly et al., 2010; Paganelli et al., 2010; Romano et al., 2012), as reviewed by Antoniou et al. (2010).
The Seralini publication, and resultant media attention, raise the profile of fundamental challenges faced by science in a world increasingly dominated by corporate influence. These challenges are important for all of science but are rarely discussed in scientific venues.

Gilles-Eric Seralini

1) History of Attacks on Risk-finding Studies. Seralini and colleagues are just the latest in a series of researchers whose findings have triggered orchestrated campaigns of harassment. Examples from just the last few years include Ignacio Chapela, a then untenured Assistant Professor at Berkeley, whose paper on GM contamination of maize in Mexico (Quist and Chapela, 2001) sparked an intensive internet-based campaign to discredit him. This campaign was reportedly masterminded by the Bivings Group, a public relations firm specializing in viral marketing – and frequently hired by Monsanto (Delborne, 2008).
The distinguished career of biochemist Arpad Pusztai, came to an effective end when he attempted to report his contradictory findings on GM potatoes (Ewen and Pusztai, 1999a). Everything from a gag order, forced retirement, seizure of data, and harassment by the British Royal Society were used to forestall his continued research (Ewen and Pusztai, 1999b; Laidlaw, 2003). Even threats of physical violence have been used, most recently against Andres Carrasco, Professor of Molecular Embryology at the University of Buenos Aires, whose research (Paganelli et al. 2010) identified health risks from glyphosate, the active ingredient in Roundup (Amnesty International, 2010).
It was no surprise therefore, that when in 2009, 26 corn entomologists took the unprecedented step of writing directly to the US EPA to complain about industry control of access to GM crops for research, the letter was sent anonymously (Pollack, 2009).
2) The Role of the Science Media. An important but often unnoticed aspect of this intimidation is that it frequently occurs in concert with the science media (Ermakova, 2007; Heinemann and Traavik, 2007; Latham and Wilson, 2007). Reporting of the Seralini paper in arguably the most prestigious segments of the science media: Science, the New York Times, New Scientist, and the Washington Post uniformly failed to “balance” criticism of the research, with even minimal coverage of support for the Seralini paper (Carmen, 2012;  Enserink, 2012; MacKenzie, 2012; Pollack, 2012). Nevertheless, less well-resourced media outlets, such as the UK Daily Mail appeared to have no trouble finding a positive scientific opinion on the same study (Poulter, 2012).
3) Misleading Media Reporting. A key pattern with risk-finding studies is that the criticisms voiced in the media are often red herrings, misleading, or untruthful. Thus, the use of common methodologies was portrayed as indicative of shoddy science when used by Seralini et al. (2012) but not when used by industry (see refs above and Science Media Centre, 2012). The use of red herring arguments appears intended to sow doubt and confusion among non-experts.  For example, Tom Sanders of Kings College, London was quoted as saying: “This strain of rat is very prone to mammary tumors particularly when food intake is not restricted” (Hirschler and Kelland, 2012 ). He failed to point out, or was unaware, that most industry feeding studies have used Sprague-Dawley rats (e.g. Hammond et al., 1996, 2004, 2006; MacKenzie et al., 2007). In these and other industry studies (e.g. Malley et al. 2007), feed intake was unrestricted. Sanders’ comments are important because they were widely quoted and because they were part of an orchestrated response to the Seralini study by the Science Media Centre of the British Royal Institution. The Science Media Centre has a long history of quelling GMO controversies and its funders include numerous companies that produce GMOs and pesticides.
4) Regulator Culpability. In our view a large part of the ultimate fault for this controversy lies with regulators. Regulators, such as EFSA (the European Food Safety Authority) in Europe and the EPA (Environmental Protection Agency) and FDA (Food and Drug Administration) in the US, have enshrined protocols with little or no potential to detect adverse consequences of GMOs (Schubert, 2002; Freese and Schubert, 2004; Pelletier, 2005).
GMOs are required to undergo few experiments, few endpoints are examined, and tests are solely conducted by the applicant or their agents.  Moreover, current regulatory protocols are simplistic and assumptions-based (RSC, 2001), which by design, will miss most gene expression changes – apart from the target trait -  induced by the process of transgene insertion (Heinemann et al., 2011; Schubert, 2002).
Puzstai (2001) and others have consequently argued that well-conducted feeding trials are one of the best ways of detecting such unpredictable changes. Yet feeding trials are not mandatory for regulatory approval, and the scientific credibility of those which have been published to date has been challenged (Domingo, 2007; Pusztai et al., 2003; Spiroux de Vendômois et al., 2009). For example, Snell et al. (2012), who assessed the quality of 12 long term (>96 days) and 12 multigenerational studies, concluded:  “The studies reviewed here are often linked to an inadequate experimental design that has detrimental effects on statistical analysis…the major insufficiencies not only include lack of use of near isogenic lines but also statistical power underestimation [and], absence of repetitions…”.
Apparently, the same issues of experimental design and analysis raised about this (Seralini) risk-finding study were not of concern to critics when the studies did not identify risk, resulting in ill-informed decision-makers. In the end, it is a major problem for science and society when current regulatory protocols approve GMO crops based on little to no useful data upon which to assess safety.
5) Science and Politics.  Governments have become habituated to using science as a political football. For example, in a study conducted by the Royal Society of Canada at the request of the Canadian government, numerous weaknesses of GM regulation in Canada were identified (RSC, 2001). The failure of the Canadian government to meaningfully respond to the many recommended changes was detailed by Andree (2006). Similarly, the expert recommendations of the international IAASTD report, produced by 400 researchers over 6 years, that GMOs are unsuited to the task of advancing global agriculture have been resolutely ignored by policymakers. Thus, while proclaiming evidence-based decision-making, governments frequently use science solely when it suits them.
6) Conclusion:  When those with a vested interest attempt to sow unreasonable doubt around inconvenient results, or when governments exploit political opportunities by picking and choosing from scientific evidence, they jeopardize public confidence in scientific methods and institutions, and also put their own citizenry at risk. Safety testing, science-based regulation, and the scientific process itself, depend crucially on widespread trust in a body of scientists devoted to the public interest and professional integrity. If instead, the starting point of a scientific product assessment is an approval process rigged in favour of the applicant, backed up by systematic suppression of independent scientists working in the public interest, then there can never be an honest, rational or scientific debate.
The Authors: Susan Bardocz (4, Arato Street, Budapest, 1121 Hungary); Ann Clark (University of Guelph, ret.); Stanley Ewen (Consultant Histopathologist, Grampian University Hospital); Michael Hansen (Consumers Union); Jack Heinemann (University of Canterbury); Jonathan Latham (The Bioscience Resource Project); Arpad Pusztai (4, Arato Street, Budapest, 1121 Hungary); David Schubert (The Salk Institute); Allison Wilson (The Bioscience Resource Project)
Signatories: Brian Wynne (Professor of Science Studies, UK Economic and Social Research Council (ESRC) Centre for Economic and Social Aspects of Genomics, Cesagen, Lancaster University); Irina Ermakova, Dr of Biology, Russian Academy of Sciences; Jo Cummins (Professor Emeritus University of Western Ontario); Michael Antoniou, (Reader in Molecular Genetics; his university (King’s College, London) has a policy not to allow Dr Antoniou to use his affiliation here); Philip L. Bereano (Professor Emeritus University of Washington & Washington Biotechnology Action Council); Dr P M Bhargava (Former and Founder Director, Centre for Cellular & Molecular Biology, Government of India); Carlo Leifert (Professor for Ecological Agriculture Newcastle University); Peter Romilly (formerly University of Abertay, Dundee); Robert Vint (FRSA); Dr Brian John (Durham University, UK, retired); Professor C. Vyvyan Howard, University of Ulster); Diederick Sprangers (Genethics Foundation); Mariam Mayet (African Centre for Biosafety, South Africa);  Eva Novotny (ret. University of Cambridge); Ineke Buskens (Research for the Future); Hector Valenzuela (Professor, University of Hawaii); Ronald Nigh, (Centro de Investigaciones y Estudio Superiores en Antropología Social, Chiapas, Mexico); Marcia Ishii-Eiteman (PhD, Senior Scientist, Pesticide Action Network North America); Naomi Salmon (Dept. of Law, Aberystwyth University, Wales); Michael W, Fox (Minnesota, Veterinarian & Bioethicist, PhD, MRCVS); Neil J. Carman (PhD Sierra Club); Vandana Shiva (India); Hans Herren (President, Millennium Institute, Washington DC, USA); John Fagan (PhD Earth Open Source, UK and USA); Sheila Berry and the Global Environmental Trust; Av Singh (PhD, Perennia); Laurel Hopwood (for the Sierra Club, USA); Philip H. Howard (Associate Professor of Community, Food and Agriculture, Michigan State University); Donald B. Clark (on behalf of Cumberland Countians for Peace & Justice and Network for Environmental & Economic Responsibility, United Church of Christ, Pleasant Hill, TN); Robert Mann (Senior Lecturer in Biochemistry & in Environmental Studies (rtd) University of Auckland, NZ); Chris Williams (PhD, FRSA, University of London); Mae-Wan Ho (PhD Director Institute of Science in Society); Peter Saunders (Prof. Emeritus of Applied Mathematics, King’s College London); Dr. Terje Traavik (Prof. Gene Ecology, Faculty of Health Sciences, University of Tromsö); Oscar B. Zamora (Prof. Crop Science University of the Philippines Los Banos College, Philippines); Adrian Gibbs (Prof. (ret.) Canberra, Australia); Christian Vélot (Senior Lecturer in Molecular Genetics, University Paris-Sud, France); André Cicolella (Scientific adviser INERIS (National Institute of Industrial Environment and Risk) France); Maurizio Pea (Bussolengo General Hospital and University of Verona, Italy) Xiulin Gu (PhD, Yunnan University of Finance and Economics, P.R.China); Brigitta Kurenbach (PhD,University of Canterbury, NZ); Elena Alvarez-Buylla (Instituto de Ecología, CU, Coyoacán, México); Elizabeth Cullen (MB, Ph.D, MD and environmental scientist); Claudia Chaufan, MD, PhD (University of California San Francisco); Marijan Jost (Prof., Croatia); Manuel Ruiz Perez (Dpto. Ecologia, Universidad Autonoma de Madrid-Spain); Rubens Onofre Nodari (Full Professor, Federal University of Santa Catarina Florianópolis, Brazil); Judy Carman (Institute of Health and Environmental Research Inc., Kensington Park, Australia); Florianne Koechlin PhD (Blueridge Institute, Switzerland); Richard Lasker (for Brabant Research, Inc., BioInformatix, Inc., Puget Environmental Group, Inc.); Anita Idel (Dr. med. vet. Mediatorin (MAB) Germany); J.R. Olarieta (PhD, Lecturer in Soil Science, Universitat de Lleida); Svein Anders Noer Lie Associate Prof. University of Tromsoe, Norway); Cathey Falvo, MD, MPH [(retired)Prof & chair, international public health, New York Medical College, NY); Thomas Bøhn (GenØk - Centre for Biosafety, Tromsø, Norway); Jiang Gaoming, PhD, Professor of Institute of Botany, The Chinese Academy of Sciences, Beijing, China); Prof. Enrique Ortega (FEA/Unicamp, Brazil); Gregory Möller (Prof. Environmental Chemistry and Toxicology, The University of Idaho-Washington State University, USA); Dr Paulo Roberto Matins, Coordinator of the Brazilian Research Network in Nanotechnology, Society and Environment); Paulo Cezar Mendes Ramos (PhD ICMBio - Chico Mendes Biodiversity Conservation Institute, Brazil); Henry Kuska (PhD ret. Associate Professor, Depart. of Chemistry, University of Akron, USA); Philipe Baret (Université de Louvain, Louvain-la-Neuve, Belgium); Marco Tulio da Silva Ferreira (MSc, UFMG, Brazil);  Facundo Martín Phd (Universidad Nacional de Cuyo, CONICET, Argentina); Jacinta Palerm (Colegio de Postgraduados, Mexico); Dr Maarten Stapper (BioLogic AgFood); Sergio dC Rubin, (Latin Research Center, Bolivian Center of BioScience Research); Dr. Jalcione Almeida (Universidade Federal do Rio Grande do Sul – UFRGS, Porto Alegre, Brasil); Jaime Breilh, Md. MSc. PhD (Universidad Andina Simón Bolívar, Quito, Ecuador); Raquel Maria Rigotto (Profa. Departamento de Saúde Comunitária, Universidade Federal do Ceará, Brasil); John J. Moore, S.J.  (D.Sc. ret. Professor of Botany UCD, Dublin and UNZA, Lusaka); Gualter Barbas Baptista (Researcher in Ecological Economics and Political Ecology, Portugal); Prof. José Carlos de Araújo (Federal University of Ceará, Fortaleza, Brazil); Ligia Regina Franco Sansigolo Kerr (Universidade Federal do Ceará, Fortaleza, Brasil); Silvana Suaiden (Professora da PUC-Campinas, Brazil); Prof. Florence Piron (Université Laval, Québec, Canada); Luigi D'Andrea, Biologist, PhD (Biome, Switzerland); Dra. Maria do Céu de Lima (Professora Associada  LEAT UFC, Brazil); Tim LaSalle, PhD, (Professor of dairy science,ret., RSA); Profa. Dra. Cecilia Campello do Amaral Mello, Universidade Federal do Rio de Janeiro, Brazil); Randy Wayne (Assoc. Professor, Department of Plant Biology, Cornell University, USA); Pr Marcello Buiatti (University of Florence, Italy); Kathya Orrico, PhD, (Brazil); Gabriel Silva Campos (Universidad Autónoma de Madrid, Espana); Prof. Dr. Andres E. Carrasco MD (Institute of Cell Biology and Neurosciences, School of Medicine Univ. of Buenos Aires, Argentina); Profa Dra. Valéria Cristina Lopes Wilke (Diretora da Faculdade de Filosofia, Universidade Federal do Estado do Rio de Janeiro - UNIRIO, Brazil); Profa Simone Benedet Fontoura (Instituto Federal de Educação, Ciência e Tecnologia do Amazonas, Campus Manaus Zona Leste, Brazil); Prof. Dr. Mauricio Chiarello (Ribeirão Preto - SP, Brazil); Prof. David O. Born (Professor, University of Minnesota School of Dentistry, USA); Isabelle Goldringer (directrice de recherche INRA, UMR de Génétique Végétale, Université Paris-Sud, France); Rueidi Bastos (EMBRAPA, Brazil); Dr Stuart Parkinson (Executive Director, Scientists for Global Responsibility); Jean-Pierre Berlan (Directeur de Recherche INRA (retired)); Marciano Silva (Federal University of Rio Grande do Sul, Brazil); Dr Ulrich Loening (ex-Director of the Centre for Human Ecology, University of Edinburgh); Flávio Fabrini, PhD; Yara Paulina Cerpa Aranda (Universidade Federal do Rio Grande do Sul - Brasil); Thomas Heams (Assistant Professor, AgroParisTech and INRA, France); Donald R. Davis, Ph.D. (Biochemical Institute, The University of Texas, Austin, USA); Pierre M. Stassart (Associate Professor, Université de Liège, Belgium); Rosemary Mason (MB ChB FRCA); Dott. Ernesto Burgio (President of ISDE Scientific Committee, Italy); Dr. Narciso Barrera-Bassols (Investigador Nacional SNI II, Unión de Científicos Comprometidos con la Sociedad (UCCS), México); Jacques Hallard (Ing. CNAM, France); Jérôme Enjalbert (INRA, FRANCE); Rupa Patel, MD,FCFP (Queens University, Canada); Carlos Sonnenschein MD (Tufts University School of Medicine, USA); Bruno Gasparini (Coordenador do Curso de Direito do Instituto Superior do Litoral do Paraná, Paranaguá - Paraguay); Rod Toms (Ret. Lecturer in Biological Sciences Cornwall College); Cristine Carole Muggler (Associate Professor, Soil Science Department, Federal University of Viçosa, Brazil); Valério Pillar (Professor Titular, Departamento de Ecologia, Universidade Federal do Rio Grande do Sul, Brazil); David Quist (Senior Scientist, Centre for Biosafety, Tromsø, Norway); Emilia Wanda Rutkowski, University of Campinas, Brasil); Raoni Japiassu Merisse (Instituto Chico Mendes de Conservação da Biodiversidade - ICMBio, Brazil); Marc Mathieu (Research scientist, Inserm, France); Prof. Jorge A Quillfeldt (Biophysics Dept, IB / UFRGS, Brazil); Adelheid Kresse, PhD (Medical University Graz, Austria); Paul Connett, PhD (Prof. Emeritus of Chemistry, Director, American Environmental Health Studies Project, USA); Thomas Kesteman, MD, MPH (Université Catholique de Louvain, Belgium/Université Aix-Marseille II, France/Institut Pasteur de Madagascar, Madagascar); Juan Carlos Martínez García, PhD (Professor, Advanced Studies and Research Center of the National Polytechnic Institut of Mexico -Cinvestav/IPN-, México); Benjamin Bathfield, (PhD student at El Colegio de la Frontera Sur, Mexico); Jan Diek van Mansvelt, (ret. Wageningen University (NL) and Timirazev University (Moscow, Russia); Anna Milena Zivian, Ph.D (Ocean Conservancy); Dr. Peter Weish (Institut für Zoologie der Universität für Bodenkultur, Wien, Austria); Prof. Fábio Kessler Dal Soglio (Faculdade de Agronomia - UFRGS; Porto Alegre, Brasil); Kristin Vala Ragnarsdottir (Institute of Earth Sciences, University of Iceland); Harald Sverdrup (Professor of Chemical Engineering, Lund University, Sweden); Abdybek J. Asanaliev (PhD Kyrgyz National Agrarian University); Dr. Mohamed Shahin (Professor of Embryology, Ain Shams University, CAIRO, EGYPT); Marcos Pereira (Acadêmico de Ciências Biológicas, Universidade Federal do Maranhão, Brazil).

and if you are a scientist or academic and would like your name added to this list, please email: isneditor (at) bioscienceresource.org and write 'Seralini letter' in the headline, providing an affiliation if you wish.
Footnotes
(1) In addition, US scientists who publish studies finding adverse environmental effects are frequently vehemently attacked by other pro-GM scientists.  As a report in Nature, which discusses numerous examples, points out, "Papers suggesting that biotech crops might harm the environment attract a hail of abuse from other scientists.  Behind the attacks are scientists who are determined to prevent papers they deem to have scientific flaws from influencing policy-makers.  When a paper comes out in which they see problems, they react quickly, criticize the work in public forums, write rebuttal letters, and send them to policy-makers, funding agencies and journal editors" (pg. 27 in Waltz. 2009a.  Indeed, when one of us wrote a Commentary in Nature Biotechnology ten years ago suggesting that more attention needs to be paid to the potential unintended effects associated with insertional mutagenesis, we received a flood of responses, and an administrator at the Salk Institute even said that the publication "was jeopardizing funding for his institution" (see Waltz, 2009a).  Similar attacks have greeted studies on adverse effects of Bt toxins on ladybird beetles and green lacewing larvae, which were used by German authorities to ban cultivation of Mon810, a Bt corn variety (see: Hilbeck et al. 2012a,b , respectively). In 2009, a group of 26 public sector corn entomologists sent a letter to the US Environmental Protection Agency which stated "No truly independent research can be legally conducted on many critical questions involving these crops [because of company-imposed restrictions]” (pg. 880 in Waltz, 2009b; it was no surprise that the letter was sent anonymously as the scientists feared retribution from the companies that funded their work (Pollack, 2009).  Furthermore, industry control over what research can be conducted in the US means that adverse findings can effectively be suppressed. In one example cited in the article, Pioneer was developing a binary Bt toxin, Cry34Ab1/Cry35Ab1, against the corn rootworm.  In 2001, Pioneer contracted with some university laboratories to test for unintended effects on a lady beetle.  The laboratories found that 100% of the lady beetles died after eight days of feeding.  Pioneer forbade the researchers from publicizing the data.  Two years later Pioneer received approval for a Bt corn variety with Cry34Ab1/Cry35Ab1 and submitted studies showing that lady beetles fed the toxin for only 7 days were not harmed.  The scientists were not allowed to redo the study after the crop was commercialized (Waltz, 2009b).  In another example, Dow AgroSciences threatened a researcher with legal action if he published information he had received from US EPA.  As the article notes, “The information concerned an insect-resistant variety of maize known as TC1507, made by Dow and Pioneer. The companies suspended sales of TC1507 in Puerto Rico after discovering in 2006 that an armyworm had developed resistance to it. Tabashnik was able to review the report the companies filed with the EPA by submitting a Freedom of Information Act request. “I encouraged an employee of the company [Dow] to publish the data and mentioned that, alternatively, I could cite the data,” says Tabashnik. “He told me that if I cited the information…I would be subject to legal action by the company,” he says. “These kinds of statements are chilling” (pg. 882 in Waltz, 2009b).
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