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Conflicts of interests, confidentiality and censorship in health risk assessment: the example of an herbicide and a GMO

Wednesday 25 June 2014

Environmental Sciences Europe 2014, 26:13 doi:10.1186/s12302-014-0013-6

http://www.enveurope.com/content/26/1/13


Conflicts of interests, confidentiality and censorship in health risk assessment: the example of an herbicide and a GMO

 

Gilles-Eric Séralini12*, Robin Mesnage12, Nicolas Defarge12 and Joël Spiroux de Vendômois2

 

Author Affiliations

 

1 Institute of Biology, EA2608, Network on Risks, Quality and Sustainable Environment MRSH-CNRS, University of Caen, Esplanade de la Paix, Caen Cedex, 14032, France

2 CRIIGEN, 40 rue Monceau, Paris, 75008, France

 

Abstract

We have studied the long-term toxicity of a Roundup-tolerant GM maize (NK603) and a whole Roundup pesticide formulation at environmentally relevant levels from 0.1 ppb. Our study was first published in Food and Chemical Toxicology (FCT) on 19 September, 2012. The first wave of criticisms arrived within a week, mostly from plant biologists without experience in toxicology. We answered all these criticisms. The debate then encompassed scientific arguments and a wave of ad hominem and potentially libellous comments appeared in different journals by authors having serious yet undisclosed conflicts of interests. At the same time, FCT acquired as its new assistant editor for biotechnology a former employee of Monsanto after he sent a letter to FCT to complain about our study. This is in particular why FCT asked for a post-hoc analysis of our raw data. On 19 November, 2013, the editor-in-chief requested the retraction of our study while recognizing that the data were not incorrect and that there was no misconduct and no fraud or intentional misinterpretation in our complete raw data - an unusual or even unprecedented action in scientific publishing. The editor argued that no conclusions could be drawn because we studied 10 rats per group over 2 years, because they were Sprague Dawley rats, and because the data were inconclusive on cancer. Yet this was known at the time of submission of our study. Our study was however never attended to be a carcinogenicity study. We never used the word ‘cancer’ in our paper. The present opinion is a summary of the debate resulting in this retraction, as it is a historic example of conflicts of interest in the scientific assessments of products commercialized worldwide. We also show that the decision to retract cannot be rationalized on any discernible scientific or ethical grounds. Censorship of research into health risks undermines the value and the credibility of science; thus, we republish our paper.

 

Keywords: Conflicts of interests; Confidentiality; Retraction; GMO; Roundup; Glyphosate; NK603

Background

There is an ongoing debate on the potential health risks of the consumption of genetically modified (GM) plants containing high levels of pesticide residues [1]. Currently, no regulatory authority requests mandatory chronic animal feeding studies to be performed for edible GMOs and formulated pesticides. This fact is at the origin of most of the controversies. Only studies consisting of 90-day rat feeding trials have been conducted by manufacturers for GMOs. Statistical differences in the biochemistry of treated rats versus controls may represent the initial signs of long-term pathologies [2], possibly explained at least in part by pesticide residues in the GM feed. This is why we studied the long-term toxicity of a Roundup-tolerant GM maize (NK603) and a whole Roundup pesticide formulation at environmentally relevant levels from 0.1 ppb.

 

We first published these results in Food and Chemical Toxicology (FCT) on 19 September, 2012 [3] after a careful and thorough peer review. However, 1 year and 2 months later, in an unusual step, the editor-in-chief requested the retraction of our study, while conceding that the data were not incorrect and that there was no misconduct and no fraud or intentional misinterpretation. According to him, some data were inconclusive, but for reasons already known at the time of submission of the paper. The present paper is a summary of the debate resulting in this retraction, which in our view is a historic example of conflicts of interests in the scientific assessments of products commercialized worldwide.

 

Read the full article in Open Access on Environmental Sciences Europe : http://www.enveurope.com/content/26/1/13