THIRD WORLD NETWORK BIOSAFETY INFORMATION SERVICE
Dear Friends and Colleagues
How Commercial Interests Can Undermine Scientific Research
In November 2013, the editors of the journal Food and Chemical Toxicology retracted a research paper by Seralini et al., a year after publication. In June 2014, this paper was republished in the refereed journal Environmental Sciences Europe. The study by Seralini et al. had presented evidence implicating NK603 (a genetically engineered (GE) maize tolerant to the herbicide glyphosate) and Roundup (a glyphosate formulation) in kidney and liver toxicity in rats, the latter well below the regulatory threshold. NK603, Roundup and the two in combination were also reported to increase mortality and tumor incidence in rats. This evidence is now part of the peer-reviewed scientific literature.
A recent paper has analyzed the events surrounding the retraction of the Seralini et al. paper in relation to risk assessment policy for GE crops and pesticides as well as the scientific process in which peer-reviewed publication should stimulate new research that drives the evolution of scientific understanding. It also reviewed currently published evidence on the safety of NK603 and Roundup for human and livestock health and found confirmation of the toxicity findings of Seralini et al.
The paper noted several developments as a result of the republication of the Séralini et al. paper. Among these is the conclusion that the evidence of liver and kidney toxicity in rats is sufficient to justify further studies on NK603, glyphosate and Roundup including a formal, long-term carcinogenicity study to investigate the increased incidence of tumors and mortality unexpectedly observed by Séralini et al. The evidence also calls for a thorough reevaluation of the regulatory status of NK603, glyphosate and Roundup in particular, and an upgraded risk assessment of the chronic toxicity of GE crops and pesticides in general.
Furthermore, the events surrounding the imposed retraction of Séralini et al. point to the need to recognize the tension inherent between commercial interests of product developers and the scientific process, and to put in place basic safeguards to protect the latter. Conflicts of interests inherent in allowing product developers to conduct safety assessment research that serves as the basis for regulatory approval also need to be reconsidered.
The Abstract and Conclusions of the paper are reproduced below.
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THE SERALINI AFFAIR: DEGENERATION OF SCIENCE TO RE-SCIENCE?
Fagan J, Traavik T and Bøhn T
Environmental Sciences Europe 2015, 27:19
http://www.enveurope.com/content/27/1/19
Abstract
A paper reporting findings relevant to safety of the genetically modified (GM) maize NK603 and the herbicide Roundup (Séralini et al., Food Chem Toxicol. 501221–4231, 2012) was retracted against the wishes of the authors, and subsequently republished in another peer-reviewed journal (Séralini et al. Environ Sci Europe, doi:10.1186/s12302-014-0014-5, 2014). These events exemplify a trend in which disputes between interest groups vying for retraction and republication of papers that report controversial results overshadow the normal scientific process in which peer-reviewed publication stimulates new research, generating new empirical evidence that drives the evolution of scientific understanding. This paper reviews the current status of research on safety of NK603 maize and Roundup herbicide for human and livestock health, and attempts to glean from recent developments insights relevant to risk assessment policy for GM crops and pesticides as well as relevant to the scientific process in general. Our analysis of currently published evidence confirms NK603 and Roundup are kidney and liver toxicants at levels below current regulatory thresholds. Consequently, the regulatory status of NK603, glyphosate and Roundup requires reevaluation. Additionally, preliminary evidence indicates Roundup and NK603, individually and in combination, may increase tumor incidence and mortality. Follow-up long-term carcinogenicity studies, using test animal strains and numbers of
animals that assure robust conclusions, are required to confirm/refute this preliminary evidence. The inherent tension between the scientific process and commercial interests of product developers necessitates implementation of safeguards that protect the scientific process and prevent degeneration of Science to Re-Science (typified by retraction and republication disputes).
Conclusions
Six notable developments emerge as a result of the republication of Séralini et al. as Séralini et al. :
1. Evidence is now part of the peer-reviewed scientific literature implicating NK603 maize and Roundup pesticide as chronic liver and kidney toxicants with potentially significant public and animal health consequences. Séralini et al. is not the first study on this topic, but builds on earlier studies. Although it is the first to assess the toxicity of formulated Roundup, findings are consistent with the existing literature, documenting toxicity of glyphosate alone, showing that formulations are toxic at levels well below regulatory thresholds for glyphosate.
2. Now, it is time for critics of this evidence to provide substantive new empirical evidence that contributes constructively to scientific dialog regarding NK603, glyphosate and Roundup. Four distinct lines of research need to be followed up at this time. First, the logical next step regarding liver and kidney toxicity will be to conduct detailed cause/effect studies. However, given the commercial implications of the toxicity findings, we can also expect additional replicative studies to be conducted to confirm/refute the findings of Séralini et al. Second, a formal, long-term carcinogenicity study, with larger numbers of animals, is needed to investigate the increased incidence of tumors and mortality unexpectedly observed by Séralini et al. Third, if carcinogenicity is confirmed, follow-up cause/effect studies are needed to understand the biological processes involved. Finally, evidence of carcinogenicity should be followed up with comparative studies using a set of carefully selected experimental protocols and animal species/ strains.
3. The currently extant evidence of liver and kidney toxicity in rats is sufficient to justify a thorough review of the regulatory status of NK603, glyphosate and Roundup.
4. Risk assessment policy needs to be upgraded to consistently include assessment of chronic toxicity of GM crops and formulated pesticides, and to require that products be assessed, not as isolated “active ingredients”, but in formulations and combinations, and under conditions, used in actual practice.
5. The conflicts of interest inherent in allowing product developers to conduct the safety assessment research that serves as the basis for regulatory approval of their own products also need to be reconsidered.
6. The events surrounding the imposed retraction of Séralini et al. point to the need to recognize the tension inherent between commercial interests of product developers and the scientific process, and to put in place at least basic safeguards to protect the latter. If this is not done, there is growing risk that the standard of the future will not be Science, but Re-Science, which focuses, not on new research results that build humanity’s knowledge base, but on disputes among interest groups for (i) retraction of papers that report inconvenient results, and (ii) republishing—the new Re-Science: Re-publish or Perish.