Scientific Peer Review - It works!

DISCLAIMER:  I DO NOT WORK FOR MONSANTO... I DON'T EVEN KNOW ANYONE AT MONSANTO!

Be careful of latching on to research that merely supports your biases!  The ultimate validity of any scientific paper is gained in the long term through a combination of processes - to include a couple of important methods - analysis of metholdology, peer review by experts in the field and replication through further studies.  The recently retracted study fails - an astute analysis of the Seralini et al paper:

“Rat feeding studies with genetically modified maize – a comparative evaluation of applied methods and risk assessment standards”

by Hartmut Meyer (European Network of Scientists for Social and Environmental Responsibility) and Angelika Hilbeck (Swiss Federal Institute of Technology, Institute of Integrative Biology) published in Environmental Sciences Europe 2013, 25:33

The report was financed by the European Network of Scientists for Social and Environmental Responsibility (not Monsanto!)

http://www.enveurope.com/content/pdf/2190-4715-25-33.pdf

Abstract:

A 2-year rat feeding study with genetically modified NK603 maize sparked an international
scientific and public debate as well as policy responses by the European Commission. The
European Food Safety Authority (EFSA) evaluated the study as defective based on
conceptual and methodological shortcomings by retroactive application of the
recommendations of its recent guidance on 90-day feeding studies. Our comparative analysis
of the three relevant NK603 publications, including a 90-day feeding study of Monsanto,
showed that all of them satisfy or fail to satisfy the EFSA evaluation criteria to a comparable
extent; the rejection of only one of the papers is, thus, not scientifically justified. We also
show that EFSA's criteria are not standard practice in 21 other rat feeding studies lasting at a
minimum of 12 months. The review reveals critical double standards in the evaluation of
feeding studies submitted as proof of safety for regulatory approval to EFSA. We specifically
argue that the current approach to DE CLARE statistically significant differences between
genetically modified organisms and its parents as ‘biologically irrelevant’ based on additional
reference controls lacks scientific rigor and legal justification in the European uniion (EU)
system. Only recently, the EU authorities started building up an implementing system based
on its own legislation and supportive of the EU approach to risk assessment in the context of
technology assessment. Until these issues are resolved, we do not expect that neither the
public acceptance nor the scientific debate will subside.

In light of the result-triggered, selective application of evaluation criteria in the Seralini paper, the authors evaluated the study as defective based on numerous conceptual and methodological shortcomings reflecting non-compliance with European Food Safety Authority (EFSA) research criteria.  The EFSA has regulated and monitored GM organisms and various GM crop risk assessments and approvals, regulatory sciences and methodology for 23 years in the EU.

Specific issues cited where there was either low level or NO compliance with EFSA criteria:

1. The study objectives need to be clearly stated a priori in the study protocol.

2. The small number of rats per group and the biological relevance of the rat strain used should be justified with respect to the design choices.

3. Suitable controls for all treatment groups are not present.

4. Measures taken to reduce the risk of bias (e.g. blinding) are not reported.

5. The appropriateness and comparability of the diets cannot be assessed as critical information about their composition is not reported.

6. The stability of the diets cannot be assessed as details of their storage conditions are not provided.

7. It is impossible to evaluate whether or not there was any contamination of the diets, e.g. by mycotoxins, as it is not reported.

8. The amount of residues of glyphosate and its metabolites in treated maize NK603 is not reported.

9. The exposure to GMO, GMO + R, and R cannot be evaluated since the food and water intakes of the GM- and R-treated groups, respectively, are not clearly reported.

10. All collected endpoints should be reported openly and transparently.

11. The sample size (power) calculation must be presented, especially when the study objectives are unclear.

 

 

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