Evaluation reveals indications of negative health impacts on kidneys, liver and pancreas

Several scientists have expressed concern to GMWatch about the recently published paper detailing the results of the publicly funded EU GMO safety research project, GRACE.

Their concerns focus on the fact that while the authors of the paper conclude "no adverse effects" in rats fed Monsanto's pesticidal maize MON810 for 90 days, in fact there were many statistically significant differences in the GM-fed rats and some of them were potentially adverse.

Now Testbiotech has published an analysis of the data and concluded that they "revealed indications of negative health impacts on kidneys, liver and pancreas". Testbiotech also found numerous conflicts of interest with industry among the authors of this study and even among the editors of the journal that published it, Archives of Toxicology.

Testbiotech is calling for the paper to be retracted.

The outcome of the GRACE project is especially important because European policy-makers are planning to use the results to inform their decisions on whether animal feeding trials will be required at all for future GMO risk assessments (see below). Current regulation contains weasel wording which states that animal feeding trials will only be required "for the time being", leaving the door open for them to be abolished entirely.

The apparent manipulation of the outcome of the GRACE project represents a betrayal of the public and a misuse of public funds.

Testbiotech report:

Suspected manipulation in the outcome of EU research project

Testbiotech, 7 Nov 2014

* Evaluation of data from feeding trial with genetically engineered maize MON810 indicates negative health impact in rats

Testbiotech has today published an independent evaluation of data from feeding trials with rats that were conducted under the GRACE project funded by the EU Commission. The rats were fed over a period of 90 days with genetically engineered maize MON810, which produces an insecticidal protein. The results were published in October 2014 in the journal Archives of Toxicology. The authors conclude that there were no relevant observable toxicological effects. However, an evaluation by Testbiotech has now revealed indications of negative health impacts on kidneys, liver and pancreas. Furthermore, the failure in this study to determine a concentration of MON810 at which there were no observable toxic effects, makes the entire study more or less invalid. For the evaluation of the data, additional external expertise was made available by a toxicologist with long-term experience in regulatory toxicology.

Testbiotech also criticizes the authors purposely published the results of the study in a scientific journal with close affiliation to industry. One could assume that this journal was deliberately chosen to avoid a rigorous examination of the data.

“We are shocked by the outcome of our own evaluation. According to the EU Commission, the outcome of these feeding studies will be decisive for future standards of risk assessment for genetically engineered plants in the EU. Now it looks as though the outcome was manipulated to eradicate doubts concerning the safety of these products”, says Christoph Then for Testbiotech. Amongst other things, Testbiotech can show that the leading editors of Archives of Toxicology, Jan G. Hengstler and Hermann Bolt have a close affiliation with industry and a similar position to industry when it comes to the risk assessment of chemicals. Also, the lead author of the GRACE study, Pablo Steinberg, has active collaborations with industry-funded institutions such as the International Life Science Institute (ILSI), furthermore he is one of the editors of Archives of Toxicology.

Given the importance of this study, Testbiotech recommends the retraction of the paper. Republication should only be considered under a rigorous peer review process, in a journal with a scientific reputation not tarnished by questionable cooperation with industry, which is not impacted by affiliations to the authors and has the highest standards regarding avoidance of conflicts of interest.

“If toxicological studies are publicly funded we must demand the highest standards in scientific quality and in the avoidance of conflicts of interest. This is not the case with this project. This case shows that the mechanisms for securing quality in scientific work are not functioning”, says Christoph Then.

Contact: Christoph Then, This email address is being protected from spambots. You need JavaScript enabled to view it., Tel 0049 15154638040
The new Testbiotech report:
The publication in Archives of Toxicology:
Testbiotech backgrounder about GRACE: