GRACE Consortium cannot invalidate criticism of feeding trials

The EU project GRACE, has published a first response to Testbiotech’s exposure of flaws in a rat feeding study with genetically engineered maize. In an open letter to Testbiotech, Joachim Schiemann, coordinator of the GRACE Consortium, rejected the objections raised by Testbiotech. At the same time, he neither rebutted Testbiotech’s critique nor did he address the network of vested interests around the publication. In regard to the toxicological data, he mostly repeated what was already stated in the study and therefore criticised by Testbiotech. Consequently, the GRACE Consortium cannot invalidate the evidence presented by Testbiotech.
Testbiotech has shown that the journal Archives of Toxicology, in which the controversial study was published, has very close ties to industry, and that relevant conflicts of interest were not mentioned. Furthermore, there is a very specific relationship between the main author of the study, Pablo Steinberg and the editors of the journal. Testbiotech is concerned that under these circumstances the publication was not thoroughly assessed by independent experts. This problem is not mentioned at all in the open letter.
GRACE has rejected Testbiotech’s interpretation of the toxicological data. However, a detailed analysis by an experienced toxicologist shows that the arguments put forward by GRACE cannot rebut the evidence presented by Testbiotech. On the contrary, it has to be restated that according to the data gained from the GRACE feeding study, rats fed with genetically engineered maize MON810 showed biologically relevant, statistically significant and dose-dependent effects. These effects concern total serum protein and the relative weight of the pancreas, the latter accompanied by an increase in blood glucose levels. These findings can be an indication of severe health deficiencies in the rats.
Testbiotech has written to the new EU Commissioner, Vytenis Andriukaitis and GRACE asking for clarification and restating its request to withdraw the publication and subject it to further scrutiny. Furthermore, Testbiotech is demanding the experts who participated in the peer review process before publication are named. Testbiotech is also requesting access to the data of an ongoing one-year feeding study with MON810 performed by the GRACE team. According to international OECD guidance, data from chronic feeding studies on biochemical and haematological parameters have to be assessed after three and six months. The one-year feeding study started at the beginning of 2014. Therefore, these data should be available.