Testbiotech demands access to further data
Recently the research group Testbiotech published its critique of researchers' interpretation of their 90-day animal feeding trial on MON810 corn, conducted under the EU-funded research project GRACE.
The GRACE authors concluded that statistically significant toxicological findings in the GM-fed rats were toxicologically irrelevant. But Testbiotech found that this conclusion was "not based on a sufficiently thorough assessment of the data". Testbiotech added that no safe dose (no-effect level) of MON810 was found in the study.
Now Joachim Schiemann, coordinator of the GRACE consortium, has replied to Testbiotech's criticisms – but is unable to refute them, as Testbiotech reports (see item 1 below).
Schiemann tries to argue that the toxicological findings are not biologically relevant – an argument that's been used frequently to dismiss signs of toxicity in numerous animal feeding studies with GMOs (see GMO Myths and Truths for a full discussion). However, it is not a scientifically valid argument, as proof would need to be provided that the changes are not biologically relevant. The only way of doing this would be to extend the study length and see if the physiological changes develop into disease or premature death. This was not done in the current GRACE study.
The Testbiotech report on the GRACE study was cited in an article in The Guardian on last week's European Parliament vote for national bans on GMO cultivation (see item 3 below).
The Testbiotech report was cited in an article in The Guardian on last week's European Parliament vote for national bans on GMO cultivation (see item 3 below).
The researchers at Testbiotech are not the only scientists to voice concerns about the GRACE authors' interpretation of their study. Even before the publication of the Testbiotech report, several scientists unconnected with Testbiotech had contacted GMWatch to relay their criticisms of the GRACE authors' claims of no toxicity from MON810 maize. We have summarised some of their comments in item 2 below.
1. GRACE Consortium cannot invalidate criticism of feeding trials
2. Scientists’ comments on GRACE findings
3. MEPs vote to firm up national bans on GM crops in Europe
---
1. GRACE Consortium cannot invalidate criticism of feeding trials
Testbiotech, 18 Nov 2014
https://www.testbiotech.org/en/node/1115
* In a letter to the new EU Commissioner, Testbiotech demands access to further data
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.
Contact: Christoph Then, This email address is being protected from spambots. You need JavaScript enabled to view it., Tel 0049 15154638040
Further information:
Testbiotech comment on letter from GRACE Consortium: www.testbiotech.org/en/node/1114
Open letter from GRACE Consortium: http://www.grace-fp7.eu/content/open-letter-testbiotech-response-its-report-and-press-release-dated-7-11-2014
Testbiotech report dated 7-11-2014: www.testbiotech.org/node/1107
The publication in Archives of Toxicology: http://www.grace-fp7.eu/sites/default/files/GRACE-FeedingTrials_AB_ArchToxicol_2014.pdf
Testbiotech backgrounder about GRACE: www.testbiotech.org/node/785
---
2. Scientists’ comments on GRACE findings
GMWatch, 18 November 2014
Two 90-day rat feeding studies, Study A and Study B, were carried out with two different varieties of MON810 Bt maize.
In both studies, the intestine was ignored, even though it is the first target organ of any GM food eaten and the intestine has been found in previous studies to be adversely affected by Bt corn[1] and Bt potatoes.[2] Histopathological investigations should have been carried out on this organ. It is poor scientific practice to conduct a study on a GMO while ignoring previous scientific findings on similar GMOs.
The conventional maize in two of the diets was contaminated with 1.2% and 2.6% GM DNA. The effect of this is to dilute the differences that may have otherwise emerged even more strongly between the GMO and non-GMO diets.
A large number of significant differences were reported in both Studies A and B, though below we only focus on Study A, due to considerations of length.
Study A findings
Blood changes that indicate immune responses in the GM-fed groups were dismissed by the study authors as unrelated to the GMO diet partly on the grounds that there was no linear dose-response effect. However, there are no linear dose and effect relationships with immune system-related measurements, and there is hardly ever a linear relationship with allergy.
In male rats, total protein (TP) levels in blood serum were significantly lower in the animals fed the 11% GMO and 33% GMO diets than in those fed the control diet. This effect was found with both doses of GM maize. Total protein levels are indicators of liver and kidney health and changes in these levels in humans can also be indicators of blood diseases such as multiple myeloma.
Glucose, cholesterol, triglyceride, chloride, sodium and phosphorus levels in blood serum were significantly higher in the animals fed both the 11% GMO and 33% GMO diets than in those fed the control diet, and males fed the 33% GMO diet had significantly higher potassium levels. Female rats fed the 11% GMO diet also had significantly changed blood parameters compared with those fed the control diet. All these changes could indicate changes in metabolism and should be investigated further.
Organ weights were changed in GM-fed rats. For example:
• The pancreas weight in male rats fed the 11% GMO diet was lower than in control rats. This might indicate changes in pancreatic function and/or enzyme secretion, and needs further investigation.
• The absolute weight of the left adrenal gland was significantly higher and the relative weight of the brain (relative to the total body weight) was significantly lower in male rats fed the 33% GMO diet than in control males.
• The relative liver weight was significantly higher, and the relative pancreas weight was significantly lower in male rats fed the 11 and 33% GMO diet. In male animals fed the 33% GMO diet, the relative weight of the left adrenal gland was significantly higher when compared to that of control male rats.
• In female rats fed the 33% GMO diet, the absolute weight of the lung was significantly lower than in control females.
These anatomical and physiological changes demand further investigation.
Male rats in the 11% GMO diet group ate significantly less than the males in the control and the 33% GMO groups. Feed consumption in male rats increased in the first 3 weeks, remained fairly constant until week 9 and then slightly decreased. The male rats grew continuously, so this decrease in feed consumption might indicate that some dietary components are accumulating, for example, in the bowel, decreasing the rats' appetite and feed intake. Similarly, the female rats fed on 11% GMO diet consumed significantly less than the groups fed the control diet.
The GRACE authors dismiss some statistically significant differences in the GM-fed animals through the standard industry tactic of introducing data from irrelevant non-GM “reference” diets, and failing to restrict the comparison to the GMO and non-GMO isogenic diets. These reference diets have the effect of widening the dataset so that there is less chance of seeing a significant difference between the GM and non-GM fed animals. For more details, see GMO Myths and Truths, “The right and wrong way to do a comparative assessment”.
Notes
[1] El-Shamei ZS, Gab-Alla AA, Shatta AA, Moussa EA, Rayan AM. Histopathological changes in some organs of male rats fed on genetically modified corn (Ajeeb YG). J Am Sci. 2012;8(10):684–696.
[2] Fares NH, El-Sayed AK. Fine structural changes in the ileum of mice fed on delta-endotoxin-treated potatoes and transgenic potatoes. Nat Toxins. 1998;6(6):219-33.
---
3. MEPs vote to firm up national bans on GM crops in Europe
Arthur Neslen
The Guardian, 11 Nov 2014
http://www.theguardian.com/environment/2014/nov/11/meps-likely-to-allow-national-bans-on-gm-crops-in-europe
* European Commission proposal to prevent national bans on environmental or health grounds is defeated
MEPs voted on Tuesday to allow national bans on genetically modified food crops for environmental reasons, even if the EU has already approved them for cultivation.
Under current bloc rules, GM crops can be cultivated after a satisfactory risk assessment by the European Food Safety Authority but several countries wanted stronger rights to block crops under the principle of ‘subsidiarity’, or devolution of powers to nation states. Some cited concerns over contamination from GM crops, others flagged scientific uncertainties.
A European Commission compromise proposal which would have prevented national GM bans on grounds of environmental or health concerns was amended, after securing support from just one political bloc: the European Conservatives and Reformists, whose largest member is the UK Conservative Party.
The commission’s compromise with pro-GM countries such as the UK and Spain, would have allowed countries a two-year window in which they could ban individual GM crops for reasons such as planning and agricultural objectives.
But these could have been challenged under the bloc’s internal market guidelines, and any governments wanting to ban GM would first have had to try to strike an ‘opt out’ deal with biotech companies, to exclude their territory from GM crop cultivation zones.
Sceptical MEP’s successfully argued that this would have allowed biotech companies to pressure states that wanted GM bans - and put them at risk of legal squabbling.
“We want to keep this issue out of the courts as companies are much more likely to challenge a member states’ decision that is unclear,” the Liberal-Democrat MEP Catherine Bearder said. The environment committee’s proposals were “really taking power away from the commission and giving it back to member states,” she added.
Paul Brannen MEP, Labour’s European spokesperson on agriculture, said that the amended proposal “will leave GM cultivation firmly in the hands of national governments, who can decide for themselves, as long as the right protections are in place, whether they want to grow GM or not.”
The Conservative Party has championed the subsidiarity principle in other EU fields. But for GM, the Conservative party’s environment spokeswoman, Julie Girling, said that the commission’s opt-out idea was a fairer way of obtaining a quick, simple and legally certain solution to the approvals issue.
“GM crops offer a great potential for growth and jobs in the EU while protecting the environment,” she told the Guardian. “Currently we are not able to access these crops because of the political block on approvals at the EU level. We need access to these crops to encourage investment and ensure European farming remains competitive.”
The likely amendments would make it “difficult, if not impossible, to agree,” a way forward from the current blockage, she said. That in turn, could raise the spectre of a UK veto in future EU ministerial meetings.
Separately, a new report published on Friday claimed to have linked the only genetically modified maize strain grown in Europe to negative health impacts in rats, despite its approval by EU regulators.
The non-peer-reviewed paper by Test Biotech, a platform of ecological scientists, evaluated data used by the EU’s GRACE project, and published in Archives of Toxicology. This official paper logged no observable toxicological effects from the MON810 maize strain made by Monsanto, which enables plants to grow insect-repelling toxins.
But the Test Biotech assessment found “indications of negative health impacts on kidneys, liver and pancreas” of rats and called for the the paper to be retracted. “It is unacceptable to dismiss the decrease in the total serum protein concentration and pancreas weight and the increase in blood glucose levels as toxicologically irrelevant,” it says.
“We are shocked by the outcome of our own evaluation,” added Christoph Then, a spokesman for Test Biotech. “It looks as though the outcome was manipulated to eradicate doubts concerning the safety of these products.”
The GM maize strain might be affected under a new GM regime, Then told the Guardian, as “some countries might be unwilling to grow it because of food safety uncertainties with this product.”
In a sign of the bitterness the GM debate has produced, Test Biotech linked the GRACE papers’ authors and Archive of Toxicology editors to industry affiliated journals and institutes.