German MON810 feeding trial results are worthless
*Did the researchers manipulate the trial so as to obtain their desired "no harm" result?

Dr Brian John
GM Free Cymru [Wales, UK], 9 December 2009
http://www.gmfreecymru.org

Recent work in Germany, flagged up as the "the most detailed and most precise study ever conducted worldwide" and involving MON810 fed to cattle over a period of 25 months, has been shown to be worthless.

The results were promoted to the media as showing "that feeding with transgenic maize does not have any impact on the food chain" and that "transgenic maize has no impact on lactating cows." The study has also been cited in the course of a German dairy industry campaign in support of GM components in soy-based and Bt corn-based feed: http://www.bio-pro.de/magazin/thema/03700/index.html?lang=en

In an English-language paper (Steinke et al, 2009) it was claimed that "Feeding Bt maize over a period of 25 months had no effects on the performance and metabolic parameters in this study. The statistical differences between isogenic and transgenic fed dairy cows (milk protein, milk fat and glucose) in the first lactation were not confirmed in the second lactation and are probably due to individual or physiological differences between animals."

However, a close examination of the original German-language study by Greenpeace(1) and Testbiotech(2) revealed that the conclusions arising from the research had effectively been announced before it had even commenced! The lead researchers declared in a joint statement of 14 January 2005: "It is secured in the science and common ground that the feeding of genetically modified feed to cows does not mean that the milk of these cows is any different from the milk that comes conventionally-fed cows." During the feeding trial, the researchers in charge of the work, from Munich Technical University, then changed or ignored their original protocols in a number of ways that must have corrupted their results. For example, only 18 of the 54 cows used in the trial were fed for the full 25 months; the rest were changed at unspecified times and for unspecified reasons, without this being revealed in the English-language paper published afterwards. Only nine of the cows were kept on the GM diet for the full research period. The data relating to the cows that survived the whole trial were aggregated with data for replacement animals. The exact reasons for the removal of other animals were not given, let alone scientifically defined precisely. Some animals might have been removed from the trial simply because they were reacting badly to a GM diet. It is striking, however, that the number of medical treatments in the animals fed with GM maize was consistently higher than in the control group animals. The physical condition of animals fed on conventional maize in the second lactation was significantly better than in the animals on the GM diet. These differences were simply glossed over or dismissed by the researchers. The statistics do not show which animals took part in the feeding trials, and over which periods of time. Specific and detailed investigations concerning certain organs, as well the examination of the calves, are missing from the published study. In spite of abundant and clear evidence of experiment manipulation, the researchers finally aggregated their data sets in such a way as to show that there were "no significant differences" between the various groups of animals used.

Further, it is not clear to which extent the Bt toxin was deactivated by the heating process performed for the preparation of the feedstuff. With regard to the test methods used for the identification of plant DNA in milk and animal tissues, the techniques and protocols used were not in accordance with international standards and were technically not sufficiently precise for showing any metabolic or physiological Bt effects that might have occurred in those animals fed on MON810. The techniques were not verified against other proven accurate techniques. Finally, it was not clear whether some of the "control group" of animals had been fed on GM material (incorporating GM soy or maize) prior to the commencement of the trial; if they had been, that would have rendered the trial useless.

These manipulations and data presentation defects cannot have been accidental, and it must be concluded that they were made in order to disaggregate or scramble data and to obtain a desired "no harm" result. In the Greenpeace critique of the study, it is stated:

"Chronic subclinical adverse effects, in cows which consumed genetically modified corn, can not be excluded by this study. Under the chosen experimental conditions (with disturbed animal health and performance oriented feeding) signs of acute damage to the health of the animals could not be picked up. Unfortunately, the experimental setup was not suited to investigate the serious questions of DNA transfer and health damage".

These criticisms -- arising from a close reading of the German- language report of the study -- have been presented to the research team on a number of occasions, without response.

What is particularly galling about this latest piece of scientific manipulation is that the research was conducted under the leadership of a senior academic at a public university, and not by Monsanto, Syngenta or any other industry organization.

Other studies arising from the same 25-month feeding trial must now also be suspect, and deserve very careful scrutiny. See for example Paul et al, 2009, "Degradation of Cry1Ab protein from genetically modified maize (MON810) in relation to total dietary feed proteins in dairy cow digestion".
http://www.springerlink.com/content/717h6n4215l5u32u/

Commenting on behalf of GM-Free Cymru, Dr Brian John said: "It is profoundly disappointing that this study, widely flagged up as showing that cows suffer no ill-effects when fed on MON810 as part of their diet, should turn out to be deeply flawed. It is even more disturbing that admissions about slapdash procedures and deviations from international standards of project management should have been mentioned in passing (but not properly quantified) in the German- language report of the work, and not mentioned at all in English- language reports. The research team, when confronted with this and other research defects over a period of months, has not seen fit to reply. On the face of it, therefore, we have to conclude that there has been research manipulation in pursuit of a pre-determined result, and that statements to the press, and abstracts presented to the scientific community, have been designed to mislead. We would be only too happy to revise our opinions on this worthless study, should the research team see fit to answer the questions properly raised by Greenpeace and Testbiotech."

ENDS

Contact

Dr Brian John
GM-Free Cymru
Tel: + 44 1239 820470

(1) Then, C. (2009) "Bayerische Fütterungsstudie der TU München zu Gen-Mais weist Mängel auf", Greenpeace Germany e.V., April 2009 (Bavarian GM Maize feeding study by the Technical University of Munich has shortcomings), Critical opinion on the "Final Report on Research Projects A/05/12, Use of transgenic maize (MON810) in dairy cows: breakdown, transfer and potential interactions of DNA and Bt protein in cattle" (TU Munich, Bavarian State Institute of Agriculture Food, Land use and Environment, by Heinrich H.D. Meyer, Hubert Spieker, Frieder Black, Patrick Guertler, Vijay Paul, Kerstin Steinke, Wolfgang Preissinger, Christiane Albrecht, Steffi Wiedemann, 2009), by Dr. Christoph Then for Greenpeace e.V., April 2009

(2) Risk Reloaded Risk analysis of genetically engineered plants within the European Union
A report by Testbiotech e.V. Institute for Independent Impact Assessment in Biotechnology
http://www.testbiotech.org
October 2009
by Christoph Then and Christof Potthof
---
Extract

"A research project involving feeding trials with the transgenic maize MON810 illustrates how difficult the conditions for independent research into risks in Germany are. Its results were presented by the Technical University of Munich (TUM) in 2009 (Meyer et al., 2009), in the midst of political discussions in Germany about the prohibition of the cultivation of MON810 maize. According to scientists involved in this feeding trial, which lasted 25 months, the findings can be taken as proof that the transgenic maize has no impact on lactating cows. It further highlighted that no residues from the transgenic maize could be detected in the animals' meat or milk. The study was presented to the press as the best study ever made:

"The study by Munich Technical University, the most detailed and most precise study ever conducted worldwide, has shown yet again that feeding with transgenic maize does not have any impact on the food chain." (Prof. Dr. Wolfgang Herrmann, president of the Technical University Munich, quoted in Landshuter Zeitung, page 2, 7st Aprile, 2009.) The results were also published in an international magazine (Steinke et al, 2009). The publication mentions that the findings are of robust quality because of the long duration of the feeding trials: "Feeding Bt maize over a period of 25 months had no effects on the performance and metabolic parameters in this study. The statistical differences between isogenic and transgenic fed dairy cows (milk protein, milk fat and glucose) in the first lactation were not confirmed in the second lactation and are probably due to individual or physiological differences between animals."

But as a comparison between the results as presented in German (Meyer et al. 2009) and English (Steinke et al., 2009) shows (Then 2009 c), the international publication does not mention several relevant data and furthermore hides the fact that many animals were removed from the trials during them. Only one third of the cows (18 animals) were fed over a period of 25 months as stated by Steincke et al., 2009. The rest of the 54 cows were changed during the trials without concrete reasons or the exact timing of the substituting being made public. Despite the fact that changing the animals in this way is highly plausible as the main reason why significant results could not be confirmed over the whole period of the study, the official international publication does not mention this important fact.

Further analyses of the data shows that the study hardly allows any final conclusions to be made. As mentioned, the statistical figures do not show which animals took part in the feeding trials over which period of time. Specific and detailed investigations concerning certain organs, as well the examination of the calves, are missing. Further, it is not clear to which extent the Bt toxin was deactivated by the heating process performed for the preparation of the feedstuff. All in all the conclusions of Steincke et al (2009) and the presentation of the results in the press have to seen as being as inadequate and even misguiding.

The second part of the study, which aimed to detect residues (such as specific DNA) of the genetically engineered plants in animal products (especially milk), also has to be discussed in a critical way. The methods and protocols used are not in accordance with international standards and technically not sufficient for showing the highest likelihood of making such a detection successfully (Then, 2009c).

The project was funded partially by the dairy industry. Some of its members were repeatedly criticised by consumer and environmental organisations because they allowed the use of genetically engineered plants in their animal feed. Even before the trials were started, the leading scientist in the project signed a declaration stating that residues from genetically engineered plants cannot be found in animal products (see Then, 2009c). All in all this research project provides a lot of good reasons to raise doubts in the independence of public research."

End of extract
---
This extract is from:

Risk Reloaded
Risk analysis of genetically engineered plants within the European Union
A report by Testbiotech e.V. Institute for Independent Impact Assessment in Biotechnology
http://www.testbiotech.org
October 2009
Christoph Then, Christof Potthof
Editing: Andrea Reiche

References:

Meyer, H.H.D. et al. (2009) Abschlussbericht zum Forschungsvorhaben A/ 05/12, "Einsatz von transgenem Mais (MON810) bei Milchkühen: Abbau, Transfer sowie potentielle Interaktionen von DNA und Bt-Protein im Rind", TU München, Bayerische Landesanstalt für Landwirtschaft (LfL) und Wissenschaftszentrum Weihenstephan für Ernährung, Landnutzung und Umwelt. http://www.lfl.bayern.de/ite/rind/35021/linkurl_0_2_0_0.pdf

Steinke K., Paul V., Gürtler P., Preissinger W., Wiedemann S., Albrecht C., Spiekers H., Meyer H.H.D., Schwarz F.J. (2009) Effects of long- term feeding of genetically modified maize (Bt-maize, MON810) to dairy cows on performance and metabolic parameters. Proceedings of the Society of Nutrition Physiology 18 (2009) 110

Then, C. (2009c) Bayerische Fütterungsstudie der TU München zu Gen- Mais weist Mängel auf, on hehalf of Greenpeace Germany e.V., April 2009 http://www.greenpeace.de/fileadmin/gpd/user_upload/themen/gentechnik/Kritische_Stellungnahme_Fuetterungsversuch_final_gesamt.pdf