Press Release 31st May 2005 from GM Free Cymru,
Now that the three parts of Dr Arpad Pusztai's Evaluation of the MON863 rat feeding study have found their way onto the web, with the blessing of Monsanto (we are greatly blessed) it is worth remembering that none of this is new. Over a year ago (April 2004) this was reported in the French media:
"the French Commission for Genetic Engineering (CGB) worried about many biological effects: "significant increase in the white globules and the lymphocytes in the males" of the batch fed with the MON863; "reduced levels of reticulocytes" (immature red blood cells) in the females; "significant increase in blood sugar in the females"; "higher frequency of anomalies (inflammation, regeneration)" in kidneys of the males. After a long debate, the CGB indicated, in "the absence of satisfactory interpretation of some of the significant differences observed", that it was "not able to show the absence of health risks to animals".
What Dr Pusztai has done, in his work for the German authorities, is to confirm these concerns and to show that the rat feeding study is also scientifically defective. Monsanto has clearly sought to play down the statistically significant findings of its own research team by issuing censored "summaries" and other statements -- but the fact remains that in the full 1139-page Research Report (MSL-18175 / Covance Study 6103-293) and in its "Supplemental Analysis of Selected Findings" a number of statistically significant differences between MON863-fed and parental control rat parameter means are revealed.
These are some of the key criticisms of the study identified by Dr Pusztai:
** The design of the feeding study and presentation of its results confusing. It contains a lot of superfluous data but at the same time many important parameters are missing
** The design of the feeding study is not well focussed, with many flaws and crucial omissions in it and not up to date of what is expected of such an important study. The experiments are poorly executed in many instances and the presentation of the results is fragmentary, repetitive, not well set out and confusing
** There is no demonstration of the fact that the maize diet of the "control group" of rats was genuinely GM-free
** It is unacceptable for any experimental scientist to regard something as important as significant increases in white blood cell and lymphocyte counts and decreases in kidney weights in male rats, or a decrease in reticulocyte counts in females, as representing normal biological variability.......... The authors must be aware of the fact that increased lymphocyte counts are strong indicators of infection or even tumour development
** Overall, this study....... has no scientific value. However, the study strongly indicates that feeding rats on diets containing significant amounts of MON 863 GM corn can potentially be detrimental to the health of these animals and may cause major lesions in important organs (kidneys, liver, etc), interfere with the function of their immune system (lymphocyte, WBC, granulocyte counts) and change their metabolism (glucose)
** The so-called reference groups are only selectively used in the comparisons when this serves the purpose of the authors
** The food conversion ratio dropped catastrophically in the last few weeks of the experiment. No explanation was given
** No part of the gastrointestinal tract or any of the muscles are weighed to establish whether the GM maize diet did have any effect on them despite the fact that there are many papers in the literature that indicate such effects
** There were many significant differences between the blood constituents of the 33% GM maize diet-fed rats and the REF controls. However, the possible significance of these is underplayed by the authors
** This imperfectly designed and executed study has revealed a huge list of significant differences between the various biologically meaningful parameters of rats fed GM maize diets and the proper controls
** The list of significant differences suggest that the authors' confidence (that the genetic modification of the maize sample has induced no significant changes in the nutritional value and the biological/immunological, etc. properties of this important food/feed crop) is almost certainly groundless. It is almost impossible to imagine that major lesions in important organs (kidneys, liver, etc) or changes in blood parameters (lymphocytes, granulocytes, glucose, etc) that occurred in GM maize-fed rats, is incidental and due to simple biological variability
** With reference to the kidney weight study: This type of relatively crude and insensitive study on organ weights should only be regarded as starting point in GM food risk assessment. We need more detailed structural, pathohistological, immunological, hormonal and functional dynamic studies into organ function
Having considered these criticisms in detail, EFSA simply brushed them aside as 'biologically insignificant." The French, German and British regulatory authorities also dismissed them and voted for approval of MON863 as a food and feed component at the EU meeting of 19 May.
All we are asking for is a free and open scientific debate on these matters, with no restriction of documents and no gagging orders. Such secrecy is sinister and dangerous, and only serves to further the impression that Monsanto has something serious to hide and that the EC is not interested in safeguarding the health of the people of Europe. The "CBI" classification for the full 90-day rat feeding study MUST now be revoked, so that independent scientists can subject it to peer review.
Dr Brian John GM Free Cymru May 31st 2005