Use your BACK button to return to article index.

Press Release 31st May 2005
from GM Free Cymru,

COMMENTS CONTAINED IN THE "PUSZTAI REPORT" ON THE MON863 RAT FEEDING
STUDY

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