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[SANET-MG] Mon *63 report 1
The manner in which the statistically significant differences between
treated and control was dismissed by the original Monsanto and
Government "scientists" as being irrelevant shows why the subterfuge of
a CBI designation was required. Those "scientists" were aware that the
impact of toxic feed and food would be hidden by the failure to label
the GM food and feed.It is time to evaluate all of the current CBI
designations for hidden toxicity.
From GM watch
Mon863 - Pusztai report
This is the first of three reports to be found on the Internet.
Interim report and preliminary evaluation of the summary report on the
“13 Week Dietary Subchronic Comparison Study with MON 863 Corn in Rats
Preceded by a 1-Week Baseline Food Consumption Determination with PMI
Certified Diet #5002 (Report MSL-18175/Covance Study No. 6103-293)”.
This preliminary report is based on the Monsanto summary report.
However, as this 19-page report contains no description of the design of
the feeding experiment, there will be occasional references to the full
A general comment: I find 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: (see below)
1. The precise composition of the diets is not given in either the
short or the full study report. No proper high impact factor
nutritional journal would ever accept a paper without such. It is not
sufficient or acceptable to refer to a commercial diet (PMI Rodent
#5002) or to just compute the composition, the protein, energy, etc.
contents of the diets. These need to be confirmed by actual analyses on
the diets, particularly as the full report mentions that there were
difficulties of mixing the ingredients into a homogenous diet.
2. The length of the study it should have made it imperative to
store the diets in a frozen state because some of the essential fats and
vitamins could have been destroyed by storing them at room temperature.
3. In the USA it is quite possible that the33% commercial maize
grain is already contaminated by GM corn, e.g. glyphosate-resistant corn
such as NK 603.
4. Why is it that the 11% test diet is not supplemented with the
parental line instead of commercial maize? (p. 2).
5. In the study (and in Table 1) it is only the first 4 diets that
are relevant; the comparison should strictly be between the GM and its
control diet. The use of historic values and the comparisons with the
additional six reference groups only serves to widen the value range of
the data and thus reduce the chances of finding significant differences.
References to broiler feeding studies are irrelevant for this evaluation!
6. Instead of irrelevant reference groups one additional major
control group should have been used. In addition to the parent line
control the authors should have set up a control group in which the
parental line diet was supplemented with the gene product isolated from
MON 863 corn at the same concentration as it is expressed in this GM
corn. This could have shown up any potential changes due to the splicing
of the Bt gene construct into the corn genome. (p. 2) as other studies
7. Body weight-, food consumption-data, etc. (p. 3) cannot be
statistically or otherwise evaluated or interpreted without the full
report and as such references to these in this summary report are
8. References to statements such as “A statistically significant
finding may not automatically constitute definitive evidence of an
adverse or toxicologically significant effect” is unacceptable in this
form. So who is going to define what is biologically significant?
Apparently, it is the authors of the report! We have to remind the
authors that if they accept the principle of substantial equivalence any
non-equivalence must at least be subjected to further detailed studies.
What is the point of performing sophisticated tests and measurements if
after finding significant differences they are dismissed as not
biologically significant? (See for example differences in kidney weights
and many others!)
9. Re: the Monsanto supplemental analysis of “selected data” for
consideration by the CGB. It is unacceptable for many 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. This is particularly so
after the established and published fact of lymphocyte infiltration in
the rat gut after feeding them on GM potato diets or finding significant
humoral and mucosal antibody responses in mice that were orally given Bt
toxins The authors must be aware of the fact that increased lymphocyte
counts are strong indicators of infection or even tumour development.
10. The last para on page 4 gives a graphic example why the authors use
the additional six reference control groups: “All of the high dose
individual male lymphocyte values, i.e. 7.1-11.3 fall within the range
of values measured for the reference control groups”. This comparison
has no biological meaning; its only purpose is to try to make the
significant differences between the test and the proper control groups
11. Incidentally Table on p. 5 does not contain the 5 weeks’ data, some
of which were previously (p. 4 in para Hematology and Clinical Chemistry
Findings) indicated to be significantly different.
12. On p. 6, second para it is startingly stated: “The 34% and 52%
decrease in reticulocyte counts in the is attributable to normal
biological variability”. Again the six reference control values come to
the help of the authors. It is truly incredible!
13. And this goes on with the glucose values despite the fact that in
females the differences are significant with the 11% diet and remain so
14. Apart from the kidney weight data no other organ weights are given!
It is incredible that no actual values are given for parts of the
gastrointestinal tract even though that is where any food, including GM
foods, will first impact on!
15. Postmortem examination is only given for “selected” tissues. Why?
16. “In this study tissues from reference control animals were not
processed for histopathological examination”How could the authors then
make comparisons with the test animals? Using “historical control”
pathology data by Monsanto is irrelevant
17. In Table 5 (p. 9) the proper comparison must be between the test
and parental control values. All other values are irrelevant! All test
values, except the kidney tube mineralization, are higher than the
corresponding parental controls! The explanations offered by Monsanto
are either irrelevant or invalid!
18. On the basis of the reported study and its results the Monsanto
scientists have no justification to conclude that “the weight of
evidence supports a conclusion that there are no MON 863-induced adverse
effects observed in this 90-day rat feeding study.” Fortunately they
qualify that it is only their opinion! (p. 10 last sentence).
Overall, this study, particularly as given in this short and almost
meaninglessly abbreviated and highly selective format has no scientific
value. However, even as it stands 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). Moreover, and even more
importantly, the omissions in the design and execution of this study
would make it impossible to consider the results to be acceptable for
publication in any high-profile international nutritional journal. These
deficiencies will be fully outlined and discussed in the Final Report.
12 September 2004
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