Why the Mon 863 Study Should Have Been Rejected

Why the Mon 863 Study Should Have Been Rejected—July 2005

The Mon 863 feeding study was poorly designed and reported. It is doubtful whether any prominent nutritional journal would consider it. It is odd, therefore, that it remains the key document used by government regulators to protect the health of European citizens.

Nutritional data missing: Nutrition studies require measurement and disclosure of the nutritional composition of the feed and the demonstration that it remains stable for the duration of the 90-day experiment. This assurance backed up by actual chemical analysis is not provided.

Methodology missing: The study fails to describe most of the methods used in the study. When methods cannot be evaluated or repeated, they remain suspect.

Older animals masked results: Nutritional studies use young, fast-growing animals, which are sensitive to toxic and nutritional effects. The study uses a mix of younger and more mature animals, which can mask serious problems.

Bizarre and conflicting animal weights: The starting rat weights given at two different places in the study were different. Thus, for male rats at the beginning of the report it was given as between 198.4 to 259.8 g while in Appendix 2, the values were 143 to 186 g. (similar differences for female rats). No high-class journal would tolerate such imprecision. Normally differences in starting weight should not be more than mean weight (typically about 80 g) 2%. Using such a wide range can make it impossible to find significant differences in animal weights at the end of the experiment.

The growth rates reported were inexplicable. During the experiment, for example, one rat lost 53 g in one week and then gained 102 g the next. Rats with the highest starting weight sometimes ended up with the smallest final weight. In the last four weeks, rats hardly grew at all, in spite of the similar feed intake and even though rats typically continue to grow throughout their lives. There is too little information provided to judge whether these are the result of animal mismanagement, degradation of the feed stored at room temperature, or some other problem.

Ignored modern methods: The analytical methods used are decades old. Powerful new methods, such as various profiling techniques, DNA chips, proteomix, and others, were ignored. The 90-day length can also miss chronic problems, reproductive problems, and problems arising in subsequent generations. Also, the study relied on only two observation times, missing the rate of appearance (kinetics) of the changes.

Inappropriate and missing controls: The study’s use of six irrelevant controls and reference to historical databases obscured the true findings. The study should have included a control group fed the non-GM parent line, spiked with the Bt gene product obtained from the GM maize, to isolate results of the transformation process. A second parental line spiked with a known toxin would also be useful as a positive control.

“Follow-up study” was inadmissible: Monsanto defended changes in kidney weights by comparing results from the test animals with rats used in a completely different study, conducted in a different laboratory, using Mon 863 hybrids with other GM maize samples. In this study the results of the original MON 863-study was quoted (but not actually re-done) for comparison. This inter-experimental comparison is entirely inappropriate for nutritional evaluation and should be disregarded.

Nutritional scientists and leading journals would not accept these blatant inadequacies and misinterpretations. How can regulators accept it for a novel genetically modified food?

from July 2005 Spilling the Beans newsletter

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