Healthy soil and sustainable growing

["TradingPostPaul" <tradingpost@riseup.net>]

 >>A recent case in point is Monsanto’s feeding study submitted in
2003 to the European Food Safety Authority (EFSA) for market approval
of its GM maize MON 863 that claimed to find no adverse impacts.
Independent review9 however, found serious flaws in the study at
every stage, from experimental design, to data collection, reporting
and analysis. Monsanto, supported by EFSA, kept the study from public
scrutiny under a false claim of confidential business information
until a German court order forced Monsanto to release the full report
in 2005. Monsanto published the study in 2006,10 restating its
position that the significant differences between transgenic and non-
transgenic fed groups were “not biologically meaningful.” But a
reanalysis of the data using the appropriate statistical tests and
found signs of toxicity to the liver and kidney of rats fed the GM
maize.11<<
==========
http://www.i-sis.org.uk/NatureBiotechnologyLetterErmakova.php
ISIS Press Release 07/01/08
Letter to Nature Biotechnology: Systematic bias in favour of no adverse
impacts from GM feed

I am writing in response to your article1 defending the ‘new format’
of your Feature2 on Ermakova’s findings of adverse health and
reproductive impacts on rats fed genetically modified (GM) soya, and
on the validity of the ‘scientific criticisms’ of her work.

You are still being unfair to Ermakova, especially in allowing the
panel of critics in your original Feature2 - all well known for their
writings and public appearances if not in declared financial
interests to be strongly pro-GM - to have the last word.3

You asked for suggestions regarding the format you might use for
Features of this kind. The real issue, however, is not the format but
the journal’s policy on reviewing. When there is a debate or a
controversy about an issue, reviewers must apply the same standards
to papers on both sides, and that Chassy et al2,3 did not do. They
explicitly wrote that Ermakova’s work should be judged by a more
rigorous standard because it contradicts earlier work that showed no
adverse effects from GM food. Yet the crucial earlier work4 that they
repeatedly cited was indeed, not subjected to same rigorous standard
they are demanding for Ermakova’s study; far from it. The same
applies to other earlier research purportedly demonstrating that GM
food is safe.

The specific GM food in question, Monsanto’s Roundup Ready soya (RR
soya, event 40-3-2), has been commercially grown since 1996 if not
before.  But contrary to the assertions of proponents such as Chassy
et al,2,3 its market approval - as indeed the market approval of all
genetically modified organisms (GMOs) - has been contested right from
the start.5 At issue was a reductionist regulatory regime that
allowed companies to present results of the most undiscerning tests
to bolster the claim that the GMO is ‘substantially equivalent’ to,
and hence as safe as, its conventional counterpart(s).

Feeding trials, typically conducted by the company seeking market
approval,6 tended to focus on agronomic performance, not on safety,
and were not of sufficient duration to assess any but the most acute,
short-term effects.

Ermakova’s experiment is new in that it involves long-term
transgeneration feeding through two generations (parent and their
offspring), and in contrast with other investigations in which
females started to be fed GM soya during their pregnancy, she began
to feed the rats before and during mating, and continued during
pregnancy and beyond.

The ‘multi-generational’ study by Brake and Evenson,4 which found no
adverse effect, is widely seen as the most comparable to Ermakova’s
study,2,3 though that’s far from being the case. Brake and Evenson
used mice, not rats; more importantly, the experiment did not involve
trans-generational feeding with RR soya. The misleading term ‘multi-
generational’ merely refers to breeding the mice for three
generations, and carrying out a separate feeding experiment for each
generation. The study was otherwise also fatally flawed and we are
surprised it got through peer review.

It claimed to have used a batch of RR soya harvested in a middle of a
certain field in South Dakota, processed by a commercial company, and
fed to mice of indeterminate age and body weight. The compositions of
the RR and conventional soy-formulated diets were remarkably similar;
so much so that 59 of the 78 components listed were identical to 2 or
3 significant figures, and the rest differed so slightly that they
would have been within standard errors. Could it be that the
researchers have been feeding both groups the same diet? No evidence
was provided to indicate that the two diets were different; no PCR
tests were performed to ascertain that one contained RR soya and the
other conventional soya. If there is any doubt that Ermakova had fed
RR soya to her rats, at least she has provided PCR data documenting
that transgenic soya was fed to the experimental group and non-
transgenic soya to the controls.7

The Brake and Evenson study, like many other ‘peer-reviewed’
published studies claiming no adverse health impacts, suffers from at
least as many flaws as the largely unpublished study of Ermakova, if
not more. This tells us that journals including Nature Biotechnology
are applying different, mainly uncritical, criteria in favour of
papers and commentaries claiming to find no adverse impacts.

More disturbing still, our regulators too, have been equally
uncritical, if not systematically biased in accepting flawed data and
unsubstantiated claims of safety in unpublished reports submitted by
companies seeking market approval for a whole range of GM food and
feed while ignoring and dismissing a long string of evidence
preceding Ermakova’s findings suggesting that the GM technology may
be inherently hazardous, as we have documented elsewhere.8

A recent case in point is Monsanto’s feeding study submitted in 2003
to the European Food Safety Authority (EFSA) for market approval of
its GM maize MON 863 that claimed to find no adverse impacts.
Independent review9 however, found serious flaws in the study at
every stage, from experimental design, to data collection, reporting
and analysis. Monsanto, supported by EFSA, kept the study from public
scrutiny under a false claim of confidential business information
until a German court order forced Monsanto to release the full report
in 2005. Monsanto published the study in 2006,10 restating its
position that the significant differences between transgenic and non-
transgenic fed groups were “not biologically meaningful.” But a
reanalysis of the data using the appropriate statistical tests and
found signs of toxicity to the liver and kidney of rats fed the GM
maize.11

Nature Biotechnology, like our regulators, have forgotten that the
safety of RR soya is a matter of public health, and any new data
suggesting it might not be safe should be taken most seriously,
especially as one commentary puts it,12 “the prior research is
inconclusive at best.” The ‘interview’ with Ermakova and the follow-
up in which Chassy et al are given the last word indicates that,
“Nature Biotechnology has for some time been unclear where the line
that traditionally separates trade magazines from science journals
lies.”

Mae-Wan Ho
Institute of Science in Society
PO Box 51885
London NW2 9DH, UK

e-mail: m.w.ho@i-sis.org.uk

------

Marshall, A. Nat. Biotechnol. 25, 1359-1360 (2007).
Marshall, A. Nat. Biotechnol. 25, 981-987 (2007).
Chassy, B. et al. Nat. Biotechnol. 25, 1356-1358 (2007).
Brake, D.G. & Evenson, D.P. Food Chem. Toxicol. 42, 29-36 (2004).
Ho, M.W. & Steinbrecher, R. Journal of Nutritional and Environmental
Interactions 2, 51-84 (1998).
Hammond, B. et al. J. Nutr. 126, 717-727 (1996).
Ermakova, I. Nat. Biotechnol. 25, 1351-1354 (2007).
Ho, M.W., Cummins, J. & Saunders, P.T. Microbial Ecology in Health
and Disease 19, 66-77 (2007).
Preliminary report by Criigen on the “First public investigation of
the crude data in Mon 863 toxicity tests on rats” 2005, http://
www.greenpeace.de/fileadmin/gpd/user_upload/themen/gentechnik/
MON_863_French_report_statistics.pdf
Hammond, B. et al. Food Chem Toxicol 44. 147–160 (2006).
Séralini. G.-E., Cellier. D., & Spiroux de Vendomois, J. Arch
Environmental Contamination and Toxicology  published online 13 March
2007, Doi 10.1007/s00244-0149-5.
The Bioscience Resource Project, Dec 4 2007, http://
www=2Ebioscienceresource=2Eorg/commentaries/brc6=2Ephp