Key study has passed through three peer reviews.
July 9, 2014 |
A scientific study that identified serious
health impacts on rats fed on 'Roundup ready' GMO maize
has been republished following its controversial
retraction under strong commercial pressure. Now
regulators must respond and review GMO and agro-chemical
licenses, and licensing procedures.
A highly controversial paper by Prof Gilles-Eric
Séralini and colleagues has been republished after a
stringent peer review process.
The
chronic toxicity study examines the health impacts
on rats of eating a commercialized genetically modified
(GM) maize, Monsanto's NK603 glyphosate-based herbicide
Roundup.
The original study, published in Food and Chemical
Toxicology (FCT) in September 2012, found severe liver
and kidney damage and hormonal disturbances in rats fed
the GM maize and low levels of Roundup that are below
those permitted in drinking water in the EU.
However it was retracted by the editor-in-chief of
the Journal in November 2013 after a
sustained campaign of criticism and defamation by
pro-GMO scientists.
Toxic effects were found from the GM maize tested
alone, as well as from Roundup tested alone and together
with the maize. Additional unexpected findings were
higher rates of large tumours and mortality in most
treatment groups.
Criticisms addressed in the new version
Now the
study has been republished by Environmental Sciences
Europe. The republished version contains extra material
addressing criticisms of the original publication.
The raw data underlying the study's findings are also
published - unlike the raw data for the industry studies
that underlie regulatory approvals of Roundup, which are
kept secret. However, the new paper presents the same
results as before and the conclusions are unchanged.
The republication restores the study to the
peer-reviewed literature so that it can be consulted and
built upon by other scientists.
The republished study is accompanied by a
separate commentary by Prof Séralini's team (also
published on The Ecologist) describing the lobbying
efforts of GMO crop supporters to force the editor of
FCT to retract the original publication.
The authors explain that the retraction was "a
historic example of conflicts of interest in the
scientific assessments of products commercialized
worldwide."
"We also show that the decision to retract cannot
be rationalized on any discernible scientific or ethical
grounds. Censorship of research into health risks
undermines the value and the credibility of science;
thus, we republish our paper."
Paper subjected to extraordinary scrutiny and
peer review
Claire Robinson, editor of GMOSeralini.org,
commented: "This study has now successfully passed no
less than three rounds of rigorous peer review."
First the paper was peer reviewed for its initial
publication in Food and Chemical Toxicology, and
according to the authors it passed with only minor
revisions.
The second review involved a non-transparent
examination of Prof Séralini's raw data by a secret
panel of unnamed persons organized by the
editor-in-chief of FCT, A. Wallace Hayes, in response to
criticisms of the study by pro-GMO scientists.
In a
letter to Prof Séralini, Hayes admitted that the
anonymous reviewers found nothing incorrect about the
results, but argued that the tumour and mortality
observations in the paper were "inconclusive", and this
justified his decision to retract the study:
"A more in-depth look at the raw data revealed
that no definitive conclusions can be reached with this
small sample size regarding the role of either NK603 or
glyphosate in regards to overall mortality or tumor
incidence. Given the known high incidence of tumors in
the Sprague-Dawley rat, normal variability cannot be
excluded as the cause of the higher mortality and
incidence observed in the treated groups."
"The rationale given for the
retraction was
widely criticized by scientists as an act of
censorship and a bow to the interests of the GMO
industry", says Robinson.
"Some scientists pointed out that numerous
published scientific papers contain inconclusive
findings, including Monsanto's own short (90-day) study
on the same GM maize, and have not been retracted. The
retraction was even
condemned by a former member of the editorial board
of FCT."
Now the study has passed a third peer review arranged
by the journal that is republishing the study,
Environmental Sciences Europe.
Let the critics carry out their own studies
Dr Michael Antoniou, a molecular geneticist based in
London, commented, "Few studies would survive such
intensive scrutiny by fellow scientists.
"The republication of the study after three
expert reviews is a testament to its rigour, as well as
to the integrity of the researchers. If anyone still
doubts the quality of this study, they should simply
read the republished paper. The science speaks for
itself.
"If even then they refuse to accept the results,
they should launch their own research study on these two
toxic products that have now been in the human food and
animal feed chain for many years."
Dr Jack A Heinemann, Professor of Molecular Biology
and Genetics, University of Canterbury New Zealand,
said: "I applaud Environmental Sciences Europe for
submitting the work to yet another round of rigorous
blind peer review and then bravely standing by the
process and the recommendations of its reviewers,
especially after witnessing the events surrounding the
first publication.
"This study has arguably prevailed through the
most comprehensive and independent review process to
which any scientific study on GMOs has ever been
subjected."
'Significant biochemical disturbances and
physiological failures'
The study examines the health effects on rats of
eating Roundup-tolerant NK603 genetically modified (GM)
maize (from 11% in the diet), cultivated with or without
Roundup application, and Roundup alone (from 0.1 ppb of
the full pesticide containing glyphosate and adjuvants)
in drinking water. It found:
- "Biochemical analyses confirmed very
significant chronic kidney deficiencies, for all
treatments and both sexes; 76% of the altered
parameters were kidney-related.
- "In treated males, liver congestions and
necrosis were 2.5 to 5.5 times higher. Marked and
severe nephropathies were also generally 1.3 to 2.3
times greater.
- "In females, all treatment groups showed a
two- to threefold increase in mortality, and deaths
were earlier.
- "This difference was also evident in three
male groups fed with GM maize.
- "All results were hormone- and
sex-dependent, and the pathological profiles were
comparable.
- "Females developed large mammary tumors more
frequently and before controls;
- "the pituitary was the second most disabled
organ;
- "the sex hormonal balance was modified by
consumption of GM maize and Roundup treatments.
- "Males presented up to four times more large
palpable tumors starting 600 days earlier than in
the control group, in which only one tumor was
noted.
- "These results may be explained by not only
the non-linear endocrine-disrupting effects of
Roundup but also by the overexpression of the EPSPS
transgene or other mutational effects in the GM
maize and their metabolic consequences.
- "Our findings imply that long-term (2 year)
feeding trials need to be conducted to thoroughly
evaluate the safety of GM foods and pesticides in
their full commercial formulations."
The paper concludes: "Taken together, the
significant biochemical disturbances and physiological
failures documented in this work reveal the pathological
effects of these GMO and R treatments in both sexes,
with different amplitudes.
"They also show that
the conclusion of the Monsanto authors that the
initial indications of organ toxicity found in their
90-day experiment were not 'biologically meaningful' is
not justifiable.
"We propose that agricultural edible GMOs and
complete pesticide formulations must be evaluated
thoroughly in long-term studies to measure their
potential toxic effects."
Regulators must take these results seriously
Dr Heinemann commented: "The work provides important
new knowledge that must be taken into account by the
community that evaluates and reports upon the risks of
genetically modified organisms, indeed upon all sources
of pesticide in our food and feed chains."
According to Patrick Holden, Chief Executive of the
Sustainable Food Trust (SFT) the study highlights
the inadequacy of current safety testing:
"The most obvious deficiency relates to the fact
that the current approval process is based on animal
feeding trials of only 90 days, a totally inadequate
duration when one considers that chronic diseases in
animals and humans do not usually manifest until
mid-life."
A second deficiency, he added, relates to the newly
emerging science of epigenetics - which demonstrates
that endocrine systems can be seriously disrupted by the
presence of chemical residues at concentrations as low
as a few parts per billion.
"This turns on its head the logic of an approval
process based on MRL (maximum residue levels), since it
is becoming increasingly apparent that these chemicals
have patterns of non-linear response."
An 'urgent review' of pesticide licensing is
needed
Given these concerns, said Holden, "there is a strong
case for an urgent review of the regulatory process for
licensing both the herbicide Roundup and the
neonicotinoid class of insecticides. A fundamental
review of the entire process for licensing agricultural
chemicals is required to ensure that in future the
public interest is better served."
Professor Pete Myers, Chief Executive of
Environmental Health Sciences and scientific advisor to
the SFT points out that only "the tiniest fraction of
agricultural chemicals" have been studied for health
effects by independent scientists:
"Over the last two-decades there has been a
revolution in environmental health sciences that
suggests the proportion of diseases attributable to
chemical exposures is far bigger and more significant
than previously understood.
"The tools we have available to us to say what is
safe and not safe are deeply flawed. They are not based
on two decades of development in the fields of endocrine
disruption and epigenetics, but instead on tests
developed in the 1950s.
"They do not reflect the complexity of mixtures,
or the way in which chemicals interact."
http://www.alternet.org/food/major-study-demonstrates-monsanto-gmo-corn-product-can-cause-damage-liver-and-kidneys-and