Transgenics and biosafety | NIH journal publishes condemnation of Séralini retraction

Image courtesy of Permaculture News

 

Moderator’s
Note: In December we posted a
report on a statement issued by the European Network of Scientists for Social
and Environmental Responsibility (ENSSER). The statement
was a sharp condemnation of the retraction of a research article by Séralini and colleagues (Séralini et al. 2012) by the
Editor-in-Chief of the journal Food and
Chemical Toxicology.

Now comes an even bigger bomb in the form
of a harsh set of criticisms leveled in an editorial letter published in the on-line version of the prestigious
journal, Environmental HealthPerspectives, a flagship journal of the National Institutes of Health
(NIH). Is this an opening to a conflict between the NIH and the FDA and USDA?
One wonders. In the current February 2014 issue, the journal features a letter
from three American scientists condemning the retraction of the Séralini study. 




A brief refresher is in order about the study and the
controversy unleashed by the journal’s retraction. First, we should note that the
study exceeded the minimal time span in the research design of the commercial
biotechnology companies’ own experimental data, which typically involves very
short term feeding trials of 90 days or less. Séralini et al used a more
realistic and proven minimum of 2 years length for the feeding trials since
toxic, mutagenic, teratogenic, or carcinogenic effects from any given food
source usually have cumulative and long-term exposure effects.

The Séralini team used 200 rats divided into ten
groups, each of ten males and ten females. The GM maize alone was tested on
three groups at 11%, 22% and 33% of the total diet. GM maize, which had been
sprayed with Roundup in the field, was tested on three groups in the same
proportions. Roundup alone, given in drinking water at three different doses,
was tested on three groups. The lowest dose corresponded to contamination found
in some tap water, the intermediate dose to the maximum level permitted in the
USA in animal feed, and the highest dose to half the strength of Roundup as
used in agriculture. Controls were fed a diet containing 33% non-GM maize and
plain drinking water.

A previous study in
2009 by the Séralini team found the signs of liver and kidney
toxicity in Monsanto’s 90-day trial (Hammond et al. 2009) on the same maize
that Seralini tested over two years. His longer study found that these
initial signs of liver / kidney toxicity escalated over two years into liver
and kidney failure and premature death, especially in males, and an
unexpected increase in tumor incidence, especially via Roundup in females
(mammary tumors). There was an unexpected low dose toxicity result from Roundup
in the rat’s drinking water, with a toxicity measured at 10,000 times lower than that permitted in drinking water in
USA and in which females died prematurely from mammary
tumors and pituitary dysfunction.

Séralini’s findings have provoked a major controversy
in part because the retraction was not based on any evidence of misconduct,
fraud, or even a failure of methodological design. The study was withdrawn
because it was judged to be “inconclusive” and that is truly amazing since the very nature
of scientific inquiry is that it produces a lot of inclusive results – that is
the pathway of what Kuhn calls “normal science”. Indeed, many critics of the
retraction note that the Séralini study used a more rigorous methodology that
will likely influence future feeding trials and that is what has the
biotechnology advocates so angry and worried.

A growing number of scholars feel the study provides
a serious finding that should remain part of the published record and that the
retraction appears to indicate an unresolved dispute over the need for redesign
of all future corporate-run feeding trials. In other words, Séralini also means
that corporate trials are methodologically flawed but the same Editor does not
consider asking for a retraction of the previously published feeding trials
that used industry-suggested designs including short-span feeding trials of as
little as six to ten days. This apparent double standard should be grounds for
the resignation of the Food and Chem.
editor.

We are re-positing the entire text of the criticism made in the editorial letters of the February 2014 Environmental Health
Perspectives and mark the significance of
this that in many ways represents a first for the mainstream public
health discourse in the USA. The authors note this sort of retraction has never
happened before:

“The nature of science is such that individual
studies are rarely, if ever, conclusive. Numerous published studies have later
been found to be deeply flawed through further scientific investigation, as may
well be the study by Séralini et al. To our knowledge, there is no precedent
for ‘inconclusive data’ being a reason for retraction for Elsevier or other
publishers, or elsewhere in the scientific literature.”

For complete and continuing coverage of this
controversy, I invite my readers and followers to visit the website, GMOSeralini. I also invite my science readers, including social scientists whose expertise is technology assessment and risk assessment to sign the Statement on Scientific Censorship, which is a response to this retraction.

Image courtesy of The Politicus

Inconclusive Findings

NOW YOU SEE THEM, NOW YOU DON’T!

Christopher J. Portier | Lynn R. Goldman | Bernard D.
Goldstein

The
environmental health literature is rife with controversial papers that evoke
criticism, support, and, most importantly, a desire to better understand the
findings put forth by the authors. A research article by Séralini and
colleagues (Séralini et al. 2012), published in the journal Food and Chemical
Toxicology (FCT), is one such article resulting in considerable discourse (Arjó
et al. 2013; Barale-Thomas 2013; Grunewald and Bury 2013; Ollivier 2013;
Wagner et al. 2013; Sanders et al. 2013; Schorsch 2013; Séralini et al. 2013)
and a call for new research (European Commission 2013). This is all part of the
scientific process in a modern research environment. However, the retraction of
the article by Séralini et al. from FCT sets a new precedent in the management
of peer-reviewed publications that we believe has serious implications for
environ mental public health. The
retraction announcement by the Editor-in-Chief specifically states,
“Ultimately, the results presented (while not incorrect) are inconclusive, and
therefore do not reach the threshold of publication for Food and Chemical
Toxicology” (FCT 2013). The Editor-in-Chief also was very clear that he “found
no evidence of fraud or intentional misrepresentation of the data.”

This
article (Séralini et al. 2012) has been controversial from its initial
publication. We do not wish to discuss the merits of the authors’ conclusions
or their implications for the commercial products in question. Those issues
have been debated in the open scientific literature since the publication of
the paper, and we agree with many of the critiques. However, the retraction of
any paper because it is “inconclusive” has adverse implications on the
integrity of the concept of the peer review process as the critical foundation
of unbiased scientific inquiry.

The
paper was peer reviewed by scientists on behalf of the FCT and published
accordingly. Hence, it initially met the threshold for publication. In our
opinion, there must be a different threshold for forced retraction of the
paper, and we believe that this paper did not reach that threshold. The COPE
guidelines for retracting articles (Committee on Publication Ethics 2009) provide
four reasons for retraction: scientific misconduct/honest error, prior
publication, plagiarism, or unethical research. None of these reasons apply to
this particular article, and yet Elsevier, a member of COPE, chose to retract
the paper.

The
nature of science is such that individual studies are rarely, if ever,
conclusive. Numerous published studies have later been found to be deeply
flawed through further scientific investigation, as may well be the study by
Séralini et al. To our knowledge, there is no precedent for “inconclusive data”
being a reason for retraction for Elsevier or other publishers, or elsewhere in
the scientific literature. To single out this one study for retraction is
almost certainly due to the controversy following its publication. The
repercussions of this directed action extend well beyond this single
publication and raise several larger scientific questions. Will these data,
which could well have been accepted by another journal, now be tainted beyond
possibility for inclusion in usual weight-of-evidence reviews of the body of
peer-reviewed science? Will the response to new science by interested parties
now be focused on dueling attempts to have the paper retracted rather than on
performing additional studies to replicate or refute the findings? Does this
retraction strengthen the scientific process, or does it confuse scientific
discourse with public relations?

Efforts
to suppress scientific findings, or the appearance of such, erode the
scientific integrity upon which the public trust relies. The retraction by the
FCT marks a significant and destructive shift in management of the publication
of controversial scientific research. Equally troublesome is that this
retraction does not really impact how the science will be viewed by scientists,
but only how it is viewed by others outside of the scientific community. We
feel the decision to retract a published scientific work by an editor, against
the desires of the authors, because it is “inconclusive” based on a post hoc
analysis represents a dangerous erosion of the underpinnings of the peer-review
process, and Elsevier should carefully reconsider this decision. The authors
declare they have no actual or potential competing financial interests.

Christopher
J. Portier is with International Agency
for Research on Cancer (Senior Visiting Scientist), Lyon, France.

Lynn
R. Goldman is at George Washington
University School of Public Health and Health Services, Washington, DC, USA.

Bernard
D. Goldstein teaches at the Graduate
School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.

Direct correspondence to Email: cportier@mac.com.

REFERENCES

Arjó G, Portero M, Piñol C, Viñas J, Matias-Guiu X,
Capell T, et al. 2013. Plurality of opinion, scientific discourse and pseudo
science: an in depth analysis of the Séralini et al. study claiming that
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Barale-Thomas E. 2013. The SFPT feels compelled to
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Toxicol 53:473–474.

Committee on Publication Ethics. 2009. Retraction
Guidelines. Available: http://publicationethics.org/files/retraction
guidelines.pdf  [accessed 8 January 2014].

de Vendomois JS, Roullier
F, Cellier D, Séralini GE. A comparison of the effects of three GM corn
varieties on mammalian health. Int J Biol Sci. 2009; 5(7): 706–726. 

European Commission. (2013). FEEDTRIALS KBBE 2013.
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FCT (Food and Chemical Toxicology). 2013. Retraction
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Hammond, B., et al. (2004). Results of a 13 week
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Sanders D, Kamoun K, Williams B, Festing M. 2013. Re:
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Schorsch F. 2013. Serious inadequacies regarding the
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Séralini GE, Mesnage R, Defarge N, Gress S, Hennequin
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Wagner R, Lerayer A, Fedoroff N, Giddings LV, Strauss
SH, Leaver C, et al. 2013. We request a serious reconsideration of the recent
paper by Séralini et al. alleging tumorigenesis in rats resulting from
consumption of corn derived from crops improved through biotechnology (Séralini
et al., 2012) [Letter]. Food Chem Toxicol 53:455–456.