Food and Chemical Toxicology Editor-in-Chief, A. Wallace Hayes, Publishes Response to Letters to the Editors

  Food and Chemical Toxicology Editor-in-Chief, A. Wallace Hayes, Publishes
                      Response to Letters to the Editors

  PR Newswire

  CAMBRIDGE, Massachusetts, December 10, 2013

CAMBRIDGE, Massachusetts, December 10, 2013 /PRNewswire/ --

The following statement will be published in the journal, Food and Chemical
Toxicology , alongside a selection of letters to the editors regarding the
decision to retract the paper by Séralini et al.(Séralini et al., 2012).

In November 2012, this journal published an article titled "Long term toxicity
of a Roundup herbicide and a Roundup-tolerant genetically modified maize," by
Séralini et al .(Séralini et al., 2012). The publication of this article
caused quite a stir in the media, as well as in the scientific community. The
journal received many letters expressing concerns about the validity of the
findings. A careful and time-consuming analysis found that the data were
inconclusive, and therefore the conclusions described in the article were
unreliable. Accordingly, the article was retracted. Since the public
announcement of the retraction, the journal has received many letters to the
editor; a selection of these letters will be published, along with this
response to those letters. Many of these letters expressed concerns about the
decision making process behind this action, particularly what role (if any)
current or former Monsanto employees played, whether or not COPE guidelines
were followed, and if the journal was also considering retraction of a similar
paper by Hammond et al . (Hammond et al., 2004). The answers to these
questions are below.

The membership of the editorial board is composed of academic, government, and
industrial scientists. Contrary to what has been suggested by some, the
appointment of Professor Richard Goodman, University of Nebraska, as an
Associate Editor was not influenced by Monsanto or any other party. Members of
the editorial board are chosen based on their expertise as scientists. It is
the goal of this journal to have a variety of different viewpoints. In this
case, as in other cases, I as Editor-in-Chief listened to as wide and diverse
a set of expertise as possible. To wit, Professor Goodman, along with all
other members of the editorial board was involved in initial discussions of
the Séralini paper and the request to view raw data. When the request was
made to Dr. Séralini to review the raw data, the journal suggested to Dr.
Séralini that all parties involved sign a confidentiality agreement. This
confidentiality agreement was designed to protect Dr. Séralini and his data so
that it was (A) not viewed by anyone he did not want to view his data and (B)
that it would not go beyond the people he agreed would review the raw data.
Not initially, but during the process, Dr. Séralini made a direct request that
Professor Goodman be excluded, and we at FCT readily and quickly agreed. It is
understandable that Dr. Goodman's involvement, however small, might be cause
for concern for some. However, the decision to retract the paper was mine
alone, made by me exclusively and not by a vote of the editorial board.
Further, when Dr. Séralini asked for Dr. Goodman's involvement to stop, I
agreed, fully and promptly.

The Monsanto Company did write a letter to the editor regarding this article,
and it was published along with a number of other letters to the editor
(Hammond et al., 2013); neither the company nor any of their scientists put
any pressure on the Editor in Chief regarding this matter.

A second concern that has been raised is whether this retraction follows the
COPE guidelines. The COPE guidelines were consulted when making this decision.
According to the COPE guidelines, "Journal editors should consider retracting
a publication if… they have clear evidence that the findings are unreliable,
either as a result of misconduct (e.g. data fabrication) or honest error (e.g.
miscalculation or experimental error)."(COPE, 2009). The retraction statement
could have been clearer, and should have referred to the relevant COPE
guidelines. The data are inconclusive, therefore the claim (ie, conclusion)
that Roundup Ready maize NK603 and/or the Roundup herbicide have a link to
cancer is unreliable. Dr. Séralini deserves the benefit of the doubt that this
unreliable conclusion was reached in honest error. The review of the data made
it clear that there was no misconduct. However, to be very clear, it is the
entire paper, with the claim that there is a definitive link between GMO and
cancer that is being retracted. Dr. Séralini has been very vocal that he
believes his conclusions are correct. In our analysis, his conclusions cannot
be claimed from the data presented in this article.

At this point it is very important to state that the retraction does not
reflect or impact the journal's view on GMOs or associated organizations. Our
journal would, in fact, very much welcome the opportunity to review follow-up
studies that have a greater sample size, a fine-tuned method, and proper
controls. We are also actively searching and recruiting people to provide a
balance view on this topic to serve on the editorial board.

Finally, the letters post-retraction have questioned whether an earlier study
done by Monsanto received different treatment from our journal. This article
was published in 2004, well before I became Editor-in-Chief. However, I take
the issue seriously and have reviewed this paper in detail. The Hammond et al
. article was a 13 week feeding study performed in rats feed grain from
Roundup Ready corn which is tolerant to the herbicide glyphosate (Hammond et
al., 2004). The authors reported the following: "Purina TestDiets formulated
Roundup Ready corn grain into rodent diets at levels of 11 and 33% (w/w). The
responses of rats fed diets containing Roundup Ready corn grain were compared
to that of rats fed diets containing non-transgenic grain (controls). All
diets were nutritionally balanced and conformed to Purina Mills, Inc.
specifications for Certified Lab Diet 5002. There were 400 rats in the study
divided into 10 groups of 20 rats/sex/group. Overall health, body weight, food
consumption, clinical pathology parameters (hematology, blood chemistry,
urinalysis), organ weights, gross and microscopic appearance of tissues were
comparable between groups fed diets containing Roundup Ready and control corn
grain… This study complements extensive agronomic, compositional and farm
animal feeding studies with Roundup Ready corn grain, confirming it is as safe
and nutritious as existing commercial corn hybrids." The authors also stated
"The study design was adapted from OECD Guideline No. 408 (1981) and the study
was reported to have been conducted in general compliance with OECD Good
Laboratory Practice (GLP) guidelines at the Metabolism and Safety
Evaluation-Newstead, toxicology laboratory." 

In accordance with OECD Guideline No. 408 (OECD, 2009a), the Hammond et al .
study was limited to 90 days following and used 20 rats/sex/group, and was
conducted in general compliance with OECD Good Laboratory Practice (GLP)
guidelines, as previously stated. The Séralini et al. study ran for two (2)
years with only 10 rats/sex/group and was reported to be done in a GLP
environment according to OECD guidelines (which guideline is not explicitly
stated in the paper).  Séralini et al . state that they had "had no reason to
settle at first for a carcinogenesis protocol using 50 rats per group," as
recommended in OECD Nos. 451 and 453 (guidelines for Carcinogenicity Studies
and Combined Chronic Toxicity/Carcinogenicity Studies, respectively)(OECD,
2009a; OECD, 2009b), and instead seem to have opted for 10 rats/sex/group as
recommended by OECD No. 408 (guidelines for Repeated Dose 90-day Oral Toxicity
Study in Rodents). While the number of animals used may have been sufficient
to reach conclusions regarding oral toxicity, it proved insufficient for
conclusions related to the carcinogenicity of the test substances.

In conclusion, FCT has retracted this article because our thorough
investigations revealed that its methods were scientifically flawed. The low
number of animals, and the strain selected, rendered the conclusions
unreliable. No definitive conclusions could be drawn from the inconclusive
data. Therefore, in accordance with both the COPE guidelines and the journal
policy, it was necessary to take this action of retracting the article. 

A. Wallace Hayes, PhD, DABT, FATS, FIBiol, FACFE, ERT Registered Toxicologist
(France and EUROTOX registries)Harvard School of Public Health
Editor-in-Chief, Food and Chemical Toxicology

References

COPE, 2009. Retraction guidelines.

Hammond, B., Dudek, R., Lemen, J., Nemeth, M., 2004. Results of a 13 week
safety assurance study with rats fed grain from glyphosate tolerant corn. Food
Chem. Toxicol. 42, 1003-14.

Hammond, B., Goldstein, D. a, Saltmiras, D., 2013. Response to original
research article, in press, corrected proof, "'Long term toxicity of a Roundup
herbicide and a Roundup-tolerant genetically modified maize'". Food Chem.
Toxicol. 53, 459-64.

OECD, 2009a. OECD Guideline for the Testing of Chemicals.

OECD, 2009b. Combined Chronic Toxicity \ Carcinogenicity Studies.

Séralini, G.-E., Clair, E., Mesnage, R., Gress, S., Defarge, N., Malatesta,
M., Hennequin, D., de Vendômois, J.S., 2012. Long term toxicity of a Roundup
herbicide and a Roundup-tolerant genetically modified maize. Food Chem.
Toxicol. 50, 4221-31.

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