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Comment from in-house editors

Posted by PLOS_ONE_Group on 02 Jul 2015 at 18:05 GMT

While this article was in production, in-house editorial staff identified a number of items that were not, as reported, in compliance with the journal’s editorial policies. As a result the processing of the article was put on hold while the editorial team followed up on the following items:

Data availability – The raw data underlying the study had not been included prior to the manuscript entering production.

Competing interests – The competing interests statement did not include a number of items that the editors considered should be declared in accordance with the PLOS Competing Interests policy.

Abstract – Parts of the abstract were considered to be overly-speculative; the editors requested removal of information not directly related to the reported findings.

The editors regret that the items above were not identified earlier in the processing of the submission. The published version of the article incorporates the changes to the abstract and statements above which were requested by the in-house editorial staff.

No competing interests declared.

RE: Comment from in-house editors

marcrr replied to PLOS_ONE_Group on 03 Jul 2015 at 12:24 GMT

Dear PLOS One staff,

I appreciate your attention to these important aspects. But I am intruigued to notice that as published the paper still has

"The authors have declared that no competing interests exist."
at http://www.plosone.org/ar...

whereas under funding we find:
Funding: The authors have received funding for this and earlier research from CRIIGEN, the Foundation Lea Nature and Malongo, the JMG Foundation and Foundations Charles Léopold Mayer for the Progress of Humankind, Nature Vivante, Denis Guichard, Institute Bio Forschung Austria, and the Sustainable Food Alliance. The laboratory received funding from Sevene Pharma in the last five years to study the detoxifying capacity of plant extracts on Roundup residues, bisphenol A and atrazin. Prof Seralini participated in and received payment for a lecture organized by Sevene Pharma.

This seems contradictory.

Competing interests declared: I blog about science, which has included criticising previous work of Séralini et al.
I am AE at PLOS One, and thus concerned about the quality of the science published there.
I do not receive any funding on any topic related in any way to this paper, and I have no relation with the authors, whom I don't know personnally.

RE: Comment from in-house editors

WackesSeppi replied to PLOS_ONE_Group on 03 Jul 2015 at 15:08 GMT

Dear PlosOne Staff,

Your initiative to explain why the paper was not published as scheduled is very valuable and much appreciated. It will hopefully assuage unwarranted concerns and limit – lets be realistic, eliminate is not in the cards – wild claims of undue interference in the publication policy and process.

I too have great concerns with the authors declaring, and you accepting, a declaration of absence of conflicting interests.

With respect to this publication, the authors received funding from a series of foundations engaged in, and supporting, activism against GMOs, pesticides, current regulatory processes, etc. And also from commercial entities which, by reason of their involvement in the « organic » sector, have a keen interest in GMOs, etc. being vilified.

If the « funding » box is assumed, as it should be, to be a description of the funding sources for this and earlier papers, then it is a gross misrepresentation of the facts. Mr. Seralini has received substantial funding for his welknown and much criticized rat study from, in particular, two large retailers (Carrefour and Auchan) and other, undisclosed, companies. This funding has been concealed through the creation of a brass plate association (CERES), as Mr. Séralini has himself explained in one of his books. The Carrefour and Auchan funding is thus a matter of common knowledge, including in English-speaking circles. It is similarly a matter of common knowledge that he is/was involved in Greepeace campaigns and received support, in kind and cash, from Greenpeace (acknowledged in one of his papers).

To sum up, whilst your efforts to shed some light into the conflicting interests – which should not be restricted to financial but also to extend to political, philosophical or ideological ones – are acknowledged, the efforts have not been good enough. If you allow the declarations at issue to stand as are, you may contribute to the concealment of interests that are of a much greater magnitude than the involvement in the small company Sevene Pharma.

http://tempsreel.nouvelob...
http://www.ncbi.nlm.nih.g...


Competing interests declared: I blog about agriculture, food, bioscience, which has included criticising previous work and attitudes of Séralini et al. (At http://imposteurs.over-bl... and lately http://seppi.over-blog.co...)

(I am retired and have no financial conflict of interest. As a grandfather conscious of the challenges of feeding a world of 9 billion + by 2050, I hold strong views on the contribution that science can make to meeting the challenge.

No competing interests declared.

RE: RE: Comment from in-house editors

Django100 replied to WackesSeppi on 08 Jul 2015 at 10:59 GMT

Wherever the funding came from, this is essentially a very simple paper with simple and verifiable findings. The analytical procedures and interpretation methods are clearly documented. So if anyone disagrees with them, the solution is simple: commission your own measurements of these lab feeds! If Purina or Monsanto measured the GMO or pesticide amounts in these feeds, would the results be any different? Why not find out if you are so concerned about good science?

No competing interests declared.

RE: RE: RE: Comment from in-house editors

MaryM replied to Django100 on 08 Jul 2015 at 14:01 GMT

Claire--I really think you should also have disclosed your affiliations with several anti-GMO organizations. And your relationship with Seralini.

That said, as we've noted, the data provided are incomplete. We are just asking for the data as per the PLOS requirements for providing the necessary information to evaluate the claims. That does not exist at this time.

Competing interests declared: I also blog about science topics, and may have been critical of Séralini group work in the past. I own some index funds in my retirement accounts, which might contain companies in the index associated with some of the compounds or plants tested. I really haven't looked, I just buy the indexes every so often. I have done writing for an educational company (OpenHelix, my company and employer). I had a membership in The Nature Conservancy. Well, they called me a member, but I just gave them donations. I have a bottle of RoundUp in my basement and I'm not afraid of it.

RE: RE: RE: Comment from in-house editors

chadn737 replied to Django100 on 08 Jul 2015 at 16:49 GMT

Failure to disclose conflicts of interest, in particular financial COI, is considered unethical. So it is a matter of concern.

Competing interests declared: I am a plant geneticist at the University of Georgia and funded by the NSF.

RE: RE: Comment from in-house editors

Lion4 replied to WackesSeppi on 25 Aug 2015 at 14:04 GMT


From WackesSeppi, yet another attempt to undermine the valuable work being done by the CRIIGEN team in France. Who cares where they got their money from, or whether they have accurately declared everything that some people with their own rather suspect agendas might consider to represent "competing interests"? Every study needs money, and research teams which are outside the control of Monsanto, Syngenta and the other biotech giants have vast problems in getting their work off the ground, as everybody knows. They have to scrape around and put together their funding packages rather as a beggar might wander about with his begging bowl. So a little more tolerance, please. I would rather trust a study like this than a study vetted, controlled and manipulated by Monsanto, any day. So let's go through WackesSeppi's smokescreen and accept that this paper is really rather a good one which makes some very serious points.

No competing interests declared.

RE: Comment from in-house editors

MattJHodgkinson replied to PLOS_ONE_Group on 03 Jul 2015 at 16:31 GMT

There is an error in the Declaration of Competing Interests included in the article. The declaration currently listed does not reflect the changes requested by the in-house editorial staff. We apologize for this error, and we will ensure the declaration is updated. The correct Declaration of Competing Interests is as below:

The authors have received funding for this and earlier research from CRIIGEN, the Foundation Lea Nature and Malongo, the JMG Foundation and Foundations Charles Léopold Mayer for the Progress of Humankind, Nature Vivante, Denis Guichard, Institute Bio Forschung Austria, and the Sustainable Food Alliance. The laboratory received funding from Sevene Pharma in the last five years to study the detoxifying capacity of plant extracts on Roundup residues, bisphenol A and atrazin. Prof Seralini participated and received payment for a lecture organized by Sevene Pharma.

Competing interests declared: I am a PLOS ONE staff Senior Editor

RE: Comment from in-house editors

MattJHodgkinson replied to MattJHodgkinson on 28 Jul 2015 at 14:49 GMT

The competing interests statement has now been updated.

Competing interests declared: I am a PLOS ONE staff Senior Editor

RE: Comment from in-house editors

Pdiff replied to PLOS_ONE_Group on 03 Jul 2015 at 23:29 GMT

To PLOS One Staff,

In regards to the first item you list, Data, the paper does not currently contain "raw data" as stipulated by the PLOS One submission guidelines. In the article, the authors state "The sampling in triplicate was precisely performed according to 2002/63/CE guidelines." and "Residues of 262 pesticides (see Table 1 for the detailed list) were measured once by sample..." Yet the supplementary data contains no triplicate values by sample, only what appear to be summary information.

As the authors are implying their work brings all past, and future, animal trials involving controlled feeding into question, it is of the upmost importance that they be forth coming with the base level raw data regarding all responses such that the scientific community can thoroughly evaluate the work. I would hope that they will do so promptly.

Bill Price
Statistician
University of Idaho

No competing interests declared.

RE: RE: Comment from in-house editors

MaryM replied to Pdiff on 04 Jul 2015 at 00:48 GMT

I was also interested in the raw data for pesticides, and was disappointed that it was not yet included. I was curious to see if the omission of glufosinate from Table 1 was just an oversight, or if really was not tested. The paper speaks to not having detected other herbicides, but if you didn't look for one used with the GMOs tested that's hardly a statement to be confident about.

Mary Mangan
OpenHelix

Competing interests declared: I also blog about science topics, and may have been critical of Séralini group work in the past. I own some index funds in my retirement accounts, which might contain companies in the index associated with some of the compounds or plants tested. I really haven't looked, I just buy the indexes every so often. I have done writing for an educational company (OpenHelix, my company and employer). I had a membership in The Nature Conservancy. Well, they called me a member, but I just gave them donations. I have a bottle of RoundUp in my basement and I'm not afraid of it.

RE: RE: Comment from in-house editors

Seralini_group replied to Pdiff on 06 Jul 2015 at 15:07 GMT

Mr Bill Price,

The European Commission guideline 2002/63/CE is not about biological replicates and statistics, but about sampling methods. Measurements were performed "one-shot" by a validated method, as indicated in the Material and Methods. All the raw data of the study is presented in the supplementary file.

No competing interests declared.

RE: RE: RE: Comment from in-house editors

Pdiff replied to Seralini_group on 06 Jul 2015 at 17:51 GMT

Seralini_group,

Thank you for the reply. If I may expand on my concerns:

The material and methods, as I stated above, indicate that three samples were taken. If the data file does indeed contain base level raw data, then this leaves four possibilities:

1) Two of the primary samples were discarded,
2) The three primary samples were bulked prior to analytical sampling,
3) The three analytical samples were intrinsically averaged in the lab or by the lab equipment, or
4) The three analytical samples were computationally averaged outside the lab, prior to quantitative assessment.

If I am misinterpreting the methods, please clarify them here. If not, then these are not raw data. As I read it, three 100g primary samples were taken as per the 2002/63/CE guidelines for processed, bulk products less than 50kg/lot. Then "100 g of each sample were grinded in a MaxiGrinder Solo (Genomic Industry, Archamps, France) to ensure homogeneity and representativity, and 5 g of this homogenate were extracted." To me this implies that there were three 5g analytical samples to be assessed in the lab.

I do understand that the Horwitz method was used to assess uncertainty in this "one shot" study, although it's use is typically used to assess variability and systematic deviations between labs, not, as done in this paper, to extrapolate an estimate of variability within different source materials. Even as such, the supplementary data file is incomplete, both in data and description. The listed residues for pesticides contain no estimates of "Uncertainty", which I am forced to guess would be the Horwitz estimate of sigma because the term is not defined for other analytes. Why is this information missing? Additionally, the LOD, LOQ values for all tested compounds are not listed in either the paper, or the supplementary data file. Note that these can vary from lab to lab depending on their abilities, and the paper states in the methods "... all measurements were performed in laboratories accredited by COFRAC, the French accreditation body." Hence, multiple labs are implied. There is no information regarding these labs, nor their associated methodologies, LOD, or LOQ values. Admittedly, these may be common across labs, but, at the very least, they should be clearly stated somewhere.

Again, I will restate: The authors are implying that their work invalidates, or at best brings into question, all past, current, and future research involving the use of animals in controlled feeding studies. This is an exceedingly broad and serious charge, one that must be backed by complete and sound information. I am not currently seeing this presented.

Bill Price
Statistician
University of Idaho.

No competing interests declared.

RE: RE: RE: RE: Comment from in-house editors

Seralini_group replied to Pdiff on 23 Jul 2015 at 15:38 GMT

We do not imply that our “work invalidates, or at best brings into question, all past, current, and future research involving the use of animals in controlled feeding studies.” This is a serious misunderstanding of our paper.
Our results indicate that the high background rate of pathologies in laboratory rodents could be due to dietary contaminants. This invalidates the use of external controls called historical data in regulatory tests essentially from industry to commercialize products, consisting of comparisons of toxicological effects to control rats from other experiments, because these control rats are fed different mixtures of pollutants. This also questions the use of 50 rats per group in carcinogenicity studies to increase the statistical power lost due to the elevated pathological background.

No competing interests declared.

RE: RE: RE: RE: RE: Comment from in-house editors

Pdiff replied to Seralini_group on 25 Jul 2015 at 23:07 GMT

Thank you for your reply, but I believe you have ignored the question asked: where is the non-summarized data?
As for your claim on the term "invalidates", I used that verbatim from the front page title on this work given by your institution's (CRIIGEN) web site. I would also note that the historical controls referred to often predate GMO feeds or some of the chemistries you outline. I do agree that such things (contamination) should be considered, but, from the data and results presented, see no warning evidence of this is a problem. In fact, the results seem surprisingly devoid of pesticide residues and completely absent of some expected compounds such as glufosinate, as mentioned above. Given the claims you make and their potential impact, this is why we would like to see base level data.

Bill Price
Statistician
University of Idaho

No competing interests declared.

RE: RE: Comment from in-house editors

Lion4 replied to Pdiff on 25 Aug 2015 at 14:02 GMT

Bill Price says: "The authors are implying that their work invalidates, or at best brings into question, all past, current, and future research involving the use of animals in controlled feeding studies. This is an exceedingly broad and serious charge, one that must be backed by complete and sound information. I am not currently seeing this presented."

THAT IS NOT AT ALL WHAT THE AUTHORS ARE SAYING OR IMPLYING. Please be more careful before throwing out wild accusations. The authors imply that their work calls into question past, current or future lab work with animals where the chow fed to control groups and test groups is not certified as free of contaminants. That is the crucial point. Where the chow is not certified as contaminant-free, it has to be assumed that the chemical pollutants and GMOs contained in the diet will screw up the experimental results to such an extent that they become worthless. That point has nothing to do with statistics. It is a perfectly simple point, comprehensible, I should have thought, to the average 15-year-old school science pupil.

As the editors point out, this is a perfectly simple and straightforward paper. It can easily be countered by the GMO industry, if it wishes, by bringing forward certification that the control diets used in their experiments are genuinely free of contaminants. If they do not do that, we can be sure that their control diets are indeed never checked for purity, and that we are dealing with scientific fraud on a substantial scale.

No competing interests declared.