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Retraction Watch

Tracking retractions as a window into the scientific process

Retracted Seralini GMO-rat study republished

with 39 comments

env sci europeA highly controversial — and retracted — 2012 study by Gilles Seralini and colleagues of the effects of genetically modified maize and the Roundup herbicide on rats has been republished.

Retraction Watch readers may recall that the editor of Food and Chemical Toxicology decided to retract the heavily criticized paper because it was “inconclusive.” The editor, A. Wallace Hayes, claimed that this was consistent with Committee on Publication Ethics (COPE) guidelines, although we and many others disagreed.

Here’s the original abstract of the Food and Chemical Toxicology paper, which has been cited 55 times, according to Thomson Scientific’s Web of Knowledge:

The health effects of a Roundup-tolerant genetically modified maize (from 11% in the diet), cultivated with or without Roundup, and Roundup alone (from 0.1 ppb in water), were studied 2 years in rats. In females, all treated groups died 2-3 times more than controls, and more rapidly. This difference was visible in 3 male groups fed GMOs. All results were hormone and sex dependent, and the pathological profiles were comparable. Females developed large mammary tumors almost always more often than and before controls, the pituitary was the second most disabled organ; the sex hormonal balance was modified by GMO and Roundup treatments. In treated males, liver congestions and necrosis were 2.5-5.5 times higher. This pathology was confirmed by optic and transmission electron microscopy. Marked and severe kidney nephropathies were also generally 1.3-2.3 greater. Males presented 4 times more large palpable tumors than controls which occurred up to 600 days earlier. Biochemistry data confirmed very significant kidney chronic deficiencies; for all treatments and both sexes, 76% of the altered parameters were kidney related. These results can be explained by the non linear endocrine-disrupting effects of Roundup, but also by the overexpression of the transgene in the GMO and its metabolic consequences.

The new paper, which appears in a different journal (more on that in a moment), includes a new analysis. Here’s the abstract:

Background

The health effects of a 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, were evaluated for 2 years in rats. This study constitutes a follow-up investigation of a 90-day feeding study conducted by Monsanto in order to obtain commercial release of this GMO, employing the same rat strain and analyzing biochemical parameters on the same number of animals per group as our investigation. Our research represents the first chronic study on these substances, in which all observations including tumors are reported chronologically. Thus, it was not designed as a carcinogenicity study. We report the major findings with 34 organs observed and 56 parameters analyzed at 11 time points for most organs.

Results

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.

Conclusion

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 team circulated an embargoed version of the study to members of the media last week. They withheld the name of the journal — a highly unusual move about which our sister blog, Embargo Watch, has more — and said the name would be released at a press conference that’s starting as this post goes live. That omission — which Seralini told Retraction Watch was to prevent GMO and Roundup maker Monsanto from pressuring editors to revoke publication — extended to a passage that appears in italics before the study (more on this passage in a moment):

Empirical natural and social sciences produce knowledge which should describe and explain past and present phenomena and estimate their future development. To this end quantitative methods are used. Progress in science needs controversial debates aiming at the best methods as basis for objective, reliable and valid results approximating what could be the truth. Such methodological competition is the energy needed for scientific progress. In this sense, [the editor] aims to enable rational discussions dealing with the article from G.-E. Séralini et al. (Food Chem. Toxicol. 2012, 50:4221–4231) by re-publishing it. By doing so, any kind of appraisal of the paper’s content should not be connoted. The only aim is to enable scientific transparency and, based on this, a discussion which does not hide but aims to focus methodological controversies. [the editor and journal's name will be released at the press conference, June 24th]

Retraction Watch learned yesterday, however, that Environmental Sciences Europe — a journal where Seralini has published before — was the journal publishing the new version. The journal, part of SpringerOpen, is too young to have an official Impact Factor (IF). Using the same calculation, however, the journal would have an IF of .55. That would place it about 190th out of the 210 journals in the “environmental sciences” category at Thomson Scientific. (For comparison, Food and Chemical Toxicology has an IF of just above 3, and a ranking of 27th.)

This is hardly the first time that the authors of a retracted paper have republished it. In a recent case, they did so in the same journal. But in a more typical case, they republished the work in another journal, with a lower IF.

The republished study was peer-reviewed, according to the press materials, and Seralini confirmed that it was in an email to Retraction Watch. But we were curious what “any kind of appraisal of the paper’s content should not be connoted” meant. We asked Seralini and the editor of Environmental Sciences Europe, Henner Hollert, but neither responded.

Seralini and his colleagues provide a timeline in the press materials of their version of events. One element in particular caught our eye:

Wallace Hayes wrote an article to defend his position that raises doubts about his understanding of the study and raw data. He mentions in his defense he was unable to conclude that “there was a clear link between GMO and cancer.” An obvious error of W. Hayes as the term “cancer” has never been mentioned in the paper of Séralini’s research team. And it does not affect any aspect of the research on Roundup.

Now, “tumor” and “cancer” are not necessarily the same thing. But the original paper certainly referred to tumors repeatedly, and Seralini, as Nature reported at the time,

…has promoted the cancer results as the study’s major finding, through a tightly orchestrated media offensive that began last month and included the release of a book and a film about the work.

Speaking of the book and film about Seralini’s work, the authors — who have lambasted their critics for failing to disclose potential conflicts of interest, including in a paper published alongside the new version – didn’t declare them as conflicts:

The author(s) declare that they have no competing interests, and that, in contrast with regulatory assessments for GMOs and pesticides, they are independent from companies developing these products.

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Written by Ivan Oransky

June 24, 2014 at 5:00 am

39 Responses

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  1. averger

    June 24, 2014 at 5:32 am

    • …And why does the U.S. have the 7th Highest Cancer Rate in the World and also the highest production of GMO’s?

      http://www.webmd.com/cancer/news/20110123/us-has-7th-highest-cancer-rate-in-the-w

      Truth-Seeker

      June 25, 2014 at 11:40 am

      • That link doesn’t work. Anyways, your argument is a single-data-something and not even a correlation, right?

        Prof. Dr. Alexander Lerchl

        June 25, 2014 at 1:00 pm

      • Just no.

        Andrés

        June 25, 2014 at 2:48 pm

      • Truth-Seeker, Age-adjusted cancer rates in the US, including the effects of smoking, have been dropping since the late-1990s. If GMOs had the influence you imply, rates would increase not decrease. In addition to the problem noted with a single-data-point-something, correlation doesn’t prove causation. If it did, then we’d erroneously conclude that the introduction of GMO foods has reduced cancer rates in the US.

        (Minus the effects of smoking, overall age-adjusted cancer rates in the US have been dropping since the late 1950s). However, the reality is that neither fact gives us insight on GMOs.

        DTX

        June 26, 2014 at 12:59 pm

  2. Cancer (in French) is definitely mentioned in the very brief part of the book as per “Look Inside” on Amazon
    As for the conflicts of interest, one can only hope it just means the sales figures of the book are so low, they cannot possibly impact the authors’ finances. But it is common and natural to be wary when authors are willing and able to orchestrate media campaigns.

    omnologos

    June 24, 2014 at 5:37 am

    • omnologos, I’m afraid you can’t damn the authors of the published paper on the use of the word “cancer” in Seralini’s book. Even if he had made misleading claims in his book, that would be equivalent to damning every published paper by a GM industry author because of the “aspirational” and “forward-looking” claims he has made in a media article. Where would it end?!

      However, out of interest, I just checked Seralini’s book and can’t find any misleading claims about cancer. Please cite any actual sentences you find mendacious.

      What is scientifically important are the claims that are made in the published paper regarding cancer. You will notice, if you read it, that there aren’t any claims made about links between the test substances and cancer. Some of the tumours were analysed (according to good scientific practice in such chronic toxicity tests) and found to be carcinomas, but that is all. Please don’t panic.

      Claire Robinson

      June 24, 2014 at 8:03 am

      • Claire – Ivan quotes Séralini and colleagues as saying the original paper never mentioned cancer. I’d assume that to be true. However when the book mentions cancer in the very first pages, one has to wonder if the retracted/republished work was/is really only about tumors, and not also about cancer.

        FYI in Italian and I suspect in French too, tumor is often a synonym of cancer. But cancer is not necessarily a synonym of tumor. In other words “tumor” (the homophone word in each language) is often meant to be a malignant growth, but “cancer” is always meant to be a malignant growth.

        So when the book says (in French) “cancer” I surmise they do not mean just a tumor (in English). Finally if some of the authors disagree with the book, they should say so by now given the timing of each publication.

        omnologos

        June 24, 2014 at 9:27 am

        • Sorry but it’s not enough to say the French book “says ‘cancer’”. We are discussing whether Seralini and team made false claims about cancer in his published paper and book. You have provided no actual quote from the book or the published paper that is false or misleading. That’s not good enough for a scientific discussion.

          Claire Robinson

          June 25, 2014 at 12:51 pm

  3. When I read statements like “Biochemical analyses confirmed *very* significant chronic kidney deficiencies…” I start to be sceptical. After a first quick reading of the paper, I can’t really identify such *very* significant differences, especially taking into account the high number of variables analyzed. What makes me even more sceptical is the fact that the tumors shown in Fig. 5 are really huge. According to OECD guidelines it appears that the rats should have been sacrificed much earlier. Why did they wait so long? Did they want to produce some shocking pictures? Poor rats!

    Prof. Dr. Alexander Lerchl

    June 24, 2014 at 5:38 am

  4. I’m afraid Nature is as wrong as all the other critics who claimed Séralini emphasised “cancer” results. The original paper didn’t mention “cancer”; tumours are not necessarily cancer, and the Séralini team has been very clear on this, though they can be as or more lethal, due to their blocking vital processes. Regarding Prof Lerchl’s point about the right time to euthanise, the experiments were conducted according to French government ethical guidelines, so if he disagrees with their standards, maybe he would like to lobby them?

    Claire Robinson

    June 24, 2014 at 7:01 am

    • @Claire Robinson, please provide links to back up your statement regarding French regulations around study termination as related to tumor burden. Your description runs counter to my experiences, where IACUC guidelines are quite specific about not only tumor size, but also take into account “body condition scoring.” Also, IIRC, the retracted paper described “manual palpitation” as the method for measuring tumors, when standardized methods using accurate calipers is the commonly used best practice.

      a cancer researcher

      June 24, 2014 at 7:48 am

      • “A cancer researcher”: The original published paper stated that the study was conducted according to French government ethical standards. The authors’ subsequent published “Answers to critics” goes into more detail. The experiments were monitored by veterinarians. I’m beginning to wonder if any of the critics has actually read Seralini’s published papers! But seriously, the animal welfare criticism of the Seralini paper first surfaced nearly two years ago and if it had any legs, someone would have offered some proof or detailed evidence in court by now.

        Claire Robinson

        June 24, 2014 at 8:11 am

        • So that no one is left in the dark on conflicts of interest, Claire Robinson runs Seralini’s fansite, “gmoseralini.org” which is claiming with a press release that the republication of the study is proof of the quality of the study. However, as has already been pointed out here, according to the journal that is not a correct interpretation of its republication, and they are trying to separate themselves from it. I don’t rightly understand how they might expect to be interpreted correctly when they say “any kind of appraisal of the paper’s content should not be connoted” and the first press out of the gate from this group shows that this statement has been ignored. I agree with Claire that reading things more carefully before passing judgement on them is a good plan.
          To respond to Claire’s suggestion that taking Seralini to court over animal mistreatment is the only way to demonstrate that the animals were treated unethically, that’s just silly. I used to work in a mouse toxicology lab before I got my Ph.D. in plant genetics. Non-cancer studies should follow specific ethical guidelines for the humane treatment of research animals, which involves euthanasia when tumors are still small. Only when this is a specific and expected research outcome being studied (which Seralini says was not) should the animals be allowed to live longer to develop the tumors further. Seralini kept them alive way past the point at which they should have been euthanized for no justified reason. That’s unethical. Saying that someone’s got to go to court to call it unethical is like saying that Seralini had to go to court to call the retraction of his study unethical. You believe the latter, but reject the former, yet the logic is the same.
          I find it strange that Claire is coming here to deny claims about Cancer, when her GMO Seralini site has the word plastered all over the place: http://www.gmoseralini.org/en/?s=cancer
          Let’s get really specific. On the “Ten things you need to know about the Séralini study” page, http://www.gmoseralini.org/ten-things-you-need-to-know-about-the-seralini-study/ it says:
          “Signs of toxicity found in Monsanto’s 90-day studies were found to develop into organ damage, cancer, and premature death in Séralini’s two-year study.”
          So basically, Claire Robinson, who manages GMO Seralini saw fit to frequently publish claims that the paper found links to cancer, while correcting people elsewhere and here when they criticize it for the same reason. That is not only hypocritical, but ironic because using the word “cancer” is enough for her to suggest that critics haven’t read the paper. Does this mean she hasn’t?

          Karl Haro von Mogel

          June 24, 2014 at 8:34 pm

          • In case the readers haven’t actually read Seralini, he set out to repeat Monsanto’s OWN study on NK603, when he discovered that it suggested hepato-renal toxicity. He improved on Monsanto’s design by growing the crops side by side because environmental factors have significant effects on plant gene expression. He segregated Round Up from the GMO corn to study the effects of the herbicide separately from any toxic effects due to transgene insertion on the plant. He used three doses instead of two-which Monsanto did. And he provided raw data on ALL the rats, while Monsanto did NOT. I recommend that folks actually read the Seralini study AS WELL AS the original Monsanto toxicology study which triggered Seralini’s investigation ( linked below in my blog). I am pretty certain that some people would rather have readers forget to examine Monsanto’s science comparing it to Seralini’s with a panoply of red herrings and diversions. Regardless of whether NK603 is carcinogenic there is sufficient evidence to warrant BLINDED life-long feeding trials- whether Monsanto and/or regulators like it or not.
            As someone who had formal coursework in animal ethics, I am finding it particularly difficult to take claims about experimental rat suffering Seralini is being accused of seriously, because such suffering pales in comparison to the pain and suffering this product could be causing animals and people if/when it causes kidney or liver failure.

            Ena Valikov

            June 25, 2014 at 12:07 am

            • For people who are interested there is actually a large amount of independent research on genetically engineered crops in addition to the industry-funded research, which we are compiling together in a database that will be publicly beta-tested soon. For more information, see http://www.biofortified.org/genera/ There is not just one study that should be compared to Seralini’s work, but a great many of them. His is the outlier, which suffered from a lack of statistical power, and could not demonstrate a dosage effect for any of the differences claimed. I think examining all the studies in greater detail is a good idea, and our project will help facilitate that.
              Thankfully standards of research ethics do not depend on individual ideologies.
              http://www.biofortified.org/community/forum/off-topic-group7/compost-pile-forum32/dogctor-slime-thread397/

              Karl Haro von Mogel

              June 25, 2014 at 2:22 am

              • For the real state of the scientific research on GMOs, I suggest reading GMO Myths and Truths, available here: http://earthopensource.org/index.php/reports/gmo-myths-and-truths
                Chapter 3 deals with the food safety research and we cite many peer reviewed papers that can be followed up and checked out. Particularly interesting to us were the common claims that long lists of studies prove the safety of GM foods. We do a detailed analysis of these claims and show why they misrepresent the science utterly.

                Claire Robinson

                June 25, 2014 at 1:49 pm

                • The “Myths and Truths” document misrepresents the conclusions of the scientific literature, and also misrepresents the efforts of scientists who attempt to communicate it. We’ve been up and down the field rows with Claire discussing the way that her organization’s motivated reasoning has come to the opposite conclusion of both the data and the scientists who report and interpret it in previous discussions:

                  http://science.kqed.org/quest/audio/californias-prop-37-are-gmo-labels-a-scarlet-letter/

                  In fact I detailed how a feeding study that concluded that GMOs were safe was deliberately twisted to the opposite conclusion.

                  http://science.kqed.org/quest/audio/californias-prop-37-are-gmo-labels-a-scarlet-letter/#comment-646858327

                  They have also been informed about how they misrepresent the research, and their only response to this is to say ‘nuh uh’ and accuse their critics of being shills in their report. Indeed, with the new version of this document, they go conspiratorial about online criticisms:
                  “There are few of them and their names or aliases pop up again and again under any article on GM published in a significant enough outlet. What normal person is interested in reading and commenting on so many articles on GM, and even in commenting on the comments, unless they are paid to do so?”
                  Apparently everyone who disagrees with them is a paid Monsanto shill? (Note: I am not, and I know of no one else who is.)

                  They dismiss the science by cherry-picking what they want to find, and ignoring the rest by dismissing entire review studies, or “lists” of studies, such as our own. Except as Claire et al. have been informed, we know that a mere list does not help people to understand the state of the science. The “Myths and Truths” document is a symptom of the lack of good science communication from scientists in the past, creating a vacuum where poorly-reasoned conclusions can thrive. I wrote more about the “lists of studies” issue here:

                  http://www.biofortified.org/2013/10/making-sense-of-lists-of-studies/

                  The great thing about science is that it is true no matter whether you accept it or not.

                  Karl Haro von Mogel

                  June 26, 2014 at 11:16 am

              • I am not clear what miRNA has to do with this discussion…. remember, this is a thread about NK603. Do you have a new study to cite on NK603…bioinformatics perhaps, demonstrating that the transgene or the gene disruption accompanying the crude random technology created DNA with self complimentarity? Because, evidently, I am not the only person in the world who is concerned about toxic miRNA, nor the exceptional scientist who gags at Biofortifed and Co.unethical conduct. http://www.boulderweekly.com/article-12640-muzzled-by-monsanto.html

                Seralini cited a very well done analysis conducted at the Baylor School of Medicine: http://www.ncbi.nlm.nih.gov/pubmed/16330350 Could you please post a link to an HPLC-MS analysis on NK 603 to assure the audience that NK603 does not contain this serious hazard to public health?

                Ena Valikov

                June 25, 2014 at 3:02 pm

          • Karl, if you think that republication after surviving three rounds of peer review isn’t a sign of quality of the study, then presumably you also think its retraction for very dubious reasons wasn’t a sign it was a bad paper? You can’t have it both ways.
            I wonder if Monsanto’s 90-day toxicity studies on its own products would pass 3 peer reviews, one of them hostile?
            Regarding animal welfare, you failed to address my point, which is that the experiments were conducted according to French government ethical standards. If you disagree and think that Seralini’s experiments were conducted unethically, then you will have to go to court and prove that he has broken French law, or alternatively that the French laws are inadequate. You appear to be accusing scientists of breaching research ethics set by a national government and yes, I say that if you want to make allegations that someone has broken the law, as you are doing, then you must put up the evidence or… (I let you complete the sentence).
            My statement about signs of toxicity in Monsanto’s 90-day studies escalating into cancer over 2 years is technically correct. The tumours were analysed and some (not all) were found to be carcinomas. However, that is my statement, not Seralini’s. I cannot find a single false or misleading statement about cancer in Seralini’s paper, and evidently neither can you.
            You may not be aware of this but your fixation on cancer has fixed the notion in minds of many that GMOs are indeed cancer-causing. Is that really your aim?

            Claire Robinson

            June 25, 2014 at 1:14 pm

            • Claire, try to explain your errors while trying to criticize others for the same error. You say both that Seralini did not mention cancer in this study, and that Seralini’s study found cancer. You are the one who is fixated on both claiming and denying the mention of cancer in the study, not me. I’m pointing out the hypocrisy.
              As for the retraction = bad paper claim, you are putting words in my mouth and stating an opinion I have not uttered. The paper was known to be bad with or without the retraction, and you have not addressed that the journal in question specifically disowned the quality of the paper in the note attached to the paper. You are misrepresenting the journal and their stated reasons for republication.
              You are also fixated on the Seralini vs. Monsanto conflict. But in fact feeding studies on these crops have undergone peer review many many times in dozens upon dozens of journals, with research groups around the world, funded by many different public and private organizations.
              Perhaps you could move the discussion forward by providing a citation (with a link) to the specific ethical guidelines that you say Seralini followed? I find references only to those that he contradicts.

              Karl Haro von Mogel

              June 25, 2014 at 1:53 pm

              • I will try once again to explain. Seralini did not mention cancer in his study. He observed increased rates of tumours — not all of which were “cancer” — in some treatment groups. Tumours were analysed and some were found to be carcinomas. He reported that in his study, in line with the requirements of chronic tox protocol designed by the OECD (and followed by industry). My statement on GMOSeralini that the pathologies led to cancer in some cases (one of very few places on the site we mention cancer) is therefore accurate. Is that clear at last? I have repeatedly asked you to point out where Seralini or I make untrue statements about cancer and you have failed to do so.

                Regarding the ethical guidelines, I have provided you with the citations: read Seralini’s original paper, the republished paper, and his “Answers to critics”. Search the terms “ethic” and “welfare”.
                As for the other feeding studies you mention, the only studies relevant to Seralini’s study are long-term studies on NK603 maize and Roundup. Where are the other studies on this GMO and this pesticide?

                In my view no journal editor in his right mind would publish a paper he thought to be bad, especially after consulting three peer reviewers, but pehaps you have another insight on that.

                Claire Robinson

                June 27, 2014 at 7:08 am

                • Claire, you cannot both say that Seralini never mentioned cancer and also reported carcinomas. Carcinomas are a type of cancer. That’s what I’m trying to point out about the hypocritical way that you are approaching this. I didn’t say he necessarily made untrue statements about cancer, I’m saying you did. You’re trying to suggest cancer from GMOs, using Seralini as the source, playing a rhetorical game. Then when you are called on it, you say “Seralini didn’t use the word cancer!” Logic: You’re doing it wrong.
                  What you are telling me is that you don’t have a link to the ethical guidelines he followed, and are punting the question to his publications. I figured since you ran his fan site that you would have the link in your bookmarks.
                  “In my view no journal editor in his right mind would publish a paper he thought to be bad, especially after consulting three peer reviewers” I am indeed surprised that you would say this, and I’ll add that the corollary is that no editor in her or his right mind would retract a paper she or he thought was NOT bad, especially after reviewing the evidence along with additional peer reviewers.

                  Karl Haro von Mogel

                  June 29, 2014 at 3:08 am

            • There were not three rounds of peer review, Claire. The editor of the new journal has stated clearly that they did not peer review the republished article.

              http://sciblogs.co.nz/code-for-life/2014/06/26/seralini-study-republished-with-no-scientific-peer-review/

              Karl Haro von Mogel

              June 26, 2014 at 11:29 am

    • The following considerations should be helpful: “Additional signs in neoplasia studies that may constitute an endpoint include, but are not limited to:
      1) A tumor burden greater than 10% body weight. In an adult mouse, a tumor should not exceed 20 mm in any one dimension; in an adult rat, a tumor should not exceed 40 mm in any one dimension. Formulas for calculating tumor size can be found in the literature (see tumor size references).
      2) Tumors that ulcerate, become necrotic or infected.
      3) Tumors that interfere with eating or impair ambulation.”
      Source: http://oacu.od.nih.gov/ARAC/documents/ASP_Endpoints.pdf
      Now look at the figure where the poor rats ars shown with the huge, multiple, ulcerating tumors which clearly interfere with eating. I have problems with studies that violate basic ethical standards.

      Prof. Dr. Alexander Lerchl

      June 24, 2014 at 12:11 pm

      • Prof Lerchl, I sympathise with your desire to reduce animal suffering but would you prefer that we refrain rom such testing and instead subject large populations of animals and humans to the levels of GM maize and Roundup that are associated with these pathologies? For me this is an odd moral compass.

        Claire Robinson

        June 25, 2014 at 1:25 pm

        • On the contrary Claire, there is no excuse for imposing such suffering on animals merely to aid an ideologically-driven agenda.
          There are proper ways of testing the safety of chemicals and foods and this paper was not one of them.

          Chris Preston

          June 27, 2014 at 1:54 pm

  5. My dear professional in research, I am not a scientist, but have followed this study as a documentary maker interested in the role GE organisms and the pesticides that accompany them play in our food system. A question: With the republishing of this study, is the research and analysis any more credible than in the first instance?

    Jan Weber

    June 24, 2014 at 5:09 pm

    • No. On the contrary, this republishing damages the reputation of the researchers further (i.e. why don’t they do a proper replication study instead of recycling the heavily criticized old stuff). It also damages the reputation of the journal (i.e. why do they republish this study which does not fulfill the minimum quality standards of such type of studies as outlined by OECD guidelines etc.).

      Prof. Dr. Alexander Lerchl

      June 24, 2014 at 6:12 pm

    • No, the analysis is no more credible than in the original paper. The most disappointing thing with this republication is that they have not learned from the criticism of the first publication, and performed further rigorous tests in which the researchers were blinded, the animals were randomized, the endpoints were determined in advance, the numbers of animals in the control groups was increased, a complete data set was made available in the supplementary material etc. etc. The best response to criticism is more data and better quality data.

      michaelhbriggs

      June 24, 2014 at 6:13 pm

      • Please cite a single blinded feeding trial on any commercialized GMO! I have the same exact criticism about all the GMO feeding trials, and I’ve yet to find a single blinded feeding trial.
        At a minimum Seralini supplied all the raw data and outcomes on all the rats, while Monsanto had to be taken to court to release their raw data and published biochemical tests for less than half the rats. I don’t intend to take anything published in FCT at face value, and wouldn’t if it was the number 1 journal in the country, while it practices blatant double standards, and I sure as heck wouldn’t attempt to republish in a journal I consider biased. The editors of this “high” impact factor journal, evidently believe that disappearance of half the experimental and control animals isn’t worth a retraction, but challenging the idea that 90 days and data on 4-6 rats are adequate to detect chronic adverse effects -Seralini’s bottom line conclusion- is heresy. So, while I strongly agree that we need more data-on a statistically significant number of rats- I think the burden of proof of safety by Monsanto has not been met, given the concerns about hepatorenal toxicity arising from their own studies as well as Seralini’s As a veterinarian, based on Monsanto’s low scientific standards- I don’t recommend that dogs and cats eat these crops, and I would run as fast as I could from any physician who claimed Round Up Ready corn was safe based on this shoddy sloppy work and the political-media circus surrounding this debate. http://beachvethospital.blogspot.com/2014/01/dear-food-and-chemical-toxicology.html

        Ena Valikov

        June 24, 2014 at 7:45 pm

        • Isn’t it ironic that the original study was published in an Elsevier journal but the republished paper was published in a Springer journal?

          JATdS

          June 25, 2014 at 12:38 am

          • Yes it is! Both publishers claim to follow the highest ethical standards .. lol

            Prof. Dr. Alexander Lerchl

            June 25, 2014 at 12:58 pm

            • Specifically:

              “SpringerOpen journals and books are made freely and permanently available online immediately upon publication. They are subject to high-level peer review, author and production services ensuring quality and reliability of the work. Authors publishing with SpringerOpen retain the copyright to their work, licensing it under a Creative Commons license. To cover the cost of the publication process, all SpringerOpen journals and books charge an open access fee. To support the individual researchers in covering these costs, institutions can join our Open Access Membership Program which we offer together with BioMed Central. We currently have over 450 members in more than 45 countries.

              Publishing with SpringerOpen enables authors to widen their readership, comply with open access mandates, retain copyright, and benefit from Springer’s trusted brand!”

              tekija

              June 25, 2014 at 2:10 pm

              • Tekija, that’s what I think, too (I also enjoyed how you squeezed the lemon, and the “lol” by Lerchl). Both Elsevier and Springer are paying COPE members, and COPE is supposedly the globe’s most influential “ethics” group. How then would COPE explain how one of their members found a paper unfit for publication while another member (ranked 1 and 2 in the world, respectively) did not? Is that ironic? What it ultimately suggests to me, however, assuming that there was genuine, blind peer review at Springer, is that the paper has intrinsic value and that, perhaps, strong conflicts of interest were at play in the peer review and editor board in the Elsevier journal. According to Claire Robinson, COPE responded this way: http://www.endsciencecensorship.org/en/page/press-release#.U6vX1EB77Sg

                JATdS

                June 25, 2014 at 3:37 pm

      • michaelbriggs: In fact in this study the analyses were conducted by independent researchers (of Seralini’s team) in a blinded manner, as clearly stated in the authors’ “Answers to critics”, also published in FCT. The animals were indeed randomly assigned to the different groups. It seems I have to make the point yet again that Seralini’s critics should read his published papers before voicing their opinions.

        As for endpoints being determined in advance, the industry studies on GMOs are adaptations of OECD408, and the endpoints are not clear. This is explained in detail in this paper: http://www.enveurope.com/content/pdf/2190-4715-25-33.pdf

        As for the numbers of animals in the control groups, it is standard in toxicology to have the same number of animals in the control group as in each treatment group: each treatment group is compared with the one global control group, separately. You will not find a well designed experiment with extra control animals, though you will find plenty of Monsanto studies that use the ruse of spurious controls. Essentially this method dilutes out any effects found in the treatment groups. It is bad science.

        Claire Robinson

        June 25, 2014 at 1:39 pm

        • You will not find a well designed experiment with extra control animals, though you will find plenty of Monsanto studies that use the ruse of spurious controls. Essentially this method dilutes out any effects found in the treatment groups. It is bad science.

          I’m not particularly familiar with the design of toxicity studies, but on its face, this doesn’t seem to make statistical sense. If you have some condition with a 10% background, what you can detect with two N = 10 groups (95% C.L., 80% power) is an elevation to 66.1%. Double the control group, and that signal threshold drops to 57.2%.

          Narad

          June 25, 2014 at 5:17 pm

          • I don’t think her claim was on study power, but about bias. E.g. industry and OECD TG love of “historical controls”, a concept always inimical to science. Or the use of insensitive species as neg. controls, e.g. in the Tyl et al. paper used for bPA safe doses by USEPA & EU’s EFSA.

            As to animal welfare complaint, claimants are literally advocating having rest of world suffer so that reality not be tested, due to animal welfare. In fact this is the 2nd biggest insensitivity of all in the OECD TGs — large majority of chronic animal disease develops after early 60s of age (the equiv. at which dosing stops & test animals are sacrificed. Labs that let either exposure or life or both continue get much more sensitive results, as Ramazzini Institute in Italy has shown. Good on Seralini.

            Animal welfare will finally happen when industry stops cheating and denying reality on toxicity tests, including government’s promotion of the insensitive methods. Much of the brazen cheating stopped after the whistle was blown in the IBT scandal of 1970’s (GLP was the effective response, but my theory is that caused industry to propose & enact (w/ OECD) the TGs, enshrining industry’s insensitive methods).

            ttweed

            June 30, 2014 at 9:43 am

            • I don’t think her claim was on study power, but about bias. E.g. industry and OECD TG love of “historical controls”, a concept always inimical to science. Or the use of insensitive species as neg. controls, e.g. in the Tyl et al. paper used for bPA safe doses by USEPA & EU’s EFSA.

              My response wasn’t about power, either; I just selected a common value to point out what a larger control group does. I see no reason to start inventing alternate meanings for “you will not find a well designed experiment with extra control animals.”

              Narad

              June 30, 2014 at 5:44 pm


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