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    European Food Safety Authority Reviews, Dismisses Séralini Maize Study As Hopelessly Flawed
    By Jon Entine | October 5th 2012 01:05 PM | 14 comments | Print | E-mail | Track Comments
    The European Food Safety Authority has weighed in with its assessment of the maize study by Gilles-Eric Séralini and his research team at France’s University of the Caen, which purportedly showed that rodents fed a strain of genetically modified corn with Monsanto’s Roundup Ready developed tumors and died.

    Scientists have been almost uniformly critical of the design of the study and the framing of its results, and except for a few activist journalists-apologists, the science press has been in an uproar at the clear attempt by the Seralini research team to manipulate the media coverage when the study was released.

    The EFSA is respected for its independence and has no apparent institutionalized bias for or against GM foods. It has encountered Seralini before, however. In 2007, it sharply criticized the quality of Seralini’s research on GM soy, as did Europe’s independent Public Research and Regulation Initiative (PRRI).

    The EFSA noted that the “study has unclear objectives and is inadequately reported in the publication, with many key details of the design, conduct and analysis being omitted.” The EFSA requested access to the raw data—scientists commonly share data so conclusions can be either reaffirmed or discarded as anomalous. “Without such details,” the EFSA wrote, “it is impossible to give weight to the results.” Seralini has refused, claiming he would not release his raw findings until Monsanto is compelled to release its patent-protected research on the NK603 maize strain—a bizarre, politicized stance for a scientist. Other scientists have welcomed critical reviews of their GM studies.

    The EFSA observed that the Séralini team reached its conclusions based on only 10 rats per treatment, which scientists and the agency say is far too few to demonstrate that anything more than chance caused the tumors. In a conclusion in line with almost every mainstream geneticist, the food regulatory oversight agency concluded: “Considering that the study as reported in the Séralini et al. (2012) publication is of inadequate design, analysis and reporting, EFSA finds that it is of insufficient scientific quality for safety assessment.” The EFSA decided not to reopen its safety assessment of the GM maize.

    Another independent body, the European Federation of Biotechnology, endorsed the EFSA conclusion, which it says are “largely consistent with the observations of a wide number of scientists who reviewed the paper's findings, soon after its publication.” The group also raised questions about the peer review process that led to the paper’s publication. “This paper represents a dangerous case of failure of the peer-review system, which threatens the credibility not just of the Journal but of the Scientific method overall," wrote Professor Marc Van Montagu, the president of the EFB.

    Predictably, Séralini dismissed the findings, claiming a conflict of interest on the part of EFSA—but also reiterated his refusal to release the raw data for review by any other agency or independent oversight group.

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    Jon Entine, founding director of the Genetic Literacy Project, is senior fellow at the Center for Health&Risk Communication at George Mason University, and a senior fellow at the Statistical Assessment Service (STATS).

    Comments

    Hank
    I like the verbage from the hard-left anti-science fringe; that the EU is 'siding' with Monsanto.  As if the EFSA researchers didn't want to have a reason to ban GMOs.  They are just too honest to be advocates, like Séralini.  Though I hope his book has sold well.
    Gerhard Adam
    Good post, thanks.
    Mundus vult decipi
    I'm particularly interested in the second to last paragraph of this post.

    What the heck is going on with peer review? This is a study that has drawn uniform criticism for design and statistical methodology, was within weeks dismissed by the most important food regulator on a continents, and basically withheld pertinent data without apology. But it got through peer review, and was accepted by a journal I can only assume has some legitimacy.

    It's one thing to publish a study that may have some technical flaws, or reports results with disclaimer for need of further study. But you'd be hard pressed to find a scientist right now that would have peer reviewed this without comment (s) or flat out rejection. So who did the peer review? Were their comments ignored by the publisher?

    I don't mean this rhetorically. I think if this kind of thing goes on, "peer reviewed" or "scientifically proven" won't mean anything.

    Apparently the research is not as flawed as suggested. Here the response of the researcher.

    http://tempsreel.nouvelobs.com/ogm-le-scandale/20120920.OBS3130/ogm-9-cr...

    It is more likely that the Gentech lobby has a firm hold on the EFSA.

    Hank
    You're certainly echoing Séralini, it's why he has so far refused to even let anyone see his data.  Instead, he now says his study was so poorly designed because he did not expect to find any problems with GM foods anyway - yes, an anti-GM activist is saying he spent two years of his life expecting a null hypothesis. But he still won't show anyone because all of anti-GM Europe is so pro-GM they would pick on him if he let them see numbers.

    While he won't show anyone his data, we do all get a nice picture of him posing with the book about his conclusions. It's always a sign of quality science when the researcher has a public relations blitz plan in place and a book written before a study even goes into peer review.

    Bonny Bonobo alias Brat
    That is a very interesting link Anonymous, it responds to most of the Seralini experiment and research criticisms made here in this article, here is the Google translation:-
    First critical 200 rats is too low for a study sample solid ...
    - The sample of 200 rats, 20 rats per batch, is the number of rats used by Monsanto in his study on three months. In contrast, we have studied much of toxicological endpoints. To work with more rats, it was more money. The study has already cost $ 3.2 million.
    Type rats employee, "Sprague-Dawley" is known to easily develop tumors ...
    - Yes, but what are the strains of rats used in the world for toxicological research. These rats have the advantage of being stable in biological and physical. They all pretty much the same profile, same weight ... These are the rats used from the beginning in the research on transgenic organisms by firms produce. Including by Monsanto. And the facts are there: those who have been fed GM corn, with or without Roundup develop more diseases. And much faster.
    Looking closely, male rats fed GM corn does not generally develop more tumors than the controls ...
    - What to look for, it is precisely the speed triggers. In all three groups of rats, tumors or diseases of the kidneys and liver are involved from the 4th month and explode 11th and 12th months. Which corresponds to the age of 35 to 40 years for a man. For the control group, tumors occur mostly at the end of life, to the 23rd month and 24 months, which seems normal rats.
    Scientists point to the lack of information on the exact composition of the diet on which rats were ...
    - These are croquettes standards, the same again as those used by the producers of GMOs in their studies. The only difference is that we have precisely measured the concentration of GM maize: 11% for the first group, 22% for the second and 33% for the third.
    The amount of GMO consumption by rats is more important than what that is absorbed men ...
    - Think again. Assays NK 603 are comparable to what eat in a life populations in the Americas, where GMOs are sold freely, unlabeled, untraced. This prevents also be identified as pathogens and opens the door to denial. This is why we hear for example that Americans eat GM for 15 years and are not sick.
    The magazine chosen to publish the study, "Food and Chemical Toxicology," is not the most prestigious in the United States.
    - It is far from being secondary: it is an internationally known scientific journal. Publications are subject to peer review, in which express contradictory visions. And this is where Monsanto and other manufacturers publish their cons-expertise.
    We also hear that Gilles-Eric Seralini is a patented anti-GM, he got the results he wanted.
    - Absolutely not. Gilles-Eric Seralini the Criigen (Committee for Research and Independent Information on Genetic Engineering) and researchers in his lab at the University of Caen also working on genetically modified organisms, because it gives them access to knowledge of life. They have nothing against GMOs for the manufacture of drugs. Insulin, for example, is produced from GMOs. This does not prevent me to prescribe to my patients with diabetes. It is recognized by the presence of these drugs on the record, the term "recombinant protein". So yes GMOs in pharmaceutical laboratory.However, Gilles-Eric Seralini and we are against other agricultural GMOs, mislabelled and whose toxicity during short is poorly studied.
    You are not oncologists, what do you know ... tumors
    - No, we are not oncologists and have never said otherwise. This is a toxicity study, no carcinogenicity study, following other protocols. Moreover, we have nowhere stated that tumors are cancerous. These are fibro-adenomas and chirato-acantomes, which can turn into cancer when older rats.
    It takes a cons-expertise.
    - We agree. We also want a second opinion against, but done by independent researchers. Not by those who produce studies for manufacturers of GMOs. That is not the position of the EFSA for the moment (European Food Safety Agency).
    I'm curious to know what Jon Entine thinks of these responses defending the criticisms of the Seralini GM and roundup research and the rats with tumors.
    My article about researchers identifying a potential blue green algae cause & L-Serine treatment for Lou Gehrig's ALS, MND, Parkinsons & Alzheimers is at http://www.science20.com/forums/medicine
    JonEntine
    This article was in the French Le nouvel Observateur, which became the laughing stock of journalism by allowing Seralini to manipulate coverage. It's a well known anti-GM publication, uncritically passing along anti-GM propaganda. And they served their cause well, carrying a rebuttal, not from an independent researcher but an activist NGO whose embrace of the Seralini study predated its release. I think we on this stick to real scientists with no real ideological agendas.
    Bonny Bonobo alias Brat
    This article was in the French Le nouvel Observateur, which became the laughing stock of journalism by allowing Seralini to manipulate coverage. It's a well known anti-GM publication, uncritically passing along anti-GM propaganda..._I think we on this stick to real scientists with no real ideological agendas.
    I don't understand why that made the French Le Nouvel Observateur the laughing stock of journalism? How did Seralini manipulate coverage? And what does 'I think we on this stick to real scientists with no real ideological agendas' even mean? Actually, never mind, I don't really care about scientists squabbles and their ridiculing of each other and who is the laughing stock, I'm just interested in the facts and want to know the answers to the following 5 questions regarding the Seralini criticisms :-
    1. The criticism that 200 rats is too low for a study sample
    Is it true that the sample of 200 rats, 20 rats per batch, is the same number of rats that was used by Monsanto in their three month rat study? 

    The criticism that the rat strain "Sprague-Dawley" is known to easily develop tumors
    Is it true that this strain of rats is commonly used in the world for toxicological research because these rats have the advantage of being biologically and physically stable with pretty much the same profile and weight and that they have been used from the beginning in the research on transgenic organisms by firms including by Monsanto? And that the facts show that those who have been fed GM corn, with or without Roundup develop more diseases and much faster?

    3 The criticism that male rats fed GM corn do not generally develop more tumors than the controls 
    Is it true that in all three groups of rats, tumors or diseases of the kidneys and liver occurred from the 4th month and exploded in the 11th and 12th months and that this corresponds to the age of 35 to 40 years in humans? Is it also true that for the control group, tumors occurred mostly at the end of life, in he 23rd month and 24 months, which is normal for these rats?

    4. Criticism that scientists point to the lack of information on the exact composition of the diet on which rats were fed
    Is it true that these are 'croquette' standards, the same as those used by the producers of GMOs in their studies and that the only difference was that Seralini precisely measured the concentration of GM maize: 11% for the first group, 22% for the second and 33% for the third?

    5. Criticism that the magazine chosen to publish the study, "Food and Chemical Toxicology," is not the most prestigious in the United States.
    Is it true that this magazine is far from being secondary, that it is an internationally known scientific journal where publications are subject to peer review and that this is where Monsanto and other manufacturers also publish their articles and expertise?

    My article about researchers identifying a potential blue green algae cause & L-Serine treatment for Lou Gehrig's ALS, MND, Parkinsons & Alzheimers is at http://www.science20.com/forums/medicine
    JonEntine
    Helen,

    Just READ the critiques form independent scientists and you will realize the scam that is Seralini. There is no place in reputable science for self-promoters who put causes and selling books above the facts. To be generous, it's clear you have no science background or you wouldn't be posting Seralini's propaganda. It's literally him against 95% of the mainstream science community.
    Hank
    95% is you being really generous.  His claim that GMOs are a 'pesticide sponge' caused even the 'at least he is on our side against genetic modification' fringe of biology to abandon him. He's Andrew Wakefield, except for GM food.
    Bonny Bonobo alias Brat
    it's clear you have no science background or you wouldn't be posting Seralini's propaganda
    And its clear to me that you don't want to answer my questions Jon. Surely a scientist should be less interested in propaganda and more interested in answering anyone's scientific questions? What does it matter what my scientific background is? I think it was Einstein who said that a scientific concept should be explainable even to one's grandma. I'm not a grandma yet and my mind is also not yet made up about whether Bt GMs and roundup is safe for long term human and animal consumption but without any supposedly credible or respectable long term research to answer these questions, I might well be a grandma before I have the answers. These are simple questions not Seralini's propoganda, why can't you simply answer them?
    My article about researchers identifying a potential blue green algae cause & L-Serine treatment for Lou Gehrig's ALS, MND, Parkinsons & Alzheimers is at http://www.science20.com/forums/medicine
    EFSA is not independent. This is accepted for human consumption! Hank would you feed your kids this after 90 days study?

    90 days, one group of 10 rats only fed with this GMO, here are the results accepted by EFSA without problems for animal consumption of the new GM potato: a shame!! EFSA do not explains why they accepted that.
    In female animals, statistically significant differences in white blood cells and spleen weight were noted between animals that were fed the transgenic potato and those given a diet containing the parental cultivar. However, these differences fell within the range of values observed in animals fed the standard rodent laboratory diet. Moreover, these changes were not accompanied by any changes in other lymphoid organs besides the spleen.

    In addition, the findings of cysts in thyroids checked by microscopy were slightly increased in male animals fed diets containing the transgenic potato compared with animals fed the standard laboratory rodent diet. No cysts were observed in the thyroids of female animals fed either diet. Thyroid cysts occur commonly in rats, while their frequency varies during ageing (e.g. Takaoka et al., 1995). No findings were reported that could be related to any possible thyroid malfunction. Therefore, the GMO Panel considers that the slightly increased incidence of thyroid cysts in males fed transgenic potato is likely to be due to natural variability and does not trigger a further safety assessment.

    JonEntine
    These issues have been extensively addressed by the EFSA and at least 150 responses from independent scientists from around the world. The EFSA is totally independent. Seralini hates it because it independently reviewed his work on a similar study and like an independent German science agency found his research shoddy. Even scientists skeptical of GM technology view his work and lab as among the least reputable in Europe. You can believe what u want but it's not based in independent science. That's ideology and not science. His work has been peer reviewed by the top independent geneticists in the world. It's not competent or quality.
    This is how EFSA is indepented.
    News
    On 10 May, the European Parliament voted against granting discharge of the European Food Safety Authority (EFSA) budget for the year 2010. By doing so, it adopted a report from its Committee on Budgetary Control criticising EFSA very harshly for conflicts of interest and revolving door cases (http://www.testbiotech.org/en/node/661).

    On 8 May, just two days before the vote, Diána Bánáti, Chair of the EFSA Management Board, had resigned with immediate effect. She will take up a professional position at the International Life Sciences Institute (ILSI). Diána Bánáti had been subject to criticism since September 2010 because she was Board Member of ILSI Europe. After leaving ILSI, she was re-elected as chair of EFSA’s Management Board in October 2011. Now she is returning to ILSI Europe, which is funded by food industry and agrochemical companies (http://www.testbiotech.org/en/node/656).

    EFSA wrote a letter to ILSI explaining that according to its new regulations on independence, experts from ILSI are excluded from various working levels at EFSA:

    "Regarding the classification of ILSI involvement as a category V activity “ad hoc or occasional consultancy”, EFSA’s new rules explicitly exclude the involvement of scientific experts participating in scientific work related to services provided to products, their development and/or assessment methods carried out on behalf of trade associations or other bodies with an interest in this subject matter, such as ILSI."
    http://www.efsa.europa.eu/en/press/news/120516a.htm

    Obviously, in a reaction to the pressure from the EU Parliament, EFSA then decided to postpone the nomination of new experts for several scientific panels. The nominations, which were scheduled for 8 May, will now take place on 27 June.