Banner
    GMOs Are A Pesticide Sponge And Other Weird Tales Of Gilles-Eric Seralini
    By Hank Campbell | September 21st 2012 11:10 AM | 60 comments | Print | E-mail | Track Comments
    About Hank

    I'm the founder of Science 2.0® and co-author of "Science Left Behind".

    A wise man once said Darwin had the greatest idea anyone...

    View Hank's Profile
    If sloppy, agenda-based science is all that is needed for activists to latch on to a belief and never let go, then the anti-GMO contingent may have found its Andrew Wakefield in French biologist Gilles-Eric Séralini. It won't matter that the methods in his latest study are causing biologists all over the world to facepalm, they will insist it must be true and Big Science is the squelching the results.

    In the Washington Post, for example, Marion Nestle, the Paulette Goddard professor in the Department of Nutrition, Food Studies and Public Health at New York University who supports labeling of genetically modified foods on a national scale, nonetheless told Tim Carman, “It’s weirdly complicated and unclear on key issues: what the controls were fed, relative rates of tumors, why no dose relationship, what the mechanism might be. I can’t think of a biological reason why GMO corn should do this.”

    Indeed, biology gets thrown out the window when it comes to fallacious beliefs; the genetic modification in the maize to help them resist Roundup is a protein that is naturally present in all plants that we eat every day. But the study was backed by the Committee for Research and Independent Information on Genetic Engineering, which exists to oppose GM foods. Who is the founder of that group? That same Gilles-Eric Séralini. Note that no anti-GMO group has claimed that the funding source tainted the results in this instance.  With mainstream science studies there are claims of black helicopters hovering over labs and lobbyists controlling government scientists but here the agenda seems to be regarded as pure. The agenda is not pure, it is the latest in a series of agenda-based efforts by a researcher out to scare people about genetic modification.

    Henry Miller and Bruce Chassy compare Séralini to Duke ESP researcher J.B. Rhine in the 1950s, because Rhine also selectively counted data in his experiments, omitting results because he conspiratorially believed they could not happen by chance.   Chassy and Miller are just jumping on the bandwagon to pump up pageviews for Forbes about this study, right?  No, they wrote that about Séralini's last paper, in which he claimed Bacillus thuringiensis (Bt) toxin, which has been used for almost 100 years and is still sprayed by organic farmers today, caused 'cell death' when administered in incredibly high levels to defenseless cells. Well, what doesn't cause cell death in a petri dish at high levels?  The line between medicine and poison varies, but it is always there. Regardless, Séralini was lauded by the anti-science contingent as a lone voice standing strong against Evil Business while biologists muttered that his experiments are "poorly designed, irrelevant, uninterpretable (but over-interpreted)". 

    That ESP researcher comparison is apt once again because the paper states "All data cannot be shown in one report and the most relevant are described here". This was science by press release.

    Other problems were evident right away; namely the line of rats they chose and the duration of the study.  The Sprague-Dawley rats they chose for this study was not by chance, especially considering that Séralini wanted to prove harm and said 90-day studies were the issue in why no harm has been found - so they went out of their way to pick rats bound to get cancer and kept them eating well beyond the 90-day adulthood period for rats.  2 years is a long time for rats but for the specific line of rats they chose, two years is a really long time, especially for rats known to get this cancer, especially when the food is not limited and that is known to be a risk factor for tumors. Such a long time that "for humane reasons this study would not have been given approval in the UK". 

    Professor Andrew Kniss, biologist at the University of Wyoming, noted that oddity also, and went a step further and took the known cancer rates of this line of rats and made the control group 10,000 instead of the bizarre 10.  The simulation  "found that 71.4% of them will develop tumors by the end of a 2 year study. That’s pretty close to 72%. But here is where sample size becomes so critically important. If we only select 10 female rats, the chances of finding exactly 72% of them with tumors is much less." Right, if the control group is 10 you could get no rats or 1 or 10, a statistical fluke result. Every biologist noted this same flaw yet anti-science activists insist it makes no difference.


    See, GMOs are a pesticide sponge and then corporations sit there in their... in their corporation buildings, and... and, and see, they're all corporation-y... and they make money... photo: Shutterstock

    Choosing a tiny control group was brilliant for producing the results they wanted to produce.  So it's not a surprise that given the length of time and that species, 50 percent of male and 70 percent of female rats died early compared with only 30 percent and 20 percent in the control group. The control group was statistically silly.  If we wanted to use their statistical sleight of hand, it looks like GM foods kept a whole lot of male rats from getting cancer and females broke even.

    What was the standard deviation for the data, since some groups that ate GM food got less tumors and some groups got more? No one knows. The kind of undergraduate college-level requirement that would distinguish results from random variation was not done, and they did not show their data so no one else can do it either. 

    Kevin Folta, who writes here, was quoted in the Los Angeles Times and The New York Times,
    "you are likely seeing variation of normal tumor incidence in a small population of rats"
    In other words, using a custom statistical analysis means they were on what Tom Sanders, head of nutritional research at King's College London, called a statistical fishing trip.  Aggravated by the fact that they didn't have as many controls as test subjects.  You know you have a problem when the LA Times is debunking your study. Los Angeles is a hotspot of kook beliefs. When I wrote an article for them the first comment was, "That was a refreshing and unexpected read in the Anti-Science LA Times", but they debunk this one thoroughly, with barely a hint of false equivalence. Andrew Revkin at NYT said anti-GM types are engaged in the “single-study syndrome” about dubious research. Prof. Michael Eisen (he has also guest posted here) wrote an email to Revkin that read
    This particular study was so poorly designed – the highly sensitized line, the inexcusably small number of animals – that you didn’t even have to look at the ridiculous statements from the lead author (like GMOs are a pesticide sponge”) to see that it was biased.
    It's not easy to make Monsanto look like the victim but with overtly biased efforts like Prop 37 and now a study written for the gullible among the anti-science community, activists are making that happen. What you see are scientists on one side and public relations people for anti-science groups on the other.  Those are not equivalent and yet advocates side with the public relations groups.

    The anti-science groups who invoke funding on every study showing GMOs are safe are conveniently ignoring that this study was funded by a partisan group that exists only to oppose GMOs. All of the methodological errors they would note (if they knew how studies were designed) in a study showing GMOs were safe are allowed to slide by here, and are simply considered more evidence we need warning labels.

    They also ignore pesky facts about the rats themselves. As Tim Worstall at Forbes notes, the laboratory rats used likely had GMO food across the board. "Virgin albino Sprague-Dawley rats at 5 weeks of age were obtained from Harlan (Gannat, France)" the latest Séralini study says, but Harlan says "We do not exclude GM materials from rodent diets”. GM food for animals is quite common, even in France.

    France is, as has been noted many times, the most anti-science country in anti-science Europe. Without even reading the study, France's Jose Bove, vice-chairman of the European Parliament's commission for agriculture and vocal opponent of any genetic modification, called for an immediate suspension of all EU cultivation and importing of any GM crops.

    Dr. Anne Glover, EU Science Advisor, likely did a facepalm of her own over that statement, since she took the job and noted her top priority was to try and make Europeans less anti-science, and now an agriculture vice-chairman is calling for more supernatural beliefs.

    Comments

    Gerhard Adam
    Choosing a tiny control group was brilliant for producing the results they wanted to produce.
    I've said it before, and I'll say it again.  This is precisely the number recommended by the OECD protocols, so why is it suddenly unacceptable when it was used routinely as the standard for safety testing.
    Mundus vult decipi
    Hank
    'Said it before' doesn't mean it makes any sense, no matter how times you bring it up. That is an oral toxicity standard designed to establish a minimum threshold of 'no effect' for each dosage level and you are saying therefore a study of 10 rats is fine for a GMO study. It's one of 500 test guidelines they publish but you seem to keep bringing that one up because it has the number 10 and that matches Seralini's number in each group.  Skin sensitization protocols only need 4 animals so to you, does that mean this study was 150% more rigorous?

    If a pro-GMO study is mismatching controls and test subject numbers, cherrypicking data or not even thinking about its confidence interval, it should absolutely be ridiculed. Claiming this one is okay because an OECD standard for drug testing uses 10 rats is muddying the water.
    Would OECD minimum standards take into account the propensity of tumors with this particular rat, specifically at old age, and when potentially allowed access to unlimited food? I doubt it. I'm not an expert, but I'd assume guidelines are minimums and generally good for typical experimentation where complicating factors were not in play.

    If you want a win on a technicality then maybe you can have one here. If you want solid statisitistical analysis, then you might have to admit that the OECD guidelines wouldn't necessarily be good enough when you start stacking risk factors. You would necessarily need a larger sample size and much larger control group.

    Or if you happen to be a crafty activist researcher, and also have experience with such things, you can find and exploit factors that can make results look significant when they are not.

    Am I wrong is saying that a bunch of positives in your control group significantly weakens it's power, or that high variability in the control group is very bad? So would OECD expect that type of thing to happen?

    Hank
    That one protocol is the wrong one to use anyway.  Why pick number 408 out of 500 protocols and claim this study was valid because it used the same number of rats as #408?  It isn't like OECD in  1998 said 'this GMO stuff will never take off and we have 500 tests for other things but let's lump GM food in with oral drug toxicity' and that is why Seralini picked 10 rats.
    Gerhard Adam
    That one protocol is the wrong one to use anyway.
    Based on what?  Unless you have a document indicating what the recommended protocol is, then let's indicate what protocol was used for the safety studies and see if they hold up.

    If OECD # 408 is inappropriate to this objective, then you can throw out all your safety studies, because the majority use this standard [hence the 10 rats per sex/group and the 90 day evaluation period].


    Mundus vult decipi
    Hank
    Noooo, they supplemented that in Europe and then clarified that for studies that use it, researchers had to do a power analysis to obtain a legitimate sample size capable of detecting the  biologically relevant effect.  It seems pretty obvious how this study did not pass the basic smell test.





    Gerhard Adam
    Then neither have the safety tests.
    Mundus vult decipi
    Hank
    Fine by me, we also know that 70% of Americans should have cancer by now.  I mean, if a poorly controlled rat study used 10 animals and supposedly every GM study you have read did the same thing, we should have a 70% cancer rate. Because not finding harm and finding harm are equivalent.

    Gerhard Adam
    You aren't serious?  You're going to counter this with anecdotal evidence of what we should expect to see?  Don't you think the proper response would be that we might need follow up studies to determine whether these results are real or anomalous?

    It would also be appropriate to consider large populations precisely for that purpose.  However, it should be clear that the safety studies use 10 animals of each sex precisely to see if there's something further to investigate.  If so, that doesn't render the experiment conclusive.  It isn't simply the recommended protocol that is designed to establish whether something may or may not exist.

    In the safety studies, those 10 animals/sex were used to establish [in those studies] that nothing unusual was detected, so there was the conclusion drawn that nothing further needed to be looked at.  It should be quite obvious that if something had been found, then it would argue for further, more detailed tests.

    That's all this study would represent at its most optimistic, liberal interpretation.  Whether others do more with it than that is of no interest to me.  What it should NOT represent, is some knee-jerk reaction that it must be fraudulent.  It has been "peer-reviewed" for what that's worth, but if you expect that I should believe "science" when they tell me something you favor, then grant me the same courtesy by considering that I expect "science" and not popular opinion to determine whether this study has any merit or not.

    Also, let's be clear that the "critics" aren't providing an informed review.  They are simply expressing an opinion.  It's no different than your hamburger and diesel truck example.  Initially you might reject the claim, but in reading the data you may have to admit it's correct.

    Until the data is reviewed and someone finds flaws in the data or the analysis, or can't replicated the results, then we need to watch ... opinions are cheap.
    Mundus vult decipi
    Hank
    No one can make an informed review because he refuses to show the data.  He only shows the data he wants people to see.  Even EFSA, whose methodology you said validated his study, is not allowed to see his data.

    Instead of putting scare quotes around everything, make a positive difference and show biologists how they are wrong in their understanding of genes, GM food and its risks, animal models and control groups, and this study.
    Gerhard Adam
    ...show biologists how they are wrong in their understanding of genes, GM food and its risks, animal models and control groups, and this study.
    Where have I made such a claim?  I don't dispute their understanding about genes, which, of course, isn't quite the same thing as doing food studies, is it?

    One of the most telling aspects of this [again this doesn't require any specific scientific knowledge] is to question why there don't appear to be any long-term studies in most animals.  The 90-day tests are toxicity tests.  OK ... so we know that if you eat them you won't drop over dead.  Cigarettes aren't toxic either, although oxygen is.  So what.

    Was fen-fen toxic?  We've run into this time and time again regarding pharmaceuticals which clearly illustrates that toxicity studies are inadequate in assessing long-term effects and/or risks.  So, while I'm not defending this study, I will ask again ... point me to any long-term studies that have demonstrated that no effects were detected.

    This study may be seriously flawed, it may not be.  Until it is assessed, it is academic to argue about it.  All we do know, is what it claims and the point in science is to demonstrate how it is wrong, not merely dismiss it because we disagree with its conclusions.  This isn't some article on Huffington Post.  So, if peer-review determined that it was worthy of publication, then that suggests that it warrants serious refutation.  Now you can ridicule peer-review, but then let's include all the safety studies as well, if we're going to go that route.
    Mundus vult decipi
    Don't forget that even if you want to accept the protocol, that the findings are not very statistically meaningful due in large part to the elongated test with trouble-prone participants.

    So if it's appropriate for a 90 day test with these rats, with a small control group, bu it may very well be inappropriate for with a small control group when there are compounded risks due to feed rate an experiment length. You add risk factors, you add variables that require larger sample size to make sense of.

    So, it may not be an issue with negative results, but may be a problem weeding out false positives when the other risk factors are introduced. What Monsanto did is thus more defensible than Seralini.

    Let's not act as if this study go definitive results - at least according to every expert analysis I've seen and I've been looking. If anything positive resulted, it may be that subject selection and lifespan must be taken into account if you want meaningful results for long-term testing. Or it will teach european hack researchers how to engineer experimentation for results.

    Gerhard Adam
    I fully agree that there is nothing definitive about this and no conclusions should be drawn from it.  There's absolutely no question that longer-term effects require more careful scrutiny as to whether they are statistically significant or whether they can be accounted for my random events, or small control groups.

    I don't have a quarrel with that.  Arguing about whether the sample size is proper for positive versus negative results misses the point.  The protocol is specifically recommended so that ANY effects can be noted.  If none are detected [i.e. a positive result] then there is no compelling reason to do more exhaustive testing when assessing toxicity.  However, correspondingly, if negative results were obtained, then clearly that would be an indication that further follow-up needs to occur. 

    In the same way that you're arguing that this study isn't definitive [and I agree], I would argue that 90-day rodent studies are also not definitive when it comes to establishing "zero-effect" in humans.  This becomes especially relevant when it comes to assessing long-term effects.  As an example ... a 90-day study assessing the effects of asbestos would show nothing.
    Mundus vult decipi
    Gerhard Adam
    You're sounding like this is something that was just made up.  This was the recommended protocol for the GM food safety studies.  The original reference is from the review of those animal studies, which was intended to assess how they acted overall.  This was provided to me as evidence for GM safety.  Now you're telling me that it's wrong and everyone else is wrong.
    The method is based on the repeated oral administration of the substance of interest over a prolonged period (one dose level daily during 90 days). This Test Guideline is intended primarily for use with rodents (rat preferably). At least 20 animals (10 female and 10 male) should be used for each test group. Three concentrations, at least, should be used. The test compound is administered by gavage or via the diet or drinking water. A limit test may be performed if no effects would be expected at a dose of 1000 mg/kg bw/d. The results of this study include: measurements (weighing at least once a week, food and water consumption) and daily and detailed observations (ophtalmological examination, haematology, clinical biochemistry and urinalysis), each day preferably at the same time; as well as gross necropsy and histopathology. A properly conducted 90-day subchronic test should provide a satisfactory estimation of a no-effect level.
    http://www.oecdbookshop.org/oecd/display.asp?lang=EN&sf1=identifiers&st1=5lmqcr2k7p9x
    So, tell me what's right?
    Mundus vult decipi
    Hank
    This was provided to me as evidence for GM safety. Now you're telling me that it's wrong and everyone else is wrong.
    I encourage you to write an article defending this study and its methodology.  Spreading doubt is easy, here is your chance to change GMO studies for the better and educate the public.
    It says 90 day right in it.

    So they did NOT follow the protocol. They used a short term protocol for long term tests.

    Also I thought they did not include urinalysis. Also I thought they did not record consumption.

    So other than sample size, did they follow international protocol?

    Gerhard Adam
    I fully agree that any conclusions aren't going to be definitive or even very representative, because it was long-term.

    However, a single study should never be interpreted as something conclusive regardless of who conducts it or how it is conducted.  The point here is that he followed the same protocols that anyone else would follow to determine whether there was any risk that would warrant further investigation.

    I agree that it is wrong to draw any conclusions from this.  However, until the data is examined, then we simply don't know if there is something further to investigate or not.  My problem with this whole thing is that the safety studies don't seem to be as numerous nor as conclusive as everyone is representing.

    I'm certainly not arguing that this study is definitive or even defensible.  I just find it interesting that most of the reaction seems to focus on Seralini rather than the study.  This sounds very similar to the attacks on E.O. Wilson, Nowak, et al.  Similarly when we saw a report about arsenic-based life forms, there was a set of good responses that raises legitimate questions about the published results.  Instead I'm seeing a lot of comments that aren't scientifically refuting the claims, but rather just engaged in generic attacks.

    What I find most disturbing about this whole thing, is that it would seem that the simplest approach would be to discredit Seralini's findings by simply citing some comprehensive studies that clearly refute his claims.  Again ... it's surprisingly silent on that front.
    Mundus vult decipi
    Hank
      The point here is that he followed the same protocols that anyone else would follow to determine whether there was any risk that would warrant further investigation.
    Still not sure why you are perpetuating this myth.  Nothing in any protocol says 'use 10 rats' (or 20 - if you can figure it out, educate us all) and 190 test subjects and it is valid.  It is not valid. 
    Gerhard Adam
    The method is based on the repeated oral administration of the substance of interest over a prolonged period (one dose level daily during 90 days). This Test Guideline is intended primarily for use with rodents (rat preferably).
    ===> At least 20 animals (10 female and 10 male) <===
    should be used for each test group. Three concentrations, at least, should be used. The test compound is administered by gavage or via the diet or drinking water. A limit test may be performed if no effects would be expected at a dose of 1000 mg/kg bw/d. The results of this study include: measurements (weighing at least once a week, food and water consumption) and daily and detailed observations (ophtalmological examination, haematology, clinical biochemistry and urinalysis), each day preferably at the same time; as well as gross necropsy and histopathology. A properly conducted 90-day subchronic test should provide a satisfactory estimation of a no-effect level.
    http://www.oecdbookshop.org/oecd/display.asp?lang=EN&sf1=identifiers&st1=5lmqcr2k7p9x

    From the study:
    This 2 year life-long experiment was conducted in a GPL environment according to OECD guidelines. After 20 days of acclimatization, 100 male and 100 female animals were randomly assigned on a weight basis into 10 equivalent groups. For each sex, one control group had access to plain water and standard diet from the closest isogenic non-transgenic maize control; six groups were fed with 11, 22 and 33% of GM NK603 maize either treated or not with R. The final three groups were fed with the control diet and had access to water ...
    Where is the myth?
    Mundus vult decipi
    Hank
    Just cut to the chase.  You read this study and say the methodology is fine, the statistical analysis is fine and therefore the conclusions are warranted.  GM or some combination or GM and Roundup causes cancer.  Right? 


    Not my graphic.  Gentomaat on Twitter did this because, like the rest of this paper, it is pretty arcane.

    3 groups got GM-feed (3 proportions)
    3 groups got GM-feed treated with herbicide (3 proportions)
    3 groups got normal feed, but with herbicide in the water (3 doses)
    1 control group got normal food and water.


    So yes, it is a myth that they followed any legitimate protocol.  You persist in advancing the idea that having 10 rats in a control group makes anything valid, including among all these different experimental groups. You have to have done rock solid statistical analysis (including some kind of confidence interval) to use this kind of control and make a wild claim and not be called out for it.  That's without even getting into the rest of the problems.

    We can fault the peer review of the journal, to be sure -tThe same journal printed homeopathy articles too -  but that is no reason to excuse this.
    Gerhard Adam
    Yet, it appears to be considered valid when it is done in a safety study.
    Apparently these studies (Brake and Evenson, 2004; Haryu et al., 2009) roughly followed the OECD Test Guideline (OECD, 1998) (see Table 3). Twenty animals (10 female and 10 male) were used at each dose level, of which there were three, and a control was used (OECD, 1998; ANSES, 2011).
    Assessment of the health impact of GM plant diets in long-term and multigenerational animal feeding trials: A literature review, Snell Chelsea, et al.  Dec. 2011

    From another study entitled:
    Nutritional Evaluation of Genetically Modified Maize Corn Performed on Rats
    The abstract indicates:
    "From these results can be concluded that regarding nutrient composition and utilisation, genetally modified (RR) maize is equivalent to isogenic maize."
    From the conclusion:
    "It can be concluded that the genetically modified (RR) maize used in our experiments revealed equivalence in chemical composition and nutritional value compared to conventional maize."
    Yet in the study itself, we again find:
    "The animals were weighed before preliminary and experimental period, at beginning and end of balance experiment and end of feeding experiment, respectively.  Each group consisted of 10 animals."
    http://cera-gmc.org/docs/articles/09-215-015.pdf
    I'm not disputing that reported claims are invalid or at least wildly inappropriate.  Certainly no single study should claim conclusions without confirmation and repeatable tests.  However, that doesn't render the actual methodology invalid.

    I agree, that you can certainly argue that there is too little data to draw conclusions from the statistical analysis.  Again, it is inappropriate to claim conclusions, however it may well be legitimate to argue that further testing is necessary.  After all, that's exactly what would have occurred in any other such study had unusual results been found. 

    For the sake of argument, let's assume that no studies had ever been done.  This is the recommended protocol for making an initial assessment.  If no effect was found, then the protocol suggests that nothing further need be done.  If an effect is found, then obviously further study is necessary.  So, that's precisely what is happening [other than the hype and claims that aren't supported by the study]. 
     You read this study and say the methodology is fine, the statistical analysis is fine and therefore the conclusions are warranted.
    No, I didn't say that.  I said that the protocol was followed and that criticizing it was setting a double standard.  However, in fairness, let's remember that the methodology of many of the safety studies is also criticized as being flawed.  For example, approximately 15 [out of 24] of the studies reviewed in the paper quoted earlier failed to use an isogenic line.  A few failed to even indicate the number of animals used, while others used an incorrect number of animals.  Let's keep in mind, that these are all studies that indicated that GM foods are safe.

    Similarly with the statistical analysis, there is little doubt that 10 animals is too small a sample to draw any conclusions; pro or con, and yet this is precisely what has been done repeatedly in safety studies.

    Even the criticisms I've read of the study don't mention the OECD protocol, which is precisely why I raised my objections.  Whatever else might be wrong and whatever unwarranted conclusions are drawn there is a difference between responding to the hype and contributing to it, versus criticizing the data and any conclusions drawn from it.

    As you know, I don't think GM foods are harmful [at least, it seems unlikely], but I am appalled at the lack of scientific data that could and should have been gathered over the past 20 years.  It is unfathomable that if a GM critic or skeptic comes along, we have nothing better to offer than a few 90-day rodents studies, of which even those have legitimate criticisms leveled at them.
    Mundus vult decipi
    Gerhard Adam
    The commentary on the graphic leaves a bit to be desired.  The "Cause of Death" heading only occurs that way because it's the first of three graphs, and anyone reading the legend isn't going to infer that it was GMO, since that isn't a "cause of death".

    As for the comment about the "scientific term 'etc.'", perhaps a more thorough reading and being less of a smart-ass would do this poster some good.  The legend actually reads:
    "...necessary euthanasia because of suffering in accordance with ethical rules (tumors over 25% body weight, more than 25% weight loss, hemorrhagic bleeding, etc.)" 
    It is quite clear that they mean for any reason in compliance with ethical rules and wasn't intended to be an exhaustive list of such conditions.  In other words, it refers to the conditions of ethical euthanasia and not a specific cause of death.

    As I've said, let's criticize the data, or the conclusions, but this kind of nit-picky nonsense serves no one.
    The same journal printed homeopathy articles too -  but that is no reason to excuse this.
    This kind of reasoning simply increases the level of skepticism regarding science.  Who decides which peer-reviewed papers are "scientific" versus which ones aren't?  If peer-review doesn't work, then let's simply say so, and then the whole thing is up for grabs until someone comes along with something that can actually be trusted.  It's like ... "trust peer-review when it supports our ideas" or "peer-review doesn't count because they also publish trash". 

    BTW ... it appears that the scientific term "etc." appears in quite a few studies.
    "The appropriate methods used to measure phenotypic responses (body weight, food consumption, clinical biochemistry, etc.) in test animals throughout the test are also provided."


    Mundus vult decipi
    As I pointed out in the other thread, OECD 408 is for acute/subchronic toxicity. 451 is for chronic/carcinogenicity.

    And it recommends 50 of each sex, not 10. It also tells you to take into consideration factors that would require more subjects when you need to improve the statistical power.
    It also recommends 12 months for chronic toxicity and 24 for carcinogen. But it warns about geriatric effects, which makes the selection of the strain in question quite suspiscious.

    Seralini is an expert in the field. He is not confused here. He is selectively following different protocols to drive results. Are you seeing why I have an ad hominem grudge against this guy? You can't trust the results because a supposed expert intentionally followed SOME protocol just enough to look legit. Then did a press release. Then is releasing a book...

    Can we dismiss this yet? Or at least wait with baited breath for a redo that will confirm the results while doing it right?

    Gerhard Adam
    Seralini is an expert in the field. He is not confused here. He is selectively following different protocols to drive results. Are you seeing why I have an ad hominem grudge against this guy?
    So you're saying that he's intentionally lying and defrauding the public?  If this is so, then why would any peer-reviewed journal accept a paper from him?  Why is he affiliated with a university?  Is science really that broken?


    Mundus vult decipi
    Hank
    When it comes to GMOs in France, science is that broken.  The journal took the paper because they either did not peer review it or the peer was someone who thought that was acceptable.  It isn't all or nothing.  Just because one crank paper gets through does not mean science is broken but you keep trying to make it black and white.  It is not black and white.
    Gerhard Adam
    It is not black and white.
    It is black and white to the non-specialist.  You can't claim that science is based on peer-review and then when someone looks up the paper say ... Ahh .. not that peer.  You've already seen how the credibility of many scientists has been compromised by AGW.  To the non-specialist this is simply another case of scientists over-stating their case and creating the impression that economics is more important than good science.

    That's why everyone that has a negative paper gets so much attention, because people are waiting around for the other shoe to drop.  They simply don't trust those in authority and they're increasingly not trusting scientists. 

    I know your perspective is that this is precisely what the role of a site like Science 2.0 is, because it can provide the necessary buffer or even interpretation to help people sort out such discrepancies.  I agree ... but to do so requires a real bonafide critique of the paper; not simply calling Seralini a fraud.  That simply sounds like someone has an axe to grind.

    There is no question that the people that fundamentally oppose such technologies will never be convinced, so there's not much point in even criticizing the paper from that perspective.  People that simply wish to embrace it or believe it will do so regardless of what anyone else says.   However, others will not be swayed simply be declaring someone a fraud.  For many people it is frustrating to lack the scientific information necessary to actually debunk such claims because everyone is so busy calling each other names, they never actually provide the scientific basis for why such claims should be discounted.
    Mundus vult decipi
    Gerhard Adam
    When it comes to GMOs in France, science is that broken.
    Do you see how that statement could easily be translated to:
    "When it comes to GMOs from Monsanto, science is that broken." 

    Aren't you doing exactly the same thing that you accuse others of when they question the integrity of scientists that work for Monsanto?  Aren't you simply claiming that any science originating in France is to be arbitrarily discounted?
    Mundus vult decipi
    Hank
    No, their beliefs are despite the evidence, mine are because of it.
    Bonny Bonobo alias Brat
    Because of what evidence Hank? What links to evidence have you got to specific long term studies showing no harmful effects of Bt GMOs upon animals internal organs? 
    There are plenty of 90 and 120 days studies showing either adverse or significant effects that require further long term research but there is only one 30 day study of sheep eating Bt cotton, showing absolutely no adverse or significant effects on the organs of animals eating Bt GMO food that I know of. 

    Even the Hammond paper Results of a 90-day safety assurance study with rats fed grain from corn borer-protected corn from Monsanto that I was kindly sent a free copy of, showed some significant effects present in both the control group and the GMO food group but then there were significantly high levels of chlordane insecticide in the control groups grain, which was also used in the previous study, so I don't understand why they continued with these experiments, as it proved nothing to me.

    Yes, there are a few quail and mice studies showing that these vermin can reach adulthood and reproduce in a couple of months, after eating Bt GMos but that doesn't mean we can assume that there are no long term adverse or significant health effects on these same mice and quails and their internal organs does it? They just breed quickly.

    I agree with Gerhard that the two sides calling eachother names and blanket statements claiming that all people in France or at Monsanto are anti or pro science doesn't really help people like me, who are still undecided about GMOs and just want to see long term, multiple, preferably conclusive, peer reviewed, respectable, scientific papers and evidence demonstrating either lack of adverse health effects or evidence that there are some significant, long term, adverse or even non-adverse health effects so that we can make informed decisions and have to rely upon blind faith in one or other group of scientists. That makes it more like religion to me, not science.
    My latest forum article 'Australian Researchers Discover Potential Blue Green Algae Cause & Treatment of Motor Neuron Disease (MND)&(ALS)' Parkinsons's and Alzheimer's can be found at http://www.science20.com/forums/medicine
    I'm sorry Helen, but are you claiming a 2002 study, ( or is it the 2004 or 2006?) used as a control corn tainted with chloradene, and insecticide banned in 1988?

    I searched the 2002 monsanto study. No mention of chloradene.

    I think that needs serious clarification, or at very least you need to show your source for that and maybe question it. If the source is an anti-GMO website, then maybe you'll see why I have such little regard

    Bonny Bonobo alias Brat
    I'm sorry Helen, but are you claiming a 2002 study, ( or is it the 2004 or 2006?) used as a control corn tainted with chloradene, and insecticide banned in 1988?
    I searched the 2002 monsanto study. No mention of chloradene.
    I think that needs serious clarification, or at very least you need to show your source for that and maybe question it. If the source is an anti-GMO website, then maybe you'll see why I have such little regard
    Its the Hammond et al 2006 paper under results on page 1093. Also, I said chlordane not chloradene, do another search with the right name! Here is the excerpt form the 2006 paper  :-
    3. Results
    Compositional, contaminant, and nutritional content of the experimental diets met the specifications for Certified Rodent LabDiet 5002 established by PMI. The levels of heavy metals, aflatoxins, and chlorinated and organophosphate insecticides were below detection limits. For chlordane, the analytical limit of detection was higher (250 ppb) than the maximum allowable concentration of 50 ppb, but was not considered to have an impact on the study.

    According to Wikipedia chlordane is an insecticide with dangerous health effects, including adverse effects on the liver and it is also cancer causing, so in my opinion using a control grain with above acceptable levels of chordane made the 2006 Hammond study redundant and also the previous studies that Hammond et al said used the same control grain. 

    Chlordane, or chlordan, is an organochlorine compound used as a pesticide. This white solid was sold in the U.S. until 1983 as an insecticide for crops like corn and citrus and on lawns and domestic gardens.
    Health effects of chlordane
    Exposure to chlordane metabolites may be associated with testicular cancer. The incidence of seminoma in men with the highest blood levels of cis-nonachlor was almost double that of men with the lowest levels.[8] Prostate cancer has been associated with trans-nonachlor levels, a component of chlordane.[9] Japanese workers who used chlordane over a long period of time had minor changes in liver function.[10]Heptachlor and chlordane are some of the most potent carcinogens tested in animal models. No human epidemiological study has been conducted to determine the relationship between levels of chlordane/heptachlor in indoor air and rates of cancer in inhabitants. However, studies have linked chlordane/heptachlor in human tissues with cancers of the breast, prostate, brain, and cancer of blood cells—leukemia and lymphoma.
    The paper's abstract says :-
    There were a total of 400 rats in the study divided into 10 groups of 20 rats/sex/group. The responses of rats fed diets containing MON810 were compared to those of rats fed grain from conventional corn varieties. Overall health, body weight, food consumption, clinical
    pathology parameters (hematology, blood chemistry, urinalysis), organ weights, and gross and microscopic appearance of tissues were comparable between groups fed diets containing MON 810 and conventional corn varieties.

    So, these Monsanto Hammond et al studies deduced that there were no significant health outcome differences between feeding rats control grain with a much higher than the maximum allowable concentration of harmful chlordane insecticide compared to feeding rats borer resistant Bt GMO corn, so what does that prove? That they are both harmful maybe? The good news is that it was only a 90 day study therefore it was not really very useful for identifying long term health effects upon rats and their internal organs. Also, one rat was euthanased because it was injured, I would like to know how it was injured as exposure to the risk of injury normally implies exposure to stress, which could have been another significant factor in the experiment.


    My latest forum article 'Australian Researchers Discover Potential Blue Green Algae Cause & Treatment of Motor Neuron Disease (MND)&(ALS)' Parkinsons's and Alzheimer's can be found at http://www.science20.com/forums/medicine
    I'd like to know where (outside of the activist/nature obsessed blogosphere) are the hordes of experts criticizing and dismissing Monsanto's research? What about the hundreds of other safety assesments - I put out a link last week to the biofortified list.

    I see experts piling on criticism on this on. I see it released as a press blitz, with exclusions on allowing released copies being scrutinized by scientists. I see a guy claiming to be the target of a conspiracy selling a book. I see researchers putting their information in the hands of incredibly disreputable sources in the antigmo internet rings.

    What exactly would tell me as a non-researcher that this is to be taken seriously? Statements from Dr. Michael Antoniou supporting it? He was an advisor on the project and known anti-gmo scientist. He put his name on the incredulous "GMO Myths and Facts" misinformation document. Where are the scientists supporting this and not legitimately criticizing the methods?

    The insinuation that this is just as valid as any feeding study does not pass the smell test. When you follow a protocol and find too much variability to make statistically valid conclusions, you don't publish as if you found conclusions. But that doesn't mean that when similar studies are done and are found to have sufficiently low variability so as to allow you to draw statistically relevant conclusions, then you can be confident in them.

    You cannot draw the conclusion that GMO feeding studies based on OECD toxicity protocols are all illegitimate based on it being insufficient in this case. If the statistical relevency proves out, then great. If not, then redesign.

    There has been plenty of pretty damning analysis already linked in the threads related to this paper. I don't know how much more we need before we can preceed to call a hack a hack. Especially when history is in our favor in doing so.

    Hi Gerhard,
    I'm having a hard time determining your issue with the author. The point of his article is that the paper in question is flawed and that no conclusions can be drawn from it due to poor experimental design. You've stated a couple of times here that you feel that no conclusions can be drawn from it as well. So what's your problem here exactly?

    Gerhard Adam
    My problem is that the fundamental aspects of the experiment are executed exactly according to the recommended protocols.  However, the two most striking issues are that there was no carcinogensis protocol involved and that the conclusions are too dramatic for the protocols that were employed. 

    In many studies one can simply poke fun at the researchers and be done with it, but in this case [given the high level of interest many people have] I feel that a more thorough examination and specific level of critique needs to be employed.  In particular, this is because it isn't adequate in a topic this controversial to simply blow off a study as being "trash" or being handled by a "crackpot".  Instead it would be more beneficial to employ specific arguments to illustrate why something is wrong or what should have been done to achieve greater statistical significance or more credible results.

    You may consider that nit-picky, but in the generic types of criticisms being offered there's simply too much opportunity for people to pick up contrary views that muddy the water instead of providing coherent arguments as to why this study lacks merit compared to others than have been conducted.
    Mundus vult decipi
    "France is, as has been noted many times, the most anti-science country in anti-science Europe. "

    So, you are a xenophobic american who has the same view about the world that the republican party, the most anti-science party in the western world. And of all the countries in the world, the one you pick as "anti-science" is ... France, I think it says a lot about your intellectual honesty (or lack of).

    Hank
    It is what it is.  The same reason you call Republicans anti-science - 49% of them deny biology - is why France is anti-science. Except that the French are 82% anti-science, so even more kooky than Republicans.
    French are 82% anti-science? I don't know to which fringe opinion poll you are referring to but to try to justify your prejudices with some made up number is not very different that what Séralini did (anything to justify a preconceived opinion).

    Next time, try to learn about a country before to talk about it.

    Hank
    Hey, don't feel too bad, it's gone down a little.  In 2003 it was 89% of French denying biology.  At that rate, in 42 years the French will be as pro-science about biology as the Republicans you ridicule.

    Maybe you should spend less time ranting about America and more on curing your problems.   Seralini has refused to show anyone his data, even to EFSA, which is responsible for food safety in Europe, because he says showing data would be a 'conflict of interest'.

    Why do you think a scientist would be afraid to show his data to other scientists?
    So, one french scientist is on a personal crusade against Monsanto and, immediately, you feel entitled to insult the country (and even the continent) he happens to live in?

    And what do you mean by "denying biology"? I don't know exactly which question they were answering to but if it was, as I suspect, their opinion about GMO, I don't see how their answer can deny biology. After all, they can dislike the use of a technology without denying the knowledge behind it.

    But I won't convince you. I have met enough prejudiced people to know that persons like you are very fond of their irrationnal beliefs and that nothing that I say could change your mind.

    Hank
    What do I mean by 'denying biology'? The same thing you meant when you wrote "the republican party, the most anti-science party in the western world" - they deny biology, that is what I mean by denying biology.

    Those results, about Republicans and the French, were based on surveys and surveys show the French are  more anti-science about biology than any group in America, including religious fundamentalists. So you now say if Republicans deny evolution but not genetics, then they are also not anti-science to French thinking?  So much for your "prejudiced" and "irrational beliefs" that they are the most anti-science party in the western world.  It still means they are nearly twice as scientific as your entire country.
    So you equal an official denial of climate change and evolution by a major political party (and I won't even talk about their religious views) with some survey saying (and you don't even have any proof that it is true) that French people don't like Monsanto?

    Your own words clearly show that you are actually a right-wing activist who will say anything to defend your ideology. And it is probably why you hate France. Like most ignorant people in the republican party, you imagine that France (and Europe in general) is a secret pawn of the Komintern. Well, that is a fantasy, wake up.

    Hank
    I love France.  And I love lots of other countries despite the irrational beliefs of some of their members too, including the US.  I am just not as fervently nationalistic as you so I can criticize America or France when they are wrong.

    On Republicans, you don't know what you are talking about.  A Democrat took a rifle and shot a hole in the crap and trade bill in a television commercial, not a Republican.  That is as officially denying global warming as it gets. 41% of Democrats and 49% of Republicans deny biology - still a lot less than the 82% in France.  But you insist your anti-science denial does not count, nor does the denial of Democrats. Only Republicans count in anti-science denial.  Why is that? It seems the educational and logical nuance is as terrible as the science in France.
    Hank
    David Spiegelhalter of the Statistical Laboratory in the University of Cambridge, has found a glass half full way to look at this study.
    I am grateful for the authors for publishing this paper, as it provides a fine case study for teaching a statistics class about poor design, analysis and reporting. I shall start using it immediately.

    Have his students break their statistical teeth on this marvel of science:
    Results of a 90-day safety assurance study with rats fed grain
    from corn rootworm-protected corn
    B. Hammond a,*, J. Lemen a, R. Dudek a, D. Ward a, C. Jiang a, M. Nemeth a, J. Burns b
    a Monsanto Company, 800 North Lindbergh Blvd., St Louis, MO 63167, United States
    b Covance Laboratories, Inc., 9200 Leesburg Pike, Vienna, VA 22182-1699, United States
    Received 1 June 2005; accepted 22 June 2005

    This study assures us that Bt corn is safe for Millions of Animals and billions of People to Ingest for Many Years-Generation
    based on the following:
    Table 1
    Experimental design
    Groupa Animals/sex State corn
    grown
    Dietary level
    (% w/w)
    1. Control 20 Hawaii 11
    2. Control 20 Hawaii 33
    3. MON 863 20 Hawaii 11
    4. MON 863 20 Hawaii 33
    5. Reference A 20 Illinois 33
    6. Reference B 20 Illinois 33
    7. Reference C 20 Hawaiib 33
    8. Reference D 20 Hawaiib 33
    9. Reference E 20 Hawaiib 33
    10. Reference F 20 Illinois 33
    a Control and reference grain are from conventional varieties
    Table 7
    Summary incidence microscopic findings in high dose (33%) male and female rats following 90 days of exposure to MON 863 grain in the diet
    Tissue Microscopic finding Males Females
    Control, N = 20 MON 863, N = 20 Control, N = 20 MON 863, N = 20
    Adrenal, cortex Vacuolization 20 20 15 15
    Heart Cardiomyopathy 11 6 7 7
    Kidney Focal chronic inflammation 7 11 7 6
    Focal tubular regeneration 8 14 2 3
    Tubular mineralization 0 0 9 2*
    Liver Vacuolization 17 20 18 20
    Congestion 1 1 3 3
    Foci of chronic inflammation 17 17 19 18
    Bile duct, inflammation, chronic 6 10 5 6
    Bile duct hyperplasia 6 5 2 2
    Hemorrhage 0 2 2 0
    Necrosis (minimal) 0 3 1 0
    Rectum Parasitism 1 3 6 2
    Spleen Pigment, increased 18 20 19 20
    Stomach Dilation, glandular 1 4 1 2
    Thyroid Cyst, ultimobranchial 7 8 5 9

    Essential rudimentary test results are Not Published. Names of pathologists are Unavailable.

    GMO proponents have some nerve.

    Ask the class to answer the following questions:

    1. Is it possible to claim normal kidney function without a urinalysis?
    2. Is it Ok to have 5months old rats with those pathological findings

    and Most Importantly since this is a class on statistics

    Please show me the statistical work which indicates clearly how findings in 80 experimental rats fed Bt corn for 90 days equate to safety in People, Cats and dogs-- Billions of whom are ingesting this crap.

    Studies which form the basis of a decision declaring Bt crops safe to eat:

    http://www.epa.gov/oppbppd1/biopesticides/pips/bt_brad2/2-id_health.pdf

    Sjoblad, R. D., J. T. McClintock, and R. Engler (1992) “Toxicological Considerations for
    Protein Components of Biological Pesticide Products,” Regulatory Toxicology and
    Pharmacology 15:3-9.
    Vázquez-Padrón, R.I., L. Moreno-Fierros, L. Neri-Bazán, A.F. Martínez-Gil, G.A. de la Riva &
    R. López-Revilla (2000) Characterization of the mucosal and systemic response induced by
    Cry1Ac protein from Bacillus thuringiensis HD 73 in mice, Brazilian Journal of Medical and
    Biological research 33:147-155.
    Vázquez-Padrón, R.I., L. Moreno-Fierros, L. Neri-Bazán, G.A. de la Riva & R. López-Revilla
    (1999) Intragastric and intraperitoneal administration of Cry1Ac protoxin from Bacillus
    thuringiensis induces systemic and mucosal antibody responses in mice, Life Sciences 64: 1897-
    1912.
    Vázquez-Padrón, R.I., L. Moreno-Fierros, L. Neri-Bazán, G.A. de la Riva & R. López-Revilla
    (1999) Bacillus thuringiensis Cry1Ac protoxin is a potent systemic and mucosal adjuvant,
    Scandinavian Journal of Immunology 49:578-584.
    43130801 Williams, D. (1994) Product Characterization: Bacillus thuringiensis var. kurstaki
    (Btk) Protein in Corn: Lab Project Number: NKJNV2. Unpublished study prepared by
    Northrup King Co. 13 p.
    43352602 Williams, D. (1994) Product Characterization: Bacillus thuringiensis var. kurstaki
    Protein in Corn: Supplemental Information: Lab Project Number: NK5PDCH.
    Unpublished study prepared by Northrup King Co. 6 p.
    437548-01 Williams, D. (1995) Product Characterization: Bacillus thuringiensis var. kurstaki
    Protein in Corn: Registration Application. Unpublished study prepared by Northrup
    King Co. 23p.
    43397202 Meeusen, R.; Mettler I. (1994) Equivalence of Plant and Microbially Produced
    Bacillus thuringiensis kurstaki HD-1 Protein: Lab Project Number: 1/NK5EQ.
    Unpublished study prepared by Nothrup King Co.; University of Wisconsin; and
    Kendrick Labs. 43 p.
    43533201 Keck, P.; Fromm, M.; Sanders, P.; et al. (1995) Molecular Characterization of Insect
    Protected Corn Line MON 80100: Lab Project Number: MSL 13924. Unpublished study
    prepared by Monsanto Co. 100 p.
    IIB33Bt Plant-Incorporated Protectants October 15, 2001 Biopesticides Registration Action Document
    43533203 Lee, T.; Bailey, M.; Sanders, P. (1995) Compositional Comparison of Bacillus
    thuringiensis subsp. kurstaki HD-1 Protein Produced in European Corn Bore43533203 Lee, T.; Bailey, M.; Sanders, P. (1995) Compositional Comparison of Bacillus
    thuringiensis subsp. kurstaki HD-1 Protein Produced in European Corn Borer Resistant
    Corn and the Commercial Microbial Product, DIPEL: Lab Project Number: 94-01-39-12:
    MSL 13876. Unpublished study prepared by Monsanto Co. 35 p.
    43665501 Levine, E.; Groth, M.; Kania, J.; et al. (1995) Molecular Characterization of Insect
    Protected Corn Line MON 810: Lab Project Number: MSL 14204. Unpublished study
    prepared by Monsanto Co. 61 p.
    43533204 Lee, T.; Bailey, M.; Sims, S. (1995) Assessment of the Equivalence of the Bacillus
    thuringiensis subsp. kurstaki HD-1 Protein Produced in Escherichia coli and European
    Corn Borer Resistant Corn: Lab Project Number: 94-01-39-09: MSL 13879.
    Unpublished study prepared by Monsanto Co. 94 p.
    43145201 Keck, P. (1994) Determination of Copy Number and Insert Integrity for Cotton Line
    531: Lab Project Number: 92/01/36/12: 92/427/713. Unpublished study prepared by
    Monsanto Agricultural Group. 66 p.
    43145202 Sammons, D. (1994) Assessment of Equivalence Between E. coli-Produced and
    Cotton-Produced B.t.k. HD-73 Protein and Characterization of the Cotton-Produced B.t.k.
    HD-73 Protein: Lab Project Number: 92/01/36/14: 13170. Unpublished study prepared
    by Monsanto Agricultural Group. 45 p.
    43145203 Sammons, D. (1994) Characterization of Purified B.t.k. HD-73 Protein Produced in
    Escherichia coli: Lab Project Number: 92/01/36/18: 92/427/721: 13171. Unpublished
    study prepared by Monsanto Agricultural Group. 84 p.
    43145204 Sims, S. (1994) Sensitivity of Insect Species to the Purified CryIA(c) Insecticidal
    Protein from Bacillus thuringiensis var. kurstaki (B.t.k. HD-73): Lab Project Number:
    92/01/36/17:92/427/720: 13273. Unpublished study prepared by Monsanto Agricultural
    Group. 39 p.
    42932201 Keck, P. (1993) Molecular Characterization of CPB Resistant Russet Burbank
    Potatoes: Bacillus thuringiensis var tenebrionis: Lab Project Number: 92-01-37-14: 93-
    081E:92-448-715. Unpublished study prepared by Monsanto Co. 325 p.
    42932202 Rogan, G.; Anderson, J.; McCreary, J.; et al. (1993) Determination of the
    Expression Levels of B.t.t and NPTII Proteins in Potato Tissues Derived from Field
    Grown plants: Lab Project Number: 92-01-37-02: 93-081E: 12735. Unpublished study
    prepared by Monsanto Co. 349 p.
    42932205 Bartnicki, D.; Leimgruber, R.; Lavrik, P.; et al. (1993) Characterization of the Major
    Tryptic Fragment from Colorado Potato Beetle Active Protein from Bacillus
    thuringiensis subsp. tenebrionis (B.t.t): Lab Project Number: 92-01-37-15:93-081E:
    12994. Unpublished study prepared by Monsanto Co. 53p.
    42932204 Lavrik, P. (1993) Characterization of Colorado Potato Beetle Active Bacillus
    thuringiensis subsp. tenebrionis Protein Produced in Escherichia coli: Lab Project
    Number: 92-01-37-10:93-081E: 92-448-711. Unpublished study prepared by Monsanto
    Co. 82 p.
    42932206 Rogan, G.; Lavrik, P. (1993) Compositional Comparison of Colorado Potato Beetle
    (CPB) Active Bacillus thuringiensis subsp. tenebrionis (B.t.t.) Protein Produced in CPB
    Resistant Potato plants and Commercial Microbial Products: Lab Project Number: 92–
    01-37-17: 93-081E: 12988. Unpublished study prepared by Monsanto Co. 46 p.
    43468001 Naylor, M. (1992) Acute Oral Toxicity Study of Btk HD-1 Tryptic Core Protein in
    Albino Mice: Lab Project Numbers: 92069: 11985:ML92069. Unpublished study
    prepared by Monsanto Co. 264 p.
    43439201 Ream, J. (1994) Assessment of the In vitro Digestive Fate of Bacillus thuringiensis
    subsp. kurstaki HD-1 Protein: Lab Project Number: 93-01-39-04. Unpublished study
    prepared by Monsanto Co. 44 p.
    43145213 Naylor, M. (1993) Acute Oral Toxicity of Bacillus thuringiensis var. kurstaki (Cry
    IA(c)) HD-73 Protein in Albino Mice: Lab Project Number: 92197: ML/92/493.
    Unpublished study prepared by Monsanto Agriculture Group. 187 p.
    43145214 Ream, J. (1994) Assessment of the In vitro Digestive Fate of Bacillus thuringiensis
    var. kurstaki HD-73 Protein: Lab Project Number: 92/01/36/22: 92/427/728.
    Unpublished study prepared by Monsanto Agriculture Group. 43 p.
    42932217 Naylor, M. (1993) Acute Oral Toxicity Study of B.t.t. Protein in Albino Mice: Lab
    Project Number: 92170: ML-92-407. Unpublished study prepared by Monsanto Co.
    191 p.

    Creative framing makes some questions look pertinent when they are not:

    1. Who says they didn't do urinalysis? They say they did:
    http://www.ncbi.nlm.nih.gov/pubmed/15110110
    about 3 lines up from the bottom of the abstract
    http://www.ncbi.nlm.nih.gov/pubmed/16084637
    different study, same group. About 3 lines up.

    So, they did urinalysis. Question 1 is not valid.

    2. This is the wrong question to ask. The question you have to ask is whether the results are better or worse relative to a proper control group. Putting rats on a high corn diet could cause bad results in the first place (again, the same could be said for humans, which is why we do this with rats. If you really suspect that this stuff causes tumors, and your conclusion is "try it on a person," I really have to question your sanity.)

    Answer to Question 1:
    3.2.3. Urine chemistry
    There were no statistically significant differences in
    urinalysis parameters between the male and female
    33% MON 863 group and the 33% control group (data
    not shown).

    The answer to your other question is : there is no way to know, because the test results actually reported were only reported for 9-10 animals/ 20, out of a total of 80 experimental animals/ 400!

    What happened to the rest?

    And you have the audacity to critique Seralini?

    Table 2
    Hematology mean values ± SD in male rats following 90 days of exposure to MON 863 grain in the diet
    Parameter N 11% Control 33% Control 11% MON 863 33% MON 863 N Reference population
    mean ± 2SD
    WBC (103/ll) 10 7.27 ± 2.31 8.64 ± 2.24 8.39 ± 1.20 10.40 ± 1.57** 58 7.95 ± 3.82
    NEU (103/ll) 10 0.96 ± 0.25 1.03 ± 0.27 1.16 ± 0.40 1.13 ± 0.19 58 1.14 ± 0.98
    LYM (103/ll) 10 5.88 ± 2.10 7.21 ± 2.30 6.71 ± 1.11 8.80 ± 1.48** 58 6.41 ± 3.56
    Baso (103/ll) 10 0.00 ± 0.00 0.00 ± 0.00 0.00 ± 0.00 0.03 ± 0.05** 58 0.01 ± 0.04
    RBC (106/ll) 10 9.45 ± 0.39 9.44 ± 0.43 9.24 ± 0.39 9.35 ± 0.45 58 9.27 ± 1.05
    HGB (g/dl) 10 16.6 ± 0.3 17.0 ± 0.5 16.4 ± 0.5 16.9 ± 0.3 58 16.7 ± 1.62
    HCT (%) 10 46.9 ± 0.7 48.4 ± 1.4 46.2 ± 1.2 48.1 ± 0.9 58 47.7 ± 4.8
    Retic count 10 0.06 ± 0.03 0.07 ± 0.04 0.07 ± 0.03 0.06 ± 0.04 58 0.06 ± 0.06
    MCV (fl) 10 49.7 ± 1.64 51.3 ± 2.43 50.0 ± 1.71 51.4 ± 2.16 58 51.5 ± 4.8
    MCH (pg) 10 17.6 ± 0.60 18.0 ± 0.73 17.7 ± 0.70 18.1 ± 0.73 58 18.1 ± 1.61
    MCHC (g/dl) 10 35.4 ± 0.28 35.2 ± 0.50 35.5 ± 0.51 35.1 ± 0.60 58 35.0 ± 1.3
    PLT (103/ll) 10 1041 ± 90 1103 ± 147 1057 ± 64 1139 ± 137 58 1065 ± 356
    PT (s) 10 15.4 ± 0.47 15.3 ± 0.39 15.2 ± 0.51 15.3 ± 0.35 59 15.0 ± 1.46
    APTT (s) 10 19.3 ± 1.22 19.8 ± 0.94 18.8 ± 1.82 20.0 ± 0.92a 58 21.8 ± 5.76

    Table 3
    Hematology mean values ± SD in female rats following 90 days of exposure to MON 863 grain in the diet
    Parameter N 11% Control 33% Control 11% MON 863 33% MON 863 N Reference population
    mean ± 2SD
    WBC (103/ll) 9–10 6.78 ± 1.71 5.64 ± 1.52 8.20 ± 1.59 6.78 ± 2.20 58 6.43 ± 3.56
    NEU (103/ll) 9–10 0.80 ± 0.26 0.66 ± 0.24 0.83 ± 0.41 0.77 ± 0.25 58 0.65 ± 0.58
    Baso (103/ll) 9–10 0.00 ± 0.00 0.00 ± 0.00 0.00 ± 0.00 0.01 ± 0.03 58 0.00 ± 0.00
    LYM (103/ll) 9–10 5.69 ± 1.52 4.73 ± 1.39 7.06 ± 1.32 5.74 ± 1.98 58 5.52 ± 3.28
    RBC (106/ll) 9–10 8.64 ± 0.28 8.35 ± 0.63 8.65 ± 0.33 8.60 ± 0.18 58 8.53 ± 0.73
    HGB (g/dl) 9–10 16.3 ± 0.3 16.1 ± 0.5 16.4 ± 0.5 16.3 ± 0.5 58 16.2 ± 1.07
    HCT (%) 9–10 45.8 ± 1.1 45.6 ± 1.4 46.3 ± 2.0 45.8 ± 1.7 58 46.1 ± 3.6
    Retic count 9–10 0.09 ± 0.04 0.09 ± 0.05 0.06 ± 0.04 0.04 ± 0.03 58 0.07 ± 0.08
    MCV (fl) 9–10 53.1 ± 1.26 54.8 ± 3.88 53.5 ± 2.29 53.2 ± 1.93 58 54.1 ± 4.38
    MCH (pg) 9–10 18.9 ± 0.45 19.4 ± 1.14 19.0 ± 0.74 18.9 ± 0.56 58 19.0 ± 1.34
    MCHC (g/dl) 9–10 35.6 ± 0.23 35.4 ± 0.53 35.5 ± 0.46 35.6 ± 0.47 58 35.2 ± 0.96
    PLT (103/ll) 9–10 1099 ± 288 1016 ± 140 1026 ± 337 991 ± 119 58 1047 ± 298
    PT (s) 8–10 14.9 ± 0.42 15.3 ± 0.29 15.4 ± 0.20* 15.0 ± 0.45 56 14.7 ± 0.80
    APTT (s) 8–10 17.0 ± 1.91 15.8 ± 1.57 17.2 ± 1.22 16.5 ± 1.10a 56 20.0 ± 4.80

    You can certainly question my sanity, just as I question your ethics and morality: of engaging millions of experimental subjects without consent while lying about their products' safety.
    I have a better question for you " do people who practice censorship, character assassination of scientists critical of the corporate pseudo-science and experimentation without consent ( the kind they performed on concentration camp victims) scientists?

    Table 4
    Serum chemistry mean values ± SD in male rats following 90 days of exposure to MON 863 grain in the diet
    Parameter N 11% Control 33% Control 11% MON 863 33% MON 863 N Reference population
    mean ± 2SD
    ALP (U/l) 10 118.6 ± 25 106.3 ± 31 105.8 ± 20 107.5 ± 22a 60 91.5 ± 36
    ALT (U/l) 10 67.1 ± 35.0 55.0 ± 17.5 47.3 ± 4.5 50.3 ± 8.3 60 51.7 ± 36.0
    AST (U/l) 10 133.3 ± 94 99.2 ± 28 97.0 ± 15 94.4 ± 15 60 103.4 ± 70
    GGT (U/l) 10 0.50 ± 0.71 0.20 ± 0.42 0.10 ± 0.32 0.20 ± 0.42 60 0.20 ± 0.88
    BUN (mg/dl) 10 15.4 ± 1.4 14.0 ± 2.1 14.1 ± 1.4 14.7 ± 3.2 60 14.6 ± 0.76
    CREA (mg/dl) 10 0.58 ± 0.04 0.52 ± 0.04 0.54 ± 0.05 0.59 ± 0.09 60 0.55 ± 0.14
    TBIL (mg/dl) 10 0.11 ± 0.03 0.14 ± 0.07 0.11 ± 0.03 0.11 ± 0.03 60 0.11 ± 0.10
    TP (g/dl) 10 7.14 ± 0.29 6.86 ± 0.28 6.81 ± 0.31 7.20 ± 0.32 60 7.12 ± 0.60
    ALB (g/dl) 10 4.41 ± 0.16 4.27 ± 0.25 4.30 ± 0.21 4.40 ± 0.22 60 4.30 ± 0.42
    CHOL (mg/dl) 10 60.1 ± 12.8 65.3 ± 8.1 63.9 ± 11.1 64.6 ± 12.2 60 61.8 ± 25.4
    TRIG (mg/dl) 10 65.0 ± 18.8 69.8 ± 28.2 74.6 ± 27.0 70.6 ± 13.5 60 57.5 ± 43.6
    A/G 10 1.63 ± 0.17 1.66 ± 0.20 1.73 ± 0.20 1.59 ± 0.23 60 1.55 ± 0.34
    GLOB (g/dl) 10 2.73 ± 0.27 2.59 ± 0.21 2.51 ± 0.24 2.80 ± 0.32 60 2.81 ± 0.50
    GLU (mg/dl) 10 108 ± 6 109 ± 6 105 ± 8 116 ± 20 60 110 ± 17
    CA (mg/dl) 10 11.0 ± 0.64 10.7 ± 0.69 10.7 ± 0.45 11.3 ± 0.56 60 11.0 ± 1.24
    PHOS (mg/dl) 10 6.99 ± 1.00 7.72 ± 0.84 7.19 ± 0.75 8.16 ± 0.70 60 7.6 ± 1.4
    NA (mmol/l) 10 153 ± 2.5 152 ± 2.0 150 ± 0.9** 151 ± 2.9 60 153 ± 6.6
    CL (mmol/l) 10 107.7 ± 2.7 107.5 ± 1.7 107.2 ± 1.4 104.8 ± 2.2* 60 105 ± 6.0
    K (mmol/l) 10 5.70 ± 0.61 5.88 ± 0.45 5.59 ± 0.39 5.85 ± 0.73 60 5.88 ± 1.04
    Statistically significant differences *P < 0.05, **P < 0.01.
    a Statistically significant difference from reference population mean only, P < 0.05.
    Table 5
    Serum chemistry mean values ± SD in female rats following 90 days of exposure to MON 863 grain in the diet
    Parameter N 11% Control 33% Control 11% MON 863 33% MON 863 N Reference population
    mean ± 2SD
    ALP (U/l) 10 52.5 ± 16 52.5 ± 8 58.2 ± 17 48.8 ± 16 58 48 ± 22
    ALT (U/l) 10 47.1 ± 16.1 41.0 ± 7.6 64.7 ± 50.8 39.4 ± 5.7 58 38.2 ± 27
    AST (U/l) 10 96.5 ± 22 97.4 ± 9 149.4 ± 97 94.8 ± 12a 58 89 ± 56
    GGT (U/l) 10 0.80 ± 0.63 0.80 ± 1.32 0.40 ± 0.70 0.60 ± 0.84 58 0.62 ± 1.18
    BUN (mg/dl) 10 13.2 ± 2.3 14.6 ± 1.8 15.5 ± 2.5 14.4 ± 1.9 58 15.0 ± 3.48
    CREA (mg/dl) 10 0.56 ± 0.05 0.61 ± 0.06 0.63 ± 0.07 0.60 ± 0.07 58 0.60 ± 0.12
    TBIL (mg/dl) 10 0.18 ± 0.04 0.14 ± 0.05 0.18 ± 0.09 0.14 ± 0.05 58 0.14 ± 0.10
    TP (g/dl) 10 7.35 ± 0.46 7.37 ± 0.51 7.39 ± 0.40 7.57 ± 0.46 58 7.60 ± 0.66
    ALB (g/dl) 10 5.13 ± 0.33 4.86 ± 0.39 4.83 ± 0.29 5.11 ± 0.38 58 5.03 ± 0.64
    CHOL (mg/dl) 10 74.9 ± 16.1 72.9 ± 13.2 81.9 ± 14.6 87.1 ± 24.6 58 84.5 ± 2.2
    TRIG (mg/dl) 10 40.9 ± 12.3 43.9 ± 8.3 50.9 ± 7.8** 46.7 ± 15.0a 58 39.5 ± 15.2
    A/G 10 2.33 ± 0.27 1.95 ± 0.21 1.91 ± 0.26** 2.09 ± 0.22 58 1.99 ± 0.52
    GLOB (g/dl) 10 2.22 ± 0.25 2.51 ± 0.25 2.56 ± 0.31** 2.46 ± 0.21 58 2.57 ± 0.52
    GLUC (mg/dl) 10 103 ± 8 105 ± 8 113 ± 11* 116 ± 8* 58 115 ± 22
    CA (mg/dl) 10 11.1 ± 0.49 11.2 ± 0.33 11.1 ± 0.39 11.2 ± 0.32a 58 11.5 ± 1.3
    PHOS (mg/dl) 10 6.79 ± 0.68 6.91 ± 1.33 7.18 ± 1.19 6.98 ± 1.16 58 6.30 ± 2.16
    NA (mmol/l) 10 152 ± 2.4 150 ± 1.8 150 ± 2.5 152 ± 1.8 58 151 ± 5
    CL (mmol/l) 10 107.8 ± 1.9 107.1 ± 2.0 107.0 ± 2.3 108.6 ± 2.2b 58 104 ± 4.8
    K (mmol/l) 10 5.73 ± 0.54 5.72 ± 0.50 5.74 ± 0.48 5.62 ± 0.36 58 5.57 ± 1.04
    Statistically significant differences *P < 0.05, **P < 0.01.
    a Statistically significant difference from reference population mean only, P < 0.05.
    b Statistically significant difference from reference population mean only, P < 0.01.

    You said no urinalysis was done.

    The truth you are trying to point out is as follows:

    The Monsanto study had 20/sex/group. All were studied for body weight and were killed and necropsied in the end. Only 10/sex/group were studied at week 5 and 14 for urinalysis and heptology.

    My immediate non expert thought is that 1) 10/sex/group is within the protocol # for 90 toxicology, so good enough, 2) taking blood from all subjects at the midpoint could induce changes that would interfere with the overall study, so only 50% were studied for this. The same could likley be said for collecting urine...I don't know what that is like for rats, but I imagine it could cause some type of change.

    So they studied all 400 rats. 200 were studied for urinalysis and heptology, leaving 200 that were not, 50% in each group for comparison.

    Also notable is that they used 6 control groups in their experiment. What did Seralini do?

    Hammond et. al did not find any statisitical differences, Seralini re-analyzed and claimed he did, EFSA re-re-evaluated both Monsanto an Seralini and found Seralini's analysis and conclusions flawed. If you think you have somethign to add that has not been evaluated in this highly scrutinized case (like a claim that Hammond et al selectivley chose 50% of their rats and hid the rest) then I guarantee a journal will publish you. You might get a book deal, a media blitz and make a bunch of money.

    But in reality, you are listening to activist outlets making unsubstantiated claims like "where are the rest of the rats?" It's a non-academic appeal that sounds legit until you look deeper." No offense, but if your claim was anywhere approaching valid, it would have come up in the re or re-re-analyisis. I don't think Seralini even made that criticism in 2007.

    http://www.efsa.europa.eu/en/efsajournal/doc/19r.pdf

    hematology is what I meant to type. Not heptology

    Hank
    And I am wrong on something I said earlier, namely that even though this was under embargo they refused to give the paper to anyone, which is "Ida" levels of red alert suspicion

     Ivan Oransky at the invaluable Embargo Watch notes they did give out the paper to some in advance; but only if they agreed to certain *ahem* conditions.
    In a move regarded as unusual by the media, the French research group refused to provide copies of the journal paper to reporters in advance of its publication, unless they signed non-disclosure agreements. The NDAs would have prevented the journalists from approaching third-party researchers for comment.

    - BBC (one of the many examples he listed)


    "No one can make an informed review because he refuses to show the data."

    are Monsanto data publicly available?

    Hank
    Sure, if they published it in journals.  Their internal tests aren't required to be made public any more than any null or unpublished result of any scientist is.

    Plus, like this group did, you can just buy the GM food and run tests on it. It isn't like Monsanto was stopping them from testing the corn and thousands have done the same thing. What most have not done is publish selective chunks of data, say GM food causes cancer, and then tell every testing agency they cannot have the data because those testing agencies have a 'conflict of interest'.
    Science20 is clearly not safety oriented. Any study that brings up serious dangers in a food deserves more study, rather than ramming it through the mouths of people. The precautionary principle is absolutely necessary when it comes to food, water and air, that is, if we want to live healthy lives.

    Or is that not important to you?

    Monsanto's new sweet corn is also "RoundUp Ready," meaning it can tolerate unlimited amounts of Monsanto's herbicide RoundUp. Roundup causes endocrine disruption, damage to DNA, reproductive and developmental toxicity, neurotoxicity, and cancer, as well as birth defects. Many of these effects occur from very low doses, like those of pesticide residues found on food and in the environment.

    Farmers have used Bt-toxin from soil bacteria as a natural pesticide for years, and biotech companies have therefore claimed  that Bt-toxin has a "history of safe use in agriculture." But there's a huge difference between spraying it on plants, where it biodegrades in sunlight and can be carefully washed off, and genetically altering the plant to produce it internally.

    Bt crops have the Bt-toxin gene built-in, so the toxin cannot be washed off. You simply cannot avoid consuming it. Furthermore, the plant-produced version of the poison is thousands of times more concentrated than the spray.

    More grist for the mill....

    Last year, doctors at Sherbrooke University Hospital in Quebec found Bt-toxin in the blood of:
    • 93 percent of pregnant women tested
    • 80 percent of umbilical blood in their babies, and
    • 67 percent of non-pregnant women
    The study authors speculate that the Bt toxin was likely consumed in the normal diet of the Canadian middle class—which makes sense when you consider that genetically engineered corn is present in the vast majority of all processed foods and drinks in the form of high fructose corn syrup. They also suggest that the toxin may have come from eating meat from animals fed Bt corn, which most livestock raised in confined animal feeding operations (CAFO, or so-called "factory farms") are.
    These shocking results raise the frightening possibility that eating Bt corn might actually turn your intestinal flora into a sort of "living pesticide factory"… essentially manufacturing Bt-toxin from within your digestive system on a continuing basis.
    If this hypothesis is correct, is it then also possible that the Bt-toxin might damage the integrity of your digestive tract in the same way it damages insects? Remember, the toxin actually ruptures the stomach of insects, causing them to die. The biotech industry has insisted that the Bt-toxin doesn't bind or interact with the intestinal walls of mammals (which would include humans). But again, there are peer-reviewed published research showing that Bt-toxin does bind with mouse small intestines and with intestinal tissue from rhesus monkeys.
    Bt-Toxin Linked to Allergies, Auto-Immune Disease, and More
    If Bt genes are indeed capable of colonizing the bacteria living in the human digestive tract, scientists believe it could reasonably result in:
    • Gastrointestinal problems
    • Autoimmune diseases
    • Food allergies
    • Childhood learning disorders
    And lo and behold, all of these health problems are indeed on the rise… The discovery of Bt-toxin in human blood is not proof positive of this link, but it certainly raises a warning flag. And there's plenty of other evidence showing that the Bt-toxin produced in GM corn and cotton plants is toxic to humans and mammals and triggers immune system responses. For example, in government-sponsored research in Italy , mice fed Monsanto's Bt corn showed a wide range of immune responses, such as:
    • Elevated IgE and IgG antibodies, which are typically associated with allergies and infections
    • An increase in cytokines, which are associated with allergic and inflammatory responses. The specific cytokines (interleukins) that were found to be elevated are also higher in humans who suffer from a wide range of disorders, from arthritis and inflammatory bowel disease, to MS and cancer
    • Elevated T cells (gamma delta), which are increased in people with asthma, and in children with food allergies, juvenile arthritis, and connective tissue diseases.
    Rats fed another of Monsanto's Bt corn varieties called MON 863, also experienced an activation of their immune systems, showing higher numbers of basophils, lymphocytes, and white blood cells. These can indicate possible allergies, infections, toxins, and various disease states including cancer. There were also signs of liver- and kidney toxicity.
    Topical versus Internal Toxins
    Farmers have used Bt-toxin from soil bacteria as a natural pesticide for years, and biotech companies have therefore claimed  that Bt-toxin has a "history of safe use in agriculture." But there's a huge difference between spraying it on plants, where it biodegrades in sunlight and can be carefully washed off, and genetically altering the plant to produce it internally.
    Bt crops have the Bt-toxin gene built-in, so the toxin cannot be washed off. You simply cannot avoid consuming it. Furthermore, the plant-produced version of the poison is thousands of times more concentrated than the spray.
    There are also peer-reviewed studies showing that natural Bt-toxin from soil bacteria is not a safe pesticide either:
    • When natural Bt-toxin was fed to mice, they had tissue damage, immune responses as powerful as cholera toxin , and even started reacting to other foods that were formerly harmless.
    • Farm workers exposed to Bt also showed immune responses .
    • The EPA's Bt Plant-Pesticides Risk and Benefits Assessment, created by their expert Scientific Advisory Panel, states that "Bt proteins could act as antigenic and allergenic sources."

    The "GMO in Babyblood"-paper is another delicious piece of activist science.
    It completely disregards the use of Bt toxin in organic farming as a potential source. But that doesn't really matter because the Bt-measurements are crap anyway. They used an assay that was never validated for blood samples. And if I'm not mistaken they quantified well bellow the quantification limit of said assay.

    You are correct.

    Besides that, it violates the "extreme claims require extreme evidence" criteria.

    If it is to be accepted, we have to believe that bt toxin is not digested by cows, passes from gi system to the blood to the meat. It must not be metabolized at a high rate as to excrete it. Then we must believe that it is not digested by people eating meat, and it passes from gi to blood where it must be bioaccumulated and not metabolized very quickly. OR that pregnant women in canada munch on pretty raw field corn and soy all day long.

    The findings seemingly contradicted logic and reality. Yet instead of rock solid evidence, they used a missapplied assay without validation and used it quantataively outside of the detection limits.

    Big results, lackluster supporting evidence.

    In order to clarify the subject, Seralini should obviously release the data behind his paper. I recommend as many people as possible sign the petition asking him to do so at http://www.ipetitions.com/petition/dr-seralini-please-release-data/

    Hank
    The fact that he needs a petition to show data (who doesn't put data in the supplement?  I never heard of that before) means he is not doing science, he is conducting advocacy.  So don't expect him to do it any time soon, since all of planet Earth has a 'conflict of interest' in his mind.
    I suspect you are right. Nevertheless I still think we should try.