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    Conflict Of Interest? Ethics Debate Intensifies Over Retraction Of Flawed Séralini Rat Study
    By Jon Entine | January 17th 2014 05:00 AM | 13 comments | Print | E-mail | Track Comments

    Jon Entine is executive director of the Genetic Literacy Project, where this article first appeared.

    The ethics controversy over Food and Chemical Toxicology’s decision in November to retract a controversial GMO corn rat study by Gilles-Eric Séralini and colleagues at Caen University in France continues to simmer.

    Writing for the Hasting Center’s Bioethics Forum blog, two Georgetown University professors—Adriane Fugh-Berman, an associate professor in the Department of Pharmacology and Physiology and in the Department of Family Medicine, and Thomas G Sherman, director of the university’s Biomedical Sciences Program—blast the retraction, writing that it “reeks of industry pressure” and is a “black mark on medical publishing, a blow to science, and a win for corporate bullies.”

    Fugh-Berman is well known for her belief that industry is a corrupting force in science, and this broadside applies that scrim to this issue.

    The professors favorably cite a European NGO known for its anti-GMO views, SpinWatch, and make a number of controversial points:

    • The quality or scientific integrity of a journal article should not be a factor when a retraction is being considered; in other words, the fact that the Séralini study has been reviewed and rejected as sound science by every major food and biotechnology oversight organization in the world is of no consequence
    • It would have been perfectly appropriate for the journal to have written an editorial expressing its concerns. Instead, it seems the editors may have succumbed to industry pressure to do the wrong thing.
    • The media coverage in the U.S. has been one-sided; criticism of Séralini’s study has been widely covered in mainstream press, while information about the conflicts of interest of critics have remained in the alternative press.

    “There are hundreds of studies that should be permanently removed from the scientific literature, but the Séralini study is not one of them,” the authors conclude.

    The Hastings Center report was widely circulated by anti-GMO activists, such as GMWatch, and including anti-GMO foodie Michael Pollan, who immediately headlined it on his Facebook page (more than 75,000 followers ‘liked’ his post) and tweeted it while ignoring articles and the dozens of international independent science organizations supportive of the journal’s decision.Pollan
    The Hastings Center article prompted an analysis and searing rebuke by Marc Brazeau, who writes the RealFood.org blog.

    “First, Fugh-Berman and Sherman fail to put the retraction in the context of Séralini’s own ethical lapses,” he notes. “There were lapses in both the execution of the study and in his handling of the publicity following publication.”

    In an unprecedented step that infuriated journalists worldwide, Séralini embargoed the release of the study except to journalist’s with well known anti-GMO views in an apparent attempt to foil critical coverage and promote the simultaneous release of his book.

    Brazeau also challenges the Georgetown professors for claiming that the fact that the study’s data was incomplete, misrepresented or inconclusive was not grounds enough for a retraction. Séralini made “confident conclusions,” he noted, unsupported by the data. “It’s one thing to publish inconclusive results. It’s another thing to portray the evidence as demonstrating something that it does not. Even more problematic is that he went around the world trumpeting his conclusions,” despite an “avalanche of criticism … debunking his research.”

    Did Food and Chemical Toxicology cave to industry pressure, as the professors claim? “The incentives don’t really seem to point in that direction. For the industry, the retraction is a formality,” he writes. “The paper had already been universally discredited. It could only reflect poorly on the industry and stir up paranoia in those rallying to Séralini’s cause.”—which is exactly what has happened, encapsulated by the professors’ attack piece.

    They state that the quality of the Séralini’s work is beside the point. This is wrong. They seem to think that the Séralini Affair is a he said/she said affair; as if it were impossible for bystanders to assess whose position is stronger. It isn’t. Anyone with an 8th grade science education can understand the issues with the paper. Unless they are trying not to. The insinuation that the motivations of those who slammed the study could be explained by conflicts of interest is beside the point. It is beside the point because Séralini’s work was clearly substandard.

    Brezeau upbraids the professors for what he suggests is a cheap shot in their assertion that the journal and Séralini’s critics are all industry tools with ‘conflicts of interest.’

    “[I]t becomes a ‘Get (out) of Jail Free Card’,” he writes. “[I]t becomes an excuse for dismissing strong evidence and sound analysis. It leaves you lost in a hall of mirrors, surrounded by industry-funded research, revolving door regulators, and defending bad research that confirms your biases. It leaves you lost in a fever swamp of paranoia without firm footing. … “Fugh-Berman and Sherman level charges of conflict of interest while dismissing the questions about the quality of Séralini’s work. This is upside down and backwards. They should know better.”

    As Brezeau and others have pointed, the familiar anti-GMO charges of ‘industry corruption’ or ‘conflict of interest’ are often tactics designed to divert attention from the empirical data. The central question here: Does Séralini’s data sync with his conclusions? The post publication peer review process has overwhelmingly concluded “no.”

    And of course similar ‘conflict of interest’ allegations could be leveled against Séralini, but the professors tellingly do not adresss the French professors problematic history. The Séralini study was released the same week in 2012 that he launched a promotional campaign for his book titled “Tous cobayes!” (which translates to “We’re all guinea pigs!”). He is a consultant for Sevene Pharma (a homeopathic pharma company) and there is evidence that he is linked to Invitation to Life, a New Age faith healing cult, which touts his work.

    Seralini’s research campaign (reported to be more than 5 million Euros was funded in part with more than 3.2 million Euros by French organic food giants Auchan and Carrefour. Publicity for the release of his GMO rat feeding study claims was coordinated by the Sustainable Food Trust (SFT) lead by former UK organic industry Soil Association executive director Patrick Holden. Former SFT staffer Henry Rowlands, now an organic marketing exporter and publisher, hosts and maintains the GMO-Seralini official websites.

    Greenpeace, which is steadfastly critical of GMOs, has funded previous Séralini studies of GMO corn that raised other health concerns–a clear conflict of interest. Those studies were reviewed by the independent European Food Safety Authority, which concluded that the authors’ claims were not supported by the data.

    It appears that in their ethics critique, the Georgetown University professors presented only one side of the story.

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

    Additional Resources:

    Comments

    Bonny Bonobo alias Brat
    I find it difficult to understand all this hysteria and the ogoing intensification of this ethics debate about Seralini's now retracted and defunct 2012 rat cancer study? What I also find really amazing is why no one appears to have redone this experiment correctly with adequate sample numbers and appropriate strains of rats and levels of peer review. Surely that would be the best way to disprove to the public the possibility that NK603 or Glysophate is causing significant cancer in rats and/or humans?

    Your link above to the Elsevier article says the following about the now retracted 2012 Seralini paper :- 'Unequivocally, the Editor-in-Chief found no evidence of fraud or intentional misrepresentation of the data. However, there is a legitimate cause for concern regarding both the number of animals in each study group and the particular strain selected. The low number of animals had been identified as a cause for concern during the initial review process, but the peer review decision ultimately weighed that the work still had merit despite this limitation.' 

    'A more in-depth look at the raw data revealed that no definitive conclusions can be reached with this small sample size regarding the role of either NK603 or glyphosate in regards to overall mortality or tumor incidence. Given the known high incidence of tumors in the Sprague-Dawley rat, normal variability cannot be excluded as the cause of the higher mortality and incidence observed in the treated groups. '

    'Ultimately, the results presented (while not incorrect) are inconclusive, and therefore do not reach the threshold of publication for Food and Chemical Toxicology. The peer review process is not perfect, but it does work. The journal is committed to getting the peer-review process right, and at times, expediency might be sacrificed for being as thorough as possible. The time-consuming nature is, at times, required in fairness to both the authors and readers. Likewise, the Letters to the Editor, both pro and con, serve as a post-publication peer-review. '

    'The back and forth between the readers and the author has a useful and valuable place in our scientific dialog. The Editor-in-Chief again commends the corresponding author for his willingness and openness in participating in this dialog. The retraction is only on the inconclusiveness of this one paper. The journal’s editorial policy will continue to review all manuscripts no matter how controversial they may be. The editorial board will continue to use this case as a reminder to be as diligent as possible in the peer review process.'


    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
    Hank
     What I also find really amazing is why no one appears to have redone this experiment correctly with adequate sample numbers and appropriate strains of rats and levels of peer review. 
    It's not amazing to anyone else because it's illegal. That study was unethical and inhumane in almost every country. He'd be in jail if he had done it in the US because of the duration. Studies that are humane and done with adequate sample numbers and appropriate methodology have found no issue. Yet anti-science people insist those are all invalid because they were not done long enough, i.e., they are only willing to believe inhumane tests conducted so long that 70 percent of rats are guaranteed to get cancer. Then this one crazy crackpot is latched onto because it matches their confirmation bias, though every real study is considered inconclusive or too limited.
    Bonny Bonobo alias Brat
    It is often reported that we and our children are eating foods that have been sprayed with glysophate and that we are also drinking water that contains glysophate residues and this has been ongoing for all of our children's lives and most of ours, so why can't a rat study using an appropriate strain and sufficient numbers of rats that are not predisposed to getting cancer be done for longer than 120 days? Domestic rats usually live for 3 to 4 years, that is well over 1000 days. 


    Most people live for roughly 60 to 80 years, so wouldn't a 2 to 3 year long study feeding rats with the same food that we eat that has been sprayed with glysophate but that has maybe not been washed off by a dutiful chef and drinking the same water that we drink containing the same low levels of glysophate residues that are being reported in many areas, be no more inhumane or unethical than feeding these same levels of glysophate residues to us and our children and to their children for all of their lives?

    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
    Hank
    Why ask me? Get the Australian government to approve 3 year studies in rats.
    Bonny Bonobo alias Brat
    Well I would be happy to see even a one year study as I've never seen anything longer than 120 days. If anyone knows of any I would be grateful for the links. 
    It is not unethical to do long term feeding studies to rats of the same food and water that humans are already eating and drinking long term and then compare their health outcomes to a control group that is eating the same food types and ratios and drinking water long term that has definitely had no contact with glysophate and contains no glysophate residues. 

    Probably there are plenty of pet rats that are being kept this way in the houses of people who are also eating glysophate sprayed food and drinking the same glysophate contaminated water :)

    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
    Hank
    Why talk about it here, it is a waste of everyone's time for you to pontificate about someone who keeps rats in their houses. Why not write all of the anti-science groups against this stuff and ask them to do a study? Clearly the concern is there yet, based on their PR campaigns against science, but none of them bother to do studies, even though it only costs a few hundred dollars. And the ones who do studies that affirm your beliefs end up being frauds.

    So write the others and ask them to do some science instead of promoting fear.
    I think Helen posed the correct question. Each individual ingredient of Roundup has been studied in a variety of lab conditions, but the product itself is rarely studied "in the wild". When it is, there are so many variables that the results are always inconclusive in some way.
    (See, for example, http://www.scientificamerican.com/article.cfm?id=weed-whacking-herbicide-p)

    Hank
    Good luck finding a product that can't "suffocate human cells in a laboratory" - 100% of my Thanksgiving dinner would be banned for causing cancer in rats or humans if it did not occur naturally. 

    Outside that, I know most people don't realize how in vivo studies are misunderstood (and in cases like GMOs and pesticides, intentionally spun - and Environmental Health News, which guest-posted that on SciAm, is in the spin business), not sure what you mean about "in the wild"? Not only has this product been studied extensively in the wild, it is arguably the most exhaustively studied product in history.
    Hank
    Following up on my disbelief that Scientific American publishes guest posts by anti-science shills, this chemistry teacher created a label for what an egg label would have to look like, if a chicken didn't poop it naturally:
    I see what you did there. You attacked the source without responding to the argument, you created a straw man argument that had little (or nothing) to do with the link I provided, and then you reduced the argument to absurdity so you could make fun of an extreme example that no one mentioned. This is the kind of behavior that we usually see from chemical company shills and Fox News.

    To try to get the discussion back on track, I would point out that the argument I made was not just a mistake by SciAm. It was a summary of a study that was done for NIH, and never refuted.
    http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1281320/

    Rather than refuting the study, Monsanto simply made a few slight changes to the formula. This would be responsible behavior if, in fact, the combination of chemicals was one of the most "exhaustively studied in history". It is not. Each ingredient has been studied individually in different conditions, but the combination is lightly studied, if at all. That was the point of the original link.

    Hank
    This is the kind of behavior that we usually see from chemical company shills and Fox News.
    Or, if we are playing that game, your comment means you are a shill for MSNBC or Mother Jones?

    I fail to see how 'if you do not agree with me, you work for Fox News' passes for logic on whatever planet you hail from.

    The main problem is you take a court action as a scientific one. Monsanto got in trouble for making a marketing claim but that is some sort of super-trump card to you - meanwhile, the thousands of actual science studies are apparently dismissed as being done by shills for Big Demon Corn. Seriously, that sort of condemnation by allegation only convinces MSNBC viewers and people who read Mother Jones/Greenpeace/Grist/Union of Concerned Scientists/(insert your favorite nonsensical anti-science group here)
    Just because something is heavily studied does not mean that every study concluded it was safe.
    http://www.reuters.com/article/2013/04/25/roundup-health-study-idUSL2N0D...

    Just because Monsanto is able to find flaws in the most widely publicized recent study does not mean that they were able to reject every single study. (http://big.assets.huffingtonpost.com/carrasco_0.pdf)

    Just because I am making the same argument as a discredited report does not make me a liar. (Nor does it make you a corporate shill to do the opposite. All I said was that you were using the same arguments.)

    In fact, many of the mistakes made by Séralini were similar to the mistakes made in countless Monsanto studies. You can hardly indict one without indicting the other. Séralini and his colleagues have been sparring with Monsanto for years, and in 2009, they released a study re-analyzing the data in three Monsanto-funded safety studies on NK603 and two other corn varieties that were submitted to European regulators. Like Séralini's own recent study, Monsanto analyzed 10 out of a group of 20 Sprague-Dawley rats from each test group. Séralini's team was forced to fight legal battles in court in order to secure Monsanto's data for the comparative analysis, but once they did, they found that Monsanto somehow missed evidence that linked pesticide residue on the corn to toxic side effects. Hello. (http://truth-out.org/news/item/12284-inside-the-controversy-over-a-frenc...)

    More to the point of your sarcastic responses, Monsanto did not just get in trouble for making a false marketing claim. They got in trouble for routinely falsifying data in the studies they sponsored, and then using the fake studies in their marketing. (http://www.1hope.org/glyphos8.htm - search for the phrase "routine falsification of data")

    This is one of the more serious charges ever made against a chemical company. In fact, it is equally (or more) serious compared to the charges made against Séralini, yet you dismissed them as a "marketing claim" spat.

    One of the "marketing claims" that got them in trouble was the claim that the chemical was "biodegradable" and that the resulting crops themselves contained only "trace amounts" of glyphosate. In fact, nearly every single one of their own studies concluded that the crops contained higher amounts of glyphosate than were studied in their safety tests. (http://www.sciencedirect.com/science/article/pii/S0308814613019201)

    That last study is interesting in another respect as well. If you read carefully, you will see that monsanto intentionally faked the data in order to make sure the GM soy was not measured properly. (http://www.gmfreecymru.org/pivotal_papers/gmscience.html)

    This is a pretty significant omission. But it is not isolated. It is part of a pattern. Monsanto is desperately creating new studies to bolster their claims, while the majority of independent studies turn against them. (http://www.greenmedinfo.com/blog/monsanto-funded-science-denies-emerging...)

    They are doing the same thing in public and on the internet by actually hiring PR shills to repeat their claims, and to advance their arguments regardless of scientific evidence.

    In 1999, the New York Times revealed that Monsanto hired public relations giant Burson Marsteller to pay fake protesters who posed as “pro-GMO” food demonstrators outside a Washington, DC FDA meeting. The Biotech Industry Organization, a Monsanto-supported trade group, similarly was caught bringing African and Asian pro-GMO speakers to the 2002 Earth Summit and posing them as poor farmers. In 2003, EU environmentalists documented that Monsanto was covering up the industry ties of a group of African “farm experts” that attended a European Parliament meeting. Monsanto admits that these practices would violate their own rules of conduct, but the PR company has no such commitment. (http://www.nytimes.com/1999/12/08/business/monsanto-campaign-tries-to-ga...)

    But this discussion goes way beyond the name-calling nature of pointing out that someone is a paid shill.

    In the most widely known incident of falsifying test results in 1991, the owner of Craven Laboratories and three employees were indicted on 20 felony counts, the owner was sentenced to 5 years in prison and fined $50,000, the lab was fined 15.5 million dollars and ordered to pay 3.7 million dollars in restitution. Monsanto was hardly the only chemical company to hire Craven Labs, but you have to wonder how all these chemical companies managed to locate Craven Labs every time they had equivocal data to support.

    Monsanto claimed that they did not use any of the Craven Labs data, and that every study had been repeated by an independent lab. This was another of their "marketing" claims that did not stand up to examination. In fact, the primary "new" lab they were referring to in their 1993 filing was IBT.

    The EPA also found Industrial Biotest Laboratories (IBT) to have "serious deficiencies and improprieties" in toxicology studies and stated that "countless deaths of rats and mice that were not reported," and IBT had "fabricated data tables (Cox, 1995)." (http://darwin.bio.uci.edu/sustain/global/sensem/burry298.html)

    When the liver damage test was finally repeated by an independent lab two years ago, it confirmed exactly the amount of mouth and liver damage that the "Greenpeace" activists had originally claimed. (http://www.i-sis.org.uk/Glyphosate_Toxic_to_Mouth_Cells.php)

    As you mentioned, Glyphosate is one of the most studied chemicals in history. But we are increasingly finding that the majority of studies that support its safety turned out to be spun by Monsanto, or outright falsified. The remaining studies that are used in safety filings have serious question marks, such as studying a single chemical in Roundup without studying the remaining ingredients, studying concentrations much lower than farmers are actually using, and even studying slightly different formulations that are being marketed.

    This is what is known in the business as an "information war". Monsanto is picking out the straw men arguments and publicly slapping down every research study with even the slightest flaw. This distracts the public's attention from other studies that are more complex, and harder to summarize in a single sentence. (Plant disease, for example. http://www.responsibletechnology.org/posts/monsanto’s-roundup-triggers-over-40-plant-diseases/)

    I understand where the argument is going. The bottom line is that there are places in the world where GM crops mean the difference between food and starvation. There are poor countries that do not have the luxury of discussing long-term effects of pesticide, herbicide, or anything else. They are fighting for short-term survival, and fast-growing protein is a powerful tool that is not being offered by anyone else. If you toss someone a life preserver, no one cares whether it contains lead paint, PCB, or even DDT. They live through the day and worry about the future some other time.

    We are fortunate to live in a world, though, where much of the human race is not on the precipice of starvation. As such, we have an obligation to examine the long-term consequences of our actions, and to weight the benefits against the risks. A risk that might seem acceptable in Bangladesh might be unnecessary in Nebraska. (The last major swarm of locusts in Egypt was 2013. The last one in the U.S. was 1902.)

    One of the few tools that we have to evaluate the risk-vs-reward calculation is peer-reviewed scientific research. By waging an information war against their critics, Monsanto does a disservice to honest science, and to future generations who rely on us not to poison the environment.

    Monsanto is not suppressing dissent to save the Earth, though. They are suppressing dissent to increase their short-term profits. There is a big difference.

    Written by somebody trying to "minor" in global sustainability. Sites greenpeace...so pretty useless.
    http://darwin.bio.uci.edu/sustain/global/sensem/burry298.html

    All about something the dubious non-scientist, yogic flying Jeffery Smith....uselesser than useless.
    http://www.gmfreecymru.org/pivotal_papers/gmscience.html

    If it's just this easy to "prove" that all the published, accepted studies are faked, and all the trashed, debunked and discredited studies are real, than why are we scraping the bottom of the barrel.