In the light of the recently published study by Prof Gilles-Eric Seralini's team showing a Monsanto GM maize, as well as tiny amounts of Roundup, caused massive tumours, premature death, and organ damage when fed to rats over their lifespan, we are devoting the whole of the first part of this Monthly Review to considering this study in detail, particularly in the light of the ferocious backlash from the GM lobby and regulatory bodies. All the rest of the month's news will be contained in a separate Part 2 to this Monthly Review.
Since the release of the Seralini study our site has been coming under aggressive Distributed Denial of Service (DDOS) attacks, peaking on the day EFSA released its rushed preliminary rejection of the study. We are doing everything we can to counter the attacks and keep our site online. We are currently having to operate a simplified home page in order to do this, but the main site content is currently all still available. If the attacks do force our site offline at any time, please remember that you can follow all the latest news and links to sources via Twitter. You can do this even without being on Twitter yourself by going to this site and just scrolling down through the tweets: https://twitter.com/gmwatch
This is an important time to stay in touch!
Claire Robinson, Monthly Review editor
RESPONSES - PRECAUTIONARY
RESPONSES - RAPID REBUTTAL
RESPONSES - REGULATORY
RESPONSES TO THE ATTACKS
+ STUDY LINKS COMMERCIALISED GM MAIZE AND ROUNDUP WITH TUMOURS, ORGAN DAMAGE
On 19 September Prof Gilles-Eric Seralini's team published a study that showed a commercialised Monsanto GM maize (corn), NK603, as well as tiny amounts of Roundup claimed to be safe, caused massive tumours, premature death, and organ damage when fed to rats over their lifespan.
This was the most in-depth long-term toxicological study that has ever been done on a GM food. The results were shocking. France's former Environment Minister, Corinne Lepage MEP, called the study "a bomb" because it casts into question all existing regulatory authorisations of GMOs.
GM foods are routinely approved in the EU and elsewhere on the basis of, at best, inadequate 90-day feeding trials, which have not been mandatory and which the GM companies can design themselves. The key point about Seralini's study was that tumours and other serious effects only showed up 4-7 months into the study. These effects would be missed in a 90-day study.
+ THE PAPER BY SERALINI ET AL
+ INTRODUCTORY VIDEO ON THE STUDY
An informative video on Seralini's study (12:51)
RESPONSES - PRECAUTIONARY
+ RUSSIA SUSPENDS IMPORT AND USE OF US CORN
Russia suspended the import and use of American GM maize after the study was released.
+ AUSTRIA WANTS REVIEW OF GM APPROVALS PROCESS
+ FRANCE ORDERS PROBE
+ GM FIELD TRIALS DROPPED IN FRANCE
The huge French seed company Vilmorin has dropped plans to conduct field tests of GM crops next year in France in the aftermath of the Seralini study. "The political climate led us to put the question on hold for now," its Finance Director said. "We don't want to be provocative."
RESPONSES - RAPID REBUTTAL
+ MASSIVE ATTACK LAUNCHED AGAINST SERALINI
In the items below we take apart the attacks and the attackers of Seralini's paper. Many of the attacks repeat the same points, many circulated to the global media very soon after the study was published - most notably, by the UK's Science Media Centre. GMWatch has briefly answered some of the most common criticisms (wrong rat, wrong protocol, too few rats, etc.):
+ SCIENCE MEDIA CENTRE "EXPERTS" MASQUERADE AS INDEPENDENT
In what has become the norm for studies that show problems with GM foods, a collection of quotes from "experts" was rushed out to the media on the same day that the study was released, all trying to discredit Seralini's study. The source was the UK's Science Media Centre (SMC). The SMC's quotes were also pumped out via its clones in Australia and New Zealand and were circulated by Monsanto and the GM industry lobby group Europabio.
Because the UK's SMC successfully projects itself and its experts as independent, the critical quotes have been reproduced in media pieces around the world and some emdia outlets even backed away from giving coverage to the study. But the SMC is far from independent and seven out of the eight "experts" that the SMC quoted to discredit Seralini's study have clear conflicts of interest, which were not disclosed by the SMC.
+ FOOD WRITER ATTACKS SMC's DISHONESTY
In a letter to the Guardian, the well known British food writer Joanna Blythman pointed out that "the SMC is a well-oiled PR machine, funded in part by chemical, pharmaceutical, and biotech companies with a vested interest in seeing potentially profitable new technologies and products commercialised. Recently, the SMC tried to stifle concerns arising from a study by molecular biologists at the University of Caen... Within minutes of the results being published in a peer-reviewed journal, the SMC swung into action, spoon-feeding journalists ready-made quotes from eight hand-picked scientists, rubbishing the research and its authors. The SMC introduced these experts to the media solely by listing the universities and public institutions that employ them, failing to give the full flavour of their interests: seven out of eight are either evangelical advocates of GM food, or have received funding from, or worked with, prominent biotech corporations. Unless their intention is to
deliberately mislead the public, GM advocates within the science community must stop masquerading as objective by packaging their partisan views in a veil of 'pure' science."
+ SCIENCE MEDIA CENTRE EXPERTS GET IT WRONG - REPEATEDLY
The conflicts of interest impinging on the Science Media Centre's "experts" would not matter so much if what they said was scientifically accurate. But they came out with highly misleading statements - statements that were widely quoted as expert condemnation.
For example, Tom Sanders claimed that the Sprague-Dawley (SD) strain of rat that Seralini used "is very prone to mammary tumours", suggesting the tumours were to do with Seralini's choice of rat and nothing to do with the effects of their consuming NK603 maize or Roundup. But not only is the SD rat used by industry in its studies to gain approval for GM foods, it was also used in long-term toxicity and carcinogenicity tests performed by Monsanto on glyphosate to gain the 2002 approval for marketing it in the EU.
And it doesn't stop there. The European Network of Scientists for Social and Environmental Responsibility (ENSSER) reports that the National Toxicology Program of the U.S. Department of Health and Human Services uses the same strain of rat as Seralini in its 2-year studies, uncontested. They also found from a "brief, quick and still preliminary literature search of peer-reviewed journals" that Sprague Dawley rats were also used:
- in 36-month studies by Voss et al. (2005);
- in 24-month studies by Hack et al. (1995), Klimisch et al. (1997), Minardi et al. (2002),
Soffritti et al. (2006) and Gamez et al. (2007);
- in 18-month studies by Lee et al. (2010); and
- in 12-month studies by Perry et al. (1981), Conti et al. (1988), Morcos & Camilo
(2001), Flamm et al. (2003) and Gutierrez et al. (2011).
So if Seralini used "the wrong rat", so does industry as well as many other researchers into toxicity and carcinogenicity, and so we would need to throw out the hundreds of industry studies on chemicals and GMOs that have used the SD rat in support of regulatory approvals. That means goodbye glyphosate, thousands of chemicals, and many GM foods. More on Sanders' misleading caims:
Sanders used to be a consultant for Nutrasweet when it was owned by Monsanto. Maurice Moloney, director of Rothamsted Research, is another impartial expert quoted by the SMC. He developed the GM tech used in Monsanto's GM canola, founded a GM company invested in by Dow, and is so besotted GMOs that he got himself a Porsche with a GMO numberplate!
Moloney told the world's media, via the SMC, that Seralini used less control rats than treatment rats. That is untrue, as the control groups had the same number as each treatment group, in line with normal scientific practice. Boloney Moloney also dismissed Seralini's findings on the grounds that toxins should have a linear dose-response relationship - again nonsense, as scientists have published numerous papers since the 1990s showing that many toxins don't work in that way.
Ottoline Leyser, associate director of the Sainsbury Laboratory, funded by the well known GM enthusiast and biotech investor Lord Sainsbury, even claimed that Seralini's study "has very little to do with GM" and that, "The authors of the paper do not suggest that the effects are caused by genetic modification". While Leyser's statement is a bold attempt to limit the damage caused to GMOs by the new study, it is also plain wrong. Seralini's study was specifically designed to separate out the toxic effects of genetic modification from the effects of the herbicide Roundup. He found that both substances had similar toxic effects, both alone and in combination.
Disturbingly, it is these poorly based claims rushed out by the SMC that have been widely repeated in articles around the world. Astonishingly, some of them have even been repeated by regulators in their own rapid rebuttals of Seralini's paper. For more SMC "expert" boloney:
+ UK FOOD WATCHDOG SCIENTIST PRAISES SMC's FIXING OF THE MEDIA
Andrew Wadge, chief scientist at the UK Food Standards Agency (FSA), which is supposed to be safeguarding the interests of consumers, has praised Fiona Fox, the controversial director of the Science Media Centre, and her team for their impact on the reporting of science-related stories in the media. He notes how the SMC has won praise for "working quickly to put journalists in touch with impartial experts when science-based news stories break". Giving the Seralini study as a case in point, he expresses satisfaction at the way the SMC helped to shape coverage of the study.
+ MONSANTO'S RESPONSE TO SERALINI STUDY IS INVALID
Monsanto also dismissed Seralini's findings, saying that they "fall within historical norms for this strain of laboratory rats, which is known for a high incidence of tumours". Monsanto means historical control data - data from various other studies that they find in the scientific literature or elsewhere.
However, the use of historical control data is an unscientific strategy used by industry and regulators to dismiss findings of toxicity in studies intended to evaluate safety of pesticides, chemicals, and GMOs. While this topic may seem obscure, routine abuse of historical control data by industry and regulators puts public health and the environment at risk. See Earth Open Source's briefing:
RESPONSES - REGULATORY
+ RAPID REGULATORY REBUTTAL PREDICTABLE
A series of regulatory agencies moved quickly to issue rebuttals to the Seralini study. This was widely predicted, not only because of the clamour from the GM lobby, the concern over trade implications and the behind the scenes pressure from the United States, but because the study directly challenges the independence and the reliability of the expertise drawn on for public decision-making, and the key role played by the regulatory agencies themselves.
As Corporate Europe Observatory (CEO) notes the funding of the study reflects growing scepticism about GM regulatory decision making, "It is striking that Seralini's study's initial funding came from CERES, an association funded by major French supermarkets; being wary of both official studies and the possibility of a new major mad cow-type public health scandal, they decided to provide enough resources to produce a reliable risk assessment."
In addition, CEO points out that even though regulatory bodies like the European Food Safety Authority (EFSA) are supposed to be the "independent voice of science", many regulatory experts on key panels have had significant conflicts of interest, resulting in flawed guidelines for risk assessment. In other words, the biotech and pesticide industries have been able to influence key decision making.
For example, CEO has shown that "more than half of the GMO panel experts who signed the approval for this GM maize [NK603] had links with industry resulting in conflicts of interest, as defined by the OECD. Seralini in his press conference yesterday attacked the 'competence and even the honesty' of the EFSA experts at stake."
+ EFSA INSISTS "NO PROBLEM" WITH MAIZE IT PREVIOUSLY CLAIMED WAS SAFE
The European Food Safety Authority (EFSA) has issued its initial review of Seralini's study, pending a more detailed review to be released in the coming weeks. In its pre-opinion, EFSA claims there's no need to re-evaluate the safety of the GM maize and concludes that Seralini's study is of "insufficient scientific quality".
This was not unexpected considering that it was EFSA that claimed this maize was as safe as conventional maize - leading to the EU allowing it into its food and feed supply. EFSA has also argued against the need for mandatory feeding trials on GMOs and claimed that if they are done, 90 days is enough time to see any ill effects.
All these EFSA decisions are proven false if Seralini's findings are accepted. So if EFSA had come out with a decision that found any merit in Seralini's study, EFSA would be condemning many of its own previous decisions, as well as the credibility of its entire approach to 'regulating' GMOs. This is why Seralini requested that his study be reviewed by a new group of independent experts.
+ EFSA COORDINATES REGULATORY CRITICISM OF THE STUDY
Within days of the publication of the Seralini study, the European Food Safety Authority (EFSA) held a teleconference with representatives of a few member states, in order, as EFSA put it, "to discuss scientific concerns and avoid divergence".
EFSA said the study was of "poor quality." The conclusions "cannot be supported" and "there is no need for re-evaluation of NK603 and glyphosate". Germany and the Netherlands agreed with EFSA. France had requested historical control data from the rat supplier - suggesting that France will base its assessment on such irrelevant data (see above), which will only serve to create 'noise' and mask the effects of the GM maize and Roundup.
Astonishingly, Belgium even offered to write to the editor of the journal that published Seralini's study, regarding "the identified scientific weaknesses". The other participants responded that this may not be needed because "the scientific community is already reacting on this issue" and "Elsevier [the publisher] has received a significant number of letters requesting the reconsideration of the reviewing procedure for this paper". Thanks, no doubt, to the efforts of the Science Media Centre and its well-oiled disinformation machine.
+ PUSZTAI HITMAN OVERSAW EFSA DEMOLITION OF SERALINI
France's former Environment Minister, Corinne Lepage MEP, has flagged up serious concerns about EFSA'S rejection of Seralini's study - notably that EFSA is applying standards to Seralini's study that it fails to apply to the far less adequate studies underlying its own GM crop approvals, and appears to be trying to stifle debate and sweep the Seralini study under the carpet rather than asking for further investigation of the issue.
Lepage has also suggested that the criticisms contained in EFSA's response do not read like carefully considered opinions but like a rapidly assembled copy/paste job of points already circulated by others ("wrong rat" etc.), and which largely fail to stand up to serious scrutiny.
But there is another serious concern being raised about EFSA's rapid review of Seralini's study. This is the fact that Andrew Chesson from EFSA's GMO panel was one of only two people appointed by EFSA to oversee that review. Chesson was not only on the EFSA panel that originally approved the GM maize NK603 for consumption in 2003, but he helped prepare the draft document recommending its approval, so Chesson was being asked to oversee a review of a study that suggested he personally might have made a terrible mistake that has put the health of millions of European consumers at risk.
Lepage has accused EFSA of "absurdity and an ethical conflict. This makes him [Chesson], at the same time, judge and jury on this opinion." This, she says, constitutes a major conflict of interest. She also says that Chesson's co-reviewer from the pesticides panel also had a conflict of interest, and she is now calling for the executive director of EFSA, Catherine Geslain-Laneelle, to resign.
But there is yet another disturbing aspect to Chesson's key role in EFSA's review. This is the fact that Chesson was previously involved in discrediting high profile research that raised serious questions about GM food safety and regulation - that of his former colleague Dr Arpad Pusztai. It was Chesson who chaired the audit committee which found fault with Pusztai's research, and which later rejected Pusztai's detailed response to its audit.
By rejecting Pusztai's conclusions, Chesson's audit report not only rubbished his research but effectively justified Pusztai having been forced to retire after expressing concerns about GM. However, when an independent panel of scientists from 13 different countries subsequently reviewed Chesson's audit report, they found serious fault with it, even suggesting its selection of data had been made with a view to disproving Pusztai's conclusions.
+ FRIENDS OF THE EARTH RESPONDS TO EFSA
Mute Schimpf, food campaigner for Friends of the Earth Europe said: "For the past decade, EFSA has consistently sided with the biotech industry and disregarded health or environment concerns about genetically modified crops. Instead of picking holes in independent, peer-reviewed research, it should be taking public concerns seriously and making long-term safety tests for genetically modified foods compulsory in the EU. The reaction from EFSA shows their double standards. If they had been as thorough with Monsanto's applications as they were with this new research then no GMO would have been approved in the EU."
FoE is calling for:
*National governments and EU safety authorities to suspend immediately from the market all Roundup-tolerant GM crops.
*The European Commission to suspend all new GMO approvals and to start a root-and-branch reform of how the risks of GM foods are assessed.
*The EU to review the safety of the herbicide Roundup (glyphosate), including the link between GM crops and the use of this herbicide.
+ GREENPEACE RESPONDS TO EFSA
Greenpeace EU agriculture policy director Marco Contiero said: "There is an unacceptable gap in current EU safety testing which largely ignores potential long-term health and environmental impacts of GM crops. This is yet another reason to immediately freeze approvals of new GM crops. The EU needs to redesign safety testing so that it routinely assesses impacts over the long term."
"EFSA recognises that appropriate methodology is crucial for serious scientific research, but omits to mention the fact that no agreed methods currently exist to carry out comprehensive testing of long-term exposure to GM food. This is why suitable methodologies must be developed and the French study should be replicated according to these agreed methods."
+ FSANZ USES WITHDRAWN STUDY TO DEFEND GM MAIZE
Another regulatory body that rushed to rebut Seralini, Food Standards Australia New Zealand (FSANZ), cited a study by Velimirov (2008) to counter Seralini's work and support the claim NK603 maize is safe. But Velimirov's study, which was commissioned by the Austrian government, found that NK603xMON810 stacked maize made mice less fertile when fed over several generations. The study met with the usual storm of attacks from the GM lobby and was withdrawn by the Austrian government after challenge from EFSA.
It's a sign of the desperation of pro-GM regulators more anxious to defend their GM approvals than investigate further, that they resort to citing a withdrawn study, showing that a GM maize caused infertility in mice, in order to try to discredit Seralini's study showing that a different GM maize caused different toxic effects - tumours, mortality, and liver and kidney disease - in a different animal. The message that consumers might reasonably draw from FSANZ's ham-fisted attempt to rescue Monsanto's GM maize is: eat GMOs and get tumours or become infertile - it's one or the other!
After GMWatch revealed its faux pas, FSANZ removed all mention of Velimirov from its online opinion, but you can read its original post here:
+ FRENCH FOOD AGENCY TO REVIEW STUDY
The French Agency for Food, Environmental and Occupational Health Safety (ANSES) will report on Seralini's study.
+ COURT OF AUDITORS SLAMS EFSA
Embarrasingly for the the European Food Safety Authority, the European Court of Auditors has just slammed it for its inadequate management of conflicts of interest which it says is "not robust enough." The Court - the independent audit institution of the European Union, whose job is to examine whether the EU's monies are being used in accordance with the rules - found serious shortcomings in the policies and procedures followed by EFSA, including not screening thoroughly enough the declared conflicts of interests of the scientists it appointed, and the presence of industry figures on its management board.
The Court's findings come as no surprise. Earlier this year the European Parliament postponed approval of EFSA's budget in the light of all the problems over conflicts of interest at the agency. In fact, EFSA and its GMO Panel have been riven with such conflicts for years. And in May of this year the Chair of EFSA's Management Board, which should be taking the lead in tackling the problem, was forced to quit because of her own flagrant industry links. Just a month earlier EFSA admitted to the European ombudsman that it had not properly responded to the case of Suzy Renckens, the former head of EFSA's GM unit, who left EFSA and moved directly to a lobbying job with the biotech giant Syngenta. Disturbingly, all the concern over conflicts of interest at EFSA didn't stop the European Commission earlier this year from nominating a food industry lobbyist and former Monsanto employee to become a member of EFSA's Management Board. The nomination was only withdrawn because of the highly critical public response.
Similarly, Corporate Europe Observatory say the GMO panel chair, Harry Kuiper, clearly used his position to influence the work of the panel in a pro-industry direction. The role played by Kuiper for 10 years is now under scrutiny by the European Ombudsman.
+ EU COMMISSION CHOOSES BAD TIME TO WATER DOWN GM REGULATION
The European Commission is currently trying to push through a new draft Regulation that fatally weakens the way GM foods are assessed for safety.
+ SERALINI'S PAPER EXPOSES MAJOR REGULATORY FAILINGS
When Seralini's paper is attacked as inadequate, it is useful to compare it to the data and research on which regulatory approvals of GM foods are being made. CBAN has domne exactly that in a Canadian context, and what it shows is startling.
-Seralini's research was on Monsanto's GM Roundup-Ready corn NK603, and it studied over a two-year period the impacts of consumption of this corn on rats, with and without Monsanto's Roundup herbicide, and of Roundup alone.
-Monsanto, by point of comparison, published a 13 week "safety assurance study" with rats fed NK603 corn, but this wasn't until some 4 years after the Canadian regulators (Health Canada) had already approved Monsanto's NK603 GM corn for human consumption. It's important to remember that the health problems that Seralini's study highlighted only emerged after 13 weeks.
-Canada's regulators have not conducted any tests on NK603, or on any other GM food. In 2001, Health Canada approved Monsanto's GM NK603 for human consumption, based on a data package submitted by Monsanto. This data is not accessible to the public or to the wider scientific community, so nobody knows or can comment with certainty on its contents.
Health Canada did publish a 3-page summary of their 2001 decision and this makes no reference to a feeding trial, but "does refer to a gavaging study (typically a few days long), in which mice were force-fed a high dose of the single purified protein coded for by the modified Roundup Ready gene", i.e. it didn't involve the actual GM corn.
As CBAN also note, the Royal Society of Canada's 2001 Expert Panel on the Future of Food Biotechnology found with regard to the data behind Health Canada's decisions to approve GM foods, "there is no means of independent evaluation of either the quality of the data or the statistical validity of the experimental design used to collect those data." Although the Royal Society's Expert Panel, set up at the request of the Canadian Government, made a series of recommendations for improving GM regulatory decision making, these have all been ignored.
The failings of the Canadian regulatory system typify GM regulation worldwide.
RESPONSES TO THE ATTACKS
+ SCIENTISTS SIGN OPEN LETTER IN SUPPORT OF SERALINI
A long and growing list of scientists and academics have signed an open letter condemning the attacks on Seralini's study and the orchestrated campaigns of harassment against scientists whose research finds problems with GMOs. The letter speaks out for scientific freedom and honest debate. It says that the Seralini publication and resulting attacks "raise the profile of fundamental challenges faced by science in a world increasingly dominated by corporate influence. These challenges are important for all of science but are rarely discussed in scientific venues." It details the problems that need to be addressed. If you're a scientist or academic, please consider signing:
+ SCIENTISTS' RESPONSE TO SERALINI CRITICS SLAMS DOUBLE STANDARDS
The European Network of Scientists for Social and Environmental Responsibility (ENSSER) has published a very useful detailed response to criticisms of the Seralini study. It finds one weakness in the study - there were too few animals to do a statistical analysis of the tumours and mortality data, a factor that the authors acknowledged - but finds other criticisms of the study spurious.
ENSSER says, "The controversy and vitriolic attacks evoked by the study reveal one underlying aspect: The lack of appropriate and agreed methodologies for long-term studies to scientifically assess the effects of life-time consumption of GM foods." ENSSER calls for an end to the double standards that lead to regulators accepting at face value inadequate studies commissioned by GM crop companies for authorisations, while independent studies that find risks from GM crops are torn to shreds.
+ CANCER SCIENTIST SUPPORTS STUDY
Mustafa Djamgoz, professor of cancer biology at Imperial College, London, said Seralini's findings were a "surprise" but "significant. The experiments are, more or less, the best of their kind to date." He added that it is now important to ensure they are repeated with more animals by independent laboratories to confirm the outcome. "We are not scaremongering here. More research, including a repetition of this particular study are warranted," he said.
+ ATTACKS ON SERALINI A BARREL OF RED HERRINGS - PROFESSOR
Dr E. Anne Clark, a retired professor in plant agriculture at the University of Guelph, said many of the attacks on Seralini's study were "red herring" arguments. She cited Tom Sanders' "wrong rat" claim, as well as his claim that the tumours might have been due to unrestricted food intake - when allowing unrestricted food intake is a norm for industry studies on GMOs!
Dr Clark noted the use of "third party authorities" to criticise the study. This is a respected person whose views on a controversial subject are accepted simply because of their position. "Most of the academic and institutional commentators participating in the attack on Seralini's work have never conducted original research into the health effects of GM crops," writes Dr Clark. "Nonetheless, the authority of their titles accords the aura of impartial purveyors of sound, scientific reason."
+ ATTACKS ON SERALINI'S STATISTICS MISPLACED
Various charges have been made concerning the adequacy or appropriacy of the statistics used by Seralini's team, which included an expert statistician. Paul Deheuvels, member of France's prestigious Academy of Sciences and a renowned statistician, however, strongly rejects these attacks, "To my knowledge, these surveys were designed and analyzed in accordance with the best professional standards, and should be appreciated as such... I think Professor Seralini provided very strong evidence sufficient to establish the existence of some unexpected toxic effects from products previously considered safe. Of course, there will always be people who challenge these results, because of the fact that they are likely to have important consequences for industry. Their point of view cannot be sustained in the light of new experimental results, since there is no doubt about the seriousness and reliability of the actual conclusions of Professor Seralini."
+ GOVERNMENT ANALYST SAYS SERALINI'S FINDINGS SOUND
A former research analyst with a major government agency sent GMWatch an analysis of Seralini's findings. The analysis addresses the criticism that the groups of rats were too small to draw any real conclusions, as follows: "Too many things are going on here, both in terms of gross anatomy observations and timing, but also the biochemical measures and mechanisms, that are consistent with these observations [that there is a real effect of the test substances (NK603 and Roundup)]. Overall, it is the big picture, of all the results taken together, that is too striking to dismiss based on an assertion that the sample size is too small. Bottom line, something is going on in this study that cannot be - must not be - swept away. I conclude that GMOs must be assessed for safety using the lifetime of the test organism."
The Science Media Centre published a critique of Seralini's paper, produced by their team of statisticians (mostly employed by Big Pharma/Big Biotech), which predictably concluded that the study didn't show anything much at all. The former government analyst takes apart their critique, here:
+ PROFESSOR JOHN MOORE SAYS STUDY'S FINDINGS MUST BE TAKEN SERIOUSLY
Professor John Moore, a biologist and Jesuit priest based in Zambia, explains why criticisms of Seralini's study miss the point and why the biological reality of the findings is self-evident and must not be dismissed:
+ SERALINI IS NOT A FRINGE SCIENTIST
Many of the attacks seek to give the impression that Gilles-Eric Seralini is some kind of maverick or fringe scientist. In reality, as well as being Professor of Molecular Biology at the University of Caen, in charge of the Laboratory of Biochemistry and Molecular Biology, Seralini has written over 100 scientific articles and conference papers for international specialist symposiums.
He has also been an appointed member of two government regulatory commissions on GMOs - the Biomolecular Engineering Commission (CGB - Commission du Genie Biomoleculaire) which oversees risk assessment, on which he served for nine years, and the Biovigilance Committee looking at commercialised GMOs, on which he served for ten years. In 2003 he was appointed an expert advisor on GM to the European Commission in the context of its WTO dispute. And in 2008, Prof. Seralini was made a Knight of the French Order of Merit in recognition of his scientific research.
However, since the time that he began to voice serious concerns about GM, and about the quality of GM, food and pesticide regulation, he has come under sustained personal attack, particularly after his research exposing problems in this area was published in the peer reviewed literature.
In January 2011 he won a libel case against Marc Fellous, head of the French Association of Plant Biotechnology and the former Chair of the CGB on which Seralini served, but the defamatory attacks have continued, and have reached a new pitch following the publication of his most recent paper.
While serving as a regulator, Seralini saw GM regulatory decisions being pushed through independently of the full CGB by Fellous, who unlike Seralini has not published any research in international scientific journals relating to plant genetics, plant biotechnology, or food safety in regards to farm GMOs.
Seralini also points out that while Fellous and his associates, and bodies like EFSA, launch well-publicised attacks on his peer reviewed studies, their own opinions are not published in international peer-reviewed journals and are not therefore scrutinized with the same rigour, which limits their scientific validity.
+ WHY SCIENCE WON'T GIVE US THE ANSWERS ON GMOs - AGRO EXPERT
Attempts to prove the harmfulness of GMOs through the scientific route are doomed to fail, not because GMOs are safe but because of industry manipulation of science, says Jean-Pierre Berlan, an agronomist, economist, and retired director of research at the ag research institute INRA, France. Berlan says that just like with asbestos, "Industry and its mercenaries will always find some fault on any study, ask for more evidence, gain time, and hope, in the case of GMOs, that the genetic smog created meantime will make any scientific evidence impossible."
+ GMWATCH RESPONDS TO CRITICISMS OF STUDY
GMWatch has briefly answered some of the common criticisms of Seralini's study (wrong rat, wrong protocol, too few rats, etc.) here:
+ SERALINI'S CO-AUTHOR RESPONDS TO CRITICISMS
Dr Joel Spiroux, co-author of the study, responds to criticisms of the study:
+ DO LONG-TERM STUDIES ON GMOs SHOW THEY'RE SAFE?
A review of studies on GMOs is much cited by attackers of Seralini's study to claim GM foods have been found safe: Snell et al (2011) Assessment of the health impact of GM plant diets in long-term and multigenerational animal feeding trials: A literature review. Food and Chemical Toxicology.
The review looked at 12 long-term feeding studies and 12 multigenerational studies on GM crops and concluded, "Results from all the 24 studies do not suggest any health hazards".
However, many of these studies did find statistically significant differences in the GM-fed animals compared with non-GM-fed animals. Nevertheless the authors of the Snell review concluded, without justification, that these were of "no biological or toxicological significance".
In addition, many of the studies were not toxicological studies looking at health effects, but feeding studies to see how much weight an animal gained in relation to how much feed they consumed.
And the review authors applied strange double standards. They drew attention to numerous weaknesses in the study designs, but all the same accepted the conclusions of those studies that reported no adverse effects, as proof of safety!
+ WHY DID SERALINI BLOCK PRE-PUBLICATION ACCESS TO HIS PAPER?
One of the charges made against Seralini's team is that they sought to manipulate media coverage of their study. The BBC reported that they "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."
What could justify blocking pre-publication access to the paper? Well, how about what has happened to other studies with findings that raised concerns about GM food crops?
In the case of Arpad Pusztai, after news got out that The Lancet was planning to publish his research showing harm from GM potatoes, attempts to rubbish the study began ahead of publication, with one UK newspaper's science correspondent running a spoiler piece incorrectly claiming that the research was going to be published despite having failed peer review. A similar campaign was waged against Ignacio Chapela's study prior to publication. The reality is, as an article in the journal Nature notes, that papers suggesting that GM crops might cause harm attract a hail of abuse and find it immensely difficult to get a fair hearing.
+ BOGUS ATTACKS OVER TRANSPARENCY
Seralini's critics are demanding the full disclosure of his study's raw data - something there is not room for in the published paper, and in some cases implying he must have something to hide as he has not yet done so. But the European Network of Scientists for Social and Environmental Responsibility (ENSSER) note: "CRIIGEN announced its willingness to disclose data in the context of a fair and independent review. Again, the many calls for full disclosure as for example posted at an internet petition (Prakash et al. 2012) reveal familiar double standards. None of those experts - many of them with a long documented record of rejecting the basic principles of the EU biosafety legislation and opposing the improvement of risk assessment standards to meet these principles - were heard when data related to the applications for release and marketing of GM crops were kept secret by the regulator (on request by the applicants) and some of which could only be obtained by court decision."
Prof. Seralini is also asking the regulators to release on a public website all the health and environmental risks studies on GMOs including the most detailed blood analyses in the longest mammalian tests performed, as well as for the herbicide Roundup, for all scientists, journalists and citizens who want to compare everything about Seralini's study with those studies that led to the market release of these products. He will then do the same.
+ BOGUS ATTACKS OVER FUNDING
Seralini has also been attacked over the fact that some of his funding sources have concerns about GM - the implication being that this must inevitably lead to bias in his study. But ENSSER point out that this again shows double standards because following this funding logic "would invalidate all studies funded or conducted by industry and accepted by risk assessors and regulators." As it is almost invariably these studies which underlie GM food approvals, this would mean that GM foods would have to be withdrawn from the market.
According to ENSSER, "Clearly industrial promoters must be involved in risk assessment studies; but others funded indirectly by those interests, but not influenced directly or indirectly by them, have to be free to perform fully independent risk assessments. This will require new institutional and perhaps legislative arrangements in regulation and science funding, and this focused debate urgently needs to be initiated, by the responsible public authorities."
+ BOGUS ATTACKS OVER BIAS
Some of Seralini's critics say that the fact that Seralini is part of an institute - CRIIGEN - that has concerns about GM, this constitutes bias and makes his study automatically suspect. But this again reflects a double standard because the same logic is not used by these critics in relation to researchers who operate out of institutions that have a vested interest in GMOs. If the same logic was applied, all of their research would have to be rejected.
And according to Margarida Silva, a biotechnology expert at the Portugese Catholic University in Porto, who published a review in 2011 reporting a link between favorable outcomes in GMO studies and author affiliation with industry, Seralini's affiliations make him significantly less vulnerable to bias than the industry affiliated scientists who undertake GM studies.
"Conflict of interest is very real, and it does change the study outcome," Silva says but she suggests that affiliation with a non-governmental organization that opposes GMOs does not present the same hazards. "The NGO didn't stand to lose dozens of millions of Euros" in the light of the research results, she points out.
As university research funding has been drying up, many academics have been turning increasingly to industry for help. This, says Silva, is the problem. "It's not likely that people who develop such convenient, comfortable connections to industry are going to be interested in doing research that might effect that funding source," she said.