Hundreds of scientists defend Seralini against EFSA and other GM apologists
Below we have assembled some recent information which demonstrates that the "scientific community" (whatever that might be) is by no means obsessed with attacking Seralini and ignoring his results -- or portraying them as aberrations publicised by a charlatan. Enough is enough, and recently more and more scientists have been putting their heads above the parapet to signal their disgust at the tactics employed by EFSA, pro-GM groups in France, the Science Media Centre and many other organizations with links to the GM industry. They are clearly angry about the use of double standards, personal vilification, spurious scientific arguments and downright lies in the attempts being made to discredit the French research.
As Susan Bardocz and others wrote in their Open Letter: "When those with a vested interest attempt to sow unreasonable doubt around inconvenient results, or when governments exploit political opportunities by picking and choosing from scientific evidence, they jeopardize public confidence in scientific methods and institutions, and also put their own citizenry at risk. Safety testing, science-based regulation, and the scientific process itself, depend crucially on widespread trust in a body of scientists devoted to the public interest and professional integrity. If instead, the starting point of a scientific product assessment is an approval process rigged in favour of the applicant, backed up by systematic suppression of independent scientists working in the public interest, then there can never be an honest, rational or scientific debate."
We echo these sentiments, and we are appalled at the manner in which sound science has now been replaced by political expediency in the determination and guidance of public policy on GM products. We are not surprised when politicians tell lies about their policies being based on "sound science" -- when they patently are not -- but we are saddened by the manner in which so many scientists who so vigorously defend the interests of the GM industry appear to have forgotten entirely that there used to be something called scientific ethics.
INDUSTRY GETS AWAY WITH MISERABLE GMO TRIALS
Ingeniøren, Denmark, by Magnus Bredsdorff, translated by a volunteer fro GM Watch
05.11.2012 GM Watch, UK
SUMMARY: "There are stricter requirements for research demonstrating that GM plants are harmful than for the tests on which approvals are based. This is the opinion of several international lobby organisations, and they are supported by a member of the Danish Ethical Council. [...] According to a Danish senior scientist, Rikke Bagger Jørgensen, EFSA must correct its attitude. [...] "Only one standard must be applied in the assessment of this type of scientific research. It does not make sense that EFSA is criticising one party, but not the other, for the same mistakes."
There are stricter requirements for research demonstrating that GM plants are harmful than for the tests on which approvals are based. This is the opinion of several international lobby organisations, and they are supported by a member of the Danish Ethical Council.
Tougher and completely different standards are demanded of scientists to prove that GM crops constitute a considerable risk to human health than are requested of the industry to show that GMOs are safe to eat.
That is the critical message from a range of international lobby organisations. Recently, the German organisation Testbiotech published a report that is strongly critical of the European Food Safety Authority (EFSA).
EFSA delivers the final assessments on which the approval of GM crops for human consumption is based.
According to the German organisation, which aims to put a critical focus on GM crops, EFSA is ‰in deep water‰ in its criticisms of a French study on rats.
According to the scientist who performed the study, Professor Gilles-Eric Séralini from the University of Caen, the rats that ate GM corn developed tumours more quickly, and the tumours were larger. The same picture appeared if the animals drank water polluted with concentrations of Roundup approved for drinking water.
EFSA strongly challenged the conclusions, and at the same time listed a number of criticisms of the French professor. EFSA pointed out that the number of rats in the test were too few ˆ ten of each sex ˆ in each test group, which according to EFSA was insufficient to determine if the fluctuations were significant or random. Furthermore, the strain of the rat used in the tests, Sprague-Dawley, is known for its tendency to develop tumours, if it has unlimited access to food.
On top of that, EFSA said there were several other problems with the scientific paper, including lack of information on the exact composition of the feed.
The problem with the arguments of EFSA, according to the strong criticism published by green NGOs, is that the tests on the basis of which EFSA has approved the introduction of certain GMO products into Europe are based on poorly designed research.
Testbiotech concluded in its report: ‰Several times EFSA has unquestioningly accepted the results of trials which are not conducted in accord with the scientific standards that EFSA now invokes to criticise the French tests. But unlike Séralini's study, the previous studies concluded that there were no health effects from eating GM plants.‰ This inconsistency indicates that EFSA cherry-picks the most convenient scientific standards to suit its argument.
The criticism of ‰double standards‰ in scientific experimentation is not only expressed by green NGOs.
According to a Danish senior scientist, Rikke Bagger Jørgensen, EFSA must correct its attitude. Rikke Bagger Jørgensen is employed at DTU Risø [Danish Technical University at Risø near the City of Roskilde] and is a member of the Danish Ethical Council. She performs risk assessments on GM crops, including on gene flow, and sees several ethical problems with research in relation to GM technology.
Rikke Bagger Jørgensen said: "Only one standard must be applied in the assessment of this type of scientific research. It does not make sense that EFSA is criticising one party, but not the other, for the same mistakes."
The Danish scientist points to an article in the scientific journal Food and Chemical Toxicology, which also published the article about the French rat study. The article was an assessment of 24 long-term GMO feeding studies. Of these several were included in different agencies' evaluations of industry requests for authorisations of GM crops.
The overall conclusion is that none of them show any risk from eating GMO products. However, the authors ˆ most of them are from France ˆ sharply criticise the scientific methods used in a wide range of articles. As an example, only 6 out of the 24 studies used the recommended number of test animals. The majority violated the OECD guidelines just as much as EFSA accuses the latest French rat tests of doing.
The same applies to another criticism: the non-GM control feed. Only 7 out of the 24 studies that considered GMOs safe to consume mentioned that the isogenic control lines were used. It means that the crops are the same apart from the genetic modification ˆ another important criticism of Professor Séralini's tests. [GMW: In fact Seralini did use the non-GM isogenic control line, so it's difficult to know what this means.]
"The use of isogenic strains is absolutely basic. Otherwise it's like comparing apples with pears," according to Rikke Bagger Jørgensen.
The results of Monsanto's research must be made public
Rikke Bagger Jørgensen has obtained right of access to documents relating to the previous test (from a Freedom of Information request), which gave Monsanto approval of the GM corn (maize) NK603, the same GMO that Séralini tested. She is surprised that Monsanto's results are not immediately made public.
Rikke Bagger Jørgensen emphasizes: "We must know how much of the corn has been consumed by the rats. We can't see that in the French trial, and it is not revealed by Monsanto."
She finds it remarkable that both EFSA and in Denmark the DTU and The Food Institute immediately rejected the French results. She said: "A lot of people consider EFSA an oracle, but that is not always so. You may find strong opinions in these cases and all parties have an interest one way or another. That's why we need impartial research, assessed by the same standards. We don't want to listen to results if the research is not conducted properly."
However, she is certainly aware that the funding of proper tests may be a problem. It may, for example, require at least ten times as many rats than the 200 used in Séralini's trial, if OECD's guidelines are to be met. According to international media the budget for the research was about 24 million Danish Krone.
The Danish scientist is not convinced that it is necessary to include that many rats in the test, and this point was also disputed by some statistics experts after Séralini published his paper. Her comments are: "I have been involved in developing guidelines, and I don't think that they are always particularly well thought out. However, if a proper test requires 50 rats, in that case Séralini's test is of course trashed. It is necessary that scientific standards are properly considered and established. Otherwise researchers may get away with something as basic as not using the correct control."
ANSES, the French equivalent to the Danish Environmental Protection Agency and Food Standards Agency, has previously criticized the EU for its over-lax approvals process for GMOs.
COMMENTS ON SERALINI ET AL AND ON THE CRITICISMS
Dr Ulrich E Loening, retired Reader in Dept of Zoology, and former Director of Centre for Human Ecology, University of Edinburgh
27.10.2012
GM Watch, UK
SUMMARY: "The two most frequent and substantive criticisms of Seralini's paper were that the numbers of rats were too small, with too few control rats, and that the high incidence of spontaneous tumours in Sprague Dawley (SD) rats made them not suitable for these long term experiments. I show here how neither of these criticisms invalidate the results as a whole and suggest some other interpretations. In some ways, a feeding trial like this one does not need a control sample at all, because SD rats have been studied worldwide for several decades and their health and the appearance of tumours over their lifetimes has been well documented"
The two most frequent and substantive criticisms of Seralini's paper were that the numbers of rats were too small, with too few control rats, and that the high incidence of spontaneous tumours in Sprague Dawley (SD) rats made them not suitable for these long term experiments.
I show here how neither of these criticisms invalidate the results as a whole and suggest some other interpretations.
In some ways, a feeding trial like this one does not need a control sample at all, because SD rats have been studied worldwide for several decades and their health and the appearance of tumours over their lifetimes has been well documented, as quoted in the paper (refs. Chandra et al., 1992 and Brix et al., 2005; one could add an old study that also showed how increased fat in the diet raised the incidence of mammary tumours, (R. K. Davis, G. T. Stevenson and K. A. Busch, Tumor Incidence in Normal Sprague-Dawley Female Rats, Cancer Res 1956;16:194-197.) The main need for an internal control is to confirm normal behaviour of the rats and to check against any unforeseen local anomaly, which could distort the findings or raise unexpected matters. In fact in these experiments the control rats lived closely as expected, with lifetimes similar to any other SD rats, of 680+/-21 days for males and 757+/-20 days for females.
Of course the controls become important in the older rats when their pathology increases; in other words when the signal-to-noise ratio becomes too low, hence the criticisms. This problem can be largely overcome by limiting the evaluations to periods of high signal-to-noise ratio, which can be done from the published data. The experimental animals appeared to acquire tumours sooner and in larger numbers than the controls. The difference is shown in the paper in Figure 2 as the area bounded between the control and experimental lines. The units for this area can be called ‰accumulated tumour days‰. These can be easily summed from the graphs in Figure 2, to put numbers to otherwise intuitive visualisation. One can then express the results as the ratio of tumour days of the experimental to control rats, for any specified period. For example, I added the tumour days from Fig 2 FEMALES GMO (top right) summing together all three feeding doses of 11, 22, and 33% GMO (divided by 3 to apply per 10 rats) since there seems no regular difference between doses. In this way all 30 female rats are compared to 10 control rats. The ratios of tumour days of treated to control are:
from 100 to 550 days 3.04 (91)
from 100 to 650 days 2.58 (192)
from 550 to 650 days 1.81 (103)
from 650 to 750 days 1.23 (94)
(the parentheses indicate the total number of tumours)
Of course a ratio of 1 would indicate no difference from control; this is approached in the last 100 days, showing numerically what can be seen in the Fig.2.
The fall in this ratio with time then provides as a measure of internal control, a high ratio suggesting a period of meaningful data. This example shows that while 100-650 days still shows about 2 ∏ times more tumours in the experimental than control and so may seem a useful valid period, in fact the last 100 days of this (550-650) already show a much reduced ratio, suggesting to limit significant results to 550 days, rather than 650. The large ratio of 3.04 up to 550 days suggests that the results are significant.
Of course, a single very early tumour could distort these figures; outliers must be removed - playing tricks with numbers is no substitute for common sense!
I conclude that the criticism of this paper that SD rats get tumours anyway, far from negating the paper, in fact confirms its validity. Unwittingly, Seralini et al., who did not set out or expect to find tumourogenesis, chose a most appropriate strain of rats. By monitoring tumours over time they created a sensitive assay for some (unknown) biological factor in the rat chow. This would not have been discovered in any shorter term experiments - there were no effects at 90 days - nor quite possibly by using other strains of rat that are less liable to tumours. Standard trials of potential poisons or carcinogens over 90 days as in internationally agreed protocols are employed for a different question, and comparisons with them are irrelevant to this paper. The difference is of course that standard protocols are designed to be tests of safety. To confirm the absence of disease requires much more stringent conditions and more animals; an infrequent disease might otherwise be missed. In contrast a few diseased animals suffice to confirm a lack of safety.
It is important to stress that the paper is concerned with many other cellular changes and not primarily with tumorigenesis, which appeared as an unexpected finding. My comments are addressed mainly at the latter, since this has raised so much debate, whereas the organ and cellular findings have raised little comment.
This work confirmed how agreed standard safety tests are too short and missed effects, much as use of only small numbers of animals would be inadequate.
Nevertheless, the results are surprising in many ways and deserve close scrutiny. The two experimental treatments, of Roundup and a GM corn, have nothing in common. That each, in very low doses, should lead to broadly comparable cellular change and tumours is extraordinary. One must question, what was it in the feed that has given these results? One critic considered the possibility of mycotoxins; the careful monitored drying of the corn makes this unlikely. A more extreme question would be: why do SD rats, like humans, acquire tumours frequently in later life? Is there something in normal feed that acts like the two agents in these experiments? Could one avoid this with a more 'ultimate' control? The findings could open new approaches to sensitive nutritional and environmental assays of safety.
I propose not only that this work be expanded and checked by replication, but also propose a 'repeat in reverse,' in which the commercial rat chow becomes the experimental treatment, and the control would be a suitably designed diet equivalent to or better than the UK Government's recommended "five-a-day" of fresh fruit and vegetables for humans. Rats are notoriously more resistant to dietary and environmental abuse than humans, but maybe SD rats are suitably sensitive and compare to humans in these respects. Seralini et al., might have set up an experimental animal model to investigate the "diseases of civilisation."
I add some comment about the criticisms: I have read many of these, including much of the dismissal by the EFSA, the Science Media Centre's number of critics and the UK "NHS Choices". Almost all the comments are generalisations made from the stance of safety tests, like the main one that SD rats get tumours anyway, and they lack technical substance that would apply to this study. A few are clearly technical mistakes from misreading the paper.
None seem to take account of the basic difference between this paper and standard protocols: an absence of disease is difficult to confirm and requires a different set of stricter criteria than confirmation of the presence of disease. A low incidence of disease could be easily missed if too few animals are used. But similarly a slow incidence of disease would be missed if too short a time is allowed. Seralini et al. show how this is the case with the standard protocols and justifies the criticism of their short duration.
Many of the criticisms of the paper are from distinguished biologists, some of whom are my friends and colleagues. I find it disturbing to see how rapidly this work was attacked by a blanket of condemnation, much of which, as indicated above, does not apply to the issues at stake. This condemnation may come to be counter-productive for the science of biotechnology. Distrust and disillusion may result, rather than better public understanding and education. Some of the criticism compares in quality with some of the blanket objections from more extreme anti-GMO campaigners, some of whom also do not serve public understanding even when backed by good science.
Of course, as in any other research, someone may yet demonstrate some substantive flaw in the work which could explain the results in other ways. Until then, it would be wise for the EFSA, the EU and Governments take this finding seriously.
Finally, I declare an interest: I have for nearly 70 years been an amateur grower practising and promoting what we now call "organic" horticulture. This, plus my career in molecular biology, certainly influences my approach and has sharpened my scientific critical imagination.
SCIENCE AND CONSCIENCE
NOTE: A powerful statement challenging the attacks on Seralini has been published in the French newspaper Le Monde. The statement is signed by a large number of French scientists, including many researchers from the agricultural sector.
It directly challenges the condemnation of Seralini's recent study published in the name of France's science academies. That statement subsequently proved to be the work of a small group that included a leading member of an industry-linked pro-GM lobby group with a record of defamatory attacks on Seralini. http://www.gmwatch.org/latest-listing/51-2012/14362
Published in Le Monde, 14 November 2012
http://www.lemonde.fr/idees/article/2012/11/14/science-et-conscience_1790174_3232.html
Translation into English by GMWatch
Given the incredible outcry over the paper by Gilles-Eric Seralini and his team published in the journal Food and Chemical Toxicology, we, members of the scientific community, would like to say the following.
On the one hand, scientists who have spoken out on this subject have done so in their own name and cannot claim to represent the entire scientific community. The fact that a group of a dozen people claiming to represent six academies [of science] have agreed a joint statement [condemning Seralini] without debate is contrary to the normal functioning of these institutions and brings into question the image of science and technology (and their social usefulness) as well as that of those who presided over such a decision (contrast this, for example, with the debate organized by the Academy of Sciences in the context of the controversy over climate change, after which human responsibility [for climate change] was established). We welcome in this respect the healthy reaction of the Academy of Sciences' statistician, Paul Deheuvels. [http://www.gmwatch.org/latest-listing/51-2012/14336 ]
On the other hand, the protocol followed in this study has flaws that make for debate within the scientific community. But at the same time, disallowing the protocol followed in this study has the effect of simultaneously disqualifying the evidence underlying the approval decisions on GMOs by the [regulatory] experts. It is remarkable to see these same experts accept (even if they sometimes criticize) an experimental protocol when it gives results that are in line with the acceptance of a technique [GM] and demolish it so ardently when the results are in the opposite direction. This is in our opinion totally contrary to all scientific ethics. We therefore affirm that if the findings of larger scale experiments [like Seralini's] are open to question, then this [scepticism] also applies to the tests that were used to approve all the transgenic crops currently on the market. If this is the net result of this saga, then it will have been useful.
We are deeply shocked by the image of our [scientific] community that this controversy is giving people. The understanding of the risks to human health or the environment is a difficult task that has to face many uncertainties. Many of the threats to our planet have been proven by individual scientists and confirmed by numerous studies coming from the scientific community. In this case, it would be much more efficient to implement research on the health and environmental risks of GMOs and pesticides, improve toxicological protocols used for their marketing, and fund a diversity of researchers in this domain, rather than create clashes between two camps fed by prejudices and ideologies. We believe that our [scientific] community should keep in mind the memory of [our] past mistakes, for example asbestos.
Finally, we want to assure our citizens that there are also a large number of researchers in the scientific community who are convinced that we must take seriously the risks associated with technology and who feel that, if the researchers on the one hand, and the social applications of science on the other, are tied into ideologies, beliefs and / or vested interests, the scientific approach must be to try to remain as independent as possible [of such influences] in order [for science] to fully play its [proper] role in society.
Andalo Christophe MC UPS Toulouse ;
Arnaud-Haond Sophie Chercheuse IFREMER ;
Atlan Anne CR CNRS --------- and about 135 other scientists
THE COVERT WAR TO DISCREDIT SERALINI'S STUDY
Benjamin Sourice Rue 89, 12 November 2012
http://blogs.rue89.com/de-interet-conflit/2012/11/12/ogm-la-guerre-secrete-pour-decredibiliser-letude-seralini-228894
Translation by GMWatch
There's a simple way to definitively discredit Professor Gilles-Eric Seralini's controversial study that apears to show the potentially harmful effects of GMOs: pressurise the journal Food and Chemical Toxicology (FCT) that published it to "retract" the study from its list of publications.
This is what many experts are fighting to achieve in what appears to be an orchestrated attack. It's a veritable public relations war with no holds barred.
The journal has received many letters from critics. It has published around twenty, and a response to the critics by the Séralini team is also available online.
Legitimate scientific debate, you might say. But behind the cohort of academic titles that are listed is a hidden "biotech sphere" which brings together biotechnology researchers, regulatory policy experts and representatives of industry.
These biotechnology proponents denounce the "bad science" ("junk science") of the "militant researchers", who are routinely described as "activists linked to the environmental movement" and as "motivated by personal interests."
An international network
Among the first letters published, there is one that stands out because it has no author listed. It is a joint letter signed by 26 people, most of them scientists, including the [French] national critic of Seralini, Marc Fellous of the French Association for Plant Biotechnology [AFBV]. http://www.sciencedirect.com/science/article/pii/S0278691512007922
The AFBV is behind the Academies' attack on Gilles-Eric Seralini as a "militant" responsible for the "orchestration of a scientific reputation [...] by spreading fear". [http://www.gmwatch.org/latest-listing/51-2012/14362 ]
A number of Marc Fellous' co-signatories are linked to the pro-GM group AgBioWorld, led by the geneticist CS Prakash, who is himself a signatory of the joint letter.
Prakash and his organization are also the originators of two petitions the first collected 57 signatures and the second 731) calling for "the release of the raw data" of Gilles-Eric Seralini. Astonishingly, the first signatories of each petition are the same people who sent the letters to the journal FCT.
Viral campaigns of defamation
In 2002, the British newspaper The Guardian revealed that AgBioWorld had played a major role in a "viral campaign" of defamation against the whistleblower Ignacio Chapela after he uncovered the genetic contamination of Mexican corn. http://www.guardian.co.uk/politics/2002/may/14/greenpolitics.digitalmedia
The inquiry revealed that the [AgBioWorld] organisation's website was hosted by the communications firm Bivings, which was employed by Monsanto and directed by one Jay Byrne. http://www.powerbase.info/index.php/Jay_Byrne
It used false identities ("Mary Murphy" and "Andura Smetacek") to speak in the name of "the scientific community" and promote the idea that Chapela was linked to environmentalists, who were likened to "terrorists" and "vandals". http://powerbase.info/index.php?title=Center_for_Food_and_Agricultural_Research
The Bivings company was dissolved in December 2011 after a cyber attack by Anonymous in the guise of "Operation End Monsanto." But Byrne has continued to operate from a headquarters in St. Louis (Illinois, USA), where Monsanto is also headquartered along with his new company V-fluence. http://www.v-fluence.com/
This strategy of defamation was exactly the one used by Henry Miller, a signatory of the joint letter to FCT, "health regulation" expert at AgBioWorld, and member of the neoconservative think tank, the Hoover Institution. http://www.agbioworld.org/experts/index.html
In a series of articles published by Forbes, he describes Seralini's study as "fraudulent", and he denounces the "fear profiteers" of a "protest industry funded by organic interests".
This vitriolic attack has Jay Byrne as a co-author, who, the magazine had to disclose, was responsible for viral [PR] communications for Monsanto (1997-2001).
Henry Miller's CV is just as interesting because he is the "founding father" (1989-1994) of GMO regulation at the US Food and Drug Administration. He is the architect, with former Monsanto lawyer Michael Taylor, of the infamous "principle of substantial equivalence", the cornerstone of GMO regulation across the world.
Hidden conflicts of interest
Another striking tactic among critics of Seralini is concealing their relationship with industry and systematically presenting themselves as scientists from universities or research centers.
This applies to Anthony Trewavas and Bruce Chassy, experts in biology and GMOs at AgBioWorld, and both authors of a letter demanding the retraction of Seralini's paper by the journal, Food and Chemical Toxicology.
Presenting himself as Professor Emeritus of Food Safety at the University of Illinois, Chassy is a lobbyist who participated in the drafting of a paper for Dow Chemicals, another biotech giant, aimed at simplifying or removing food safety regulations for GMOs. He is also the lead author, with an employee of Monsanto, of two policy reports [2004, 2008] on the regulation of GMOs for the International Life Sciences Institute (ILSI), the main lobby group of the food industry.
Note that two leaders of the GMO Panel of the European Agency for Food Safety (EFSA), Harry A. Kuiper, its former chair for nearly ten years (2003-2012) and Gijs A. Kleter, current vice-chair, appear on these strategic documents of ILSI under the direction of Chassy.
Furthermore, while three of the letter writers [to the journal] openly specify their contractual relationship with Monsanto, Dr. Andrew Cockburn modestly presents himself as a toxicologist at the University of Newcastle. However, until 2003, Mr. Cockburn was Scientific Director for Monsanto Europe/Africa before setting up his lobbying firm Toxico-Logical Consulting Ltd..
And since it's a small world, Dr. Cockburn is also the director of the ILSI expert task force on the evaluation of foods containing nanomaterials.
Lobbying for $13 billion
The litany of conflicts of interest and pro-biotech positions of the fifty or so public critics of Seralini's study could continue for pages. We meet representatives of Indian organisations that promote the trade in biotechnology, others who want to end world hunger with a ration of GMOs, or pro-GMO communications specialists (David Tribe), and other lobbyists working between São Paulo, Washington and Brussels, the golden triangle of GMOs...
A closed world, dressed in the garb of science; the well-oiled marketing strategy of a GM seed industry that reaped 13 billion dollars in 2011 – all this stands to be disrupted by Seralini's study. It remains to be seen whether the journal Food and Chemical Toxicology can resist the weight of the lobby that is determined to bury Seralini's study.
The letters to the journal that the article refers to can be found here: http://www.sciencedirect.com/science/article/pii/S0278691512005637
And Seralini et al's response can be found here: http://www.sciencedirect.com/science/article/pii/S0278691512008149?v=s5
THE OPEN LETTER
In addition, 191 scientists from 33 countries have written in support of Seralini and his colleagues, and 95 scientists have thus far signed the Open Letter entitled "Seralini and Science" and found here:
http://independentsciencenews.org/health/seralini-and-science-nk603-rat-study-roundup/#comment-4292
Here is the text of the letter:
A new paper by the French group of Gilles-Eric Seralini describes harmful effects on rats fed diets containing genetically modified maize (variety NK603), with and without the herbicide Roundup, as well as Roundup alone. This peer-reviewed study (Seralini et al., 2012), has been criticized by some scientists whose views have been widely reported in the popular press (Carmen, 2012; Mestel, 2012; Revkin, 2012; Worstall, 2012). Seralini et al. (2012) extends the work of other studies demonstrating toxicity and/or endocrine-based impacts of Roundup (Gaivão et al., 2012; Kelly et al., 2010; Paganelli et al., 2010; Romano et al., 2012), as reviewed by Antoniou et al. (2010).
The Seralini publication, and resultant media attention, 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.
1) History of Attacks on Risk-finding Studies. Seralini and colleagues are just the latest in a series of researchers whose findings have triggered orchestrated campaigns of harassment. Examples from just the last few years include Ignacio Chapela, a then untenured Assistant Professor at Berkeley, whose paper on GM contamination of maize in Mexico (Quist and Chapela, 2001) sparked an intensive internet-based campaign to discredit him. This campaign was reportedly masterminded by the Bivings Group, a public relations firm specializing in viral marketing – and frequently hired by Monsanto (Delborne, 2008).
The distinguished career of biochemist Arpad Pusztai, came to an effective end when he attempted to report his contradictory findings on GM potatoes (Ewen and Pusztai, 1999a). Everything from a gag order, forced retirement, seizure of data, and harassment by the British Royal Society were used to forestall his continued research (Ewen and Pusztai, 1999b; Laidlaw, 2003). Even threats of physical violence have been used, most recently against Andres Carrasco, Professor of Molecular Embryology at the University of Buenos Aires, whose research (Paganelli et al. 2010) identified health risks from glyphosate, the active ingredient in Roundup (Amnesty International, 2010).
It was no surprise therefore, that when in 2009, 26 corn entomologists took the unprecedented step of writing directly to the US EPA to complain about industry control of access to GM crops for research, the letter was sent anonymously (Pollack, 2009).
2) The Role of the Science Media. An important but often unnoticed aspect of this intimidation is that it frequently occurs in concert with the science media (Ermakova, 2007; Heinemann and Traavik, 2007; Latham and Wilson, 2007). Reporting of the Seralini paper in arguably the most prestigious segments of the science media: Science, the New York Times, New Scientist, and the Washington Post uniformly failed to "balance" criticism of the research, with even minimal coverage of support for the Seralini paper (Carmen, 2012; Enserink, 2012; MacKenzie, 2012; Pollack, 2012). Nevertheless, less well-resourced media outlets, such as the UK Daily Mail appeared to have no trouble finding a positive scientific opinion on the same study (Poulter, 2012).
3) Misleading Media Reporting. A key pattern with risk-finding studies is that the criticisms voiced in the media are often red herrings, misleading, or untruthful. Thus, the use of common methodologies was portrayed as indicative of shoddy science when used by Seralini et al. (2012) but not when used by industry (see refs above and Science Media Centre, 2012). The use of red herring arguments appears intended to sow doubt and confusion among non-experts. For example, Tom Sanders of Kings College, London was quoted as saying: "This strain of rat is very prone to mammary tumors particularly when food intake is not restricted" (Hirschler and Kelland, 2012 ). He failed to point out, or was unaware, that most industry feeding studies have used Sprague-Dawley rats (e.g. Hammond et al., 1996, 2004, 2006; MacKenzie et al., 2007). In these and other industry studies (e.g. Malley et al. 2007), feed intake was unrestricted. Sanders' comments are important because they were widely quoted and because they were part of an orchestrated response to the Seralini study by the Science Media Centre of the British Royal Institution. The Science Media Centre has a long history of quelling GMO controversies and its funders include numerous companies that produce GMOs and pesticides.
4) Regulator Culpability. In our view a large part of the ultimate fault for this controversy lies with regulators. Regulators, such as EFSA (the European Food Safety Authority) in Europe and the EPA (Environmental Protection Agency) and FDA (Food and Drug Administration) in the US, have enshrined protocols with little or no potential to detect adverse consequences of GMOs (Schubert, 2002; Freese and Schubert, 2004; Pelletier, 2005).
GMOs are required to undergo few experiments, few endpoints are examined, and tests are solely conducted by the applicant or their agents. Moreover, current regulatory protocols are simplistic and assumptions-based (RSC, 2001), which by design, will miss most gene expression changes – apart from the target trait - induced by the process of transgene insertion (Heinemann et al., 2011; Schubert, 2002).
Puzstai (2001) and others have consequently argued that well-conducted feeding trials are one of the best ways of detecting such unpredictable changes. Yet feeding trials are not mandatory for regulatory approval, and the scientific credibility of those which have been published to date has been challenged (Domingo, 2007; Pusztai et al., 2003; Spiroux de Vendômois et al., 2009). For example, Snell et al. (2012), who assessed the quality of 12 long term (>96 days) and 12 multigenerational studies, concluded: "The studies reviewed here are often linked to an inadequate experimental design that has detrimental effects on statistical analysis…the major insufficiencies not only include lack of use of near isogenic lines but also statistical power underestimation [and], absence of repetitions…".
Apparently, the same issues of experimental design and analysis raised about this (Seralini) risk-finding study were not of concern to critics when the studies did not identify risk, resulting in ill-informed decision-makers. In the end, it is a major problem for science and society when current regulatory protocols approve GMO crops based on little to no useful data upon which to assess safety.
5) Science and Politics. Governments have become habituated to using science as a political football. For example, in a study conducted by the Royal Society of Canada at the request of the Canadian government, numerous weaknesses of GM regulation in Canada were identified (RSC, 2001). The failure of the Canadian government to meaningfully respond to the many recommended changes was detailed by Andree (2006). Similarly, the expert recommendations of the international IAASTD report, produced by 400 researchers over 6 years, that GMOs are unsuited to the task of advancing global agriculture have been resolutely ignored by policymakers. Thus, while proclaiming evidence-based decision-making, governments frequently use science solely when it suits them.
6) Conclusion: When those with a vested interest attempt to sow unreasonable doubt around inconvenient results, or when governments exploit political opportunities by picking and choosing from scientific evidence, they jeopardize public confidence in scientific methods and institutions, and also put their own citizenry at risk. Safety testing, science-based regulation, and the scientific process itself, depend crucially on widespread trust in a body of scientists devoted to the public interest and professional integrity. If instead, the starting point of a scientific product assessment is an approval process rigged in favour of the applicant, backed up by systematic suppression of independent scientists working in the public interest, then there can never be an honest, rational or scientific debate.