EFSA slammed for "institutionalised pseudo-science" after rat study review
Now that EFSA has produced its initial reaction to the rat feeding study (1) by Seralini et al, it's possible to assess the state of play. The waters are very muddy indeed, following the cynical campaign by the Science Manipulation Centre (SMC) to bury the newly published study beneath a welter of abuse, false assertions about the methods and the results, and protestations that the findings relating to tumours were at best aberrations and at worst a consequence of scientific fraud (2). The tame SMC experts have all strutted into battle with their six-shooters blazing, on the basis that it is easier in the strange world of GM science to shoot the messenger than to refute the science. So where do we stand?
There is no point in seeking to refute the silly points made by the tame "experts" quoted by the SMC -- all of whom have powerful vested interests in the GMO research and development fields (3). They, after all, will all lose their jobs and their status (not to mention their own self-esteem) if GMOs really are proved to be toxic to mammals. The French team and other independent scientists have already dealt very effectively with all of the points made (4).
But what about the EFSA response which has now been published? (5) As pointed out already by others (6) it is so biased and unbalanced as to be laughable. We should not be surprised, since any support from EFSA for the Caen research results would have constituted an admission that the application dossier for NK603 consent was defective, and that the consent should never have been recommended. So entirely predictably, EFSA has simply put the shutters up and has decided neither to look nor to see. In particular:
(a) EFSA does not reveal what the membership of its "investigating panel" or "multidisciplinary task force" is. Who are these learned scientists who find that the Seralini study is entirely inadequate? If they will not reveal their names, we may assume that they all have vested interests in GMOs.
(b) EFSA complains that the Seralini team has not followed the correct protocols for a carcinogenesis trial -- entirely failing to see that this was NOT a carcinogenesis trial. It was simply a long-term feeding trial designed to reveal whether there are any safety concerns associated with the use of NK603 and Roundup in the food chain. It happened to reveal strong evidence of carcinogenic effects -- which EFSA simply chooses to ignore.
(c) EFSA complains that the paper (published in a peer-reviewed journal) does not contain the full data sets relating to the experiments as reported. This is an absurd point, as EFSA knows full well. No scientific papers in journals of this type contain full data sets -- and if the authors had attempted to include them, they would have been cut out by the Editor.
(d) EFSA complains about inadequate sample size, claiming that groups of ten rats were inadequate to obtain statistically significant results. Seralini has already dealt with this point, and has observed that if there is a problem with his study, then every other study used to demonstrate the "safety" of GM crops and foods should also have been rejected.
(e) EFSA fails to recognize and applaud the fact that this study was conducted on whole feed obtained from the GM plants as grown in the field -- and not from surrogate proteins as used in the majority of other "safety studies" submitted by the applicants for GMO consents. This study is MUCH more likely to be reliable than any of the other studies submitted to EFSA in the past -- most of which were not safety studies at all, but short-term studies designed to demonstrate nutritional equivalence.
(f) EFSA fails to accept and applaud the fact that this study is the first long-term (lifetime) safety study on a GM product, and on Roundup, ever conducted according to OECD and other guidelines. It apparently prefers to accept other short-term "advocacy" studies submitted in the past with the key objective of obtaining a planting or an import consent. Unlike all other studies submitted to EFSA in the past, this one had no commercial imperative behind it -- so it should have been accepted as inherently honest.
(g) EFSA complains that the type of rat used in this study is particularly prone to developing tumours -- and apparently fails to notice that almost all prior "safety" studies submitted to it in the past have used the same type of rats. Needless to say, all of these studies have been accepted by EFSA without question.
(h) EFSA complains that the research team has not stated its objectives, and suggests that this somehow invalidates the study. That is absurd -- if the team had stated at the outset that it was looking for tumours, EFSA would have attacked it for undertaking a biased study aimed at a predetermined set of results.
(i) EFSA complains about many endpoints not being reported in the paper -- ignoring the fact that the Seralini team has already stated that there are so many results coming from the two years of work that another five papers (at least) will be needed to cover all of them.
(j) EFSA fails to give the Seralini team any credit at all for conducting this study under almost impossible circumstances, and for bringing it to fruition -- in the full knowledge that Monsanto would have sabotaged the research if it had had any opportunity to do so, as it has with many other independent studies in the past.
All in all, the points raised by EFSA are predictable, petty and downright puerile. Its "panel of experts" has apparently never heard of the Precautionary Principle. In our view EFSA shows itself -- yet again -- to be involved in another exercise designed to bolster its own conviction that it is infallible. In so doing it fails signally to afford the Seralini team members the respect which they deserve, and aligns itself with SMC and the GM industry's rottweilers who are more interested in personal vilification than in serious science (6) (7). What we see here is institutionalised pseudo-science. That is bad enough, but yet again EFSA is revealed as criminally irresponsible, since what is at stake is the health of the population of Europe. EFSA's GMO Panel has once again shown itself to be unfit for purpose. It should be disbanded forthwith.
NOTES
1. Séralini, G-E., E. Clair, R. Mesnage, S. Gress, N. Defarge, M. Malatesta, D. Hennequin, J. Spiroux de Vendômois. 2012. Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize. Food Chem. Toxicol. http://www.criigen.org/SiteEn/index.php?option=com_content&task=view&id=367&Itemid=130 http://www.criigen.org/SiteEn/index.php?option=com_content&task=view&id=368&Itemid=1
2. Science Media Centre. 2012. Study on cancer and GM maize – experts respond. Posted 20 Sept 2012. Worstall, Tim. 2012. Proof Perfect That The Seralini Paper On GM Corn And Cancer In Rats Is Rubbish. Forbes 21 Sept 2012.
3. http://www.gmfreecymru.org/documents/seralini_defends.html
4. http://www.criigen.org/SiteEn/index.php?option=com_content&task=view&id=368&Itemid=1
6. Testbiotech note reproduced below http://www.testbiotech.org/en/node/716 ENSSER Statement on Séralini et al. (2012) publication and reactions evoked Questionable Biosafety of GMOs, Double Standards and, once again, a "Shooting-the-Messenger" style Debate
7. http://independentsciencenews.org/health/seralini-and-science-nk603-rat-study-roundup/#comment-4292 Seralini and Science: an Open Letter
Controversy over study with genetically engineered maize and Roundup: Still no certainty for consumers
EFSA opinion not sufficient to prove safety of relevant products http://www.testbiotech.org/en/node/716
4. October 2012 Munich/ Parma
The European Food Safety Authority (EFSA) and the German Federal Institute for Risk Assessment (BfR) published their opinion on a French study that found severe impacts on the health of rats fed with genetically engineered maize or exposed to a low dosage of herbicides. The authorities conclude that the study does not provide final evidence of health risks.
Testbiotech believes that these opinions cannot eliminate severe doubts about the safety of the relevant products. While it is true that the French study does not claim final proof of health hazards it highlights the urgent need for further investigations. According to EU regulations, precautionary measures should come into play if there are sufficiently detailed reasons for doubting the safety of a food product. Thus, the marketing of such products should be stopped until the doubts about their safety are eliminated.
"As long as there are no new data showing that the French researchers are completely wrong, it would be irresponsible to set aside the outcomes of the French study just because of some methodological deficiencies", Christoph Then says of Testbiotech. "Even if this study is not considered to be final evidence of health hazards caused by genetically engineered plants, the burden of proof is now with industry. They have to show that their products are safe. This is not just a theoretical dispute but very much concerns the protection of the consumers."
Testbiotech emphasises that EFSA and BfR have their own vested interests in this discussion. By attacking the French study, the authority is defending its own assessments, claiming the safety of the relevant products. They do not require that companies give evidence about the safety of their products, but assume safety as long as the opposite is not proven.
So far no feeding studies with the genetically engineered plants are requested by the authority, only isolated proteins are tested regarding acute toxicity. Some companies provide data from feeding trials with the plants, which are normally performed for around 90 days only. Investigations over the life-time of the animals or even including following generations are very rare.
Furthermore, independent risk research can hardly be conducted since the companies can block access to research material or ask the scientists to sign contracts where they agree not to publish anything that is not agreed with the company. There are even some cases where researchers were not able to publish due to intervention by industry.
"It is of extreme importance that these results were published after a peer reviewed process. Those questions being discussed right now should have been answered long time ago," Christoph Then argues.
The measurements made by the French scientists are much more detailed than those normally done by industry. As Testbiotech was informed by the French scientists, the original planning for the study was 90 days but was then prolonged after unexpected observations. Testbiotech demands that further results which are not yet published should now be assessed by the French researchers and properly published to get a full picture about their findings.
Contact: Christoph Then, Tel: +4915154638040, info@testbiotech.org
European Scientists: EU GM Crop Safety Testing Flawed (from GM Freeze)
The European Network of Scientists for Social and Environmental Responsibility (ENSSER) today responded to the criticism levelled at the recent research paper reporting the results of the long-term feeding of GM maize to rats. [1] The statement points out that the same criticism could be applied to tests carried out by Monsanto, which are used of proof of safety by the European Food Safety Authority (EFSA).
The response follows the 4 October publication of the EFSA GMO Panel's initial response to the experimental results of CRIIGEN's work by a team led by Professor Gilles-Eric Séralini. It details arguments raised against the CRIIGEN work and explains why they don't stand up.
ENSSER welcomed CRIIGEN's scientific paper and notes that the work follows on the lab's study of the data submitted by Monsanto to EFSA in support of the application to market the company's own GM maize. This analysis indicated toxicological effects in liver and kidneys in a 90-day oral feeding trial conducted by the company. [2]
Séralini's team's latest experiment extended the length of the trial to two years (ie, lifetime exposure) using various treatments and compared results with untreated controls. [3] The prolonged exposure to GM maize and Monsanto's weedkiller Roundup (using the chemical glyphosate as an active ingredient) produced a similar, but more serious, impact on the kidneys and livers in male rats.
ENSSER concludes:
"After a careful comparative analysis of both industry published data and that of CRIIGEN, ENSSER concludes that most arguments which attempt to invalidate the Séralini et al. study cannot hold up to closer scrutiny. Raised criticisms are to a large extent either wrong or apply double standards."
The group acknowledges that the Séralini study is not perfect:
"The weak point of the pilot study by Séralini et al. is the number of animals used, which does not allow a statistical analysis of the raw data regarding one parameter measured out of over 30 - mortality. This has been acknowledged by the authors and needs to be considered/remediated in follow-up studies."
Yet ENSSER clearly points out:
• EFSA had already approved the GM maize (NK603) and its associated use of the herbicide glyphosate as safe in 2009 [5], so "their credibility is at stake" if they were to concede that the extended rat feeding trial conducted by CRIIGEN raised significant concerns about the crop's safety. A clear case of conflict of interest. • The CRIIGEN trials followed OECD guidance for oral toxicity testing and used: • The same breed of rats as Monsanto. • The same feeding method as Monsanto (free access). • The same procedures for monitoring the health and growth of the rats as Monsanto. The Statement goes on to say:
"All previous studies finding adverse effects of GE crops have been treated by regulators with: Only those studies showing adverse effects receive a rigorous evaluation of their experimental and statistical methods, while those that claim proof of safety are taken at face value."
ENNSER says critics of CRIIGEN have, "A long-documented record of rejecting the basic principles of the EU biosafety legislation and opposing the improvement of risk assessment standards." The scientists are critical of, "The proven close links between industry and EU risk assessors and the documented, disproportional influence on regulations by developers and owners of the technology."
Pete Riley of GM Freeze said:
"Professor Séralini's team are to be congratulated on a genuine attempt to unearth the facts about the safety of GM crops. They exposed the double standards of the regulators and those who clamour for the deregulation of GM crop approvals. There are clear flaws in the EU's GM crop approval process that urgently need addressing, but EFSA is not the right body to do this.
"The obvious next steps are: 1) For a review and overhaul of the statutory risk assessment process by a group with no vested interests, and 2) For an independent group to carry out further long-term toxicological trials on GM crops building on what the CRIIGEN team have done.
"In the meantime we need a freeze on all GM imports with the RR trait, as well as on any future approvals for either cultivation or import."
ENDs
Calls to: Pete Riley, GM Freeze 07903 341 065
Notes
[1] ENSSER, 4 October 2012. "Review of the Séralini et al. (2012) publication on a 2-year rodent feeding study with glyphosate formulations and GM maize NK603 as published online on 19 September 2012 in Food and Chemical Toxicology". Available at CRIIGEN 2012 study: Long-term health impacts of GM and Roundup
[2] Séralini et al, 2009. "A Comparison of the Effects of Three GM Corn Varieties on Mammalian Health". Int J Biol Sci 5:706-726
[3] Séralini G-E, Clair E, Mesnage R, Gress S, Defarge N, Malatesta M, Hennequin D, Spiroux de Vendômois J, 2012. "Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize". Food and Chemical Toxicology (copy available on request)