From the Editors - GM Cancer Warning Can No Longer Be Ignored

In the Vatican Museums in Rome stands a statue of La0coön and his sons. Legend has it that Laocoön tried to warn his fellow citizens against taking in the wooden horse that the Greeks had left outside their gates. It was not a gift, but a ruse designed to allow Greek soldiers to enter the city. The Greek gods, who wanted to see Troy destroyed, sent sea serpents to kill Laocoön. This convinced the Trojans that the horse was indeed sacred; so they opened the gates and dragged it into the city. The result was the total destruction of Troy and its empire.

The biotech industry is doing its best to convince us that GMOs are the key to feeding a hungry world, when all the evidence is that they profit only the companies. Whenever anyone tries to warn of the dangers of GMOs, the industry responds by doing its utmost to discredit the whistle blower and prevent the warning from being heard. We have already witnessed what happened to Arpad Pusztai (Pusztai Publishes Amidst Fresh Storm of Attack , ISIS News 3), David Quist and Ignacio Chapela (Who's Afraid of Horizontal Gene Transfer?, SiS 15) and Irina Ermakova (Science and Scientist Abused, SiS 36) to name but a few; also Nancy Oliviera ( Big Business = Bad Science? ISIS News 9/10) and David Healy (The Depressing Side of Medical Science, SiS 39) with the pharmaceutical industry no less corrupt than biotechnology.

GM maize and herbicide link to cancer “a bomb”

The latest warning - perhaps the most dramatic to-date – comes in a paper published online 19 September 2012 in the journal Food and Chemical Toxicology reporting high rates of death and cancers in rats fed Monsanto’s GM maize NK603 and/or Roundup herbicide compared with controls. The study carried out by Gilles-Eric Séralini and his group at the University of Caen involved the largest number of rats followed for their entire lifespan of two years. By all accounts, it was the most in-depth long-term toxicology study ever done on GM food. Séralini reported the results in the European Parliament.

France’s former Environment minister Corinne Lepage MEP said the study was “a bomb” calling into question all existing regulatory authorizations of GMOs. GMOs are approved in the European Union and elsewhere on the basis of a 90-day toxicology study at best, carried out by the biotech companies. The key finding of the new study is that tumours and other serious health impacts appeared at 4-7 months, which would have been missed in all previous tests.

On the same day the study was published, the French government asked a health watchdog, The National Agency for Health Safety to investigate the new findings. The next day, Austria called for EU to review its approval process for GM food. Within a week, Russia suspended import and use of GM corn from the USA. On 10 October, the company Vilmorin, the world’s fourth largest seed group and a holding of Limagrain dropped its planned GM field trials in France.

The response from the pro-GM lobby was equally dramatic and immediate. The UK industry-funded Science Media Centre (SMC) issued quotes from “experts” (with undisclosed conflict of interest) in an attempt to discredit the study. This was followed by a deluge of attacks and off the cuff and largely irrelevant criticisms from the scientific establishment and official regulatory bodies around the world (see later).

The notorious European Food Safety Authority (EFSA), which authorized the GM maize, issued its initial review of the study – pending a detailed review - claiming, unsurprisingly, that there is no need to re-evaluate the safety because the study is of “insufficient scientific quality”.  Lepage expressed serious concerns about EFSA’s initial review, which did not read like carefully considered opinions but hastily put-together points circulated by the pro-GM lobby. She highlighted the conflict of interest in Andrew Chesson, one of the only two people appointed by EFSA to review the study, who was on the panel that originally approved the GM maize NK603 and actually helped prepare the draft document recommending its approval. Thus, Chesson is acting as “both judge and jury”. Chesson, it turns out, was also involved in discrediting his former colleague Arpad Pusztai; he chaired the audit committee that found fault with Pusztai’s research.

EFSA has since been criticized by the European Court of Auditors for inadequate management of conflicts of interest. This came as no surprise as conflicts of interests are rife within EFSA. Earlier in May 2012, the Chair of EFSA’s Management Board was forced to quit because of her 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 to a lobbying job with the biotech giant Syngenta. And GMO panel chair Harry Kuiper clearly used his position to influence the work of the panel in a pro-industry direction.

Friends of the Earth condemned EFSA for having consistently sided with the biotech industry and disregarded health or environmental concerns about GM crops. It called on national governments and EU safety authorities to immediately suspend all Roundup-t0lerant GM crops from market, the European Commission to suspend all new GMO approvals and to start and root-and-branch reform of how the risks of GM foods are to be assessed, and for the EU to review the safety of the herbicide Roundup (glyphosate), including the link between GM crops and the use of the herbicide. Greenpeace too, called for immediate freeze on approvals of new GM crops and a redesign of safety testing over the long term. They should both call for banning glyphosate as the damning evidence on glyphosate is even stronger than for GMOs, and the maximum permitted levels of glyphosate are set to rise by 100-150 times in the European Union if Monsanto has its way (see Why Glyphosate Should Be Banned, ISIS Report).

The most thorough and long-term toxicology test to-date

The findings reported by Séralini’s group are not those of an isolated study suddenly to reveal that GM feed and the most widely used herbicide in the world may be toxic or carcinogenic. They are the latest of similar findings from laboratory experiments backed up by the experience of farmers and farm workers around the world.

In 2007, EFSA gave approval for Monsanto’s MON 863, MON 810 and NK603 maize, all genetically engineered to be tolerant to Monsanto’s Roundup herbicide, on the basis of evidence from the company’s feeding trials on rats. Differences showed up between rats fed GM maize and the controls, but were dismissed as “not biologically significant”.

Séralini and his group at Caen brought a Freedom of Information suit in the European Court to obtain the raw data from Monsanto. On re-analyzing the data, they found that contrary to what the company had claimed and the regulator had accepted, there were indeed statistically and biologically significant differences.

But EFSA analysed the data again, and reported that they were still satisfied that none of the differences was biologically significant. Séralini and his group decided that the best way to settle the issue would be to conduct their own experiment.

It turned out to be difficult to arrange the trials because the stewardship agreements farmers have to sign forbid not only saving seeds but also their use for research without specific permission [14]. This effectively prevents anyone else to learn anything about GM crops beyond what the company wants them to hear.

After some effort, the group in Caen were able to get hold of suitably grown GM maize, NK 603, and a near equivalent non-GM variety. They used 200 animals (100 males and 100 females) in their experiment, which lasted for two years; in contrast, regulatory tests usually last only up to three months and may involve as few as 10 animals. They ran the experiment following Good Laboratory Practice (GLP) and the OECD protocol for toxicity trials, and measured more parameters and more frequently than the OECD protocol requires.

In order to distinguish effects caused by the GM maize, or the herbicide, or both, Séralini and his colleagues divided the male and female rats separately into nine treatment groups,each with ten rats. Three were given in their feed different proportions of GM maize that had been sprayed with Roundup herbicide, three were given the same proportions of GM feed that had not been sprayed, and three were given the closest isogenic (i.e. non-GM) maize but had different amounts of Roundup added to their water. The tenth group was given only non-GM maize with standard feed and plain water.

The amounts of Roundup that were added were (a) the amount often found in tap water,  50ng/L glyphosate, (b) the US maximum residue limit (MRL) for glyphosate in some feeds, 400 mg/kg, and 2.25 g/L, half the minimal agricultural working dilution. They used Roundup in the experiments, whereas most trials have been conducted using only glyphosate. The difference is that like most proprietary formulations, Roundup contains adjuvants, substances added to enable the active principle (i.e. glyphosate) to penetrate the target plant organism efficiently, and it seems reasonable to suppose that these might alter its effect on non-target organisms as well.

As they expected from their analysis of Monsanto’s results, Séralini and his team found signs of toxicity in the livers and kidneys of the treated rats. The most worrying effect, however, and one that had not been anticipated when the experiment was designed, was the increase in the number of early deaths and of tumours.  Among females, there were 2-3 times as many deaths in all treated groups compared to controls by the end of the experiment. By the beginning of the 24^th month, 50-80 percent of female animals had developed tumours in all treated groups, whereas only 30 per cent of controls were affected.

In treated males, liver congestions and necrosis were 2.5-5.5 times controls, with marked and severe kidney disease 1.3-2.3 times controls. Males also presented 4 times as many large tumours than controls and up to 600 days earlier.

Biochemical data confirmed “very significant” kidney chronic deficiencies for all treatments and in both sexes; as 76 % of the altered parameters were related to the kidney.

A summary of the most striking observations are given in Table 2.  For the six most frequently observed anatomical pathologies, in all but 3 of the 54 cases (i.e., 9 differently treated groups for each of the 6 pathologies) the number of rats affected was greater than in the corresponding control. The results were backed up with photographs of the afflicted rats and histological changes in the tissues, as well as biochemical analyses, which gave strong indications of kidney deficiency in both sexes. The results clearly cannot be dismissed as being due to chance.

The anatomical pathologies  are so striking that the team did not bother to carry out any of the standard tests that could have been used, as pointed out by a former research analyst with a major government agency, who defended the study against critics but wishes to remain anonymous. He commented: “Table 2 stood out, with the doubling and tripling of pathologies in treatment groups compared with controls, with as many as 8, 9, or even all 10 treatment rats in a group affected. This made me question how a study in which such high numbers of rats were affected, could be dismissed.”

The criticisms do not stand up

As collated and reviewed by UK group GMWatch, most if not all the criticisms are irrelevant or ill-considered, being hastily put together to confuse the public, and have been answered in full, by Seralini’s group and a host of other scientists. For example, they complained that the Sprague-Dawley rats were the wrong animals to use; that strain happens to be the standard for routine toxicology tests. Monsanto dismissed the findings, in that they “fall within historical norms for this strain of laboratory rats, which is known for a high incidence of tumours”. Monsanto meant by ‘historical norm’ control data cobbled from various other studies in the scientific literature or elsewhere, a thoroughly unscientific and non-standard practice designed to explain away undesirable results. Controls are specific to experiments and precise conditions of rearing, and it is totally unacceptable to lump data from different controls together to compare them with any one specific experiment.

Another complaint was that Séralini and his team did not follow the OECD protocol for tests for carcinogenesis, which would have required groups of 50 animals instead of 10. In fact, they used the toxicity protocol because that was what the experiment had been designed to do, and which actually made it less likely to detect carcinogenesis. The fact that high rates of cancer were detected with far fewer animals makes the findings all the more serious (see Excess Cancers and Deaths with GM Feed: the Stats Stand Up, SiS 56).

The dust had hardly settled when another attack was launched; one purporting to be from the six French Academies (science, technologies, medicine, veterinary science, agricultural sciences, pharmacy). In fact, it was put together in great haste by a group of two representatives from each of the Academies. It is not known who the members are or who appointed them or by what process. The group specifically did not include or consult Paul Deheuvel, the only member of the Academy of Sciences who represents statistics.  Deheuvel has since issued his own favourable comments on Séralini’s work, which he judges to be of high quality and to have used statistics appropriately. He points out in particular that the critics have concentrated on the carcinogenesis part of the results, which are the most dramatic but which the experiments had not been designed for, and largely ignored the toxicology, which is still very important.

The citizens of Troy came to bitterly regret their decision to ignore Laocoön’s warnings and allow the Trojan horse to enter their city. The citizens of the world can no longer afford to ignore Seralini’s warnings and allow GMOs and Roundup herbicide to continue devastating people and planet.

Fully referenced versions of this editorial and all articles are available on ISIS members website: http://www.i-sis.org.uk/sismembers.php

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