Saturday, September 22, 2012

Monsanto, Roundup, and the Devil We Didn't Know

Female (9255) fed with the GMO
alone (22%) and developing a mammary adenocarcinoma
in a fibroadenoma
(day 645) photo: Criigen website

So what do we know? We know that Roundup-tolerant corn is approved for human consumption on the basis of 90-day rat trials. We know that groundwater levels have been approved on the strength of 90-day rat trials. We know that food activists (among whom I number myself) have been saying for years that 90-day rat trials are not really the best way to approve a radical new technology. We know that Monsanto, Cargill, and other plant science patent holders have said that all they need to do are 90-day rat trials, and that those trials are sufficient to approve and use a “substantially equivalent” genetically modified organism. And we know our governments have agreed.
But that was yesterday. Today is a different world. Today, the paper, "Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize" reporting on a study conducted by a team of scientists led by molecular biologist and endocrinologist Professor Gilles-Eric Seralini, (co-director of the Risk Quality and Sustainable Environment Unit at the University of Caen, France, who is an authority on studies into the health impact of GMO's and pesticides) has been published. This is the first study of both NK603 Roundup tolerant GM maize, and water containing Roundup at levels permitted in drinking water and GM crops in the US that has followed the test rats longer than the required 90 days—in fact, the study followed them through their entire 24 month life span. And the news is not good.
Whether the test rats were fed NK603 Roundup-tolerant maize (illegal in France, where the study was conducted, the maize had to be imported from Canada, where its use is approved), or whether they received a measured dose of Roundup in their drinking water, they developed two to three times more tumours than the control group. Tumours appeared in the male rats after four months and in the female rats after seven months. Tumours only began appearing in the female control group after 14 months, and in the male control group after 23 months.
Three groups were given Roundup in their drinking water, at three different levels consistent with exposure through the food chain from crops sprayed with the weedkiller: the mid level corresponded to the maximum level permitted in the US in some GM feed; the lowest corresponded to contamination found in some tap waters. Three groups were fed diets which contained different proportions of NK603—11%, 22% and 33%. Three groups were given both Roundup and NK603 at the same three dosages. The final control group was fed an equivalent diet with no Roundup or NK603 but containing 33% of equivalent non-GM maize.
So test populations dosed with Roundup-contaminated water, Roundup-tolerant NK603 maize, and both Roundup-contaminated water AND the NK603 maize. And as it turns out, it didn't matter. Both the maize and the Roundup, individually and together, triggered the same problems: Females developed fatal mammary tumours and pituitary disorders. Males suffered liver damage, developed kidney and skin tumours and experienced problems with their digestive system. Treated males suffered severe liver and kidney dysfunction. Liver congestion and necrosis were 2.5 to 5.5 times higher than in the control group. There were also 1.3 - 2.3 times more instances of "marked and severe" kidney disease. And this happened regardless of whether the rats received the lowest or the highest dose, or whether they received either the maize or the Roundup.
This tends to indicate that the doses exceed some important threshold level. Worse, the 50ng/L of glyphosate in R-formulation (that is to say, the lowest concentration of Roundup in drinking water in the tests) was a level found in some contaminated tap waters, a level of contamination which is legal in some jurisdictions, caused the same reaction as the higher levels of contamination.
Dr Michael Antoniou, molecular biologist at Kings College, London, and a member of the CRIIGEN scientific council, says:
"This is the most thorough research ever published into the health effects of GM food crops and the herbicide Roundup on rats. It shows an extraordinary number of tumors [sic] developing earlier and more aggressively - particularly in female animals. I am shocked by the extreme negative health impacts."
"The rat has long been used as a surrogate for human toxicity. All new pharmaceutical, agricultural and household substances are, prior to their approval, tested on rats. This is as good an indicator as we can expect that the consumption of GM maize and the herbicide Roundup, impacts seriously on human health."
And corn is contained in almost every manufactured food. Corn is ubiquitous in the food system as it is currently constituted, and practically all that corn is genetically modified maize (this does not apply to sweet corn as far as I know. Only to the maize grown for feed and industrial use).
This isn't just bad news for Monsanto, or other manufacturers of glyphosate. This throws into doubt every test done on food additives that was ended after 90 days. This study has not only dropped a bomb on GM corn, it has dropped one on the whole structure of additive approval. We have not been testing for long-term effects, and this study has demonstrated that we need to change that.

As is to be expected, there has been reaction to the study. Primarily, they seem to be centred around the statistical analysis and the sample size (ie. not enough rats). Tom Philpott, over at Mother Jones, has written a well researched piece on the burgeoning controversy:
Predictably, industry-aligned scientists are raising questions about the study, but even long-time critics like Consumers Union's Hansen have concerns. Now, Hansen stresses that the new paper is "longer and better designed than any of the industry studies," adding that the journal in question, Food and Chemical Toxicity, is "well-respected."
But the sample size—ten males and ten females per group—is simply too small to draw any conclusions, Hansen says. Moreover, he adds, the researchers used a strain of rat that is known to be highly prone to developing mammary tumors. That factor, plus the small sample size, means that the prevalence of mammary tumors found among the treated female rats could be happenstance, he said.

However, Hansen told me, while all of the individual comparisons—say, kidney dysfunction or mammary tumors between 10 females eating a certain level of GMO feed and 10 females eating non-GMO feed—are "statistically insignificant" because of sample size, taken as a whole, the results paint a troubling picture. Overall, the study made 54 comparisons between treated rats and control rats, and in all but four of them—two involving females, two involving males—the treated rats showed worse outcomes. "That's suggestive that there's something going on and there that should be further research," he said.
And, unlike me, Philpott has access to events like the press conference with study author Gilles-Eric Séralini, where he raised some of the concerns with the study design. Ted Schettler, science director of the Science and Environmental Health Network (SEHN), said:
 he's "intrigued" by the results, but isn't convinced. "I don't want to trash" the study, he said, "but I just don't see enough there that's very persuasive to me at this point." He added: "It does suggest to me that we need longer term feeding studies with GM foodstuff, in a standardized way with the right number of animals in each group so we can pick up the changes and be confident that they exist." He stressed that using enough rats to show robust, statistically significant results would be very expensive.
The expense of a larger sample size trial seems to be the reason the French study was so small. Large sample long-term animal studies are really expensive. Small non-industry-aligned groups, like Criigen, simply don't have the necessary cash to do massive studies. But, as said above, with the results viewed together this study does paint a troubling picture.

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