November 28, 2012
A new review of Roundup, the pesticide glyphosate, clearly documents how EU regulators have played fast and loose with the truth about its ability to cause life destroying birth defects.
Monsanto, Syngentia, Dow: Troika of Death
by Heidi Stevenson
The penchant for industry studies to lie, to claim that they found something other than what their data shows, seems unlimited. But the story grows even murkier as government agents take the lying even further. A new and independent review of industry studies of Monsanto’s Roundup (glyphosate) and their whitewashing … um, review by an EU regulator demonstrates how extreme the misrepresentations can be. Not only do the industry studies clearly demonstrate that glyphosate is teratogenic—that it causes birth defects—but a government determined to approve a product will take the misrepresentations to a new level.
The study, published in Environmental & Analytical Toxicology, is unusually direct in its assessments. In the conclusion, they state:
Regulatory authorities and industry affiliates have defended the use of glyphosate largely by citing the industry-sponsored toxicological tests conducted for regulatory purposes, which they claimed showed no evidence of teratogenicity. However, the German authorities’ draft assessment report revealed that even these industry tests contained clear evidence of glyphosate-mediated teratogenicity and reproductive toxicity. [Emphasis mine.]
Truly, what they found is stunning in its blatancy.
The EU’s Approval
The European Union gave a 10-year approval for the use of glyphosate in 2002. In 2010, an investigation by Paganelli et al found that it causes severe malformations in the embryos of South African clawed frogs and chickens. They also confirmed that this harm is caused by disruption of the retinoic acid signalling pathway. This is significant in humans because the same pathway is involved in the development of all vertebrate embryos, including humans. Therefore, it must be assumed that humans will also be affected. Several other studies also found severe and related deformities associated with the retinoic acid signalling pathway, along with increased mortality.
German regulatory authorities act as the rapporteur on glyphosate in the EU authorization process. That means they’re they official reporter on the topic, so they were authorized to “report” on the validity of Paganelli’s study. In 2010, Germany’s Federal Office for Consumer Protection and Food Safety, with German acronym of BVL, officially rebutted the study, stating:
There is a huge and reliable database for developmental toxicity of glyphosate and no evidence of teratogenicity has been obtained. In particular, studies in rats and rabbits failed to reveal craniofacial malformations as … would be expected if a substance affects mainly the neural crest.
They failed to say what that “huge and reliable database” consists of. However, all the studies they did cite were commissioned by glyphosate manufacturers. Most of the manufacturers’ studies were never published and received no peer review.
Nonetheless, BVL concluded that Paganelli’s findings:
… do not put the current risk assessment for glyphosate and glyphosate-based PPP [plant protection products – pesticides] into question with regard to human health.
Thus, the EU Commissioner for health and consumer policy stated that there was no need to ban or even restrict glyphosate. He even issued a directive delaying the review required at the end of the 10-year temporary approval until 2015.
Monsanto, Syngenta, and Dow all produce different versions of glyphosate, so they were certainly pleased with the BVL’s statement. They issued a joint statement saying:
Glyphosate does not cause adverse reproductive effects in adult animals or birth defects in offspring of these adults exposed to glyphosate, even at very high doses.
Not so fast! Let’s take a look at the new findings by:
- Head, Gene Expression and Therapy Group, Department of Medical and Molecular Genetics, King’s College London School of Medicine, UK
- Professor of entomology, former director, Institute of Biology, UNICAMP, and former provost of extension and community affairs, UNICAMP, São Paulo, Brazil
- Professor, Centre for Molecular Biosciences, University of Ulster, Northern Ireland
- Affiliated research scholar, Department of History and Philosophy of Science, University of Cambridge, UK
- Research development professor for ecological agriculture at the University of Newcastle, UK. Interests: director and trustee of the Stockbridge Technology Centre Ltd (STC), UK
- Professor, Center for Agricultural Sciences (department of plant science), Federal University of Santa Catarina, Brazil, Research director, Earth Open Source, London, UK. Interests: editor, GM Watch, UK
- Director, Earth Open Source. Interests: employed at a GMO testing and certification company
They’re certainly a group of respected and highly qualified researchers.
The Study: General Errors
The study systematically demonstrates how the deeply flawed the industry studies are and how extremely absurd the excuses used to ignore the studies’ data are, and it reviews the specific damages documented.
Here’s what they have to say about the BVL’s draft assessment report:
Examination of the draft assessment report revealed that the industry toxicological studies on rabbits and rats that BVL said showed “no evidence of teratogenicity” did, in fact, report malformations from glyphosate exposure.
Notice that there’s no hemming or hawing about the point. What they stated was equivalent to saying that the BVL authors were outright lying—that, or incompetent beyond belief. They point out several instances that clearly document the absurdity of their statement that no evidence of teratogenicity (birth defects) was shown.
First, we’ll review the general flaws identified by our study:
The lack of an adequate number of animals in toxicity studies done by industry is a recurring issue, because, as this study noted, “There is a high risk that this type of study design can miss compound-specific effects that occur at low- and medium-frequency.”
In the case of maternal toxicity studies, the EU Commission’s 2002 report concluded that developmental abnormalities found could be discounted “on the grounds that they were confined to ‘maternally toxic doses’, though how this conclusion was reached is unclear.” The EU Commission is saying that toxic doses in the mothers, for which there’s no indication, could have caused abnormalities in the offspring—but they offered nothing to back that assumption up.
The authors of this study point out:
An equally valid conclusion that could be drawn from the industry studies is that maternal toxicity could be obscuring a compound specific teratogenic effect and may not be the only cause of the observed malformations.
Therefore, other studies should have been done, using larger groups of animals, lower doses more in line with what would be expected in the real world, and for a significantly longer period of time, preferably lifelong.
In some arenas, a linear dose-response is expected before results can be accepted. There are, though, a few exceptions—and this is one. Glyphosate is noted as an endocrine disruptor, which are known for having irregular dose-response toxicity levels. Unfortunately, though this is known to be true, regulators—rather conveniently—stick to the outmoded concept that dose-response levels must increase at a linear rate.
The BVL German regulators, of course, used the claim that only linear dose-response effects are valid, thereby falsely claiming that genuine results were not legitimate.
Historical Control Data
The only controls that can be considered valid in any study are ones selected as appropriate matches and on which the same trial is performed at the same time. That should be obvious, and any claims referring to any other control data should obviously be suspect.
Yet, that’s precisely what the German regulators did! They consistently claimed that trial results were meaningless in comparison to “historical control data”. But it’s even worse than that.
They didn’t even bother to specify what historical control data they were using. We don’t know if the animal strains were the same, whether the substances applied to them were the same, whether the animals were fed the same diets, whether there were pathogens in the environment, or even what year or laboratory where these experiments were performed. And they didn’t even offer a reason for this lack of information!
Now that the groundwork has been laid, we’ll take a look at specific ways that the BVL gave Roundup-glyphosate cover. It’s truly stunning how blatant they are. Soon available: Government Agents Gave Cover for Roundup’s Birth Defects (Part 2).