The management of Monsanto’s Roundup demonstrates that there is truly no limit to the depths that our own governments will go when they’re in bed with international corporations. And that’s the definition of fascism, isn’t it?

by Heidi Stevenson

Part 1, Industry Studies Prove Roundup Causes Birth Defects, told about the general types of games played in the coverup of Roundup’s ability to cause birth defects. Here in Part 2, we discuss the specifics. It’s stunning how blatant they are. Most things should be obvious to anyone with a 7^th grade education.

We’d like to believe that government agencies tasked with assuring that our health and the environment are protected would do that. But as we can see in a scientific review by Germany’s Federal Office for Consumer Protection and Food Safety (German acronym of BVL), which was tasked by the European Union’s Commission to review research on glyphosate (brand name Roundup), that’s far from reality.

Specific Errors Made by Government Agents

First, here is a table, produced by the reviewers referenced here^[1], that shows the results of selected industry-financed studies that are discussed below:

Now we’ll look into specific industry-sponsored studies that the BVL reviewed, focusing on their particular findings:

Increased Skeletal, Visceral, and Heart Malformations

A study on rabbits by Suresh found that the number of fetuses with “major visceral anomalies was high in all treated groups”. They also found that the percentage of fetuses with dilated hearts was increased at all dosage levels and that skeletal variations, anomalies, and malformations were found, though without a definitive dose-response pattern.

The Germans dismissed this finding by claiming that the actual number of fetuses with dilated hearts was small, that there was no increase at the mid-dose range, that no other soft organ malformations occurred, and that “the supposed consequences of this heart malformation were ‘equivocal’”.  They also found that the study showed No Observable Adverse Effect Levels (NOAELs).

The reviewers of that paper agree that NOAEL should have been found, but rather than state that it means there is no indication of a problem, they said it means that more studies, and more appropriately-designed ones, need to be done. As they state:

Their comment that the number of foetuses with abnormalities was small merely identifies a shortcoming of the standardised industry studies performed for regulatory purposes. Larger numbers of animals are preferable. If the number of animals used is small, any effect will only be seen in a few animals and statistical significance will be difficult to obtain. This is especially true at lower doses, where observable effects will be smaller and/or less frequent.

They also consider the claim that a lack of other soft organ malformations negates the finding of heart problems is “scientifically and clinically indefensible”. There is no doubt that toxic agents can have effects only on specific organs.

Increased Heart Malformations and Embryonic Deaths

An industry-funded study done on rabbits by Brooker et al found a significant increase in embryo deaths in all treatment groups. The German regulators again argued that applying “historical control data” gives different results. As explained in the previous article, using historical data as controls is nonsense. Clearly, they’re grasping at straws.

They also claimed that an increase in heart malformations in the high dose groups was within the range of “historical control data”. Can you see a pattern emerging?

Decrease in Viable Fetsuses, Increase in Malformations

In another industry-funded rabbit study done by Bhide and Patil, results showed a decreased number of viable fetuses per litter and an increase in embryo deaths. In the high-dose group, visceral and skeletal malformations were increased.

In this instance, the German regulators acknowledged that harm was shown. However, they set the level that can cause birth defects at an absurdly high 250 mg/kg, in spite of the fact that the study demonstrated increases in most defects at 125 mg/kg doses.

The study’s authors did not provide an analysis of statistical significance and used only 15 animals. The small number of trial subjects means that, most likely, there was no statistical significance at lower doses. Therefore, it would have been more appropriate to define a Lower Observed Adverse Effect Level (LOAEL) at 250 mg/kg, possibly even 125 mg/kg, instead of declaring NOAEL. There was simply no evidence provided for that rating.

Increased Fetal Deaths

A study done on rats and rabbits in which the researchers remained anonymous recorded no malformations, but did find more fetal deaths at the upper dose levels of 50.7 and 255.3 mg/kg. The German regulators said that the findings were not meaningful because the feedings were not done by gavage, forced feeding, usually done to assure equivalent doses.

Our reviewers state:

The German regulators’ assumption that low-dose findings were non-treatment-related because oral feeding resulted in different effects than gavage is not defensible. As was pointed out by the UK’s PSD [Pesticide Safety Directorate], another study supported this study’s findings.

Increased Unossified Sternebrae

A study on rats by Tasker and Rodwell found more fetuses with unossiffied sternebrae, that is, the breastbones had not converted cartilage to bone, at the highest dose level of 3500 mg/kg. The German regulators said that this was within the range of “historical data” and wasn’t related to the glyphosate. They called it “rather a developmental variation than a malformation”.

Again, the undocumented, undefined, and unrelated “historical data” was called into play. Our reviewers stated that, considering the findings of other studies, this is “not justified”. Further, they said that calling unossified sternebrae merely a “developmental variation” is “scientifically unjustified” since, “Unossified sternebrae in the rat are clearly defined as a skeletal deformity in ‘The Handbook of Pesticide Toxicology’”.

The point comes when one must wonder what the Germans were imbibing!

Increased Skeletal Malformations

This study on rats by Brooker et al found an increased incidence of skeletal malformations and reduction in ossification at both the middle and high level doses. It won’t surprise you that the German regulators said this was “within the range of historical control data”. They also claimed that “maternal toxicity was a confounding factor and described the significance of the malformations as ‘equivocal’”.

Again, they referenced “historical control data” with no further explanation of what it was or where it came from. They also ignored that Paganelli found the same kinds of malformations and was able to associate them with disturbance in the retinoic acid signalling pathway.

EU Commission’s Response to the German Regulators

The EU Commission practically rubber-stamped Germany’s commentary. They considered the possibility of heart malformations, but:

… dismissed them on the grounds that they were “within the range of the historical control data” . Again, it is unclear from the panel’s statement whether it saw the historical control data and, if so, whether it systematically assessed the validity of that data set. Subsequently, in 2002, the EU Commission authorised glyphosate.

That’s all. Could there have been any question that the German regulators and the EU Commission set out with their conclusion predetermined?

Our reviewers also noted that the issue is worldwide, with the World Health Organization (WHO) also captured by Agribusiness money. The WHO routinely relies on industry-created pseudo science to make its decisions on chemicals and pesticides.

The blatancy of it all can be seen in a BVL claim that no craniosacral deformities were found in  the 2003 Dallegrave study^[2]. They stated, “The most frequent skeletal alterations observed were incomplete skull ossification and enlarged fontanel[le].” But skull ossification and an enlarged fontanelle are both craniosacral deformities! One gets the distinct impression that Hitler’s technique of lying big and lying often is being used. Yet that obviously false claim was accepted by the EU Commission in its decision to allow the use of glyphosate.

The management of Monsanto’s Roundup demonstrates that there is truly no limit to the depths that our own governments will go when they’re in bed with international corporations. And that’s the definition of fascism, isn’t it?

Sources:

1. Teratogenic Effects of Glyphosate-Based Herbicides: Divergence of Regulatory Decisions from Scientific Evidence, Environmental & Analytical Toxicology, M Antoniou, MEM Habib, CV Howard, RC Jennings, C Leifert, RO Nodari, CJ Robinson* and J Fagan
2. The teratogenic potential of the herbicide glyphosate Roundup in Wistar rats, Toxicology Letters, Eliane Dallegrave, Fabiana DiGiorgio Mantese, Ricardo Soares Coelho, Janaı´na Drawans Pereira, Paulo Roberto Dalsenter, Augusto Langeloh