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Government Agents Gave Cover for Roundup’s Birth Defects


 

Government Agents Gave Cover for Roundup’s Birth Defects

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 7th 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:

Study author and date Submitter company Experimental animal/exposure route Doses used
mg/kg bw/d
Effects found Dose-related effects/Statistical significance
Suresh, 1993 Feinchemie Rabbits/gavage 0, 20, 100, 500 Dilated heart Linear dose-response relationship. Significantly elevated at all doses, including low dose
        Unspecified "major visceral malformations" Linear dose-response relationship. Increased in all treatment groups, significantly increased at highest dose
        Extra 13th rib Linear dose-response relationship. Statistically significant increase at highest dose
Brooker et al., 1991 Monsanto/Cheminova Rabbits/gavage 0, 50, 150, 450 Heart malformations (only type specified is interventricular septal defect) Effect found at highest dose. No information provided by Germany on statistical significance
        Embryonic deaths Significant at all doses, though no clear dose/response relationship
Bhide and Patil, 1989 Barclay/Luxan Rabbits/route unstated 0, 125, 250, 500 Heart malformation (ventricular septal defect) Linear dose-response relationship. No statistical analysis provided by authors. Increased heart malformations found in all treatment groups
        Lungs: postcaval lobe absent Linear dose-response relationship. No statistical analysis provided by authors. Dose-dependent increases found in all treatment groups
        Kidneys absent Linear dose-response relationship. No statistical analysis provided by authors. Dose-dependent increases found in all treatment groups
        Rudimentary 14th rib, unilateral No statistical analysis provided by authors. Dose-dependent increases found in mid- and high-dose groups
        Number of viable foetuses per litter decreased and number of non-viable implants increased Linear dose-response relationship in case of non-viable implants. No statistical analysis provided by authors.  Effects found at high dose level.
Tasker et al., 1980 Monsanto/Cheminova Rabbits/gavage 0, 75, 175, 350 Increased number of deaths in dams Linear dose-response relationship. 1, 2, and 10 deaths in low, mid- and high-dose treatment groups respectively (no. of rabbits per group: 16 or 17). 75 mg/kg stated by Germany to be NOAEL
Anon., 1981 Alkaloida Rats and rabbits/oral feeding 0, 10.5, 50.7, 255.3 Increased number of foetal deaths Effect seen at two upper dose levels
Zhu et al., 1984 Barclay Mice/gavage 80, 420, 1050 Germany comments that there is "No evidence of dose-related toxic effects" and "no ... structural malformations" but that description of experiment was "poor" Data not provided by Germany
Brooker et al., 1991 Monsanto/Cheminova Rats/gavage 0, 300, 1000, 3500 Distortions affecting thoracic ribs Dose-dependent increases found in mid- and high-dose groups. Statistically significant at high dose
        Reduced ossification of one or more cranial centres Dose-dependent increases found in mid- and high-dose groups.
        Reduced ossification of sacro-caudal vertebral arches Dose-dependent increases found in mid- and high-dose groups
        Unossified sternebrae Increases found in all treated groups, statistically significant at high dose
        Skeletal variations Dose-dependent increases found in all treated groups, statistically significant in mid-dose and high-dose groups.
Tasker and Rodwell, 1980 Monsanto/Cheminova Rats/gavage 0, 300, 1000, 3500 Unossified sternebrae Increase found at highest dose level
        Unspecified malformations Increase at highest dose level
        No. of viable foetuses per litter and mean foetal weight decreased Effects found at highest dose level
        Early resorption of embryos Data not provided by Germany
Suresh, 1991 Feinchemie Rats/gavage 0, 1000 Increase in delayed ossification (caudal vertebral arch, forelimb proximal and hindlimb distal phalanges) found in treatment group, but increase in delayed ossification of skull found in control group Conflicting data led Germany to conclude that the NOAEL for developmental toxicity was 1000 mg/kg
Bhide, 1986 Barclay/Luxan Rats/gavage 0, 100, 500 No effects found but Germany commented that "serious reporting deficiencies" and lack of statistical analysis led it to consider the study as supplementary information only In spite of lack of reliable data, Germany derived a NOAEL for developmental toxicity of 500 mg/kg
Anon., 1981 Alkaloida Rats and rabbits/oral feeding 22, 103, 544 Germany commented that description of study is so "poor" that it only considered the study as supplementary information. There were "no malformations recorded" and effects on foetuses were "not observed" but it is unclear from Germany's summary whether this was due to poor reporting by the study's authors or if there was an actual absence of effects In spite of lack of reliable data, Germany derived a NOAEL for developmental toxicity of 544 mg/kg

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 EvidenceEnvironmental & 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 ratsToxicology Letters, Eliane Dallegrave, Fabiana DiGiorgio Mantese, Ricardo Soares Coelho, Janaı´na Drawans Pereira, Paulo Roberto Dalsenter, Augusto Langeloh

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Sayer Ji
Founder of GreenMedInfo.com

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Depression: 21st Century Solutions + The Dark Side of Wheat

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