Dewayne Johnson vs. Monsanto on Glyphosate and Cancer: What the Jury Saw

THE PRESS has pundits that answer to corporations for advertising revenue.  So for the last week, we’ve had to read stories like this one from the BBC:

BBC

Note the headline cites Bayer as the source of the knowledge claim.

Scott Partridge, a vice president with Monsanto, published a letter disputing the verdict:

“Like everyone else following the Dewayne Johnson v. Monsanto Co. trial, my colleagues and I have deep sympathy for Mr. Johnson’s plight. Our hearts go out to the Johnson family, and we understand their desire for answers.

Glyphosate is not the answer. Glyphosate does not cause cancer. The jury got it wrong. We will appeal the jury’s opinion and continue to vigorously defend glyphosate, which is an essential tool for farmers and others. We are confident science will prevail upon appeal.

The jury’s opinion does not change the science. Glyphosate has a more than 40-year history of safe use. Over those four decades, researchers have conducted more than 800 scientific studies and reviews that prove glyphosate does not cause cancer. The National Institutes of Health (NIH) and the Joint FAO/WHO Meeting on Pesticide Residues (JMPR) both recently reaffirmed glyphosate does not cause cancer. The U.S. Environmental Protection Agency (EPA) and other regulatory authorities in Europe, Canada, Japan, Australia, Korea, and elsewhere routinely review all approved pesticide products and have consistently reaffirmed that glyphosate does not cause cancer.”

Mr. Partridge did not report in his letter something the BBC did report, namely that in 2015, the International Agency for Research on Cancer, the World Health Organisation’s cancer agency, concluded that glyphosate was “probably carcinogenic to humans“.

He also did not report that the jury saw material that will likely have Monsanto and Bayer reeling for decades.

What the Jury Saw

All materials are excerpted and paraphrased from the Monsanto Documents from the trial in a collection hosted for the public by Baum, Hedlund, Aristei and Goldman PC, who represented Dewayne Johnson.  I have not sought nor received compensation from that firm nor from Mr. Johnson for this summary.  I have a working relationship with Mr. Robert F. Kennedy Jr. as a Guest Contributor at World Mercury Project, but have never received any compensation for that honor.

The jury, in San Francisco, saw evidence in the form of internal emails showing that

(1) Monsanto was told by Dr. James Parry, who was working under contract to review the evidence of carcinogenicity of glyphosate, that the evidence that glyphosate was capable of causing cancer was credible.  Specifically, Parry reported that he found the evidence that glyphosate was clastogenic credible.  (A clastogen is a substance capable and breaking up and re-arranging chromosomes, something one should never see as “safe”).  Parry wrote:

“My overall view is that if the reported genotoxicity of glyphosate and glyphosate formulations can be shown to be due to the production of oxidative damage then a case could be made that any genetic damage would be thesholded…it may be necessary to consider the possibility of susceptible groups within the human population.”

In one email, Monsanto toxicologist Donna Farmer wrote:

 “Dr. Parry concluded on his evaluation of the four articles that glyphosate is capable of producing genotoxicity both in vivo and in vitro by a mechanism based upon the production of oxidative damage” but nevertheless Farmer held that “You cannot say that Roundup is not a carcinogen…”

(2) When Dr. Parry made this conclusion and suggested studies that would allow Monsanto to determine whether their product would produce cancer, Farmer wrote that “further studies should be sent to him in order to move Dr. Parry from his position.”

(3) Rather than do the science that Dr. Parry suggested, others at Monsanto communicated that they should stop working with Parry and find another scientist who would be willing to help them get the question of genotoxicity under control:

(William Heydens):”We want to find/develop someone who is comfortable with the genetox profile of glyphosate/Roundup and who can be influential with regulators and Scientific Outreach operations when genetox issues arise. My read is that Parry is not currently such a person, and it would take quite some time and $$$/studies to get him there. We simply aren’t going to do the studies Parry suggests.

(4) That Monsanto had a long-standing history of manipulating scientific studies by a practice by which Monsanto employees would conduct the studies, and contract scientists to act as if THEY conducted the studies, and just put their name on it:

The jury saw an email in which the goal of finding ghostwriters was clear; in one email, Dr. Heydens explicitly identifies one of the goals as “Publication on Animal Data Cited by IARC…Manuscript to be initiated by Mon as ghost writers”.

In another email shown to the jury, Heyden reveals that ghostwriting was a matter of common practice; Heydens suggests adding the names of experts to scientific papers to cut down on costs of independent research: “An option would be to add Greim and Kier or Kirkland to have their names on the publication, but we would be keeping the cost down by us doing the writing and they would just edit & sign their names so to speak. Recall that is how we handled Williams Kroes & Munro, 2000.

That paper, published in the journal Regulatory Toxicology and Pharmacology should now, by all rights, be retracted. Here’s the article and abstract:

Williams GM, Kroes R, Munro IC. Safety evaluation and risk assessment of the herbicide Roundup and its active ingredient, glyphosate, for humans.
Regul Toxicol Pharmacol. 2000 Apr;31(2 Pt 1):117-65.

Abstract
Reviews on the safety of glyphosate and Roundup herbicide that have been conducted by several regulatory agencies and scientific institutions worldwide have concluded that there is no indication of any human health concern. Nevertheless, questions regarding their safety are periodically raised. This review was undertaken to produce a current and comprehensive safety evaluation and risk assessment for humans. It includes assessments of glyphosate, its major breakdown product [aminomethylphosphonic acid (AMPA)], its Roundup formulations, and the predominant surfactant [polyethoxylated tallow amine (POEA)] used in Roundup formulations worldwide. The studies evaluated in this review included those performed for regulatory purposes as well as published research reports. The oral absorption of glyphosate and AMPA is low, and both materials are eliminated essentially unmetabolized. Dermal penetration studies with Roundup showed very low absorption. Experimental evidence has shown that neither glyphosate nor AMPA bioaccumulates in any animal tissue. No significant toxicity occurred in acute, subchronic, and chronic studies. Direct ocular exposure to the concentrated Roundup formulation can result in transient irritation, while normal spray dilutions cause, at most, only minimal effects. The genotoxicity data for glyphosate and Roundup were assessed using a weight-of-evidence approach and standard evaluation criteria. There was no convincing evidence for direct DNA damage in vitro or in vivo, and it was concluded that Roundup and its components do not pose a risk for the production of heritable/somatic mutations in humans. Multiple lifetime feeding studies have failed to demonstrate any tumorigenic potential for glyphosate. Accordingly, it was concluded that glyphosate is noncarcinogenic. Glyphosate, AMPA, and POEA were not teratogenic or developmentally toxic. There were no effects on fertility or reproductive parameters in two multigeneration reproduction studies with glyphosate. Likewise there were no adverse effects in reproductive tissues from animals treated with glyphosate, AMPA, or POEA in chronic and/or subchronic studies. Results from standard studies with these materials also failed to show any effects indicative of endocrine modulation. Therefore, it is concluded that the use of Roundup herbicide does not result in adverse effects on development, reproduction, or endocrine systems in humans and other mammals. For purposes of risk assessment, no-observed-adverse-effect levels (NOAELs) were identified for all subchronic, chronic, developmental, and reproduction studies with glyphosate, AMPA, and POEA. Margins-of-exposure for chronic risk were calculated for each compound by dividing the lowest applicable NOAEL by worst-case estimates of chronic exposure. Acute risks were assessed by comparison of oral LD50 values to estimated maximum acute human exposure. It was concluded that, under present and expected conditions of use, Roundup herbicide does not pose a health risk to humans.

The jury also saw an email from Dr. John Acquavella protesting Monsanto’s ghost-writing activities: “I can’t be a part of deceptive authorship on a presentation or publication… We call that ghost writing and it is unethical.” 

The jury saw emails that Forbes magazine also published articles ghost-written by Monsanto: In an email correspondence between Eric Sachs (Monsanto) and Henry Miller, a Forbes contributor and fellow of the Stanford Hoover institute. Mr. Sachs asks Mr. Miller: “Are you interested in writing a column on this topic? Ideally, your article would precede the IARC decision. Why not set the table with the weight of scientific evidence before IARC convenes? Then, regardless of what they do, your article will set the stage for a science-based response.” 

Sachs then emailed his Monsanto colleagues: “Henry agreed to author an article on Forbes.com. John will work with a team internally to provide a draft and Henry will edit/add to make it his own.”

(5) So there was ghostwriting, and they wanted to move on from Dr. Parry who found the evidence credible that glyphosate might cause cancer.  The final word from Dr. Farmer?

“We have not done the necessary testing on the formulation to make that statement.”

(6) But way back in 2004, there was very, very good cause for concern – and Monsanto had the knowledge in-house:

An email by Michael Cunningham (Monsanto) to several other colleagues found them discussing  N-nitrosoglyphosate (“NNG”), a known carcinogen, that can be formed as reaction between glyphosate and nitrites, which are found in many foods.  Specifically, Cunningham quoted Dr. Ruth Shearer from 1984: “The problem with glyphosate… is that it combines readily with nitrites, found in normal human saliva, to form an N-nitroso compound called Nnitrosoglyphosate. Although that particular compound has not been tested as a cancer-causing agent, over 75% of all other N-nitroso compounds so tested have been shown to cause cancer by way of tumour formation.”

Glyphosphate was recently detected in many consumer products, many consumed by children:

From Fox Business:

Lab tests conducted by the left-leaning Environmental Working Group (EWG), a nonprofit advocacy group that specializes in toxic chemicals and corporate accountability, indicated almost three-fourths of the 45 food products tested detected high levels of glyphosate, which has been identified as a “probable carcinogen” by the World Health Organization in 2015.

Some of the food products that tested positive for glyphosate include General Mills’ Cheerios Toasted Whole Grain Oat Cereal, Lucky Charm’s, Kellogg’s Cracklin’ Oat Bran and Quaker’s Old Fashioned Oats; all were found to have levels of glyphosate that exceed EWG’s safety guidelines.

Many are worried about the implications of the high concentrations, no matter what cause and effect might be proven.

From CBS:

“I was shocked,” said Dr. Jennifer Lowry, who heads the Council on Environmental Health for the American Academy of Pediatrics and is a toxicologist at Children’s Mercy Kansas City.

“We don’t know a lot about the effects of glyphosate on children,” Lowry said. “And essentially we’re just throwing it at them.”

From NPR:

GARCIA-NAVARRO: All right. What’s the takeaway here for you as someone who’s reported on this industry, on these issues for so long?
CHARLES: What I find most interesting is the fact that the jury did not believe or give credibility to the sort of the official institutions that are responsible for evaluating safety of a chemical. It didn’t matter what the EPA says, the Environmental Protection Agency or the European Food Safety Agency. The plaintiffs basically said the government is too cozy—the regulators are too cozy with the companies. And that was convincing to the jury.

There are those who claim that the jury dismissed Science.  What it looks like to me is that the party who refused to do the objective science necessary to critically test the hypothesis is the party who dismissed Science.  That party was Monsanto.

(7) The jury learned that Dewayne Johnson had called Monsanto – and, sadly, was blown off.

An internal e-mail between Monsanto product specialist Patricia Biehl and her colleague, Daniel Goldstein, a toxicologist, Biehl wrote:

“I spoke to Dewayne Johnson and he told me he works for a school district in California and nine months ago he had a hose break on a large tank sprayer”… This resulted in him being soaked to the skin on his face, neck, and head with Ranger Pro. He said he was wearing a white exposure suit and it even went inside that. A few months after this incident he noticed a rash on his knee and then on his face and later on the side of his head. His entire body is covered in this now and doctors are saying it is skin cancer. He is just trying to find out if it could be related to such a large exposure to Ranger Pro since he stated his skin was always perfect until this happened. He is looking for answers.”

Goldstein replied “I will call him. This story is not making any sense to me at all.”

Goldstein never called Johnson; the transcript of Goldstein’s deposition confirms that he did not recall calling Johnson back.

The jury ruled that roundup gave Mr. Johnson terminal cancer (non-Hodgkin’s lymphoma), and awarded him him $289.3 million in damages.

In response to the jury, Monsanto also tweeted:

Monsanto Company

@MonsantoCo
“Glyphosate does not cause cancer. We will continue to stand by the science and vigorously defend glyphosate.” https://monsanto.info/2B5tEQo #glyphosate #monsanto https://monsanto.com/news-stories/statements/roundup-glyphosate-trial/

6:02 PM – Aug 13, 2018

The Jury Got it Wrong on Glyphosate | Monsanto
Rather than arguing the science, the plaintiff’s lawyers repeatedly crossed the line, distorted the facts and used baseless and egregious emotional appeals to inflame the jury.

monsanto.com

The question all humans on the planet should ask is: If Monsanto has not done the studies necessary to test whether glyphosate and/or RoundUp cause – or do not cause – cancer, how can they make such knowledge claims?  Do they just disagree with the established science that convinced Dr. Parry? And if so, on what grounds?  Certainly any studies they funded or that were ghost-written by them can not be taken seriously as an independent source of their opinion.

For an in-depth, peer-reviewed analysis of how extensive corporate manipulation of science has been in the case of glyphosate, read McHenry (2018), an incredibly detailed review in the International Journal of Risk & Safety in Medicine:

The Monsanto Papers: Poisoning the scientific well

Leemon B. McHenry
Abstract.
OBJECTIVE: Examination of de-classified Monsanto documents from litigation in order to expose the impact of the company’s efforts to influence the reporting of scientific studies related to the safety of the herbicide, glyphosate.
METHODS: A set of 141 recently de-classified documents, made public during the course of pending toxic tort litigation, In Re Roundup Products Liability Litigation were examined.
RESULTS: The documents reveal Monsanto-sponsored ghostwriting of articles published in toxicology journals and the lay media, interference in the peer review process, behind-the-scenes influence on retraction and the creation of a so-called
academic website as a front for the defense of Monsanto products.
CONCLUSION: The use of third-party academics in the corporate defense of glyhphosate (sp) reveals that this practice extends beyond the corruption of medicine and persists in spite of efforts to enforce transparency in industry manipulation.

Leemon

7 comments

  1. I think it would be great if states would start passing legislation that requires any entity that files an appeal to pay at least 50% of the opposing side’s legal costs UP FRONT – and if they win on appeal they can make payment arrangements at that time. It would stop the law fare.

  2. I hope you will fill us in on the credentials of Henry Miller. Is this the same Henry Miller who was employed by the FDA and basically served as a GMO cheerleader?

  3. Great summary, thanks! Monsanto is following the well-laid path from other propaganda campaigns, as described in Sheldon Rampton’s book, Trust Us We’re the Experts (complete with a picture of a cigarette-smoking doctor on the cover).

    Monsanto/Bayer is making $6+ billion per year from glyphosate and related GMO’s — the longer they can keep selling it, the more money they make. One can hope that lawsuits and punitive damages will put them out of business.

    See https://www.amazon.com/Trust-Us-Were-Experts-Manipulates/dp/1585421391/ref=sr_1_1?ie=UTF8&qid=1535390696&sr=8-1&keywords=trust+us+were+experts

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