Critical Reviews in Toxicology

Trimmed-Down Testimony as Monsanto Cancer Trial Winds Down

Print Email Share Tweet
Posted on by Stacy Malkan

(Transcript of today’s proceedings) 

Lawyers for Edwin Hardeman have substantially cut down the number of witnesses and evidence to present to jurors who must decide if Monsanto and its new owner Bayer are liable for Hardeman’s development of non-Hodgkin lymphoma after years of use of Monsanto’s Roundup. They have but a few hours left allotted to them by the judge, who has said he expects closing arguments by Tuesday.

The six-member jury team decided last week that Roundup was in fact a substantial factor in causing Hardeman’s cancer. The trial is now focused on whether or not Monsanto should be blamed, and if so, how much – if anything – the company should pay Hardeman in damages.

But making that case may be difficult given the short amount of time the plaintiff’s attorneys have left in the total “time clock” that Judge Vince Chhabria set. He gave each side 30 hours to make their case.

Hardeman’s attorneys used most of their time in the first half of the trial and now have but a few remaining hours. As a result, they have informed the judge that they will not be calling planned testimony from Monsanto executives Daniel Goldstein, Steven Gould, David Heering, or Daniel Jenkins. They also will not be presenting planned testimony from Roger McClellan, editor of the scientific journal Critical Reviews in Toxicology (CRT), and at least four other witnesses.

McClellan was overseeing CRT when the journal published a series of papers in September 2016 that rebuked the finding by the International Agency for Research on Cancer (IARC) finding that glyphosate was a probable human carcinogen. The papers purported to be written by independent scientists who found that the weight of evidence showed the weed killer was unlikely to pose any carcinogenic risk to people. But internal Monsanto documents show that the papers were conceptualized from the outset as a strategy by Monsanto to discredit IARC. One of Monsanto’s top scientists not only reviewed the manuscripts but had a hand in drafting and editing them, though that was not disclosed by CRT.

Hardeman’s attorneys plan about three more hours of testimony from various witnesses, including former Monsanto Chairman and CEO Hugh Grant, who received an exit payment of about $32 million when Bayer AG bought Monsanto last summer.

Discussion of Damages

Both sides have already agreed that Hardeman has suffered a loss of approximately $200,000 in economic damages, but Hardeman’s attorneys are expected to ask for many tens of millions of dollars, and possibly hundreds of millions of dollars for total damages, including punitive.

Lawyers for Monsanto have objected to any discussion of Monsanto’s wealth and the $63 billion Bayer paid for Monsanto, but the judge has allowed some financial information to be shared with jurors.

Jurors may not ever be told exactly how much money Monsanto has made over the years in sales of its glyphosate herbicides, but a look at just one year of financials – 2012, the year Hardeman stopped using Roundup – shows the company made roughly $2 billion in total profits that year.

Judge Chhabria noted in discussions with attorneys out of the presence of the jury that Hardeman’s attorneys might want to argue that Monsanto spent a lot of money on advertising and payouts to executives rather than conducting long-term safety studies on its products. The money issues might be relevant to jurors’ deliberation over potential punitive damages, Chhabria said.

“It may be relevant to Monsanto’s ability to pay, but it seems even more relevant to the issue of what was knowable — both liability and punitive damages, whether Monsanto’s conduct was extreme and outrageous,” Judge Chhabria said.  “Why can’t they argue, look at all the money Monsanto has been willing to spend on advertising and it’s not willing to, you know, conduct any sort of objective inquiry into the safety of its product.”

“It is not as much about the company’s ability to pay as it is about the company’s conduct with respect to the safety of its product,” Chhabria said. “Look at all these things that the company is spending extreme amounts of money on, and it’s not willing to lift a finger to conduct any sort of objective inquiry about the safety of its product.  That, I assume, is their argument.”

Chhabria said the evidence of Monsanto’s finance could be “probative” of the  “outrageousness of the company’s conduct.”

Pilliod Trial Beginning 

A third Roundup cancer trial gets underway this week in Alameda County Superior Court in Oakland, California. Alva and Alberta Pilliod,  husband and wife, take on Monsanto and Bayer with claims they both are suffering from non-Hodgkin lymphoma due to exposure to Monsanto’s Roundup products. Voir dire for jury selection begins today in Oakland and opening statements are expected to begin Thursday.  See documents related to that case at this link. 

The judge in the Pilliod case rejected Monsanto’s request to bifurcate the trial. The legal team presenting the Pilliod case includes Los Angeles attorney Brent Wisner, who gained notoriety for the win by plaintiff Dewayne “Lee” Johnson over Monsanto in the first-ever Roundup cancer trial last summer.

Hepatitis C and… Hugh Grant?

Print Email Share Tweet
Posted on by Gary Ruskin

(See video update here)

(Transcript from today’s proceedings)

Monsanto’s legal team on Monday presented testimony from Dr. Alexandra Levine, a hematologist/oncologist with City of Hope Comprehensive Cancer Center, seeking to convince the jury that exposure to glyphosate-based herbicides was not a cause of Hardeman’s cancer, and that a more likely factor is the hepatitis C Hardeman had for many years. Levine testified that she has seen “many, many, thousands of patients with non-Hodgkin’s lymphoma,” and she is in fact considered a specialist in that specific disease.

Judge Chhabria said last week that he would like to see this first phase of the trial wrapped up early this week, meaning the case should be with the jury soon. A verdict requires all six jurors to be unanimous in their finding regarding whether or not Hardeman’s exposure to Roundup “was a substantial factor” in causing his cancer. The judge will define for jurors what that means. (See Friday’s entry for more details.)

If the jury does not unanimously decide either for Hardeman or Monsanto then the case would be a mistrial. Chhabria has also said that if that happens he is considering retrying it in May.

If the jury finds for Hardeman on causation, the trial would quickly move into Phase II using the same jury. And that is where things will really start to get interesting. Hardeman’s attorneys plan to call several Monsanto executives for testimony, including former Monsanto Chairman and CEO Hugh Grant. Grant spent more than 35 years at the company and was named CEO in 2003. He led the company until its acquisition by Bayer AG last summer.

Additionally, lawyers for Hardeman plan to call Roger McClellan, editor of the scientific journal Critical Reviews in Toxicology (CRT), which published a series of papers in September 2016 that rebuked the finding by the International Agency for Research on Cancer (IARC) finding that glyphosate was a probable human carcinogen. The papers purported to be written by independent scientists who found that the weight of evidence showed the weed killer was unlikely to pose any carcinogenic risk to people.

However, internal Monsanto documents show that the papers were conceptualized from the outset as a strategy by Monsanto to discredit IARC. One of Monsanto’s top scientists not only reviewed the manuscripts but had a hand in drafting and editing them, though that was not disclosed by CRT.

Hardeman’s lawyers additionally said they plan to call Doreen Manchester, of CropLife America, the agrochemical industry’s lobbying organization. Manchester’s role at CropLife has been helping “lead federal and state litigation to support pesticide regulatory issues.”

A Story Behind the Monsanto Cancer Trial — Journal Sits on Retraction

Print Email Share Tweet
Posted on by Susan Lang

What “ghostwriting” by Monsanto means, how it has influenced, and still is influencing, material found in peer-reviewed scientific journals

This article was originally published in Environmental Health News.

By Carey Gillam and Nathan Donley

Consumers and journalists around the world were stunned earlier this month when Monsanto, after being forced in a court of law for the first time to defend the safety of its popular weed killer Roundup, was found liable for the terminal cancer of California groundskeeper Dewayne Johnson.

The unanimous 12-member jury found that Mr. Johnson’s exposure to Monsanto’s weedkiller was a “substantial” contributing factor to his disease and that there was “clear and convincing” evidence that Monsanto acted with “malice or oppression” because the risks were evident and Monsanto failed to warn of those known risks.

Aside from dueling expert testimony on both sides, the jury was provided with internal company emails and work plans indicating that Monsanto had been corrupting the scientific record by ghostwriting literature asserting safety.

As the jury’s decision sets in, and thousands of additional plaintiffs who have filed similar suits wait for their day in court, it is worth taking time to understand exactly what “ghostwriting” by Monsanto means, how it has influenced, and still is influencing, material found in peer-reviewed scientific journals.

We offer this example:

When the scientific journal Critical Reviews in Toxicology (CRT) published a series of papers reviewing the carcinogenic potential of weed-killing agent glyphosate, the main ingredient in Monsanto’s Roundup, in September 2016, the findings were so significant that they were widely reported by media outlets around the world.

The papers, published in a special issue of CRT entitled “An Independent Review of the Carcinogenic Potential of Glyphosate,” directly contradicted the findings of the World Health Organization’s International Agency for Research on Cancer (IARC), which in 2015 found glyphosate to be a probable human carcinogen. The authors of the 2016 review found that the weight of evidence showed the weed killer was unlikely to pose any carcinogenic risk to people.

The findings were critical to Monsanto – the company was facing doubts by European regulators about allowing glyphosate to remain on the market. As well, Monsanto was facing a growing mass of lawsuits claiming its weed killer caused people to develop non-Hodgkin lymphoma.

Sixteen scientists from “four independent panels” signed their names to the published work, declaring to readers that their conclusions were free of Monsanto’s intervention. Underscoring the supposed independence of the work, the declaration of interest section stated: “Neither any Monsanto company employees nor any attorneys reviewed any of the Expert Panel’s manuscripts prior to submission to the journal.”

It has since become evident that these papers were anything but independent. Internal Monsanto documents forced into the public spotlight through litigation show that the papers were conceptualized from the outset as a deceptive strategy for Monsanto. One of Monsanto’s top scientists not only reviewed the manuscripts but had a hand in drafting and editing them. The finished papers were aimed directly at discrediting IARC’s classification.

In one internal email, Monsanto’s chief of regulatory science, William Heydens, told the organizer of the panel: “I have gone through the entire document and indicated what I think should stay, what can go, and in a couple spots I did a little editing.”

The internal documents show that Heydens even argued over statements that he wanted included but that author John Acquavella deemed “inflammatory” and “not necessary” criticisms of IARC. Draft documents show Heydens’ edits contradicted Acquavella’s edits even though Heydens was not supposed to have even reviewed the papers. Heydens went so far as to state: “I would ignore John’s comment” and “I don’t see a reason for deleting the text that John did below.”

Other edits show Heydens attempting to control the tone of the manuscript, stating: “The deleted statement below has nothing to do with IARC criticism and should be put back in, John over-stepped the bounds here” and “I can live with deleting the text below, assuming that exposure text above … is added back in.” He also argued for putting a deleted phrase back in because it gave “clarity about IARC’s approach.” “This is not inflammatory, it is descriptive,” he wrote.

The importance of the papers to Monsanto as a tool to counter IARC’s classification of glyphosate as a probable carcinogen was laid out in a confidential document dated May 11, 2015, naming several of the scientists who could be used as authors to give the papers credibility. The internal documents speak of “ghost-writing” strategies aimed at using non-company scientists as authors to lend credibility to the findings.

When placed under oath in a deposition, Heydens acknowledged that the manuscripts were sent to him and he read “parts of some of them,” prior to their submission to the journal. He said he did not “recall” whether or not he made the 28 edits that plaintiffs’ attorneys counted in the internal records.

All of this was among the evidence presented to jurors in San Francisco Superior Court as they considered Johnson’s claims. But the evidence of ghostwriting and misconduct have far broader implications than one lawsuit.

How many ghostwritten papers declaring pesticide safety are littering the scientific literature? And given the evidence of misconduct in this instance, why are these papers still in publication? Why has there been no retraction, no clarification, no correction to the obviously deceptive disclosure?

Last August, after the documents gained media attention CRT editor Roger McClellan said the “serious accusations” deserved “careful investigation,” and he and CRT publisher Taylor & Francis would take “appropriate action.”

Shortly thereafter the Center for Biological Diversity and three other national environmental-health organizations sent a letter to CRT and Taylor & Francis detailing the ethical misconduct and formally asking for a retraction. It’s been more than a year since this investigation was begun and, despite multiple follow-up requests by the organizations, no action has been taken.

With Taylor & Francis’s own policy being to issue a retraction for misconduct “when there has been an infringement of publishing ethics,” the case for retraction couldn’t be more clear.

Monsanto’s fingerprints are all over this “independent” review, as laid out in Monsanto’s own internal documents.

Taylor & Francis must determine the standards to which it is willing to hold scientists who publish in its journals – if not for the reputation of the journals themselves, then for the sake of scientific integrity itself and the public’s right to the truth.

Upcoming EPA Meetings on Safety of Monsanto Weed Killer Drawing Scrutiny

Print Email Share Tweet
Posted on by Carey Gillam

By Carey Gillam

Bayer better be paying attention to this.

The German company’s intended $66 billion acquisition of Monsanto Co. comes amid growing concern over the future of the company’s top-selling weed killer, a chemical called glyphosate that Monsanto introduced to the world 40 years ago as the active ingredient in its Roundup herbicide. Monsanto reaps billions of dollars annually, roughly a third of its sales, from those products.

So it’s no small matter that in mid-October the Environmental Protection Agency (EPA) plans to spend four days holding public meetings with a scientific advisory panel on the topic of whether or not glyphosate can cause cancer. The idea of shining a public spotlight on this mounting concern about the world’s most widely used herbicide has not set well with Monsanto and the rest of the industry that profits from glyphosate products like Roundup. Agrichemical interests have gone so far as to tell the EPA that the meetings should not be held at all, and have said that if they are, many of the world’s top scientists should be excluded from participating.

The industry clearly does not welcome the public scrutiny the meetings bring, but it should be satisfied that the EPA has made it clear it has no intention of contradicting Monsanto’s claims of glyphosate’s safety. After all, in a Sept. 12 report issued to the public, the EPA offered a 227-page evaluation of glyphosate’s cancer-causing potential that ended with a “proposed” conclusion that glyphosate was ‘“not likely to be carcinogenic to humans’ at doses relevant to human health risk assessment.” All of this before the meetings are held.

To its credit, the EPA did issue several caveats in that report, acknowledging that some research does link glyphosate to cancer, but offering various explanations as to why the agency doesn’t believe those study results are significant, and/or are outweighed by other studies. The agency also added a host of qualifiers, stating that with respect to epidemiological studies, the data is limited and outdated. Because there has been such an “increased use of glyphosate following the introduction of glyphosate-tolerant crops in 1996, there is a need for more recent studies since a large number of studies were conducted prior to 1996,” the EPA stated. The agency also said that research needs to be done on glyphosate formulations, not just glyphosate alone.

And the agency included a specific caveat with respect to research tying glyphosate to non-Hodgkin lymphoma (NHL), saying: “There are conflicting views on how to interpret the overall results for NHL. Some believe that the data are indicative of a potential association between glyphosate exposure and risk of NHL.” The agency added: “Due to study limitations and contradictory results across studies… a conclusion regarding the association between glyphosate exposure and risk of NHL cannot be determined based on the available data.”

There is obviously a lot at stake – Monsanto is currently being sued by dozens of people who say the company’s Roundup herbicide gave them or their family members NHL, and the company is fighting a court battle with the state of California over regulatory efforts to add glyphosate to a list of known or probable carcinogens. And there remains the matter of the EPA’s long overdue environmental and health risk assessment for glyphosate, in which the EPA could add restrictions to the use of glyphosate if the agency deems those are necessary. That risk assessment was due out in 2015. Then the agency said it would be released in 2016. Now the agency says it may be completed by spring of 2017.

With the Bayer acquisition, the lawsuits and the risk assessment looming, Monsanto has been pulling out all the stops to defend glyphosate. The pressure on the EPA to defend glyphosate began immediately after the World Health Organization’s International Agency for Research on Cancer (IARC) declared in March 2015 that research showed glyphosate was “probably” carcinogenic to humans. The IARC decision was announced on Friday, March 20, 2015 and by the following Monday morning, Monsanto’s Dan Jenkins, the company’s regulatory affairs leader, was already calling and emailing EPA officials demanding they “correct” the record on glyphosate. Emails obtained through Freedom of Information request show Jenkins submitted “talking points” to the EPA to try to contradict IARC. And since then Monsanto has only intensified its efforts to invalidate the findings of the IARC group, attacking the veteran scientists as an “unelected, undemocratic, unaccountable and foreign body.”

Monsanto has also subpoenaed emails and other records from the chairman of that IARC committee, Aaron Blair, a scientist emeritus at the National Cancer Institute, who served as chairman of the IARC team. Blair has a long career of accolades and appointments that acknowledge his expertise, and he has served on numerous national and international scientific review groups, including for the EPA. But Monsanto has deemed Blair’s work suspect.

And Monsanto’s apparently has done some arm-twisting in Congress. On Monday, the chairman of the House Committee on Oversight and Government Reform wrote to the National Institutes of Health, reciting many of the complaints Monsanto and its allies have made about IARC and challenging grants the NIH has made to IARC.

The EPA’s appearance of aligning with Monsanto angers many in the scientific community who say the EPA is straying from established scientific principles and ignoring key evidence so it can keep the corporate interests who profit from glyphosate herbicides happy.

“This chemical is a probable human carcinogen by any reasonable definition. It is nonsense to say otherwise,” said Christopher Portier, former director of the National Center for Environmental Health and Agency for Toxic Substances and Disease Registry at the U.S. Centers for Disease Control and Prevention (CDC). Prior to that role, Portier spent 32 years with the National Institute of Environmental Health Sciences (NIEHS), where he served as the NIEHS associate director, director of the Environmental Toxicology Program, and associate director of the National Toxicology Program. In retirement, Portier, who was an “invited specialist” to the IARC review on glyphosate, has done some part-time work for the Environmental Defense Fund.

Portier and more than 90 other international scientists have issued a detailed report laying out the specific research that ties glyphosate to cancer both in animal studies and in human observations. The scientists said the only way for regulators to discount the evidence is to bend well-established rules for scientific evaluations. They say available human evidence does show an association between glyphosate and non-Hodgkin lymphoma, while significant carcinogenic effects are seen in laboratory animals for rare kidney and other types of tumors. There is also “strong evidence of genotoxicity and oxidative stress,” including findings of DNA damage in the peripheral blood of people exposed to glyphosate, the scientists said.

“The most appropriate and scientifically based evaluation of the cancers reported in humans and laboratory animals as well as supportive mechanistic data is that glyphosate is a probable human carcinogen,” the report states. “On the basis of this conclusion and in the absence of evidence to the contrary, it is reasonable to conclude that glyphosate formulations should also be considered likely human carcinogens.”

“The EPA is in a bad spot with this. The pushback really has come out of the industry based on things that are not scientifically sound,” said Maarten Bosland, one of the authors of the report on glyphosate research. Bosland is director of the Center for Global Health Outreach Department of Pathology at The University of Illinois at Chicago, and holds a Ph.D. in experimental pathology. “The amount of money that is involved in this compound is gigantic. It’s a worldwide conglomerate of financial interests that are affected by this.”

It seems more than coincidental that the EPA’s rationale for dismissing scientific studies that IARC said showed cancer links closely dovetails with the findings of a 16-member Monsanto-funded panel. That group of 16 scientists, all but four of whom had previously worked either as employees or consultants for Monsanto, issued a report in December that supported Monsanto’s contention that there is no real evidence that glyphosate can cause cancer. Leading the work was Gary M. Williams, director of environmental pathology and toxicology at New York Medical College, and a consultant to Monsanto. Williams has a history of publishing positive findings about glyphosate; he was an author of one of Monsanto’s most-touted studies, a 2000 research report that concluded glyphosate is not only not a carcinogen, but “is considered to be practically nontoxic.”

That panel is preparing to release five articles supporting glyphosate safety in the journal Critical Reviews of Toxicology soon, according to Intertek Scientific & Regulatory Consultancy, which was paid by Monsanto to arrange the panel.

In the EPA report, the one bright spot for critics of glyphosate is that the EPA does call for more testing. Specifically, the agency acknowledges the need to explore the fears that glyphosate formulations may be more toxic than glyphosate alone. The EPA is developing a “research plan” with the National Institute of Environmental Health Sciences to “evaluate the role of glyphosate in product formulations and the differences in formulation toxicity,” the EPA said.

Fresh answers can’t come soon enough for consumers who worry about persistent levels of glyphosate in the food they eat. The FDA this year found high levels of glyphosate in U.S. honey, some levels more than double what is considered safe in the European Union.

The meetings in Washington run Oct. 18-21, and are expected to draw a variety of attendees – lawyers, activists, farmers, environmentalists and corporate allies are all making their travel plans.

It should be interesting.

(Article first appeared in The Huffington Post)