In Roundup Cancer Trial, Now the Gloves Come Off

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(Transcript from today’s proceedings)

Following Tuesdays’ jury finding that Roundup use caused plaintiff Edwin Hardeman’s cancer, the second phase of Hardeman V. Monsanto began this morning in California with a shift away from the scientific evidence and on to allegations that Monsanto has spent years suppressing information about the dangers of its glyphosate-based herbicides.

While Hardeman’s lead counsel Aimee Wagstaff was sanctioned in the first phase for barely giving a nod to such claims, in the second phase the focus is squarely on Monsanto’s conduct in studying, manufacturing and selling its popular Roundup products.

“Roundup has been Monsanto’s billion-dollar baby for decades,” Wagstaff said in an interview Wednesday morning. “The evidence demonstrates Monsanto was far more interested in protecting its bottom line or Roundup’s continued sales than making sure the product was safe. In the meantime, people like Mr. Hardeman got cancer and are dying. We are confident the jury will do the right thing in phase two and send Monsanto a message it needs to hear.”

The jury verdict finding Roundup causes cancer is the second such jury determination in seven months, and indicates Bayer, which purchased Monsanto last summer, has a hard road ahead defending against thousands of plaintiffs who all claim exposure to Monsanto’s glyphosate-based herbicides caused their cancers. Another trial gets underway next week in Oakland, California.

Bayer shares fell more than 12% in early trading Wednesday after the jury’s determination that Roundup was a “substantial factor” in causing Hardeman’s cancer.

Judge Vince Chhabria plans to continue to keep a tight rein on what the jury will be allowed to hear, however. He generally has agreed with requests from Monsanto to prohibit evidence about Monsanto’s actions after 2012, the year Hardeman stopped using Roundup. The rationale is that the company’s actions after the plaintiff stopped using the product have no bearing on Hardeman’s development of non-Hodgkin lymphoma.

Plaintiff’s attorneys argued that there are many internal Monsanto emails dated after 2012 that illustrate a pattern of behavior, showing how the company has long worked to ghostwrite scientific papers, manipulate regulators and attack and silence critics. That evidence is critical to establishing Monsanto’s liability and damages, the plaintiff’s attorneys have told Chhabria.

In a discussion Tuesday about the evidence for the second phase, the judge indicated he sees a middle ground, saying “conduct that occurred post-2012 that sheds light on what was happening pre-2012 should generally be admissible, potentially subject to a limiting instruction if Monsanto wants it.”  But he also said this: “Even if post-2012 conduct sheds light on what was happening pre-2012, there may be other reasons to exclude it.”

Notably, the judge is barring evidence about Monsanto’s efforts to discredit the International Agency for Research on Cancer, which in 2015 classified glyphosate as a probable human carcinogen. Monsanto spent millions of dollars on various secretive tactics aimed at discrediting IARC.  Documents that have come to light through discovery show the company discussing using third parties who appeared to be independent of Monsanto to publicly criticize IARC and push Monsanto propaganda points. The internal Monsanto records show the company’s role in ghostwriting an article that appeared on Forbes’ contributors’ platform, and they show that the company was behind a story published by Reuters in 2017 that falsely claimed an IARC scientist withheld information from IARC that would have changed the classification.

The judge is also barring evidence about how Monsanto worked to discredit French scientist Gilles-Éric Séralini after publication of his 2012 study findings about rats fed water dosed with Roundup. Internal Monsanto records show a coordinated effort to get the Seralini paper retracted, including this email string.

Monsanto employees apparently were so proud of what they called a “multimedia event that was designed for maximum negative publicity” against Seralini that they designated it as an “achievement” worth recognition.

The plaintiff’s attorneys will also not be able to introduce evidence of Monsanto’s efforts to kill a toxicity review of glyphosate by the Agency for Toxic Substances and Disease Registry.

The judge is allowing portions of a 2015 internal Monsanto email in which company scientist Bill Heydens discusses plans to ghostwrite a series of new scientific papers that will contradict IARC’s classification of glyphosate because in that email, Heydens remarks on how this plan is similar to the ghostwriting of a scientific paper published in 2000 that found glyphosate to be safe.

See all updates at Trial Tracker blog.

In Blow to Bayer, Jury Finds Roundup Caused Plaintiff’s Cancer

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(Video update)

(Transcript of today’s proceedings)

A unanimous jury decision on Tuesday handed a first-round victory to plaintiff Edwin Hardeman, as the six jury members found that Hardeman’s exposure to Roundup was a “substantial factor” in causing his non-Hodgkin lymphoma.

The jury decision means the trial now moves into a second phase in which jurors will take up the issue of liability and damages.

Jurors deliberated for nearly a week before weighing in on the one question they had to answer in the first phase of the bifurcated trial.  U.S. District Judge Vince Chhabria sharply limited the evidence jurors could hear in the first phase to evidence dealing solely with general and specific causation. That meant the first phase was filled with discussions and debates over various scientific studies. The first phase mostly excluded evidence about Monsanto’s alleged actions to control or manipulate the scientific record and claims that Monsanto has worked to suppress evidence of harm with its herbicides. But such evidence will be allowed in the second phase as the jury considers the company’s conduct.

Following the verdict, Judge Chhabria told the jurors about the second phase: “The issues that you will be considering are whether Monsanto is legally liable for the harm caused to Mr. Hardeman and, if so, what the damages should be. So those are the issues that you will begin considering tomorrow.”

The verdict was a significant victory not just for Hardeman, but for the other thousands of plaintiffs around the United States who have sued Monsanto and also allege exposure to the company’s glyphosate-based herbicides caused non-Hodgkin lymphoma. The company already has one loss from last summer’s jury verdict in favor of a dying California groundskeeper. Another case begins next week in nearby Oakland, California.

In response to today’s verdict, Aimee Wagstaff of Andrus Wagstaff, PC and Jennifer Moore of Moore Law Group, PLLC, co-trial counsel for the Plaintiff, issued the following statement:

 “Mr. Hardeman is pleased that the jury unanimously held that Roundup caused his non-Hodgkin’s lymphoma. Now we can focus on the evidence that Monsanto has not taken a responsible, objective approach to the safety of Roundup. Instead, it is clear from Monsanto’s actions that it does not particularly care whether its product is in fact giving people cancer, focusing instead on manipulating public opinion and undermining anyone who raises genuine and legitimate concerns about the issue. We look forward to presenting this evidence to the jury and holding Monsanto accountable for its bad conduct.”

Bayer issued a statement as well: “We are disappointed with the jury’s initial decision, but we continue to believe firmly that the science confirms that glyphosate-based herbicides do not cause cancer. We are confident the evidence in phase two will show that Monsanto’s conduct has been appropriate and that the company should not be liable for Mr. Hardeman’s cancer. Regardless of the outcome, however, the decision in phase one of this trial has no impact on future cases and trials because each one has its own factual and legal circumstances. We have great sympathy for Mr. Hardeman and his family, but an extensive body of science supports the conclusion that Roundup™ was not the cause of his cancer. Bayer stands behind these products and will vigorously defend them.”

As Jury Deliberates, a New Study Shows Cancer Links to Glyphosate

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Jurors will continue deliberating today, while lawyers for both sides were busy preparing for a second phase in the event the jury finds for plaintiff Edwin Hardeman in this first phase. As part of the preparation, lawyers for both sides have been jockeying over many issues, including what witnesses will and will not be allowed to testify about in a second phase, what type of liability Hardeman’s lawyers can argue, and even how much time Hardeman’s attorneys should be allowed to present their evidence.

Judge Chhabria set specific parameters for how much time each side would have for the trial in total, and Hardeman’s lawyers used much more of their time than did Monsanto’s lawyers during the first phase. As it stands, Hardeman’s side has but 7-1/2 hours left while Monsanto has more than 18 hours left.

Judge Chhabria said he would consider adding some time for the plaintiff, given that side had the burden of proof and had used a good deal of time explaining many scientific principles to the jury necessary for them to understand evidence put on by both sides.

Monsanto attorney Brian Stekloff said that Hardeman’s attorneys had not been as efficient as they could have been, giving a two-hour opening in the first phase. “I don’t know if that was necessary,” he told the judge.

Hardeman’s attorneys have also made it clear that they will be putting on a good deal of evidence about Monsanto’s knowledge of the dangers of its Roundup formulations. “Plaintiff intends to introduce even more evidence in Phase 2 that Roundup is more dangerous than glyphosate because surfactants increase the danger of glyphosate exponentially,” plaintiff’s attorneys told the judge. 

Chhabria has agreed – over Monsanto’s objections – to allow Hardeman’s attorneys to proceed in the second phase with a “design defect” argument, though with several caveats.

Meanwhile, yet another new study has been published showing links between glyphosate herbicides and non-Hodgkin lymphoma. The study analyzes data from more than 300,000 farmers and agricultural workers from studies done in France, Norway, and the United States. The researchers said that they found “elevations in risks” of non-Hodgkin lymphoma associated with certain insecticides and with glyphosate herbicides. With respect to glyphosate, the specific type of non-Hodgkin lymphoma linked to glyphosate exposure was diffuse large B-cell lymphoma, the same type of cancer Hardeman has.

Rachel Carson Environment Book Award Winner: Whitewash by Carey Gillam

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Carey Gillam’s “Whitewash: The Story of a Weed Killer, Cancer and the Corruption of Science (Island Press) has received rave reviews since its release last fall and has received several awards for outstanding reporting:

Hard-hitting, eye-opening narrative…A forceful argument for an agricultural regulatory environment that puts public interest above corporate profits.”  Kirkus Reviews

This is a must-read for everyone concerned about the increasing burden of toxic chemicals in water and food, the health and environmental consequences thereof, and corporate influence on government agencies.Booklist 

“Gillam expertly covers a contentious front where corporate malfeasance intersects with issues of public health and ecology.” Publishers Weekly 

“a gutsy, compelling read from beginning to end, especially for readers who enjoy the kind of hard-nosed, shoe-leather reporting that used to be the hallmark of great journalism.” Society for Environmental Journalists BookShelf

“well-documented compendium of wrongs, fraud, conflicts of interest, undue influence, and troubling forms of plain old [PR]….Some of its revelations are downright infuriating. Los Angeles Review of Books 

See also: Carey Gillam’s testimony before a joint committee of the European Parliament on 10/11/2017 and her reporting from the Daubert Hearings in the Cancer Victims Vs. Monsanto glyphosate litigation.

Book Description

It’s the pesticide on our dinner plates, a chemical so pervasive it’s in the air we breathe, our water, our soil, and even found increasingly in our own bodies. Known as Monsanto’s Roundup by consumers, and as glyphosate by scientists, the world’s most popular weed killer is used everywhere from backyard gardens to golf courses to millions of acres of farmland. For decades it’s been touted as safe enough to drink, but a growing body of evidence indicates just the opposite, with research tying the chemical to cancers and a host of other health threats.

In Whitewash, veteran journalist Carey Gillam uncovers one of the most controversial stories in the history of food and agriculture, exposing new evidence of corporate influence. Gillam introduces readers to farm families devastated by cancers which they believe are caused by the chemical, and to scientists whose reputations have been smeared for publishing research that contradicted business interests. Readers learn about the arm-twisting of regulators who signed off on the chemical, echoing company assurances of safety even as they permitted higher residues of the pesticide in food and skipped compliance tests. And, in startling detail, Gillam reveals secret industry communications that pull back the curtain on corporate efforts to manipulate public perception.

Whitewash is more than an exposé about the hazards of one chemical or even the influence of one company. It’s a story of power, politics, and the deadly consequences of putting corporate interests ahead of public safety.

http://careygillam.com/book
Publication date October 2017

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More Praise for Whitewash

“The book unravels a tapestry of pesticide industry tricks to manipulate the scientific truths about their products while placing profits above human health and the environment. As someone who has experienced similar actions by corporations firsthand in my work far too often, I am hopeful that Carey’s book will be a wake-up call for more transparency about the dangers surrounding many chemicals in the marketplace.” Erin Brockovich, environmental activist and author

Carey Gillam has brilliantly assembled the facts and describes how Monsanto and other agricultural chemical companies lied about their products, covered up the damaging data and corrupted government officials in order to sell their toxic products around the world.  David Schubert, Ph.D., Professor and Head of the Cellular Neurobiology Laboratory at the Salk Institute For Biological Studies

Carey Gillam is a brave warrior in the mold of Rachel Carson. She has exposed the ruthless greed and fraud which have led to the poisoning of our planet. Brian G.M. Durie, M.D. Chairman of the International Myeloma Foundation, oncology specialist and attending physician at Cedars-Sinai Medical Center

In the grand tradition of Silent Spring, Carey Gillam’s Whitewash is a powerful exposé that sheds light on a chemical that — to most of us — is both entirely invisible and yet profoundly damaging to our bodies and our environment. It is a deeply researched, entirely convincing exposé of the politics, economics and global health consequences implicit in the spread of the world’s most common herbicide. Gillam has done what all great journalists strive to do: she has made us see clearly what has long been right before our eyes. Highly recommended.  McKay Jenkins, author, Professor of English, Journalism and Environmental Humanities at the University of Delaware

FDA FOIA Documents Regarding Glyphosate Residue Testing

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The Food and Drug Administration has responded to Freedom of Information Act (FOIA) requests for information regarding its efforts to start testing food samples for residues of glyphosate as well as some other herbicides, including 2,4-D.

Many of those documents can be accessed below:

FDA FOIA 2017-7005

FDA FOIA 2017-7005 part 2

FDA Final Responsive Records (2017-7005) Part 3 (Redacted)

FDA FOIA 2017-7005 attachments

CFSAN Responsive Records (2017-7005) Interim Response Part 2 (OC-ORA red boxed emails)_Redacted (1)

FDA FOIA Objectives herbicide analysis

CFSAN Responsive Records (Redacted) 2017-10178

FDA Pestag Meeting Minutes April 19, 2017

FDA March 15, 2017 PesTAG Meeting Minutes

FDA Minutes of phone call Feb 10, 2016

Email of intrigue: “IARC is killing us!”

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As researchers we often look to documents to shed new light on issues important to food policy. Sometimes, they simply reflect what we already know.

That’s the case with one new communication string that adds to evidence of a far-reaching strategy by food industry players to discredit and diminish the world’s leading cancer research agency. We’ve already seen documents from Monsanto and other chemical industry interests laying out plans to tear apart the credibility of the International Agency for Research on Cancer (IARC) because of its classification of Monsanto’s weed killer glyphosate as a probable human carcinogen.

Now we see evidence that other food industry players are part of the scheme; working to head off potentially damaging IARC scrutiny of food additives such as aspartame, sucralose, and more.

The email of intrigue was obtained through a state open records request.  It shows communication between James Coughlin, a one-time scientist for Kraft General Foods Inc. who operates a food and “nutritional” consulting business, and Timothy Pastoor, a retired toxicologist with the agrochemical giant Syngenta AG who now runs his own “science communications” business. Also included on a portion of the email string is Monsanto PR man Jay Byrne, who runs a “reputation management” and public relations business, and Douglas Wolf, a former Environmental Protection Agency scientist now with Syngenta.

In the October 2016 email, Coughlin tells Pastoor how he’s been “fighting IARC forever!!” dating back to his time at Kraft. He relates the time he spent criticizing the international cancer agency to a U.S. House of Representatives staffer who was coordinating an effort to strip U.S. funding from IARC.

And then, articulating the deep fear the food industry holds for the cancer agency, he gets to the meat of the matter: “IARC is killing us!” he writes. The 2-page string can be found here. An excerpt is below:

EPA Glyphosate Registration Review Public Comments Now Due

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For anyone interested in commenting on the EPA’s latest safety review of the weed killing chemical glyphosate:

  • Docket ID:EPA-HQ-OPP-2009-0361
  • Abstract:Federal Register for Tuesday, February 27, 2018 (83 FR 8476) (FRL–9973–07) EPA–HQ–OPP–2017–0720; Registration Review; Draft Human Health and/or Ecological Risk Assessments for Several Pesticides; Notice of Availability
  • Document Type:Notice
  • Status:Posted
  • Received Date:Feb 27, 2018
  • FR Citation:83
  • Start-End Page:8476 – 8478
  • Comment Start Date:Feb 27, 2018
  • Comment Due Date:Apr 30, 2018
  • Glyphosate Case 0178 EPA-HQ-OPP-2009-0361 glyphosateRegReview@epa.gov (703) 347-0292.

See all details here: https://www.regulations.gov/docket?D=EPA-HQ-OPP-2009-0361

Corporate power, not public interest, at root of science committee hearing on IARC

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(First published in Environmental Health News)

Score another point for corporate power over protection of the public.

U.S. Rep Lamar Smith, chairman of the U.S. House of Representatives Committee on Science, Space, & Technology, has slated a full committee hearing for Feb. 6 with an agenda aimed squarely at attacking some of the world’s top cancer scientists.

Given the fact that cancer is the second-leading cause of death in the United States, it seems obvious that our lawmakers should be supporting cancer science rather than trying to thwart it. But Smith’s action comes after the World Health Organization’s International Agency for Research on Cancer ( IARC) angered Monsanto Co. when it declared the pesticide glyphosate, a key ingredient in Monsanto’s weed killing products, to be a probable carcinogen.

Though the hearing is titled “In Defense of Scientific Integrity: Examining the IARC Monograph Programme and Glyphosate Review,” the irony of the descriptor is not lost on those who have been following Smith’s efforts to derail and defund this cancer research agency.

In letters to IARC’s leadership, Smith has repeated false narratives and inaccurate news stories planted by Monsanto and chemical industry allies, and cited the “serious nature of these concerns related to expenditures of taxpayer dollars.”

It’s worth noting that the plan to put the International Agency for Research on Cancer on the hot seat was put into motion roughly three years ago when Monsanto predicted the international cancer scientists would find its weed killer to have carcinogenic potential. The company said as much in internal communications brought to light through recent litigation.

The documents also show that it was February 2015, a month before the IARC classification, when Monsanto executives laid out a strategic plan to discredit the cancer scientists. The plan was designed to “orchestrate outcry with IARC decision.”

The efforts to manipulate public perception about IARC ramped up last summer when Monsanto allies spoon-fed a false narrative to a Reuters reporter who produced a news story that shot around the globe and has been a key talking point for the chemical industry attack against IARC.

The story relied on the deposition of an IARC scientist named Aaron Blair and reported that Blair withheld critical information that would have altered the IARC glyphosate classification. Reuters never provided a link to the deposition, which at that point was not filed in any court and was not publicly available.

Chairman Smith ran with the story, stating that Blair “admitted to knowing that this research could have prevented” the classification of glyphosate as a probable carcinogen.

Anyone taking time to actually read the deposition, which is now public, would see that Blair never said any such thing, and in fact protested multiple times that the data in question was not fully analyzed and not published and thus was not suitable to be considered by IARC.

A similar false narrative pushed by the chemical industry and repeated by Smith accused IARC of deleting assessments finding no connection between glyphosate and cancer from its final report. Smith and team either don’t know or don’t care that IARC’s deletions were of Monsanto assertions that the cancer scientists said could not be substantiated.

IARC officials have detailed the falsehoods perpetuated against them by the chemical industry but the defense has fallen on deaf ears.

Monsanto needs to discredit the international cancer scientists because it was the IARC finding that triggered waves of lawsuits against Monsanto, and prompted moves to ban the chemical in some European countries.

But while Monsanto and other chemical industry interests are concerned about the billions of dollars in revenues they rake in annually from glyphosate-based products, the attack on this independent science group should have all of us concerned.

Approximately 39 percent of men and women living in the United States are expected to be diagnosed with cancer during their lifetimes, according to the National Cancer Institute.

For this year alone, the American Cancer Society has estimated there will be more than 1.68 million people newly diagnosed with cancer and more than 600,000 deaths from cancer. Worldwide, there are more that 14 million cases of cancer occurring each year, and that number is expected to hit nearly 22 million by 2030.

Cancer “affects almost everyone’s life, either directly or indirectly,” and beyond the toll on life and health it costs the United States more than $200 billion in medical costs and lost productivity, according to the U.S. Department of Health and Human Services (HHS).

In order to reduce deaths from cancer we have to put more emphasis on preventing it in the first place, and a big part of that “primary prevention” according to a 2016 report by the HHS National Toxicology Program (NTP) “is to identify the carcinogens.”

Clearly, the companies that sell chemicals linked to cancer prefer to see IARC defunded and dismantled. They’ve said as much through the disingenuously named Council for Accuracy in Public Health Research (CAPHR), a nonprofit established by the American Chemistry Council a year ago with the specific goal of promoting the “reform” of IARC.

But to see our lawmakers so eagerly promoting corporate interests when such dire public safety interests are at stake marks perhaps a new low in American politics. These are literally life and death matters.

Our public servants must be held to account, to support the scientists who work to identify carcinogens, and push back against the corporate interests who want to discredit the science that threatens its profits.

Scientific integrity should mean exactly that.

Collusion or Coincidence? Records Show EPA Efforts to Slow Herbicide Review Came in Coordination with Monsanto

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Newly released government email communications show a persistent effort by multiple officials within the Environmental Protection Agency (EPA) to slow a separate federal agency’s safety review of Monsanto’s top-selling herbicide. Notably, the records demonstrate that the EPA efforts came at the behest of Monsanto, and that EPA officials were helpful enough to keep the chemical giant updated on their progress.

The communications, most of which were obtained through Freedom of Information Act (FOIA) requests, show that it was early 2015 when the EPA and Monsanto began working in concert to stall a toxicology review that a unit tied to the Centers for Disease Control and Prevention (CDC) was conducting on glyphosate, the key ingredient in Monsanto’s branded Roundup herbicide products. The details revealed in the documents come as Monsanto is defending itself against lawsuits alleging that it has tried to cover up evidence of harm with its herbicides.

The Agency for Toxic Substances and Disease Registry (ATSDR), a federal public health agency that along with the CDC is part of the U.S. Department of Health and Human Services (HHS), is charged with evaluating the potential adverse human health effects from exposures to hazardous substances in the environment. So it made sense for the ATSDR to take a look at glyphosate, which is widely used on U.S. farms, residential lawns and gardens, school playgrounds and golf courses. Glyphosate is widely used in food production and glyphosate residues have been found in testing of human urine.

The ATSDR announced in February 2015 that it planned to publish a toxicological profile of glyphosate by October of that year. But by October, that review was on hold, and to this date no such review has yet been published.

The documents reveal this was no accident, no bureaucratic delay, but rather was the result of a collaborative effort between Monsanto and a group of high-ranking EPA officials.

For Monsanto, the timing of the ATSDR review was worrisome. In March 2015, the World Health Organization’s International Agency for Research on Cancer (IARC) had declared glyphosate to be a probable human carcinogen, and Monsanto feared ATSDR might have similar concerns about the chemical. Previous reports have described how one EPA official, Jess Rowland, communicated to Monsanto in April 2015 his willingness to try to kill the ATSDR review. Rowland, who retired in 2016, was the deputy division director within the health effects division of the EPA’s Office of Pesticide Programs (OPP). Allegations of collusion between Rowland and Monsanto have prompted a probe by the EPA’s Office of Inspector General.

But the trove of documents newly obtained from within EPA and HHS demonstrate that the assistance to Monsanto came not only from Rowland but also from even higher-level EPA officials. Rather than encourage and assist the toxicology review of glyphosate, Monsanto and EPA officials repeatedly complained to ATSDR and HHS that such a review was unnecessarily “duplicative” and should take a back seat to an EPA review also underway.

The following timeline shows how the events unfolded:

May 19, 2015 – Michael Dykes, who at that time was Monsanto’s long-time vice president of government affairs, wrote directly to the EPA’s Jim Jones, the Assistant Administrator for the Office of Chemical Safety & Pollution Prevention. Jones had oversight of the EPA’s Office of Pesticide Programs (OPP) and was a presidential appointee who carried significant clout. The afternoon was waning when the email came in at 3:28 p.m. Dykes reminded Jones that they had recently discussed the HHS’ ATSDR glyphosate review at a meeting. “You were not aware of their review. Did you learn anything more about their efforts?” Dykes asked.

Jones did not waste time. Roughly an hour later he forwarded the message to OPP Director Jack Housenger, writing “Monsanto thinks atsdr is doing a glyphosate Assessment. Could you guys run that down?” Housenger responds quickly: “Yes. Jess checked with them…. It has been difficult to get information.”

Within an hour Jones instructed a member of his staff to get him contact information for the head person responsible for ATSDR. She replied the next morning that Dr. Patrick Breysse was the point person. Breysse joined the CDC in 2014 as director of its National Center for Environmental Health, overseeing the NCEH’s ATSDR.

May 20, 2015 It was only a little after 8:30 a.m. but Jones told the staff member to instruct Housenger to get in touch with Breysse, and within two hours Housenger had penned an email to Breysse explaining that an EPA’s own re-evaluation/risk assessment of glyphosate was nearing completion, and asking Breysse if “you would still feel the need to do your assessment.” Housenger told Breysse that he already had reached the individual assigned to the ATSDR assessment and she had indicated she would “coordinate” with EPA, but that was not sufficient. Housenger did not mention Monsanto’s outreach to EPA on the issue, but instead questioned “whether this is a good use of government resources” for ATSDR to continue with its review. Breysse responded that he would “look into this” and Housenger thanked him for his quick response. Breysse then reached out to an ATSDR division director named James Stephens to arrange a discussion about the EPA request.

May 21, 2015 James Stephens wrote back to Patrick Breysse that the ATSDR team thought the EPA work “overlaps but isn’t totally duplicative…” and stated that the ASTDR team has not been able to see draft copies of the EPA’s work. “I think we would all welcome further discussion with EPA but would hope to use it to help us find out more about what they are doing, ” he told Breysse. After hearing from Stephens, Breysse wrote back to Housenger saying ATSDR staff would be in touch to discuss. Housenger replied with his reiteration that the ATSDR review would be a “duplicative government effort” and that the EPA draft would be out in July of 2015. (As of this writing, that EPA preliminary risk assessment still has not been released, though in 2016 the EPA did release a cancer assessment report that declared glyphosate was not likely to cause cancer.)

June 4, 2015 Pressing the issue, EPA’s Housenger wrote again to Breysee to say he had not heard from anyone yetThe ATSDR’s Stephens wrote back promising to make sure “someone gives you a ring.” Internal Monsanto emails show that at the same time, Monsanto was also pushing the “duplicative” narrative with HHS, meeting on June 4 with HHS Deputy Assistant Secretary for Global Health Mitchel Wolfe to ask him to help repudiate the IARC classification and to recognize that a review of glyphosate was “not the primary role” for his agency. “Dr. Wolfe said he would follow up on what was going on with ATSDR and he was encouraged to have discussions with EPA staff, as well,” a Monsanto memo detailing the meeting states.

June 9, 2015 Henry Abadin, an ATSDR supervisory scientist, reported to Stephens that he had talked with Housenger and explained that the agency did not believe it was “duplicating efforts.” Nevertheless, he said he told EPA, “we did not have a problem with putting the glyphosate profile on hold, pending the OPP final report.”

June 19, 2015 To further ensure the ATSDR review didn’t move forward, Monsanto’s Dykes talked again with HHS’s Wolfe, asking for an update on ATSDR. “I explained… our question was about the purpose and scope of such a duplicative review by ATSDR. I also told him that we were concerned that ATSDR may come out any day with a report. I again stressed that we were concerned that they were even reviewing glyphosate as were the people we talked with at EPA,” Dykes wrote to colleagues.

June 21, 2015 It was a Sunday, but Monsanto’s Dykes was still concerned enough about the ATSDR review to copy multiple colleagues on a late night email to report that he had continued to press the “duplicative” point with ATSDR but was concerned about a “glyphosate review coming any day.” In a text message sent that same day, Monsanto scientist Eric Sachs reached out to a former EPA toxicologist named Mary Manibusan asking for contacts at ATSDR. “We’re trying to do everything we can to keep from having a domestic IARC occur w this group. may need your help,” Sachs wrote. The text messages were among certain internal Monsanto records obtained by cancer victims who are suing Monsanto alleging Roundup caused their diseases.

June 23, 2015 By Tuesday, Monsanto’s Jenkins had good news: He had heard from Housenger that the EPA official had been successful in garnering a promise from ATSDR to put its report “on hold.” The review was not dead, however, he wrote: ATSDR argues “that their process is distinguishable and not duplicative. They look at different endpoints and told EPA they don’t “make a call on cancer”, but I think we should continue to be cautious.”

On June 24, 2015 Monsanto’s chief scientist William Heydens responded:“’Distinguishable and not duplicative’? Seriously? And I will believe the not ‘making a call on cancer’ part when I see it. Anyway, at least they know they are being watched, and hopefully that keeps them from doing anything too stupid…” Jenkins wrote back, acknowledging that Monsanto had much more to fear from ATSDR than EPA as the two agencies had arrived at “different conclusions” on other issues. He reported he had been told ATSDR was “VERY conservative and IARC like…”

By October 23, 2015 EPA and Monsanto had the ATSDR review fully on hold. EPA’s Housenger wrote to update Monsanto’s Jenkins: “They are waiting for our glyphosate RA. And they agreed to share what they do.”

That same month, the EPA’s Cancer Assessment Review Committee (CARC), which was chaired by Rowland, issued an internal report stating that contrary to IARC, the EPA’s review of glyphosate found it “not likely to be carcinogenic to humans.”

The EPA still has yet to issue the overall new risk assessment it said would be out in 2015. The agency has offered ever-changing timelines for the assessment, but now says its intends to release a draft risk assessment sometime this year. That will be followed by a 60-day public comment period. After the public comment period the EPA will determine whether any risk management is needed. In the meantime, Monsanto has cited the EPA’s backing of glyphosate safety as repudiation of the IARC finding both in court and with regulators in Europe who are also looking at glyphosate safety issues.

The EPA did not respond to a request for comment about its efforts to delay the ATSDR report or communications with Monsanto regarding that effort.

But Brent Wisner, a lawyer representing many of the cancer victims who are suing Monsanto, said the documents offer damning evidence of improperly close ties between the EPA and the chemical company.

“I think it’s very clear… that EPA officials and Monsanto employees worked together to accomplish a goal of stopping that analysis at ATSDR. That is collusion. I don’t know what else you’d call that,” said Wisner.

For its part, the ATSDR said this week that the review it started in 2015 “is not complete” but that it anticipates a draft glyphosate toxicological profile to be issued for public comment by the end of this year. A spokesperson for the agency declined to discuss the circumstances surrounding the delay in the review.

And Jones, whose EPA job ended when the Trump administration took over, defended his responsiveness to Monsanto’s concern about the ATSDR review, saying it had only to do with the “efficient use of government resources.”

“Had any party contacted me and informed me that another agency within the Administration was simultaneously assessing a chemical as my organization, I would have intervened,” Jones said. “There is no value to the same government investing limited resources to work on the same issue. As you know resources at the federal level were and are scarce which made duplication even more problematic.” Jones said additionally that “when two organizations assess the same chemical, it is very likely there will be differences in their assessments. Even when these differences don’t matter from a public health perspective, an enormous amount of energy is spent attempting to resolve these differences” and that is not ultimately in the “public interest.”

New ‘Monsanto Papers’ Add To Questions Of Regulatory Collusion, Scientific Mischief

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The other shoe just dropped.

Four months after the publication of a batch of internal Monsanto Co. documents stirred international controversy, a new trove of company records was released early Tuesday, providing fresh fuel for a heated global debate over whether or not the agricultural chemical giant suppressed information about the potential dangers of its Roundup herbicide and relied on U.S. regulators for help.

More than 75 documents, including intriguing text messages and discussions about payments to scientists, were posted for public viewing early Tuesday morning by attorneys who are suing Monsanto on behalf of people alleging Roundup caused them or their family members to become ill with non-Hodgkin lymphoma, a type of blood cancer. The attorneys posted the documents, which total more than 700 pages, on the website for the law firm Baum Hedlund Aristei Goldman, one of many firms representing thousands of plaintiffs who are pursuing claims against Monsanto. More than 100 of those lawsuits have been consolidated in multidistrict litigation in federal court in San Francisco, while other similar lawsuits are pending in state courts in Missouri, Delaware, Arizona and elsewhere. The documents, which were obtained through court-ordered discovery in the litigation, are also available as part of a long list of Roundup court case documents compiled by the consumer group I work for, U.S. Right to Know.

It was important to release the documents now because they not only pertain to the ongoing litigation, but also to larger issues of public health and safety, while shedding light on corporate influence over regulatory bodies, according to Baum Hedlund attorneys Brent Wisner and Pedram Esfandiary.

“This is a look behind the curtain,” said Wisner. “These show that Monsanto has deliberately been stopping studies that look bad for them, ghostwriting literature and engaging in a whole host of corporate malfeasance. They (Monsanto) have been telling everybody that these products are safe because regulators have said they are safe, but it turns out that Monsanto has been in bed with U.S. regulators while misleading European regulators.”

Esfandiary said public dissemination of the documents is important because regulatory agencies cannot properly protect public and environmental health without having accurate, comprehensive, and impartial scientific data, and the documents show that has not been the case with Monsanto’s Roundup herbicide and the active ingredient glyphosate.

Monsanto did not respond to a request for comment.

Several of the documents discuss a lack of robust testing of formulated Roundup products. In one email, Monsanto scientist Donna Farmer writes “you cannot say that Roundup is not a carcinogen … we have not done the necessary testing on the formulation to make that statement. The testing on the formulations are not anywhere near the level of the active ingredient.”

The release of the documents Tuesday came without the blessing of Judge Vince Chhabria, who is overseeing the multidistrict litigation moving its way through the U.S. District Court for the Northern District of California. In March, Chhabria did agree to unseal several other discovery documents – over Monsanto’s objections – and those documents prompted a wave of outrage for what they revealed: questionable research practices by Monsanto, cozy ties to a top official within the U.S. Environmental Protection Agency, and indications that Monsanto may have engaged in “ghostwriting,” of research studies that appeared to be independent of the company.

The revelations within those documents prompted an investigation by the EPA’s Office of Inspector General into possible Monsanto-EPA collusion, and roiled Europe where regulators now are trying to decide whether or not to reauthorize glyphosate, which is the most widely used herbicide in the world and is found in numerous products in addition to Roundup.

The lawyers said they are sending copies of the documents to European authorities, to the EPA’s OIG and to the California Office of Environmental Health Hazard Assessment (OEHHA), which has been sued by Monsanto for moving to list glyphosate as a known carcinogen

Monsanto has fought to keep most of the documents it turned over in discovery sealed, complaining to Judge Chhabria that in several court filings plaintiffs’ attorneys presented discovery materials out of context and tried to exploit the information to influence public opinion. Chhabria has both chided Monsanto for trying to improperly seal certain documents and warned plaintiffs’ attorneys against unfairly publicizing certain documents. It is unclear how Judge Chhabria will react, if at all, to the law firm’s release of these documents.

Baum Hedlund attorneys said they notified Monsanto on June 30 of their intent to unveil the 86 documents and gave Monsanto the legally required 30-day window to formally object. That period expired Monday, clearing the way for them to make the release early Tuesday, said Wisner.

Concerns about the safety of glyphosate and Roundup have been growing for years amid mounting research showing links to cancer or other diseases. But the lawsuits only began to accumulate after the International Agency for Research on Cancer (IARC) in 2015 classified glyphosate as a probable human carcinogen. The plaintiffs in the lawsuits allege that the combination of glyphosate with certain surfactants used in Monsanto-branded Roundup products is even more toxic than glyphosate alone, and Monsanto has sought to cover up that information.

Monsanto has publicly denied that there are cancer connections to glyphosate or Roundup and says 40 years of research and scrutiny by regulatory agencies around the world confirm its safety.

Monsanto has made billions of dollars a year for decades from its glyphosate-based herbicides, and they are the linchpin to billions of dollars more it makes each year from the genetically engineered glyphosate-tolerant crops it markets. The company is currently moving toward a planned merger with Bayer AG.

(Article first appeared in Huffington Post)