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Biosafety Science » Science Policy

Title: Court Documents Reveal Monsanto's Efforts to Manipulate Science
Publication date: April 19, 2017
Posting date: April 19, 2017

THIRD WORLD NETWORK BIOSAFETY INFORMATION SERVICE

 

Dear Friends and Colleagues

Court documents reveal Monsanto's efforts to manipulate science

The herbicide Roundup is used around the world on everything from row crops to home gardens. It is Monsanto’s flagship product and is also used widely in conjunction with herbicide-resistant GM crops. In 2015, the International Agency for Research on Cancer (IARC), a branch of the World Health Organization, classified glyphosate (the active ingredient in Roundup) as a probable carcinogen to humans.

In March 2017, a court in San Francisco ordered a series of internal Monsanto's documents to be unsealed formore than 55 lawsuits brought by individuals from around the U.S. who allege that exposure to Monsanto’s Roundup herbicide had caused them or their loved ones to develop non-Hodgkin lymphoma. The documents reveal Monsanto's efforts to manipulate science through questionable means.

The court documents include Monsanto’s internal emails and email traffic between the company and federal regulators. The records suggest that Monsanto had ghostwritten research that was later attributed to academics. They also indicate that a senior official at the Environmental Protection Agency had worked to quash a review of glyphosate that was to have been conducted by the United States Department of Health and Human Services.

Items 1-4 below underscore how seriously scientific research and the U.S. regulatory system have become infected by the influence of incredibly powerful companies like Monsanto in pushing their agenda.

With best wishes,

Third World Network
131 Jalan Macalister
10400 Penang
Malaysia
Email: twn@twnetwork.org
Websites: http://www.twn.my/and http://www.biosafety-info.net/
To subscribe to other TWN information services: www.twnnews.net

____________________________________________________________________________

Item 1

MONSANTO WEED KILLER ROUNDUP FACES NEW DOUBTS ON SAFETY IN UNSEALED DOCUMENTS

Danny Hakim
https://www.nytimes.com/2017/03/14/business/monsanto-roundup-safety-lawsuit.html?_r=3

The reputation of Roundup, whose active ingredient is the world’s most widely used weed killer, took a hit on Tuesday when a federal court unsealed documents raising questions about its safety and the research practices of its manufacturer, the chemical giant Monsanto.

Roundup and similar products are used around the world on everything from row crops to home gardens. It is Monsanto’s flagship product, and industry-funded research has long found it to be relatively safe. A case in federal court in San Francisco has challenged that conclusion, building on the findings of an international panel that claimed Roundup’s main ingredient might cause cancer.

The court documents included Monsanto’s internal emails and email traffic between the company and federal regulators. The records suggested that Monsanto had ghostwritten research that was later attributed to academics and indicated that a senior official at the Environmental Protection Agency had worked to quash a review of Roundup’s main ingredient, glyphosate, that was to have been conducted by the United States Department of Health and Human Services.

The documents also revealed that there was some disagreement within the E.P.A. over its own safety assessment.

The files were unsealed by Judge Vince Chhabria, who is presiding over litigation brought by people who claim to have developed non-Hodgkin’s lymphoma as a result of exposure to glyphosate. The litigation was touched off by a determination made nearly two years ago by the International Agency for Research on Cancer, a branch of the World Health Organization, that glyphosate was a probable carcinogen, citing research linking it to non-Hodgkin’s lymphoma.

Court records show that Monsanto was tipped off to the determination by a deputy division director at the E.P.A., Jess Rowland, months beforehand. That led the company to prepare a public relations assault on the finding well in advance of its publication. Monsanto executives, in their internal email traffic, also said Mr. Rowland had promised to beat back an effort by the Department of Health and Human Services to conduct its own review.

Dan Jenkins, a Monsanto executive, said in an email in 2015 that Mr. Rowland, referring to the other agency’s potential review, had told him, “If I can kill this, I should get a medal.” The review never took place. In another email, Mr. Jenkins noted to a colleague that Mr. Rowland was planning to retire and said he “could be useful as we move forward with ongoing glyphosate defense.”

The safety of glyphosate is not settled science. A number of agencies, including the European Food Safety Agency and the E.P.A., have disagreed with the international cancer agency, playing down concerns of a cancer risk, and Monsanto has vigorously defended glyphosate.

But the court records also reveal a level of debate within the E.P.A. The agency’s Office of Research and Development raised some concern about the robustness of an assessment carried out by the agency’s Office of Pesticide Programs, where Mr. Rowland was a senior official at the time, and recommended in December 2015 that it take steps to “strengthen” its “human health assessment.”

In a statement, Monsanto said, “Glyphosate is not a carcinogen.”

It added: “The allegation that glyphosate can cause cancer in humans is inconsistent with decades of comprehensive safety reviews by the leading regulatory authorities around the world. The plaintiffs have submitted isolated documents that are taken out of context.”


Item 2

MONSANTO WEED KILLER DESERVES DEEPER SCRUTINY AS SCIENTIFIC MANIPULATION REVEALED

Carey Gillam
Huffington Post
http://www.huffingtonpost.com/entry/58cc5541e4b0e0d348b34348

The puzzle pieces are starting to fall into place, but so far it’s not a pretty picture.

A series of internal Monsanto Co. documents revealed this week via a court order show that the company’s long-standing claims about the safety of its top-selling Roundup herbicide do not necessarily rely on sound science as the company asserts, but on efforts to manipulate the science.

Congressman Ted Lieu of California has called for an investigation by Congress and the Department of Justice to look into the matter, and he is advising consumers to “immediately” stop using Roundup.

“We need to find out if Monsanto or the Environmental Protection Agency misled the public,” Lieu said in a statement.”

Hundreds of pages of emails and other records became part of a public court file this week over Monsanto objections after a federal judge in San Francisco ordered they would no longer be kept sealed despite potential “embarrassment” to Monsanto. U.S. District Judge Vince Chhabria is overseeing more than 55 lawsuits brought by individuals filed by people from around the United States who allege that exposure to Monsanto’s Roundup herbicide caused them or their loved ones to develop non-Hodgkin lymphoma. In addition to those cases, which are moving forward jointly in what is known as “multdistrict litigation (MDL), hundreds of other cases making similar claims are pending in state courts.

Questions about the key ingredient in Roundup, a chemical called glyphosate, have been circulating for years amid mounting research showing links to cancer or other diseases. The International Agency for Research on Cancer in 2015 classified glyphosate as a probable human carcinogen and many international scientists have reported research that shows the chemical can have a range of harmful impacts on people.

The plaintiffs in the lawsuit 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 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. On Wednesday a European Chemicals Agency’s committee said its review found glyphosate is not a carcinogen.

But a look at the documents obtained by plaintiffs from Monsanto as part of court-ordered discovery seem to show a company less interested in exploring mounting concerns about its products than in protecting the billions of dollars in revenue it makes each year from the herbicides. The documents show discussions by Monsanto officials about many troubling practices, including ghostwriting a glyphosate manuscript that would appear to be authored by a highly regarded, independent scientist who Monsanto and other chemical industry players would pay for participation. One such scientist would need “less than 10 days” to do the work needed but would require payment of more than $21,000, the records show.

In a 2015 email, Monsanto executive William Heydens suggested that Monsanto employees could ghostwrite a research paper as he said had been done in the past: “We would be keeping the cost down by us doing the writing and they would just edit & sign their names so to speak,” Heydens wrote.

The internal communications also show company executives expressing dissatisfaction with a scientist who had concerns about glyphosate, and an unwillingness to do the studies he suggested needed to be done. Monsanto officials discussed a need to “find/develop someone who is comfortable with the genetox profile of glyphosate/Roundup and who can be influential with regulators… when genetox issues arise.”

Other records show an internal discussion of how glyphosate and surfactants it is formulated with work together in penetrating human skin upon exposure; documents that discuss a need to “protect” formulations that use tallow amine as a surfactant despite formulations, despite concerns about enhanced toxicity when glyphosate and tallow amine are combined.

And perhaps most damning - the internal records indicate that a senior EPA official in the agency’s pesticide division worked collaboratively with Monsanto to protect glyphosate’s safety record. Jess Rowland, who headed an EPA Cancer Assessment Review Committee (CARC) report that backed the safety of glyphosate, told Monsanto he would try to block a planned U.S. Department of Health and Human Services’ review of glyphosate’s safety, saying: “If I can kill this I should get a medal,” according to a 2015 internal Monsanto email.

Rowland “could be useful as we move forward with ongoing glyphosate defense,” Dan Jenkins, Monsanto’s chief regulatory liaison, wrote in a 2015 email. Rowland left the agency shortly after the CARC report was leaked to the public, posted to an agency website in late April 2016 before it was deleted a few days later. Plaintiffs’ attorneys hope to depose Rowland within the next few weeks, though the EPA has opposed the deposition.

The documents released this week provide only a snapshot of the internal workings of Monsanto when it comes to glyphosate, and the company has argued that the emails and other communications are being taken out of context by plaintiffs’ attorneys and media. The company’s work is built on “sound science,” and “governed by the highest principles of integrity and transparency,” Monsanto states.

The EPA has also consistently defended the safety of glyphosate, issuing a report in September that concluded that glyphosate was “not likely carcinogenic to humans.”

But in a report released Thursday, a special advisory panel to the EPA said they could not fully agree with that determination. Some of the panel members who reviewed the research said studies on glyphosate “suggest a potential for glyphosate to affect cancer incidence.” The group said the EPA was improperly discounting the findings of some studies, and “many of the arguments put forth” by the EPA as supporting glyphosate safety “are not persuasive.”

Real answers about the real impacts of Roundup on human health are long overdue, considering the fact that glyphosate is the most widely used herbicide in the world, and is commonly found in food and water and human urine samples.

“The importance of this issue of whether Roundup causes cancer is immense,” the plaintiffs’ attorneys stated in a recent court filing. “Unfortunately, Monsanto is not forthcoming with sharing information on Roundup with the public.”


Item 3

MONSANTO MANUFACTURED SCIENTIFIC STUDIES AND THEN USED THOSE STUDIES TO INFLUENCE EPA, OTHER REGULATORS

http://www.huffingtonpost.com/entry/monsanto-manufactured-scientific-studies-and-then-used_us_58c95699e4b0009b23bd94d9

Newly-accessible court papers allege that agrichemical giant Monsanto manufactured scientific studies affirming the safety of their star product, the hugely-popular weedkiller Roundup, and paid scientists to publish them. In February 2015, Monsanto executive William “Bill” Heydens emailed his staff instructions to ghostwrite portions of a scientific study on the safety of Roundup, and that he would tell scientists to, quote: “just sign their names” to the study.  According to this same email, Heydens knew that ghostwriting the study would work: he said that Monsanto had already ghostwritten a study on Roundup in the year 2000.

In the 2015 emails, Bill Heydens and his employees scramble to prepare for an international review of glyphosate by the the cancer arm of the World Health Organization. The emails reveal that some Monsanto employees were apprehensive about “noise” coming from independent scientific studies―studies that indicated Roundup is carcinogenic. In the emails, executives weigh the cost of paying independent experts to create studies ($250,000) versus the free option of “ghost-writing” studies.

“A less expensive/more palatable approach might be to involve experts only for the areas of contention...and we ghost-write the Exposure Tox & Genetox sections,” one email reads. Bill Heydens suggested that Dr. David Kirkland may put his name on the study.  In response to these allegations, Dr. Kirkland told The New York Times yesterday that: “I would not publish a document that had been written by someone else.” He added, “We had no interaction with Monsanto at all during the process of reviewing the data and writing the papers.”

However, this is not the only released email chain about Dr. Kirkland. In another series of emails, Monsanto negotiates with chemical giants Dow and Syngenta for money to pay Dr. Kirkland to review internal, unpublished studies on Roundup, and then for him to sign-off on a published study with another Monsanto-paid scientist.  The emails reveal that Christophe Gustin, Monsanto’s Crop Protection Regulatory Affairs Lead at Monsanto Europe, had to negotiate heavily with other chemical manufacturers before they could raise the money to pay Dr. Kirkland.

Despite Monsanto’s attempts to influence the World Health Organization’s agency decision in 2015, the agency concluded that glyphosate is a probable carcinogen weeks after this exchange. Monsanto spent huge amounts of money attempting to delegitimize the agency’s conclusion. These new emails, coupled with countless well-funded attacks from the chemical industry on independent science, are deeply troubling. Scientific research, and in turn our regulatory system, has become infected by corporate influence. Incredibly powerful companies like Monsanto have the ability to push out their agenda, cloaked in a legitimate white coat.

The most disturbing allegation in these court documents is that the Environmental Protection Agency relied on these studies in its scientific panel on Roundup and its active ingredient, glyphosate. The EPA is currently reviewing the carcinogenic potential of glyphosate―but has yet to publish the final results. Court documents indicate that the EPA is relying on the above-mentioned 2000 study and Dr. Kirkland’s 2013 publication, which was paid for by Monsanto, Syngenta, Dow, and other companies.


Item 4

EPA OFFICIAL ACCUSED OF HELPING MONSANTO ‘KILL’ CANCER STUDY

Joel Rosenblatt, Lydia Mulvany and Peter Waldman

https://www.bloomberg.com/news/articles/2017-03-14/monsanto-accused-of-ghost-writing-papers-on-roundup-cancer-risk

The Environmental Protection Agency official who was in charge of evaluating the cancer risk of Monsanto Co.’s Roundup allegedly bragged to a company executive that he deserved a medal if he could kill another agency’s investigation into the herbicide’s key chemical.

The boast was made during an April 2015 phone conversation, according to farmers and others who say they’ve been sickened by the weed killer. After leaving his job as a manager in the EPA’s pesticide division last year, Jess Rowland has become a central figure in more than 20 lawsuits in the U.S. accusing the company of failing to warn consumers and regulators of the risk that its glyphosate-based herbicide can cause non-Hodgkin’s lymphoma.

“If I can kill this I should get a medal,” Rowland told a Monsanto regulatory affairs manager who recounted the conversation in an email to his colleagues, according to a court filing made public Tuesday. The company was seeking Rowland’s help stopping an investigation of glyphosate by a separate office, the Agency for Toxic Substances and Disease Registry, that is part of the U.S. Health and Human Service Department, according to the filing.

A federal judge overseeing the glyphosate litigation in San Francisco said last month he’s inclined to order Rowland to submit to questioning by lawyers for the plaintiffs, who contend he had a "highly suspicious" relationship with Monsanto. Rowland oversaw a committee that found insufficient evidence to conclude glyphosate causes cancer and quit last year shortly after his report was leaked to the press.

Monsanto Statement

Monsanto vice president of global strategy Scott Partridge said in a phone interview that it would be "remarkable" if Monsanto could manipulate the EPA under the Obama administration. The unsealed emails represent "a natural flow of information" between the company and the EPA, Partridge said. "It’s not an effort to manipulate the system."

Asked about emails specifically describing Monsanto working with Rowland to kill the glyphosate investigation by the toxic substances agency, Partridge said he would review the messages and respond at a later date.

The company also issued a statement defending its use of glyphosate.

“The allegation that glyphosate can cause cancer in humans is inconsistent with decades of comprehensive safety reviews by the leading regulatory authorities around the world,’ Monsanto said.

The company on March 10 lost a court bid to keep glyphosate off California’s public list of cancer-causing chemicals. A state judge rejected Monsanto’s arguments that the chemical shouldn’t be added to a list created by a voter-approved ballot initiative that requires explicit warnings for consumer products containing substances that may cause cancer or birth defects.

Rowland’s Communications

The plaintiffs’ lawyers say Rowland’s communications with Monsanto employees show the regulator who was supposed to be policing the company was actually working on its behalf.

The unsealing of the court documents "represents a huge development in public health," said Tim Litzenburg, one of the lawyers suing Monsanto. Regulatory agencies, scientists, consumers and physicians "can see some of what Monsanto was actually engaging in behind the scenes, and how they have manipulated the scientific literature to date. That’s important to their decision-making, not just our lawsuits."

After the phone conversation with Rowland, the Monsanto head of U.S. regulatory affairs, Dan Jenkins, cautioned his colleagues not to “get your hopes up,” according to an email cited in the court filing.

“I doubt EPA and Jess can kill this,” Jenkins wrote. He may have spoken too soon. Another internal Monsanto memorandum unsealed on Tuesday said the ATSDR, as the federal toxics agency is known, "agreed, for now, to take direction from EPA."

“While Monsanto cannot speak for EPA, our understanding of this comment is that EPA was concerned about ATSDR starting a duplicative safety analysis of glyphosate without realizing that EPA was already far along in its own comprehensive safety analysis,” Monsanto spokeswoman Christi Dixon said in an email.

The ATSDR announced in the Federal Register in February 2015 that it planned to publish a toxicological profile of glyphosate by October that year. It never did. The agency’s press office didn’t respond to multiple phone messages seeking comment. EPA representatives also didn’t immediately respond to phone messages seeking comment.

Plaintiffs’ lawyers said in another filing made public Tuesday that Monsanto’s toxicology manager and his boss, Bill Heydens, were ghost writers for two of the reports, including one from 2000, that Rowland’s committee relied on in part to reach its conclusion that glyphosate shouldn’t be classified as carcinogenic.

The EPA “may be unaware of Monsanto’s deceptive authorship practice,” the lawyers said.

Among the documents unsealed was a February 2015 internal email exchange at the company about how to contain costs for a research paper. The plaintiff lawyers cited it to support their claim that the EPA report is unreliable, unlike a report by an international agency that classified glyphosate as a probable carcinogen.

“A less expensive/more palatable approach” is to rely on experts only for some areas of contention, while “we ghost-write the Exposure Tox & Genetox sections,” Heydens wrote to a colleague.

The names of outside scientists could be listed 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,” according to the email, which goes on to say that’s how Monsanto handled the 2000 study.

Monsanto said the ghost writing allegations are false, and in a blog post Tuesday accused the plaintiffs’ lawyers of taking an email comment out of context to mischaracterize the role of a company scientist.

The contributions by Heydens to the 2000 paper were fully disclosed in the report’s acknowledgments section and his own reference to ghost writing in the 2015 email was an overstatement for the “minor editorial contributions” he made, the company said.

“It was things like editing relatively minor things, editing for formatting, just for clarity, really just for overall readability to make it easier for people to read in a more organized fashion,” Heydens said in sworn testimony in the San Francisco litigation, according to the company.

The case is In re: Roundup Products Liability Litigation, MDL 2741, U.S. District Court, Northern District of California (San Francisco).


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