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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.
Three years ago this month Monsanto executives realized they had a big problem on their hands.
It was September 2014 and the company’s top-selling chemical, the weed killer called glyphosate that is the foundation for Monsanto’s branded Roundup products, had been selected as one among a handful of pesticides to undergo scrutiny by the World Health Organization’s International Agency for Research on Cancer (IARC). Monsanto had spent decades fending off concerns about the safety of glyphosate and decrying scientific research indicating the chemical might cause cancer or other diseases. And even though the IARC review was still months away, Monsanto’s own scientists knew what the outcome would likely be—and they knew it wouldn’t be good.
Internal company records show not just the level of fear Monsanto had over the impending review, but notably that company officials fully expected IARC scientists would find at least some cancer connections to glyphosate. Company scientists discussed the “vulnerability” that surrounded their efforts to defend glyphosate amid multiple unfavorable research findings in studies of people and animals exposed to the weed killer. In addition to epidemiology studies, “we also have potential vulnerabilities in the other areas that IARC will consider, namely, exposure, genetox and mode of action…” a Monsanto scientist wrote in October 2014. That same email discussed a need to find allies and arrange funding for a “fight”—all months before the IARC meeting in March 2015.
And Monsanto predicted internally before IARC even met that the review of the scientific evidence would result in a decision that glyphosate “possibly” was carcinogenic or “probably” was. Monsanto officials had forecast the IARC decision in an internal “preparedness” plan that warned colleagues to “assume and prepare for the outcome…” The document shows Monsanto thought it most likely that IARC would peg glyphosate as a “possible human carcinogen.” The rating of probable carcinogen was “possible but less likely,” the Monsanto memo stated. IARC ultimately did classify glyphosate as “probably carcinogenic to humans.”
As the IARC meeting loomed, the internal documents show that Monsanto did not wait for the actual IARC decision before acting. It enlisted teams of PR and lobbying experts, scientists and others in a plan aimed at creating what was designed to appear as a storm of “outcry” and “outrage” to follow the IARC classification. IARC had a history of “questionable and politically charged rulings,” the Monsanto memo said.
The plan was to create enough controversy to thoroughly discredit IARC’s evaluation because Monsanto officials knew that regulators would be influenced by IARC, and continued widespread use of the top-selling chemical could be at risk.
“It is possible that IARC’s decision will impact future regulatory decision making,” Monsanto stated in its internal correspondence.
The timing was critical because in 2015 both the U.S. Environmental Protection Agency (EPA) and the European Commission were evaluating re-authorizations of Monsanto’s weed killer. Following IARC’s classification, both the European Union and the EPA delayed final decisions on glyphosate amid the still-brewing debate over the chemical’s safety.
“What this indicates to me is that it was obvious to Monsanto that there was evidence of carcinogenicity,” said Peter Infante, an epidemiologist who worked for more than 24 years for the U.S. government studying cancer risks to workers from exposure to toxic substances. “It would seem to me that Monsanto does not like the public to be informed of the cancer hazard.”
“What this indicates to me is that it was obvious to Monsanto that there was evidence of carcinogenicity.”
After the IARC ruling, a storm of protest did erupt from various individuals and organizations alongside Monsanto’s howls of indignant outrage. Some have questioned the wisdom of U.S. funding for IARC and Monsanto has perpetuated a false narrative that the chairman of the IARC working group withheld critical information from the team.
The document trail, which includes internal emails, memos and other communications obtained from Monsanto by plaintiffs’ attorneys through litigation pending in the U.S., makes clear that the debate over, and challenge to, IARC’s classification did not sprout authentically from a variety of voices, but rather was manufactured by Monsanto in advance of IARC’s decision and continued afterward. The goal was—and is—to convince regulators to discount the findings of the team of independent scientific experts who made up the IARC team that examined glyphosate.
The internal records obtained through litigation, combined with documents obtained through Freedom of Information Act (FOIA) and state records requests also show that the actions employed to discredit IARC were part of a decades-long pattern of deceptive tactics by Monsanto to persuade regulators, lawmakers and members of the press and public that glyphosate and Roundup are safe. The company has used these tactics multiple times over the years to try to discredit several scientists whose research has found harmful effects associated with glyphosate.
The IARC attack plan, which was laid out in a February 2015 memo, involved not only Monsanto’s internal PR people, scientists and marketing experts, but a range of outside industry players. Various individuals were assigned tasks. The “strategies and tactics” included:
- “Orchestrate Outcry” with IARC Decision—Industry conducts robust media/social media outreach on process and outcome.
- “Identify/request third-party experts to blog, op/ed, tweet and/or link, repost, retweet, etc.” The documents show one such “expert,” academic Henry Miller, was provided a draft article to submit to Forbes for publication under his name with no mention of Monsanto’s involvement. Forbes learned of the deceit last month and severed relations with Miller.
- “Inform/Inoculate/Engage Industry Partners”—Notably the industry partners listed included three organizations that purport to be independent of Monsanto but have long been seen by critics as front groups for the company—Monsanto named Academics Review and the Genetic Literacy Project, both based in the U.S. and Sense About Science, which has run operations in the United Kingdom and the U.S., as groups to help with its mission. In fact, Sense About Science was the group identified by Monsanto to lead the industry response and “provide a platform for IARC observers.” The groups did as Monsanto planned, posting scathing attacks on IARC on their websites.
- Engagement with Regulatory Agencies—Monsanto planned for grower associations/ growers to “write regulators with an appeal that they remain focused on the science, not the politically charged decision by IARC.”
- “Push opinion leader letter to key daily newspaper on day of IARC ruling” with assistance of the Potomac Group marketing firm.
The preparedness plan also called for supporting “the development of three new papers on glyphosate focused on epidemiology and toxicology.” As planned, shortly after the IARC decision Monsanto arranged for several scientists—many of them former employees or paid consultants—to author and publish research papers supporting glyphosate safety. It was revealed through discovery documents that Monsanto discussed ghostwriting the papers. In one email, company scientist William Heydens told colleagues the company could “ghost-write” certain reports that would carry the names of outside scientists—”they would just edit & sign their names so to speak,” he wrote. He cited as an example a 2000 study that has been regarded as influential by regulators. Documents show Monsanto’s heavy writing and editing involvement in the resulting purportedly “independent” review.
Monsanto has adamantly denied ghostwriting, but one memo from August 2015 from the files of Monsanto scientist David Saltmiras actually uses that term, stating that he “ghostwrote cancer review paper Greim et al (2015)…” referring to a paper that showed authorship by German scientist Helmut Greim along with Saltmiras. (Monsanto has acknowledged that Greim worked as a consultant to the company with part of his job being to publish peer-reviewed data on glyphosate).
Another internal email illustrates the writing by a Monsanto scientist of a research paper titled “Developmental and Reproductive Outcomes… after Glyphosate Exposure.” The scientist, Donna Farmer, did extensive work, including what she called a “cut and paste” of certain information. But her name was not included as an author before the paper was submitted to a journal. The published version concluded there was “no solid evidence linking glyphosate exposure to adverse developmental or reproductive effects.”
The paper trail of documents also show that Monsanto feared that a U.S. health agency planning to review glyphosate in 2015 might agree with IARC and collaborated with the EPA to successfully block that agency—the Agency for Toxic Substances & Disease Registry (ATSDR)—from doing its review. “We’re trying to do everything we can to keep from having a domestic IARC occur,” a company official wrote.
The record also shows that well before IARC, Monsanto recruited networks of academic scientists in the U.S and Europe who have defended Monsanto’s products, including its weed killer, without declaring their collaborations with Monsanto. And that these silent soldiers helped Monsanto discredit scientists who reported research showing harm associated with glyphosate and Roundup, including working at Monsanto’s bidding to get one damaging study by French scientist Gilles-Éric Séralini retracted from a scientific journal where it was published in September 2012. The company even discounted concerns by one of its own paid consultants who found evidence of glyphosate’s genotoxicity and refused to do the additional tests he recommended.
If what Monsanto says is true, that glyphosate is so very safe, and that there is no evidence it causes cancer or other health problems, then why all the smoke and mirrors? Why would the company need to ghostwrite research papers to present to regulators? Why would Monsanto need to establish networks of scientists to promote glyphosate safety and to tear down scientists whose research raises concerns? Why would Monsanto try to block a review of glyphosate by the U.S. ATSDR?
Two committees of the European Parliament have scheduled a hearing for Oct. 11 in Brussels to delve into these and other questions as the European Commission faces a looming deadline for making a decision on the re-authorization of glyphosate before the end of 2017.
Lawmakers should take note of evidence that their own food safety agency appears to have dropped the ball on independent assessments of glyphosate research. Records show that the European Food Safety Authority (EFSA) dismissed a study linking Monsanto’s weed killer to cancer at the advice of an EPA official who Monsanto deemed “useful” and who is part of a probe now into possible collusion between the EPA and Monsanto.
They should also pay heed to news that EFSA based its recommendation on glyphosate on a report that copied and pasted analyses from a Monsanto study.
Monsanto Chairman Hugh Grant was invited to address the Parliament meeting in October, but declined to appear or to send anyone else from Monsanto. Dr. Roland Solecki, head of chemical safety for the German Federal Institute for Risk Assessment (BfR), has also declined, according to organizers. I do plan to participate, as will a representative from IARC and several others.
Throughout this debate, it is worthwhile to remember that the concerns about glyphosate safety have deep roots that date all the way back to at least 1985 when EPA toxicologists looked at data showing rare tumors in mice dosed with glyphosate and determined that glyphosate was “possibly carcinogenic to humans.”
Monsanto protests eventually reversed that classification but in light of all of the deceptive tactics recently revealed in documents, the words of an EPA scientist more than 30 years ago are worth considering today: “Glyphosate is suspect… Monsanto’s argument is unacceptable.”
The EPA scientist in that 1985 memo also wrote: “Our viewpoint is one of protecting the public health when we see suspicious data. It is not our job to protect registrants…”
European lawmakers would be wise to recall those words.
This article was originally published in EcoWatch.
Carey Gillam is a veteran reporter and author of Whitewash – The Story of a Weed Killer, Cancer and the Corruption of Science. She is research director for U.S. Right to Know, a nonprofit consumer watchdog group working for truth and transparency in our food system.
By Carey Gillam
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.
Documents 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.
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.”