Bayer AG, which bought Monsanto last summer, said Monday that it was making scientific studies available for public scrutiny in an effort to counter growing concerns about the safety of Monsanto’s flagship glyphosate-based herbicide products.
“Transparency is a catalyst for trust, so more transparency is a good thing for consumers, policymakers and businesses, Liam Condon, president of Bayer’s crop science division, said in a statement. Safety, he said, is the company’s top priority.
The comments come as pressure is mounting on Bayer management as roughly 11,000 people are suing Monsanto alleging glyphosate-based herbicides such as Roundup cause non-Hodgkin lymphoma, and Monsanto has hidden the risks and manipulated the scientific record. The first Roundup cancer trial resulted in a jury verdict of $289 million in damages against Monsanto, though a judge later lowered that to $78 million. The second such trial ended last month with a jury verdict of $80.2 million against Monsanto. The third trial is now underway.
Last week U.S. District Judge Vince Chhabria told Bayer attorneys and plaintiffs’ attorneys that he would like the parties to enter into mediation to discuss a possible settlement. He vacated a fourth trial set to begin in May.
Monsanto and Bayer deny the allegations and say the weight of science supports the safety of glyphosate herbicides. They also deny claims that company scientists ghost-wrote seemingly independent scientific papers and otherwise manipulated the scientific record.
“By making our detailed scientific safety data available, we encourage anyone interested to see for themselves how comprehensive our approach to safety is. We embrace the opportunity to engage in dialogue so we can build more trust in sound science,” said Condon.
The company said it was providing access to 107 Bayer-owned glyphosate safety study reports that were submitted to the European Food Safety Authority as part of the substance authorization process in the European Union. The studies are accessible on Bayer’s transparency platform.
The news from Bayer comes ahead of an April 26 shareholders meeting in which some investors are calling for the head of Bayer CEO Werner Baumann for leading the company into the Monsanto acquisition. Monsanto’s top management walked away with millions of dollars in exit packages just before the first Roundup cancer trial, leaving Bayer holding the bag for the litigation losses and the bad publicity. Since last summer, the company has seen an exodus of customers as retailers, cities, school districts and others say they are backing away from the Monsanto herbicides.
As Bayer focuses on its messaging outside the court room, epidemiologist Beate Ritz, professor at the University of California Los Angeles School of Public Health, is due to take the stand today in Pilliod v. Monsanto, the third Roundup cancer trial. Ritz has testified in the two prior trials that her analysis of several scientific studies shows that there is a “credible link” between glyphosate-based herbicides such as Monsanto’s Roundup and non-Hodgkin’s lymphoma.
The current case was brought by Alva and Alberta Pilliod, a married couple who both have non-Hodgkin lymphoma they allege is due to years of Roundup use.
Following Ritz will be testimony from Dennis Weisenburger, a pathologist specializing in studying the causes of non-Hodgkin lymphoma. Weisenburger testified in the Edwin Hardeman v. Monsanto trial that Roundup is a “substantial cause” of cancer in people who are exposed.
Meanwhile, plaintiffs’ attorneys continue to worry about what they believe to be “geofencing” by Monsanto. Geofencing is a popular advertising technique that delivers specific messaging/content to anyone within a specific geographic area designated by the company or group paying for the ad. The area can be very small, a mile radius around a specific address, for instance. Anyone within that designated area using an app on a smart phone – such as a weather app or a game – would then be delivered the ad. Targeted individuals don’t have to be searching for information; it just appears on their smart phone.
Plaintiffs’ attorneys raised the issue in the Hardeman case, and had concerns that Monsanto was pushing messaging to jurors through geofencing in the first Roundup cancer trial, which was brought by groundskeeper Dewayne “Lee” Johnson.
In the Pilliod case, the issue was discussed Thursday in court as the plaintiffs attorneys sought a judicial order to prohibit Monsanto from the tactic, but the judge was skeptical and declined to issue such an order.
Here is part of the exchange. All can be seen in the trial transcript.
PLAINTIFFS’ ATTORNEY BRENT WISNER: Your Honor, I think there’s one — and I get your point. I think just to clarify one procedural factual thing. Right? If I were to walk over to a juror personally and say to you, “Hey, Juror Number 3, Monsanto’s stuff causes cancer and all these studies show it,” I mean, that would be a mistrial. Instantaneously. That’s jury tampering. Right? Now if they do that same thing — if I did the same thing by targeting every person’s phone in this courtroom or every single person’s phone in this courthouse and pushing that information, that same message to them on their phone — and what happens is - I don’t know if you use your phone for this kind of purposes, but, for example, when I look at my ESPN app and I’m looking at the scores for the UCLA water polo team, or whatever, you know, there’s little ads that pop up.
THE COURT: Sure.
MR. WISNER: And those ads are saying “Federal judge says Roundup is safe.” That’s the kind of stuff
we’re seeing. We saw this happening with quite intensity in the Johnson trial. Numerous jurors during voir dire mentioned that they were having these things pushed on them as soon as they walked in the building. And so whether or not Monsanto is or is not doing that, I think that if they are, that should be
prohibited. That’s not really a point of First Amendment. That is now clearly targeting people that
they know they can’t speak to.
THE COURT: And you’re asking me to assign a subjective intent that I don’t know exists and it’s
still prior restraint. I mean, technology has taken us places probably we never thought it would go… I guess if I were picking sides, I might believe that. But I can’t pick sides.
Study says evidence ‘supports link’ between exposure to glyphosate and increased risk
This article was originally published in the Guardian.
By Carey Gillam
A broad new scientific analysis of the cancer-causing potential of glyphosate herbicides, the most widely used weedkilling products in the world, has found that people with high exposures to the popular pesticides have a 41% increased risk of developing a type of cancer called non-Hodgkin lymphoma.
The evidence “supports a compelling link” between exposures to glyphosate-based herbicides and increased risk for non-Hodgkin lymphoma (NHL), the authors concluded, though they said the specific numerical risk estimates should be interpreted with caution.
The findings by five US scientists contradict the US Environmental Protection Agency’s (EPA) assurances of safety over the weed killer and come as regulators in several countries consider limiting the use of glyphosate-based products in farming.
Monsanto and its German owner Bayer AG face more than 9,000 lawsuits in the US brought by people suffering from NHL who blame Monsanto’s glyphosate-based herbicides for their diseases. The first plaintiff to go to trial won a unanimous jury verdict against Monsanto in August, a verdict the company is appealing. The next trial, involving a separate plaintiff, is set to begin on 25 February, and several more trials are set for this year and into 2020.
Monsanto maintains there is no legitimate scientific research showing a definitive association between glyphosate and NHL or any type of cancer. Company officials say the EPA’s finding that glyphosate is “not likely” to cause cancer is backed by hundreds of studies finding no such connection.
The company claims the scientists with the International Agency for Research on Cancer (IARC) who classified glyphosate as a probable human carcinogen in 2015 engaged in improper conduct and failed to give adequate weight to several important studies.
But the new analysis could potentially complicate Monsanto’s defense of its top-selling herbicide. Three of the study authors were tapped by the EPA as board members for a 2016 scientific advisory panel on glyphosate. The new paper was published by the journal Mutation Research /Reviews in Mutation Research, whose editor in chief is EPA scientist David DeMarini.
The study’s authors say their meta-analysis is distinctive from previous assessments. “This paper makes a stronger case than previous meta-analyses that there is evidence of an increased risk of NHL due to glyphosate exposure,” said co-author Lianne Sheppard, a professor in the Environmental and Occupational Health Sciences department at the University of Washington. “From a population health point of view there are some real concerns.”
Sheppard was one of the scientific advisers to the EPA on glyphosate and was among a group of those advisers who told the EPA that it failed to follow proper scientific protocols in determining that glyphosate was not likely to cause cancer. “It was wrong,” Sheppard said of the EPA glyphosate assessment. “It was pretty obvious they didn’t follow their own rules. “Is there evidence that it is carcinogenic? The answer is yes.”
An EPA spokesperson said: “We are reviewing the study.” Bayer, which bought Monsanto in the summer of 2018, did not respond to a request for comment about the study.
A Bayer statement on glyphosate cites the EPA assessment and says that glyphosate herbicides have been “extensively evaluated” and are proven to be a “safe and efficient weed control tool”.
The study authors said their new meta-analysis evaluated all published human studies, including a 2018 updated government-funded study known as the Agricultural Health Study (AHS). Monsanto has cited the updated AHS study as proving that there is no tie between glyphosate and NHL. In conducting the new meta-analysis, the researchers said they focused on the highest exposed group in each study because those individuals would be most likely to have an elevated risk if in fact glyphosate herbicides cause NHL.
Looking only at individuals with real-world high exposures to the pesticide makes it is less likely that confounding factors may skew results, the authors said. In essence – if there is no true connection between the chemical and cancer then even highly exposed individuals should not develop cancer at significant rates.
In addition to looking at the human studies, the researchers also looked at other types of glyphosate studies, including many conducted on animals.
“Together, all of the meta-analyses conducted to date, including our own, consistently report the same key finding: exposure to GBHs are associated with an increased risk of NHL,” the scientists concluded.
David Savitz, professor of epidemiology in the Brown University School of Public Health, said the work was “well conducted” but lacking “fundamentally new information”.
“I would suggest it sustains the concern and need for assessment but doesn’t put the question to rest in any definitive sense,” Savitz said.
In a statement Bayer later said, “[The study] does not provide new epidemiology data; instead, it is a statistical manipulation that is at odds with the extensive body of science, 40 years of real world experience and the conclusions of regulators.”
It added: “[The study] provides no scientifically valid evidence that contradicts the conclusions of the extensive body of science demonstrating that glyphosate-based herbicides are not carcinogenic.”
Glyphosate, a synthetic herbicide patented in 1974 by the Monsanto Company and now manufactured and sold by many companies in hundreds of products, has been associated with cancer and other health concerns. Glyphosate is best known as the active ingredient in Roundup-branded herbicides, and the herbicide used with “Roundup Ready” genetically modified organisms (GMOs).
Herbicide tolerance is the most prevalent GMO trait engineered into food crops, with some 90% of corn and 94% of soybeans in the U.S. engineered to tolerate herbicides, according to USDA data. A 2017 study found that Americans’ exposure to glyphosate increased approximately 500 percent since Roundup Ready GMO crops were introduced in the U.S in 1996. Here are some key facts about glyphosate:
Most Widely Used Pesticide
- Americans have applied 1.8 million tons of glyphosate since its introduction in 1974.
- Worldwide 9.4 million tons of the chemical has been sprayed on fields – enough to spray nearly half a pound of Roundup on every cultivated acre of land in the world.
- Globally, glyphosate use has risen almost 15-fold since Roundup Ready GMO crops were introduced.
The scientific literature and regulatory conclusions regarding glyphosate and glyphosate-based herbicides show a mix of findings, making the safety of the herbicide a hotly debated subject:
In 2015, the World Health Organization’s International Agency for Research on Cancer (IARC) classified glyphosate as “probably carcinogenic to humans” after reviewing years of published and peer-reviewed scientific studies. The team of international scientists found there was a particular association between glyphosate and non-Hodgkin lymphoma.
At the time of the IARC classification, the Environmental Protection Agency (EPA) was conducting a registration review. The EPA’s Cancer Assessment Review Committee (CARC) issued a report in September 2016 concluding that glyphosate was “not likely to be carcinogenic to humans” at doses relevant to human health. In publishing the CARC report, the EPA said that it was beginning work with the National Toxicology Program to investigate the mechanisms and toxic effects of glyphosate formulations.
The agency then convened a Scientific Advisory Panel (SAP) in December 2016 to review the CARC report conclusion that glyphosate was not likely to be carcinogenic. The scientific advisory panel members were divided in their assessment of EPA’s work, with some finding the EPA erred in how it evaluated certain research. Additionally, the EPA’s Office of Research and Development determined that the agency’s Office of Pesticide Programs had not followed proper protocols in its evaluation of glyphosate. An ORD memo stated that the government scientists agreed in part with IARC and believed EPA was not properly following guidelines in coming to the conclusion that glyphosate was not likely to be carcinogenic. ORD said the evidence could be deemed to support a “likely” carcinogenic or “suggestive” evidence of carcinogenicity classification. Nevertheless the EPA issued a draft report on glyphosate in December 2017 continuing to hold that the chemical is not likely to be carcinogenic.
The European Food Safety Authority and the European Chemicals Agency have said glyphosate is not likely to be carcinogenic to humans. But a March 2017 report by environmental and consumer groups argued that regulators relied improperly on research that was directed and manipulated by the chemical industry.
The WHO/FAO Joint Meeting on Pesticide Residues determined that glyphosate was unlikely to pose a carcinogenic risk to humans from exposure through the diet, though the finding was tarnished by conflict of interest concerns after it was revealed that certain members of the group, including its chair, worked for the International Life Sciences Institute, a group funded in part by Monsanto and one of its lobbying organizations.
On March 28, 2017, the California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment confirmed that it would add glyphosate to California’s Proposition 65 list of chemicals known to cause cancer. Monsanto sued to block the action but the case was dismissed. In a separate case, the court found that California could not require cancer warnings for products containing glyphosate. On June 12, 2018, the United States District Court for the Eastern District of California denied the California Attorney General’s request for the court to reconsider the decision. The court found that California could only require commercial speech that disclosed “purely factual and uncontroversial information,” and the science surrounding glyphosate carcinogenicity was not proven.
A long-running U.S. government-backed prospective cohort study of farm families in Iowa and North Carolina has not found any connections between glyphosate use and non-Hodgkin lymphoma, though researchers found that “among applicators in the highest exposure quartile, there was an increased risk of acute myeloid leukemia (AML) compared with never users…” The most recent published update to the study was made public in late 2017.
New studies in 2019 report cancer links and concerns about the validity of the EPA classification:
- An analysis published January 2019 argues that the U.S. EPA’s classification of glyphosate disregarded substantial scientific evidence of genotoxicity (the negative impact on a cell’s genetic material) associated with weed killing products such as Roundup.
- A February 2019 meta-analysis of scientific studies reported a “compelling link” between glyphosate-based herbicides and non-Hodgkin lymphoma. Three of the study authors were members of the EPA’s scientific advisory panel on glyphosate who have stated publicly that the EPA failed to follow proper scientific practices in its glyphosate assessment.
- A March 2019 study analyzed data from more than 30,000 farmers and agricultural workers from studies done in France, Norway and the U.S., and reported links between glyphosate and diffuse large B-cell lymphoma.
More than 650 lawsuits against Monsanto Co. are part of multi district litigation (MDL) being overseen by Judge Vince Chhabria in U.S. District Court in San Francisco, filed by people alleging that exposure to Roundup herbicide caused them or their loved ones to develop non-Hodgkin lymphoma, and that Monsanto covered up the risks. An estimated 9,000 similar actions are pending in state courts. U.S. Right to Know is posting key documents from the litigation on our Monsanto Papers pages. See Carey Gillam’s Roundup Trial Tracker for news and tips about the ongoing legislation.
In March 2017, the federal court judge unsealed some internal Monsanto documents that raised new questions about Monsanto’s influence on the EPA process and about the research regulators rely on. The documents suggest that Monsanto’s long-standing claims about the safety of glyphosate and Roundup do not necessarily rely on sound science as the company asserts, but on efforts to manipulate the science.
A study for the European Parliament published January 15, 2019 asserts that the EU approval of glyphosate was based on plagiarized text from Monsanto. The study found plagiarism in 50.1 percent of chapters dealing with the assessment of published studies on health risks related to glyphosate in Germany’s Federal Institute for Risk Assessment, including whole paragraphs and entire pages of plagiarized text.
See also 2018 journal articles about scientific interference:
- “The Monsanto Papers: Poisoning the Scientific Well,” by Leemon McHenry
- “Roundup litigation discovery documents: implications for public health and journal ethics,” by Sheldon Krimsky and Carey Gillam
- Letter to Nature by Stéphane Horel and Stéphane Foucart
The first trial concluded in August 2018 with the jury ruling that Monsanto’s weed killer was a substantial contributing factor in causing DeWayne “Lee” Johnson’s cancer, and ordering Monsanto to pay $289.25 million in damages, including $250 million in punitive damages. The judge in the case reduced the punitive damages to $39 million, bringing the total award to $78 million. Monsanto declared it would appeal and Johnson has cross-appealed, seeking to reinstate the jury award.
March 19, 2019 update: In a blow to Bayer, a federal journey 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.
Endocrine Disruption and Other Health Concerns
Some research suggests that glyphosate may be an endocrine disruptor. It has also been linked to liver disease, birth defects and reproductive problems in laboratory animals; and may kill beneficial gut bacteria and damage the DNA in human embryonic, placental and umbilical cord cells. Many scientists have raised concerns about the health risks of glyphosate. See:
- Is it time to reassess current safety standards for glyphosate-based herbicides? – Journal of Epidemiology and Community Health
- Concerns over use of glyphosate-based herbicides and risks associated with exposure: a consensus statement – Environmental Health Journal
Recent studies have shown adverse biological effects from low-dose exposures to glyphosate at levels to which people are routinely exposed.
- A birth cohort study in Indiana published in 2017 – the first study of glyphosate exposure in US pregnant women using urine specimens as a direct measure of exposure – found detectable levels of glyphosate in more than 90% of the pregnant women tested and found the levels were significantly correlated with shortened pregnancy lengths.
- A 2018 ecological and population study conducted in Argentina found high concentrations of glyphosate in the soil and dust in agricultural areas that also reported higher rates of spontaneous abortion and congenital abnormalities in children, suggesting a link between environmental exposure to glyphosate and reproductive problems. No other relevant sources of pollution were identified.
- A 2017 study associated chronic, very low-level glyphosate exposures to non-alcoholic fatty liver disease in rats. According to the researchers, the results “imply that chronic consumption of extremely low levels of a GBH formulation (Roundup), at admissible glyphosate-equivalent concentrations, are associated with marked alterations of the liver proteome and metabolome,” the biomarkers for NAFLD.
- A 2018 rat study conducted by the Ramazzini Institute reported that low-dose exposures to Roundup at levels considered safe significantly altered the gut microbiota in some of the rat pups. Another 2018 study reported that higher levels of glyphosate administered to mice disrupted the gut microbiota and caused anxiety and depression-like behaviors.
- A 2018 rat study by Argentinian researchers linked low-level perinatal glyphosate exposures to impaired female reproductive performance and congenital anomalies in the next generation of offspring.
Glyphosate has also been linked by recent studies to harmful impacts on bees and monarch butterflies.
- A 2018 study reported that glyphosate damaged the beneficial gut bacteria in honeybees and made them more prone to deadly infections. This followed research from China showing that honeybee larvae grew more slowly and died more often when exposed to glyphosate, and a 2015 study that found field-levels of exposure impaired the cognitive capacities of honeybees.
- Research from 2017 correlated glyphosate use with reduced populations of monarch butterflies, possibly due to reductions in milkweed, the main food source for monarch butterflies.
Some farmers use glyphosate on non-GMO crops such as wheat, barley, oats, and lentils to dry down the crop ahead of harvest in order to accelerate the harvest. This practice, known as desiccation, may be a significant source of dietary exposure to glyphosate.
Glyphosate Found in Food: U.S. Drags Its Feet on Testing
The USDA quietly dropped a plan to start testing food for residues of glyphosate in 2017. Internal agency documents obtained by U.S. Right to Know show the agency had planned to start testing over 300 samples of corn syrup for glyphosate in April 2017. But the agency killed the project before it started. The U.S. Food and Drug Administration began a limited testing program in 2016, but the effort was fraught with controversy and internal difficulties and the program was suspended in September 2016. Both agencies have programs that annually test foods for pesticide residues but both have routinely skipped testing for glyphosate.
Before the suspension, one FDA chemist found alarming levels of glyphosate in many samples of U.S. honey, levels that were technically illegal because there have been no allowable levels established for honey by the EPA. Here is a recap of news about glyphosate found in food:
- October 2018: FDA issued its first-ever report showing the results of its glyphosate residue in food testing. The FDA said no residues of glyphosate were found in milk or eggs, but residues were found in 63.1 percent of corn samples and 67 percent of soybean samples, according to FDA data. The agency did not disclose in that report the findings of glyphosate in oatmeal or honey products.
- April 2018: internal FDA emails indicated the agency had trouble finding food sample without traces of glyphosate.
- Sept. 2016: FDA found glyphosate in US honey at double the levels allowed in the EU, and FDA tests confirm oatmeal and baby foods contain glyphosate.
- Nov. 2016: FDA chemist found glyphosate in honey in Iowa at 10X higher levels than allowed in EU. Also in November, independent testing by consumer group Food Democracy Now found glyphosate in Cheerios, oatmeal cookies, Ritz crackers and other popular brands at high levels.
Pesticides in Our Food: Where’s the Safety Data?
USDA data from 2016 shows detectable pesticide levels in 85% of more than 10,000 foods sampled, everything from mushrooms to grapes to green beans. The government says there are little to no health risks, but some scientists say there is little to no data to back up that claim. See “Chemicals on our food: When “safe” may not really be safe: Scientific scrutiny of pesticide residue in food grows; regulatory protections questioned,” by Carey Gillam (11/2018).
- Landmark Lawsuit Claims Monsanto Hid Cancer Danger of Weedkiller for Decades, by Carey Gillam in The Guardian
- First Monsanto Roundup Cancer Trial Jury Selection, Carey Gillam’s blog
By Carey Gillam
Let the battle begin. Opening statements are slated for Monday in the landmark legal case that for the first time puts Monsanto and its Roundup herbicide on trial over allegations that the company’s widely used weed killer can cause cancer.
Dewayne “Lee” Johnson, a San Francisco-area school groundskeeper who used a form of Roundup regularly at his job, will face off against the global seed and chemical giant in a trial expected to extend into August. Johnson hopes to persuade a jury that Monsanto, which last month became a subsidiary of Bayer AG, is to blame for the non-Hodgkin lymphoma that doctors have said leaves him only weeks or months left to live.
Hints of the courtroom drama to come unfolded over the last week of June as jury selection dragged on for days, with Monsanto claiming widespread bias among prospective jurors. A number of the members of the jury pool, Monsanto’s attorney said, revealed in jury questionnaires that they view Monsanto as “evil.” Some even said they believe the company has “killed people,” a Monsanto attorney lawyer told San Francisco Superior Court Judge Suzanne Bolanos.
Monsanto’s attorneys cited similar issues in seeking to quell media coverage of the trial, telling the judge that she should not allow news cameras to televise the events because the publicity would “create a significant safety risk” for Monsanto’s employees and attorneys who have been targeted with “multiple threats and disturbing communications,” related to the litigation. Monsanto said employees have received threatening phone calls as well as ominous postcards sent to their homes. One postcard displayed a skull and crossbones along with a photo of the recipient, Monsanto said in a court filing.
Judge Bolanos ruled that some parts of the trial will be allowed to be broadcast, including opening statements, closing arguments and the announcement of a verdict. The trial is expected to be closely followed by people around the world; the French news outlet Agence France Presse is among the contingent of media who sought permission to cover the case.
Heated debates over the safety of Roundup and the active ingredient glyphosate have spanned the globe for years. Concerns mounted after internal Monsanto documents came to light through court-ordered discovery, showing conversations among Monsanto employees about “ghost” writing certain scientific papers to help influence regulatory and public opinion about Monsanto products.
Many of those internal corporate records are expected to be a key part of Johnson’s case. Johnson’s attorneys say they have evidence that Monsanto has long known that glyphosate-based herbicides such as Roundup are carcinogenic and have hidden that information from consumers and regulators. They allege Monsanto has manipulated the scientific record and regulatory assessments of glyphosate in order to protect corporate glyphosate-related revenues. Monsanto knew of the dangers and “made conscious decisions not to redesign, warn or inform the unsuspecting public,” the Johnson lawsuit claims.
If they can convince a jury of the allegations, the lawyers say they plan to ask for potentially “hundreds of millions of dollars.”
Johnson’s lawsuit against Monsanto makes him one of roughly 4,000 plaintiffs who sued the company after the International Agency for Research on Cancer (IARC) classified glyphosate as a probable human carcinogen in March 2015. The IARC classification was based on a review of more than a decade of published, peer-reviewed scientific studies analyzing glyphosate and glyphosate-based herbicides. Johnson’s case is the first to go to trial. Another is scheduled for trial in October in St. Louis, Missouri.
Monsanto argues there is no justification for any of the claims, and asserts it has decades of regulatory findings of safety and hundreds of research studies to back its defense. “Glyphosate is the most tested herbicide in history,” Monsanto stated in its trial brief.
The company says it plans to introduce expert testimony demonstrating that the science is firmly on its side—”the entire body of epidemiology literature shows no causal association” between its glyphosate-based herbicides and non-Hodgkin lymphoma, the company states. As well, the animal testing database “is most consistent with glyphosate not being a human carcinogen,” according to Monsanto.
The company’s attorneys also plan to show that Johnson’s exposure was minimal, and notably, that development of his type of cancer—a disease called mycosis fungoides that causes lesions on the skin—takes many years to form and could not have developed in the short period between Johnson’s exposure and his diagnosis.
Monsanto’s attorneys argue in court filings that Johnson’s claims are so weak the judge should instruct the jury to provide a directed verdict in Monsanto’s favor.
But Johnson’s attorneys plan to tell jury members that Johnson began to experience a skin rash not long after being accidentally doused in a Monsanto glyphosate-based herbicide called Ranger Pro. He saw the rash—which turned to lesions and then invaded lymph nodes—worsen after he would use the chemical, which was frequently as he treated school grounds. Johnson’s attorneys plan to tell jurors that Johnson was so worried that the herbicide was to blame that he called Monsanto’s offices as well as a poison hotline number listed on the herbicide label. Monsanto employees recorded his outreach and his concerns, internal Monsanto documents show. But even after the IARC classification of glyphosate as a probable carcinogen, Monsanto did not inform him of any risk, according to evidence to be presented at the trial.
As part of their case, Johnson’s attorneys intend to present video depositions of 10 former or current Monsanto employees, and of former Environmental Protection Agency official Jess Rowland, whose relationship with Monsanto has sparked allegations of collusion and an inquiry from the EPA’s Office of Inspector General. They also will call to the stand Johnson himself, his wife, his doctors, and several scientists as expert witnesses.
The Monsanto witness list includes 11 expert witnesses who will testify both about the necessity of herbicides, including glyphosate-based herbicides; certain scientific literature; the plaintiff’s type of cancer and potential causes; and other evidence that Monsanto says discredits Johnson’s claims.
Johnson’s attorneys will start the opening statements on Monday, and have projected that initial explanation of their case to the jury will take roughly 1-1/2 hours. Monsanto’s attorneys have told the court they expect their opening statements to take roughly 1-1/4 hours.
This story originally appeared in EcoWatch.
By Carey Gillam
My friend died from cancer today.
His was a short, eight-month-long battle for survival, but it was a brutal one. Now his wife and young children are not planning for Christmas; instead they are planning his funeral.
This man’s passing is a tragedy for his family and friends to be sure. But it also serves as a sad reminder of the tight grip cancer has taken on so many lives.
Approximately 39 percent of men and women living in the United States are expected to be diagnosed with cancer at some point 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. Cancer is the second-leading cause of death in the United States.
One of the sinister twists to this creeping killer is that while we know the myriad types of cancers are caused by mutations to the DNA within cells, pinpointing exactly what agent or actions triggered the deadly DNA changes that led to a specific cancer in a specific individual is not easy.
Researchers say there are an array of causes for cancer, including an unhealthy diet, obesity and alcohol intake. Researchers also point to what they call “environmental pollutants” ― substances such asbestos, arsenic, benzene, chromium and, notably, the pesticides that have become pervasive in our lives in recent decades and are used by farmers in food production.
Data from our Food and Drug Administration (FDA) and U.S. Department of Agriculture (USDA) show that foods we eat on a regular basis contain residues of hundreds of different pesticides, tiny invisible traces of insecticides and weed killers in thousands of commonly consumed foods, including fruits and vegetables. We are also exposed to pesticides in our drinking water, and through applications made to our parks and playgrounds, lawns and gardens and schoolyards. Pesticides are also often sprayed from the air across fields and forestry.
Research suggests a possible connection between pesticides and cancers such as non-Hodgkin lymphoma, multiple myeloma, and prostate, liver, pancreatic, lung and non-melanoma skin cancers. The American Academy of Pediatrics is so concerned that it is on record voicing its concerns about pesticides and ties to childhood cancers, and has called for greater protections from exposures.
The Pesticide Action Network North America, a consumer and environmental advocacy group, says that evidence is growing ever stronger that pesticide exposure is a key contributor to what the organization calls a “cancer epidemic.”
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” has to do with addressing environmental causes, according to a 2016 report by the HHS National Toxicology Program (NTP). “An important step in primary prevention,” the NTP states, “is to identify the carcinogens.”
It is not a good sign that some members of Congress are now working to discredit and defund the International Agency for Research on Cancer (IARC), an arm of the World Health Organization specifically charged with identifying and classifying potential carcinogens. The actions by Republicans within the U.S. House of Representatives Committee on Science, Space, and Technology come after IARC angered Monsanto Co. when it declared the pesticide glyphosate, a key ingredient in Monsanto’s weed killing products, a probable carcinogen.
It is also not encouraging that President Trump nominated a pesticide safety advocate to oversee the Environmental Protection Agency’s chemical safety division. The nominee, Michael Dourson, has spent many years helping companies fight restrictions on potentially toxic chemicals. It is heartening, however, that strong opposition and outrage over Dourson’s nomination forced him to withdraw from consideration for the post on Wednesday.
Certainly, we all know someone with cancer or someone who has had it. But we cannot afford to become complacent, to accept this as normal, to allow politics to take precedence over public health. We need to work harder to support the science that identifies carcinogens, to encourage and fund research into alternatives to a toxic landscape, and to hold our regulators and lawmakers accountable for enforcing protective measures that limit our exposures to environmental pollutants.
I lost a friend to cancer today. It was just before dawn when he slipped away. A wife lost her husband of 30 years, a son and a daughter lost a father, and countless neighbors and friends lost a kind and generous soul, a man who devoted endless hours to coaching, mentoring and encouraging a community’s children alongside his own.
The losses are too great.
This article first appeared in the Huffington Post.
By Carey Gillam
CAMBRIA, Calif.- Standing on the ridge overlooking her central California farm, new widow Teri McCall sees her husband Jack nearly everywhere. There, atop the highest hill, is where the couple married in 1975- two self-described “hippies’ who knew more about how to surf than farm. And over there, surrounded by the lemon, avocado and orange trees Jack planted, sits the 800-square-foot house the young Vietnam veteran built for his bride and a family that grew to include two sons and a daughter. Solar panels Jack set up in a sun-drenched stretch of grass power the farm’s irrigation system.
And down there, clasped in the cusp of the velvet green valley sits the century-old farmhouse Jack and Teri eventually made their permanent home. Jack installed a stained glass window featuring a heart and flowers over the front door.
“Literally hundreds of times a day, something reminds me of him,” McCall says, as she and a visitor strolled through the orchards on a recent sunny spring morning. “That’s part of why it’s so hard to believe… I can never see him again.”
Anthony ‘Jack’ McCall, 69, died Dec. 26 after a painful and perplexing battle with non-Hodgkin lymphoma. The loss is certain, fixed forever into his family’s heartbreak. But questions about why and how he was stricken – a man who never smoked, stayed fit and had no history of cancer in his family – are part of what some legal experts see as a potential landmark legal claim against one of the world’s largest agrichemical companies, Monsanto Co.
McCall shunned pesticide use on his farm, except for the herbicide called Roundup – marketed by Monsanto as having extremely low toxicity. He used Roundup regularly, spraying it himself around the farm to drive back worrisome weeds. He even recommended Roundup to friends, telling them it was supposed to be much safer than alternatives on the market, and touting its effectiveness.
But now in his death, McCall is one of several plaintiffs in more than a dozen lawsuits that claim the active ingredient in Roundup – a chemical called glyphosate – gave them cancer, and that Monsanto has long known glyphosate poses “significant risks to human health, including a risk of causing cancer.”
The lawsuits, brought by plaintiffs in California, Florida, Missouri, Delaware, Hawaii,and elsewhere over the last several months, claim Monsanto has hidden evidence, and manipulated regulators and the public into believing in the safety of glyphosate, which annually brings in about $5 billion, or a third of total sales, for the agribusiness giant. Like McCall, many farmed, or worked in agricultural jobs in which they regularly were using or exposed to glyphosate.
The claims come at a critical time for Monsanto and its signature product as regulators in the United States and other countries evaluate whether or not to continue to allow glyphosate herbicides. Last year the World Health Organization’s cancer experts classified glyphosate as a probable human carcinogen. That team, the International Agency for Research on Cancer (IARC), said glyphosate shows a “positive association” for non-Hodgkin lymphoma.
The outcomes of the legal battle and the regulatory reviews could have broad implications. Glyphosate is the most widely used herbicide on the planet, sprayed on fields for row crops like corn, soybeans and wheat, as well as a variety of fruits, nuts and vegetable crops such as almonds, apples, cherries and oranges.
That ubiquitous role played by glyphosate means the litigation, plaintiffs’ lawyers say, marks the beginning of a potential wave of legal actions against Monsanto. Teams of attorneys have been criss-crossing the country lining up potential plaintiffs who they say will likely number in the hundreds and possibly thousands. It’s a time-tested practice by plaintiffs’ attorneys who have brought similar mass actions in the past against tobacco, pharmaceutical and chemical industries.
“Monsanto has deliberately concealed or suppressed information about the dangers of its product,” said environmental and chemical pollution attorney Robert F. Kennedy Jr., who is assisting in litigating glyphosate cases. “This is big. It’s on every farm in the world.”
Kennedy predicts glyphosate liability litigation will become as widespread as has been decades of litigation over asbestos, which is seen in legal circles as the longest-running mass tort action in U.S. history. Asbestos was used for years as a safe and effective flame retardant in the construction industry but has been tied to lung diseases and cancers, and spawned hundreds of millions of dollars in legal claims.
The glyphosate litigation partly mirrors courtroom battles Monsanto has been fighting for years involving the polychlorinated biphenyls, or PCBs it once manufactured. Plaintiffs in those cases also claim PCBs caused them to fall ill while Monsanto hid the risks. Monsanto claims plaintiffs cannot definitively link illnesses to PCB exposure.
AMONG THE SAFEST OPTIONS
Patented by Monsanto and commercialized in 1974, glyphosate herbicide has long been considered among the safest pesticide options on the market. The weed-killer came off patent in 2000 and is now used in more than 700 products around the world, beloved by farmers, homeowners, and groundskeepers. The chemical is the world’s most widely used herbicide with an estimated 1.8 billion pounds applied in 2014, up 12-fold from 1994, according to recently published research.
But as use has grown, concerns about safety have also mounted. Residues have been documented by public and private researchers in waterways, air, food and in human bodily fluids. Several scientific studies tied the chemical to cancers and other health problems before the March 2015 classification by IARC.
Lawyers for plaintiffs in the glyphosate cases say that among the evidence that glyphosate’s toxicity has long been known is an EPA memo detailing how glyphosate was classified by agency scientists as a possible human carcinogen in 1985 before classified in 1991 as a having “evidence of non-carcinogenicity” for humans. The classification was changed despite the fact that some peer review members did not concur. The lawsuits also cite evidence of fraud at laboratories used by Monsanto to perform toxicology studies of glyphosate, and point to fraud convictions of executives at those labs.
St. Louis-based Monsanto, a global agrichemical and seed powerhouse, cites its own evidence to counter both the validity of the allegations in the lawsuits, as well as the IARC findings. Last year, the company hired a team of experts to review the safety of glyphosate, and said that team found no cancer links.
“Comprehensive long-term toxicological studies repeated over the last 30 years have time and again demonstrated that glyphosate is unlikely to pose a cancer risk in humans,” Monsanto states on its website. ‘Regulatory authorities and independent experts around the world have reviewed numerous long-term/carcinogenicity and genotoxicity studies and agree that there is no evidence that glyphosate… causes cancer, even at very high doses.”
Monsanto attorneys have been seeking to dismiss and/or delay several cases thus far filed, asserting that federal law and approvals by the Environmental Protection Agency for labels on Roundup herbicide products protect Monsanto from the claims in the lawsuits. In recent arguments in U.S. District Court in Northern California, for example, lawyers for Monsanto argued that “EPA repeatedly has concluded that glyphosate is not a carcinogen.” But in April a federal judge in California ruled that Monsanto was not protected from liability by the EPA registration and approved labels.
In a Missouri case that Monsanto also was unable to get dismissed, discovery is starting, and plaintiffs’ lawyers are eagerly awaiting what they hope will be a treasure trove of evidence for their clients.
The legal claims come at the same time that European and U.S. regulators are conducting their own assessments of the safety of glyphosate and considering restrictions, processes that have become fraught with infighting and accusations of bias from both fans and foes of glyphosate. The European Food Safety Authority (EFSA) said in November that evidence shows glyphosate is unlikely to be carcinogenic. But the European Parliament has said the herbicide use should be reined in with a ban on non-professional use and around parks and playgrounds because of the health worries.
The EPA was due to release a fresh risk assessment on glyphosate nearly a year ago, but has stalled the process amid the uproar. And in an odd twist to the saga, on April 29, the agency posted an internal document to its website, showing that the EPA’s cancer assessment experts have determined that glyphosate is “Not Likely to be Carcinogenic to Humans.”
On May 2, EPA withdrew the memo from its website and said it was not supposed to have been released because the cancer assessment is ongoing. But Monsanto heralded the release of the document as proof of what it has been saying about glyphosate’s safety.
Wall Street is keeping a wary eye on the litigation. But generally market watchers care less about Monsanto’s risk from potential liability payouts and more about any potential long-term revenue hit if regulators were to restrict or ban glyphosate, said Piper Jaffray analyst Brett Wong, who tracks Monsanto’s business strategies and financial health. The courtroom battles could influence regulators, he said.
“There are obviously a lot of lawsuits,” Wong said. “They aren’t intrinsic to impacting their business but there is always some sentiment pressure on investors. If it were to impact the regulatory structure and glyphosate was banned… that could obviously have an impact.”
Legal experts with experience defending the chemical industry are watching the cases with interest, and many say given a lack of regulatory support for the cancer linkage, plaintiffs’ attorneys have an uphill climb to make such claims stick.
“The evidence to support the claims isn’t there, said one prominent lawyer, declining to be quoted by name. “It’s not mothers’ milk by any means. I wouldn’t mix it in my drink, but it’s one of the safest chemicals out there,” he said.
Attorney Brent Wisner, who is representing the McCall family, said he is confident in the strength of the evidence against Monsanto. “It’s going to be a fairly large litigation when it’s all said and done. We’re confident we’ll be able to show that Monsanto controlled research and suppressed science,” he said.
Back in Cambria, Jack McCall’s son Paul McCall is running the farm in his father’s place. His eyes tear quickly when asked about his father’s diagnosis in September 2015 and death only three months later, the day after Christmas. He doesn’t want to talk about the lawsuit, other than to say he has no use for glyphosate now, and wants to warn others away from it.
“This is a battle that has to be fought,” he said.
How big and how bloody the litigation becomes is still an open question. The shouting from both sides of the issues is getting louder with each passing day. But the deep questions about the safety of this herbicide deserve serious and scientific review as the answers hold implications for our food production, our environment and the health of our families well into the future.
This article originally appeared in Huffington Post.
Carey Gillam is a veteran former Reuters journalist, current freelance writer/editor and research director for U.S. Right to Know, a food industry research group