cancer

Glyphosate: Cancer and Other Health Concerns

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Posted on by Carey Gillam

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. 

Why is Bayer taking glyphosate off the U.S. consumer market?

In July 2021, Monsanto owner Bayer AG said it would remove glyphosate-based herbicides from the U.S. consumer market by 2023 due to litigation. More than 100,000 people are suing Bayer alleging they developed non-Hodgkin lymphoma from exposure to the company’s glyphosate herbicides, such as Roundup. For more information about the lawsuits and documents released via discovery, see our Monsanto Papers page. 

How much glyphosate is used around the world? 

According to a February 2016 study, glyphosate is the most widely used pesticide: “In the U.S., no pesticide has come remotely close to such intensive and widespread use.” Findings include:

  • Americans applied 1.8 million tons of glyphosate (or 1.6 billion kilograms) from its introduction in 1974 to 2014. 
  • Worldwide 9.5 million tons (or 8.6 billion kilograms) 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. 

In the U.S., approximately 281 million pounds of glyphosate were applied to 298 million acres annually, on average, from 2012 to 2016, according to the Environmental Protection Agency. Most glyphosate was applied to soybean (117.4 million pounds applied annually), corn (94.9 million pounds annually), and cotton (20 million pounds annually). Many citrus fruits, including grapefruit, oranges and lemons, and field crops such as soybeans, corn and cotton have  high percentages of their acres treated with glyphosate.

Approximately 24 million pounds of glyphosate are applied to non-agricultural sites annually, according to EPA.  The majority of non-agricultural use is in the homeowner market. About 5 million pounds is applied annually for residential use.

What do scientists and health care providers say about glyphosate? 

Many scientists, health care professionals and public interest groups have raised concern about the health impacts of glyphosate. Here are some key statements: 

Monsanto owner Bayer AG maintains that glyphosate and glyphosate-based herbicides are safe when used as directed and do not cause cancer.  “Glyphosate is one of the most studied herbicides in the world – and, like all crop protection products, it is subject to rigorous testing and oversight by regulatory authorities,” Bayer states on its website. “There is an extensive body of research on glyphosate and glyphosate-based herbicides…  that confirm that glyphosate and our glyphosate-based formulated products can be used safely and do not cause cancer.”  

How much glyphosate is in our bodies? 

More than 80% of urine samples drawn from children and adults in a U.S. health study contained glyphosate, according to data from the U.S. Centers for Disease Control and Prevention. Out of 2,310 urine samples taken from Americans intended to be representative of the population, CDC found that 1,885 contained detectable levels of glyphosate. Scientists described this finding as “disturbing” and “concerning.”

A 2017 study in JAMA found that Americans’ exposure to glyphosate increased approximately 500 percent since Roundup Ready GMO crops were introduced in the U.S in 1996. 

While it is clear that most Americans are being exposed to glyphosate, the literature on glyphosate exposure levels, especially in children, remains limited, according to a 2020 paper in Environmental Health.  “Without more data collected in a standardized way, parsing out the potential relationship between glyphosate exposure and disease will not be possible,” the researchers concluded.

Why are corporate studies a problem? 

Regulators in Europe and the United States, Canada and elsewhere have repeatedly affirmed the corporate assertions of glyphosate safety. In making determinations about safety, these regulators have relied in part on tests that are conducted by or for the companies that have not been published or peer reviewed.  

The corporate studies have long been kept secret, even by regulators. But in Europe, litigation by a group of European Parliament lawmakers led to the release of dozens of such studies. More than 50 of those corporate studies were analyzed in 2021 by two independent scientists – Armen Nersesyan and Siegfried Knasmueller, both from the Institute of Cancer Research, Department of Medicine at the Medical University of Vienna.

The goal of the analysis was to determine if the industry studies examined comply with current international guidelines for chemical testing. 

The resulting analysis was released July 2, 2021 and concluded that the bulk of the industry studies were outdated and did not meet current guidelines. An array of shortcomings and flaws were found in the studies, rendering most of them unreliable, according to the analysis.

In fact, of the 53 studies submitted to regulators by the companies, only two were acceptable under current internationally recognized scientific standards, said Knasmueller. See more details here. 

What do scientific and regulatory agencies say about glyphosate and cancer?

The scientific literature and regulatory conclusions regarding cancer links to 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.

U.S. agencies: 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 December 2016, the EPA convened a Scientific Advisory Panel to review the report; 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 EPA’s Office of Pesticide Programs had not followed proper protocols in its evaluation of glyphosate, and 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. In April 2019, the EPA reaffirmed its position that glyphosate poses no risk to public health. But earlier that same month, the U.S. Agency for Toxic Substances and Disease Registry (ATSDR) reported that there are links between glyphosate and cancer. According to the draft report from ATSDR, “numerous studies reported risk ratios greater than one for associations between glyphosate exposure and risk of non-Hodgkin’s lymphoma or multiple myeloma.” The report was finalized in August 2020. 

The EPA issued an Interim Registration Review Decision in January 2020 with updated information about its position on glyphosate, continuing to hold the position that glyphosate is unlikely to cause cancer. In June 2022, the Ninth Circuit Court of Appeals rejected EPA’s decision that glyphosate likely poses no “unreasonable risk” to the environment and human health. EPA withdrew its interim decision in September 2022 and the agency will start over in its review. 

European Union: The European Food Safety Authority and the European Chemicals Agency have said glyphosate is not likely to be carcinogenic to humans. 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. A 2019 study found that Germany’s Federal Institute for Risk Assessment report on glyphosate, which found no cancer risk, included sections of text that had been plagiarized from Monsanto studies.  In February 2020, reports surfaced that 24 scientific studies submitted to the German regulators to prove the safety of glyphosate came from a large German laboratory that has been accused of fraud and other wrongdoing.

In June 2021, the European Union’s (EU) Assessment Group on Glyphosate (AGG) issued an 11,000-page draft report concluding that glyphosate is safe when used as directed and does not cause cancer. The finding is based in part on a dossier of roughly 1,500 studies submitted to European regulators by the “Glyphosate Renewal Group (GRG),” a collection of companies that includes Monsanto owner Bayer AG. The companies are seeking the renewal of the EU authorization of glyphosate. Current authorization in Europe expires in December 2022. The companies say they also gave regulators a “literature review” of around 12,000 published scientific articles on glyphosate.

WHO/FAO Joint Meeting on Pesticide Residues determined in 2016 that glyphosate was unlikely to pose a carcinogenic risk to humans from exposure through the diet, but this finding was tarnished by conflict of interest concerns after it came to light that the chair and co-chair of the group also held leadership positions with the International Life Sciences Institute, a group funded in part by Monsanto and one of its lobbying organizations.

California OEHHA: On March 28, 2017, the California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment confirmed 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, a U.S. District Court 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.

Agricultural Health Study: 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, but the researchers reported 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.

What health problems are linked to glyphosate exposure? 

Cancer

Endocrine disruption, fertility and reproductive concerns 

Kidney disease 

The American Association for the Advancement of Science awarded two Sri Lankan scientists, Drs. Channa Jayasumana and Sarath Gunatilake, the 2019 Award for Scientific Freedom and Responsibility for their work to “investigate a possible connection between glyphosate and chronic kidney disease under challenging circumstances.” The scientists reported that glyphosate plays a key role in transporting heavy metals to the kidneys of those drinking contaminated water, leading to high rates of chronic kidney disease in farming communities.  

The AAAS award to the scientists had been suspended amidst a fierce opposition campaign by pesticide industry allies to undermine the work of the scientists. After a review, the AAAS reinstated the award.

Liver disease 

  • 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.

Microbiome disruption

  • November 2020 paper in the Journal of Hazardous Materials reports that approximately 54 percent of species in the core of the human gut microbiome are “potentially sensitive” to glyphosate. With a “large proportion” of bacteria in the gut microbiome susceptible to glyphosate, the intake of glyphosate “may severely affect the composition of the human gut microbiome,” the authors said in their paper. 
  • A 2020 literature review of glyphosate’s effects on the gut microbiome concludes that, “glyphosate residues on food could cause dysbiosis, given that opportunistic pathogens are more resistant to glyphosate compared to commensal bacteria.” The paper continues, “Glyphosate may be a critical environmental trigger in the etiology of several disease states associated with dysbiosis, including celiac disease, inflammatory bowel disease and irritable bowel syndrome. Glyphosate exposure may also have consequences for mental health, including anxiety and depression, through alterations in the gut microbiome.”
  • 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.

Neurotoxicity

  • A large nationwide study published in the journal NeuroToxicology (December 2021) reports that “several neurotoxic pesticide exposures estimated using residential location were associated with statistically significant increased risk of ALS (amyotrophic lateral sclerosis). These include the herbicides 2,4-D and glyphosate, and the insecticides carbaryl and chlorpyrifos.” ALS is a progressive nervous system disease that affects nerve cells in the brain and spinal cord, causing loss of muscle control. 

What are the environmental impacts of glyphosate?

Harm to bees and monarch butterflies

Why are people suing Bayer over glyphosate?

More than 100,000 people have filed suit against Monsanto Company (now Bayer) alleging that exposure to Roundup herbicide caused them or their loved ones to develop non-Hodgkin lymphoma (NHL), and that Monsanto covered up the risks. As part of the discovery process, Monsanto has had to turn over millions of pages of internal records. We are posting these Monsanto Papers as they become available. The first three trials ended in large awards to plaintiffs for liability and damages, with juries ruling that Monsanto’s weed killer was a substantial contributing factor in causing them to develop NHL. Bayer is appealing the rulings. The U.S. Supreme Court has so far upheld the rulings against Bayer. 

Monsanto influence in research

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. 

More information about scientific interference

Why is desiccation of wheat and other crops a problem?

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.

How much glyphosate is in our food? 

Despite having annual pesticide residue testing programs for more than 30 years, the USDA U.S. FDA mostly skipped testing food for glyphosate until after criticism from the Government Accountability Office in 2014. The USDA said it would start testing but then dropped the plan in 2017. Internal government documents obtained by U.S. Right to Know show USDA 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. FDA 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. The FDA did later resume limited testing. 

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:

What mixtures of glyphosate and other pesticides are in our food? 

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.”

In 2020, a group of FDA scientists published a research paper  examining pesticide residue data collected from 2009-2017. The scientists said this: “In this study, results for over 56,000 human food samples collected and analyzed under the FDA pesticide residue monitoring program between fiscal years (FY) 2009 to 2017 were reviewed to identify trends not apparent in annual reports. The overwhelming majority of these samples, 98.0% of domestic and 90.9% of import human foods, were compliant with federal standards. Although herbicides may be more widely used, the 10 most frequently detected residues were insecticides and fungicides. On a yearly basis, the violation rate for imported samples is 3-5 times higher than the rate for domestic samples. The import violation rate increased over time, as did the number of residues detected. Targeted sampling of foods with higher commodity-specific violation rates appears to be a major contributor to the increased violation rate. Mismatches between US tolerances and international MRLs can lead to violations; this was especially marked for rice. Overall, the majority of violations are due to residues of pesticides not authorized for use in the US (lack of tolerances). While DDT continues to persist in the environment and was found in 2.2% of domestic samples and 0.6% of imported samples, 42.3% of DDT-positive samples were below the limit of quantitation. The trends and analyses identified in this paper may help FDA plan future sampling and continue to protect the food supply.”

Monsanto owner Bayer AG maintains that residues of glyphosate in food are not harmful at levels approved by the Environmental Protection Agency.  A 2021 paper written by longtime Bayer (former Monsanto) scientist John Vicini and published in Comprehensive Reviews in Food Science and Food Safety states that  “dietary exposures to glyphosate are within established safe limits.” 

For a complete history of the use of glyphosate, including regulatory action and inaction, scientific controversies, human and environmental impact data, read Whitewash – The Story of a Weed Killer, Cancer and the Corruption of Science, winner of the 2018 Rachel Carson Book Award from the Society of Environmental Journalists.

This fact sheet was updated July 13, 2022 by USRTK staff

Aspartame: Decades of Science Point to Serious Health Risks

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Posted on by Stacy Malkan

Long History of Concerns
Key Scientific Studies on Aspartame
Industry PR Efforts
Scientific References

Key Facts About Diet Soda Chemical 

What is Aspartame?

  • Aspartame is the world’s most widely used artificial sweetener. It is also marketed as NutraSweet, Equal, Sugar Twin and AminoSweet.
  • Aspartame is present in more than 6,000 products, including Diet Coke and Diet Pepsi, Kool Aid, Crystal Light, Tango and other artificially sweetened drinks; sugar-free Jell-O products; Trident, Dentyne and most other brands of sugar-free gum; sugar-free hard candies; low- or no-sugar sweet condiments such as ketchups and dressings; children’s medicines, vitamins and cough drops.
  • Aspartame is a synthetic chemical composed of the amino acids phenylalanine and aspartic acid, with a methyl ester. When consumed, the methyl ester breaks down into methanol, which may be converted into formaldehyde.

Decades of Studies Raise Concerns about Aspartame

Since aspartame was first approved in 1974, both FDA scientists and independent scientists have raised concerns about possible health effects and shortcomings in the science submitted to the FDA by the manufacturer, G.D. Searle. (Monsanto bought Searle in 1984).

In 1987, UPI published a series of investigative articles by Gregory Gordon reporting on these concerns, including early studies linking aspartame to health problems, the poor quality of industry-funded research that led to its approval, and the revolving-door relationships between FDA officials and the food industry. Gordon’s series is an invaluable resource for anyone seeking to understand the history of aspartame/NutraSweet:

Flaws in EFSA Assessment

In a July 2019 paper in the Archives of Public Health, researchers at the University of Sussex provided a detailed analysis of the EFSA’s 2013 safety assessment of aspartame and found that the panel discounted as unreliable every one of 73 studies that indicated harm, and used far more lax criteria to accept as reliable 84% of studies that found no evidence of harm. “Given the shortcomings of EFSA’s risk assessment of aspartame, and the shortcomings of all previous official toxicological risk assessments of aspartame, it would be premature to conclude that it is acceptably safe,” the study concluded.

See EFSA’s response and a follow up by researchers Erik Paul Millstone and Elizabeth Dawson in the Archives of Public Health, Why did EFSA to reduce its ADI for aspartame or recommend its use should no longer be permitted? News coverage:

  • “World’s most popular artificial sweetener must be banned, say experts. Two food safety experts have called for the widely used artificial sweetener, aspartame, to be banned in the UK and questions why it was deemed acceptable in the first place,” New Food Magazine (11.11.2020) 
  • “‘Sales of aspartame should be suspended’: EFSA accused of bias in safety assessment,” by Katy Askew, Food Navigator (7.27.2019)

Health Effects and Key Studies  

While many studies, some of them industry sponsored, have reported no problems with aspartame, dozens of independent studies conducted over decades have linked aspartame to a long list of health problems, including:

Cancer

A large 2022 cohort study in PLOS Medicine, involving 102,865 French adults, found that artificial sweeteners — especially aspartame and acesulfame-K — were associated with increased cancer risk. Higher risks were observed for breast cancer and obesity-related cancers. “These findings provide important and novel insights for the ongoing re-evaluation of food additive sweeteners by the European Food Safety Authority and other health agencies globally,” the researchers wrote.

  • “Study suggests association between consuming artificial sweeteners and increased cancer risk,” Science Daily (3.24.2022)

Three lifespan studies conducted by the Cesare Maltoni Cancer Research Center of the Ramazzini Institute, provide consistent evidence of carcinogenicity in rodents exposed to the substance.

  • Aspartame “is a multipotential carcinogenic agent, even at a daily dose of … much less than the current acceptable daily intake,” according to a 2006 lifespan rat study in Environmental Health Perspectives.
  • A follow-up study in 2007 found significant dose-related increases in malignant tumors in some of the rats. “The results … confirm and reinforce the first experimental demonstration of [aspartame’s] multipotential carcinogenicity at a dose level close to the acceptable daily intake for humans … when life-span exposure begins during fetal life, its carcinogenic effects are increased,” the researchers wrote in Environmental Health Perspectives.
  • The results of a 2010 lifespan study “confirm that [aspartame] is a carcinogenic agent in multiple sites in rodents, and that this effect is induced in two species, rats (males and females) and mice (males),” the researchers reported in American Journal of Industrial Medicine.

A 2021 review of the Ramazzini Institute data validated the conclusions of the original RI studies. See, “Aspartame and cancer — new evidence of causation,” Environmental Health. The findings, “confirm that aspartame is a chemical carcinogen in rodents. They confirm the very worrisome finding that prenatal exposure to aspartame increases cancer risk in rodent offspring.”

Harvard researchers in 2012 reported a positive association between aspartame intake and increased risk of non-Hodgkin lymphoma and multiple myeloma in men, and for leukemia in men and women. The findings “preserve the possibility of a detrimental effect … on select cancers” but “do not permit the ruling out of chance as an explanation,” the researchers wrote in the American Journal of Clinical Nutrition.

In a 2014 commentary in American Journal of Industrial Medicine, the Maltoni Center researchers wrote that the studies submitted by G. D. Searle for market approval “do not provide adequate scientific support for [aspartame’s] safety. In contrast, recent results of life-span carcinogenicity bioassays on rats and mice published in peer-reviewed journals, and a prospective epidemiological study, provide consistent evidence of [aspartame’s] carcinogenic potential. On the basis of the evidence of the potential carcinogenic effects … a re-evaluation of the current position of international regulatory agencies must be considered an urgent matter of public health.”

Brain Tumors

In 1996, researchers reported in the Journal of Neuropathology & Experimental Neurology on epidemiological evidence connecting the introduction of aspartame to an increase in an aggressive type of malignant brain tumors. “Compared to other environmental factors putatively linked to brain tumors, the artificial sweetener aspartame is a promising candidate to explain the recent increase in incidence and degree of malignancy of brain tumors … We conclude that there is need for reassessing the carcinogenic potential of aspartame.”

  • Neuroscientist Dr. John Olney, lead author of the study, told 60 minutes in 1996: “there has been a striking increase in the incidence of malignant brain tumors (in the three to five years following the approval of aspartame) … there is enough basis to suspect aspartame that it needs to be reassessed. FDA needs to reassess it, and this time around, FDA should do it right.”

Early studies on aspartame in the 1970s found evidence of brain tumors in laboratory animals, but those studies were not followed up.

Cardiovascular Disease 

A 2017 meta-analysis of research on artificial sweeteners, published in the Canadian Medical Association Journal, found no clear evidence of weight loss benefits for artificial sweeteners in randomized clinical trials, and reported that cohort studies associate artificial sweeteners with “increases in weight and waist circumference, and higher incidence of obesity, hypertension, metabolic syndrome, type 2 diabetes and cardiovascular events.” See also:

  • “Artificial sweeteners don’t help with weight loss and may lead to gained pounds,” by Catherine Caruso, STAT (7.17.2017)
  • “Why one cardiologist has drunk his last diet soda,” by Harlan Krumholz, Wall Street Journal (9.14.2017)
  • “This cardiologist wants his family to cut back on diet soda. Should yours, too?” by David Becker, M.D., Philly Inquirer (9.12.2017)

 A 2016 paper in Physiology & Behavior reported, “there is a striking congruence between results from animal research and a number of large-scale, long-term observational studies in humans, in finding significantly increased weight gain, adiposity, incidence of obesity, cardiometabolic risk, and even total mortality among individuals with chronic, daily exposure to low-calorie sweeteners – and these results are troubling.”

Women who consumed more than two diet drinks per day “had a higher risk of [cardiovascular disease] events … [cardiovascular disease] mortality … and overall mortality,” according to a 2014 study from the Women’s Health Initiative published in the Journal of General Internal Medicine.

Stroke, Dementia and Alzheimer’s Disease

People drinking diet soda daily were almost three times as likely to develop stroke and dementia as those who consumed it weekly or less. This included a higher risk of ischemic stroke, where blood vessels in the brain become obstructed, and Alzheimer’s disease dementia, the most common form of dementia, reported a 2017 study in Stroke.

In the body, the methyl ester in aspartame metabolizes into methanol and then it may be converted to formaldehyde, which has been linked to Alzheimer’s disease. A two-part study published in 2014 in the Journal of Alzheimer’s Disease linked chronic methanol exposure to memory loss and Alzheimer’s Disease symptoms in mice and monkeys.

  • “[M]ethanol-fed mice presented with partial AD-like symptoms … These findings add to a growing body of evidence that links formaldehyde to [Alzheimer’s disease] pathology.” (Part 1)
  • “[M]ethanol feeding caused long-lasting and persistent pathological changes that were related to [Alzheimer’s disease] … these findings support a growing body of evidence that links methanol and its metabolite formaldehyde to [Alzheimer’s disease] pathology.” (Part 2)

Seizures

“Aspartame appears to exacerbate the amount of EEG spike wave in children with absence seizures. Further studies are needed to establish if this effect occurs at lower doses and in other seizure types,” according to a 1992 study in Neurology.

Aspartame “has seizure-promoting activity in animal models that are widely used to identify compounds affecting … seizure incidence,” according to a 1987 study in Environmental Health Perspectives.

Very high aspartame doses “might also affect the likelihood of seizures in symptomless but susceptible people,” according to a 1985 study in The Lancet. The study describes three previously healthy adults who had grand mal seizures during periods when they were consuming high doses of aspartame.

Neurotoxicity, Brain Damage and Mood Disorders

Aspartame has been linked to behavioral and cognitive problems including learning problems, headache, seizure, migraines, irritable moods, anxiety, depression, and insomnia, wrote the researchers of a 2017 study in Nutritional Neuroscience. “Aspartame consumption needs to be approached with caution due to the possible effects on neurobehavioral health.”

“Oral aspartame significantly altered behavior, anti-oxidant status and morphology of the hippocampus in mice; also, it may probably trigger hippocampal adult neurogenesis,” reported a 2016 study in Neurobiology of Learning and Memory.

“Previously, it has been reported that consumption of aspartame could cause neurological and behavioural disturbances in sensitive individuals. Headaches, insomnia and seizures are also some of the neurological effects that have been encountered,” according to a 2008 study in the European Journal of Clinical Nutrition. “[W]e propose that excessive aspartame ingestion might be involved in the pathogenesis of certain mental disorders … and also in compromised learning and emotional functioning.” 

“(N)eurological symptoms, including learning and memory processes, may be related to the high or toxic concentrations of the sweetener [aspartame] metabolites,” states a 2006 study in Pharmacological Research.

Aspartame “could impair memory retention and damage hypothalamic neurons in adult mice,” according to a 2000 mice study published in Toxicology Letters.

“(I)ndividuals with mood disorders are particularly sensitive to this artificial sweetener and its use in this population should be discouraged,” according to a 1993 study in the Journal of Biological Psychiatry.

High doses of aspartame “can generate major neurochemical changes in rats,” reported a 1984 study in American Journal of Clinical Nutrition.

Experiments indicated brain damage in infant mice following oral intake of aspartate, and showing that “aspartate [is] toxic to the infant mouse at relatively low levels of oral intake,” reported a 1970 study in Nature.

Headaches and Migraines

“Aspartame, a popular dietetic sweetener, may provoke headache in some susceptible individuals. Herein, we describe three cases of young women with migraine who reported their headaches could be provoked by chewing sugarless gum containing aspartame,” according to a 1997 paper in Headache Journal.

A crossover trial comparing aspartame and a placebo published in 1994 in Neurology, “provides evidence that, among individuals with self-reported headaches after ingestion of aspartame, a subset of this group report more headaches when tested under controlled conditions. It appears that some people are particularly susceptible to headaches caused by aspartame and may want to limit their consumption.”

A survey of 171 patients at the Montefiore Medical Center Headache Unit found that patients with migraine “reported aspartame as a precipitant three times more often than those having other types of headache … We conclude aspartame may be an important dietary trigger of headache in some people,” 1989 study in Headache Journal.

A crossover trial comparing aspartame and a placebo on the frequency and intensity of migraines “indicated that the ingestion of aspartame by migraineurs caused a significant increase in headache frequency for some subjects,” reported a 1988 study in Headache Journal.

Kidney Function Decline

Consumption of more than two servings a day of artificially sweetened soda “is associated with a 2-fold increased odds for kidney function decline in women,” according to a 2011 study in the Clinical Journal of American Society of Nephrology.

Weight Gain, Increased Appetite and Obesity Related Problems

Several studies link aspartame to weight gain, increased appetite, diabetes, metabolic derangement and obesity-related diseases. See our fact sheet: Diet Soda Chemical Tied to Weight Gain.

This science linking aspartame to weight gain and obesity-related diseases raises questions about the legality of marketing aspartame-containing products as “diet” or weight loss aids. In 2015, USRTK petitioned the Federal Trade Commission and FDA to investigate the marketing and advertising practices of “diet” products that contain a chemical linked to weight gain. See related news coverage, response from FTC, and response from FDA.

Diabetes and Metabolic Derangement

Aspartame breaks down in part into phenylalanine, which interferes with the action of an enzyme intestinal alkaline phosphatase (IAP) previously shown to prevent metabolic syndrome (a group of symptoms associated with type 2 diabetes and cardiovascular disease) according to a 2017 study in Applied Physiology, Nutrition and Metabolism. In this study, mice receiving aspartame in their drinking water gained more weight and developed other symptoms of metabolic syndrome than animals fed similar diets lacking aspartame. The study concludes, “IAP’s protective effects in regard to the metabolic syndrome may be inhibited by phenylalanine, a metabolite of aspartame, perhaps explaining the lack of expected weight loss and metabolic improvements associated with diet drinks.”

People who regularly consume artificial sweeteners are at increased risk of “excessive weight gain, metabolic syndrome, type 2 diabetes, and cardiovascular disease,” according to a 2013 Purdue review over 40 years published in Trends in Endocrinology & Metabolism.

In a study that followed 66,118 women over 14 years, both sugar-sweetened beverages and artificially sweetened beverages were associated with risk of Type 2 diabetes. “Strong positive trends in T2D risk were also observed across quartiles of consumption for both types of beverage … No association was observed for 100% fruit juice consumption,” reported the 2013 study published in American Journal of Clinical Nutrition.

Intestinal Dysbiosis, Metabolic Derangement and Obesity

A 2022 study in Frontiers in Nutrition found that maternal consumption of aspartame and stevia influences the gut microbiota of offspring. “Consumption of low-dose aspartame and stevia showed limited influence on the overall structure of cecal microbiota in dams but significantly altered cecal microbiota of their 3-week old offspring.”

Artificial sweeteners can induce glucose intolerance by altering the gut microbiota, according to a 2014 study in Nature. The researchers wrote, “our results link NAS [non-caloric artificial sweetener] consumption, dysbiosis and metabolic abnormalities, thereby calling for a reassessment of massive NAS usage … Our findings suggest that NAS may have directly contributed to enhancing the exact epidemic [obesity] that they themselves were intended to fight.”

A 2016 study in Applied Physiology Nutrition and Metabolism reported, “Aspartame intake significantly influenced the association between body mass index (BMI) and glucose tolerance… consumption of aspartame is associated with greater obesity-related impairments in glucose tolerance.”

According to a 2014 rat study in PLOS ONE, “aspartame elevated fasting glucose levels and an insulin tolerance test showed aspartame to impair insulin-stimulated glucose disposal … Fecal analysis of gut bacterial composition showed aspartame to increase total bacteria…”

 Pregnancy Abnormalities: Pre Term Birth 

According to a 2010 cohort study of 59,334 Danish pregnant women published in the American Journal of Clinical Nutrition, “There was an association between intake of artificially sweetened carbonated and noncarbonated soft drinks and an increased risk of preterm delivery.” The study concluded, “Daily intake of artificially sweetened soft drinks may increase the risk of preterm delivery.”

  • See also: “Downing Diet Soda Tied to Premature Birth,” by Anne Harding, Reuters (7.23.2010)

Overweight Babies

Artificially sweetened beverage consumption during pregnancy is linked to higher body mass index for babies, according to a 2016 study in JAMA Pediatrics. “To our knowledge, we provide the first human evidence that maternal consumption of artificial sweeteners during pregnancy may influence infant BMI,” the researchers wrote.

Early Menarche

The National Heart, Lung, and Blood Institute Growth and Health Study followed 1988 girls for 10 years to examine prospective associations between consumption of caffeinated and noncaffeinated sugar- and artificially sweetened soft drinks and early menarche. “Consumption of caffeinated and artificially sweetened soft drinks was positively associated with risk of early menarche in a US cohort of African American and Caucasian girls,” concluded the study published in 2015 in Journal of American Clinical Nutrition.

Sperm Damage

“A significant decrease in sperm function of aspartame treated animals was observed when compared with the control and MTX control,” according to a 2017 study in the International Journal of Impotence Research. “… These findings demonstrate that aspartame metabolites could be a contributing factor for development of oxidative stress in the epididymal sperm.”

Liver Damage and Glutathione Depletion

A mouse study published in 2017 in Redox Biology reported, “Chronic administration of aspartame … caused liver injury as well as marked decreased hepatic levels of reduced glutathione, oxidized glutathione, γ-glutamylcysteine, and most metabolites of the trans-sulphuration pathway…”

A rat study published in 2017 in Nutrition Research found that, “Subchronic intake of soft drink or aspartame substantially induced hyperglycemia and hypertriacylglycerolemia… Several cytoarchitecture alterations were detected in the liver, including degeneration, infiltration, necrosis, and fibrosis, predominantly with aspartame. These data suggest that long-term intake of soft drink or aspartame-induced hepatic damage may be mediated by the induction of hyperglycemia, lipid accumulation, and oxidative stress with the involvement of adipocytokines.”

Caution for Vulnerable Populations

A 2016 literature review on artificial sweeteners in the Indian Journal of Pharmacology reported, “there is inconclusive evidence to support most of their uses and some recent studies even hint that these earlier established benefits … might not be true.” Susceptible populations such as pregnant and lactating women, children, diabetics, migraine, and epilepsy patients “should use these products with utmost caution.”

Industry PR Efforts and Front Groups 

From the start, G.D. Searle (later Monsanto and the NutraSweet Company) deployed aggressive PR tactics to market aspartame as a safe product. In October 1987, Gregory Gordon reported in UPI:

“The NutraSweet Co. also has paid up to $3 million a year for a 100-person public relations effort by the Chicago offices of Burson Marsteller, a former employee of the New York PR firm said. The employee said Burson Marsteller has hired numerous scientists and physicians, often at $1,000 a day, to defend the sweetener in media interviews and other public forums. Burson Marsteller declines to discuss such matters.”

Recent reporting based on internal industry documents reveals how beverage companies such as Coca-Cola also pay third party messengers, including doctors and scientists, to promote their products and shift the blame when science ties their products to serious health problems.

See reporting by Anahad O’Connor in the New York Times, Candice Choi in the Associated Press, and findings from the USRTK investigation about sugar industry propaganda and lobbying campaigns.

News articles about soda industry PR campaigns:

Overview news stories about aspartame:

USRTK Fact Sheets

Reports on Front Groups and PR Campaigns

Scientific References

Charlotte Debras, et al. “Artificial sweeteners and cancer risk: Results from the NutriNet-Santé population-based cohort study.” PLOS Medicine. Published: March 24, 2022 https://doi.org/10.1371/journal.pmed.1003950

Soffritti M, Belpoggi F, Degli Esposti D, Lambertini L, Tibaldi E, Rigano A. “First experimental demonstration of the multipotential carcinogenic effects of aspartame administered in the feed to Sprague-Dawley rats.” Environ Health Perspect. 2006 Mar;114(3):379-85. PMID: 16507461. (article)

Soffritti M, Belpoggi F, Tibaldi E, Esposti DD, Lauriola M. “Life-span exposure to low doses of aspartame beginning during prenatal life increases cancer effects in rats.” Environ Health Perspect. 2007 Sep;115(9):1293-7. PMID: 17805418. (article)

Soffritti M et al. “Aspartame administered in feed, beginning prenatally through life span, induces cancers of the liver and lung in male Swiss mice.” Am J Ind Med. 2010 Dec; 53(12):1197-206. PMID: 20886530. (abstract / article)

Schernhammer ES, Bertrand KA, Birmann BM, Sampson L, Willett WC, Feskanich D., “Consumption of artificial sweetener– and sugar-containing soda and risk of lymphoma and leukemia in men and women.” Am J Clin Nutr. 2012 Dec;96(6):1419-28. PMID: 23097267. (abstract / article)

Soffritti M1, Padovani M, Tibaldi E, Falcioni L, Manservisi F, Belpoggi F., “The carcinogenic effects of aspartame: The urgent need for regulatory re-evaluation.” Am J Ind Med. 2014 Apr;57(4):383-97. doi: 10.1002/ajim.22296. Epub 2014 Jan 16. (abstract / article)

Olney JW, Farber NB, Spitznagel E, Robins LN. “Increasing brain tumor rates: is there a link to aspartame?” J Neuropathol Exp Neurol. 1996 Nov;55(11):1115-23. PMID: 8939194. (abstract)

Azad, Meghan B., et al. “Nonnutritive sweeteners and cardiometabolic health: a systematic review and meta-analysis of randomized controlled trials and prospective cohort studies.” CMAJ July 17, 2017 vol. 189 no. 28 doi: 10.1503/cmaj.161390 (abstract / article)

Fowler SP. Low-calorie sweetener use and energy balance: Results from experimental studies in animals, and large-scale prospective studies in humans. Physiol Behav. 2016 Oct 1;164(Pt B):517-23. doi: 10.1016/j.physbeh.2016.04.047. Epub 2016 Apr 26. (abstract)

Vyas A et al. “Diet Drink Consumption And The Risk of Cardiovascular Events: A Report from The Women’s Health Initiative.” J Gen Intern Med. 2015 Apr;30(4):462-8. doi: 10.1007/s11606-014-3098-0. Epub 2014 Dec 17. (abstract / article)

Matthew P. Pase, PhD; Jayandra J. Himali, PhD; Alexa S. Beiser, PhD; Hugo J. Aparicio, MD; Claudia L. Satizabal, PhD; Ramachandran S. Vasan, MD; Sudha Seshadri, MD; Paul F. Jacques, DSc. “Sugar and Artificially Sweetened Beverages and the Risks of Incident Stroke and Dementia. A Prospective Cohort Study.” Stroke. 2017 April; STROKEAHA.116.016027 (abstract / article)

Yang M et al. “Alzheimer’s Disease and Methanol Toxicity (Part 1): Chronic Methanol Feeding Led to Memory Impairments and Tau Hyperphosphorylation in Mice.” J Alzheimers Dis. 2014 Apr 30. (abstract)

Yang M et al. “Alzheimer’s Disease and Methanol Toxicity (Part 2): Lessons from Four Rhesus Macaques (Macaca mulatta) Chronically Fed Methanol.” J Alzheimers Dis. 2014 Apr 30. (abstract)

Camfield PR, Camfield CS, Dooley JM, Gordon K, Jollymore S, Weaver DF. “Aspartame exacerbates EEG spike-wave discharge in children with generalized absence epilepsy: a double-blind controlled study.” Neurology. 1992 May;42(5):1000-3. PMID: 1579221. (abstract)

Maher TJ, Wurtman RJ. “Possible neurologic effects of aspartame, a widely used food additive.” Environ Health Perspect. 1987 Nov; 75:53-7. PMID: 3319565. (abstract / article)

Wurtman RJ. “Aspartame: possible effect on seizure susceptibility.” Lancet. 1985 Nov 9;2(8463):1060. PMID: 2865529. (abstract)

Choudhary AK, Lee YY. “Neurophysiological symptoms and aspartame: What is the connection?” Nutr Neurosci, 2017 Feb 15:1-11. doi: 10.1080/1028415X.2017.1288340. (abstract)

Onaolapo AY, Onaolapo OJ, Nwoha PU. “Aspartame and the hippocampus: Revealing a bi-directional, dose/time-dependent behavioural and morphological shift in mice.” Neurobiol Learn Mem. 2017 Mar;139:76-88. doi: 10.1016/j.nlm.2016.12.021. Epub 2016 Dec 31. (abstract)

Humphries P, Pretorius E, Naudé H. “Direct and indirect cellular effects of aspartame on the brain.” Eur J Clin Nutr. 2008 Apr;62(4):451-62. (abstract / article)

Tsakiris S, Giannoulia-Karantana A, Simintzi I, Schulpis KH. “The effect of aspartame metabolites on human erythrocyte membrane acetylcholinesterase activity.” Pharmacol Res. 2006 Jan;53(1):1-5. PMID: 16129618. (abstract)

Park CH et al. “Glutamate and aspartate impair memory retention and damage hypothalamic neurons in adult mice.” Toxicol Lett. 2000 May 19;115(2):117-25. PMID: 10802387. (abstract)

Walton RG, Hudak R, Green-Waite R. “Adverse reactions to aspartame: double-blind challenge in patients from a vulnerable population.” J. Biol Psychiatry. 1993 Jul 1-15;34(1-2):13-7. PMID: 8373935. (abstract / article)

Yokogoshi H, Roberts CH, Caballero B, Wurtman RJ. “Effects of aspartame and glucose administration on brain and plasma levels of large neutral amino acids and brain 5-hydroxyindoles.” Am J Clin Nutr. 1984 Jul;40(1):1-7. PMID: 6204522. (abstract)

Olney JW, Ho OL. “Brain Damage in Infant Mice Following Oral Intake of Glutamate, Aspartate or Cysteine.” Nature. 1970 Aug 8;227(5258):609-11. PMID: 5464249. (abstract)Blumenthal HJ, Vance DA. “Chewing gum headaches.” Headache. 1997 Nov-Dec; 37(10):665-6. PMID: 9439090. (abstract/article)

Van den Eeden SK, Koepsell TD, Longstreth WT Jr, van Belle G, Daling JR, McKnight B. “Aspartame ingestion and headaches: a randomized crossover trial.” Neurology. 1994 Oct;44(10):1787-93. PMID: 7936222. (abstract)

Lipton RB, Newman LC, Cohen JS, Solomon S. “Aspartame as a dietary trigger of headache.” Headache. 1989 Feb;29(2):90-2. PMID: 2708042. (abstract)

Koehler SM, Glaros A. “The effect of aspartame on migraine headache.” Headache. 1988 Feb;28(1):10-4. PMID: 3277925. (abstract)

Julie Lin and Gary C. Curhan. “Associations of Sugar and Artificially Sweetened Soda with Albuminuria and Kidney Function Decline in Women.” Clin J Am Soc Nephrol. 2011 Jan; 6(1): 160–166. (abstract / article)

Gul SS, Hamilton AR, Munoz AR, Phupitakphol T, Liu W, Hyoju SK, Economopoulos KP, Morrison S, Hu D, Zhang W, Gharedaghi MH, Huo H, Hamarneh SR, Hodin RA. “Inhibition of the gut enzyme intestinal alkaline phosphatase may explain how aspartame promotes glucose intolerance and obesity in mice.” Appl Physiol Nutr Metab. 2017 Jan;42(1):77-83. doi: 10.1139/apnm-2016-0346. Epub 2016 Nov 18. (abstract / article)

Susan E. Swithers, “Artificial sweeteners produce the counterintuitive effect of inducing metabolic derangements.” Trends Endocrinol Metab. 2013 Sep; 24(9): 431–441. (article)

Guy Fagherazzi, A Vilier, D Saes Sartorelli, M Lajous, B Balkau, F Clavel-Chapelon. “Consumption of artificially and sugar-sweetened beverages and incident type 2 diabetes in the Etude Epidémiologique auprès des femmes de la Mutuelle Générale de l’Education Nationale–European Prospective Investigation into Cancer and Nutrition cohort.” Am J Clin Nutr. 2013, Jan 30; doi: 10.3945/ ajcn.112.050997 ajcn.050997. (abstract/article)

Weilan Wang et al., “A Metagenomics Investigation of Intergenerational Effects of Non-nutritive Sweeteners on Gut Microbiome.” Front. Nutr., 14 January 2022 | https://doi.org/10.3389/fnut.2021.795848

Suez J et al. “Artificial sweeteners induce glucose intolerance by altering the gut microbiota.” Nature. 2014 Oct 9;514(7521). PMID: 25231862. (abstract / article)

Kuk JL, Brown RE. “Aspartame intake is associated with greater glucose intolerance in individuals with obesity.” Appl Physiol Nutr Metab. 2016 Jul;41(7):795-8. doi: 10.1139/apnm-2015-0675. Epub 2016 May 24. (abstract)

Palmnäs MSA, Cowan TE, Bomhof MR, Su J, Reimer RA, Vogel HJ, et al. (2014) Low-Dose Aspartame Consumption Differentially Affects Gut Microbiota-Host Metabolic Interactions in the Diet-Induced Obese Rat. PLoS ONE 9(10): e109841. (article)

Halldorsson TI, Strøm M, Petersen SB, Olsen SF. “Intake of artificially sweetened soft drinks and risk of preterm delivery: a prospective cohort study in 59,334 Danish pregnant women.” Am J Clin Nutr. 2010 Sep;92(3):626-33. PMID: 20592133. (abstract / article)

Meghan B. Azad, PhD; Atul K. Sharma, MSc, MD; Russell J. de Souza, RD, ScD; et al. “Association Between Artificially Sweetened Beverage Consumption During Pregnancy and Infant Body Mass Index.” JAMA Pediatr. 2016;170(7):662-670. (abstract)

Mueller NT, Jacobs DR Jr, MacLehose RF, Demerath EW, Kelly SP, Dreyfus JG, Pereira MA. “Consumption of caffeinated and artificially sweetened soft drinks is associated with risk of early menarche.” Am J Clin Nutr. 2015 Sep;102(3):648-54. doi: 10.3945/ajcn.114.100958. Epub 2015 Jul 15. (abstract)

Ashok I, Poornima PS, Wankhar D, Ravindran R, Sheeladevi R. “Oxidative stress evoked damages on rat sperm and attenuated antioxidant status on consumption of aspartame.” Int J Impot Res. 2017 Apr 27. doi: 10.1038/ijir.2017.17. (abstract / article)

Finamor I, Pérez S, Bressan CA, Brenner CE, Rius-Pérez S, Brittes PC, Cheiran G, Rocha MI, da Veiga M, Sastre J, Pavanato MA., “Chronic aspartame intake causes changes in the trans-sulphuration pathway, glutathione depletion and liver damage in mice.” Redox Biol. 2017 Apr;11:701-707. doi: 10.1016/j.redox.2017.01.019. Epub 2017 Feb 1. (abstract/article)

Lebda MA, Tohamy HG, El-Sayed YS. “Long-term soft drink and aspartame intake induces hepatic damage via dysregulation of adipocytokines and alteration of the lipid profile and antioxidant status.” Nutr Res. 2017 Apr 19. pii: S0271-5317(17)30096-9. doi: 10.1016/j.nutres.2017.04.002. [Epub ahead of print] (abstract)

Sharma A, Amarnath S, Thulasimani M, Ramaswamy S. “Artificial sweeteners as a sugar substitute: Are they really safe?” Indian J Pharmacol 2016;48:237-40 (article)

U.S. Supreme Court sets date to consider review of Monsanto Roundup case

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Posted on by Carey Gillam

Bayer AG’s effort to get the U.S. Supreme Court to review a key trial loss in the nationwide Roundup litigation inched forward this week when the high court said it would include Bayer’s petition for a writ of certiorari in a December 10 conference where the justices will discuss which cases to accept for review.

Bayer, which bought Monsanto in 2018, filed the petition in August, asking the court to review the Ninth Circuit Court of Appeals’ decision that affirmed the district court’s judgment in Monsanto’s 2019 trial loss to plaintiff Edwin Hardeman. The jury in the case found that exposure to Monsanto’s glyphosate-based herbicide was a cause of Hardeman’s non-Hodgkin lymphoma (NHL).

Hardeman’s attorneys presented jurors with a range of scientific research showing cancer connections to Monsanto’s herbicides as well as evidence of many Monsanto strategies aimed at suppressing the scientific information about the risks of its products. Hardeman’s attorneys argued that instead of hiding information, Monsanto should have warned consumers about the risks that its products could cause cancer.

Two key issues

Bayer maintains Monsanto’s glyphosate herbicides do not cause cancer, and it additionally argues that  the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), which governs the registration, distribution, sale, and use of pesticides in the United States, preempts “failure-to-warn” claims by Hardeman and other plaintiffs in the Roundup litigation. Because the Environmental Protection Agency (EPA) has approved labels with no cancer warning, failure-to-warn claims should be barred, the company maintains.

In addition to the FIFRA issue, the company petition filed in August urged the Supreme Court to also address whether or not the Ninth Circuit’s standard for admitting expert testimony “is inconsistent with this Court’s precedent and Federal Rule of Evidence 702.” Bayer argues that the admission of expert testimony in the Hardeman case “departed from federal standards, enabling plaintiff’s causation witnesses to provide unsupported testimony on the principal issue in the case, Roundup’s safety profile.”

In response to Bayer’s petition that the Supreme Court review the case, Hardeman’s attorneys filed a reply brief arguing the company’s request “is unworthy of review,” mischaracterizes elements of the case, and the company’s petition should be denied.

No certainty

There is no certainty the Supreme Court will agree to take up the case; nor a certainty that there will even be much discussion of the case, but if the court does decide to grant the company’s request, it would shine a national spotlight on the product liability litigation that has seen more than 100,000 plaintiffs sue over allegations Roundup herbicide causes cancer.

A favorable Supreme Court decision is widely seen as Bayer’s best hope for putting an end to the Roundup litigation, which has attracted tens of thousands of plaintiffs, all alleging they developed NHL due to exposure to Monsanto’s herbicides.

Several organizations have joined in the request for Supreme Court review of the Hardeman decision, including the industry lobbying group CropLife America, The Chamber of Commerce of the United States of America; Pharmaceutical Research and Manufacturers of America; the American Tort Reform Association; the Product Liability Advisory Council; the Washington Legal Foundation; and Lawyers for Civil Justice.

The Supreme Court typically takes fewer than 200 cases out of thousands of case review requests each year, and favors accepting cases that have national significance, or deal with conflicting decisions in lower courts and those that are seen as setting an important precedent.

California court rejects Bayer’s petition to review Pilliod Roundup trial victory

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Posted on by Carey Gillam

Bayer AG suffered yet another setback this week in the company’s ongoing effort to undo at least one of the trial losses dealt to Monsanto Co. in U.S. litigation alleging that the company’s Roundup herbicide causes cancer and Monsanto spent decades covering up the risks.

Bayer, which bought Monsanto in 2018 just as the first Roundup trial was getting underway, petitioned the California Supreme Court in September seeking a review of the case of Pilliod v. Monsanto.  The court rejected that petition for review on Wednesday.

Husband and wife Alva and Alberta Pilliod were awarded over $2 billion in 2019 after a trial in which their lawyers presented evidence that the non-Hodgkin lymphoma (NHL) suffered by both was caused by their long-term exposure to Roundup herbicide. Alberta was diagnosed with non-Hodgkin lymphoma brain cancer  in 2015, while her husband Alva was diagnosed in 2011 with non-Hodgkin lymphoma that spread from his bones to his pelvis and spine. The couple had started using Roundup in the 1970s and used it for more than 30 years.

The trial judge then lowered the jury award to $87 million.

Alberta Pilliod told US Right to Know that she and her husband were very happy to hear of the court’s rejection of Bayer’s petition, and hope to soon see their judgment paid.

“We’ve jumped through all the hoops. We’d like to get to the final score,” she said.

Alva Pilliod, 79, remains in remission, and though 77-year-old Alberta is also currently in remission she has had multiple recurrences of her cancer and has to be hospitalized frequently for health problems, she said.

The California Supreme  Court’s refusal to review the Pilliod case comes three months after the 1st Appellate District in the Court of Appeal for California rejected Monsanto’s bid to overturn the trial loss.

The appeals court ruling had scathing words for Monsanto: “We find that substantial evidence supports the jury’s verdicts,” the court stated. “Monsanto’s conduct evidenced reckless disregard of the health and safety of the multitude of unsuspecting consumers it kept in the dark. This was not an isolated incident; Monsanto’s conduct involved repeated actions over a period of many years motivated by the desire for sales and profit.”

The court also said there was substantial evidence that Monsanto acted with a “willful and conscious disregard for the safety of others,” supporting the awarding of punitive damages.

The evidence showed that Monsanto “failed to conduct adequate studies on glyphosate and Roundup, thus impeding discouraging, or distorting scientific inquiry concerning glyphosate and Roundup,” the court said.

The court specifically rejected the argument that federal law preempts such claims, an argument Bayer has told investors offers a potential path out of the litigation. Bayer has said it hopes it can get the U.S. Supreme  Court to agree with its preemption argument.

Damning evidence

Evidence laid out in the Pilliod trial and two previous trials included numerous scientific studies that showed what plaintiffs’ attorneys said was proof Monsanto’s herbicides cause NHL. As well, the attorneys presented jurors with many internal Monsanto communications obtained through court-ordered discovery that show Monsanto has intentionally manipulated the public record to hide the cancer risks.

Bayer has settled several other cases that were scheduled to go to trial over the last two years. And in 2020, the company said it would pay roughly $11 billion to settle about 100,000 existing Roundup cancer claims. This year, Bayer said it would set aside another $4.5 billion toward Roundup litigation liability.

Bayer also announced it would stop selling Roundup, and other herbicides made with the active ingredient glyphosate, to U.S. consumers by 2023. But the company continues to sell the products for use by farmers and commercial applicators.

Stephens trial drags on

Even as Bayer attempts to settle cases, it also is proceeding to trial with several. One trial that has turned into a sluggish, on-again-off-again, Zoom-based trial is the case of Donnetta Stephens v. Monsanto.

The case, in the Superior Court of San Bernardino County in California, has been held via Zoom due to concerns about the spread of Covid-19, but has been marred by numerous technical problems as well as scheduling conflicts.

The jury trial has generally only been in session 2-3 days per week after getting underway in July. The next session is set for Monday, which will be the 51st day of trial.

Stephens suffers from non-Hodgkin lymphoma she blames on her use of Roundup. Her trial is a “preference” case, meaning her case was expedited after her lawyers informed the court that Stephens was “in a perpetual state of pain” and losing cognition and memory due.

Stephens trial drags on, toxicologist testifies about studies of herbicide and cancer risk

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Posted on by Carey Gillam

A scientist testified Monday that a California woman’s regular use of Monsanto’s Roundup herbicide “vastly” exceeded the exposure scientific research shows more than doubles the risk of developing non-Hodgkin lymphoma (NHL).

William Sawyer, a toxicologist and expert witness for plaintiff Donnetta Stephens in her lawsuit against Monsanto, cited scientific research that links use of Monsanto’s glyphosate-based herbicides, including Roundup, to cancer and specifically to NHL.  Sawyer has testified in prior Roundup cancer trials, including a 2019 trial that resulted in a jury verdict of more than $2 billion for a husband-and-wife who both suffered from NHL.

The Stephens v. Monsanto trial has been underway for roughly three months, starting in late July. The proceedings have been  handled via Zoom, and multiple technical problems have at time hindered the delivery of testimony and sharing of evidence with jury members.

Jurors have heard from Stephens, her son, various cancer  experts and from some of Monsanto’s top scientists, including longtime Monsanto toxicologist Donna Farmer. Farmer now works for Bayer AG, the German pharmaceutical company that bought Monsanto in 2018.

“Perpetual” pain

Stephens’ trial is a “preference” case, meaning her case was expedited after her lawyers informed the court that Stephens was “in a perpetual state of pain” and losing cognition and memory.

The case is being tried in the Superior Court of San Bernardino County in California under the oversight of Judge Gilbert Ochoa. Stephens is one of tens of thousands of plaintiffs who filed lawsuits against Monsanto after the World Health Organization’s cancer experts classified glyphosate as a probable human carcinogen with an association to non-Hodgkin lymphoma.

Juries in the first three trials found in favor of the plaintiffs, agreeing with claims that Monsanto’s glyphosate-based weed killers, such as Roundup, cause non-Hodgkin lymphoma and Monsanto spent decades covering up the risks, and failing to warn users.

Monsanto won a recent trial involving a mother who claimed her son developed NHL because of exposure he experienced while she sprayed the weed killer.

More trouble for Bayer

Angry investors can proceed with litigation against Bayer over allegations that the company made misleading statements about its $63 billion 2018 acquisition of Monsanto, and of the extent of concerns about the company’s herbicide products.

A federal judge ruled last week that a class action led by a group of pension funds can proceed with their claims that Bayer proceeded with its purchase of Monsanto despite analyst warnings and an awareness that acquiring Monsanto brought significant risks, and assuring investors Bayer management had fully assessed those risks.

Bayer has settled several cases that were scheduled to go to trial over the last two years. And in 2020, the company said it would pay roughly $11 billion to settle a majority of the more than 100,000 existing Roundup cancer claims. The company recently said it was setting aside another $4.5 billion toward Roundup litigation liability.

Bayer also announced it would stop selling Roundup, and other herbicides made with the active ingredient glyphosate, to U.S. consumers by 2023. But the company continues to sell the products for use by farmers and commercial applicators.

2,4-D: Concerns about Cancer and Other Serious Illnesses

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Posted on by Stacy Malkan

Since its introduction in the 1940s, the herbicide 2,4-dichlorophenoxyacetic acid (2,4-D) has been widely used to control weeds in agriculture, forestry, and urban and residential settings.

According to documents obtained by public records requests, the U.S. Food and Drug Administration (FDA) forecast sharp increases in the levels of 2,4-D in American food after regulators approved new genetically modified (GMO) crops that tolerate being sprayed directly with 2,4-D. The agency said it expected use of 2,4-D “to triple” after the introduction of these GMO crops. The  U.S. Environmental Protection Agency (EPA) has also approved Dow Agroscience’s “Enlist Duo,” a mixture of glyphosate and 2,4-D for use on GMO corn, cotton and soybean seeds that Dow developed to tolerate the chemicals. 

FDA said 2,4-D use is “expected to triple” due to GMO crops 

Both glyphosate and 2,4-D have been linked to cancer and other health problems, and there is little known about the synergistic toxicity of these chemicals.

Chemical manufacturers are now seeking approval from the U.S. Department of Agriculture (USDA) for five-trait GMO maize seeds that are genetically engineered to tolerate five herbicides: 2,4-D, dicamba, glyphosate, glufosinate and quizaofop.

See our fact sheets on glyphosate and dicamba. 

What is 2,4-D?

Scientific studies link 2,4-D to certain types of cancer, birth defects, immunosuppression and other health impacts in highly exposed populations including farmers, farmworkers and farming communities. More than 1,000 products containing 2,4-D are sold in the United States. The herbicide, which will kill many broadleaf weeds but not most grasses, comes in many forms, including liquids, dusts, and granules. Use of 2,4-D is so widespread that residues have been detected in surface and groundwater sources.

2,4-D was one of two active ingredients in the “Agent Orange” herbicide formulation used during the Vietnam War, though adverse health effects associated with Agent Orange have been blamed on a separate ingredient – 2,4,5-Trichlorophenoxyacetic acid, and its contaminant, dioxin.

In 2015 the World Health Organization’s International Agency for Research on Cancer (IARC) said a review of scientific literature showed that 2,4-D is “possibly” carcinogenic to humans. IARC said that although there is “inadequate evidence in humans and limited evidence in experimental animals” of ties between 2,4-D and cancer, it based the classification on epidemiological studies that provided “strong evidence that 2,4-D induces oxidative stress … and moderate evidence that 2,4-D causes immunosuppression.”

The IARC classification contradicted a 2007 assessment by the U.S. EPA, which said scientific data did not support a link between human cancer and 2,4-D exposure. The EPA stated that 2,4-D “generally has low toxicity for humans.” However, many experts point out that U.S. regulations have not kept pace with scientific advances for understanding chemical risk. 

Is 2,4-D in our food? 

The EPA allows 2,4-D to be used in the production of fruits and vegetables and is sprayed directly on some crops used for human and animal food. The U.S. FDA has found residues of 2,4-D in food samples but asserts the pesticide traces people consume pose no health dangers. Documents obtained from the FDA through Freedom of Information Act (FOIA) requests show the government forecast sharp increases in the levels of 2,4-D in American food after regulators approved new 2,4-D tolerant crops developed by Dow AgroSciences that tolerate being sprayed directly with the herbicide. 

In March of 2017, the Center for Food Safety and five other organizations sued the EPA over its approval of Dow’s new 2,4-D herbicide, designed to be used with 2,4-D-tolerant crops. The groups alleged the regulatory agency violated its duties under the Pesticide Act and violated its duties to protect endangered species. The group said the agency’s approval of Dow’s “Enlist Duo” product, which combines glyphosate and 2,4-D, was “part of a disturbing, industry-wide trend” in which crops are genetically engineered to withstand being sprayed with multiple pesticides. “While these GE crop systems initially provide a quick-fix way to kill weeds, the intensive spraying triggers rapid evolution of weed resistance to the chemicals. Just as overuse of antibiotics breeds resistant bugs and more antibiotics to kill them, so these GE crop systems drive a toxic spiral of increasing weed resistance and pesticide use.”   

In July 2020 the U.S. Court of Appeals for the Ninth Circuit rejected the claims and ruled that Dow’s Enlist Duo could stay on the market. The court agreed with the petitioners that the EPA did not properly assess harm to the monarch butterflies associated with increased use of 2,4-D. But the court merely instructed the agency to review the risks to monarch butterflies.  

What does science say about health impacts linked to 2,4-D?

Scientific studies link 2,4-D to the following health concerns: 

Non-Hodgkin lymphoma

A systematic review and meta-analysis of studies of associations between 2,4-D and NHL [non-Hodgkin lymphoma] found “new evidence for an association between NHL and exposure to the herbicide 2,4-D… Overall, in our analysis focused on the highest exposure group from each study, we identified a statistically significant association between 2,4-D exposure and increased RRs [relative risks] of NHL.” 2,4-dichlorophenoxyacetic acid (2,4-D) and risk of non-Hodgkin lymphoma: a meta-analysis accounting for exposure levels. Annals of Epidemiology, 2017. 

Systematic review and meta-analyses of nearly three decades of epidemiological research on the relationship between non-Hodgkin lymphoma and occupational exposure to agricultural pesticides finds that “Diffuse large B-cell lymphoma was positively associated with phenoxy herbicide exposure.” Non-Hodgkin Lymphoma and Occupational Exposure to Agricultural Pesticide Chemical Groups and Active Ingredients: A Systematic Review and Meta-Analysis. International Journal of Environmental Research and Public Health, 2014.

A population-based case-control study in Italy found that “the positive association found between phenoxy herbicides exposures and NHL [non-Hodgkin lymphoma], when we restricted the analysis to the subjects who never used personal protective equipment, confirms previously reported associations…” Cancer and Pesticides: An Overview and Some Results of the Italian Multicenter Case–Control Study on Hematolymphopoietic Malignancies. Annals of the New York Academy of Sciences, 2006.

A population-based, case-control study in Nebraska found a “50% excess of NHL [non-Hodgkin lymphoma] associated with mixing or applying 2,4-D. The risk for NHL increased with the average frequency of use to more than threefold among those exposed more than 20 days per year.” A case-control study of non-Hodgkin’s lymphoma and the herbicide 2,4-dichlorophenoxyacetic acid (2,4-D) in eastern Nebraska. Epidemiology, 1990.

Birth defects 

Study of rates of adverse birth outcomes in Minnesota, Montana, North Dakota, and South Dakota found that “in rural, agricultural counties where wheat acreage occupies a larger percentage of the land and where use of chlorophenoxy herbicides is higher, anomalies of the circulatory/respiratory and musculoskeletal/integumentary system significantly increased.” Birth Malformations and Other Adverse Perinatal Outcomes in Four U.S. Wheat-Producing States. Environmental Health Perspectives, 2003.

Study of offspring of pesticide appliers in Minnesota found that “the rate of birth defects increased in…offspring born to the general population residing in high-use chlorophenoxy herbicide/fungicide regions…” Pesticide appliers, biocides, and birth defects in rural Minnesota. Environmental Health Perspectives, 1996.

Breast cancer

Case-control study of breast cancer in California farm workers found “suggestive increases” in breast cancer risk “were seen for a phenoxyacetic acid herbicide, 2,4-D, an organophosphate, malathion, and an organochlorine insecticide, chlordane, ” and that the “risk associated with chemical use was stronger in younger women, those with early-onset breast cancer, and those diagnosed earlier.” Breast Cancer Risk in Hispanic Agricultural Workers in California. International Journal of Occupational and Environmental Health, 2013. 

Gastric cancer

Nested case-control study of gastric cancer found that “Working in areas with high use of the phenoxyacetic acid herbicide 2,4-D was associated with gastric cancer…” Agricultural exposures and gastric cancer risk in Hispanic farm workers in California. Environmental Research, 2007. 

Parkinson’s disease 

Case-control study investigating the risk of parkinsonism in occupations found “Three individual compounds, the organochlorine 2,4-dichlorophenoxyacetic acid, the herbicide paraquat, and the insecticide and acaricide permethrin, were associated with more than a 3-fold increased risk of disease”. Occupation and Risk of Parkinsonism: A Multicenter Case-Control Study. Journal of the American Medical Association, 2009.

Amyotrophic lateral sclerosis 

Large nationwide study published in the journal NeuroToxicology (December 2021) reports that “several neurotoxic pesticide exposures estimated using residential location were associated with statistically significant increased risk of ALS (amyotrophic lateral sclerosis). These include the herbicides 2,4-D and glyphosate, and the insecticides carbaryl and chlorpyrifos.” ALS is a progressive nervous system disease that affects nerve cells in the brain and spinal cord, causing loss of muscle control. Pesticides applied to crops and amyotrophic lateral sclerosis risk in the U.S. NeuroToxicology, December, 2021.

Endocrine disruption/thyroid

Study of the association between pesticide use and thyroid diseases found “increased odds of hypothyroidism with ever-use of the herbicides 2,4-D, 2,4,5-T, 2,4,5-TP, alachlor, dicamba, and petroleum oil.” Hypothyroidism and pesticide use among male private pesticide applicators in the agricultural health study. Journal of Occupational and Environmental Medicine, 2013.

Sperm disorders/decreased male fertility

Study of the reproductive function of 32 male farmers exposed to 2,4-D found that “2,4-D can affect spermatogenesis in occupationally exposed farmers. The decrease of fertility in exposed subjects results from asthenospermia, necrospermia and teratospermia, frequently associated. The most important pathological aspects of the spermatogenesis of the exposed subjects are increase and permanence over time of abnormal spermatozoa.” Study of reproductive function in persons occupationally exposed to 2,4-dichlorophenoxyacetic acid (2,4-D).  Mutation Research Letters, 1991. 

Lipid/glucose metabolism/heart risk

Study on the toxicity of chlorophenoxy herbicides using linear regression found that “exposure to 2,4-D was associated with changes in biomarkers that, based on the published literature, have been linked to risk factors for acute myocardial infarction and type-2 diabetes.” Perturbation of lipids and glucose metabolism associated with previous 2,4-D exposure: a cross-sectional study of NHANES III data, 1988-1994.  Environmental Health, 2010.

Immunosuppression

Study of blood samples from farmers found that “exposure to commercial 2,4-dichlorophenoxyacetic acid (2,4-D) and 4-chloro-2-methylphenoxyacetic acid (MCPA) formulations may exert short term immunosuppressive effects.” Immunological changes among farmers exposed to phenoxy herbicides: preliminary observations. Occupational and Environmental Medicine, 1996. 

Microbiome perturbations in mice 

Study of sub-chronic low-dose 2,4-D exposure in a mouse model “revealed a distinct gut microbial community with profound changes in diverse microbial pathways including urea degradation, amino acid and carbohydrate metabolism in 2,4-D-treated mice. Moreover, the metabolomics results revealed that the metabolic profiles in treatment group were differentiated from control group in both fecal and plasma samples. Toxic effects on the host of 2,4-D at an occupationally relevant dose were observed indicated by decreased acylcarnitine levels in plasma. These findings indicated that 2,4-D can cause toxicity and substantially impact the gut microbiome in mice at occupationally relevant doses”. Subchronic low-dose 2,4-D exposure changed plasma acylcarnitine levels and induced gut microbiome perturbations in mice. Scientific Reports, 2019.

Where can I find more information about 2,4-D? 

Fact sheets about 2,4-D

Agency for Toxic Substances and Disease Registry, U.S. Department of Health and Human Services: Toxicological Profile for 2,4-Dichlorophenoxyacetic Acid (2,4-D), July 2020.

Natural Resources Defense Council: 2,4-D: The Most Dangerous Pesticide You’ve Never Heard Of.

Beyond Pesticides: Chemical Watch Factsheet 2,4-D

Pesticide Action Network: The risks of the herbicide 2,4-D

Civil Eats: Five Things to Know About 2,4-D, the “Possibly Cancer-Causing Herbicide.”

Journalism and opinion

EPA tosses aside safety data, says Dow pesticide for GMOs won’t harm people, by Patricia Callahan, Chicago Tribune. (12.8.15) “For use on its new genetically engineered corn and soybeans, Dow Chemical Co. is reviving 2,4-D, a World War II-era chemical linked to cancer and other health problems. If these crops are widely adopted, the government’s maximum-exposure projections show that U.S. children ages 1 to 12 could consume levels of 2,4-D that the World Health Organization, Russia, Australia, South Korea, Canada, Brazil and China consider unsafe.” 

Congress questions EPA about Dow’s Enlist Duo pesticide risks, by Patricia Callahan, Chicago Tribune. (2.15.16) “When the EPA approved Enlist Duo in 2014, the agency tossed aside evidence of kidney lesions in lab rats that Dow’s own scientists said were caused by 2,4-D, clearing the way for children to be exposed to levels considered for decades to be unsafe, the Tribune investigation found.”

Reps. Blumenauer, DeFazio, Other Members Call on EPA to Reevaluate Risks of Powerful Herbicide Before Reapproved, Press Release. (2.12.16) “We were concerned to learn that … EPA dismissed a key study linking 2,4-D to kidney abnormalities based on one scientist’s analysis, and in doing so, effectively gave the green light for 41 times more of the chemical to enter the America diet than was previously allowed.”

Agent Orange in Your Backyard: The Harmful Pesticide 2,4-D, by Gina Solomon, The Atlantic. (2.24.12). “Newer science shows that it’s not just a cancer problem, but that this pesticide interferes with several essential hormones, thereby increasing the risks of birth defects and neurologic damage in children. Studies in Midwest wheat-growing areas (where 2,4-D is heavily used) have shown increased rates of certain birth defects, especially in male children, and lower sperm counts in adults.”

Last year it was dicamba, this year it’s 2,4-D, by Johnathan Hettinger, Midwest Center for Investigative Reporting. (3.29.19) “A volatile weed killer linked to cancer and endocrine issues will likely be sprayed on millions more acres of soybeans and cotton across the Midwest and South starting this year. In January, China approved imports of a new genetically modified soybean variety — Enlist E3 soybeans jointly made by Corteva Agriscience, a division of DowDupont and seed company MS Technologies — that can withstand the herbicide 2,4-D.”

What to know before you spray your lawn with pesticides, by Amanda Mascarelli, The Washington Post. (7.7.14) “Researchers are learning a great deal about how vulnerable children’s brains are to pesticides during fetal and early childhood development. “These delicate developmental processes are easily disrupted by very small doses of toxic chemicals that would be virtually harmless for an adult,” said Phil Landrigan, dean for global health and a professor of pediatrics at the Mount Sinai School of Medicine in New York. 

Chemical spray damage results in record $7m negligence court payout, by Clint Jasper, ABC. (8.10.17) A grape grower in Australia was awarded $7 million in damages for losses caused by a neighbor’s negligent spraying of 2,4-D and other chemicals. “The chemical 2,4-D has been at the centre of a number of controversies, including in 2013 when it was revealed imported 2,4-D herbicides contained elevated levels of deadly dioxins.”

WHO unit finds 2,4-D herbicide ‘possibly’ causes cancer in humans, by Carey Gillam, Reuters. (6.22.15)  “IARC’s findings on 2,4-D have been awaited by environmental and consumer groups that are lobbying U.S. regulators to tightly restrict its use, as well as by farm groups and others that defend 2,4-D as an important agent in food production that does not need more restrictions.”

Chemicals on our food: When “safe” may not really be safe, by Carey Gillam, Environmental Health News. (11.27.18) “Toxicologist Linda Birnbaum, who directs the U.S. National Institute of Environmental Health Sciences (NIEHS), has also raised concerns about pesticide dangers through exposures once assumed to be safe …. Last year she called for “an overall reduction in the use of agricultural pesticides” due to multiple concerns for human health, stating that “existing US regulations have not kept pace with scientific advances showing that widely used chemicals cause serious health problems at levels previously assumed to be safe.’”

Bayer wins Roundup trial; plaintiff fails to prove exposure caused child’s disease

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Posted on by Carey Gillam

The former Monsanto Co., now owned by Bayer AG, notched its first win in the mass tort U.S. Roundup litigation on Tuesday, defeating at trial a mother who alleged her use of Roundup exposed her child to the pesticide and caused him to develop cancer.

Ezra Clark was born in May 2011 and diagnosed in 2016 with Burkitt’s lymphoma, a form of non-Hodgkin lymphoma (NHL) that has a high tendency to spread to the central nervous system, and can also involve the liver, spleen and bone marrow, according to the court filings. Ezra’s mother, Destiny Clark, is the plaintiff in the case, which was heard in Los Angeles County Superior Court. A different Roundup trial is underway in San Bernardino County Superior Court.

Ezra Clark was “directly exposed” to Roundup many times as he accompanied his mother while she sprayed Roundup to kill weeds around the property where the family lived, according to court documents. Ezra has autism and his mother said it calmed him to play outdoors while she worked in the yard, which meant he often played in areas freshly sprayed with Roundup, according to the court filings.

Fletch Trammell, lead attorney for Clark, said his case was subject to a bifurcation order that organized the case into two phases. In the first phase he was limited to presenting evidence that focused on the child’s personal exposure to Roundup and whether or not it could have been enough to have contributed to his disease. The case would have proceeded to a second phase had the plaintiff won the first phase, but the loss in the first phases ends the trial.

“This was nothing like any of the other three trials,” Trammell said.

The jury was asked to address one key question in the first phase: Whether or not the child’s exposure to  Roundup was a “substantial factor” in his development of Burkitt’s lymphoma.

In a 9 to 3 decision, the jury found that it was not.

Trammell said the jury decision was because the jury doubted the child’s exposure to Roundup could have been enough to cause cancer. The decision did not address the larger question of the alleged carcinogenicity of Roundup overall, he said.

But Bayer, which bought Monsanto in 2018 as the first Roundup trial was getting underway, said the jury’s decision was in line with scientific research showing glyphosate, the main ingredient in Roundup, is safe and does not cause cancer.

“The jury carefully considered the science applicable to this case and determined that Roundup was not the cause of his illness,” the company said in a statement.

80 hours

During the trial, Trammel presented evidence indicating Ezra was exposed to Roundup for about 80 cumulative hours over the years his mother sprayed with him at her side. He paired that with research showing there could ben an increased risk of NHL associated with repeated spraying of glyphosate herbicides, such as Roundup. And he noted language on Roundup labels in Canada that advise users to wear protective gloves and avoid getting the chemical on bare skin.

“The studies… they show that Roundup does three different things when it gets to your
lymphocyte cells…   It can kill cells, which is bad enough; but it also causes the exact DNA damage
that results in Burkitt’s lymphoma; it also, in a variety of ways, devastates your body’s ability to
repair DNA damage,” Trammell told jurors in his closing argument.

Trammell also sought to counter problems with deposition testimony given by Destiny Clark. Trammell said the mother also has suffered from cancer, a cervical cancer that metastasized to her brain. The illness and treatments she has undergone made it difficult for her to recall details and she “made a lot of mistakes” in the deposition she gave to Monsanto’s attorneys, Trammell told jurors. But she was very clear, he told jurors, on recalling her use of Roundup nearly “every weekend” when Ezra was young.

Monsanto attorney  Brian Stekloff told jurors that Ezra’s exposure was in doubt. He told jurors that while they might have sympathy for the family, they could not ignore inconsistencies in Destiny Clark’s testimony about how often her son was exposed, and could not ignore statements by other family members that they did not see her spraying around Ezra.

“And there is an old adage or old saying, and it goes like this: The truth is simple because there’s nothing to remember,” Stekloff told jurors. “When you tell the truth, you don’t mix up the facts. It’s when it didn’t happen that you can’t remember what you said the first time and the next time, and the next time, and the next time. And the inconsistencies start piling up and piling up, and the explanations start coming and piling up and piling up. And that’s what you have seen here in this trial.”

Stekloff told jurors the evidence did not support a finding that exposure to Roundup was a substantial factor in causing his cancer.

“This is not a popularity contest. This is not a referendum on Monsanto. It’s not even a referendum on Roundup,” he said in his closing argument. “Roundup did not cause Ezra Clark’s Burkitt’s lymphoma.”

Clark is one of tens of thousands of plaintiffs who filed U.S. lawsuits against Monsanto after the World Health Organization’s cancer experts in 2015 classified glyphosate – the active ingredient in Monsanto’s herbicides – as a probable human carcinogen with an association to NHL.

Monsanto lost each of the three previous trials, after lawyers for the plaintiffs presented jurors with multiple scientific studies finding potential health risks with glyphosate and Roundup  The plaintiffs lawyers also used internal Monsanto documents as evidence, arguing the so-called “Monsanto Papers” showed intentional efforts by the company to manipulate regulators and control scientific research.

The jury in the last trial ordered $2 billion in damages though the award was later shaved to $87 million.

Bayer has maintained that there is no cancer risk with the glyphosate herbicides it inherited from Monsanto, but it has agreed to pay close to $14 billion to try to settle the litigation and said it will remove glyphosate products from the U.S. consumer market by 2023. The company will continue to sell the herbicides to farmers and other commercial users.

Mike Miller, who heads the Virginia law firm that won two of the three previously held Roundup trials, i but who was not involved in the Clark case, said the verdict does not change anything about the litigation, nor Bayer’s liability.

“Nothing about that verdict change the fact: Roundup causes cancer,” he said.

See transcript of closing arguments in Clark v. Monsanto. 

Monsanto scientist tells jurors company’s side of Roundup cancer controversy

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Posted on by Carey Gillam

A senior scientist at the former Monsanto Co. on Tuesday told jurors in a California trial that regulators around the world support the company’s position that its glyphosate-based herbicides, such as the popular Roundup brand, are safe for users.

Donna Farmer, who worked as a toxicologist at Monsanto for more than two decades and now works at Monsanto owner Bayer AG, spent long hours testifying in the case of Donnetta Stephens v. Monsanto. Farmer has been a key witness in the Stephens case and was quizzed intently for days by lawyers for Stephens before Monsanto’s lawyers took up the questioning.

Stephens is one of tens of thousands of plaintiffs who filed U.S. lawsuits against Monsanto after the World Health Organization’s cancer experts in 2015 classified glyphosate – the active ingredient in Monsanto’s Roundup and other herbicides – as a probable human carcinogen with an association to non-Hodgkin lymphoma.

The Stephens case is the fourth Roundup cancer lawsuit to go to trial and the first since 2019. Stephens suffers from non-Hodgkin lymphoma she blames on her use of Roundup herbicide for more than 30 years.

A chance to explain

Monsanto lawyer Monsanto lawyer Manuel Cachan questioned Farmer about several issues that were raised earlier by plaintiffs’ attorneys, telling Farmer it was her chance to explain details about several matters that Stephens’ lawyers had presented as evidence of Monsanto wrong-doing.

One such issue involved comments Farmer wrote in a 2003 email to colleagues about the importance of distinguishing between the chemical glyphosate and the Roundup formulation, which is made with glyphosate as the active ingredient.

In the email, Farmer wrote “The terms glyphosate and Roundup cannot be used interchangeably nor can you use “Roundup” for all glyphosate-based herbicides any more. For example you cannot say that Roundup is not a carcinogen… we have not done the necessary testing on the formulation to make that statement. The testing on the formulations are not anywhere near the level of the active ingredient.”

Plaintiffs’ lawyers have pointed to that language as part of a broad argument disputing Monsanto’s contention that thorough testing of Roundup has demonstrated it does not cause cancer.

In testimony Tuesday, Farmer said that she merely was trying to be “very precise” when explaining to colleagues the distinctions between products. She was not indicating in the email that there was any question about whether or not Roundup might cause cancer, Farmer testified.

She pointed out that in that internal email she also wrote “there is no reason to believe that Roundup would cause cancer.”

And though it was true at that time that Monsanto had not conducted extensive carcinogenicity testing on Roundup formulations, that changed over time, Farmer testified.

“I think we’ve got a lot more studies on Roundup than we had, and so I think we have a lot more information about the Roundup formulations that still supports the conclusions and safety about the formulation,” Farmer told the jury.

A regulatory pass

At another point in the questioning by Monsanto’s lawyer, Farmer told jurors that regulators had never required the company to conduct animal carcinogenicity testing on Roundup. She said not only had the U.S. EPA not demanded such testing, but regulators in Canada, Europe, Australia and Japan had similarly not required any such animal testing on Roundup products.

She also told jurors that while it was true that Roundup products contain formaldehyde, it was a “very, very small amount” and posed no danger to human health. Regulators agreed there was no reason for concern, Farmer testified.

“We produce formaldehyde every day in our bodies,” said Farmer. “Small amounts of formaldehyde like in the formulations at those low levels do not present a health hazard to humans.”

Farmer’s testimony sought to rebut other points of evidence raised by Stephens’ lawyers, seeking to cast Monsanto as a responsible, science-based organization that has been the innocent target of activist-driven misinformation. Plaintiffs’ lawyers have twisted internal conversations seen in emails and other communications to confuse and mislead jurors, according to arguments by Monsanto attorneys.

Monsanto lost each of the three previous trials, after lawyers for the plaintiffs presented jurors with multiple scientific studies finding potential health risks with glyphosate and Roundup  The plaintiffs lawyers also used internal Monsanto documents as evidence, arguing they showed intentional efforts by the company to manipulate regulators and control scientific research.

Bayer, which bought Monsanto in 2018, has settled other cases that had been scheduled to go to trial. And in 2020, the company said it would pay roughly $11 billion to settle about 100,000 existing Roundup cancer claims. Bayer also recently said it would set aside another $4.5 billion toward Roundup litigation liability.

To try to quell future litigation, Bayer said it would stop selling Roundup, and other herbicides made with the active ingredient glyphosate, to U.S. consumers by 2023. But the company continues to sell the products for use by farmers and commercial applicators.

EPA exposed for hiding chemical risks, favoring corporate interests

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Posted on by Carey Gillam

The U.S. Environmental Protection Agency (EPA) has a long and well-documented history of questionable conduct when it comes to regulation of chemicals important to the profit centers for many large and powerful corporations.  Numerous examples show a pattern of agency actions that allow for the use of dangerous chemicals by consumers, farmers, groundskeepers and others despite evidence of harm.

Documents and other evidence, including information provided in public disclosures by multiple EPA scientists, reveals actions in which EPA managers have intentionally covered up risks associated with certain chemicals. According to the evidence from these EPA insiders, pressure from chemical manufacturers, chemical industry lobbyists and from certain U.S. lawmakers drives internal agency manipulations that protect corporate interests but endanger public health.

Evidence indicates the misconduct dates back decades and has occurred in administrations led by Democrats and Republican alike.

A research project sponsored by Harvard University’s Edmond J. Safra Center for Ethics said while the EPA has “many dedicated employees who truly believe in its mission,” the agency has been “corrupted by numerous routine practices,” including a “revolving door” between EPA and industry in which corporate lawyers and lobbyists gain positions of agency power; constant  industry lobbying against environmental regulations; pressure from  lawmakers who are beholden to donors; and meddling by the White House.

Most recent news

Background: Blowing the whistle

The Frank R. Lautenberg Chemical Safety for the 21 Century Act, signed into law on June 22, 2016, was the first substantive reform to Toxic Substances Control Act (TSCA). The law requires EPA to make an affirmative determination on whether a new chemical substance presents an “unreasonable risk” to human health or the environment under “known, intended or reasonably foreseen conditions of use.” See information here.

Despite the law, the EPA has failed to make valid determinations about the risk presented by numerous chemicals.

In June 2021, four EPA scientists, each working within the agency’s Office of Chemical Safety and
Pollution Prevention (OCSPP), publicly accused the the EPA of deliberate tampering with chemical risk assessments. The four whistleblowers made their complaints public through a group called Public  Employees for Environmental Responsibility (PEER).

In a June 28 letter to the U.S. House Committee on Oversight and Reform, PEER said the four EPA scientists were providing “disturbing evidence of fraud and corruption,” involving “deliberate tampering with chemical risk assessments conducted under the Toxics Substances Control Act (TSCA), including PFAS (a.k.a. “forever chemicals”), and the deletion of potential health effects without the knowledge or consent of the human health assessors.”

The letter further states:

“All four clients have experienced numerous instances where their risk assessments were changed
by their managers or by colleagues in response to direction by management. These changes
include –
● Deleting language identifying potential adverse effects, including developmental toxicity,
neurotoxicity, mutagenicity, and/or carcinogenicity;
● Major revisions that alter the report conclusions to indicate that there are no toxicity
concerns despite data to the contrary; and
● Risk assessments being reassigned to inexperienced employees in order to secure their
agreement to remove issues whose inclusion would be protective of human health.”

As a result of the manipulations, people who work with these chemicals are not receiving information they need to protect themselves, such as “proper handling procedures, personal protection needed, accidental release measures, and first aid and firefighting measures,” according to PEER.
This is a particular concern for pregnant women, according to the PEER complaint.

Erasing important information

On August 26, 2021, PEER filed a separate complaint alleging that the EPA has been breaking the law by erasing original versions of internal communications and draft documents and retaining only the final version of key documents. The practice violates the Federal Records Act by eliminating details of the decision-making process from outside review, according to PEER.

PEER states that that discarding of documents trails is not only contrary to law but also violates the EPA’s own records retention policy. According to PEER, its complaint focuses on two classes of documents:

  • Alterations of chemical risk assessments by managers in which both the identity of the manager and the alterations themselves are not apparent; and
  • Internal comments related to the development of its Waters of the United States (WOTUS) rule, in which EPA software overwrote the original and all prior versions any time there was an edit. Thus, only the “final” version was saved.

“It is as if EPA memorializes its internal decision-making in disappearing ink,” PEER Executive Director Tim Whitehouse, a former EPA enforcement attorney, said in a press release. “EPA’s record-keeping practices allow unknown officials to make changes while disguising what precisely was changed and who changed them.”

PEER said it has asked the National Archives and Records Administration to intervene to prevent the EPA from destroying more records and to adopt safeguards to prevent any recurrences.

The case of Ruth Etzel

Ruth Etzel,  former director of the EPA’s Office of Children’s Health Protection (OCHP), filed a  whistleblower complaint with the U.S. Merit Systems Protection Board contending she was subject to illegal retaliation in 2018 and 2019. Etzel said the agency retaliated against her after she complained publicly about what she said was  EPA resistance to stronger public protections against lead poisoning.

At the EPA it was Etzel’s job to determine the impacts of regulations on children. But she alleges she was improperly removed from her position after speaking out about EPA failures, and was assigned to a division where she was not allowed to work on prevention of lead poisoning.

Etzel is both a pediatrician and an epidemiologist and is recognized internationally as an expert on child health and the environment. She was named the 2021 winner of the Public Policy and Advocacy Award by the Academic Pediatric Association.

More than 120 environmental and health organizations  complained to EPA about Etzel’s removal, saying the agency was sending a “signal that children’s health is not a priority for the agency.”

Reporting on EPA’s misconduct

See here information, including news articles, regarding alleged EPA misconduct and regulatory failures:

New evidence of corruption at EPA chemicals division, by Sharon Lerner, The Intercept, September 18, 2021

EPA whistleblower testifies her advocacy for stronger health protections drew agency retaliation, by Carey Gillam, USRTK, September 13, 2021

‘The harm to children is irreparable’: Ruth Etzel speaks out ahead of EPA whistleblower hearing, Carey Gillam, The Guardian, September 12, 2021

The EPA’s rationale for banning chlorpyrifos may make it harder to eliminate other brain-harming pesticides , Sharon Lerner, The Intercept, August 24, 2021.

Formaldehyde causes leukemia, according to EPA assessment suppressed by Trump officials, Sharon Lerner, The Intercept, August 19, 2021.

EPA exposed: Leaked audio shows pressure to overrule scientists in “hair-on-hire” cases,  Sharon Lerner, The Intercept, August 4, 2021.

Whistleblowers expose corruption in EPA chemical safety office, Sharon Lerner, The Intercept, July 2, 2021.

How pesticide companies corrupted the EPA and poisoned America, Sharon Lerner, The Intercept, June 30, 2021.

Flawed analysis of an intentional human dosing study and its impact on chlorpyrifos risk assessment,  Lianne Sheppard, Seth McGrew, Richard Fenske, Environment International, July 2020.

Further Efforts Needed to Uphold Scientific Integrity Policy at EPA,  U.S. Environmental Protection Agency Office of Inspector General, May 20, 2020.

EPA Allowed Companies to Make 40 New PFAS Chemicals Despite Serious Risks, Sharon Lerner, The Intercept, September, 19, 2019.

E.P.A. Won’t Ban Chlorpyrifos, Pesticide Tied to Children’s Health Problems, Lisa Friedman, New York Times, July 18, 2019.

Emails show Trump EPA overruled career staff on Wisconsin air pollution, Timothy Gardner, Reuters, May 28, 2019.

US environment agency cuts funding for kids’ health studies, Sara Reardon, Nature, May 13, 2019.

Meet 3 women who stood up to Trump to protect the American people — and lost their jobs,  The Hill, January 19, 2019.

White House, EPA headed off chemical pollution study, Annie Snider, Politico, May 14, 2018.

Whitewash: The Story of a Weed Killer, Cancer, and the Corruption of Science, Carey Gillam, Island Press, October 10, 2017.

Records Show EPA Efforts to Slow Herbicide Review Came in Coordination with Monsanto, Carey Gillam, Huffington Post, August 18, 2017.

EPA Official Accused of Helping Monsanto “Kill” Cancer Study, Joel Rosenblatt, Lydia Mulvany, and Peter Waldman, Bloomberg, March 14, 2017.

Poison Spring- The Secret History of Pollution and the EPA, Evaggelos Vallianatos and McKay Jenkins, Bloomsbury Press, April 14, 2014.

Monsanto scientist defends Roundup safety in California trial

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Posted on by Carey Gillam

A senior scientist at the former Monsanto Co. told jurors in a California trial that the company’s Roundup herbicide is so safe that the scientist uses it regularly at her home, and suggests friends also use the weed killing product.

Donna Farmer, who worked as a toxicologist at Monsanto for more than two decades and now works at Monsanto owner Bayer AG, spent long hours testifying Monday and on multiple days last week in the case of Donnetta Stephens v. Monsanto. The Stephens case is the fourth Roundup cancer lawsuit to go to trial and the first since 2019. Stephens suffers from non-Hodgkin lymphoma she blames on her use of Roundup herbicide for more than 30 years.

Stephens is one of tens of thousands of plaintiffs who filed U.S. lawsuits against Monsanto after the World Health Organization’s cancer experts in 2015 classified glyphosate – the active ingredient in Monsanto’s herbicides – as a probable human carcinogen with an association to non-Hodgkin lymphoma.

Monsanto lost each of the three previous trials, after lawyers for the plaintiffs presented jurors with multiple scientific studies finding potential health risks with glyphosate and Roundup  The plaintiffs lawyers also used internal Monsanto documents as evidence, arguing the so-called “Monsanto Papers” showed intentional efforts by the company to manipulate regulators and control scientific research.

The jury in the last trial ordered $2 billion in damages though the award was later shaved to $87 million.

Bayer, which bought Monsanto in 2018, insists there is no cancer risk with its glyphosate herbicides, but it has agreed to pay close to $14 billion to try to settle the litigation and said it will remove glyphosate products from the U.S. consumer market by 2023. The company will continue to sell the herbicides to farmers and other commercial users.

Combative exchanges

In testimony delivered under cross-examination by Stephens’ lawyer William Shapiro, Farmer was combative, going beyond answering the yes or no questions Shapiro posed to her in an effort to “explain” the context she said Shapiro was misrepresenting.

Shapiro quizzed Farmer about emails and documents dating back to the late 1990s that Shapiro presented as evidence that Farmer and other company scientists engaged in misconduct, including ghostwriting scientific papers to fraudulently assert the safety of its glyphosate-based herbicides and buried information that found cancer risk with the products.

On Monday, Monsanto lawyer Manuel Cachan questioned Farmer about many of the same pieces of evidence focused on by Shapiro, but cast the emails and other evidence as innocent exchanges that bear no signs of deceit or misconduct.

Under Cachan’s questioning, Farmer said that based on the science that she is familiar with, she does not believe glyphosate causes cancer, and is confident that Roundup is safe to use. She said that she is so certain of the safety of Roundup that she has used it around her yard for about 25 years. She does not wear gloves or special protective gear when spraying, she testified. Farmer said she has no worries about recommending the product to family members and friends.

Farmer said the phase-out for consumers is not due to any safety concerns and is being removed from consumer markets simply “because of the litigation and the lawsuits.” Farmer said she does not think the product should be withdrawn.

“The product is in my opinion – and not just my opinion but regulators around the world – the product is safe and is not a carcinogen,” Farmer testified.

Even after Bayer stops selling Roundup to consumers in 2023, Farmer said she plans to keep using it.

“It has a good shelf life so I’ll probably buy some extra bottles,” she said. “You can go to dealerships in farm country, you can buy some of the products there.”

Monsanto has been persecuted by an anti-pesticide movement, according to Farmer.

“There are a lot of people who don’t like pesticides. They don’t like glyphosate and quite frankly don’t like Monsanto. There are a lot of people who make allegations and spread misinformation about the safety of our products,” Farmer testified.

Beyond Pesticides

At one point in her testimony, Farmer weighed in on a nonprofit group and Monsanto critic called Beyond Pesticides, telling jurors that Beyond Pesticides was not a scientific group but rather an activist group that was “misrepresenting the science” about synthetic pesticides such as glyphosate.

“Their mission is to stop the use of synthetic pesticides and so what they publish is misinformation, inaccurate information about pesticides,” she testified.

Monsanto’s lawyer asked her to address a 2008 internal Monsanto email regarding a press release issued by Beyond Pesticides. The press release by the nonprofit group shared a research study that found glyphosate exposure could increase a person’s risk of developing non-Hodgkin lymphoma. The group advised people should embrace organic agriculture and use “non-toxic land care” on residential lawns.

In the email, Farmer had written to colleagues: “We have been aware of this paper for awhile and knew it would only be a matter of time before the activists picked it up.” Mentioning the Beyond Pesticides line about embracing organic agriculture, Farmer had written: How do we combat this?”

Under questioning from Monsanto’s lawyer, Farmer explained that she was not indicating Monsanto should try to combat the scientific research but was addressing only the Beyond Pesticide advice about avoiding pesticide use.

The Stephens trial started as an in-person proceeding but was changed to a Zoom trial due to concerns about the spread of Covid-19, and has been plagued by repeated “technical problems” ever since the change. Several times jurors and/or a witness have lost their audio and/or video connections to the trial.

Judge Gilbert Ochoa of the Superior Court of San Bernardino County in California, is overseeing the proceedings.

The trial does not resume until Monday Oct. 4 because of scheduling conflicts for some of the trial participants.