A death and a settlement as Bayer continues trying to end Roundup litigation

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Seven months after Bayer AG announced plans for a sweeping settlement of U.S. Roundup cancer litigation, the German owner of Monsanto Co. continues to work to settle tens of thousands of claims brought by people suffering from cancer they say was caused by Monsanto’s weed killing products. On Wednesday, one more case appeared to find closure, though the plaintiff did not live to see it.

Lawyers for Jaime Alvarez Calderon, agreed earlier this week to a settlement offered by Bayer after U.S. District Judge Vince Chhabria on Monday denied summary judgment in favor of Monsanto, allowing the case to move closer to a trial.

The settlement will go to Alvarez’s four sons because their 65-year-old father, a longtime winery worker in Napa County, California, died just over a year ago from non-Hodgkin lymphoma he blamed on his work spraying Roundup around winery property for years.

In a hearing held in federal court Wednesday, Alvarez family lawyer David Diamond told Judge Chhabria that the settlement would close out the case.

After the hearing, Diamond said Alvarez had worked in the wineries for 33 years, using a backpack sprayer to apply Monsanto’s glyphosate-based herbicides to sprawling acreage for the Sutter Home group of wineries. He would often go home in the evenings with clothing wet with herbicide due to leaks in the equipment and weed killer that drifted in the wind.  He was diagnosed in 2014 with non-Hodgkin lymphoma, undergoing multiple rounds of chemotherapy and other treatments before dying in December 2019.

Diamond said he was happy to settle the case but has “400 plus” more Roundup cases still unresolved.

He is not alone. At least half a dozen other U.S. law firms have Roundup plaintiffs they are seeking trial settings for in 2021 and beyond.

Since buying Monsanto in 2018, Bayer has been struggling to figure out how to put an end to the litigation that includes more than 100,000 plaintiffs in the United States. The company lost all three trials held to date and has lost the early rounds of appeals seeking to overturn the trial losses. Juries in each of the trials found that Monsanto’s glyphosate-based herbicides do cause cancer and that Monsanto spent decades hiding the risks.

In addition to efforts to resolve claims currently pending, Bayer also hopes to create a mechanism for resolving potential claims that it could face from Roundup users who develop non-Hodgkin lymphoma in the future. Its initial plan for handling future litigation was rejected by Judge Chhabria and the company has yet to announce a new plan.

International Life Sciences Institute (ILSI) is a Food Industry Lobby Group

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The International Life Sciences Institute (ILSI) is a corporate-funded nonprofit organization based in Washington DC, with 17 affiliated chapters around the world. ILSI describes itself as a group that conducts “science for the public good” and “improves human health and well-being and safeguards the environment.” However, investigations by academics, journalists and public interest researchers show that ILSI is a lobby group that protects the interests of the food industry, not public health.

Recent news:

  • Coca-Cola has severed its longtime ties with ILSI. The move is “a blow to the powerful food organization known for its pro-sugar research and policies,” Bloomberg reported in January 2021.  
  • ILSI helped Coca-Cola Company shape obesity policy in China, according to a September 2020 study in the Journal of Health Politics, Policy and Law by Harvard Professor Susan Greenhalgh. “Beneath ILSI’s public narrative of unbiased science and no policy advocacy lay a maze of hidden channels companies used to advance their interests. Working through those channels, Coca Cola influenced China’s science and policy making during every phase in the policy process, from framing the issues to drafting official policy,” the paper concludes.

  • Documents obtained by U.S. Right to Know add more evidence that ILSI is a food industry front group. A May 2020 study in Public Health Nutrition based on the documents reveal “a pattern of activity in which ILSI sought to exploit the credibility of scientists and academics to bolster industry positions and promote industry-devised content in its meetings, journal, and other activities.” See coverage in The BMJ, Food and drink industry sought to influence scientists and academics, emails show  (5.22.20)

  • Corporate Accountability’s April 2020 report examines how food and beverage corporations have leveraged ILSI to infiltrate the U.S. Dietary Guidelines Advisory Committee, and cripple progress on nutrition policy around the globe. See coverage in The BMJ, Food and soft drink industry has too much influence over US dietary guidelines, report says (4.24.20) 

  • New York Times investigation by Andrew Jacobs reveals that a trustee of the industry-funded nonprofit ILSI advised the Indian government against going ahead with warning labels on unhealthy foods. The Times described ILSI as a “shadowy industry group” and “the most powerful food industry group you’ve never heard of.” (9.16.19) The Times cited a June study in Globalization and Health co-authored by Gary Ruskin of U.S. Right to Know reporting that ILSI operates as a lobby arm for its food and pesticide industry funders.

  • The New York Times revealed the undisclosed ILSI ties of Bradley C. Johnston, a co-author of five recent studies claiming red and processed meat don’t pose significant health problems. Johnston used similar methods in an ILSI-funded study to claim sugar is not a problem. (10.4.19)

  • Marion Nestle’s Food Politics blog, ILSI: true colors revealed (10.3.19)

ILSI ties to Coca-Cola 

ILSI was founded in 1978 by Alex Malaspina, a former senior vice president at Coca-Cola who worked for Coke from 1969-2001. Coca-Cola has kept close ties with ILSI. Michael Ernest Knowles, Coca-Cola’s VP of global scientific and regulatory affairs from 2008–2013, was president of ILSI from 2009-2011. In 2015, ILSI’s president was Rhona Applebaum, who retired from her job as Coca-Cola’s chief health and science officer (and from ILSI) in 2015 after the New York Times and Associated Press reported that Coke funded the nonprofit Global Energy Balance Network to help shift blame for obesity away from sugary drinks.  

Corporate funding 

ILSI is funded by its corporate members and company supporters, including leading food and chemical companies. ILSI acknowledges receiving funding from industry but does not publicly disclose who donates or how much they contribute. Our research reveals:

  • Corporate contributions to ILSI Global amounting to $2.4 million in 2012. This included $528,500 from CropLife International, a $500,000 contribution from Monsanto and $163,500 from Coca-Cola.
  • A draft 2013 ILSI tax return shows ILSI received $337,000 from Coca-Cola and more than $100,000 each from Monsanto, Syngenta, Dow Agrisciences, Pioneer Hi-Bred, Bayer CropScience and BASF.
  • A draft 2016 ILSI North America tax return shows a $317,827 contribution from PepsiCo, contributions greater than $200,000 from Mars, Coca-Cola, and Mondelez, and contributions greater than $100,000 from General Mills, Nestle, Kellogg, Hershey, Kraft, Dr. Pepper, Snapple Group, Starbucks Coffee, Cargill, Uniliver and Campbell Soup.  

Emails show how ILSI seeks to influence policy to promote industry views 

A May 2020 study in Public Health Nutrition adds evidence that ILSI is a food industry front group. The study, based on documents obtained by U.S. Right to Know via state public records requests, reveals how ILSI promotes the interests of the food and agrichemical industries, including ILSI’s role in defending controversial food ingredients and suppressing views that are unfavorable to industry; that corporations such as Coca-Cola can earmark contributions to ILSI for specific programs; and, how ILSI uses academics for their authority but allows industry hidden influence in their publications.

The study also reveals new details about which companies fund ILSI and its branches, with hundreds of thousands of dollars in contributions documented from leading junk food, soda and chemical companies.

A June 2019 paper in Globalization and Health provides several examples of how ILSI advances the interests of the food industry, especially by promoting industry-friendly science and arguments to policymakers. The study is based on documents obtained by U.S. Right to Know via state public records laws.  

The researchers concluded: “ILSI seeks to influence individuals, positions, and policy, both nationally and internationally, and its corporate members deploy it as a tool to promote their interests globally. Our analysis of ILSI serves as a caution to those involved in global health governance to be wary of putatively independent research groups, and to practice due diligence before relying upon their funded studies and/or engaging in relationship with such groups.”   

ILSI undermined obesity fight in China

In January 2019, two papers by Harvard Professor Susan Greenhalgh revealed ILSI’s powerful influence on the Chinese government on issues related to obesity. The papers document how Coca-Cola and other corporations worked through the China branch of ILSI to influence decades of Chinese science and public policy on obesity and diet-related illnesses such as Type 2 diabetes and hypertension. Read the papers:

ILSI is so well-placed in China that it operates from inside the government’s Centre for Disease Control and Prevention in Beijing.

Professor Geenhalgh’s papers document how Coca-Cola and other Western food and beverage giants “helped shape decades of Chinese science and public policy on obesity and diet-related diseases” by operating through ILSI to cultivate key Chinese officials “in an effort to stave off the growing movement for food regulation and soda taxes that has been sweeping the west,” the New York Times reported.  

Additional academic research from U.S. Right to Know about ILSI 

The UCSF Tobacco Industry Documents Archive has over 6,800 documents pertaining to ILSI.  

ILSI sugar study “right out of the tobacco industry’s playbook”

Public health experts denounced an ILSI-funded sugar study published in a prominent medical journal in 2016 that was a “scathing attack on global health advice to eat less sugar,” reported Anahad O’Connor in The New York Times. The ILSI-funded study argued that warnings to cut sugar are based on weak evidence and cannot be trusted.  

The Times story quoted Marion Nestle, a professor at New York University who studies conflicts of interest in nutrition research, on the ILSI study: “This comes right out of the tobacco industry’s playbook: cast doubt on the science,” Nestle said. “This is a classic example of how industry funding biases opinion. It’s shameful.” 

Tobacco companies used ILSI to thwart policy 

A July 2000 report by an independent committee of the World Health Organization outlined a number of ways in which the tobacco industry attempted to undermine WHO tobacco control efforts, including using scientific groups to influence WHO’s decision-making and to manipulate scientific debate surrounding the health effects of tobacco. ILSI played a key role in these efforts, according to a case study on ILSI that accompanied the report. Findings indicate that ILSI was used by certain tobacco companies to thwart tobacco control policies. Senior office bearers in ILSI were directly involved in these actions,” according to the case study. See: 

The UCSF Tobacco Industry Documents Archive has more than 6,800 documents pertaining to ILSI

ILSI leaders helped defend glyphosate as chairs of key panel 

In May 2016, ILSI came under scrutiny after revelations that the vice president of ILSI Europe, Professor Alan Boobis, was also chairman of a UN panel that found Monsanto’s chemical glyphosate was unlikely to pose a cancer risk through diet. The co-chair of the UN Joint Meeting on Pesticide Residues (JMPR), Professor Angelo Moretto, was a board member of ILSI’s Health and Environment Services Institute. Neither of the JMPR chairs declared their ILSI leadership roles as conflicts of interest, despite the significant financial contributions ILSI has received from Monsanto and the pesticide industry trade group. See: 

ILSI’s cozy ties at U.S. Centers for Disease Control and Prevention  

In June 2016, U.S. Right to Know reported that Dr. Barbara Bowman, director of a CDC division charged with preventing heart disease and stroke, tried to help ILSI’s founder Alex Malaspina influence World Health Organization officials to back off policies to reduce sugar consumption. Bowman suggested people and groups for Malaspina to talk to, and solicited his comments on some CDC summaries of reports, the emails show. (Bowman stepped down after our first article was published reporting on these ties.)

This January 2019 study in the Milbank Quarterly describes key emails of Malaspina cozying up to Dr. Bowman. For more reporting on this topic, see: 

ILSI influence on the U.S. Dietary Guidelines Advisory Committee

report by the nonprofit group Corporate Accountability documents how ILSI has major influence on U.S. dietary guidelines via its infiltration of the U.S. Dietary Guidelines Advisory Committee.  The report examines the pervasive political interference of food and beverage transnationals like Coca-Cola, McDonald’s, Nestlé, and PepsiCo, and how these corporations have leveraged the International Life Sciences Institute to cripple progress on nutrition policy across the globe.

ILSI influence in India 

The New York Times reported on ILSI’s influence in India in its article titled, “A Shadowy Industry Group Shapes Food Policy Around the World.”

ILSI has close ties to some Indian government officials and, as in China, the nonprofit has pushed similar messaging and policy proposals as Coca-Cola – downplaying the role of sugar and diet as a cause of obesity, and promoting increased physical activity as the solution, according to the India Resource Center. 

Members of ILSI India’s board of trustees include Coca-Cola India’s director of regulatory affairs and representatives from Nestlé and Ajinomoto, a food additive company, along with government officials who serve on scientific panels that are tasked with deciding about food safety issues.  

Longstanding concerns about ILSI 

ILSI insists it is not an industry lobby group, but concerns and complaints are longstanding about the group’s pro-industry stances and conflicts of interest among the organization’s leaders. See, for example:

Untangle food industry influences, Nature Medicine (2019)

Food agency denies conflict-of-interest claim. But accusations of industry ties may taint European body’s reputation, Nature (2010)

Big Food Vs. Tim Noakes: The Final Crusade, Keep Fitness Legal, by Russ Greene (1.5.17) 

Real Food on Trial, by Dr. Tim Noakes and Marika Sboros (Columbus Publishing 2019). The book describes “the unprecedented prosecution and persecution of Professor Tim Noakes, a distinguished scientist and medical doctor, in a multimillion rand case that stretched over more than four years. All for a single tweet giving his opinion on nutrition.”

Bayer’s bid to settle U.S. Roundup cancer claims making progress

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Monsanto owner Bayer AG is making progress toward a sweeping settlement of thousands of U.S. lawsuits brought by people alleging they or their loved ones developed cancer after exposure to Monsanto’s Roundup herbicides.

Recent correspondence from plaintiffs’ lawyers to their clients underscored that progress, confirming a large percentage of plaintiffs are opting to participate in the settlement, despite complaints by many plaintiffs that they are facing unfairly small payout proposals.

By some calculations, the average gross settlement will leave little to no compensation, perhaps a few thousand dollars, for individual plaintiffs after attorneys’ fees are paid and certain insured medical costs are reimbursed.

Nevertheless, according to a letter sent to plaintiffs in late November by one of the lead law firms in the litigation, more than 95 percent of the “eligible claimants” decided to participate in the settlement plan negotiated by the firm with Bayer. A “settlement administrator” now has 30 days to review the cases and confirm the plaintiffs’ eligibility to receive settlement funds, according to the correspondence.

People can choose to opt out of the settlement and take their claims to mediation, followed by binding arbitration if they wish or try to find a new lawyer who would take their case to trial. Those plaintiffs could have a difficult time finding a lawyer to help them take their case to trial because the law firms agreeing to the settlements with Bayer have agreed not to try any more cases or assist in future trials.

One plaintiff, who asked not to be identified by name due to the confidentiality of the settlement proceedings, said he is opting out of the settlement in hopes of obtaining more money through mediation or a future trial. He said he requires ongoing tests and treatments for his cancer and the proposed settlement structure would leave him nothing to cover those ongoing costs.

“Bayer wants a release by paying as little as possible without going to trial,” he said.

The rough estimate on average gross payouts per plaintiff is about $165,000, lawyers and plaintiffs involved in the discussions have said.  But some plaintiffs could receive far more, and some less, depending upon the details of their case. There are many criteria determining who can participate in the settlement and how much money that person may receive.

To be eligible, the Roundup user has to be a U.S. citizen, have been diagnosed with non-Hodgkin lymphoma (NHL), and had exposures to Roundup for at least one year prior to being diagnosed with NHL.

The settlement agreement with Bayer will be complete when the administrator confirms that more than 93 percent of claimants qualify, according to the terms of the deal.

If the settlement administrator finds a plaintiff ineligible, that plaintiff has 30 days to appeal the decision.

For plaintiffs deemed eligible the settlement administrator will award each case a number of points based on specific criteria. The amount of money each plaintiff will receive is based on the number of points calculated for their individual situation.

Basis points are established using the age of the individual at the time they were diagnosed with NHL and the level of severity of the “injury” as determined by the degree of treatment and outcome. The levels run 1-5. Someone who died from NHL is assigned basis points for a level 5, for instance. More points are given to younger people who suffered multiple rounds of treatment and/or died.

In addition to the basis points, adjustments are allowed that give more points to plaintiffs who had more exposure to Roundup. There are also allowances for more points for specific types of NHL. Plaintiffs diagnosed with a type of NHL called Primary Central Nervous System (CNS) lymphoma receive a 10 percent boost to their points tally, for example.

People can also have points deducted based on certain factors. Here are a few specific examples from the points matrix established for the Roundup litigation:

  • If a Roundup product user died before January 1, 2009, the total points for the claim brought on their behalf will be reduced by 50 percent.
  • If a deceased plaintiff had no spouse or minor children at the time of their death there is a deduction of 20 percent.
  • If a plaintiff had any prior blood cancers before using Roundup their points are cut by 30 percent.
  • If the span of time between a claimant’s Roundup exposure and the diagnosis of NHL was less than two years the points are cut 20 percent.

The settlement funds should begin to flow to participants in the spring with final payments hopefully made by summer, according to lawyers involved.

Plaintiffs can also apply to be part of an “extraordinary injury fund,” set up for a small group of plaintiffs who suffer from severe NHL-related injuries. A claim may be eligible for the extraordinary injury fund if the individual’s death from NHL came after three or more full courses of chemotherapy and other aggressive treatments.

Since buying Monsanto in 2018, Bayer has been struggling to figure out how to put an end to the litigation that includes more than 100,000 plaintiffs in the United States. The company lost all three trials held to date and has lost the early rounds of appeals seeking to overturn the trial losses. Juries in each of the trials found that Monsanto’s glyphosate-based herbicides, such as Roundup, do cause cancer and that Monsanto spent decades hiding the risks.

The jury awards totaled well over $2 billion, though the judgments have been ordered reduced by trial and appellate court judges.

The company’s efforts to resolve the litigation have been stymied in part by the challenge of how to head off claims that could be brought in the future by people who develop cancer after using the company’s herbicides.

Trial Appeals Continue

Even as Bayer aims to head off future trials with settlement dollars, the company continues to try to overturn the outcomes of the three trials the company lost.

In the first trial loss – the Johnson v. Monsanto case – Bayer lost efforts to overturn the jury finding that Monsanto was liable for Johnson’s cancer at the appellate court level, and in October, the California Supreme Court refused to review the case.

Bayer now has 150 days from that decision to ask for the matter to be taken up by the U.S. Supreme Court. The company has not made a final decision regarding that move, according to a Bayer spokesman, but has indicated previously that it does intend to take such action.

If Bayer does petition the U.S. Supreme Court, Johnson’s attorneys are expected to file a conditional cross-appeal asking the court to examine the judicial actions that slashed Johnson’s jury award from $289 million to $20.5 million.

Other Bayer/Monsanto court cases

In addition to the liability Bayer faces from Monsanto’s Roundup cancer litigation, the company is struggling with Monsanto liabilities in PCB pollution litigation and in litigation over crop damage caused by Monsanto’s dicamba herbicide-based crop system.

A federal judge in Los Angeles last week rejected a proposal by Bayer to pay $648 million to settle class-action litigation brought by claimants alleging contamination from polychlorinated biphenyls, or PCBs, made by the Monsanto.

Also last week, the trial judge in the case of Bader Farms, Inc. v. Monsanto rejected Bayer’s motions for a new trial.  The judge cut the punitive damages awarded by the jury, however, from $250 million to $60 million, leaving intact compensatory damages of $15 million, for a total award of $75 million.

Documents obtained through discovery in the Bader case revealed that Monsanto and chemical giant BASF were aware for years that their plans to introduce a dicamba herbicide-based agricultural seed and chemical system would probably lead to damage on many US farms.

New glyphosate papers point to “urgency” for more research on chemical impact to human health

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Newly published scientific papers illustrate the ubiquitous nature of the weed killing chemical glyphosate and a need to better understand the impact exposure to the popular pesticide may be having on human health, including the health of the gut microbiome.

In one of the new papers, researchers from the University of Turku in Finland said that they were able to determine, in a “conservative estimate,” that approximately 54 percent of species in the core of the human gut microbiome are “potentially sensitive” to glyphosate. The researchers said they used a new bioinformatics method to make the finding.

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, which was published this month in the Journal of Hazardous Materials.

The microbes in the human gut include a variety of bacteria and fungi and are believed to impact immune functions and other important processes. Unhealthy gut microbiomes are believed by some scientists to contribute to a range of diseases.

“Although data on glyphosate residues in human gut systems are still lacking, our results suggest that glyphosate residues decrease bacterial diversity and modulate bacterial species composition in the gut,” the authors said. “We may assume that long-term exposure to glyphosate residues leads to the dominance of resistant strains in the bacterial community.”

The concerns about glyphosate’s impact on the human gut microbiome stem from the fact that glyphosate works by targeting an enzyme known as 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS.) This enzyme is critical to the synthesizing of essential amino acids.

“To determine the actual impact of glyphosate on the human gut microbiota and other organisms, further empirical studies are needed to reveal glyphosate residues in food, to determine the effects of pure glyphosate and commercial formulations on microbiomes and to assess the extent to which our EPSPS amino acid markers predict bacterial susceptibility to glyphosate in in vitro and real-world scenarios,” the authors of the new paper concluded.

In addition to the six researchers from Finland, one of the authors of the paper is affiliated with the department of biochemistry and biotechnology at Rovira i Virgili University, Tarragona, Catalonia, in Spain.

“The consequences for human health are not determined in our study. However, based on previous studies… we know that alterations in the human gut microbiome may be connected to several diseases,” University of Turku researcher Pere Puigbo said in an interview.

“I hope that our research study opens the door to further experiments, in-vitro and in the field, as well as population-based studies to quantify the effect the use of glyphosate has on human populations and other organisms,” Puigbo said.

Introduced in 1974

Glyphosate is the active ingredient in Roundup herbicides and hundreds of other weed killing products sold around the world. It was introduced as a weed killer by Monsanto in 1974 and grew to become the most widely used herbicide after Monsanto’s introduction in the 1990s of crops genetically engineered to tolerate the chemical. Residues of glyphosate are commonly found on food and in water. Consequently, residues are also often detected in the urine of people exposed to glyphosate through either diet and/or application.

U.S. regulators and Monsanto owner Bayer AG maintain there are no human health concerns with glyphosate exposure when the products are used as intended, including from residues in the diet.

The body of research contradicting those claims is growing, however. The research on the potential impacts of glyphosate on the gut microbiome is not nearly as robust as the literature associating glyphosate to cancer, but is an area many scientists are probing.

In a somewhat related paper published this month, a team of researchers from Washington State University and Duke University said that they had found a correlation between the levels of bacteria and fungi in the gastrointestinal tracts of children and the chemicals found in their homes. The researchers did not look at glyphosate specifically, but were alarmed to find that children with higher levels of common household chemicals in their bloodstream showed a reduction in the amount and diversity of important bacteria in their gut.

Glyphosate in urine

An additional scientific paper published this month underscored a need for better and more data when it comes to glyphosate exposure and children.

The paper, published in the journal Environmental Health by researchers from the Institute for Translational Epidemiology at the Icahn School of Medicine at Mount Sinai in New York, is the outcome of a literature review of multiple studies reporting actual values of glyphosate in people.

The authors said they analyzed five studies published in the last two years reporting glyphosate levels measured in people, including one study in which urinary glyphosate levels were measured in children living in rural Mexico. Of 192 children living in the Agua Caliente area, 72.91 percent had detectable levels of glyphosate in their urine, and all of the 89 children living in Ahuacapán, Mexico, had detectable levels of the pesticide in their urine.

Even when including additional studies, overall, there is sparse data regarding glyphosate levels in people. Studies globally total only 4,299 people, including 520 children, the researchers said.

The authors concluded that it is not currently possible to understand the “potential relationship” between glyphosate exposure and disease, especially in children, because data collection on exposure levels in people is limited and not standardized.

They noted that despite the lack of solid data about the impacts of glyphosate on children, the amount of glyphosate residues legally allowed by U.S. regulators on food has increased dramatically over the years.

“There are gaps in the literature on glyphosate, and these gaps should be filled with some urgency, given the large use of this product and its ubiquitous presence,” said author Emanuela Taioli.

Children are especially vulnerable to environmental carcinogens and tracking exposure to products such as glyphosate in children is “a pressing public health priority,” according to the authors of the paper.

“As with any chemical, there are multiple steps involved in evaluating risk, which include gathering information about human exposures, so that the levels that produce harm in one population or animal species can be compared to typical exposure levels,” the authors wrote.

“However, we have previously shown that data on human exposure in workers and the general population are very limited. Several other gaps in knowledge exist around this product, for example results on its genotoxicity in humans are limited. The continued debate regarding the effects of glyphosate exposure makes establishing exposure levels in the general public a pressing public health issue, especially for the most vulnerable.”

The authors said monitoring of urinary glyphosate levels should be conducted in the general population.

“We continue to suggest that inclusion of glyphosate as a measured exposure in nationally representative studies like the National Health and Nutrition Examination Survey will allow for a better understanding of the risks that glyphosate may pose and allow for better monitoring of those who are most likely to be exposed and those who are more susceptible to the exposure,” they wrote.

Aspartame: Decades of Science Point to Serious Health Risks

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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 European Food Safety Authority 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 on Aspartame 

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

In the most comprehensive cancer research to date on aspartame, 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.1
  • 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.2
  • 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.3

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.4

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.”5

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.”6

  • 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.”7 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.”8

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.9

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.10

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)11
  • “[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)12

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.13

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.14

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.15

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.”16

“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.17 

“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.”18 

“(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.19

Aspartame “could impair memory retention and damage hypothalamic neurons in adult mice,” according to a 2000 mice study published in Toxicology Letters.20

“(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.21

High doses of aspartame “can generate major neurochemical changes in rats,” reported a 1984 study in American Journal of Clinical Nutrition.22

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.23

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.24

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.”25

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.26

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.27

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.28

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.”29

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.30

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.31

Intestinal Dysbiosis, Metabolic Derangement and Obesity

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.”32

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.”33

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…”34

 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.”35

  • 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.36

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.37

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.”38

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…”39

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.”40

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.”41

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

[1] 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)

[2] 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)

[3] 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)

[4] 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)

[5] 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)

[6] 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)

[7] 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)

[8] 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)

[9] 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)

[10] 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)

[11] 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)

[12] 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)

[13] 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)

[14] 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)

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

[16] 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)

[17] 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)

[18] 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)

[19] 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)

[20] 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)

[21] 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)

[22] 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)

[23] 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)

[24] Blumenthal HJ, Vance DA. “Chewing gum headaches.” Headache. 1997 Nov-Dec; 37(10):665-6. PMID: 9439090. (abstract/article)

[25] 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)

[26] 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)

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

[28] 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)

[29] 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)

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

[31] 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)

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

[33] 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)

[34] 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)

[35] 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)

[36] 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)

[37] 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)

[38] 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)

[39] 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)

[40] 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)

[41] 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)

New research adds evidence that weed killer glyphosate disrupts hormones

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New research is adding worrisome evidence to concerns that the widely used weedkilling chemical glyphosate may have the potential to interfere with human hormones.

In a paper published in the journal Chemosphere titled Glyphosate and the key characteristics of an endocrine disruptor: A review, a trio of scientists concluded that glyphosate appears to have eight out of ten key characteristics associated with endocrine disrupting chemicals . The authors cautioned, however, that prospective cohort studies are still needed to more clearly understand the impacts of glyphosate on the human endocrine system.

The authors, Juan Munoz, Tammy Bleak and Gloria Calaf, each affiliated with the University of Tarapacá in Chile, said their paper is the first review to consolidate the mechanistic evidence on glyphosate as an endocrine-disrupting chemical (EDC).

Some of the evidence suggests that Roundup, Monsanto’s well-known glyphosate-based herbicide, can alter the biosynthesis of the sexual hormones, according to the researchers.

EDCs may mimic or interfere with the body’s hormones and are linked with developmental and reproductive problems as well as brain and immune system dysfunction.

The new paper follows publication earlier this year of an assortment of animal studies that indicated glyphosate exposures impact reproductive organs and threaten fertility.

Glyphosate is the world’s most widely used herbicide, sold in 140 countries. Introduced commercially in 1974 by Monsanto Co, the chemical is the active ingredient in popular products such as Roundup and hundreds of other weed killers used by consumers, municipalities, utilities, farmers, golf course operators, and others around the world.

Dana Barr, a professor at Emory University’s Rollins School of Public Health, said the evidence “tends to overwhelmingly indicate that glyphosate has endocrine disrupting properties.”

“It’s not necessarily unexpected since glyphosate has some structural similarities with many other endocrine disrupting pesticides; however, it is more concerning because glyphosate use far surpasses other pesticides,” said Barr, who directs a program within a National Institutes of Health-funded human exposure research center housed at Emory. “Glyphosate is used on so many crops and in so many residential applications such that aggregate and cumulative exposures can be considerable.”

Phil Landrigan, director of the Global Observatory on Pollution and Health, and a professor of biology
at Boston College, said the review pulled together “strong evidence” that glyphosate is an endocrine disruptor.

“The report is consistent with a larger body of literature indicating that glyphosate has a wide range of adverse health effects – findings that overturn Monsanto’s long-standing portrayal of glyphosate as a benign chemical with no negative impacts on human health,” said Landrigan.

EDCs have been a subject of concern since the 1990s after a series of publications suggested that some chemicals commonly used in pesticides, industrial solvents, plastics, detergents, and other substances could have the capacity to disrupt connections between hormones and their receptors.

Scientists generally recognized ten functional properties of agents that alter hormone action, referring to these as ten “key characteristics” of endocrine-disruptors. The ten characteristics are as follows:

EDC’s can:

  • Alter hormone distribution of circulating levels of hormones
  • Induce alterations in hormone metabolism or clearance
  • Alter the fate of hormone-producing or hormone-responsive cells
  • Alter hormone receptor expression
  • Antagonize hormone receptors
  • Interact with or activate hormone receptors
  • Alter signal transduction in hormone-responsive cells
  • Induce epigenetic modifications in hormone-producing or hormone-responsive cells
  • Alter hormone synthesis
  • Alter hormone transport across cell membranes

The authors of the new paper said a review of the mechanistic data showed that glyphosate met all of the key characteristics with the exception of two:  “Regarding glyphosate, there is no evidence associated with the antagonistic capacity of hormonal receptors,” they said. As well, “there is no evidence of its impact on hormonal metabolism or clearance,” according to the authors.

Research over the last few decades has largely focused on links found between glyphosate and cancer, particularly non-Hodgkin lymphoma (NHL.) In 2015, the World Health Organization’s International Agency for Research on Cancer classified glyphosate as a probable human carcinogen.

More than 100,000 people have sued Monsanto in the United States alleging exposure to the company’s glyphosate-based herbicides caused them or their loved ones to develop NHL.

The plaintiffs in the nationwide litigation also claim Monsanto has long sought to hide the risks of its herbicides. Monsanto lost three out of three trials and its German owner Bayer AG has spent the last year and a half trying to settle the litigation out of court.

The authors of the new paper took note of the ubiquitous nature of glyphosate, saying “massive use” of the chemical has “led to a wide environmental diffusion,” including rising exposures tied to human consumption of the weed killer through food.

The researchers said that though regulators say the levels of glyphosate residue commonly found in foods are low enough to be safe, they “cannot rule out” a “potential risk” to people consuming foods containing contaminated with the chemical,  particularly grains and other plant-based foods, which often have higher levels than milk, meat or fish products.

U.S. government documents show glyphosate residues have been detected in a range of foods, including organic honey, and granola and crackers.

Canadian government researchers have also reported glyphosate residues in foods. One report issued in 2019 by scientists from Canada’s Agri-Food Laboratories at the Alberta Ministry of Agriculture and Forestry found glyphosate in 197 of 200 samples of honey they examined.

Despite the concerns about glyphosate impacts on human health, including through dietary exposure, U.S. regulators have steadfastly defended the safety of the chemical. The Environmental Protection Agency maintains that it has not found any human health risks from exposure to glyphosate.”

Bayer’s Shady PR Firms: FleishmanHillard, Ketchum, FTI Consulting

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Originally posted May 2019; updated November 2020

In this post, U.S. Right to Know is tracking public deception scandals involving PR firms that agrichemical giants Bayer AG and Monsanto have relied on for their product defense campaigns: FTI consulting, Ketchum PR and FleishmanHillard. These firms have long histories of using deceptive tactics to promote the political agendas of their clients, including pesticide, tobacco and oil industry defense campaigns.

Recent scandals

NYT exposes FTI Consulting firm’s shady tactics for the oil industry: In a Nov. 11, 2020 New York Times article, Hiroko Tabuchi reveals how FTI Consulting “helped design, staff and run organizations and websites funded by energy companies that can appear to represent grassroots support for fossil-fuel initiatives.” Based on her interviews with a dozen former FTI staffers and hundreds of internal documents, Tabuchi reports on how FTI monitored environmental activists, ran astroturf political campaigns, staffed two news and information sites and wrote pro-industry articles on fracking, climate lawsuits and other hot-button issues with direction from Exxon Mobile.

Monsanto and its PR firms orchestrated GOP effort to intimidate cancer researchers: Lee Fang reported for The Intercept in 2019 on documents suggesting that Monsanto antagonized regulators and applied pressure to shape research of the world’s leading herbicide, glyphosate. The story reports on deceptive PR tactics, including how FTI Consulting drafted a letter about glyphosate science signed by a senior GOP congressman.

Monsanto documents reveal tactics to discredit public interest investigation: Internal Monsanto documents released via litigation in August 2019 revealed a range of tactics the company and its PR firms used to target journalists and other influencers who raised concerns about pesticides and GMOs, and tried to counter an investigation into their activities by U.S. Right to Know.

See also USRTK’s fact sheets, based on documents obtained from our investigation, reporting on third-party allies who assist with pesticide industry defense: Tracking the Pesticide Industry Propaganda Network.

In May 2019, we reported on several scandals involving Bayer’s PR firms:

‘Monsanto File’ scandal

Journalists at Le Monde reported May 9 that they obtained a “Monsanto File” created by the public relations firm FleishmanHillard listing a “multitude of information” about 200 journalists, politicians, scientists and others deemed likely to influence the debate on glyphosate in France. Le Monde filed a complaint with the Paris prosecutor’s office alleging that the document involved illegal collection and processing of personal data, spurring the prosecutor’s office to open a criminal probe. “This is a very important discovery because it shows there are objective strategies to silence strong voices. I can see they were trying to isolate me,” France’s former Environment Minister Segolene Royal, who is on the list, told France 24 TV.

“This is a very important discovery because it shows there are objective strategies to silence strong voices.”

Francois Veillerette, an environmentalist also on the list, told France 24 that it contained personal contact details, opinions and level of engagement in relation to Monsanto. “This is a major shock in France,” he said. “We don’t think this is normal.” Bayer has since admitted that FleishmanHillard drew up “‘watch lists’ of pro- or anti-pesticides figures” in seven countries across Europe, the AFP reported. The lists contained information about journalists, politicians and other interest groups. The AFP said it filed a complaint with a French regulatory agency because some of its journalists were on the list that surfaced in France.

Bayer apologized and said it suspended its relationship with the firms involved, including FleishmanHillard and Publicis Consultants, pending an investigation. “Our highest priority is to create transparency,” Bayer said. “We do not tolerate unethical behavior in our company.” (The firms were later cleared of wrongdoing by the law firm hired by Bayer.)

Further reading:

Posing as reporter at Monsanto trial 

Adding to Bayer’s PR troubles, AFP reported on May 18 that an employee of another “crisis management” PR firm that works with Bayer and Monsanto — FTI Consulting — was caught posing as a freelance journalist at a federal trial in San Francisco that ended with an $80 million judgment against Bayer over glyphosate cancer concerns.

The FTI Consulting employee Sylvie Barak was seen chatted up reporters about story ideas at the trial. She claimed to work for the BBC and did not disclose that she actually worked for a PR firm.

Further reading:

Ketchum and FleishmanHillard run GMO PR salvo

In 2013, the agrichemical industry tapped FleishmanHillard and Ketchum, both owned by Omnicom, to head up a PR offensive to rehabilitate the image of its embattled GMO and pesticide products. Monsanto selected FleishmanHillard to “reshape” its reputation amid “fierce opposition” to genetically modified foods, according to the Holmes Report. Around the same time, FleishmanHillard also became the PR agency of record for Bayer, and the Council for Biotechnology Information (CBI) — a trade group funded by Bayer (Monsanto), Corteva (DowDuPont), Syngenta and BASF — hired Ketchum public relations firm to launch a marketing campaign called GMO Answers.

Spin tactics employed by these firms included “wooing mommy bloggers” and using the voices of supposedly “independent” experts to “clear up confusion and mistrust” about GMOs. However, evidence surfaced that the PR firms edited and scripted some of the “independent” experts. For example, documents obtained by U.S. Right to Know show that Ketchum scripted posts for GMO Answers that were signed by a University of Florida professor who claimed to be independent as he worked behind the scenes with Monsanto on PR projects. A senior vice president at FleishmanHillard edited the speech of a UC Davis professor and coached her how to “win over people in the room” at an IQ2 debate to convince the public to accept GMOs. Ketchum also gave the professor talking points for a radio interview about a scientific study.

Academics were important messengers for industry lobbying efforts to oppose GMO labeling, reported the New York Times in 2015. “Professors/researchers/scientists have a big white hat in this debate and support in their states, from politicians to producers,” Bill Mashek, a vice president at Ketchum, wrote to the University of Florida professor. “Keep it up!”  The industry trade group CBI has spent over $11 million on Ketchum’s GMO Answers since 2013, according to tax records.

GMO Answers ‘crisis management’ success

As one sign of its success as a PR spin tool, GMO Answers was shortlisted for a CLIO advertising award in 2014 in the category of “Crisis Management & Issue Management.” In this video for CLIO, Ketchum bragged about how it nearly doubled positive media attention of GMOs and “balanced 80% of interactions”  on Twitter. Many of those online interactions are from accounts that appear independent and do not disclose their connection to industry’s PR campaign.

Although the Ketchum video claimed GMO Answers would “redefine transparency” with information from experts with “nothing filtered or censored, and no voices silenced,” a Monsanto PR plan suggests the company counted on GMO Answers to help spin its products in a positive light. The document from 2015 listed GMO Answers among the “industry partners” that could help protect Roundup from cancer concerns; in a “resources” section on page 4, the plan listed links to GMO Answers alongside Monsanto documents that could communicate the company message that “Glyphosate is not carcinogenic.”

This Ketchum video was posted to the CLIO website and removed after we called attention to it.

Further reading:

Omnicom’s FleishmanHillard and Ketchum: histories of deception

Why any company would put FleishmanHillard or Ketchum in front of efforts to inspire trust is difficult to understand, given their histories of documented deceptions. For example:

Until 2016, Ketchum was the PR firm for Russia and Vladimir Putin. According to documents obtained by ProPublica, Ketchum was caught placing pro-Putin op-eds under the names of “seemingly independent professionals” in various news outlets. In 2015, the embattled Honduran government hired Ketchum to try to rehabilitate its reputation after a multi-million dollar corruption scandal.

Documents leaked to Mother Jones indicate that Ketchum worked with a private security firm that “spied on Greenpeace and other environmental organizations from the late 1990s through at least 2000, pilfering documents from trash bins, attempting to plant undercover operatives within groups, casing offices, collecting phone records of activists, and penetrating confidential meetings.” FleishmanHillard was also caught using unethical espionage tactics against public health and tobacco control advocates on behalf of the tobacco company R. J. Reynolds, according to a study by Ruth Malone in the American Journal of Public Health. The PR firm even secretly audiotaped tobacco control meetings and conferences.

FleishmanHillard was the public relations firm for The Tobacco Institute, the cigarette industry’s main lobbying organization, for seven years. In a 1996 Washington Post article, Morton Mintz recounted the story of how FleishmanHillard and the Tobacco Institute converted the Healthy Buildings Institute into a front group for the tobacco industry in its effort to spin away public concern about the dangers of second-hand smoke. Ketchum also did work for the tobacco industry.

Both firms have at times worked on both sides of an issue. FleishmanHillard has been hired for anti-smoking campaigns. In 2017, Ketchum launched a spin-off firm called Cultivate to cash in on the growing organic food market, even though Ketchum’s GMO Answers has disparaged organic food, claiming that consumers pay a “hefty premium” for food that is no better than conventionally-grown food.

Further reading:

FTI Consulting: climate deception and more tobacco ties

FTI Consulting, the “crisis management” PR firm that works with Bayer and whose employee was caught impersonating a journalist at the recent Roundup cancer trial in San Francisco, shares several similarities with FleishmanHillard and Ketchum, including its use of covert tactics, lack of transparency and history of working with the tobacco industry.

The firm is known as a key player in ExxonMobil’s efforts to evade responsibility for climate change. As Elana Schor and Andrew Restuccia reported in Politico in 2016:

“Aside from [Exxon] itself, the most vocal resistance to the greens has come from FTI Consulting, a firm filled with former Republican aides that has helped unify the GOP in defense of fossil fuels. Under the banner of Energy in Depth, a project it runs for the Independent Petroleum Association of America, FTI has peppered reporters with emails that suggest “collusion” between green activists and state AGs, and has raised questions over InsideClimate’s Rockefeller grants.”

FTI Consulting employees have been caught impersonating journalists before. Karen Savage reported in January 2019 in Climate Liability News, “Two public relations strategists representing Exxon recently posed as journalists in an attempt to interview an attorney representing Colorado communities that are suing Exxon for climate change-related damages. The strategists—Michael Sandoval and Matt Dempsey—are employed by FTI Consulting, a firm long linked with the oil and gas industry.” According to Climate Liability News, the two men were listed as writers for Western Wire, a website run by oil interests and staffed with strategists from FTI Consulting, which also provides staff to Energy In Depth, a pro-fossil fuel “research, education and public outreach campaign.”

Energy In Depth presented itself as a “mom and pop shop” representing small energy providers but was created by major oil and gas companies to lobby for deregulation, DeSmog blog reported in 2011. The Greenpeace group uncovered a 2009 industry memo describing Energy In Depth as a “new industry-wide campaign… to combat new environmental regulations, especially with regard to hydraulic fracturing” that “would not be possible without the early financial commitments” of major oil and gas interests including BP, Halliburton, Chevron, Shell, XTO Energy (now owned by ExxonMobil).

Another feature in common with all these firms is their tobacco industry ties. FTI Consulting has “a long history of working with the tobacco industry,” according to Tobacco Tactics.org. A search of the UCSF Tobacco Industry Documents library brings up over 2,400 documents relating to FTI Consulting.

Further reading:

More reporting on Bayer’s PR scandals

Coverage in French:

Coverage in English:

California Supreme Court denies review of Monsanto Roundup trial loss

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The California Supreme Court will not review a California man’s trial win over Monsanto, dealing another blow to Monsanto’s German owner, Bayer AG.

The decision to deny a review in the case of Dewayne “Lee” Johnson marks the latest in a string of court losses for Bayer as it tries to complete settlements with close to 100,000 plaintiffs who each claim they or their loved ones developed non-Hodgkin lymphoma from exposure to Roundup and other Monsanto weed killers. Juries in each of three trials held to date have found not only that the company’s glyphosate-based herbicides cause cancer but also that Monsanto spent decades hiding the risks.

“We are disappointed with the Court’s decision not to review the intermediate appeals court’s decision in Johnson and will consider our legal options for further review of this case,” Bayer said in a statement.  

The Miller Firm, Johnson’s Virginia-based law firm, said the California Supreme Court’s decision denied “Monsanto’s latest attempt to skirt responsibility” for causing Johnson’s cancer.

“Multiple judges have now affirmed the jury’s unanimous finding that Monsanto maliciously  concealed Roundup’s cancer risk and caused Mr. Johnson to develop a deadly form of cancer. The time has come for Monsanto to end its baseless appeals and pay Mr. Johnson the money it owes him,” the firm said.

A unanimous jury found in August 2018 that exposure to Monsanto’s herbicides  caused Johnson to develop a deadly form of non-Hodgkin lymphoma. The jury further found that Monsanto acted to hide the risks of its products in conduct so egregious that the company should pay Johnson $250 million in punitive damages on top of $39 million in past and future compensatory damages.

Upon appeal from Monsanto, the trial judge reduced the $289 million to $78 million. An appeals court then cut the award to $20.5 million, citing the fact that Johnson was expected to live only a short time.

The appeals court said it reduced the damages award despite finding there was “abundant” evidence that glyphosate, together with the other ingredients in Roundup products, caused Johnson’s cancer and that “there was overwhelming evidence that Johnson has suffered, and will continue to suffer for the rest of his life, significant pain and suffering.”

Both Monsanto and Johnson sought review by the California Supreme Court, with Johnson asking for restoration of a higher damage award and Monsanto seeking to reverse the trial judgment.

Bayer has reached settlements with several of the leading law firms who collectively represent a significant share of the claims brought against Monsanto. In June, Bayer said it would provide $8.8 billion to $9.6 billion to resolve the litigation.

Bayer’s Monsanto headache persists

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The migraine that is Monsanto doesn’t appear to be going away anytime soon for Bayer AG.

Efforts at settling the mass of lawsuits brought in the United States by tens of thousands of people who claim Monsanto’s Roundup herbicides gave them cancer continue to inch forward, but are not addressing all outstanding cases, nor are all plaintiffs offered settlements agreeing to them.

In a letter to U.S. District Judge Vince Chhabria, Arizona attorney David Diamond said that representations made by the lawyers leading settlement talks with Bayer on behalf of plaintiffs did not accurately reflect the situation for his own clients. He cited a “lack” of “settlement-related experiences” with Bayer and he requested that Judge Chhabria advance several of Diamond’s cases forward for trials.

“Leadership’s representations regarding settlement do not represent my clients’ settlement
related experiences, interests or position,” Diamond told the judge.

Diamond wrote in the letter that he has 423 Roundup clients, including 345 who have cases pending before Chhabria in the multidistrict litigation (MDL) in the U.S. District Court for the Northern District of California. Alongside the MDL are thousands of plaintiffs whose cases are pending in state courts.

Diamond’s outreach to the judge followed a hearing late last month in which several of the leading firms in the litigation and lawyers for Bayer told Chhabria they were close to resolving most, if not all, of the cases before the judge.

Bayer has reached important settlements with several of the leading law firms who collectively represent a significant share of the claims brought against Monsanto. In June, Bayer said it would provide $8.8 billion to $9.6 billion to resolve the litigation.

But controversy and conflict have dogged the overall settlement offers.

Several plaintiffs represented by the large firms and who spoke on condition that their names not be used, said they are not agreeing to the terms of the settlements, meaning their cases will be directed into mediation and, if that fails, to trials.

After buying Monsanto in 2018, Bayer has been struggling to figure out how to put an end to the litigation that includes more than 100,000 plaintiffs. The company lost all three of the three trials held to date and has lost the early rounds of appeals seeking to overturn the trial losses. Juries in each of the trials found that Monsanto’s glyphosate-based herbicides, such as Roundup, do cause cancer and that Monsanto spent decades hiding the risks.

The company’s efforts to resolve the litigation have been stymied in part by the challenge of how to head off claims that could be brought in the future by people who develop cancer after using the company’s herbicides.

Problems Just Keep Mounting  

Bayer has threatened to file for bankruptcy if it cannot quell the Roundup litigation and on Wednesday the company issued a profit warning and announced billions in cost cuts, citing a “lower than expected outlook in the agricultural market” amid other factors. The news sent shares in the company tumbling.

In reporting Bayer’s troubles Barron’s noted: “The problems just keep mounting for Bayer and its investors, who by now must be used to regular bouts of disappointing news. The stock has now fallen more than 50% since the Monsanto deal was closed in June 2018. “This latest update only adds to the case for the Monsanto deal being one of the worst in corporate history.”

Glyphosate Fact Sheet: Cancer and Other Health Concerns

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Glyphosate, a synthetic herbicide patented in 1974 by the Monsanto Company and now manufactured and sold by many companies in hundreds of products, has been associated with cancer and other health concerns. Glyphosate is best known as the active ingredient in Roundup-branded herbicides, and the herbicide used with “Roundup Ready” genetically modified organisms (GMOs).

Herbicide tolerance is the most prevalent GMO trait engineered into food crops, with some 90% of corn and 94% of soybeans in the U.S. engineered to tolerate herbicides, according to USDA data. A 2017 study found that Americans’ exposure to glyphosate increased approximately 500 percent since Roundup Ready GMO crops were introduced in the U.S in 1996. Here are some key facts about glyphosate:

Most Widely Used Pesticide

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 have applied 1.8 million tons of glyphosate since its introduction in 1974.
  • Worldwide 9.4 million tons of the chemical has been sprayed on fields – enough to spray nearly half a pound of Roundup on every cultivated acre of land in the world.
  • Globally, glyphosate use has risen almost 15-fold since Roundup Ready GMO crops were introduced.

Statements from scientists and health care providers 

Cancer Concerns

The scientific literature and regulatory conclusions regarding glyphosate and glyphosate-based herbicides show a mix of findings, making the safety of the herbicide a hotly debated subject. 

In 2015, the World Health Organization’s International Agency for Research on Cancer (IARC) classified glyphosate as “probably carcinogenic to humans” after reviewing years of published and peer-reviewed scientific studies. The team of international scientists found there was a particular association between glyphosate and non-Hodgkin lymphoma.

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 EPA issued an Interim Registration Review Decision in January 2020 with updated information about its position on glyphosate. 

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.

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.

Recent studies linking glyphosate to cancer and other health concerns 

Cancer

Endocrine disruption, fertility and reproductive concerns 

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.

Harmful impacts bees and monarch butterflies.

Cancer lawsuits

More than 42,000 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. For news and tips about the ongoing legislation, see Carey Gillam’s Roundup Trial Tracker. 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. 

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:

Sri Lankan scientists awarded AAAS freedom award for kidney disease research

The AAAS has 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 have 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. See papers in  SpringerPlus (2015), BMC Nephrology (2015), Environmental Health (2015), International Journal of Environmental Research and Public Health (2014). The AAAS award 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

Desiccation: another source of dietary exposures 

Some farmers use glyphosate on non-GMO crops such as wheat, barley, oats, and lentils to dry down the crop ahead of harvest in order to accelerate the harvest. This practice, known as desiccation, may be a significant source of dietary exposure to glyphosate.

Glyphosate in food: U.S. drags its feet on testing

The USDA quietly dropped a plan to start testing food for residues of glyphosate in 2017. Internal agency documents obtained by U.S. Right to Know show the agency had planned to start testing over 300 samples of corn syrup for glyphosate in April 2017. But the agency killed the project before it started. The U.S. Food and Drug Administration began a limited testing program in 2016, but the effort was fraught with controversy and internal difficulties and the program was suspended in September 2016. Both agencies have programs that annually test foods for pesticide residues but both have routinely skipped testing for glyphosate.

Before the suspension, one FDA chemist found alarming levels of glyphosate in many samples of U.S. honey, levels that were technically illegal because there have been no allowable levels established for honey by the EPA. Here is a recap of news about glyphosate found in food:

Pesticides in our food: Where’s the safety data?

USDA data from 2016 shows detectable pesticide levels in 85% of more than 10,000 foods sampled, everything from mushrooms to grapes to green beans. The government says there are little to no health risks, but some scientists say there is little to no data to back up that claim. See “Chemicals on our food: When “safe” may not really be safe: Scientific scrutiny of pesticide residue in food grows; regulatory protections questioned,” by Carey Gillam (11/2018).