Pursuing truth and transparency for public health

The Monsanto Papers – Deadly Secrets, Corporate Corruption, and One Man’s Search for Justice

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USRTK Research Director Carey Gillam’s new book is out now and garnering glowing reviews. Here is a brief description of the book from publisher Island Press:

Lee Johnson was a man with simple dreams. All he wanted was a steady job and a nice home for his wife and children, something better than the hard life he knew growing up. He never imagined that he would become the face of a David-and-Goliath showdown against one of the world’s most powerful corporate giants. But a workplace accident left Lee doused in a toxic chemical and facing a deadly cancer that turned his life upside down. In 2018, the world watched as Lee was thrust to the forefront of one the most dramatic legal battles in recent history.

The Monsanto Papers is the inside story of Lee Johnson’s landmark lawsuit against Monsanto. For Lee, the case was a race against the clock, with doctors predicting he wouldn’t survive long enough to take the witness stand. For the eclectic band of young, ambitious lawyers representing him, it was a matter of professional pride and personal risk, with millions of their own dollars and hard-earned reputations on the line.

With a gripping narrative force, The Monsanto Papers takes readers behind the scenes of a grueling legal battle, pulling back the curtain on the frailties of the American court system and the lengths to which lawyers will go to fight corporate wrongdoing and find justice for consumers.

See more about the book here. Buy the book at AmazonBarnes & Noble, publisher Island Press or independent book sellers.

Reviews

“A powerful story, well told, and a remarkable work of investigative journalism. Carey Gillam has written a compelling book from beginning to end, about one of the most important legal battles of our time.”  — Lukas Reiter, TV executive producer and writer for “The Blacklist,” “The Practice,” and “Boston Legal”

“The Monsanto Papers blends science and human tragedy with courtroom drama in the style of John Grisham. It is a story of corporate malfeasance on a grand scale – a chilling revelation of the chemical industry’s greed, arrogance, and reckless disregard for human life and the health of our planet. It is a must read.”  — Philip J. Landrigan, MD, Director, Program for Global Public Health and the Common Good, Boston College

“Veteran investigative journalist Carey Gillam tells Johnson’s story in her latest book, “The Monsanto Papers,” a fast-paced, engaging account of how Monsanto and Bayer’s fortunes changed dramatically in such a short span of time. Despite the subject matter — complicated science and legal proceedings — “The Monsanto Papers” is a gripping read that provides an easy-to-follow explanation of how this litigation unfolded, how the jurors reached their verdict and why Bayer appears to be, in effect, throwing up a white flag now.”  — St. Louis Post-Dispatch

“The author builds a convincing case that Monsanto was more interested in protecting the reputation of its cash cow than heeding scientific evidence of its dangerous properties. Gillam is especially good at rendering the complex dynamics of the legal personalities, which adds a further humanizing dimension to Johnson’s story…An authoritative takedown of a corporation that evidently cares little for public health.”  ― Kirkus

“Gillam narrates an of-the-moment reckoning with a major corporation whose products have been marketed as safe since the 1970s. As an examination of both corporate malfeasance and legal maneuvering in torts cases, Gillam’s book personifies the need for consumer protections and safety.”  ― Booklist

“A great read, a page turner. I was totally engrossed by the deception, distortions, and lack of decency of the company.”  — Linda S. Birnbaum, Former Director, National Institute of Environmental Health Sciences and National Toxicology Program, and Scholar in Residence, Duke University

“A powerful book that sheds light on Monsanto and others who have been untouchable for so long!”
— John Boyd Jr., Founder and President, National Black Farmers Association

About the Author

Investigative journalist Carey Gillam has spent more than 30 years reporting on corporate America, including 17 years working for Reuters international news agency. Her 2017 book about pesticide dangers, Whitewash: The Story of a Weed Killer, Cancer, and the Corruption of Science, won the 2018 Rachel Carson Book Award from the Society of Environmental Journalists and has become a part of the curriculum in several university environmental health programs. Gillam is currently Research Director for the non-profit consumer group U.S. Right to Know and writes as a contributor for The Guardian.

Bayer’s plan for settling future Roundup cancer claims faces broad opposition

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Dozens of U.S. law firms have formed a coalition to fight a new $2 billion settlement proposal by Monsanto owner Bayer AG that aims to contain the company’s ongoing liability related to claims that Roundup herbicides cause a type of cancer known as non-Hodgkin lymphoma (NHL).

The settlement is designed to compensate people who have been exposed to Roundup products and either already have NHL or may develop NHL in the future, but who have not yet taken steps to file a lawsuit.

The small group of lawyers who put the plan together with Bayer say it will “save lives” and provide substantial benefits to people who believe they developed cancer from exposure to the company’s herbicide products.

But many lawyers criticizing the plan say if it is approved it would set a dangerous precedent for other types of litigation involving large numbers of people injured by the products or practices of powerful corporations.

“This is not the direction we want the civil justice system to go,” said attorney Gerald Singleton, whose firm has joined with more than 60 other law firms to oppose Bayer’s plan. “There is no scenario under which this is good for plaintiffs.”

Bayer’s settlement plan was filed with the U.S. District Court for the Northern District of California on Feb. 3, and must be approved by U.S. District Judge Vince Chhabria in order to become effective. A prior settlement plan submitted last year was scorned by Chhabria and then withdrawn. The judge has been overseeing the federal multidistrict Roundup litigation involving thousands of plaintiffs from around the United States.

Responses to the settlement plan are due March 3 and a hearing on the matter is set for March 31.

A key concern is that current Roundup users who may develop cancer and want to sue in the future will automatically be subject to terms of the class settlement unless they officially opt out of the settlement within a specific time period. One of the terms they would be subject to would bar them from seeking punitive damages in any future lawsuit.

Those terms and others laid out are wholly unfair to farm workers and others who are expected to develop cancer in the future from exposure to the company’s herbicide products, according to Singleton. The plan benefits Bayer and provides “blood money” to the four law firms that worked with Bayer to design the plan, he said.

Those firms working with Bayer to draft and administer the plan would receive a proposed $170 million if the plan takes effect.

Elizabeth Cabraser, one of the lawyers who crafted the new proposed settlement, said the criticism is not a fair description of the settlement. In truth, she said, the plan “provides significant and urgently-needed outreach, education, healthcare access, and compensation benefits” for people who have been exposed to Monsanto’s Roundup herbicides but have not yet developed non-Hodgkin lymphoma (NHL).

“We seek approval of this settlement because it will save lives and enhance quality of life through early diagnosis, assist people… inform them and raise public awareness about the link between Roundup and NHL…” she said.

A spokesman for Bayer did not respond to a request for comment.

The new proposed settlement is aimed at future cases and is separate from the $11 billion Bayer has earmarked to settle existing U.S. Roundup cancer claims. The people impacted by the class settlement proposal are only individuals who have been exposed to Roundup but are not yet in litigation and have taken no steps toward any litigation.

Bayer has been struggling to figure out how to put an end to the Roundup cancer litigation since buying Monsanto in 2018. The company lost all three trials held to date and lost the early rounds of appeals seeking to overturn the trial losses.

Juries in each of the trials found not only that Monsanto’s glyphosate-based herbicides cause cancer but also that Monsanto spent decades hiding the risks.

Though the proposed settlement states that it “addresses the four concerns the Court raised regarding the prior, withdrawn settlement,” Singleton and other lawyers involved in the opposition said the new settlement proposal is just as bad as the first.

In addition to the concerns that class members would not have the right to seek claims for punitive damages, the critics also object to the four-year “standstill” period blocking the filing of new lawsuits. The critics also say the plan for notifying people of the class settlement is not sufficient. Individuals would have 150 days following the notification to “opt out” of the class. If they do not opt out, they are automatically in the class.

Critics also object to the proposed formation of a science panel that would act as a “guidepost” for an “extension of compensation options into the future” and to provide evidence about the carcinogenicity – or not – of Bayer’s herbicides.  Given Monsanto’s documented history of manipulating scientific findings, the science panel work would be suspect, said Singleton.

The initial settlement period would run for at least four years and could be extended after that period.  If Bayer elects not to continue the compensation fund after the initial settlement period, it will pay an additional $200 million as an “end payment” into the compensation fund, the settlement summary states.

“Substantial compensation” offered

The law firms that drafted the agreement with Bayer said in their filing to the court that the settlement is structured to provide potential future plaintiffs with “what most serves their interests,” including an option for “substantial compensation” if they develop non-Hodgkin lymphoma.

The plan calls for the establishment of a compensation fund to make awards of between $10,000 and $200,000 per individual class member. “Accelerated Payment Awards” of $5,000 would be available on an expedited basis, requiring just a showing of exposure and diagnosis.

Those people first exposed to Roundup products at least 12 months prior to their diagnosis would be qualified for awards. Awards of  more than $200,000 could be made for “extraordinary circumstances.” Those qualified class members who were diagnosed with NHL before January 1, 2015, would not receive awards more than $10,000, according to the plan. 

The settlement would provide free legal advice and provide ”support to assist class members in navigating, registering, and applying for Settlement benefits.”

Additionally, the proposal states that the settlement will fund medical and scientific research into the diagnosis and treatment of NHL.

Notably, the plan states that no one will lose their right to sue unless they choose to accept compensation from the compensation fund, and no one needs to make that choice until that individual class member is diagnosed with NHL. They would not be able to seek punitive damages but could seek other compensation.

“Any class members who do not file a claim and accept individual compensation retain their right to sue Monsanto for compensatory damages on any legal theory, including personal injury, fraud, misrepresentation, negligence, fraudulent concealment, negligent misrepresentation, breach of warranty, false advertising, and violation of any consumer protection or unfair and deceptive acts or practices statute,” the plan states.

To alert people to the class action settlement, notices would be mailed/emailed to 266,000 farms, businesses and organizations and government entities where the company’s herbicides could have been used as well as to 41,000 people who have non-Hodgkin lymphoma and asked to receive information about their disease. Additionally posters would be mailed to 2,700 stores asking them to post notices of the class action settlement.

As part of the proposed settlement, Bayer said it would seek permission from the Environmental Protection Agency (EPA) to add information on the labels of its glyphosate-based products such as Roundup that would provide links to access to scientific studies and other information about glyphosate safety. But critics say providing a website links is inadequate and Bayer needs to put a straightforward warning of cancer risk on the weed killing products.

The proposed class action settlement threatens to affect “hundreds of thousands or even millions” of people who have been exposed to Roundup and “raises ‘unique’ and profound questions” under the U.S. Constitution, according to a court filing in opposition to the Bayer plan made by plaintiffs’ lawyer Elizabeth Graham.

Graham told the court that if the plan is approved it could have a “dramatic effect not only on this litigation, but on the future of mass tort litigation.”

Black farmers

 The National Black Farmers Association (NBFA) weighed in on the issue on Wednesday, submitting a lengthy filing with Chhabria’s court that states a “substantial proportion” of its more than 100,000 members “have been exposed to and potentially injured by Roundup, and its active ingredient glyphosate.”

Many of the farmers have already developed non-Hodgkin’s lymphoma they blame on Roundup use, and “an even larger proportion fear that they will soon develop symptoms,” the NBFA filing states.

The NBFA wants to see Roundup products removed from commerce or other changes made to protect farmers, the filing states.

The concerns of the NBFA need to be addressed by the court, particularly as Bayer looks to “settle a class action with a set of attorneys who purport to be representing the future interests of all farmers who have been exposed to Roundup but are yet to develop the cancers it causes.”

Lawsuits in Australia

As Bayer works to bring an end to Roundup litigation in the United States, the company is also dealing with similar claims by farmers and others in Australia. A class action filed against Monsanto is underway, and the lead plaintiff John Fenton, who applied Roundup as part of farm work. Fenton was diagnosed with non-Hodgkin lymphoma in 2008.

A series of key dates have been established: Monsanto has until March 1 to provide discovery documents to plaintiffs’ lawyers and June 4 is the deadline set for the exchange of expert evidence.  The parties are to enter into mediation by July 30 and if nothing is resolved the case would go to trial in March 2022.

Fenton said while he would “love the opportunity” to go to trial and tell his story, he hopes mediation will resolve the matter. “I think the consensus is starting to change thanks to what has been happening in the US. Farmers are more aware and I believe they do take more precautions than they used to.

Fenton said he hopes that Bayer ultimately will put a warning label on Monsanto’s glyphosate herbicides.

“At least with a warning the user can make up their own mind about what PPE (personal protective equipment) they choose to wear.”

Another Roundup study finds links to potential human health problems

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(Updated February 17, adding criticism of study)

A new scientific paper examining the potential health impacts of Roundup herbicides found links between exposure to the weed killing chemical glyphosate and an increase in a type of amino acid known to be a risk factor for cardiovascular disease.

The researchers made their determinations after exposing pregnant rats and their newborn pups to glyphosate and Roundup through drinking water. They said they looked specifically at the effects of glyphosate-based herbicides (GBH) on urinary metabolites and interactions with the gut microbiome in the animals.

The researchers said they found a significant increase of an amino acid called homocysteine in male rat pups exposed to glyphosate and Roundup.

“Our study provides initial evidence that exposures to commonly used GBH, at a currently acceptable human exposure dose, is capable of modifying urine metabolites in both rat adults and pups,” the researchers stated.

The paper, titled “Low-dose exposure of glyphosate-based herbicides disrupt the urine metabolome and its interaction with gut microbiota,” is authored by five researchers affiliated with the Icahn School of Medicine at Mount Sinai in New York and four from the Ramazzini Institute in Bologna, Italy. It was published in the journal Scientific Reports February 5.

The authors acknowledged many limitations with their study, including a small sample size, but said their work showed that “gestational and early-life low-dose exposure to glyphosate or Roundup significantly altered multiple urine metabolomic biomarkers, in both dams and offspring.”

The study is the first on urinary metabolomic changes induced by glyphosate-based herbicides at doses currently considered safe in humans, the researchers said.

The paper follows the publication last month of a study in the journal Environmental Health Perspectives that found glyphosate and a Roundup product can alter the composition of the gut microbiome in ways that may be linked to adverse health outcomes. Scientists from the Ramazzini Institute were also involved in that research.

Robin Mesnage, one of the authors of the paper published last month in Environmental Health Perspectives, took issue with the validity of the new paper. He said the data analysis showed the differences detected between the animals exposed to glyphosate and those not exposed – the control animals – could have been similarly detected with randomly generated data.

“Overall, the data analysis doesn’t support the conclusion that glyphosate disrupts the urine metabolome and the gut microbiota of the exposed animals,” said Mesnage. “This study will only further confuse a bit more the debate on the toxicity of glyphosate.”

Several recent studies on glyphosate and Roundup have found an array of concerns.

Bayer, which inherited Monsanto’s glyphosate-based herbicide brand and its glyphosate-tolerant genetically engineered seed portfolio when it bought the company in 2018, maintains that an abundance of scientific study over decades confirms that glyphosate does not cause cancer. The U.S. Environmental Protection Agency and many other international regulatory bodies also do not consider glyphosate products to be carcinogenic.

But the World Health Organization’s International Agency for Research on Cancer in 2015 said a review of scientific research found ample evidence that glyphosate is a probable human carcinogen.

Bayer has lost three out of three trials brought by people who blame their cancers on exposure to Monsanto’s herbicides, and Bayer last year said it would pay roughly  $11 billion to settle more than 100,000 similar claims.

 

 

Bayer makes new $2 billion plan to head off future Roundup cancer claims

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Monsanto owner Bayer AG said Wednesday it was attempting again to manage and resolve potential future Roundup cancer claims, laying out a $2 billion deal with a group of plaintiffs’ attorneys that Bayer hopes will win approval from a federal judge who rejected a prior plan last summer.

Notably, the deal calls for Bayer to seek permission from the Environmental Protection Agency (EPA) to add information on the labels of its glyphosate-based products such as Roundup that would provide  links to access to scientific studies and other information about glyphosate safety.

Additionally, according to Bayer, the plan calls for establishment of a fund that would compensate “qualified claimants” over a four-year program; setting up an advisory science panel whose findings could be used as evidence in potential future litigation; and development of research and diagnostic programs for medical and/or scientific research into the diagnosis and treatment of non-Hodgkin lymphoma.

The plan must be approved by U.S. District Judge Vince Chhabria of the U.S. District Court for the Northern District of California. Chhabria has been overseeing the Roundup multidistrict litigation.

Bayer said qualifying class members over the next four years would be eligible for levels of compensatory awards based on guidelines set forth in the agreement. The “settlement class” refers to people who were exposed to Roundup products but have not yet filed a lawsuit claiming injury from that exposure.

Settlement class members would be eligible for compensation between $10,000 and $200,000, Bayer said.
According to the agreement, the distribution of the settlement fund would break out as follows:
* Compensation Fund – At least $1.325 billion
* Diagnostic Accessibility Grant Program – $210 million
* Research Funding Program – $40 million
* Settlement Administration Costs, Advisory Science Panel Costs, Settlement Class Notice Costs, Taxes,
and Escrow Agent Fees and Expenses – Up to $55 million
The proposed settlement plan for future class action litigation is separate from the settlement agreement Bayer made with lawyers for tens of thousands of plaintiffs who have already brought claims alleging exposure to Roundup and other Monsanto glyphosate-based weed killers caused them to develop non-Hodgkin lymphoma.
Bayer has been struggling to figure out how to put an end to the Roundup cancer litigation since buying Monsanto in 2018. The company lost all three trials held to date and lost the early rounds of appeals seeking to overturn the trial losses.
Juries in each of the trials found not only that Monsanto’s glyphosate-based herbicides cause cancer but also that Monsanto spent decades hiding the risks.

New study finds glyphosate-related alterations in gut microbiome

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A new animal study by a group of European researchers has found that low levels of the weed killing chemical glyphosate and the glyphosate-based Roundup product can alter the composition of the gut microbiome in ways that may be linked to adverse health outcomes.

The paper, published Wednesday in the journal Environmental Health Perspectives, is authored by 13 researchers, including study lead Dr. Michael Antoniou, head of the Gene Expression and Therapy Group within the Department of Medical and Molecular Genetics at King’s College in London, and Dr. Robin Mesnage, a research associate in computational toxicology within the same group.  Scientists from the Ramazzini Institute in Bologna, Italy, participated in the study as did scientists from France and the Netherlands.

The effects of glyphosate on the gut microbiome were found to be caused by the same mechanism of action by which glyphosate acts to kill weeds and other plants, the researchers said.

The microbes in the human gut include a variety of bacteria and fungi that impact immune functions and other important processes, and a disruption of that system can contribute to a range of diseases, the researchers said.

“Both the glyphosate and the Roundup did have an effect on gut bacterial population composition,” Antoniou said in an interview. “We know that our gut is inhabited by thousands of different types of bacteria and a balance in their composition, and more important in their function, is crucial for our health. So anything that disturbs, negatively disturbs, the gut microbiome… has the potential of causing ill health because we go from balanced functioning that is conducive to health to imbalanced functioning that may lead to a whole spectrum of different diseases.”

See Carey Gillam’s interview Dr. Michael Antonoiu and Dr. Robin Mesnage about their new study looking at glyphosate impact on the gut microbiome.

The authors of the new paper said they determined that, contrary to some assertions by critics of glyphosate use, glyphosate did not act as an antibiotic, killing off necessary bacteria in the gut.

Instead, they found – for the first time, they said – that the pesticide interfered in a potentially worrisome way with the shikimate biochemical pathway of the gut bacteria of the animals used in the experiment. That interference was highlighted by changes in specific substances in the gut. Analysis of  gut and blood biochemistry revealed evidence that the animals were under oxidative stress, a condition associated with DNA damage and cancer.

The researchers said it was not clear if the disturbance within the gut microbiome influenced the metabolic stress.

The indication of oxidative stress was more pronounced in experiments using a glyphosate-based herbicide called Roundup BioFlow, a product of Monsanto owner Bayer AG, the scientists said.

The study authors said they were conducting more studies to try to decipher if the oxidative stress they observed was also damaging DNA, which would raise the risk of cancer.

The authors said more research is needed to truly understand the health implications of glyphosate inhibition of the shikimate pathway and other metabolic disturbances in the gut microbiome and blood but the early findings could be used in the development of bio-markers for epidemiological studies and to understand if glyphosate herbicides can have biological effects in people.

In the study, female rats were given glyphosate and the Roundup product. The doses were delivered through the drinking water provided to the animals and were given at levels representing the acceptable daily intakes considered safe by European and U.S. regulators.

Antoniou said the study results build on other research that makes it clear regulators are relying on outdated methods when determining what constitutes “safe” levels of glyphosate and other pesticides in food and water. Residues of pesticides used in agriculture are commonly found in a range of regularly consumed foods.

“Regulators need to come into the twenty-first century, stop dragging their feet… and embrace the types of analyses that we have done in this study,” Antoniou said. He said molecular profiling, part of a branch of science known as “OMICS,” is revolutionizing the base of knowledge about the impacts chemical exposures have on health.

The rat study is but the latest in a series of scientific experiments aimed at determining if glyphosate and glyphosate-based herbicides – including Roundup – can be harmful to humans, even at levels of exposure regulators assert are safe.

Several such studies have found an array of concerns, including one published in November  by researchers from the University of Turku in Finland who 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.

As researchers increasingly look to understand the human microbiome and the role it plays in our health, questions about potential glyphosate impacts on the gut microbiome have been the subject not only of debate in scientific circles, but also of litigation.

Last year, Bayer agreed to pay $39.5 million to settle claims that Monsanto ran misleading advertisements asserting glyphosate only effected an enzyme in plants and could not similarly impact pets and people. The plaintiffs in the case alleged glyphosate targeted an enzyme found in humans and animals that bolsters the immune system, digestion and brain function.

Bayer, which inherited Monsanto’s glyphosate-based herbicide brand and its glyphosate-tolerant genetically engineered seed portfolio when it bought the company in 2018, maintains that an abundance of scientific study over decades confirms that glyphosate does not cause cancer. The U.S. Environmental Protection Agency and many other international regulatory bodies also do not consider glyphosate products to be carcinogenic.

But the World Health Organization’s International Agency for Research on Cancer in 2015 said a review of scientific research found ample evidence that glyphosate is a probable human carcinogen.

Since that time, Bayer has lost three out of three trials brought by people who blame their cancers on exposure to Monsanto’s herbicides, and Bayer last year said it would pay roughly  $11 billion to settle more than 100,000 similar claims.

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.

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 EFSA assessment

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

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

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

Health effects and key studies  

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

Cancer

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.”

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