An Unappetizing Analysis from the FDA

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Last month the Food & Drug Administration published its latest annual analysis of the levels of pesticide residues that contaminate the fruits and veggies and other foods we Americans routinely put on our dinner plates. The fresh data adds to growing consumer concern and scientific debate over how pesticide residues in food may contribute – or not – to illness, disease and reproductive problems.

Over 55 pages of data, charts and graphs, the FDA’s “Pesticide Residue Monitoring Program” report also provides a rather unappetizing example of the degree to which U.S. farmers have come to rely on synthetic insecticides, fungicides and herbicides in growing our food.

We learn, for instance, in reading the latest report, that traces of pesticides were found in 84 percent of domestic samples of fruits, and 53 percent of vegetables, as well as 42 percent of grains and 73 percent of food samples simply listed as “other.” The samples were drawn from around the country, including from California, Texas, Kansas, New York and Wisconsin.

Roughly 94 percent of grapes, grape juice and raisins tested positive for pesticide residues as did 99 percent of strawberries, 88 percent of apples and apple juice, and 33 percent of rice products, according to the FDA data.

Imported fruits and vegetables actually showed a lower prevalence of pesticides, with 52 percent of fruits and 46 percent of vegetables from abroad testing positive for pesticides. Those samples came from more than 40 countries, including Mexico, China, India and Canada.

We also learn that for the most recently reported sampling, among the hundreds of different pesticides, the FDA found traces of the long-banned insecticide DDT in food samples, as well as chlorpyrifos, 2,4-D and glyphosate.  DDT is linked to breast cancer, infertility and miscarriage, while chlorpyrifos – another insecticide – has been scientifically shown to cause neurodevelopmental problems in young children.

Chlorpyrifos is so dangerous that the European Food Safety Authority has recommended a ban of the chemical in Europe, finding that there is no safe exposure level. The herbicides 2,4-D and glyphosate are both linked to cancers and other health problems as well.

Thailand recently said it was banning glyphosate and chlorpyrifos due to the scientifically established risks of these pesticides.

Despite the prevalence of pesticides found in U.S. foods, the FDA, along with the Environmental Protection Agency (EPA) and the U.S. Department of Agriculture (USDA), assert that pesticide residues in food are really nothing to worry about. Amid heavy lobbying by the agrichemical industry the EPA has actually supported continued use of glyphosate and chlorpyrifos in food production.

The regulators echo the words of Monsanto executives and others in the chemical industry by insisting that pesticide residues pose no threat to human health as long as the levels of each type of residue falls under a “tolerance” level set by the EPA.

In the most recent FDA analysis, only 3.8 percent of domestic foods had residue levels that were considered illegally high, or “violative.” For imported foods, 10.4 percent of the foods sampled were violative, according to the FDA.

What the FDA did not say, and what regulatory agencies routinely avoid saying publicly, is that the tolerance levels for certain pesticides have risen over the years as the companies that sell the pesticides request higher and higher legal limits. The EPA has approved several increases allowed for glyphosate residues in food, for instance. As well, the agency often makes the determination that it need not comply with a legal requirement that states the EPA  “shall apply an additional tenfold margin of safety for infants and children” in setting the legal levels for pesticide residues. The  EPA has overridden that requirement in the setting of many pesticide tolerances, saying no such extra margin of safety is needed to protect children.

The bottom line: The higher the EPA sets the “tolerance” allowed as the legal limit, the lower the possibility that regulators will have to report “violative” residues in our food.  As a result, the U.S. routinely allows higher levels of pesticide residues in food than other developed nations. For example, the legal limit for the weed killer glyphosate on an apple is 0.2 parts per million (ppm) in the United States but only half that level – 0.1 ppm – is allowed on an apple in the European Union. As well, the U.S. allows residues of glyphosate on corn at 5 ppm, while the EU allows only 1 ppm.

As legal limits rise for pesticide residues in food, many scientists have been increasingly raising alarms about the risks of regular consumption of the residues, and the lack of regulatory consideration of the potential cumulative impacts of consuming an array of bug and weed killers with every meal.

A team of Harvard scientists are calling for in-depth research about potential links between disease and consumption of pesticide as they estimate that more  than 90 percent of people in the United States have  pesticide residues in their urine and blood due to consumption of pesticide-laced foods.  A study connected to Harvard found that dietary pesticide exposure within a “typical” range was associated both with problems women had getting pregnant and delivering live babies.

Additional studies have found other health problems tied to dietary exposures to pesticides, including to glyphosate.  Glyphosate is the most widely used herbicide in the world and is the active ingredient in Monsanto’s branded Roundup and other weed killing products.

Pesticide Industry Push Back 

But as the concerns mount, agrichemical industry allies are pushing back. This month a group of three researchers with long-standing close ties to the companies that sell agricultural pesticides released a report seeking to soothe consumer worries and discount the scientific research.

The report, which was issued Oct. 21, stated that “there is no direct scientific or medical evidence indicating that typical exposure of consumers to pesticide residues poses any health risk. Pesticide residue data and exposure estimates typically demonstrate that food consumers are exposed to levels of pesticide residues that are several orders of magnitude below those of potential health concern.”

Not surprisingly, the three authors of the report are closely tied to the agrichemical industry. One of the report’s authors is Steve Savage, an agrichemical industry consultant and former DuPont employee. Another is Carol Burns, a former scientist for Dow Chemical and current consultant for Cortevia Agriscience, a spin-off of  DowDuPont. The third author is Carl Winter, Chair of the Department of Food Science and Technology at the University of California at Davis. The university has received approximately $2 million a year from the agrichemical industry, according to a university researcher, though the accuracy of that figure has not been established.

The authors took their report directly to Congress, holding three different presentations in Washington, D.C., designed to promote their message of pesticide safety for use in “media food safety stories, and consumer advice regarding which foods consumers should (or should not) consume.”

The pro-pesticide sessions were held at the office buildings for members of Congress and, appropriately it seems, at the headquarters for CropLife America, the lobbyist for the agrichemical industry. 

 

A Message from Maine: It’s Time to Get Serious About Sustainability

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As summer turns to fall, the Maine landscape is beautiful to behold. Lush forests stretch as far as the eye can see in a tapestry of green, yellow and crimson-colored leaves. Every few miles along a narrow roadway, restored wooden barns adjoin modest homes set on tidy acres where farm families coax food from the soil and tend to livestock.

I was fortunate to visit this northeastern farm state recently, spending time at the “Common Ground Country Fair” in Unity, Maine. Only about 2,000 people live in the tiny town, but an estimated 57,000 people jammed the single-lane roads to swarm this year’s three-day event in late September.

The fair was part celebration and part education – a festival of first-hand knowledge about how to produce food in ways that focus on enhancing, not endangering, human and environmental health. Young and old gathered in yellow-and-white striped tents to discuss such topics as the marketing of organic lowbush wild blueberries, how to develop “micro-dairies,” and science that shows healthy, chemical-free soils can better sequester carbon from the atmosphere as a mitigant to the climate crisis.

In a jangly parade running through the middle of the fairgrounds, children and adults dressed as honeybees, fresh vegetables, sunflowers and trees and carried colorful signs calling for protections from the threats posed by industrial agriculture. One small child carried a sign that read “No sprays on me.”

The messages carried through that parade and across the fairgrounds speak to the fact that alongside this jovial festival of food and farming are mounting concerns about a lack of leadership in Washington and federal promotion of the permissive use of synthetic fertilizers and pesticides in farming; as well as the monoculture cropping practices that have become a mainstay of U.S. agriculture and are stripping away essential biodiversity.

This week, a group of state leaders cut the ribbon on a project to help address those concerns by promoting sustainable solutions in Maine that they intend as an example for the rest of the nation to follow.

The Maine Harvest Federal Credit Union opened its doors Oct. 8 as the first U.S. member-owned financial institution focused solely on funding small farms and food businesses that engage in sustainable agricultural practices. The credit union aims to provide financing for endeavors that improve access to fresh, locally grown food and are environmentally protective. With roughly 40 percent of the state’s 7,600 farms run by men and women under the age of 40, there is an appetite for progressive strategies to improve food production systems, supporters say.

“We are not there to finance commodity agriculture. We are organized to serve a re-vitalized and re-localized food economy,” co-founder Sam May told me. “The modern food system has it all wrong. It is killing the planet, the soil, our personal health and putting our civilization at risk. We are doing what we are doing in Maine because it needs to be done and we can do it.”

The credit union founders, former veterans of Wall Street, have raised $2.4 million in capital that includes a $300,000 conservation innovation grant from the U.S. Department of Agriculture.  The founders have garnered the support of the state’s U.S. congressional delegation, including Republican U.S. Sen. Susan Collins.

U.S. Rep. Chellie Pingree, a Democrat from Maine, emphasized the need for more of this type of support: “Our food economy is growing rapidly and financial support will be a big part of that continued growth going forward. I’m so pleased to see this first-in-the-country credit union that will support the unique needs of small farms and food businesses. I hope other states take note and help to close the gap between farmers and their financial institutions,” she said in a statement.

The work is not just admirable but urgent. In addition to scientific reports linking industrial agriculture and agrochemicals to water pollution, sterile soils, human diseases and reproductive problems, recently released research shows additional links to sharp declines in important bird and insect populations.

But rather than heed the warnings, the Trump Administration is racing to rollback regulatory protections at a rapid rate.

It seems fitting that it was here in Maine, more than 50 years ago, where author Rachel Carson kept a cottage and would sometimes retreat as she wrote about the dire consequences of a world awash in chemicals, a world where nature is sacrificed, and the sounds of song birds going silent.

To visit a country fair in the fall in Maine is to see what that long-ago call for action from Carson looks like in modern form. These are people who recognize that they must protect and build upon systems that sustain and nourish, not systems that destroy. These are people who hope their children and grandchildren will always be able to behold a landscape of lush forests and rich farmland as far as the eye can see.

It’s a lesson the rest of the country needs to learn. There is no time to waste.

UPDATED- St. Louis Trial over Monsanto Roundup Cancer Claims in Limbo

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(UPDATE) – On Sept. 12, the Missouri Supreme Court closed the case, agreeing with plaintiffs’ attorneys that Monsanto’s request for the high court to take up the venue issue was moot.   St. Louis Circuit Court Judge Michael Mullen then transferred all plaintiffs except Winston to St. Louis County in a Sept. 13 order.)

An October trial pitting a group of cancer patients against Monsanto in the company’s former home state of Missouri is snared in a tangled web of actions that threaten to indefinitely postpone the case.

New court filings show that lawyers for both sides of Walter Winston, et al v. Monsanto have been engaging in a series of strategic moves that may now be backfiring on them leading up to the trial date of Oct. 15 date set by St. Louis Circuit Court Judge Michael Mullen. Lawyers for the 14 plaintiffs named in the Winston lawsuit have been pushing to keep their case on track so they can present claims from the cancer victims to a St. Louis jury next month. But Monsanto lawyers have been working to delay the trial and disrupt the combination of plaintiffs.

The Winston lawsuit, filed in March of 2018, would be the first trial to take place in the St. Louis area. Before selling to the German company Bayer AG last year, Monsanto was based in the suburb of Creve Coeur and was one of the largest St. Louis area-based employers.  Roundup cancer trials that had been set for St. Louis area in August and September have both already been delayed until next year.

The plaintiffs in the Winston case are among more than 18,000 people in the United States suing Monsanto claiming that exposure to the company’s glyphosate-based herbicides caused them to develop non-Hodgkin lymphoma and that Monsanto hid the risks associated with its weed killers.

The back and forth battling over where and when the Winston trial may or may not take place began more than a year ago and has involved not only the local St. Louis court but also the appeals court in Missouri and the state Supreme Court.

In March of this year Monsanto filed a motion to sever and transfer 13 of the 14 plaintiffs in the Winston case from the St. Louis City Court to the Circuit Court for the County of St. Louis, where the company’s registered agent was located and where “venue is proper.”  The motion was denied. The company had filed a similar motion in 2018 but it also was denied.

The plaintiffs’ lawyers opposed such a severing and transfer earlier this year, but they have now changed that stance because amid all the maneuvering, Monsanto has been seeking intervention by the Missouri Supreme Court. The state’s high court ruled earlier this year in an unrelated case that it was not proper for plaintiffs located outside St. Louis City to join their cases to a city resident in order to obtain venue in St. Louis City. St. Louis City court has long been considered a favorable venue for plaintiffs in mass tort actions

Monsanto’s bid for intervention by the Missouri Supreme Court was rewarded on Sept. 3 when the Supreme Court issued a “preliminary writ of prohibition” allowing Walter Winston’s individual case to “proceed as scheduled” in St. Louis City Circuit Court. But the court said that the cases of the 13 other plaintiffs joined in Winston’s lawsuit could not proceed at this time as it considers how to handle the cases. The court ordered a freeze on any further actions by the St. Louis City Court, “until the further order of this Court.”

Fearing their case will be broken apart and/or delayed waiting for a Supreme Court decision on venue, the plaintiffs’ lawyers on Sept. 4 said they were withdrawing their opposition to Monsanto’s request for a transfer of the case to St. Louis County.

But now Monsanto no longer wants the case transferred given the Supreme Court’s action. In a filing last week the company said: “Plaintiffs fought venue at every opportunity, instead of agreeing to transfer their claims to St. Louis County and seeking a trial setting in that Court long ago. Rewarding the Winston Plaintiffs for this choice will only encourage further gamesmanship.”

On Monday, the plaintiffs’ attorneys filed a response arguing that the Winston plaintiffs should be transferred to St. Louis County as Monsanto had previously requested and that would make the venue issue before the court moot. They also argued that the judge in St. Louis City who has been presiding over the Winston case should continue to handle the case within the county court system.

“With the withdrawal of their opposition to Monsanto’s motion, Plaintiffs have consented to the very relief that Monsanto requests of this Court – transfer of the Winston plaintiffs to St. Louis County,” the plaintiffs’ filing states.  “The Winston plaintiffs’ case is trial ready. If the case is transferred to St. Louis County in short order, the Plaintiffs can begin trial on or close to the schedule currently in place.”

Whether or not a trial will still take place in mid October in St. Louis is still an open question.

Tech, Medical and Farm Groups Ask Appeals Court to Overturn Verdict Against Monsanto

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Groups representing farm, medical and biotechnology interests have filed briefs with the California Court of Appeal, aligning with Monsanto in asking the court to overturn last summer’s jury verdict that found Monsanto’s glyphosate-herbicides cause cancer and determined that the company spent years covering up the risks.

The groups are urging the appeals court to either throw out the win a San Francisco jury gave to school groundskeeper Dewayne “Lee” Johnson in August of 2018 or to invalidate an order for Monsanto to pay punitive damages to Johnson. The Johnson trial was the first against Monsanto over claims that its glyphosate-based herbicides such as Roundup can cause non-Hodgkin lymphoma.

Johnson is one of more than 18,000 plaintiffs making similar claims. The lawsuits allege that Monsanto was aware of scientific research showing an association between its herbicides and cancer but rather than warn consumers the company worked to suppress the research and manipulate scientific literature.

The jury in the Johnson case decided Monsanto should pay $289 million in damages, including $250 million in punitive damages. The trial judge in the case later slashed the punitive damage amount, reducing the total award to $78 million. Two other juries in subsequent trials over similar claims have also found in favor of plaintiffs and ordered large punitive damages against Monsanto.

Monsanto appealed the verdict and Johnson cross-appealed, seeking reinstatement of the full $289 million. Oral arguments are expected in this appeals court this fall with a potential decision from the appeals court before the end of the year.

One of the parties filing a brief supporting Monsanto’s position is Genentech Inc., a San Francisco biotech company with a history of doing research for cancer treatments. In its appeal to the court, Genentech argues that it has expertise as a “science company” and sees the Johnson verdict as a threat to scientific progress. “Courts must ensure the proper use of science in the courtroom in order for innovation to flourish in the marketplace…” the Genentech brief states.

Genentech announced earlier this year a fast-track review from the Food and Drug Administration for a drug treatment for people with non-Hodgkin lymphoma.

In backing Monsanto’s appeal, Genentech echoed complaints by Monsanto that Johnson’s lawyers did not properly present expert scientific testimony: “Genentech writes to highlight the importance of the proper screening of scientific expert testimony for companies with scientifically innovative products and consumers who rely on their innovations.”

The company also sided with Monsanto on the issue of punitive damages, arguing that companies should not be subject to punitive damages if their product has been reviewed by a regulatory agency such as the Environmental Protection Agency (EPA) and found to not pose a risk to human health.

“Allowing juries to award punitive damages for products that have been specifically examined and approved by regulatory agencies creates a large risk of confusion for life-science-based companies and may deter the progress of science,” the Genentech brief states. “If such punitive damages awards are allowed, companies face the risk of massive punitive damages awards unless they routinely second guess the safety decisions of regulators.”

On Tuesday the California Farm Bureau Federation filed its own brief supporting Monsanto. The farm bureau, which says it represents 36,000 members, said the case is of “vital concern” to farmers and ranchers who “depend on crop protection tools to grow food and fiber.”

Even though the Johnson verdict does not impact the regulation of glyphosate herbicides, the farm bureau argues in its brief that the industry fears restrictions on the chemical. The farm group additionally argued that the “trial court’s decision disregards federal law, as well as state law…” because it conflicts with the EPA’s finding that glyphosate is not likely to cause cancer.

Additionally, California associations representing doctors, dentists and hospitals weighed in on behalf of Monsanto arguing that the jury’s decision in the Johnson case was “subject to emotional manipulation” and not based on “scientific consensus.”

“The answer to the complex scientific question the jury was required to resolve in this case should have been based on accepted scientific evidence and rigorous scientific reasoning, not the jury’s policy choices. Even worse, there is reason to suspect the jury’s analysis was based on speculation and emotion,” the associations said in their brief.

Johnson’s attorney, Mike Miller, said he feels “real good” about the chances of victory in the appeals court and described the brief from the California Medical Association as the “same sophomoric brief they file against every victim of negligence.”

Missouri Trial Can Proceed

In separate action in Missouri , the state’s supreme court said on Tuesday that a trial set to start Oct. 15 in the city of St. Louis can proceed as planned on behalf of plaintiff Walter Winston. Other plaintiffs who had joined in Winston’s complaint against Monsanto are expected to be severed and/or have their cases delayed, according to a decision by the Missouri Supreme Court. Monsanto had asked the high court to prohibit the trial from taking place due to the fact that several plaintiffs do not reside in the area.

The Supreme Court instructed St. Louis City Judge Michael Mullen “take no further action” at this time in the cases of the 13 plaintiffs.

Monsanto was acquired by Bayer AG in June of 2018, and Bayer’s share prices fell sharply following the Johnson verdict and have remained depressed. Investors are pressing for a global settlement to end the litigation.

Emails Reveal Science Publisher Found Papers On Herbicide Safety Should Be Retracted Due to Monsanto Meddling

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Secretive influence by Monsanto in a set of papers published in the scientific journal Critical Reviews in Toxicology was so unethical that an investigation by the publisher found that at least three of the papers should be retracted, according to a series of internal journal communications. The journal editor refused to retract the papers, which declared no cancer concerns with the  company’s herbicides, saying a retraction could impact last summer’s first-ever Roundup trial and harm the authors’ reputations, the emails show.

The journal communications were obtained through discovery by lawyers representing several thousand people suing Monsanto over claims that the company’s glyphosate-based herbicides cause cancer and that Monsanto has covered up the evidence of the dangers.

Unlike the internal Monsanto emails that have thus far come to light revealing the agrochemical company’s manipulation of scientific literature about its herbicides, these emails detail the inner battle within a major scientific publishing house over how it should confront Monsanto’s covert meddling. They were obtained as part of a deposition of Roger McClellan, the longtime editor in chief of the peer-reviewed journal Critical Reviews in Toxicology (CRT.)

The papers in question were published by CRT in September 2016 as an “Independent Review” of the carcinogenic potential of the weed-killing agent glyphosate, the main ingredient in Monsanto’s Roundup herbicide and other brands. The five papers published as part of the review directly contradicted the findings of the World Health Organization’s International Agency for Research on Cancer (IARC), which in 2015 found glyphosate to be a probable human carcinogen. The 16 authors of the papers concluded that the weight of evidence showed the weed killer was unlikely to pose any carcinogenic risk to people.

At the end of the papers the authors stated that their conclusions were free of Monsanto’s intervention. Underscoring the supposed independence of the work, the declaration of interest section stated: “Neither any Monsanto company employees nor any attorneys reviewed any of the Expert Panel’s manuscripts prior to submission to the journal.”

That statement was proven false in the fall of 2017 after internal Monsanto records came to light showing extensive involvement by Monsanto scientists in the drafting and editing of the papers as well as company involvement in selecting the authors. Additionally, internal records showed direct payments to at least two of the so-called independent authors. Monsanto had a contract with author Larry Kier, for instance, paying him $27,400 to work on the papers.

In response to those revelations and questions from media outlets, CRT publisher  Taylor & Francis Group  launched an investigation in the fall of 2017. The newly released communications reveal that after spending months questioning the authors about how the papers came together,  a team of legal and ethics experts put together by Taylor & Francis concluded that the authors had hidden Monsanto’s direct  involvement in the papers, and had done so knowingly. Indeed, some of the authors did not even fully disclose Monsanto involvement in initial questioning by Taylor & Francis during the investigation, the emails show.

The “only tenable outcome is to retract 3 of the articles; specifically the summary, epidemiology and genotoxicity papers,” Taylor & Francis’ Charles Whalley wrote to McClellan on May 18, 2018. Whalley was managing editor of the publishing group’s medicine and health journals at the time.

The internal emails show McClellan refused to accept the idea of retraction, saying that he believed the papers were “scientifically sound” and produced “without external influence” from Monsanto. He said a retraction would tarnish the reputations of the authors, the journal and his own reputation.

“I can not agree to the proposal for retraction you have offered in your memo of May 18th, McClellan wrote in response.  In a series of emails McClellan laid out his arguments against retraction, saying   “Retractions of the papers would do irreparable harm to multiple parties including, most of all, the authors, the Journal , the publisher and key employees such as you and, in addition, me in my role as the Scientific Editor of CRT.”

In an email dated June 5, 2018, McClellan declared that he knew Monsanto had a “vested interest” in the publication of the papers and was personally aware of Monsanto’s relationships, including compensation agreements, with the authors, and still was satisfied that the papers were “scientifically sound.”

“In my professional opinion, the five Glyphosate papers are scholarly pieces of work clearly documenting the process used to critique the IARC report and provide an alternative hazard characterization,” McClellan wrote. “The five papers are scientifically sound. It would be a breach of scientific ethics and my own standards of scientific integrity to agree to retraction of any or all of the Glyphosate papers…”

Whalley pushed back, saying that the authors of the papers were clearly guilty of “misconduct and a breach of publishing ethics,” so severe as to warrant retraction. The “breaches of publication ethics that we have identified in this case are clear breaches of fundamental and clearly defined standards, and not attributable to misunderstandings of detail or nuance,” Whalley wrote to McClellan. He said the publisher had reviewed the guidelines from the Committee on Publication Ethics (COPE) before making the decision.  “Retractions are evidence that editorial policies are working, not that they have failed,” he wrote.

Whalley and McClellan argued over the retraction for months, the records show.  In one July 22, 2018 email McClellan pointed out that the first trial against Monsanto over the Roundup cancer claims was taking place at the time so the journal discussions of a retraction were “quite sensitive since the Johnson vs. Monsanto trial is underway in San Francisco.”  He suggested that instead of retracting the papers, they simply correct  the section at the end of the papers where the authors disclose potential conflicts.

“I urge you to agree to my recommendation to publish corrected and expanded Declaration of Interest statements and abandon the “we gotcha” approach with Retraction of the papers,” McClellan wrote to Whalley in a July 2018 email.  “I will not allow my well-earned reputation to be tarnished by arbitrary and capricious actions by others.”

“In this case, we need to collectively attempt to reach agreement on an equitable outcome that is FAIR to the authors, the publisher, CRT readers, the public and me as the Editor-in-Chief and the CRT Editorial board. We must not take an approach that determines winners and losers in legal cases based on what is allowed to appear in the peer reviewed literature,” McClellan wrote.

Neither McClellan nor Whalley responded to a request for comment regarding this article.

The CRT glyphosate series was considered so significant that its findings were widely reported by media outlets around the world and cast doubt upon the validity of the IARC classification. The papers were published at a critical time as Monsanto was facing doubts by European regulators about allowing glyphosate to remain on the market and growing unease in U.S. markets as well. The 2016 series was “widely accessed,” with one of the papers in the series accessed “over 13,000 time,” according to the internal journal correspondence.

The importance of the papers to Monsanto was laid out in a confidential document dated May 11, 2015, in which Monsanto scientists spoke of “ghost-writing” strategies that would lend credibility to the “independent” papers the company wanted to have created and then to be published by CRT.  Monsanto had announced in 2015 that it was hiring Intertek Scientific & Regulatory Consultancy to put together a panel of independent scientists who would review the IARC classification of glyphosate as a probable carcinogen. But the company had pledged that it would not be involved in the review.

Though Monsanto’s involvement was revealed in 2017 Taylor & Francis took no public action until September 2018 as the publisher and editor wrestled over the retraction issue. McClellan ultimately won the argument and no retractions were made. The internal emails show that Whalley notified the 16 authors of the glyphosate papers of the decision to merely publish corrections to the articles and update the declarations of interest at the end of the papers. That Aug. 31, 2018 email states:

            “We note that, despite requests for full disclosure, the original Acknowledgements and Declaration of Interest statements did not fully represent the involvement of Monsanto or its employees or contractors in the authorship of the articles. As referred to in our previous memos to you, this specifically relates to the statements that:

           ‘Neither any Monsanto company employees nor any attorneys reviewed any of the Expert Panel’s manuscripts prior to submission to the journal.’ and that ‘The Expert Panelists were engaged by, and acted as consultants to, lntertek, and were not directly contacted by the Monsanto Company.’ 

          “From information you have provided to us, we now believe that neither of these statements was accurate at time of submission. This is in contradiction to declarations you made on submission and to warranties you made in the Author Publishing Agreements regarding your compliance with Taylor & Francis’ policies. To provide the necessary transparency to our readers, we will publish corrections to your articles to update their respective Acknowledgements and Declaration of Interest statements as per the material you have provided.”

In September of 2018 the papers were updated to carry an “Expression of Concern” and updates to the acknowledgements and declaration of interests. But despite the findings of Monsanto’s involvement, the papers are still titled with the word “independent.”

Whalley left Taylor & Francis in October of 2018.

The journal’s handling of the matter has troubled some other scientists.

“McClellan’s comments about why he did not retract the paper was disingenuous, self-serving, and violate sound editorial practice,” said Sheldon Krimsky,  a Tufts University professor and a fellow of the Hastings Center, an independent bioethics research institution. Krimsky is also associate editor for a Taylor & Francis journal called “Accountability in Research.”

Nathan Donley, a senior scientist employed by the nonprofit Center for Biological Diversity said the journal’s failure to retract was a failure of transparency.  “This was one of the most disgraceful events in scientific publishing that I have ever witnessed,” Donley said. “What we’re left with is an expression of concern that no one will read and a blatant misrepresentation that this was somehow an ‘independent’ endeavor.  This was a win for the most powerful player in the pesticide industry, but it came at the expense of ethics in science.”

Click here to read 400-plus pages of the emails.  

Sick Children Among Cancer Victims Suing Monsanto Over Roundup

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A 12-year-old boy suffering from cancer is among the newest plaintiffs taking on Monsanto and its German owner Bayer AG in growing litigation over the safety of Roundup herbicides and Monsanto’s handling of scientific concerns about the products.

Lawyers for Jake Bellah were in court Monday in Lake County Superior Court in Lakeport, California arguing that Bellah’s young age and diagnosis of non-Hodgkin lymphoma (NHL) qualified him for “trial preference,” or a speedy trial. In their motion, lawyers for the Baum Hedlund law firm of Los Angeles asked for a trial that would begin before the end of this year, within 120 days after a judge’s order if their motion is granted.

Monsanto lawyers opposed the request, arguing that the company would need more time to prepare a defense given the unusual scientific issues of surrounding alleged causation of cancer in a child.

The four plaintiffs who have already had trials against Monsanto were all adults diagnosed with non-Hodgkin lymphoma, and all were victorious. Bellah would likely be the first case of a child with cancer to challenge Monsanto before a jury.

In May, a jury in Oakland, California ordered Monsanto to pay more than $2 billion in damages to Alberta and Alva Pilliod, a married couple who both suffer from NHL they blame on exposure to Roundup. That followed a verdict in March in which a San Francisco jury ordered Monsanto to pay roughly $80 million in damages to plaintiff Edwin Hardeman who also suffers from NHL.  On July 15, the judge in that case reduced the award to $25 million. Last year jurors in state court in San Francisco ordered Monsanto to pay $289 million  in damages to school groundskeeper Dewayne “Lee” Johnson, who has been diagnosed with a terminal type of non-Hodgkin lymphoma.  The judge in that case lowered the total verdict to $78 million and the verdict is now on appeal.

Lawyers representing Bellah said the child was exposed to Monsanto’s glyphosate-based herbicide products repeatedly over many years as he played in his family’s yard and around their garden area where his father frequently sprayed the chemicals.

Bellah developed B-cell lymphoma and has been hospitalized and treated with chemotherapy and is currently in remission, according to Pedram Esfandiary, one of the family’s attorneys.

We’re looking forward to having more trials,” said Esfandiary. “It’s unfortunate that the victims include not only hardworking folks like Lee and the Pilliods but also people at the start of their lives.  He is entitled to his day in court.”

A ruling on the Bellah request for a speedy trial is expected by the end of July.

Another lawsuit brought on behalf of a sick child was filed July 12 in Alameda County Superior Court in California, also by the Baum Hedlund firm.

In that case, the plaintiff is identified only as G.B. Bargas. Her father Richard Bargas is listed as a plaintiff individually and on behalf of his daughter. The child’s mother Ronza Bargas is also a plaintiff. The complaint alleges that the child was diagnosed with NHL as a result of exposure to Roundup.

The addition of children to the mass litigation comes as Bayer is exploring whether or not to try to settle the cases. The company’s shares have been battered by the repeated losses in court, and by the revelations of questionable Monsanto conduct with respect to scientific and public scrutiny of its products.

In his court ruling reducing the damages awarded in the Hardeman case, U.S. District Judge Vince Chhabria said that Monsanto’s actions were “reprehensible.” He said evidence showed “Monsanto employees crassly attempting to combat, undermine or explain away challenges to Roundup’s safety.”

He said the company showed a “lack of concern about the risk that its product might be carcinogenic.”

Moms Exposed to Monsanto Weed Killer Means Bad Outcomes for Babies

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Concerns about the world’s most widely used herbicide are taking a new twist as researchers unveil data that indicates pervasive use of Monsanto Co.’s weed killer could be linked to pregnancy problems.

Researchers looking at exposure to the herbicide known as glyphosate, the key ingredient in Monsanto’s Roundup branded herbicides, said they tested and tracked 69 expectant mothers and found that the presence of glyphosate levels in their bodily fluids correlated with unfavorable birth outcomes. The research is still in preliminary stages and the sample size is small, but the team is scheduled to present their findings on Thursday at a conference put on by the Children’s Environmental Health Network (CEHN) in Washington, D.C.

“This is a huge issue,” said Paul Winchester, medical director of the neonatal intensive care unit at the Franciscan St. Francis Health system and professor of clinical pediatrics at Riley Hospital for Children in Indianapolis, Indiana. He said this is the first U.S. study to demonstrate glyphosate is present in pregnant women. “Everyone should be concerned about this.”

Glyphosate is a popular agricultural pesticide, used widely in farming operations around the world. It’s commonly sprayed directly on many food crops and those used for livestock feed. But it has become the subject of hot debate over the last few years because of research that links the herbicide to types of cancer and other health ailments. Monsanto is being sued by hundreds of people who claim they or their loved ones developed non-Hodgkin lymphoma because of exposure to glyphosate-based Roundup. Monsanto, the EPA and other regulatory bodies, say evidence of carcinogenicity is lacking and the chemical is among the safest of all pesticides used in food production. But documents discovered in the course of the litigation indicate the company may have manipulated scientific research to hide evidence of harm.

The team that presented their report Wednesday included scientists who have long been skeptical of Monsanto’s products as well as medical researchers who have come to have concerns about glyphosate and other pesticides through their study of pediatric health problems.

Winchester, who led the urine sampling study, said his look at glyphosate and pregnant women is in very early stages and he and co-researchers are hoping to launch a much larger project later this year. The preliminary work detected glyphosate in the urine of 63 of 69 (91%) pregnant women receiving prenatal care through an Indiana obstetric practice. Researchers collected the data over two years, from 2015-2016, and found that higher glyphosate levels in women correlated with significantly shorter pregnancies and with lower adjusted birth weights.

Correlation does not prove causation. Still, the findings are worrisome because low birth weights and shortened gestation are seen as risk factors for many health and/or neurodevelopmental problems over the course of an individual’s life. Low birth-weight babies are more likely to have diabetes, heart disease, high blood pressure, and to be obese, research shows.

People can be exposed to glyphosate through food and through association with farming operations that spray glyphosate on corn and soybean production fields. Both soy and corn, along with several other crops, have been genetically engineered to tolerate direct application of glyphosate. Farmers often also use glyphosate directly on wheat, oats and other non-genetically engineered crops shortly before harvest, leading to residues in grain-based food products.

Glyphosate use has climbed sharply over the last two decades with the rise of genetically engineered crops and in connection with the subsequent spread of glyphosate-resistant weeds. Dr. Charles Benbrook, one of the scheduled presenters at the CEHN conference, projects that by 2020, “more acres of cropland in the Midwest will harbor three or more glyphosate-resistant weeds than one or none.” Farmers have been trying to fight the resistant weeds with more glyphosate and other chemicals. New crops engineered to tolerate 2,4-D and dicamba herbicides mixed with glyphosate are being rolled out now. Industry data indicates herbicide use is expected to continue to climb, making it ever more critical for scientists and medical professional to get a handle on exposure levels and impacts on reproductive health, the team said in their presentation.

Winchester has been conducting research into pesticide exposures and impacts on pregnant women for many years, including in-depth work on atrazine, another herbicide popular with farmers. He said he was surprised to see such a high percentage of women tested showing glyphosate in their urine. He said much more research on glyphosate impacts is needed, and more data is needed on levels of exposure through food. He was sharply critical of the U.S. government, which routinely skips testing for glyphosate residues in food even though regulatory agencies test thousands of food products each year for residues of other types of pesticides, including atrazine.

He and the other researchers are calling on the Centers for Disease Control to include glyphosate and its primary metabolite, aminomethylphosphonic acid (AMPA) in biomonitoring work it does to track levels of pesticides and other chemicals in urine and blood.

“Is this level of exposure safe or not? We’ve been told it is, but exposures haven’t been measured,” Winchester said. “It’s mind-boggling.”

(First posted in The Huffington Post)