Internal FDA Emails: Weedkiller Found in Granola and Crackers

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This article was published the Guardian on April 30, 2018

By Carey Gillam

US government scientists have detected a weedkiller linked to cancer in an array of commonly consumed foods, emails obtained through a freedom of information request show.

The Food and Drug Administration (FDA) has been testing food samples for residues of glyphosate, the active ingredient in hundreds of widely used herbicide products, for two years, but has not yet released any official results.

But the internal documents obtained by the Guardian show the FDA has had trouble finding any food that does not carry traces of the pesticide.

“I have brought wheat crackers, granola cereal and corn meal from home and there’s a fair amount in all of them,” FDA chemist Richard Thompson wrote to colleagues in an email last year regarding glyphosate. Thompson, who is based in an FDA regional laboratory in Arkansas, wrote that broccoli was the only food he had “on hand” that he found to be glyphosate-free.

That internal FDA email, dated January 2017, is part of a string of FDA communications that detail agency efforts to ascertain how much of the popular weedkiller is showing up in American food. The tests mark the agency’s first-ever such examination…

See full article in The Guardian and more reporting about glyphosate here.

Email of intrigue: “IARC is killing us!”

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As researchers we often look to documents to shed new light on issues important to food policy. Sometimes, they simply reflect what we already know.

That’s the case with one new communication string that adds to evidence of a far-reaching strategy by food industry players to discredit and diminish the world’s leading cancer research agency. We’ve already seen documents from Monsanto and other chemical industry interests laying out plans to tear apart the credibility of the International Agency for Research on Cancer (IARC) because of its classification of Monsanto’s weed killer glyphosate as a probable human carcinogen.

Now we see evidence that other food industry players are part of the scheme; working to head off potentially damaging IARC scrutiny of food additives such as aspartame, sucralose, and more.

The email of intrigue was obtained through a state open records request.  It shows communication between James Coughlin, a one-time scientist for Kraft General Foods Inc. who operates a food and “nutritional” consulting business, and Timothy Pastoor, a retired toxicologist with the agrochemical giant Syngenta AG who now runs his own “science communications” business. Also included on a portion of the email string is Monsanto PR man Jay Byrne, who runs a “reputation management” and public relations business, and Douglas Wolf, a former Environmental Protection Agency scientist now with Syngenta.

In the October 2016 email, Coughlin tells Pastoor how he’s been “fighting IARC forever!!” dating back to his time at Kraft. He relates the time he spent criticizing the international cancer agency to a U.S. House of Representatives staffer who was coordinating an effort to strip U.S. funding from IARC.

And then, articulating the deep fear the food industry holds for the cancer agency, he gets to the meat of the matter: “IARC is killing us!” he writes. The 2-page string can be found here. An excerpt is below:

SciBabe says eat your pesticides. But who is paying her?

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SciBabe’s bad science tries to make the pesticide industry look good.

Blogging under the name SciBabe, Yvette d’Entremont defends toxic chemicals in food products and promotes pesticides as safe. She does not disclose all her funding sources. The manufacturer of the artificial sweetener Splenda discloses here their partnership with SciBabe to “debunk junk science” about Splenda.

SciBabe has been a featured speaker at various chemical and food industry sponsored events such as the 2017 Atlantic Farm Women conference sponsored by CropLife and Monsanto, and the 2015 Suppliers Showcase where her talk was sponsored by DuPont. In interviews, she frequently cites her former job in a pesticide lab as the basis for her knowledge about pesticide safety.

Worked for a controversial pesticide company that had agreement with Monsanto to promote GMOs

Before becoming a full time blogger, Yvette d’Entremont worked as an as an analytical chemist at Amvac Chemical Corporation, which “does a booming business selling some of the world’s most dangerous pesticides,” according to a 2007 story in the Los Angeles Times:

“Amvac has fueled double-digit revenue growth through an unusual business practice: It has bought from larger companies the rights to older pesticides, many of them at risk of being banned or restricted because of safety concerns. The company has fought to keep those chemicals on the market as long as possible, hiring scientists and lawyers to do battle with regulatory agencies. Amvac’s focus on older pesticides has come at a cost to human health and the environment, according to federal Environmental Protection Agency (EPA) and state records, regulatory investigations and a string of lawsuits. Accidents involving the company’s pesticides have led to the evacuation of neighborhoods and the poisoning of scores of field workers in California and elsewhere.”

Amvac Chemical Corporation has an exclusive agreement with Dow Chemical Corporation to sell Lorsban made with chlorpyrifos, a controversial pesticide that decades of science strongly suggests harms children’s brains. The EPA has said chlorpyrifos should be banned, but it is still widely used on apples, oranges, strawberries and broccoli, and Amvac markets it as “the right choice!” Amvac also has an agreement with Monsanto to promote Roundup Ready GMO crops.

2016 Monsanto sponsored SciBabe talk.

False statements about pesticides and GMOs, and Amvac influence

SciBabe makes false claims about the health risks and safety protocols of pesticides, GMOs and chemicals in food:

  • “We’ve proven very, very carefully that, once they get into the food supply, [pesticides] are safe for people … because we’re in such a heavily regulated environment, the odds of you getting something in your food supply that’s unsafe at this point is very, very low. I mean, extraordinarily low.” (podcast with University of Florida professor Kevin Folta)
  • Artificial sweeteners are safe with no evidence of harm. (SciBabe blog; here are facts about the health risks of aspartame)
  • For GMOs, “There are serious testing standards in place from the EPA, FDA, and USDA. GMOs are basically tested down to the last strand of DNA.” (article for Genetic Literacy Project)

SciBabe credits her former job at the Amvac lab for inspiring her to get involved as a science communicator:

  • “When I was working there, that was when I started really getting into the fray of this kind of battle that we have on the Internet with people who say there is no research done into these pesticides before the hit the market. And I’m like yes, I really just lick the vile and say it’s probably not going to kill your kids before approving it for sale – which, I promise you, that’s not how it works.” (podcast)
  • “I started the blog when I was working there, and it’s partially because I kept seeing really bad information online about pesticides.” (Popular Science Q&A)
  • “Whenever I saw the argument online that (GMOs) aren’t tested for safety, I realized in my own pesticide lab that I was working in, we were. I’m like, ‘How can these not be tested for safety when my exact job is testing for safety?’ And sometimes I spent two weeks calibrating one instrument, and I’m just one cog in a machine. And I know the other sides are just as meticulous as I am.” (Popular Science)

Front group friends

SciBabe’s work is regularly promoted by chemical industry front groups, such as the American Council on Science and Health (which has received funding from Amvac Chemical Corporation) and the Genetic Literacy Project.

The “Kevin Folta Fan Club” is a who’s who of Monsanto friends and pesticide defenders.

SciBabe is part of what she calls the “Kevin Folta Fan Club” defending the University of Florida professor who has repeatedly made false and misleading statements. The fan club photo features d’Entremont with Julie Gunlock of the Independent Women’s Forum, a Koch-funded group that partners with Monsanto to downplay fears about pesticides; pesticide propagandist Julie Kelly; and Monsanto’s social sciences lead Cami Ryan.

More on Yvette d’Entremont:

  • “SciBabe is Neither a Scientist Nor a Babe: She’s Bullshit,” Medium
  • “Response to Gawker ‘The Food Babe Blogger is Full of …,” FoodBabe
  • “SciBabe, paid by Splenda, touts its product,” by Jerry Coyne, PhD, professor at Univ. of Chicago.

Doctors, scientists recommend reducing exposure to pesticides 

Resources to learn more about pesticide risks and weak regulations that fail to protect health:

The American Academy of Pediatrics recommends reducing children’s exposure to pesticides. Here is the AAP’s 2012 science position paper.

“Epidemiologic evidence demonstrates associations between early life exposure to pesticides and pediatric cancers, decreased cognitive function, and behavioral problems. Related animal toxicology studies provide supportive biological plausibility for these findings. Recognizing and reducing problematic exposures will require attention to current inadequacies in medical training, public health tracking, and regulatory action on pesticides.”

The President’s Cancer Panel Report recommends reducing children’s exposure to cancer-causing and cancer-promoting environmental exposures.

“The American people—even before they are born—are bombarded continually with myriad combinations of these dangerous exposures. The Panel urges you most strongly to use the power of your office to remove the carcinogens and other toxins from our food, water, and air that needlessly increase health care costs, cripple our Nation’s productivity, and devastate American lives.”

The President’s Cancer Panel chapter on pesticides starts on page 43:

“Nearly 1,400 pesticides have been registered (i.e., approved) by the EPA for agricultural and non-agricultural use. Exposure to these chemicals has been linked to brain/central nervous system, breast, colon, lung, ovarian (female spouses), pancreatic, kidney, testicular, and stomach cancers, as well as Hodgkin and non-Hodgkin lymphoma, multiple myeloma, and soft tissue sarcoma. Pesticide-exposed farmers, pesticide applicators, crop duster pilots, and manufacturers also have been found to have elevated rates of prostate cancer, melanoma, other skin cancers, and cancer of the lip.”

The 2016 European Parliament Science and Technology Option Assessment recommended reducing dietary intake of pesticides, especially for women and children.

Pesticide risk assessments “disregard evidence from epidemiological studies that show negative effects of low-level exposure to organophosphate insecticides on children’s cognitive development, despite the high costs of IQ losses to society. While the intake of fruit and vegetables should not be decreased, existing studies support the ideal of reduced dietary exposure to pesticide residues, especially among pregnant women and children.”

Journal of American Medical Association commentary by Phillip Landrigan, MD, recommends eating organic food.

  • “our current laissez-faire attitude toward the regulation of pesticides is failing us”
  • “multiple lines of evidence suggest that human fertility is on the decline and that the frequency of reproductive impairment is increasing.” These trends are “almost certainly” linked to environmental exposures to chemicals
  • See also Harvard pesticide/infertility study in JAMAHarvard researchers followed 325 women at an infertility clinic for two years and reported that women who regularly ate pesticide-treated fruits and vegetables had lower success rates getting pregnant with IVF

Consensus statement from leading scientists: Concerns over the risks of glyphosate-based herbicides and risks associated with exposure, Environmental Health Journal

Recent news on pesticides

Dow’s insecticide chlorpyrifos has been shown to harm children’s brains and EPA’s own scientists said in 2016 they could no longer vouch for safety of the pesticide in food or water, but it remains widely used in farming due to political pressure from the agrichemical industry.

A Strong Case Against a Pesticide Does Not Faze E.P.A. Under Trump, By Roni Caryn Rabin New York Times

This is what a common pesticide does to a child’s brain, By Nicholas Kristof New York Times

EPA Glyphosate Registration Review Public Comments Now Due

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For anyone interested in commenting on the EPA’s latest safety review of the weed killing chemical glyphosate:

  • Docket ID:EPA-HQ-OPP-2009-0361
  • Abstract:Federal Register for Tuesday, February 27, 2018 (83 FR 8476) (FRL–9973–07) EPA–HQ–OPP–2017–0720; Registration Review; Draft Human Health and/or Ecological Risk Assessments for Several Pesticides; Notice of Availability
  • Document Type:Notice
  • Status:Posted
  • Received Date:Feb 27, 2018
  • FR Citation:83
  • Start-End Page:8476 – 8478
  • Comment Start Date:Feb 27, 2018
  • Comment Due Date:Apr 30, 2018
  • Glyphosate Case 0178 EPA-HQ-OPP-2009-0361 glyphosateRegReview@epa.gov (703) 347-0292.

See all details here: https://www.regulations.gov/docket?D=EPA-HQ-OPP-2009-0361

Are You Ready for the New Wave of Genetically Engineered Foods?

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A version of this article was first published in Common Ground Magazine March 2018 (PDF version).

By Stacy Malkan

Everyone loves a feel-good story about the future. You’ve probably heard this one: high-tech foods enhanced by science will feed the 9 billion people expected on the planet by 2050. Food made in labs and crops and animals genetically engineered to grow faster and better will make it possible to feed the crowded world, according to stories that spin through our institutions of media and education.

“6th grade students brainstorming big biotech ideas to #Feedthe9″ touted a recent tweet tagged to the chemical industry’s promotional website GMOAnswers. Student ideas included “breed carrots to have more vitamins” and “corn that will grow in harsh winter conditions.”

It all sounds so promising until you look at the realities behind the rhetoric.

For starters, in a country that leads the world in growing genetically modified organisms (GMOs), millions go hungry. Reducing food waste, addressing inequality and shifting to agroecological farming methods, not GMOs, are the keys to world food security, according to experts at the United Nations. Most genetically engineered foods on the market today have no consumer benefits whatsoever; they are engineered to survive pesticides, and have greatly accelerated the use of pesticides such as glyphosate, dicamba and soon 2,4D, creating what environmental groups call a dangerous pesticide treadmill.

Despite decades of hype about higher nutrients or heartier GMO crops, those benefits have failed to materialize. Vitamin-A enhanced Golden Rice, for example – “the rice that could save a million kids a year,” reported Time magazine 17 years ago – is not on the market despite millions spent on development. “If golden rice is such a panacea, why does it flourish only in headlines, far from the farm fields where it’s intended to grow?” asked Tom Philpott in Mother Jones article titled, WTF Happened to Golden Rice?

“The short answer is that the plant breeders have yet to concoct varieties of it that work as well in the field as existing rice strains…When you tweak one thing in a genome, such as giving rice the ability to generate beta-carotene, you risk changing other things, like its speed of growth.”

Nature is complex, in other words, and genetic engineering can produce unexpected results.

Consider the case of the Impossible Burger.

The plant-based burger that “bleeds” is made possible by genetically engineering yeast to resemble leghemoglobin, a substance found in soybean plant roots. The GMO soy leghemoglobin (SLH) breaks down into a protein called “heme,” which gives the burger meat-like qualities — its blood-red color and sizzle on the grill — without the environmental and ethical impacts of meat production. But the GMO SLH also breaks down into 46 other proteins that have never been in the human diet and could pose safety risks.

As The New York Times reported, the burger’s secret sauce “highlights the challenges of food tech.” The story was based on documents obtained by ETC Group and Friends of the Earth under a Freedom of Information Act request – documents the company probably hoped would never see the light of day. When Impossible Foods asked the Food and Drug Administration to confirm its GMO ingredient was “generally recognized as safe” (GRAS), the Times reported, the agency instead “expressed concern that it has never been consumed by humans and may be an allergen.”

FDA officials wrote in notes describing a 2015 call with the company, “FDA stated that the current arguments at hand, individually and collectively, were not enough to establish the safety of SLH for consumption.” But, as the Times story explained, the FDA did not say the GMO leghemoglobin was unsafe, and the company did not need the approval of FDA to sell its burger anyway.

The arguments presented did not establish safety – FDA

So Impossible Burger is on the market with the company’s assurances of safety and most consumers are in the dark about what’s in it. While the GMO process is explained on the website it is not marketed that way at the point of sale. On a recent visit to a Bay Area restaurant that sells the Impossible Burger, a customer asked if the burger was genetically modified. He was inaccurately told, “no.”

Lack of government oversight, unknown health risks and consumers left in the dark – these are recurring themes in the unfolding narrative about the Wild West of genetic engineering experimentation that is galloping toward a store near you.

A GMO By Any Other Name …

Synthetic biology, CRISPR, gene editing, gene silencing: these terms describe the new forms of genetically engineered crops, animals and ingredients that companies are rushing to get onto the market.

The old method of genetic engineering, called transgenics, involves transferring genes from one species to another. With the new genetic engineering methods – what some environmental groups call GMOs 2.0 – companies are tampering with nature in new and possibly riskier ways. They can delete genes, turn genes on or off, or create whole new DNA sequences on a computer. All these new techniques are GMOs in the way consumers and the U.S. Patent Office consider them – DNA is altered in labs in ways that can’t occur in nature, and used to make products that can be patented. There are a few basic types of GMOs 2.0.

Synthetic biology GMOs involve changing or creating DNA to artificially synthesize compounds rather than extract them from natural sources. Examples include genetically engineering yeast or algae to create flavors such as vanillin, stevia and citrus; or fragrances like patchouli, rose oil and clearwood – all of which may already be in products.

Some companies are touting lab-grown ingredients as a solution for sustainability. But the devil is in the details that companies are reticent to disclose. What are the feedstocks? Some synthetic biology products depend on sugar from chemical-intensive monocultures or other polluting feedstocks such as fracked gas. There are also concerns that engineered algae could escape into the environment and become living pollution.

And what is the impact on farmers who depend on sustainably grown crops? Farmers around the world are worried that lab-grown substitutes, falsely marketed as “natural,” could put them out of business. For generations, farmers in Mexico, Madagascar, Africa and Paraguay have cultivated natural and organic vanilla, shea butter or stevia. In Haiti, the farming of vetiver grass for use in high-end perfumes supports up to 60,000 small growers, helping to bolster an economy ravaged by earthquake and storms.

Does it make sense to move these economic engines to South San Francisco and feed factory-farmed sugar to yeast in order to make cheaper fragrances and flavors? Who will benefit, and who will lose out, in the high-tech crop revolution?

Genetically engineered fish and animals: dehorned cattle, naturally castrated pigs, and chicken eggs engineered to contain a pharmaceutical agent are all in the genetic experimentation pipeline. An all-male “terminator cattle” project – with the code name “Boys Only” – aims to create a bull that will father only male offspring, thereby “skewing the odds toward maleness and making the (meat) industry more efficient,” reported MIT Technology Review.

What could go wrong?

The geneticist working on the terminator cattle, Alison Van Eenennaam of the  University of California, Davis, is lobbying FDA to reconsider its 2017 decision to treat CRISPR-edited animals as if they were new drugs, thereby requiring safety studies; she told the MIT Review that would “put a huge regulatory block on using this gene-editing technique on animals.” But shouldn’t there be requirements for studying the health, safety and environmental impacts of genetically engineered foods, and a framework for considering the moral, ethical and social justice implications? Companies are pushing hard for no requirements; in January, President Trump talked about biotechnology for the first time during his presidency and made a vague declaration about “streamlining regulations.”

The only GMO animal on the market so far is the AquaAdvantage salmon engineered with the genes of an eel to grow faster. The fish is already being sold in Canada, but the company won’t say where, and US sales are held up due to “labeling complications.” The urge for secrecy makes sense from a sales perspective: 75% of respondents in a 2013 New York Times poll said they would not eat GMO fish, and about two-thirds said they would not eat meat that had been genetically modified.

Gene silencing techniques such as RNA interference (RNAi) can turn genes off to create particular traits. The non-browning Arctic Apple was engineered with RNAi to turn down the expression of genes that cause apples to become brown and mushy. As the company explains on its website, “when the apple is bitten, sliced, or otherwise bruised … no yucky brown apple left behind.”

Are consumers actually asking for this trait? Ready or not here it comes. The first GMO Arctic Apple, a Golden Delicious, began heading for test markets in the Midwest last month. Nobody is saying exactly where the apples are landing, but they won’t be labeled GMO. Look out for the “Arctic Apples” brand if you want to know if you’re eating a genetically engineered apple.

“I am confident we’ll see more gene-edited crops falling outside of regulatory authority.” 

Gene editing techniques such as CRISPR, TALEN or zinc finger nucleases are used to cut DNA in order to make genetic changes or insert genetic material. These methods are faster and touted as more precise than the old transgenic methods. But the lack of government oversight raises concerns. “There can still be off-target and unintended effects,” explains Michael Hansen, PhD, senior scientist of Consumers Union. “When you alter the genetics of living things they don’t always behave as you expect. This is why it’s crucial to thoroughly study health and environmental impacts, but these studies aren’t required.”

A non-browning CRISPR mushroom escaped US regulation, as Nature reported in 2016. A new CRISPR canola oil, engineered to tolerate herbicides, is in stores now and may even be called “non-GMO,” according to Bloomberg, since the US Department of Agriculture has “taken a pass” on regulating CRISPR crops. The story noted that Monsanto, DuPont and Dow Chemical have “stepped through the regulatory void” and struck licensing deals to use the gene-editing technology.

And that raises another red flag with the narrative that new GMOs will provide consumer benefits that the old transgenic methods didn’t. “Just because the techniques are different doesn’t mean the traits will be,” Dr. Hansen pointed out. “The old method of genetic engineering was used mostly to make plants resist herbicides and increase sales of herbicides. The new gene editing techniques will probably be used in much the same way, but there are some new twists.”

Corporate Greed Versus Consumer Needs

The Atlantic’s “transforming food” summit was sponsored by DowDuPont. See our reporting on that story.

The world’s largest agrichemical companies own the majority of seeds and pesticides, and they are consolidating power in the hands of just three multinational corporations. Bayer and Monsanto are closing in on a merger, and the mergers of ChemChina/Syngenta and DowDuPont are complete. DowDuPont just announced its agribusiness unit will operate under the new name Corteva Agriscience, a combination of words meaning “heart” and “nature.”

No matter what re-branding tricks they try, these corporations have a nature we already know: all of them have long histories of ignoring the warnings of science, covering up the health risks of dangerous products and leaving behind toxic messes – Bhopal, dioxin, PCBs, napalm, Agent Orange, teflon, chlorpyrifos, atrazine, dicamba, to name just a few scandals.

The future-focus narrative obscures that sordid past and the present reality of how these companies are actually using genetic engineering technologies today, mostly as a tool for crops to survive chemical sprays. To understand how this scheme is playing out on the ground in leading GMO-growing pesticide-using areas, read the reports about birth defects in Hawaii, cancer clusters in Argentina, contaminated waterways in Iowa and damaged cropland across the Midwest.

The future of food under the control of big agribusiness and chemical corporations is not hard to guess – more of what they are already trying to sell us: GMO crops that drive up chemical sales and food animals engineered to grow faster and fit better in factory farm conditions, with pharmaceuticals to help. It’s a great vision for the future of corporate profits and concentration of wealth and power, but not so great for farmers, public health, the environment or consumers who are demanding a different food future.

Growing numbers of consumers want real, natural food and products. They want to know what’s in their food, how it was produced and where it came from. For those who want to be in the know about what they are eating, there is still a surefire way to avoid old and new GMOs: buy organic. The Non-GMO Project verified certification also ensures products are not genetically engineered or made with synthetic biology.

It will be important for the natural foods industry to hold the line on the integrity of these certifications against the wild stampede of new GMOs.

Stacy Malkan is the co-director of US Right to Know and author of the book, “Not Just a Pretty Face: The Ugly Side of the Beauty Industry.”

Report from the Glyphosate Daubert Hearings

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Update 3/19: Judge Chhabria ordered an additional hearing for two of the plaintiffs’ witnesses. Follow Carey Gillam on Twitter for more updates about the legislation and we continue to post documents on our Monsanto Papers page.

Court Transcripts from Daubert Hearings 

Friday March 9 transcript

Thursday March 8 transcript

Wednesday March 7 transcript

Tuesday March 6 transcript

Monday March 5 transcript

Oral arguments and other court documents posted here

Science Week Blog 

U.S. Right to Know Research Director Carey Gillam reported from U.S. Federal Court in San Francisco during the March 5-9, 2018 Daubert Hearings, where Judge Vince Chhabria heard expert testimony about the science regarding the safety of glyphosate and Monsanto’s Roundup weed killer. Some reports were filed by USRTK Co-Director Stacy Malkan.

For updates, documents and analysis from the litigation, see the Monsanto Papers page. More more information about glyphosate, see our science fact sheet, Carey Gillam’s reporting on glyphosate and Gillam’s book, “Whitewash: The Story of a Weed Killer, Cancer and the Corruption of Science” (Island Press, 2017)

Reports in chronological order.

Updated: 03/05/2018 10:09

Farmers Vs. Monsanto: Glyphosate Showdown Comes to US Court in San Francisco:
“Science Week” in a federal court will decide if farmer cancer lawsuits move forward

US Right to Know News Release, March 5, 2018 — A federal court hearing in San Francisco this week will turn a spotlight on the science surrounding the world’s most widely used pesticide, glyphosate, and will determine whether farmers and their families will be able to proceed with legal action against Monsanto Co. over cancer concerns.

More than 365 lawsuits are pending against Monsanto in U.S. District Court in San Francisco, filed by people alleging that exposure to Roundup herbicide caused them or their loved ones to develop non-Hodgkin lymphoma, and that Monsanto covered up the risks.

The court has dubbed the March 5-9 events as “science week” because the only evidence to be presented will come from experts in cancer science, including epidemiologists, toxicologists, and biomedical statistical analysts called to analyze relevant research. The scientists will present their best scientific evidence to U.S. Judge Vince Chhabria, who will decide if the lawsuits move forward or are halted in their tracks.

Journalist and author Carey Gillam of U.S. Right to Know will be live blogging the event from the court house. Follow her posts here: https://usrtk.org/live-updates-monsanto-hearing/

See also:

03/05/2018 10:39 by Carey Gillam

Michael Baum of Baum Hedlund, counsel for the farmers and their families who are suing Monsanto over cancer concerns explains what’s at stake in this week’s hearings. https://www.facebook.com/USRightToKnow/videos/1662246967174627/

Updated: 03/06/2018 10:10 by Carey Gillam 

Showdown in San Fran underway 

The showdown is underway in San Francisco.

Teams of dark-suited attorneys filled the courtroom of U.S. District Judge Vince Chhabria on Monday morning to wrestle over the science surrounding cancer concerns and Monsanto’s Roundup herbicide.

With more than 365 lawsuits combined in the multi district litigation under the purview of Judge Chhabria, there were more plaintiffs attorneys than seats at the plaintiffs table, so they spilled out into the rows set aside for the public.

Laptops and yellow, lined legal pads crowded the tables for the opposing counsels as many furiously took notes and kept track of the time, well aware that each side has a limit of 11 hours to present their scientific case to the judge in a hearing that runs through Friday. The plaintiffs must demonstrate that they have scientific evidence to back their claims that glyphosate, the active ingredient in Roundup, causes non-Hodgkin lymphoma (NHL).

The hearings are an interim, but very important step in the litigation as these hearings allow for Chhabria to determine if the expert scientists plaintiffs have lined up to testify regarding causation will be permitted to testify at trial. The focus in those determinations is whether the experts used a recognized, reliable methodology for arriving at their opinions. If the judge the litigation can proceed to trial, a jury would then decide whether the evidence more likely than not shows Roundup caused the individual’s NHL.

First up to testify is plaintiffs’ expert witness Beate Ritz, Chair of the Epidemiology Department at UCLA, of Occupational and Environmental Health (COEH).

Under the questioning of plaintiffs’ attorney Kathryn Forgie, Ritz walked the judge through a series of epidemiology studies conducted over the years that show statistically significant risk factors linking glyphosate to cancer. The literature shows that the risk to individuals considered “routine users” of glyphosate was significant, she testified.

Judge Chhabria quizzed Ritz on several aspects of the scientific research and appeared concerned about whether or not studies were adjusted for exposure to other pesticides.

When asked about a study Monsanto has pointed to as critical evidence that there is no non-Hodgkin lymphoma link to glyphosate, Ritz explained that the study – a cohort called the Agricultural Health Study (AHS) – had several short-comings.

Among the problems, she testified, the AHS data on glyphosate relied heavily on memories of individuals filling out questionnaires to asses usage. It also is smaller than desired and has not followed people long enough, she said. “Recall error” is “really the enemy of exposure assessment,” she said.

03/05/2018 13:25 by Carey Gillam 

Getting Interesting 

A lawyer sitting next to me in first row describes this as the “post -lunch sag.”

But it’s just starting to get interesting – After a brief lunch break, epidemiologist Beate Ritz resumed testimony with a detailed discussion of meta-analyses. She says that with respect to glyphosate, there is animal data but “more importantly“ human data that shows an association between lymphoma and glyphosate. She said “DNA breaks have been shown to occur when individuals are exposed.” She says that her conclusion is that glyphosate and glyphosate based herbicides “do indeed cause NHL.”

But when Judge Chhabria asks her to be more specific – does she believe the pesticide is currently causing NHL or is “capable” of causing NHL, she said it was the latter. “We know that the toxicology is in the dose,” she said. That prompted some whispering among plaintiffs’ counsel and further questioning under which Ritz  said it would depend on the individual’s cases.

Monsanto attorneys now get their shot at Ritz.

03/05/2018 15:29 by Carey Gillam 

Ritz Concludes Testimony With Congrats from Judge

Whew – Five hours of testimony featuring plaintiffs’ expert witness, epidemiologist Beate Ritz, concluded in chuckles all around as Federal Court Judge Vince Chhabria told Ritz “congratulations” for her enthusiastic, though sometimes-prickly, testimony regarding her views of multiple studies looking at glyphosate and connections to cancer, specifically non-Hodgkin lymphoma.

Chhabria had to admonish Ritz more than once during her cross-examination by Monsanto attorney Eric Lasker to stop asking Lasker questions and telling him what questions to ask. The judge offered – in jest – to set aside time later in the week for Ritz to do her own cross-examination of Lasker in what was a rare light moment in the otherwise serious scrutiny of the science.

Before she exited the witness chair, Chhabria asked her if she believes that current levels of glyphosate exposures is causing or has caused non-Hodgkin lymphoma. Ritz said that good exposure quantification data is lacking but when pressed by the judge to say whether or not the studies she reviewed show that glyphosate has caused NHL in people she replied: “Yes I think they do.”

Next up: Dennis Weisenburger, a physician and pathologist who specializes in the study of NHL, takes the stand. He is Chair of the Pathology Department of the City of Hope Medical Center, Omaha, Nebraska.

03/05/2018 17:02 by Carey Gillam

“There is biological plausibility”

A long day of testimony presented by plaintiffs’ witnesses concluded with strong statements by NHL expert Dennis Weisenburger laying out multiple studies that lend support to the plaintiffs’ allegations that Monsanto’s glyphosate-based Roundup herbicide causes non-Hodgkin lymphoma.

As he did with prior witness Beate Ritz, the judge asked Weisenburger if he believed not just that the pesticide was capable of causing NHL but if it is at exposures people are currently experiencing. Weisenburger answered affirmatively.

“The body of evidence is strong evidence,” said Weisenburger. Glyphosate and the glyphosate-based formulations, including Roundup can cause non-Hodgkin lymphoma (NHL), he told Judge Chhabria.

Weisenburger spent time walking the court through studies that show DNA damage in people exposed to glyphosate, including through aerial spraying. Research shows that both glyphosate and formulations cause genetic damage, the type that leads to NHL, he said.

“There is biological plausibility.”

He testified that both animal studies and studies of human exposed to glyphosate showed connections between the chemical and cancer.

In one study, the North American Pooled Project (NAPP) the risk for NHL increased almost two fold when for people who used glyphosate more than two days per year. In animal studies, Weisenburger said there were “dose-related effects for multiple tumors.” As well, one mouse study showed rare tumors in exposed animals.

“There is a body of evidence that is pretty compelling that glyphosate and the formulations are genotoxic in living cells,” he testified.

Like Ritz, Weisenburger was dismissive of new results recently published as part of the Agricultural Health Study that showed no connection between glyphosate and NHL.

Though Monsanto has sought to portray this research as definitive evidence of no relationship between cancer and its weed killer, both scientists who testified today said the research has several flaws that made it unreliable for a determination on glyphosate, including that its span was too short, recall bias concerns, and lack of actual data on increased glyphosate usage over years.

Monsanto’s attorneys will get their chance to cross examine Weisenburger on Tuesday.

Stay tuned…..

Updated: 03/06/2018 10:58 by Stacy Malkan 

Transcript March 5, 2018 

Here is the link to the transcript of testimony from Monday, March 5 in the Roundup Products Liability litigation. This document and all court and discovery documents from the litigation are posted on the US Right to Know Monsanto Papers page.

Updated: 03/06/2018 11:20 by Carey Gillam 

Science Week, Day Two 

Testimony was about to get underway for the second day of “science week” with plaintiffs’ expert witness Dennis Weisenburger due to get back on the stand. Weisenburger, Chair of the Pathology Department of the City of Hope Medical Center in Omaha, Nebraska, specializes in the study of non-Hodgkin lymphoma (NHL).

Weisenburger spent much of Monday afternoon summarizing for Judge Vince Chhabria his belief that analysis of many research studies provides strong evidence that glyphosate and glyphosate-based weed killers like Monsanto’s Roundup can cause exposed individual’s to develop NHL.

Monsanto attorneys will get their chance to cross examine Weisenburger Tuesday afternoon after he completes his direct testimony.

Each side is claiming they have science on their side: “The question before this Court is all about the science,” Monsanto attorneys wrote in a pre-hearing court filing. “The science at issue consists of actual studies and data, not conjecture and speculation.” Monsanto argues that plaintiffs’ evidence is “littered with carefully selected, out-of-context, e-mails, memoranda, and other internal Monsanto documents which, according to plaintiffs’ allegations in their briefing, show purported ghostwriting of review articles (not original studies themselves) or allegedly improper corporate conduct.

Plaintiffs’ counter to that argument is this: “The methodology applied by Monsanto’s experts turns not on sound science but rather on whether the evidence at issue is favorable or unfavorable to Monsanto’s position. Where the evidence is favorable, it receives minimal scrutiny and Monsanto’s experts often fail to find any flaws or shortcomings. Yet when the evidence shows a positive association between exposure to glyphosate-based formulations (GBFs) and Non-Hodgkin Lymphoma (NHL), Monsanto’s experts concoct an inquiry that consistently leads them to disregard the positive evidence in its entirety. Inconsistencies or controverting evidence do not curtail this approach. Rather, when confronted with reliable positive evidence of causation, Monsanto’s experts develop novel methods to discount findings, including manufacturing new theories or facts.”

Plaintiffs’ initial exhibit list totaled 252 listed items, while Monsanto’s listed more than 1,000 total items.

One of many sticking points in the presentation of evidence has been Monsanto’s fierce objection to the potential use of an estimated 1,500 pages of data from a controversial 1983 mouse study that EPA scientists initially saw as concerning evidence of the potential carcinogenicity of glyphosate. Monsanto was eventually successful in convincing EPA that its analysis was flawed and that the study actually reflected no reason for concern.

Plaintiffs have sought to dig into that study data, which Monsanto has opposed. “The hundreds of pages of raw data that plaintiffs seek to have de-designated are inarguably confidential,” Monsanto wrote of the plaintiffs’ desire to discuss the mouse study in the hearings this week.

One issue that the experts must address for Judge Chhabria has to do with studies that make connections between glyphosate exposure and NHL but do not adjust for exposure to other pesticides. The judge stated multiple times that he sees that as a concern and wants a better understanding of the issue as the hearing progresses. “This continues to be an issue for me,” he said shortly before court concluded on Monday.

The judge also has warned attorneys that he needs a better understanding of the issue of “recall bias” in epidemiology research and how that may impact findings.

Following Weisenburger’s testimony, plaintiffs’ plan to present testimony from Alfred Neugut and then Charles “Bill” Jameson.

Neugut is a practicing medical oncologist, a professor of cancer research and professor of medicine and epidemiology at Columbia University.

Jameson has participated as a member of the working group of the International Agency for Research on Cancer and is a member of the American Chemical Society and the Society of Toxicology and he participates in peer reviews for six scientific journals.

Updated: 03/06/2018 15:56 by Carey Gillam

Rough and Tumble 

It was a tough cross-examination for plaintiffs’ expert Dennis Weisenburger, who was grilled on multiple areas of his analysis by Monsanto attorney Kirby Griffis. After leaving the witness stand and taking a seat in the front row of the public seating area, he expressed relief to be finished, remarking, “It’s like going to hell and coming back.”

Monsanto’s attorney opened his cross by showing a slide with text from a deposition that showed Weisenburger answering affirmatively to a question asking if his standard for offering opinions in published articles was more rigorous for offering his opinion in litigation matters. He accused Weisenburger of not presenting a full picture of the available data regarding glyphosate, and Griffis elicited testimony from Weisenburger confirming that a wave of NHL was identified in the 1950s, a time long before glyphosate was introduced to the market by Monsanto in 1974, underscoring there are other causes for the cancer.

Toward the end of this testimony, even questions from Judge Chhabria were hot to handle. The judge wanted to know how was it possible to connect glyphosate to non-Hodgkin lymphoma in people diagnosed in the late 1970s and early 1980s given glyphosate only came on the market in 1974 and given expert testimony that NHL can take more than two decades to develop from pesticide exposure. The judge suggested it should be “assumed” that something other than glyphosate caused the NHL in those people who were part of early studies.

“That is obviously what the defense is trying to say,” Weisenburger replied, but acknowledged that there are other pesticides associated with non-Hodgkin lymphoma.

Next on the stand- Alfred Neugut. a practicing medical oncologist who is professor of cancer research and professor of medicine and epidemiology at Columbia University. In his opening direct testimony he says there is great specificity with research showing a connection between glyphosate and NHL.

Scientists do not see repeated evidence of ties between glyphosate and several other types of cancer, but commonly see non-Hodgkin lymphoma. “Every time you look what comes up? Glyphosate and NHL,” he said.

Neugut testified that there is no perfect scientific study but consistency in study findings cannot be ignored.

He spoke so rapidly that the judge and court reporter had to caution him to slow down. “I’m from Brooklyn,” he replied, drawing courtroom laughter.

03/06/2018 16:05 by Carey Gillam

“Shit Happens” 

Expert witness Alfred Neugut, testifying for plaintiffs Tuesday, addressed a study that Monsanto has claimed is significant evidence backing its claims that says glyphosate and Roundup do not cause non-Hodgkin lymphoma (NHL). The Agricultural Health Study (AHS) is an “excellent study for many things,” Neugut said, but for understanding any association – or lack of – between glyphosate and NHL, the study fails, he testified. An extraordinary increase in the use of glyphosate that started in the late 1990s dramatically changed the exposure level of farmers to glyphosate from the beginning of the study when baseline exposures were established. There are other flaws with the study, including a “loss to follow-up,” he said.

“You have an error on top of an error on top of an error… the AHS study is basically not so useful,” he said

When asked how a study that was so poorly done could get published as the AHS study was in November 2017, he shrugged and said “shit happens.”

Next up: Monsanto attorney Eric Lasker to begin his cross examination.

03/07/2018 10:33 by Carey Gillam 

Day 3 – Notes and Gift & a Shift to Toxicology 

Day three of the Roundup cancer “science week” hearing opened with a gift from Judge Chhabria to plaintiffs – a gift of time. The plaintiffs will have an extra 60 minutes to present their expert witness testimony added to the total of 11 hours each side has been allotted for this week’s events. The judge said because he has frequently taken up some of plaintiffs’ time with questions of witnesses, he decided the extra time was warranted. Plaintiffs had requested an additional 90 minutes. Monsanto is not due any extra time, he said.

The judge also noted that he had received an email message from a “citizen” regarding the proceedings, but that he had elected not to read the message. He did pass copies of it to both plaintiffs’ and Monsanto’s attorneys.

The hearing Wednesday began with a continuation of Monsanto’s cross of plaintiffs’ witness Alfred Neugut, an expert in epidemiology who is a practicing medical oncologist and professor of cancer research and professor of medicine and epidemiology at Columbia University.

Monsanto attorney Eric Lasker pushed Neugut on his position on the science, and repeatedly challenged the scientist’s memory regarding previous statements and analysis that the attorney portrayed as conflicting with his testimony in these events. Neugut at one point said he must have been mistaken before but was now correct.

Following Neugut’s testimony, the focus of the hearing today will move from epidemiology to toxicology research that plaintiffs’ cite as evidence backing their claims that Monsanto’s weed killer causes cancer.

The first toxicology expert to take the stand will be Charles Jameson (who goes by Bill). Jameson has served as program leader for the National Toxicology Program at the NIH’s National Institute of Environmental Health Sciences for 12 years. He was a member of the working group for the International Agency for Research on Cancer that found glyphosate to be a probable human carcinogen in March 2015.

With the turn to toxicology will likely come a turn to discussion of the 1983 mouse study that initially prompted EPA scientists to say the study showed evidence of glyphosate’s cancer-causing potential. It was only after pressure from Monsanto and a report from a pathologist hired by Monsanto – and years of discussions with EPA – that the official assessment of that study was changed to reflect no sign of carcinogenicity.

Monsanto sought to keep much of the data from that study out of court after plaintiffs said they would be introducing it, but the judge has said the study data will be allowed as evidence.

03/07/2018 10:49 by Carey Gillam 

Transcript from Tuesday’s Hearing 

03/07/2018 11:59 by Carey Gillam

Testimony About Animal Tumor Data 

Testimony by toxicology expert Bill Jameson on Wednesday sparked early objections from Monsanto attorneys as the former government scientist explained the body of research that led him to conclude that glyphosate and glyphosate-based herbicides (like Roundup) can cause non-Hodgkin lymphoma at real-world exposures – levels farm workers and others face when using the weed killer. Judge Vince Chhabria overruled Monsanto’s objections.

Jameson was a member of the working group of the International Agency for Research on Cancer  (IARC) which analyzed research on glyphosate and declared it to be a probable human carcinogen in March 2015.

Judge Chhabria posed several questions to Jameson about that IARC finding, noting that in human studies the IARC group concluded there was “limited” evidence of carcinogenicity, compared to “sufficient” evidence in animal research.

That led Jameson to explain that some scientists on the IARC working group thought the evidence was stronger than limited but others disagreed. Jameson joked: “If there are three epidemiologists in a room and you ask them their opinions you’ll get four opinions.”

He, like the scientists who testified Monday and Tuesday, said it is the weight of the combined animal and human data that demonstrates the carcinogenicity of the herbicide.

There are many animal studies on glyphosate, Jameson testified, saying that it is “extraordinary” to have so many animal studies to evaluate a chemical due to the cost of such studies. The fact that researchers have as many animal studies as they do for glyphosate adds to the strength of his conclusion that the chemical causes cancer, he said. Importantly, the animal research shows there is replication of several tumor sites, including liver tumors and malignant lymphoma, he said.

“We had a lot of replication for malignant lymphomas in the mouse,” he said. The same tumors were seen in different studies in different labs at different times, which underscores strength of conclusion of carcinogenicity, he said.

In her questioning of Jameson, plaintiffs’ attorney Aimee Wagstaff at one point presented a slide showing a page from an eight-hour deposition of Jameson, pointing out that Monsanto had only provide the judge with one small segment of Jameson’s actual statement regarding the data. The entire statement provided the needed context for the court, she said.

Updated: 03/07/2018 14:38 by Carey Gillam 

After lunch break, Monsanto crosses Jameson 

Following a short break for lunch, Monsanto attorney Joe Hollingsworth stepped up to cross examine plaintiffs’ expert witness Bill Jameson.

Hollingsworth launched his cross by pressing Jameson about distinctions between hazard and risk assessments, and comments Jameson made in a deposition.

They judge admonished Hollingsworth and suggested that rather than continuously asking Jameson about what he said in a deposition, the attorney should ask him about what he actually thinks.

“Why don’t you ask his about his opinion now, the judge told Hollingsworth. “That’s normally how we do it,” the judge said.

Hollingsworth did adjust his inquiry but when again asking Jameson about comments he made in a deposition led Jameson to reply that in his depositions taken by Monsanto “I’ve been misquoted and things have been taken out of context so many times… ”

When Hollingsworth continues to press Jameson to address comments Hollingsworth says Jameson made in a deposition, the judge again interrupts to admonish Hollingsworth, say that if Hollingsworth wants to ask Jameson questions about prior deposition testimony in the way that he is asking then Hollingsworth must provide him the full transcript of the deposition and the page number that contains the comment.

The Monsanto attorney say he has the comment available on a slide to show Jameson and the court. The judge tells him that is not good enough. The witness has to be able to see the comments in context, not pulled out on a slide, the judge tells Hollingsworth. Jameson is then allowed to find and read aloud his full comment.

Repeatedly the judge seems to take issue with Hollingsworth’s style of questioning, including saying it is “his fault” for talking over Jameson as the witness tries to answer questions.

Updated: 03/07/2018 15:47 by Carey Gillam

Little Bit of Legal Drama

A little bit of legal drama in afternoon testimony by plaintiffs’ expert witness Bill Jameson as Judge Vince Chhabria repeatedly admonished Monsanto lead attorney Joe Hollingsworth over his tactics in cross examining Jameson.

Chhabria seems especially vexed by Hollingsworth’s effort to open a line of questioning by asking Jameson about statements he made in a deposition. The judge told Hollingsworth multiple times throughout the cross examination to ask Jameson directly what his opinions about the science are now, and then if that contradicted something he said earlier Hollingsworth could explore the contradiction. He also criticized Hollingsworth for talking over Jameson as he tried to answer questions.

The judge showed noted concern over the possibility that Monsanto might be taking expert statements out of context. That concern was underscored when, in a particularly stern move that left plaintiffs’ attorneys giddy with delight, Judge Chhabria ordered Monsanto’s attorney to read aloud into the record two pages of testimony from a deposition that supported the expertise of Jameson’s analysis before he would allow Hollingsworth to introduce a separate example from a deposition that undercut Jameson’s expertise.

Hollingsworth protested the action but finally capitulated as the judge insisted. He then ended his cross examination of Jameson.

As Jameson’s testimony ended and he stepped down from the witness stand, he turned to the judge: “Thank you for the honor, your honor,” he said.

Following Jameson, Chris Portier, another in the line-up of plaintiffs’ expert witnesses, took the stand. Portier, who traveled from his home in Switzerland to testify, expressed a bit of nervousness before beginning his testimony under direct examination from New York-based attorney Robin Greenwald.

Portier introduced his expert view that the probability that glyphosate cause non-Hodgkin lymphoma is “high.”

In his testimony, Portier tacked the Greim 2015 study, which Monsanto and supporters have said supports their position that glyphosate doesn’t cause cancer. ( Internal Monsanto documents state the Greim paper was ghost-written by a Monsanto scientist.) Portier said the work was poorly documented, providing only summary data and not providing individual animal data, among other short-comings.

Updated: 03/07/2018 16:54 by Carey Gillam  

Court Adjourns for the Day 

UPDATE – Dust up after court adjourns: Plaintiffs’ had provided Monsanto attorneys with a copy of the slide deck they were using for Portier’s direct testimony. But when court adjourned in the middle of testimony, they wanted the slide deck back – or at least the portions they had not yet covered. Monsanto attorneys having their game plan overnight was “prejudicial” plaintiffs’ attorneys protested. But Monsanto attorney Eric Lasker shrugged off the request from plaintiffs’ attorney Aimee Wagstaff that they return the slide deck. A Monsanto attorney had already walked out with the documents and Lasker was not inclined to try to retrieve them. A frustrated Wagstaff requested “judicial assistance” from the judge but retreated after Lasker said they had written notes on the slide deck and refused to give them back.

A long day of testimony wrapped up with plaintiffs’ expert witness Chris Portier laying out for the court detailed and highly technical methodology and analysis that he said supports his views that glyphosate has a strong causal connection to non-Hodgkin lymphoma.

Monsanto has criticized Portier for pooling results from multiple research studies in ways that are aimed at intentionally generating data that favors plaintiffs’ claims against Monsanto, but Portier denied that bias in his testimony Wednesday.

The scientist explained such things as “latency” to the court, and discussed his “sensitivity analysis” of studies done in rats and mice in the 1980s and 1990s.

More direct testimony is slated for Thursday morning from Portier and then his cross-examination. After that, Monsanto will likely get its turn to present its own experts to the judge. The company has said they will present four witnesses.

After this week’s testimony, lawyers for both sides will get their chance to make oral arguments to the judge sometime in the next two weeks. The judge will make a ruling on whether or not the plaintiffs’ witnesses who are providing their scientific opinions regarding causation will be permitted to testify at trial.

The focus for the judge’s decision is whether the experts are using recognized, reliable methodology to arrive at their opinions. If he determines any or all of the witnesses are not relying on this proper scientific foundation he can exclude them from testifying, a move that would be a powerful blow to plaintiffs’ case and a win for Monsanto.

I am sorry to say I have to head to New York City on Thursday, and so will miss the final two days of testimony. But USRTK will be making transcripts available and the video recording of the full hearing when the web link becomes available after the conclusion of this week’s events.

Updated: 03/09/2018 09:50 by Carey Gillam

Transcripts from March 7 & 8 hearing 

I had to jet off to another city but here is the transcript from March 7’s hearing, https://usrtk.org/wp-content/uploads/2018/03/Transcript-hearing-March-7-2018.pdf and here is the transcript from Thursday’s events https://usrtk.org/wp-content/uploads/2018/03/Transcript-for-Daubert-Hearing-March-8-2018.pdf

Colleague Stacy Malkan is headed to court today to keep you all informed!

Updated: 03/09/2018 14:43 by Stacy Malkan

Last Day of Daubert Testimony 

Entering the final inning of Science Week as the plaintiff’s attorney is about to begin cross examination of cancer epidemilogist Dr. Lorelei Mucci, an associate professor of epidemiology at Harvard T.H. Chan School of Public Health. Last witness! More updates soon from the testimony of Dr. Mucci and earlier testimony by plaintiff’s witness Dr. Chadi Nabhan, a board certified clinical medical oncologist and past assistant professor at the University of Chicago.

Updated: 03/15/2018 10:45 by Stacy Malkan

Science Week Concludes in Federal Court 

(updated)

Dr. Mucci’s cross exam is complete, and that’s a wrap for testimony for glyphosate Science Week. Judge Chhabria calls for a round of applause for the court reporter; “we can all agree she had the hardest job in the room this week.” Oral arguments are set for Weds at 10 a.m.

Today, the last two witnesses presented: Dr. Chadi Nabhan for the plaintiffs (he couldn’t get here until today) and Dr. Lorelei Mucci for the defense. Dr. Nabhan is an oncologist who serves as medical director of Cardinal Health and has 17 years of clinical practice and academic research focused on lymphomas.

Dr. Nabhan discussed the process by which the International Agency for Research on Cancer conducts its monographs to determine whether chemicals cause cancer. The agency has a high bar to consider what it reviews, he said – exposures must be high and animal data strong. Since 1965, IARC has reviewed 1003 agents and found 20% to be carcinogens; 120 classified as carcinogenic and 81 classified as probably carcinogenic, including glyphosate.

“In my opinion, the (NHL) risk (of glyphosate exposure) is clinically significant enough that patients should be aware of it,” Dr, Nabhan said. “The IARC report is very convincing.”

Dr. Nabhan does not have a high opinion of the Agricultural Health Study (AHS) that was the topic of much of today’s discussion. “There are so many flaws in this study that it’s impossible to draw any conclusions,” he said. He shrugged off the updated analysis is “an updated analysis of an already flawed study.”

Last up was Dr. Lorelei Mucci for the Monsanto defense. Dr. Mucci is an associate professor of epidemiology at Harvard T.H. Chan School of Public Health and assistant professor of medicine at Harvard Medical School. Her major research and teaching area is cancer epidemiology.

Dr. Mucci discussed in her view the strengths and limitations of four epidemiological studies (transcript here with details) in particular the AHS study. Investigators of the AHS cohort analysis reported no evidence of association between exposure to glyphosate and risk of NHL, accounting for both short and long term exposures.

Much of Dr. Mucci’s testimony focused on questions from the judges about the validity of self reporting in the questionnaires filled out by pesticide applicators about their exposure to glyphosate. Dr. Mucci explained why she believes the reporting was reliable, and is confident in the study findings of no evidence of positive association between exposure and NHL risk and no evidence of dose response.

In cross examination, Dr. Mucci clarified that her expert opinion was based on epidemiological data that IARC looked at and that has come out since, the updated AHS and updated analysis of the North American Pooled Project. She did not consider toxicological data or animal data.

Updated: 03/12/2018 11:58 by Stacy Malkan

Transcripts and What’s Next? 

Testimony is complete in five days of Daubert Hearings to review the scientific evidence linking glyphosate, the key chemical in Monsanto’s Roundup weed killer, to a type of cancer found more commonly in farmers than the general population. Closing arguments are set for Wednesday March 14 (time TBD). U.S. District Court Judge Vince Chhabria will then decide whether there is evidence to support the plaintiffs’ claim that exposure to Roundup can cause non-Hodgkin Lymphoma (NHL), and if the experts providing scientific opinions regarding causation will be permitted to testify at trial.

The events, dubbed “Science Week” by the court because all the testimony came from experts in cancer science, marked the first time that the body of research relating to glyphosate and NHL was analyzed under oath. The stakes are high for the farmers and their families suing Monsanto, and for the company that derives nearly a third of its revenue from glyphosate-based products.

Below are the transcripts from glyphosate Science Week. Other court and discovery documents from the glyphosate trails, along with reporting and analysis, are posted on the USRTK Monsanto Papers page.

Friday March 9 transcript

Thursday March 8 transcript

Wednesday March 7 transcript

Tuesday March 6 transcript

Monday March 5 transcript

Updated: 03/13/2018 12:22 by Stacy Malkan

Videos of Daubert Hearings Now Posted 

The US Court, Northern District of California has posted all video footage of the March 5-9 “Science Week” Daubert Hearings in the Roundup products liability litigation against Monsanto Company.

You can find the videos here: http://www.uscourts.gov/cameras-courts/re-roundup-products-liability-litigation

The court website provides some interesting history about cameras in courts, and the continuing pilot program under which the glyphosate hearings were recorded — the only Daubert Hearings to date available for viewing on the court website. A win for transparency in our view!

That’s a wrap for Science Week reporting, sign up for the USRTK newsletter to keep up to date with our investigations and reporting.

If you value this type of independent reporting, please consider making a donation to US Right to Know.

# # #

Farmers Vs. Monsanto: The Glyphosate Trials

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“Science Week” in a federal court will decide if farmer cancer lawsuits move forward

Live updates from court hearings by Carey Gillam
Transcripts of Daubert Hearings posted here

News Release
For Immediate Release: Monday, March 5, 2018
For More Information Contact: Carey Gillam (913) 526-6190; Stacy Malkan (510) 542-9224

San Francisco, Calif.; March 5, 2018 — A federal court hearing in San Francisco this week will turn a spotlight on the science surrounding the world’s most widely used pesticide, glyphosate, and will determine whether farmers and their families will be able to proceed with legal action against Monsanto Co. over cancer concerns.

More than 365 lawsuits are pending against Monsanto in U.S. District Court in San Francisco, filed by people alleging that exposure to Roundup herbicide caused them or their loved ones to develop non-Hodgkin lymphoma, and that Monsanto covered up the risks.

The court has dubbed the March 5-9 events as “science week” because the only evidence to be presented will come from experts in cancer science, including epidemiologists, toxicologists, and biomedical statistical analysts called to analyze relevant research. The scientists will present their best scientific evidence to U.S. Judge Vince Chhabria, who will decide if the lawsuits move forward or are halted in their tracks.

Journalist and author Carey Gillam of U.S. Right to Know will be live blogging the event from the court house. Follow her posts here: https://usrtk.org/live-updates-monsanto-hearing/

See also: “Monsanto says its pesticides are safe: Now a court wants to see the proof,” by Carey Gillam, The Guardian.

Gillam is author of “Whitewash: The Story of a Weed Killer, Cancer and the Corruption of Science” (Island Press, 2017) — “a gutsy, compelling read from beginning to end, especially for readers who enjoy the kind of hard-nosed, shoe-leather reporting that used to be the hallmark of great journalism,” according to the Society for Environmental Journalists’ BookShelf review.

Gillam is also research director of U.S. Right to Know, a consumer and public health watchdog group. USRTK is posting documents and analysis from the MDL glyphosate cancer cases on our Monsanto Papers page.

U.S. Right to Know is a nonprofit consumer and public health organization that investigates the risks associated with the corporate food system, and the food industry’s practices and influence on public policy.  For more information, see usrtk.org.

GMO Answers is a Crisis Management PR Tool for GMOs & Pesticides

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Update May 2018: Tax records show that the Council for Biotechnology Information, a chemical industry trade group, paid Ketchum public relations firm more than $11 million from 2013-2016 to to run GMO Answers. See also this related post, “Monsanto Relied on These Partners to Attack Top Cancer Scientists” (5/31/18).

ketchum gmo answers

By Stacy Malkan

GMO Answers is billed as a forum where consumers can get straight answers from independent experts about genetically engineered foods, and some journalists take it seriously as an unbiased source. But the website is a straight-up industry marketing tool to spin GMOs in a positive light.

Evidence that GMO Answers is a crisis-management propaganda tool that lacks credibility:

1) GMO Answers was created as a vehicle to sway public opinion in favor of GMOs. Soon after Monsanto and its allies beat back the 2012 ballot initiative to label GMOs in California, Monsanto announced plans to launch a new public relations campaign to reshape the reputation of GMOs. They hired the public relations firm FleishmanHillard (owned by Omnicom) for a seven-figure campaign.

As part of the effort, the PR firm Ketchum (also owned by Omnicom) was hired by the Council for Biotechnology Information – funded by Monsanto, BASF, Bayer, Dow, Dupont and Syngenta – to create GMOAnswers.com. The site promised to clear up confusion and dispel mistrust about GMOs using the unedited voices of so-called “independent experts.”

But how independent are those experts?

The website hews to carefully crafted talking points that tell a positive story about GMOs while downplaying or ignoring the health and environmental risks. For example, when asked if GMOs are driving up the use of pesticides, the site offers a convoluted no, despite peer-reviewed data showing that, yes, in fact, they are.

“Roundup Ready” GMO crops have increased use of glyphosate, a probable human carcinogen, by hundreds of millions of pounds. A new GMO/pesticide scheme involving dicamba has led to the destruction of soybean crops across the U.S., and the FDA is bracing this year for triple the use of 2,4-D, an older toxic herbicide, due to new GMO crops that are engineered to resist it. All of this is nothing to worry about, according to GMO Answers.

Questions about safety are answered with false statements such as “every leading health organization in the world stands behind the safety of GMOs.” We found no mention of the statement signed by 300 scientists, physicians and academics who say there is “no scientific consensus on GMO safety,” and we received no answers to questions we posted about the statement.

Examples have since come to light that Ketchum PR scripted some of the GMO answers that were signed by “independent experts.”

2) As further evidence the site is a spin vehicle: In 2014, GMO Answers was shortlisted for a CLIO advertising award in the category of “Public Relations: Crisis Management & Issue Management.”

3) And the PR firm that created GMO Answers boasted about its influence on journalists. In a video posted to the CLIO website, Ketchum bragged that GMO Answers “nearly doubled positive media coverage of GMOs.” The video was removed after U.S. Right to Know called attention to it, but we saved it here.

Why reporters would trust a marketing vehicle designed by Ketchum as a reliable source is difficult to understand. Ketchum, which until 2016 was the PR firm for Russia, has been implicated in espionage efforts against nonprofits concerned about GMOs. Not exactly a history that lends itself to dispelling mistrust.

Given that GMO Answers is a marketing tool created and funded by companies that sell GMOs, we think it’s fair game to ask: Are the “independent experts” who lend credibility to the website – several of whom work for public universities and are paid by taxpayers – truly independent and working in the public interest? Or are they working in league with corporations and public relations firms to help sell the public a spin story?

In search of these answers, U.S. Right to Know submitted Freedom of Information Act requests seeking the correspondence of publicly funded professors who write for GMOAnswers.com or worked on other GMO promotion efforts. The FOIA’s are narrow requests that cover no personal or academic information, but rather seek to understand the connections between the professors, the agrichemical companies that sell GMOs, their trade associations and the PR and lobbying firms that have been hired to promote GMOs and fight labeling so we’re kept in the dark about what we’re eating.

Follow the results of the U.S. Right to Know investigation here.