I began graduate school the same week as 9/11. The sense of loss among our first year class was immense – many had just moved to California from New York City. The orientation activities felt frivolous – booze cruise, random scandalous make-outs, icebreakers and even placement exams. I didn’t find my icebreaker factoid — I know how to juggle — particularly pertinent to the times.
The next year, I took a class that focused on the state of US security, terrorism, and effectively what to stay up at night worrying about. After perusing a truly grim set of potential ways we could all die en masse — I won’t share those details because we don’t need any more concerns — the one that has always stuck with me was bioterrorism.
We saw images of crop sprayers and learned about how bad actors could easily poison our food system and easily, efficiently wipe out vast swaths of life in our country.
Tragically, this scenario is not just hypothetical after all. Just ask the bees, butterflies, sea life, soil bacteria, and my pissed-off, in-house microbiome. A large portion of our microbiome has lost permanent residency status.
If we can get to Phase 2 this week in this bifurcated trial, the jury will see that Monsanto most certainly knew about the harm of Roundup. Furthermore, the third Roundup trial, which is set to start in Oakland on March 25th, will reportedly have a great deal MORE evidence of Monsanto’s crooked, corrupt behavior than that of the Johnson or Hardeman trials.
Today’s trial coverage is dense, so I apologize to those who prefer a lighter read!! Epidemiology tends to always be dense.
TRIAL
Before the jury enters, Plaintiff lawyer Aimee Wagstaff clarifies with Chhabria that Monsanto epidemiologist Dr. Mucci would be providing testimony on epidemiology only. Last week, Monsanto updated a list showing what evidence Mucci would rely upon to form her opinion. That list suddenly included genotoxicity and animal studies, in addition to the previously listed epidemiology. Monsanto attorney Tamarra Johnson says that Mucci will only use the genotoxicity and animal studies as evidence that she has looked at, but not relied upon. All parties agree.
Apparently, BART service (for non-locals, that’s our San Franciscan, filthy subway equivalent) is delayed and thus so is a jury member. After a short wait, the jury enters the courtroom.
DEPOSITION – DR WILLIAM REEVES
A video testimony begins immediately as the jury takes their seats. Since November 2018, Dr. Reeves has been the Global Health and Safety Issues Management Lead at Bayer Crop Science, where he oversees a portfolio of products in addition to agriculture. A suspicious one might say that he was put into that position in November to train for trial depositions, given the thousands of impending lawsuits. Unsurprisingly, Reeves is a product of a Postdoc program in toxicology at UC Davis, AKA a hotbed for Monsanto supporters.
My first impression is that Reeves is extremely well coached and practiced. Appearing calm, confident, and perhaps a bit cocky, his performance is aggravatingly okay. Of course, the content of his deposition was aggravatingly incorrect.
Reeves gives an overview of glyphosate – that it acts on a broad spectrum of leaves, kills weeds at the root, and acts systemically. He claims that once glyphosate is sprayed, it 1) is degraded by bacteria in the soil or 2) binds to the soil. He continues that the benefit of glyphosate is that it doesn’t run off or leach into groundwater, nor does it accumulate in the food chain.
GG Sidebar: Glyphosate was banned this week in Miami because of the blue green algae and red tides forming in Key Biscayne from land runoffs of glyphosate.
I am highly suspicious that the recent, terribly sad shoring of starving, sick dolphins and baby sea lions amidst toxic algae on the Southern Californian coast is a result of rain runoff containing deadly large quantities of Roundup. Interestingly, there has been a movement in the very same beach cities of Newport Beach and Corona del Mar to stop spraying such enormous quantities of Roundup. Sounds like the same Miami situation. How could “no one” know what is causing it? Monsanto and members of government, how can you watch these innocent sea animals shore, and really wonder how it is happening?
Not that they care – just in 2018, Newport Beach approved the regular spraying of Roundup on a new elementary school playfield.
Back to Dr. Reeves.
Plaintiff attorney Brent Wisner takes a turn questioning Reeves about the Magic Tumor study. Reeves is so extremely well prepared for this discussion, and skirts perfectly over the issues. Wisner highlights that the EPA requires both a mouse and rat oncological study for a chemical to receive regulatory approval. As we know, Monsanto delayed and delayed performing another mouse study, after the first study was suspiciously manipulated to appear non-carcinogenic.
When the EPA requested a second mouse study, Reeves says that Monsanto told the EPA that perhaps they could just do a repeat on the rat study instead. Of course, we know that the mouse studies are considerably more revealing of the carcinogenicity of glyphosate than rat studies are. Reeves concludes that Monsanto did exactly what the EPA asked them to do, and that a second rat study was all they ultimately needed.
DEPOSITION – DR. DONNA FARMER
Ah, there she is again in her glory as the Defender of Glyphosate. I might expect to see her tomorrow, playing the villain in new movie release Captain Marvel.
The Donna Farmer video clip is extremely truncated to just a few minutes. In Phase 2, I would anticipate much more of the lying and corruption to be apparent when more evidence on the “sideshow” is permitted.
Farmer worked for 27 years at Monsanto, and is currently employed with Bayer. I’m surprised that she is still with Bayer, because I’m sure the payout that she received upon the Monsanto acquisition must have been substantial. Perhaps she is hiding behind the shield of Bayer legal protection. I noticed that Monsanto Medical Science Lead Dr. Daniel Goldstein left Monsanto right after the acquisition.
Wisner asks Farmer about an email from 1999 in which Farmer writes about potential flaws in the design of the AHS.
Many groups have been highly critical of the study as being a flawed study, in fact some have gone so far as to call it junk science. It is small in scope and the retrospective questioneer on pesticide usage and self reported diagnoses also from the questioneer is thought to be unreliable…but the bottom line is scary…there will be associations identified between glyphosate use and some health effects just because of the way this study is designed.
In response, Farmer claims that she probably learned that information about the AHS study from a colleague in epidemiology. Today, she thinks that the researchers studying the AHS have done a great job in calculating the exposure algorithm to accurately represent the cancer risk of glyphosate (that there is no effect).
The video is abruptly and awkwardly stopped. I really hope that we get to see more of the deposition next week, if only for entertainment value.
EXPERT TESTIMONY OF DR. LORELEI MUCCI
Dr. Mucci is a cancer epidemiologist from Harvard, and a key witness for Monsanto/Bayer. I would enjoy hearing Dr. Mucci and Dr. Ritz debate simultaneously and live one day.
Dr. Mucci opted to wear a conservative, professional navy blue dress this time around. Remember, during the Johnson trial she looked like a delightful summer bouquet of pink flowers. Some Monsanto legal psychology must be at work in determining her wardrobe, because she seems more like a pink floral woman at heart than this conservative number.
Everyone who saw the Johnson trial knows that Mucci is Monsanto’s strongest expert witness, and so we wait with tense, nervous stomachs. Mucci looks a bit nervous as well, as one would be when Bayer’s best hope of success lies on her performance.
Click here for a background on Mucci’s education and professional experience.
Monsanto attorney Tamarra Johnson takes the lead on the direct examination. Team Monsanto does an excellent job presenting slides with emboldened conclusions from their experts. For people who are visual learners like me, such an exhibit could potentially lead me to consider their point of view more strongly only because my brain absorbs written information more effectively. So they are wisely covering their bases for all learning styles.
The slide reads that Mucci saw:
NO EVIDENCE OF A CAUSAL ASSOCIATION BETWEEN ROUNDUP AND NHL.
Mucci claims that the best model of evidence of carcinogenicity is in studying populations of humans. Animal and genotoxic studies can be helpful if 1) no epidemiological studies exist and 2) there is strong epidemiological evidence and one wants to see why the effect is mechanically happening.
In a lead up to discussing the 2018 AHS Andreotti cohort study, Mucci explains in depth why “case control” studies are significantly weaker than “cohort studies.” The Plaintiff, as well as IARC, has presented the case control studies as evidence of the link between glyphosate and NHL. Mucci tries to dismantle that argument by claiming that case control studies are exploratory, have small numbers of cases, and fail to properly adjust for other pesticides.
We enter a long and dull – but meaningful – deep dive into the 2018 AHS Andreotti study, which predictably is the basis of Monsanto’s entire defense. But oh-my-goodness is it boring. Unfortunately for the pro-Plaintiff side, the jurors seem to be paying ample attention. Johnson and Mucci acknowledge the award that Andreotti won for outstanding research paper by a staff scientist or staff clinician. Some highlights of the discussion:
- In contrast to Dr. Ritz’s opinion that farmers just signed up for the AHS because they had time to kill when getting registered for pesticide application, Mucci claims that the farmers who enrolled in the AHS were very enthusiastic and wanted to help better understand their own health.
- Mucci says that the farmers would have been very precise when filling in accurate information into the enrollment questionnaire because they would then get accurate information from others in return.
- Mucci claims that imputation to compensate for missing survey follow up data isn’t like guessing. She discusses Dr. Ritz’s hypothetical Farmer Ted example, in which he is misrepresented in the study because he didn’t fill out a follow-up questionnaire about his pesticide usage. Mucci argues that through the application of various statistical techniques, they can impute the responses for the missing farmers and there were only a small number of farms for which they truly had trouble predicting with absolute confidence.
- In the AHS questionnaire, farmers could check off what protective equipment they used in order to better estimate exposure levels. In the Andreotti study, data is broken into four equal groups depending on exposure levels. The difference in NHL cases between the exposure groups is negligible, and thus shows no evidence of a dose-response to glyphosate.
- The study shows no difference between the level of NHL incidence in someone that is exposed to glyphosate vs the general population.
CROSS EXAMINATION
Aimee Wagstaff looks sharp and ready for what will be the most important cross-examination of the trial. With her usual vibe of friendly sweetness, it will be interesting to watch her step up the intensity.
Wagstaff opens with a confirmation that Mucci never researched glyphosate until Monsanto called her to be an expert witness and that none of her 300 published papers relate to pesticides.
ZINGER
I am anticipating a normal line of questioning, but I’m wrong. Wagstaff launches into quite a zinger.
Wagstaff asks if it is true that in 2008, Mucci was involved in a congressional investigation for saying a toxic chemical was not a risk despite available research that said otherwise.
A sidebar is immediately called, and Monsanto was clearly anticipating that this juicy tidbit about Mucci’s questionable opinion could surface. Monsanto attorneys look concerned over in the sidebar huddle, as Johnson argues with a strained smile on her face to appear composed under the sound canceling static.
Wagstaff continues questioning on the topic, highlighting a letter from members of congress. The chemical in question is acrylamide, a chemical used in the production of paper, dyes and plastics, and in the treatment of drinking water and wastewater. The letter says:
In reviewing this matter, we note that a number of EPA panels accessing the human health effects of toxic chemicals have included individuals alleged to have pecuniary interests in the chemical industry.
The letter goes on to specifically cite Mucci, as a contributor to the EPA panel on acrylamide, as making statements that can be refuted with the available scientific evidence. Mucci defends herself, claiming that she was selected for the panel because of the research that she had done previously on acrylamide. She continues that she was funded by the National Cancer Institute, not a suspicious source. Mucci concludes that in any case, it is generally accepted in 2019 that the amount of acrylamide one might be exposed to is not enough to consider it a carcinogen. In my own quick research, it seems to be that the available studies have mixed findings for kidney, endometrial and ovarian cancer. It is currently classified as an EPA Group B2, probable human carcinogen.
Bummer that the jury can’t hear that.
Chhabria instructs Wagstaff: “Time to move on.”
MONSANTO TRICKS
Wagstaff changes course, and seeks to clarify for the jury that Mucci should only be considered for her opinion on epidemiology, not animal or genotoxicity studies. Earlier this morning, Monsanto confirmed with Chhabria and the Plaintiff that Mucci would only testify with an opinion on the epidemiology. Well – Monsanto lied.
Wagstaff asks Mucci to confirm that her “opinion is based SOLELY on the epidemiological literature.” Mucci responds that the genotox and animal studies actually “strengthen her opinion” and that she “was very familiar with the animal and genotox studies.”
Wagstaff is stunned that Mucci so blatantly claimed to be considering the studies outside of her expertise. It is in direct contradiction to Chhabria’s instructions. Wagstaff craftily pulls herself together, and says: “I didn’t think you’d be giving an answer that you relied on the mechanistic and animal studies.” Considering what to do next, she tells Mucci to turn to the transcript of her testimony from the Johnson trial last summer. Because this situation was so unanticipated, the page is not tabbed and there is some flubbing around.
Chhabria calls for a jury break and the jury leaves.
Chhabria is annoyed. “I don’t understand what’s going on here. We had a discussion this morning. She [Wagstaff] did not ask her [Mucci] if she had read any of the other studies. All she asked is that you are only offering an opinion on the epidemiology. I thought we had established very clearly this morning that would be inappropriate.”
Monsanto attorney Johnson says that she takes full responsibility for her expert. She recommends that Mucci could tell the jury that actually she only is offering testimony on epidemiology. She and the Monsanto team are smiling a bit. I don’t think Mucci’s misstep was an error of misunderstanding.
Chhabria says that he will strike the testimony and give a curative instruction to the jury.
The jury re-enters, and Chhabria gives the curative instruction: “Dr. Mucci is only able to testify about the epidemiology literature,” and that he’d be striking all of her testimony about the animal and mechanistic studies.
MUCCI’S TEXTBOOK CHAPTER
Mucci published the book Textbook of Cancer Epidemiology in 2018. Wagstaff photocopied pages of the textbook for all parties to reference. She asks Mucci to look at a section Causal Inference in Epidemiology, and talk about the advice to use the Bradford Hill causation analysis. Mucci admits that she didn’t do a formal BH analysis for glyphosate, but that she did use components of it.
We move to another section of the book that states that a chemical can, in some instances, cause cancer even if the epidemiology disagrees. Mucci says that she doesn’t really agree with that. Next, we look at a chart from the textbook with a list of chemicals known to be carcinogens as per IARC classification. The title of the charts is: Group 1 agents with less than sufficient evidence in humans but with strong mechanistic evidence. In the chart, there are several instances of inadequate epidemiology but sufficient animal and mechanistic evidence.
Mucci stumbles a bit, with some UH UH UHs. Wagstaff lets Mucci sit in that discomfort. Mucci replies that: “Ummmm, Group 1 agents, ummmm, are different than glyphosate.”
Wagstaff restates: “This is your book.”
AHS QUESTIONNAIRE
Wagstaff revisits the question on the original AHS enrollment questionnaire about exposure and protective clothing. On the exposure question, the form asks farmers to check the circle for all methods the farmer uses to apply pesticides. Wagstaff says, if I am a farmer, I may use a hand spray gun to spray glyphosate, but maybe a canister for toxic pesticide 2,4-D. How does the study know which method is used to apply the 2,.4-D vs glyphosate? Investigators would have no way of knowing what the actual exposure might be. Mucci responds that it wouldn’t make a difference with the exposure level.
Wagstaff moves to the next question covering what protective equipment was used. There is one question is for all 50 pesticides. So, a farmer might wear a face shield and goggles for 2,4-D, but just gloves for glyphosate. There would be no way to tell from the study design. Mucci counters that the only purpose of the question is whether you wore protective equipment or not.
ACQUAVELLA
Wagstaff uses this opportunity to slide in a 1997 email written by then-Monsanto epidemiologist John Acquavella that shows Monsanto’s opinion of the study design of the AHS. He wrote about his opinion of the AHS before there were any results from the study regarding glyphosate. The email reads:
Hypothesis: Most of the diseases to be studied in the AHS have scant reasoning to link them putatively to pesticide exposure. Thus, much of the research can be termed exploratory. That’s not unusual in epidemiology, but is unusual on this big scale.
The downside of industry and agriculture in this approach is that exploratory research tends to yield uncertain findings. Uncertain findings, at the least, cast double on the safety of products. This energizes pesticide opponents, may cause the public to dictate a market change, and typically makes the manufacturer adopt a defensive stance. It would have been preferable if the AHS had a limited scope and focused more detail on a few worthy questions.
DEROOS HIERARCHICAL REGRESSION
Another deep dive – this time into the DeRoos 2003 paper. Wagstaff would like to discuss the calculation of the study’s hierarchical regression results that fell just shy of statistical significance. In a hierarchical regression, there is some subjectivity in adjusting the weight of certain inputs to attempt to better estimate the true risk ratio.
In this case, there are different weights assigned to a variety of pesticides and herbicides. The weight is based on the EPA and IARC carcionogenicity classifications. At the time of the study in 2003, there was not yet a classification from IARC, so it couldn’t be used as an input in the weighting of the regression. Wagstaff asks how that weight would look today, given IARC’s classification as a probable human carcinogen.
Mucci starts speaking nervously and rapidly. Chhabria smiles ever so slightly. She is extremely evasive, and repeats that it “is not clear where it would fit into the [weight] categories actually.” Wagstaff pushes her repeatedly, and Mucci is uncomfortable. She refuses to respond that the risk ratio would have to change given the weighting framework of the study. However, it is quite obvious to anyone able to follow the discussion that the weight would certainly go up and significantly impact the study results towards the conclusion that glyphosate causes NHL.
The jury takes a final break, and Chhabria announces that Wagstaff’s reference to animal and mechanistic studies in the chart in Mucci’s epidemiology book reopens the door on whether Mucci could say that she also considered animal and genotoxicity studies in her evaluation. Chhabria has a valid point.
WRAP UP MUCCI
Johnson drops back in for the re-direct. She and Mucci discuss the appropriate weight for the DeRoos study, and agree that it would not be substantially different even though IARC classified the study a Class 2A.
Johnson and Mucci constantly say: “Just to be clear,” and it’s getting a bit grating.
Mucci’s testimony is over, thank goodness. Wagstaff and team did an outstanding job prodding at Mucci’s few weaknesses, and certainly the jury must have caught on to some of the Plaintiff wins. Nevertheless, Mucci has made me nervous in both trials, because she is clearly very bright and accomplished.
EXPERT TESTIMONY OF DR. LEVINE
We only have a few moments of the beginning of the testimony of physician Dr. Alexandra Mary Levine, which she spelled out clearly for all to hear, including phonetic alphabet clarifications like “V as in Victor.”
She is a hemotologist and oncologist because she cares deeply for those who are suffering with a constant hope that she can help. She enjoys the area of cancer because treatment is always changing, and there can always be hope for improvements from ongoing research. Likely moving into partial retirement, Levine sees patients 1-2 days a week and teaches as a professor at USC.
Her voice is so incredibly low, soft and calm that it instantly makes my eyes heavy. The yawns start pouring out. I am visualizing a best-selling audio recording featuring her voice to settle those with insomnia or high anxiety.
Fortunately, we are done for the day. Thank goodness, because my head was starting to seriously bob.
FINAL NOTES
Monday morning we continue with Dr. Levine. Closing statements are likely Tuesday, and we may have a verdict the same day. Time for everyone to send out positive energy for the jury to make the right decision.
I heard rumor that one of the jurors may be unfailingly pro-Monsanto, which will make a unanimous verdict rather challenging.
Cheers to goodness prevailing!
© 2019 Kelly Ryerson ALL RIGHTS RESERVED
