Day 2 – Pink

Roundup Glyphosate Cancer Epidemiology

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After today’s session, I hustle to grab a table in the cafeteria next to a much coveted electrical outlet. The brown-on-brown painted cafeteria is eerily abandoned at five o’clock, with no soul to be found. The dishwashers hum, clank and echo. I’ve been reading and hearing a lot about trusting gut instincts recently. My gut is telling me to hightail out of the Federal Courthouse cafeteria abyss so that I won’t be kidnapped or locked in for the night.

With that, I head over to a crazy cool dive bar in San Francisco’s Mission District to attend a screening of several environmental documentary shorts, all hosted by the San Francisco Green Film Festival.  Fortunately, I have a screenwriting friend in the know about these things. As we all know, I am a relatively late add to the team of environmental advocates/activists. While the films are beautiful, the crowd is even more so. The small room is packed with people who are interested in combining art with environmental activism.

If you happen to be concerned that bees and butterflies are nearing extinction, you will be happy to know that I met some dynamic women who are working to tackle the problem. Two women from the Environmental Defense Fund work daily on developing ways to foster growth in the Monarch butterfly population, including the strategic planting of milkweed. Another woman is committed to restoring the bee population. I just put in an online order for “Common Milkweed” to plant someplace undecided, but decidedly free of Roundup.

WOW

Twitter is abuzz about yesterday’s showdown in court between Judge Chhabria and lead Plaintiff counsel Aimee Wagstaff. A few people have asked me my opinion, so I’ll open today’s trial post with a rehash. Preview: I didn’t find the conflict between Chhabria and Wagstaff quite as dramatic nor as offensive as others are recounting.

Chhabria was irate with Wagstaff following her Opening Statements that apparently “crossed the line” of permissible content several times. She was threatened with sanctions of $1000. After the jury left for the day, everyone else reconvenes to argue whether her actions warranted sanctions.

Plaintiff attorney Jennifer Moore represents Wagstaff on the matter. She begins to apologize for discussing the controversial mouse cancer study. Chhabria is shocked because the mouse tumor study hasn’t even made his list of Wagstaff’s transgressions. Moore seeks more clarification as to what Chhabria found so appalling in the Opening. Chhabria lists the points of contention, including:

  1. Wagstaff shared too much information about Phase 2
  2. A significant amount of time was spent detailing Hardeman’s personal history, which Chhabria considers irrelevant for Phase 1. Even with a warning to wrap that part up, Wagstaff continued talking about “needles” and “needles” and “blood”
  3. The 1985 EPA memo was not admitted during Phase 1, yet was a focal point of Wagstaff’s presentation
  4. The inclusion of IARC and its analysis was to be significantly limited. Meanwhile, Wagstaff elaborated on how IARC reached its conclusion and the meta-analysis that they performed
  5. A pre-trial order limited EPA evidence. Wagstaff violated that order by telling the jury that the EPA is vulnerable to political shifts and internal disagreements

Chhabria says that these transgressions weren’t reckless, they were made in bad faith (which, I gather, in legal terms is worse).

I always hope to be in full support of the Plaintiff counsel, but Chhabria has some valid points. I remember these pre-trial debates. The issues that he raises unfortunately seem….fair.  A debate continues on each point, and nothing Plaintiffs present appear to successfully defends their actions.

The most controversy arises when Chhabria claims that Wagstaff must have acted in bad faith (fully knowing that she was breaking the rules) given her “steely” body language and expression when he called her out for her transgressions during the Opening Statements. Chhabria continues that she must have premeditatedly braced herself for his criticism, because she didn’t look surprised by any objection he gave.

A strong Wagstaff swiftly defends herself. She explains that the fact that she has composure should not be used against her. Being composed is not evidence of acting in bad faith. Go girl!

Chhabria moves on.

When further defending Wagstaff, Moore tells Chhabria that Wagstaff is an involved leader in women’s legal group, where she is highly thought of. Chhabria says: “Are you suggesting I apply a different standard?” I’m kind of bummed that Moore brought that up, because it did indeed seem out of place and as if she was expecting better treatment. These things are tricky.

In the end, Chhabria addresses Hardeman, who has driven in last minute at Chhabria’s request. Hardeman is reminded that his attorneys work for him, and that his case could be dismissed if the attorneys don’t conduct themselves appropriately.

In conclusion, my take is that Chhabria is sometimes arrogant and condescending to both the women and men on the Plaintiff side. My knee-jerk reaction was initially that he reminded me of every domineering manager I ever had in my first job out of college. On further reflection, I don’t think it was necessarily a sex issue. Chhabria has said some truly awful, mean spirited things to Brent Wisner, among other attorneys. He continually refers to Dr. Nabhan as mostly a provider of junk science. And of course, in Chhabria’s opinion, the expert witnesses couldn’t even write their own reports.

The guy’s got a sharp tongue.

Ultimately, Chhabria issues an order for sanctions of $500, with further discussion to take place after the trial about which other Plaintiff attorneys are subject to the sanctions.

DR. RITZ CONTINUED

The entire morning has been reserved for Dr. Ritz to thoroughly grind through all details of the Agricultural Health Study (AHS), the kingpin of Monsanto’s general causation argument. For those who didn’t follow along in the Johnson trial, Monsanto’s defense has predominantly relied upon the AHS study, religious adherence to the rules of statistical significance, and the EPA’s purported infallibility. As learned from the Johnson trial, Plaintiff needs to commit a substantial amount of time to explaining the nuances of AHS to prove that the 2018 AHS-based Andriotti study conclusion, that Roundup does not cause NHL, are unfounded.

I don’t want the Chhabria/Wagstaff excitement to in anyway detract from the phenomenal, inspiring expert testimony that epidemiologist Dr. Ritz delivered today in support of Hardeman. Ritz is an absolute brainiac ace.

AHS STUDY

For review, I’ll give an overview of Dr. Ritz’s crystal-clear explanation of the Agricultural Health Study, with which she was involved as the Chair of the External Advisory Committee for many years. If only I could receive course credit for the report.

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IN CASE YOU ARE INTERESTED – THE AHS STUDY AS PER DR. RITZ

The Agricultural Health Study was an ambitious undertaking to better understand the impact of pesticides on human health by studying farmers. North Carolina and Iowa both had extension programs that enabled farmers to learn about pesticides and acquire licensing for their use. When farmers took the licensing test, research assistants asked if they would be part of a large cohort study that would track pesticide use patterns and health over time. Participating farmers then filled out a twenty-two-page bubble questionnaire that included twenty-two listed pesticides and questions on frequency of use and method of application.

The study had 54,000 participants enrolled between 1993-1997. That time period is highly significant because the pesticide type and quantity farmers reported using at the time of their initial enrollment in the study changed dramatically with the introduction of Roundup Ready GMOs. Therefore, a fundamental problem with this study as it relates to glyphosate is that the enrollment surveys couldn’t adequately capture glyphosate use, when Roundup Ready GMOs weren’t introduced until 1996 and then completely changed the common practices of herbicide use in the US. Ritz shows the following maps, which I have shown before but are good to review.

Glyphosate use prior to the introduction of Roundup-Ready GMOs.
Explosion of glyphosate use due to the mid-1990s introduction of Roundup-Ready GMOs

Ritz draws an excellent comparison to the use of the iPhone. If one is studying whether mobile phones are harmful, and enrolled participants between 2005-2010, they would not have known in the study design that the iPhone would be released in 2007 and go on to dominate the market. It didn’t exist yet. So, what if something in the iPhone technology is particularly harmful versus other phones, but the data doesn’t capture it because enrollment surveys were completed before the industry shift?  

Another complication involves what details one can collect, use, or misuse in an analysis of case exposure levels. The study used models to estimate how much pesticide was sprayed on a typical user from details like how much protective gear was worn and what spraying techniques were used. Any errors in the model would lead to a problem called Exposure Misclassification.

Ever a teacher who utilizes compelling metaphors, Dr. Ritz asks the jury to imagine that you have a white can of paint (pesticide exposed farmer) and a red can of paint (unexposed farmer). If you make an error as to what weights you put in the model, it is comparable to putting a bit of red in the white can, which turns it a bit pink. The next weighting error requires pouring a bit from the white can into the red paint. Each error compounds itself until you ultimately have pink in both cans. You can no longer differentiate between the exposed and unexposed.

Between 1999-2004, AHS researchers tried to find and contact the original farmer study participants to get additional information. For those who they were able to reach, they collected info on the farmer’s pesticide practices over the previous 12 months. 38% of farmers did not respond to the follow-up study, leaving data on only 62% of the original study participants.

Ritz asks the jury: “You can see what guesswork?” Monsanto objects and Chhabria instructs Dr. Ritz that we are not in a classroom so engaging with the jury as though they are students is inappropriate. Ritz says she will try not to pose the lesson in questions going forward.

Ritz explains (very loosely quoted):

You use all of of the information you have because it is the best you can do. You try to set up informed guesswork based on a few people. Farmer Joe who came back for the second survey may be the same or different than Farmer Ted who didn’t respond to the second survey. But now, using the guesswork methods, Ted is likened to Joe.

GG Sidebar: If the populations of Farmer Teds look very different than Farmer Joes, this can really distort things. What if Farmer Ted didn’t respond because he was sick?  This idea is called “statistical confounding.”

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Wagstaff shows the court images of class slides from Ritz’s Intro to Cohort Studies class that she taught in 2012. Ritz clarifies that she did not become a Plaintiff expert witness until the Fall of 2016, so the content of her slides would not have been influenced by any paying party.

Ritz criticizes cohort stories and walks through the disadvantages of cohort methods. She teaches classes from the same slides today.

Wagstaff and Ritz walk through a list of published research that describes the problem with exposure misclassification in the AHS. The conclusion of the presented papers can be summarized in that the AHS exposure misclassification is nothing but a can of pink paint. That’s a bit more delightful of an image than “weighting shit with a gold scale” though I appreciate Neugut for that gem as well.

Wagstaff and Ritz describe the details in DeRoos 2005 and Andreotti 2018. She explains that when a risk estimate falls below 1, it theoretically means that the substance (in this case, glyphosate) offers a protection from NHL, not risk. In such cases, the scientist must look at the data and see where the misclassification or incorrect weighting of data occurred.

Sadly, a lovely chart that lines up all of the epidemiology discussed by Ritz over the last two days has its back to me and thus I cannot report. With that, Ritz’s conclusion is that there is an increased risk of NHL with exposure to glyphosate across all included studies.

CROSS EXAMINATION OF DR. RITZ

Tamarra Johnson takes on what will likely be a challenging cross examination. During the direct, Johnson was often standing rather than sitting, moving around the courtroom to absorb all presented information. She politely begins her questioning.

Highlights:

  • Johnson puts the UCLA class slides back up on the screen, this time focusing on the slide discussing the advantages of cohort studies.
  • When questioned on certain slides that explore the usefulness of a cohort study design, Ritz explains that one should not conclude anything from the slides. Without attending her class to hear the lecture, it would be impossible to know what she is teaching. Her slides contain intellectually probatory questions to inspire deeper considerations of study design.
  • Johnson shares a slide that includes a profile picture of Ritz sitting at a conference between two other individuals. Johnson asks Ritz who the person is next to her in the picture, and she says that’s her friend Jane. Monsanto asks several follow-up questions that are trying to drive a “gotcha” moment, but nothing sticks. Ritz emerges the winner.
  • Several more attempts are made to impeach Ritz, but she remains solid. At the end, Ritz says: “So that’s consistent right?”

After a brief re-direct, Dr. Ritz successfully completes an astoundingly flawless, extremely enriching expert testimony of the epidemiological proof that Roundup is capable of causing cancer. She must be relieved.

FINAL NOTES

I anticipate to hear more tomorrow about the squabble over sanctions.

The video testimony of Dr. Portier is up next!

© 2019 Kelly Ryerson ALL RIGHTS RESERVED

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