Expert gets his sums wrong in attempt to use historical control data to dismiss tumours
Attorneys Robert F. Kennedy and Kevin Baum, who are involved in the US cancer litigation on the side of the cancer sufferer plaintiff Dewayne Johnson, have written a crushing commentary on the expertise of Monsanto’s bought-in witness. The witness, Dr Warren Foster, reportedly made elementary errors in his use of "historical control data" to dismiss findings of increased tumours in glyphosate-exposed mice.
At GMWatch we've often criticised the incorrect use of historical control data to dismiss statistically significant increases in harm to experimental animals from toxic chemicals like glyphosate.
The correct controls for any experiment are those within the experiment itself, since all variables except the test substance are controlled for. Diet and environmental conditions are the same in test and control groups and the only variable is the addition in the test groups of the particular substance under test.
But industry instead uses the unscientific ruse of comparing the results in the test groups with so-called "historical control data" – control animal data from numerous historical experiments, often unpublished and thus unverifiable, which were conducted in widely differing conditions. The range of values obtained in these experiments will be broad – so much so that comparing the test group results with the historical control data will almost invariably result in finding no difference between the test groups and the historical controls. Thus "no effect" is concluded for the test substance even where there is an effect.
In this way, industry routinely dismisses statistically significant increases in harm in test group animals in pesticide safety studies.
In principle, such misuse of historical control data is unscientific and irresponsible.
However, even those who convince themselves that the practice is acceptable must balk at the point where the person who is applying the historical control data gets the basic sums wrong.
This is the situation that was exposed by attorney Brent Wisner, who works for the Baum Hedlund Law firm that is representing Dewayne Johnson.
The extreme seriousness of the case doesn't change the fact that Kennedy and Baum's account of this fiasco is very funny indeed.
Monsanto witness admits calculations were wildly wrong
by Robert F. Kennedy, Jr. and Kevin Baum
Organic Consumers Association, 9 Aug 2018
[links to sources at the URL above]
Dewayne Johnson v. Monsanto Company is the first Roundup cancer lawsuit to proceed to trial. Plaintiff Dewayne “Lee” Johnson, a 46-year-old former school groundskeeper, alleges exposure to Monsanto’s Roundup weed killer and its active ingredient, glyphosate, caused him to develop non-Hodgkin lymphoma (NHL).
Johnson is one of thousands of plaintiffs to file suit against Monsanto in state court over the alleged link between Roundup and NHL. More than 450 other lawsuits filed in federal court are currently pending in U.S. District Court for the Northern District of California. Since the start of the Johnson trial, Robert F. Kennedy, Jr., co-counsel to Baum Hedlund Aristei & Goldman, has provided running commentary of the events in court each day. Here's his post for Aug. 2 on the Monsanto trial:
As its expert in reproductive toxicology, Monsanto called Dr. Warren Foster to the stand on August 2 to attack the animal studies cited by the International Agency for Research on Cancer (IARC). IARC relied on those studies for its determination that glyphosate is a carcinogen.
Foster, a professor at McMaster University in Ontario, has Ph.Ds in “medical sciences” and veterinary sciences. He admitted under cross that he never studied glyphosate nor its carcinogenicity before Monsanto paid him to testify.
When I learned that Foster hailed from Ontario and worked for Environment Canada (Canada’s EPA), I wondered how a Canadian environmental bureaucrat, a species famous for straight shooting, integrity and idealism, could have become mired in Monsanto’s sordid mischief. His long ponytail somehow made his association with the chemical company even more incongruous.
During a break, my colleague, Brent Wisner of Baum Hedlund Law, asked Foster, good naturedly, about his queue, “Are you a hippy or a Harley enthusiast?” Foster chuckled, “I’m no motorcycle rider.” By the end of the morning session, Wisner had developed an amiable rapport with the witness, and Foster all but confessed that the temptation of Monsanto’s money had set him on this mathematical misadventure.
Wisner: “You're not a statistician, right?”
Foster: “No, I'm not.”
Wisner: “But you would agree that numbers are important?”
Foster: “Numbers are always important, especially on my paycheck.”
Reflecting about Foster over lunch, Wisner remarked to me, “It’s clear his head isn’t in this. He just is not a natural liar. I almost want to ask him to come work for us, I get the idea that he’d flip in a second.”
On direct examination, Monsanto’s attorney, Kirby Griffis, had led Foster through each of the animal studies relied upon by IARC. The legal justification for Foster’s objection was his contention that, in virtually all of those studies, the exposed mice developed tumors at lower rates than historical background levels, which he pegged at six tumors for every 50 mice, or 12 percent of mice.
Foster arrived at that astonishingly lofty 12 percent, by averaging the data he said he compiled on background cancer rates in mice from the so-called “Charles River” studies and the “Wood Analysis” published respectively in 2000, 2005 and 2009. After establishing that background threshold, Foster described how he had literally thrown away the IARC studies one at a time when they all showed glyphosate-exposed mice with fewer than six tumors in every 50 mice.
Under direction by Griffis, Foster drew a line on a graph plotting the six tumors/50 mice slope showing each of the IARC studies with all the exposed mice below the plot line. It was all very convincing, but, unfortunately for Monsanto, not true!
When on cross examination, Wisner escorted Foster on more attentive stroll through the same calculations of the “Charles River” data, Foster cheerfully discovered that he had made an essential mathematical error in determining his background average. He now confessed that it was mathematically impossible to arrive at an average of six tumors per 50 mice as the background range, and that his proposed 12 percent of control group mice with tumors was categorically false. Foster blamed afternoon drowsiness for his consequential error.
Wisner: “Mr. Griffis just pointed this out to you, and this is your chart talking about the lymphomas, right?”
Wisner: “And you opined and told this jury that the rate is at six out of 50, so that's 12 percent, right?”
Wisner: “Now, you arrived at that 12 percent number and you showed the jury this document. Do you recall that?”
Foster: “I do.”
Wisner: “Now, the Wood study that you’re referring to, that was published in 2009, right?”
Wisner: “And… I was going through it over lunch, and I found this table. This is Table 3. Do you see that?”
Foster: “Yes, I do.”
Wisner: “And this is the neoplasms in males, right?”
Wisner: “And this is tabulating all the data from [your] charts?”
Wisner: “And if we turn to "Malignant Lymphoma, Whole Body"—Do you see that?”
Wisner: “—it says "Percent of Total, 4.09 Percent" –”
Wisner: “—right? 4.09 percent of 50 would be two tumors, not six?”
Wisner: “Right? Are you familiar with this document, sir?”
Foster: “Yes, I am.”
Wisner: “This is an updated version of the [earlier 2000 study about which he earlier testified?]”
Wisner: “This is the same group of authors, and they're talking about the same thing, Spontaneous Neoplastic Lesions in CD-1 mice, but this is dated March 2005.”
Wisner: “And we have the lymphoma? Do you see that, sir?”
Wisner: “Again, that's a 4.5 percent, right?”
Wisner: “And that would be—4.5 percent out 50 would be what? What would that be, 2.25?”
Foster: “About that, yes.”
Wisner: “We talked about how important numbers are, and this is that chart you created. If, in fact, we were to use the numbers from those publications, [your plot] line would actually be a third. It would be down here, wouldn't it?”
[Wisner points to a trajectory that puts virtually all the IARC studies at the high end of the new plot line.]
Foster: “It would be if we accepted those numbers, yes.”
Wisner: “And, in fact, if we did that, a lot of these high-dose groups, they're outside of that range, right?”
Foster: “They would be outside the range, yes.”
Finally, Wisner showed Foster the actual list of numbers that he had then divided to achieve his average of six tumors per 50 mice. It was hard to imagine how anyone could have calculated the numbers to reach an average of six.
Wisner: “Doctor, I'm just going to show you the document again. We just showed it to the jury. This is the Charles River March 2000 document. Do you see that one?”
Wisner: “And I am not good at math. I'll be honest with you. Okay? But when I look at these numbers, you know, to 2, 2, 1, 4, 1, 3, 1—it goes on, and on to the next page, and even when I throw in that one 13 on the next page, how does that average to 6?”
Foster: “Yeah, it's late, and I'm looking at it. And—yeah. When I did my assessment of the data, I used range.”
And thus, Monsanto’s key witness on the animal studies admitted his earlier calculations were all wildly wrong.
Here are key highlights from the Monsanto trial based off of Robert F. Kennedy's daily entries:
Day 1, July 9: opening statements
Here’s a link to the opening statement for the Plaintiff by Brent Wisner of Baum Hedlund Aristei & Goldman:
“This case really is about choice. It's about the right of every single person in this room to make a choice about what chemicals they expose themselves, their family or their children to…If you don’t warn, you don’t give someone the choice, and if someone gets hurt from that, or, God forbid, someone gets cancer, then I believe someone should be held responsible for that.”
Day 2, July 10: Did Monsanto suppress its own research?
On day 2 of the Johnson trial, the jury heard deposition testimony from Monsanto toxicologist, Dr. Mark Martens. Johnson’s attorneys asked Martens why Monsanto decided to abandon research conducted in 1999, by Dr. James Parry, an independent toxicologist Monsanto hired as a consultant after deeming him a top expert in his field.
Dr. Parry’s research concluded that glyphosate and the Roundup formulation may cause genetic mutations, a potential precursor to cancer. According to Martens, Monsanto did not allow independent scientists to review Dr. Parry’s research for further study after it was received, nor did the company give Dr. Parry’s research to the U.S. Environmental Protection Agency (EPA).
Day 3, July 12: Dr. Christopher Portier discusses the tumors in glyphosate animal studies, and the EPA’s initial findings in 1985, that glyphosate is a “possible” human carcinogen
On day 3, Judge Suzanne Ramos denied attorney Brent Wisner’s request that epidemiology/toxicology expert, Dr. Christopher Portier, be permitted to share his opinions before the jury concerning the amount of glyphosate exposure the state of California has determined causes cancer.
Wisner argued that a previous ruling allowed Monsanto witnesses to testify about foreign regulatory decisions to not list glyphosate as carcinogenic, so it did not make sense to deny the plaintiff the opportunity to discuss California’s own regulatory decision to list glyphosate as a chemical known to the state to cause cancer.
Nevertheless, Dr. Portier testified that his analysis of 13 rodent studies on glyphosate, and the findings of the International Agency for Research on Cancer (IARC) led him to conclude that exposure to glyphosate causes NHL. Portier said:
“If you have multiple tumors of the same type in multiple species, it adds to the strength of causality. By seeing lots of different tumor types hit in the same animal, the more important it is to the human causal.”
Day 4, July 13: Dr. Christopher Portier discusses flaws with U.S. and EU regulatory Evaluations for glyphosate
On day 4, Monsanto counsel, Kirby Griffis, tried to rattle Dr. Christopher Portier during cross-examination, confronting the expert witness with the EPA’s conclusion that glyphosate is not likely to be carcinogenic to humans. During testimony, Dr. Portier slammed U.S. and European regulators over their methodology in evaluating glyphosate.
For example, Dr. Portier testified that European Food Safety Authority (EFSA) missed 15 tumors in a series of rodent studies on glyphosate because the agency used the wrong methodology. During cross-examination, he said:
“My entire career been about using scientific evidence to make decisions, primarily about the carcinogenicity of compounds, and we’ve worked for years and years to do that appropriately. This was just so amazingly wrong in the way they were doing it.”
Day 5, July 16: fireworks during cross-examination as Monsanto lawyer attempts to discredit expert witness
On day 5, as cross-examination continued Monday, Monsanto counsel Kirby Griffis accused cancer expert, Dr. Christopher Portier, of basing his opinion that glyphosate and Roundup cause cancer on lucrative consulting contracts from law firms and not on scientific evidence.
“You said EPA was ‘so amazingly wrong;’ EFSA was ‘so amazingly, astonishingly wrong.’ ECHA (European Chemicals Agency) got one thing right,” Griffis said, attempting to poke holes in Dr. Portier’s prior testimony about U.S. and European regulators’ evaluations of glyphosate.
Undaunted, Dr. Portier responded: “It’s absolutely clear they’re not using [their guidelines] appropriately.”
During redirect, Dr. Portier also pointed out that a reassessment report for glyphosate conducted by a German agency that participated in EFSA’s review of glyphosate, contained verbatim passages written by herbicide manufacturers.
Day 6, July 17: Plaintiff Dewayne Johnson called Monsanto to ask if using Roundup caused his skin rashes, later diagnosed as non-Hodgkin lymphoma
On day 6, Monsanto executive Dr. Daniel Goldstein attempted to rebut plaintiff Dewayne “Lee” Johnson’s allegation that he failed to tell him whether exposure to Monsanto’s Roundup weed killer caused him to develop skin rashes over a significant portion of his body.
In his lawsuit, Johnson alleges he developed cancerous lesions on his body after using Roundup between 2012 and 2015, as part of his groundskeeper job, including two instances where he was drenched in the weed killer.
The jury saw video testimony from Dr. Goldstein, who was asked whether he returned calls that Johnson had made to the company in 2014, asking if exposure to Roundup created the widespread lesions all over his body.
Dr. Goldstein testified that he did not recall speaking to Johnson, though an internal Monsanto email shows that he intended to call Johnson.
“It would certainly be helpful to have spoken with him, and I don’t recall whether I did,” Goldstein testified.
Day 7, July 18: Tempers flare as Monsanto lawyer becomes visibly frustrated with cancer expert, Dr. Alfred Neugut
On day 7, oncology and epidemiology expert Dr. Alfred Neugut of Columbia University took the stand and things got a bit heated during his cross-examination. At one point, Monsanto attorney George Lombardi gave the court an inaccurate characterization of a statement Dr. Neugut had made. Dr. Neugut yelled back to Lombardi to stop “misquoting” him.
Another highlight was Dr. Neugut’s dismissal of the Agricultural Health Study, which Monsanto routinely points to as conclusive proof that glyphosate is safe. Like other expert witnesses for the plaintiff, Dr. Neugut told the jury about several key flaws with the study, including the imputation of data to make up for poor follow-up among the study’s subjects, which rendered the study a “throwaway.” Dr. Neugut said:
“You use imputation when you’ve got a screwed-up study with poor follow-up. Unfortunately, this is a case of measurings—with a gold scale, where it turns out the results just don’t turn out to be what they should be because there are so many problems.”
Day 8, July 20: Plaintiffs oncologist testified that exposure to Roundup “was a major contributing factor in the development of Mr. Johnson’s cutaneous T-cell lymphoma”
On day 8, the court heard from Cardinal Health oncologist and physician, Dr. Chadi Nabhan, one of Dewayne “Lee” Johnson’s medical witnesses. Dr. Nabhan testified that Lee Johnson’s exposure to Roundup “was a major contributing factor in the development of Mr. Johnson’s cutaneous T-cell lymphoma.”
One of Monsanto’s points of emphasis during the Johnson trial is how long it takes for cancer symptoms to manifest after exposure to a carcinogenic agent. Lawyers for the agrochemical giant say it takes 20 years, which would eliminate Roundup exposure as the cause of Mr. Johnson’s NHL.
Dr. Nabhan, however, told the jury that cancer symptoms can show in just one month. “There is no agreed-upon latency period with these types of exposures and these types of cancers,” said Nabhan, who specializes in lymphomas. “Some patients can develop the disease early on and some patients can develop it in 20 years.”
Day 9, July 23: Dewayne “Lee” Johnson testifies he “never would’ve sprayed that product on school grounds or around people if I knew it would cause them harm”
On day 9, Dewayne “Lee” Johnson and his wife, Araceli, took the stand and gave the jury a heartbreaking glimpse at how their lives have changed since Lee’s cancer diagnosis.
During her testimony, Araceli recalled when Lee first told her about his diagnosis. “I couldn’t believe it. My world just shut down,” she said, adding, “I only cried at nigt... it was very hard.”
In order to make a dent in the family’s rising medical bills, Araceli took a second job working 14-hour days while shuttling her two sons an extra 45 minutes to Napa Valley School District in hopes of providing them better educational opportunities.
When Lee took the stand, he testified in agonizing detail how he tried to hide the pain of his diagnosis from his family. “I’m trying to show my kids an example of how to deal with things and crying is not going to help you,” he said. “But I’m raising two little boys, so I’m teaching them to deal with pain and learn to deal with it and to deal with a situation if it comes to you. And sitting around sorrowful and crying is not going to help.”
Mr. Johnson also made it clear that he never would have used Roundup if he had known it causes cancer.
“I never would’ve sprayed that product on school grounds or around people if I knew it would cause them harm,” Mr. Johnson said in court on Monday. “It’s unethical, it’s wrong. People don’t deserve that.”
Day 10, July 24: Secret documents reveal Monsanto’s war on cancer scientists
On day 10, the jury heard video testimony from Monsanto toxicologist, Donna Farmer, who leads the chemical company’s deceptively named Product Safety Center.
Getting Farmer to testify proved to be a challenge. When our legal team sent a process server to subpoena her testimony, Farmer was observed fleeing through a backyard fence of her St. Louis home. We had the block staked out and successfully served the summons.
In her deposition, Farmer adamantly denied that her role at Monsanto was to protect Roundup until she was confronted with an internal company document showing that, in fact, her “number one goal is to defend and maintain the global glyphosate or Roundup business.”
Under questioning from attorney Mike Miller, Farmer admitted that her primary concern was regulatory compliance rather than public health, acknowledging that she orchestrated the ghostwriting of articles for supposedly independent scientists who agreed to defend glyphosate.
“There’s nothing wrong with that,” she said.
Day 11 & 12, July 25 & July 26: Disappointing rulings in Monsanto’s favor keeps important evidence from the jury
Judge Bolanos issued a series of rulings on day 11 that favored Monsanto and prohibited plaintiff’s attorneys from presenting key evidence to the jury.
In one ruling, Judge Bolanos held that plaintiff’s expert, Dr. Charles Benbrook, could not offer any opinions or descriptions about a collection of Monsanto’s internal studies on Roundup’s health effects that are highly damaging to Monsanto’s case.
We had hoped to show the jury these documents, which involve transparently deceptive statistical machinations designed to cloud the results of Monsanto’s own glyphosate research. One important internal study shows that glyphosate causes cancer in mice. Another internal Monsanto research study detailed higher human skin absorption rates of the herbicide than reported elsewhere.
Day 12 started with more of the same; Judge Bolanos blocked us from mentioning Monsanto’s “TNO dermal absorption” studies, which found far higher rates of glyphosate and Roundup absorption through the skin than previously reported. The afternoon brought some good news, however, as plaintiff’s expert, Dr. William Sawyer, testified that glyphosate alone is “clearly” carcinogenic, and that Monsanto’s practice of adding chemical surfactants “increase and enhance [Roundup’s] carcinogenicity.”
Dr. Sawyer also noted that Lee Johnson’s job as Integrated Pest Manager for the Benicia School District required him to apply Roundup in ways that maximized his exposure. In fact, Dr. Sawyer testified that Lee sprayed more than three times more Roundup per hour than the average individual in Monsanto’s premier safety studies.
Day 13, July 27: Plaintiff’s expert testifies that Roundup uses a potent surfactant that dramatically amplifies toxicity
On day 13, plaintiff’s expert, Dr. Charles Benbrook testified that EPA’s focus on glyphosate in isolation is a sham intended to gloss over the more important question of “whether the Roundup formulation itself, not just a single ingredient, is toxic and carcinogenic.”
According to Dr. Benbrook, Monsanto uses a potent surfactant in the Roundup formulated product that dramatically amplifies its toxicity.
The jury also heard videotaped testimony from Steven Gould, Monsanto’s head of west coast sales. In his deposition, Gould acknowledged trading emails with Greg Fernald, a chief marketer for Roundup’s California distributor, Wilbur-Ellis.
Gould complained to Fernald that California school districts were banning the use of Roundup on school grounds.
“It’s hard to understand how against all science and law they can do that—can do this,” Fernald responded. “We are being overrun by liberals and morons, sort of like a zombie movie. So we just have to start taking them out one at a time, starting with the elections next year.”
Unfortunately, since we are before a California jury, Judge Bolanos had us redact out all reference to California, but the video was still effective.
Day 14, July 30: Monsanto Herbicide Expert Has Bad Day in Court
On day 14, Monsanto’s attorneys filed an obligatory motion to nonsuit the case—a Hail Mary asking the judge to dismiss our claims on grounds that Plaintiff’s counsel had not produced sufficient evidence to bring the case before the jury.
The motion was denied. Unfortunately, that was about the only motion we won, as Judge Bolanos continued her pattern of favorable rulings for Monsanto.
Monsanto called UC Davis professor Kassim Al-Khatib to testify on “weed science” and herbicide use. Al-Khatib has a long history as a paid expert for Monsanto on various cases. Under usual circumstances, payment in exchange for “expert” testimony would be a rich and permissible subject for impeachment because Al-Khatib has incentive to tailor his testimony to keep his gig as a paid Monsanto expert.
A jury should be able to hear this evidence of potential bias. Yet Judge Bolanos ruled we could impeach Al-Khatib only about the money he received for this particular case. The amounts were still substantial—invoices revealed that Monsanto paid professor Al-Khatib $70,000 for 200 hours of work.
When Baum, Hedlund, Aristei & Goldman attorney Brent Wisner asked what he did during those 200 hours, Al-Khatib testified that he read one of Johnson’s three depositions and his trial testimony, and reviewed the photograph of Johnson’s sprayer.
Day 15, July 31: Monsanto Pays Harvard Wizard $100k to Perform Statistical Magic Show for Jury
On day 15, Monsanto expert witness, Dr. Lorelei Mucci, took the stand. Dr. Mucci is a cancer epidemiologist and associate professor at the Harvard School of Public Health (HSPH).
Despite its impressive name, the HSPH has earned a dubious reputation for taking rich contributions from polluters in exchange for producing scientific “research” that fortifies corporate profit-taking. Big Tobacco, the chemical industry, Detroit automakers, corporate food processors, and industrial meat and grain barons have all turned to HSPH for corporate-friendly science anointed with the Harvard name.
Under cross examination, Mucci admitted that Monsanto paid her $100,000 for her testimony. It was money well spent, as Dr. Mucci met questions from attorney Brent Wisner with a cacophony of smokescreen, jargon-heavy double-talk, at one point even disputing that she was Monsanto’s expert.
Robert F. Kennedy Jr. is a longtime environmental advocate and author of American Values: Lessons I Learned From My Family. He is co-counsel to Baum Hedlund Aristei & Goldman, representing nearly 800 people across the nation who allege Roundup exposure caused their non-Hodgkin lymphoma. Follow him on Twitter: @RobertKennedyJr. Like him on Facebook.
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