I’ve heard several references to RoundUp as “safe enough to drink.” Regarding this catch phrase about hydrating yourself with RoundUp, Johnson was fed the same line. I received a comment from a woman who just attended a commodities trade show. For two days, Monsanto tried to convince her that drinking a bottle of RoundUp wouldn’t hurt her at all, and that she needs someone to explain things to her “since she’s a Californian (wink wink).” Carcinogenic or not, in what world would it possibly be a good idea to drink RoundUp, and why are the salespeople sharing this stupidity?
A LITTLE BUSINESS
I have yet to post reviews of three depositions played for the jury on Tuesday, but that will be posted soon. Also, Wednesday is the jury’s day off, so my coverage will be limited on those days unless something noteworthy happens in meetings.
OK everyone – I’m pretty psyched because the rockstar of toxicology, biostats, cancer and the intersection of those subjects is in the house today. It’s worthy of a brighter shade of lipstick for the occasion. For reals.
At 9:20, Judge Bolanos enters the courtroom and attorneys are ready to debate a controversy surrounding the NSRL (No Significant Risk Level) and the admissibility for it to be used in Dr. Portier’s testimony.
Some background: In June of 2017, in response to the IARC classification of glyphosate as a Class 2A probable carcinogen, California’s EPA (OEHHA) listed glyphosate under Prop 65 “to be known to the state to cause cancer.” OEHHA also issued a notice that it would adopt an NSRL at 1100 micrograms per day for glyphosate. (This level is unfortunately too high according to GG). OEHHA permitted 75 days for public commentary submissions. They received over 1300 oral and written arguments disputing this NSRL level, but the level ultimately stayed the same. (1)
Mr. Portier’s primary feedback comment to OEHHA was that the NSRL would have yielded a much lower safe limit if they considered a specific solid study: Wood, et al. 2009a. OEHHA hadn’t read that study, and were happy to just use a different one that IARC had reviewed which concluded a higher NSRL.
Back to the trial, Monsanto does not want Portier to discuss anything to do with NSRL, as it could be used by the Plaintiff to introduce Prop 65, which Monsanto is desperate to keep out of this courtroom.
Bolanos concludes that there was not a formal notice made by the plaintiff to advise Monsanto that Dr. Portier would be discussing NSRL or documents related to it. Therefore, it should not be brought up.
Wisner is in a state of dismay, and tells Bolanos that discussions surrounding NSRL will need to happen during the trial. Notably, he also states that he “seems to lose everything here.” I agree on that. However, Judge Bolanos is sharp, so I’ll continue to give her the benefit of the doubt. It is really hard not to laugh when she remains aloof, annoyed and friendly all at the same time – she really needs her own show.
THE BONO OF TOXICOLOGY + BIOSTATS + CANCER
The jury files in – maybe it is customary, and I’m a newbie, but is it normal to stand as the jury comes and goes from the room? It must be, because it is a constant up and down in this crowd.
Dr. Portier is wearing a blue tie and has a genius-like, professorial demeanor. He also wears glasses so he must be smart. Wisner spends a very long time discussing Dr. Portier’s pedigree. To highlight just a few of many qualifying achievements that make him an expert in the areas of Toxicology, BioStats and Cancer:
- BS in Math/Ph.D in Biostatistics
- National Institue of Environmental Health Sciences ( NIEHS) – Associate Director, Director of the Environmental Toxicology Program, Associate Director of National Toxicology Program & Senior Scientific Advisor to the Director
- Director of the National Center for Environmental Health at CDC
- Director of the Agency for Toxic Substances and Disease Registry
- Authored more than 200 peer-reviewed publications and book chapters
- Member of numerous WHO/IARC scientific committees
- Several mind-blowing prestigious awards
- Made a long distance relationship work for 10 years between US and Switzerland; now moved to Switzerland and got married
Two more cool things Dr. Portier has done:
- Directed efforts of the US government to develop a research agenda with Vietnam on the health effects of Agent Orange
- Worked on a fascinating project that equipped Google Street View cars with pollution gauges. This data was initially collected in Oakland and combined with data from Kaiser. It turns out that pollution levels can vary from block to block, and it most definitely does impact health pending on where one lives. (2) Please swing by my address.
IARC IN DETAIL
Dr. Portier has some significant inside scoop on what went down at the meeting of IARC in France. In 2014, he was asked to be an expert on a panel that would review five pesticides. One was glyphosate. IARC aims to make scientific decisions about what causes cancer, but does not ever say that a substance should be banned. The monographs published by IARC are used by national and international authorities to make assessments and formulate their own decisions concerning preventative measures.
For example, DDT is STILL used in some countries along the equator because it is up to individual countries to ban it. How tragically sad for trusting residents in those countries.
An IARC working group is a group of international scientists selected to study, discuss and debate appropriate scientific data about a suspected carcinogen. The team ultimately votes upon the likelihood of carcinogenicity of the substance in question. Dr. Portier was not included in this working group due to his current part time salary from an advocacy group, but he still was quite involved as the only expert on that panel to provide background advice on the methodological assessment of data and science.
Other people that attended the IARC meetings included national and international health agencies, the European Crop Protection industry trade group, Cheminova (also manufactures glyphosate) and Monsanto.
Wisner and Portier have a fabulous, hour-long exchange in which, with perfectly paced questioning by Wisner, Portier describes the nuances of the science upon which the IARC decision was based. For purposes of this blog, I will point you to the summary from the IARC report itself, with quite a bit of description. Hopefully, however, not too much to overwhelm.
For the herbicide glyphosate, there was limited evidence of carcinogenicity in humans for non-Hodgkin lymphoma. The evidence in humans is from studies of exposures, mostly agricultural, in the USA, Canada, and Sweden published since 2001. In addition, there is convincing evidence that glyphosate also can cause cancer in laboratory animals. On the basis of tumours in mice, the United States Environmental Protection Agency (US EPA) originally classified glyphosate as possibly carcinogenic to humans (Group C) in 1985. After a re-evaluation of that mouse study, the US EPA changed its classification to evidence of non-carcinogenicity in humans (Group E) in 1991. The US EPA Scientific Advisory Panel noted that the re-evaluated glyphosate results were still significant using two statistical tests recommended in the IARC Preamble. The IARC Working Group that conducted the evaluation considered the significant findings from the US EPA report and several more recent positive results in concluding that there is sufficient evidence of carcinogenicity in experimental animals. Glyphosate also caused DNA and chromosomal damage in human cells, although it gave negative results in tests using bacteria. One study in community residents reported increases in blood markers of chromosomal damage (micronuclei) after glyphosate formulations were sprayed nearby.
Regarding the dismal description “limited evidence of carcinogenicity in humans” — that refers to the body of epidemiological reports taken into consideration by the working group. While “limited evidence” sounds like a pretty negative label, in IARC labeling procedure it means that while a credible causal relationship has been observed, it is statistically possible that the observed association is just due to chance.
The final working group vote for classification as a probable carcinogen was unanimous.
For this case, Portier was asked to work with a law firm as a scientific expert. To do so, he looked for all publications available, read all of the material, and methodically walked through the science. The studies include some that were not available at the time of the IARC meeting. IARC requires all studies used in working groups to be publicly available, but Portier is not bound by those rules as a scientific expert in this case, so he has added some additional proprietary data to his review.
Portier considered 22 long, chronic carcinogenic rodent studies for this case. Several were discarded for quality, but 5 mouse studies, 7 rat studies, and a different type of study were accepted.
Plaintiffs present a lovely chart of pink, purple, navy and yellow shades. I believe that the pink and purple are both recent Pantone Colors of Year. Dr. Portier appears sapiently scholarly in front of the jury, standing beside his easel-supported XTRA-large poster board.
On the board is a chart showing the outcomes of five different mouse studies. Each of the studies were performed in different years, but all with carefully bred lab mice. He walks the jury through each of the studies, highlighting cancer after cancer. We see lymphomas, multiple malignant tumors, lung carcinoma, kidney carcinomas, and a few cancer types that are new to me.
A second jumbo poster board chart is hoisted into place by the bearded, flannel-shirt-cladded Clerk. He must be headed to a Giants game after work.
Portier talks through seven different rat studies. We see testicular cancer, thyroid carcinomas, pancreatic tumors, thyroid cancer, liver tumors, arena carcinomas, kidney tumors, skin cancers and more.
Portier helped to develop the EPA guidelines for cancer risk assessment. Wisner asks him to run through that EPA checklist in consideration of the presented rodent studies:
- Uncommon tumor types – yes
- Tumors in multiple sites – yes
- Tumors by more than one route of administration – no
- Tumors in multiple species – yes
- Reduced latency of neoplastic lesions – yes
- Metastasis – yes
- Unusual magnitude – no
- Proportion of malignant tumors – N/A
- Dose related increases – yes
The studies show multiple tumors of the same type in multiple studies in multiple species. It is a very strong finding worthy of serious consideration.
THE BIOLOGY OF CANCER
Wisner and Portier are jamming here, but the expressions of the jury are those of fatigue, deep thought and a little confusion. One female juror is yawning into her coat repeatedly and a male juror has been staring blankly at the wall across the room for some time now. Not even blinking. There were no false promises – they were told it was going to be science and biology heavy.
Portier has another nice graphic depicting the mechanistic progression of a healthy cell to a malignancy. Normal cells → DNA damaged cells → mutated cells → cancer. Cellular machinery can repair genetic damage. If damage is not repaired, cells can lose growth control, replicating too often. In that replication, there can be increasing mutations, and an early group of mutated cells can change from a benign tumor to a malignant tumor.
If a chemical compound effects any of these processes, it can help “promote” cancer. The George Study investigated the cancer “initiator” and “promoter” qualities of glyphosate by painting glyphosate on 20 rodents and observing their skin through time. 40% of the rodents developed skin tumors. Portier concludes that this study is an indication of the mechanistic underpinnings of glyphosate in that it has the ability to have cancer promoting qualities.
Tomorrow I will continue with Portier’s review of some noteworthy epidemiological reports.
AS SEEN OR HEARD IN THE COURTROOM
Portier tells us that mice are like cats because there are many different types of mice and many types of cats. He must be a cat person, because couldn’t the same be said of dogs? I smell bias.
There were so many sidebars today – Monsanto objects often and objections are mostly sustained.
Wisner is whip smart and cheeky. I can’t imagine what he was like in elementary school.
My Philz Iced Tea set off the metal detector on the way into the courthouse. Should this be a cause for concern? Perhaps we shouldn’t drink RoundUp or the metal-laden tea.
Glyphosate Girl Copyright 2018