Day 217: The variable views of Kenneth Mundt

There are some edge-of-the-seat moments at the Blais-Létourneau trial this week. It is really beginning to feel like play-off season - with every play, every call, every bench switch getting super-charged attention.

Justice Riordan has also upped the intensity, with a much more assertive refereeing than at any previous point in the trial. (Today he actually told Simon Potter to stop interrupting!)

Today was the second-last lap in the defendant's tag-team wrestling match against the conclusions of the plaintiff's expert epidemiologist (Jack Siemiatycki). This morning was the end of (epidemiologist) Kenneth Mundt's turn, and this afternoon statistician Bertram Price began to present his views.

Both these men are in the same line of business -- they are consultants to industries described by Mr. Mundt as having a "dark" past.  Asbestos. Roofing. Chromium. Tobacco. (Mr. Mundt works with Environ, and Mr. Price with his own eponymous consultancy).

Both are experienced expert defence witnesses, based in the United States and initially recruited by U.S. law-firms. Both were given the job of finding fault with Mr. Siemiatycki's estimates of how much one had to smoke before a subsequent illness in the Blais category (emphysema, or cancers of the lung, larynx or pharynx) could be attributed to smoking. (Mr. Mundt's expert report is Exhibit 30217, and Mr. Price's is Exhibit 21315).

Let's pick up where we left off yesterday -- with the cross-examination of Mr. Mundt by plaintiff lawyer André Lespérance.

Not your regular hatchet job?

Mr. Lespérance had seemingly rattled Mr. Mundt last night by showing him that he had once adopted or approved similar methods to those he is now criticizing.

Among those was a citation from an expert opinion written in early 2010 by Mr. Mundt, when he was engaged to help fend off a U.S. lawsuit involving light cigarettes. At that point, he expressed support for the use of pack-years as a measure of how much harmful exposure to which a smoker might have been exposed. But a few months later, in late 2010, when he filed his report in his case (Blais), he said that results based on pack-years were not up to the job.

This morning, Mr. Mundt looked and sounded more confident. He gave a nice-sounding explanation for these differing views in the same year.

He said his own thinking during that period had evolved as he became more "intimately" involved in the topic of exposure to cigarette smoke -- and underlined that the old way of thinking was inadequate. Thsi court would also "benefit from embracing the more recent" perspective.

He quite smoothly worked to keep on his main message track - and to reflect questions about his own choices back to the flaws he saw in the plaintiffs' measurements. "There are simple methods that are attractive because of their simplicity, but sometimes you need a more precise tool. A hatchet works for some jobs, a scalpel is required for others."

Some concessions

But while Mr. Lespérance was mostly unsuccessful at getting Mr. Mundt to agree with his interpretation of published results, he did succeed in having this epidemiologist say some useful things:

* Mr. Mundt said that a relative risk of over 1 would still suggest an association with exposure, even if it did not pass the "magic number" of RR=2 used in this trial. (Mr. Marais had made a great deal about not using any figures whose confidence intervals fell below 2)

* He validated the use of the cancer registry as an appropriate source for information.

* He described the growth of lung cancer as an "epidemic" largely due to smoking.

But no number - no matter how pressed for one

Mid morning, Mr. Lespérance asked the questions that have clearly been on Justice Riordan's mind. "What would be your critical amount. At what point would you be confident that on a population basis the number [indicating causality] is reasonable?"

Mr. Mundt steadfastly refused to give a number. He gave a long methodological rationale for his decision,
citing his desire not to "hamstring" the court, or to make assumptions or inputs that would make the conclusions speculative. "I cannot and I will not give a number."

Justice Riordan stepped up his pressure on the defence witnesses to produce a number. (Each of them has watched the testimony of the others -- so they know what is happening).

He told Mr. Mundt that in his role in this trial he should be prepared to do more than just criticize the numbers of another witness. "An expert witness in Canada comes to assist the Court in the job it has to do. I am looking to you for help, as I looked to Dr. Marais to help. Basically, I am getting 'you can't do it.' I am not getting help."

Mr. Mundt's response to the judge was a differently worded version of that given by Mr. Marais: an estimate or range of estimates can be produced, but only in a long and costly way. He repeated that the Siemiatycki method could not be made to work, and then offered the possibility of setting up a panel of experts to review the matter.

He bristled at the suggestion that he should have anticipated this need. "Had they (the plaintiffs) asked me, I would have done it. But it is hardly my role for this purpose."

There are none so naive as those who will not see?

With an agreement to end this witness by noon, the plaintiffs were racing the clock -- rushing their questions and growing impatient with Mr. Mundt when his answers grew long. (A marked - strategic? - difference from his laconic replies to Mr. Potter yesterday.)

Mr. Johnson had the second round of questions. As he often does, he raised issues that cast a poor light on Mr. Mundt's credibility. And, as he often does, he used analyses from U.S. scholars to connect this witness' testimony to documented industry tactics south of the border.

Almost an hour was spent detailing the role that Mr. Mundt had played in an effort to develop "good epidemiology."

Ong and Glantz
2001

Mr. Johnston gave Mr. Mundt reason to question whether he might have been a willing or unwilling dupe of industry lawyers, showing an analysis of this exercise that linked the effort to a sophisticated tobacco industry strategy to try to avoid restrictions on public smoking.

Mr. Mundt showed neither surprise nor concern. To the contrary, he maintained that furthering good science - no matter at whose behest or on what side in court - was a worthy objective. "All clients have dark past," he said "including governments – we can't let that blind us."

Mr. Johnston gave him several opportunities to consider his work in light of concerns within his profession about the role of the tobacco industry. To each of these Mr. Mundt made it clear that he thought he was part of a respectable -- maybe even laudable -- attempt to improve scientific methods for decision makers.

A flexible witness

The morning had opened with Mr. Mundt being challenged to explain his differing statements to courts on the value of pack years as a measure of smoking. It closed with his being asked to explain a dramatic discrepancy between this week, and his views at a deposition in 2000. (The Falise case).

Fourteen years ago Mr. Mundt did not willingly agree that smoking and lung cancer were causally linked. Instead, he said that causality could not be inferred from observational data. He did not use the term causal without qualifying it: "At best we can make guesses about causality. So we temper it by saying potentially causal."

Although he remained poised and kept his voice on the level, Mr. Mundt seemed stressed by the questions. His face reddened, and his replies became obtruse and a little rambling.

He said that over the years he had changed the way he described things to better communicate in courts, but that the uncertainty he referred to then was nonetheless still part of to epidemiology. He appealed to "the philosophy of science."

Despite good intentions, Mr. Mundt was not freed to go until shortly after the noon recess. Two down, one remain.

A report on Mr. Price's testimony (which began this afternoon) will appear here tomorrow.

A juicy story about Mr. Mundt -- but not from this trial! Sadly one of the other enlightening stories about Mr. Mundt never made it to this court record.  Only last year, Mr. Mundt's work was the focus of an enforcement action by the EPA.  Mr. Mundt had looked into the relationship between occupational exposure to hexavalent chromium and lung cancer among workers, and had found a dose-response in a study of four sites.  But the study had been repressed by Mr. Mundt's client, Elementis Chromium - and the EPA ultimately imposed a fine of more than $2 million on this company for hiding its results. Mr. Mundt did not publish the study in its original form. Instead, he split his report into two separate studies -- neither of which had the "statistical power" to demonstrate the strong relationships evident in the four-site study.   They were individually published -- one for Germany, one for the United States. The weaker conclusions of the disaggregated studies were more favourable to the interests of his sponsors, More on this story can be found in David Michael's book, Doubt is their Product or the Defending Science web-site.

Day 216: The one-question questionnaire

There will be early starts and maybe late closings this week at the Montreal Tobacco Trials.

The days have been extended as part of an agreement to take only three more days to finish the industry's critique of the plaintiffs' expert epidemiologist, Jack Siemiatycki.

That leaves one and a half (long) days each for the second (Mr. Kenneth Mundt) and third (Mr. Bertram Price) of the three men hired to kill off the idea that it is reasonable to conclude that if someone has smoked for 5 pack-years and has one of the diseases covered by the Blais class action, then their illness is more likely due to smoking than not.

It's not just the compression of time - nor the fast pace of the questions and answers - that gave today an unusual intensity and concentrated focus.

Ever since Mr. Siemiatycki testified, it's been clear that his numbers and the principles behind them are key to the Blais case, and therefore key to the companies' defence. With that defence winding to a close, this is a make-or-break moment for both sides.

The first of Mr. Siemiatycki's three critics testified last week. Mr. Laurentius Marais testified on behalf of JTI-Macdonald, with erudition and mannered precision, took a fine-tooth comb to the methods used by Mr. Siemiatycki. He pounded especially hard on the idea the way in which confidence intervals were treated by Mr. Siemiatycki's meta-analysis, saying that the result was statistically unreliable and that the results could not be trustedt.  Justice Riordan may have been convinced of the methodological sincerity, but he did not sound satisfied that this criticism helped him address his challenge of finding something reasonably reasonable to apply to this case.

All that to say that it didn't look (to me at least) that Mr. Marais had scored a home run.

The second man up to bat

American epidemiologist, Mr. Kenneth Mundt, was hired by Philip Morris/Rothmans, Benson and Hedges (PMI/RBH), and given essentially the same mandate as Mr. Marais -- i.e. to critique Mr. Siemiatcyki's methods and conclusions.

He is a man with long experience in studying the link between toxins and diseases on behalf of industries that produce toxins and don't want them linked to disease. Now only 54 years old, he has spent about half of  his professional life as a consultant to industries in need of "Applied Epidemiology", and is now a principal at Environ, a one-stop shop for industries in search of expert witnesses and regulatory friends.

Although Mr. Mundt has been hired as an expert in about a dozen tobacco trials, and has testified at "ten or eleven" other trials, this is only his second appearance as a witness in a tobacco suit.

The voir-dire process was no longer than it had to be (the plaintiffs asked few questions and did not oppose his role). Within an hour, Justice Riordan qualified Mr. Mundt as an expert in "epidemiology, epidemiological methods and principles, cancer epidemiology, etiology and environmental and lifestyle risk factors, and disease causation in populations." 

Much of a sameness

Although it is shorter (a mere 27 pages!) and less dense than the report discussed last week, Mr. Mundt covers much of the same ground, and takes a similarly harsh view. He concludes that the numbers produced by Mr. Siemiatycki are "unreliable for their intended purpose, and cannot be scientifically or convincingly substantiated."

And, like the previous witness, Mr. Mundt produced no estimates of his own, nor gave any advice on where more reliable numbers could be found.

But a different line of attack 

Although the message was the same, the messengers and the delivery (of both lawyers and witness) were vastly different today. Different also was the angle of attack on Mr. Siemiatycki.

Mr. Pratte had used open-ended questions to invite Mr. Marais to give bookish answers about profound methodological concerns. Today, Mr. Simon Potter (counsel to PMI/RBH) used very pointed questions to invite Mr. Mundt to say "yes" or "no" to questions that gradually painted Mr. Siemiatycki's report as one which was flawed and misleading.

The goal seemed to be to demonstrate to Justice Riordan that using Mr. Siemiatycki's numbers would not only be unreasonable from a statistical point of view, but would also be unjust. Such a broad-brush approach would cover too many people who should not be considered harmed by cigarettes.

And such different style!

Each of the lawyers in this case has their own distinct style, but that of Mr. Potter is perhaps more overwhelmingly distinct than others'. (If you can remember what over-acting looked like in the years when people still said "thespian", then you might have a flavour of the day).

From an audience perspective, it worked for him today. His points were made memorably - and there was a narrative arch to his message.

He had distilled his points and was careful to not walk over them. If Law and Order were about toxic torts, this could have been television.

One question is never enough

The thread that was used to weave Mr. Mundt's views together was the denouncement of a "one question questionnaire," and the elaboration of the many ways in which such an approach would be a bad route to follow.

The "one question" refers to Jack Siemiatycki's estimate that if someone with the four Blais diseases had smoked a "critical amount" of cigarettes before becoming ill, then their disease could be considered, on a balance of probabilities, to have resulted of smoking. The critical amount -- 5 pack-years, or a lifetime smoking of 36,500 cigarettes or more -- is now part of the definition of the Blais class.

(The "one question" isn't quite accurate! In addition to answering a question about whether or not they had smoked 36,600 cigarettes, a potential class member would also have to say "yes" to whether or not they had a fatal disease.)

In a volley of short questions, and one word answers, Mr. Mundt confirmed the many ways in which this "one question questionnaire" was inadequate to the task.

It would not take into account how many cigarettes per day (intensity) or how many years (duration) or how long ago one quit. Nor did it reflect the age at which one started smoking, the types of cigarettes one smoked or the amount of tar they produced. It provided no information on whether one knew about the risks of smoking, or were exposed to tobacco advertising or tobacco industry positions on harm. Etc.etc. etc.

Yes. Yes. Certainly. Yes. Yes. Then, a change of pace to No. No. Absolutely Not. No.

For much of the morning, Mr. Potter did the heavy lifting. Mr. Mundt had little to do but nod along. (Perhaps he too was lulled by the steady rhythm of the questions - at least once he said "yes" too quickly to an improperly phrased question, which later required Mr. Potter to back-track.)

Special attention was paid to:

*  the benefits of quitting. Mr. Mundt agreed that it came close to that of a never-smoker after a few decades, and with the studies and Health Canada statements to that effect. (Exhibit 30219)

* the shape of the dose-response curve. Mr Siemiatiycki had used a straight line to represent the increase in risk from increased smoking. Mr. Mundt felt it should be "s" shaped. (words for the day: Sigmoidal and Spline)

* the need for "other metrics".  Pack-years were deficient, as they did not take into account the variables in ways people smoked that might affect disease outcomes.

* heterogeneity. Lumping people together, combining study results, lumping cancers together, or averaging risk continued to come under heavy fire.

Past studies 

A non-linear dose
response curve (Exhibit 30223)

A second device used by Mr. Potter to good effect was to contrast the methods used by Mr. Siemiatycki in his expert report with those that he used in previous studies.  The clear inference in the questions, if not in the answers, was that the methods used for court purposes had been chosen to exaggerate the plaintiffs' case.

Among Mr. Siemiatycki's long publication record, Mr. Potter introduced papers where more heterogeneity had been used, more concern for confounding were expressed, non-linear dose response curves had been considered, and smokers who quit a long time ago were considered to be at low risk. (Exhibits 30221, 20023, 30221).

These were all missing from Mr. Siemiatycki's "overly simplistic" expert report, said Mr. Mundt.

It was only when Mr. Mundt was asked to conclude that he spoke at length without additional prompting from Mr. Potter. He delivered a well-constructed and very polished-sounding summary of his concerns. He directly addressed Justice Riordan:

 "I find it (the report) too simplistic and too blunt to be of the use that I think I understand you will put it." 

"I wish to raise before you that this is not indicative of the strongest science. The other papers from Dr. Siemiatycki are a testimony of what he is capable of producing, but has not produced for your purposes in this matter." 

He elaborated his concerns for several minutes, concluding with advice that echoed that given last week by Mr. Marais': "Collectively, these [faults] make it an unreliable summary for your purposes."

Questions from the other side

It was a much tougher André Lespérance who stood to cross-examine Mr. Mundt following a brief mid-afternoon break. The body language was tough, the tone of voice unusually firm and there was no sugar-coating of questions.

Nor was there any of the usual softening-up exchanges. Mr. Lespérance went quickly to a paper that Mr. Mundt had co-authored -- one in which he had employed essentially the same analytic approach that he now criticized in Mr. Siemiatycki. (Exhibit 1705)

Mr. Mundt's recent harsh words when contrasting Mr. Siemiatycki's earlier works heightened the drama of this moment. As did the change in tone by Mr. Mundt, who looked genuinely non-plussed. He looked at the paper as if he had never seen it before. (As third author, is it possible he had not?). He said he had trouble recalling it or the methods used in it.

The paper studied the cause of lung cancer among roofers. Although published in a scientific journal, it had been underwritten by trade organizations representing roofing companies. They were, I presume, pleased at the conclusion that it was roofers' smoking that was the cause of their disease, not their occupational exposure to asphalt.

Mr. Lespérance pointed out that in coming to that conclusion, Mr. Mundt and his co-authors used an even more crude categorization of smoking history than pack-years. Nor did they distinguish between types of cancer or make other adjustments for heterogeneity in their "random effects model."

"Is it good epidemiology?" Mr. Lespérance asked Would it pass muster with Mr. Marais?

"It serves its purposes," said Mr. Mundt opaquely, before conceding that his paper also would also have been vulnerable to criticism by Mr. Marais.

Mr. Lespérance challenged him to address the issues as if he were in a judge's position. "You have somebody working as a roofer, who has smoked and has quit smoking. ...  How are you going to determine whether smoking was the cause of disease? ...."In a smoker you will never know because we can't see - we need to work with probabilities.

Mr. Mundt took refuge in his message box. "You are asking me to speculate on any one individual. I wouldn’t speculate on the specific causes of his disease on those circumstances..." But he also defended his profession and the use of epidemiology in such an instance. "Individual causation may not be knowable" but "epidemiology is the right place to go."  

Mr. Mundt said that science had marched on since that paper was published  in 2007. His views on multiplicativity and pack years had changed because there were now newer techniques and better methods of collecting data. (Mr. Siemiatycki's expert report was written only 2 years later).

Mr. Lespérance showed him the opinion of other prominent epidemiologists who recently reconfirmed support for the use of pack-years. (Exhibit 1707). Over the objections of Mr. Potter, he asked Mr. Mundt to respond to the views of an unidentified proponent of pack-years: "More accurate estimations [of tar dose] can be approximated through the combination of measures such as duration and intensity of smoking like pack years." 

Mr. Mundt's looked quite uncomfortable, and reasonably so as Mr. Lespérance revealed that man behind those words was none other than Mr. Mundt -- and that he had said his as recently as 2010.

It was already past 5:00, and the court soon adjourned. Saved by the bell -- at least temporarily.

The cross-examination of Mr. Mundt will continue Tuesday morning.

This post was back-timed to make indexing consistent