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Events, Outcomes, and Effects – Media Responsibility to Be Accurate

July 29th, 2015

Thanks to Dr. David Schwartz for the pointer to a story, by a Bloomberg, Reuters health reporter, on a JAMA online-first article on drug “side effects.” See David Schwartz, “Lack of compliance on ADR Reporting: Some serious drug side effects not told to FDA within 15 days” (July 29, 2015).

The reporter, Lisa Rapaport, wrote about an in-press article in JAMA Internal Medicine, about delays in drug company mandatory reporting. Lisa Rapaport, “Some serious drug side effects not told to FDA within 15 days,” (July 27, 2015). The article that gave rise to this media coverage, however, was not about side effects, or direct effects, for that matter; it was about adverse events. See Paul Ma, Iván Marinovic, and Pinar Karaca-Mandic, “Drug Manufacturers’ Delayed Disclosure of Serious and Unexpected Adverse Events to the US Food and Drug Administration,” JAMA Intern. Med. (published online July 27, 2015) (doi:10.1001/jamainternmed.2015.3565).

The word “effect[s]” occurs 10 times in Rapaport’s news item; and yet, that word does not appear at all in the JAMA article, except in a footnote that points to a popular media article. And Reuters is the source of the footnoted popular media article.[1] Apparently, Reuter’s reporters are unaware of the difference between an event and an effect. The companies’ delay in reporting apparently made up 10% of all adverse event reports, but spinning the story as though it were about adverse effects makes the story seem more important and the delays more nefarious.

Why would a reporter covering a medical journal article not be familiar with the basic terminology and concepts at issue? The FDA’s description of its adverse event system makes clear that adverse events have nothing to do with “effects.” The governing regulations for post-marketing reporting of adverse drug experiences are even more clear that adverse events or experiences are not admissions or conclusions of causality. 21 C.F.R. 314.80(a), (k). See also ICH Harmonised Tripartite Guideline for Good Clinical Practice E6(R1) (10 June 1996).

Perhaps this is an issue with which Sense about Science USA can help? Located in the brain basket of America – Brooklyn, NY – Sense about Science is:

“a non-profit, non-partisan American branch of the British charitable trust, Sense About Science, which was founded in 2003 and which grew to play a pivotal role in promoting scientific understanding and defending scientific integrity in the UK and Europe.”

One of the organization’s activities is offering media help in understanding scientific and statistical issues. Let’s hope that they take the help being offered.

[1] S. Heavey, “FDA warns Pfizer for not reporting side effects” (June 10, 2010).

Posted in Causation, Scientific Evidence | Comments Off on Events, Outcomes, and Effects – Media Responsibility to Be Accurate

California Actos Decision Embraces Relative-Risk-Greater-Than-Two Argument

July 28th, 2015

A recent decision of the California Court of Appeal, Second District, Division Three, continues the dubious state and federal practice of deciding important issues under cover of unpublished opinions. Cooper v. Takeda Pharms. America, Inc., No. B250163, 2015 Cal. App. Unpub. LEXIS 4965 (Calif. App., 2nd Dist., Div. 3; July 16, 2015). In Cooper, plaintiff claimed that her late husband’s bladder cancer was caused by defendant’s anti-diabetic medication, Actos (pioglitazone). The defendant moved to strike the expert witness testimony in support of specific causation. The trial judge expressed serious concerns about the admissibility of plaintiff’s expert witnesses on specific causation, but permitted the trial to go forward. After a jury returned its verdict in favor of plaintiff, the trial court entered judgment for the defendants, on grounds that the plaintiff lacked admissible expert witness testimony.

Although a recent, large, well-conducted study[1] failed to find any meaningful association between pioglitazone and bladder cancer, there were, at the time of trial, several studies that suggested an association. Plaintiff’s expert witnesses, epidemiologist Dr. Alfred Neugut and bladder oncologist Dr. Norm Smith interpreted the evidence to claim a causal association, but both conceded that there were no biomarkers that allowed them to attribute Cooper’s cancer to pioglitazone. The plaintiff also properly conceded that identifying a cause of the bladder cancer was irrelevant to treating the disease. Cooper, 2015 Cal. App. Unpub. LEXIS 4965, at *13. Specific causation was thus determined by the so-called process of differential etiology, with the ex ante existence of risk substituting for cause, and using risk exposure in the differential analysis.

The trial court was apparently soured on Dr. Smith’s specific causation assessment because of his poor performance at deposition, in which he demonstrated a lack of understanding of Cooper’s other potential exposures. Smith’s spotty understanding of Cooper’s actual and potential exposures and other risks made any specific causation assessment less than guesswork. By the time of trial, Dr. Smith and plaintiff’s counsel had backfilled the gaps, and Smith presented a more confident analysis of Cooper’s exposures and potentially competing risks.

Cooper had no family history of bladder cancer, no alcohol consumption, and no obvious exposure to occupational bladder carcinogens. His smoking history would account for exposure to a known bladder carcinogen, cigarette smoke, but Cooper’s documented history was of minor tobacco use, and remote in time. Factually, Cooper’s history was suspect and at odds with his known emphysema. Based upon this history, along with their causal interpretation of the Actos bladder cancer association, and their quantitative assessment that the risk ratio for bladder cancer from Actos was 7.0 or higher for Mr. Cooper (controlled for covariate, potential confounders), the plaintiff’s expert witnesses opined that Actos was probably a substantial factor in causing Mr. Cooper’s bladder cancer. The court did not examine the reasonableness of Dr. Smith’s risk ratios, which seem exorbitant in view of several available meta-analyses.[2]

The court stated that under the applicable California law of “substantial factor,” the plaintiff’s expert witness, in conducting a differential diagnosis, need not exclude every other possible cause of plaintiff’s disease “with absolute certainty.” Cooper, at *41-42. This statement leaves unclear and ambiguous whether the plaintiff’s expert witness must (and did in this case) rule out other possible causes with some level of certitude less than “absolute certainty,” such as reasonable medical certainty, or perhaps reasonable probability. Dr. Smith’s testimony, as described, did not attempt to go so far as to rule out smoking as “a cause” of Cooper’s bladder cancer; only that the risk from smoking was a lower order of magnitude than that for Actos. In Dr. Smith’s opinion, the discrepancy in magnitude between the risk ratios for smoking and Actos allowed him to state confidently that Actos was the most substantial risk.

Having estimated the smoking-related increased risk to somewhere between 0 and 100%, with the Actos increased risk at 600% or greater, Dr. Smith was able to present an admissible opinion that Actos was a substantial factor. Of course, this all turns on the appellate court’s acceptance of risk, of some sufficiently large magnitude, as evidence of specific causation. In the Cooper court’s words:

“The epidemiological studies relied on by Dr. Smith indicated exposure to Actos® resulted in hazard ratios for developing bladder cancer ranging from 2.54 to 6.97.¹⁸ By demonstrating a relative risk greater than 2.0 that a product causes a disease, epidemiological studies thereby become admissible to prove that the product at issue was more likely than not responsible for causing a particular person’s disease. “When statistical analyses or probabilistic results of epidemiological studies are offered to prove specific causation . . . under California law those analyses must show a relative risk greater than 2.0 to be ‘useful’ to the jury. Daubert v. Merrell Dow Pharmaceuticals Inc., 43 F.3d 1311, 1320 (9th Cir.), cert. denied 516 U.S. 869 (1995) [Daubert II]. This is so, because a relative risk greater than 2.0 is needed to extrapolate from generic population-based studies to conclusions about what caused a specific person’s disease. When the relative risk is 2.0, the alleged cause is responsible for an equal number of cases of the disease as all other background causes present in the control group. Thus, a relative risk of 2.0 implies a 50% probability that the agent at issue was responsible for a particular individual’s disease. This means that a relative risk that is greater than 2.0 permits the conclusion that the agent was more likely than not responsible for a particular individual’s disease. [Reference Manual on Scientific Evidence (Federal Judicial Center 2d ed. 2000) (“Ref. Manual”),] Ref. Manual at 384, n. 140 (citing Daubert II).” (In re Silicone Gel Breast Implant Prod. Liab. Lit. (C.D. Cal. 2004) 318 F.Supp.2d 879, 893; italics added.) Thus, having considered and ruled out other background causes of bladder cancer based on his medical records, Dr. Smith could conclude based on the studies that it was more likely than not that Cooper’s exposure to Actos® caused his bladder cancer. In other words, because the studies, to varying degrees, adjusted for race, age, sex, and smoking, as well as other known causes of bladder cancer, Dr. Smith could rely upon those studies to make his differential diagnosis ruling in Actos®—as well as smoking—and concluding that Actos® was the most probable cause of Cooper’s disease.”

Cooper, at *78-80 (emphasis in the original).

Of course, the epidemiologic studies themselves are not admissible, regardless of the size of the relative risk, but the court was, no doubt, speaking loosely about the expert witness opinion testimony that was based upon the studies with risk ratios greater than two. Although the Cooper case does not change California law’s facile acceptance of risk as a substitute for cause, the case does base its approval of plaintiff’s expert witness’s attribution as turning on the magnitude of the risk ratio, adjusted for confounders, as having exceeded two. The Cooper case leaves open what happens when the risk that is being substituted for cause is a ratio ≤ 2.0. Some critics of the risk ratio > 2.0 inference have suggested that risk ratios greater than two would lead to directed verdicts for plaintiffs in all cases, but this suggestion requires demonstrations of both the internal and external validity of the studies that measure the risk ratio, which in many cases is in doubt. In Cooper, the plaintiff’s expert witnesses’ embrace of a high, outlier risk ratio for Actos, while simultaneously downplaying competing risks, allowed them to make out their specific causation case.

[1] James D. Lewis, Laurel A. Habel, Charles P. Quesenberry, Brian L. Strom, Tiffany Peng, Monique M. Hedderson, Samantha F. Ehrlich, Ronac Mamtani, Warren Bilker, David J. Vaughn, Lisa Nessel, Stephen K. Van Den Eeden, and Assiamira Ferrara, “Pioglitazone Use and Risk of Bladder Cancer and Other Common Cancers in Persons With Diabetes,” 314 J. Am. Med. Ass’n 265 (2015) (adjusted hazard ratio 1.06, 95% CI, 0.89-1.26).

[2] See, e.g., R.M. Turner, et al., “Thiazolidinediones and associated risk of bladder cancer: a systematic review and meta-analysis,” 78 Brit. J. Clin. Pharmacol. 258 (2014) (OR = 1.51, 95% CI 1.26-1.81, for longest cumulative duration of pioglitazone use); M. Ferwana, et al., “Pioglitazone and risk of bladder cancer: a meta-analysis of controlled studies,” 30 Diabet. Med. 1026 (2013) (based upon 6 studies, with median follow-up of 44 months, risk ratio = 1.23; 95% CI 1.09-1.39); Cristina Bosetti, “Cancer Risk for Patients Using Thiazolidinediones for Type 2 Diabetes: A Meta-Analysis,” 18 The Oncologist 148 (2013) (RR = 1.64 for longest exposure); Shiyao He, et al., “Pioglitazone prescription increases risk of bladder cancer in patients with type 2 diabetes: an updated meta-analysis,” 35 Tumor Biology 2095 (2014) (pooled hazard ratio = 1.67 (95% C.I., 1.31 – 2.12).

Posted in Causation, Expert Witnesses, Risk and Risk Factor, Rule 702, Scientific Evidence | Comments Off on California Actos Decision Embraces Relative-Risk-Greater-Than-Two Argument

Ramazzini Serves Courtroom Silica Science Al Dente

July 25th, 2015

Collegium Ramazzini styles itself as an “independent, international academy.” The Collegium Ramazzini was founded in 1982, by the late Irving Selikoff and others to serve as an advocacy forum for their pro-compensation and aggressive regulation views on social and political issues involving occupational and environmental health.

The Collegium is a friendly place where plaintiffs’ expert witnesses, consultants, and advocates never have to declare their conflicts of interest.[1] Last year, in October 2014, the Collegium conducted a conference on silica health issues, entitled “Silica Three Hundred Years Later: Occupational Exposure, Medical Monitoring, and Regulation.”

The silica session was chaired by Christine Oliver, one of plaintiff’s key expert witnesses in Allen v. Martin Surfacing, 263 F.R.D. 47 (D. Mass. 2009). See “Bad Gatekeeping or Missed Opportunity – Allen v. Martin Surfacing” (Nov. 30, 2012). The purported goal of the session was

“to shine a light on silica as a persistent and dangerous threat to the health of exposed workers worldwide,” focusing on the following issues:

“1) Occupational silica exposures, new and old;

2) silica as a recognized human lung carcinogen and its interaction with other lung carcinogens such as tobacco smoke;

3) the role of silica and silicosis in tuberculosis;

4) issues relevant to medical surveillance of silica-exposed workers as set forth in OSHA’s proposed silica standard;

5) the role of the US Government in protecting the health of silica-exposed workers; and

6) international variability in addressing the threat to worker health posed by silicosis.”

Recently, the Collegium updated its website to provide PDF files of some of the conference presentations:

Carol H. Rice, “Silica – old, new and emerging uses result in worker exposure”

Arthur L. Frank, “Silica as a lung carcinogen”

Rodney Ehrlich, “Silica in the head of the snake. Silica, gold mining, and tuberculosis in southern Africa”

Christine Oliver, “Medical surveillance for silica-related disease: the Collegium responds to OSHA’s proposed rulemaking,”

Gregory R. Wagner, “US Government role in recognizing, reducing, and regulating silica risk: 80 years and counting”

Sverre Langard, “Silicosis 300 years after Ramazzini: Eradication in some countries, increased incidence in others”

A poster session chaired by Melissa McDiarmid and Carol Rice, revealingly titled “Sustainable Work 2020 – an advocacy platform for Horizon 2020,” followed. Casey Bartrem asked whether “Asbestos-induced lung cancer in Germany: is the compensation practice in accordance with the epidemiological findings?” Odds are that this presentation was a brief for greater compensation. Xaver Baur of Germany, presented on the “Ethics in the applied sciences: The challenge of preventing corporate influence over public health regulation,” but remarkably no one presented on the challenge of preventing the litigation and compensation industry’s influence over public health regulation.

You won’t find any cutting-edge science in the linked slides, but you will find some interesting revelations. Sverre Langard’s presentation makes the dramatic point that silicosis has been declining, despite the hand waving of OSHA Administrator David Michaels, and the histortions of Rosner and Markowitz. Consider Langard’s slide, based upon CDC data:

And consider the admissions of Arthur Frank, veteran plaintiffs’ expert witness, who acknowledged that:

“until very recently it [silica] was not recognized as a carcinogen.”

True to form, Dr. Frank blamed Selikoff and his other teachers at Mt. Sinai Hospital in New York City, where he trained:

“At Mount Sinai I did not get trained that silica was a carcinogen”

Well, even a scurry of blind squirrels sometimes find their nuts!

[1][1] Some of the names on the list of Fellows and Emeritus Fellows reads like a “Who’s Who” of testifying expert witnesses, consultants, and advocates for the litigation industry:

Henry A. Anderson, Barry Castleman, David C. Christiani, Carl F. Cranor, Devra Lee Davis , John M. Dement, Arthur Frank, Bernard D. Goldstein, Howard Frumkin, Lennart Hardell, Peter F. Infante, Joseph LaDou, Philip Landrigan, Richard A. Lemen, Barry S. Levy, Roberto G. Lucchini, Steven B. Markowitz, Myron A. Mehlman, Ronald L. Melnick, Donna Mergler, Albert Miller, Franklin E. Mirer, Herbert L. Needleman, L. Christine Oliver, David M. Ozonoff, Carol H. Rice, Kenneth D. Rosenman, Sheldon W. Samuels, Ellen K. Silbergeld, Peter D. Sly, Martyn Thomas Smith, Colin L. Soskolne, Leslie Thomas Stayner, Daniel T. Teitelbaum, Laura Welch

Posted in Conflicts of Interest, Expert Witnesses, Silica, State of the Art | Comments Off on Ramazzini Serves Courtroom Silica Science Al Dente

The Unreasonable Success of Asbestos Litigation

July 25th, 2015

In asbestos litigation, the plaintiffs’ bar has apparently invented a perpetual motion machine that feeds on outrage that will never run out. Still, lawyers who have not filled their wallets with legal fees from asbestos cases sometimes attempt to replicate the machine. For the most part, the imitators have failed.

What accounts for the unreasonable success of asbestos litigation? Unlike pharmaceutical litigation, exposure does not require a prescription. Although asbestos insulators and applicators experienced the most exposure, other trades and occupations worked with, or near, asbestos materials. Anecdotal testimony of exposure suffices in almost every case. Add para-occupational exposure, and the sky’s the limit for the class of potential plaintiffs. See Lester Brickman, “Fraud and Abuse in Mesothelioma Litigation,” 88 Tulane L. Rev. 1071 (2014); Peggy Ableman, “The Garlock Decision Should be Required Reading for All Trial Court Judges in Asbestos Cases,” 37 Am. J. Trial Advocacy 479, 488 (2014).

Then there is the range of diseases and disorders attributable to asbestos. Excessive exposure to asbestos minerals cause non-malignant pleural plaques and thickening, as well as lung fibrosis, asbestosis. Some asbestos minerals cause mesothelioma, and despite a differential in potency among some of the minerals (between amosite and crocidolite), the general and specific causation of mesothelioma is often uncontested. Furthermore, lung cancer in the presence of asbestosis may be the result of interaction of asbestos exposure and cigarette smoking. Plaintiffs’ counsel and The Lobby have expanded the list of attributable diseases to include non-pulmonary cancers, only to find some defendants willing to pay money on these claims as well.

In addition to the ease of claiming, or manufacturing, exposure, and the willing cooperation of the occupational medical community in supporting medical causation, asbestos litigation is a lightning rod for moral outrage in the courtroom. Plaintiffs claim that “industry” knew about the hazards of asbestos, including its carcinogenicity, long before warnings appeared. Defending the knowledge claim requires nuanced explanation of shifting standards for establishing causality as epidemiology developed and was applied to putative asbestos-related cancer outcomes, as well as changing views about the latencies of asbestos-related diseases.

Every once in a while, plaintiffs’ and defense counsel[1], the media[2], the academy[3], and the insurance industry[4] ask whether “silica” is the next asbestos. Although the prospects have been, and remain, dim, plaintiffs’ counsel continue to try to build their litigation palace on sand, with predictably poor results. See Kimberley A. Strassel, “He Fought the Tort Bar — and Won,” Wall St. J. (May 4, 2009).

There are many serious disanalogies between asbestos and silica litigation. One glaring difference is the inability to summon any outrage over suppressed or nondisclosed knowledge of alleged silica cancer hazards. The silica cancer state of the art, written by those who are lionized in the asbestos litigation – Hueper, Schepers, and Hardy, along with NIOSH and the Surgeon General, all appropriately denied or doubted silica as a cause of lung cancer. See below. When the IARC shifted its views in the 1990s, under the weight of determined advocacy from some partisans in the occupational medicine community, and with the help from some rather biased reviews, industry promptly warned regardless of the lack of scientific support for the IARC’s conclusion. The manufacturing of faux consensus and certainty on silica and lung cancer is an important counter to the incessant media stories about the manufacturing of doubt on topics such as climate change.

[1] Robert D. Chesler, James Stewart, and Geoffrey T. Gibson, “Is Silica the Next Asbestos?” 176 N.J.L.J. 1 (June 28, 2004); Mark S. Raffman, “Where Will Silica Litigation Go?” 1 LJN Silica Legal News 1 (2005); Chris Michael Temple, “A Case for Why Silica Litigation Is Not the ‘Next Asbestos’,” LJN Product Liability Law & Strategy (2004).

[2] Jonathan D. Glater, “Suits on Silica Being Compared To Asbestos Cases,” N.Y. Times (Sept. 6, 2003).

[3] Michelle J. White, “Mass Tort Litigation: Asbestos,” in Jürgen Georg Backhaus, ed., Encyclopedia of Law and Economics 1 (2014); Melissa Shapiro, “Is Silica the Next Asbestos? An Analysis of the Silica Litigation and the Sudden Resurgence of Silica Lawsuit Filings,” 32 Pepperdine L. Rev. 4 (2005).

[4] “Is silica the new asbestos?” The Actuary (2005).

Historical Statements – – State-of-the-Art

Maxcy, ed., Rosenau Preventive Medicine and Hygiene 1051 (N.Y., 7th ed. 1951) (“Thus, there is no evidence that lung cancer is related in any way to silicosis.”)

May Mayers, “Industrial Cancer of the Lungs,” 4 Compensation Medicine 11, 12 (1952) (“Nevertheless, silicosis is not, apparently associated with, or productive of, lung cancer, whereas asbestosis very probably is.”) (Chief, Medical Unit, Division of Industrial Hygiene and Safety Standards, N.Y. Dep’t of Labor)

Geritt Schepers, “Occupational Chest Diseases,” Chap. 33, p. 455, ¶3, in A. Fleming, et al., eds., Modern Occupational Medicine (Phila. 2d ed. 1960) (“Lung cancer, of course, occurs in silicotics and is on the increase. Thus far, however, statistical studies have failed to reveal a relatively enhanced incidence of pulmonary neoplasia in silicotic subjects.”)

Spencer, Pathology of the Lung (1962) (“Silicosis and lung cancer inhaled silica, unlike asbestos, does not predispose to the development of lung cancer.”)

Wilhelm Hueper, Occupational and Environmental Cancers of the Respiratory System at 2-6 (N.Y. 1966) (“The bulk of the available epidemiologic evidence on the association of silicosis and lung cancer supports the view of a mere coincidental role of silicosis in this combination. *** From the evidence on hand, it appears that a well advanced silicosis does not seem to furnish a favorable soil for the development of cancer of the lung.”) (chief of the National Cancer Institute)

Harriet L. Hardy, “Current Concepts of Occupational Lung Disease of Interest to the Radiologist,” 2 Sem. Roentgenology 225, 231-32 (1967) (“cancer of the lung is not a risk for the silicotic. It is a serious risk following asbestos exposure and for hematite, feldspar, and uranium miners. This means that certain dusts and ionizing radiation alone or perhaps with cigarette smoke act as carcinogens.”)

Raymond Parkes, Occupational Lung Disorders 192 (London 1974) (“Bronchial carcinoma occasionally occurs in silicotic lungs but there is no evidence of a causal relationship between it and silicosis; indeed the incidence of lung cancer in miners with silicosis is significantly lower than in non-silicotic males.”)

Kaye Kilburn, Ruth Lilis, Edwin Holstein, “Silicosis,” in Maxcy-Rosenau, Public Health and Preventive Medicine, 11th ed., at 606 (N.Y. 1980) (“Lung cancer is apparently not a complication of silicosis.”)

Robert Jones, “Silicosis,” Chap. 16, in W. Rom, et al., eds., Environmental and Occupational Medicine 205 (Boston 1983) (“The weight of epidemiologic evidence is against the proposition that silicosis carries an increased risk of respiratory malignancy.”)

W. Keith C. Morgan & Anthony Seaton, eds., Occupational Lung Diseases 266 (1984) (“It is generally believed that silicosis does not predispose to lung cancer. * * * On balance, it seems unlikely that silicosis itself predisposes to lung cancer.”)

1 Anderson’s Pathology at 910b (1985) (“There is no evidence that silica increases the risk of lung cancer, nor does it enhance tobacco induced carcinogenesis.”)

U.S. Dep’t of Health and Human Services, The Health Consequences of Smoking – Cancer and Chronic Lung Disease in the Workplace: A Report of the Surgeon General at 348, Chapter 8 “Silica‑Exposed Workers” (1985) (“the evidence does not currently establish whether silica exposure increases the risk of developing lung cancer in men.”)

J. Cotes & J. Steel, Work-Related Lung Disorders 156 (Oxford 1987) (“The inhalation of silica dust does not contribute to malignancy.”)

NIOSH Silicosis and Silicate Disease Committee, “Diseases Associated With Exposure to Silica and Non-fibrous Silicate Minerals,” 112 Arch. Path. & Lab. Med. 673, 707 (1988) (“Epidemiologic studies have been conducted in an effort to assess the role of silica exposure in the pathogenesis of lung cancer. *** Thus, the results are inconclusive … .”)

Arthur Frank, “Epidemiology of Lung Cancer, in J. Roth, et al., Thoracic Oncology, Chap. 2, at p. 8 (Table 2-1), 11 (Phila. 1989) (omitting silica from list of lung carcinogens) (“The question of the relationship of coal mining to the development of lung cancer has been frequently considered. Most evidence points to cigarette smoking among coal miners as the major causative factor in the development of lung cancer, and neither a recent84 nor a British study of lung cancer among coal miners has found any relationship to occupational exposure.”)

Posted in Asbestos, Historian Testimony, Silica, Sophisticated User, State of the Art | Comments Off on The Unreasonable Success of Asbestos Litigation

Canadian Judges’ Reference Manual on Scientific Evidence

July 24th, 2015

I had some notion that there was a Canadian version of the Reference Manual on Scientific Evidence in the works, but Professor Greenland’s comments in a discussion over at Deborah Mayo’s blog drew my attention to the publication of the Science Manual for Canadian Judges [Manual]. See “‘Statistical Significance’ According to the U.S. Dept. of Health and Human Services (ii),” Error Statistics Philosophy (July 17, 2015).

The Manual is the product of the Canadian National Judicial Institute (NJI), which is an independent, not-for-profit group that is committed to educating Canadian judges. The NJI’s website describes the Manual:

“Without the proper tools, the justice system can be vulnerable to unreliable expert scientific evidence.

* * *

The goal of the Science Manual is to provide judges with tools to better understand expert evidence and to assess the validity of purportedly scientific evidence presented to them. …”

The Chief Justice of Canada, Hon. Beverley M. McLachlin, contributed an introduction to the Manual, which was notable for its frank admission that:

“[w]ithout the proper tools, the justice system is vulnerable to unreliable expert scientific evidence.

****

Within the increasingly science-rich culture of the courtroom, the judiciary needs to discern ‘good’ science from ‘bad’ science, in order to assess expert evidence effectively and establish a proper threshold for admissibility. Judicial education in science, the scientific method, and technology is essential to ensure that judges are capable of dealing with scientific evidence, and to counterbalance the discomfort of jurists confronted with this specific subject matter.”

Manual at 14. These are laudable goals, indeed.

The first chapter of the Manual is an overview of Canadian law of scientific evidence, “The Legal Framework for Scientific Evidence,” by Canadian law professors Hamish Stewart (University of Toronto), and Catherine Piché (University of Montreal). Several judges served as peer reviewers.

The second chapter, “Science and the Scientific Method,” contains the heart of what judges supposedly should know about scientific and statistical matters to serve as effective “gatekeepers.” Like the chapters in the Reference Manual on Scientific Evidence, this chapter was prepared by a scientist author (Scott Findlay, Ph.D., Associate Professor of Biology, University of Ottawa) and a lawyer author (Nathalie Chalifour, Associate Professor of Law, University of Ottawa). Several judges, and Professor Brian Baigrie (University of Toronto, Victoria College, and the Institute for the History and Philosophy of Science and Technology) provided peer review. The chapter attempts to cover the demarcation between science and non-science, and between scientific and other expert witness opinion. The authors describe “the” scientific method, hypotheses, experiments, predictions, inference, probability, statistics and statistical hypothesis testing, data reliability, and related topics. A subsection of chapter two is entitled “Normative Issues in Science – The Myth of Scientific Objectivity,” which suggests a Feyerabend, post-modernist influence at odds with the Chief Justice’s aspirational statement of goals in her introduction to the Manual.

Greenland noted some rather cavalier statements in Chapter two that suggest that the conventional alpha of 5% corresponds to a “scientific attitude that unless we are 95% sure the null hypothesis is false, we provisionally accept it.” And he pointed elsewhere where the chapter seems to suggest that the coefficient of confidence that corresponds to an alpha of 5% “constitutes a rather high standard of proof,” thus confusing and conflating probability of random error with posterior probabilities. Some have argued that these errors are simply an effort to make statistical concepts easier to grasp for lay people, but the statistics chapter in the FJC’s Reference Manual shows that accurate exposition of statistical concepts can be made understandable. The Canadian Manual seems in need of some trimming with Einstein’s razor, usually paraphrased as “Everything should be made as simple as possible, but no simpler.”[1] The razor should certainly applied to statistical concepts, with the understanding that pushing to simplify too aggressively can sometimes result in simplistic, and simply wrong, exposition.

Chapter 3 returns to more lawyerly matters, “Managing and Evaluating Expert Evidence in the Courtroom,” prepared and peer-reviewed by prominent Canadian lawyers and judges. The final chapter, “Ethics of the Expert Witness,” should be of interest to lawyers and judges in the United States, where the topic is largely ignored. The chapter was prepared by Professor Adam Dodek (University of Ottawa), along with several writers from the National Judicial Institute, the Canadian Judicial Council, American College of Trial Lawyers, Environment Canada, and notably, Joe Cecil & the Federal Judicial Center.

Weighing in at 228 pages, the Science Manual for Canadian Judges is much shorter than the Federal Judicial Center’s Reference Manual on Scientific Evidence. Unlike the FJC’s Reference Manual, which is now in its third edition, the Canadian Manual has no separate chapters on regression, DNA testing and forensic evidence, clinical medicine and epidemiology. The coverage of statistical inference is concentrated in chapter two, but that chapter has no discussion of meta-analysis, systematic review, evidence-based medicine, confounding, and the like. Perhaps there will soon be a second edition of the Science Manual for Canadian Judges.

[1] See Albert Einstein, “On the Method of Theoretical Physics; The Herbert Spencer Lecture,” delivered at Oxford (10 June 1933), published in 1 Philosophy of Science 163 (1934) (“It can scarcely be denied that the supreme goal of all theory is to make the irreducible basic elements as simple and as few as possible without having to surrender the adequate representation of a single datum of experience.”).

Posted in Expert Witnesses, Rule 702, Scientific Evidence, statistical evidence, Trial Procedure | Comments Off on Canadian Judges’ Reference Manual on Scientific Evidence

Stanford Professor Smokes Out Tobacco Defense Expert Witnesses

July 18th, 2015

“Bullshit is unavoidable whenever circumstances require someone to talk without knowing what he is talking about. Thus the production of bullshit is stimulated whenever a person’s obligations or opportunities to speak about some topic exceed his knowledge of the facts that are relevant to that topic.”

Harry Frankfurt, On Bullshit 63 (Princeton 2005)

*****************************************************

An in-press paper that attacks the ethics and motives of tobacco defense expert witnesses is making some ripples in the science and legal popular media. See, e.g., Tracie White, “Physicians testified for tobacco companies against plaintiffs with head, neck cancers, study finds,” ScienceDaily (July 17, 2015); Joyce E. Cutler, “Motives of Tobacco’s Experts Questioned by Study,” BNA Snapshot -Product Safety & Liability Reporter⁽July 20, 2015) [cited as Cutler]. The paper is now available in an in-press version. Robert K. Jackler, “Testimony by Otolaryngologists in Defense of Tobacco Companies 2009-2014,” The Laryngoscope (July 17, 2015) (in press) (doi: 10.1002/lary.25432). The paper is worth close study.

Dr. Robert Jackler, the Edward C. and Amy H. Sewall Professor in Otorhinolaryngology, at the Standford Medical School, has previously published his views of the tobacco industry’s role in obscuring medical research on the causal role of tobacco in human cancer.[1] In his most recent contribution, Jackler has reviewed tobacco companies’ expert witnesses’ testimonies to assess their consistency with what Jackler takes to be well-warranted scientific conclusions of known human cancer risks. From his one-sided review (of only defense witnesses) of a limited number of cases, Jackler concludes that tobacco defense expert witnesses were systematically biased in their under-estimation of the magnitude of tobacco-related risks, and their consistent inflation of non-tobacco risks, both in terms of their magnitude, prevalence, and scientific warrant of causality. Although one-sided in his review, Jackler does cite to transcripts that are available on-line from repositories at the University of California San Francisco Legacy Tobacco Documents Library. Disinterested observers can explore further the allegations and their merits by reading the primary documents.

The cases reviewed by Jackler included nine cases of upper aerodigestive-tract cancers (mostly larynx and esophagus), in which six defense otolaryngologists testified that tobacco played no role, or that there was no scientific basis for attributing individual cancers to tobacco. Jackler’s review interestingly identifies a tobacco defense strategy of “leveling” known causes with suspected causes and risk factors, to create a laundry list of differentials in a differential etiology for specific causation. Some of the risk factors that defense expert witnesses postulated included human papillomavirus (HPV), alcohol, mouthwash, heredity, asbestos, diesel fumes, gasoline fumes, salted fish, mouthwash, and urban living.

This epistemic dilution is indeed objectionable, but of course, it is the same epistemic bootstrapping that plaintiffs’ expert witnesses routinely use to place questionable, weakly supported differentials in their specific causation assessments. Consider the recent Tennessee appellate decision in Russell v. Illinois Central RR, in which the court rejected a defense challenge to the dodgy testimony of plaintiffs’ expert witness, Dr. Arthur Frank, that plaintiff’s throat cancer was caused by a etiological soup of asbestos, diesel fume, and environmental tobacco smoke. Russell v. Illinois Central RR, No. W2013-02453-COA-R3-CV, 2015 Tenn. App. LEXIS 520 (Tenn. App. June 30, 2015) (affirming judment for plaintiff in excess of $3 million).

Jackler notes that tobacco witnesses frequently raised the specter of “etiological soup.” Jackler at 3. For instance, some tobacco defense expert witnesses raised even possible asbestos exposure as a cause of laryngeal cancer, but Jackler is appropriately skeptical: “Although some studies suggest an additive effect with smoking, a meta-analysis concluded that the weight of the evidence does not support a causal association.” Jackler at 6 (citing H. Griffiths & N.C. Molony, “Does asbestos cause laryngeal cancer?” 28 Clin. Otolaryngol. & Allied Sci. 177 (2003); and Kevin Browne & J. Bernard L. Gee, “Asbestos exposure and laryngeal cancer,” 44 Ann. Occup. Hyg. 239 (2000). Jackler might be surprised by the stridency and the overreaching of a large segment of the occupational medicine community’s disagreement with his assessment.

Tobacco defense expert witnesses frequently raised diesel fume exposure as an alternative cause, but Jackler finds this testimony disingenuous. “The relationship of diesel fume exposure to laryngeal cancer has been discounted.” Jackler at 6 (citing J.E. Muscat & Ernst L. Wynder, “Diesel exhaust, diesel fumes, and laryngeal cancer,” 112 Otolaryngol. Head Neck Surg. 437 (1995)). So where is Jackler’s outrage against plaintiffs’ expert witness excesses, and the judicial acquiescence in accepting testimony such as that given by Dr. Arthur Frank in the Russell case.

Some of the risks, risk factors, and alternative causes invoked by the tobacco defense expert witnesses, as related by Dr. Jackler, did appear fantastical or false. Jackler, however, does not explore how the plaintiffs’ counsel addressed such over-reaching, or how the court responded to objections and challenges to the defense expert witness testimony. Plaintiffs’ counsel may have strategically allowed tobacco defense expert witnesses to overreach, in order to have a “harder” target on cross-examination.

Improper to Criticize Expert Witnesses

A spokesperson for Philip Morris, Bill Phelps, responded to Jackler’s critique by telling the BNA reporter that:

“We believe that out-of-court attempts to criticize experts for testifying on behalf of defendants in these cases have no place in our judicial system.”

Cutler. Phelps’ criticism is ambiguous between suggesting that any criticism of expert witnesses outside court is improper and suggesting that criticizing expert witnesses simply on the basis for testifying for the tobacco companies is improper.

If Phelps’s point was the latter, then it seems unexceptionable. Surely, the companies have a right to defend themselves, as long as they sponsor expert witness testimony in a responsible way. And certainly, any number of anti-tobacco scientists and physicians have resorted to bullying and name calling in efforts to chill scientists from speaking or testifying for tobacco companies, not by criticizing the substantive merits of testimony, but by asserting a contagious moral leprosy from merely having associated with tobacco companies.

Jackler comes very close to saying that physicians and scientists should not testify on behalf of tobacco companies. He casts aspersion on all tobacco defense expert witnesses by quoting others who state that “[t]he tobacco industry pays generously and gets its money worth.” Jackler at 7 (quoting L. Maggi, “Bearing Witness for Tobacco,” 21 J. Pub. Health Pol. 296 (2000). Jackler notes that “[u]nethical experts bias their testimony to bolster the position of the side who hired them.” Jackler at 7. But Jackler’s review is itself biased by his failure to examine the contentions and degrees of warrant of plaintiffs’ expert witnesses on any issues. Jackler does not articulate a view in his own voice, but states that “[s]ome medical ethicists question whether it could ever be ethical for a physician to testify on behalf of the tobacco industry.” Jackler at 7. Jackler’s implication begs the question whether plaintiffs, and their expert witnesses, are correct on all their medical claims, in every case.

The former point — that any out-of-court criticism of courtroom testimony — is wrong. Trenchant criticism of expert witness testimony is very much needed, and it is hard to see how it would not be helpful to public debate and to improvement of the judicial process. (Again, assuming that the critical discussions are fair and evidence-based.)

In an interview with the BNA, Jackler speculates:

“I think that these [tobacco defense] physicians testifying did so with the belief that their behavior would not become public. And this is an area where shedding light and creating dialogue will help to encourage people to behave ethically when giving their testimony.”

Cutler (quoting Jackler). If expert witnesses on either side think that they can escape critical scrutiny by advocating fabulous fictions in the courtroom, then we would all be better off if we could disabuse them of their notions. In his article, Jackler notes that his professional organization, the American Academy of Otolaryngology – Head and Neck Surgery (AAO–HNS) has, since 2003, had a policy that states:

“Physician expert witnesses should not adopt a position as an advocate or partisan in the legal proceedings”; and that

“the physician expert witness should be aware that transcripts of their deposition and courtroom testimony are public records, subject to independent peer review.”

Jackler at 7 (citing American Academy of Otolaryngology–Head and Neck Surgery official policy on expert witnesses (revised October, 2012)). So the tobacco defense expert witnesses should certainly have been prepared for the post-trial “peer review” that Jackler provides. What is curious about Jackler’s article, and his obvious sense of outrage, is that he does state whether he has filed an ethics complaint with the American Academy or with any other reviewing organization.

Philip Morris Claims that Jackler Has Undisclosed Conflicts of Interests

The Philip Morris spokes person also noted “[Dr. Jackler had] failed to disclose that he has previously worked with counsel for plaintiffs in the Engle cases.” Cutler. Jackler responded to the BNA, stating “[c]ategorically, I have never testified in tobacco litigation. Specifically, I have never worked for lawyers on either side in any capacity in Engle cases.” What about other cases, outside Florida? Jackler’s in-press article states that it was “[s]upported by Stanford Research into the Impact of Tobacco Advertising, Stanford University School of Medicine, Stanford, CA. The authors have no other funding, financial relationships, or conflicts of interest to disclose.”

One Defense Expert Witness Responds

One defense expert witness, otolaryngologist Dr. Michael Bertino, responded to Cutler in an interview. Dr. Bertino noted that Jackler was out of touch with the risk factor epidemiology of laryngeal cancer, and that strong evidence had emerged that tobacco is not the only strong risk for this cancer. Many older studies, for instance, did not look at the role of human papilloma virus (HPV), which has been identified as a prevalent cause of oral and esophageal cancers. Cutler (citing oral interview with Dr. Bertino). Jackler’s article acknowledges that HPV has been identified in substantial percentages of oral pharyngeal cancers, but disputes that the virus is a substantial independent cause of these cancers. I will leave to others to determine whether Jackler’s review of the HPV studies is fair and balanced, and to what extent it “falsifies” Dr. Bertino’s testimony.

[1] Robert K. Jackler & H. Samji, “The price paid: Manipulation of otolaryngologists by the tobacco industry to obfuscate the emerging truth that smoking causes cancer,” 122 The Laryngoscope 75 (2011).

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“Secret Histories” in Litigation

July 14th, 2015

A recent, special issue of The Public Historian, published by the University of California Press on behalf of the National Council on Public History, focuses on the role and nature of historian expert witnesses in judicial proceedings[1]. The collection raises interesting methodological questions about the historian’s craft and the interrelation between historical research and the law. The various contributions, listed at the end of this post, cover some of the diverse activities and subject-matter expertise that historians bring to the litigation process, in the United States, in Canada, and elsewhere.

My interest was drawn, not to the articles on native peoples or land rights, but to the one article on health-effect claims. See Keith A. Zahniser, “Why Litigation-Driven History Matters: Lessons Learned from the Secret History of TCE,” 37 The Public Historian 46 (2015). The author, Keith Zahniser, is a member of Historical Research Associates, Inc., which provides litigation support services, ranging from research to expert witness testimony. In his contribution to this collection of articles, Zahniser argues that litigation-driven historical research can live up to the professional standards of historians. Using an example of the history of trichloroethylene (TCE) use and its health hazards, he laments that relevant historical scholarship often remains secret and inaccessible, unpublished, and unimproved by peer review. Id. at 47-48.

Zahniser attributes the secretive nature of litigation-driven history to:

(1) confidentiality agreements;

(2) assertion of “work product” protections for documents uncovered by historical research; and

(3) assertion of “attorney-client privilege” for consulting expert historians’ opinions and identification of documents.

Id. at 49-50. Confidentiality agreements certainly could silence an expert witness during the course of the litigation, and forever after, perhaps. The assertion of work product or attorney-client privilege to avoid production of historical documents found by consulting or testifying historians is, however, more questionable. Unless the documents involved client communications made for the purpose of obtaining legal counsel, the attorney-client privilege would not apply. Opinions developed by a consulting expert witness might well be off limits to discovery in most common law jurisdictions, but historical documents, even if obtained with a consultant’s expertise and knowledge of archival sources, would not fall under the protection of the so-called work-product doctrine.

But what of Zahniser’s claim that the history of TCE has remained a “secret”? A briefest of internet searches suggests otherwise. Another consulting historian, Steve Swisdak of History Associates, presented on the history of TCE at an American Bar Association conference in 2013[2]. A scientist at GeoInsight, Inc., has published on the history of TCE, both in a journal and in a toxicology text[3]. The medicinal use of TCE is readily ascertained through publications listed in PubMed and other publication databases[4]. And a publisher of scientific bibliographies has published a timeline of TCE history[5].

Notwithstanding the complaint about “secret history,” Zahniser has not published on TCE; nor has he, or the company with which he is affiliated, made key historical documents available on their website, or any of the myriad websites that host documents for wider viewing. Finally, many historians’ reports or declarations are available through legal archives of case materials, such as WestlawNext or Lexis Advance. Zahniser’s reports on TCE do not appear to be available.

====================================

Randolph Bergstrom, “Expert History and the Tribulations of Trials,” 37 The Public Historian 8 (2015)

Michael M. Brescia, “Bridging Troubled Waters: Historians, Natural Resource Litigation, and the Expert Witness Phenomenon,” 37 The Public Historian 11 (2015)

Jay C. Martin, “The Advocate’s Devil: The Maritime Public Historian as Expert,” 37 The Public Historian 25 (2015)

Emily Greenwald and Ian Smith, “Bury My Documents in Lenexa, Kansas: Expert Witness Work and the American Indian Records Repository,” 37 The Public Historian 39 (2015)

Keith A. Zahniser, “Why Litigation-Driven History Matters: Lessons Learned from the Secret History of TCE,” 37 The Public Historian 46 (2015)

Susan E. Gray, “Indigenous Space and the Landscape of Settlement: A Historian as Expert Witness,” 37 The Public Historian 54 (2015)

Jennifer A. Stevens, “From Archive to Evidence: Historians and Natural Resource Litigation,” 37 The Public Historian 68 (2015)

Gwynneth C. D. Jones, “Documentary Evidence and the Construction of Narratives in Legal and Historical,” 37 The Public Historian 88 (2015)

Bidtah N. Becker, “The Lawyer’s Guidebook for the Expert Witness in Natural Resources Litigation,” 37 The Public Historian 95 (2015)

[1] Thanks to Ramses Delafontaine for calling my attention to this issue of the Public Historian. Ramses’ new book provides an in-depth analysis of the role of historians as expert witnesses, in the context of tobacco litigation, as well as others. See Ramses Delafontaine, Historians as Expert Judicial Witnesses in Tobacco Litigation: A Controversial Legal Practice (2015).

[2] Steve Swisdak, “A Historical Survey of the Use and Regulation of TCE” (Oct. 11, 2013).

[3] Richard E. Doherty, “History of TCE,” in Kathleen M. Gilbert & Sarah J. Blossom, Trichloroethylene: Toxicity and Health Risks Molecular and Integrative Toxicology, at 1-14 ( 2014); Richard E. Doherty, “A History of the Production and Use of Carbon Tetrachloride, Tetrachloroethylene, Trichloroethylene and 1,1,1-Trichloroethane in the United States: Part 1 — Historical Background; Carbon Tetrachloride and Tetrachloroethylene,” 1 Envt’l Forensics 69 (2000); Richard E. Doherty, “A History of the Production and Use of Carbon Tetrachloride, Tetrachloroethylene, Trichloroethylene and 1,1,1-Trichloroethane in the United States: Part 2–Trichloroethylene and 1,1,1-Trichloroethane,”1 Envt’l Forensics 83 (2000).

[4] See, e.g., Gordon Ostlere, “The History of Trichloroethylene,” 8 Anaesthesia 21 (1953); Cecil Striker, “Clinical experiences with the use of trichlorethylene in the production of over 300 analgesias and anesthesias,” 14 Curr. Res. Anesth. 68 (1935).

[5] Icon Group Internat’l, Trichloroethylene: Webster’s Timeline History, 1949 – 2007 (2010).

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Conflict Over Conflicts of Interest

July 12th, 2015

“Let him who is without sin among you be the first to throw a stone … .” John 8:7

In the recent issue of Carcinogenesis, Jonathan Samet attempts to defend the monograph and carcinogen identification process of the International Agency for Research on Cancer (IARC). Jonathan M. Samet, “The IARC monographs: critics and controversy,” 36 Carcinogenesis 707 (2015) [cited below as Samet]. The defense is largely redundant of a publication earlier this year, in which a gaggle (124) of scientists rallied around the IARC and its carcinogenicity assessments. Neil Pearce, et al., “IARC Monographs: 40 Years of Evaluating Carcinogenic Hazards to Humans,” 123 Envt’l Health Persp. 507 (2015) [cited below as Pearce].

Professor Samet’s editorial is remarkable in several respects. First, the editorial covers the same points and arguments as the opinion piece in the Environmental Health Perspectives. Samet was one of the gaggle of 124, and so his more recent editorial in Carcinogenesis is a redundant, duplicate publication.

Samet identifies recent criticisms of IARC as falling into four categories:

“(i) reliance on epidemiological evidence that may be limited;

(ii) limitations of the IARC process and reluctance to participate in it;

(iii) issues related to specific evaluations and

(iv) issues related to the composition of the Working Groups.”

Samet at 707. Samet’s defense consists largely in following the public health meme of attributing any dissent or disagreement to industry’s conflicts of interest. In his view, IARC used to have a problem with “not maintaining sufficient distance from industrial stakeholders and the associated potential for conflict of interest[1],” but the “industry” problem has now been remedied[2]. And so Samet reasons that any continued criticisms must be the result of the industrial critics’ conflicts of interest[3]. To be sure, industry conflicts of interest are given strict scrutiny. As we shall see, litigation and compensation industry credentials are welcomed at the IARC.

Samet’s defense, which is really an attack on the bona fides of the critics, has become a commonplace in the public health community, and has degraded debate into charges and counter-charges as to who has the greater conflict of interest. This defense ignores both the specific and the general criticisms of the IARC decision process.

As Professor Cornelia Baines has noted, the IARC “process,” carries the risk of group think and of ignoring substantive disagreement. “When experts in the field are chosen, some will come armed with their zealously-promoted and ferociously-defended versions of the ‘truth’, making predictable what they will recommend at the end of the review process.” Cornelia J. Baines, “Transparency at the International Agency for Research on Cancer (IARC),” 361 Lancet 781 (2003). This danger looms especially large when members of IARC working groups have already committed to the conclusion ultimately reached, or have written and published key studies the status of which will be enhanced or undermined by the outcome of the working group’s decision. Samet and the gaggle give no consideration to this potent source of conflicts of interest.

And Geoffrey Kabat, a senior epidemiologist at Albert Einstein School of Medicine, who was one of the gaggle’s “targets,” noted that the gaggle

“confine[] themselves to generalities and fail to come to grips with any specific criticisms on their merits. The EHP defense of IARC has all the subtlety of using an elephant gun to kill a gnat.”

Geoffrey Kabat, “How Many Scientists Does It Take To Squelch A Critic? Hint: 124,” Forbes (Mar. 10, 2015) (documenting how errant and mean-spirited the gaggle’s criticisms were).

Samet argues that the likelihood that other groups, such as the Environmental Protection Agency and the National Toxicology Program, walk in lockstep with IARC, suggests how “robust” the IARC system is. Using the IARC evaluation of formaldehyde as an example, Samet points to the “confirmation” of IARC’s judgments by EPA and NTP. Samet at 707. But this example and many others merely show that the IARC and the regulatory world are robust for group think. And yet the robust agreement is not always based upon robust evidence[4].

Like the gaggle’s editorial, Samet suggests that criticisms are good except that criticisms of the IARC, and especially his IARC working group, are “unfair and unconstructive.” Pearce at 514. Samet graciously acknowledges that “[w]ith regard to particular monographs, inevitably if evidence is lacking or mixed and at equipoise, any classification can be reasonably questioned.” Samet at 707. Like the gaggle, however, he never engages with Dr. Kabat’s procedural and substantive criticisms of Samet’s working group on electromagnetic radiation exposures.

There is, of course, a serious danger of placing so much emphasis on conflicts of interest as a proxy for truth and validity. One could be hoisted with his own conflict-of-interest petard. Samet, for instance, in his Carcinogenesis editorial declares no conflict of interest, and yet he was the Chairman of the IARC working group on radiofrequency electromagnetic radiation exposure[5] that was the subject of Dr. Kabat’s and others’ scathing criticisms.

Carcinogenesis has the following policy on conflicts:

“Carcinogenesis policy requires that each author reveal any financial interests or connections , direct or indirect, or other situations that might raise the question of bias in the work reported or the conclusions, implications, or opinions stated – including pertinent commercial or other sources of funding for the individual author(s) or for the associated department(s) or organization(s), personal relationships, or direct academic competition.”

Carcinogenesis CONFLICT OF INTEREST FORM <accessed July 10, 2015>.

In addition to Samet’s personal role in the criticized IARC determination, several of the gaggle have been regular testifiers for litigation-compensation industry[6]. There are no disclosures of litigation conflicts of interest in the gaggle’s editorial. Pearce.

Samet himself has been at the center of other conflict-of-interest controversies. In 2011, two tobacco companies sued the United States Food and Drug Administration (FDA) to challenge how the agency staffed its Tobacco Products Scientific Advisory Committee (“TPSAC”), which was charged with investigating the public health implications of using menthol in cigarettes. The companies alleged that the FDA failed to comply with the Federal Advisory Committee Act (“FACA”). The TPSAC, formed after the enactment of the Family Smoking Prevention and Tobacco Control Act (“Tobacco Act”) reported that menthol in cigarettes adversely affected public health, and that menthol should be removed to promote public health.

The basis of the suit was that three members of the TPSAC had served, or continued to serve, as paid expert witnesses for plaintiffs in litigation against tobacco companies. The companies claim was that the these TPSAC members, including Dr. Samet, created a partial, interested, imbalanced committee that was unfairly predisposed to view menthol in cigarettes as harmful. In 2012, a federal district court refused the FDA’s motion to dismiss[7], and last year, the court granted the tobacco companies substantially the relief they sought[8].

The FDA appealed Judge Leon’s ruling, but in March 2015, the agency announced that four members of the TPSAC were removed, including Dr. Samet. Ironically, the American Thoracic Society (ATS) submitted an amicus brief, despite having an obvious conflict of interest. Dr. Samet is a member of the ATS’s Tobacco Action Committee, through which he organizes and coordinates the ATS’s anti-tobacco activities. The ATS and Dr. Samet’s anti-tobacco activism may be laudable, but that activism, along with Dr. Samet’s engagement as a litigation expert witness for plaintiffs against tobacco companies, surely constitute a conflict of interest, if anything is.

[1] Editorial, “Transparency at IARC,” 361 Lancet 189 (2003).

[2] citing Herbert Needleman & James Huff, “The International Agency for Research on Cancer and obligate transparency,” 6 Lancet Oncol. 920 (2005)

[3] citing those who would be manufacturers of faux certainty, Naomi Oreskes & Erik Conway, Merchants of Doubt: How a Handful of Scientists Obscured the Truth on Issues from Tobacco Smoke to Global Warming (N.Y. 2010); David Michaels, Doubt Is Their Product: How Industry’s Assault on Science Threatens Your Health (N.Y. 2008).

[4] See, e.g., C. Bosetti, Joseph K. McLaughlin, Robert E. Tarone, E. Pira & Carlo La Vecchia, “Formaldehyde and cancer risk: a quantitative review of cohort studies through 2006,” 19 Ann. Oncol. 29 (2008).

[5] IARC Press Release N° 208, “IARC Classifies Radiofrequency Electromagnetic Fields as Possibly Carcinogenic to Humans” (31 May 2011).

[6] Including Martyn T. Smith, whose testimony has been the subject of several judicial exclusions for lack of validity.

[7] Lorillard, Inc. v. United States Food and Drug Admin., Civ. No. 11-440 (RJL), 2012 WL 3542228 (Aug. 1, 2012).

[8] Lorillard, Inc. v. United States Food and Drug Admin., 56 F. Supp. 3d 37 (D.D.C. 2014) (Leon, J.). Judge Leon’s decision is discussed in “Conflict of Interest Regulations Apply Symmetrically” (July 25, 2015). The case is currently on appeal to the Court of Appeals for the District of Columbia Circuit.

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Unguarded Historian’s Inquiry into Nazi Science of Silica and Lung Cancer

July 10th, 2015

Robert N. Proctor is Professor of the History of Science, in Stanford University. In the litigation world, he is known mostly for his advocacy on behalf of tobacco plaintiffs. He has testified in dozens of cases over the years, always on behalf of claimants. See Ramses Delafontaine, “Making History in Court: A Survey of Historians as Expert Witnesses in Tobacco Litigation in the US – Robert N. Proctor,” The Judge and the Historian (last visited July 6, 2015).

Proctor’s book, The Nazi War on Cancer (Princeton 1999), which won the American Public Health Association’s 1999 Viseltear Award, is an extended exploration of the Nazi ideology of health. The value of the book is not merely in its discussion of the scientific record on various issues, such as

tobacco and asbestos, in the Nazi empire; rather Proctor’s historical narrative provides a valuable insight into how science can become the plaything of political ideologies. The Nazi War illustrates that the political pressures do not always come from corporations. Some of the most intense and unremitting pressures come from popular movements such as those made up of consumerists and environmentalists.

Although Proctor’s focus is on tobacco, and to a lesser extent, asbestos, he does have some intriguing things to say about silica, silicosis, and lung cancer. According to Proctor:

“Cancer was an occasional concern of the German industrial hygienists who worried about silicosis. A 1934 dissertation explored the coincidence of silicosis and lung cancer, the primary question being whether the quartz dust inhaled by Ruhr Valley coal miners could cause malignancies. Though the results of this particular study were negative (silicosis did not seem to predispose to lung cancer), the prescience of the interest is notable.¹³²”

Nazi War at 107 & n. 132 (citing Kurt Kollmeier, Silikose und Lungenkrebs (Bonn: Medical Dissertation, 1934), and noting that Ludwig Teleky, “Der berufliche Lugenkrebs,” 3 Actio Unio Internationalis Contra Cancrum 253 (1938) “failed to find a link.”). Lack of resolution was not a common occurrence in Nazi politics or science, but Proctor notes that:

“The question of whether silica exposure could cause cancer was never resolved in the Nazi era — and remains confused even today, more than a half century later.”

Nazi Science at 107. And despite the political ideology of OSHA’s administrator and white-hat public health zealots, the question whether silica can cause lung cancer is still not resolved.

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Crayons Help Divert California from Real Risks – Tales from the Fearmonger’s Shop

July 8th, 2015

Living in a state, California, beset by the actuality of drought and the real, imminent threat of earthquake, must be scary. And still, Californians seem to relish increasing the appearance of risks everywhere. The state has astonishing epistemic insights, knowing risks not known to anyone else, through its Proposition 65. And then there are legislative fiats that posit risks, again unknown outside California. David Lazarus, “Berkeley’s warning about cellphone radiation may go too far,” Los Angeles Times (June 26, 2015). And now there are killer crayons from China. Victoria Colliver, “Asbestos fibers found in some crayons, toys from China,” SFGate (July 8, 2015).

Ms. Colliver is largely the uncritical conduit for an advocacy group, which speaks through her, without any scientific filter:

“Environmental health advocates said there is no safe level of exposure to asbestos, a group of naturally occurring minerals with microscopic fibers. The fibers can accumulate in the lungs and have been linked to cancer and other health problems.”

Id. At best, some scientists, mostly of the zealot brand, say that there is no known safe level of exposure to asbestos, but this is quite different from saying there is known to be no safe level. Honest scientists will acknowledge a dispute about whether low-level exposures are innocuous, but uncertainty about safety at low doses does not translate into certainty about unsafety at low doses. And the suggestion that fibers can accumulate in the lungs may be true for occupational and paraoccupational exposures, but human beings have defense mechanisms that block entry by, and rid the lungs of, asbestos fibers. At the cellular and subcellular level, humans have robust defenses to low-levels of carcinogens in the form of DNA repair mechanisms. Of course, as wild and unpredictable as little children can be, they rarely inhale crayons. If they do, asbestos won’t be their problem. (To be fair, one of the products tested was a powder, which could be aerosolized, but there is no quantitative assessment of the extent of asbestos in this powder product.)

Ms. Colliver’s source is a report put out by Environmental Working Group Action Fund, the website for which does not acknowledge any scientific oversight or membership. Colliver’s “hot quotes” are from Richard Lemen, who is a regular testifier for the asbestos litigation industry.

What you will not see in Colliver’s “science” coverage is that there is no mineral asbestos; rather it is a commercial term for six different fibrous naturally occurring minerals. Five of the asbestos minerals are amphiboles – crocidolite (blue), amosite (brown), tremolite, anthophyllite, and actinolite. The remaining mineral fiber is chrysotile. There are, to be sure, many other fibrous minerals, but none with any suggested carcinogenicity, other than the non-asbestos zeolite mineral erionite. The most serious health effect of some kinds of asbestos is mesothelioma, a malignancy of the serosal tissues around the lung, heart, and gut. Crocidolite and amosite are by far the major causes of mesothelioma.

Although Colliver does not link to the EWG’s report, it is easy enough to find the report on the group’s website. See Bill Walker and Sonya Lunder, “Tests Find Asbestos in Kids’ Crayons, Crime Scene Kits” (2015). Most of the products tested had no detectable asbestos fiber of any kind. The EWG report provides no quantification of the findings so it is hard to assess the extent of the asbestos present. The report does provide the identity of the fibrous asbestos minerals present: tremolite, anthophyllite, actinolite, which suggests that the fibers were present in low levels in the talcs used as binding agents or mold release for the crayons. The EWG report fails to provide quantitative information on the distribution of morphology of the so-called fibers. The biologically dangerous fibers have a high-aspect ratio. Importantly, crocidolite and amosite, which collectively are the major causes of mesothelioma, were not found.

Assuming the report is correct, the hazard to children is remote and incredibly speculative. Fibers in the crayons would not be readily aerosolized, and the fibers could not represent even a theoretical hazard unless they were inhaled. The only disease for which low exposures is even a theoretical concern is mesothelioma. Back in 2000, a similar scare erupted in the media. At that time the Consumer Product Safety Commission tested the crayons, and concluded that the risk of a child’s inhaling asbestos fiber was “extremely low.” No airborne fibers could be detected after a simulation of a child’s “vigorously coloring” with a crayon. U.S. Consumer Product Safety Commission, CPSC Staff Report on Asbestos Fibers in Children’s Crayons (2000). The business of defining what counts as an asbestos fiber, as opposed to a non-carcinogenic particle, is complicated and sometimes controversial. See Bruce W. Case, Jerrold L. Abraham, G. Meeker , Fred D. Pooley & K. E. Pinkerton, “Applying definitions of “asbestos” to environmental and “low-dose” exposure levels and health effects, particularly malignant mesothelioma,” 14 J. Toxicol. Envt’l Health B Crit. Rev. 3 (2011) (noting lack of consensus about the specific definitions for asbestos fibers).

As for low-exposure alleged risks, the evidence varies by disease outcome. For lung cancer, there is actually rather strong evidence of a threshold. And lack of conclusive evidence of a threshold below which mesothelioma will not occur is hardly evidence that mesothelioma could result from any theoretical exposure postulated from children’s use of the crayons. The business of attributing a case of mesothelioma to a low-level previous exposure is, of course, very different from predicting that a very low level exposure will have a public health effect in a large population. Asbestos minerals occur naturally, and rural and urban residents, even those without occupational exposure, have a level of asbestos that can be found in their lung tissue. There is, however, a business of attributing mesotheliomas to low-level exposures, that has become a big business indeed, in courtrooms all around the United States. The business is run by expert witnesses who regularly conflate “no known safe level” with “known no safe level,” just as Ms. Colliver did in her article. What a coincidence! See Mark A. Behrens & William L. Anderson, “The ‘any exposure’ theory: an unsound basis ·for asbestos causation and expert testimony,” 37 Southwestern Univ. L. Rev. 479 (2008); Nicholas P. Vari and Michael J. Ross, “State Courts Move to Dismiss Every Exposure Liability Theory in Asbestos Lawsuits,” 29 Legal Backgrounder (Feb. 28, 2014).

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