A few egregious articles in the biomedical literature have begun to endorse explicitly asymmetrical standards for inferring causation in the context of environmental or occupational exposures. Very little if anything is needed for inferring causation, and nothing counts against causation.  If authors refuse to infer causation, then they are agents of “industry,” epidemiologic malfeasors, and doubt mongers.

For an example of this genre, take the recent article, entitled “Toolkit for detecting misused epidemiological methods.”[1] [Toolkit] Please.

The asymmetry begins with Trump-like projection of the authors’ own foibles. The principal hammer in the authors’ toolkit for detecting misused epidemiologic methods is personal, financial bias. And yet, somehow, in an article that calls out other scientists for having received money from “industry,” the authors overlooked the business of disclosing their receipt of monies from one of the biggest industries around – the lawsuit industry.

Under the heading “competing interests,” the authors state that “they have no competing interests.”[2]  Lead author, Colin L. Soskolne, was, however, an active, partisan expert witness for plaintiffs’ counsel in diacetyl litigation.[3] In an asbestos case before the Pennsylvania Supreme Court, Rost v. Ford Motor Co., Soskolne signed on to an amicus brief, supporting the plaintiff, using his science credentials, without disclosing his expert witness work for plaintiffs, or his long-standing anti-asbestos advocacy.[4]

Author Shira Kramer signed on to Toolkit, without disclosing any conflicts, but with an even more impressive résumé of pro-plaintiff litigation experience.[5] Kramer is the owner of Epidemiology International, in Cockeysville, Maryland, where she services the lawsuit industry. She too was an “amicus” in Rost, without disclosing her extensive plaintiff-side litigation consulting and testifying.

Carl Cranor, another author of Toolkit, takes first place for hypocrisy on conflicts of interest. As a founder of Council for Education and Research on Toxics (CERT), he has sterling credentials for monetizing the bounty hunt against “carcinogens,” most recently against coffee.[6] He has testified in denture cream and benzene litigation, for plaintiffs. When he was excluded under Rule 702 from the Milward case, CERT filed an amicus brief on his behalf, without disclosing that Cranor was a founder of that organization.[7]^{, [8]}

The title seems reasonably fair-minded but the virulent bias of the authors is soon revealed. The Toolkit is presented as a Table in the middle of the article, but the actual “tools” are for the most part not seriously discussed, other than advice to “follow the money” to identify financial conflicts of interest.

The authors acknowledge that epidemiology provides critical knowledge of risk factors and causation of disease, but they quickly transition to an effort to silence any industry commentator on any specific epidemiologic issue. As we will see, the lawsuit industry is given a complete pass. Not surprisingly, several of the authors (Kramer, Cranor, Soskolne) have worked closely in tandem with the lawsuit industry, and have derived financial rewards for their efforts.

Repeatedly, the authors tell us that epidemiologic methods and language are misused by “powerful interests,” which have financial stakes in the outcome of research. Agents of these interests foment uncertainty and doubt about causal relationships through “disinformation,” “malfeasance,” and “doubt mongering.” There is no correlative concern about false claiming or claim mongering..

Who are these agents who plot to sabotage “social justice” and “truth”? Clearly, they are scientists with whom the Toolkit authors disagree. The Toolkit gang cites several papers as exemplifying “malfeasance,”[9] but they never explain what was wrong with them, or how the malfeasors went astray.  The Toolkit tactics seem worthy of Twitter smear and run.

The Toolkit

The authors’ chart of “tools” used by industry might have been an interesting taxonomy of error, but mostly they are ad hominem attack on scientists with whom they disagree. Channeling Putin on Ukraine, those scientists who would impose discipline and rigor on epidemiologic science are derided as not “real epidemiologists,” and, to boot, they are guilty of ethical lapses in failing to advance “social justice.”

Mostly the authors give us a toolkit for silencing those who would get in the way of the situational science deployed at the beck and call of the lawsuit industry.[10] Indeed, the Toolkit authors are not shy about identifying their litigation goals; they tell us that the toolkit can be deployed in depositions and in cross-examinations to pursue “social justice.” These authors also outline a social agenda that greatly resembles the goals of cancel culture: expose the perpetrators who stand in the way of the authors’preferred policy choices, diminish their adversaries’ their influence on journals, and galvanize peer reviewers to reject their adversaries’ scientific publications. The Toolkit authors tell us that “[t] he scientific community should engage by recognizing and professionally calling out common practices used to distort and misapply epidemiological and other health-related sciences.”[11] What this advice translates into are covert and open ad hominem campaigns as peer reviewers to block publications, to deny adversaries tenure and promotions, and to use social and other media outlets to attack adversaries’ motives, good faith, and competence.

None of this is really new. Twenty-five years ago, the late F. Douglas K. Liddell railed at the Mt. Sinai mob, and the phenomenon was hardly new then.[12] The Toolkit’s call to arms is, however, quite open, and raises the question whether its authors and adherents can be fair journal editors and peer reviewers of journal submissions.

Much of the Toolkit is the implementation of a strategy developed by lawsuit industry expert witnesses to demonize their adversaries by accusing them of manufacturing doubt or ignorance or uncertainty. This strategy has gained a label used to deride those who disagree with litigation overclaiming: agnotology or the creation of ignorance. According to Professor Robert Proctor, a regular testifying historian for tobacco plaintiffs, a linguist, Iain Boal, coined the term agnotology, in 1992, to describe the study of the production of ignorance.[13]

The Rise of “Agnotology” in Ngram

Agnotology has become a cottage sub-industry of the lawsuit industry, although lawsuits (or claim mongering if you like), of course, remain their main product. Naomi Oreskes[14] and David Michaels[15] gave the agnotology field greater visibility with their publications, using the less erudite but catchier phrase “manufacturing doubt.” Although the study of ignorance and uncertainty has a legitimate role in epistemology[16] and sociology,[17] much of the current literature is dominated by those who use agnotology as propaganda in support of their own litigation and regulatory agendas.[18] One lone author, however, appears to have taken agnotology study seriously enough to see that it is largely a conspiracy theory that reduces complex historical or scientific theory, evidence, opinion, and conclusions to a clash between truth and a demonic ideology.[19]

Is there any substance to the Toolkit?

The Toolkit is not entirely empty of substantive issues. The authors note that “statistical methods are a critical component of the epidemiologist’s toolkit,”[20] and they cite some articles about common statistical mistakes missed by peer reviewers. Curiously, the Toolkit omits any meaningful discussion of statistical mistakes that increase the risk of false positive results, such as multiple comparisons or dichotomizing continuous confounder variables. As for the Toolkit’s number one identified “inappropriate” technique used by its authors’ adversaries, we have:

“A1. Relying on statistical hypothesis testing; Using ‘statistical significance’ at the 0.05 level of probability as a strict decision criterion to determine the interpretation of statistical results and drawing conclusions.”

Peer into the hearings of any federal court so-called Daubert motion, and you will see the lawsuit industry, and its hired expert witnesses, rail at statistical significance, unless of course, there is some subgroup that has nominal significance, in which case, they are all in for endorsing the finding as “conclusive.” 

Welcome to asymmetric, situational science.

[1] Colin L. Soskolne, Shira Kramer, Juan Pablo Ramos-Bonilla, Daniele Mandrioli, Jennifer Sass, Michael Gochfeld, Carl F. Cranor, Shailesh Advani & Lisa A. Bero, “Toolkit for detecting misused epidemiological methods,” 20(90) Envt’l Health (2021) [Toolkit].

[2] Toolkit at 12.

[3] Watson v. Dillon Co., 797 F.Supp. 2d 1138 (D. Colo. 2011).

[4] Rost v. Ford Motor Co., 151 A.3d 1032 (Pa. 2016). See “The Amicus Curious Brief” (Jan. 4, 2018).

[5] See, e.g., Sean v. BMW of North Am., LLC, 26 N.Y.3d 801, 48 N.E.3d 937, 28 N.Y.S.3d 656 (2016) (affirming exclusion of Kramer); The Little Hocking Water Ass’n v. E.I. Du Pont De Nemours & Co., 90 F.Supp.3d 746 (S.D. Ohio 2015) (excluding Kramer); Luther v. John W. Stone Oil Distributor, LLC, No. 14-30891 (5th Cir. April 30, 2015) (mentioning Kramer as litigation consultant); Clair v. Monsanto Co., 412 S.W.3d 295 (Mo. Ct. App. 2013 (mentioning Kramer as plaintiffs’ expert witness); In re Chantix (Varenicline) Prods. Liab. Litig., No. 2:09-CV-2039-IPJ, MDL No. 2092, 2012 WL 3871562 (N.D.Ala. 2012) (excluding Kramer’s opinions in part); Frischhertz v. SmithKline Beecham Corp., 2012 U.S. Dist. LEXIS 181507, Civ. No. 10-2125 (E.D. La. Dec. 21, 2012) (excluding Kramer); Donaldson v. Central Illinois Public Service Co., 199 Ill. 2d 63, 767 N.E.2d 314 (2002) (affirming admissibility of Kramer’s opinions in absence of Rule 702 standards).

[6]  “The Council for Education & Research on Toxics” (July 9, 2013) (CERT amicus brief filed without any disclosure of conflict of interest). Among the fellow travelers who wittingly or unwittingly supported CERT’s scheme to pervert the course of justice were lawsuit industry stalwarts, Arthur L. Frank, Peter F. Infante, Philip J. Landrigan, Barry S. Levy, Ronald L. Melnick, David Ozonoff, and David Rosner. See also NAS, “Carl Cranor’s Conflicted Jeremiad Against Daubert” (Sept. 23, 2018); Carl Cranor, “Milward v. Acuity Specialty Products: How the First Circuit Opened Courthouse Doors for Wronged Parties to Present Wider Range of Scientific Evidence” (July 25, 2011).

[7] Milward v. Acuity Specialty Products Group, Inc., 664 F. Supp. 2d 137, 148 (D. Mass. 2009), rev’d, 639 F.3d 11 (1st Cir. 2011), cert. den. sub nom. U.S. Steel Corp. v. Milward, 565 U.S. 1111 (2012), on remand, Milward v. Acuity Specialty Products Group, Inc., 969 F.Supp. 2d 101 (D. Mass. 2013) (excluding specific causation opinions as invalid; granting summary judgment), aff’d, 820 F.3d 469 (1st Cir. 2016).

[8] To put this effort into a sociology of science perspective, the Toolkit article is published in a journal, Environmental Health, an Editor in Chief of which is David Ozonoff, a long-time pro-plaintiff partisan in the asbestos litigation. The journal has an “ombudsman,”Anthony Robbins, who was one of the movers-and-shakers in forming SKAPP, The Project on Scientific Knowledge and Public Policy, a group that plotted to undermine the application of federal evidence law of expert witness opinion testimony. SKAPP itself now defunct, but its spirit of subverting law lives on with efforts such as the Toolkit. “More Antic Proposals for Expert Witness Testimony – Including My Own Antic Proposals” (Dec. 30, 2014). Robbins is also affiliated with an effort, led by historian and plaintiffs’ expert witness David Rosner, to perpetuate misleading historical narratives of environmental and occupational health. “ToxicHistorians Sponsor ToxicDocs” (Feb. 1, 2018); “Creators of ToxicDocs Show Off Their Biases” (June 7, 2019); Anthony Robbins & Phyllis Freeman, “ToxicDocs (www.ToxicDocs.org) goes live: A giant step toward leveling the playing field for efforts to combat toxic exposures,” 39 J. Public Health Pol’y 1 (2018).

[9] The exemplars cited were Paolo Boffetta, MD, MPH; Hans Olov Adami, Philip Cole, Dimitrios Trichopoulos, Jack Mandel, “Epidemiologic studies of styrene and cancer: a review of the literature,” 51 J. Occup. & Envt’l Med. 1275 (2009); Carlo LaVecchia & Paolo Boffetta, “Role of stopping exposure and recent exposure to asbestos in the risk of mesothelioma,” 21 Eur. J. Cancer Prev. 227 (2012); John Acquavella, David Garabrant, Gary Marsh G, Thomas Sorahan and Douglas L. Weed, “Glyphosate epidemiology expert panel review: a weight of evidence systematic review of the relationship between glyphosate exposure and non-Hodgkin’s lymphoma or multiple myeloma,” 46 Crit. Rev. Toxicol. S28 (2016); Catalina Ciocan, Nicolò Franco, Enrico Pira, Ihab Mansour, Alessandro Godono, and Paolo Boffetta, “Methodological issues in descriptive environmental epidemiology. The example of study Sentieri,” 112 La Medicina del Lavoro 15 (2021).

[10] The Toolkit authors acknowledge that their identification of “tools” was drawn from previous publications of the same ilk, in the same journal. Rebecca F. Goldberg & Laura N. Vandenberg, “The science of spin: targeted strategies to manufacture doubt with detrimental effects on environmental and public health,” 20:33 Envt’l Health (2021).

[11] Toolkit at 11.

[12] F.D.K. Liddell, “Magic, Menace, Myth and Malice,” 41 Ann. Occup. Hyg. 3, 3 (1997). See “The Lobby – Cut on the Bias” (July 6, 2020).

[13] Robert N. Proctor & Londa Schiebinger, Agnotology: The Making and Unmaking of Ignorance (2008).

[14] Naomi Oreskes & Erik M. Conway, Merchants of Doubt: How a Handful of Scientists Obscured the Truth on Issues from Tobacco Smoke to Global Warming (2010); Naomi Oreskes & Erik M. Conway, “Defeating the merchants of doubt,” 465 Nature 686 (2010).

[15] David Michaels, The Triumph of Doubt: Dark Money and the Science of Deception (2020); David Michaels, Doubt is Their Product: How Industry’s Assault on Science Threatens Your Health (2008); David Michaels, “Science for Sale,” Boston Rev. 2020; David Michaels, “Corporate Campaigns Manufacture Scientific Doubt,” 174 Science News 32 (2008); David Michaels, “Manufactured Uncertainty: Protecting Public Health in the Age of Contested Science and Product Defense,” 1076 Ann. N.Y. Acad. Sci. 149 (2006); David Michaels, “Scientific Evidence and Public Policy,” 95 Am. J. Public Health s1 (2005); David Michaels & Celeste Monforton, “Manufacturing Uncertainty: Contested Science and the Protection of the Public’s Health and Environment,” 95 Am. J. Pub. Health S39 (2005); David Michaels & Celeste Monforton, “Scientific Evidence in the Regulatory System: Manufacturing Uncertainty and the Demise of the Formal Regulatory Ssytem,” 13 J. L. & Policy 17 (2005); David Michaels, “Doubt is Their Product,” Sci. Am. 96 (June 2005); David Michaels, “The Art of ‘Manufacturing Uncertainty’,” L.A. Times (June 24, 2005).

[16] See, e.g., Sibilla Cantarini, Werner Abraham, and Elisabeth Leiss, eds., Certainty-uncertainty – and the Attitudinal Space in Between (2014); Roger M. Cooke, Experts in Uncertainty: Opinion and Subjective Probability in Science (1991).

[17] See, e.g., Ralph Hertwig & Christoph Engel, eds., Deliberate Ignorance: Choosing Not to Know (2021); Linsey McGoey, The Unknowers: How Strategic Ignorance Rules the World (2019); Michael Smithson, “Toward a Social Theory of Ignorance,” 15 J. Theory Social Behavior 151 (1985).

[18] See Janet Kourany & Martin Carrier, eds., Science and the Production of Ignorance: When the Quest for Knowledge Is Thwarted (2020); John Launer, “The production of ignorance,” 96 Postgraduate Med. J. 179 (2020); David S. Egilman, “The Production of Corporate Research to Manufacture Doubt About the Health Hazards of Products: An Overview of the Exponent BakeliteVR Simulation Study,” 28 New Solutions 179 (2018); Larry Dossey, “Agnotology: on the varieties of ignorance, criminal negligence, and crimes against humanity,” 10 Explore 331 (2014); Gerald Markowitz & David Rosner, Deceit and Denial: The Deadly Politics of Industrial Revolution (2002).

[19] See Enea Bianchi, “Agnotology: a Conspiracy Theory of Ignorance?” Ágalma: Rivista di studi culturali e di estetica 41 (2021).

[20] Toolkit at 4.