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David Egilman, Rest in Peace, Part 3

April 30th, 2024

Egilman was sufficiently clever to discern that if his “method” led to a conclusion that silicone gel breast implants cause autoimmune disease, but the Institute of Medicine, along with court-appointed experts, found no basis for a causal conclusion, then by modus tollens Egilman’s “method” was suspect and must be rejected.[1] This awareness likely explains the extent to which he went to cover up his involvement in the plaintiffs’ causation case in the silicone litigation.

Egilman’s selective leaking of Eli Lilly documents was also a sore point. Egilman’s participation in an unlawful conspiracy was carefully detailed in an opinion by the presiding judge, Hon. Jack Weinstein.[2] His shenanigans were also widely covered in the media,[3] and in the scholarly law journals.[4] When Egilman was caught with his hand in the cookie jar, and conspiring to distribute confidential Zyprexa documents to the press, he pleaded the fifth amendment. The proceedings did not go well, and Egilman ultimately stipulated to his responsibility for violating a court order, and agreed to pay a monetary penalty of $100,000. Egilman’s settlement was prudent. The Court of Appeals affirmed sanctions against Egilman’s co-conspirator, for what the court described as “brazen” conduct.[5]

 

Despite being a confessed contemnor, Egilman managed to attract a fair amount of hagiographic commentary.[6] An article in Science, described Egilman as “the scourge of companies he accuses of harming public health and corrupting science,”[7] and quoted fawning praise from his lawsuit industry employers: “[h]e’s a bloodhound who can sniff out corporate misconduct better than security dogs at an airport,”[8] In 2009, a screen writer, Patrick Coppola, announced that he was developing a script for a “Doctor David Egilman Project”. A webpage (still available on the Way-Back machine)[9] described the proposed movie as Erin Brockovich meets The Verdict. Perhaps it would have been more like King Kong meets Lenin in October.

After I started my blog, Tortini, in 2010, I occasionally commented upon David Egilman. As a result, I received occasional emails from various correpondents about him. Most were lawyers aggrieved by his behavior at deposition or in trial, or physicians libeled by him. I generally discounted those partisan and emotive accounts, although I tried to help by sharing transcripts from Egilman’s many testimonial adventures.

One email correspondent was Dennis Nichols, a well-respected journalist from Cincinnati, Ohio. Nichols had known Egilman in the early 1980s, when he was at NIOSH, in Cincinnait. Nichols had some interests in common with Egilman, and had socialized with him 40 years ago. Dennis wondered what had become of Egilman, and one day, googled Egilman, and found my post “David Egilman’s Methodology for Divining Causation.”  Nichols found my description of Egilman’s m.o. consistent with what he remembered from the early 1980s. In the course of our correspondence, Dennis Nichols shared his recollections of his interactions with the very young David Egilman. Dennis Nichols died in February 2022,[10] and I am taking the liberty of sharing his first-hand account with a broader audience.

“I met David Egilman only two or three times, and that was more than 30 years ago, when he was an epidemiologist at NIOSH. When I remarked on the content of conversation with him in about 1990, he and a lawyer representing him threatened to sue me for libel, to which I picked up the gauntlet. I had a ‘blood from the turnip’ defense to accompany my primary defense of truth, and besides, Egilman was widely known as a Communist.

I had lunch with Egilman in a Cincinnati restaurant in 1982 after someone suggested that he might be interested in supporting an arts and entertainment publishing venture that I was involved with, called The Outlook; notwithstanding that I was a conservative, The Outlook leaned left, and its key staff were Catholic pacifists and socialists. Over lunch, Egilman explained to me that he considered himself a Marxist-Leninist, his term, and that the day would come when people like him would have to kill people like me, again his language.

He subsequently invited me and the editor of The Outlook to a reception he had at his house on Mt. Adams, a Cincinnati upscale and Bohemian neighborhood, or at least as close as Cincinnati gets to Bohemian, where he served caviar that he had brought back from his most recent trip to Moscow and displayed poster-size photographs of Lenin, Marx, Stalin, Luxemburg, Gorky and other heroes of the Soviet Union and Scientific Socialism. I do not recall that Egilman admired Mao; the USSR had considerable tension in those years with China, and Egilman was clearly in the USSR camp in those days of Brezhnev, and he said so. Egilman said he traveled often to the Soviet Union, I think in the course of his work, which probably was not common in 1982.

The Outlook editor had met Egilman in the course of his advocacy journalism in reporting on the Fernald Feed Materials Production Center, now closed, which processed fuel cores for nuclear weapons.

Probably none of this matters a generation later, but is just nostalgia about an old communist and his predations before he got into exploiting medical mal. May he rot.”[11]

The account from Mr. Nichols certainly rings true. From years of combing over Egilman’s website (before he added password protection), anyone could see that he viewed litigation as class warfare that would advance his political goals. Litigation has the advantage of being lucrative, and bloodless, too – perfect for fair-weather Marxists.

Did Egilman remain a Marxist into the 1990s and the 21st century? Does it matter?

If Egilman was as committed to Marxist doctrine as Mr. Nichols suggests, he would have recognized that, as an expert witness, he needed to tone down his public rhetoric. Around the time I corresponded with Mr. Nichols, I saw that Egilman was presenting to the Socialist Caucus of the American Public Health Association (2012-13). Egilman always struck me as a bit too pudgy and comfortable really to yearn for a Spartan workers’ paradise. In any event, Egilman was probably not committed to the violent overthrow of the United States government because he had found a better way to destabilize our society by allying himself with the lawsuit industry. The larger point, however, is that political commitments and ideological biases are just as likely to lead to motivated reasoning, if not more so.

Although Egilman’s voice needed no amplification, he managed to turn up the wattage of his propaganda by taking over the reins, as editor in chief, of a biomedical journal. The International Journal of Occupational and Environmental Health (IJOEH) was founded and paid for by Joseph LaDou, in 1995. By 2007, Egilman had taken over as chief editor. He ran the journal out of his office, and the journal’s domain was registered in his name. Egilman published frequently in the journal, which became a vanity press for his anti-manufacturer, pro-lawsuit industry views. His editorial board included such testifying luminaries as Arthur Frank, Barry S. Levy, and David Madigan.

Douglas Starr, in an article in Science, described IJOEH as having had a reputation for opposing “mercenary science,” which is interesting given that Egilman, many on his editorial board, and many of the authors who published in IJOEH were retained, paid expert witnesses in litigation. The journal itself could not have been a better exemplar[12] of mercenary science, in support of the lawsuit industry.

In 2015, IJOEH was acquired by the Taylor & Francis publishing group, which, in short order, declined to renew Egilman’s contract to serve as editor. The new publisher also withdrew one of Egilman’s peer-reviewed papers that had been slated for publication. Taylor & Francis reported to the blog Retraction Watch that Egilman’s article had been “published inadvertently, before the review process was completed,” and was later deemed “unsuitable for publication.”[13] Egilman and his minions revolted, but Taylor & Francis held the line and retired the journal.[14]

Egilman recovered from the indignity foisted upon him by Taylor & Francis, by finding yet another journal, the Journal of Scientific Practice and Integrity (JOSPI).[15] Egilman probably said all that was needed to describe the goals of this new journal by announcing that the

Journal’s “partner” was the Collegium Ramazzini. Egilman of course was the editor in chief, with an editorial board made up of many well-known, high-volume testifiers for the lawsuit industry: Adriane Fugh-Berman, Barry Castleman, Michael R. Harbut, Peter Infante, William E. Longo, David Madigan, Gerald Markowitz, and David Rosner.

Some say that David Egilman was a force of nature, but so are hurricanes, earthquakes, volcanoes, and pestilences. You might think I have nothing good to say about David Egilman, but that is not true. The Lawsuit Industry has often organized and funded mass radiographic and other medical screenings to cull plaintiffs from the population of workers.[16] Some of these screenings led to the massive filing of fraudulent claims.[17] Although he was blind to many of the excesses of the lawsuit industry, Egilman spoke out against attorney-sponsored and funded medico-legal screenings. He published his criticisms in medical journals,[18] and he commented freely in lay media. He told one reporter that “all too often these medical screenings are little more than rackets perpetrated by money-hungry lawyers. Most workers usually don’t know what they’re getting involved in.”[19] Among the Collegium Ramazzini crowd, Egilman was pretty much a lone voice of criticism.

[1] See “David Egilman’s Methodology for Divining Causation,” Tortini (Sept. 6, 2012).

[2] In re Zyprexa Injunction, 474 F.Supp. 2d 385 (E.D.N.Y. 2007). The Zyprexa case was not the first instance of Egilman’s involvement in a controversy over a protective order. Ballinger v. BrushWellman, Inc., 2001 WL 36034524 (Colo. Dist. June 22, 2001), aff’d in part and rev’d in part, 2002 WL 2027530 (Colo. App. Sept. 5, 2002) (unpublished).

[3] “Doctor Who Leaked Documents Will Pay $100,000 to Lilly,” N. Y. Times (Sept. 8, 2007).

[4] William G. Childs, “When the Bell Can’t Be Unrung: Document Leaks and Protective Orders in Mass Tort Litigation,” 27 Rev. Litig. 565 (2008).

[5] Eli Lilly & Co. v. Gottstein, 617 F.3d 186, 188 (2d Cir. 2010).

[6] Michelle Dally, “The Hero Who Wound Up On the Wrong Side of the Law,” Rhode Island Monthly 37 (Nov. 2001).

[7] Douglas Starr, “Bearing Witness,” 363 Science 334 (2019).

[8] Id. at 335 (quoting Mark Lanier, who fired Egilman for his malfeasance in the Zyprexa litigation).

[9] Doctor David Egilman Project, at <https://web.archive.org/web/20130902035225/http://coppolaentertainment.com/ddep.htm>.

[10] Bill Steigerwald, “The death of a great Ohio newspaperman,” (Feb. 08, 2022) (“Dennis Nichols of Cincinnati’s eastern suburbs was a dogged, brilliant and principled journalist who ran his family’s two community papers and gave the local authorities all the trouble they deserved.); John Thebout, Village of Batavia Mayor, “Batavia Mayor remembers Dennis Nichols,” Clermont Sun (Feb. 9, 2022).

[11] Dennis Nichols email to Nathan Schachtman, re David Egilman (Mar. 9, 2013)

[12] Douglas Starr, “Bearing Witness,” 363 Science 334, 337 (2019).

[13] See “Public health journal’s editorial board tells publisher they have ‘grave concerns’ over new editor,” Retraction Watch (April 27, 2017).

[14] “David Egilman and Friends Circle the Wagon at the IJOEH,” Tortini (May 4, 2017).

[15] See “A New Egilman Bully Pulpit,” Tortini (Feb. 19, 2020).

[16] Schachtman, “State Regulators Impose Sanction Unlawful Screenings 05-25-07,” Washington Legal Foundation Legal Opinion Letter, vol. 17, no. 13 (May 2007); Schachtman, “Silica Litigation – Screening, Scheming, and Suing,” Washington Legal Foundation Critical Legal Issues Working Paper (December 2005); Schachtman & Rhodes, “Medico-Legal Issues in Occupational Lung Disease Litigation,” 27 Seminars in Roentgenology 140 (1992).

[17] In re Silica Prods. Liab. Litig., 398 F. Supp. 2d 563 (S.D. Tex. 2005) (Jack, J.).

[18] See David Egilman and Susanna Rankin Bohme, “Attorney-directed screenings can be hazardous,” 45 Am. J. Indus. Med. 305 (2004); David Egilman, “Asbestos screenings,” 42 Am. J. Indus. Med. 163 (2002).

[19] Andrew Schneider, “Asbestos Lawsuits Anger Critics,” St. Louis Post-Dispatch (Feb. 11, 2003).

Posted in Cognitive Biases, Conflicts of Interest, Expert Witnesses, Public Nuisances, Scientific Publishing | 41 Comments »

David Egilman, Rest in Peace – Part 1

April 26th, 2024

After close to a 40 year career as a testifying expert witness, David Egilman died earlier this month.[1] He was a work horse of the lawsuit industry.  Although he made plenty of money as a retained witness, Egilman was motivated by his political agenda. As he noted in a 2004 lecture at the Center for Science in the Public Interest: “my bias is ideological.”[2]

By the mid-1980s, Egilman was actively engaged in medico-legal testimonial adventures. In 1986, he was sued for negligence and fraud in connection with medical reports he wrote to support worker compensation claims filed against the Dayton-Walther Corporation. Thanks to the excellent lawyering of Frank Woodside and others, the case was ultimately dismissed on grounds that the alleged fraud was not legally cognizable as pleaded.[3]

Not long after Egilman dodged the Ohio fraud case, he testified for a claimant in a disability case against the Norfolk & Western Railroad. The administrative tribunals found the claim “was not fully credible or supported by substantial evidence in the record.”[4] By 1990, testifying in the Virgin Islands, Egilman had appeared upon the asbestos scene. [5] And then, Egilman seemed to be everywhere.

With the decision in Daubert, Egilman became gun shy, and he would not appear in courtrooms in which he faced a substantial risk of being excluded.  Egilman submitted reports in the cases before Judge Jones, in the District of Oregon, but after the court appointed technical advisors, Egilman decided to stay on the east coast. Egilman also sat out the hearings before Judges Weinstein and Baer, and Justice Lobis, in Brooklyn, in October 1996.

Up to the fall of 1996, Egilman had never showed up in any my cases. As I was preparing for the hearing before Judge Weinstein, I received a letter by telecopy and post, from David Egilman. The circumstances surrounding this letter were nothing less than bizarre. Earlier in the winter of 1996, George Gore (Al’s cousin) tried a silicone breast implant case for Bristol Myers Squibb in Oregon state court. I was there for the trial, mostly to monitor the proceedings, and help with witness preparation. Tragically, George’s father died during the trial, and for want of a better candidate, I substituted for him while he had to be away. When George returned (after a detour to be invested as President of the IADC), he wanted his case back.  After some tussling, we agreed to share the remaining witnesses, but George was adamant that he wanted to present the closing argument.

With the jury out, the defense prospects did not look promising, and George vamoosed again. The case had been bifurcated, and there was a punitive damages phase still to go. Once again, I re-entered the fray and tried the second phase of the case. In its deliberations on the second phase, the jury deadlocked, and the parties were left to fight what the Oregon requirement of a unified jury meant.

And then, in late September 1996, a faxed letter came across my desk, from none other than David Egilman. I had a breast implant case, set for trial in Middlesex County, New Jersey, and Egilman was one of the main  causation expert witnesses for the plaintiff, represented by the Wilentz firm. Perhaps the only way to tell what happened is simply to share with you what Egilman wanted from me, and then to share with you my response to the Wilentz firm. Very shortly after I wrote my letter, Chris Placitella, the Wilentz trial lawyer, withdrew Egilman from the case, and I never got another opportunity to take his deposition or to cross-examine him.

 

And my response directed to the firm that represented the plaintiff:

 

 

 

[1] Clay Risen, “David Egilman, Doctor Who Took On Drug Companies, Dies at 71,” N.Y. Times (Apr. 15, 2024).

[2] David Egilman and Susanna Rankin Bohme, “The suppression of science: How corporate interests hide the truth & how to stop them” CSPI Conference (July 2004).

[3] Dayton-Walther Corp. v. Kelly, 42 Ohio App. 3d 184 (1987).

[4] Freels v. U.S. RR Retirement Bd., 879 F.2d 335 (1989).

[5] Dunn v. Owens-Corning Fiberglas, 774 F. Supp. 929 (D.V.I. 1991).

Posted in Asbestos, Cognitive Biases, Expert Witness Hall of Shame, Public Nuisances | 5 Comments »

The Rise of Agnothology as Conspiracy Theory

July 19th, 2022

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.

Posted in Causation, Cognitive Biases, Conflicts of Interest, Public Nuisances, Scientific Evidence, Scientific Misconduct, Scientific Publishing, statistical evidence | 1 Comment »

When the American Medical Association Woke Up

November 17th, 2021

“You are more than entitled not to know what the word ‘performative’ means. It is a new word and an ugly word, and perhaps it does not mean anything very much. But at any rate there is one thing in its favor, it is not a profound word.”

J.L. Austin, “Performative Utterances,” in Philosophical Papers 233 (2nd ed. 1970).

John Langshaw Austin, J.L. to his friends, was a English philosopher who focused on language and how it actually worked in the real world. Austin developed the concept of performative utterances, which have since come to be known as “speech acts.” Little did J.L. know that performative utterances would come to dominate politics and social media.

The key aspect of spoken words that function as speech acts is that they do not simply communicate information, which might have some truth value, and some epistemic basis. Speech acts consist of actual conduct, such as promising, commanding, apologizing, etc.[1] The law has long implicitly recognized the distinction between factual assertions or statements and speech acts. The Federal Rules of Evidence, for instance, limits the rule against hearsay to “statements,” meaning written assertions or nonverbal conduct (such as nodding in agreement) that is intended as an assertion.[2]

When persons in wedding ceremonies say “I do,” at the appropriate moments, they are married, by virtue of their speech acts. Similarly for contracts and other promising under circumstances that give rise to enforceable contracts. A witness’s recounting another’s vows or promises is not hearsay because the witness is offering a recollection only for the fact that the utterance was made, and not to prove the truth of a matter asserted.[3]

The notion of a speech act underlies much political behavior these days. When people palaver about Q, or some QAnon conspiracy, the principle of charity requires us to understand them as not speaking words that can be true or false, but simply signaling their loyalty to a lost cause, usually associated with the loser of the 2020 presidential election. By exchanging ridiculous and humiliating utterances, fellow cultists are signaling loyalty, not making a statement about the world. Their “speech acts” are similar to rituals of exchanging blood with pledges of fraternity.

Of course, there are morons who show up at concerts expecting John F. Kennedy, Jr., to appear, or who show up at pizza places in Washington, D.C., armed with semiautomatic rifles, because their credulity outstripped the linguistic nuances of performative utterances about the Clintons. In days past, members of a cult would get a secret tatoo or wear a special piece of jewelry. Now, the way to show loyalty is to say stupid things in public, and not to laugh when your fellow cultists say similar things.

Astute observers of political systems, on both the left (George Orwell) and the right (Eric Voegelin) have long recognized that ideologies destroy language, including speech acts and performative utterances. The destructive capacities of ideologies are especially disturbing when they invade science and medicine. Alas, the ideology of the Woke has arrived in the halls of the American Medical Association (AMA).

Last month, AMA issued its guide to politically correct language, designed to advance health “equity”: “Advancing Health Equity: A Guide to Language, Narrative and Concepts (Nov. 2, 2021).” The 54 page guide is, at times, worthy of a MAD magazine parody, but the document quickly transcends parody to take us into an Orwellian nightmare of thought-control in the name of neo-Marxist “social justice” goals.[4]

In its guide to language best practices, the AMA urges us to promote health equity by adding progressive political language to what were once simple statements of fact. The AMA document begins with what seems affected, insincere humility:

“We share this document with humility. We recognize that language evolves, and we are mindful that context always matters. This guide is not and cannot be a check list of correct answers. Instead, we hope that this guide will stimulate critical thinking about language, narrative and concepts—helping readers to identify harmful phrasing in their own work and providing alternatives that move us toward racial justice and health equity.”

This pretense at humility quickly evaporates as the document’s tone become increasingly censorious and strident. The AMA seems less concerned with truth, evidence-based conclusions, or dialogue, than with conformity to social justice norms of the Woke mob.

In Table 1, the AMA introduces some “Key Principles and Associated Terms.” “Avoid use of adjectives such as vulnerable, marginalized and high-risk,” at least as to persons. Why? The AMA tells us that the use of such terms to describe individuals is “stigmatizing.” The terms are vague and imply (to the AMA) that the condition is inherent to the group rather than the actual root cause, which seems to be mostly, in the AMA’s view, the depredations of white cis-gendered men. To cure the social injustice, the AMA urges us to speak in terms of groups and communities (never individuals) that “have been historically marginalized or made vulnerable, or underserved, or under-resourced [sic], or experience disadvantage [sic].” The squishy passive voice pervades the AMA Guide, but the true subject – the oppressor – is easy to discern.

Putting aside the recurrent, barbarous use of the passive voice, we now must have medical articles that are sociological treatises. The AMA appears to be especially sensitive, perhaps hypersensitive, to what it considers “unintentional blaming.” For example, rather than discuss “[w]orkers who do not use PPE [personal protective equipment” or “people who do not seek healthcare,” the AMA instructs authors, without any apparent embarrassment or shame, to “try” substituting “workers under-resourced with” PPE, or “people with limited access to” healthcare.

Aside from assuaging the AMA’s social justice warriors, the substitutions are not remotely synonymous. There have been, there are, and there will likely always be workers and others who do not use protective equipment. There have been, there are, and there will likely always be persons who do not seek healthcare. For example, anti-vaxxing yutzballs can be found in all social strata and walks of life. Access to equipment or healthcare is a completely independent issue and concern. The AMA’s effort to hide these facts with the twisted passive-voice contortions assaults our language and our common sense.

Table 2 of the AMA Guide provides a list of commonly used words and phrases and the “equity-focused alternatives.”

“Disadvantaged” in Woke Speak becomes “historically and intentionally excluded.” The aspirational goal of “equality” is recast as “equity.” After all, mere equality, or treating everyone alike:

“ignores the historical legacy of disinvestment and deprivation through policy of historically marginalized and minoritized [sic] communities as well as contemporary forms of discrimination that limit opportunities. Through systematic oppression and deprivation from ethnocide, genocide, forced removal from land and slavery, Indigenous and Black people have been relegated to the lowest socioeconomic ranks of this country. The ongoing xenophobic treatment of undocumented brown people and immigrants (including Indigenous people disposed of their land in other countries) is another example. Intergenerational wealth has mainly benefited and exists for white families.”

In other words, treating people equally is racist. Non-racist is also racist. “Fairness” must also be banished; the equity-focused AMA requires “Social Justice.” Mere fairness pays “no attention” to power relations, and enforced distribution outcomes.

Illegal immigrants are, per AMA guidelines, transformed into “undocumented Immigrant,” because “illegal” is “a dehumanizing, derogatory term,” and because ‘[n]o human being is illegal.” The latter is a lovely sentiment, but human beings can be in countries unlawfully, just as they can be in the Capitol Building illegally.

“Non-compliance” is transmuted into “non-adherence,” because the former term “places blame for treatment failure solely on patients.” The latter term is suggested to exculpate patients, even though patients can be solely responsible for failing to follow prescribed treatment. The AMA wants, however, to remind us that non-adherence may result from “frustration and legitimate mistrust of health care, structural barriers that limit availability and accessibility of medications (including cost, insurance barriers and pharmacy deserts), time and resource constraints (including work hours, family responsibilities), and lack of effective communication about severity of disease or symptoms.” All true, but why not add sloth, stupidity, and superstition? We are still in a pandemic that has been fueled by non-compliance that largely warrants blame on the non-compliant.

The AMA wanders into fraught territory when it tells us impassively that identifying a “social problem” is now a sign of insensitivity. The AMA Woke Guide advises that social problems are really “social injustices.” Referring to a phenomenon as a social problem risks blaming people for their own “marginalization.” The term “marginalization” is part of the Social Justice jargon, and it occurs throughout the AMA Woke Guide. A handy glossary at the end of the document is provided for those of us who have not grown up in Woke culture:

“Marginalization: Process experienced by those under- or unemployed or in poverty, unable to participate economically or socially in society, including the labor market, who thereby suffer material as well as social deprivation.”[5]

The Woke apparently know that calling something a mere “social problem” makes it “seem less serious than social injustice,” and there is some chance that labeling a social phenomenon as a social problem risks “potentially blaming people for their own marginalization.” And yet not every social problem is a social injustice. Underage drinking and unprotected sex are social problems, as is widespread obesity and prevalent diabetes. Alcoholism is a social problem that is prevalent in all social strata; hardly a social injustice.

At page 23 of the Woke Guide, the AMA’s political hostility to individual agency and autonomy breaks through in a screed against meritocracy:

“Among these ideas is the concept of meritocracy, a social system in which advancement in society is based on an individual’s capabilities and merits rather than on the basis of family, wealth or social background. Individualism is problematic in obscuring the dynamics of group domination, especially socioeconomic privilege and racism. In health care, this narrative appears as an over-emphasis on changing individuals and individual behavior instead of the institutional and structural causes of disease.”

Good grief, now physicians cannot simply treat a person for a disease, they must treat entire tribes!

Table 5

Some of the most egregious language of the Woke Guide can be seen in its Table 5, entitled “Contrasting Conventional (Well-intentioned) Phrasing with Equity-focused Language that Acknowledges Root Causes of Inequities.” Table 5 makes clear that the AMA is working from a sociological program that is supported by implicit claims of knowledge for the “root causes” of inequities, a claim that should give everyone serious pause. After all, even if often disappointed, the readers of AMA journals expect rigorous scientific studies, carefully written and edited, which contribute to evidence-based medicine. There is nothing, however, in the AMA Guide, other than its ipse dixit, to support its claimed social justice etiologies.

Table 5 of the AMA Guide provides some of its most far-reaching efforts to impose a political vision through semantic legerdemain. Despite the lack of support for its claimed root causes, the AMA would force writers to assign Social Justice approved narratives and causation. A seemingly apolitical, neutral statement, such as:

“Low-income people have the highest level of coronary artery disease in the United States.”

now must be recast into sanctimonious cant that would warm the cockles of a cold Stalinist’s heart:

“People underpaid and forced into poverty as a result of banking policies, real estate developers gentrifying neighborhoods, and corporations weakening the power of labor movements, among others, have the highest level of coronary artery disease in the United States.”

Banks, corporations, and real estate developers have agency; people do not. With such verbiage, it will be hard to enforce page limits on manuscripts submitted to AMA journals. More important, however, is that the “root cause” analysis is not true in many cases. In countries where property is banned and labor owns the means of production, low-income people have higher rates of disease. The socio-economic variable is important, and consistent, across the globe, even in democratic socialist countries such as Sweden, or in Marxist paradises such as the People’s Republic of China and the former Soviet Union. The bewildered may wonder whether the AMA has ever heard of a control group. Maybe, just maybe, the increased incidence of coronary artery disease among the poor has more to do with Cheez Doodles than the ravages of capitalism.

CRITICAL REACTIONS

The AMA’s guide to linguistic etiquette is a transparent effort to advance a political agenda under the guise of language mandates. The AMA is not merely prescribing thoughtful substitutions for common phrases; the AMA guide is nothing less than an attempt to impose a “progressive” ideology with fulsome apologies. The AMA not only embraces, unquestioningly, the ideology of “white fragility, Ibram Kendi, and Robin DiAngelo; the AMA at times appears on the verge of medicalizing the behaviors of those who question or reject its Woke ideology. Is a psychiatric gulag the next step?

Dr. Michelle Cretella, the executive director of the American College of Pediatricians, expressed her concern that the AMA’s “social justice” plans are “rooted not in science and the medical ethics of the Hippocratic Oath, but in a host of Marxist ideologies that devalue the lives of our most vulnerable patients and seek to undermine the nuclear family which is the single most critical institution to child well-being.”[6]

Journalist Jesse Singal thinks that the AMA has gone berserk.[7] And Matt Bai, at the Washington Post, saw the AMA’s co-opting of language and narratives as having an Orwellian tone, resembling Mao’s “Little Red Book.”[8] The Post writer raised the interesting question why the AMA was even in the business of admonishing physicians and scientists about acceptable language. After all, the editors of Fowler’s Modern English Usage have managed for decades to eschew offering guidance on performing surgery. The Post opinion piece expresses a realistic concern that proposing “weird language” will worsen the current fraying of the social fabric, and pave the way for a Trump Restoration. Perhaps the AMA should stick to medicine rather than “mandating versions of history and their own lists of acceptable terminology.”

AMA Woke Speak has its antecedents,[9] and it will likely have its followers. For lawyers who work with expert witnesses, the AMA guide risks subjecting their medical witnesses to embarrassment, harassment, and impeachment for failing to comply with the new ideological orthodoxy. Just say no.

[1] See generally John L. Austin, How to Do Things with Words: The William James Lectures delivered at Harvard University in 1955 (1962).

[2] See Fed. R. Evid. Rule 801(a) & Notes of Advisory Comm. Definitions That Apply to This Article; Exclusions from Hearsay (defining statement).

[3] See, e.g., Emich Motors Corp. v. General Motors Corp., 181 F.2d 70 (7th Cir. 1950), rev’d on other grounds 340 U.S. 558 (1951).

[4] Harriet Hall, “The AMA’s Guide to Politically Correct Language: Advancing Health Equity,” Science Based Medicine (Nov. 2, 2021).

[5] Citing, Foster Osei Baah, Anne M Teitelman & Barbara Riegel, “Marginalization: Conceptualizing patient vulnerabilities in the framework of social determinants of health-An integrative review,” 26 Nurs Inq. e12268 (2019).

[6] Jeff Johnston, “Woke Medicine: ‘The AMA’s Strategic Plan to Embed Racial Justice and Advance Health Equity’,” The Daily Citizen (May 21, 2021) .

[7] Jesse Singal, “The AMA jumps the Woke Shark, introduces Medspeak,” Why Evolution is True (Nov. 1, 2021).

[8] Matt Bai, “Paging Dr. Orwell. The American Medical Association takes on the politics of language,” Wash. Post (Nov. 3, 2021).

[9] Office of Minority Health, U.S. Department of Health and Human Services, “National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care: A Blueprint for Advancing and Sustaining CLAS

Policy and Practice” (2013); Association of State and Territorial Health Officials, “Health equity terms” (2018).

Posted in Cognitive Biases, Expert Witnesses, Uncategorized | 1 Comment »

Scientists Suing Scientists, and Behaving Badly

June 2nd, 2021

In his 1994 Nobel Prize acceptance speech, the Hungarian born chemist George Andrew Olah acknowledged an aspect of science that rarely is noted in popular discussions:

“[One] way of dealing with errors is to have friends who are willing to spend the time necessary to carry out a critical examination of the experimental design beforehand and the results after the experiments have been completed. An even better way is to have an enemy. An enemy is willing to devote a vast amount of time and brain power to ferreting out errors both large and small, and this without any compensation. The trouble is that really capable enemies are scarce; most of them are only ordinary. Another trouble with enemies is that they sometimes develop into friends and lose a good deal of their zeal. It was in this way the writer lost his three best enemies. Everyone, not just scientists, need a few good enemies!”[1]

If you take science seriously, you must take error as something for which we should always be vigilant, and something we are committed to eliminate. As Olah and Von Békésy have acknowledged, sometimes an enemy is required. It would thus seem to be quite unscientific to complain that an enemy was harassing you, when she was criticizing your data, study design, methods, or motives.

Elisabeth Margaretha Harbers-Bik would be a good enemy to have. Trained in the Netherlands in microbiology, Dr. Bik came to the United States, where for some years she conducted research at Stanford University. In 2018, Bik began in earnest a new career in analyzing published scientific studies for image duplication and manipulation, and other dubious practices.[2]

Her blog, Scientific Integrity Digest, should be on the reading list of every lawyer who labors in the muck of science repurposed for litigation. You never know when your adversary’s expert witness will be featured in the pages of the Digest!

Dr. Bik is not a lone ranger; there are other scientists who have committed to cleaning up the scientific literature. After an illustrious career as an editor of prestigious journals, and a director of the Rockefeller University Press, Dr. Mike Rossner founded Image Data Integrity, Inc., to stamp out image fraud and error in scientific publications.

On March 16, 2020, a gaggle of French authors, including Dr. Didier Raoult, uploaded a pre-print of a paper to medRxiv, reporting on hydroxychloroquine (HCQ) and azithromycin in Covid-19 patients. The authors submitted their manuscript that same day to the International Journal of Antimicrobial Agents, which accepted it in 24 hours or less, on March 17, 2020. The journal published the paper online, three days after acceptance, on March 20th. Peer-review, to the extent it took place, was abridged.[3]

The misleading title of the paper, “Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial,” may have led some untutored observers into thinking the paper reported a study high in the hierachy of evidence. Instead the paper was a rather flawed observational study, or perhaps just a concatenation of anecdotes. In any event, the authors reported that patients who had received both medications cleared the SARS-CoV2 the fastest.

Four days after publication online at a supposedly peer-reviewed journal, Elisabeth Bik posted an insightful analysis of the Raoult paper.[4] If peer review it were, her blog post pointed out the review’s failure by identifying an apparent conflict of interest and various methodological flaws, including missing data on six (out of 26) patients, including one patient who died, and three whose conditions worsened on therapy.

Raoult’s paper, and his overly zealous advocacy for HCQ did not go unnoticed in the world of kooks, speculators, and fraudfeasors. Elon Musk tweeted about Raoult’s paper; and Fox News amplified Musk’s tweet, which made it into the swamp of misinformation, Trump’s mind and his twitterverse.[5]

In the wake of the hoopla over Raoult’s paper, the journal owner admitted that the paper did not live up to the society’s standards. The publisher, Elsevier, called for an independent investigation. The French Infectious Diseases Society accused Raoult of spreading false information about hydroxychloroquine’s efficacy in Covid-19 patients. To date, there has been no further official discussions of disciplinary actions or proceedings at the Society.

Raoult apparently stewed over Bik’s criticisms and debunking of his over-interpretation of his flawed HCQ study.  Last month, Raoult filed a complaint with a French prosecutor, which marked the commencement of legal proceedings against Bik for harassment and “extortion.” The extortion charge is based upon nothing more than Bik’s having a Patreon account to support her search for fraud and error in the published medical literature.[6]

The initial expression of outrage over Marseille Raoult’s bad behavior came from Citizen4Science, a French not-for-profit organization that works to promote scientific integrity. According to Dr. Fabienne Blum, president of Citizen4Science, the organization issued its press release on May 5, 2021, to call on authorities to investigate and to intervene in Raoult’s harassment of scientists. Their press release about “the French scandal” was signed by scientists and non-scientists from around the world; it currently remains open for signatures, which number well over 4,000. “Harassment of scientific spokespersons and defenders of scientific integrity: Citizen4Science calls on the authorities to intervene urgently” (May 5, 2021). Dr. Blum and Citizen4Science are now harassed on Twitter, where they have been labeled “Bik’s gang.” Inevitably, they will be sued as well.

On June 1st, Dr. Raoult posted his self-serving take on the controversy on that scholarly forum known as YouTube. An English translation of Raoult’s diatribe can be found at Citizen4Science’s website. Perhaps others have noted that Raoult refers to Bik as “Madame” (or Mrs.) Bik, rather than as Dr. Bik, which leads to some speculation that Raoult has trouble taking criticism from intelligent women.

Having projected his worst characteristics onto adversaries, Raoult lodged accusations against Bik, which actually reflected his own behaviors closely. Haven’t we seen someone in public life who operates just like this? Raoult has criticized Bik in the lay media, and he released personal information about her, including her residential address. Raoult’s intemperate and inappropriate personal attacks on Bik have led several hundred scientists to sign an open letter in support of Bik.[7]

This scientist doth protest too much, methinks.

[1] George Andrew Olah Nobel Prize Speech (1994) (quoting from George Von Békésy, Experiments in Hearing 8 (1960).

[2] Elisabeth M. Bik, Arturo Casadevall, and Ferric C. Fang, “The Prevalence of Inappropriate Image Duplication in Biomedical Research Publications,” 7 mBio e00809 (2016); Daniele Fanelli, Rodrigo Costas, Ferric C. Fang, Arturo Casadevall, Elisabeth M. Bik, “Testing Hypotheses on Risk Factors for Scientific Misconduct via Matched-Control Analysis of Papers Containing Problematic Image Duplications,” 25 Science & Engineering Ethics 771 (2019); see also Jayashree Rajagopalan, “I have found about 2,000 problematic papers, says Dr. Elisabeth Bik,” Editage Insights (Aug 08, 2019).

[3] Philippe Gautret, Jean-Christophe Lagier, Philippe Parola, Van Thuan Hoang, Line Meddeb, Morgane Mailhe, Barbara Doudier, Johan Courjon, Valérie Giordanengo, Vera Esteves Vieira, Hervé Tissot Dupont, Stéphane Honoré, Philippe Colson, Eric Chabrière, Bernard La Scola, Jean-Marc Rolain, Philippe Brouqui, and Didier Raoult, “Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial,” 56 Clinical Trial Internat’l J. Antimicrob. Agents e105949 (2020).

[4] Bik, “Thoughts on the Gautret et al. paper about Hydroxychloroquine and Azithromycin treatment of COVID-19 infections,” Scientific Integrity Digest (March 24, 2020).

[5] Charles Piller, “‘This is insane!’ Many scientists lament Trump’s embrace of risky malaria drugs for coronavirus,” Science Mag. (Mar. 26, 2020).

[6] Melissa Davey, “World expert in scientific misconduct faces legal action for challenging integrity of hydroxychloroquine study,” The Guardian (May 22, 2021); Kristina Fiore, “HCQ Doc Sues Critic,” MedPage Today (May 26, 2021).

[7] Lonni Besançon, Alexander Samuel, Thibault Sana, Mathieu Rebeaud, Anthony Guihur, Marc Robinson-Rechavi, Nicolas Le Berre, Matthieu Mulot, Gideon Meyerowitz-Katz, Maisonneuve, Brian A. Nosek, “Open Letter: Scientists stand up to protect academic whistleblowers and post-publication peer review,” (May 18, 2021).

Posted in Cognitive Biases, Conflicts of Interest, Peer Review, Scientific Evidence, Scientific Misconduct | No Comments »

Larding Up the Literature

February 20th, 2021

Another bio-medical journal?

In October 2019, The Journal of Scientific Practice and Integrity published its inaugural volume one, number one issue, online. This journal purports to cover scientific integrity issues, which may well not be adequately covered in the major biomedical journals. There are reasons to believe, however, that this journal may be more of a threat to scientific integrity than a defender.

Thenew journal describes itself as:

“an interdisciplinary, peer-reviewed journal that publishes scholarly debate and original research on scientific practices that impact human and environmental health.”

The editorial board reads like a Who’s Who’s list of “political scientists” who testify a LOT for claimants, and who, when not working for the lawsuit industry, practice occupational and environmental medicine for the redistribution of wealth.

David Egilman, contemnor and frequent plaintiffs’ expert witness in personal injury litigation is editor in chief. Tess Bird, an Egilman protégé, is managing editor. Another Egilman protégé, Susana Rankin Bohme, an associate Director of Research at Corporate Accountability International, also sits on the editorial board. You may be forgiven for believing that this journal will be an Egilman vanity press. The editorial board also includes some high-volume testifying plaintiffs expert witnesses:

Peter Infante, of Peter F. Infante Consulting, LLC, Virginia

Adriane Fugh-Berman, of PharmedOut

Barry Castleman,

William E. Longo, President, MAS, LLC

David Madigan,

Michael R. Harbut,

David Rosner, and

Gerald Markowitz

The journal identifies the Collegium Ramazzini as one of its “partners.” Cue the “Интернационал”!

The first issue of this new journal features a letter[1] from the chief and managing editors, Egilman and Bird, which states wonderfully aspirational goals. The trick will be whether the journal can apply its ethical microscope to all actors in the world of scientific publishing, or whether this new journal is just not another lawsuit industry propaganda outlet.

Egilman’s previous editorial perch was at the International Journal of Occupational and Environmental Health, which was published by Maney Publishing. In 2015, the British company, the Taylor & Francis Group, acquired the IJOEH, with Maney’s other journals, and installed a new editor-in-chief, Andrew Maier. Egilman was cast out; hence the new journal.

Egilman’s new journal will feature among other types of articles, “reviews of legal testimony,” as a scholarly subject. It will be interesting to see whether such reviews assess the testimony of lawsuit industry witnesses, as well as manufacturing industry witnesses.

The new journal requires the use of the International Committee of Medical Journal Editors (ICMJE) conflict-of-interest and funding disclosure rules, and the use of the ICMJE form. Accordingly, authors “should” report all conflicts, including:

“[a]ny financial contributions, payments, or funding for the present work;

relevant financial activities outside of the submitted work;

any patents or copyrights broadly relevant to the work; and

any relationships that readers could perceive to influence the submitted work.”

There have been only two issues of Egilman’s new journal so far, but I decided to spot check compliance. The first article[2] I saw was by Colin Soskolne, who has testified for the lawsuit industry in a diacetyl case.[3] Oops; no disclosure.

Does Soskolne’s bias show? In the spot-checked article, authors Sokolne and Baur reprise a publication previously part of a 2018 Collegium Ramazzini convocation entitled “Corporate Influence Threatens the Public Health.” The aim of the convocation speakers was to press their claims that [manufacturing] corporate influence undermines scientific integrity through discernible methods, all by “those in the pay of industry”:

  • infiltrating journal editorial boards by scientists, with the resulting publication of poorly designed, biased research that foments doubt;
  • interfering with “the independent activities of IARC” and similar agencies;
  • blocking “much needed” regulation of “hazardous agents,” such as pesticides and polyfluoroalkyl substances (PFAS); and
  • promulgating causal criteria, which are baseless and which “block workers’ access to legal remedies for occupational illness and premature death.”[4]

There can be little doubt that Soskolne is not interested in messing with “those in the pay of the lawsuit industry.” Soskolne’s biases are fairly clear, clear enough for us to complain that he has not disclosed that he has been compensated by the lawsuit industry, and that he has deep positional conflicts as well. Ironically, he is writing in a journal that itself appears to lack “balance.” The editorial board of the journal for which Soskolne was writing is composed of many of “those in the pay of the lawsuit industry.”

Soskolne is keen to preserve the independence of IARC, but that perceived independence has become a sad, sick joke, with the exclusion of most anyone who has had any working relationship with manufacturing industry, while engaging many with deep ties to the lawsuit industry. Soskolne’s assessment of “much needed” regulation ultimately must be evaluated on the facts and data of each putative toxic substance. If the claim of harmful effects is correct, then regulation may well be “much needed.” If the claim is not correct, then regulation will be much “unneeded.” As for promulgating causal criteria, there is no doubt that the Soskolne, along with the editorial board of this new journal, would like to see the abrogation of causal criteria, so that workers have legal remedies ad libitum.

Soskolne and Baur provide their hit list of the methods of obfuscation or of techniques used to undermine science and policy.[5] There is precious little in their list, however, that is not common place among all journals that publish occupational and environmental epidemiology, including the journals that have been captured by the lawsuit industry’s scientists. Soskolne and Baur also provide a catalogue of how lawsuit industry scientists would subvert science and lock in their biased and selective interpretation of data:

  • elevate biological plausibility into sufficient basis for causal inference
  • conflate species and ignore species differences in order to allow animal studies to suffice for causal inference for humans
  • ignore substantial, relevant biological differences in even slight structural differences among various molecules to enable assertions of harm based upon similar molecular structure of a putative toxic substance

Soskolne ends with a quote from the “pink panthers,” two radical, labor historians, both editorial board members of this new journal, and who both have testified many times for the lawsuit industry:

“[A]s a society, we cannot entrust those with self-interest to be the judge and jury of what is and what is not a danger[;] … that can only lead to compromised science, a questionable decisionmaking process, and a potentially polluted world.”[6]

The pink panthers are, of course, correct, but we must understand that self-interest and conflict of interest can be, and are, both ideological, positional, as well as economic.

[1]  Tess Bird & David Egilman, “Letter from the Editors: An Introduction to the Journal of Scientific Practice and Integrity,” 1 J. Sci. Practice & Integrity 1 (2019).

[2]  Colin Soskolne & Xaver Baur, “How Corporate Influence Continues to Undermine the Public’s Health,” 1 J. Sci. Practice & Integrity 1 (2019), available at DOI: 10.35122/jospi.2019.878137 [cited as Soskolne & Baur]

[3]  See Watson v. Dillon Companies, 797 F. Supp. 2d 1138 (D. Colo. 2011) (addressing Soskolne’s testimony).
[4]  Soskolne & Baur at 1-2.

[5]  Soskolne & Baur at 3.

[6]  Soskolne & Baur at 4, quoting from Gerald Markowitz & David Rosner, “Monsanto, PCBs, and the creation of a ‘world-wide ecological problem’,” 39 J. Pub. Health Policy 463 (2018).

Posted in Cognitive Biases, Conflicts of Interest, Expert Witnesses, Scientific Publishing | No Comments »

Pernicious Probabilities in the Supreme Court

December 11th, 2020

Based upon Plato’s attribution,[1] philosophers credit pre-Socratic philosopher Heraclitus, who was in his prime about 500 B.C., for the oracular observation that πάντα χωρεῖ και οὐδε ν μένει, or in more elaborative English:

all things pass and nothing stays, and comparing existing things to the flow of a river, he says you could not step twice into the same river.

Time changes us all. Certainly 2016 is not 2020, and the general elections held in November of those two years were not the same elections, and certainly not the same electorate. No one would need a statistician to know that the population of voters in 2016 was different from that in 2020.  Inevitably, some voters from 2016 died in the course of the Trump presidency; some no doubt died as a result of Trump’s malfeasance in handling the pandemic. Inevitably, some new voters came of age or became citizens and were thus eligible to vote in 2020, when they could not vote in 2016. Some potential voters who were unregistered in 2016 became new registrants. Non-voters in 2016 chose to vote in 2020, and some voters in 2016 chose not to vote in 2020. Overall, many more people turned out to vote in 2020 than turned out in 2016.

The candidates in 2016 and 2020 were different as well. On the Republican side, we had ostensibly the same candidate, but in 2020, Trump was the incumbent and had a record of dismal moral and political failures, four years in duration. Many Republicans who fooled themselves into believing that the Office of the Presidency would transform Trump into an honest political actor, came to realize that he was, and always has been, and always will be, a moral leper. These “apostate” Republicans effectively organized across the country, through groups like the Lincoln Project and the Bulwark, against Trump, and for the Democratic candidate, Joseph Biden.

In the 2016 election, Hilary Clinton outspent Donald Trump, but Trump used social media more effectively, with a big help from Vladimir Putin. In the 2020 election, Russian hackers did not have to develop a disinformation campaign; the incumbent president had been doing so for four years.

On the Democratic side of the 2016 and 2020 elections, there was a dramatic change in the line-up. In 2016, candidate Hilary Clinton inspired many feminists because of her XX 23rd chromosomes. She also suffered significant damage in primary battles with social democrat Bernie Sanders, whose supporters were alienated by the ham-fisted prejudices of the Clinton-supporters on the Democratic National Committee. Many of Sanders’ supporters stayed home on election day, 2016. In 2020, Sanders and the left-wing of the Democratic party made peace with the centrist candidate Joseph Biden, in recognition that the alternative – Trump – involved existential risks to our republican democracy.

In 2016, third party candidates, from the Green Party and the Libertarian Party, attracted more votes than they did in 2020. The 2016 election saw more votes siphoned from the two major party candidates by third parties because of the unacceptable choice between Trump and Clinton for several percent of the voting public. In 2020, with Trump’s authoritarian kleptocracy fully disclosed to Americans, a symbolic vote for a third-party candidate was tantamount to the unacceptable decision to not vote at all.

In 2016, after eight years of Obama’s presidency, the economy and the health of the nation were good. In 2020, the general election occurred in the midst of a pandemic and great economic suffering. Many more people voted by absentee or mail-in ballot than voted in that manner in 2016. State legislatures anticipated the deluge of mail-in ballots; some by facilitating early counting, and some by prohibiting early counting. The Trump administration anticipated the large uptick in mail-in ballots by manipulating the Post Office’s funding, by anticipatory charges of fraud in mail-in procedures, and by spreading lies and disinformation about COVID-19, along with spreading the infection itself.

On December 8, 2020, without apparently tiring of losing so much, the Trump Campaign orchestrated the filing of the big one, the “kraken lawsuit.” The State of Texas filed a complaint in the United States Supreme Court, in an attempt to invoke that court’s original jurisdiction to adjudicate Texas’ complaint that it was harmed by voting procedures in four states in which Trump lost the popular vote. All four states had certified their results before Texas filed its audacious lawsuit. Legal commentators were skeptical and derisive of the kraken’s legal theories.[2] Even the stalwart National Review saw the frivolity.[3]

Charles J. Cicchetti[4] is an economist, who is a director at the Berkeley Research Group. Previously, Cicchetti held academic positions at the University of Southern California, and the Energy and Environmental Policy Center at Harvard University’s John F. Kennedy School of Government. At the heart of the kraken is a declaration from Cicchetti, who tells us under penalty of perjury, that he was “formally trained statistics and econometrics [sic][5] and accepted as an expert witness in civil proceedings.”[6] Declaration of Charles J. Cicchetti, Ph.D., Dec. 6, 2020, filed in support of Texas’ motion at ¶ 2.

Cicchetti’s declaration is not a model of clarity, but it is clear that he conducted several statistical analyses. He was quite transparent in stating his basic assumption for all his analyses; namely, the outcomes for the two Democratic candidates, Clinton and Biden, for the two major party candidates, Clinton versus Trump and Biden versus Trump, and for in-person and for mail-in voters were all randomly drawn from the same population. Id. at ¶ 7. Using a binomial model, Cicchetti calculated Z-scores for the observed disparities in rates, which was very good evidence to reject the “same population” assumptions.

Based upon very large Z-scores, Cicchetti rejected the null hypothesis of “same population” and of Biden = Clinton. Id. at ¶ 20. But nothing of importance follows from this. We knew before the analysis that Biden ≠ Clinton, and the various populations compare were definitely not the same. Cicchetti might have stopped there and preserved his integrity and reputation, but he went further.

He treated the four states, Georgia, Michigan, Pennsylvania, and Wisconsin, as independent tests, which of course they are not. All states had different populations from 2016 to 2020; all had no pandemic in 2016, and pandemic in 2020; all had been exposed for four years of Trump’s incompetence, venality, corruption, bigotry, and bullying. Cicchetti gilded the lily with the independence assumption, and came up with even lower, more meaningless probabilities that the populations were the same. And then he stepped into the abyss of the fallacy and non sequitur:

“In my opinion, this difference in the Clinton and Biden performance warrants further investigation of the vote tally particularly in large metropolitan counties within and adjacent to the urban centers in Atlanta, Philadelphia, Pittsburgh, Detroit and Milwaukee.”

Id. at ¶ 30. Cicchetti’s suggestion that there is anything amiss, which warrants investigation, follows only from a maga, mega-transposition fallacy. The high Z-score does not mean that observed result is not accurate or fair; it means only that the starting assumptions were outlandishly false.

Early versus Late Counting

Texas’ claim that there is something “odd” about the reporting before and after 3 a.m., on the morning after Election Day fares no better. Cicchetti tells us that “many Americans went to sleep election night with President Donald Trump (Trump) winning key battleground states, only to learn the next day that Biden surged ahead.” Id. at ¶ 7.

Well, Americans who wanted to learn the final count should not have gone to sleep, for several days. Again, the later counted mail-in votes came from a segment of the population that was obviously different from the in-person voters. Cicchetti’s statistical analysis shows that we should reject any assumption that they were the same, but who would make that assumption?  These expected values for the mail-in ballots differed from the expected values for in-person votes; the difference was driven by Republican lies and disinformation about Covid-19, and by laws that prohibited early counting.  Not surprisingly, the Trumpist propaganda had an effect, and there was a disparity between the rate at which Trump and Biden supporters voted in person, and who voted by mail-in ballot. The late counting and reporting of mail-in ballots was further ensured by laws in some states that prohibited counting before Election Day. Trump was never winning in the referenced “key battleground” states; he was ahead in some states, at 2:59 a.m., but the count changed after all lawfully cast ballots had been counted.

The Response to Cicchetti’s Analyses

The statistical “argument,” such as it is, has not fooled anyone outside of maga-land.[7] Cicchetti’s analysis has been derided as “ludicrous” and “incompetence, by Professors Kenneth Mayer and David Post. Mayer described the analysis as one that will be “used in undergraduate statistics classes as a canonical example of how not to do statistics.”[8] It might even make its way into a Berenstain Bear book on statistics. Andrew Gelman called the analysis “horrible,” and likened the declaration to the infamous Dreyfus case.[9]

The Texas lawsuit speaks volumes of the insincerity of the Trumpist Republican party. The rantings of Pat Robertson, asking God to intervene in the election to keep Trump in office, are more likely to have an effect.[10] The only issue the kraken fairly raises is whether the plaintiff, and plaintiff intervenor, should be be sanctioned for “multipl[ying] the proceedings in any case unreasonably and vexatiously.”[11]

[1]  Plato, Cratylus 402a = A6.

[2] Adam Liptak, “Texas files an audacious suit with the Supreme Court challenging the election results,” N.Y. Times (Dec. 8, 2020); Jeremy W. Peters and Maggie Haberman, “17 Republican Attorneys General Back Trump in Far-Fetched Election Lawsuit,” N.Y. Times (Dec. 9, 2020); Paul J. Weber, “Trump’s election fight puts embattled Texas AG in spotlight,” Wash. Post (Dec. 9, 2020).

[3] Andrew C. McCarthy, “Texas’s Frivolous Lawsuit Seeks to Overturn Election in Four Other States,” Nat’l Rev. (Dec. 9, 2020); Robert VerBruggen, “The Dumb Statistical Argument in Texas’s Election Lawsuit,” Nat’l Rev. (Dec. 9, 2020).

[4] Not to be confused with Chicolini, Sylvania’s master spy.

[5] Apparently not formally trained in English.

[6] See, e.g., K N Energy, Inc. v. Cities of Alliance & Oshkosh, 266 Neb. 882, 670 N.W.2d 319 (2003), Center for Biological Diversity v. Pizarchik, 858 F. Supp. 2d 1221 (D. Colo. 2012), National Paint & Coatings Ass’n, v. City of Chicago, 835 F. Supp. 421 (N.D. Ill. 1993), National Paint & Coatings Ass’n, v. City of Chicago, 835 F. Supp. 414 (N.D. Ill. 1993); Mississippi v. Entergy Mississippi, Inc. (S.D. Miss. 2012); Hiko Energy, LLC v. Pennsylvania Public Utility Comm’n, 209 A.3d 246 (Pa. 2019).

[7] Philip Bump, “Trump’s effort to steal the election comes down to some utterly ridiculous statistical claims,” Wash. Post (Dec. 9, 2020); Jeremy W. Peters, David Montgomery, Linda Qiu & Adam Liptak, “Two reasons the Texas election case is faulty: flawed legal theory and statistical fallacy,” N.Y. Times (Dec. 10, 2020); David Post, “More on Statistical Stupidity at SCOTUS,” Volokh Conspiracy (Dec. 9, 2020).

[8] Eric Litke, “Lawsuit claim that statistics prove fraud in Wisconsin, elsewhere is wildly illogical,”  PolitiFact ((Dec. 9, 2020).

[9] Andrew Gelman, “The p-value is 4.76×10^−264 1 in a quadrillion” Statistical Modeling, Causal Inference, and Social Science (Dec. 8, 2020).

[10]  Evan Brechtel, “Pat Robertson Calls on God to ‘Intervene’ in the Election to Keep Trump President in Bonkers Rant” (Dec. 10, 2020).

[11] See “Counsel’s liability for excessive costs,” 28 U.S. Code § 1927.

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The Knowledge Remedy Proposal

November 14th, 2020

Alexandra D. Lahav is the Ellen Ash Peters Professor of Law at the University of Connecticut School of Law. This year’s symposium issue of the Texas Law Review has published Professor Lahav’s article, “The Knowledge Remedy,” which calls for the imposition of a duty to conduct studies by defendants, to provide evidence relevant to plaintiffs’ product liability claims. Alexandra D. Lahav, “The Knowledge Remedy,” 98 Texas L. Rev. 1361 (2020) [cited as Lahav].

Professor Lahav’s advocated reform is based upon the premises that (1) the requisite studies needed for causal assessment “are too costly for plaintiffs to fund,” (2) are not done by manufacturers, or (3) are not done in good faith, and (4) are not conducted or adequately funded by government. Lahav believes that plaintiffs are injured by exposure to chemicals but they cannot establish causation in court because the defendant “hid its head in the sand,” or worse, “engaged in misconduct to prevent or hide research into its products.”[1] Lahav thus argues that when defendants have been found to have engaged in misconduct, courts should order them to fund studies into risks posed by their products.

Lahav’s claims are either empty or non-factual. The suggestion that plaintiffs are injured by products but cannot “prove” causation begs the question how she knows that these people were injured by the products at issue. In law professors’ language, Lahav has committed the fallacy of petitio principia.

Lahav’s poor-mouthing on behalf of claimants is factually unsupported in this article. Lahav tells us that:

“studies are too expensive for individuals or even groups to fund.”

This is assertion is never backed up with any data or evidence about the expense involved. Case-control studies for rare outcomes suffer from potential threats to their validity, but they can be assembled relatively quickly and inexpensively. Perhaps a more dramatic refutation of Lahav’s assertions come from the cohort studies done in administrative databases, such as the national healthcare databases of Denmark or Sweden, or the Veterans’ Administration database in the United States. These studies involve querying existing databases for the exposures and outcomes of interest, with appropriate controls; such studies are frequently of as high quality and validity as can be had in observational analytical epidemiology.

There are, of course, examples of corporate defendants’ misconduct in sponsoring or conducting studies. There is also evidence of misconduct in plaintiffs’ sponsorship of studies,[2] and outright fraud.[3] And certainly there is evidence of misconduct or misdirection in governmentally funded and sponsored research, sometimes done in cahoots with plaintiffs’ counsel.[4]

Perhaps more important for the intended audience of the Texas Law Review, Lahav’s assertion is demonstrably false. Plaintiffs, plaintiffs’ counsel, and plaintiffs’ advocacy groups have funded studies, often surreptitiously, in many litigations, including those involving claims of harm from Bair Hugger, asbestos, silicone gel breast implants, welding fume, Zofran, isotretinoin, and others. Lahav’s repetition of the claim does not make it true.[5] Plaintiffs and their proxies, including scientific advocates, can and do conduct studies, very much with a view toward supporting litigation claims. Mass tort litigation is a big business, often run by lawyer oligarchs of the plaintiffs’ bar. Ignorantia facti is not an excuse for someone who argues for a radical re-ordering of an already fragile litigation system.

Lahav also complains that studies take so long that the statute of limitations will run on the injury claims before the scientific studies can be completed. There is a germ of truth in this complaint, but the issue could be resolved with minor procedural modifications. Plaintiffs could be allowed a procedure to propound a simple interrogatory to manufacturing firms to ask whether they believe that causality exists between their product and a specific kind of harm, or whether a claimant should reasonably know that such causality exists to warrant pursuing a legal claim. If the manufacturers answer in the negative, then the firms would not be able to assert a limitations defense for any injury that arose on or before the date of its answer. Perhaps the court could allow the matter to stay on its docket and require that the defendant answer the question annually. Plaintiffs and their proxies would be able to sponsor studies necessary to support their claims, and putative defendants would be on notice that such studies are underway.

Without any serious consideration of the extant regulations, Lahav even extends her claims of inadequate testing and lax regulation to pharmaceutical products, which are subject to extensive requirements of showing safety and efficacy, both before and after approval for marketing. Lahav’s advocacy ignores that an individual epidemiologic study rarely “demonstrates” causation, and many such studies are required before the scientific community can accept the causal hypothesis as “disproven.” Lahav’s knowledge remedy is mostly an ignorance ruse.

[1]  Lahav at 1361.

[2]  For a recent, egregious example, see In re Zofran Prods. Liab. Litig., MDL No. 1:15-md-2657-FDS, Order on Defendant’s Motion to De-Designate Certain Documents as Confidential Under the Protective Order (D.Mass. Apr. 1, 2020) (uncovering dark data and dark money behind April Zambelli‐Weiner, Christina Via, Matt Yuen, Daniel Weiner, and Russell S. Kirby, “First Trimester Pregnancy Exposure to Ondansetron and Risk of Structural Birth Defects,” 83 Reproductive Toxicology 14 (2019)). See also In re Zofran (Ondansetron) Prod. Liab. Litig., 392 F. Supp. 3d 179, 182-84 (D. Mass. 2019) (MDL 2657);  “April Fool – Zambelli-Weiner Must Disclose” (April 2, 2020); “Litigation Science – In re Zambelli-Weiner” (April 8, 2019); “Mass Torts Made Less Bad – The Zambelli-Weiner Affair in the Zofran MDL” (July 30, 2019). See also Nate Raymond, “GSK accuses Zofran plaintiffs’ law firms of funding academic study,” Reuters (Mar. 5, 2019).

[3]  See Hon. Jack B. Weinstein, “Preliminary Reflections on Administration of Complex Litigation” 2009 Cardozo L. Rev. de novo 1, 14 (2009) (“[t]he breast implant litigation was largely based on a litigation fraud. …  Claims—supported by medical charlatans—that enormous damages to women’s systems resulted could not be supported.”) (emphasis added).

[4]  See, e.g., Robert M. Park, Paul A. Schulte, Joseph D. Bowman, James T. Walker, Stephen C. Bondy, Michael G. Yost, Jennifer A. Touchstone, and Mustafa Dosemeci, “Potential Occupational Risks for Neurodegenerative Diseases,” 48 Am. J. Ind. Med. 63, 65 (2005).

[5]  Lahav at 1369-70.

Posted in Cognitive Biases, Rule 702, Scientific Misconduct, Underlying Data | Comments Off on The Knowledge Remedy Proposal

Is Your Daubert Motion Racist?

July 17th, 2020

In this week’s New York Magazine, Jonathan Chait points out there is now a vibrant anti-racism consulting industry that exists to help white (or White?) people to recognize the extent to which their race has enabled their success, in the face of systematic inequalities that burden people of color. Chait acknowledges that some of what this industry does is salutary and timely, but he also notes that there are disturbing elements in this industry’s messaging, which is nothing short of an attack on individualism as racist myth that ignores that individuals are subsumed completely into their respective racial group. Chait argues that many of the West’s most cherished values – individualism, due process, free speech and inquiry, and the rule of law – are imperiled by so-called “radical progressivism” and “identity politics.”[1]

It is hard to fathom how anti-racism can collapse all identity into racial categories, even if some inarticulate progressives say so. Chait’s claim, however, seems to be supported by the Smithsonian National Museum of African American History & Culture, and its webpages on “Talking about Race,” which provides an extended analysis of “whiteness,” “white privilege,” and the like.

On May 31, 2020, the Museum’s website published a graphic that presented its view of the “Aspects & Assumptions of Whiteness and White Culture in the United States,” which made many startling claims about what is “white,” and by implication, what is “non-white.” [The chart is set out below.] I will leave it to the sociologists, psychologists, and anthropologists to parse the discussion of “white-dominant culture,” and white “racial identity,” provided in the Museum’s webpages. In my view, the characterizations of “whiteness” were overtly racist and insulting to all races and ethnicities. As Chait points out, with an abundance of irony, Donald Trump would seem to be the epitome of non-white, by his disavowal of the Museum’s identification of white culture’s insistence that “hard work is the key to success.”

The aspect of the graphic summary of whiteness, which I found most curious, most racist, and most insulting to people of all colors and ethnicities, is the chart’s assertion that white culture places “Emphasis on the Scientific Method,” with its valuation of “[o]bjective, rational linear thinking; “[c]ause and effect relationships”; and “[q]uantitative emphasis.” The implication is that non-whites do not emphasize or care about the scientific method. So scientific method, with its concern over validity of inference, and ruling out random and systematic errors, is just white privilege, and a microaggression against non-white people.

Really? Can the Smithsonian National Museum of African American History & Culture really mean that scientific punctilio is just another manifestation of racism and cultural imperialism. Chait seems to think so, quoting Glenn Singleton, president of Courageous Conversation, a racial-sensitivity training firm, who asserts that valuing “written communication over other forms” is “a hallmark of whiteness,” as is “scientific, linear thinking. Cause and effect.”

The Museum has apparently removed the graphic from its website, in response to a blitz of criticism from right-wing media and pundits.[2]  According to the Washington Post, the graphic has its origins in a 1978 book on White Awareness.[3] In response to the criticism, museum director Spencer Crew apologized and removed the graphic, agreeing that “it did not contribute to the discussion as planned.”[4]

The removal of the graphic is not really the point. Many people will now simply be bitter that they cannot publicly display their racist tropes. More important yet, many people will continue to believe that causal, rational, linear thinking is white, exclusionary, and even racist. Something to remember when you make your next Rule 702 motion.

   

[1]  Jonathan Chait, “Is the Anti-Racism Training Industry Just Peddling White Supremacy?” New York Magazine (July 16, 2020).

[2]  Laura Gesualdi-Gilmore “‘DEEPLY INSULTING’ African American museum accused of ‘racism’ over whiteness chart linking hard work and nuclear family to white culture,” The Sun (Jul 16 2020); “DC museum criticized for saying ‘delayed gratification’ and ‘decision-making’ are aspects of ‘whiteness’,” Fox News (July 16, 2020) (noting that the National Museum of African American History and Culture received a tremendous outcry after equating the nuclear family and self-reliance to whiteness); Sam Dorman, “African-American museum removes controversial chart linking ‘whiteness’ to self-reliance, decision-making The chart didn’t contribute to the ‘productive conversation’ they wanted to see,” Fox News (July 16, 2020); Mairead McArdle, “African American History Museum Publishes Graphic Linking ‘Rational Linear Thinking,’ ‘Nuclear Family’ to White Culture,” Nat’l Rev. (July 15, 2020).

[3]  Judy H. Katz, White Awareness: Handbook for Anti-Racism Training (1978).

[4]  Peggy McGlone, “African American Museum site removes ‘whiteness’ chart after criticism from Trump Jr. and conservative media,” Wash. Post (July 17, 2020).

Posted in Causation, Cognitive Biases, Rule 702, Scientific Evidence | Comments Off on Is Your Daubert Motion Racist?

ACGIH TLVs Lack Scientific Integrity & Transparency – The Mica NIC

June 2nd, 2020

The American Conference of Governmental Industrial Hygienists (ACGIH®) is a non-profit corporation established in 1938, to advance occupational and environmental health.  The corporation’s motto, included in its logo, hubristically announces:  “Defining the Science of Occupational and Environmental Health.”

Philosophers of science may demur from “the” in “the Science,” as well as from the intellectual arrogance in suggesting that this private organization has any such ability to commandeer the complex social nature of scientific knowledge. And yet, in the small area of setting permissible exposure limits to potential environmental or occupational toxic substances, the ACGIH is in the business of “defining” safety. Starting in 1941, the group started to review and recommend “exposure limits.” In 1956, the group coined (literally and figuratively) the term “threshold limit values” (TLVs®), and started to publish documentation for its recommended values.

From the beginning, the ACGIH has asserted that TLVs® are not standards; rather they are guidelines for use, with other information, in determining safe levels of workplace and environmental exposure. The ACGIH maintains that its TLVs are based upon published, peer-reviewed scientific studies in industrial hygiene, toxicology, occupational medicine, and epidemiology, without consideration for economic or technical feasibility.

Beginning in the 1980s, “the Lobby”[1] started to throw brushback pitches at the ACGIH to bully the organization out of positions that the Lobby thought were too comforting to manufacturing industry.[2]  The result was a dramatic shift in the ACGIH’s perspective. The bullying created a “white-hat” bias that operates as a one-way ratchet to push the ACGIH always to lower TLVs, regardless whether there was a scientific warrant for doing so. Efforts to curb ACGIH overreach by litigation have generally failed. The TLVs have becoming increasingly controversial and non-evidence-based.[3]

What follows is what a hypothetical stakeholder might submit in response to a recent ACGIH Notice of Intended change for its TLV for mica dust. Like other mineral dusts, mica when inhaled in large quantities over long time periods, causes a pneumoconiosis. Documenting a “reasonable safe” level requires studies with adequate quantification of exposure. I will leave the reader to decide whether the ACGIH has that evidence in hand, based upon the following.

[1]  F.D.K. Liddell, “Magic, Menace, Myth and Malice,” 41 Ann. Occup. Hyg. 3, 3 (1997); see “The Lobby Lives – Lobbyists Attack IARC for Conducting Scientific Research” (Feb. 19, 2013).

[2]  Barry I. Castleman & Grace E. Ziem, “Corporate influence on threshold limit values,” 13 Am. J. Indus.  Med. 531 (1988); Grace Ziem & Barry I. Castleman, “Threshold limit values: historical perspectives and current practice,” 31 J. Occup. Med. 910 (1989); S.A. Roach & S.M. Rappaport, “But they are not thresholds:  a critical analysis of the documentation of Threshold Limit Values,” 17 Am. J. Indus. Med. 727 (1990).

[3]  Philip E. Karmel, “The Threshold Limit Values Controversy,” N.Y. L. J. (Jan. 3, 2008).

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

These comments are in response to the proposed change in the ACGIH® TLV® for Mica, as explained in the ACGIH “Mica: TLV® Chemical Substances Draft Documentation, Notice of Intended Change” (“NIC”).  For the reasons stated below, the change in the Mica TLV-TWA (time-weighted average) in the NIC is not warranted and the existing Mica TLV should not be changed.

The ACGIH® TLVs® are important non-governmental standards, largely because a number of government entities incorporate TLVs by reference into regulations and thus give TLVs the force of law.[4]  For example, some states and Canadian provinces simply adopt TLVs as state or provincial occupational exposures levels, and some states have established “maximum allowable ambient concentrations” or similar limits on “toxic air contaminants” based entirely or in part on TLVs.  The U.S. Mine Safety and Health Administration (MSHA) uses the 1973 ACGIH TLV for crystalline silica (quartz) as a legally enforceable permissible exposure level.[5]  The U.S. Occupational Health and Safety Administration (OSHA) Hazard Communication Standard requires that ACGIH TLVs be disclosed in required Safety Data Sheets.  The process by which the ACGIH develops TLVs is critically important, and furthermore, given the regulatory and legal significance of the ACGIH TLVs, the ACGIH has the burden to support proposed changes in TLVs by an adequate process, which includes transparency and evidence sufficient to support any proposed change.

The flaws in the ACGIH TLV setting process are well known and the subject of several publications, most recently in paper titled “142 ACGIH Threshold Limit Values® established from 2008-2018 lack consistency and transparency.”

The following specific comments address the ACGIH’s process disclosed in the ACGIH’s NIC in support of its proposed change for the TLV-TWA for mica, which illustrate the process problem — the ACGIH NIC for the proposed Mica TLV-TWA change does not support the change proposed by the ACGIH.   Again, the ACGIH TLVs have regulatory and legal significance; therefore, the ACGIH should not make TLV changes arbitrarily and capriciously.  Instead, the changes should be made pursuant to a transparent process, and the ACGIH should support the proposed changes with the weight of the available evidence, and the evidence in support of and the reasons for the proposed change should be publicly disclosed.  It has not done that in this case, and its own NIC makes it clear that it has not:

  1. There is no evidence that “mica is an important cause of disabling occupational pneumoconiosis” as stated in the NIC. 

The NIC provides no citation or other supporting evidence for this conclusion; it merely states the conclusion as “fact” and a premise for the proposed change.[6] The NIC fails to estimate the number of workers currently potentially exposed to mica in the U.S. (or elsewhere), what industries these workers work in, what forms of mica these workers may be exposed to, what levels of respirable mica these workers may be exposed to, and to what extent pneumoconiosis caused by the inhalation of respirable mica exists.[7]

  1. The NIC proposes to materially lower the TLV for mica, but, other than noting that there are “nine different major species”, does not adequately address the mineralogical differences between the different species of mica, makes no attempt to assess the potential adverse health effects for the different species of mica, does not examine the “dose-response” data (as inadequate as it is) for the different species of mica, and so on. 

The “Chemical and Physical Properties” section of the NIC suggests the wide variety of materials that fall within the general term “mica”.  In spite of this, the ACGIH appears to have ignored differences and concluded that the TLV for “mica” as a general category of substances should be applicable to all forms of mica, with no support for this conclusion in the NIC.[8]

  1. The human studies (sic) cited in the NIC are inadequate to support a decision to change the mica TLV and do not support the mica TLV proposed.

The first cited study involved four employees in a muscovite milling plant, with an alleged exposure to respirable mica (as muscovite) dust between 1.86 and 5.77 mg/m3.

The second cited study involved a (one) South African man who worked in a mica milling factory.  As noted in the NIC, “[q]uantitative exposure data were not reported.”

The third cited study involved a (one) 65-year old who worked in the rubber industry for 40 years, where he was exposed to numerous dusts, including mica.  There was no exposure data reported.

The fourth study involved a (one) 62-year old woman allegedly exposed to “pure mica” for seven years; no quantitative exposure data were available.

The NIC cites the case of a worker who bagged mica flake for 36 years.  In this case, there were, apparently, two dust samples taken – one at the time of a medical exam of the worker at age 54, total dust of 0.2 mg/m3 — and one taken 17 years earlier – 0.7 mg/m3.  The bulk mica samples disclosed 7.1% to 8.4% silica (presumably, respirable crystalline silica as quartz).  The reference to the silica content of the “bulk samples” suggests that there was no analysis of the material collected in the two air samples taken.

The NIC cites the case of two British men who worked as “grinders of imported muscovite,” one starting in 1957. The “workplace dust concentrations were not quantified.”

The next paper cited in the NIC was from 1940 and involved employees who were exposed to the dust caused by “mica-scrap” grinding.  There was actually an attempt to quantify mica exposures (the data from before 1940), but it was done by particle count.  The NIC notes that the available information regarding mica health effects may be “limited by potential uncertainty converting from mppcf (million particles per cubic foot) to mg/m3 (which might not apply to all dust exposure scenarios).”  The difficulties associated with converting from mppcf to mg/m3 are well known in the cases of minerals far more extensively studied than mica (e.g., crystalline silica as quartz).  In addition to the conversion factor issue, there are other concerns raised by relying upon a paper published in 1940 to support a TLV today, such as, the quality of the sampling, the quality of the chest x-rays, and issues with the classification of the chest x-rays.  With that said, the NIC noted that “[n]one of the workers exposed at less than 10 mppcf (1.8 mg/m3), irrespective of employment duration, developed pneumoconiosis.”

The remaining studies cited in the NIC are similar.  But, to close this section of the comments, I will refer to the last study, a study of 71 South African workers employed in mica milling.  Twelve personal and static samples were taken during the course of the study.  The results of the personal samples indicated a range of respirable dust (or was it mica?) between 0.4 to 1.68 mg/m3.  The radiologic examination disclosed that 19 of the 71 workers had changes consistent with one or more of asbestos, silica and/or mica.  “The specific dust concentrations to which the individuals presenting with lung changes were exposed were not reported.”

The ACGIH is proposing a reduction in the mica TLV based on the studies as described in the NIC.  We submit that this is a process and transparency problem – there is simply no way to conclude that a reduction in the mica TLV is warranted based on the Human Studies (the “evidence”) cited in the NIC.  In most cases, the Human Studies are simply case reports involving one, two, or a few people, with no quantitative exposure data.  The studies with exposure data are inadequate, i.e., date from before 1940, and among other things measured exposure as mppcf, with one study literally including two samples.  Given the legal and regulatory significance of ACGIH TLVs, the evidence cited in support of the change in the mica TLV, and the reasonable conclusion that can be drawn from the evidence cited, should exceed some threshold and meet some burden.  The evidence in the NIC is grossly insufficient to support the proposed change.

  1. The NIC for mica does not disclose any evidence to support the proposed TLV of a TWA of 0.1 mg/m3. 

The comparison to OSHA’s notice of proposed rulemaking for occupational exposure to respirable crystalline silica (RCS) is instructive.  The supporting documentation sets forth a preliminary quantitative risk assessment outlining life-time risks for various disease end points associated with occupational exposure to RCS at various levels.  The preliminary quantitative risk assessment disclosed all of the underlying studies and methodology, sufficient to allow a reader to understand the basis for the risk assessment conclusions and agree or disagree with the conclusions.  Based on the risks (and other factors not considered by the ACGIH) set forth in the documentation, OSHA proposed a PEL (permissible exposure level) for RCS.

By contrast, the ACGIH simply contends for its proposed mica TLV: “Consequently, a TLV-TWA of 0.1 mg/m3 measured as respirable fraction (containing no asbestos and <1% crystalline silica) is recommended.”  The materials preceding “[c]consequently”, which in normal reading would be expected to support the conclusion following, are not a risk assessment or anything similar to one, and in no way even superficially support the conclusion – the recommendation – stated.[9]  Therefore, the ACGIH proposed a TLV-TWA of 0.1. The NIC materials do not support a TLV of 0.1 mg/m3, any more than they support a TLV of 0.0001 or 10.  It cannot be stated too emphatically that the NIC is devoid of any evidence to support any TLV, including the recommended TLV-TWA of 0.1 mg/m3.

Of course, the ACGIH TLV process is not a federal rulemaking.  And readers should be aware of the ACGIH Position Statement regarding TLVs (“TLVs … are not quantitative levels of risk at different exposure levels…”). But the same Position Statement notes that “TLVs®…represent conditions under which ACGIH® believes that nearly all workers may be repeatedly exposed without adverse health effects.”  So, presumably, the ACGIH concluded that its proposed mica TLV was that level, and yet there is simply no evidence in the NIC to support that conclusion.  Given the regulatory and legal significance of TLVs, the process of establishing TLVs should have some basis in science and evidence.

References

ACGIH® TLV/BEI® Position Statement, available at: https://www.acgih.org/tlv-bei-guidelines/policies-procedures-presentations/tlv-bei-position-statement

ACGIH® TLV/BEI® Policy Statement, available at: https://www.acgih.org/tlv-bei-guidelines/policies-procedures-presentations/tlv-bei-policy-statement

30 C.F.R. § 56.5001 (MSHA exposure to airborne contaminants)

29 C.F.R. § 1910.1200 (OSHA Hazard Communications)

D. Davies & R. Cotton, “Mica pneumoconiosis,” 40 Br. J. Indus. Med. 22 (1983)

Subhabrata Moitra, “Mica pneumoconiosis: a neglected occupational lung disease – letter,” 6 The Lancet Respir. Med. e39 (2018), available at: https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(18)30178-4/fulltext

Notice of Proposed Rule Making (NPRM) for Occupational Exposure to Respirable Crystalline Silica, 56 Fed. Reg. 56273 (Sept. 12, 2013)

Knut R. Skulburg, “Mica pneumoconiosis – a literature review,” 11 Scand. J. Work & Envt’l Health 65 (1985)

Carl J. Smith & Thomas A. Perfetti, “142 ACGIH Threshold Limit Values® (TLV®s) established from 2008-2018 lack consistency and transparency,” 3 Toxicol. Research & Application 1 (2019)

[4] ACGIH states that TLVs are not intended to be legal standards, but the ACGIH recognizes the broad use of TLVs and should reasonably anticipate that TLVs will be used in ways beyond the scope of the legal disclaimers that the ACGIH publishes.

[5] 30 C.F.R. 56.5001

[6] The problems cited by Moitra — illegally operated mica mines exploiting vulnerable populations to work without protections in India and some African countries — speak to the need to eliminate illegal mining and protect vulnerable populations from exploitation, not the adequacy or inadequacy of any TLV.

[7] By comparison, see the OSHA documentation for the NPRM for Occupational Exposure to Respirable Crystalline Silica published September 12, 2013.  The citation to the 1985 Skulberg article (in “Major Sources of Exposure”) is inadequate on its face in 2020; the article summarizes world mica use from 1905-1981, and provides no information regarding use post-1981.  Likewise, the citation to the “Campaign for Safe Cosmetics” does not provide information on occupational exposure.

[8] The case of crystalline silica again provides a useful contrast.  There is no ACGIH TLV for “crystalline silica,” which as a general term includes many polymorphs.

[9] Actually, the materials that precede “consequently” explicitly refute the conclusion stated by the ACGIH (the TLV-TWA of 0.1 mg/m3) — “the published literature has established an association between mica exposure and pneumoconiosis typically at concentrations in the range of 1-6 mg/m3,”  and “no cases were observed among workers exposed to mica dusts at concentrations of 1.8 mg/m3 or less….”

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