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Let Me Not Be Frank With You – Frank Subpoena Quashed

August 19th, 2015

In June 2015, Honeywell International Inc. subpoenaed non-party witness Dr. Arthur Frank, to produce documents and to testify, in Yates v. Ford Motor Co., et al., No. 5:12-cv-752-FL (E.D.N.C.). Although Dr. Frank is a “prolific plaintiffs’ expert” witness, he was not retained in Yates. Dr. Frank thus moved to quash the subpoena in the district where he was served, and the matter ended up on the docket of Judge Gerald J. Pappert. Frank v. Honeywell Int’l, Inc., No. 15-mc-00172, 2015 U.S. Dist. LEXIS 106453, 2015 BL 260668 (E.D. Pa. Aug. 12, 2015) [cited below as Yates]. See also Steven M. Sellers, “Asbestos Expert Tops Honeywell in Subpoena Battle,” BNA Bloomberg Law (Aug. 18, 2015).

Back in 2009, Dr. Frank lobbied the National Cancer Institute (“NCI”), and succeeded in having the NCI change its website and “Fact Sheets” about the supposed cancer risks among auto mechanics from exposure to asbestos in repairing brakes. The NCI had proposed describing any increased risk of mesothelioma or lung cancer among brake repairman as “controversial,” and not supported by the available evidence. Dr. Frank, who routinely testifies for the litigation industry that the risk is certain, known, and substantial, believed the NCI statement would be “misleading, erroneous, and contrary to the public health.” Frank believed that the NCI was basing its evaluation upon studies that were “unreliable,” and so set out to lobby the NCI. As a result of his telephoning and letter writing campaign, the NCI eliminated citations to two studies deemed unreliable (or inconvenient) to Dr. Frank, and adopted the following Frank-approved language:

“Studies into the cancer risk experienced by automobile mechanics exposed to asbestos through brake repair are limited, but the overall evidence suggests that there is no safe level for asbestos exposure.”

Yates at *4.

Operating in cahoots with, and under the guidance of asbestos plaintiffs’ counsel, Frank wrote to the NCI, of course mindful to run a draft of his correspondence past his litigation industry members. Plaintiffs’ counsel made various suggestions that Frank adopted. Yates at *5-7.

Frank objected to the subpoena on grounds that it:

(1) was too broad and unduly burdensome, as well as intended to harass;

(2) sought communications protected by attorney-client privilege; and

(3) sought the opinion of an unretained expert witness, contrary to Federal Rule of Civil Procedure 45(d)(3)(B)(ii).

The court quashed Honeywell’s subpoena only on grounds of burden, Rule 45(d)(3)(A), and did not reach Frank’s other arguments. Yates at *8.

Citing local Eastern District of Pennsylvania precedent, Judge Pappert noted that a claim of undue burden is resolved by considering several factors:

“(1) relevance of the requested materials,

(2) the party’s need for the documents,

(3) the breadth of the request,

(4) the time period covered by the request,

(5) the particularity with which the documents are described,

(6) the burden imposed, and

(7) the recipient’s status as a non-party.”

Yates at *12.

Honeywell was easily able to show the relevance of Frank’s lobbying shenanigans. Plaintiffs’ counsel have used the Frank-approved NCI website language to cross-examine defense expert witnesses, in asbestos personal injury cases.

Judge Pappert was not persuaded that Honeywell needed the requested discovery because Frank had given much of the material before, and he had previously acknowledged his working in concert with plaintiffs’ lawyers to change the NCI statement.

Honeywell thus had the evidence it needed to rehabilitate defense expert witnesses challenged with the Frank-approved NCI language. The court thus left the discovery into Frank’s ex parte lobbying activities for a case in which Frank was actually a retained expert witness, which surely will be soon. Judge Pappert exercised restraint by not addressing Frank’s improvident claim of attorney-client privilege and involuntarily servitude as an expert witness.

Frank’s lawyer, John O’Riordan, was quoted by the BNA as chastizing Honeywell:

“What the auto industry, Honeywell and others are trying to do is attack Dr. Frank personally, and what they tried to do was improper. … If they think he was wrong as a matter of science, the answer is to come back with good science.”

Steven M. Sellers, “Asbestos Expert Tops Honeywell in Subpoena Battle,” BNA Bloomberg Law (Aug. 18, 2015).

O’Riordan’s response is rather disingenuous, given that plaintiffs’ counsel in asbestos cases exploit the imprimatur of the NCI in its Frank-approved statement to challenge defense expert witnesses. This game is not about science, it is about name dropping and authority-based decision making, the antithesis of science.

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Ramazzini Serves Courtroom Silica Science Al Dente

July 25th, 2015

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

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

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

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

“1) Occupational silica exposures, new and old;

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

3) the role of silica and silicosis in tuberculosis;

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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Stanford Professor Smokes Out Tobacco Defense Expert Witnesses

July 18th, 2015

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

Harry Frankfurt, On Bullshit 63 (Princeton 2005)

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

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

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

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

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

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

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

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

Improper to Criticize Expert Witnesses

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

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

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

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

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

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

In an interview with the BNA, Jackler speculates:

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

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

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

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

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

Philip Morris Claims that Jackler Has Undisclosed Conflicts of Interests

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

One Defense Expert Witness Responds

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

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

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Conflict Over Conflicts of Interest

July 12th, 2015

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

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

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

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

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

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

(iii) issues related to specific evaluations and

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

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

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

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

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

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

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

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

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

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

Carcinogenesis has the following policy on conflicts:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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Transparency, Confusion, and Obscurantism

October 31st, 2014

In NIEHS Transparency? We Can See Right Through You (July 10, 2014), I chastised authors Kevin C. Elliott and David B. Resnik for their confusing and confused arguments about standards of proof, the definition of risk, and conflicts of interest (COIs). See Kevin C. Elliott and David B. Resnik, “Science, Policy, and the Transparency of Values,” 122 Envt’l Health Persp. 647 (2014) [Elliott & Resnik]. In their focus on environmentalism and environmental policy, Elliott and Resnik seem intent upon substituting various presumptions, leaps of faith, and unproven extrapolations for actual evidence and valid inference, in the hope of improving the environment and reducing risk to life. But to get to their goal, Elliott and Resnik engage in various equivocations and ambiguities in their use of “risk,” and they compound the muddle by introducing a sliding scale of “standards of evidence,” for legal, regulatory, and scientific conclusions.

Dr. David H. Schwartz is a scientist, who received his doctoral degree in Neuroscience from Princeton University, and his postdoctoral training in Neuropharmacology and Neurophysiology at the Center for Molecular and Behavioral Neuroscience, in Rutgers University. Dr. Schwartz has since gone to found one of the leading scientific consulting firms, Innovative Science Solutions (ISS), which supports both regulatory and litigation claims and defenses, as may scientifically appropriate. Given his experience, Dr. Schwartz is well positioned to address the standards of scientific evidentiary conclusions across regulatory, litigation, and scientific communities.

In this month’s issue of Environmental Health Perspectives (EHP), Dr. David Schwartz adds to the criticism of Elliott and Resnik’s tendentious editorial. David H. Schwartz, “Policy and the Transparency of Values in Science,” 122 Envt’l Health Persp. A291 (2014). Schwartz points out that “[a]lthough … different venues or contexts require different standards of evidence, it is important to emphasize that the actual scientific evidence remains constant.” Id.

Dr. Schwartz points out transparency is needed in how standards and evidence are represented in scientific and legal discourse, and he takes Elliott and Resnik to task for arguing, from ignorance, that litigation burdens are different from scientific standards. At times some writers misrepresent the nature of their evidence, or its weakness, and when challenged, attempt to excuse the laxness in standards by adverting to the regulatory or litigation contexts in which they are speaking. In some regulatory contexts, the burdens of proof are deliberately reduced, or shifted to the regulated industry. In litigation, the standard or burden of proof is rarely different from the scientific enterprise itself. As the United States Supreme Court made clear, trial courts must inquire whether an expert witness ‘‘employs in the courtroom the same level of intellectual rigor that characterizes the practice of an expert in the relevant field.’’ Kumho Tire Co. v. Carmichael, 526 U.S. 137, 152 (1999). Expert witnesses who fail to exercise the same intellectual rigor in the courtroom as in the laboratory, are eminently disposable or excludable from the legal process.

Schwartz also points out, as I had in my blog post, that “[w]hen using science to inform policy, transparency is critical. However, this transparency should include not only financial ties to industry but also ties to advocacy organizations and other strongly held points of view.”

In their Reply to Dr. Schwartz, Elliott and Resnik concede the importance of non-financial conflicts of interest, but they dig in on the supposed lower standard for scientific claims:

“we caution against equating the standards of evidence expected in tort law with those expected in more traditional scientific contexts. The tort system requires only a preponderance of evidence (> 50% likelihood) to win a case; this is much weaker evidence than scientists typically demand when presenting or publishing results, and confusion about these differing standards has led to significant legal controversies (Cranor 2006).”

Rather than citing any pertinent or persuasive legal authority, Elliott and Resnik cite an expert witness, Carl Cranor, neither a lawyer nor a scientist, who has worked steadfastly for the litigation industry (the plaintiffs’ bar) on various matters. The “caution” of Elliott and Resnik is directly contradicted by the Supreme Court’s pronouncement in Kumho Tire, and is fueled by a ignoratio elenchi that is based upon a confusion between the probability of repeated sampling with confidence intervals (usually 95%) and the posterior probability of a claim: namely, the probability of the claim given the admissible evidence. As the Reference Manual for Scientific Evidence makes clear, these are very different probabilities, which Cranor and others have consistently confused. Elliott and Resnik ought to know better.

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Can Expert Bias and Prejudice Disqualify a Witness From Testifying?

October 11th, 2014

The Center for Science in the Public Interest (CSPI) bills itself as a consumer advocate committed to research and education in sound science. The CSPI considers itself to be “one of the nation’s top consumer advocates,” which works to “ensure that science is used to promote the public welfare.”

You may wonder whether and why “science” turns out to promote the public welfare envisioned by the CSPI? According to the CSPI, you should just accept that it does. So sure is the CSPI that industry corrupts science that it features a web-based, open database of scientists with ties to industry. There is no database of scientists’ ties to the litigation industry (plaintiffs’ lawyers), to organized labor, or advocacy groups. No doubt, implicit in its choice, is the claim that all science done by scientists with “ties” to the plaintiffs’ bar, to labor, or to advocacy groups, is “in the public interest.”

The arrogance of the implicit claim is made even more clear by how the CSPI addresses supposed corruption and conflicts of interest in science. The CSPI features an Integrity in Science Project to ferret out corruption in science, but the Project concerns itself only with industry-sponsored and funded science. The Project is candid about its one-sided jihad against industry-based science:

“Although many have cheered partnerships between industry and the research community, it is also acknowledged that they entail conflicts of interest that may compromise the judgment of trusted professionals, the credibility of research institutions and scientific journals, the safety and transparency of human subjects research, the norms of free inquiry, and the legitimacy of science-based policy.

For example:

There is strong evidence that researchers’ financial ties to chemical, pharmaceutical, or tobacco manufacturers directly influence their published positions in supporting the benefit or downplaying the harm of the manufacturers’ product.

A growing body of evidence indicates that pharmaceutical industry gifts and inducements bias clinicians’ judgments and influence doctors’ prescribing practices.

There are well-known cases of industry seeking to discredit or prevent the publication of research results that are critical of its products.

Studies of life-science faculty indicate that researchers with industry funding are more likely to withhold research results in order to secure commercial advantage.

Increasingly, the same academic institutions that are responsible for oversight of scientific integrity and human subjects protection are entering financial relationships with the industries whose product-evaluations they oversee.

In response to the commercialization of science and the growing problem of conflicts of interest, the Integrity in Science Project seeks to:

raise awareness about the role that corporate funding and other corporate interests play in scientific research, oversight, and publication;
investigate and publicize conflicts of interest and other potentially destructive influences of industry-sponsored science;
advocate for full disclosure of funding sources by individuals, governmental and non-governmental organizations that conduct, regulate, or provide oversight of scientific investigation or promote specific scientific findings;
encourage policy-makers at all levels of government to seek balance on expert advisory committees and to provide public, web-based access to conflict-of-interest information collected in the course of committee formation;
encourage journalists to routinely ask scientists and others about their possible conflicts of interests and to provide this information to the public.”

The CSPI inquiry then is entirely one-sided, with no apparent or manifest interest in exploring and revealing conflicts created by scientists’ affiliations with advocacy groups, labor, or the litigation industry. The concern about conflicts of interests is, in my view, simply an attempt to disqualify industry-sponsored scientific studies from inclusion in policy discussions. To be sure, there are notorious examples of industry-sponsored, compromised studies. But there are similarly notorious examples of union and plaintiff-lawyer sponsored studies gone awry. Why then is there no concern at the CSPI about researchers’ ties with advocacy groups, labor unions, and most important, and the litigation industry? The obvious answer is that the CSPI is engaging in advocacy for certain conclusions. The CSPI wants to put its hand on one side of the balance, and do its best to ensure that scientific debates and discussions come out a certain way, a way that favors conclusions it desires. The CSPI wants to disqualify dissenters from the conversation. The so-called “Integrity” project thus appears to be a pretense, exactly the opposite of what it purports to be.

In 2004, the CSPI’s Integrity in Science Project sponsored a conference on, among other topics, Corporate and Government Suppression of Research. Actually, there was barely any discussion of governmental suppression; the speakers spoke almost entirely on corporate conduct.

One speaker on the panel presented about corporate conflicts of interest in the starkest Marxist terms. Corporations must cheat and lie because they are capable only of acting to maximize profits, and they will inevitably see safety as a dispensable cost. The speaker, who is a frequent testifier in mass tort litigation, held forth that the problem with corporations is not that there are some rotten apples, but that the entire barrel is rotten. Suppression of scientific research, according to this speaker is not an anomaly, but totally determined by the nature of the firm. Ethical companies cannot compete, and they go out of business; ergo, any company in business is unethical.

Of course, the same uncharitable determinist views can be applied to expert witnesses, to plaintiffs’ counsel, to labor unions, and to advocacy groups. Remarkably, this speaker acknowledged that is ideology is a much larger bias than money, and then confessed that

“My bias is ideological.”

This speaker testifies frequently for the litigation industry, and his zeal is so uncabined that he has been held in contempt and fined as part of his litigation activities. When one federal court judge excluded his testimony, he attacked the bona fides of the judge and sought to appeal his exclusion personally. And yet the Integrity project featured him as a speaker!

The CSPI and its cadre of anti-industry scientists brings me to the question du jour: Can an expert witness be too biased or prejudiced in a matter to serve as an expert witness? We exclude judges and jurors who have potential conflicts of interest. Surely there are fact or expert witnesses, who are so untrustworthy that they should not be allowed to testify. Consider whether an expert witnesses who, having demonstrated that they will violate court orders or other laws, want the court to qualify them as “expert witnesses” to give their opinions in a pending case. The trial court does not necessarily endorse the opinions proffered, but should the court give its imprimatur to the witnesses’ standing as having opinions that could be considered, relied upon to the exclusion of competing opinions, and form the basis for verdicts for the parties offering these suspect witnesses?

Just asking.

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Scientific Prestige, Reputation, Authority & The Creation of Scientific Dogmas

October 4th, 2014

Since 1663, the Royal Society has sported the motto: “Nullius in verba,” on no one’s authority. The motto is a recognition that science, and indeed, all of knowledge turns on data properly collected, analyzed, and interpreted, and not on the prestige or authority of the speaker. In England today, there could be no better example of the disconnect between authority and knowledge than the pronouncements of Crown Prince Charles on science and medicine[1].

Although science should be about the data and methodology, the growing complexity and inaccessibility of modern science has fostered greater reliance upon reputation of researchers as a proxy for the correctness of factual statements. In some quarters, scientists are held up as shamans who are lionized and revered, at least when the scientists are advancing research and conclusions that are politically approved. When the scientists conduct research that threatens politically correct beliefs, then the scientists must be attacked, diminished, and discredited. Because the scientific claims at issue involve evidence and hard thought, the attackers and defenders seem to prefer proceed with ad hominem attacks on the personal standing and credibility of scientists whose work they embrace or distain.

The sad truth is that the persistence of interpreting science by personal charm, credibility, and political correctness of scientists’ personality remains as a legacy of our authority-based approach to knowledge. As a result, we have the spectacle of public intellectuals who complain about the demonization of scientists, while in the next breath, demonize scientists whose work threatens their political and personal preferences[2].

It would be lovely if we could ignore attacks on the personal credibility of researchers, but the sociology of knowledge and science requires us to acknowledge that reputation, prestige, and authority remain as determinants of belief. The more political and personal preferences are involved, and the greater the complexity of the underlying scientific analysis, the more we should expect people, historians, judges, and juries, to ignore the Royal Society’s Nullius in verba,” and to rely upon the largely irrelevant factors of reputation.

We would thus be on a fool’s errand not to pay attention to the social construction of reputation, both in terms of how reputations are created and how they are diminished. I have focused on Irving Selikoff, because he is such a difficult case. For virtually every advance in the scientific understanding of asbestos health effects, Selikoff did not have priority. Sir Richard Doll was ahead of Selikoff by a decade in reporting the epidemiologic association between asbestosis and lung cancer.[3] Christopher Wagner was ahead of Selikoff by several years in describing the association between amphibole asbestos and mesothelioma[4]. And the United States Navy was ahead of Selikoff in terms of detailing the difficulty in controlling confined-space asbestos lagging operations onboard ships, and the consequent asbestosis hazards[5].

Much of Selikoff’s asbestos work that was original was wrong. His advocacy of a connection between asbestos and extrapulmonary cancers, his claim that all asbestos varieties were equivalent in potency for causing mesothelioma, and his risk assessments of total attributable asbestos risks are just some examples of where Selikoff outran his scientific headlights. Still, the United States public owes Selikoff a debt of gratitude for having popularized and disseminated information about asbestos hazards at a crucial time in our history. Although Doll and Wagner had priority with respect to lung cancer and mesothelioma, they both wrote in foreign journals about exposures that were typical in the U.K. and South Africa. And while the Navy’s understanding of its own catastrophic neglect of safety in its shipyards came before Selikoff’s publications, the Navy’s coyness kept its information from being widely disseminated. Selikoff, in his 1964 publication[6], in an American journal, the Journal of the American Medical Association, thus incorporated a good amount of prior learning and showed that asbestos was a problem among asbestos insulators in the United States. At the time, insulators were often thought of as having relatively low-level asbestos exposure. Furthermore, Selikoff used his findings of asbestos-related disease among the union insulators to advance a political goal, the federalization of workplace safety and health regulation. That goal ultimately came to have bipartisan support in the United States, largely as a result of Selikoff’s advocacy.

Selikoff’s legitimate achievements should not be diminished, and historians McCulloch and Tweedale are correct to bemoan the ad hominem attacks on Selikoff, based upon ethnicity and personal characteristics. They are wrong, however, to claim that Selikoff’s training, scientific acumen, advocacy, and false positive claims are somehow off limits. Selikoff’s substantial contributions to public health by publicizing the dangers of high exposure, long-term exposure to exposure do not privilege every position he took. Selikoff is a difficult case because he was wrong on many issues, and his reputation, authority and prestige ultimately became much greater than the evidence would ultimately support.

The labor historians and anti-asbestos zeolots are right to bristle and emote when historians and others challenge the reputation of Irving Selikoff. Like Rachel Carson and Wilhelm Heuper, Selikoff is one of the icons of the environmental and occupational safety movement. Environmentalists, labor leaders, and left-leaning politicians, have invested heavily in Selikoff’s reputation and authority to support legislation and regulations. Given Selikoff’s reputation and prestige in the field of asbestos health effects, and his role in helping pass the Williams-Steiger Act of 1969, we might wonder why no one has written a full-length biography. There are some hagiographic articles to be sure, but a full-length biography would raise questions not politely answerable.

Selikoff the Testifier

Selikoff may have been a media plodder in the mid-1950s, but his experience as a testifying witness made him particularly effective in advancing his advocacy on behalf of the asbestos and other unions in the 1960s and forward. See “Medical Horizons,” Broadcasting * Telecasting at 14 (Nov. 21, 1955) (describing Selikoff as a plodding presenter). Those who would lionize Selikoff, and privilege his claims from evidence-based scrutiny, are embarrassed by his frequent testifying. They are, however, wrong to distort Selikoff’s record of participating in the litigation process. He had an obligation to do so, to some extent. Many physicians gladly would avoid the courtroom confrontations that Dr. Selikoff undertook. Despite these feelings, physicians have an ethical obligation, by virtue of their special training and experience, to assist in the administration of justice[7]. Indeed, the Board of Trustees of the American Medical Association has recommended that the presentation of expert testimony should be considered part of the practice of medicine and thus subject to peer review[8]. Ultimately, the courtroom testimony should be judged for the validity of its conclusions just as any other scientific opinion would be.

Of course, frequent testifying can be undertaken for venal or political purposes, and the reputation makers behind Selikoff have been keen to protect him from charges of being a “frequent testifier.” Much of protection probably took place because Selikoff’s testifying took place in the past before electronic files of transcripts could circulate rapidly, and even minor cases were posted to internet databases. Thus, Judge Jack Weinstein, writing after the death of Dr. Selikoff, could incorrectly describe him as an “independent” scientist, who should not be coerced to testify when he preferred to publish his “results only in scientific journals.” Jack B. Weinstein, Individual Justice in Mass Tort Litigation: The Effect of Class Actions, Consolidations, and other Multi-Party Devices 117 (1995).

Judge Weinstein was clearly wrong in his assessment that Selikoff preferred scholarly journals to the courtroom, but his assessment reflects the influence of the reputation that Selikoff and his followers worked so hard to create. Of course, Judge Weinstein was also wrong to suggest that Selikoff was “independent.” He had deep ties to unions, the plaintiffs’ bar, a cadre of plaintiffs’ expert witnesses, and to positions to which all these groups subscribed. The greatest art is that which conceals itself[9].

Selikoff’s participation in litigation proceedings has thus become a debating point between those who would acclaim and those who would detract from Selikoff’s reputation. Oxford University historian Peter Bartrip, for one, noted that Selikoff had testified frequently. Peter W.J. Bartrip, Beyond the Factory Gates: Asbestos and Health in Twentieth Century America 77 & n.4 (2006); Peter W.J. Bartrip, “Irving John Selikoff and the Strange Case of the Missing Medical Degrees,” 58 J. History Med. 3, 27 & n.88-92 (2003). Bartrip’s history has in turn been attacked by the Lobby of anti-asbestos zealots. Marxist historians Jock McCulloch and Geoffrey Tweedale, and others, have attacked Bartrip for serving as an apologist for industry, and have suggested, in their publications, that Selikoff testified infrequently:=

“[Selikoff] gave testimony in two of the early landmark legal cases, but thereafter avoided the drama of the courtroom and the role of the expert witness, not only because it would have been a drain on his time and made his confidential trade union medical files open to legal scrutiny, but also because he felt that antagonizing industry would not help his broader agenda.”

Jock McCulloch & Geoffrey Tweedale, Defending the Indefensible : The Global Asbestos Industry and its Fight for Survival: The Global Asbestos Industry and its Fight for Survival 95 & n.36 (2008).

Two and only two; or two and then some? What was McCulloch and Tweedale’s source? They cite a personal communication from one of Selikoff’s protégés and acolytes, Dr. Stephen Levin, who testified frequently on behalf of asbestos claimants in litigation, and who no doubt shared the authors’ desire to protect and enhance Dr. Selikoff’s reputation. Perhaps more interesting is Levin’s revelation that Selikoff wished to hide his “confidential” union files from scrutiny. See “The Selikoff – Castleman Conspiracy” (Mar. 13, 2011) (describing memorandum, dated November 5, 1979, from plaintiffs’ expert witness Barry Castleman to Selikoff urging resistance to lawful discovery attempts to obtain information about asbestos workers union).

Well, who is right? Did Selikoff testify frequently or not? On this point, McCulloch and Tweedale appear to be demonstrably wrong. I have previously pointed out some of Selikoff’s testimonial adventures[10]. See “Selikoff and the Mystery of the Disappearing Testimony” (Dec. 3, 2010).

There are other instances, however, of Selikoff’s medico-legal activities. According to Jon Gelman, a worker’s compensation lawyer in New Jersey, his father, also a New Jersey lawyer, employed Dr. Selikoff, in the early 1950s, as an expert witness in the “original 17” UNARCO (Union Asbestos and Rubber Co.) asbestos worker claims. Gelman reports that these claims were successfully litigated with Selikoff’s examinations and services, in front of the New Jersey Division of Workers’ Compensation. Jon L. Gelman, “Dr. Yasunosuke Suzuki, A Pioneer of Mesothelioma Medical Research” (Nov. 23, 2011); Jon L. Gelman, History of Asbestos and the Law (Jan. 02, 2001). See also Michael Nevins, Meanderings in New Jersey’s Medical History 146-47 (2011). Unfortunately, the reports and transcripts of the UNARCO 17 cases are not available.

For about two decades after the UNARCO 17, Selikoff went on to have an active testimonial career, always testifying for the claimant, and against the employer or the supplier. In 1972, Andrew Haas, President of the asbestos workers union thanked Selikoff for his “frequent” expert witness testimony on behalf of union members. Andrew Haas, Comments from the General President, 18 Asbestos Worker (Nov. 1972)[11].

In addition to the cases cited in the footnotes, Selikoff testified or was involved as an expert witness in other cases. See, e.g., Babcock & Wilcox, Inc. v. Steiner, 258 Md. 468, 471, 265 A.2d 871 (1970) (affirming workman compensation award for asbestosis); Culp Industrial Insulation v. Commonwealth of Pennsylvania Workmen’s Compensation Appeal Board, 57 Pa. Commonwealth Ct. 599, 601-602 (1981). One of the earliest reported decisions in which Selikoff testified as a party expert witness was in a federal court admiralty case, in which a seaman sued the ship owner for injuries allegedly sustained as a result of a slip and fall accident. No pulmonary injury was involved. Barros v. United States, 147 F.Supp. 340, 343-44 (E.D.N.Y. 1957) (noting that Dr. Selikoff testified for seaman suing for maintenance and cure as a result of a slip and fall; finding for respondent against libelant).

Perhaps the most egregious testimonial adventure was Selikoff’s serving as an expert witness, in 1966, for a union worker who claimed that his colon cancer had been caused by asbestos. What was remarkable about this testimony was not that it was for the worker; Selikoff’s testimony seemed always to be for the claimant. What stands out is how weak and unreliable any scientific claim for colon cancer would have been in 1966 (and after for that matter). Despite the insufficiency of the evidence, and the dubious validity of the early study relied upon, Selikoff’s participation helped obtain a favorable outcome, which led to the asbestos union’s praise for his efforts:

“The research into health hazards of insulation workers developed by the members of Local No. 12 and Local No. 32 has resulted in widening the basis of compensation claims in New York State.

Until now, the courts have been reluctant to accept many of the conditions to which insulation workers are prone, as related to employment. However, facts produced during the research investigations of Dr. 1. J. Selikoff, Dr. J. Churg, and Dr. E. Cuvler Hammond of the Environmental Sciences Laboratory of the Mt. Sinai Hospital in New York are resulting in a changing of this picture.

A recent decision has widened the range of compensable diseases for insulation workers even further. A member of Local No. 12. unfortunately died of a cancer of the colon. Dr. Selikoff reported to the compensation court that his research showed that these cancers of the intestine were at least three times as common among the insulation workers as in men of the same age in the general population.

Based upon Dr. Selikoff’s testimony, the Referee gave the family a compensation award, holding that the exposure to many dusts during employment was responsible for the cancer. The insurance company appealed this decision. A special panel of the reviewed the matter and agreed with the Referee’s judgement and affirmed the compensation award. This was the first case in which a cancer of the colon was established as compensable and it is likely that this case will become an historical precedent.”

“Health Hazard Progress Notes: Compensation Advance Made in New York State,” 16(5) Asbestos Worker 13 (May 1966). See Viskovich v. Robert A. Keasbey Co., 36 A.D.2d 665 (3d Dep’t 1971)(affirming decision of the Compensation Board in awarding an asbestos insulator benefits for colon cancer; Selikoff’s case or perhaps a subsequent claim). Historians will search long, hard, and unsuccessfully for any disclosure of Selikoff’s consultancies or his testimonies on the issue of asbestos and colorectal cancer in any of his publications on the issue, or any other asbestos issue.

Even after Selikoff stopped participating directly in the litigation process, he continued his interest in the outcome of litigation. This interest was both intellectual and practical. For instance, at the fall meeting of the Medical History Society of New Jersey, Selikoff gave a presentation on “Nellie Keershaws [sic] and Frederick Legrand,” two of the bellwether asbestos litigants, in the U.K., and the U.S., respectively. Irving J. Selikoff, “Nellie Keershaws and Frederick Legrand,” at Fall Meeting, UMDNJ-New Jersey Medical School, Newark, N.J. (Saturday, Oct. 8, 1988). See 9(1) MHSNJ Newsletter (Jan. 1989).

Nellie Kershaw was diagnosed with asbestosis in the early 1920s, but her employer, Turner Brothers Asbestos, refused to pay her compensation for disability and her ultimate death. The investigation into her death gave rise to the first set of Asbestos Industry Regulations, in the United Kingdom, in 1931. Frederick LeGrande was one of the first plaintiffs in a civil action against Johns-Manville, for asbestos-related disease. Frederick LeGrande v. Johns-Manville Prods. Corp., No. 741-57 (D.N.J. filed in 1957, by William L. Brach, attorney for plaintiff).

As McCulloch and Tweedale note, Selikoff became too politically vulnerable to continue his direct participation in litigation, but he did not cease his involvement altogether. After asbestos litigation went viral in the late 1970s, Selikoff encouraged his juniors at Mt. Sinai Hospital to testify on behalf of union members and other asbestos claimants. The roster of physicians who trained at Mt. Sinai, in Selikoff’s department, read like a “Who’s Who” of asbestos plaintiffs’ expert witnesses[12]. Indeed, Selikoff trained a generation of testifying expert witnesses for the plaintiffs’ bar.

Another measure of Selikoff’s influence in the litigation arena was his attempt to influence the litigation process by conducting an ex parte seminar for key judges, with responsibility for important cases or large dockets. Plaintiffs’ lawyers, with the collaboration of Selikoff’s protégés as their “expert witnesses,” persuaded school districts and property owners that they should sue for the costs of asbestos removal and abatement. Selikoff and his acolytes then called a meeting, “The Third Wave conference,” to reflect their concern about the alleged danger of asbestos in place. Philip J. Landrigan & H. Kazemi, eds. “The Third Wave of Asbestos Disease: Exposure to Asbestos in Place – Public Health Control,” 643 Ann. N.Y. Acad. Sci. (1991). Under cover of support from the Collegium Ramazzini, and with the active support and participation of organized labor and plaintiffs’ asbestos bar, Selikoff invited judges to what was clearly a lopsided medical conference, dominated by his acolytes and plaintiffs’ expert witnesses in the very cases in which the invited judges presided. The corrupt affair led to the disqualification of Judge James McGirr Kelly, who attended the conference. In re School Asbestos Litigation, 977 F.2d 764 (3d Cir. 1992); see Cathleen M. Devlin, “Disqualification of Federal Judges – Third Circuit Orders District Judge James McGirr Kelly to Disqualify Himself so as to Preserve the Appearance of Justice under 28 U.S.C.§ 455,” 38 Vill. L. Rev. 1219 (1993); W.K.C. Morgan, “Asbestos and cancer: history and public policy,” 49 Br. J. Indus. Med. 451, 451 (1992); see also “Historians Should Verify Not Vilify or Abilify – The Difficult Case of Irving Selikoff” (Jan. 4, 2014).

Perhaps even more interesting than the public corruption is the scientific corruption that took place at the Third Wave Conference. McCulloch and Tweedale report that one scientist who attended, Dr. Bruce Case, was so upset about the nonsense spouted at the Conference that he wrote an angry letter to one of the leaders in occupational pulmonary medicine, Dr. J. Bernard L. Gee., to report that the conference was “a stage-managed piece of Broadway theater[13].” The controversy led to Julian Peto’s review of the Third Wave Conference papers, and writing to the President of Mt. Sinai Hospital Center to register his observation that many of the conference papers were scientifically “dubious” and systematically biased in favor of exaggerating the risks of asbestos in place[14].

McCulloch and Tweedale attempt to defend this (indefensible) incident in the history of asbestos litigation by claiming that Selikoff and his “team” of acolytes had not been invited to an earlier conference at Harvard, on the issue of asbestos property damage. Health Effects Institute, Asbestos in Public and Commercial Buildings: A Literature Review and Synthesis of Current Knowledge (1991); Jacqueline Karn Corn, Environmental Public Health Policy for Asbestos in Schools: Unintended Consequences at 115-16 (1999). Their complaint does not ring true, however. The so-called Harvard conference had the participation of a large group of independent experts[15] as well as some scientists from the inner sanctum of Mt. Sinai[16]. The world of science ultimately has not been kind to the Selikoff view of asbestos in place[17].

Historical perspective is much needed in considering Selikoff and his contributions, both good and bad. Even after his death, Selikoff remains an important player in the passion play of the American asbestos litigation and regulation[18], and any biographer who steps up to the task will have to confront all aspects of Selikoff’s long career, both scientific advances and missteps.

[1] See Steven Novella, “Prince Charles Alternative Medicine Charity Closes” Science-Based Medicine (May 16, 2012); Laura Donnelly, “Prince Charles makes plea on alternative medicine: Prince of Wales calls for alternative medicine to be treated fairly and for regulation to govern its use,” The Telegraph (Jan. 19, 2014).

[2] Compare Jock McCulloch & Geoffrey Tweedale, “Shooting the messenger: the vilification of Irving J. Selikoff,” 37 Internat’l J. Health Services 619, 619 (2007) (complaining that some historians have “demonized” Dr. Irving Selikoff as “a media zealot”); Jock McCulloch & Geoffrey Tweedale, “Science is not sufficient: Irving J. Selikoff and the asbestos tragedy,” 17 New Solutions 292 (2007); Jock McCulloch and Geoffrey Tweedale, Defending The Indefensible: The Global Asbestos Industry and its Fight for Survival (2008), with Geoffrey Tweedale, “Hero or Villain?—Sir Richard Doll and Occupational Cancer” 13 Internat’l J. Occup. Envt’l Health 233 (2007) (demonizing Sir Richard Doll for his affiliations and consultancies in the field of occupational cancer).

[3] Richard Doll, “Mortality from Lung Cancer in Asbestos Workers,” 12 Br. J. Indus. Med. 81 (1955).

[4] See J. Christopher Wagner, C.A. Sleggs, and Paul Marchand, “Diffuse pleural mesothelioma and asbestos exposure in the North Western Cape Province,” 17 Br. J. Indus. Med. 260 (1960); J. Christopher Wagner, “The discovery of the association between blue asbestos and mesotheliomas and the aftermath,” 48 Br. J. Indus. Med. 399 (1991).

[5] Capt. H.M. Robbins & William T. Marr, “Asbestosis,” 19 Safety Review 10 (1962) (noting that asbestos dust counts of 200 million particles per cubic foot were not uncommon during insulation ripouts onboard naval vessels, and the existence of asbestosis cases among workers).

[6] Irving J. Selikoff, Jacob Churg & E. Cuyler Hammond, “Asbestos Exposure and Neoplasia,” 188 J. Am. Med. Ass’n 22 (1964)

[7] American Medical Association Council on Ethical and Judicial Affairs Current Opinion 9.07 on Medical Testimony (1989); Council of Medical Specialty Societies, Statement on Qualifications and Guidelines for the Physician Expert Witness, (Approved March 20,1989); American College of Physicians, Guidelines for the Physician Expert Witness. Ann Intern Med 113:789, 1990; Ethics Committee, American College of Chest Physicians Guidelines for an Expert Witness. Chest 98:1006 (1990).

[8] AMA Board of Trustees, Proceedings: House of Delegates 149-154 (June 18-22,1989). See generally Nathan Schachtman & Cynthia Rhodes, “Medico-Legal Issues in Occupational Lung Disease Litigation,” 27 Seminars in Roentgenology 140 (1992).

[9] Quintilian, IV Institutio Oratoria 1.57 (“But to avoid all display of art in itself requires consummate art.”)

[10] Bradshaw v. Twin City Insulation Co. Ltd., Industrial Court of Indiana, Claim No. O.D.1454 (Oct. 14, 1966); Bradshaw v. Johns-Manville Sales Corp., E. D. Michigan Southern Division, Civ. Action No. 29433 (July 6, 1967); Bambrick v. Asten Hill Mfg. Co., Pa. Commonwealth Ct. 664 (1972); Tomplait v. Combustion Engineering Inc.., E. D. Tex. Civ. Action No. 5402 (March 4, 1968); Rogers v. Johns-Manville Products Corp., Cir. Ct. Mo., 16th Jud. Cir., Div. 9, Civ. Action No. 720,071 (Feb. 19, 1971); Utter v. Asten-Hill Mfg. Co., 453 Pa. 401 (1973); Karjala v Johns-Manville Products Corp., D. Minn., Civ. Action Nos. 5–71 Civ. 18, and Civ. 40 (Feb. 8, 1973).

Selikoff also participated as a testifying witness for the government, in the Reserve Mining case. See United States v. Reserve Mining Co., 56 F.R.D. 408 (D. Minn.1972); Armco Steel Corp. v. United States, 490 F.2d 688 (8th Cir. 1974); United States v. Reserve Mining Co., 380 F.Supp. 11 (D. Minn.1974); Reserve Mining Co. v. United States, 498 F.2d 1073 (8th Cir. 1974); Minnesota v. Reserve Mining Co., 418 U.S. 911 (1974); Minnesota v. Reserve Mining Co., 419 U.S. 802 (1974); United States v. Reserve Mining Co., 394 F.Supp. 233 (D.Minn.1974); Reserve Mining Co. v. Environmental Protection Agency, 514 F.2d 492 (8th Cir. 1975); Reserve Mining Co. v. Lord, 529 F.2d 181 (8th Cir. 1976); United States v. Reserve Mining Co., 408 F.Supp. 1212 (D. Minn.1976); United States v. Reserve Mining Co., 412 F.Supp. 705 (D.Minn.1976); United States v. Reserve Mining Co., 417 F.Supp. 789 (D. Minn.1976); United States v. Reserve Mining Co., 417 F.Supp. 791 (D.Minn.1976); 543 F.2d 1210 (1976).

[11] See Peter W.J. Bartrip, “Irving John Selikoff and the Strange Case of the Missing Medical Degrees,” 58 J. History Med. 3, 27 & n.88-92 (2003) (citing Haas).

[12] Ruth Lilis, Albert Miller, Yasunosuke Suzuki, William Nicholson, Arthur Frank, Henry Anderson, Stephen Levin, Steven Markowitz, Jacqueline Moline, Susan Daum, et al.

[13] Jock McCulloch & Geoffrey Tweedale, “Shooting the messenger: the vilification of Irving J. Selikoff,” 37 Internat’l J. Health Services 619, 626 & n.33 (2007).

[14] Jock McCulloch & Geoffrey Tweedale, “Shooting the messenger: the vilification of Irving J. Selikoff,” 37 Internat’l J. Health Services 619, 626 & n34 (2007) (citing letter from Prof. Julian Peto to Dr. Thomas Chalmers, Mount Sinai Medical Center, June 28, 1990, from the Selikoff Archive, at Mount Sinai Hospital, NY).

[15] Arthur C. Upton, Jonathan Samet, Margaret R. Becklake, John M.G. Davis, David G. Hoel (of the National Institute of Environmental Health Sciences) Morton Lippmann, Gordon Gamsu, and Julian Peto

[16] William J. Nicholson and Arthur Langer, although Dr. Langer had by this time left Mt. Sinai.

[17] See, e.g., Philip H. Abelson, “The Asbestos Removal Fiasco,” 247 Science 1017 (1990).

[18] See Department of Labor, Occupational Safety and Health Administration, Final Rule re Docket No. H-033-dl Occupational Exposure to Asbestos, Tremolite, Anthophyllite and Actinolite, 29 C.F.R. Parts 1910 and 1926, 57 Fed. Reg 24310 (June 8, 1992) (rejecting Selikoff’s and the Lobby’s attempt to have cleavage fragments regulated as though they were fibers).

Posted in Conflicts of Interest, Expert Witnesses, Historian Testimony | Comments Off on Scientific Prestige, Reputation, Authority & The Creation of Scientific Dogmas

CHARGE: Coyness in Disclosing Conflicts

October 1st, 2014

Back in June, the Environmental Health Perspectives posted an “in-press” version of a study from the CHARGE group on autism disorders and pesticide exposures. This month, the October issue of EHP has the final version of the article. Janie F. Shelton, Estella M. Geraghty, Daniel J. Tancredi, Lora D. Delwiche, Rebecca J. Schmidt, Beate Ritz, Robin L. Hansen, and Irva Hertz-Picciotto, “Neurodevelopmental disorders and prenatal residential Proximity to Agricultural pesticides: the CHARGE Study,” 122 Envt’l Health Persp. (2014).

At the time of the in-press publication, I posted a plea that the media pay attention to principal investigator Dr. Hertz-Picciotto’s conflict of interest disclosure, and its failure to acknowledge her advocacy role on the advisory board of Autism Speaks. See “NIEHS Study – CHARGE Failure to Disclose Conflicts of Interest” (June 23, 2014). The published version does indeed, by way of an erratum, acknowledge Hertz-Picciotto’s, and other authors’, membership in Autism Speaks, and their regret in omitting this information earlier.

Unfortunately, the erratum fails to mention that Hertz-Picciotto also serves on the advisory board of the radically anti-chemical Healthy Child, Healthy World organization, located in California (12100 Wilshire Blvd. Suite 800, Los Angeles CA 90025). Healthy Child Healthy World is a California non-profit corporation that advocates to:

“Demand corporate accountability
Engage communities for collective action
Support safer chemicals and products
Influence legislative and regulatory reform.”

It looks as though more regrets and more errata are in order.

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The Funding Effect in Science and in Law

September 8th, 2014

In some circles, the mere mention that a study or a paper was sponsored by an oil company is sufficient to discredit its findings, methods, and analyses, on the merits. For instance, in Exxon Shipping Co. v. Baker, 554 U.S. 471, 501 (2008), the Supreme Court struck down a $2.5 billion punitive damage award. Justice Souter, writing for the Court in a 5-3 decision, observed that:

“We are aware of no scholarly work pointing to consistency across punitive awards in cases involving similar claims and circumstances.¹⁷”

In his now infamous footnote 17, Justice Souter explained:

“The Court is aware of a body of literature running parallel to anecdotal reports, examining the predictability of punitive awards by conducting numerous ‛mock juries’, where different ‛jurors’ are confronted with the same hypothetical case. See, e.g., C. Sunstein, R. Hastie, J. Payne, D. Schkade, W. Viscusi, Punitive Damages: How Juries Decide (2002); Schkade, Sunstein, & Kahneman, Deliberating About Dollars: The Severity Shift, 100 Colum. L.Rev. 1139 (2000); Hastie, Schkade, & Payne, Juror Judgments in Civil Cases: Effects of Plaintiff’s Requests and Plaintiff’s Identity on Punitive Damage Awards, 23 Law & Hum. Behav. 445 (1999); Sunstein, Kahneman, & Schkade, Assessing Punitive Damages (with Notes on Cognition and Valuation in Law), 107 Yale L.J. 2071 (1998). Because this research was funded in part by Exxon, we decline to rely on it.”

Somehow it escaped Justice Souter’s attention that some of the investigators (Sunstein, Viscusi, Kahneman, et al.) in the papers were outstanding scientists and scholars. The mere funding disclosure gave Justice Souter the excuse to avoid any hard thinking and intellectual engagement with the merits of these papers.

The world of philosophy provides another example. Massimo Pigliucci is professor of philosophy at the City University of New York, and a frequent commentator on junk science. Pigliucci, Nonsense on Stilts: How to Tell Science from Bunk (2010). In railing against positions taken by a so-called “think tank,” the Competitive Enterprise Institute, Professor Pigliucci felts compelled to note, on almost every mention, that the Institute is partially funded by Exxon-Mobil, and so its pronouncements should be discounted. See, e.g., id. at 156.

Chris Prandoni, a contributor to Forbes, recently published a story about a Senate investigation into the “funding effect” of various environmentalist organizations. Chris Prandoni, “Senate Committee Report Details Environmentalists’ Inner Workings,” (July 30, 2014). Prandoni notes that the environmental movement has morphed into a billion-dollar industry, with funding by many one-percenters. The minority staff of the United States Senate Committee on Environment and Public Works (EPW) has issued a report entitled The Chain of Command: How a Club of Billionaires and Their Foundations Control the Environmental Movement and Obama’s EPA (July 30, 2014), which documents how a “Billionaires’ Club” funds many, if not most, of the environmental non-government organizations and their media and grassroots activities.

The Committee report also describes how many scientists and leaders from the funded organizations have entered the “revolving door” of the Obama Administration’s agencies. The Committee might have expanded its focus to include organizations such as the Project on Scientific Knowledge and Public Policy (SKAPP), a pass-through organization for the plaintiffs’ bar, a/k/a the litigation industry. SKAPP was formerly headed by David Michaels, now head of OSHA. See “SKAPP a Lot” (April 30, 2010).

Other organizations that front for the interests of wealthy lawyers seeking to expand the largesse of the tort system include the Council for Education and Research on Toxics (“CERT”), and the Center for Progressive Reform. See “Milward Symposium Organized By Plaintiffs’ Counsel and Witnesses” (Feb. 16, 2013).

The Senate Committee report highlights the hypocrisy of some critics of the Supreme Court’s recent decision in, Citizens United v. FEC, 130 S. Ct. 876 (2010), which held that the First Amendment prohibits governmental restrictions of corporations’ independent political expenditures. The hypocritical criticism lay in denouncing the political expenditures and speech of corporations, as corrupted by the wealth and motivations of the speakers, while turning blind eyes from huge expenditures by wealthy self-styled public interest groups through think tanks and non-governmental organizations. Even foreign governments have joined in the spending spree. See Eric Lipton, Brooke Williams & Nicolas Confessore, “Foreign Powers Buy Influence at Think Tanks,” N.Y. Times (Sept. 6, 2014).

Perhaps it is time to follow the data as ardently as we follow the money?

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Frank Advocacy on Welding Health “Effects”

September 1st, 2014

Arthur L. Frank is a professor and the chair of Drexel University School of Public Health’s program in Environmental and Occupational Health. Frank testifies fairly extensively for plaintiffs in asbestos litigation. See, e.g., Frank Affidavit. He also has testified for plaintiffs in manganese fume litigation brought by welders, although he has no specialty training in movement disorder neurology.

Although Arthur Frank has testified for plaintiffs in asbestos cases, he does not appear to comply with professional association disclosure of conflicts, when he presents on asbestos issues. See, e.g., “More Hypocrisy Over Conflicts of Interest” (Dec. 4, 2010). The same disregard for conflict disclosures seems to hold for his work on welding health outcomes.

Last year, in September 2013, Frank presented a poster at the 11th Inhaled Particles XI (IPXI) conference, organized by the British Occupational Hygiene Society (BOHS). Frank’s poster was entitled, “Health Effects of Welding Fumes,” although the poster reported only a cross-sectional study without controls from Qingdao City, China. Frank provided no conflict-of-interest disclosure in the poster. Arthur Frank, Huanqiang Zhang, and Chunsheng Xu, “Health Effects of Welding Fumes,” Inhaled Particle XI Conference, Nottingham, U.K. (Sept. 2013). His current C.V., available online, reports this as an abstract from the Inhaled Articles conference. One does not need an epidemiologic study to see how scientists could choke on this article if inhaled.

Frank’s study was based upon an anonymous questionnaire to 505 steel welders, at state-owned, foreign-funded, and privately owned companies, in Qingdao City, China. No industrial hygiene exposure measurements or use of personal respiratory protection is reported. No physical examinations are reported. No statistical tests are reported. Frank reported a “symptom” of unsteady gait/difficulty walking of 1%, but he and his Chinese colleagues did not report whether this 1% had musculo-skeletal or neurological problems. The former would be fairly common among tradesmen such as welders whose work often puts them at risk of traumatic injury.

According to Frank, a “striking” finding was an 18% prevalence hand tremor among those working at least 15 years, with lower prevalence reported for less than 5 years (4%), at 5 years (3%), and at 10 years (5%). Frank offered no explanation of how these prevalence rates were ascertained in a cross-sectional questionnaire based study; nor did Frank offer any qualification as to whether these hand tremors were rest or action tremor, bilateral or unilateral, or of any particular kind. Notwithstanding the severe limitations of this “study,” Frank offers a conclusion that “[m]anganese from inhaled particles from welding fumes cause serious outcomes in welders. Welding fumes also cause other health effects. Workplace hygiene correlates with health outcome.”

Shortly after the Inhaled Particles conference, a colleague reported that Frank had testified in an asbestos case that he had submitted a “manganese in welding” manuscript to the Annals of Industrial Hygiene, which is the journal of the (BOHS). To date, no article by Frank has appeared in this, or any, journal.

Perhaps the only interesting aspect of this little cross-sectional study, based upon self-reported symptoms, is that workers employed by the communist state report a higher rate of symptoms than those employed by privately owned companies. More evidence that worker illness, if any there should be, is not necessarily the result of the “profit motive” of private corporations. The abstract also shows that at some scientific conferences, anything goes with respect to conflicts-of-interest disclosures and shameless advocacy.

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