TORTINI

For your delectation and delight, desultory dicta on the law of delicts.

Irving Selikoff and the Right to Peaceful Dissembling

June 5th, 2013

Among concerned writers on corporate conflicts of interest, it is a commonplace that industrial sponsors of epidemiologic and other research selectively publish studies favorable to their positions in litigation and regulatory controversies.  In my experience, most companies are fairly scrupulous about publishing the studies they funded.  If there is a correlation in industry funding and outcome, it is largely the result of corporate funding being directed to areas in which weak or corrupt politically motivated, public-interested scientists have already published studies with dubious results.  Common sense suggests that a fair test of the their claims will result in exonerative results.

It is also a commonplace that academic and public-spirited researchers will not have similar motives to suppress unfavorable results.  Again, in my experience, the opposite is true.  Consider that paragon of public-interested, political scientist, the late Dr. Irving Selikoff. During the course of discovery in the Caterinnichio case, I obtained manuscripts of two studies that Selikoff and his colleague, Bill Nicholson, prepared, but never published.  One study examined the mortality, and especially the cancer mortality, of workers at a Johns-Manville asbestos product manufacturing plant in New Jersey.  William J. Nicholson& Irving J. Selikoff, “Mortality experience of asbestos factory workers; effect of differing intensities of asbestos exposure”(circa 1988).

Selikoff’s failure to publish this manuscript on the Manville plantworkers is curious given his tireless and repeated republication of data from his insulator cohort.  For those familiar with Selikoff’s agenda, the failure to publish this paper appears to have an obvious goal:  suppress the nature and extent of Johns Manville’s use of crocidolite asbestos in its products:

“[O]ther asbestos varieties (amosite, crocidolite, anthophyllite) were also used for some products. In general, chrysotile was used for textiles, roofing materials, asbestos cements, brake and friction products, fillers for plastics, etc.; chrysotile with or without amosite for insulation materials; chrysotile and crocidolite for a variety of asbestos cement products.”

Id.  The suppression of studies obviously takes place outside the world of commercial or industrial interests.  SeeSelikoff and the Mystery of the Disappearing Amphiboles.”

There was yet another studied never published by Selikoff, his work, again with Bill Nicholson, on the mortality of shipyard workers at the Electric Boat Company, in Groton, Connecticut. Irving Selikoff & William Nicholson, “Mortality Experience of 1,918 Employees of the Electric Boat Company, Groton, Connecticut January 1, 1967 – June 30, 1978” (Jan. 27, 1984) [cited below as Electric Boat].

Many of the asbestos cases that worked their way through the legal system in the 1980s and 1990s were filed by shipyard workers.  Most of these shipyard workers were not insulators, but claimed asbestos bystander exposure from work near insulators.  Invariably, the expert witnesses for these shipyard worker plaintiffs relied upon risk data from the Selikoff of asbestos insulators, even though Selikoff himself cautioned against using the insulator data for non-insulators:

“These particular figures apply to the particular groups of asbestos workers in this study.  The net synergistic effect would not have been the same if their smoking habits had been different; and it probably would have been different if their lapsed time from first exposure to asbestos dust had been different or if the amount of asbestos dust they had inhaled had been different.”

Selikoff, et al., “Asbestos Exposure, Cigarette Smoking and Death Rates,” 330 Ann. N.Y. Acad. Sci. at 487 (1979).

Having access to Selikoff’s shipyard worker data would have been extremely useful to the fact-finding process, because these data failed to support the cancer projections used by testifying expert witnesses.  Selikoff and Nicholson pointed out that about 50% of the Electric Boat shipyard workers had X-ray abnormalities  Electric Boat at 2. (This finding must be interpreted in the darkness of Selikoff’s documented propensity to overread chest X-rays for asbestos findings.  Rossiter, “Initial repeatability trials of the UICC/ Cincinnati classification of the radiographic appearances of pneumoconioses.” 29 Brit. J. Indus. Med. 407 (1972) (reporting IJS’s readings as among the most extreme outliers in a panel of pulmonary and radiology physicians; showing that IJS films were read as showing abnormal profusion of small, irregular densities up to twice as often as the most reliable readers in the study.)).

Selikoff’s unpublished Electric Boat study cautioned that the mortality data reflected short duration and latency, and that the full extent of asbestos-related manifestations had not been reached.  Electric Boat at 3.  This assertion was not really borne out by the data.  Selikoff’s paper reported the following observed and expected data for lung cancer:

Years from onset of employment 10-14 15-19 20-24 25-29 30+ TOTAL
OBSERVED 4 23.3 15 3 4 35
EXPECTED 1.3 17.7 8.1 4.7 5.1 25.9

The study is primitive even by then contemporary standards.  There is no control for smoking; and no data on smoking habits.  There is no data on radiation exposure. (Electric Boat built nuclear submarines.) No p-values or confidence intervals are supplied; nor are any estimates of trends included.

Despite Selikoff’s assertion that the follow-up period was not sufficiently long to capture asbestos-related malignancies, the data tell a different story.  The lung cancer Obs./Exp. ratios are increased for 10-14 years, and for 15-19 years, and so these risk ratios reflect that the cohort likely had non-asbestos-related risks for lung cancer, which risks are at work before the cohort entered the lagged period in which they might have elevated asbestos-related risks.  Although the numbers are smaller for the time intervals that involve more than 20 years from first employment, the observed numbers and risk ratios of lung cancers hardly suggests very much in terms of an occupational asbestos risk.

These data were obtained only because Bill Nicholson often served as an expert witness for plaintiffs in personal injury actions.  When he did so in New Jersey, he was subject to fairly broad discovery obligations, and thus I was able to obtain his unpublished studies.  Otherwise, the public and the scientific community learned only what Selikoff selectively disclosed in media interviews.  See Samuel G. Freedman, “Worker’s suit over asbestos at Groton shipyard to openNew York Times (Jan. 19, 1982) (noting the 50% prevalence finding, but not the mortality data).

The Lobby Lives – Lobbyists Attack IARC for Conducting Scientific Research

February 19th, 2013

“[A]n anti-asbestos lobby, based in the Mount Sinai School of Medicine of the City University of New York, promoted the fiction that asbestos was an all-pervading menace, and trumped up a number of asbestos myths for widespread dissemination, through media eager for bad news.”

This statement was not the ranting of an industrialist whose company was bankrupted by asbestos personal injury cases; nor was it the complaint of an industry scientist, dismayed at a body of research that showed his industry’s product to be harmful.  The statement was made by one of the most independent, thoughtful scientists who has worked on asbestos health effects, the late Doug Liddell, of the Department of Epidemiology and Biostatistics, in McGill University.  F.D.K. Liddell, “Magic, Menace, Myth and Malice,” 41 Ann. Occup. Hyg. 3, 3 (1997).

Although Professor Liddell died in 2003,  the “Lobby” lives and thrives.  Witness the article published earlier this month, in The Lancet.   David Holmes, “IARC in the dock over ties with asbestos industry,” 381 Lancet 359 (2013).   A Scientist at the International Agency for Research on Cancer (IARC), Valerie McCormack, accepted an invitation to present data at a scientific conference in Kiev, Russia, on chrysotile asbestos risk assessment and management.  McCormack’s decision set off a firestorm of protest from various sources, claiming that the Russian scientists were in “cahoots” with the Russian asbestos industry.

The Lancet article presents a muddled account of the issues, but a persistent reader may make out several supposed concerns of the “Lobbyists.” First, the Lobbyists objected on grounds that an earlier version of the paper to be delivered by McCormack, “Estimating the asbestos-related lung cancer burden from mesothelioma mortality,” was too favorable to chrysotile in relation to commercial amphibole asbestos. (The Lancet fails to mention that McCormack’s paper has since been published, with co-authorship by some distinguished scientists.  See Valerie McCormack, Julian Peto, G. Byrnes, K. Straif, and P. Boffetta, “Estimating the asbestos-related lung cancer burden from mesothelioma mortality,” 106 Brit. J. Cancer 575 (2012).)

Second, the Lobbyists objected to IARC’s decision to collaborate on a study of Russian miners and millers, with Evgeny Kovalevkiy. The study, entitled  “Historical cohort study of cancer mortality following exposure to chrysotile asbestos at the Uralasbest plant in Asbest, Russian Federation” is supported by the Russian Scientific Research Institute of Occupational Health (SRIOH), which supports the continued mining and exporting of chrysotile asbestos.  Especially vexing to the Lobbyists, Kovalevskiy has personally advocated public policy that encourages the continued use of chrysotile.  In the words of three American political scientists who sent a letter of protest to the IARC:

“Kovalevskiy is a leading promoter of use of chrysotile asbestos. He testified before the Supreme Court of Brazil in August 2012, as witness on behalf of the Brazilian Chrysotile Institute.  He testified that there is no evidence whatsoever to justify banning the use of chrysotile asbestos; that he opposes placing chrysotile asbestos on the Rotterdam Convention’s List of Hazardous Substances; that, in the past, harm to health was caused by the use of amphibole asbestos and excessive, prolonged exposure levels to chrysotile asbestos, but that, today, chrysotile asbestos is causing no harm to health in Russia. We consider that it is unacceptable that a scientist, who is a promoter of chrysotile asbestos use, should be a lead scientist on an IARC research project regarding chrysotile asbestos.”

“IARC in the dock” at 360 (quoting letter signed by Richard Lemen, Arthur Frank, and Barry Castleman).  The Lancet article conveniently omits any reference to the remunerative and unremunerative work by these gentlemen for the American anti-asbestos litigation industry.

Egilman’s Allegations Against McDonald and His Epidemiologic Research Are Baseless

October 20th, 2012

Dr. David Egilman has been trash-talking the epidemiologic studies of Quebec asbestos miners and millers for so long that most sensible people have tuned out his diatribe.  The studies attacked by Egilman were done under the supervision of a capable epidemiologist, J. Corbett McDonald, Emeritus Professor of McGill University, in Montreal.  McDonald is now in his late 90’s, but remains active as a Honorary Professorial Research Fellow at the National Heart & Lung Institute, in the Imperial College of London (UK).

McDonald’s studies showed a significant fiber-type differential in mesothelioma causation.  Even though his studies have been corroborated by the work of researchers from around the world, McDonald’s studies remain among the largest, and best-conducted.  As such, the McDonald work has always stuck in the craw of Selikoff and his co-conspirators who have tried to politicize the science of fiber-type differential.

Irving Selikoff died 20 years ago, but his political heirs have continued to prosecute the reputation of scientists (Doll, McDonald, Wagner, and others) who dared to disagree with Selikoff dogma.  Egilman has often led the charge against McDonald, in publications and ultimately in an ethics complaint to McDonald’s former employer, McGill University.  This complaint was then used by Egilman’s trial lawyer supporters to impugn the studies that are anathema to their mission to squeeze every last possible cent from the asbestos fiasco.  See, e.g., Shein Law Center, Ltd., “McGill University Asbestos Study under Attack” (Feb. 12, 2012) (republishing Egilman’s attack on McDonald’s studies).

In response to Egilman’s scurrilous attacks upon McDonald and his work, McGill University undertook a formal investigation of the allegations.  In a report prepared by the University’s Research Integrity Officer, Abraham Fuks, the Egilman allegation were found to be baseless and unsupported.  Consultation Report to Dean David Eidelman (Sept. 23, 2012). The Report’s Conclusions and Recommendations decisively rebuffed the Egilman complaint:

“Following review of the documentation presented, the data available in the published literature, and materials available at the University, I was unable to find any support for these allegations. The financial support from the industry was acknowledged in publications and there is no evidence to suggest that the sponsors influenced the data analyses or the conclusions. In fact, JCM [J.Corbett McDonald] noted an excess of lung cancers in asbestos workers in the earliest papers and reports and this could not have been a happy outcome for the asbestos companies. JCM’s findings and conclusions have been replicated by other groups and their robustness has endured many critical analyses and legal inquiries. In fact, the recent statement by the combined epidemiology societies notes the gradient of toxicities of different types of asbestos fibers and refers to this as the current consensus, thus corroborating what the McGill group foreshadowed almost forty years ago.

Thus, I find no warrant to initiate further investigations of the allegations that we have received.

Id. at 13-14.

* * * * *

b. Did the asbestos industry launch its research programs with its own interests in mind?

To frame the question in those terms is to invite the obvious answer. Indeed, the documents made available during the many years of legal discovery make it clear that by supporting JCM and his group, and for that matter, the group at Mt Sinai led by Dr. Selikoff, the asbestos companies hoped to develop information that would vindicate their claims that asbestos, in certain forms and treated in certain ways, could continue to be used with safety. This is not surprising as such. One must acknowledge that other sources of support were not as readily available as they ought to have been and moreover, the researchers were aware of the pitfalls of the relationship they had accepted. It is all the more important to recognize that the research by JCM and other groups throughout the world generated the information that led to the near complete disappearance of the asbestos industry in the developed world and the universal recognition of the toxicity of the product. It is also clear that the industry attempted to misuse the research data to its own purposes in policy debates throughout the world and in setting standards for occupational exposures. However, it was these very same studies that permitted and permeated the litigation and policy statements clarifying the toxicity of the product.

c. Did McGill University collude with the asbestos industry in promoting the use of asbestos and in opposing the recommendations of the UICC?

These are amongst the allegations leveled at the University, albeit with no documentation or plausible evidence. The review of the materials described previously lends no credence to these allegations and claims.

Id. at 14.

Although the report falls into the trap of adopting the accusers’ loose language, such as condemning all companies through its use of term “the industry,” the report exculpates Professor McDonald for the alleged “collusion,” as well as the “industry” for attempting to manipulate his publications.  The advocacy uses or misuses of the Quebec studies by one or another companies seem mild in comparison with the distortions of the anti-asbestos zealots and their trial lawyer friends.