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

Manufactured Certainty

May 27th, 2011

With the help of Selikoff’s Lobby, the anti-asbestos zealots have created a false, manufactured certainty about various asbestos issues. The manufacturing of faux certainty has taken place with respect to the history of knowledge about asbestos, as well as to the current state of knowledge about asbestos hazards.

The Selikoff lobby exercised a great deal of influence on regulators and scientists. The Lobby was able to bully many scientists and policy makers into adopting a position that held all asbestos mineral fiber types as relatively equal in their potency to cause disease. The Lobby accomplished this by suppressing evidence of past use of amphibole asbestos, and by overstating the hazards of chrysotile asbestos.

In the past, I have marshaled evidence of Selikoff’s activities as a crocidolite denier. But was there really a controversy among honest scientists outside the Lobby?

Of course, there was and there is, but the Lobby has done a good job of branding the contrarians as tools of industry. It is important, therefore, to come to terms with evidence that scientists without connections to industry took similar positions.

For many years, starting in the late 1970s, Dr. Gerrit Schepers was a mainstay of the plaintiffs’ state-of-the-art case against asbestos mining and manufacturing companies in asbestos personal litigation. Dr. Schepers testified as a hired expert witness for plaintiffs near and far. I encountered and crossexamined Dr. Schepers on several occasions, for different clients. He was a fascinating witness, filled with contradictions and mixed motives. In one particularly horrible mesothelioma case (Hill v. Carey Canada), I confronted Dr. Schepers with his own publication, from 1973, in which he largely exonerated chrysotile as a carcinogen. Dr. Schepers twisted and turned, but he really had no where to go to avoid the full force of his own statements. This publication is worth revisiting as an historical document, to show that there was a good deal of dissent from the Lobby’s positions, at least until the asbestos personal injury and property damage litigations mushroomed out of control in the early 1980s.

Here is what Dr. Schepers wrote, in 1973, while an employee of the United States government (Chief of the Medical Service, Veterans Administration, Lebanon, Pa.):

“There are marked differences between the capacities of the individual classes of silicate minerals to provoke responses in human and animal tissues. There also are major misconceptions as to what these substances can do when inhaled by man or other mammals. Two of the most extreme of these are (1) that all siliceous minerals are equally pathogenic and (2) that there is even the least semblance between the effects of the asbestiform and the non-asbestiform silicates.”

Gerrit W. H. Schepers, M.D. D.Sc., “The Biological Action of Talc and Other Silicate Minerals,” at 54, in Aurel Goodwin, Proceedings of the symposium on talc: U.S. Bureau of Mines; Information Circular 8639 (1974) [available at http://www.scribd.com/doc/56461314]. The symposium was sponsored by the United States Department of the Interior, in May 1973. Recall that the dispute of non-asbestiform amphibole health effects was very much at issue in the Reserve Mining case, and the trial proceedings were about to start when Dr. Schepers delivered his paper, in 1973. Members of the Lobby, from Selikoff on down, were very much involved in the Reserve Mining case. See U.S. Environmental Protection Agency v. Reserve Mining Co., 514 F.2d 492 (8th Cir. 1975) (en banc).

“Is chrysotile a carcinogen? This is a very perplexing question. A crescendo of popular opinion has sought to incriminate chrysotile. This author remains unconvinced. The main premise for carcinogenicity stems from epidemiological observation of employees of the insulation and shipbuilding industries. In both these industries there has been in the past considerable exposure of pipe laggers to asbestos dust. Only in recent decades, however, have these insulation bats been composed predoninantly of chrysotile. In former years crocidolite and amosite were important components.

***

Finally, it should be pointed out that the role of cigarette smoking has not been satisfactorily discounted in the referenced epidemiological studies of lung cancer among insulation workers. In some groups reported an excess prevalence of lung cancer was not demonstrable when cigarette smoking was taken into consideration. Epidemiological surveys of chrysotile workers in Quebec showed no excess of lung cancer. A review of pleural mesothiliomatosis in Canada also failed to focus attention on Quebec or any other center where chrysotile industries are concentrated.”

Id. at 70.

That was in 1973, but within a few years, Dr. Schepers was coopted by the asbestos plaintiff industry, which manufactured lawsuits and epistemic certainty about the hazards of all asbestos minerals. The rest is “history.”

Interestingly, another would-be historian in the asbestos litigation, Dr. David S. Egilman, has written a paper, highly critical of W.R. Grace, based in part on another presentation given at the 1973 symposium, referenced above. David Egilman, Wes Wallace, and Candace Hom, Corporate corruption of medical literature: Asbestos studies concealed by W. R. Grace & Co., 6 Accountability in Research 127 (1998)(citing a paper in the same volume by Dr. William E. Smith, “Experimental studies on biological effects of tremolite talc on hamsters.”). Egilman’s paper was available at is website, http://www.egilman.com/Documents/publications/Wr_Grace.pdf The paper by Dr. Schepers no doubt missed Egilman’s attention, even though it follows immediately after Dr. Smith’s contribution.

Posted in Conflicts of Interest, Historian Testimony | No Comments »

Sub-group Analyses in Epidemiologic Studies — Dangers of Statistical Significance as a Bright-Line Test

May 17th, 2011

Both aggregation and disaggregation of outcomes poses difficult problems for statistical analysis, and for epidemiology. If outcomes are bundled into a single composite outcome, there has to be some basis for the bundling to make sense. Even so, a composite outcome, such as all cardiovascular disease events, could easily hide an association in a component outcome. For instance, studies of a drug under scrutiny may show no increased risk for all cardiovascular events, but closer inspection may show an increased risk for heart attacks while also showing a decreased risk for strokes.

The opposite problem arises when studies report multiple subgroups. The opportunity for post hoc data mining runs rampant, and the existence of multiple subgroups means that the usual level of statistical significance becomes ineffective for ruling out chance as an explanation for an increased or decreased risk in a subgroup. This problem is well known and extensively explored in the epidemiology literature, but it receives no attention in the Federal Judicial Center’s current Reference Manual on Scientific Evidence. I hope that the authors of the Third Edition, which is due out in a few months, give some attention to the problem of subgroup analysis in epidemiology. This seems to be an area where judges need a good deal of assistance, and where the Reference Manual lets them down.

Litigation tends to be a fertile field for the data dredging or the Texas Sharp shooters’ approach to epidemiology. (The Texas Sharp shooter shoots first and draws the target later.) When studies look at many outcomes, or many subgroups, chance alone will lead to results that have p-values less than the usual level for statistical significance (p < 0.05). Accepting a result as “significant” when there is a multiplicity of testing or comparisons resulting from subgroup analyses is a form of “data torturing.” Mills, “Data Torturing,” 329 New Engl. J. Med. 1196, 1196 (1993)(“If you torture the data long enough, they will confess.”).

The multiple testing or comparison issue arises in both cohort and case-control studies. Cohort studies have the ability to look at cancer morbidity or mortality at 20 different organs, with multiple histological subtypes for each cancer. There are hundreds of diseases, by World Health Organization disease codes, which can be a possible outcome in a cohort study. The odds are very good that several disease outcomes will be significantly elevated or decreased by chance alone. Similarly, in a case-control study, participants with the outcome of interest can be questioned about hundreds of lifestyle and exposure variables. Again, the finding of a “risk factor,” with statistical significance is not very compelling under these circumstances.

The problem of subgroup analyses is exacerbated by defense counsel’s emphasis on statistical significance as a “bright-line” test. When subgroup analyses yield a statistically significant result, at the usual p < 0.05, which they will often do by chance alone, plaintiffs’ counsel obtain a “gotcha” moment. Having built up the importance of statistical significance, defense counsel are hard pressed to dismiss the “significant” finding, even though study design makes it highly questionable if not downright meaningless.

Although the Reference Manual ignores this recurrent problem, several authors have issued severe alerts to the issue. For instance, Lisa Bero, who writes frequently on science and the law issues, admonishes:

“Specifying subgroup analysis after data collection for the review has already begun can be a ‘fishing expedition’ or “data dredging” for statistically significant results and is not appropriate.”

L. Bero, “Evaluating Systematic Reviews and Meta-Analyses,” J. L. & Policy 569, 576 (2006).

Eggers and Davey Smith, two well-respected English authors, who write about methodological issues in epidemiology, warn:

“Similarly, unplanned data-driven subgroup analyses are likely to produce spurious results.”

Matthias Egger & George Davey Smith, “Principles of and procedures for systematic reviews,” 24 chap. 2, in M. Egger, G. Davey Smith, D. Altman, eds., Systematic Reviews in Health Care: Meta-Analysis in Context (2d ed. 2001).

Stewart and Parmar explain the genesis of the problem and the result of diluting the protection that statistical significance usually provides against Type I errors:

“In general, the results of these subgroup analyses can be very misleading owing to the very high probability that any observed differences is due solely to chance.⁸ For example, if 10 subgroup analyses are carried out, there is a 40% chance of finding at least one significant false-positive effect (5% significance level). Further, when the results of subgroup analyses are reported, often only those that have yielded a significant result are presented, without noting that many other analyses have been performed.”

Stewart and Parmar, “Bias in the Analysis and Reporting of Randomized Controlled Trials,” 12 Internat’l J. Tech. Assessment in Health Care 264, 271 (1996)

“Such data dredging must be avoided and subgroup analyses should be limited to those that are specified a priori in the trial protocol.”

Id. at 272.

“Readers and reviewers should be aware that subgroup analyses, exploratory or otherwise, are likely to be particularly unreliable in situations where no overall effect of treatment has been observed. In this case, if one subgroup exhibits a particularly positive effect of treatment, then another subgroup has to have a counteracting negative effect.”

* * *

“Consequently, perhaps the most sensible advice to readers and reviewers is to be very skeptical about the results of subgroup analyses.”

Id. See also Sleight, “Subgroup analyses in clinical trials – – fun to look at, but don’t believe them,” 1 Curr. Control Trials Cardiovasc. Med. 25 (2000) (“Analysis of subgroup results in a clinical trial is surprisingly unreliable, even in a large trial. This is the result of a combination of reduced statistical power, increased variance and the play of chance. Reliance on such analyses is likely to be erroneous, and hence harmful, than application of the overall proportional (or relative) result in the whole trial to the estimate of absolute risk in that subgroup. Plausible explanations can usually be found for effects that are, in reality, simply due to the play of chance. When clinicians believe such subgroup analyses, there is a real damage of harm to the individual patient.”)

These warnings and admonitions are important caveats to statistical significance. In emphasizing the importance of statistical significance in evaluating statistical evidence, defense lawyers are sometimes unwittingly hoisted with their own petard, in the form of studies that have results that meet the usual p-value threshold of lower than 5%. Courts see these defense lawyers as engaged in special pleading when counsel argues that study multiplicity requires changing the p-value threshold to preserve the desired rate of Type I error, but that is exactly what must be done.

A few years ago, the New England Journal of Medicine published an article that detailed the problem and promulgated guidelines for avoiding the worst abuses. R. Wang, S. Lagakos, J. H. Ware, et al., “Statistics in Medicine — Reporting of Subgroup Analyses in Clinical Trials,” 357 New Engl. J. Med. 2189 (2007). Wang and colleagues provide some important insights for how subgroup analyses can lead to increased rates of Type I errors, and they provide guidelines for authors on appropriate descriptions of subgroup analyses:

“However, subgroup analyses also introduce analytic challenges and can lead to overstated and misleading results.”

Id. at 2189a.

“When multiple subgroup analyses are performed, the probability of a false positive finding can be substantial.”

Id. at 2190a.

“There are several methods for addressing multiplicity that are based on the use of more stringent criteria for statistical significance than the customary P < 0.05.”

Id. at 2190b.

“A pre-specified subgroup analysis is one that is planned and documented before any examination of the data, preferably in the study protocol.”

Id. at 2190b.

“Post hoc analyses refer to those in which the hypotheses being tested are not specified before any examination of the data. Such analyses are of particular concern because it is often unclear how many were undertaken and whether some were motivated by inspection of the data. However, both pre-specified and post hoc subgroup analyses are subject to inflated false positive rates arising from multiple testing. Investigators should avoid the tendency to pre-specify many subgroup analyses in the mistaken belief that these analyses are free of the multiplicity problem.”

Id. at 2190b.

“When properly planned, reported, and interpreted, subgroup analyses can provide valuable information.”

Id. at 2193b.

Although Wang and colleagues take their primary aim at the abuse of subgroup analyses in randomized clinical trials, they make clear that the abuse is equally present in observational studies:

“In other settings, including observational studies, we encourage complete and thorough reporting of the subgroup analyses in the spirit of the guidelines listed.”

Id. at 2193b.

Wang and colleagues provide some very specific guidelines for reporting subgroup analyses. These guidelines are a helpful source for helping courts make sober assessments of results from subgroup analyses.

Recently, another guideline initiative, STROBE, in the field of observational epidemiology provided similar guidance to authors and journals for reporting subgroup analyses:

“[M]any debate the use and value of analyses restricted to subgroups of the study population. Subgroup analyses are nevertheless often done. Readers need to know which subgroup analyses were planned in advance, and which arose while analyzing the data. Also, it is important to explain what methods were used to examine whether effects or associations differed across groups … .”

Jan P. Vandenbroucke, Erik von Elm, Douglas G. Altman, Peter C. Gøtzsche, Cynthia D. Mulrow, Stuart J. Pocock, Charles Poole, James J. Schlesselman, and Matthias Egger, for the STROBE Initiative, “Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): Explanation and Elaboration,” 18 Epidemiology 805, 817 (2007).

“There is debate about the dangers associated with subgroup analyses, and multiplicity of analyses in general. In our opinion, there is too great a tendency to look for evidence of subgroup-specific associations, or effect-measure modification, when overall results appear to suggest little or no effect. On the other hand, there is value in exploring whether an overall association appears consistent across several,

preferably pre-specified subgroups especially when a study is large enough to have sufficient data in each subgroup. A second area of debate is about interesting subgroups that arose during the data analysis. They might be important findings, but might also arise by chance. Some argue that it is neither possible nor necessary to inform the reader about all subgroup analyses done as future analyses of other data will tell to what extent the early exciting findings stand the test of time. We advise authors to report which analyses were planned, and which were not … . This will allow readers to judge the implications of multiplicity, taking into account the study’s position on the continuum from discovery to verification or refutation.”

Id. at 826-27.

Bibliography

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Susan Assmann, Stuart Pocock, Laura Enos, Linda Kasten, “Subgroup analysis and other (mis)uses of baseline data in clinical trials,” Lancet 2000; 355: 1064–69.

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Posted in Rule 702 | 28 Comments »

The Law’s Obsession with Warnings

May 11th, 2011

Professor Beth J. Rosenberg is Assistant Professor, in the Department of Public Health & Community Medicine, in Tufts University School of Medicine, Boston, Massachusetts. Rosenberg is an unabashed activist. She is driven by concerns that humans are ruining the environment and poisoning themselves. She is a champion of workers’ safety and workers’ rights. So when she writes about her personal experience with the lack of interest among workers in the hazards of silica, we all can learn something about whether the law’s obsession with warnings makes sense.

In 2003, Rosenberg wrote an article about her experiences in trying to have silica added to the list of substances regulated under the Massachusetts’ Toxics Use Reduction Act (TURA). Beth Rosenberg, “Second Thoughts About Silicosis,” 13 New Solutions 223 (2003) (http://www.ncbi.nlm.nih.gov/pubmed/17208725). Working with support from the Environmental League of Massachusettes and the Massachusettes Public Health Association, Rosenberg petitioned to have silica added to the TURA list of substances, in part out of a desire to help fuel a ban on abrasive blasting with silica in Massachusettes. She figured that by piggybacking on the environmental movement, or riding “the green wave,” as she put it, the state’s environmental laws could be used to help control occupational exposures.

Rosenberg’s ideals and aspirations ran into the wall of worker expectations and needs. They did not want abrasive blasting banned; they wanted stronger enforcement from OSHA, and better respirators. Rosenberg admits that the workers were pursuing a path that was not her goal, and she learned that, at legislative hearings, she needed “to take tighter control of the scripts of any hearings that I’m orchestrating.” Id. at 227.

Rosenberg worked with the Painters’ union to study substitutes for silica in abrasive blasting. Motivated by a recognition that “[s]ilica-related disease is completely preventable,” id. at 224, she hoped to move them towards supporting a ban on silica for abrasive blasting. After several years of this work, however, Rosenberg decided to give up on her silica mission. Her experience is instructive for correcting the misapplication of “failure to warn” products liability law to the use of a raw material such as silica in the workplace:

“The main point here is that the men I’ve interviewed are not terribly concerned about silica dust. They care about being treated decently and respectfully by their bosses. They’re concerned about being encouraged to work too fast to work safely. They care about lead dust, particularly bringing it home to their families, so they get really angry when the foreman wants to lock up the yard at five o’clock and doesn’t leave them enough time to shower and change their clothes. They feel that they are expendable. And although most are fully aware of silica’s dangers, silica is not a top priority for them. The silica agenda was set by some physicians and health professionals who are outraged that anybody is still dying of this 100 percent preventable disease. This is understandable, and I am one of those people, but I’m not sure this is the best way to be of service. I see that there are other, more pressing issues than silica.

I’ve chosen to serve working people, and yet they’ve had little or no role in setting the research agenda. Not only is this unrewarding for me, but it’s also a bad political strategy because you need a lot of support and collaboration to accomplish anything—even when everyone agrees that action is required—and interest in silica is tepid among the people most affected. This may not be true in other trades or in other countries, but it is true with abrasive blasters. And I stress that is not an awareness problem; they know breathing dust is bad for them, but it’s just not their top concern, and I can see why. So, henceforth, I’m going to let the community I choose to serve set the research agenda, and I will offer my assistance in their battles. That to me is the best way to do public health.”

Id. at 229 (emphasis added). Rosenberg’s epiphany should lead to some thoughtful re-evaluation of how the law of products liability is applied to the use of a natural material such as crystalline silica. While Professor Rosenberg was working with the Painters’ Union, and having her “Second Thoughts about Silicosis,” plaintiffs’ lawyers were screening, scheming, and suing for silicosis among the same union’s members. If only plaintiffs’ law firms took heed of Professor Rosenberg’s lessons, and stopped signing up sand blasters under the paternalistic pretense that the law must provide a remedy for the alleged failure to warn. The faux historians of silicosis, with their conspiratorial theories, could learn a great deal from Professor Rosenberg, as well.

Posted in Historian Testimony | No Comments »