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EPA Cherry Picking (WOE) – EPA 1992 Meta-Analysis of ETS & Lung Cancer – Part 1

December 2nd, 2012

Somehow, before the Supreme Court breathed life into Federal Rule of Evidence 702, parties sometimes found a way to challenge dubious scientific evidence in court. One good example is the challenge to the United States Environmental Protection Agency’s risk assessment of passive smoking, also known as environmental tobacco smoke (ETS). In 1992, the Environmental Protection Agency (EPA) published a risk assessment of lung cancer (and other) risks from ETS. See Respiratory Health Effects of Passive Smoking: Lung Cancer and Other Disorders EPA/600/6-90/006F (1992). The agency concluded that ETS causes about 3,000 lung cancer deaths each year among non-smoking adults in the United States. See also EPA “Fact Sheet: Respiratory Health Effects of Passive Smoking,” Office of Research & Development; EPA Document Number 43-F-93-003 (Jan. 1993).

Various plaintiffs, including tobacco companies, challenged the EPA’s conclusions as agency action that violated administrative and statutory procedures. The plaintiffs further claimed that the EPA had manufactured its methods to achieve the result it desired in advance of the analyses. In other words, plaintiffs asserted that the EPA’s issuance of the ETS report violated the Administrative Procedures Act’ procedural requirements, as well as the requirements of the specific enabling legislation, the Radon Gas and Indoor Air Quality Research Act, Pub.L. No. 99–499, 100 Stat. 1758–60 (1986) (codified at 42 U.S.C. § 7401 note (1994)). A federal district court agreed with the methodological challenges to the EPA’s report, but the Court of Appeals reversed on grounds that the agency’s report was not reviewable agency action. Flue-Cured Tobacco Cooperative Stabilization Corp. v. EPA, 4 F. Supp. 2d 435 (M.D.N.C. 1998), rev’d on other grounds, 313 F.3d 852, 862 (4th Cir. 2002) (Widener, J.) (holding that the issuance of the report was not “final agency action”). The district court’s assessment of the validity issues were not addressed by the appellate court.

Notwithstanding the district court’s findings, the EPA continues to claim that it had reached valid scientific conclusions using a “scientific approach”:

“EPA reached its conclusions concerning the potential for ETS to act as a human carcinogen based on an analysis of all of the available data, including more than 30 epidemiologic (human) studies looking specifically at passive smoking as well as information on active or direct smoking. In addition, EPA considered animal data, biological measurements of human uptake of tobacco smoke components and other available data. The conclusions were based on what is commonly known as the total weight-of-evidence” rather than on any one study or type of study.

The finding that ETS should be classified as a Group A carcinogen is based on the conclusive evidence of the dose-related lung carcinogenicity of mainstream smoke in active smokers and the similarities of mainstream and sidestream smoke given off by the burning end of the cigarette. The finding is bolstered by the statistically significant exposure-related increase in lung cancer in nonsmoking spouses of smokers which is found in an analysis of more than 30 epidemiology studies that examined the association between secondhand smoke and lung cancer.”

EPA “Fact Sheet: Respiratory Health Effects of Passive Smoking,” Office of Research and Development; EPA Document Number 43-F-93-003, January 1993 (emphasis added).

A prominent feature of the EPA’s analysis was a meta-analysis of epidemiologic studies of ETS and lung cancer. Interestingly, the tobacco industry plaintiffs did not appear to challenge the legitimacy of the basic meta-analytic enterprise, which was still controversial at the time. See, e.g., “Samuel Shapiro, Meta-analysis/Smeta-analysis,” 140 Am. J. Epidem. 771 (1994); Alvan Feinstein, “Meta-Analysis: Statistical Alchemy for the 21st Century,” 48 J. Clin. Epidem. 71 (1995). Their challenge went straight to the validity of the EPA’s meta-analysis, and a documented post hoc change in the agency’s statistical plan for analyzing the meta-analysis results. Only a few years earlier, the defense in polychlorobiphenyl (PCB) litigation broadly challenged a plaintiffs’ expert witness’s use of meta-analysis of observational epidemiologic studies, only to have the Third Circuit reject the challenge and to direct the district court to review the validity of the meta-analysis as conducted by the witness. In re Paoli RR Yard PCB Litig., 706 F. Supp. 358, 373 (E.D. Pa. 1988), rev’d, 916 F.2d 829, 856-57 (3d Cir. 1990), cert. denied, 499 U.S. 961 (1991); see also Hines v. Consol. Rail Corp., 926 F.2d 262, 273 (3d Cir. 1991).

The EPA report was not the first attempt to use meta-analysis for the epidemiology of ETS and lung cancer. In 1986, the National Academy of Sciences reported a meta-analysis on the subject. See National Research Council, National Academy of Sciences, Environmental tobacco smoke: measuring exposures and assessing health effects (Wash. DC 1986). This earlier meta-analysis was also controversial. Indeed, some of the early concerns over the use of meta-analysis for observational epidemiologic studies arose in the context of studies of ETS. See, e.g., Joseph L. Fleiss & Alan J. Gross, “Meta-Analysis in Epidemiology, with Special Reference to Studies of the Association between Exposure to Environmental Tobacco Smoke and Lung Cancer: A Critique,” 44 J. Clin. Epidem. 127 (1991) (criticizing the National Research Council 1986 meta-analysis of ETS and lung cancer studies as unwarranted based upon the low quality of the studies included). These concerns were heightened by politicized use of meta-analyses in regulatory agencies to overclaim scientific conclusions from weak, inconclusive data.

In the EPA’s meta-analysis, statistical significance was achieved only by changing the criterion of significance, post hoc, from a two-tailed to a one-tailed 5% test. Perhaps more disturbing was the scientific gerrymandering that took place as to which studies to include and exclude from the meta-analysis.

In its first review of the EPA’s draft report, a committee of the agency’s Scientific Advisory Board, the IAQC [the Indoor Air Quality/Total Human Exposure Committee] found that the EPA’s ETS risk assessment violated one of the necessary criteria for a valid meta-analysis – a “precise definition of criteria used to include (or exclude) studies.” 4 F. Supp. 2d at 459 (citing EPA, An SAB Report: Review of Draft Environmental Tobacco Smoke Health Effects Document, EPA/SAB/IAQC/91/007 at 32–33 (1991) (SAB 1991 Review) (JA 9,497–98)). The agency had not provided specific criteria for including studies. The IAQC also noted that it was important to evaluate the consequences of having excluded studies in the form of sensitivity studies. In a later review, in 1992, both the EPA and the IAQC dropped this critique of the agency’s meta-analysis, without explanation. Id. at 459.

By the time the EPA released its ETS report in 1993, there were about 58 published epidemiologic studies available for inclusion in any meta-analysis. The EPA included only 31. The agency limited its analysis to nonsmoking women married to smoking spouses. There were 33 studies of this exposed group; the EPA included 31 of the 33. There were also available 12 studies of women exposed to ETS in their workplace, and 13 studies of women who were exposed to ETS as children. Id. at 458. There were three late-breaking studies of women with spousal exposures, but the EPA excluded two, without explanation. Id. at 459.

In reviewing the plaintiffs’ challenge, the district court noted that the EPA had given a bare, unconvincing explanation for excluding the childhood and workplace studies. Id. The EPA argued that there was less data in the childhood and workplace studies, but this assertion struck the court as an evasive rationale when one of the purposes of conducting a meta-analysis was to incorporate the data from smaller, less powerful studies. Id. 458-59. The primary author of the disputed chapter of the EPA report, Kenneth Brown, called the disputed studies “inadequate,” without providing a rational basis or explanation. The IAQC, in its earlier review of a 1991 draft report, recognized that the excluded studies provided less information, but concluded that the agency’s “the report should review and comment on the data that do exist… .” Id. at 459.

The court found the EPA’s selection of studies for inclusion in a meta-analysis to be “disturbing”:

“First, there is evidence in the record supporting the accusation that EPA ‘cherry picked’ its data. Without criteria for pooling studies into a meta-analysis, the court cannot determine whether the exclusion of studies likely to disprove EPA’s a priori hypothesis was coincidence or intentional. Second, EPA’s excluding nearly half of the available studies directly conflicts with EPA’s purported purpose for analyzing the epidemiological studies and conflicts with EPA’s Risk Assessment Guidelines. See ETS Risk Assessment at 4–29 (“These data should also be examined in the interest of weighing all the available evidence, as recommended by EPA’s carcinogen risk assessment guidelines (U.S.EPA, 1986a) ….” (emphasis added)). Third, EPA’s selective use of data conflicts with the Radon Research Act. The Act states EPA’s program shall ‘‘gather data and information on all aspects of indoor air quality….’’ Radon Research Act § 403(a)(1) (emphasis added). In conducting a risk assessment under the Act, EPA deliberately refused to assess information on all aspects of indoor air quality.”

4 F. Supp. 2d at 460.

The court was no doubt impressed by the duplicity of the agency’s claim to have used a “total weight of the evidence” approach to the question of causality, and its censoring of the analysis in a way that appeared to game the result. Id. at 454 The EPA’s guidelines called for basing conclusions on all available evidence. EPA’s Guidelines for Carcinogen Risk Assessment, 51 Fed. Reg. 33,996, 33,999-34,000 (1986).

Using evidence selectively, with a post hoc adoption of a one-tailed test of statistical significance, the EPA reported a summary estimate of risk of 1.19, and categorized ETS as a “Group A” carcinogens. In most of its previous Group A classifications, the agency had based its decisions upon much higher relative risks. Indeed, the agency had rejected Group A classifications when relative risks were found to be less than three. 4 F. Supp. 2d at 461. The sum total of the agency’s methodological laxity was too much for the district court, which struck the chapters of the EPA report. Four years later, the Fourth Circuit of the U.S. Court of Appeals reversed, on grounds that the EPA report was not reviewable agency action.

The EPA report became a lightning rod for methodological criticism of meta-analysis for observational studies, and the EPA’s use of meta-analysis. Critics argued that the EPA had succumbed to political pressure from the anti-tobacco lobby. See, e.g., Gio B. Gori & John C. Luik, Passive Smoke: The EPA’s Betrayal of Science and Policy (Vancouver, BC: The Fraser Institute 1999); John C. Luik, “Pandora’s Box: The Dangers of Politically Corrupted Science for Democratic Public Policy,” Bostonia 54 (Winter 1999-94). See also Elizabeth Fisher, “Case law analysis. Passive smoking and active courts: the nature and role of risk regulators in the US and UK. Flue-cured Tobacco Co-op v US Environmental Protection Agency,” 12 J. Envt’l Law 79 (2000).

The federal government has been trying to defend the EPA’s 1992 report, ever since. In 1998, upon listing ETS as a known carcinogen, the Department of Health and Human Services noted that “[t]he individual studies were carefully summarized and evaluated” in the 1992 EPA report. U.S. Dep’t of Health & Human Services, National Toxicology Program, Final Report on Carcinogens – Background Document for Environmental Tobacco Smoke: Meeting of the NTP Board of Scientific Counselors – Report on Carcinogens Subcommittee at 24 (Research Triangle Park, NC 1998). Anti-tobacco scientists, including scientists involved in the EPA report, have attacked the motives of the industry, and of the scientists who have challenged the report. See, e.g., Jonathan M. Samet & Thomas A. Burke, “Turning Science Into Junk: The Tobacco Industry and Passive Smoking,” 91 Am. J. Pub. Health 1742 (2001); Monique E. Muggl, Richard D. Hurt, and James Repace, “The Tobacco Industry’s Political Efforts to Derail the EPA Report on ETS,” 26 Am. J. Prev. Med. 167 (2004); Deborah E. Barnes & Lisa A. Bero, “Why review articles on the health effects of passive smoking reach different conclusions,” 279 J. Am. Med. Ass’n 1566 (1998).

Of course, science did not remain status quo 1992. Later studies were published, and the controversy continued, such that the 1992 meta-analysis is now largely scientifically irrelevant. See James Enstrom & Geoffrey Kabat, “Environmental tobacco smoke and tobacco related mortality in a prospective study of Californians, 1960-98,” 326 Br. Med. J. 1057 (2003); G. Davey Smith, “Effect of passive smoking on health: More information is available, but the controversy still persists,” 326 Br. Med. J. 1048–9 (2003).

A troubling implication of those who attack the tobacco industry is that the industry was not allowed to raise methodological challenges to the EPA’s purported use of a scientific method. The EPA defenders rarely engage with the specifics of the methodological challenge or the district court’s review. Another implication is that the EPA’s meta-analysis remains a clear example of where a regulatory agency could have acted upon a precautionary principle, but chose to dress up its analysis as something it was not: a scientific conclusion of causality. Given that the agency was not even engaged in reviewable agency action, and that it had plenty of biological plausibility for a precautionary finding that ETS causes lung cancer, the agency could easily have avoided the vitriolic debate it engendered with its 1992 report.

Posted in Causation, Conflicts of Interest, Meta-analysis | Comments Off on EPA Cherry Picking (WOE) – EPA 1992 Meta-Analysis of ETS & Lung Cancer – Part 1

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.

Posted in Conflicts of Interest, Scientific Evidence, Scientific Misconduct | Comments Off on Egilman’s Allegations Against McDonald and His Epidemiologic Research Are Baseless

Exposure, Epidemiology, and External Validity under Rule 702

May 14th, 2012

Sometimes legal counsel take positions in court determined solely by the expediency of what expert witnesses are available, and what opinions are held by those witnesses.

Back in the early days of the asbestos litigation in Philadelphia, a hotbed of early asbestos litigation, plaintiffs and defendants each identified a pool of available expert witnesses on lung diseases. Each side found witnesses who held views on important issues, such as whether asbestos caused lung cancer, with or without pre-existing asbestosis, whether all types of asbestos caused mesothelioma, whether asbestos caused gastrointestinal cancers, and whether “each and every exposure was a substantial factor” in producing an asbestos-related disease. Some expert witnesses adopted opinions as a matter of convenience and malleability, but most witnesses expressed sincerely held opinions. Either way, each expert witness active in the asbestos litigation, came to be seen as a partisan of one side. Because of the volume of cases, there was the opportunity to be engaged in a large number of cases, and to earn sizable fees as an expert witness. Both side’s expert witnesses struggled to avoid being labeled hired guns.

A few expert witnesses, eager to avoid being locked in as either a “plaintiff’s” or a “defendant’s” expert witness, with perhaps some damage to their professional reputations, balanced their views in a way to avoid being classified as working exclusively for one side or the other. The late Paul Epstein, MD, adopted this strategy to great effect. Dr. Epstein had excellent credentials, and he was an excellent physician. He was on the faculty at the University of Pennsylvania, and he was a leader in the American College of Physicians, where he was the deputy editor of the Annals of Internal Medicine. Dr. Epstein exemplified gravitas and learning. He was not, however, above adopting views in such a way as to balance out his commitments to both the plaintiffs’ and defense bars. By doing so, Dr. Epstein made himself invaluable to both sides, and he made aggressive cross-examination difficult, if not impossible, when he testified. I suspect his positions had this strategic goal.

In his first testimonies, in the late 1970’s and early 1980’s, Dr. Epstein expressed the view that asbestos exposure caused parietal pleural plaques, but these plaques rarely interfered with respiration. Pleural plaques did not cause impairment or disability, and thus they were not an “injury.” Dr. Epstein’s views were very helpful in obtaining defense verdicts in cases of disputed pleural thickening or plaques, and they led to his being much sought after by defense counsel for their independent medical examinations. Dr. Epstein also strongly believed, based upon the epidemiologic evidence, that asbestos did not cause gastrointestinal or laryngeal cancer.

Dr. Epstein was wary of being labeled a “defendants’ expert” in the asbestos litigation, especially given the social opprobrium that attached to working for the “asbestos industry.” And so, by the mid-1980’s, Dr. Epstein surprised the defense bar by showing up in a plaintiff’s lung cancer case, without underlying asbestosis. Dr. Epstein took the position that if the plaintiff worked around asbestos, and later developed lung cancer, then asbestos caused his lung cancer, and “each and every exposure to asbestos” contributed substantially to the outcome. Risk was causation; ipse dixit. Dr. Epstein recited the Selikoff multiplicative “synergy” theory, with relative risks of 5 (for non-smoking asbestos workers), 10 (for smoking non-asbestos workers), and 50 (for smoking asbestos-exposed workers). Every worker was described with the same set of risk ratios. Remarkably, and unscientifically, Dr. Epstein gave the same risk figures in every plaintiff’s lung cancer case, regardless of the duration or level of exposure. In mesothelioma cases, Dr. Epstein took the unscientific position that all fiber types (chrysotile, amosite, crocidolite, and anthopyllite) contributed to any patient’s mesothelioma.

Dr. Epstein’s views made him off limits to plaintiffs in non-malignancy cases, and off limits to defendants in lung cancer and mesothelioma cases.

Because of his careful alignment with both plaintiffs’ and defense bars, Dr. Epstein’s views were never forcefully challenged. Of course, the Pennsylvania case law in the 1980’s and 1990’s was not particularly favorable to challenges to the validity of opinions about causation, but even as Rule 702 evolved in federal court, both plaintiffs’ and defense counsel were unable to antagonize Dr. Epstein. The inanity of “each and every exposure” was not seriously hurtful in the early asbestos litigation, when the defendants were almost all manufacturers of asbestos-containing insulation, and if a manufacturer had supplied insulation to a worksite, then the proportion of asbestos exposure for that manufacturer would likely have been “substantial.”

Today, the nature of the asbestos litigation has changed, but it when we examine Pennsylvania law and procedure, it is not surprising to see that Dr. Epstein’s views have had a long-lasting effect. Claimants with only pleural plaques have been relegated to an “inactive” docket. Plaintiffs’ expert witnesses still opine that each and every exposure was substantial, without any basis in evidence, and they still recite the same 5x, 10x, and 50x risk ratios, based upon Selikoff’s insulator studies, even though the Philadelphia Court of Common Pleas probably has not seen more than a handful of insulators’ cases in the last decade. Dozens of epidemiologic studies have shown that asbestos exposures of bystander trades, chrysotile factory workers, and other non-insulator, occupational exposures have lower risks of asbestos-related diseases.

The failure to challenge the Selikoff risk ratios is regrettable, especially considering that it was based upon politics, personalities, and not on scientific or legal evidentiary grounds.

As Irving Selikoff observed about his frequently cited statistics:

“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.”

E. Cuyler Hammond, Irving Selikoff, and Herbert Seidman, “Asbestos Exposure, Cigarette Smoking and Death Rates,” 330 Ann. N.Y. Acad. Sci. 473, 487 (1979).

The Selikoff risk figures were unreliable even for insulators, given that the so-called non-smokers were admittedly occasional smokers, and the low relative risk for smokers in the general population came from an historical cohort of relatively healthy American Cancer Society volunteers. The updated risk figures for smokers in the general population placed their lung cancer risk closer to, and above, 20-fold, which raised doubts about Selikoff’s neat multiplicative theory.

The more important lesson though is that the Philadelphia courts, with acquiescence from most defense counsel, never challenged the use of Selikoff’s 5x, 10x, and 50x risk ratios to describe asbestos effects and smoking interactions. Dr. Epstein made such a challenge impolitic and imprudent. In Philadelphia, the Selikoff risk ratios gained a measure of respectability that they never deserved in science, or in the courtroom.

*****

Under Rule 702, the law has evolved to require reasonable exposure assessments of plaintiffs’ exposures, and supporting epidemiology that shows relevant increase risks at the level and the latency actual experienced by each plaintiff. This criterion does not come from a “sufficiency” review as some have suggested; it is clearly a requirement of external validity of the epidemiologic studies relied upon by expert witnesses.

The following cases excluded or limited expert witness opinion testimony with respect to epidemiological studies that the court concluded were not sufficiently similar to the facts of the case to warrant the admission of an expert’s opinion based on their results:

SUPREME COURT

General Electric Co. v. Joiner, 522 U.S. 136 (1997)(questioning the external validity of a study of massive injected doses of PCBs in baby mice, with an outcome unrelated to the cancer claimed by paintiff)

1st Circuit

Sutera v. Perrier Group of America Inc., 986 F. Supp. 655 (D. Mass. 1997)(occupational epidemiology of benzene exposure and benzene does not inform health effects from vanishingly low exposure to benzene in bottled water)

Whiting v. Boston Edison Co., 891 F. Supp. 12 (D. Mass. 1995) (excluding plaintiff’s expert witnesses; holding that epidemiology of Japanese atom bomb victims, and of patients treated with X-rays for spinal arthritis, and acute lymphocytic leukemia (ALL), was an invalid extrapolative model for plaintiff’s much lower exposure)

2d Circuit

Wills v. Amerada Hess Corp., 2002 WL 140542 (S.D. N.Y. 2002)(excluding plaintiff’s expert witness who attempted to avoid exposure assessment by arguing no threshold)(‘‘[E]ven though benzene and PAHs have been shown to cause some types of cancer, it is too difficult a leap to allow testimony that says any amount of exposure to these toxins caused squamous cell carcinoma of the head and neck in the decedent… . It is not grounded in reliable scientific methods, but only Dr. Bidanset’s presumptions. It fails all of the Daubert factors.’’), aff’d, 379 F.3d 32 (2d Cir. 2004)(Sotomayor, J.), cert. denied, 126 S.Ct. 355 (2005)

Amorgianos v. National RR Passenger Corp., 137 F. Supp. 2d 147 (E.D. N.Y. 2001), aff’d, 303 F.3d 256 (2d Cir. 2002);

Mancuso v. Consolidated Edison Co., 967 F.Supp. 1437, 1444 (S.D.N.Y. 1997)

3d Circuit

Magistrini v. One Hour Martinizing Dry Cleaning, 180 F. Supp. 2d 584(D.N.J. 2002), aff’d, 68 Fed. Appx. 356 (3d Cir. 2003);

In re W.R. Grace & Co., 355 B.R. 462 (Bankr. D. Del. 2006)

4th Circuit

White v. Dow Chemical Co., 321 F.Appx. 266, 273 (4th Cir. 2009)

Newman v. Motorola, Inc., 78 Fed. Appx. 292 (4th Cir. 2003)

Cavallo v. Star Enterprise, 892 F. Supp. 756, 764, 773 (E.D. Va. 1995) (excluding opinion of expert witness who failed to identify plaintiff ’s exposure levels to jet fuel, and failed to characterize the relevant dose-response relationship), aff’d in relevant part, 100 F.3d 1150, 1159 (4th Cir. 1996)

5th Circuit

LeBlanc v. Chevron USA, Inc., 396 Fed. Appx. 94 (5th Cir. 2010)

Knight v. Kirby Inland Marine Inc.,482 F.3d 347 (5th Cir. 2007);

Cotroneo v. Shaw Environmental & Infrastructure, Inc., 2007 WL 3145791 (S.D. Tex. 2007)

Castellow v. Chevron USA, 97 F. Supp. 2d 780, 796 (S.D. Tex. 2000) (‘‘[T]here is no reliable evidence before this court on the amount of benzene, from gasoline or any other source, to which Mr. Castellow was exposed.’’)

Moore v. Ashland Chemical Inc., 151 F.3d 269, 278 (5th Cir. 1998) (en banc);

Allen v. Pennsylvania Engineering Corp., 102 F.3d 194, 198-99 (5th Cir. 1996)

6th Circuit

Pluck v. BP Oil Pipeline Co., 640 F.3d 671 (6th Cir. 2011)(affirming district court’s exclusion of Dr. James Dahlgren; noting that he lacked reliable data to support his conclusion of heavy benzene exposure; holding that without quantifiable exposure data, the Dahlgren’s causation opinion was mere “speculation and conjecture”)

Nelson v. Tennessee Gas Pipeline Co., 243 F.3d 244, 252 (6th Cir. 2001)(noting ‘‘with respect to the question of dose, plaintiffs cannot dispute that [their expert] made no attempt to determine what amount of PCB exposure the Lobelvill subjects had received and simply assumed that it was sufficient to make them ill.’’)

Conde v. Velsicol Chemical Corp., 24 F.3d, 809, 810 (6th Cir. 1994)(excluding expert testimony that chlordane,although an acknowledged carcinogen that was applied in a manner that violated federal criminal law, caused plaintiff’s injuries when expert witness’s opinion was based upon high-dose animal studies as opposed to the low-exposure levels experienced by the plaintiffs)

7th Circuit

Cunningham v. Masterwear Corp., 2007 WL 1164832 (S.D. Ind., Apr. 19, 2007)(excluding plaintiff’s expert witnesses who opined without valid evidence of plaintiffs’ exposure to perchloroethylene (PCE)), aff’d, 569 F.3d 673 (7th Cir. 2009) (Posner, J.)(affirming exclusion of expert witness and grant of summary judgment)

Wintz v. Northrop Corp., 110 F.3d 508, 513 (7th Cir. 1997)

Schmaltz v. Norfolk & Western Ry. Co., 878 F. Supp. 1119, 1122 (N.D. Ill. 1995) (excluding expert witness opinion testimony that was offered in ignorance of plaintiff’s level of exposure to herbicide)

8th Circuit

Junk v. Terminix Intern. Co. Ltd. Partnership, 594 F. Supp. 2d 1062, 1073 (S.D. Iowa 2008).

Medalen v. Tiger Drylac U.S.A., Inc., 269 F. Supp. 2d 1118, 1132 (D. Minn. 2003)

National Bank of Commerce v. Associated Milk Producers, Inc., 22 F. Supp. 2d 942 (E.D. Ark. 1998)(excluding causation opinion that lacked exposure level data), aff’d, 191 F.3d 858 (8th Cir. 1999)

Bednar v. Bassett Furniture Mfg. Co., Inc.,147 F.3d 737, 740 (8th Cir. 1998) (“The Bednars had to make a threshold showing that the dresser exposed the baby to levels of gaseous formaldehyde known to cause the type of injuries she suffered”)

Wright v. Willamette Industries, Inc., 91 F.3d 1105, 1106 (8th Cir. 1996) (affirming exclusion; requiring evidence of actual exposure to levels of substance known to cause claimed injury)

National Bank of Commerce v. Dow Chemical Co., 965 F. Supp. 1490, 1502 (E.D. Ark., 1996)

9th Circuit

In re Bextra & Celebrex Marketing Sales Practices & Product Liab. Litig., 524 F. Supp. 2d 1166, 1180 (N.D. Cal. 2007)(granting Rule 702 exclusion of expert witness’s opinions with respect to low dose, but admitting opinions with respect to high dose Bextra and Celebrex)

Henricksen v. ConocoPhillips Co., 605 F. Supp. 2d 1142, 1157 (E.D. Wash. 2009)

Valentine v. Pioneer Chlor Alkali Co., Inc., 921 F. Supp. 666, 676 (D. Nev. 1996)

Abuan v. General Electric Co., 329 F.3d 329, 333 (9th Cir. 1993) (Guam)

10th Circuit

Maddy v. Vulcan Materials Co., 737 F.Supp. 1528, 1533 (D.Kan. 1990) (noting the lack of any scientific evidence of the level or duration of plaintiff’s exposure to specific toxins).

Estate of Mitchell v. Gencorp, Inc., 968 F. Supp. 592, 600 (D. Kan. 1997), aff’d,165 F.3d 778, 781 (10th Cir. 1999)

11th Circuit

Brooks v. Ingram Barge Co., 2008 WL 5070243 *5 (N.D. Miss. 2008)) (noting that plaintiff’s expert witness “acknowledges that it is unclear how much exhaust Brooks was exposed to, how much exhaust it takes to make developing cancer a probability, or how much other factors played a role in Brooks developing cancer.”)

Cuevas v. E.I. DuPont de Nemours & Co., 956 F. Supp. 1306, 1312 (S.D. Miss. 1997)

Chikovsky v. Ortho Pharmaceutical Corp., 832 F. Supp. 341, 345–46 (S.D. Fla. 1993)(excluding opinion of an expert witness who did not know plaintiff’s actual exposure or dose of Retin-A, and the level of absorbed Retin-A that is unsafe for gestating women)

Savage v. Union Pacific RR, 67 F. Supp. 2d 1021 (E.D. Ark. 1999)

STATE CASES

California

Jones v. Ortho Pharmaceutical Corp., 163 Cal. App. 3d 396, 404, 209 Cal. Rptr. 456, 461 (1985)(duration of use in relied upon studies not relevant to plaintiffs’ use)

Michigan

Nelson v. American Sterilizer Co., 566 N.W. 2d 671 (Mich. Ct. App. 1997)(affirming exclusion of expert witness who opined, based upon high-dose animal studies, that plaintiff’s liver disease was caused by low-level exposure to chemicals used in sterilizing medical equipment)

Mississippi

Watts v. Radiator Specialty Co., 2008 WL 2372694 *3 (Miss.2008);

Ohio

Valentine v. PPG Indus., Inc., 158 Ohio App. 3d 615, 821 N.E.2d 580 (2004)

Oklahoma

Christian v. Gray, 2003 Okla. 10, 65 P.3d 591, 601 (2003);

Holstine v. Texasco, 2001 WL 605137 (Okla. Dist. Ct. 2001)(excluding expert witness testimony that failed to assess plaintiff’s short-term, low-level benzene exposure as fitting the epidemiology relied upon to link plaintiff’s claimed injury with his exposure)

Texas

Merrell Dow Pharm., Inc. v. Havner, 953 S.W.2d 706, 720 (Tex. 1997) (“To raise a fact issue on causation and thus to survive legal sufficiency review, a claimant must do more than simply introduce into evidence epidemiological studies that show a substantially elevated risk. A claimant must show that he or she is similar to those in the studies.”).

Merck & Co. v. Garza, 347 S.W.3d 256 (Tex. 2011)

Frias v. Atlantic Richfield Co., 104 S.W.3d 925, 929 (Tex. App. Houston 2003)(holding that plaintiffs’ expert witness’s testimony was inadmissible for relying upon epidemiologic studies that involved much higher levels of exposure than experienced by plaintiff)

Daniels v. Lyondell-Citgo Refining Co, 99 S.W.3d 722 (Tex. App. 2003) (claim that benzene exposure caused plaintiff’s lung cancer had to be supported with studies of comparable exposure, and latency, as that observed and reported in the studies)

Austin v. Kerr-McGee Refining Corp., 25 S.W.3d 280, 292 (Tex. App. Texarkana 2000)

Posted in Causation, Conflicts of Interest, Risk and Risk Factor, Rule 702, Scientific Evidence | Comments Off on Exposure, Epidemiology, and External Validity under Rule 702

Discovery into the Origin of Historian Expert Witnesses’ Opinions

January 30th, 2012

As every trial lawyer in America knows, the Federal Rules of Civil Procedure were recently changed to protect expert witness draft reports and lawyer-expert witness communications from discovery. See Rule 26. Duty to Disclose; General Provisions Governing Discovery (amended effective December 2010).

In particular, Rule 26(b) (4)(B), and (C) provides:

(4)(B) Trial-Preparation Protection for Draft Reports or Disclosures. Rules 26(b)(3)(A) and (B) protect drafts of any report or disclosure required under Rule 26(a)(2), regardless of the form in which the draft is recorded.

(C) Trial-Preparation Protection for Communications Between a Party’s Attorney and Expert Witnesses. Rules 26(b)(3)(A) and (B) protect communications between the party’s attorney and any witness required to provide a report under Rule 26(a)(2)(B), regardless of the form of the communications, except to the extent that the communications:

(i) relate to compensation for the expert’s study or testimony;

(ii) identify facts or data that the party’s attorney provided and that the expert considered in forming the opinions to be expressed; or

(iii) identify assumptions that the party’s attorney provided and that the expert relied on in forming the opinions to be expressed.

In some ways, this amendment was a retrograde step. Although protecting drafts and communications from discovery helps ease the expense and inconvenience of working with expert witnesses, the amendment also serves to protect unscrupulous lawyers and expert witnesses who work in concert to present tendentious opinions.

In the sciences, tendentious opinions will ultimately be embarrassed by future facts, but in the field of history, the interpretative narratives are often unfalsifiable and malleable. Discovery into the creative process of historian expert witnesses’ opinions needs to be complete and thorough.

Consider the consider the case of Barry Castleman, who has testified for decades for the asbestos litigation industry, on historical issues in asbestos personal injury cases. Back in 1986, when Castleman was still “researching” his opinions, he received a letter from plaintiffs’ lawyer, Tom Hart:

Mr. Barry Castleman January 9, 1986
1722 Linden Avenue
Baltimore, Maryland 21217

RE: Kenneth Lynch

Dear Barry:

As a follow-up to our conversation on January 6, 1986, I have reviewed our files and find that we do not have a file on Kenneth Lynch. Apparently I was provided with some of these papers indirectly. I seem to recall that the attorneys from California came to South Carolina and conducted the search for Kenneth Lynch’s papers.

We have not been eager to pursue this due to our understanding that Dr. Lynch was not convinced that asbestos was a cause of cancer. Despite his earlier publications, he remained personally reluctant to state that asbestos was causally related to the formation of cancers until some time in the late 1950’s or early 1960’s. This indecision on his part would be contrary to our best interests in the asbestos litigation and, accordingly, we have discouraged other counsel from exploring this further.

Since we do not have the specific documents you need, perhaps Marcia Hughes could provide them to you from Dick Gerry’s office in San Diego.

With best regards, I am

Very truly yours,

Thomas H. Hart, III

Dr. Lynch was a well-known South Carolina pathologist, who, along with Dr. William Smith, published a case report of lung cancer in a patient with asbestosis. See Kenneth M. Lynch & William A. Smith, “Pulmonary asbestosis III: carcinoma of lung in asbestosilicosis,” 23 Am. J. Cancer 56 (1935). Plaintiffs’ counsel were eager to over interpret this case report as showing an association, which was beyond the ability of a single, uncontrolled case to do.

The new Rule can be seen to have a few holes in it. Discovery is permitted into facts or data provided by counsel, and which were considered by the expert witness. Discovery is also permitted into the identity of assumptions given by the directing counsel, and relied upon by the expert witness. The letter from Hart to Castleman above, however, illustrates that important insights may result from suggestions, implicit or explicit, not to look at certain facts.

Posted in Conflicts of Interest, Historian Testimony, Trial Procedure, Underlying Data | No Comments »

Ethics and Statistics

January 21st, 2012

Chance magazine has started a new feature, the “Ethics and Statistics column, which is likely to be of interest to lawyers and to statisticians who work on litigation issues. The column is edited by Andrew Gelman. Judging from the Gelman’s first column, I think that the column may well become a valuable forum for important scientific and legal issues arising from studies used in public policy formulation, and in reaching conclusions that are the bases for scientific expert witnesses’ testimony in court.

Andrew Gelman is a professor of statistics and political science in Columbia University. He is also the director of the University’s Applied Statistics Center. Gelman’s inaugural column touches on some issues of great importance to legal counsel who litigate scientific issues involving scientific studies: access to underlying data in the studies that are the bases for expert witness opinions. See Andrew Gelman, “Open Data and Open Methods,” 24 Chance 51 (2011).

Gelman acknowledges that conflicts are not only driven by monetary gain; they can be potently raised by positions or causes espoused by the writer:

“An ethics problem arises when you are considering an action that

(a) benefits you or some cause you support,

(b) hurts or reduces benefits to others, and

(c) violates some rule.”

Id. at 51a.

Positional conflicts among scientists whose studies touch upon policy issues give rise to “the ethical imperative to share data.” Id. at 51c. Naming names, Professor Gelman relates an incident in which he wrote to an EPA scientist, Carl Blackman, who had presented a study on the supposed health effects of EMF radiation. Skeptical of how Blackman had analyzed data, Gelman wrote to Blackman to request his data to carry out additional, alternative statistical analyses. Blackman answered that he did not think these other analyses were needed, and he declined to share his data.

This sort of refusal is all too common, and typical of the arrogance of scientists who do not want others to be able to take a hard look at how they arrived at their conclusions. Gelman reminds us that:

“Refusing to share your data is improper… .”

* * * *

“[S]haring data is central to scientific ethics. If you really believe your results, you should want your data out in the open. If, on the other hand, you have a sneaking suspicion that maybe there’s something there you don’t want to see, and then you keep your raw data hidden, it’s a problem.”

* * * *

“Especially for high-stakes policy questions (such as the risks of electric power lines), transparency is important, and we support initiatives for automatically making data public upon publication of results so researchers can share data without it being a burden.”

Id. at 53.

To be sure, there are some problems with sharing data, but none that is insuperable, and none that should be an excuse for withholding data. The logistical, ethical, and practical problems of data sharing should now be anticipated long before publication and the requests for data sharing arrive.

Indeed, the National Institutes of Health requires data sharing plans to be part of a protocol for a federally funded study. See Final NIH Statement on Sharing Research Data (Feb. 26, 2003). Unfortunately, the NIH’s implementation and enforcement of its data-sharing policy is as spotty as a Damien Hirst painting. See “Seeing Spots” The New Yorker (Jan. 23, 2012).

Posted in Conflicts of Interest, Data Sharing, Rule 702, Scientific Evidence, statistical evidence | No Comments »

Beware the Academic-Publishing Complex!

January 11th, 2012

Today’s New York Times contains an important editorial on an attempt by some congressmen to undermine access to federally funded research. See Michael B. Eisen, “Research Bought, Then Paid For” New York Times (January 11, 2012). Eisen’s editorial alerts us to this attempt to undo a federal legal requirement that requires federally funded medical research be made available, for free, on the National Library of Medicine’s Web site (NLM).

As a founder of the Public Library of Science (PLoS), which is committed to promoting and implementing the free distribution of scientific research, Eisen may be regarded as an “interested” ora biased commentator. Such a simple-minded ascription of bias would be wrong. The PLoS has become an important distribution source of research results in the world of science, and competes with the publishing oligarchies: Elsevier, Springer, and others. The articles of the sort that PLoS makes available for free are sold by publishers for $40 or more. Subscriptions from these oligarchical sources are often priced in the thousands of dollars per year. Eisen’s simple and unassailable point is that the public, whether the medical profession, patients and citizens, students and teachers, should be able to read about the results of research funded with their tax monies.

“[I]f the taxpayers paid for it, they own.”

The United States government and its employees do not enjoy copyright protections for their creative work (and they do not), neither should their contractors.

Public access is all the more important given that the mainstream media seems so reluctant or unable to cover scientific research in a thoughtful and incisive way.

The Bill goes beyond merely unraveling a requirement of making published papers available free of charge at the NLM. The language of the Bill, H.R.3699, the Research Works Act, creates a false dichotomy between public and private sector research:

“SEC. 2. LIMITATION ON FEDERAL AGENCY ACTION.

No Federal agency may adopt, implement, maintain, continue, or otherwise engage in any policy, program, or other activity that—

(1) causes, permits, or authorizes network dissemination of any private-sector research work without the prior consent of the publisher of such work … .”

Work that is conducted in private or in state universities, but funded by the federal taxpayers, cannot be said to be “private” in any meaningful sense. The public’s access to this research, as well as its underlying data, is especially important when the subject matter of the research involves issues that are material to public policy and litigation disputes.

Who is behind this bailout for the private-sector publishing industry? Congressman Darrell Issa (California) introduced the Bill, on December 16, 2011. The Bill was cosponsored by Congresswoman Carolyn B. Maloney, the Democratic representative of New York’s 14th district. Oh Lord, Congresswoman Maloney represents me! NOT. How humiliating to be associated with this regressive measure.

This heavy-handed piece of legislation was referred to the House Committee on Oversight and Government Reform. Let us hope it dies a quick death in committee. See Michael Eisen, “Elsevier-funded NY Congresswoman Carolyn Maloney Wants to Deny Americans Access to Taxpayer Funded Research” (Jan. 5, 2012).

Posted in Conflicts of Interest, Data Sharing, Peer Review | No Comments »

The Continuing Saga of Bad-Faith Assertions of Conflicts of Interest

December 28th, 2011

Conflicts of interest (COI), real or potential, have become a weapon used to silence the manufacturing industry in various scientific debates and discussions. Other equally “interested” parties, labor unions, advocacy groups, and consultants to the other industry – the litigation industry – have used conflicts and ethical claims to silence the manufacturing industry and to engage in unfettered false scientific speech. The public, unwilling and untrained to look at evidence on the merits, is conditioned to accepting an allegation of COI as the end of the discussion on scientific issues.

Recently, journalist Shannon Brownlee criticized the FDA for its suggestion that the agency was having difficulty in finding experts who cleared the agency’s conflict-of-interest prohibitions. Brownlee explicitly contended that she could easily find “unbiased” scientists who could advise the agency on drug and device issues.

Shannon Brownlee, “Is There an Independent Unbiased Expert in the House” (Aug. 3, 2011).

Indeed, Brownlee sent FDA Commissioner Margaret Hamburg a list of allegedly neutral experts who could advise the agency. Brownlee gave everyone on her list a clean bill of ethical health, and has published the list on multiple occasions, both on the website Healthnewsreview.org, and a few years ago, in the British Medical Journal: Jeanne Lenzer & Shannon Brownlee, “Is there an (unbiased) doctor in the house?” 337 Brit. Med. J. 206 (2008).

Brownlee tells us that journalists from respectable print media, including the New York Times, and the Wall Street Journal, have requested the list, apparently to contact the “unbiased” experts to help investigate news stories about drugs and medical devices. What the gullible may not appreciate is that the list fallaciously is based upon only one exclusionary criterion: having consulted for the pharmaceutical industry. The list omits other important COI exclusionary criteria, such as having consulted for the litigation industry, or having taken erroneous, unwarranted, and ideologically driven positions on scientific issues.

What litigation industry? Brownlee may have missed the fact that plaintiffs’ lawyers represent a huge financial interest in obtaining compensation for others, with 40 percent of the proceeds going to themselves. This litigation industry thrives, even with Dickie Scruggs in prison, and Stanley Chesley in disrepute.

In today’s litigation environment, with aggregation of claims in federal multi-district cases, plaintiffs’ counsel stand to profit in the billions from scientific positions espoused by their expert witnesses.

Who are the litigation industry expert witnesses on Brownlee’s list? Here are some obvious candidates:

Peter R. Breggin, MD, psychiatrist, clinical psychopharmacologist, independent author and scientist; Founder and Director Emeritus, International Center for the Study of Psychiatry and Psychology

Adriane Fugh-Berman, MD, Professor, Department of Physiology and Biophysics, Georgetown University Medical Center; Director, PharmedOut.org

Curt Furberg, MD, PhD, Professor of Public Health Sciences, Wake Forest University School of Medicine

Joseph Glenmullen, MD, Clinical instructor in psychiatry, Harvard Medical School

Bruce Psaty, MD, PhD, Professor, Medicine & Epidemiology, University of Washington Cardiovascular Health Research Unit

Also on the list were well-known anti-industry zealots, who focus almost exclusively on the manufacturing industry, while ignoring or endorsing the excesses and unwarranted claims of the litigation industry:

Lisa Bero, PhD, Professor, University of California, San Francisco U.S.

Sheldon Krimsky, PhD, Tufts University & Council for Responsible Genetics

Sidney Wolfe, MD, Director, Health Research Group of Public Citizen.

Now some people may claim that the litigation industry consultants, and the anti-industry zealots, take their positions not to please their sponsors, or to pursue lucrative opportunity, but because they fervently believe the positions that they take. But then why not give the pharmaceutical industry consultants the same benefit of the doubt? Indeed, why not move beyond COI allegations to creating lists of scientists and physicians who have demonstrated proficiency in advancing evidence-based judgments that have withstood the test of time?

This anti-industry hypocrisy manifests not only in assertions of conflicts of interest, but also in calls for industry to disclose all underlying data from industry-funded or sponsored studies, while taking a protectionist stance on all other underlying data.

Let’s hope that in 2012, industry fights back, and evidence regains its primary role in resolving scientific disputes.

Posted in Conflicts of Interest, Scientific Evidence | 1 Comment »

Silica Science – Junk Science is Not Limited to The Courts

December 12th, 2011

“Clowns to the left of me; Jokers to the right; here I am, stuck in the middle with you.”

David Michaels, head of OSHA, back in October, was testifying at a House congressional oversight hearing, “Workplace Safety: Ensuring a Responsible Regulatory Environment.” The Congressmen were inquiring into OSHA’s enforcement and regulatory initiatives on several fronts, including silica exposures.

This is the same David Michaels who used to be a hired expert witness for plaintiffs in toxic tort cases. See “David Michaels’ Public Relations Problem,” (Dec. 2, 2011).

Not surprisingly, when the questioning turned to silica, Michaels played the cancer card: crystalline silica is a “known” human carcinogen.

Republican congressman Larry Bucshon (R-IN), a surgeon when he is not holding forth in Congress, found the talk of cancer to be provocative. Buchson scolded Michaels:

“I don’t like it when people use buzz words that try to get people’s attention, and cancer is one of those.”

* * * * *

“…I’m a thoracic surgeon, so I want to focus a little bit on what you said earlier as it relates to silica dust. I’m curious about your comment about silica-dust related lung cancer, because I’ve been a thoracic surgeon for 15 years and I’ve done a lot of lung cancer surgery, and I haven’t seen one patient that’s got it from silica dust.”

A fascinating exchange for several reasons.

First, we could expect Michaels to play the cancer card, just as he has in his role as plaintiffs’ expert witness. As we will see, his cancer evidence is not far fetched, although it is also not particularly convincing.

Second, the junk science from Congressman Buchson is distressing. As a physician, he should know better that his experience in surgery has no relevance at all to the question whether crystalline silica can cause lung cancer.

Back in 1996, a working group of the World Health Organization’s International Agency for Research on Cancer (IARC) voted to reclassify crystalline silica, the most ubiquitous mineral on the face of Planet Earth, a known human carcinogen. Michaels recited this “evidence,” but he failed to mention that the evidence was conflicting, as were the votes of the working group. The response of the scientific community to the IARC pronouncement was highly critical. See Patrick A. Hessel, John F. Gamble, J. Bernard L. Gee, Graham Gibbs, Francis H.Y. Green, W. Keith C. Morgan, and Brooke T. Mossman, “Silica, Silicosis, and Lung Cancer: A Response to a Recent Working Group Report,” 42 J. Occup. Envt’l Med. 704 (2000).

The vote of the working group was very close; indeed, the swing of a single vote would have changed the outcome. One of the working group members later wrote:

“Some equally expert panel of scientists presented with the same information on another occasion could of course have reached a different verdict. The evidence was conflicting and difficult to assess and such judgments are essentially subjective.”

Corbett McDonald & Nicola Cherry, “Crystalline Silica and Lung Cancer: The Problem of Conflicting Evidence,” 8 Indoor Built Environment 121, 121 (1999). Remarkably, this panel member explained his decision to vote for reclassification as follows:

“The basic problem was that the evidence for carcinogenicity was conflicting – generally absent in situations of high and widespread exposure and strong only in a few rather special occupations. The advice by the IARC to consider hazard rather than risk did much to resolve the difficulty.”

Id. at 125. I suspect that the evidence for a difference in meaning between “hazard” and “risk” is even more tenuous and conflicting than the evidence in favor of carcinogenicity.

IARC classifications, however, take on a life of their own. They are an invitation to stop thinking, and to stop analyzing the evidence. Federal bureaucrats and staff scientists love them for exactly this reason: they can hide behind the authority of the WHO without having to work on reviewing the evidence, or updating their judgment when new studies come out.

It should not be surprising, therefore, that the National Institutes of Health’s National Toxicology Program (NTP), working off the WHO decision, recognized crystalline silica as a human carcinogen. Other groups followed in lock step. Other agencies and medical groups followed.

What you will not hear from Michaels or his followers is that when the National Institute for Occupational Safety and Health conducted the largest mortality study on the issue, it found a decreased lung cancer risk among men who actually had sufficient silica exposure to develop silicosis. See Geoffrey Calvert, et al., “Occupational silica exposure and risk of various diseases: an analysis using death certificates from 27 states of the United States,” 60 Occup. Envt’l Med. 122 (2003). Cf. “Congressman tells OSHA chief not to use “buzz” words like cancer.” (Oct. 10, 2011).

To give the devil his due, at least Michaels had “some” evidence to support his pronouncement, even if the evidence was incomplete and contradicted by other important evidence. Congressman Bucshon’s recitation of his experience as a surgeon was completely off the mark. His staffers obviously failed him in their research, and Bucshon’s reliance upon his own anecdotal experience was quite inappropriate to rebut the dubious judgment of the OSHA Administrator.

Some people might describe the exchange between Bucshon and Michaels as resembling two monkeys playing chess. I think of it as exemplifying the scientific illiteracy in all three branches of our government.

David Michaels’ Public Relations Problem

Posted in Conflicts of Interest, Scientific Evidence | No Comments »

David Michaels’ Public Relations Problem

December 2nd, 2011

OSHA requires strong, credible leadership from someone who will not outrun his scientific headlights, while at the same time enforcing standards that protect workers. President Obama made a serious error in appointing David Michaels, whose scientific and enforcement bona fides are weak.

Michaels has made a career out of targeting industry for perceived ethical lapses, yet he has routinely failed to make adequate disclosures himself, and some of his disclosures are downright deceptive. This hypocrisy might be shrugged off as part of the politicization of occupational and environmental medicine, except that Michaels is now an Undersecretary of Labor. When his agency starts handing out legal opinion letters to his former employers in the United States litigation industry, Michaels’ hypocrisy becomes something of a public nuisance and a scandal. See “Manufacturing Certainty” (Oct. 25, 2011). The Department of Labor’s “Dear Mr. Wodka” letter can now be found online at OSHA’s website.

Well before David Michaels became head of OSHA, his hypocrisy over conflicts of interest was noteworthy. See “Hypocrisy In Conflict Disclosure Rules.” In his book, Doubt is Their Product: How Industry’s War on Science Threatens Your Health (2008), Michaels provides no disclosure of his prior activities and testimonial adventures on behalf of the litigation industry. There is, among his acknowledgments, a tip of the hat to friends and colleagues, such as Steven Wodka. Wodka is a plaintiffs’ lawyer who retained and paid Michaels in various litigations, but you will not learn that from reading Doubt is Their Product. Not surprisingly, this book is waved around by plaintiffs’ counsel in cross-examinations in courtrooms all across the United States.

Michaels does reveal that his organization, The Project on Scientific Knowledge and Public Policy (SKAPP), accepted funding from “the Common Benefit Trust, a fund established pursuant to a court order in the Silicone Gel Breast Implant Products Liability Litigation.” This revelation is, however, quite misleading. The “Trust” is a fund for plaintiffs’ counsel in the silicone gel breast implant litigation, which was diverted to help support Michaels, and others who would advocate against evidence-based limitations to expert witness opinions.

Michaels insists that SKAPP accepts only unrestricted funding, but this insistence is also misleading. Plaintiffs’ counsel could feel safe putting “their” money into the coffers of SKAPP, which was openly committed to undermining the implementation of evidence-based standards for causation opinion testimony in federal and state courts. If the manufacturing industry, as opposed to the litigation industry, funded a not-for-profit, headed up by one of its testifying expert witnesses, most folks would call this maneuver “money laundering.” Dirty money is dirty money, regardless whose ox is gored. See also David Michaels & Celeste Monforton, “Scientific Evidence and the Regulatory System: Manufacturing Uncertainty and the Demise of the Formal Regulatory System,” 18 J. Law & Policy 17 (2005) (“Major support for SKAPP is provided by the Common Benefit Trust, a fund established pursuant to a court order in the Silicone Gel Breast Implant Products Liability Litigation.”).

Other anemic or absent conflict of interest disclosures abound in Michaels’ publications.

Michaels has been involved in at least four different mass tort litigations, involving alleged injuries from exposures to asbestos, ortho-toluidene, beryllium, and vinyl chloride. He has collaborated with Wodka in three of these litigations, by serving as Wodka’s expert witness. This litigation collaboration should raise serious questions about the “Dear Mr. Wodka letter.”

Asbestos Litigation

Michaels has written several publications about health outcomes in sheet metal workers. The premise of these papers is that the workers were exposed to asbestos, and they might have greater than expected cancer mortality as a result. Most of Michaels’ papers fail to reveal that he consulted and testified for asbestos claimants. See, e.g., David Michaels & Stephen Zoloth, “Asbestos Disease in Sheet Metal Workers: Proportional Mortality Update,” 13 Am. J. Indus. Med. 731-734 (1988).

One of Michaels’ publications on asbestos exposure and health outcomes does contains a disclosure, which even reveals on which side of asbestos litigation he worked:

“This work was supported by the Sheet Metal Occupational Health Institute Trust. Drs. Welch, Michaels, and Dement have worked as consultants for law firms representing individuals with asbestos-related disease. None of the authors have a financial interest in any organization that could profit from the research presented here.”

Laura Welch, Elizabeth Haile, John Dement, and David Michaels, “Change in Prevalence of Asbestos-Related Disease Among Sheet Metal Workers 1986 to 2004,” 131 Chest 863, 863 (2007). Note the advocacy even in the disclosure. Law firms that represent only individuals with asbestos-related disease! Do we infer from this that Michaels did not consult for any law firms that represented individuals who claimed asbestos-related disease, but where the truth in God’s eye would have it that their claims were erroneous? Perhaps the Principle of Charity requires us to infer that Michaels meant to disclose that he consulted for firms that represented persons claiming asbestos-related disease. Having read Michaels’ litigation testimony, however, I think he really meant to say that what appears in the article.

There have been many thousands of asbestos cases, most of which have been settled or dismissed. It is thus difficult to know exactly how many asbestos cases have seen the consulting work of David Michaels. Clearly, however, some of Michaels’ asbestos testimony was given at the request of Steve Wodka, for Wodka’s clients. See David Michaels deposition testimony at p. 41, in Nicastro v. Aceto Corp., New Jersey Superior Court, Law Division for Monmouth County, Docket No. L-3062-08 (Sept. 2, 2009).

Ortho-Toluidine Litigation

According to federal Magistrate Judge H. Kenneth Schroeder, Jr., Steve Wodka represents numerous plaintiffs who claim to have been harmed by exposure to ortho-toluidine. David Michaels is a common fixture in these cases brought by Wodka. See Pardee v. E.I. DuPont Nemours & Co., Case 1:07-cv-00268-WMS-HKS Document 29 (W.D.N.Y. March 31, 2008). Faced with losing his expert witness to OSHA, Wodka noticed a trial deposition de bene esse of David Michaels in several cases.

Michaels was permitted to give his testimony, before moving into his OSHA position, in the following cases:

Pardee v. E.I. DuPont Nemours & Co., W.D.N.Y., Plaintiff, No. 07-CV-0268S(Sr)

Band v. E.I. DuPont Nemours & Co., W.D.N.Y., No. 07-CV-0267S(Sr)

Weist v. E.I. DuPont Nemours & Co., W.D.N.Y., No. 05-CV-0534A(Sr)

Nicastro v. Aceto Corp., New Jersey Superior Court, Law Division for Monmouth County, Docket No. L-3062-08

Polyvinyl Chloride Litigation

David Michaels served as a plaintiffs’ expert witness in at least one PVC case, Lattin v. Borden Chemical Co., New Jersey Superior Court, Law Div. Mercer Cty. Docket No. L-3850-01. Mr. Wodka was the attorney for plaintiff.

Beryllium Litigation

One of David Michaels’ publications criticized the beryllium industry, on grounds that it advanced weak scientific data and arguments against changes in permissible exposure limits. David Michaels & Celeste Monforton, “Beryllium’s Public Relations Problem: Protecting Workers When There Is No Safe Exposure Level,” 123 Public Health Reports 79 (2008). In this article, Michaels acknowledges that he “served as an expert witness in a civil suit involving chronic beryllium disease.” Apparently, Michaels forgot to point out that he was paid for his services, and that the payor was the claimant, whose interests he was advancing in his paper.

Marc Kolanz for one of the companies sued over beryllium health claims noted, in rebuttal, that:

“Dr. Michaels is a paid expert witness in beryllium litigation. Dr. Michaels’ has not published beryllium industrial hygiene or medical research; however, he has provided litigation support serving as a paid expert witness for plaintiffs in beryllium litigation. Consistent with this role, as a hired advocate for plaintiff’s counsel, he has sought to ‘manufacture certainty’ by applying a hindsight approach to criticize the good works of dedicated beryllium researchers.”

Marc Kolanz, “Beryllium History and Public Policy,” 123 Public Health Reports 423, 427 (2008).

Michaels was an expert witness for Philadelphia plaintiffs’ attorney, Ed Reeves, in the Lonnie Pierce case, in Pennsylvania.

* * * *

There is nothing ignoble or disreputable in serving as an expert witness. Indeed, real experts may well have an obligation to make their expertise available to the civil and criminal justice system. What is unseemly is the incessant hypocrisy in accusing manufacturing industry of conflicts of interest, while hiding and misrepresenting litigation industry conflicts. David Michaels has been in the forefront of this hypocrisy. The “Dear Mr. Wodka” letter deserves more scrutiny under the principles that Michaels has advocated for manufacturing industry.

Posted in Conflicts of Interest | 1 Comment »

Lording the Data – Scientific Fraud

November 10th, 2011

Last week, the New York Times published a news story about psychologist Diederik Stapel, of the Netherlands. Tilburg University accused him of having committed research fraud in several dozen published papers, including the journal Science, the official journal of the AAAS. See Benedict Carey, “Fraud Case Seen as a Red Flag for Psychology Research: Noted Dutch Psychologist, Stapel, Accused of Research Fraud,” New York Times (Nov. 2, 2011). The Times expressed surprise over the suggestion that psychology is plagued by fraud and sloppy research. The surprise is that there are not more stories in the lay media over the poor quality of scientific research. The readers of Retraction Watch, and the Office of Research Integrity’s blog will recognize how commonplace Stapel’s fraud is.

Stapel’s fraud has wide-ranging implications for the doctoral students, whose dissertations he supervised, and for colleagues, with whom he collaborated. Stapel apologized and expressed his regret, but his conduct leaves a large body of his work, and that of others, under a cloud of suspicion.

Lording the Data

The University committee reported that Stapel had escaped detection for a long time because he was “lord of the data,” by refusing to disclose and share the data.

“Outright fraud may be rare, these experts say, but they contend that Dr. Stapel took advantage of a system that allows researchers to operate in near secrecy and massage data to find what they want to find, without much fear of being challenged.”

Benedict Carey, “Fraud Case,” New York Times (Nov. 2, 2011). Data sharing is preached but rarely practice.

In a recent publication, Dr. Wicherts and his colleagues, at the University of Amsterdam, reported that two-thirds of his sample of Dutch research psychologists refused to share their data, in contravention of the established ethical rules of the discipline. Remarkably, many of the refuseniks had explicit contractual obligations with their publishing journals to provide data. Jelte Wicherts, Marjan Bakker, Dylan Molenaar, “Willingness to Share Research Data Is Related to the Strength of the Evidence and the Quality of Reporting of Statistical Results,” PLoS ONE 6(11): e26828 (Nov. 2, 2011)

Scientific fraud seems no more common among scientists with industry ties, which are so often the subject of ad hominem conflict of interest claims. Instead, fraudfeasors such as Stapel or Hwang Woo-suk are more often simply egotistical, narcissistic, self-aggrandizing, self-promoting, or delusional. In the United States, litigation, occasionally has brought out charlatans, but it has also resulted in high-quality studies that have provided strong evidence for or against litigation claims. Compare Hon. Jack B. Weinstein, “Preliminary Reflections on Administration of Complex Litigation” 2009 Cardozo L. Rev. de novo 1, 14 (2009) (describing plaintiffs’ expert witnesses in silicone litigation as “charlatans” and the litigation as largely based upon fraud) with Committee on the Safety of Silicone Breast Implants, Institute of Medicine, Safety of Silicone Breast Implants (Wash. D.C. 1999) (reviewing studies, many of which were commissioned by litigation defendants, and which collectively showed lack of association between silicone and autoimmune diseases).

The relation between litigation and research is one that has typically been approached by self-righteous voices, such as David Michaels and David Egilman, and others who have their own deep conflicts of interest. What is clear is that all litigants, as well as the public, would benefit from enforcing data sharing requirements. See “Litigation and Research” (April 15, 2007) (science should not be built upon blind trust of scientists: “Nullius in verba.”).

The Times article emphasized Wicherts’ research about lack of data sharing, and suggested that data sharing could improve the quality of scientific publications. The time may have come, however, for sterner measures of civil and criminal penalties for scientists who abuse and waste governmental funding, or who aid and abet fraudulent litigation.

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