The historians of conscience are at it, again.  Professor David Rosner, of Columbia University, and Gerald Markowitz, of John Jay College, City University of New York, testify for plaintiffs in products liability cases.  They are paid for their troubles, but they do not like the idea that other historians testify for the defendants.  It is another example of those pesky asymmetries that people have in their beliefs about conflicts of interest, access to underlying data, and other issues that surround contemporary products liability litigation.

In the current issues of Academe, Rosner and Markowitz describe their troubles as testifiers.  See “The Historians of Industry” (November – December 2010), at <http://www.aaup.org/AAUP/pubsres/academe/2010/ND/feat/mark.htm>

Their description of their testimonial adventures is noteworthy on several scores:

“Five years ago, one of us received an odd e-mail. ‘Dear Dr. Rosner’, it began. ‘I am writing to introduce you to the Round Table Group, and to notify you of a short-term consulting opportunity which may be of interest. Our client is seeking an historian, highly credentialed, at a prestigious university to perform some historical research, and instruct a lay jury about what was known about a particular occupational hazard (lead paint contamination) in 1950 to 1980.’

The letter went on to explain how the historian they sought “need not be a subject matter expert” but need only be a good communicator’ who could ‘easily communicate a story to a jury. The e-mail continued in some detail, telling how the process would work: if David were interested, he could send in his résumé, a brief explanation of his expertise, and a statement of his consulting fee. The note continued by informing him about the consulting group: it was a consortium of several thousand professors in management, law, medicine, science, computer science, education, engineering, economics, and other disciplines who make themselves available to law firms and companies who are clients of the Round Table Group.”

Rosner’s description of this solicitation is fascinating for what it leaves out. 

Rosner acknowledges that this article is essentially a republication of articles that previously appeared in two other journals.  Actually, he failed to acknowledge that this material actually was published previously three times.  Historians apparently are not subject to the same ethical rules as scientists on not gratuitously republishing the same material, over and over.  Rosner and Markowitz’ article in Academe is their fourth iteration of the same theme, with much of the same content.  Perhaps the inference is that historians, like history, are doomed to repeat themselves. See Schachtman, How Testifying Historians Are Like Lawn-Mowing Dogs (May 15, 2010).  The prior publications were:

1. D. Rosner & G. Markowitz, “The Trials and Tribulations of Two Historians:  Adjudicating Responsibility for Pollution and Personal Harm, 53 Medical History 271, 280-81 (2009)
2. D. Rosner & G. Markowitz, “L’histoire au prétoire.  Deux historiens dans les procès des maladies professionnelles et environnementales,” 56 Revue D’Histoire Moderne & Contemporaine 227, 238-39 (2009)
3. D. Rosner, “Trials and Tribulations:  What Happens When Historians Enter the Courtroom,” 72 Law & Contemporary Problems 137, 152 (2009)

In their earlier publication, Rosner and Markowitz expand on the Round Table Groups (RTG) and its solicitation of Rosner for paid testimony:

“What was amusing, if that is the right word, was that RTG was searching for an expert to testify on behalf of companies in a lead trial and at that very moment both of us were preparing to testify in a major lead trial on behalf of the state of Rhode Island.”

Rosner & Markowitz, “The Trials and Tribulations of Two Historians:  Adjudicating Responsibility for Pollution and Personal Harm, 53 Medical History 271, 273  (2009)`

Now, Rosner and Markowitz’ description of the Round Table Group is fascinating because, if true, RTG engaged in conduct, both incompetent and unethical. The Group, charged by defendants and their counsel, should have known that Rosner and Markowitz were adverse to their clients’ positions in the lead litigation.  A casual reading of their publications would have revealed their quasi-Marxist leanings, and their antipathy towards business interests.  Trying to recruit Rosner and Markowitz as defense historian experts was a bit like recruiting Vladimir Lenin to the University of Chicago economics department.

Furthermore, the RTG solicitation, as described, was potentially unethical.  Lawyers are not supposed to communicate with adverse parties, without the permission or presence of their counsel, and expert witnesses are agents of the party that retained them.  RTG, in addition apparently to not conducting due diligence about the views of the historians it was contacting, should have known what witnesses were already retained or likely retained by the adversary party.

Rosner and Markowitz appear more intent upon calling attention, not to the ethical or competency issues, but to the appearance of sleaziness in recruiting expert witnesses for hire.  The solicitation letter’s suggestion that one need not be a “subject-matter” expert is disquieting, but accurate.  The standard for qualifying expert witnesses is very low, and in some jurisdictions, even the reasonable pretense of expertise suffices to qualify a witness to hold forth with an “expert” opinion in court. Of course, in approaching Rosner, the RTG was attempting to recruit an historian who had written on lead issues.

Curiously, Rosner and Markowitz fail to mention that they have testified numerous times, in silica and in lead cases, and that Markowitz has testified in vinyl chloride cases.  They fail to discuss how they were recruited by plaintiffs’ lawyers, or the terms of remuneration for their testimonial efforts. 

As for the apparent sleaziness of recruiting expert witnesses, consider what appears to be Rosner’s and Markowitz’ role in recruiting faculty and students to write screeds against conservative positions.  Last May, the blogosphere erupted with news of an email sent out by Peter Drier, of the “Cry Wolf Project,” to undisclosed recipients, re “Paid activist research – request for mini-proposals.”  The email was a request for proposals to write propaganda and information pieces for left-wing causes:

“Colleagues:

We are looking for faculty and graduate students (in history, sociology, economics, political science, planning, public health, and public policy) interested in writing short (2000 word) policy briefs for which we can pay $1,000. For specifics, read on…

We are writing to ask for your help in an important project in the battle with conservative ideas. Today, as in the past, the fight to transform American politics and policy takes place on a battlefield in which ideas, narratives, and the construction of a politically driven conventional wisdom constitutes a set of highly potent weapons. Too often conservatives in the Congress and the media have captured the rhetorical high ground by asserting that virtually any substantial, progressive change in public policy, especially that involving taxes on the wealthy or regulation of business, will kill jobs, generate a stifling government bureaucracy, or curtail economic growth.

But history shows that in almost every instance the opponents of needed social and economic change are ‘crying wolf’. We therefore need to construct a counter narrative that demonstrates the falsity or exaggeration of such claims so that the first reaction of millions of people, as well as opinion leaders, will be ‘There they go again!’ Such a refrain will undermine the credibility and arguments of the organizations and individuals who use such dire social and economic prognostications to thwart progressive reform.

To give substance and scholarly integrity to this ‘crying wolf’ argument, we are calling upon historians and social scientists, in training or well established, to use their research skills to identify instances, in recent years as well as in the more distant pass, in which the ‘crying wolf’ scare was put forward by industry executives, conservative politicians, and right-wing pundits before the passage of legislation or the promulgation ofregulations that have become hallmarks of popular and progressive statecraft. On each issue we seek to document three things: First, historical examples and quotes drawn from speeches, legislative testimony, newspaper and other media opinion pieces, think-tank reports, or political platforms which claim that a proposed policy or regulation would generate a set of negative consequences; second, a discussion of how these crying-wolf claims impacted the new laws or regulations as they were passed into law; and third, a well-documented analysis of the extent to which conservative and special interest fears were or were not realized during the years and decades after the new laws or regulations went into effect.

 This work is sponsored by the San Diego-based Center on Policy Initiatives and funded by a grant from the Public Welfare Foundation. Donald Cohen of CPI, Peter Dreier of Occidental College, and Nelson Lichtenstein of UC Santa Barbara constitute the ad hoc committee now  administrating this initiative.

Based on some of the policy areas listed below, we solicit one page proposals for the kind of short studies outlined above. If we think the proposal promising, we will then ask the applicant to develop a larger policy brief, perhaps 2,000 words in length. It should be well documented and scrupulously accurate. We will pay $1,000 for each brief that meets these standards. We hope that many of these become the basis for opinion pieces designed to run in the mainstream media, on line, on the air, or in the press.

We will be focusing on the following policy areas.

We will be looking for the following things in each case study/policy brief:

1.  Taxes and public budgets
2.  Labor market standards
3.  Food, tobacco and drug health and safety
4.  Environmental protection: air, water, toxics, etc
5.  Workplace safety
6.  Financial regulation
7.  Consumer product safety
8.  Local issues (i.e. inclusionary housing, building code standards, etc.)

Proposals should be sent to Donald Cohen at dcohen@onlinecpi.org.

Please feel free to forward this RFP and/or to send ideas, references and proposals.

Sincerely,

Peter Dreier, Donald Cohen, and Nelson Lichtenstein”

And guess who were listed among the members of Cry Wolf’s Project Advisory Board? 

Gerald Markowitz, and David Rosner!!

I wonder whether they were paid $1,000 to write their piece in Academe.  If so, what easy money to recycle their triplicate 2009 publications.

The Drier email raised conservative hackles and hyperbolic criticisms in the blogosphere, but it is hard to see what is wrong with writing papers to rebut what one believes is factually or politically wrong.  See BREAKING NEWS: WOLVES IN SHEEP’S CLOTHING? CRY WOLF PROJECT: ACADEMIC INTEGRITY FOR SALE: DEM ACTIVISTS BUYING UP POLICY PAPERS TO COUNTER CONSERVATIVES IN MEDIA POWER PLAY http://theenterprisereport.typepad.com/news/2010/06/breaking-new-dems-activists-buying-up-policy-papers-to-counter-conservatives-in-media-power-play.html .

Although I do not see the Cry Wolf Project as necessarily undermining academic integrity, I do believe it raises some interesting issues.  First, for me at least, I find the analogy to what the Round Table Group did in soliciting Rosner, interesting and compelling.  The Cry Wolf Project did not seem to focus its solicitation on those academics particularly qualified and suited to write on their topics of interest.  Furthermore, the Cry Wolf Project folks were interested in soliciting faculty and students to write pieces of pre-determined positions and conclusions, which seems somewhat at odds with the open-minded, free inquiry that we, perhaps idealistically, hope goes on at colleges and universities.  Indeed, the Drier email, with hot air in its sails from Rosner and Markowitz, seems a LOT like the RTG’s solicitation of Rosner, in the lead paint litigation.  And where did the money come from to fund these earnest academicians?

Finding Rosner and Markowitz at the heart of the Cry Wolf Project, after their repeated, supercilious criticisms of the Round Table Group, and of defendants in litigation, is an irony too sweet to be overlooked. 

Crying wolves, indeed.

The goodfellas of occupational medicine are fond of telling stories about industry suppression of studies, but they don’t much like to hear or tell similar stories about how iconic public health scientists did the same.  When Sir Richard Doll died, the goodfellas attacked his consultations with industry; when Dr. Irving Selikoff died, they lauded his work.  When it comes to an iconic figure such as Dr. Irving Selikoff, the goodfellas are especially intent upon preserving his reputation at all costs.

When the biography of Irving Selikoff is written, however, the author will have to deal with Selikoff’s suppression of science on the health effects of asbestos! 

One of Selikoff’s agenda items was to treat all asbestos minerals the same, even though the scientific world differentiates between and among the different minerals that make up the class of minerals known as “asbestos.”  That class includes chrysotile (white asbestos, a fibrous serpentine mineral), crocidolite (blue asbestos, a fibrous form of riebeckite), amosite (brown asbestos, named for “asbestos mines of South Africa, a fibrous form of cummingtonite-grunerite), anthophyllite (only the fibrous form), tremolite (only the fibrous form), and actinolite (again only the fibrous form).  All the asbestos minerals are silicates, as are most of the minerals on planet Earth.  Chrysotile is in the serpentine family of silicates; whereas the other asbestos minerals are all amphiboles.  Each of these asbestos minerals has different physico-chemical properties.  All are recognized to cause asbestosis, and to the extent that they have caused asbestosis, lung cancer as well.  The asbestos minerals, however, have very different capabilities as far as mesothelioma is concerned.

Selikoff was intent upon treating all the asbestos fiber types the same, even though the scientific community has long recognized that the fiber types are very different with respect to mesothelioma causation.

By way of example, in a cohort of British workers who assembled gas masks during World War II, close to 9% of all deaths were due to mesothelioma. See J. C. McDonald, J. M. Harris, and G. Berry, “Sixty years on: the price of assembling military gas masks in 1940,” 63 Occupational & Envt’l Med. 852 (2006).  Workers who had even longer exposures to crocidolite experienced even higher mesothelioma rates.  In an American factory that used crocidolite to make filters and filter papers, including filters for cigarettes, mesothelioma made up close to 18% of all deaths.  James A. Talcott, et al., “Asbestos-associated Diseases in a Cohort of Cigarette-Filter Workers,” 321 N.Engl.J.Med. 1220 (1989).

In chrysotile only populations, the prevalence of mesothelioma as a cause of death is very low (well under 1%) and it may well be non-existent. 

Selikoff, however, was intent upon having all fiber types treated the same, both in regulation, and in litigation.  Selikoff was an amphibole denier, or at least a crocidolite denier, in the same vein as the so-called Global-Warming Deniers, who are so ridiculed these days.

Let’s start with a quote from a 1990 paper by Dr. Selikoff:

“Insulation workers in the United States and Canada were exposed to materials that contained chrysotile asbestos in early years and chrysotile plus amosite, later. The chrysotile used, from Canada, is believed to have contained small proportions of tremolite, as a contaminant, generally less than 1%. The extraordinary cancer risk demonstrated among insulation workers would therefore refer only to the fibrous materials to which they were exposed, and to the conditions of such exposure. We have no information on the effects of crocidolite in similar circumstances nor whether reduction of exposure would result in decreased risk.”

Herbert Seidman & Irving Selikoff, “Decline in Death Rates among Asbestos Insulation Workers l967-1986 Associated with Diminution of Work Exposure to Asbestos,” 609 Annals N.Y. Acad. Sci. 300, 311 (1990)

Now there are two remarkable misstatements in this passage, and they are so clearly wrong that a disinterested reader may well wonder about the motivations that gave rise to the falsehoods.

First, the suggestion that amosite exposure came about “later” in the exposure of insulators is factually wrong.  The United States Navy, and its private contractor shipyards, had a seemingly endless appetite for amosite, in the form of blankets, and later in the form of pre-molded pipecovering insulation (such as Unibestos).  The Navy’s own documents show that amosite featured heavily in the most injurious exposures that shipyard workers experienced before and during World War II.  Selikoff had written about the existence of asbestos-related disease in American shipyards.  See, e.g., Selikoff, Lilis, and Nicholson, “Asbestos Disease in United States Shipyards,” 330 Annals N.Y. Acad. Sci. 295 (1979); Irving J. Selikoff & Cuyler Hammond, “Asbestos-associated Disease in United States Shipyards,” 28 CA – A Cancer Journal for Clinicians 87 (1978).  His ignorance on this point is hard to square with the depth of his knowledge about shipyard exposure circumstances.

Second, and even more remarkable, is the suggestion that the insulators under study had no exposure to crocidolite (blue) asbestos.  This misrepresentation seems neither innocent nor immaterial.

Selikoff, himself, can be shown to have known both suggestions, about amosite’s late arrival, and the non-use of crocidolite, were false.  In a paper published in 1965, Selikoff reports on the content of asbestos insulating materials:

“In later specimens so obtained, crocidolite has also been found. Moreover, materials used for ship insulation, while containing the same amounts of asbestos as above, began in 1934 to have significant amounts of amosite in addition to chrysotile, because of the lighter weight of the material.”

I. J. Selikoff, J. Churg, E. C. Hammond, “The Occurrence of Asbestosis among Insulation Workers in the United States,” 132 Annals N.Y. Acad. Sci. 139, 142 (1965).  So Selikoff was well aware of the use of amosite, going back to the 1930s, and he was well aware of the use of crocidolite in the United States.

Selikoff had other sources of the knowledge of where, and how much, amphibole asbestos was used in the United States.  During the course of discovery in the Caterinnichio case, I obtained a manuscript of a study that Selikoff and his colleagues prepared, but never published.  The study examined the mortality, and especially the cancer mortality, of workers at a Johns-Manville asbestos product manufacturing plant in New Jersey.  William J. Nicholson, Ph.D. & Irving J. Selikoff, M.D., “Mortality experience of asbestos factory workers; effect of differing intensities of asbestos exposure”: unpublished manuscript produced in litigation (circa 1988).  Selikoff’s failure to publish this paper is curious given his tireless and repeated republication of data from his insulator cohort.  Selikoff’s failure to publish this paper, however, is more concerning because the paper acknowledges the undeniable — Johns Manville used crocidolite asbestos in its products:

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

Id.  Interestingly, the failure to publish research is a claim that is often made against industry generally.  The suppression of studies clearly takes place outside the world of commercial interests.

Johns-Manville was hardly alone in its commercial use of crocidolite.  Back in July 1962, Selikoff visited the Asbestos Corporation of America, and memorialized his observations in a memorandum.  The general manager of the company, Wade I. Duym, appeared to have hosted the visit.  Here are some quotes from Selikoff’s 1962 memorandum:

“Amosite.  This continues to be used in the insulation trade primarily; for example, it is the asbestos of choice for high temperature insulation cement inasmuch as it has less water in combination.  Similarly, it is used in the calcium silicate insulation products (“magnesia”) [sic].”

Id. at 1.

“Other insulation uses [of amosite] include spray insulation.”

Id. at 2.

“The amosite used comes only from Africa.  The two large companies involved in its exploitation are the Cape Asbestos Company and Turner & Newell.  Representatives in the U.S. are the North American Asbestos Corporation.” 

Id. at 2.

“Crocidolite.  This is relatively inexpensive (10 – 12¢) and it is also exceedingly strong and is therefore used in asbestos cement products, especially since it is fairly resistant chemically.  Its sources are primarily Africa and Bolivia and samples of both were made available to us.”

Id. at 5.

“Of historical note, and of some peripheral interest, is the fact that Kent cigarettes for years used filters made of blue asbestos.  It would have been interesting to examine the smoke inhaled through such filters for particles of asbestos.  Bolivian blue asbestos was utilized.” 

Id. at 6.

At the 1964 meeting of the New York Academy of Sciences, which Selikoff organized, and the proceedings of which he edited, several investigators reported the content of asbestos insulation.  Hendry, a Johns-Manville geologist, noted that for the year 1963, the United States used 22,000 tons of amosite in its manufactured products. For the same year, 17,000 tons crocidolite were used, in acid-resistent filters, packings, insulations, and certain types of lagging. N.W. Hendry, “The Geology, Occurrences, and Major Uses of Asbestos 132 Annals N.Y. Acad. Sci. 12, 19 (1965). 

At this meeting, Harrington reported  on the asbestos content of insulation pipe sections.  He found chrysotile and crocidolite asbestos in equal proportions in specimens of 85% magnesia pipe-covering sections. Harrington, “Chemical Studies of Asbestos,” 132 Annals N.Y. Acad. Sci. 31, 41 (1965). 

This contemporaneous evidence is hardly surprising or novel.  The United States Department of Commerce keeps statistics, on importation of various kinds of asbestos.  For several years, crocidolite imports exceeded amosite, and often both minerals were imported in similar quantities.

Selikoff’s distortions have become “evidence” that fuels the asbestos litigation industry.  Here is a typical example of how plaintiffs’ counsel, Baron & Budd, exploit the misrepresentations:

“Published epidemiological studies demonstrate significantly increased rates of mesothelioma, often more than double what was expected, in chrysotile-exposed populations.[32] The cohort of more than 17,000 insulators studied by Dr. Selikoff and Dr. Frank worked primarily with chrysotile and developed mesothelioma at a significantly higher rate than the general population.[33] Dr. Selikoff explained that the increase in mesothelioma and other asbestos-related diseases ‘cannot be ascribed to other than the one asbestos fiber that was in regular use in insulation materials during the 1930s – chrysotile’. [34] As Dr. Frank reiterated, it was hard to imagine that . . . a few percent of amphibole . . . was the sole cause of the vast amount of mesothelioma we were seeing.[35]”

Plaintiffs’ Consolidated Response to All Motions to Exclude General Causation Opinion Testimony That Chrysotile Asbestos Can Cause Mesothelioma, filed in Gasner v. A.O. Smith Corp., No. 2004-03964, In the District of Harris County, 11^th Judicial District, Texas, available at http://baronandbudd.com/briefbank/Texas_MDL_Response_to_Motion_to_Strike_Evidence_that_Chrysotile_Asbestos_Causes_Mesothelioma (citing Egilman affidavit, and in endnote 34, a letter from Irving J. Selikoff, M.D. (dated July 31, 1973), Ex. 31 to plaintiffs’ brief).

Dr. Irving Selikoff, who did so much to bring about an awareness of the hazards of asbestos, also did much to suppress the differences between and among the various mineral types of asbestos fibers.  And plaintiffs’ lawyers have continued to press this issue in order to make out their case for “every exposure” counts against low-exposure chrysotile defendants.

When Selikoff’s biography is written, this issue must be confronted directly.  Why was someone who so dedicated to public and worker health willing to take such liberties with the historical and scientific record?

The disinterested historical inquirer may observe that the companies that imported amosite and crocidolite into the United States were generally “judgment proof” in American courtrooms.  South African courts refused to acknowledge the validity of American judgments.  Plaintiffs’ lawyers, and their union sponsors, worried that chrysotile suppliers would escape liability and harsh regulation if the extent of amosite and crocidolite use, and its much greater hazardous, were appreciated.  One inference the disinterested observer might draw is that Selikoff was intent upon treating all fibers alike to advance a regulatory and litigation agenda that had nothing to do with science.

Those who seek to defend the legacy of Irving Selikoff rightly point to his publications on hazards of asbestos.  These papers were mostly epidemiologic studies.  Selikoff was not trained as an epidemiologist, and most of his papers on asbestos had co-authors who had a reasonable pretense to expertise in epidemiology.  Presumably, Selikoff’s contributions to his papers were as a clinician.  Putting aside Professor Bartrip’s concerns over the quality of Selikoff’s clinical medical education, what is known about Selikoff’s ability as a clinician?

My first experience with an asbestos case, in which Selikoff had written a report, was the Leddy case.  Mr. Leddy worked had worked for the Reading Railroad, in Reading, Pennsylvania.  Selikoff, with the union, organized a screening of the railroad workers, and Selikoff read the chest films.  He read Mr. Leddy’s films as showing 3/3 on the ILO scale — and he interpreted the films as showing severe asbestosis.  The Motley firm filed a case on behalf of Leddy in the Eastern District of Pennsylvania, around 1982, and the case landed on my desk to defend.

Shortly after being diagnosed with advanced asbestosis by Selikoff, Mr. Leddy developed signs and symptoms of lung cancer.  Leddy went to a local hospital, where he was diagnosed with lymphangitic bilateral spread of lung cancer.  He died shortly after diagnosis.  The hospital pathologist, who was aware that Mr. Leddy had a lawsuit pending, and who was aware of Selikoff’s reputation as a pioneer in the health effects of asbestos, conducted an autopsy.  The post-mortem findings were astounding.  Mr. Leddy, who had been a heavy smoker, indeed had, and died of, lung cancer.  In over 90 lung tissue sections, however, with appropriate Prussian-Blue staining, from all five lobes, the pathologist could find no evidence ofnasbestosis.  (Later fiber counting confirmed that the plaintiff had less asbestos in his lungs than the average resident of New York City.)

These were the good ole days when defense counsel were permitted to conduct ex parte interviews of treating physicians, and so I telephoned the hospital pathologist to discuss the case.  The pathologist was eager to talk about the case, because of the Selikoff’s fame and the apparent error of Selikoff’s diagnosis.  The pathologist had another motive — he was a bit put out by the widow’s reaction to the news that her late husband did not have asbestosis.  When he called Mrs. Leddy with the results of the autopsy, she accused him of being in cahoots with the railroad company!  The pathologist willingly agreed to make himself available for a videotaped deposition on his findings, after which the case, notwithstanding the Selikoff diagnosis, settled for a nominal amount.

Of course, the Leddy case is just an anecdote, and anyone could mistake lymphangitic pulmonary carcinomatosis for asbestosis.  Still, it led me to wonder about exactly how skilled Selikoff was in the clinic.  Later I heard rumors that Selikoff had taken and failed the B-Reader examination, given by NIOSH, for certifying proficiency in applying the ILO system to classify chest radiographs for the pneumoconioses.  (I would be interested to hear from anyone who has information that confirms or refutes these rumors.)

Perhaps more interesting than Selikoff’s score on the B-Reader examination is how he measured up against some of the outstanding pulmonary clinicians who had studied asbestosis, both in Europe and in North America.  In 1972, C.E. Rossiter, of the U.K.’s Medical Research Council, published an important study on the reliability of a system of classifying chest radiographs for pneumoconiotic changes.  Using 12 X-ray readers, including some of the leading radiologists and pulmonary physicians of the day, Rossiter assessed whether the classifications assigned were repeatable between and among readers, and by individual readers themselves.  Among the readers were Drs. Irving Selikoff, Leonard Bristol, Benjamin Felson, Eugene Pendergrass, Corbett McDonald, and Sluis-Cremer.  Today, such a study would be accompanied by much more statistical apparatus (Kappa statistics, etc.), but one does not need any statistical analysis to see that Selikoff was an outlier, who read films as showing abnormal profusion of small, irregular densities up to twice as often as the most reliable readers in the study.  Rossiter, “Initial repeatability trials of the UICC/ Cincinnati classification of the radiographic appearances of pneumoconioses.” 29 Brit. J. Indus. Med. 407 (1972).

Perhaps when Selikoff’s contributions to the health effects science of asbestos are honestly assessed, a disinterested observer will be able to evaluate whether Selikoff overstated the health effects of asbestos, by design, by the undue unfluence, or by lack of ability.

Perhaps the ultimate brushback pitch to challengers of the Selikoff legacy was thrown by McCulloch and Tweedale, who suggested that the challenges are solely motivated by venality.  Jock McCulloch & Geoffrey Tweedale, “Shooting the Messenger:  The Vilification of Irving J. Selikoff,” 37 International J. Health Services 619 (2007).  These authors rightly are critical of many of the mean-spirited attacks — mostly planned but not deployed — on Selikoff by industrial officers and executives.  The authors, however, go far beyond smear campaigns and attempt to portray all those who opposed Selikoff’s scientific work and political agenda as somehow acting in bad faith.  In arguing that all “adversaries” have been engaged in “shooting the messenger,” McCulloch and Tweedale, engage in – well – shooting the messenger.

What is astonishing is that with all the back and forth over Selikoff, and over his scientific and political work, no one has come forward to write a serious biography of the man and his work.  Perhaps it would be too difficult to avoid falling into the camp of hagiographers or of hatchetmen.

Still, Selikoff’s work in the mid-1960s was, and is, important, but mostly from the point of view of putting the world on notice of the hazards from what had been accepted use of asbestos in industrial insulation.  A decade earlier, in 1955, Sir Richard Doll had already published an article that suggested an increase risk of lung cancer from asbestosis.  Doll’s work, however, failed to take into account the confounding effects of smoking.  In 1960, J.C. Wagner and colleagues published their work on mesothelioma among persons exposed to crocidolite, blue asbestos, in South Africa.  And for asbestosis among insulators, the United States Navy was out in front of Selikoff, although the Navy was less generous in sharing its knowledge with its vendors and the public.  By 1961, the Navy had targeted asbestos hazards for research.  In 1962, two Navy officials published an article that noted that working conditions were at times unsafe, although the publication took place in an obscure Navy journal that was not in general circulation and thus was not available to industry and physicians.  Capt. H.M. Robbins & William T. Marr, “Asbestosis,” 19 Safety Review 10 (1962) (noting that asbestos dust counts of 200 million particles per cubic foot were not uncommon during insulation ripouts onboard naval vessels).  Two years later, roughly contemporaneously with Selikoff’s first publication on asbestos hazards among insulations, Mr. Marr published about the Navy’s observations in a journal in general circulation.  William T. Marr, “Asbestos Exposure During Naval Vessel Overhaul,” 25 Am. Indus. Hyg. Ass’n J. 264 (1964).

From the lawyers’ perspective, there can be no doubt that Selikoff helped to launch the asbestos personal injury litigation, although there were many other inciting factors.  Having a sane appreciation for who Selikoff was continues to be important in assessing both his positive and negative contributions to the scientific and legal landscape.

Judge Jack Weinstein, in addressing the ethics of scientists, held the late Dr. Irving Selikoff out as an example of “independent eminent” scientists, whom courts should protect in legal proceedings:

“A court should not coerce independent eminent scientists, such as the late Dr. Irving Selikoff, to testify if, like he, they prefer to publish their results only in scientific journals.”

Jack B. Weinstein, Individual Justice in Mass Tort Litigation:  The Effect of Class Actions, Consolidations, and other Multi-Party Devices 117 (Evanston 1995).

It is not surprising that Judge Weinstein invoked the memory of Dr. Selikoff to exemplify the “independent eminent” scientist who eschewed the courtroom in favor of scientific journals to advance learning, understanding, and scientific truth.  Dr. Selikoff had cultivated that reputation throughout the 1970s, until the time of his death in 1992.  Eminent Selikoff was, but at some point, the medical historians will have to come to grips with whether and to what extent Selikoff was really independent.

Clearly, Judge Weinstein was incorrect in asserting that Selikoff preferred to publish his results “only in scientific journals.”  Selikoff was an early adopter of a multi-media approach, and he was no stranger to the courtroom and litigation.  Selikoff testified in court proceedings before the mid-1970s.  Over the years, I have collected transcripts of Dr. Selikoff’s testimony in:

• Bradshaw v. Johns-Manville Sales Corp., E. D. Michigan Southern Division, Civ. Action No. 29433 (July 6, 1967)
• Tomplait v. Combustion Engineering Inc..,  E. D. Tex. Civ. Action No. 5402 (March 4, 1968)
• Rogers v. Johns-Manville Products Corp., Cir. Ct. Mo., 16th Jud. Cir., Div. 9, Civ. Action No. 720,071 (February 19, 1971)
• Karjala v Johns-Manville Products Corp.,  D. Minn., Civ. Action Nos. 5–71 Civ. 18, and Civ. 40 (February 8, 1973) 

There are at least two reported decisions in Pennsylvania, where Dr. Selikoff served as an expert witness for the claimaints:

• Bambrick v. Asten Hill Mfg. Co., Pa. Commonwealth Ct. 664 (1972)
• Utter v. Asten-Hill Mfg. Co., 453 Pa. 401 (1973)

Professor Bartrip, in his historical analysis of Selikoff’s medical education, provides another deposition reference:

Deposition of Dr. Irving J. Selikoff, in  Bradshaw v.Twin City Insulation Co. Ltd., Industrial Court of Indiana, Claim No. O.D.1454 (Oct. 14, 1966)

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

According to Professor Bartrip, Selikoff testified often in asbestos litigation.  Id. (quoting insulator union President Andrew Haas, as saying “[w]e all owe a great debt of thanks for often and expert testimony on behalf of our members … .” Andrew Haas, Comments from the General President, 18 Asbestos Worker (Nov. 1972)).  Of course, before 1970, most asbestosis cases were prosecuted before worker compensation referees, and decisions rarely were reported.  Another feature of worker compensation cases is that the expert witnesses often do not testify; rather, the experts’ reports are submitted to the Referee, who decides the medical issues without taking testimony.  As a result of the nature of workers’ compensation, no one has a good estimate of the extent to which Selikoff was involved in personal injury litigation in the 1950s and 1960s.

Of course, Selikoff testified in the Reserve Mining case, an environmental matter in which the government sought to regulate a non-asbestos amphibole mineral as if it were asbestos, on the basis of cleavage fragments that met only a regulatory definition of “fiber.”

To the extent that Professor Bartrip can be read to suggest that Dr. Selikoff stopped testifying to avoid inquiry into his medical qualifications, we should be mindful that Selikoff likely had other motives.  By the mid-1970s, Mt. Sinai was an officially accredited medical school (which it was not throughout the 1960s), and Selikoff began to enjoy federal funding of research grants and projects.  Selikoff’s department prospered, and he attracted new personnel, many of whom became frequent testifiers for plaintiffs in the asbestos property damage and personal injury cases. By the 1980s, Selikoff had a staff of acolytes who could be trusted to defend his theories and studies in litigation.

There was also the matter that as much as plaintiffs’ counsel liked Selikoff’s asbestos theories, they were troubled by what they believed was his overemphasis on his own research to establish the “state of the art” of asbestos science.  In order to prosecute their cases, plaintiffs’ counsel wanted to push back the date of notice and of first knowledge well before Selikoff’s publications in the mid- to late-1960s.  Selikoff believed, however, that he really had established these risks in his cohort of asbestos insulators.  In their cross-examinations of Selikoff, defense counsel elicited many concessions about how little was known or knowable about hazards to end users before Selikoff entered the field.  Plaintiffs’ counsel probably stopped calling Dr. Selikoff as a witness because there were more zealous advocates on state of the art issues, such as Dr. Schepers and Dr. Wagoner.

Perhaps the most notorious role Selikoff played in litigation was in organizing a conference with plaintiffs’ lawyers to showcase the plaintiffs’ scientific theories for judges.  The sordid affair is described in detail in a published decision of the United States Court of Appeals, In re School Asbestos Litigation, 977 F.2d 764 (3d Cir. 1992).  Plaintiffs’ counsel, working with and through Dr. Selikoff, invited judges actively involved in asbestos litigation to a conference of the Collegium Ramazzini on the so-called Third Wave of Asbestos Disease.  Dr. Selikoff’s invititations did not mention that the plaintiffs’ counsel were the predominant funding source; nor they did mention that the presenters included many of the plaintiffs’ expert witnesses in pending cases.  The whole conference was “overwhelmingly consistent with the plaintiffs’ position” in the very litigation over which the judges had to preside.  Id. at 780. 

One can only imagine the hue and cry that would arise if a defendant company had funded a lopsided medical conference, arranged for the conference to feature defendant’s expert witnesses, set out to give short shrift to opposing points of view, invited key judges to attend the conference, and paid for the judges’ travel and hotel expenses.

Judge Weinstein, who has so often been an astute observer of the mass tort litigation scene, was wrong when he opined that Selikoff was a scientist who preferred to present his results only in published journals.  Perhaps someday, someone will write a truly balanced account of Selikoff and his contribution to occupational medicine.  I am not holding my breath.

In 2005, Sheldon Samuels, advocate for the international labor movement, presented a paper at the American Public Health Association, where he lauded the late Irving Selikoff as “labor’s doctor.”  See “Sheldon Samuels, Irving Selikoff: The Legacy of Labor’s Doctor,” http://apha.confex.com/apha/133am/techprogram/paper_120225.htm

There is nothing particularly remarkable about this hagiographic effort, other than Samuels’ disclosure:

“I wish to disclose that I have NO financial interests or other relationship with the manufactures [sic] of commercial products, suppliers of commercial services or commercial supporters.”

Id. (emphasis in the original).  Presumably the organizers of the APHA thought this was a serious, sufficient disclosure of potential conflicts of interest.  Samuels obviously believed that the only conflicts of interest were financial ones, or relationships with manufacturers.  Samuels’ lifelong affiliation with organized labor and his advocacy for labor’s causes did not register, in his mind or in the minds of the APHA leadership, as a potential conflict.

Samuels and the APHA leaders probably did not believe that labeling Selikoff as “labor’s doctor,” was at all pejorative.  They would have had something very different in mind if they had labeled someone as “industry’s doctor.”

To some extent, perhaps the asymmetry is superficially justified in that organized labor will have the health and welfare of its membership as a high priority.  Historically, however, organized labor has traded known occupational hazards for better pay, sometimes candidly called “dirty money.”  Industry might not  appear to be as concerned with workers’ health, but few industries want the reputational damage of being seen as callous or indifferent to their workers.  In the end, the caricature of industry as only concerned about “profits” is as false and defamatory as the caricature of labor as only concerned about wages.  Somewhere in the caricaturing, the interest in craftsmanship and in selling products or services of value to people is lost.  Workers are more than their paychecks, and employers are more than their profits.

But to return to the conflict of interest issue, Samuels’ faint, failed attempt at a disclosure reveals the hypocrisy in the constant drumbeat over financial conflicts.  Samuels’ conflict is real and palpable.  Labor organizations have been in the forefront of pushing for compensation for injuries, and they have benefitted from scientific claims, which may have been exaggerated or false.

The asymmetry in the criticisms over funding sources is quite vocal.  Typical is an article published in the journal, Occupational and Environmental Medicine:

“There are inherent problems with industry sponsored research in relation to intellectual property and ethical issues because industry funders and academic researchers work in different systems with different goals and means.”

S. Tong & J. Olsen, “The Threat to Scientific Integrity in Environmental and Occupational Medicine,” 62 Occup. Envt’l Med. 843, 843 (2005).  The authors recount anecdotes of industry influence on studies, and they call for reform:

“Research funding for public health should not come directly from the industry to the researcher; an independent, intermediate funding scheme should be established.”

Id. at 846.  Tong and Olsen are curiously silent about studies funded or sponsored by labor or by plaintiffs’ lawyers.  As we approach 100 bankrupt companies in the asbestos litigation, we might well ask whether studies conducted by “labors’ doctors” have exaggerated or misrepresented risks and causal claims.  In several litigations, plaintiffs’ counsel conspired with researchers to produce dubious studies, and then worked to hide their involvement. 

Tong and Olsen, who also call for openness among public health professionals, acknowledge help from David Michaels.  The casual reader, however, would not know that Michaels had worked as a plaintiffs’ testifying expert witness, or that he had directed an organization known as SKAPP, which was surreptitiously funded by plaintiffs’ lawyers, and which worked to undermine judicial screening of unreliable expert witness evidence.  So much for openness on the home front.

The asymmetry, or hypocrisy, of the occupational medicine community can sometimes approach shrill hysteria.   Samuels’ hagiographic presentation is a fascinating contrast with Professor Peter Bartrip’s historical research into the mystery of Selikoff’s medical degrees.  P.W.J. Bartrip, “Irving John Selikoff and the Strange Case of the Missing Medical Degrees,” 58 J. History Med. 3 (2003).  Although Bartrip praises many of Selikoff’s accomplishments, he is critical of Selikoff’s dissembling over his actual medical training. Bartrip offers a balanced account, and concedes on any number occasions that the record is inconclusive.

Criticizing “labor’s doctor,” however, can be dangerous business.  Bartrip’s paper brought the goodfellas out in a gaggle.  “P.W.J. Bartrip’s Attack on Irving J. Selikoff.”  See 46 Am. J. Indus. Med. 151 (2004).  The authors of this letter apparently were turned down by the Journal of the History of Medicine, and so they published in a non-history journal.  It is not clear whether this path deprived Professor Bartrip of the opportunity to publish a reply.  The letter writers assail Bartrip for his “ad hominem” attacks on Selikoff, and praise Selikoff as the epitome of “the committed public health professional.”  Id. at 151.  The gaggle claim that “Selikoff’s antagonists came up with nothing to discredit him in his lifetime … .”  Id. at 152.

The letter is signed by David Egilman, Geoffrey Tweedale, Jock McCulloch, William Kovarik, Barry Castleman, William Longo, Stephen Levin, and Susanna Rankin Bohme.  Several of these signatories testify extensively in asbestos personal injury litigation for plaintiffs; others are well-known idealogues on asbestos policy issues.  No disclosure of conflict is made in connection with this letter.  Why are we not surprised?  The letter challenges some of Bartrip’s findings, but ultimately it begs the question about the quality of Selikoff’s scientific contributions.

Ultimately, most of the rancor against conflicts of interest, and failure to disclose, is ad hominem.  Nothing in Bartrip’s historical piece makes Selikoff’s scientific work more or less true; nothing in the goodfellas’ ad hominem attacks on Bartrip make Selikoff’s training or dissembling about his training more or less true.  And the gaggle’s invocation of absence of evidence (to be used as a substitute for evidence of absence) is hardly persuasive.  By the time Selikoff’s advocacy had become problematic to certain industry “antagonists,” they were beleaguered by overwhelming litigation and silenced by their own “conflicts of interest.”  On the other hand, the hagiographers have had the day because they claim to have no such conflicts.  These assumptions about Selikoff’s work, and about the “interestedness” of those who challenge and defend his work cry out for re-examination.

Even though the principles of Daubert have been embraced by the entire Supreme Court, in a rare unanimous opinion, (See Weisgram v. Marley Co., 528 U.S. 440 (2000)(Ginsburg, J. writing for a unaminous court), and incorporated into a revised Rule 702, ratified by Congress, the enemies of Daubert abound.   Some advocates simply cannot let go of the notion that they have a constitutional right to bamboozle juries with unreliable evidence.

Daubert has some friends who would kill it by reinterpreting and diluting the reliability and relevance requirements so that anything goes, and everything is admissible.  Perhaps the best example of such a “friend,” is Professor Erica Beecher-Monas, who has written a book-length roadmap on how to eviscerate the gatekeeping concept.  See E. Beecher-Monas, Evaluating Scientific Evidence:  An Interdisciplinary Framework for Intellectual Due Process (New York 2007).

Erica Beecher-Monas (EBM, not to be confused with evidence-based medicine) starts off with a trenchant defense of the epistemic approach of Daubert, and an explanation of why proxies for scientific reliability and validity are doomed to fail.  EBM proceeds to offer a five step program of “intellectual due process,” to help trial courts carry out their screening:

1.  evaluate the challenged expert witness’s theory and hypothesis for their ability and power to explain the data;

2.  evaluate the data that weighs in favor, and against, the expert witness’s theory; the gatekeeper court must weigh all the evidence collectively.  The expert witness’s “theory” should explain and account for most of the evidence. According to EBM, the “theory” should explain the data that appears to weigh against the theory as well as the supporting evidence. 

3.  invoke “supportable assumptions” to bridge the inevitable gaps between underlying data and theory; there are, according to the author, “scientifically justifiable default assumptions,” which should be honored to fill in the gaps in an expert witness’s reasoning and explanations.

4.  evaluate the testifying expert witness’s methodology; and

5.  evaluate the statistical and probabilistic inferences between underlying data and opinions.  The trial court must synthesize all the available information to evaluate how well the data, methodology, “default assumptions,” taken together support the proffered conclusions.  

Id. at 6, 46 – 47.

This program sounds encouraging in theory.  As EBM describes how this “framework for analysis,” should work, however, things go poorly, and the law and scientific method are misrepresented.  “Default assumptions” becomes the pretense to let in opinions that would gag the proverbial horsefly off the manure cart.

Not all is bad.  EBM offers some important insights into how courts should handle scientific evidence.  She defends the gatekeeping process because of the serious danger of “dilution effect” among jurors, which overwhelms jurors with evidence of varying quality.  She reminds us that there are standards of care for research science and for clinical medicine, and standards for evaluating whether experimental results can be “honestly” attributed to the data.  Id. at 53.  Courts must evaluate whether the data and method really “show” the conclusion that the expert witness claims for them.  Id.  She criticizes those commentators who confuse the burden of proof with the statistical standard used in hypothesis testing for individual studies.  Id. at 65.

The narrative becomes confused and convoluted in addressing how trial courts should function as gatekeepers.  EBM is critical of how trial courts have discharged their gatekeeping responsibilities.  In many instances, EBM is unhappy with how judges carry out their evaluations, and criticizes them on the basis of her own ipse dixit.  It turns out that intellectual due process, as conceived of by EBM, allows pretty much anything to be admissible in EBM’s ideal juridical world.

Some of EBM’s assertions about the law and the science are startling, and deeply flawed.  In this post, I discuss some of the flawed scholarship, which has the potential to confuse and mislead.

1.  “Daubert, which requires only a scintilla of scientifically valid and relevant evidence to survive an admissibility determination.” Id. at 82.                                                                                               

This assertion is wrong on its face.  Justice Blackmun, in writing his opinion in Daubert, discussed “scintilla” of evidence, not in the context of making an admissibility determination of an expert witness’s opinion, but rather in the context of ruling on motions for directed verdicts or summary judgment:

“Additionally, in the event the trial court concludes that the scintilla of evidence presented supporting a position is insufficient to allow a reasonable juror to conclude that the position more likely than not is true, the court remains free to direct a judgment, Fed.Rule Civ.Proc. 50(a), and likewise to grant summary judgment, Fed.Rule Civ.Proc. 56.  Cf., e.g., Turpin v. Merrell Dow Pharmaceuticals, Inc., 959 F.2d 1349 (6^th Cir.) (holding that scientific evidence that provided foundation for expert testimony, viewed in the light most favorable to plaintiffs, was not sufficient to allow a jury to find it more probable than not that defendant caused plaintiff’s injury), cert. denied, 506 U.S. 826 (1992); Brock v. Merrell Dow Pharmaceuticals, Inc., 874 F.2d 307 (5^th Cir. 1989) (reversing judgment entered on jury verdict for plaintiffs because evidence regarding causation was insufficient), modified, 884 F.2d 166 (5^th Cir. 1989), cert. denied, 494 U.S. 1046 (1990); Green 680-681 [Green, “Expert Witnesses and Sufficiency of Evidence in Toxic Substances Litigation: The Legacy of Agent Orange and Bendectin Litigation,” 86 Nw.U.L.Rev. 643 (1992)].”

Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579, 594 (1993) (emphasis added).

Justice Blackmun was emphasizing that Rule 702 is not the only tool on the trial judge’s workbench; he was not setting a standard for the quantum of evidence that must govern an admissibility determination of an expert witness’s opinion.   Even if Justice Blackmun were discussing scintilla of evidence in the context of addressing admissibility (rather than sufficiency), his citation to the Bendectin decisions in the Court of Appeals makes clear that the “scintilla” of evidence offered by the party suffering entry of judgment might be fairly extensive in terms of expert witnesses’ opinions and their relied upon studies.  Nonetheless, this “scintilla” could be, and was, insufficient to resist judgment in the face of evidence of higher quality and relevance. 

EBM’s scholarship here is thus flawed at two levels.  First, she conflates admissibility with sufficiency (which elsewhere she faults various courts for doing, calling the conflation “pernicious”; see id. at 83).  Second, she fails to realize or acknowledge that the scintilla must be weighed against the entire evidentiary display.  Sometimes, as in the Bendectin litigation, the “scintilla” might include a fair amount of evidence, which is trumped by evidence superior in quality and quantity, and that this trumping is what leads to the finding that opining witnesses had offered unreliable opinions, unhelpful to the jury.

2.  “[C]onsistency of the observed effect is a criterion most scientists would deem important, but it may be absent even where there is a strong causal link, such as the link between smoking and lung cancer, which, although strong, is not inevitably observed.  Although it might be persuasive to find that there was a consistent specific association between exposure and a particular disease, such association is rarely observed.”  Id. at 59.

First, EBM offers no citation for the claim that the “link” between smoking and lung cancer is “not inevitably observed.”  The association is virtually always found in modern epidemiologic studies, and it is almost always statistically significant in adequately powered studies.  The repeated finding of an association, not likely due to chance, in many studies, conducted by different investigators, in different populations, at different times, with different study designs is the important point about consistency.  EBM muddles her unsupported, unsupportable assertion by then noting that a “consistent specific association” is rarely observed, but here she has moved, confusingly, to a different consideration – namely the specificity of the association, not its consistency.  Admittedly, specificity is a weak factor in assessing the causality vel non of an association, but EBM’s reference to a “consistent specific association” seems designed to confuse and conflate two different factors in the analysis.

3.  “[A]nimal studies are superior to epidemiologic studies because of the lack of controls endemic to epidemiologic studies, the difficulty in designing and analyzing such studies, and their costliness.”  Id. at 70.

This is one of EBM’s more strident, stunning pronouncements.  Her book makes clear that as an apologist for animal evidence, EBM deprecates and misunderstands epidemiologic evidence at almost every turn.  It is perhaps possible to interpret EBM charitably by suggesting that the epidemiologic studies she is thinking of without controls are “descriptive studies,” such as case reports or case series.  Such an interpretation is unwarranted, however, given EBM’s failure to qualify “epidemiologic studies.”  She paints with a broad brush, in a deliberate attempt to upend the generally accepted hierarchy of evidence.  Even a casual reading of the cases she cites, and the Reference Manual on Scientific Evidence, shows that the epidemiologic studies that are important to real intellectual due process are precisely the ones that have appropriate controls.  Most of the world, even if not EBM, thinks of analytic epidemiologic studies when comparing and contrasting with animal studies.

EBM offers no support for the asserted difficulty in designing and analyzing epidemiologic studies.  Is she making a personal, subjective declaration of her own difficulties?  The difficulties of judges and lawyers?  Or the difficulties of expert witnesses themselves?  To be sure, some lawyers have such difficulties, but they may have a good career choice to go to law rather than medical school.  (Perhaps they would do better yet in real estate litigation rather than in torts.)  Many physicians have “difficulty in designing and analyzing such studies,” but that is because these activities are outside the scope of their expertise, which until recently was rarely taught in medical schools.  In my experience, these activities have not been beyond the abilities of appropriately qualified expert witnesses, whether engaged by plaintiffs or defendants in civil litigation.

As for the “costliness” of epidemiologic studies, many studies can be conducted expeditiously and inexpensively.  Case-control studies can often be done relatively quickly and easily because they work from identified cases back to past exposures.  Cohort studies can often be assembled from administrative medical databases maintained for other purposes.  In the United States, such databases are harder to find, but several exist as a result of Medicare, VA, National Center for Health Statistics, and other managed care programs.  In Scandinavia, the entire countries of Sweden and Denmark are ongoing epidemiologic studies because of their national healthcare systems.  Cohort and case-control studies have been quickly and inexpensively set up to study many important public health issues, ranging from MMR vaccines and thimerosal and autism, abortion and breast cancer, and welding and parkinsonism.  See, e.g., Lone Frank, “Epidemiology: When an Entire Country Is a Cohort,” 287 Science 2398-2399 (2000).  Plaintiffs’ counsel, often with more money at their disposal than the companies they sue, have organized and funded any number of epidemiologic studies.  EBM’s attempted excuses and justifications of why animal studies are “superior” to epidemiology fail.

Perhaps we should take a moment to have a small reality check:

Would we accept an FDA decision that approved a drug that was safe and efficacious in rats, without insisting on a clinical trial in human beings?  How many drugs show great therapeutic promise in animal models only to fail on safety or efficacy, or both, when tested in humans?  I believe that the answers are: “no,” and “sadly, too many.”

4. “Clinical double-blind studies are rarely, if ever, available for litigation purposes.”  Id. at 69.

EBM again cites no support for this assertion, and she is plainly wrong.  Clinical trials have been important sources of evidence relied upon by both plaintiffs’ and defendants’ expert witnesses in pharmaceutical litigation, which makes up a large, increasing portion of all products liability litigation.  Even in cases involving occupational or environmental exposures, for which randomization would be impractical or unethical, double-blinded human clinical studies of toxicokinetics, or metabolic distribution and fate, are often important to both sides involved in litigating claims of personal injury.

5.  “[B]ecause there are so few good epidemiologic studies available, animal studies are often the primary source of information regarding the impact of chemicals.”  Id. at 73.

The field of occupational and environmental epidemiology is perhaps a half a century old, with high quality studies addressing many if not most of the chemicals that are involved in important personal injury litigations.  EBM’s claims about the prevalence of “good” studies, as well as the implicit claim about what proportion of lawsuits involve chemicals for which there exists no epidemiologic data, are themselves devoid of any empirical support.

6.  “[S]cientifc conclusions are couched in tentative phrases. ‘Association’ is preferred to ‘causation.’ Thus, failing to understand that causation, like other hypotheses, can never be proven true, courts may reject as unreliable even evidence that easily meets scientific criteria for validity.”  Id. at 55 (citing Hall, Havner, and Wright).

EBM writes that scientists prefer “association” to “causation,” but the law insists upon causation.  EBM fails to recognize that these are two separate, distinct concepts, and not a mere semantic preference for the intellectually timid.  An opinion about association is not an opinion about causation.  Scientists prefer to speak of association when the criteria for validly inferring the causal conclusion are not met; this preference thus has important epistemic implications for courts that must ensure that opinions are really reliable and relevant.  EBM sets up a straw man – hypotheses can never be proven to be true – in order to advocate for the acceptance and the admissibility of hypotheses masquerading as conclusions.  The fact is that, notwithstanding the mechanics of hypothesis testing, many hypotheses come to be accepted as scientific fact.  Indeed, EBM’s talk here, and elsewhere, of opinions “proven” or “demonstrated” to be true is a sloppy incorporation of mathematical language that is best avoided in evaluating empirical scientific claims.  Scientific findings are “shown” or “inferred,” not demonstrated.  Not all opinions stall at the “association” stage; many justifiably move to opinions about causation.  The hesitancy of scientists to assert that an association is causal usually means that they, like judges who are conscientious about their gatekeeping duties, recognize that there is an unacceptable error rate from indiscriminately treating all associations as causation.

(To Be Continued)

Most parents have confronted their children’s insistence to do or to have something based upon the popularity of that something, but we would not expect such behavior from scientists.

Or should we?

In this era of bashing authors for having taken a shekel or two from industry to support their work, how are we to identify and evaluate other non-financial biases that afflict science.  Anti-industry zealots write as though money were the only error-inducing incentive at play in the scientific arena, but they are wrong.  In addition to vanity, egotism, grant-mania, prestige, academic advancement, scientists are subject to “group think”; they are prone to advancing scientific conclusions that are the “in thing” to espouse.  Call it herd-think, or Zeitgeist, or the occupational medicine mafia; error creeps in when scientists reach and defend conclusions because those conclusions are the “in” thing.

Finding examples and admissions of scientists falling into error to align themselves with popular voices on controversial issues is, however, not easy.  One of my favorites was reported in the context of the federal government’s predictions of the United States’ cancer toll expected from occupational use of asbestos.  In 1978, then Secretary of Health Education and Welfare, Joseph Califano, announced the results of a report, prepared by scientists at the National Cancer Institute, the NIEHS, and the NIOSH, which predicted that 17 percent of all future cancers would be caused by asbestos.  This prediction was based largely upon the work of Dr Irving Selikoff and colleagues, who studied heavily exposed asbestos insulators and factory workers.  Tom Reynolds, “Asbestos-Linked Cancer Rates Up Less Than Predicted,” 84 J. Nat’l Cancer Instit. 560, 560 (1984).

Within a few years of the report, the scientific community realized that it had been duped.  How did so many high-level governmental scientists fall into error?  Selikoff’s prestige was great.  (Califano’s speech occurred well before the scandal of Selikoff’s infamous seminar organized by plaintiffs’ lawyers to showcase plaintiffs’ expert witnesses for the “benefit” of key state and federal judges.  See Cathleen M. Devlin, “Disqualification of Federal Judges – Third Circuit Orders District Judge James McGirr Kelly to Disqualify Himself So As to Preserve ‘The Appearance of Justice’ Under 28 U.S.C. 455: In re School Asbestos Litigation (1992),” 38 Vill. L. Rev. 1219 (1993).)  Scientists, however, should be evidence-based people, and not make important public pronouncements, likely to generate widespread public fear and concern, on the basis of someone’s prestige.  There was more to this error than the charm and reputation of Irving Selikoff.

By the time of the Califano report, the misdeeds of Johns-Manville had become well known among the scientific community.  Little attention was paid to the role of the U.S. government in promoting the use of asbestos, and its failure to warn and to provide safe workplaces in its naval shipyards.  The imbalance in reporting led scientists to enjoy a “feel good” attitude about reaching conclusions that exaggerated and distorted the scientific data to the detriment of the so-called “asbestos industry.”  In 1984, the Journal of the National Cancer Institute reported the phenomenon as follows:

“Enterline [an epidemiologist who published several studies on asbestos factory workers and who interviewed for the story] said the government’s exaggeration of the asbestos danger reflects a 1970s’ Zeitgeist that developed partly in response to revelations of industry misdeeds.

‘It was sort of the “in” thing to exaggerate … [because] that would be good for the environmental movement,’ he said. ‘At the time it looked like you were wearing a white hat if you made these wild estimates.  But I wasn’t sure whoever did that was doing all that much good’.”

Tom Reynolds, supra at 562.  The “in” thing to exaggerate; who would have thought scientists ever did that, much less acknowledge it.  The Califano report caught its scientist authors red handed, and there was not much they could do about it.  The report’s predictions were debunked by leading scientists, and the report’s authors confessed to having tortured the data.  R. Doll & R. Peto, “The causes of cancer: quantitative estimates of avoidable risks of cancer in the United States today, 66 J. Nat’l Cancer Instit. 1191 – 308 (1981). 

What is memorable about the incident is that the report was motivated by the desire to “wear a white hat,” not by lucre.  The lesson is that the current focus on “conflicts of interest” is little better than an excuse for ad hominem attacks, and that everyone would be better off if the focus were on the evidence.