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FOIA Exemptions Gobble Up The Statute

November 27th, 2015

Last week, the Supreme Court refused to hear a case in which petitioners sought review of a First Circuit decision that upheld the “commercial information” exemption (exemption 4) to the Freedom of Information Act, 5 U.S.C. § 552 (FOIA). New Hampshire Right to Life v. Dep’t Health & Human Services, 778 F.3d 43 (1st Cir. 2015). See Lyle Denniston, “Court bypasses FOIA challenge,” SCOTUSblog (Nov. 16, 2015).

An anti-abortion group filed a FOIA request to obtain documents that Planned Parenthood had sent to the federal government’s Department of Health and Human Services, in support of federal funding, for family planning activities in New Hampshire. The requested documents described Planned Parenthood’s internal medical standards and guidelines, as well as its set fees for various services. The federal trial court upheld the agency’s refusal to disclose the Planned Parenthood documents on the basis of § 552(b)(4) (Exemption 4, for “trade secrets and commercial or financial information obtained from a per­son and privileged or confidential”), as well as internal agency documents, on the basis of § 552(b)(5) (Exemption 5). The First Circuit affirmed the non-freedom of information. 778 F.3d 43.

Justice Thomas, joined by Justice Scalia, dissented from the Court’s denial of review. New Hampshire Right to Life, No. 14–1273, SCOTUS (Nov. 16, 2015) [Thomas Dissent] Justice Thomas intimated that the First Circuit’s decision may well have offended the Supreme Court’s interpretation of FOIA as reflecting “a general philosophy of full agency disclosure unless information is exempted under clearly delineated statutory language.” Department of Defense v. FLRA, 510 U. S. 487, 494 (1994).

Justice Thomas noted that the First Circuit based its conclusion not on the ordinary meaning of the term “confidential,” but on speculation whether FOIA disclosure might harm Planned Parenthood’s position in a conjectured market. The First Circuit ordained the Planned Parenthood manual confidential because “[a]potential future competitor could take advantage of the institutional knowledge contained in the Manual” to com­pete against the organization in the future. Justice Thomas intimated that he, and concurring Justice Scalia, disapproved of this speculation upon speculation approach. Thomas Dissent at 2. The dissenters also noted that the Supreme Court has yet to interpret Exemption 4, to FOIA, and that the lower courts have embraced this exemption as a broad exclusion, in derogation of the language and spirit of FOIA.

In discovery efforts to obtain information about litigation science, funded by the National Institute of Environmental Health and Science (NIEHS), FOIA officers appear to invoke Exemption 4 routinely to deny disclosure. One case in point was the effort to obtain information about NIEHS-funded research of Dr. Brad A. Racette, on the prevalence of parkinsonism among welding tradesmen in Wisconsin Great Lakes shipyards. Racette is an academic researcher, on the faculty of Washington University St. Louis; he is not engaged in any commercial enterprise, in any imaginable use of the word “commercial.” His Wisconsin research was sponsored by the Boilermakers’ union, which had worked with the litigation industry (trial bar) to develop a litigation case against the manufacturers of welding rods. FOIA requests for scientific data, protocols, and analyses were met, by NIEHS, with over-zealous redactions with the invocation of FOIA exemptions, including assertions that data and analyses were “confidential commercial information.”

The redaction of one of Racette’s ESNAP reports, on Grant Number SR01ES13743-4, is illustrative. The multi-year grant, entitled “Epidemilogy [sic] of Parkinsonism in Welders,” was awarded to principal investigator Brad Racette in 2007. On October 29, 2009, Racette submitted a report that included data and data analysis. The NIEHS, on its own, or acting at the request of the principal investigator, redacted data, analyses, and conclusions, on grounds of “confidential commercial information.” Invoking an exemption for “commercial information” for federally funding of an epidemiologic study, conducted by university-based scientists seems an extreme distortion of the FOIA statute.

Cynics may say that Justices Thomas and Scalia dissented in the Planned Parenthood case because they were eager, to advance their theological ideology to exploit the opportunity to order disclosure that could hurt the good work that Planned Parenthood does. The dissenting justices deserve, however, to be taken at their word, and applauded for chastising their colleagues who were willing to abide the frustation of the word and spirit of the FOIA statute. Sadly, federal agencies seem to be determined to make information unfree. In the most recent evaluations, the Department of Health and Human Services received a failing grade, among the lowest grades for FOIA performance and responsiveness; only the State Department failed with a lower score. National Freedom of Information Coalition, “FOIA report card shows federal agencies missing the mark,” (Mar. 16, 2015); Center for Effective Government, “Making the Grade – Access to Information Scorecard 2015.”

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Woodside on Access to Underlying Research Data

October 10th, 2015

Access to underlying data and materials, source codes, and other research materials is a two-edged sword. Many scientists who hold forth on the issue, including some prominent plaintiffs’ expert witnesses, have been extremely critical of the pharmaceutical and other industries for not sharing underlying data of their research. On the other hand, some of the same people have resisted sharing data and information when the litigants have sought access to these materials to understand or to challenge the published conclusions and analyses.[1]

Dr. Frank Woodside, of Dinsmore & Shohl, kindly sent me a copy of his recent law review article, written with a colleague, which advocates for full disclosure of underlying research data when research becomes material to the outcome of litigation.[2] Frank C. Woodside & Michael J. Gray, “Researchers’ Privilege: Full Disclosure,” 32 West. Mich. Univ. Cooley L. Rev. 1 (2015). The authors make the case that the so-called researcher’s privilege has little or no support in federal or state law. My previous posts have largely supported this view, at least for research that has been published, and especially for research that is being relied upon by testifying expert witnesses in pending litigation. As Lord Chancellor Hardwicke put the matter, “the public has a right to every man’s evidence,”[3] and scientists should not be immune to the requirement of giving and sharing their evidence.

Woodside and Gray have updated the scholarship in this area, and their article should be consulted in any ongoing discovery, subpoena, or Freedom of Information Act (FOIA) battle. Their discussion of the evolving case law under FOIA is especially timely. Despite the strong presumption in favor of disclosure under FOIA,[4] and President Obama’s pronouncements[5] about a new era in FOIA openness and transparency, the government’s compliance is at an all-time low. See Ted Bridis, “Obama administration sets new record for withholding FOIA requests,” PBS News Hour (Mar. 18, 2015). Court decisions have made clear that researchers cannot refuse to produce underlying data simply “because disclosure would diminish the researchers’ ability to publish their results in prestigious journals.”[6] And yet the National Institute of Environmental Health and Safety continues in its aggressive resistance to disclosure of underlying data, often by invoking FOIA exemption number four. In my cases, I have seen the NIEHS resort to this exemption that protects documents that reveal “[t]rade secrets and commercial or financial information obtained from a person and privileged or confidential,”[7] even when the research in question was conducted by academic researchers funded by the NIEHS.

[1] See, e.g., Enoch v. Forest Research Institute, Inc., N.J. Law Div. Hudson Cty., Civ. Div. L-3896-14, Order Granting Defendants’ Motion to Compel Production of Documents Necessary to Verify the Validity and Accuracy of a Study by Plaintiffs’ Expert, Anick Berard, Ph.D. (Oct. 9, 2015) (Jablonski, J.) (ordering plaintiffs to “produce the documents sought by the Forest defendants to verify the validity and accuracy of the study known as “Berard et al., Sertraline Use During Pregnancy and the Risk of Major Malformations, Am. J. Obstet. Gynecol. (2015), doi 10.1016/j.ajog.2015.01.034, namely the study’s SAS source codes and the specific generalized estimating equation models that were used to generate Table 2 of the study”).

[2] And I should thank Dr. Woodside and Mr. Gray for their generous citations to your humble blogger’s posts on this subject.

[3] Debate in the House of Lords on the Bill to Indemnify Evidence, 12 Hansard’s Parliamentary History of England, 675, 693, May 25, 1742, quoted in 8 Wigmore on Evidence at 64, § 2192 (3d ed. 1940).

[4] See S. REP. No. 89-813, at 3 (1965) (the purpose of FOIA is to “establish a general philosophy of full agency disclosure . . . and to provide a court procedure by which citizens and the press may obtain information wrongfully withheld”).

[5] See Executive Order, Memorandum, 74 Fed. Reg. 4685 (Jan. 21, 2009).

[6] See Burka v. U.S. Dep’t of Health and Human Serv., 87 F.3d 508, 515 (D.C. Cir. 1996).

[7] See 5 U.S.C. § 552(b)(4).

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Clinical Trials and Epidemiologic Studies Biased by False and Misleading Data From Research Participants

October 2nd, 2015

Many legal commentators erroneously refer to epidemiologic studies as “admitted” into evidence.[1] These expressions are sloppy, and unfortunate, because they obscure the tenuousness of study validity, and the many hearsay levels that are represented by an epidemiologic study. Rule 702 permits expert witness opinion that has an epistemic basis, and Rule 703 allows expert witnesses to rely upon otherwise inadmissible facts and data, as long as real experts in the field would reasonably rely upon such facts and data. Nothing in Rule 702 or 703 make an epidemiologic study itself admissible. And the general inadmissibility of the studies themselves is a good thing, given that they will be meaningless to the trier of fact without the endorsements, qualifications, and explanations of an expert witness, and given that many studies are inaccurate, invalid, and lack data integrity to boot.

Dr. Frank Woodside was kind enough to call my attention to an interesting editorial piece in the current issue of the New England Journal of Medicine, which reinforced the importance of recognizing that epidemiologic studies and clinical trials are inadmissible in themselves. The editorial, by scientists from the National Institute of Environmental Health Studies and the National Institute on Drug Abuse, calls out the problem of study participants who lie, falsify, fail to disclose, and exaggerate important aspects of their medical histories as well as their data. See David B. Resnik & David J. McCann, “Deception by Research Participants,” 373 New Engl. J. Med. 1192 (2015). The editorial is an important caveat for those who would glibly describe epidemiologic studies and clinical trials as “admissible.”

As a reminder of the autonomy of those who participate in clinical trials and studies, we now refer to individuals in a study as “participants,” and not “subjects.” Resnik and McCann remind us, however, that notwithstanding their importance, study participants can bias a study in important ways. Citing other recent papers,[2] the editorialists note that clinical trials offer financial incentives to participants, which may lead to exaggeration of symptoms to ensure enrollment, to failure to disclose exclusionary medical conditions and information, and to withholding of embarrassing or inculpatory information. Although fabrication or falsification of medical history and data by research participants is not research misconduct by the investigators, the participants’ misconduct can seriously bias and undermine the validity and integrity of a study.

Resnik and McCann’s concerns about the accuracy and truthfulness of clinical trial participant medical data and information can mushroom exponentially in the context of observational studies that involve high-stakes claims for compensation and vindication on medical causation issues. Here are a couple of high-stakes examples.

The Brinton Study in Silicone Gel Breast Implant Litigation

In the silicone gel breast implant litigation, claimants looked forward to a study by one of their champions, Dr. Louis Brinton, of the National Cancer Institute (NCI). Brinton had obtained intramural funding to conduct a study of women who had had silicone gel breast implants and their health outcomes. To their consternation, the defendants in that litigation learned of Dr. Brinton’s close ties with plaintiffs’ counsel, plaintiffs’ support groups, and other advocates. Further investigation, including Freedom of Information Act requests to the NCI led to some disturbing and startling revelations.

In October 1996, a leading epidemiologist wrote a “concerned citizen” letter to Dr. Joseph Fraumeni, who was then the director of Epidemiology and Genetics at the NCI. The correspondent wrote to call Dr. Fraumeni’s attention to severe bias problems in Dr. Brinton’s pending study of disease and symptom outcomes among women who had had silicone breast implants. Dr. Brinton had written to an Oregon attorney (Michael Williams) to enlist him to encourage his clients to participate in Brinton’s NCI study.   Dr. Brinton had also written to a Philadelphia attorney (Steven Sheller) to seek permission to link potential study subjects to the global settlement database of information on women participating in the settlement. Perhaps most egregiously, Dr. Brinton and others had prepared a study Question & Answer sheet, from the National Institutes of Health, which ended with a ringing solicitation of “The study provides an opportunity for women who may be suffering as a result of implants to be heard. Now is your chance to make a major contribution to women’s health by supporting this essential research.” Dr. Brinton apparently had not thought of appealing to women with implants who did not have health problems.

Dr. Brinton’s methodology doomed her study from the start. Without access to the background materials, such as the principal investigator’s correspondence file, or the recruitment documents used to solicit participation of ill women in the study, the scientific community, and the silicone litigation defendants would not have had the important insights into serious bias and flaws of Brinton’s study.

The Racette-Scruggs’ Study in Welding Fume Litigation

The welding fume litigation saw its version of a study corrupted by the participation of litigants and potential litigants. Richard (Dickie) Scruggs and colleagues funded some neurological researchers to travel to Alabama and Mississippi to “screen” plaintiffs and potential plaintiffs in litigation for over claims of neurological injury and disease from welding fume exposure. The plaintiffs’ lawyers rounded up the research subjects (a.k.a. clients and potential clients), talked to them before the medical evaluations, and administered the study questionnaires. Clearly the study subjects were aware of Scruggs’ “research” hypothesis. The plaintiffs’ lawyers then invited researchers who saw the welding tradesmen, using a novel videotaping methodology, to evaluate the workers for parkinsonism.

After their sojourn, at Scruggs’ expense to Alabama and Mississippi, the researchers wrote up their results, with little or no detail of the circumstances of how they had acquired their research “participants,” or those participants’ motives to give accurate or inaccurate medical and employment history information. See Brad A. Racette, S.D. Tabbal, D. Jennings, L. Good, J.S. Perlmutter, and Brad Evanoff, “Prevalence of parkinsonism and relationship to exposure in a large sample of Alabama welders,” 64 Neurology 230 (2005); Brad A. Racette, et al., “A rapid method for mass screening for parkinsonism,” 27 Neurotoxicology 357 (2006) (a largely duplicative report of the Alabama welders study).

Defense counsel directed subpoenas to both Dr. Racette and his institution, Washington University St. Louis, for the study protocol, underlying data, data codes, and statistical analyses.  After a long discovery fight, the MDL court largely enforced the subpoenas.  See, e.g., In re Welding Fume Prods. Liab. Litig., MDL 1535, 2005 WL 5417815 (N.D. Ohio Oct. 18, 2005) (upholding defendants’ subpoena for protocol, data, data codes, statistical analyses, and other things from Dr. Racette’s Alabama study on welding and parkinsonism). After the defense had the opportunity to obtain and analyze the underlying data in the Scruggs-Racette study, the welding plaintiffs largely retreated from their epidemiologic case. The Racette Alabama study faded into the background of the trials.

Both the Brinton and the Racette studies are painful reminders of the importance of assessing the motives of the study participants in observational epidemiologic studies, and the participants’ ability to undermine data integrity. If the financial motives identified by Resnik and McCann are sufficient to lead participants to give false information, or to fail to disclose correct information, we can only imagine how powerful are the motives created by the American tort litigation system among actual and potential claimants when they participate in epidemiologic studies. Resnik and McCann may be correct that fabrication or falsification of medical history and data by research participants is not research misconduct by the investigators themselves, but investigators who turn a blind eye to the knowledge, intent, and motives of their research participants may be conducting studies that are doomed from the outset.

[1] Michael D. Green, D. Michal Freedman, Leon Gordis, “Reference Guide on Epidemiology 549, 551,” in Reference Manual on Scientific Evidence (3d ed. 2011) ( “Epidemiologic studies have been well received by courts deciding cases involving toxic substances. *** Well-conducted studies are uniformly admitted.) (citing David L. Faigman et al. eds., 3 Modern Scientific Evidence: The Law and Science of Expert Testimony § 23.1, at 187 (2007–08)).

[2] Eric Devine, Megan Waters, Megan Putnam, et al., “Concealment and fabrication by experienced research subjects,” 20 Clin. Trials 935 (2013); Rebecca Dresser, “Subversive subjects: rule-breaking and deception in clinical trials,” 41 J. Law Med. Ethics 829 (2013).

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Silicone Data Slippery and Hard to Find (Part 2)

July 5th, 2015

What Does a Scientist “Gain,” When His Signal Is Only Noise

When the silicone litigation erupted in the early 1990s, Leoncio Garrido was a research professor at Harvard. In 1995, he was promoted from Assistant to Associate Professor of Radiology, and the Associate Director of NMR Core, at the Harvard Medical School. Along with Bettina Pfleiderer, Garrido published a series of articles on the use of silicon 29 nuclear magnetic resonance (NMR) spectroscopy, in which he claimed to detect and quantify silicon that migrated from the silicone in gel implants to the blood, livers, and brains of implanted women[1].

Plaintiffs touted Garrido’s work on NMR silicone as their “Harvard” study, to offset the prestige that the Harvard Nurses epidemiologic study[2] had in diminishing the plaintiffs’ claims that silicone caused autoimmune disease. Even though Garrido’s work was soundly criticized in the scientific literature[3], Garrido’s apparent independence of the litigation industry, his Harvard affiliation, and the difficulty in understanding the technical details of NMR spectroscopic work, combined to enhance the credibility of the plaintiffs’ claims.

Professor Peter Macdonald, who had consulted with defense counsel, was quite skeptical of Garrido’s work on silicone. In sum, Macdonald’s analysis showed that Garrido’s conclusions were not supported by the NMR spectra presented in Garrido’s papers. The spectra shown had signal-to-noise ratios too low to allow a determination of putative silicon biodegradation products (let alone to quantify such products), in either in vivo or ex vivo analyses. The existence of Garrido’s papers in peer-reviewed journals, however, allowed credulous scientists and members of the media to press unsupported theories about degradation of silicone into supposedly bioreactive silica.

A Milli-Mole Spills the Beans on the Silicone NMR Data

As the silicone litigation plodded on, a confidential informant dropped the dime on Garrido. The informant was a Harvard graduate student, who was quite concerned about the repercussions of pointing the finger at the senior scientist in charge of his laboratory work. Fortunately, and honorably, this young scientist more concerned yet that Garrido was manipulating the NMR spectra to create his experimental results. Over the course of 1997, the informant, who was dubbed “Mini-Mole,” reported serious questions about the validity of the silicon NMR spectra reported by Garrido and colleagues, who had created the appearance of a signal by turning up the gain to enhance the signal/noise ratio. Milli-mole also confirmed Macdonald’s suspicions that Garrido had created noise artifacts (either intentionally or carelessly) that could be misrepresented to be silicon-containing materials with silicon 29 NMR spectra.

In late winter 1997, “Mini-Mole” reported that Harvard had empanelled an internal review board to investigate Garrido’s work on silicon detection in blood of women with silicone gel breast implants. The board involved an associate dean of the medical school, along with an independent reviewer, knowledgeable about NMR. Mini-Mole was relieved that he would not be put into the position of becoming a whistle blower, and he believed that once the board understood the issues, Garrido’s deviation from the scientific standard of care would become clear. Apparently, concern at Harvard was reaching a crescendo, as Garrido was about to present yet another abstract, on brain silicon levels, at an upcoming meeting of the International Society of Magnetic Resonance in Medicine, in Vancouver, BC. Milli-Mole reported that one of the co-authors strongly disagreed with Garrido’s interpretation of the data, but was anxious about withdrawing from the publication.

Science Means Never Having to Say You’re Sorry

By 1997, Judge Pointer had appointed a panel of neutral expert witnesses, but the process had become mired in procedural diversions. Bristol-Myers Squibb sought and obtained a commission in state court (New Jersey) cases for a Massachusetts’ subpoena for Garrido’s underlying data late in1997. Before BMS or the other defendants could act on this subpoena, however, Garrido published a rather weak, non-apologetic corrigendum to one of his papers[4].

Although Garrido’s “Erratum” concealed more than it disclosed, the publication of the erratum triggered an avalanche of critical scrutiny. One of the members of the editorial board of Magnetic Resonance in Medicine undertook a critical review of Garrido’s papers, as a result of the erratum and its fallout. This scientist concluded that:

“From my viewpoint as an analytical spectroscopist, the result of this exercise was disturbing and disappointing. In my judgement as a referee, none of the Garrido group’s papers (1–6) should have been published in their current form.”

William E. Hull, “A Critical Review of MR Studies Concerning Silicone Breast Implants,” 42 Magnetic Resonance in Medicine 984, 984 (1999).

Another scientist, Professor Christopher T.G. Knight, of the University of Illinois at Urbana-Champaign, commented in a letter in response to the Garrido erratum:

“A series of papers has appeared in this Journal from research groups at Harvard Medical School and Massachusetts General Hospital. These papers describe magnetic resonance studies that purport to show significant concentrations of silicone and chemically related species in the blood and internal organs of silicone breast implant recipients. One paper in particular details 29Si NMR spectroscopic results of experiments conducted on the blood of volunteers with and without implants. In the spectrum of the implant recipients’ blood there appear to be several broad signals, whereas no signals are apparent in the spectrum of the blood of a volunteer with no implant. On these grounds, the authors claim that silicone and its degradation products occur in significant quantities in the blood of some implant recipients. Although this conclusion has been challenged, it has been widely quoted.

******

The erratum, in my opinion, deserves considerably more visibility, because it in effect greatly reduces the strength of the authors’ original claims. Indeed, it appears to be tantamount to a retraction of these.”

Christopher T.G. Knight, “Migration and Chemical Modification of Silicone in Women With Breast Prostheses,” 42 Magnetic Resonance in Med. 42:979 (1999) (internal citations omitted). Professor Knight went on to critique the original Garrido work, and the unsigned, unattributed erratum as failing to show a difference between the spectra developed from blood of women with and without silicone implants. Garrido’s erratum suggested that his “error” was simply showing a spectrum with the wrong scale, but Professor Knight showed rather conclusively that other manipulations had taken place to alter the spectrum. Id.

In a brief response[5], Garrido and co-authors acknowledged that their silicon quantification was invalid, but still maintained that they had qualitatively determined the presence of silicon entities. Despite Garrido’s response, the scientific community soon became incredulous about his silicone NMR work.

Garrido’s fall-back claim that he had detected unquantified levels of silicon using Si29 NMR was definitively refuted, in short order[6]. Ultimately, Peter Macdonald’s critique of Garrido was vindicated, and Garrido’s work became yet another weight that helped sink the plaintiffs’ case. Garrido last published on silicone in 1999, and left Harvard soon thereafter, to become the Director of the Instituto de Ciencia y Tecnología de Polímeros, in Madrid, Spain. He is now a scientific investigator at the Institute’s Physical Chemistry of Polymers Department. The Institute’s website lists Garrido as Dr. Leoncio Garrido Fernández. Garrido’s silicone publications were never retracted, and Harvard never publicly explained Garrido’s departure.

[1] See, e.g., Bettina Pfleiderer & Leoncio Garrido, “Migration and accumulation of silicone in the liver of women with silicone gel-filled breast implants,” 33 Magnetic Resonance in Med. 8 (1995); Leoncio Garrido, Bettina Pfleiderer, B.G. Jenkins, Carol A. Hulka, D.B. Kopans, “Migration and chemical modification of silicone in women with breast prostheses,” 31 Magnetic Resonance in Med. 328 (1994). Dr. Carol Hulka is the daughter of Dr. Barbara Hulka, who later served as a neutral expert witness, appointed by Judge Pointer in MDL 926.

[2] Jorge Sanchez-Guerrero, Graham A. Colditz, Elizabeth W. Karlson, David J. Hunter, Frank E. Speizer, Matthew H. Liang, “Silicone Breast Implants and the Risk of Connective-Tissue Diseases and Symptoms,” 332 New Engl. J. Med . 1666 (1995).

[3] See R.B. Taylor, J.J. Kennan, “29Si NMR and blood silicon levels in silicone gel breast implant recipients,” 36 Magnetic Resonance in Med. 498 (1996); Peter Macdonald, N. Plavac, W. Peters, Stanley Lugowski, D. Smith, “Failure of 29Si NMR to detect increased blood silicon levels in silicone gel breast implant recipients,” 67 Analytical Chem. 3799 (1995).

[4] Leoncio Garrido, Bettina Pfleiderer, G. Jenkins, Carol A. Hulka, Daniel B. Kopans, “Erratum,” 40 Magnetic Resonance in Med. 689 (1998).

[5] Leoncio Garrido, Bettina Pfleiderer, G. Jenkins, Carol A. Hulka, Daniel B. Kopans, “Response,” 40 Magnetic Resonance in Med. 995 (1998).

[6] See Darlene J. Semchyschyn & Peter M. Macdonald, “Limits of Detection of Polydimethylsiloxane in 29Si NMR Spectroscopy,” 43 Magnetic Resonance in Med. 607 (2000) (Garrido’s erratum acknowledges that his group’s spectra contain no quantifiable silicon resonances, but their 29Si spectra fail to show evidence of silicone or breakdown products); Christopher T. G. Knight & Stephen D. Kinrade, “Silicon-29 Nuclear Magnetic Resonance Spectroscopy Detection Limits,” 71 Anal. Chem. 265 (1999).

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Silicone Data Slippery and Hard to Find (Part 1)

July 4th, 2015

In the silicone gel breast implant litigation, plaintiffs’ counsel loved to wave around early Dow Corning experiments with silicone as an insecticide. As the roach crawls, it turned out that silicone was much better at attracting and dispatching dubious expert witnesses and their testimony. On this point, it is hard to dispute the judgment of Judge Jack Weinstein[1].

The silicone wars saw a bioethics expert appear as an expert witness to testify about a silicone study in which his co-authors refuse to share their data with him, embarrassing to say the least. “Where Are They Now? Marc Lappé and the Missing Data” (May 19, 2013). And another litigation expert witness lost his cachet when the Northridge earthquake at his data. “Earthquake-Induced Data Loss – We’re All Shook Up” (June 26, 2015). But other expert witnesses were up to the challenge for the most creative and clever excuses for not producing their underlying data.

Rhapsody in Goo – My Data Are Traveling; Come Back Later

Testifying expert witness, Dr. Eric Gershwin was the author of several research papers that claimed or suggested immunogenicity of silicone[2]. His results were criticized and seemed to elude replication, but he enjoyed a strong reputation as an NIH-funded researcher. Although several of his co-authors were from Specialty Labs, Inc. (Santa Monica, CA)[3], defense requests for his Gershwin’s underlying data were routinely met with the glib response that the data were in Israel, where some of his other co-authors resided.

Gershwin testified in several trials, and the plaintiffs’ counsel placed great emphasis on his publications and on his testimony given before Judge Jones’ technical advisors in August 1996, before Judge Pointer’s panel of Rule 706 experts, in July 1997, and before the Institute of Medicine (IOM) in 1998.

Ultimately, this peer review of Gershwin’s work and claims was withering. The immunologist on Judge Jones’ panel (Dr. Stenzel-Poore) found Gershwin’s claims “not well substantiated.” Hall v. Baxter Healthcare Corp., 947 F.Supp. 1387 (D. Ore. 1996). The immunologist on Judge Pointer’s panel, Dr. Betty A. Diamond was unshakeable in her criticisms of Gershwin’s work and his conclusions. Testimony of Dr. Betty A. Diamond, in MDL 926 (April 23, 1999). And the IOM found Gershwin’s work inadequate and insufficient to justify the extravagent claims that plaintiffs were making for immunogenicity and for causation of autoimmune disease. Stuart Bondurant, Virginia Ernster, and Roger Herdman, eds., Safety of Silicone Breast Implants (Institute of Medicine) (Wash. D.C. 1999).

Unlike Kossovsky, who left medical practice and his university position, Gershwin has continued to teach, research, and write after the collapse of the silicone litigation industry. And he has continued to testify, albeit in other kinds of tort cases.

In 2011, in testimony in a botox case, Dr. Gershwin attempted to distance himself from his prior silicone testimony. Gershwin testified that he was “an expert for silicone implants in the late 90s.” Testimony of M.E. Gershwin, at at 18:17-25, in Ray v. Allergan, Inc., Civ. No. 3:10CV00136 (E.D. Va. Jan. 17, 2011). An expert witness for implants; how curious? Here is how Gershwin described the fate of his strident testimony in the silicone litigation:

“Q. And has a court ever limited or excluded your opinions?

A. So a long time ago, probably more than ten years ago or so, twice. I had many cases involving silicone implants. The court restricted some but not all of my testimony. Although, my understanding is that, when the FDA finally did reapprove the use of silicone implants, the papers I published and evidence I gave was actually part of the basis by which they developed their regulations. And there’s not been a single example in the literature of anyone that’s ever refuted or questioned any of my work. But I think that’s all, as far as I know.

* * * *
Q. Okay. So it’s not — you made it sound like it was some published work that you had. Was it your opinions that you expressed in the cases that you believe the FDA adopted as part of their guidelines, or do you —

A. So I’ll tell you, I haven’t visited this subject in a long time, and I certainly took quite a beating from a number of people over — I was very proud in the past that I did it. Women’s rights groups all over the United States applauded what I did. I haven’t looked at these documents in over ten years, so beyond that, you’d have to do your own research.”

Id. at 20:19 – 21:25. Actually, several courts excluded Gershwin, as well as other expert witnesses who relied upon his published papers. Proud to be beaten.

Some of Gershwin’s coauthors have stayed the course on silicone. Yehuda Shoenfeld continues to publish on sick-building syndrome and so-called silicone “adjuvant disease,” which Shoenfeld immodestly refers to as “Shoenfeld’s syndrome.[4]” Gershwin and Shoenfeld parted company in the late 1990s on silicone, although they continue to publish together on other topics[5].

[1] 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 the silicone gel breast implant litigation as “charlatans” and the litigation as largely based upon fraud).

[2] E. Bar-Meir, S.S. Teuber, H.C. Lin, I. Alosacie, G. Goddard, J. Terybery, N. Barka, B. Shen, J.B. Peter, M. Blank, M.E. Gershwin, Y. Shoenfeld, “Multiple Autoantibodies in Patients with Silicone Breast Implants,” 8 J. Autoimmunity 267 (1995); Merrill J. Rowley, Andrew D. Cook, Suzanne S. Teuber, M. Eric Gershwin, “Antibodies to Collagen: Comparative Epitope Mapping in Women with Silicon Breast Implants, Systemic Lupus Erythematosus and Rheumatoid Arthritis,” 6 J. Autoimmunity 775 (1994); Suzanne S. Teuber, Merrill J. Rowley, Steven H. Yoshida, Aftab A. Ansari, M.Eric Gershwin, “Anti-collagen Autoantibodies are Found in Women with Silicone Breast Implants,” 6 J. Autoimmunity 367 (1993).

[3] J. Teryberyd, J.B. Peter, H.C. Lin, and B. Shen.

[4] A partial sampler of Shoenfeld’s continued output on silicone:

Goren, G. Segal, Y. Shoenfeld, “Autoimmune/inflammatory syndrome induced by adjuvant (ASIA) evolution after silicone implants: Who is at risk?” 34 Clin. Rheumatol. (2015) [in press]

Nesher, A. Soriano, G. Shlomai, Y. Iadgarov, T.R. Shulimzon, E. Borella, D. Dicker, Y. Shoenfeld, “Severe ASIA syndrome associated with lymph node, thoracic, and pulmonary silicone infiltration following breast implant rupture: experience with four cases,” 24 Lupus 463 (2015)

Dagan, M. Kogan, Y. Shoenfeld, G. Segal, “When uncommon and common coalesce: adult onset Still’s disease associated with breast augmentation as part of autoimmune syndrome induced by adjuvants (ASIA),” 34 Clin Rheumatol. 2015 [in press]

Soriano, D. Butnaru, Y. Shoenfeld, “Long-term inflammatory conditions following silicone exposure: the expanding spectrum of the autoimmune/ inflammatory syndrome induced by adjuvants (ASIA),” 32 Clin. Experim. Rheumatol. 151 (2014)

Perricone, S. Colafrancesco, R. Mazor, A. Soriano, N. Agmon-Levin, Y. Shoenfeld, “Autoimmune/inflammatory syndrome induced by adjuvants (ASIA) 2013: Unveiling the pathogenic, clinical and diagnostic aspects,” 47 J. Autoimmun. 1 (2013)

Vera-Lastra, G. Medina, P. Cruz-Dominguez Mdel, L.J. Jara, Y. Shoenfeld, “Autoimmune/inflammatory syndrome induced by adjuvants (Shoenfeld’s syndrome): clinical and immunological spectrum,” 9 Expert Rev Clin Immunol. 361 (2013)

Lidar, N. Agmon-Levin, P. Langevitz, Y. Shoenfeld, “Silicone and scleroderma revisited,” 21 Lupus 121 (2012)

S.D. Hajdu, N. Agmon-Levin, Y. Shoenfeld, “Silicone and autoimmunity,” 41 Eur. J. Clin. Invest. 203 (2011)

Levy, P. Rotman-Pikielny, M. Ehrenfeld, Y. Shoenfeld, “Silicone breastimplantation-induced scleroderma: description of four patients and a critical review of the literature,” 18 Lupus 1226 (2009)

A.L. Nancy & Y. Shoenfeld, “Chronic fatigue syndrome with autoantibodies – the result of an augmented adjuvant effect of hepatitis-B vaccine and silicone implant,” 8 Autoimmunity Rev. 52 (2008)

Molina & Y. Shoenfeld, “Infection, vaccines and other environmental triggers of autoimmunity,” 38 Autoimmunity 235 (2005)

R.A. Asherson, Y. Shoenfeld, P. Jacobs, C. Bosman, “An unusually complicated case of primary Sjögren’s syndrome: development of transient ‘lupus-type’ autoantibodies following silicone implant rejection,” 31 J. Rheumatol. 196 (2004), and Erratum in 31 J. Rheumatol. 405 (2004)

Bar-Meir, M. Eherenfeld, Y. Shoenfeld, “Silicone gel breast implants and connective tissue disease–a comprehensive review,” 36 Autoimmunity 193 (2003)

Zandman-Goddard, M. Blank, M. Ehrenfeld, B. Gilburd, J. Peter, Y. Shoenfeld, “A comparison of autoantibody production in asymptomatic and symptomatic women with silicone breast implants,” 26 J. Rheumatol. 73 (1999)

[5] See, e.g., N. Agmon-Levin, R. Kopilov, C. Selmi, U. Nussinovitch, M. Sánchez-Castañón, M. López-Hoyos, H. Amital, S. Kivity, M.E. Gershwin, Y. Shoenfeld, “Vitamin D in primary biliary cirrhosis, a plausible marker of advanced disease,” 61 Immunol. Research 141 (2015).

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Plaintiffs Sue Friendly Physicians for Access to Opinions and to Data

February 14th, 2015

Access to underlying data continues to be a difficult and contentious issue in litigation and in the world of public health. Healthcare providers have made intemperate demands upon pharmaceutical manufacturers to produce underlying data from clinical trials, but often the same providers object the loudest when asked to share underlying data from their own observational or experimental studies.

Last month saw a judicial rejection of an effort by New York researchers to resist production of underlying data. Plaintiffs in the World Trade Center health effects litigation sought to compel their treating physicians at the Mt. Sinai Health System to testify to their opinions about general and specific causation of the plaintiffs’ alleged injuries. Previously, in discovery depositions of the plaintiffs’ treating physicians as fact witnesses, Mt. Sinai Hospital’s attorneys objected to plaintiffs’ counsel’s efforts to elicit causation opinions not recorded in the plaintiffs’ personal medical records. Plaintiffs then moved to compel the treating physicians to give opinions on causation, and to produce underlying data from their published papers on the claimed health effects of exposure to World Trade Center dust. The hospital opposed these motions on grounds that its neutrality in the litigation would be compromised by compulsory testimony and production of data.

In a short opinion, Judge Alvin K. Hellerstein refused plaintiffs’ motions to compel testimony, but granted their motion to compel production of underlying data. In re World Trade Center Lower Manhattan Disaster Site Litig., ___ F.R.D. ___, 2015 WL 220988, at *1-2 (S.D.N.Y. Jan. 15, 2015). Judge Hellerstein acknowledged that, in rare instances, federal trial courts have compelled experts to provide opinion testimony. Carter–Wallace, Inc. v. Otte, 474 F.2d 529, 536 (2d Cir.1972) (“The weight of authority holds that, although it is not the usual practice, a court does have the power to subpoena an expert witness and … require him [or her] to state whatever opinions he [or she] may have previously formed.”).

Judge Hellerstein cited the five factors articulated in Kaufman v. Edelstein, as governing the exercise of discretion in compelling expert testimony:

(1) “[T]he degree to which the expert is being called because of his knowledge of facts relevant to the case rather than in order to give opinion testimony”;

(2) “the difference between testifying to a previously formed or expressed opinion and forming a new one”;

(3) “the possibility that, for other reasons, the witness is a unique expert”;

(4) “the extent to which the calling party is able to show the unlikelihood that any comparable witness will willingly testify”; and

(5) “the degree to which the witness is able to show that he has been oppressed by having continually to testify[.]”

2015 WL 220988, at *2-3, citing and quoting Kaufman v. Edelstein, 539 F.2d 811, 822 (2d Cir.1976).

Considering these factors, Judge Hellerstein refused to enforce the subpoena ad testificandum against the Mt. Sinai physicians. Plaintiffs have their own retained expert witness, Dr. Tee Guidotti, who was prepared to testify about both specific and general causation of the plaintiffs’ claimed injuries. The underlying data gathered by Mt. Sinai physicians and scientists, however, were another matter:

“However, it is undisputed that the scope and detail of the research conducted by the Mt. Sinai WTC Health Program is unparalleled. This litigation can only benefit from a full record and the inclusion of the relevant data underlying the research conducted by the Mt. Sinai WTC Health Program is appropriate. Accordingly, Mt. Sinai is ordered to produce all Mt. Sinai WTC Health Program data pursuant to the protocol established in In re World Trade Center Disaster Site Litigation, 21–mc–100, accounting for the redaction of personal identifying information and other sensitive patient material.”

Id. at *4; see also id. at *1.

Cynical observers may wonder whether the Mt. Sinai opposition to the subpoenas and motions to compel was posturing. The hospital and many of its physicians have been outspoken advocates on many occupational and environmental issues. Perhaps like Brer Rabbit, they were protesting not to be thrown in the briar patch. Or maybe, they realized that they could not resist the subpoena for data unless they also declined to testify about their opinions. In any event, Judge Hellerstein maintained the right of expert witnesses to hold their opinions to themselves and to avoid participating in the litigation system, while ensuring that the data are available to all. The plaintiffs may well have been clever by halves in bringing their motion.

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The Illinois Medical Studies Act and Access to Underlying Research Data

August 2nd, 2014

In the course of the welding fume litigation, defense counsel sought underlying data and documentation from a study published by Dr. Brad Racette and others, on their observations of Alabama welders[1]. The Alabama study, with its duplicate publication, aroused counsel’s suspicion for several reasons, not the least of which was that plaintiffs’ counsel had participated in creating the study by providing their clients as participants at screenings to be conducted by Dr. Racette and his colleagues.  According to the disclosure in the Neurology article, the study was

“[s]upported by NIH grants K23NS43351 and NS41509, the Greater St. Louis Chapter of the American Parkinson’s Disease Association, and the Welder Health Fund. The Welder Health Fund was created by Gulf States Trial Attorneys to support medical–legal screening of welders for Parkinson disease. No author has taken any money personally related to this research.”

A little research showed that the referenced NIH grants were not for this specific study, which was a creation of the litigation industry d/b/a the Welder Health Fund.

Defense counsel directed subpoenas to both Dr. Racette and his institution, Washington University St. Louis, for the study protocol, underlying data, data codes, and statistical analyses.  After a long discovery fight, the MDL court largely enforced the subpoenas.  See, e.g., In re Welding Fume Prods. Liab. Litig., MDL 1535, 2005 WL 5417815 (N.D. Ohio Oct. 18, 2005) (upholding defendants’ subpoena for protocol, data, data codes, statistical analyses, and other things from Dr. Racette author of study on welding and parkinsonism).

Dr. Racette continued the controversy with a one-sided editorial in Neurology, which he wrote along with his legal counsel from the subpoena contest. Brad A. Racette, Ann Bradley, Carrie A. Wrisberg, and Joel S. Perlmutter, “The Impact of Litigation on Neurologic Research,” 67 Neurology 2124 (2006) [“Litigation Impact”]. Defense counsel wrote a response, which was limited due to the nature of the 400-word cap on letters to the editor. Nathan A. Schachtman, “The Impact of Litigation on Neurologic Research,” 69 Neurology 495 (2007).  A slightly more expansive response was published on the TortsProf blog. Schachtman, “Letter: Litigation and Research” (April 15, 2007).

The debate continued in October 2007, when Dr. Brad Racette and I were invited by the Committee on Science, Technology, and Law of the National Academies of Science to discuss litigation and compelled access to underlying research data.  Dr. Racette complained about how disruptive subpoenas were into the operation of his research.  The Committee members appeared unimpressed by the alleged burdens when they realized that Racette’s research grew out of medico-legal screenings organized, conducted, and paid for by plaintiffs’ lawyers, and that it had been over 30 years since the National Research Council urged scientists to plan proactively for sharing data from their research, and that current National Institutes of Health guidelines require such a plan[2]. Most members of the Committee expressed the view that nothing untoward had occurred with the subpoena of Dr. Racette’s underlying data.

The fight over Dr. Racette’s data had consequences in the courtroom.  Defense expert witnesses were able to see how Dr. Racette was able to generate the appearance of large increased prevalence of “parkinsonism” (idiosyncratically defined and ascertained), which appearance was at odds with the vast data from analytical epidemiologic studies from around the world. James Mortimer, Amy Borenstein, and Laurene Nelson, “Associations of welding and manganese exposure with Parkinson disease: Review and meta-analysis,” 79 Neurology 1174 (2012) (reporting a statistically significant decreased risk of Parkinson’s disease among welding tradesmen).  Remarkably, the plaintiffs’ counsel, who had sponsored the Alabama study, did not show the underlying Racette data and materials to their expert witnesses.  Within a short time after the subpoena was enforced, plaintiffs’ counsel mostly withdrew the epidemiologic component of their cases. Racette’s study ceased to play a major role in the plaintiffs’ claims. The debate over access to underlying data continues, both for clinical trials and for observational studies[3].

In “Litigation Impact,” Racette and colleagues offered specific remedial suggestions concerning the access of data.  One suggestion is to prohibit all data access categorically. Ironically, Racette’s suggestion run contrary to the widespread view that clinical trial data must be shared. Here is how Racette presents his suggestion:

“Stronger, more comprehensive federal legislation recognizing a research scholar privilege and ensuring that research data are uniformly protected against disclosure in all states is essential to advancing medical science.

Protections for study participants and researchers against disclosure of study data could be modeled after provisions such as those set forth in the Illinois Medical Studies Act. This Act specifically designates medical research study data and protocols as protected and prohibits the disclosure of research data obtained as part of a medical study.40,41 Enforcement includes a potential misdemeanor conviction for any person disclosing medical study data. Such legislation must strike a critical balance between the rights of industry to defend itself and the rights of researchers.”

Litigation Impact at 2128.

Is Racette correct that Illinois Medical Studies Act prevents disclosure of underlying research study data?

The claim seems dubious, but the Act is hardly a model of clarity:

Sec. 8-2101. Information obtained. All information, interviews, reports, statements, memoranda, recommendations, letters of reference or other third party confidential assessments of a health care practitioner’s professional competence, or other data of the Illinois Department of Public Health, local health departments, the Department of Human Services (as successor to the Department of Mental Health and Developmental Disabilities), the Mental Health and Developmental Disabilities Medical Review Board, Illinois State Medical Society, allied medical societies, health maintenance organizations, medical organizations under contract with health maintenance organizations or with insurance or other health care delivery entities or facilities, tissue banks, organ procurement agencies, physician-owned insurance companies and their agents, committees of ambulatory surgical treatment centers or post-surgical recovery centers or their medical staffs, or committees of licensed or accredited hospitals or their medical staffs, including Patient Care Audit Committees, Medical Care Evaluation Committees, Utilization Review Committees, Credential Committees and Executive Committees, or their designees (but not the medical records pertaining to the patient), used in the course of internal quality control or of medical study for the purpose of reducing morbidity or mortality, or for improving patient care or increasing organ and tissue donation, shall be privileged, strictly confidential and shall be used only for medical research, increasing organ and tissue donation, the evaluation and improvement of quality care, or granting, limiting or revoking staff privileges or agreements for services, except that in any health maintenance organization proceeding to decide upon a physician’s services or any hospital or ambulatory surgical treatment center proceeding to decide upon a physician’s staff privileges, or in any judicial review of either, the claim of confidentiality shall not be invoked to deny such physician access to or use of data upon which such a decision was based.
(Source: P.A. 92-644, eff. 1-1-03.)

Ill.Ann.Stat. ch. 735 § 5 (Code of Civil Procedure)/8–2101, et seq. (Medical Studies).

Racette’s suggestion that the Act protects the underlying data from research studies is not supported by reliable precedent.  Plaintiffs’ lawyers, including lawyers who worked with Dr. Racette in the welding litigation, have objected to discovery on the basis of the Act, but the objections were apparently not further litigated. See Videotape Deposition of Paul A. Nausieda, M.D. in Boren v. A.O. Smith Corp., Circuit Court of Illinois, Third Judicial Circuit (Dec. 22, 2004).

The Act itself has no ostensible connection to protecting the underlying data in an epidemiologic study.  Niven v. Siquiera, 109 Ill. 2d 357, 487 N.E.2d 937 (1985) (“the purpose of the Act is to encourage candid and voluntary studies and programs used to improve hospital conditions and patient care or to reduce the rates of death and disease”); Matviuw v. Johnson, 70 Ill. App.3d 481, 486, 388 N.E.2d 795, 799 (1st Dist. 1979). The Act protects peer-review or quality-control committees that supervise overall medical care with a view to improving the quality and standard of care, and reducing morbidity and mortality of patients. The privilege is designed to permit persons to speak freely to committees, and to protect their self-evaluative deliberations. Id.; Walker v. Alton Memorial Hospital Ass’n, 91 Ill. App.3d 310, 314, 414 N.E.2d 850, 853 (5th Dist. 1980). For a document to fall within the scope of the Act, it must be “generated specifically for the use of a peer-review committee.” Webb v. Mt. Sinai Hospital and Medical Center of Chicago, Inc., 807 N.E.2d 1026, 1033 (Ill. App. Ct. 2004)(internal citation omitted).

Given the language of the Act, and its interpretation in the Illinois courts, it is not surprising that attempts to assert the statutory privilege to defeat research subpoenas have failed.

In Andrews v. Eli Lilly & Co., Inc., 97 F.R.D. 494 (N.D. Ill. 1983), the district judge quashed a subpoena that sought production of records from research that was exploring the association between maternal use of diethylstilbestrol and daughters’ development of adenocarcinoma of the vagina. In granting the motion to quash, the district judge acknowledged that the Medical Studies Act protected the records from disclosure. Id. at 500. The party seeking discovery, argued that the Illinois statute was limited to hospital peer review.  The district court acknowledged that the purpose of the Act was to ensure confidentiality of the peer-review process, but that the “plain language” of the statute did not limit protected material to that used for peer review. Id. at 500 n.19. In any event, Andrews was stripped of any precedential force when it was vacated by the United States Court of Appeals.   Deitchman v. E.R. Squibb & Sons, Inc., 740 F.2d 556 (7th Cir. 1984).

In the Orthopedic Bone Screw MDL, plaintiffs sought research study documents from the Scoliosis Research Society. Invoking the Illinois Medical Studies Act, the Society moved for a protective order to prevent disclosure of the names of physicians and patients who participated in “The Pedicle Screw Cohort Study,” and the disclosure of documents from that study. In re Orthopedic Bone Screw Prods. Liab. Litig., MDL No. 1014, 1996 WL 34394351 (E.D. Pa. Feb. 14, 1996), app. dism’d, 94 F.3d 110 (3d Cir. 1996). The Society claimed that the Act provided an unconditional confidentiality for all data and related information underlying a “a medical study.” Id. at *2.

The MDL court denied the plaintiffs’ motion to enforce, but rejected the claim that the Act created a privilege that applied in the case. Id. at *3 (citing the predominant federal interest in determining whether a state court privilege applied, and the lack of Illinois interests in a choice of law analysis).

In another multi-district litigation, Pfizer sought peer reviewer and editorial comments from the Journal of the American Medical Association, on articles and manuscripts of studies involving its COX-2 inhibitor medications, Bextra and Celebrex.  In re Bextra & Celebrex Mktg. Sales Practices & Prod. Liab. Litig., Case No. 08 C 402, 2008 U.S. Dist. LEXIS 21098; 2008 WL 4345158 (N.D. Ill. Mar. 14, 2008). The Journals asserted privileges, including a statutory privilege under the Illinois Medical Studies Act. Id. at *10-12. The federal district court ruled that the privilege appeared not to apply to manuscripts, articles, peer reviewer and editorial comments:

“The Medical Studies Act, 735 ILCS 5/8-2101, provides that [a]ll information, interviews, reports, statements, memoranda, recommendations, letters of reference or third party confidential assessments of a health care practitioner’s professional competence, or other data …  of allied medical societies . . . used in the course of internal quality control or of medical study for the purpose of reducing morbidity or mortality, or for improving patient care or increasing organ and tissue donation, shall be privileged, strictly confidential and shall be used only for medical research, increasing organ and tissue donation, the evaluation and improvement of quality care, or granting, limiting or revoking staff privileges or agreements for services . . . . 735 ILCS 5/8-2101. The purpose of the Act is to ‛ensure that members of the medical profession can maintain effective professional self-evaluation and to improve the quality of healthcare’.

To that end, the Act clearly protects from disclosure information gathered in the course of a peer review, but only if it is used in connection with a program or study designed to improve internal quality control or patient care, or to reduce morbidity and mortality. Putting aside the question of whether the Journals would qualify as ‛allied medical societies’, the Court is not persuaded that the specific information identified in the subpoenas fits within this definition. In her declaration, Dr. DeAngelis represented that JAMA ‛publishes scientific articles, commentaries, and news involving all fields of medicine, including medical research, significant clinical observations, diagnostic and therapeutic developments, legal and social matters of interest to  physicians, and issues of medical ethics’; JAMA’s motto, she said, is ‛to promote the science and art of medicine and the betterment of the public health’. DeAngelis Declaration, PP12-13. A lofty goal – but one that far transcends the provisions of the Medical Studies Act. The Act protects from disclosure documents only when ‛used in the course of internal quality control or of medical study for the purpose of reducing morbidity or mortality, or for improving patient care or increasing organ and tissue donation’; surely not everything published in JAMA and AIM – or everything considered for publication – can fairly be described this way. And, on the limited record before it, the Court cannot say that all of the documents requested in the subpoenas can be either.”

Id. at *11-14.

Racette’s suggestion that the Illinois Medical Studies Act can provide guidance with respect to research subpoenas is wrong on the law, facts, and policy of the need for data sharing. The public, and its members, remain entitled to every man’s evidence. See Lord Hardwicke’s Speech on Lord Orford’s Bill (May 25, 1742), quoted in George Harris, The Life of Lord Chancellor Hardwicke; with Selections from His Correspondence, Diaries, Speeches, and Judgments, Vol. 2, at 8 (1847).

[1] See Brad A. Racette, S.D. Tabbal, D. Jennings, L. Good, J.S. Perlmutter, and Brad Evanoff, “Prevalence of parkinsonism and relationship to exposure in a large sample of Alabama welders,” 64 Neurology 230 (2005); Brad A. Racette, et al., “A rapid method for mass screening for parkinsonism,” 27 Neurotoxicology 357 (2006).

[2] See National Institutes of Health, Final Statement on Sharing Research Data (Feb. 26, 2003); Stephen E. Fienberg, et al., eds. Committee on National Statistics, National Research Council, Sharing Research Data (1985); Eleanor Singer, chair, Panel on Data Access for Research Purposes, National Research Council, Expanding Access to Research Data: Reconciling Risks and Opportunities (2005).  See also National Academy of Sciences Committee on Ensuring the Utility and Integrity of Research Data in a Digital Age, Ensuring the Integrity, Accessibility, and Stewardship of Research Data in the Digital Age (2009).

[3] See, e.g., Jesse A Berlin, Sandra Morris, Frank Rockhold, Lisa Askie, Davina Ghersi, and Joanne Waldstreicher, “Bumps and bridges on the road to responsible sharing of clinical trial data,” 11 Clinical Trials 7 (2014); Rebecca Kush & Michel Goldman, “Fostering Responsible Data Sharing through Standards,” 370 New Engl. J. Med. 2163 (June 5, 2014); Jerome P. Reiter & Satkartar K. Kinney, “Sharing Confidential Data for Research Purposes: A Primer,” 22 Epidemiology 632 (2011).

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NIEHS Transparency? We Can See Right Through You

July 10th, 2014

The recent issue of Environmental Health Perspectives contains several interesting articles on scientific methodology of interest to lawyers who litigate claimed health effects.[1] The issue also contains a commentary that argues for greater transparency in science and science policy, which should be a good thing, but yet the commentary has the potential to obscure and confuse. Kevin C. Elliott and David B. Resnik, “Science, Policy, and the Transparency of Values,” 122 Envt’l Health Persp. 647 (2014) [Elliott & Resnik].

David B. Resnik has a Ph.D., in philosophy from University of North Carolina, and his law degree from the on-line Concord University School of Law.  He is currently a bioethicist and the chairman of the NIEHS Institutional Review Board. Kevin Elliott received his doctorate in the History and Philosophy of Science (Notre Dame), and he is currently an Associate Professor in Michigan State University. Elliott and Resnik advance a plea for transparency that superficially is as appealing as motherhood and apple pie. The authors argue

“that society is better served when scientists strive to be as transparent as possible about the ways in which interests or values may influence their reasoning.”

The argument appears superficially innocuous.  Indeed, in addition to the usual calls for great disclosure of conflicts of interest, the authors call for more data sharing and less tendentious data interpretation:

“When scientists are aware of important background assumptions or values that inform their work, it is valuable for them to make these considerations explicit. They can also make their data publicly available and strive to acknowledge the range of plausible interpretations of available scientific information, the limitations of their own conclusions, the prevalence of various interpretations across the scientific community, and the policy options supported by these different interpretations.”

Alas, we may as well wish for the Kingdom of Heaven on Earth!  An ethos or a requirement of publicly sharing data would indeed advance the most important transparency, the transparency that would allow full exploration of the inferences and conclusions claimed in a particular study.  Despite their high-mindedness, the authors’ argument becomes muddled when it comes to conflating scientific objectivity with subjective values:

“In the past, scientists and philosophers have argued that the best way to maintain science’s objectivity and the public’s trust is to draw a sharp line between science and human values or policy (Longino 1990). However, it is not possible to maintain this distinction, both because values are crucial for assessing what counts as sufficient evidence and because ethical, political, economic, cultural, and religious factors unavoidably affect scientific judgment (Douglas 2009; Elliott 2011; Longino 1990; Resnik 2007, 2009).”

This argument confuses pathology of science with what actually makes science valuable and enduring.  The Nazis invoked cultural arguments, explicitly or implicitly to reject “Jewish” science; religious groups in the United States invoke religious and political considerations to place creationism on an equal or superior footing with evolution; anti-vaccine advocacy groups embrace case reports over rigorous epidemiologic analyses. To be sure, these and other examples show that “ethical, political, economic, cultural, and religious factors unavoidably affect scientific judgment,” but yet science can and does transcend them.  There is no Jewish or Nazi science; indeed, there is no science worthy of its name that comes from any revealed religion or cult.  As Tim Minchin has pointed out, alternative medicine is either known not to work or not known to work because if alternative medicine is known to work, then we call it “medicine.” The authors are correct that these subjective influences require awareness and understanding of prevalent beliefs, prejudices, and corrupting influences, but they do not, and they should not, upset our commitment to an evidence-based world view.

Elliott and Resnik are focused on environmentalism and environmental policy, and they seem to want to substitute various presumptions, leaps of faith, and unproven extrapolations for actual evidence  and valid inference, in the hope of improving the environment and reducing risk to life.  The authors avoid the obvious resolution: value the environment, but acknowledge ignorance and uncertainty.  Rather than allow precautionary policies to advance with a confession of ignorance, the authors want to retain their ability to claim knowledge even when they simply do not know, just because the potential stakes are high. The circularity becomes manifest in their ambiguous use of “risk,” which strictly means a known causal relationship between the “risk” and some deleterious outcome.  There is a much weaker usage, popularized by journalists and environmentalists, in which “risk” refers to something that might cause a deleterious outcome.  The might in “risk” here does not refer to a known probabilistic or stochastic relationship between the ex ante risk and the outcome, but rather to an uncertainty whether or not the relationship exists at all. We can see the equivocation in how the authors attempt to defend the precautionary principle:

“Insisting that chemicals should be regulated only in response to evidence from human studies would help to prevent false positive conclusions about chemical toxicity, but it would also prevent society from taking effective action to minimize the risks of chemicals before they produce measurable adverse effects in humans. Moreover, insisting on human studies would result in failure to identify some human health risks because the diseases are rare, or the induction and latency periods are long, or the effects are subtle (Cranor 2011).”

Elliott & Resnik at 648.

If there is uncertainty about the causal relationship, then by calling some exposures a “risk,” the authors prejudge whether there will be “adverse effects” at all. This is just muddled.  If the relationship is uncertain, and false positive conclusions are possible, then we simply cannot claim to know that there will be such adverse effects, without assuming what we wish to prove.

The authors compound the muddle by introducing a sliding scale of “standards of evidence,” which appears to involve both variable posterior probabilities that the causal claim is correct, as well as variable weighting of types of evidence.  It is difficult to see how this will aid transparency and reduce confusion. Indeed, we can see how manipulative the authors’ so-called transparency becomes in the context of evaluating causal claims in pharmaceutical approvals versus tort claims:

“Very high standards of evidence are typically expected in order to infer causal relationships or to approve the marketing of new drugs. In other social contexts, such as tort law and chemical regulation, weaker standards of evidence are sometimes acceptable to protect the public (Cranor 2008).”

Remarkably, the authors cite no statute, no case law, no legal treatise writer for the proposition that the tort law standard for causation is somehow lower than for a claim of drug efficacy before the Food and Drug Administration.  The one author they cite, Carl Cranor, is neither a scientist nor a lawyer, but a philosophy professor who has served as an expert witness for plaintiffs in tort litigation (usually without transparently disclosing his litigation work). As for the erroneous identification of tort and regulatory standards, there is of course, much real legal authority to the contrary[2].

The authors go on to suggest that demanding

“the very highest standards of evidence for chemical regulation—including, for example, human evidence, accompanying animal data, mechanistic evidence, and clear exposure data—would take very long periods of time and leave the public’s health at risk.”

Elliott & Resnik at 648.

Of course, the point is that until such data are developed, we really do not know whether the public’s health is at risk.  Transparency would be aided not by some sliding and slippery scale of evidence, but by frank admissions that we do not know whether the public’s health is at risk, but we choose to act anyway, and to impose whatever costs, inconvenience, and further uncertainty by promoting alternatives that are accompanied by even greater risk or uncertainty.  Environmentalists rarely want to advance such wishy-washy proposals, devoid of claims of scientific knowledge that their regulations will avoid harm, and promote health, but honesty and transparency require such admissions.

The authors advance another claim in their Commentary:  transparency in the form of more extensive disclosure of conflicts of interest will aid sound policy formulation.  To their credit, the authors do not limit the need for disclosure to financial benefits; rather they take an appropriately expansive view:

“Disclosures of competing financial interests and nonfinancial interests (such as professional or political allegiances) also provide opportunities for more transparent discussions of the impact of potentially implicit and subconscious values (Resnik and Elliott 2013).”

Elliott & Resnik at 649.  Problematically, however, when the authors discuss some specific instances of apparent conflicts, they note industry “ties,” of the authors of an opinion piece on endocrine disruptors[3], but they are insensate to the ties of critics, such as David Ozonoff and Carl Cranor, to the litigation industry, and of others to advocacy groups that might exert much more substantial positional bias and control over those critics.

The authors go further in suggesting that women have greater perceptions of risk than men, and presumably we must know whether we are being presented with a feminist or a masculinist risk assessment. Will self-reported gender suffice or must we have a karyotype? Perhaps we should have tax returns and a family pedigree as well? The call for transparency seems at bottom a call for radical subjectivism, infused with smug beliefs that want to be excused from real epistemic standards.


[1] In addition to the Elliott and Resnick commentary, see Andrew A. Rooney, Abee L. Boyles, Mary S. Wolfe, John R. Bucher, and Kristina A. Thayer, “Systematic Review and Evidence Integration for Literature-Based Environmental Health Science Assessments,” 122 Envt’l Health Persp. 711 (2014); Janet Pelley, “Science and Policy: Understanding the Role of Value Judgments,” 122 Envt’l Health Persp. A192 (2014); Kristina A. Thayer, Mary S. Wolfe, Andrew A. Rooney, Abee L. Boyles, John R. Bucher, and Linda S. Birnbaum, “Intersection of Systematic Review Methodology with the NIH Reproducibility Initiative,” 122 Envt’l Health Persp. A176 (2014).

[2] Sutera v. The Perrier Group of America, 986 F. Supp. 655, 660 (D. Mass. 1997); In re Agent Orange Product Liab. Litig., 597 F. Supp. 740, 781 (E.D.N.Y. 1984) (Weinstein, J.), aff’d, 818 F.2d 145 (2d Cir. 1987); Allen v. Pennsylvania Engineering Corp., 102 F.3d 194, 198 (5th Cir. 1996) (distinguishing regulatory pronouncements from causation in common law actions, which requires higher thresholds of proof); Glastetter v. Novartis Pharms. Corp., 107 F. Supp. 2d 1015, 1036 (E.D. Mo. 2000), aff’d, 252 F.3d 986 (8th Cir. 2001);  Wright v. Willamette Indus., Inc., 91 F.3d 1105 (8th Cir. 1996); Siharath v. Sandoz Pharms. Corp., 131 F. Supp. 2d 1347, 1366 (N.D. Ga. 2001), aff’d, 295 F.3d 1194 330 (11th Cir. 2002).

[3] Daniel R. Dietrich, Sonja von Aulock, Hans Marquardt, Bas Blaauboer, Wolfgang Dekant, Jan Hengstler, James Kehrer, Abby Collier, Gio Batta Gori, Olavi Pelkonen, Frans P. Nijkamp, Florian Lang, Kerstin Stemmer, Albert Li, KaiSavolainen, A. Wallace Hayes, Nigel Gooderham, and Alan Harvey, “Scientifically unfounded precaution drives European Commission’s recommendations on EDC regulation, while defying common sense, well-established science and risk assessment principles,” 62 Food Chem. Toxicol. A1 (2013)

 

Posted in Conflicts of Interest, Data Sharing, Scientific Evidence | Comments Off on NIEHS Transparency? We Can See Right Through You

Litigation-Driven Access to Underlying Data and Materials

October 23rd, 2013

On Monday, October 21, 2013, the Center for Public Integrity published an editorial criticizing Georgia-Pacific Corporation for its “secretive research program.” See “Facing lawsuits over deadly asbestos, paper giant launched secretive research program.”  

Georgia-Pacific (GP) commissioned several studies to help advance its defenses in asbestos litigation. Given that plaintiffs, plaintiffs’ counsel, proxies for the plaintiffs, and self-appointed public health zealots have commissioned and conducted research designed to advance interests of the litigation industry (a/k/a the plaintiffs’ bar) and to undermine GP’s defenses, GP’s actions seem perfectly appropriate.  GP’s attempt to claim an attorney-client and work-product privilege in the communications with investigators, however, raises serious concerns by casting a shadow over industry sponsorship generally.

In response to publication of GP’s sponsored research, plaintiffs’ counsel Jerry Kristal sought discovery of some of the studies and GP’s role in instigating, planning, conducting, and interpreting the studies.  Again, these discovery requests seem perfectly reasonable, but GP reacted by asserting that its lawyers had been involved in the communication loop between GP and the scientists who conducted and published the research, and therefore, the requested evidence was protected by the attorney-client privilege.  As I have argued previously, GP’s position was a serious mistake, and it has opened itself up to a good deal of justified criticism for “secretive research.” See, e.g., Noah S. Seixas, “Protecting Our Science,” 57 Ann. Occup. Hyg. 963 (2013) (emphasizing that there was no evidence that GP’s research was in fact fraudulent, and that the papers published in the Annals of Occupational Hygiene had appropriate disclosures).  See also “A Cautionary Tale on How Not to Sponsor a Scientific Study for Litigation” (June 21, 2013); “Using the Rule 45 Subpoena to Obtain Research Data” (July 24, 2013).

One measure of the lapse in judgment by GP in questionably asserting an attorney-client privilege is the ammunition that it gives to idealogues and zealots such as the Center for Public Integrity (CPI).  The CPI editorial quotes Harvard University Professor Sheila Jasanoff, as noting that:

“There’s something extremely smelly about claiming attorney-client privilege for something that is being claimed at the same time as good science. … Legal confidentiality protections should not be placed around good science.”

Professor Jasonoff is absolutely correct, but interestingly, her olfactory sense has been remarkably inconsistent.  Back in October 2007, Dr. Brad Racette and I were invited by the Committee on Science, Technology, and Law of the National Academies of Science to discuss, and debate, litigation and compelled access to underlying research data.  Dr. Racette moaned and groaned about how disruptive subpoenas were into the operation of his research.  Some members of the Committee seemed sympathetic until I reminded them that Racette’s research grew out of medico-legal screenings organized, conducted, and paid for by plaintiffs’ lawyers, and that it had been over 30 years since the National Research Council urged scientists to plan proactively for sharing data from their research, and that current National Institutes of Health guidelines require such a plan. See National Institutes of Health, Final Statement on Sharing Research Data (Feb. 26, 2003); Stephen E. Fienberg, et al., eds. Committee on National Statistics, National Research Council, Sharing Research Data (1985); Eleanor Singer, chair, Panel on Data Access for Research Purposes, National Research Council, Expanding Access to Research Data: Reconciling Risks and Opportunities (2005).  See also National Academy of Sciences Committee on Ensuring the Utility and Integrity of Research Data in a Digital Age, Ensuring the Integrity, Accessibility, and Stewardship of Research Data in the Digital Age (2009). Most members of the Committee expressed their reassurance that nothing untoward had occurred with the subpoena of Dr. Racette’s underlying data, but at the time, Professor Jasanoff maintained her opposition to the approach. 

Jasanoff’s selective sniffing reflects the hypocrisy and asymmetry that pervades current discussions of conflicts of interest (COI) and access to data.  COI accusations are directed at industry, but not at the litigation industry, staffed by the plaintiffs’ bar and advanced by eco-zealots.  Access to data is a rallying cry against pharmaceutical industry clinical trials, and industry-sponsored studies, but when stakeholders want access to non-industry study data, suddenly privacy interests and researchers’ privileges become paramount, and researchers “feel harrassed.”  It really is time to choose:  either we stop our insistence upon seeing the data themselves, or we formulate rules that apply across the board, independent of study sponsorship.

We are becoming, by fits and starts, a data-driven and evidence-based world.  The time has come and gone to rely upon authors’ own interpretation of the data, and to realize that there is a public trust, interest, and need for data sharing.  GP’s capital mistake was the same made by Dr. Racette, when he asserted various privileges to argue against disclosure of his underlying data.  (Had GP paid attention to prior disputes, it would have learned that the attorney-client privilege has been uniformly rejected, as it was in Racette’s case.)  Jasanoff’s capital mistake is to attribute stench to GP for asserting a privilege, but excusing it when done by scientists funded or supported by the “litigation industry.”

The CPI reported that a GP spokesman refused to answer questions, but referred a reporter to GP’s court filings, where GP maintained that it “properly commissioned studies to explore scientific issues that repeatedly arise in joint compound litigation, disclosed its role in the studies themselves, and submitted them to the technical rigors of scientific peer review by qualified scientists who were neither affiliated with nor selected by Georgia-Pacific.”

Sounds good, but then why try to assert an attorney-client privilege and an attorney-work product confidentiality?  Plaintiffs’ counsel, having relied upon some rather poorly conducted studies would likely known that peer review is not a very good filter for sound science, and they would press for access to the inner workings of the studies and the possible influence that the sponsor had on any aspect of the studies.  Furthermore, faced with the prospect of GP’s succeeding in its claim of privilege, the plaintiffs were surely warranted in trying to explore exceptions to the privilege, such as the crime-fraud exception, weak though the evidence may be to support such an exception.

Now Look Who Is Manufacturing Doubt!

In the GP case, the New York Appellate Division did not hold that GP had engaged in a fraudulent scheme, only that plaintiffs’ allegations were serious enough to support an order that the trial judge review, in camera, the supposedly privileged materials.  The CPI, however, has used the decision to support its overwrought generalization of charges against all industry-sponsored studies. 

The CPI has used the commonplace smear tactic of analogizing every company’s defensive strategies against litigation, even against unwarranted claims, as a manifestation of the same tactics used by Big Tobacco.  Unfortunately, GP advanced the attorney-client privilege theory, which had been asserted previously, and unsuccessfully, by tobacco companies.  This legal misstep, however, does not justify CPI’s smear campaign against the scientists who conducted the studies at issue.  There is nothing stated or suggested in CPI’s editorial that raises any meaningful question about the validity of the research sponsored by GP.

COI and Access to Data – Two-Way Street

GP’s misguided assertion of the attorney-client privilege opened itself and industry generally to the CPI charges of using “well-paid experts to minimize the hazards of toxic chemicals and fend off liability, regulation, or both.” Indeed, the CPI’s editorial is little more than a sustained ad hominem attack on industry’s efforts to protect itself from liability and regulation, without any acknowledgement that often the attempts to impose liability or regulation are based upon dubious science or imprudent policy. Some liability claims are corrupt, and must be defended, including many frivolous and fraudulent claims in the asbestos litigation.

While the CPI rails against industry experts, it is suspiciously silent about so-called public interest groups or claimants, using well-paid experts, or worse, over-zealous experts, to obtain litigation or regulation results. To be sure, there are many instances of plaintiffs’ expert witnesses failing to disclose their potential conflicts, as well as failing to disclose their funding or support from plaintiffs’ counsel, plaintiffs, or plaintiffs’ proxies. Mr. Kristal’s strategy of claiming fraud in failing to disclose potential conflicts of interest will lead to a regime that will be uncomfortable for many scientists and physicians who fail to make appropriate disclosures.  See, e.g., “Conflicts of Interest in Asbestos Studies – the Plaintiffs’ Double Standard” (Sept. 18, 2013); “The Mt. Sinai Catechism” (June 7, 2013).

The CPI’s complaint that GP hired experts who were aligned with their cause is curious given the history of the plaintiffs’ counsel to hire expert witnesses who were aligned with their clients’ labor unions and the like.  Irving Selikoff, who was engaged by the insulators’ union to conduct a study of their cancer mortality, had testified in worker compensation proceedings and in some of the early civil actions involving claims of asbestos-related injuries.  The CPI quotes plaintiffs’ lawyer Alan Golanski as alleging that GP had tried to “seed” the medical literature with “methodologically skewed, litigation-driven research.” Of course, this is exactly what plaintiffs’ expert witnesses have done over the last half century.

It really is time to stop.  COI disclosures cannot be a full, satisfactory answer because the most potent conflicts arise out of intellectual and political commitments, not money.  Increasing transparency and access to study protocols, data, analyses may perhaps help. 

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Irving Selikoff and the Right to Peaceful Dissembling

June 5th, 2013

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Posted in Data Sharing, Scientific Evidence, Scientific Misconduct, Underlying Data | Comments Off on Irving Selikoff and the Right to Peaceful Dissembling

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