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Statistical Deontology

March 2nd, 2018

In courtrooms across America, there has been a lot of buzzing and palavering about the American Statistical Association’s Statement on Statistical Significance Testing,1 but very little discussion of the Society’s Ethical Guidelines, which were updated and promulgated in the same year, 2016. Statisticians and statistics, like lawyers and the law, receive their fair share of calumny over their professional activities, but the statistician’s principal North American professional organization is trying to do something about members’ transgressions.

The American Statistical Society (ASA) has promulgated ethical guidelines for statisticians, as has the Royal Statistical Society,2 even if these organizations lack the means and procedures to enforce their codes. The ASA’s guidelines3 are rich with implications for statistical analyses put forward in all contexts, including in litigation and regulatory rule making. As such, the guidelines are well worth studying by lawyers.

The ASA Guidelines were prepared by the Committee on Professional Ethics, and approved by the ASA’s Board in April 2016. There are lots of “thou shall” and “thou shall nots,” but I will focus on the issues that are more likely to arise in litigation. What is remarkable about the Guidelines is that if followed, they probably are more likely to eliminate unsound statistical practices in the courtroom than the ASA State on P-values.

Defining Good Statistical Practice

“Good statistical practice is fundamentally based on transparent assumptions, reproducible results, and valid interpretations.” Guidelines at 1. The Guidelines thus incorporate something akin to the Kumho Tire standard that an expert witness ‘‘employs in the courtroom the same level of intellectual rigor that characterizes the practice of an expert in the relevant field.’’ Kumho Tire Co. v. Carmichael, 526 U.S. 137, 152 (1999).

A statistician engaged in expert witness testimony should provide “only expert testimony, written work, and oral presentations that he/she would be willing to have peer reviewed.” Guidelines at 2. “The ethical statistician uses methodology and data that are relevant and appropriate, without favoritism or prejudice, and in a manner intended to produce valid, interpretable, and reproducible results.” Id. Similarly, the statistician, if ethical, will identify and mitigate biases, and use analyses “appropriate and valid for the specific question to be addressed, so that results extend beyond the sample to a population relevant to the objectives with minimal error under reasonable assumptions.” Id. If the Guidelines were followed, a lot of spurious analyses would drop off the litigation landscape, regardless whether they used p-values or confidence intervals, or a Bayesian approach.

Integrity of Data and Methods

The ASA’s Guidelines also have a good deal to say about data integrity and statistical methods. In particular, the Guidelines call for candor about limitations in the statistical methods or the integrity of the underlying data:

“The ethical statistician is candid about any known or suspected limitations, defects, or biases in the data that may impact the integrity or reliability of the statistical analysis. Objective and valid interpretation of the results requires that the underlying analysis recognizes and acknowledges the degree of reliability and integrity of the data.”

Guidelines at 3.

The statistical analyst openly acknowledges the limits of statistical inference, the potential sources of error, as well as the statistical and substantive assumptions made in the execution and interpretation of any analysis,” including data editing and imputation. Id. The Guidelines urge analysts to address potential confounding not assessed by the study design. Id. at 3, 10. How often do we see these acknowledgments in litigation-driven analyses, or in peer-reviewed papers, for that matter?

Affirmative Actions Prescribed

In the aid of promoting data and methodological integrity, the Guidelines also urge analysts to share data when appropriate without revealing the identities of study participants. Statistical analysts should publicly correct any disseminated data and analyses in their own work, as well as working to “expose incompetent or corrupt statistical practice.” Of course, the Lawsuit Industry will call this ethical duty “attacking the messenger,” but maybe that’s a rhetorical strategy based upon an assessment of risks versus benefits to the Lawsuit Industry.

Multiplicity

The ASA Guidelines address the impropriety of substantive statistical errors, such as:

“[r]unning multiple tests on the same data set at the same stage of an analysis increases the chance of obtaining at least one invalid result. Selecting the one “significant” result from a multiplicity of parallel tests poses a grave risk of an incorrect conclusion. Failure to disclose the full extent of tests and their results in such a case would be highly misleading.”

Guidelines at 9.

There are some Lawsuit Industrialists who have taken comfort in the pronouncements of Kenneth Rothman on corrections for multiple comparisons. Rothman’s views on multiple comparisons are, however, much broader and more nuanced than the Industry’s sound bites.4 Given that Rothman opposes anything like strict statistical significance testing, it follows that he is relatively unmoved for the need for adjustments to alpha or the coefficient of confidence. Rothman, however, has never deprecated the need to consider the multiplicity of testing, and the need for researchers to be forthright in disclosing the the scope of comparisons originally planned and actually done.

2 Royal Statistical Society – Code of Conduct (2014); Steven Piantadosi, Clinical Trials: A Methodologic Perspective 609 (2d ed. 2005).

3 Shelley Hurwitz & John S. Gardenier, “Ethical Guidelines for Statistical Practice: The First 60 Years and Beyond,” 66 Am. Statistician 99 (2012) (describing the history and evolution of the Guidelines).

4 Kenneth J. Rothman, “Six Persistent Research Misconceptions,” 29 J. Gen. Intern. Med. 1060, 1063 (2014).

Posted in Data Sharing, Expert Witness Discovery, Scientific Misconduct, statistical evidence, Underlying Data | Comments Off on Statistical Deontology

Wrong Words Beget Causal Confusion

February 12th, 2018

In clinical medical and epidemiologic journals, most articles that report about associations will conclude with a discussion section in which the authors hold forth about

(1) how they have found that exposure to X “increases the risk” of Y, and

(2) how their finding makes sense because of some plausible (even if unproven) mechanism.

In an opinion piece in Significance,1 Dalmeet Singh Chawla cites to a study that suggests the “because” language frequently confuses readers into believing that a causal claim is being made. The study abstract explains:

“Most researchers do not deliberately claim causal results in an observational study. But do we lead our readers to draw a causal conclusion unintentionally by explaining why significant correlations and relationships may exist? Here we perform a randomized study in a data analysis massive online open course to test the hypothesis that explaining an analysis will lead readers to interpret an inferential analysis as causal. We show that adding an explanation to the description of an inferential analysis leads to a 15.2% increase in readers interpreting the analysis as causal (95% CI 12.8% – 17.5%). We then replicate this finding in a second large scale massive online open course. Nearly every scientific study, regardless of the study design, includes explanation for observed effects. Our results suggest that these explanations may be misleading to the audience of these data analyses.”

Leslie Myint, Jeffrey T. Leek, and Leah R. Jager, “Explanation implies causation?” (Nov. 2017) (on line manuscript).

Invoking the principle of charity, these authors suggest that most researchers are not deliberately claiming causal results. Indeed, the language of biomedical science itself is biased in favor of causal interpretation. The term “statistical significance” suggests causality to naive readers, as does stats talk about “effect size,” and “fixed effect models,” for data sets that come no where near establishing causality.

Common epidemiologic publication practice tolerates if not encourages authors to state that their study shows (finds, demonstrates, etc.) that exposure to X “increases the risk” of Y in the studies’ samples. This language is deliberately causal, even if the study cannot support a causal conclusion alone or even with other studies. After all, a risk is the antecedent of a cause, and in the stochastic model of causation involved in much of biomedical research, causation will manifest in a change of a base rate to a higher or lower post-exposure rate. Given that mechanism is often unknown and not required, then showing an increased risk is the whole point. Eliminating chance, bias, confounding, and study design often is lost in the irrational exuberance of declaring the “increased risk.”

Tighter editorial control might have researchers qualify their findings by explaining that they found a higher rate in association with exposure, under the circumstances of the study, followed by an explanation that much more is needed to establish causation. But where is the fun and profit in that?

Journalists, lawyers, and advocacy scientists often use the word “link,” to avoid having to endorse associations that they know, or should know, have not been shown to be causal.2 Using “link” as a noun or a verb clearly implies a causal chain metaphor, which probably is often deliberately implied. Perhaps publishers would defend the use of “link” by noting that it is so much shorter than “association,” and thus saves typesetting costs.

More attention is needed to word choice, even and especially when statisticians and scientists are using their technical terms and jargon.3 If, for the sake of argument, we accept the sincerity of scientists who work as expert witnesses in litigation in which causal claims are overstated, we can see that poor word choices confuse scientists as well as lay people. Or you can just read the materials and methods and the results of published study papers; skip the introduction and discussion sections, as well as the newspaper headlines.

1 Dalmeet Singh Chawla, “Mind your language,” Significance 6 (Feb. 2018).

2 See, e.g., Perri Klass, M.D., “https://www.nytimes.com/2017/12/04/well/family/does-an-adhd-link-mean-tylenol-is-unsafe-in-pregnancy.html,” N.Y. Times (Dec. 4, 2017); Nicholas Bakalar, “Body Chemistry: Lower Testosterone Linked to Higher Death Risk,” N.Y. Times (Aug. 15, 2006).

3 Fang Xuelan & Graeme Kennedy, “Expressing Causation in Written English,” 23 RELC J. 62 (1992); Bengt Altenberg, “Causal Linking in Spoken and Written English,” 38 Studia Linguistica 20 (1984).

Posted in Causation, Scientific Misconduct | Comments Off on Wrong Words Beget Causal Confusion

Stuck in Silicone

December 12th, 2017

There was a time when silicone chemistry, biocompatibility, toxicity, and litigation weighed upon my mind. What started with a flurry of scientific interest, led to a media free for all, then FDA Commissioner David Kessler’s moratorium on silicone breast implants, and then to a feeding frenzy for the lawsuit industry. Ultimately, the federal court system found its way to engage four non-party expert witnesses, who cut through the thousands of irrelevant documents that plaintiffs’ counsel used to obfuscate the lack of causation evidence. The court-appointed experts in MDL 926 were unanimous in their rejection of the plaintiffs’ claims.1 Not long after, the Institute of Medicine (now the National Academy of Medicine) issued its voluminous review of the scientific evidence, again with the conclusion that the evidence, when viewed scientifically and critically, showed a lack of association between silicone and autoimmune disease.2

Along the way to this definitive end of the lawsuit industry’s assault on the medical device industry, the parties assembled in the courtroom of the Hon. Jack B. Weinstein, for Rule 702 hearings on the opinions proffered by the plaintiffs’ expert witnesses. Judge Weinstein, along with the late Judge Harold Baer, of the Southern District of New York, and Justice Lobis, of the New York Supreme Court, held hearings that lasted two weeks, and entertained virtually unlimited argument. In characteristic style, Judge Weinstein did not grant the defendants’ Rule 702 motions; rather he cut right to the heart of the matter, and granted summary judgment in favor of the defense on plaintiffs’ claims of systemic diseases.3

Over a dozen years later, in reflecting upon a long judicial career that involved many so-called mass torts, Judge Weinstein described the plaintiffs’ expert witnesses more plainly as “charlatans” and the silicone litigation as largely based upon fraud.4

****************************

Last week, I received an email from Arthur E. Brawer, who represented himself to be an Associate Clinical Professor of Medicine.5 Dr. Brawer kindly forwarded some of his publications on the subject of silicone toxicity.6 Along with the holiday gift, Dr Brawer also gave me a piece of his mind:

“I recommend you rethink your prior opinions on the intersection of science and the law as it relates to this issue, as you clearly have no idea what you are talking about regarding the matter of silicone gel-filled breast implants. Perhaps refresher courses in biochemistry and biophysics at a major university might wake you up.”

Wow, that woke me up! Who was this Dr Brawer? His name seemed vaguely familiar. I thought he might have been a lawsuit industry expert witness I encountered in the silicone litigation, but none of his articles had a disclosure of having been a retained expert witness. Perhaps that was a mere oversight on his part. Still, I went to my archives, where I found the same Dr Brawer engaged in testifying for plaintiffs all around the country. In one early testimonial adventure, Brawer described how he came up with his list of signs and symptoms to use to define “silicone toxicity”:

Q. Doctor, if a patient presented to you with green hair and claimed that her green hair was attributable to her silicone breast implants, unless you could find another explanation for that green hair, you’d put that on your list of signs and symptoms; right?

A. The answer is yes.

Notes of Testimony of Arthur E. Brawer, at 465:7-12, in Merlin v. 3M Co., No. CV-N-95-696-HDM (D. Nev.Dec. 11, 1995) (Transcript of Rule 702 hearing)

A year later, Brawer’s opinions were unceremoniously excluded in a case set for trial in Dallas, Texas.7 Surely this outcome, along with Judge Weinstein’s rulings, the findings of the court-appointed witnesses in MDL 926, and the conclusions of the Institute of Medicine would have discouraged this Brawer fellow from testifying ever again?

Apparently not. Brawer, like the Black Knight in Monty Python and the Holy Grail, still lives and breathes, but only to be cut again and again. A quick Westlaw search turned up another, recent Brawer testimonial misadventure in Laux v. Mentor Worldwide, LLC, case no. 2:16-cv-01026, 2017 WL 5235619 (C.D. Calif., Nov. 8, 2017).8 Plaintiff Anita Laux claimed that she developed debilitating “biotoxin” disease from her saline-filled silicone breast implants. In support, she proffered the opinions of three would-be expert witnesses, a plastic surgeon (Dr Susan Kolb), a chemist (Pierre Blais), and a rheumatologist (Arthur Brawer).

Plaintiffs’ theory of biotoxin disease causation started with Blais’ claim to have found mold debris in the plaintiff’s explanted implants. The court found Blais unqualified, however, to offer an opinion on microbiology or product defects, and his opinions in the case, unreliable. Id. at *4-6. Dr Kolb, the author of The Naked Truth about Breast Implants, attempted to build upon Blais’ opinions, a rather weak foundation, to construct a “differential diagnosis.” In reasoning that Ms. Laux’s medical complaints arose from a mold infection, Kolb asserted that she had ruled out all other sources of exposure to mold. Unfortunately, Kolb either forgot or chose to hide correspondence with Ms. Laux, in which the plaintiff directly provided Kolb with information about prior environmental mold exposure on multiple occasions. Id. at *3. The trial court severely deprecated Kolb’s rather selective and false use of facts used to make the attribution of Ms. Laux’s claimed medical problems.

Dr Brawer, the author of Holistic Harmony: A Guide To Choosing A Competent Alternative Medicine Provider (1999), and my recent email correspondent, also succumbed to Judge Wright’s gatekeeping in Laux. The court found that Brawer had given a toxicology opinion with no supporting data. His report was thus both procedurally deficient under Federal Rule of Civil Procedure 26, and substantively deficient under Federal Rule of Evidence 702. Finding Brawer’s report “so lacking of scientific principles and methods,” and thus unhelpful and unreliable, the trial court excluded his report and precluded his testimony at trial. Id. at *7.

Thankfully, the ghost of litigations past, communicating now by email, can be safely disregarded. And I do not have to dig my silicone polymer chemistry and biochemistry textbooks out of storage.

1 See Barbara Hulka, Betty Diamond, Nancy Kerkvliet & Peter Tugwell, “Silicone Breast Implants in Relation to Connective Tissue Diseases and Immunologic Dysfunction: A Report by a National Science Panel to the Hon. Sam Pointer Jr., MDL 926 (Nov. 30, 1998).” The experts appointed by the late Judge Pointer all committed extensive time and expertise to evaluating the plaintiffs’ claims and the entire evidence. After delivering their reports, the court-appointed experts all published their litigation work in leading journals. See Barbara Hulka, Nancy Kerkvliet & Peter Tugwell, “Experience of a Scientific Panel Formed to Advise the Federal Judiciary on Silicone Breast Implants,” 342 New Engl. J. Med. 812 (2000); Esther C. Janowsky, Lawrence L. Kupper., and Barbara S. Hulka, “Meta-Analyses of the Relation between Silicone Breast Implants and the Risk of Connective-Tissue Diseases,” 342 New Engl. J. Med. 781 (2000); Peter Tugwell, George Wells, Joan Peterson, Vivian Welch, Jacqueline Page, Carolyn Davison, Jessie McGowan, David Ramroth, and Beverley Shea, “Do Silicone Breast Implants Cause Rheumatologic Disorders? A Systematic Review for a Court-Appointed National Science Panel,” 44 Arthritis & Rheumatism 2477 (2001).

2 Stuart Bondurant, Virginia Ernster, and Roger Herdman, eds., Safety of Silicone Breast Implants (Institute of Medicine) (Wash. D.C. 1999).

3 See In re Breast Implant Cases, 942 F. Supp. 958 (E. & S.D.N.Y. 1996) (granting summary judgment because of insufficiency of plaintiffs’ evidence, but specifically declining to rule on defendants’ Rule 702 and Rule 703 motions).

5 At the Drexel University School of Medicine, in Philadelphia, as well as the Director of Rheumatology at Monmouth Medical Center, in Long Branch, New Jersey.

6 Included among the holiday gift package was Arthur E. Brawer, “Is Silicone Breast Implant Toxicity an Extreme Form of a More Generalized Toxicity Adversely Affecting the Population as a Whole?,”1 Internat’l Ann. Med. (2017); Arthur E. Brawer, “Mechanisms of Breast Implant Toxicity: Will the Real Ringmaster Please Stand Up,”1 Internat’l Ann. Med. (2017); Arthur E. Brawer, “Destiny rides again: the reappearance of silicone gel-filled breast implant toxicity,” 26 Lupus 1060 (2017); Arthur E. Brawer, “Silicon and matrix macromolecules: new research opportunities for old diseases from analysis of potential mechanisms of breast implant toxicity,” 51 Medical Hypotheses 27 (1998).

7 Bailey v. Dow Corning Corp., c.a. 94-1199-A (Dallas Cty. Texas Dist. Ct., Sept. 15, 1996).

8 I later found that another blog had reviewed the Laux decision. Stephen McConnell, “C.D. Cal. Excludes Three Plaintiff Experts in Breast Implant Case,” Drug & Device Law (Nov. 16, 2017).

Posted in Causation, Conflicts of Interest, Expert Witness Hall of Shame, Rule 702, Scientific Evidence, Scientific Misconduct | Comments Off on Stuck in Silicone

Samuel Tarry’s Protreptic for Litigation-Sponsored Publications

July 9th, 2017

Litigation-related research has been the punching bag of self-appointed public health advocates for some time. Remarkably, and perhaps not surprising to readers of this blog, many of the most strident critics have deep ties to the lawsuit industry, and have served the plaintiffs’ bar loyally and zealously for many years.1,2,3,4 And many of these critics have ignored or feigned ignorance of the litigation provenance of much research that they hold dear, such as Irving Selikoff’s asbestos research undertaken for the asbestos workers’ union and its legal advocates. These critics’ campaign is an exquisite study in hypocrisy.

For some time, I have argued that the standards for conflict-of-interest disclosures should be applied symmetrically and comprehensively to include positional conflicts, public health and environmental advocacy, as well as litigation consulting or testifying for any party. Conflicts should be disclosed, but they should not become a facile excuse or false justification for dismissing research, regardless of the party that sponsored it.5 Scientific studies should be interpreted scientifically – that is carefully, thoroughly, and rigorously – regardless whether they are conducted and published by industry-sponsored, union-sponsored, or Lord help us, even lawyer-sponsored scientists.

Several years ago, a defense lawyer, Samuel Tarry, published a case series of industry-sponsored research or analysis, which grew out of litigation, but made substantial contributions to the scientific understanding of claimed health risks. See Samuel L. Tarry, Jr., “Can Litigation-Generated Science Promote Public Health?” 33 Am. J. Trial Advocacy 315 (2009). Tarry’s paper is a helpful corrective to the biased (and often conflicted) criticisms of industry-sponsored research and analysis by the lawsuit industry and its scientific allies and consultants. It an ocean of uninformative papers about “Daubert,” Tarry’s paper stands out and should be required reading for all lawyers who practice in the area of “health effects litigation.”

Tarry presented a brief summary of the litigation context for three publications that deserve to remembered and used as exemplars of important, sound, scientific publications that helped changed the course of litigations, as well as the scientific community’s appreciation of prior misleading contentions and publications. His three case studies grew out of the silicone-gel breast implant litigation, the latex allergy litigation, and the never-ending asbestos litigation.

1. Silicone

There are some glib characterizations of the silicone gel breast implant litigation as having had no evidentiary basis. A more careful assessment would allow that there was some evidence, much of it fraudulent and irrelevant. See, e.g., 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). The lawsuit industry worked primarily through so-called support groups, which in turn funded friendly, advocate physicians, who in turn testified for plaintiffs and their lawyers in personal injury cases.

When the defendants, such as Dow Corning, reacted by sponsoring serious epidemiologic analyses of the issue whether exposure to silicone gel was associated with specific autoimmune or connective tissue diseases, the plaintiffs’ bar mounted a conflict-of-interest witch hunt over industry funding.6 Ultimately, the source of funding became obviously irrelevant; the concordance between industry-funded and all high quality research on the litigation claims was undeniable. Obvious that is to court-appointed expert witnesses7, and to a blue-ribbon panel of experts in the Institute of Medicine8.

2. Latex Hypersensitivity

Tarry’s second example comes from the latex hypersensitivity litigation. Whatever evidentiary basis may have existed for isolated cases of latex allergy, the plaintiffs’ bar had taken and expanded into a full-scale mass tort. A defense expert witness, Dr. David Garabrant, a physician and an epidemiologist, published a meta-analysis and systematic review of the extant scientific evidence. David H. Garabrant & Sarah Schweitzer, “Epidemiology of latex sensitization and allergies in health care workers,” 110 J. Allergy & Clin. Immunol. S82 (2002). Garabrant’s formal, systematic review documented his litigation opinions that the risk of latex hypersensitivity was much lower than claimed and not the widespread hazard asserted by plaintiffs and their retained expert witnesses. Although Garabrant’s review did not totally end the litigation and public health debate about latex, it went a long way toward ending both.

3. Fraudulent Asbestos-Induced Radiography

I still recall, sitting at my desk, my secretary coming into my office to tell me excitedly that a recent crop of silicosis claimants had had previous asbestosis claims. When I asked how she knew, she showed me the computer print out for closed files for another client. Some of the names were so distinctive that the probability that there were two men with the same name was minuscule. When we obtained the closed files from storage, sure enough, the social security numbers matched, as did all other pertinent data, except that what had been called asbestosis previously was now called silicosis.

My secretary’s astute observation was mirrored in the judicial proceedings of Judge Janis Graham Jack, who presided over MDL 1553. Judge Jack, however, discovered something even more egregious: in some cases, a single physician interpreted a single chest radiograph as showing either asbestosis or silicosis, but not both. The two, alternative diagnoses were recorded in two, separate reports, for two different litigation cases against different defendants. This fraudulent practice, as well as others, are documented in Judge Jack’s extraordinary, thorough opinion. See In re Silica Prods. Liab. Litig., 398 F. Supp. 2d 563 (S.D. Tex. 2005)9.

The revelations of fraud in Judge Jack’s opinion were not entirely surprising. As everyone involved in asbestos litigation has always known, there is a disturbing degree of subjectivity in the interpretation of chest radiographs for pneumoconiosis. The federal government has long been aware of this problem, and through the Centers for Disease Control and the National Institute of Occupational Safety and Health, has tried to subdue extreme subjectivity by creating a pneumoconiosis classification schemed for chest radiographs known as the “B-reader” system. Unfortunately, B-reader certification meant only that physicians could achieve inter-observer and intra-observer reproducibility of interpretations on the examination, but they were free to peddle extreme interpretations for litigation. Indeed, the B-reader certification system exacerbated the problem by creating a credential that was marketed to advance the credibility of some of the most biased, over-reading physicians in asbestos, silica, and coal pneumoconiosis litigation.

Tarry’s third example is a study conducted under the leadership of the late Joseph Gitlin, at Johns Hopkins Medical School. With funding from defendants and insurers, Dr. Joseph Gitlin conducted a concordance study of films that had been read by predatory radiologists and physicians as showing pneumoconiosis. The readers in his study found a very low level of positive films (less than 5%), despite their having been interpreted as showing pneumoconiosis by the litigation physicians. See Joseph N. Gitlin, Leroy L. Cook, Otha W. Linton, and Elizabeth Garrett-Mayer, “Comparison of ‘B’ Readers’ Interpretations of Chest Radiographs for Asbestos Related Changes,” 11 Acad. Radiol. 843 (2004); Marjorie Centofanti, “With thousands of asbestos workers demanding compensation for lung disease, a radiology researcher here finds that most cases lack merit,” Hopkins Medicine (2006). As with the Sokol hoax, the practitioners of post-modern medicine cried “foul,” and decried industry sponsorship, but the disparity between courtroom and hospital medicine was sufficient proof for most disinterested observers that there was a need to fix the litigation process.

Meretricious Mensuration10 – Manganese Litigation Example

Tarry’s examples are important reminders that corporate sponsorship, whether from the plaintiffs’ lawsuit industry or from manufacturing industry, does not necessarily render research tainted or unreliable. Although lawyers often confront exaggerated or false claims, and witness important, helpful correctives in the form of litigation-sponsored studies, the demands of legal practice and “the next case” typically prevent lawyers from documenting the scientific depredations and their rebuttals. Sadly, unlike litigations such as those involving Bendectin and silicone, the chronicles of fraud and exaggeration are mostly closed books in closed files in closed offices. These examples need the light of day and a fresh breeze to disseminate them widely in both the scientific and legal communities, so that all may have a healthy appreciation for the value of appropriately conducted studies generated in litigation contexts.

As I have intimated elsewhere, the welding fume litigation is a great example of specious claiming, which ultimately was unhorsed by publications inspired or funded by the defense. In the typical welding fume case, plaintiff claimed that exposure to manganese in welding fume caused Parkinson’s disease or manganism. Although manganism sounds as though it must be a disease that can be caused only by manganese, in the hands of plaintiffs’ expert witnesses, manganism became whatever ailment plaintiffs claimed to have suffered. Circularity and perfect definitional precision were achieved by semantic fiat.

The Sanchez-Ramos Meta-Analysis

Manganese Madness was largely the creation of the Litigation Industry, under the dubious leadership of Dickie Scruggs & Company. Although the plaintiffs enjoyed a strong tail wind in the courtroom of an empathetic judge, they had difficulties in persuading juries and ultimately decamped from MDL 1535, in favor of more lucrative targets. In their last hurrah, however, plaintiffs retained a neurologist, Juan Sanchez-Ramos, who proffered a biased, invalid synthesis, which he billed as a meta-analysis11.

Sanchez-Ramos’s meta-analysis, such as it was, provoked professional disapproval and criticism from the defense expert witness, Dr. James Mortimer. Because the work product of Sanchez-Ramos was first disclosed in deposition, and not in his Rule 26 report, Dr. Mortimer undertook belatedly a proper meta-analysis.12 Even though Dr. Mortimer’s meta-analysis was done in response to the Sanchez-Ramos’s improper, tardy disclosure, the MDL judge ruled that Mortimer’s meta-analysis was too late. The effect, however, of Mortimer’s meta-analysis was clear in showing that welding had no positive association with Parkinson’s disease outcomes. The MDL 1535 resolved quickly thereafter, and with only slight encouragement, Dr. Mortimer published a further refined meta-analysis with two other leading neuro-epidemiologists. See James Mortimer, Amy Borenstein, and Lorene Nelson, “Associations of welding and manganese exposure with Parkinson disease: Review and meta-analysis,” 79 Neurology 1174 (2012). See also “Manganese Meta-Analysis Further Undermines Reference Manual’s Toxicology Chapter” (Oct. 15, 2012).

1 See, e.g., David Michaels & Celeste Monforton, “Manufacturing Uncertainty Contested Science and the Protection ofthe Public’s Health and Environment,” 95 Am. J. Pub. Health S39, S40 (2005); David Michaels & Celeste Monforton, “How Litigation Shapes the Scientific Literature: Asbestos and Disease Among Automobile Mechanics,” 15 J. L. & Policy 1137, 1165 (2007). Michaels had served as a plaintiffs’ paid expert witness in chemical exposure litigation, and Monforton had been employed by labor unions before these papers were published, without disclosure of conflicts.

2 Leslie Boden & David Ozonoff, “Litigation-Generated Science: Why Should We Care?” 116 Envt’l Health Persp. 121, 121 (2008) (arguing that systematic distortion of the scientific record will result from litigation-sponsored papers even with disclosure of conflicts of interest). Ozonoff had served as a hired plaintiffs’ expert witnesses on multiple occasion before the publication of this article, which was unadorned by disclosure.

3 Lennart Hardell, Martin J. Walker, Bo Walhjalt, Lee S. Friedman, and Elihu D. Richter, “Secret Ties to Industry and Conflicting Interest in Cancer Research,” 50 Am. J. Indus. Med. 227, 233 (2007) (criticizing “powerful industrial interests” for “undermining independent research on hazard and risk,” in a “red” journal that is controlled by allies of the lawsuit industry). Hardell was an expert witness for plaintiffs in mobile phone litigation in which plaintiffs claimed that non-ionizing radiation caused brain cancer. In federal litigation, Hardell was excluded as an expert witness when his proffered opinions were found to be scientifically unreliable. Newman v. Motorola, Inc., 218 F. Supp. 2d. 769, 777 (D. Md. 2002), aff’d, 78 Fed. Appx. 292 (4th Cir. 2003).

4 See David Egilman & Susanna Bohme, “IJOEH and the Critique of Bias,” 14 Internat’l J. Occup. & Envt’l Health 147, 148 (2008) (urging a Marxist critique that industry-sponsored research is necessarily motivated by profit considerations, and biased in favor of industry funders). Although Egilman usually gives a disclosure of his litigation activities, he typically characterizes those activities as having been for both plaintiffs and defendants, even though his testimonial work for defendants is minuscule.

5 Kenneth J. Rothman, “Conflict of Interest: The New McCarthyism in Science,” 269 J. Am. Med. Ass’n 2782 (1993).

6 See Charles H. Hennekens, I-Min Lee, Nancy R. Cook, Patricia R. Hebert, Elizabeth W. Karlson, Fran LaMotte; JoAnn E. Manson, and Julie E. Buring, “Self-reported Breast Implants and Connective- Tissue Diseases in Female Health Professionals: A Retrospective Cohort Study, 275 J. Am. Med. Ass’n 616-19 (1998) (analyzing established cohort for claimed associations, with funding from the National Institutes of Health and Dow Corning Corporation).

7 See Barbara Hulka, Betty Diamond, Nancy Kerkvliet & Peter Tugwell, “Silicone Breast Implants in Relation to Connective Tissue Diseases and Immunologic Dysfunction: A Report by a National Science Panel to the Hon. Sam Pointer Jr., MDL 926 (Nov. 30, 1998).” The court-appointed expert witnesses dedicated a great deal of their professional time to their task of evaluating the plaintiffs’ claims and the evidence. At the end of the process, they all published their litigation work in leading journals. See Barbara Hulka, Nancy Kerkvliet & Peter Tugwell, “Experience of a Scientific Panel Formed to Advise the Federal Judiciary on Silicone Breast Implants,” 342 New Engl. J. Med. 812 (2000); Esther C. Janowsky, Lawrence L. Kupper., and Barbara S. Hulka, “Meta-Analyses of the Relation between Silicone Breast Implants and the Risk of Connective-Tissue Diseases,” 342 New Engl. J. Med. 781 (2000); Peter Tugwell, George Wells, Joan Peterson, Vivian Welch, Jacqueline Page, Carolyn Davison, Jessie McGowan, David Ramroth, and Beverley Shea, “Do Silicone Breast Implants Cause Rheumatologic Disorders? A Systematic Review for a Court-Appointed National Science Panel,” 44 Arthritis & Rheumatism 2477 (2001).

8 Stuart Bondurant, Virginia Ernster, and Roger Herdman, eds., Safety of Silicone Breast Implants (Institute of Medicine) (Wash. D.C. 1999).

9 See also Lester Brickman, “On the Applicability of the Silica MDL Proceeding to Asbestos Litigation, 12 Conn. Insur. L. J. 289 (2006); Lester Brickman, “Disparities Between Asbestosis and Silicosis Claims Generated By Litigation Screenings and Clinical Studies,” 29 Cardozo L. Rev. 513 (2007).

10 This apt phraseology is due to the late Keith Morgan, whose wit, wisdom, and scientific acumen are greatly missed. See W. Keith C. Morgan, “Meretricious Mensuration,” 6 J. Eval. Clin. Practice 1 (2000).

11 See Deposition of Dr. Juan Sanchez-Ramos, in Street v. Lincoln Elec. Co., Case No. 1:06-cv-17026, 2011 WL 6008514 (N.D. Ohio May 17, 2011).

12 See Deposition of Dr. James Mortimer, in Street v. Lincoln Elec. Co., Case No. 1:06-cv-17026, 2011 WL 6008054 (N.D. Ohio June 29, 2011).

Posted in Asbestos, Causation, Conflicts of Interest, Meta-analysis, Rule 702, Scientific Evidence, Scientific Misconduct | Comments Off on Samuel Tarry’s Protreptic for Litigation-Sponsored Publications

Social Media, Rhetoric, and Science – Antivaxxers

February 24th, 2017

In a recent news conference, Donald Trump (née Drumpf) proclaimed that that he had won the presidency by the largest electoral college margin since Ronald Reagan. When an earnest (but obviously “dishonest”) reporter challenged him and pointed out that William Jefferson Clinton and Barack Obama had larger majorities in the electoral college, Trump, the fabulist-in-chief, did not lose a beat. Like the old Grinch, Trump was “so smart and so slick, he thought up a lie, and he thought it up quick!”

From his whopper, Trump retreated to the assertion that he was talking only about Republican presidents. But the earnest young reporter was relentless and pressed the challenge. And when pressed, Trump lamely offered1:

“I was given that information. I don’t know. I was just given it. We had a very, very big margin.”

Oh my. As John Adams, observed, before he became President:2

“Facts are stubborn things; and whatever may be our wishes, our inclinations, or the dictates of our passion, they cannot alter the state of facts and evidence.”

For a President who regularly embraces alternative facts, who has such a tenuous relationship with reality, and who says whatever was last whispered in his ear, we would expect science to be challenging. Some observers might note that Trump’s behavior mirrors how some lawyers treat scientific evidence and issues in litigation. Rhetoric has its place in science, but scientific disputes cannot be advanced simply because someone gave you “some information.” And yet, people try all the time.

If you search out the The World Mercury Project, you will be treated to a video of Robert F. Kennedy, Jr., who had made a career for the lawsuit industry of pursuing dubious scientific claims.3

The video, also available on YouTube, is vintage Kennedy, self-aggrandizing, and holding forth with accusations against pharmaceutical companies and vaccine manufacturers of “child abuse,” and “even worse.” The epistemic arrogance continues with assertions that Kennedy knows how to fight them, the greedy, murderous bullies.

The Trump presidency, with its alternative facts and its bullying, has emboldened conspiracy theorists of all stripes.

Last week, Robert F. Kennedy, Jr., along with Robert De Niro, convened a news conference on Wednesday at the National Press Club to announce their latest stunt, a $100,000 cash reward to the first person who comes forward with a “peer-reviewed scientific study demonstrating that the mercury in vaccines is safe.” National Press Club Conference (Feb. 15, 2017) [Expurgated Version].

A stunt, of course, because no one study would “demonstrate” safety, although the mass of epidemiologic evidence does. Furthermore, even in face of the overwhelming evidence that thimerosal in vaccines is not associated with autism, we could always hypothesize that there is one child who has some unique susceptibility.

The anti-vaxxers are quick to jump on the individual susceptibility argument. At their (fake) news conference, Kennedy and De Nira exhumed Bernadine Healy, who died in 2011, for a replay of a 2008 interview, in which Healy speculated that the then available science had not ruled out the existence of susceptible subgroups of children, who might be at risk from some one or multiple vaccines. Healy is best known as the first woman physician to serve as Director of the National Institutes of Health, from 1991 to 1993. For her acknowledgement that there might be vulnerable subgroups, and that this issue of idiosyncratic reaction should be studied, Healy was named 2008 “Person of the Year” by the anti-vaccine group, the Age of Autism.

Not surprisingly, anti-vaxxers Kennedy and De Niro, and their followers, missed the obvious. Healy’s suggestion that there might be a vulnerable subgroup of children is not evidence that thimerosal or any vaccine or vaccine regimen is unsafe.

Also not surprisingly, President Trump, with his affection for alternative facts and speculative conspiracy theories, is in the same epistemic muddle as Kennedy and De Niro. While still a candidate, Trump met with Andrew Wakefield and other dubious characters from the anti-vaxxer movement. With his propensity to repeat whatever was last said to him, Trump tweets about “doctor-inflicted autism,” and other claims.

And to make matters worse, toady American Republican party cannot seem to distance themselves from whatever nonsense Alt-President Trump dishes out. Pratik Chougule, an executive editor at The American Conservative recently wrote a disturbingly uncritical essay in support of Trump’s twittering approach to scientific policy. Pratik Chougule, “Why the Kennedy-De Niro Vaccine Challenge Matters – A presidential commission led by Robert Kennedy Jr. could raise uncomfortable questions about the incentives driving vaccination recommendations,” The American Conservative (Feb. 15, 2017) (noting that Trump has said that he “‘couldn’t care less’ about the ‘shills’ of conventional medical wisdom, the pharmaceutical companies, and their ‘fudged up reports’. In typical fashion, he declares that ‘the doctors lied’ and that he is ‘being proven right about massive vaccinations’.”)

Sad. Fake news. Fake science. Where is Daubert when you need it?

Posted in Rule 702, Scientific Evidence, Scientific Misconduct | Comments Off on Social Media, Rhetoric, and Science – Antivaxxers

Quackers & Cheese – Trump Picks Kennedy to Study Vaccine Safety

January 11th, 2017

Science necessarily involves a willingness to follow evidence to whatever conclusions are warranted, if conclusions properly can be had. When it comes to vaccination conspiracies, Democrats have it in their political DNA to distrust pharmaceutical companies that research, develop, and manufacture vaccines. The current Republican party, which has been commandeered by theocrats and populists, see vaccination as federal government aggrandizement, and resist vaccination policy as contrary to God’s will. Science is often the loser in the cross-fire.

And so we now have the public spectacle of watching the left and the right join in similar scientific apostasies. Consider how both McCain and Obama both suggested that vaccines and autism were related in the 2008 election. (Although both candidates were to some extent slippery in their suggestions, which might have been appropriate given how little they knew about the controversies.) And consider Michelle Bachmann was converted to a similar view about the HPV vaccine on the basis of a woman’s anecdote about her child. And then on the far left, you have the uplifting story of Robert F. Kennedy Jr, and his brief on how thimerosal supposedly causes autism.

So it should be no surprise that Donald Trump, a Birther, a Mirther, a mid-night Twitterer, should embrace the anti-vaccination movement. Trump has made it clear that he rejects evidence-based policy, and so no one should expect him to embrace a scientific policy that is driven by high-quality scientific evidence. According to Kennedy, Trump wants Kennedy to head up a “commission on vaccine safety and scientific integrity.” Michael D. Shear, Maggie Haberman & Pam Belluckjan, “Anti-Vaccine Activist Says Trump Wants Him to Lead Panel on Immunization Safety,” N.Y. Times (Jan. 10, 2017); Domenico Montanaro, “Despite The Facts, Trump Once Again Embraces Vaccine Skeptics,” National Public Radio (Jan. 10, 2017).

Who needs the National Academy of Medicine when you can put a yutzball lawyer in charge of a “commission”?

Some of the media refer to Robert F. Kennedy Jr. as a vaccine skeptic, but their terminology is grossly inaccurate and misleading. Kennedy is a vaccine denier; he has engaged in a vitriolic campaign against the safety and efficacy of vaccines. He has aligned himself with the most extreme deniers of science, medicine, and public safety, including the likes of Andrew Wakefield and Jenny McCarthy. Kennedy has not merely engaged hyperbolic rhetoric against vaccines, he has used his radio show on the lawsuit industry’s Ring of Fire, to advance his campaign against public health as well as to shill for the lawsuit industry on other issues. See “RFK, Jr.: Science Shows That Autism — Mercury Link Exists – PT. ½,” Ring of Fire (Mar 8, 2011).

Kennedy should not be characterized as a skeptic, when he is a shrill ideologue, for whom science has no method that he is bound to respect. Back in July 2005, Kennedy published an article, “Deadly Immunity,” in both Rolling Stone and on Slate’s website. The article was a hateful screed against Big Pharma and government health agencies for an alleged conspiracy to hide the autism risks of thimerosal preservatives in vaccines. Several years later, on January 16, 2011, Salon retracted the article. See “https://en.wikipedia.org/wiki/Deadly_Immunity” entry in Wikipedia. See also Phil Plait, “Robert F. Kennedy Jr.: Anti-Vaxxer,” Slate (June 5 2013) (describing Kennedy as a full-blown anti-vaccination conspiracy theorist); Rahul K. Parikh, M.D., “Inside the vaccine-and-autism scare: A pediatrician traces the rise of the anti-vaccine movement that falsely linked thimerosal with autism and turned parents away from the most lifesaving medicine in history,” Salon (Sept. 22, 2008); Keith Kloor, “Is Robert F. Kennedy Jr. Anti-Science?” Discover Magazine (June 1, 2013); Steven Novella, “RFK Jr.s Autism Conspiracy Theory,” (Jun 20 2007).

Back in 2008, President Obama apparently considered Robert Kennedy for a cabinet-level position, but on sober reflection, thought better of it. See Steven Novella, “Politics and Science – The RFK Jr. Test,” (Nov. 07 2008). The Wall Street Journal, joined by many others, are now urging Trump to think harder and better about the issue, perhaps with some evidence as well. See Alex Berezow & Hank Campbell, “Ignore Anti-Vaccine Hysteria, Mr. Trump: Robert F. Kennedy Jr.’s conspiracy theories have no place in the White House,” Wall Street J. (Jan. 10, 2017).

Posted in Causation, Cognitive Biases, Conflicts of Interest, Evidence, Public Nuisances, Scientific Evidence, Scientific Misconduct | Comments Off on Quackers & Cheese – Trump Picks Kennedy to Study Vaccine Safety

Credible Incredulity

May 19th, 2016

Has skepticism become a victim of political correctness and adversarial zeal?

In the last century, philosopher Bertrand Russell advanced intelligent skepticism against myriad enthusiams and mindless beliefs, political, religious, and pseudo-scientific. Russell saw unwarranted certainty as a serious intellectual offense:

“The fundamental cause of the trouble is that in the modern world the stupid are cocksure while the intelligent are full of doubt.”

Bertrand Russell, “The Triumph of Stupidity” (1933), Mortals and Others: Bertrand Russell’s American Essays, 1931-1935 , at 28 (1998).  When many American intellectuals were still in their love swoon over Stalin, Russell chastised the Soviet dictator for his betrayal of ideals and his enslavement of Eastern European. Stalinism’s certainty about politics and science was not a virtue, but a grave sin.  Or, in Russell’s words:

“One of the painful things about our time is that those who feel certainty are stupid, and those with any imagination and understanding are filled with doubt and indecision.”

Bertrand Russell, New Hopes for a Changing World at 4-5 (1951).

In the 21st century, ideologues of various stripes have tried to silence healthy skepticism and doubt by claiming that their critics have “manufactured doubt.”[1] This aggression against skepticism and doubt, joined with a biased conception of conflicts of interest, have become part of a concerted campaign to privilege tendentious scientific claims from critical scrutiny.

Philosopher Susan Haack, who has aligned herself on occasion with these politicized acolytes of certainty,[2] recently has pushed back, with a reminder that credulity for unwarranted claims, in all walks of life, is unethical.[3]  Haack’s essay is a delightful effort to clarify what credulity is, and to explore why credulity is an epistemologic vice and a social hazard, as well as the implications for citizens and scientists of living in an evidence-based, not a faith-based world.

Drawing inspiration from the the English mathematician and philosopher, William Kingdon Clifford, Haack has adopted one of Clifford’s bon mots as her motto:

“The credulous man is father to the liar and the cheat.”[4]

Indeed! And credulous judges and juries are the parents to specious claims and shyster lawyers.

Clifford’s essay should be required reading for politicians, judges, regulators, and legislators who evaluate the claims of scientist advocates.  Spurning ethical relativism, Clifford identified the key intellectual “sin” in an evidence-based world:

 “It is wrong always, everywhere, and for anyone, to believe anything upon insufficient evidence.”

William K. Clifford, “The Ethics of Belief,” 29 Contemporary Rev. 289, 295 (1877).

Professor Haack should be commended for her fulsome irony for publishing in a journal of one of the world’s more credulous institutions, and for reminding us that credulity is an intellectual vice.

[1] See, e.g., David Michaels, Doubt is Their Product: How Industry’s Assault on Science Threatens Your Health (2008); Naomi Oreskes and Erik M. Conway, Merchants of Doubt: How a Handful of Scientists Obscured the Truth on Issues from Tobacco Smoke to Global Warming (2010).

[2] See, e.g., “Bendectin, Diclegis & The Philosophy of Science” (Oct. 26, 2013).

[3] Susan Haack, “Credulity and Circumspection: Epistemological Character and the Ethics of Belief,” 88 Proc. Am. Catholic Philosophical Ass’n 27 (2015).

[4] citing and quoting William K. Clifford, “The Ethics of Belief ” (1877), in Leslie Stephen and Sir Frederick Pollock, eds., The Ethics of Belief and Other Essays 70, 77 (London 1947).

Posted in Scientific Evidence, Scientific Misconduct | Comments Off on Credible Incredulity

The IARC Process is Broken

May 4th, 2016

Last spring, the International Agency for Research on Cancer (IARC) convened a working group that voted to classify the herbicide glyphosate as “probably carcinogenic to humans.” The vote was followed by IARC’s Press Release, a summary in The Lancet,[1] and the publication of a “monograph,” volume 112 in the IARC series.

IARC classifications of a chemical as “probably” carcinogenic to humans are actually fairly meaningless exercises in semantics, not science. A close reading of the IARC Preamble definition of probable reveals that probable does not mean greater than 50%:

“The terms probably carcinogenic and possibly carcinogenic have no quantitative significance and are used simply as descriptors of different levels of evidence of human carcinogenicity, with probably carcinogenic signifying a higher level of evidence than possibly carcinogenic.”

Despite the vacuity of the IARC’s “probability” determinations, IARC decisions have serious real-world consequences in the realm of regulation and litigation. Monsanto, the manufacturer of glyphosate herbicide, reacted strongly, expressing “outrage” and claiming that the IARC had cherry picked data to reach its conclusion. Jack Kaskey, “Monsanto ‘Outraged’ by Assessment That Roundup Probably Causes Cancer,” 43 Product Safety & Liability Reporter 416 (Mar. 30, 2015).

In the wake of the IARC classification, in the fall of 2015, the United States Environmental Protection Agency (EPA) reviewed the evidence for, and against, glysophate’s carcinogenicity. The EPA found that the IARC had deliberately failed to consider studies that did not find associations, and that the complete scientific record did not support a conclusion of human carcinogenicity. EPA Report of the Cancer Assessment Review Committee on Glyphosate (Oct. 1, 2015).

For undisclosed reasons, however, the EPA’s report was never made public until a couple of weeks ago, when it showed up briefly on the agency’s website, only to be pulled down after a day or so. See David Schultz, “EPA Panel Finds Glyphosate Not Likely to Cause Cancer,” Product Safety & Liability Reporter (May 03, 2016). No doubt the present Administration viewed a conflict between EPA and IARC, and disparaging comments about the IARC’s “process” to be national security issues.  At the very least, the Administration would not want to undermine the litigation industry’s reliance upon the IARC cherry-picked report.

All joking aside, the incident highlights the problematic nature of the IARC decision process, and the reliance of regulatory agencies on the apparent authority of IARC determinations. The IARC process is toxic and should be remediated.

[1] Kathryn Z Guyton, Dana Loomis, Yann Grosse, Fatiha El Ghissassi, Lamia Benbrahim-Tallaa, Neela Guha, Chiara Scoccianti, Heidi Mattock, Kurt Straif, on behalf of the International Agency for Research on Cancer Monograph Working Group, IARC, Lyon, France, “Carcinogenicity of tetrachlorvinphos, parathion, malathion, diazinon, and glyphosate,” 16 The Lancet Oncology 490 (2015).

 

 

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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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Earthquake-Induced Data Loss – We’re All Shook Up

June 26th, 2015

Adam Marcus and Ivan Oransky are medical journalists who publish the Retraction Watch blog. Their blog’s coverage of error, fraud, plagiarism, and other publishing disasters is often first-rate, and a valuable curative for the belief that peer review publication, as it is now practiced, ensures trustworthiness.

Yesterday, Retraction Watch posted an article on earthquake-induced data loss. Shannon Palus, “Lost your data? Blame an earthquake” (June 25, 2015). A commenter on PubPeer raised concerns about a key figure in a paper[1]. The authors acknowledged a problem, which they traced to their loss of data in an earthquake. The journal retracted the paper.

This is not the first instance of earthquake-induced loss of data.

When John O’Quinn and his colleagues in the litigation industry created the pseudo-science of silicone-induced autoimmunity, they recruited Nir Kossovsky, a pathologist at UCLA Medical Center. Although Kossovsky looked a bit like Pee-Wee Herman, he was a graduate of the University of Chicago Pritzker School of Medicine, and the U.S. Naval War College, and a consultant to the FDA. In his dress whites, Kossovsky helped O’Quinn sell his silicone immunogenicity theories to juries and judges around the country. For a while, the theories sold well.

In testifying and dodging discovery for the underlying data in his silicone studies, Kossovsky was as slick as silicone itself. Ultimately, when defense counsel subpoenaed the underlying data from Kossovsky’s silicone study, Kossovsky shrugged and replied that the Northridge Earthquake destroyed his data. Apparently coffee cups and other containers of questionable fluids spilled on his silicone data in the quake, and Kossovsky’s emergency response was to obtain garbage cans and throw out the data. For the gory details, see Gary Taubes, “Silicone in the System: Has Nir Kossovsky really shown anything about the dangers of breast implants?” Discover Magazine (Dec. 1995).

As Mr. Taubes points out, Kossovsky’s paper was rejected by several journals before being published in the Journal of Applied Biomaterials, of which Kossovsky was a member of the editorial board. The lack of data did not, however, keep Kossovsky from continuing to testify, and from trying to commercialize, along with his wife, Beth Brandegee, and his father, Ram Kossowsky[2], an ELISA-based silicone “antibody” biomarker diagnostic test, Detecsil. Although Rule 702 had been energized by the Daubert decision in 1993, many judges were still not willing to take a hard look at Kossovsky’s study, his test, or to demand the supposedly supporting data. The Food and Drug Administration, however, eventually caught up with Kossovsky, and the Detecsil marketing ceased. Lillian J. Gill, FDA Acting Director, Office of Compliance, Letter to Beth S. Brandegee, President, Structured Biologicals (SBI) Laboratories: Detecsil Silicone Sensitivity Test (July 15, 1994); see Taubes, Discover Magazine.

After defense counsel learned of the FDA’s enforcement action against Kossovsky and his company, the litigation industry lost interest in Kossovsky, and his name dropped off trial witness lists. His name also dropped off the rolls of tenured UCLA faculty, and he apparently left medicine altogether to become a business consultant. Dr. Kossovsky became “an authority on business process risk and reputational value.” Kossovsky is now the CEO and Director of Steel City Re, which specializes in strategies for maintaining and enhancing reputational value. Ironic; eh?

A review of PubMed’s entries for Nir Kossovsky shows that his run in silicone started in 1983, and ended in 1996. He testified for plaintiffs in Hopkins v. Dow Corning Corp., 33 F.3d 1116 (9th Cir.1994) (tried in 1991), and in the infamous case of Johnson v. Bristol-Myers Squibb, CN 91-21770, Tx Dist. Ct., 125th Jud. Dist., Harris Cty., 1992.

A bibliography of Kossovsky silicone oeuvre is listed, below.

[1] Federico S. Rodríguez, Katterine A. Salazar, Nery A. Jara, María A García-Robles, Fernando Pérez, Luciano E. Ferrada, Fernando Martínez, and Francisco J. Nualart, “Superoxide-dependent uptake of vitamin C in human glioma cells,” 127 J. Neurochemistry 793 (2013).

[2] Father and son apparently did not agree on how to spell their last name.

Nir Kossovsky, D. Conway, Ram Kossowsky & D. Petrovich, “Novel anti-silicone surface-associated antigen antibodies (anti-SSAA(x)) may help differentiate symptomatic patients with silicone breast implants from patients with classical rheumatological disease,” 210 Curr. Topics Microbiol. Immunol. 327 (1996)

Nir Kossovsky, et al., “Preservation of surface-dependent properties of viral antigens following immobilization on particulate ceramic delivery vehicles,” 29 J. Biomed. Mater. Res. 561 (1995)

E.A. Mena, Nir Kossovsky, C. Chu, and C. Hu, “Inflammatory intermediates produced by tissues encasing silicone breast prostheses,” 8 J. Invest. Surg. 31 (1995)

Nir Kossovsky, “Can the silicone controversy be resolved with rational certainty?” 7 J. Biomater. Sci. Polymer Ed. 97 (1995)

Nir Kossovsky & C.J. Freiman, “Physicochemical and immunological basis of silicone pathophysiology,” 7 J. Biomater. Sci. Polym. Ed. 101 (1995)

Nir Kossovsky, et al., “Self-reported signs and symptoms in breast implant patients with novel antibodies to silicone surface associated antigens [anti-SSAA(x)],” 6 J. Appl. Biomater. 153 (1995), and “Erratum,” 6 J. Appl. Biomater. 305 (1995)

Nir Kossovsky & J. Stassi, “A pathophysiological examination of the biophysics and bioreactivity of silicone breast implants,” 24s1 Seminars Arthritis & Rheum. 18 (1994)

Nir Kossovsky & C.J. Freiman, “Silicone breast implant pathology. Clinical data and immunologic consequences,” 118 Arch. Pathol. Lab. Med. 686 (1994)

Nir Kossovsky & C.J. Freiman, “Immunology of silicone breast implants,” 8 J. Biomaterials Appl. 237 (1994)

Nir Kossovsky & N. Papasian, “Mammary implants,” 3 J. Appl. Biomater. 239 (1992)

Nir Kossovsky, P. Cole, D.A. Zackson, “Giant cell myocarditis associated with silicone: An unusual case of biomaterials pathology discovered at autopsy using X-ray energy spectroscopic techniques,” 93 Am. J. Clin. Pathol. 148 (1990)

Nir Kossovsky & R.B. Snow RB, “Clinical-pathological analysis of failed central nervous system fluid shunts,” 23 J. Biomed. Mater. Res. 73 (1989)

R.B. Snow & Nir Kossovsky, “Hypersensitivity reaction associated with sterile ventriculoperitoneal shunt malfunction,” 31 Surg. Neurol. 209 (1989)

Nir Kossovsky & Ram Kossowsky, “Medical devices and biomaterials pathology: Primary data for health care technology assessment,” 4 Internat’l J. Technol. Assess. Health Care 319 (1988)

Nir Kossovsky, John P. Heggers, and M.C. Robson, “Experimental demonstration of the immunogenicity of silicone-protein complexes,” 21 J. Biomed. Mater. Res. 1125 (1987)

Nir Kossovsky, John P. Heggers, R.W. Parsons, and M.C. Robson, “Acceleration of capsule formation around silicone implants by infection in a guinea pig model,” 73 Plastic & Reconstr. Surg. 91 (1984)

John Heggers, Nir Kossovsky, et al., “Biocompatibility of silicone implants,” 11 Ann. Plastic Surg. 38 (1983)

Nir Kossovsky, John P. Heggers, et al., “Analysis of the surface morphology of recovered silicone mammary prostheses,” 71 Plast. Reconstr. Surg. 795 (1983)

Posted in Expert Witness Hall of Shame, Expert Witnesses, Rule 702, Scientific Evidence, Scientific Misconduct | Comments Off on Earthquake-Induced Data Loss – We’re All Shook Up

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