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Disappearing Conflicts of Interest

October 29th, 2017

As the story of who funded the opposition research into Trumski and the Russian micturaters unfolds, both sides of the political spectrum seem obsessed with who funded the research. Funny thing that both sides had coins in the fountain. Funding is, in any event, an invalid proxy for good and sufficient reason. The public should be focused on the truth or falsity of the factual claims. The same goes in science, although more and more, science is evaluated by “conflicts of interest” (COIs) rather than by the strength of evidence and validity of inferences.

No one screams louder today about COIs than the lawsuit industry and its scientist fellow travelers. Although I believe we should rid ourselves of this obsession with COIs, to the extent we must put up with it, the obsession should at least be symmetrical, complete, and non-hypocritical.

In an in-press publication, Morris Greenberg has published an historical account of the role that the U.K. Medical Research Council had in studying asbestos health effects.1 Greenberg often weighs in on occupational disease issues in synch with the litigation industry, and so no one will be entirely surprised that Greenberg suspects undue industry influence (not the lawsuit industry, but an industry that actually makes things). Greenberg may be right in his historical narrative and analysis, but my point today is different. What was interesting about Greenberg’s paper was the disclosure at its conclusion, by the “American Journal of Industrial Medicine editor of record”:

“Steven B. Markowitz declares that he has no conflict of interest in the review and publication decision regarding this article.”

Markowitz’s declaration is remarkable in the era when the litigation industry and its scientific allies perpetually have their knickers knotted over perceived COIs. Well known to the asbestos bar, Markowitz has testified with some regularity for plaintiffs’ lawyers and their clients. Markowitz is also an editor in chief of the “red” journal,” the American Journal of Industrial Medicine. Many of the associate editors are regular testifiers for the lawsuit industry, such as Arthur L. Frank and Richard A. Lemen.

Even more curious is that Steven Markowitz, along with fellow plaintiffs’ expert witness, Jacqueline M. Moline, recently published a case report about mesothelioma occuring in an unusual exposure situation, in the red journal. This paper appeared online in February 2017, and carried a disclosure that “[t]he authors have served as expert witnesses in cases involving asbestos tort litigation.2” A bit misleading given how both appear virtually exclusively for claimants, but still a disclosure, whereas Markowitz, qua editor of Greenberg’s article, claimed to have none.

Markowitz, as an alumnus of the Mount Sinai School of Medicine, is, of course, a member of the secret handshake society of the litigation industry, the Collegium Ramazzini. At the Collegium, Markowitz proudly presents his labor union consultancies, but these union ties are not disclosed in Markowitz’s asbestos publications.

Previously, I blogged about Markowitz’s failure to make an appropriate COI disclosure in connection with an earlier asbestos paper.3 See “Conflicts of Interest in Asbestos Studies – the Plaintiffs’ Double Standard” (Sept. 18, 2013). At the time, there appeared to be no disclosure of litigation work, but I was encouraged to see, upon checking today, that Markowitz’s disclosure for his 2013 paper now reveals that he has received fees for expert testimony, from “various law firms.” A bit thin to leave out plaintiffs’ law firms, considering that the paper at issue is used regularly by Markowitz and other plaintiffs’ expert witnesses to advance their positions in asbestos cases. A more complete disclosure might read something like: “Markowitz has been paid to consult and testify in asbestos personal injury by plaintiffs’ legal counsel, and to consult for labor unions. In his testimony and consultations, he relies upon this paper and other evidence to support his opinions. This study has grown out of research that was originally funded by the asbestos workers’ union.”

Or we could just evaluate the study on its merits, or lack thereof.

1 Morris Greenberg, “Experimental asbestos studies in the UK: 1912-1950,” 60 Am. J. Indus. Med. XXX (2017) (doi: 10.1002/ajim.22762).

2 Steven B. Markowitz & Jacqueline M. Moline, “Malignant Mesothelioma Due to Asbestos Exposure in Dental Tape,” 60 Am. J. Indus. Med. 437 (2017).

Posted in Asbestos, Conflicts of Interest, Expert Witnesses | Comments Off on Disappearing Conflicts of Interest

Johnson & Johnson Leaves Them in the Dust – Echeverria Verdict Unraveled

October 24th, 2017

It was a tough week for the talc litigation industry. On October 17, the Missouri Court of Appeals reversed a large verdict for plaintiffs because a St. Louis trial court unconstitutionally had asserted personal jurisdiction over Johnson & Johnson. In essence, the Missouri appellate court just said no to forum shopping. Fox v. Johnson & Johnson, Mo. Ct. App., No. ED104580 (Oct. 17, 2017). And on Friday, October 20, a California trial court, on sober second thought, granted judgment notwithstanding the verdict, and in the alternative, a new trial in the recent Escheverria case, which had resulted in plaintiffs’ awards approaching half a billion dollars. See Orders regarding Defendants Combined Motion for New Trial and Judgment Notwithstanding the Verdict, Echeverria v. Johnson & Johnson, Inc., Case No. BC628228, JCCP No. 4872, Calif. Super. Ct., Los Angeles Cty. (Oct. 20, 2017) [cited below as Echeverria op.] See also Daniel Siegal, “J&J Wins Battle Against $417M Talc Award, But War Not Over,” Law360 (Oct. 23, 2017).

The trial court issued an opinion, over 50 pages long, which carefully reviewed the parties’ contentions. Only some of the issues considered by the trial court are discussed below.

Differential Etiology

Differential etiology resembles the biological process of solid waste management; both employ the process of elimination.

Most diseases in humans have a large “idiopathic” or “cause unknown” component. The differential methodology purports to take all the known causes and rule out the ones that are improbable in a given case. As a matter of logic, this is what is known as an iterative disjunctive syllogism. If you start with:

A or B or C.

And you show not B;

and then, not C.

you are left with A.

This argument is, of course, a perfectly valid syllogism. If the premises are true, then the conclusion must be true. The problem is that the initial premise, to be accurate for many if not most human chronic diseases, must include a disjunct, U, or “cause unknown.” And once U is added to the first line of the syllogism, rarely is there a way to exclude it.

Sometimes the “cause unknown” component may be very small. For instance, in human malignant mesothelioma, the overwhelming majority of occupational cases do have a known cause: amphibole asbestos. When sufficient amphibole asbestos fiber exposure has been shown, there is usually no serious issue of individual attribution left for debate. The base rate of (idiopathic) mesothelioma is very low, and the relative risk from occupational amphibole asbestos exposure is extraordinarily large.

Ovarian cancer, which is the subject of the Escheverria case, is a very different story. The rate of idiopathic cases – no known causes – is much higher, and may even make up a majority of cases. The so-called differential etiology method never gets down to a conclusion that it is the talc (assuming arguendo that talc causes ovarian cancer). You always have talc or unknown cause in the conclusion.

In Escheverria, the plaintiffs’ lawyers called only one expert witness on specific causation, Echeverria’s treating physician, Dr. Annie Yessaian (“Yessaian”). Yessaian advanced a “differential etiology” analysis, which she claimed allowed her to conclude that talc was “more probable than not” a cause of plaintiff’s ovarian cancer. Echeverria op. at 5. Upon careful review, the trial court realized that Yessaian had never properly applied the iterative disjunctive syllogism, or differential etiology, to reach a valid conclusion. Despite a good deal of hand waving, Yessaian never ruled out other causes of the plaintiff’s ovarian cancer. Echeverria op. at 30.

The plaintiff’s menarche was at age 11, and so she had had a large number of ovulatory cycles. She was obese, and over 60 years old at the time of diagnosis. Yessaian did not rule these factors out; rather she testified without foundation that these factors were “less likely than not” causes of plaintiff’s ovarian cancer1. Echeverria op. at 31. The trial court noted that these potential causes had never been eliminated from the list of differentials; Yessaian had simply “discounted” them by ipse dixit. As for the “U,” or unknown causes that are clearly at play in many if not most ovarian cancers, Yessaian admitted that Escheverria’s cancer “probably” resulted from some unknown risk factor; but then, out of thin air, she testified that the probability of idiopathic causation was less than 50%. The trial court concluded that Yessian’s ruling in and ruling out decisions were ultimately nothing more than conjecture, and the plaintiff had never properly shown specific causation. Id. at 26-27, 31.

Relative Risk Less than Two

Yessaian’s specific causation opinion cratered further as a result of her inability to identify any specific biomarker or “fingerprint” of causation. The plaintiffs’ expert witnesses had argued that chronic inflammation is the mechanism by which talc causes ovarian cancer, but there was no histopathologic evidence of inflammation in association with ovarian tissue that had given rise to the cancer.

The relative risk argument is one way to attribute specific causation, and circumvent idiopathic causes by quantifying the contribution of the specific causal factor (again assuming it really is such) vis-a-vis the baseline risk of disease from unknown causes. The plaintiff, however, had called an expert witness on epidemiology, Jack Siemiatycki, who had explained that a risk ratio of 2.0 is “the point at which the probability of causation, which is the probability that a given agent causes a specific disease, exceeds 50 percent ….” Escheverria op. at 5. The defense epidemiologic expert, Dr. Douglas Weed, similarly testified and elaborated on the concept of probability of causation and attributable risk.2

The plaintiffs’ counsel attempted to extricate themselves from this arithmetic quagmire by arguing that there was “multiple causation,” and interaction among causes. Escheverria op. at 41-42. Yessaian, however, had disavowed even the most obvious concurrent causes (ovulatory cycles and age), and put all her markers down on talc. There was no evidence of multiple causation to muck up the analysis. Of course, the talc epidemiologic studies were all multivariate analyses that measured associations of talc and ovarian cancer in the presence of co-variates, such as age at menarche, and age at diagnosis.

Furthermore, Yessian was constrained by her acknowledgement that histologic type of ovarian cancer is highly relevant, and that none of the studies of serous ovaran cancer (the type diagnosed in Ms. Escheverria) reported out risk ratios in excess of 2.0. Escheverria op. at 28-29. Yessaian could not escape the inexorable math, and testimony about probability of causation from Jack Siemiatycki. Id at 29.3

Their case in extremis, the plaintiffs’ counsel argued4 that epidemiologic studies were not needed to prove causation, which might be true in a case involving a known mechanism with highly specific biomarkers to identify the causal mechanism that had taken place in the claimant. Having cited and relied extensively upon epidemiologic studies, Yessaian was hoisted with own her petard; the trial court found the assertion that there was an alternative path to specific causation to be absent from the record and quite incredible.

State of the Art

The duty to warn is constrained by what is known or should have been known at the time of marketing, what lawyers sometimes call “state of the art.” The trial court reasoned that since Eva Echeverria developed her serous ovarian cancer in 2007, the relevant scientific state of knowledge was censored at the time of plaintiff’s diagnosis. Any warning given after 2007 could not have prevented plaintiffs’ disease. (In truth, the relevant censoring date was likely well before 2007, but an earlier date would not have made a difference in the judicial outcome.)

There was no serious claim that the defendants had “secret” knowledge other than what was known in the scientific community. Plaintiffs’ expert witness on epidemiology, Jack Siemiatycki, co-chaired the IARC working group that concluded and published in 2007, that talc was a possible cause of ovarian cancer, a finding that rejected a higher classification, such as “probable” or “known.” IARC Monograph for Carbon Black, Titanium Dioxide & Talc, vol 93 (2010); Robert Baan, et al., “Carcinogenicity of carbon black, titanium dioxide, and talc,” 7 Lancet Oncology 295 (2006)5. In Escheverria, Siemiatycki testified in accordance with his public scientific work, and his service on the IARC working group, and he conceded that in 2007, there was no known causal connection between talc and human ovarian cancer. Notably, the defense lawyers failed to convert this state-of-the-art issue into a dispositive judgment because they had failed to ask for a binding jury instruction on the issue. Escheverria op. at 32.

For the trial court, the absence of scientific knowledge up to and including 2007, the year of Escheverria’s diagnosis, was also relevant to the existence vel non of malice that would support the imposition of punitive damages. Looking at the evidence in the light most favorable to the plaintiff, the trial court found that there was a scientific debate whether talc causes ovarian cancer, which debate would not allow the imputation of scienter to the defendants to permit the jury to infer that the defendants had acted with malice. Escheverria op. at 35. Given that no one in the medical or scientific community had asserted a relevant causal conclusion in or before 2007, the trial court’s conclusion is unassailable. The court’s analysis, however, begs the question why a lay jury is permitted to find any breach of a duty to warn, in the face of an engaged scientific community that uniformly refused to advance a causal conclusion in the relevant time frame.

New Trial on General and Specific Causation

The trial court did not belabor the analysis of general causation beyond pointing out that there were substantial uncertainties for many of the Bradford Hill considerations, such as consistency, strength, and exposure-response. With respect to specific causation, all the problems discussed on the motion for judgment notwithstanding the verdict were also relevant to finding that the plaintiff failed to establish specific causation by a preponderance of the evidence. Escheverria op. at 40.

The trial court identified several grounds for the grant of a new trial, but one ground involved improper argument by plaintiffs’ counsel, who has repeatedly resorted to the same argument in previous cases. Forewarned, the defense sought a ruling in limine to exclude all evidence of lobbying and communications with federal agencies over regulations and regulatory classifications of talc. In a pretrial ruling, the trial court permitted the use of company documents about attempts to influence the National Toxicology Program (NTP) and the IARC for the limited purpose of notice to defendants that scientific organizations were considering whether to label talc as a carcinogen. Escheverria op. at 45.

Perhaps the trial court was being charitable in assessing what the lobbying evidence would be used for, but the plaintiffs did not need evidence of lobbying to prove “notice.” Early, often, and deliberately, the plaintiffs’ lawyers used evidence of lobbying for purposes well beyond the permissible, limited relevancy of notice. Escheverria’s counsel, Allen Smith argued, in opening and in closing that the defendants had “fended off” the National Toxicology Program (NTP), and that “if Johnson & Johnson would have just stayed out of it, let the scientists do their work at the U.S. government, the NTP would have listed talc as a carcinogen as far back as 2000.” So lobbying activities were not used as evidence of notice at all, but rather for arguing an inference of malice and outrageous misconduct from the prevention of regulation. Escheverria op. at 46.

Predictable.

1 Yessaian did advert to a study that she interpreted as failing to establish an association between obesity and ovarian cancer, but for the other risk factors of age and ovulatory cycles, the plaintiff’s expert witness offered no basis at all.

2 The trial court studiously avoided reference to the defense expert witness on epidemiology. See “Echeverria Talc Trial – Crossexamination on Alleged Expert Witness Misconduct” (Oct. 21, 2017).

3 citing well-known relative risk of two cases, Daubert v. Merrell Dow Pharms., Inc., 43 F. 3d 1311, 1321 (9th Cir. 1995); In re Lipitor (Atorvastatin Calcium) Mktg., Sales Prac. & Prod. Liab. Litig., 185 F. Supp. 3d 786, 791-92; Marder v. G.D. Searle & Co., 630 F. Supp. 1087, 1092 (D.Md. 1986), aff’d mem. on other grounds sub nom. Wheelahan v. G.D.Searle & Co., 814 F.2d 655 (4th Cir. 1987) (per curiam).

4 citing the dubious In re Neurontin Marketing, Sales Practices & Prods. Liab. Litig., 612 F. Supp. 2d 116, 132 (D. Mass. 2009), aff’d, 712 F.3d 21 (1st Cir. 2013).

5 Unfortunately, even the IARC classification of “probably” carcinogenic to humans is 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.”

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Echeverria Talc Trial – Crossexamination on Alleged Expert Witness Misconduct

October 21st, 2017

In a post-trial end-zone victory dance in Echeverria v. Johnson & Johnson, plaintiffs’ lawyer, Allen Smith proffered three explanations for the jury’s stunning $417 million verdict in his talc ovarian cancer case.1 One of the explanations asserted was Smith’s boast that he had adduced evidence that Johnson & Johnson’s expert witness on epidemiology, Douglas Weed, a former National Cancer Institute epidemiologist and physician, had been sanctioned in another, non-talc case in North Carolina, for lying under oath about whether he had notes to his expert report in that other case.2 Having now viewed Dr. Weed’s testimony3, through the Courtroom Video Network, I can evaluate Smith’s claim.

Weed’s allegedly perjurious testimony took place in Carter v. Fiber Composites LLC, 11 CVS 1355, N.C. Super. Ct., where he served as a party expert witness. In April 2014, Weed gave deposition testimony in the discovery phase of the Carter case. Although not served personally with a lawful subpoena, defense counsel had agreed to accept a subpoena for their expert witness to appear and produce documents, as was the local custom. In deposition, plaintiffs’ counsel asked Dr. Weed to produce any notes he created in the process of researching and writing his expert witness report. Dr. Weed testified that he had no notes. 

The parties disputed whether Dr. Weed had complied with a subpoena served upon defense counsel. The discovery dispute escalated and Dr. Weed obtained legal counsel, and submitted a sworn affidavit that denied the existence of notes. Plaintiffs’ counsel pressed on Dr. Weed’s understanding that he had no “notes.” In an Order, dated May 6, 2014, the trial court directed Dr. Weed to produce everything in his possession. In response to the order, Weed produced his calendar and a thumb drive with “small fragments of notes,” “inserts,” and “miscellaneous items.”

The North Carolina court did not take kindly to Dr. Weed’s confusion about whether his report “segments” and “inserts” were notes, or not. Dr. Weed viewed the segments and inserts to have been parts of his report, and later included within his report without any substantial change. The court concluded, however, that although Dr. Weed did not violate any court order, his assertion, in deposition, in an affidavit, and through legal counsel, was unreasonable, and directly related to his credibility in the Carter case. See Order Concerning Plaintiffs’ Motion for Sanctions Against Defendants and Non-Party Witness for Defendants (June 22, 2015) (Forrest D. Bridges, J.).

The upshot was that Dr. Weed and his counsel had provided false information to the court, on the court’s understanding of what had been requested in discovery. In the court’s view, Dr. Weed’s misunderstanding may have been understandable as a non-lawyer, but it was not reasonable for him to persist and have his counsel argue that there were no notes. The trial court specifically did not find that Dr. Weed had lied, as asserted by Allen Smith, but found that Weed’s conduct was undertaken intentionally or with reckless disregard of the truth, and that his testimony was an unacceptable violation of the oath to tell the whole truth. The trial court concluded that it could not sanction Dr. Weed personally, but its order specified that as a sanction, the plaintiffs’ counsel would be permitted to cross-examine Dr. Weed with the court’s findings and conclusions in the Carter case. Id. Not surprisingly, defense counsel withdrew Dr. Weed as an expert witness.

In the Echeverria case, the defense counsel did not object to the cross-examination; the video proceedings did not inform the viewers whether there had been a prior motion in limine concerning this examination. Allen Smith’s assertion about the North Carolina court’s findings was thus almost true. A cynic might say he too had not told the whole truth, but he did march Dr. Weed through Judge Bridges’ order of June 2015, which was displayed to the jury.

Douglas Weed handled the cross-examination about as well as possible. He explained on cross, and later on redirect, that he did not regard segments of his report, which were later incorporated into his report as served, to be notes. He pointed out that there was no information in the segments, which differed from the final report, or which was not included in the report. Smith’s cross-examination, however, had raised questions not so much about credibility (despite Judge Bridges’ findings), but about whether Dr. Weed was a “quibbler,” who would hide behind idiosyncratic understandings of important words such as “consistency.” Given how harmless the belatedly produced report fragments and segments were, we are left to wonder why Dr. Weed persisted in not volunteering them.

Smith’s confrontation of Dr. Weed with the order from the Carter case came at the conclusion of a generally unsuccessful cross-examination. Unlike the Slemp case, in which Smith appeared to be able to ask unfounded questions without restraint from the bench, in Echeverria, Smith drew repeated objections, which were frequently sustained. His response often was to ask almost the same question again, drawing the same objection and the same ruling. He sounded stymied and defeated.

Courtroom Video Network, of course, does not film the jurors, and so watching the streaming video of the trial offers no insights into how the jurors reacted in real time to Smith’s cross-examination. If Weed’s testimony was ignored or discredited by Smith’s cross-examination on the Carter order, then the Escheverria case cannot be considered a useful test of the plaintiffs’ causal claim. Dr. Weed had offered important testimony on methodological issues for conducting and interpreting studies, as well as inferring causation.

One of the peculiarities of the Slemp case was that the defense offered no epidemiologist in the face of two epidemiologists offered by the plaintiff. In Escheverria, the defense addressed this gap and went further to have its epidemiologist address the glaring problem of how any specific causal inference can be drawn from a risk ratio of 1.3. Dr. Weed explained attributable risk and probability of causation, and this testimony and many other important points went without cross-examination or contradiction. And yet, after finding general causation on a weak record, the jury somehow leaped over an insurmountable epistemic barrier on specific causation.

1 Amanda Bronstad, “New Evidence Seen as Key in LA Jury’s $417M Talc Verdict,” Law.com (Aug. 22, 2017).

3 The cross-examination at issue arose about one hour, nine minutes into Smith’s cross-examination, on Aug. 15, 2017.

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Statistical Gobbledygook Goes to the Supreme Court

October 20th, 2017

Back in July, my summer slumber was rudely interrupted by an intemperate, ad hominem rant from statistican Sander Greenland. Greenland’s rant concerned my views of the the Supreme Court’s decision in Matrixx Initiatives v. Siracusano, 563 U.S. 27 (2011).

Greenland held forth, unfiltered, on Deborah Mayo’s web blog, where he wrote:

“Glad to have finally flushed out Schachtman, whose blog did not allow my critical dissenting comments back when this case first hit. Nice to see him insult the intellect of the Court too, using standard legal obfuscation of the fact that the Court is entitled to consider science, ordinary logic, and common sense outside of that legal framework to form and justify its ruling – that reasoning is what composes the bulk of the opinion I linked. Go read it and see what you think without the smokescreen offered by Schachtman.”

“A megateam of reproducibility-minded scientists look to lowering the p-value,” Error Statistics (July 25, 2017).

Oh my! It is true that my blog does not have comments enabled, but as I have written on several occasions, I would gladly welcome requests to post opposing views, even those of Sander Greenland. On Deborah Mayo’s blog, I had the opportunity to explain carefully why Greenland has been giving a naïve, mistaken characterization of the holding of Matrixx Initiatives, in his expert witness reports for plaintiffs’ counsel, as well as in his professional publications. Ultimately, Greenland ran out of epithets, lost his enthusiasm for the discussion, and slunk away into cyber-silence.

I was a bit jarred, however, by Greenland’s accusation that I had insulted the Court. Certainly, I did not use any of the pejorative adjectives that Greenland had hurled at me; rather, I simply have given legal analysis of the Court’s opinions and a description of the legal, scientific, and statistical errors therein.1 And, to be sure, other knowledgeable writers and evidence scholars, have critiqued the Court’s decision and some of the pronouncements of the parties and the amici in Matrixx Initiatives2.

This week, John Pfaff, a professor at Fordham Law School, published an editorial in the New York Times, to argue that “The Supreme Court Justices Need Fact-Checkers,” N.Y. Times (Oct. 18, 2017). No doubt, Greenland would consider Pfaff’s editorial to be “insulting” to the Court, unless of course, Greenland thinks criticism can be insulting only if it challenges views he wants to see articulated by the Court.

In support of his criticism of the Court, Pfaff adverted to the Chief Justice’s recent comments in the oral argument of a gerrymandering case, Gill v. Whitford. In a question critical of the gerrymander challenge, Chief Justice Roberts described the supporting evidence:

“it may be simply my educational background, but I can only describe as sociological gobbledygook.”

Oral Argument before the U.S. Supreme Court at p.40, in Gill v. Whitford, No. 16-1161 (Oct. 3, 2017). The Chief Justice’s dismissive comments about gobble may well have been provoked by an amicus brief filed on behalf of 44 election law, scientific evidencce, and empirical legal scholars, who explored the legal and statistical basis for striking down the Wisconsin gerrymander. See Brief of Amici Curiae, of 44 Election Law, Scientific Evidence, and Empirical Legal Scholars, filed in Gill v. Whitford, No. 16-1161 (Sept. 1, 2017).

As with Greenland’s obsequious respect for the Matrixx Initiatives opinion, no one is likely to have been misled by Chief Justice Roberts’ false modesty. John Roberts was graduated summa cum laude from Harvard College in three years, although with a major in a “soft” discipline, history. He went on to Harvard Law School, where he was the managing editor of the Harvard Law Review, and was graduated magna cum laude. As a lawyer, Roberts has had an extraordinarily successful career. And yet, the Chief Justice went out of his way to disparage the mathematical and statistical models used to show gerrymandering in the Gill case, as “gobbledygook.” Odds are that the Chief Justice was thus not deprecating his own education; yet, inquiring minds might wonder whether that education was deficient in mathematics, statistics, and science.

Policy is a major part of the court’s docket now, whether the Justices likes it or not. The Justices cannot avoid adapting to the technical requirements of scientific and statistical issues, and they cannot simply dismiss evidence they do not understand as “gobbledygook.” Referencing a recent ProPublica report, Professor Pfaff suggests that the Supreme Court might well employ independent advisors to fact check their use of descriptive statistics3. 

The problem identified by Pfaff, however, seems to implicate a fundamental divide between the “two cultures” of science and the humanities. See C.P. Snow, The Rede Lecture 1959. Perhaps Professor Pfaff might start with his own educational institution. The Fordham University School of Law does not offer a course in statistics and probability; nor does it require entering students to have satisfied a requirement of course work in mathematics, science, or statistics. The closest offering at Fordham is a course on accounting for lawyer, and the opportunity to take a one-credit course in “quantitative methods” at the graduate school.

Fordham School of Law, of course, is hardly alone. Despite cries for “relevancy” and experiential learning in legal education, some law schools eschew courses in statistics and probability for legal applications, sometimes on the explicit acknowledgement that such courses are too “hard,” or provoke too much student anxiety. The result, as C.P. Snow saw over a half century ago, is that lawyers and judges cannot tell gobbledygook from important data analysis, even when it smacks them in the face.

1 With David Venderbush of Alston & Bird LLP, I published my initial views of the Matrixx case, in the the form of a Washington Legal Foundation Legal Backgrounder, available at the Foundation’s website. See Schachtman & Venderbush, “Matrixx Unbounded: High Court’s Ruling Needlessly Complicates Scientific Evidence Principles,” 26 (14) Legal Backgrounder (June 17, 2011). I expanded on my critique in several blog posts. See, e.g., “Matrixx Unloaded” (Mar. 29, 2011); “The Matrixx Oversold” (Apr. 4, 2011); “The Matrixx – A Comedy of Errors” (Apr. 6, 2011); “De-Zincing the Matrixx” (Apr. 12, 2011); “Siracusano Dicta Infects Daubert Decisions” (Sept. 22, 2012).

2 See David Kaye, “The Transposition Fallacy in Matrixx Initiatives, Inc. v. Siracusano: Part I” (Aug. 19, 2011), and “The Transposition Fallacy in Matrixx Initiatives, Inc. v. Siracusano: Part II” (Aug. 26, 2011); David Kaye, “Trapped in the Matrixx: The U.S. Supreme Court and the Need for Statistical Significance,” BNA Product Safety & Liability Reporter 1007 (Sept. 12, 2011).

Posted in Scientific Evidence, statistical evidence | Comments Off on Statistical Gobbledygook Goes to the Supreme Court

Love that Hormesis to Pieces

October 12th, 2017

Hermann Joseph Muller was an American biologist who won the Nobel Prize in 1946, for Physiology or Medicine, for his work on fruit fly genetics. In his Nobel Prize speech, Muller opined that there was no threshold dose for radiation-induced mutagenesis. Muller’s speech became a locus of support for what later became known as the “linear no threshold” (LNT) theory of carcinogenesis.

Muller was an ardent eugenicist, although of the communist, not the Nazi, variety.1 After 1932, Muller’s political enthusiasms took him to the Soviet Union, where Muller blithely ignored murderous purges and famines, in order to pursue his scientific interests for the greater glory of the Proletarian Dicatorship.2 Muller became enamored of a People’s eugenics program. On May 5, 1936, Muller wrote to “Comrade Stalin,” “[a]s a scientist with confidence in the ultimate Bolshevik triumph throughout all possible spheres of human endeavor,” to offer the brutal dictator “a matter of vital importance arising out of my own science – biology, and, in particular, genetics.”3

Comrade Stalin was underwhelmed by Muller’s offer, and threw his lot in with Trofim Lysenko. A disheartened Muller managed to extricate himself from the Soviet fatherland, but not so much from its politics and ideology4. After returning to the United States, he remained active in noteworthy liberal and progressive political activities. Alas, he also seemed to remain a Communist fellow traveler, who found time to criticize only the Soviet embrace of Lysenkoism and its treatment of dissident geneticists (such as himself), with nary a mention of Ukrainian farmers, political dissidents, or the Soviet subjugation of eastern and central Europe.5

In retreating from his Soviet homeland, Muller did not abandon his eugenic vision for the United States. In 1966, Muller urged the immediate establishment of sperm banks for “outstanding men,” such as himself, to make deposits for use in artificial insemination6

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

Back in a 1976, George E. P. Box outlined his notion that all models are wrong even though some may be useful7. The LNT model, as devised by Muller and embraced by regulatory agencies around the world, has long since lost its usefulness in describing and predicting biological phenomena. LNT is scientific in the sense that it is testable and falsifiable; LNT has been tested and falsified. Muller’s model ignores relevant biological processes of tolerance, defense, and adaptation8. 

The resilience of the LNT seems to be due to the advocacy of scientists and regulators who find the simplistic LNT model to be useful in ensuring regulation of, and compensation for, low-dose exposures. The perpetual machine litigation created with asbestos comes to mind. Other “political scientists” come to mind as well. Theory and data are often in tension, but at the end of any debate, scientists are obligated to “save the phenomena.” Fortunately, there are scientists who are challenging the dominance of the LNT model, and who are pointing out where the model just does not fit the data9.

In the United States, Muller’s theories were subjected to some real-world tests. In May 1947, Muller warned of the possible evolution of evil monsters born to Japanese survivors of Hiroshima and Nagasaki, on the basis of his assessment that the atomic bombs had produced countless mutants. Later that year, however, Austin Brues, director of the Argonne National Laboraty, published his findings of children born to Hiroshima survivors, who had no more mutations than baseline expectation10.

Notwithstanding the shaky evidentiary foundations of Muller’s views, his prestige as a Nobel laureate encouraged the adoption and promotion of the LNT model by the National Academy of Sciences’ Biological Effects of Atomic Radiation (BEAR) I Genetics Panel. Edward J. Calabrese, a prominent toxicologist in the Department of Environmental Health Sciences, School of Public Health and Health Sciences, University of Massachusetts, has taken pains, on multiple occasions, to trace the genealogy of this error. His most recent, and most succinct effort, is a worthwhile read for policy makers, judges, and lawyers who want to understand the historical dimension of the LNT model11. A fuller bibliography is set out as an appendix to this post.

 

1 Herman Joseph Muller, Out of the Night – a Biologist’s View of the Future (1935).

2 Elof Alex Carlson, Genes, Radiation, and Society: The Life and Work of H.J. Muller (1981).

3 John Glad, “Hermann J. Muller’s 1936 Letter to Stalin,” 43 The Mankind Quarterly 305 (2003).

4 See, e.g., Peter J. Kuznick, Beyond the Laboratory: Scientists as Political Activists in 1930’s America 121 (1987).

5 Hermann J. Muller, “The Crushing of Genetics in the USSR,” 4 Bull. Atomic Scientists 369 (1948). Some have attempted to protect Muller’s conduct by arguing that he testified before the House Un-American Activities Committee, where he was critical of Soviet restrictions on secondary education. See Thomas D. Clark, Indiana University: Midwestern Pioneer 310 (1977). Given Muller’s privileged position to observe first hand what had happened to Ukrainian farmers and others, this coming forward on Soviet education seems feeble indeed.

6 See “Sperm Banks Urged by Nobel Laureate,” N.Y. Times (Sept. 13, 1966).

7 See George E. P. Box, “Science and Statistics,” 71 J. Am. Stat. Ass’ 791 (1976); George E. P. Box, “Robustness in the strategy of scientific model building,” in R. L. Launer & G.N. Wilkinson, Robustness in Statistics at 201–236 (1979); George E. P. Box & Norman Draper, Empirical Model-Building and Response Surfaces at 74 (1987) (“Remember that all models are wrong; the practical question is how wrong do they have to be to not be useful.”).

8 See, e.g., Adam D. Thomas, Gareth J. S. Jenkins, Bernd Kaina, Owen G. Bodger, Karl-Heinz Tomaszowski, Paul D. Lewis, Shareen H. Doak, and George E. Johnson, “Influence of DNA Repair on Nonlinear Dose-Responses for Mutation,” 132 Toxicol. Sci. 87 (2013).

9 See, e.g., Bill Sacks & Jeffry A. Siegel, “Preserving the Anti-Scientific Linear No-Threshold Myth: Authority, Agnosticism, Transparency, and the Standard of Care,” 15 Dose-Response: An Internat’l J. 1 (2017); Charles L. Sanders, Radiobiology and Radiation Hormesis: New Evidence and its Implications for Medicine and Society (2017).

10 William Widder, “Probe Effects of Atom Bomb: Study Betrays No Evidence of Mutations,” Greensburg Daily News (Greensburg, Indiana) at 22 (Mon, Nov. 24, 1947).

11 Edward J.Calabrese, “The Mistaken Birth and Adoption of the LNT: An Abridged Version,” 15 Dose-Response: An Internat’l J. (2017).

Appendix

Edward J.Calabrese & Linda A. Baldwin, “Chemical hormesis: its historical foundations as a biological hypothesis,” 19 Human & Experimental Toxicol. 2 (2000)

Edward J. Calabrese and Linda A. Baldwin, “Hormesis: U-shaped dose responses and their centrality in toxicology,” 22 Trends Pharmacol. Sci. 285 (2001)

Edward J.Calabrese, “Hormesis: a revolution in toxicology, risk assessment and medicine: Re-framing the dose–response relationship,” 5 Eur. Mol. Bio. Org. Reports S37 (2004)

Edward J. Calabrese & Robyn Blain, “The occurrence of hormetic dose responses in the toxicological literature, the hormesis database: an overview,” 202 Toxicol. & Applied Pharmacol. 289 (2005);

Edward J. Calabrese, “Pain and U-shaped dose responses: occurrence, mechanisms and clinical Implications,” 38 Crit. Rev. Toxicol. 579 (2008)

Edward J. Calabrese, “Neuroscience and hormesis: overview and general findings,” 38 Crit. Rev. Toxicol. 249 (2008)

Edward J. Calabrese, “Linear No Threshold (LNT) – The New Homeopathy,” 31 Envt’l Toxicol. & Chem. 2723 (2012)

Edward J. Calabrese, “Muller’s Nobel Prize Lecture: When Ideology Prevailed over Science,” 126 Toxicol. Sci. 1 (2012)

Edward J. Calabrese, “How the U.S. National Academy of Sciences misled the world community on cancer risk assessment: new findings challenge historical foundations of the linear dose response, 87 Arch. Toxicol. 2063 (2013)

Edward J. Calabrese, “On the origins of the linear no-threshold (LNT) dogma by means of untruths, artful dodges and blind faith,” 142 Envt’l Research 432 (2015)

Edward J. Calabrese, “An abuse of risk assessment: how regulatory agencies improperly adopted LNT for cancer risk assessment,” 89 Arch. Toxicol. 647 (2015)

Edward J. Calabrese, “LNTgate: How scientific misconduct by the U.S. NAS led to governments adopting LNT for cancer risk assessment,” 148 Envt’l Research 535 148 (2016)

Edward J. Calabrese, “The threshold vs LNT showdown: Dose rate findings exposed flaws in the LNT model part 1. The Russell-Muller debate,” 154 Envt’l Res. 435 (2017)

Edward J. Calabrese, “The threshold vs LNT showdown: Dose rate findings exposed flaws in the LNT model part 2. How a mistake led BEIR I to adopt LNT,” 154 Envt’l Res. 452 (2017)

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