TORTINI

For your delectation and delight, desultory dicta on the law of delicts.

Power in the Courts — Part Two

January 21st, 2011

Post hoc calculations of power were once in vogue, but have now routinely been condemned by biostatisticians and epidemiologists in studies that report confidence intervals around estimates of associations, or “effect sizes.”  Power calculations require an alternative hypothesis against which to measure the rejection of the null hypothesis, and the choice of the alternative is subjective and often arbitrary.  Furthermore, the power calculation must make assumptions about the anticipated variance of the data to be obtained.  Once the data are in fact obtained, those assumptions may be shown wrong.  In other words, sometimes the investigators are “lucky,” and their data are less variable than anticipated.  The variance of the data actually obtained, rather than hypothesized, can best be appreciated from the confidence interval around the actually measured point estimate of risk.

In Part One of “Power in Courts,” I addressed the misplaced emphasis the Avandia MDL court put upon the concept of statistical power.  The court apparently accepted at face value the plaintiffs’ argument that GSK’s clinical trials were “underpowered,” which claim was very misleading.  Power calculations were no doubt done to choose sample size for GSK’s clinical trials, but those a priori estimates were based upon assumptions.  In the case of one very large trial, RECORD, many fewer events occurred than anticipated (which is generally a good thing to happen, and not unusual in the context of a clinical trial that gives patients in all arms of the trial better healthcare than available to the general population).  In one sense, those plaintiffs’ expert witnesses are correct to say that RECORD was “underpowered,” but once the study is done, the real measure of statistical precision is given by the confidence interval.

Because the Avandia MDL is not the only litigation in which courts and lawyers have mistakenly urged power concepts for studies that have already been completed, I have collected some key statements that reflect the general consensus and reasoning against what the Court did.

To be fair, the Avandia court did not fault the defense for not having analyzed and calculated post-hoc power of the clinical trials, all of which failed to find statistically significant associations between Avandia and heart attacks. The court, however, did appear to embrace the plaintiffs’ rhetoric that all the Avandia trials were underpowered, without any consideration given to the width and the upper bounds of the confidence intervals around those trials’ estimates of risk ratios for heart attack.  Remarkably, the Avandia court did not present any confidence intervals for any estimates of effect size, although it did present p-values, which it then badly misinterpreted.  Many of the Avandia trials (and the resulting meta-analyses) confidently ruled out risk ratios, for heart attacks, under 2.0.  The court’s conclusions about power are thus misleading at best.

Several consensus statements address whether considerations of power, after studies are completed and the data are analyzed, are appropriate.  The issue has also been addressed extensively in textbooks and in articles.  I have collected some of the relevant statements, below.  To the extent that the Federal Judicial Center’s Reference Manual on Scientific Evidence appears to urge post hoc power calculations, I hope that the much anticipated  Third Edition will correct the error.

CONSENSUS STATEMENTS

CONSORT

The CONSORT group (Consolidated Standards of Reporting Trials) is a world-wide group that sets quality standard for randomized trials in testing of pharmaceuticals.  CONSORT’s lead author is Douglas Altman, a well-respected biostatistician from Oxford University.  The advice of the CONSORT group is clear:

“There is little merit in calculating the statistical power once the results of the trial are known, the power is then appropriately indicated by confidence intervals.”

Douglas Altman, et al., “The Revised CONSORT Statement for Reporting Randomized Trials:  Explanation and Elaboration,” 134 Ann. Intern. Med. 663, 670 (2001).  See alsoDouglas Altman, et al., “Reporting power calculations is important,” 325 Br. Med. J. 1304 (2002).

STROBE

An effort similar to the CONSORT group has been put together by investigators interested in observational studies, the STROBE group (the Strengthening the Reporting of Observational Studies in Epidemiology).  The STROBE group was made up of leading epidemiologists and biostatisticians, who addressed persistent issues and errors in the reporting of observational studies.  Their advice was equally unequivocal on the issue of post hoc power considerations:

“Do not bother readers with post hoc justifications for study size or retrospective power calculations. From the point of view of the reader, confidence intervals indicate the statistical precision that was ultimately obtained. It should be realized that confidence intervals reflect statistical uncertainty only, and not all uncertainty that may be present in a study (see item 20).”

Vandenbroucke, et al., “Strengthening the reporting of observational studies in epidemiology (STROBE):  Explanation and elaboration,” 18 Epidemiology 805, 815 (2007) (Section 10, sample size).

American Psychological Association

In 1999, a committee of the American Psychological Association met to discuss various statistical issues in psychological research papers.  With respect to power analysis, the committee concluded:

“Once the study is analyzed, confidence intervals replace calculated power in describing the results.”

Wilkinson, Task Force on Statistical Inference, “Statistical methods in psychology journals:  guidelines and explanations,” 54 Am. Psychol. 594-604 (1999)

TEXTBOOKS

Modern Epidemiology

Kenneth Rothman and Sander Greenland are known for many contributions, not the least of which is their textbook on epidemiology.  In the second edition of Modern Epidemiology, the authors explain how and why confidence intervals replace power considerations, once the study is completed and the data are analyzed:

“Standard statistical advice states that when the data indicate a lack of significance, it is important to consider the power of the study to detect as significant a specific alternative hypothesis.  The power of a test, however, is only an indirect indicator of precision, and it requires an assumption about the magnitude of the effect.  * * *  In planning a study, it is reasonable to make conjectures about the magnitude of an effect in order to compute sample-size requirements or power.

In analyzing data, however, it is always preferable to use the information in the data about the effect to estimate it directly, rather than to speculate about it with sample-size or power calculations (Smith & Bates 1992; Goodman & Berlin 1994). * * * Confidence limits convey much more of the essential information by indicating a range of values that are reasonably compatible with the observations (albeit at a somewhat arbitrary alpha level).  They can also show that the data do not contain the information necessary for reassurance about an absence of effect.”

Kenneth Rothman & Sander Greenland, Modern Epidemiology 192 – 193 (1998)

And in 2008, with the addition of Timothy Lash as a co-author, Modern Epidemiology continued its guidance on power as only a pre-study consideration:

“Standard statistical advice states that when the data indicate a lack of significance, it is important to consider the power of the study to detect as significant a specific alternative hypothesis. The power of a test, however, is only an indirect indicator of precision, and it requires an assumption about the magnitude of the effect. In planning a study, it is reasonable to make conjectures about the magnitude of an effect to compute study-size requirements or power. In analyzing data, however, it is always preferable to use the information in the data about the effect to estimate it directly, rather than to speculate about it with study-size or power calculations (Smith and Bates, 1992; Goodman and Berlin, 1994; Hoening and Heisey, 2001). Confidence limits and (even more so) P-value functions convey much more of the essential information by indicating the range of values that are reasonably compatible with the observations (albeit at a somewhat arbitrary alpha level), assuming the statistical model is correct. They can also show that the data do not contain the information necessary for reassurance about an absence of effect.”

Kenneth Rothman, Sander Greenland, and Timothy Lash, Modern Epidemiology 160 (3d ed. 2008)

A Short Introduction to Epidemiology

Neil Pierce, an epidemiologist, citing Smith & Bates 1992, and Goodman & Berlin 1994, infra, describes the standard method:

“Once a study has been completed, there is little value in retrospectively performing power calculations since the confidence limits of the observed measure of effect provide the best indication of the range of likely value for true association.”

Neil Pierce, Introduction to Epidemiology (2d ed. 2005)

Statistics at Square One

The British Medical Journal publishes a book, Statistics at Square One, which addresses the issue of post hoc power:

“The concept of power is really only relevant when a study is being planned.  After a study has been completed, we wish to make statements not about hypotheses but about the data, and the way to do this is with estimates and confidence intervals.”

T. Swinscow, Statistics at Square One42 (9thed. London 1996) (citing to a book by Martin Gardiner and Douglas Altman, both highly accomplished biostatisticians).

How to Report Statistics in Medicine

Two authors from the Cleveland Clinic, in a guidebook published by the American College of Physicians:

“Until recently, authors were urged to provide ‘post hoc power calculations’ for non-significant differences.  That is, if the results of the study were negative, a power calculation was to be performed after the fact to determine the adequacy of the sample size.  Confidence intervals also reflect sample size, however, and are more easily interpreted, so the requirement of a post hoc power calculation for non-statistically significant results has given way to reporting the confidence interval (32).”

Thomas Lang & Michelle Secic, How to Report Statistics in Medicine 58 (2d ed. 2006)(citing to Goodman & Berlin, infra).  See also Thomas Lang & Michelle Secic, How to Report Statistics in Medicine 78 (1st ed. 1996)

Clinical Epidemiology:  The Essentials

The Fletchers, both respected clinical epidemiologists, describe standard method and practice:

Statistical Power Before and After a Study is Done

Calculation of statistical power based on the hypothesis testing approach is done by the researchers before a study is undertaken to ensure that enough patients will be entered to have a good chance of detecting a clinically meaningful effect if it is present.  However, after the study is completed this approach is no longer relevant.”  There is no need to estimate effect size, outcome event rates, and variability among patients, they are now known.

Therefore, for researchers who report the results of clinical research and readers who try to understand their meaning, the confidence interval approach is more relevant.  One’s attention should shift from statistical power for a somewhat arbitrarily chosen effect size, which may be relevant in the planning stage, to the actual effect size observed in the study and the statistical precision of that estimate of the true value.”

R. Fletcher, et al., Clinical Epidemiology: The Essentials at 200 (3d ed. 1996)

The Planning of Experiments

Sir David Cox is one of the leading statisticians in the world.  In his classic 1958 text, The Planning of Experiments, Sir David wrote:

“Power is important in choosing between alternative methods of analyzing data and in deciding on an appropriate size of experiment.  It is quite irrelevant in the actual analysis of data.”

David Cox, The Planning of Experiments 161 (1958)

ARTICLES

Cummings & Rivara (2003)

“Reporting of power calculations makes little sense once the study has been done.  We think that reviewers who request such calculations are misguided.”

* * *

“Point estimates and confidence intervals tell us more than any power calculations about the range of results that are compatible with the data.”

Cummings & Rivara, “Reporting statistical information in medical journal articles,” 157 Arch. Pediatric Adolesc. Med. 321, 322 (2003)

Senn (2002)

“Power is of no relevance in interpreting a completed study.

* * *

“The definition of a medical statistician is one who not accept that Columbus discovered America because he said he was looking for India in the trial plan.  Columbus made an error in his power calculation – – he relied on an estimate of the size of the Earth that was too small, but he made one none the less, and it turned out to have very fruitful consequences.”

Senn, “Power is indeed irrelevant in interpreting completed studies,” 325 Br. Med. J. 1304 (2002).

Hoenig & Heisey (2001)

“Once we have constructed a C.I., power calculations yield no additional insight.  It is pointless to perform power calculations for hypotheses outside of the C.I. because the data have already told us that these are unlikely values.”  p. 22a

Hoenig & Heisey, “The Abuse of Power:  The Pervasive Fallacy of Power Calculations for Data Analysis”? American Statistician (2001)

Zumbo & Hubley (1998)

In The Statistician, published by the Royal Statistical Society, these authors roundly condemn post hoc power calculations:

“We suggest that it is nonsensical to make power calculations after a study has been conducted and a statistical decision has been made.  Instead, the focus after a study has been conducted should be on effect size . . . .”

Zumbo & Hubley, “A note on misconceptions concerning prospective and retrospective power,” 47-2 The Statistician 385 (1998)

Goodman & Berlin (1994)

Professor Steven Goodman is a professor of epidemiology in Johns Hopkins University, and the Statistical Editor for the Annals Internal Medicine.  Interestingly, Professor Goodman appeared as an expert witness, opposite Sander Greenland, in hearings on Thimerosal.  His article, with Jesse Berlin, has been frequently cited in support of the irrelevance of post hoc power considerations:

“Power is the probability that, given a specified true difference between two groups, the quantitative results of a study will be deemed statistically significant.”

(p. 200a, ¶1)

“Studies with low statistical power have sample sizes that are too small, producing results that have high statistical variability (low precision).  Confidence intervals are a convenient way to express that variability.”

(p. 200a, ¶2)

“Confidence intervals should play an important role when setting sample size, and power should play no role once the data have been collected . . . .”

(p. 200 b, top)

“Power is exclusively a pretrial concept; it is the probability of a group of possible results (namely all statistically significant outcomes) under a specified alternative hypothesis.  A study produces only one result.”

(p. 201a, ¶2)

“The perspective after the experiment differs from that before that experiment simply because the result is known.  That may seem obvious, but what is less apparent is that we cannot cross back over the divide and use pre-experiment numbers to interpret the result.  That would be like trying to convince someone that buying a lottery ticket was foolish (the before-experiment perspective) after they hit a lottery jackpot (the after-experiment perspective).”

(p. 201a-b)

“For interpretation of observed results, the concept of power has no place, and confidence intervals, likelihood, or Bayesian methods should be used instead.”

(p. 205)

Goodman & Berlin, “The use of predicted confidence intervals when planning experiments and the misuse of power when interpreting results,” 121 Ann. Intern. Med. 200, 200, 201, 205 (1994).

Smith & Bates (1992)

This article was published in the journal, Epidemiology, which was founded and edited by Professor Kenneth Rothman:

“In conclusion, we recommend that post-study epidemiologic power calculations be abandoned.”

“Generally, a negative study with low power will be regarded as providing little evidence against the existence of a causal association.  Often overlooked, however, is that otherwise well-conducted studies of low power can be informative:  the upper bound of the (1 – α)% confidence intervals provides a limit on the likely magnitude of any actual effect.

The purpose of this paper is to extend this argument to show that the use of traditional power calculations is causal inference (that is, after a study has been carried out) can be misleading and inferior to the use of upper confidence limits of estimates of effect.  The replacement of post-study power calculations with confidence interval estimates is not a new idea.”

(p. 449a)

* * *

“It is clear, then, that the use of the upper confidence limit conveys considerable information for the purposes of causal inference; by contrast, the power calculation can be quite misleading.”

(p. 451b)

* * *

“In conclusion, we recommend that post-study epidemiologic power calculations be abandoned.  As we have demonstrated, they have little, if any, value.  We propose that, in their place, (1 – α)%  upper confidence limits be calculated.”

(p. 451b)

Smith & Bates, “Confidence limit analyses should replace power calculations in the interpretation of epidemiologic studies,” 3 Epidemiology 449-52 (1992)

Greenland (1988)

“the arbitrariness of power specification is of course absent once the data are collected, since the statistical power refers to the probability of obtaining a particular type of data.  It is thus not a property of particular data sets.  Statistical power of collected data, as the probability of heads on a coin toss that has already taken place, can, at best, meaningfully refer only to one’s ignorance of the result and loses all meaning when one examines the result.”

Greenland, “On Sample Size and Power Calculations for Studies Using Confidence Limits,” Am. J. Epidem. 236 (1988)

Simon (1986)

“Although power is a useful concept for initially planning the size of a medical study, it is less relevant for interpreting studies at the end.  This is because power takes no account of the actual results obtained.”

***

“[I]n general, confidence intervals are more appropriate than power figures for interpreting results.”

Richard Simon, “Confidence intervals for reporting results of clinical trials,” 105 Ann. Intern. Med. 429, 433 (1986) (internal citation omitted).

Rothman (1986)

“[Simon] rightly dismisses calculations of power as a weak substitute for confidence intervals, because power calculations address only the qualitative issue of statistical significance and do not take account of the results already in hand.”

Kenneth J. Rothman, “Significance Questing,” 105 Ann. Intern. Med. 445, 446 (1986)

Makuch & Johnson (1986)

“[the] confidence interval approach, the method we recommend for interpreting completed trials in order to judge the range of true treatment differences that is reasonable consistent with the observed data.”

Robert W. Makuch & Mary F. Johnson, “Some Issues in the Design and Interpretation of ‘Negative’ Clinical Studies,” 146 Arch. Intern. Med. 986, 986 (1986).

Detsky & Sackett (1985)

“Negative clinical trials that conclude that neither of the treatments is superior are often criticized for having enrolled too few patients.  These criticisms usually are based on formal sample size calculations that compute the number of patients required prospectively, as if the trial had not yet been carried out.  We suggest that this ‘prospective’ sample size calculation is incorrect, for once the trial is over we have ‘hard’ data from which to estimate the actual size of the treatment effect.  We can either generate confidence limits around the observed treatment effect or retrospectively compare it with the effect hypothesized before the trial.”

Detsky & Sackett, “When was a ‘negative’ clinicaltrial big enough?  How many patients you need depends on what you found,” 145 Arch. Intern. Med. 709 (1985).

Power in the Courts — Part One

January 18th, 2011

The Avandia MDL court, in its recent decision to permit plaintiffs’ expert witnesses to testify about general causation, placed substantial emphasis on the statistical concept of power.  Plaintiffs’ key claim is that the Avandia causes heart attacks, yet no clinical trial of the oral anti-diabetic medication Avandia found a statistically significant increased risk of heart attacks.  Plaintiffs’ expert witnesses argued that all the clinical trials of Avandia were “underpowered,” and thus the failure to find an increased risk was a Type II (false-negative) error that resulted from the small size of the clinical trials:

“If the sample size is too small to adequately assess whether the substance is associated with the outcome of interest, statisticians say that the study lacks the power necessary to test the hypothesis. Plaintiffs’ experts argue, among other points, that the RCTs upon which GSK relies are all underpowered to study cardiac risks.”

In re Avandia Marketing, Sales Practices, and Products Liab. Litig., MDL 1871, Mem. Op. and Order (E.D.Pa. Jan. 3, 2011)(emphasis in original).

The true effect, according to plaintiffs’ expert witnesses, could be seen only through aggregating the data, across clinical trials, in a meta-analysis.  The proper conduct, reporting, and interpretation of meta-analyses were thus crucial issues for the Avandia MDL court, which appeared to have difficulty with statistical concepts.  The court’s difficulty, however, may have had several sources beyond misleading plaintiffs’ expert witness testimony, and the defense’s decision not to call an expert in biostatistics and meta-analysis at the Rule 702 hearing.

Another source of confusion about statistical power may well have come from the very reference work designed to help judges address statistical and scientific evidence in their judicial capacities:  The Reference Manual on Scientific Evidence.

Statistical power is discussed in the both the chapters on statistics and on epidemiology in The Reference Manual on Scientific Evidence.  The chapter on epidemiology, however, provides misleading guidance on the use of power:

“When a study fails to find a statistically significant association, an important question is whether the result tends to exonerate the agent’s toxicity or is essentially inconclusive with regard to toxicity. The concept of power can be helpful in evaluating whether a study’s outcome is exonerative or inconclusive.79  The power of a study expresses the probability of finding a statistically significant association of a given magnitude (if it exists) in light of the sample sizes used in the study. The power of a study depends on several factors: the sample size; the level of alpha, or statistical significance, specified; the background incidence of disease; and the specified relative risk that the researcher would like to detect.80 Power curves can be constructed that show the likelihood of finding any given relative risk in light of these factors. Often power curves are used in the design of a study to determine what size the study populations should be.81

Michael D. Green, D. Michael Freedman, and Leon Gordis, “Reference Guide on Epidemiology,” in Federal Judicial Center, The Reference Manual on Scientific Evidence 333, 362-63 (2ed. 2000).  See also David H. Kaye and David A. Freedman, Reference Guide on Statistics,” Federal Judicial Center, Reference Manual on Scientific Evidence 83, 125-26 (2ed. 2000)

This guidance is misleading in the context of epidemiologic studies because power curves are rarely used any more to assess completed studies.  Power calculations are, of course, used to help determine sample size for a planned study.  After the data are collected, however, the appropriate method to evaluate the “resolving power” of a study is to examine the confidence interval around the study’s estimate of risk size.

The authors of the chapter on epidemiology cite to a general review paper, id. at p. 362n.79, which does indeed address the concept of statistical power, but the author, a well-known statistician, addresses the issue primarily in the context of planning a statistical analysis, and in discrimination litigation, where the test result will be expressed in a p-value, without a measure of “effect size,” and more important, without a measure of a “confidence interval” around the estimate of effect size:

“The chance of rejecting the false null hypothesis, under the assumptions of an alternative, is called the power of the test. Simply put, among many ways in which we can test a null hypothesis, we want to select a test that has a large power to correctly distinguish between two alternatives. Generally speaking, the power of a test increases with the size of the sample, and tests have greater power, and therefore perform better, the more extreme the alternative considered becomes.

Often, however, attention is focused on the first type of error and the level of significance. If the evidence, then, is not statistically significant, it may be because the null hypothesis is true or because our test did not have sufficient power to discern a difference between the null hypothesis and an alternative explanation. In employment discrimination cases, for example, separate tests for small samples of employees may not yield statistically significant results because each test may not have the ability to discern the null hypothesis of nondiscriminatory employment from illegal patterns of discrimination that are not extreme. On the other hand, a test may be so powerful, for example, when the sample size is very large, that the null hypothesis may be rejected in favor of an alternative explanation that is substantively of very little difference.  ***

Attention must be paid to both types of errors and the risks of each, the level of significance, and the power. The trier of fact can better interpret the result of a significance test if he or she knows how powerful the test is to discern alternatives. If the power is too low against alternative explanations that are illegal practices, then the test may fail to achieve statistical significance even though the illegal practices may be operating. If the power is very large against a substantively small and legally permissible difference from the null hypothesis, then the test may achieve statistical significance even though the employment practices are legal.”

Stephen E. Fienberg,  Samuel H. Krislov, and Miron L. Straf, “Understanding and Evaluating Statistical Evidence in Litigation,” 36 Jurimetrics J. 1, 22-23 (1995).

Professor Fienberg’s characterization is accurate, but his description of “post-hoc” assessment of power was not provided for the context of  edemiologic studies, which today virtually always report confidence intervals around the studies’ estimates of effect size.  These confidence intervals allow a concerned reader to evaluate what can reasonably ruled out by the data in a given study.  Post-hoc power calculations or considerations fail to provide meaningful consideration because they require a specified alternative hypothesis.  A wily plaintiff’s expert witness can always arbitrarily select a sufficiently low alternative hypothesis, say a relative risk of 1.01, such that any study would have a vanishingly small probability of correctly distinguishing the null and alternative hypotheses.

The Reference Manual is now undergoing a revision, for an anticipated third edition.  A saner appreciation of the concept of power as it is used in epidemiologic studies and clinical trials would be helpful to courts and to lawyers who litigate cases involving this kind of statistical evidence.

Learning to Embrace Flawed Evidence – The Avandia MDL’s Daubert Opinion

January 10th, 2011

If GlaxoSmithKline (GSK) did not have bad luck when it comes to its oral anti-diabetic medication Avandia, it would have no luck at all.

On January 4, 2011, the federal judge who oversees the Avandia multi-district litigation (MDL) in Philadelphia entered an order denying GSK’s motion to exclude the causation opinion testimony of plaintiffs’ expert witnesses.  In re Avandia Marketing, Sales Practices, and Products Liab. Litig., MDL 1871, Mem. Op. and Order (E.D.Pa. Jan. 3, 2011)(Rufe, J.)[cited as “Op.”].  The decision is available on the CBS Interactive Business Network news blog, BNET

Based largely upon a meta-analysis of randomized clinical trials (RCTs) by Dr Steven Nissen and Ms Kathleen Wolski, plaintiffs’ witnesses opined that Avandia (rosiglitizone) causes heart attacks and strokes.  Because meta-analysis has received so little serious judicial attention in connection with Rule 702 or 703 motions, this opinion by the Hon. Cynthia Rufe, deserves careful attention by all students of “Daubert” law.  Unfortunately, that attention is likely to be critical — Judge Rufe’s opinion fails to engage the law and facts of the case, while committing serious mistakes on both fronts.

The Law

The reader will know that things are not going well for a sound legal analysis when the trial court begins by misstating the controlling law for decision:

“Under the Third Circuit framework, the focus of the Court’s inquiry must be on the experts’ methods, not their conclusions. Therefore, the fact that Plaintiffs’ experts and defendants’ experts reach different conclusions does not factor into the Court’s assessment of the reliability of their methods.”

Op. at 2 (internal citation omitted).

and

“As noted, the experts are not required to use the best possible methods, but rather are required to use scientifically reliable methods.”

Op. at 26.

Although the United States Supreme Court attempted, in Daubert, to draw a distinction between the reliability of an expert witness’s methodology and conclusion, that Court soon realized that the distinction is flawed. If an expert witness’s proffered testimony is discordant from regulatory and scientific conclusions, a reasonable, disinterested scientists would be led to question the reliability of the testimony’s methodology and its inferences from facts and data, to its conclusion.  The Supreme Court recognized this connection in General Electric v. Joiner, and the connection between methodology and conclusions was ultimately incorporated into a statute, the revised Federal Rule of Evidence 702:

“[I]f scientific, technical or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue, a witness qualified as an expert by knowledge, skill, experience, training or education, may testify thereto in the form of an opinion or otherwise, if

  1. the testimony is based upon sufficient fact or data,
  2. the testimony is the product of reliable principles and methods; and
  3. the witness has applied the principles and methods reliably to the facts.”

The Avandia MDL court thus ignored the clear mandate of a statute, Rule 702(1), and applied an unspecified “Third Circuit” framework, which is legally invalid to the extent it departs from the statute.

The Avandia court’s ruling, however, goes beyond this clear error in applying the wrong law.  Judge Rufe notes that:

“The experts must use good grounds to reach their conclusions, but not necessarily the best grounds or unflawed methods.”

Op. at 2-3 (internal citations omitted).

Here the trial court’s double negative is confusing.  The court clearly suggests that plaintiffs’ experts must use “good grounds,” but that their methods can be flawed and still survive challenge.  We can certainly hope that the trial court did not intend to depart so far from the statute, scientific method, and common sense, but the court’s own language suggests that it abused its discretion in applying a clearly incorrect standard.

Misstatements of Fact

The apparent errors of the Avandia decision transcend mistaken legal standards, and go to key facts of the case.  Some errors perhaps show inadvertence or inattention, for instance, when the court states that the RECORD trial, an RCT conducted by GSK, set out “specifically to compare the cardiovascular safety of Avandia to that of Actos (a competitor medication in the same class).  Op. at 4.  In fact, Actos (or pioglitazone) was not involved in the RECORD trial, which involved Avandia, along with two other oral anti-diabetic medications, metformin and sulfonylurea. 

Erroneous Reliance upon p-values to the exclusion of Confidence Intervals

Other misstatements of fact, however, suggest that the trial court did not understand the scientific evidence in the case.  By way of example, the trial court erroneously over-emphasized p-values, and ignored the important interpretative value of the corresponding confidence intervals.  For example, we are told that “[t]he NISSEN meta-analysis combined 42 clinical trials, including the RECORD trial and other RCTs, and found that Avandia increased the risk of myocardial infarction by 43%, a statistically significant result (p = .031).”  Op. at 5.  Ignoring for the moment that the cited meta-analysis did not include the RECORD RCT, the Court should have have reported the p-value along with the corresponding two-sided 95% confidence interval:

“the odds ratio for myocardial infarction was 1.43 (95% confidence interval [CI], 1.03 to 1.98; P = 0.03).”

Steven E. Nissen, M.D., and Kathy Wolski, M.P.H., “Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes,” 356 New Engl. J. Med. 2457, 2457 (2007).

The Court repeats this error later in its opinion:

“In 2007, the New England Journal of Medicine published the NISSEN meta-analysis, which combined results from 42 double-blind RCTs and found that patients taking Avandia had a statistically significant 43% increase in myocardial ischemic events. NISSEN used all publicly available data from double-blind RCTs of Avandia in which cardiovascular disease events were recorded, thereby eliminating one major drawback of meta-analysis: the biased selection of studies.”

Op. at 17.  The second time, however, the Court introduced new factual errors.  The Court erred in suggesting that Nissen uses all publicly available data.  There were, in fact, studies available to Nissen and to the public, which met Nissen’s inclusion criteria, but which he failed to include in his meta-analysis.  Nissen’s meta-analysis was thus biased by its failure to have conducted a complete, thorough review of the medical literature for qualifying RCTs.  Furthermore, contrary to the Court’s statement, Nissen included non-double-blinded RCTs, as his own published paper makes clear.

Erroneous Interpretation of p-values

The court erred in its interpretation of p-values:

 “The DREAM and ADOPT studies were designed to study the impact of Avandia on prediabetics and newly diagnosed diabetics. Even in these relatively low-risk groups, there was a trend towards an adverse outcome for Avandia users (e.g., in DREAM, the p-value was .08, which means that there is a 92% likelihood that the difference between the two groups was not the result of mere chance). “

Op. at 25 (internal citation omitted).  The p-value is, of course, the probability that results as large or larger would have been observed, given the truth of the null hypothesis that there is no difference between Avandia and its comparator medications.  The p-value does not permit a probabilistic assessment of the correctness of the null hypothesis; nor does it permit a straightforward probabilistic assessment of the correctness of the alternative hypothesis of rejecting the null hypothesis.

See Federal Judical Center, Reference Manual Scientific Evidence 2d ed. 122, 357 (2000).

Hand Waiving over Statin Use

The Court appeared to have been confused by plaintiffs’ rhetoric that statin use masked a real risk of heart attacks in the Avandia RCTs. 

“It is not clear whether statin use was allowed in the DREAM study.”

Op. at 25.  The problem is that the Court fails to point to any evidence that the use of statins differed between the Avandia and comparator arms of the RCTs.  Statins have been one of the great pharmaceutical success stories of the last 15 years, and it is reasonable to believe that today most diabetic patients (who often high blood fats) would taking statins.  At the time of the DREAM study, the prevalence of use would have been lower than today, but there was no evidence mentioned that the use was different between the Avandia and other arms of the DREAM trial.

Errors in Interpreting RCTs by Intention to Treat Analyses

For unexplained reasons, the court was impressed by what it called a high dropout rate in one of the larger Avandia RCTs:

“The ADOPT study was marred by a very high dropout rate (more than 40% of the subjects did not complete the four year follow up) and the use of statins during the trial.”

Op. at 25.  Talk about being hoisted with one’s own petard!  The high dropout rate in ADOPT resulted from the fact that this RCT was a long-term test of “glycemic control.”  Avandia did better with respect to durable glycemic control than two major, accepted medications, metformin and sulfonylurea, and thus the dropouts came mostly in the comparator arms as patients not taking Avandia required more and stronger medications, or even injected insulin.  The study investigators were obligated to analyze their data in accord with “intention to treat” principles, and so patients removed from the trial due to lack of glycemic control could no longer be counted with respect to any outcome of interest.  Avandia patients thus had longer follow-up time, and more opportunity to have events due to their underlying pathologic physiology (diabetes and diabetic-related heart attacks).

Ignoring Defense Arguments

GSK may have hurt itself by electing not to call an expert witness at the Daubert hearing in this MDL.  Still, the following statement by the Court is hard to square with opening argument given at the hearing:

“GSK points out no specific flaws or limitations in the design or implementation of the NISSEN meta-analysis”

Op. at 6.  If true, then shame on GSK; but somehow this statement seems too incredible to be true.

Ignoring the Difference between myocardial ischemic events and myocardial infarction (MI)

MI occurs when heart muscle dies as a result of a blockage in a blood vessel that brings oxygenated blood.  An ischemic event is defined very broadly in GSK’s study:

“To minimize the possibility of missing events of interest, all events coded with broadly inclusive AE terms captured from investigator reports were reviewed. SAEs identified from the trials database included cardiac failure, angina pectoris, acute pulmonary edema, all cases of chest pain without a clear non-cardiac etiology and myocardial infarction/myocardial ischemia.”

Alexander Cobitz MD, PhD, et al., “A retrospective evaluation of congestive heart failure and myocardial ischemia events in 14 237 patients with type 2 diabetes mellitus enrolled in 42 short-term, double-blind, randomized clinical studies with rosiglitazone,” 17 Pharmacoepidem. & Drug Safety 769, 770 (2008).

In its pooled analysis, GSK was clearly erring on the side of safety in creating its composite end point, but the crucial point is that GSK included events that had nothing to do with MI.  The MDL court appears to have accepted uncritically the plaintiffs’ expert witnesses’ claim that the difference between myocardial ischemic events and MI is only a matter of degree.  The Court found “that the experts were able to draw reliable conclusions about myocardial infarction” from a meta-analysis about a different end point, “by virtue of their expertise and the available data.”  Op. at 10.  This is hand waiving or medical alchemy.

Uncritical Acceptance of Mechanistic Evidence Related to Increased Congestive Heart Failure (CHF) in Avandia Users

The court noted that plaintiffs’ expert witnesses relied upon a well-established relationship  between Avandia and congestive heart failure (CHF).  Op. at 14.  True, true, but immaterial.  Avandia causes fluid retention, but so do other drugs in this class of drugs as well.  Actos causes fluid retention, and carries the same warning for CHF, but there is no evidence that Actos causes MI or stroke.  Although the Court’s desire to have a mechanism of causation is understandable, that desire cannot substitute for actual evidence.

Misuse of Power Analyses

The Avandia MDL Court mistakenly referred to inadequate statistical power in the context of interpreting data of heart attacks in Avandia RCTs. 

“If the sample size is too small to adequately assess whether the substance is associated with the outcome of interest, statisticians say that the study lacks the power necessary to test the hypothesis. Plaintiffs’ experts argue, among other points, that the RCTs upon which GSK relies are all underpowered to study cardiac risks.”

Op. at 5.

The Court might have helped itself by adverting to the Reference Manual of Scientific Evidence:

“Power is the chance that a statistical test will declare an effect when there is an effect to declare. This chance depends on the size of the effect and the size of the sample.”

Federal Judical Center, Reference Manual Scientific Evidence 2d ed. 125 – 26, 357 (2000) (internal citations omitted).  In other words, you cannot assess the power of the study unless you specify the size of the association of the alternative hypothesis, and the sample size, among other things.  It is true that most of the Avandia trials were not powered to detect heart attacks, but the concept of power requires the user to specify at least the alternative hypothesis against which the study is being assessed for power. Once the studies were completed, and the data became available, there was no longer any need or use for the consideration of power; the statistical precision of the studies’ results was given by their confidence intervals.

Incorrect Use of the Concept of Replication

The MDL court erred in accepting the plaintiffs’ expert witnesses’ bolstering of Nissen’s meta-analytic results by their claim that Nissen’s results had been “replicated”:

“[T]he NISSEN results have been replicated by other researchers. For example, the SINGH meta-analysis pooled data from four long-term clinical trials, and also found a statistically significant increase in the risk of myocardial infarction for patients taking Avandia. GSK and the FDA have also replicated the results of NISSEN through their own meta-analyses.”

Op. at 6 (internal citations omitted).

“The SINGH, GSK and FDA meta-analyses replicated the key findings of the NISSEN study.43”

Op. at 17.

These statements mistakenly suggest that Nissen’s meta-analysis was able to generate a reliable conclusion that there was a statistically significant association between Avandia use and MI.  The Court’s insistence that Nissesn was replicated does not become more true for having been stated twice.  Nissen’s meta-analysis was not an observational study in the usual sense.  His publication made very clear what studies were included (and not at all clear what studies were excluded), and the meta-analytic model that he used.  Thus, it is trivially true that anyone could have replicated his analysis, and indeed, several researchers did so.  See, e.g., George A. Diamond, MD, et al., “Uncertain Effects of Rosiglitazone on the Risk for Myocardial Infarction and Cardiovascular Death,” 147 Ann. Intern. Med. 578 (2007).

But Nissen’s results were not replicated by Singh, GSK, or the FDA, because these other meta-analyses used different methods, different endpoints (in GSK’s analysis), different inclusion criteria, different data, and different interpretative methods.  Most important, GSK and FDA could not reproduce the statistically significant finding for their summary estimate of association between Avandia and heart attacks.

One definition of replication that the MDL court might have consulted makes clear that replication is a repeat of the same experiment to determine whether the same (or a consistent) result is obtained:

“REPLICATION — The execution of an experiment or survey more than once so as to confirm the findings, increase precision, and obtain a closer estimation of sampling error.  Exact replication should be distinguished from consistency of results on replication.  Exact replication is often possible in the physical sciences, but in the biological and behavioral sciences, to which epidemiology belongs, consistency of results on replication is often the best that can be attained. Consistency of results on replication is perhaps the most important criterion in judgments of causality.”

Miquel Porta, Sander Greenland, and John M. Last, eds., A Dictionary of Epidemiology, 5th ed., at 214 (2008).  The meta-analyses of Singh, GSK, and FDA did not, and could not, replicate Nissen’s.  Singh’s meta-analysis obtained a result similar to Nissen’s, but the other meta-analyses by GSK, FDA, and Manucci failed to yield a statistically significant result for MI.  This is replication only in Wonderland.

It is hard to escape the conclusion that the MDL denied GSK intellectual due process of law.

More Uncertainty About Reasonable Degree of Medical Certainty

December 27th, 2010

For reasons that are not clear, the Reporters for the American Law Institute’s most recent torts Restatement decided to tackle an expert witness issue, the meaning of “reasonable degree of medical certainty” (RDMC). The discussion is tucked away in a comment and the accompanying note, and might easily be missed by readers interested in the restated principles of tort law.  Restatement (Third) of Torts: Liability for Physical and Emotional Harm § 28, cmt. e (2010).  The phrase RDMC is usually incanted by an expert witness, or in a leading question by an examining lawyer, to qualify the witness’s opinion about a diagnosis, a causal attribution, a prognosis, or some other medical or scientific issue.  Indeed, the phrase is usually modified for non-medical expert witnesses, for whom it takes the form of “reasonable degree of scientific certainty.”  In any event, the phrase is used in tort cases, but also in criminal, contract, equity, trusts and estate, and other cases.  There is nothing unique about the usage in torts cases; nor is there any substantive relationship between the phrase RDMC and the law of torts. 

The Reporters for the Tort Restatement, however, found a “troubling inconsistency” between the standard of certitude for expert witnesses and the standard for the overall burden of proof in most torts cases, the so-called preponderance of evidence.  To resolve the apparent inconsistency, the Reporters suggest that courts adopt a different standard for expert witnesses to use, a “more likely than not” standard.  For most jurisdictions, this standard will be quite novel. The Restatement’s suggested standard has been the subject of previous critiques.  See James Beck & Mark Hermann, “A Critique of ALI’s Proposal to Bar Expert Testimony to a ‘Reasonable Degree of Professional Certainty’,” 2 West’s Medical Malpractice Law Report 1 (May 11, 2007); James Beck, “ALI Draft Would Abolish ‘Reasonable Degree of Professional Certainty’ Requirement” (April 12, 2007); John Day, “ALI Rejects ‘Reasonable Degree of Medical Certainity [sic]’” (May 18, 2007).

The inconsistency perceived by the Reporters, however, is non-existent.  The standards assess two very different measures – one assesses the level of certainty that an expert witness possesses about an opinion that is necessary to the case, and the other assesses the overall quantity of evidence that the party with the burden of proof has presented for each element of every claim that make up his case.  The two standards are not even close to measuring something that can or would conflict.  The independence of the standards can easily be seen when one realizes that expert witnesses in tort cases testify about issues that carry a burden of proof of clear and convincing evidence, as is often the case for tort cases involving fraud, conspiracy, or punitive damage claims.  The law of crimes typically requires proof beyond a reasonable doubt, but when expert witnesses testify about cause of death or of harm, the law does not conflate the burden of proof with the standard for expert witness certainty, and exclude experts who cannot opine about their conclusions beyond a reasonable doubt. 

Rather than creating a “troubling inconsistency” by interpreting RDMC as different from preponderance of evidence, courts are avoiding a conflation of different standards that would lead to a much deeper, more widespread “troubling confusion” throughout all areas of the law that involve expert witness opinion testimony.  One of the cases cited by the Reporters in their note to Comment e illustrates the error.  Bara v. Clarksville Mem. Hosp. Sys., Inc., 104 S.W.3d 1 (Tenn. App. 2002).  The Reporters’ explanatory parenthetical identifies this case as “holding instruction to the jury requiring plaintiff to prove causation to reasonable degree of medical certainty was erroneous and required reversal.”  This point is exactly the error made by the Reporters; the trial court involved had confused, just as the Reporters have, the standard for the jury with the standard of certitude for the expert witness.  Adopting a “more likely than not” standard for expert witness certitude would be a wholesale change in the law, and would not avoid any conflict.  Comment e is based upon a basic category mistake.

 The Restatement acknowledges that its proposal is at odds with the law of several states, such as Pennsylvania, where expert witnesses must opine to a “reasonable degree of professional certainty.”  McMahon v. Young, 442 Pa. 484, 485, 276 A.2d 534, 535 (1971).  Accord Menarde v. Philadelphia Transp. Co., 376 Pa. 497, 501, 103 A.2d 681 (1954); Nestor v. George, 354 Pa. 19, 46 A.2d 469, 472 (1946) (medical opinions of possible, or even probable, causes are incompetent to establish causation); Vorbnoff v. Mesta Machine Co., 286 Pa. 199, 206, 133 A. 256, 258 (1926) (a “less direct expression of opinion would fall below the required standard of proof, and therefore would not constitute legally competent evidence”); Griffin v. University of Pittsburgh Medical Center-Braddock Hosp., 950 A.2d 996, 2008 Pa. Super. 104, * (2008), alloc. denied, 601 Pa. 680; 970 A.2d 431 (2009); Corrado v. Thomas Jefferson Univ. Hosp., 790 A.2d 1022, 1027, 1031 (Pa. Super. 2001); McCann v. Amy Joy Donut Shops, 325 Pa. Super. 340, 472 A.2d 1194 (1984); Schwartz v. Feldman, 196 Pa. Super. 492, 175 A.2d 153 (1961).  See also Beezer v. Baltimore & Ohio RR, 107 F.Supp. 361, 362 (W.D.Pa. 1952), aff’d, 203 F.2d 954, 954 (3d Cir. 1953) (per curiam).  Pennsylvania courts have made clear that this level of certainty is more than a mere probability, and this requirement is especially important in Pennsylvania, where the reliability standard is either unclear or not confidently applied by its courts.

Pennsylvania is certainly not alone in interpreting “reasonable degree of medical certainty” to mean more than a bare probability.  The law of Kansas, like that of Pennsylvania, requires causation to be proven by expert testimony to a reasonable degree of medical certainty.  Johnston v. United States, 597 F.Supp. 374, 412 (D. Kan. 1984).  As the court noted in Johnston, a statistical method that attributes a greater than 50 percent probability to two events being causally related does not satisfy the reasonably certain level of proof.  Id.  Statistical risk calculations used to show causation require a “healthy degree of skepticism,” and should not be relied upon to give a deceptively easy answer to a complex issue.  Id. at 394 – 95.

The Reporters criticize the traditional RDMC standard because it fails to assure the quality of expert witnesses’ “qualifications, expertise, investigation, methodology, or reasoning.”  This is, of course, true but irrelevant.  The RDMC standard is not the only standard that applies to expert witnesses, and there is no reason to believe that it ever was used to as the sole guarantee of adequacy of every aspect of expert witness opinion testimony.  Indeed, as numerous cases have pointed out, the standards of Federal Rules of Evidence 702 and 703 are totally independent of witness qualifications.  Some very expert expert witnesses have been precluded from testifying to dubious opinions.

Comment e also suffers from a temporal incoherence.  The Restatement urges the adoption of “the same preponderance standard that is universally applied in civil cases.  Direct and cross-examination can be employed to flesh out the degree of certainty with which an expert’s opinion is held and identify opinions that are speculative and therefore inadmissible.” As noted above, the preponderance standard is not universally applied in civil cases, and certainly not in criminal cases.  More important, making a standard of admissibility turn on the outcome of direct and cross-examination is incoherent because the opinion must be first admissible before it can be the subject of these examinations.  Leaving the issue to motions to strike would unrealistically require courts and juries to “unring the bell,” which all have heard in the courtroom.

 The Restatement further criticizes RDMC because it “suggests reliance on medical or scientific standards of proof,” and “seems to impose a high threshold for the opinion to be admissible.”  Id. at Comment e.  These criticisms further reveal that the Restatement has wondered into the field of evidence and away from the subject of torts.  The concern implicit in these criticisms, however, curiously suggests that physicians and scientists should not rely upon medical or scientific standards in the courtroom.  (Scientists would rarely make the mistake lawyers make of referring to evidence as “proof.”)  The Restatement, having wondered into the field of expert evidence, and having waived off medical and scientific standards, begs the question as to what standards should be employed by expert witnesses. 

The Restatement’s suggestion that the expert witnesses should be held to give opinions that are “more likely than not” true fails to resolve the problems that the Reporters perceive in the RDMC standard.  Even in civil cases, subject to a preponderance standard for the burden of proof, the Restatement’s comment e would be unworkable. 

First, the certainty requirement applies to all expert testimony, regardless whether proffered by the party with the burden of proof on the issue.  If we were to follow the Reporters’ reasoning, we would have to abandon any standard for expert witnesses presented by the party without the burden of proof, to ensure a concordance between the two standards.  We would also have to raise the burden on expert witnesses when they offer opinions that are essential to satisfying elements of a claim that requires more evidence than a mere preponderance.

Second, expert witness opinion testimony is often based upon assumptions, which the trier of fact may find are not established or which are themselves subject to some level of uncertainty.  The expert witness’s opinion, expressed to a mere probability, will often then fail to be sufficiently weighty to support a verdict because of the uncertainty in the witness’s assumptions, premises, or personal credibility.  For example, a jury, in evaluating an expert witness’s opinion that was barely “more likely than not,” would have to find that the witness was absolutely credible, and that the bases of his opinion were impeccable if they were to vote for the party with the burden of proof.  Similarly, trial courts might well find themselves granting judgments notwithstanding the verdict if expert witnesses gave opinions that barely met the preponderance standard because any doubt about the credibility or witness’s premises would unravel the sufficiency of the case given to the jury.

Third, there are even more far-reaching problems with simply substituting “more likely than not” for RDMC as a threshold requirement of expert witness testimony.  The Restatement Comment implies that expert witnesses can discern the difference between an opinion that they believe is “more likely than not” and another which is “as likely as not.”  On some occasions, there may be opinions that derive from quantitative reasoning, for which an expert witness could truly say, with some level of certainty, that his or her opinion is “more likely than not.”  On most occasions, an expert witness’s degree of certainty is a qualitative opinion that simply does not admit of a quantitative characterization.  The Restatement’s comment perpetuates this confusion by casting the RDMC standard as a bare probability.

Fourth, the Restatement’s Comment suggests that expert witnesses are themselves expert in their own level of certainty, and that they have the training and experience to distinguish an opinion that is 50.1% likely from another that is only 50% likely.  The assignment of precise mathematical probabilities to personal, subjective beliefs is a doubtful exercise, at best.  See, e.g., Daniel Kahneman and Amos Tversky, “Judgment under Uncertainty:  Heuristics and Biases,” 185 Science 1124 (1974). 

Given all the vagaries of “more likely than not,” the Restatement’s novel standard is not likely to bring new clarity to this aspect of expert witness opinion testimony.  Ultimately, Comment e, to Section 28, is a frolic and detour in the law of torts.  Although professionals who find themselves on the witness stand may not recognize the legalistic locution of RDMC, they immediately recognize that there are some opinions that are not sufficiently strongly to act upon in a professional context.   The courts that impose a RDMC standard similarly recognize that the mere conjunction of expertise and opinion is an insufficient warrant to permit a jury to receive the opinion.  See Schachtman, “Reasonable Degree of Medical Certainty” (Dec. 3, 2010).

Back to Baselines – Litigating Increased Risks

December 21st, 2010

Fear and increased risk of cancer in asbestos cases have been considered by the United States Supreme Court, by the United States Court of Appeals, by federal District Courts, by state Supreme and appellate courts, all around the country, but rarely or never with the good sense and confidence exhibited by a lone Common Pleas judge in Philadelphia, back in 1986.  In a decision that has gotten way too little recognition, Judge Abraham Gafni explained the key importance of base rates in litigating risk.  Sutcliffe v. G.A.F. Corp., 15 Phila. 339, 1986 Phila. Cty. Rptr. LEXIS 22, 1986 WL 501554 (1986).  Judge Gafni’s short decision is still required reading for every lawyer who litigates issues of risk in personal injury or medical monitoring claims.

The Sutcliffe case was like many other Philadelphia asbestos cases.  James Sutcliffe had been an insulator, from 1954 to 1974, at the Philadelphia Naval Shipyard, where he personally worked with asbestos insulation materials.  Id. at 341.  After he retired, Mr. Sutcliffe was diagnosed with asbestosis.  Rather than suing the party responsible for his working conditions, the Navy, under the Federal Employer’s Liability Act, Sutcliffe sued the remote insulation suppliers, who had no control over safety at his workplace.  At trial, Sutcliffe’s counsel called Dr. William Atkinson, a local pulmonary physician, as an expert witness to give an opinion about the diagnosis of asbestosis, and an opinion as to Sutcliffe’s increased risk of cancer.  Dr. Atkinson characterized Sutcliffe’s increased risk of lung cancer – approximately three to five-fold increased risk — as a multiple of a baseline, but Atkinson failed to provide the magnitude of the baseline risk.  Id. at 342 – 43.  The court found that this testimony was meaningless without the measure of baseline risk for those who had not been exposed to asbestos, and thus directed a verdict in favor of the defendant on the subject of increased risk of lung cancer:

“Without a statistical reference point, a jury would not be able to measure, with any reasonable certainty, the increase in risk due to the asbestosis.  Otherwise stated, saying that a risk is, for example, three times greater upon exposure to asbestos can convey nothing in the absence of a statement as to the base rate of risk in the absence of such exposure.”

Id. at 342 – 43.  The plaintiff’s failure of proof set off a cascade of logically and legally required consequences.  Without sufficient evidence of increased risk, the jury was also precluded from awarding damages for fear of cancer:

“Whether damages should be awarded for fear of developing cancer and mesothelioma is directly related to the issue of risk. Unless there is a legally sufficient foundation for a plaintiff’s increased risk of harm, a determination of  damages for a plaintiff’s fear becomes subjective. There must be some basis upon which a plaintiff’s fear can be determined to be reasonable. In the instant matter, no such basis exists since the evidence on risk of harm was insufficient and warranted a nonsuit.”

Id. at 346.

Finally, the plaintiff’s omission of evidence of base rates limited the theories that plaintiff could urge in support of his failure-to-warn claim.  Without sufficient evidence of increased risk or fear of cancer, the plaintiff could not properly argue to the jury that G.A.F. Corporation’s warning was inadequate because it failed to mention cancer:

“At the end of plaintiffs’ case, this Court granted defendant’s motion for a nonsuit on the issues of risk and fear of cancer and mesothelioma on the ground that the evidence as to those claims was insufficient. As a result of the nonsuit, plaintiffs’ counsel was prohibited from mentioning the words ‘cancer‘ or ‘mesothelioma ‘ when arguing the inadequacy of defendant’s warning label in his closing argument.”

Id. at 341.

Judge Gafni explained why baseline risk statistics were so important that their absence would result in the dismissal of a large portion of the plaintiff’s case:

“Virtually every substance taken in excess can, of course be harmful to the human body including the most basic nutrients, vitamins and minerals otherwise necessary for human health. Yet, no one would suggest that every conceivable warning must be given as to each substance if the statistical risk is infinitesimal. Consider, for example, whether a warning would be required as to a substance which increased the risk of one exposed to it from one in one hundred million to two in one hundred million. This is a 100% increase in risk, but of minimal importance in actual risk. A jury would be entitled to determine in such circumstances whether the warning as to such a risk is required. If the jury would be merely told in such circumstances, however, that the risk had doubled, without being informed of the actual underlying risk, it could erroneously assume that the individual had, in fact, been exposed to a significant risk.”

Id. at 343-44.

Although Judge Gafni stumbled upon the distinction between statistical and clinical significance, his meaning is clear and his holding continues to be relevant to many so-called toxic tort cases:

“In sum, when attempting to establish increased risk of harm (as plaintiff has attempted to do for both cancer and mesothelioma) by statistical evidence, it is imperative that statistics be given for both the plaintiff and for the average individual (the base rate). One without the other is of no statistical or probative value since it would require sheer speculation as to the missing statistic in attempting to determine the actual increase in risk and whether such a risk is of sufficient significance that failing to warn of it rendered the product defective. Of course, it would also affect the jury’s ability to ultimately determine appropriate damages had that issue been reached. Accordingly, in the absence of appropriate statistical evidence, the Court granted a nonsuit on the issues of risk of cancer and mesothelioma; it was on that basis that plaintiff’s counsel was instructed that reference to such could not be made in his closing argument.”

Id. at 345-46.

Sutcliffe has barely been cited in Pennsylvania, although for a while, its authority helped shape the notion that a jury should be charged to consider the size of an increased cancer risk in fashioning an appropriate, proportional reward in damages.  Another judge on the Philadelphia Court of Common Pleas, Judge Sandra Mazer Moss, for instance, routinely gave an explanatory instruction in which she charged juries to consider the magnitude of the increased risk to make sure that any damages awarded for fear or increased risk of future cancer were reasonably proportional to the net risk that resulted from the alleged occupational asbestos exposure.  For instance, if the jury would award $1,000,000 in an actual cancer case, it should award $10,000, if the net excess risk were 1%.  (This analysis ignores a necessary further reduction to present value.)  Moss’s instruction on increased risk helped cabin excessive damages in increased risk cases in Pennsylvania, during the early 1990s.  Eventually, this jury instruction became unnecessary after the Pennsylvania Supreme Court effectively eliminated damages for fear and increased risk of cancer in asbestos non-malignant injury cases.  Simmons v. Pacor, Inc., 543 Pa. 664, 674 A.2d 232 (1996).

Outside of Pennsylvania, Sutcliffe has rarely been cited.  One law professor, Christopher Guzelian, who has insightfully addressed risk and causation questions, has cited the case in his important works on the law of increased risk and fear of future diseases. See, e.g., Christopher Guzelian, “The Kindynamic Theory of Tort,” 80 Indiana L.J. 987, 1010n.85 (2005); “Liability and Fear,” 65 Ohio State L.J. 713, 816n.312 (2004).  The leading casebooks, treatises, and hornbooks, however, fail to take stock of this case.  Sutcliffe continues to be relevant in asbestos and many other so-called toxic tort cases.

Several other academic authors have addressed base or background rates, but none has seen fit to discuss Sutcliffe.  See, e.g., Aaron Taggart & Wayne Blackmon, “Statistical base and background rates: the silent issue not addressed in Massachusetts v. EPA,” 7 Law, Probability and Risk 275 (2008); Jonathan J. Koehler, “When do courts think base rate statistics are relevant?” 42 Jurimetrics J. 373 (2002); Vern R. Walker, “The Concept of Baseline Risk in Tort Litigation, 80 Ky. L.J. 631 (1992)

Tragically, Chuck Kalinowski, the lawyer who argued the motion for compulsory non-suit in Sutcliffe, has died, and Judge Gafni now teaches and serves as a mediator.  They left behind a valuable legacy, which should not be forgotten as the courts turn their attention to increased risks in other contexts.

Narratives & Historians for Hire

December 15th, 2010

As other writers have noted, historians have testified in a wide variety of cases.  I do not have an exhaustive catalogue of types of cases in which historian testimony has offered, but a partial list would include:

1.  discrimination cases, such as the famous Sears case;

2.  constitutional cases, such as Brown v. Topeka Kansas Board of Education;

3.  deportation cases, such as those involving claims of Nazi activity;

4.  native American property rights cases;

5.  actions between States, and other cases in which historical location of rivers  determine property boundaries;

6.  creationism cases;

7.  tobacco cases, including product liability, states’ attorney generals’ parens patriae, and fraud claims;

8.  product cases, typically those involving long latencies – e.g., asbestos, silica, vinyl chloride

9.  medical research, ethical claims:  radiation and other informed consent cases;

10.  defamation cases against historians themselves.

11.  reparation cases;

12.  criminal cases against terrorists, involving claims of the historical nature of the alleged terrorists’ associations.

Historian testimony presents legal evidentiary issues, especially when the historian testifying acts as an advocate for a cause rather than as a witness whose testimony can be fairly evaluated by the jury.  Historian opinion testimony seems particularly apt to derail in product cases.

Over the years, I have written critiques of historian testimony, with a focus on product liability cases, where historians often serve as cheerleaders for the party that retained them.  See Nathan Schachtman, “On Deadly Dust And Histrionic Historians: Preliminary Thoughts On History And Historians As Expert Witnesses In Products Liability Cases,” 2 Mealey’s Litig. Rep. (Silica)  1, 1-2 (Nov. 2003).  At the recent Fourth Annual International Conference on the History of Occupational and Environmental Health, in San Francisco (June 19 – June 22, 2010), I presented a paper, “Courting Clio: Historians and Their Testimony in Products Liability Litigation,” an abstract of which can be found on-line.  Schachtman & Ulizio, Courting Clio – Historians and Their Testimony in Products Liability Litigation (June 2010).  I have also blogged about the subject previously.  See, e.g., How Testifying Historians Are Like Lawn-Mowing Dogs (May 15, 2010); A Walk on the Wild Side (July 16, 2010); Counter Narratives for Hire (Dec. 13, 2010).

In the current issues of Academe, Professors David Rosner and Gerald Markowitz describe their troubles as testifiers.  See “The Historians of Industry” (November – December 2010).  This most recent attack is the fourth, largely duplicative, publication in which the authors call me out for having the audacity to criticize their history of silicosis in the United States, and for suggesting that their testimony did not properly belong in a courtroom.  I must now constantly check behind doors, under beds, above shelves, for the Pink Panthers –  Rosner & Markowitz.  Who knows where the fifth and subsequent re-publications will appear.  I must say that I learning from their persistence. 

In the past few years, historians who have testified for plaintiffs’ counsel, mostly in tobacco litigation, have nastily attacked their counterparts, historians who have testified for defense counsel in the same litigation.  See, e.g., Robert N. Proctor, “Expert witnesses take the stand Historians of science can play an important role in US public health litigation,” 407 Nature 15 (Sept. 7, 2000); Alan Blum, “A Dissenting View of Robert Proctor by a Fellow Anti-Smoking Advocate” (Apr. 26, 2010) [last visited Dec. 13, 2010];  John C. Burnham, “In Defense of Historians as Expert Witnesses:  A Rebuttal to Jon Wiener” (Mar. 29, 2010) [last visited Dec. 13, 2010];  Jon Wiener, “Big Tobacco and the Historians,” The Nation (March 15, 2010); Robert N Proctor, ‘‘’Everyone knew but no one had proof’’: tobacco industry use of medical history expertise in US courts, 1990–2002,” 15 (Suppl IV) Tobacco Control 117 2006; Louis M Kyriakoudes, “Historians’ testimony on ‘common knowledge’ of the risks of tobacco use: a review and analysis of experts testifying on behalf of cigarette manufacturers in civil litigation,” 15 (Suppl IV) Tobacco Control 107 2006.

Historians who testify for plaintiffs seem to have a problem with dissents from their positions.  Rosner and Markowitz have extended the attack to those who have argued that any historian opinion testimony may be inappropriate, especially in product liability cases.  Here is their most recent discussion of my writing on the issue:

“The first shot across the bow occurred in 2003, when Nathan Schachtman, an attorney with the Philadelphia-based firm McCarter & English, published an attack on us in Mealey’s Litigation Report: Silica. He accused us of writing a ‘jeremiad’ that ‘resonates to the passions and prejudices of the last century.’ He took us to task for our ‘prejudice’ that ‘silicosis results from the valuation of profits over people’ and said that we should point out that in Communist countries silicosis rates were much higher. ‘They fairly consistently excuse or justify the actions of labor. . . . They excoriate the motives and actions of industry’.

But Schachtman’s true agenda emerged in the middle of his third paragraph. ‘We could safely leave the fate of Rosner’s and Markowitz’s historical scholarship to their community of academicians and historians if not for one discomforting fact’, he wrote. ‘The views of Rosner and Markowitz have become part of the passion play that we call silicosis litigation.’

Schachtman’s article seemed to be saying that as long as academics spoke only to one another and had no influence beyond academia, they could be tolerated. But once they begin to affect that wider world, they needed to be put back in their place. All this despite the fact that at the time Schachtman’s piece was published, more than a decade after the publication of Deadly Dust in 1991, each of us had appeared on the stand in only one case.”

“The Historians of Industry” (November – December 2010).  Rosner and Markowitz got many of their facts and their amateur psycho-analysis wrong.  They have participated in litigation much more broadly than their anemic disclosure suggests.  They have been listed in many silicosis lawsuits as plaintiffs’ expert witnesses, and they have given deposition testimony, for which they were compensated, in several silicosis cases.  Markowitz has testified in vinyl chloride cases, and the pair has testified in lead paint cases. 

As for my true agenda, I clearly spelled out a legal problem – historians, offering testimony along the lines of what Rosner and Markowitz had been giving in silicosis cases, should not be allowed to do so for several, compelling evidentiary reasons.  As historians, I believe that Rosner and Markowitz can and should be tolerated.  And they should be read by historians outside their close-knit community of labor and Marxist historians, and openly rebutted.  In any event, as historians, Rosner and Markowitz may have a role, even an important role, in helping lawyers find their way to important documentary evidence, but I have serious doubts about whether they should occupy witness chairs.

Although Rosner and Markowitz’ testimony was an easy target in terms of their excesses, errors, and exaggerations, my true agenda was to exclude historian testimony that attempted to substitute for the jury’s own assessment of the primary evidence.  Here is what I actually said:

“The work of Professors David Rosner and Gerald Markowitz raises important issues about the role historians seek to play in the litigation process. In writing about the social, labor, and political history of silicosis, Rosner and Markowitz interpret and draw inferences from an evidentiary display on the credibility, motives, and goals of industry, labor, and government.

Their ‘story’ is often tendentious, and rarely charitable to industry. They fairly consistently excuse or justify the actions of labor, even when those actions lacked contemporaneous (or subsequent) basis in scientific or medical fact. They excoriate the motives and actions of industry, even when supported by sound science, or when the plight of workers was ameliorated. They hint at, or announce, conspiracies to hurt workers. Every effort at industrial cost-savings is denounced; whereas little or no attention is paid to the huge expenditures made, often voluntarily, by industry to improve the health of workers.

Deadly Dust [Rosner and Markowitz’ book on silicosis] is a book that resonates to the passions and prejudices of the last century. The authors argue their case that silicosis results from the valuation of profits over people.  Their thesis ignores the practical, often refractory problem, of motivating or mandating workers to take appropriate measures to protect themselves. Their ascription of motives and their evaluation of causality are often devoid of any empirical support. Their jeremiad against industry’s positions on scientific and medical issues is similarly unsupported and frequently demonstrable false. Witness how silicosis, as a serious, prevalent fatal disease has passed into the dustbin of medical history in the Western World. Compare the rarity of disabling silicosis in the United States with the high silicosis mortality in Communist countries, where profits are outlawed and labor controls the means of production. These observations and comparison embarrass the scholarship and the world view of Deadly Dust, but they receive virtually no acknowledgement.

We could safely leave the fate of Rosner’s and Markowitz’s historical scholarship to their community of academicians and historians if not for one, discomforting fact. Either directly through their participation in court cases as expert witnesses, or indirectly through opinions offered or sneaked into evidence, the views of Rosner and Markowitz have become part of the passion play that we call silicosis litigation. Their  participation in the litigation process thus raises the question of exactly what is the proper role of historians in litigation.

Upon initial inquiry, historians would appear to have little or no role in the litigation process.  Trial lawyers, in courthouses throughout the common-law world, try cases ranging from automobile wrecks to antitrust conspiracies, by researching, documenting, and adducing evidence of historical fact. At trial, the proof of historical facts relevant to claims and defenses proceeds under a system of rules of evidence, which have evolved and have been refined over centuries in the crucible of judicial experience.

The intrusion of historians into the litigation process thus raises several important problems. First, historians may claims to have  ‘proven’ or  ‘supported’ particular factual assertions, which they could not prove up in a courtroom with competent, admissible evidence. Their participationundermines the legal requirement of ‘primary sources’ for the proof of facts. Various exclusionary rules, ranging from the rule against hearsay to the best-evidence rule, dramatically limit the scope and content of what historians might actually offer at trial.

Second, historians will usually be inappropriate witnesses because they do not contribute anything beyond what trial lawyers may accomplish through competent proofs and argument to the trier of fact. Indeed, much of what historians do, in advancing a particular thesis, is argue from an evidentiary display, which may often be interpreted in various, competing ways. Generally, we have more than enough argument from trial lawyers. How historians could be helpful to the trier of fact is thus far from clear.

Finally, if historians were allowed to offer opinion testimony, much of what they would have to say might fail to satisfy any reasonable criteria of reliability. Although a decade has elapsed since the United States Supreme Court decided Daubert, trial courts have yet to address reliability challenges to historians and their opinions. The absence of published cases seems to result from the rarity of historians as expert witnesses. For the most part, historians are noted in only a few cases, typically involving issues such as state boundary disputes, navigability of rivers andriparian rights, Indian Tribal status, or Nazi deportations. The common themes to these cases are the arcane proofs, serious authenticity issues, and foreign language of the documentary evidence.  None of these distinguishing features is present in historical opinion on the motives, credibility, and conduct of labor or industry on the control of silicosis in American workplaces.”

See Nathan Schachtman, “On Deadly Dust And Histrionic Historians: Preliminary Thoughts On History And Historians As Expert Witnesses In Products Liability Cases,” 2 Mealey’s Litig. Rep. (Silica) 1, 1-2 (Nov. 2003) (endnotes omitted).

Rosner and Markowitz have chosen to attack me for having an agenda, which dares to be different from their agenda – testifying for causes that have political significance to them, and being compensated for doing so.  These authors, however, have failed to respond to my substantive challenges.  Since my article appeared in 2003, several other writers have questioned the indiscriminate admission of historian testimony in cases.  See, e.g., Maxine D. Goodman, “A Hedgehog on the Witness Stand — What’s the Idea?:  The Challenges of Using Daubert to Assess Social Science and Non-scientific Testimony,” 59 Amer. L. Rev. 635 (2010); Maxine D. Goodman, “Slipping through the Gate:  Trusting Daubert and Trial Procedures to Reveal the ‘Pseudo-Historian’ Expert Witness and to Enable the Reliable Historian expert Witness — Troubling Lessons from the Holocaust-Related Trials,” 60 Baylor L. Rev. 824  (2008); William G. Childs, “The Proper Role of Historians as Expert Witnesses,” DRI Annual Meeting (2007).

More important, since I wrote Histrionic Historians in 2003, courts have begun to address the admissibility of historian testimony.  Recently in one of Markowitz’ cases, the trial judge, the well-respected Justice Francis E. Sweeney, ruled that Markowitz’ testimony was improper and had to be excluded.   Quester v. B.F. Goodrich Co., Cuyahoga Cty. Ct. Common Pleas Case No. 03-50939 (Jan. 15, 2009).  Justice Sweeney succinctly stated the problem, and the solution:

“Dr. Markowitz’s opinions as to the conspiratorial actions and motives of ‘the vinyl industry’ are excluded, as both within the ken of lay jurors, and impermissible attempts to introduce expert opinion as to the intent and motive of Defendants.

Dr. Markowitz’s area of expertise is history. Here the basis for his opinions is exclusively the voluminous documentation produced through vinyl chloride injury litigation. Dr. Markowitz neither holds, nor asserts, scientific expertise. In order to put forward admissible expert opinions based upon the documents at issue, those documents themselves must be admitted into evidence. However, Dr. Markowitz’s historic expertise, when limited purely to interpretation of the documents in evidence in this case, invades the ken of lay jurors. He is not qualified, nor offered, to testify as to the state of the art, or to the technical/scientific details in the documentation, but rather opines as to what the documents mean. In this regard, Dr. Markowitz is no more qualified than lay jurors, and as such his ‘conspiracy’ opinions invade the province of the jury.

Moreover, Dr. Markowitz’s interpretation of the documents and resultant opinions are replete with discussion of the intent and motives of ‘the industry’ or the authors of the documents. Such opinion is not appropriate for expert testimony in a court of law. Dr. Markowitz has placed evidence in the record that his book is well-regarded and legitimate historical scholarship, which the Court does not dispute. It is merely that the relevant opinions and scholarly arguments that he makes in his book are inherently ill-suited to the role of expert witness in court proceedings. His opinions related to scholarly arguments for the rationale, intent, and motive of various entities individually and collectively is more appropriately within the purview of counsel in argument rather than the expert witness on stand.”

Id. (footnotes omitted).    ‘’

And that was a judgment from which there was no appeal.

Counter Narratives for Hire

December 13th, 2010

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

“Colleagues:

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

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

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

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

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

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

We will be focusing on the following policy areas.

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

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

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

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

Sincerely,

Peter Dreier, Donald Cohen, and Nelson Lichtenstein”

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

Gerald Markowitz, and David Rosner!!

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

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

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

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

Crying wolves, indeed.

Selikoff and the Mystery of the Disappearing Amphiboles

December 10th, 2010

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Id. at 1.

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

Id. at 2.

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

Id. at 2.

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

Id. at 5.

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

Id. at 6.

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

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

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

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

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

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

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

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

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

Selikoff and the Mystery of the Disappearing Asbestosis

December 6th, 2010

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

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

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

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

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

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

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

More Hypocrisy Over Conflicts of Interest

December 4th, 2010

The Center for Science in the Public Interest, through its “Integrity in Science Project,” has declared war on corporate influence on science and science-related public policy.  Lest you think that I am overstated its animosity, check out the CSPI website, where the CSPI states that the project “combats” corporate influence by maintaining surveillance of federal advisory committees, media, and scientific publications for failures to disclose conflicts of interest.  http://www.cspinet.org/integrity/.  The project also maintains a database of public records that document scientists’ connections to industry.

Remarkably, the Center does not track connections to labor, consumer advocacy groups, plaintiffs’ litigation firms and consortia, NGOs, or ideologies that seek to influence science public policy.  This is just another example of hypocrisy in the continuing wars over supposed conflicts of interest, and a distraction from evidence-based policy.  See “Hypocrisy In Conflict Disclosure Rules,” <http://schachtmanlaw.com/hypocrisy-in-conflict-disclosure-rules/> (Nov. 30, 2010).  In an earlier discussion of conflicts, I pointed out that Sheldon Samuels, an advocate for the international labor movement, presented a paper at an American Public Health Association (APHA), for which he declared that he had “NO financial interests or other relationship with the manufactures [sic] of commercial products, suppliers of commercial services or commercial supporters.”  Id. (emphasis in the original). See  http://apha.confex.com/apha/133am/techprogram/paper_120225.htm  I do not know what the APHA’s disclosure rules were at the time Samuels submitted his abstract, and so I cannot say that he violated the APHA’s rules.  I can say that it seems peculiar to have a rule that requires disclosure of relationships with manufacturers, but not with unions or with advocacy groups.

Just last month, the APHA held its 138th Annual Meeting in Denver, Colorado.  One of the many panels dealt with issues of asbestos health effects, and I was interested to see what sort of disclosures were given by the presenters in this highly politicized area of science and medicine.  I was not disappointed.  See 4374.0, Disease Prevention and Social Justice: the Case of Asbestos.  http://apha.confex.com/apha/138am/webprogram/Session29243.html

The panel included three scientists – Richard Lemen, Arthur Frank, and Barry Castleman, all of whom have testified for plaintiffs in asbestos personal injury litigation, as well as some other litigations, for many years. 

Dr. Frank presented a “Case Study of Asbestos: History and Epidemiology.”  His abstract contains a disclosure, which is typical of all three:

“Presenting author’s disclosure statement:

Qualified on the content I am responsible for because: Longstanding national and international research regarding asbestos disease and exposure.

Any relevant financial relationships? No

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.”

http://apha.confex.com/apha/138am/webprogram/Paper229357.html

Dr. Frank thus made no mention of his expert witness activities in litigation; nor did he apparently feel that such a disclosure was necessary.  Barry Castleman similarly failed to mention that he had served as an expert witness in litigation, and that he participates in several advocacy organizations that have strong political positions concerning asbestos. 

Dr. Lemen did at least mention that he felt qualified on the content because he had served as an expert witness in asbestos litigation.  The casual reader would be left guessing what parties had asked, and paid, Dr. Lemen for his services.  Lemen’s statement of qualification is curious in that it suggests that he is qualified to present at a scientific conference because he was found qualified to testify in court.  Some people might think that this was a reversal of the usual path to expertise, especially given that in many courts, all one must show to be qualified as an expert is that one knows more than the average juror on the matter.  The bar is set very low.

None of the three presenters disclosed expert witness work and compensation as a conflict of interest.  None disclosed memberships in advocacy groups.

I was intrigued by the reference, in each of these gentlemen’s disclosures, to the American Public Health Association Conflict of Interest and Commercial Support Guidelines.  A quick search of the APHA website did not identify these guidelines, but a telephone call to the APHA quickly led to my receiving the Guidelines by email.  The APHA Guidance on conflicts of interest, revised December 2009, provides:

“Policy 2:  Policy on Conflicts of Interest (COI).

Definitions of a COI:  A COI may be actual or potential.  If a reasonable person might perceive a COI, then it is a perceived conflict.  If there is only a potential or perceived COI, then these must be treated the same as if a COI actually exists.  An actual COI exists when one has a financial, professional and/or personal relationship that may influence the educational content.  These types of relationships may overlap or exist simultaneously. 

  • A ‘financial interest’ may include, but is not limited to, a financial benefit that is expected by the individual through employment, … independent contractor, … consulting or speaking fee, … . 
  • A ‘professional interest’ may include, but is not limited to, a situation in which an entity receives a contract or grant and manages the funds, but an individual is the principal, named investigator, or is in any position to influence the results or outcomes.  This includes students. 
  • A ‘personal interest’ may include, but is not limited to, a financial relationship that is held by one’s spouse or partner.  Also any of the relationships above may also be a ‘personal interest’.

 A) A COI must be disclosed while a conflict is present and for 12 months after it is ended.”

 The APHA Guidance is not absolutely clear, but it would seem that it covers expert witness work as a “financial interest.”  Furthermore, consulting for legal counsel, or testifying at counsel’s request, would appear to be a “personal interest.”  Both interests seem to suggest a potential or perceived conflict, which under the Guidance, must be treated as an actual conflict, and thus must be disclosed.  Of course, there is a time limit on the conflict of interest, which expires in 12 months, which seems unduly short but was the APHA’s policy choice.

The disclosures made by Frank, Lemen, and Castleman seem to omit important information about their backgrounds, professional and personal interests, finances, memberships and activities in advocacy groups, and consultations and testimonial adventures in litigation.  Their disclosures do not seem to line up with the words or the spirit of the APHA rules.

Do not expect the Center for Science in the Public Interest to flag this issue in its Integrity of Science Project.

The opinions, statements, and asseverations expressed on Tortini are my own, or those of invited guests, and these writings do not necessarily represent the views of clients, friends, or family, even when supported by good and sufficient reason.