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Canadian Remedy for American Taliban

August 29th, 2012

A few years ago, Quebec introduced a very interesting religious education program for public school.  The Province’s Ethics and Religious Culture (“ERC”) Program, which went into effect in 2008, requires that children learn facts about the many different religions practiced in the Canada.  The intent and the content of the ERC program was to maintain neutrality between faiths, and to help children understand the beliefs of others in the Province.

Two parents of school children sought to have their children removed from the education program on the ground that their children’s “freedom of religion” was infringed by their having to learn facts about other religions.  The challenge might seem peculiar because nothing in the ERC Program kept the children from practicing their own faith, or the faith of their parents thrust upon them; nor did the Program require them to practice any faith, or cult for that matter.

The briefs of the parents and of organized churches, however, made clear what the gravaman of the complaint was.  Being required to learn about other faiths (and cults) would undermine the parents’ claims that their faith was the “one true faith,” and would lead to the children’s rejection of their parents’ faith.  The school system, by opening children’s eyes to the existence of many different faiths, making competing claims to truth and understanding, would interfere with the parents’ “obligation” to indoctrinate the Catholic faith in their children by causing their children to question their faith.  Maybe more to the point, but unstated, the education program would not just cause children to question their faith, but rather it would allow the children to see that the existence of competing faiths undermined any claim to Truth in one.  All the faiths might take on an arbitrary and capricious appearance.

Now if the parents believed that their Catholic faith was somehow privileged and True, it would have been a relatively simple matter to teach their children the how and why of their own religious beliefs.  We would think that the children would be inoculated against the heretical views of the diverse religions practiced in Canada.  Perhaps the parents’ anxiety, and their resort to pleadings, reveals some insecurity about their faith’s ability to withstand critical scrutiny.  Better to put off the day of reckoning until the brainwashing of the children is complete.

On February 17, 2012 the Supreme Court of Canada upheld Quebec’s Ethics & Religious Culture Program, in S.L. v. Commission scolaire des Chênes, 2012 SCC 7.  The Court held that the parents, whose names are not revealed (due to shame?), and their children suffered no infringement of their freedom of religion.  Accepting that the parents were sincere in their professions of faith, the Court unanimously held that the ERC Program did not interfere with those beliefs.  Parents in Canada remain free to do their best to indoctrinate their children in parental religious beliefs, whether those beliefs be Protestant, Catholic, Muslim, Jewish, Jain, Scientology, Satanic, Astrological, or even Pastafarian.

Merely causing children to open their eyes and compare religions in a factual way is not an infringement of the Canadian Charter of Rights and Freedoms.  Learning about the diversity of faiths is not a restraint of the free exercise of religion.  The Supreme Court of Canada noted that the ERC Program maintained neutrality in presenting facts about religion and morals.

Refusing to accept that the ERC Program interfered with parental “obligations” to inculcate and indoctrinate their own faith was perhaps non-empirical.  The parents’ claim is not implausible, and it might well be true.  The Court’s holding ignored that neutrality was the LAST thing the litigious parents wanted in matters of religion.  The parents, S.L. and D.J., took their anonymous children out of public school, and placed them in Catholic schools, where they can have their children indoctrinated without scrutiny or appeal to law or reason.

Indeed, let’s hope that it is true that teaching facts about competing faiths, which cannot all be equally correct, might lead to some epistemic humility and even skepticism.  Surely that would be welcomed. We have something here to learn from our northern neighbor.  Teaching “anthropology of religion” in the United States might have great benefits to break the stranglehold of cults on our politics.  The Quebec ERC Program would be a step in moving from a faith-based to an evidence-based world.  American Taliban beware.

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Extraordinary Claims Require Extraordinary Evidence – Cold Fusion

August 18th, 2012

According to the font of knowledge, Wikipedia, the oft-quoted expression, “An extraordinary claim requires extraordinary proof,” is due to Macello Truzzi.  See Marcello Truzzi, “On the Extraordinary: An Attempt at Clarification,” 1(1) Zetetic Scholar 11 (1978).  I certainly recall hearing a similar statement from Carl Sagan, who popularized the expression on his PBS specials. But Pierre-Simon Laplace, in his Bayesian phase, stated the matter best, over two centuries ago:

“The weight of evidence for an extraordinary claim must be proportioned to its strangeness.”

Martin Fleischmann and his associate, B. Stanley Pons, might have avoided some embarrassment if they had taken Laplace’s maxim to heart.  With a very low posterior probability, they needed an extraordinary likelihood ratio to make their claimed outcome of “cold fusion” credible.

In March 1989, Fleischmann and Pons held a news conference to announce their illusory discovery of so-called “cold fusion.” The immediate reaction from many in the media was uncritical acclaim.  Fleischmann and Pons made the front page of major newspapers, and the covers of the then popular weekly news magazines (Time and Newsweek).  The media frenzy was clearly justified if the claim were true.  Their spectacular claim invited attempts at replication, but no amount of wish bias could make dream into fact. Scientists from around the world, including the American Physical Society and from the United States Department of Energy, in short order, put Fleischmann and Pons’ claim to rest.

Martin Fleischmann died earlier this month, and the New York Times published a lengthy obituary.  Douglas Martin, Martin Fleischmann, Seeker of Cold Fusion, Dies at 85, N.Y. Times A18 (Aug. 12, 2012). Not surprisingly, the Times focused on the “cold fusion” fiasco, and the discredited research claim of Fleischmann and Pons.  The obituary quoted Richard Petrasso, a Massachusetts Institute of Technology physicist who, in a 1991 interview, expressed his initial conviction that Fleischmann and Pons’ work was an “absolute fraud,” but later softened in noting that the two scientists “probably believed in what they were doing.” William J. Broad, “Cold-Fusion Claim Is Faulted on Ethics as Well as Science, ” New York Times (Mar. 17, 1991).

Petrasso was probably correct, but his interpretation, while charitable, highlights the power of wish and confirmation biases in science.  Fleischmann was a capable, well-trained scientist.  He received his doctorate from the University of London, held respectable academic appointments, and was elected a fellow of the Royal Society.  He had over 240 articles published in journals. While social constructivists anguish over corporate influence in science, a great deal of really bad science receives a pass because wish and confirmation biases are so commonplace.  The Times quoted Fleischmann as saying, in 2009, that “unless we get fusion to work in some fashion, we are doomed, aren’t we?” Perhaps his sense of doom helped make his slippery evidence easier to accept.  According to the obituary, Fleischmann and Pons planned their experimental approach while hiking in Utah.  Whiskey was involved.

Inexpensive, limitless energy attracted a great deal of attention.  Unfortunately, many science and health claims do not elicit prompt attempts at replication, and the public and the scientific communities are often willing to accept claims at face value.  They would be prudent to heed Laplace’s dictum. I can think of any number of litigation claims which evaded expert witness gatekeeping because of violations of Laplace’s guidance.

As for Fleischmann’s death, the obituary in the Times probably suffices to prove the fact.

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The Dow-Bears Debate the Decline of Daubert

August 10th, 2012

Last month, I posted a short screenplay about how judicial gatekeeping of expert witnesses has slackened recently.  See “Daubert Approaching the Age of Majority” (July 17, 2012).

Dr. David Schwartz, of Innovative Science Solutions, has adapted the screenplay to the cinematic screen, and directed a full-length feature movie, The Daubert Will Set Your Client Free, using text-to-talk technology. Dr. Schwartz is not only a first-rate scientist, but he is also an aspiring film maker and artist.

OK; full-length is only a little more than 90 seconds, but you may still enjoy our movie-making debut.  And it is coming to a YouTube screen near you, now.

Posted in Expert Witnesses, Rule 702, Scientific Evidence, statistical evidence | Comments Off on The Dow-Bears Debate the Decline of Daubert

Eighth Circuit Holds That Increased Risk Is Not Cause

August 4th, 2012

The South Dakota legislature took it upon itself to specify the “risks” to be included in the informed consent required by state law for an abortion procedure:

(1) A statement in writing providing the following information:
* * *
(e) A description of all known medical risks of the procedure and statistically significant risk factors to which the pregnant woman would be subjected, including:
(i) Depression and related psychological distress;
(ii) Increased risk of suicide ideation and suicide;
* * *

S.D.C.L. § 34-23A-10.1(1)(e)(i)(ii).  Planned Parenthood challenged the law on constitutional grounds, and the district court granted a preliminary injunction against the South Dakota statute, which a panel of the Eight Circuit affirmed, only to have that Circuit en banc reverse and remand the case for further proceedings.  Planned Parenthood Minn. v. Rounds, 530 F.3d 724 (8th Cir. 2008) (en banc).

On remand, the parties filed cross-motions for summary judgment.  The district court held that the so-called suicide advisory was unconstitutional.  On the second appeal to the Eight Circuit, a divided panel affirmed the trial court’s holding on the suicide advisory. 653 F.3d 662 (8th Cir. 2011).  The Circuit, however, again granted rehearing en banc, and reversed the summary judgment for Planned Parenthood on the advisory.  Planned Parenthood Minnesota v. Rounds, Slip op. July 24, 2012 (en banc)[Slip op.].

In support of the injunction, Planned Parenthood argued that the state’s mandatory suicide advisory violated women’s abortion rights and physicians’ free speech rights. The en banc court rejected this argument, holding that the required advisory was “truthful, non-misleading information,” which did not unduly burden abortion rights, even if it might cause women to forgo abortion.  See Planned Parenthood of Southeastern Pennsylvania v. Casey, 505 U.S. 833, 882-83 (1992).

Risk  ≠ Cause

Planned Parenthood’s success in the trial court turned on its identification of risk (or increased risk) with cause, and its expert witness evidence that causation had not been accepted in the medical literature. In other words, Planned Parenthood argued that the advisory required disclosure of a conclusive causal “link” between abortion and suicide or suicidal ideation.  See 650 F. Supp. 2d 972, 982 (D.S.D. 2009).  The en banc court, on the second appeal, sought to save the statute by rejecting Planned Parenthood’s reading.  The court parsed the statute to suggest that the term “increased risk” is more precise and limited than the umbrella term of “risk,” standing alone.  Slip op. at 6.  The statute does not define “increased risk,” which the en banc court noted had various meanings in medicine.  Id. at 7.

Reviewing the medical literature, the en banc court held that the term “increased risk” does not refer to causation but to a much more modest finding of “a relatively higher probability of an adverse outcome in one group compared to other groups—that is, to ‘relative risk’.”  Id.  The en banc majority seemed to embroil itself in some considerable semantic confusion.  One the hand, the majority, in a rhetorical rift proclaimed that:

“It would be nonsensical for those in the field to distinguish a relationship of ‘increased risk’ from one of causation if the term ‘risk’ itself was equivalent to causation.”

Id. at 9.  The majority’s nonsensical labeling is, well, … nonsensical.  There is a compelling difference in assessment of risk and causation.  Risk is an ex ante concept, applied before the effect has occurred. Assessment or attribution of causation takes place after the effect. Of course, there is a sense of risk or “increased risk,” which is epistemologically more modest, but that hardly makes the more rigorous use of risk as an ex ante cause, nonsensical.

The majority, however, is not content to leave the matter alone.  Elsewhere, the en banc court contradicts itself, and endorses a view that risk = causation.  For instance, in citing to a civil action involving a claimed causal relationship between Bendectin and a birth defect, the Eighth Circuit reduces risk to cause.  See Slip op. at 26 n. 9 (citing Brock v. Merrell Dow Pharms., Inc., 874 F.2d 307, 312 , modified on reh’g, 884 F.2d 166 (5th Cir. 1989)).  The en banc court’s “explanatory” parenthetical explains the depths of its confusion:

“explaining that if studies establish, within an acceptable confidence interval, that those who use a pharmaceutical have a relative risk of greater than 1.0—that is, an increased risk—of an adverse outcome, those studies might be considered sufficient to support a jury verdict of liability on a failure-to-warn claim.”

This reading of Brock is wrong on two counts.  First, the Fifth Circuit, in Brock, and consistently since, has required the relative risk greater than 1.0 to be statistically significant at the conventional significance probability, as well as other indicia of causality, such as the Bradford Hill factors.  So Brock and its progeny did not confuse or conflate risk with cause, or dilute the meaning of cause such that it could be satisfied by a mere showing of an increased relative risk.

Second, Brock itself made a serious error in interpreting statistical significance and confidence intervals. The Bendectin studies at issue in Brock were not statistically significant, and the confidence intervals did not include a measure of no association (relative risk = one). Brock, however, in notoriously incorrect dicta claimed that the computation of confidence intervals took into account bias and confounding as well as sampling variability.  Brock v. Merrill Dow Pharmaceuticals, Inc., 874 F.2d 307, 311-12 (5th Cir. 1989)(“Fortunately, we do not have to resolve any of the above questions [as to bias and confounding], since the studies presented to us incorporate the possibility of these factors by the use of a confidence interval.”)(emphasis in original).  See, e.g., David H. Kaye, David E. Bernstein, and Jennifer L. Mnookin, The New Wigmore – A Treatise on Evidence:  Expert Evidence § 12.6.4, at 546 (2d ed. 2011); Michael O. Finkelstein, Basic Concepts of Probability and Statistics in the Law 86-87 (2009)(criticizing the over-interpretation of confidence intervals by the Brock court); Schachtman, “Confidence in Intervals and Diffidence in the Courts” (Mar. 4, 2012).

The en banc majority’s discussion of the studies of abortion and suicidality make clear that the presence of bias and confounding in a study may prevent inference of causation, but they do not undermine the conclusion that the studies show an increased risk.  A conclusion that the body of epidemiologic studies was inconclusive, and that it failed to “to disentangle confounding factors and establish relative risks of abortion compared to its alternatives,” did not, therefore, render the suicide advisory about risk or increased risk unsupported, untruthful, or misleading.  Slip op. at 20.  Indeed, the en banc court provided an example, outside the context of abortion, to illustrate its meaning.  The en banc court’s use of the example of prolonged television viewing and “increased risk” of mortality suggests that the court took risk to mean any association, no matter how likely it was the result of bias or confounding.  See id. at 10 n. 3 (citing Anders Grøntved, et al., “Television Viewing and Risk of Type 2 Diabetes, Cardiovascular Disease, and All-Cause Mortality, 305 J. Am. Med. Ass’n 2448 (2011). The en banc majority held that the advisory would be misleading only if Planned Parenthood could show that the available epidemiologic studies conclusively ruled out causation.  Slip op. at 24-25.

The Suicide Advisory Has Little Content Because Risk Is Not Cause

The majority decision clarified that the mandatory disclosure does not require a physician to inform a patient that abortion causes suicide or suicidal thoughts.  Slip op. at 25.  The en banc court took solace in its realization that physicians’ reviewing the available studies could provide a disclosure that captures the difference between risk, relative risk, and causation.  In other words, physicians are free to tell patients that this thing called increased risk is not concerning because the studies are highly confounded, and they do not show causation.  Id. at 25-26.  Indeed, it would be hard to imagine an ethical physician telling patients anything else.

Dissent

Four of the Eight Circuit judges dissented, pointing to evidence that the South Dakota legislators intended to mandate a disclosure about causality.  Slip op. at 29.  Putting aside whether the truthfulness of the suicide advisory can be saved by reverting to a more modest interpretation of risk or of increased risk, the dissenters appear to have the better argument that the advisory is misleading.  The majority, however, by driving its wedge between causation and increased risk have allowed physicians to explain that the advisory has little or no meaning.

NOCEBO

The nocebo effect is the dark side of the placebo effect.  As pointed out recently in the Journal of the American Medical Association, nocebos can induce harmful outcomes because of the expectation of injury from the “psychosocial context or therapeutic environment” affecting patients’ perception of their health.  Luana Colloca & Damien Finniss, “Nocebo Effects, Patient-Clinician Communication, and Therapeutic Outcomes,” 307 J. Am. Med. Ass’n 567, 567 (2012).  It is fairly well accepted that clinicians can inadvertently prejudice health outcomes by how they frame outcome information to patients.  Colloca and Finniss note that the negative expectations created by nocebo communication can take place in the process of obtaining informed consent.

Unfortunately, there is no discussion of nocebo effects in the Eight Circuit’s decision. Planned Parenthood might well consider the role the nocebo effect has on the risk-benefit of an informed consent disclosure about a risk that really is not a risk, or is not a risk in the sense that it is a factor that will result in the putative cause, but rather only something that is under study and which cannot be separated from many confounding factors.  Surely, physicians in South Dakota will figure out how to give truthful, non-misleading disclosures that incorporate the mandatory suicide advisory, as well as the scientific evidence.

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