18 November 2015

Brandeis and Pragmatism

'Reinventing Brandeis: Legal Pragmatism for the Twenty-First Century' by Daniel Farber in (1995) University of Illinois Law Review 163-190 comments
If Brandeis is the answer, what was the question?
No doubt many different responses are possible. My purpose is to consider whether Brandeis.can help resolve the postmodernist crisis in constitutional law. Many scholars have now lost faith in the possibility of providing constitutional law with a firm theoretical foundation. One response would be to give up on the entire constitutional enterprise, but another is to abandon the need for a foundational theory. Legal pragmatists, looking for inspiration to pragmatist philosophers, such as William James and John Dewey, favor this nonfoundationalist approach. But, if we are to proceed without a foundation, is anything left for us but a rudderless journey of ad hoc decision making?
Critics on both the Left and the Right argue that pragmatism is bankrupt as a source of legal theory. Opponents on the Left consider it a complacent ideology based on facile acceptance of the status quo. Those on the Right scorn legal pragmatism as unprincipled and incompatible with the rule of law.  Thus, legal pragmatism stands accused of being on the one hand tradition-bound and on the other a source of unrestrained judicial activism. As a legal pragmatist, I consider these to be serious criticisms which implicate important legal values.
It is certainly possible to fight out this dispute purely on the level of theory,  but that strategy itself seems decidedly unpragmatic, for pragmatism is, in part, a call for less obsession with theory and more attention to concrete practice.  Taking a more concrete approach, I will argue that Justice Brandeis provides a strong counterexample to these criticisms. While a notable practitioner of pragmatism, he also was known for his crusades for social change, his deep adherence to moral principle, and his legal craftsmanship. His example can teach much about how legal pragmatism can be translated from jurisprudence to practice.
In part I of this essay, I will explain the genesis of legal pragmatism and explore the arguments of its critics. Part II then presents Brandeis as a counterexample to these criticisms. Critics might well respond that Brandeis did have various admirable qualities, but that those qualities were independent of - or even inconsistent with - his pragmatism. In part III, I will argue that the various themes in Brandeis's thought are coherent. In his judicial opinions, we can discern a basis for a coherent pragmatist vision of law and community. Consideration of this vision also highlights connections between Brandeis and another current school of constitutional theory known as republicanism. The Brandeisian vision combines the claims of individuality with those of community. In the course of this essay, I hope to dispel the view - common among both its critics and supporters - that legal pragmatism is essentially banal.  On the contrary, it can offer passion and principle as well as prudence.

Medical Innovation and Mammoth Onesies

'A Property Theory of Medical Innovation' by Anna Laakmann in (2016) 56(2) Jurimetrics comments
In discussions about the proper scope and strength of intellectual property (IP) protection, commentators frequently note that robust IP rights for medical technology developers are necessary to offset the costs of regulatory scrutiny by the U.S. Food and Drug Administration (FDA). This observation, while true, fails to capture important nuances in the relationship between IP and FDA regulation. Ostensibly conflicting IP and regulatory systems actually are overlapping, complementary components of a composite legal scheme governing information production and distribution. Both systems create incentives to produce intangible goods, albeit different types of goods at different points in technology development timelines. IP pulls inventions into the commercial arena, and public health regulation pushes developers to move nascent discoveries downstream along innovation pathways. Importantly, interplay between IP and regulation creates feedback loops of cumulative technological innovation.
This Article highlights the functional relationships between IP and regulatory laws to advance a holistic approach to medical innovation policy. It introduces the term “regulatory property” to describe how administrative oversight gives rise to the creation of valuable information resources. Regulatory takings and givings involve government redistributions of preexisting goods that transfer wealth among affected members of society. By contrast, regulatory property refers to the process whereby government regulation leads to the production of new information goods. As regulatory property is generated, interacting federal and state laws manage its allocation across private and public domains. The Article proposes strategies to address the unique challenges raised by innovation that is not tied to the creation of new tangible things, such as diagnostic algorithms and newly discovered uses for known products. More broadly, it suggests that understanding the dynamics between intellectual and regulatory property aids in developing coherent governance schemes for all potentially beneficial, risky medical technologies.
The delicious 'How not to clone a mammoth' by Steve Jones in (2015) 386(9989) The Lancet 125, in reviewing Beth Shapiro's How To Clone A Mammoth, comments
The first line of the US mule-training manual is said to read: “First gain the animal's attention by striking it smartly between the ears with a stout stick”. For authors, their book's title does the same job. I got some odd glances on the tube a while ago when I was reading a work provocatively labelled (in sixty-point capitals) The Wisdom of Whores which, despite the empty seats that opened up on both sides of me, is in fact an enthralling account of the epidemiology of HIV/AIDS. The most recent Diagram Prize for Oddest Book Title of the Year at the Frankfurt Book Fair was won by Strangers Have the Best Candy, which should also guarantee a seat on a crowded train. How to Clone a Mammoth, too, might be a contestant for the titular crown. 
However, this is a book that waves a stout stick but never really gets round to using it. It is full of attention-grabbing speculations about the potential scientific process of “de-extinction”, but its ultimate response to its own front cover is that “You won't be able to” and, yes, there it is, in the author's own words on page 99: “Mammoth cloning is not going to happen”. The elephant in the room is not, it seems, a mammoth. .... 
There's not much hope of inserting the mammoth genes for thick hair and cold-resistant haemoglobin into a modern elephant. Another idea, Shapiro explains, is to cut and paste your pachyderm; to compare the most mammoth-like sections of a number of elephant genomes and then to assemble a simulacrum of the extinct proboscid that is really an elephant in disguise. Rather more rational (albeit needing several lifetimes' work) is the idea of breeding from hairy elephants with dumpy legs until an individual emerges hirsute and squat enough to withstand the arctic cold. Other schemes include the possibility of finding frozen sperm in a mammoth carcase and fertilising an elephant with it, but that idea is fantastical indeed. If the spurious Mammoth ever does appear the creatures could move to Pleistocene Park in Siberia, a recent attempt to simulate what the tundra looked like in the days when it was grazed by their extinct relatives. 
The mammoth steppe was the largest single block of habitat ever seen, far larger than the tropical rainforest, and those great beasts were what ecologists call a “keystone species”: a creature whose activities determine the fate of many others. Wolves are the same: when they were introduced into the USA's Yellowstone National Park 15 years ago, they reduced elk numbers by half, so that ground cover increased, sheltering voles that were eaten by hawks, and so on and on. A Russian enthusiast has already fenced off a section of Siberian tundra and filled it with wild horses, bison, and deer. Shapiro describes how the effect has been dramatic; a great increase in rich grassland as the animals trample the soil and recycle nutriments and, less predictably, less snow cover in winter as their hooves sweep it away. That, in turn, means that the permafrost gets colder than before, and—an unexpected bonus—releases less carbon dioxide. A new behemoth might then play a part in keeping the whole planet cool. 
Another approach to populating Pleistocene Park is simpler: why not get the conservationists of the world to knit great woolly suits for the animals to keep them warm and comfortable in wintry Siberia?

17 November 2015


The report of the Review of the Australian Government Rebate on Private Health Insurance for Natural Therapies has been released.

The expectation was that
The Department would review ‘natural therapies’ to identify services that are not underpinned by a robust evidence base and for which the private health insurance rebate should be withdrawn.
The purpose of the Review was to ensure that natural therapies are underpinned by a credible evidence base that demonstrates their clinical efficacy, cost-effectiveness and safety and quality. The Rebate will be paid for insurance products that cover natural therapy services as described in the previous Government’s media release: "The Private Health Insurance Rebate will be paid for insurance products that cover natural therapy services only where the Chief Medical Officer finds there is clear evidence they are clinically effective".
Such clear evidence has not been found.
The review examined the evidence of clinical efficacy, cost effectiveness, safety and quality of natural therapies 'in scope', ie those
  • covered under private health insurance between December 2012 to January 2013 (as compiled from information provided by private health insurers); 
  • not subsidised directly under Medicare; and
  •  not provided by a health professional accredited under the Australian Health Practitioner Regulation Agency. 
They include Alexander Technique, Aromatherapy, Ayurveda, Buteyko, Herbalism/Western Herbalism, Homeopathy, Iridology, Naturopathy and Rolfing.

The Department received 46 submissions in relation to the Review. The report states
For a few modalities (Alexander technique, Buteyko, massage therapy, tai chi, yoga), there was evidence, which was graded as low to moderate quality, that these natural therapies may improve certain health outcomes for a limited number of clinical conditions. However, in most cases the quality of the overall body of evidence was not sufficient to enable definite conclusions to be drawn about the clinical effectiveness of the therapies. Very little literature exists in the area of health service delivery for most of the health-care disciplines evaluated in this report and this particularly affected consideration of herbalism, naturopathy and myotherapy. Overall, there was not reliable, high-quality evidence available to allow assessment of the clinical effectiveness of any of the natural therapies for any health conditions. Component treatment modalities in herbalism (see page 64) and naturopathy (see page 102) were not considered.
The absence of evidence does not in itself mean that the therapies evaluated do or do not work. Natural therapies emerged in an environment where there was not a premium on rigorous evidence base. Where there is limited evidence in some modalities, there is value in conducting more research.
In considering homeopathy the report states "The available evidence failed to demonstrate that homeopathy is an effective treatment for any of the clinical conditions for which it has been examined". It comments -
Homeopathy overview report
Objective The objective of this overview is to summarise the evidence from SRs regarding the effectiveness of homeopathy as a treatment for any clinical condition. In considering the effectiveness of homeopathy for this review, the HWC determined the following uses are also within scope: (i) homeopathy used to treat the side effects of another treatment/intervention; and (ii) homeopathy used in conjunction with another treatment/intervention, where the design of the study does not confound the results (that is, where the specific effect of homeopathy can be determined). For example, studies that examined ‘homeopathy plus other intervention’ versus ‘other intervention’ were included. The use of homeopathy as a preventative/prophylactic intervention was considered out of scope. In addition, the report did not include studies that exclusively examined safety or homeopathic aggravations, defined as a temporary worsening of existing symptoms following the administration of a homeopathic remedy (Grabia and Ernst, 2003); however, safety results reported in otherwise included studies were presented in the report.
NHMRC were tasked with examining the available evidence on effectiveness (and where available, the safety, quality and cost-effectiveness) of a selection of in-scope and prioritised natural therapies. Independently of the Department’s Natural Therapies Review, NHMRC had begun its own review of the evidence for the effectiveness of homeopathy. To avoid duplication, it was agreed that NHMRC would provide the Department with a copy of its homeopathy evidence review, to inform the Natural Therapies Review. At the start of the Review, the Department invited public submissions from stakeholder groups and members of the public. The purpose of this report is to review and evaluate any extra literature submitted to the Department that has not already been considered during NHMRC’s homeopathy review process.
It goes on to state
Prior to the Department’s request that NHMRC examine the effectiveness of the in-scope natural therapies, which included homeopathy, the NHMRC had independently begun a review of the scientific evidence for the effectiveness of homeopathy. The purpose of the NHMRC’s homeopathy review was to inform development of an information paper and position statement to help Australians make informed health-care choices as a part of NHMRC’s activities under its Strategic Plan. Due to the requirements of the National Health and Medical Research Council Act 1992 (the NHMRC Act), this review had a different process and purpose, and differed from the approach to the other natural therapies in the following respects:
  • A Homeopathy Working Committee (HWC) comprised of experts in evidence-based medicine and complementary and alternative medicine was set up by the NHMRC to oversee the review.
  • For the information paper to be useful to the public, it needed to provide an NHMRC position on the effectiveness of homeopathy, based on the evidence as well as the HWC’s expert judgment. As the underlying principles of homeopathy lack scientific plausibility, the review used the null hypothesis that homeopathy has no effect as a treatment for a condition, unless there was sufficient reliable evidence to demonstrate otherwise. Evidence for each clinical condition was summarised and evidence statements were formulated after consultation and agreement with the HWC. In contrast, the evidence statements for the other in-scope natural therapies in this report state that the evidence is uncertain, unless there was sufficient evidence to demonstrate otherwise. 
  • The external reviewers for the homeopathy overview appraised all SRs published between January 1997 and 3 January 2013, whereas the other natural therapies overviews included all SRs done since 2008. In addition, the homeopathy overview included any prospectively designed and controlled studies included within SRs; that is, level III evidence, whereas for the other therapies, studies assessed as level III evidence or below were excluded. 
  • In line with NHMRC’s requirements under the NHMRC Act, the draft information paper was open for public consultation from 9 April to 2 June 2014. Submissions received during public consultation, along with comments received from independent experts in evidence-based medicine and/or complementary medicine, are being considered by the HWC in finalising the information paper. 
What were the results? The report states
Results of the Review
There is a paucity of good-quality studies of sufficient size that examine the effectiveness of homeopathy as a treatment for any clinical condition. The available evidence is not compelling and fails to demonstrate that homeopathy is an effective treatment for any of the reported clinical conditions.
Plain language summary
The paucity of good-quality primary studies, the preponderance of studies with small sample size and insufficient power, and the lack of replication of results in multiple studies made the interpretation of apparent ‘significant’ differences in favour of homeopathy over placebo difficult. Many studies also failed to use (or report) appropriate comparators, blinding, or randomisation, all of which would be necessary to permit a high level of confidence in the outcomes reported. Accordingly, in rating the body of evidence, the overall shortcomings of the primary evidence limited the ability of the evidence review team to draw conclusions about the efficacy of homeopathy for many of the clinical conditions included in this overview.
Research gaps
A major challenge in assessing the evidence and interpreting the results for this overview has been the paucity of good-quality primary studies that are of sufficient size to demonstrate the effectiveness of homeopathy for specific clinical conditions. If further primary research is conducted, investigators should try to:
  • recruit substantially larger samples of patients and include statistical tests to demonstrate the significance of results 
  • utilise blinding/double blinding methodology and randomised assignment of subjects to treatment groups 
  • improve trial reporting and follow-up (for example, reporting of drop outs) 
  • improve reporting of conflicts of interest 
  • provide more detailed descriptions of interventions (including doses, dilutions), better descriptions of outcomes and how they were measured, and better discussion of potential confounders or bias 
  • justify the use of active comparators and comment on the effectiveness of those comparators compared to placebo 
  • use a methodological approach that can differentiate between the effect of homeopathic medicines and treatment by a homeopath (that is, interaction at a consultation).
In addition, systematic reviewers should:
  • justify the pooling of results in meta-analyses and provide a detailed discussion of heterogeneity between the primary studies 
  • adequately and accurately report study details including treatment regimens, length of follow-up, outcomes studied and the clinical and statistical significance of results.

Bear Wrestling

In the curiosa and animal law department, restrictions on bear wrestling (a practice fortunately not found at my university) -
Alabama Code s 13A-12-5: Unlawful Bear Exploitation
(a) A person commits the offense of unlawful bear exploitation if he or she knowingly does any one of the following:
(1) Promotes, engages in, or is employed at a bear wrestling match.
(2) Receives money for the admission of another person to a place kept for bear wrestling.
(3) Sells, purchases, possesses, or trains a bear for bear wrestling.
(4) For purposes of exploitation, subjects a bear to surgical alteration in any form, including, but not limited to, declawing, tooth removal, and severing tendons.
(b) Unlawful bear exploitation is a Class B felony and is punishable as provided by law.
(c) Upon the arrest of any person for violating this section, the arresting law enforcement officer, conservation officer, or animal control officer shall have authority to seize and take custody of any bear in the possession of the arrested person.
(d) Upon the conviction of any person for violating the provisions of this section, any court of competent jurisdiction shall have authority to order the forfeiture by the convicted person of any bear, the use of which was the basis of the conviction. Any bears ordered forfeited under this section shall be placed in the custody of a humane shelter, a society that is incorporated for the prevention of cruelty to animals, or the state Department of Conservation and Natural Resources.
(e) In addition to the fines, penalties, and forfeitures imposed under this section, the court may require the defendant to make restitution to the state, any of its political subdivisions, or a humane shelter or a society that is incorporated for the prevention of cruelty to animals for housing, feeding, or providing medical treatment to bears used for unlawful wrestling.
Section 13A-12-6 deals with 'hog and canine fighting' thus -
(a) As used in this section, the term "hog" shall mean a pig, swine, or boar.
(b) The crime of hog and canine fighting occurs when a person organizes or conducts any commercial or private event, commonly referred to as a "catch," wherein there is a display of combat or fighting between one or more domestic or feral canines and feral or domestic hogs and in which it is intended or reasonably foreseeable that the canines or hogs would be injured, maimed, mutilated, or killed.
(c) The crime of hog and canine fighting occurs when a person intentionally does any of the following for the purpose of organizing, conducting, or financially or materially supporting any event as provided in subsection (b):
(1) Finance, commercially advertise, sell admission tickets, or employ persons.
(2) Own, manage, or operate any facility or property.
(3) Supply, breed, train, or keep canines or hogs.
(4) Knowingly purchase tickets of admission.
(d) This section shall not apply to the lawful hunting of hogs with canines or the use of canines for the management, farming, or herding of hogs which are livestock or the private training of canines for the purposes enumerated in this subsection provided that such training is conducted in the field and is not in violation of this section.
(e) A violation of this section is a Class A misdemeanor upon conviction for a first offense. A second or subsequent violation is a Class C felony. After a first violation, a judge shall inform the defendant of the enhanced penalty upon a second or subsequent violation.
In Missouri s 578.176 deals with bear wrestling thus -
Any person who commits any of the following acts is guilty of a class A misdemeanor:
(1) Bear wrestling;
(2) Permitting bear wrestling to be done on any premises under his charge or control;
(3) Promoting, conducting, or staging bear wrestling;
(4) Advertising bear wrestling;
(5) Collecting any admission fee for bear wrestling;
(6) Purchasing, selling, or possessing a bear which he knows will be used for bear wrestling;
(7) Training a bear for bear wrestling;
(8) Subjecting a bear to surgical alteration for bear wrestling.