A hypothetical neurological association between dehumanization and human rights abuses

Dehumanization is anecdotally and historically associated with reduced empathy for the pain of dehumanized individuals and groups and with psychological and legal denial of their human rights and extreme violence against them. We hypothesize that ‘empathy’ for the pain and suffering of dehumanized social groups is automatically reduced because, as the research we review suggests, an individual''s neural mechanisms of pain empathy best respond to (or produce empathy for) the pain of people whom the individual automatically or implicitly associates with her or his own species. This theory has implications for the philosophical conception of ‘human’ and of ‘legal personhood’ in human rights jurisprudence. It further has implications for First Amendment free speech jurisprudence, including the doctrine of ‘corporate personhood’ and consideration of the potential harm caused by dehumanizing hate speech. We suggest that the new, social neuroscience of empathy provides evidence that both the vagaries of the legal definition or legal fiction of ‘personhood’ and hate speech that explicitly and implicitly dehumanizes may (in their respective capacities to artificially humanize or dehumanize) manipulate the neural mechanisms of pain empathy in ways that could pose more of a true threat to human rights and rights-based democracy than previously appreciated.     

New science,old convictions ? Texas Senate Bill 344: identifying further necessary reform in forensic science

In June 2013, Texas Senate Bill 344 (SB 344) was signed into law after strong Innocence Project support. SB 344 has since transformed the Texan judicial landscape. Known as the ‘Junk Science Writ’, SB 344 enables the court to grant habeas corpus relief based on scientific evidence that ‘(1) was not available to be offered by a convicted person at the convicted person''s trial; or (2) contradicts scientific evidence relied on by the state at trial’. Inmates, such as the ‘San Antonio Four’, whose convictions were based upon what is now considered ‘faulty’ medical and forensic testimony, have been released under SB 344. Yet, science, as a field dependent on innovation, is inherently prone to debunking the scientific and forensic methods the law has relied upon to convict individuals. This commentary identifies policy behind SB 344, how SB 344 may influence the perception of science in the courtroom, and how ‘junk science’ is defined and/or limited. Furthermore, this commentary concludes that to achieve justice in the legal system through habeas relief based on ‘junk science’, it is necessary to revitalize and standardize forensic science.     

Back to first principles: a new model for the regulation of drug promotion

The US Food and Drug Administration''s (‘FDA’ or the ‘Agency’) current regulatory framework for drug promotion, by significantly restricting the ability of drug manufacturers to communicate important, accurate, up-to-date scientific information about their products that is truthful and non-misleading, runs afoul of the First Amendment and actually runs counter to the Agency''s public health mission. Our article proposes a New Model that represents an initial proposal for a modern, sustainable regulatory framework that comprehensively addresses drug promotion while protecting the public health, protecting manufacturers’ First Amendment rights, establishing clear and understandable rules, and maintaining the integrity of the FDA approval process. The New Model would create three categories of manufacturer communications—(1) Scientific Exchange and Other Exempt Communications, (2) Non-Core Communications, and (3) Core Communications—that would be regulated consistent with the First Amendment and according to the strength of the government''s interest in regulating the specific communications included within each category. The New Model should address the FDA''s concerns related to off-label speech while protecting drug manufacturers’ freedom to engage in truthful and non-misleading communications about their products.     

Forward,Gillick: Are competent children autonomous medical decision makers? New developments in Australia

Another chapter has opened in the tortured history of the status of Gillick competence. Never before has Gillick been extended to permit a mature child to make autonomous medical decisions over and above the curial ‘parens patriae’ power. In 2013, two judicial decisions promulgated from different Australian courts are in conflict over this most fundamental of questions. This Article situates the law of the ‘parens patriae’ power in Australia and, drawing on overseas conceptualizations of analogous doctrine, explores the bases for and potential consequences of this conflict.     

Military genomic testing: proportionality,expected benefits,and the connection between genotypes and phenotypes

Mehlman and Li offer a framework for approaching the bioethical issues raised by the military use of genomics that is compellingly grounded in both the contemporary civilian and military ethics of medical research, arguing that military commanders must be bound by the two principles of paternalism and proportionality. I agree fully. But I argue here that this is a much higher bar than we may fully realize. Just as the principle of proportionality relies upon a thorough assessment of harms caused and military advantage gained, the use of genomic research, on Mehlman and Li''s view, will require an accurate understanding of the connection between genotypes and phenotypes – accurate enough to ameliorate the risk undertaken by our armed forces in being subject to such research. Recent conceptual work in evolutionary theory and the philosophy of biology, however, renders it doubtful that such knowledge is forthcoming. The complexity of the relationship between genotypic factors and realized traits (the so-called ‘G→P map’) makes the estimation of potential military advantage, as well as potential harm to our troops, incredibly challenging. Such fundamental conceptual challenges call into question our ability to ever satisfactorily satisfy the demands of a sufficiently rigorous ethical standard.     

The most plausible pro-coercion view: requiring informed agreement while penalizing non-participation in research

In ‘(Why) should we require consent to research?’ Alan Wertheimer probes whether it is legitimate for the government to ‘coerce’ people into participating in biomedical research, including interventional biomedical research. In debating the rules that ought to govern participation in interventional biomedical research, we should distinguish two separate moral claims. First, interventional research should proceed only when the subject has given her informed agreement. Second, it is legitimate for the state to set a requirement that people participate in interventional biomedical research, and to penalize or punish those who refuse to participate. The most plausible ‘pro-coercion’ view accepts both of these claims. Though I stop short of endorsing this view, it captures important ‘pro-coercion’ and ‘anti-coercion’ intuitions.     

The problems of liminal states,line drawing,and false dichotomies

This commentary focuses on the tenuous line between health and disease and the conflicting characterizations of genetic predisposition that sometimes place it on one side of that line, and sometimes on the other. For example, GINA uses the line between health and disease to distinguish between, respectively, the healthy (including, those with genetic predispositions), who are shielded from discrimination, and those with ‘manifested illness,’ who are not. At the same time, some have argued that the Americans with Disabilities Act protects individuals with genetic predispositions, relying on a label akin to disability, as opposed to health, to characterize this group. Similarly, courts have described genetic predisposition as a disease of sorts to justify insurance payment for medical intervention. Attempts to fit genetic predisposition neatly into the binary world of health or illness can be problematic because this dichotomy doesn''t capture the complex continuum between those states. Some individuals reside in yet another ‘liminal’ state when they develop mild symptoms or biomarkers, placing them somewhere between genetic predisposition and actual disease manifestation. As a result, they may be unprotected under existing frameworks. Liminal states are therefore problematic not only with respect to insurance reimbursement, but in other areas as well.     

Universities and Patent Demands

Research universities have made enormous contributions to the field of medicine and the treatment of human disease. Alone or in collaboration with pharmaceutical companies, academic researchers have added to the store of knowledge that has led to numerous life science breakthroughs. A new chapter may be opening for academic researchers, however, that could lead to a darker tale. ‘The mouse that trolled: the long and tortuous history of a gene mutation patent that became an expensive impediment to Alzheimer''s research, by Bubela et al., chronicles one such tale.’ The authors do an excellent job of bringing to life the twisting saga that engulfed numerous academic and non-profit Alzheimer''s researchers over many years. The authors note that the story is an outlier, but sadly, that may not be the case. There are increasing signs that academic researchers and their institutions are being caught up in the rush for gold that is accompanying the proliferation of the non-practicing entity business model. As I have noted before, academic institutions have a dual role, as keepers of the academic flame and guardians of the public monies entrusted to them through state and federal research funding. The specter of taxpayer money being used, not to advance research and for the betterment of society, but as part of schemes to extract money from productive companies may not sit well with voters, and ultimately, with legislators. In that case, researchers and institutions themselves may have much to lose.‘The Mouse that Trolled: The Long and Tortuous History of A Gene Mutation Patent That Became an Expensive Impediment to Alzheimer''s Research’ describes an important case in which a gene mutation patent, owned by a non-practicing entity, was asserted against researchers studying the causes and effects of Alzheimer''s disease. Non-practicing entities (NPEs) are parties whose core activity involves licensing or litigating patents, rather than making products. The article details nearly two decades of litigation—targeted at universities, foundations, and non-profits—and illustrates the immeasurable damage to disease research caused by the battle. Although the authors examine a single example of an NPE targeting biopharmaceutical research, observational evidence suggests that such cases will be neither rare nor uncommon across time, raising concerns about the way in which the public interest may be lost along the way. Particularly troubling is the possibility that universities themselves may increasingly partner with NPEs, in an effort to join the patent gold rush.Universities play a dual role in society, serving both as keepers of the academic flame and as guardians of society''s money. State and federal governments entrust universities with substantial amounts of research funding in the hope that academic minds can contribute to the store of knowledge that will lead to societal improvements in human health, technology, and other fields. And universities have, indeed, made profound contributions to knowledge and innovation, from which all of society has benefitted. In fact, in an effort to facilitate the translation of academic research into products for society, Congress adopted the 1980 Bayh-Dole Act.¹ Prior to Bayh-Dole, commentators had complained that the ‘return on investment’ from public research funding for universities failed to justify the dollars spent.² Bayh-Dole attempted to rectify that problem by allowing universities to control patenting and licensing of inventions created with federal money.³ The goal was to facilitate the creation of actual products from the storehouse of knowledge resulting from public funding of university research. In keeping with the idea that universities are trustees of public resources, Bayh-Dole created an environment in which universities would foster innovation through the commercial application of its patents.Bayh-Dole flowed from the basic principle that patents are granted, not solely to reward the inventor, but rather to incentivize activity that benefits society as a whole.⁴ In granting patents, we temporarily remove items from the store of what would otherwise be free to all and reserved to none in the hopes that this will redound to the benefit of society at large.⁵ Thus, patents are not the natural right of an inventor, but rather are rights created by the sovereign in the United States for limited societal purposes.⁶The federal government itself recently explored this concept in arguments before the Federal Circuit—the appeals court that hears cases related to patents—in Astornet Technologies Inc. v. BAE Systems, Inc. In Astornet, the patent holder claimed that three government contractors had violated its patent with their equipment to authenticate boarding passes at airports.⁷ The court dismissed the claims under 28 U.S.C. §1498, which stipulates that when the government uses a patented invention, any patent infringement action must be taken against the United States and not the individuals of companies with whom it contracts.⁸The government''s amicus curiae noted that the US does not ‘infringe’ when it uses a patented invention without authorization, and commentators have pointed out that according to this characterization, one must never think of the US as an ‘infringer,’ but rather as a sovereign that has simply chosen to offer compensation.⁹ According to the brief, the court cannot interpret the U.S. government''s actions as patent infringement. Rather, 28 U.S.C. §1498 stipulates that the only remedy for damages caused by the government''s use of a patent is just compensation after a complaint has been raised in the U.S. Court of Federal Claims. In other words, the government can always use a patent without permission, as long as it provides compensation at a later date if and only if a court rules in favor of a complaint raised by a patent grantee. Therefore, the government may force compulsory licensing and is never actually a patent infringer. This is not to say that the patent grantee has no remedy against the government. Rather, 28 U.S.C. §1498 waives sovereign immunity and establishes the process by which an inventor can claim royalties. At the end of the day, however, the government''s brief reminds us that patents are not granted for inventors to aggrandize their wealth but rather in the interest of society as represented by the sovereign.Bayh-Dole, of course, is a manifestation of this principle. Having entrusted universities with public funds for research, the sovereign then gives universities the right to patent and license the fruits of that research. The intent is not to further fill the university''s coffers with more money but to fill society''s coffers with new products. In other words, under Bayh-Dole, universities are given control over the licensing system specifically to foster the creation of new commercial products for the benefit of society. NPEs, however, muddy the waters.NPEs are individuals or businesses whose core activity involves licensing or litigating patents, rather than making products. NPEs make no products of their own but generate a return by asserting patents against companies that make products.¹⁰ Over the last few years, at least half of all the patent infringement suits filed in the United States have been filed by NPEs.¹¹ Often referred to as patent trolls, many scholars and commentators have argued that NPEs simply create a tax on production—the production of companies already making products. Although one could conceivably argue that they play some role in the innovation system,¹² whatever role they play, NPEs certainly do not make new products. They also do not appear to connect inventors with others who make new products out of their inventions.¹³Traditionally, universities have avoided engaging in widespread patent litigation. For example, a study of 15,000 patent lawsuits filed across four years in the United States found that NPEs filed a majority of those suits.¹⁴ Universities accounted for only one half of one percent of all first-named plaintiffs, making them almost invisible in the dataset.¹⁵Universities have also traditionally avoided partnering with NPEs. In fact, the Association of University Technology Managers (AUTM) released a public interest statement on ethical technology transfer principles in 2007, which universities could sign. The statement is advisory, not mandatory—setting out guidelines for best practices, rather than requirements. For those universities that signed the statement, the code specified that universities should not operate under a business model that is predicated on infringement litigation rather than commercialization to create products. AUTM, which includes some members who are already licensing technology to NPEs, has decided to reexamine the code.¹⁶ Even if AUTM upholds its original statement, however, it is possible that universities increasingly will license technology to the highest bidder, regardless of whether any new commercial products will result.Money is tempting, and the lure for universities to monetize their patents is becoming irresistible. For example, Intellectual Ventures, one of the largest patent holding companies in the United States and a notorious NPE, claims that it has handled patent licensing for 60 American universities but acknowledges that only two of which (Duke and Caltech) have led to commercial products.¹⁷ Notably, both Duke and Caltech had signed the 2007 AUTM Statement opposing transferring patents to NPEs.¹⁸ In addition, press reports have identified examples of patents funded by federal programs that have been transferred to NPEs.¹⁹ Faced with the incentive to profit from research, at least some universities appear to be shifting away from the policy of avoiding NPEs. As the practice spreads, there is a significant risk that more and more universities will be rushing into the waiting arms of NPEs. In this case, universities may end up fueling the type of litigation that hindered Alzheimer''s researchers, as chronicled in ‘The Mouse that Trolled’.Moreover, these new university commercialization methods may have particularly serious consequences for the life science industry. Many people wrongly believe that biotechnology and the pharmaceutical industry are immune to NPE litigation. However, a study of the patent holdings in the fiscal year 2011 of five universities (the University of California system, MIT, the University of Texas system, Caltech, and the University of South Florida) identified numerous patents that could be deployed with the same techniques that patent trolls have used in the technology sector. These included patents on active ingredients of existing drugs, methods of treatment, screening methods to identify new drugs, manufacturing methods, dosage forms, as well as related technologies.²⁰If universities continue to move toward interactions with NPEs, such portfolios will provide tempting morsels to feed the patent trolling appetite, and could help drive patent trolling more toward the life sciences, a result that cannot be good for life science innovation. It would be troubling if taxpayer money that flows to universities ends up fueling patent trolling, rather than encouraging the creation of new products. In that case, the implicit agreement between the public and the research it funds would be disrupted.‘The Mouse that Trolled: The Long and Tortuous History of A Gene Mutation Patent That Became an Expensive Impediment to Alzheimer''s Research’ tells the cautionary tale of the ways in which NPEs, through patent assertion, hinder progress that affects the public. It is clear, however, that there will be similar examples in the future. The authors’ tale not only casts doubt on the NPE model; it should also make us think deeply about the role that the public expects universities to play in society. The public interest requires that universities act responsibly with public funding and remain dedicated to society''s benefit. University patent monetization via NPEs both fails the spirit of Bayh-Dole and damages the public''s trust.     

Dolly and Alice

The opinion of the United States Court of Appeals for the Federal Circuit, In re Roslin Institute, rejecting patent claims to mammals cloned from somatic cells, was rendered about a month before the United States Supreme Court''s decision in Alice Corp. v. CLS Bank International. The Alice opinion explicitly sets out the standard for determining whether an invention falls within statutory patentable subject matter. Thus one is thus left to wonder what the Roslin opinion might have looked like had it been decided only a few weeks later, after the Alice decision was published, with the benefit of the Supreme Court''s further direction on patentable subject matter. In this essay I explore whether in hindsight the Alice standard might have dictated a different outcome in Roslin, suggesting how the two-part test articulated by the Supreme Court in Alice might apply to a ‘products of nature’ analysis for cloned mammals. Drawing on that analysis, I then use the Roslin case as a vehicle to highlight certain issues with the Supreme Court''s current subject matter jurisprudence as applied to biotechnology. By juxtaposing Dolly with Alice, it becomes clear that the Supreme Court has revivified a number of dormant biotechnology patent problems in the guise of subject matter analysis.     

Neuroscientific and behavioral genetic information in criminal cases in the Netherlands

In this contribution an empirical approach is used to gain more insight into the relationship between neuroscience and criminal law. The focus is on case law in the Netherlands. Neuroscientific information and techniques have found their way into the courts of the Netherlands. Furthermore, following an Italian case in which a mentally ill offender received a penalty reduction in part because of a ‘genetic vulnerability for impulsive aggression’, the expectation was expressed that such ‘genetic defenses’ would appear in the Netherlands too. To assess how neuroscientific and behavioral genetic information are used in criminal justice practice in the Netherlands, we systematically collect Dutch criminal cases in which neuroscientific or behavioral genetic information is introduced. Data and case law examples are presented and discussed. Although cases are diverse, several themes appear, such as prefrontal brain damage in relation to criminal responsibility and recidivism risk, and divergent views of the implications of neurobiological knowledge about addiction for judging criminal responsibility. Whereas in the international ‘neurolaw literature’ the emphasis is often on imaging techniques, the Dutch findings also illustrate the role of neuropsychological methods in criminal cases. Finally, there appears to be a clear need of practice oriented instruments and guidelines.     

Regulation of cognitive enhancement devices: commentary

Maslen et al. (2013) have provided us with a comprehensive overview of the current legislation regulating non-clinical cognitive enhancement devices (CEDs) in the European Union and have proposed a specific model whereby CEDs would be regulated in the same way as medical devices. An alternative model would be to require manufacturers to quantify risks only. Irrespective of the purported ‘benefits’ of a product, this would allow the consumer freedom of choice to use the product at their will and allow the periodic review of worthwhile indications and unexpected adverse events. Although this departs from the standard Cochrane-type assessment, it takes into account the facts that (i) the evaluation of clinically used cognitive enhancement techniques may not be as rigorous as one might expect, (ii) variations and case-by-case use might be widespread, and (iii) independent variables of significance and useful endpoints may not be obvious ab initio. We consider cerebrospinal fluid diversion techniques which are widely used clinically to enhance cognition in patients with normal pressure hydrocephalus despite any large-scale clinical studies demonstrating substantial benefit, and the real risks of paralysis and death from these invasive procedures. The risks of CEDs which have been available for some time need to be kept in perspective: are the risks really more than using conventional cognitive enhancement techniques such as imbibing too caffeinated drinks? Furthermore, the loss of Europe as a market for CEDs which do not comply with the proposed regulatory model implies a potential gain in the market for other parts of the world. This could impact on the ability of companies in Europe being able to compete in an evolving market demand for CEDs. Legislation to regulate CEDs should be guided by the principle of ‘do no harm’ and allow for innovation and competition.     

Trust,vulnerable populations,and genetic data sharing

Recent policies and proposed regulations, including the Notice of Proposed Rulemaking for the Common Rule and the 2014 NIH Genetic Data Sharing Policy, seek to improve research subject protections. Protections for subjects whose genetic data is shared are critical to reduce risks such as loss of confidentiality, stigma, and discrimination. In the article ‘It depends whose data are being shared: considerations for genomic data sharing policies’, Robinson et al. provide a response to our article, ‘The Growth and Gaps of Genetic Data Sharing Policies’. Robinson et al. highlight the importance of individual and group preferences. In this article, we extend the conversation on models for improving protections which will mitigate consequences for individuals and groups that are vulnerable to stigma and discrimination.     

Yesterday's war; tomorrow's technology: peer commentary on ‘Ethical,legal, social and policy issues in the use of genomic technologies by the US military’

A recent article by Maxwell J. Mehlman and Tracy Yeheng Li, in the Journal of Law and the Biosciences, sought to examine the ethical, legal, social, and policy issues associated with the use of genetic screening and germ-line therapies (‘genomic technologies’) by the US Military. In this commentary, we will elaborate several related matters: the relationship between genetic and non-genetic screening methods, the history of selection processes and force strength, and the consequences and ethics of, as Mehlman and Li suggest, engineering enhanced soldiers. We contend, first, that the strengths of genomic testing as a method of determining enrollment in the armed forces has limited appeal, given the state of current selection methods in the US armed forces. Second, that the vagaries of genetic selection, much like other forms of selection that do not bear causally or reliably on soldier performance (such as race, gender, and sexuality), pose a systematic threat to force strength by limiting the (valuable) diversity of combat units. Third, that the idea of enhancing warfighters through germ-line interventions poses serious ethical issues in terms of the control and ownership of ‘enhancements’ when members separate from service.     

Medical regulation of cognitive enhancement devices: some concerns

The authors present a cogent and detailed case for altering the Medical Devices Directive to allow regulation of cognitive enhancement devices (CEDs). Protection against significant risk of harm, especially for the vulnerable, and promotion of benefit through informed use of CEDs are all good features of the proposal. However, the pre-market approval process has limitations, which we explore. We raise the possibility of ‘risk compensation’ in response to the introduction of safety measures, which could alter its effectiveness. The proposal alludes to use of ‘formally trained practitioners,’ which provide a further tier of regulation for CEDs within the proposal. We consider some positive and negative implications of this aspect of the proposal that might warrant further consideration.     

Egg freezing and egg banking: empowerment and alienation in assisted?reproduction

With the development of rapid freezing of human oocytes, many programs have reported IVF success rates comparable to those achieved with fresh eggs and thawed frozen embryos. Egg freezing is now gaining professional and regulatory acceptance as a safe and effective technique for women who wish to avoid discarding excess embryos, who face fertility-threatening medical treatments, or who want to preserve their eggs for use when they are better situated to have a family. This article focuses on the uses of and justification for egg freezing, the path to professional acceptance, the variability in success rates, and the controversy over freezing eggs for social rather than medical reasons. It also addresses the emergence of egg banking as a separate sector in the infertility industry, the regulatory issues that it poses, and its effect on egg donation. Key here is the legal control of stored eggs by banking women and their options when they wish to dispose of those eggs. The analysis is framed around empowerment and alienation. Egg freezing is generally empowering for women, but the donation or sale of unused eggs to infertile women, egg bankers, and researchers also raises issues of alienation.     

It depends whose data are being shared: considerations for genomic data sharing policies

There is an urgent need for consistent data sharing policies that promote the advancement of science while respecting the values and interests of those providing their genetic data for research. Responding to the article of Jalayne J. Arias, Genevieve Pham-Kanter, and Eric G. Campbell, ‘The Growth and Gaps of Genetic Data Sharing Policies in the United States’, this commentary further explores the challenges of human subjects’ protection in existing data sharing policies. We will elaborate on the need for data sharing policies to accommodate variation in individual and group preferences around data sharing and privacy concerns by comparing our previously published data on patients’ and parents’ consent to data sharing and attitudes about privacy to data from focus groups with HIV-positive, underserved individuals who were asked about their willingness to participate in genetic research and share their data broadly. These studies support the observation of Arias, Pham-Kanter, and Campbell that researchers, and funding agencies will need to balance the privacy interests of groups as well as individuals in future genomic data sharing policies.     

The mouse that trolled: the long and tortuous history of a gene mutation patent that became an expensive impediment to Alzheimer's research

This case study presents the tale of the academic discovery of a rare mutation for early-onset Alzheimer''s disease that was patented by a sole inventor and licensed to a non-practicing entity (NPE), the Alzheimer''s Institute of America (AIA). Our aims are (1) to relate this story about patents, research tools, and impediments to medical progress, and (2) to inform ongoing debates about how patents affect research, disposition of university inventions, and the distribution of benefits from publicly funded research. We present an account of the hunt for Alzheimer''s genes, their patenting, assignment, and enforcement based on literature, litigation records and judicial decisions. While AIA''s litigation eventually failed, its suits against 18 defendants, including one university, one foundation, and three non-profit organizations were costly in court years, legal fees, and expert time. Reasons for the failure included non-disclosure of co-inventors, State laws on ownership and assignment of university inventions, and enablement. We discuss the policy implications of the litigation, questioning the value of patents in the research ecosystem and the role of NPEs (“patent trolls”) in biotechnological innovation. The case illustrates tactics that may be deployed against NPEs, including, avenues to invalidate patent claims, Authorization and Consent, legislative reforms specifically targeting NPEs, reforms in the America Invents Act, and judicial action and rules for judicial proceedings. In the highly competitive research environment of Alzheimer''s genetics in the 1990s, patents played a minor, subordinate role in spurring innovation. The case produces a mixed message about the patent system. It illustrates many mistakes in how patents were obtained, administered, and enforced, but, eventually, the legal system rectified these mistakes, albeit slowly, laboriously, and at great cost.