A great deal has been made of the question of whether nano-materials provide a unique set of ethical challenges. Equally important is the question of whether they provide a unique set of regulatory challenges. In the last 18 months, the US Environmental Protection Agency has begun the process of trying to meet the regulatory challenge of nano using the Toxic Substances Control Act (1976)(TSCA). In this central piece of legislation, ‘newness’ is a critical concept. Current EPA policy, (...) we argue, does not adequately (or ethically) deal with the novelty of nano. This paper is an exploration of how to do a better job of accounting for nanomaterials as ‘new.’ We explore three alternative ways that nanomaterials might be made to fall under the TSCA regulatory umbrella. Since nanomaterials are of interest precisely because of the exciting new properties that emerge at the nano-scale, each of these three alternatives must meet what we call the ‘novelty condition’ and avoid what we call the ‘central paradox’ of existing regulatory policy. Failure to meet either of these conditions is a moral failure. We examine both the strengths and weaknesses of each alternative in order to illuminate the conceptual, practical, and moral challenges of novelty. (shrink)

Book reviewed in this article: PBB: An American Tragedy. By Edwin Chen. The Law and Policy of Toxic Substances Control: A Case Study of Vinyl Chloride. By David D. Doniger.

In this book, Carl Cranor utilizes material from ethics, philosophy of law, epidemiology, tort law, regulatory law, and risk assessment to argue that the evidentiary standards for science used in the law to control toxics ought to be ...

When the Toxic Substances Control Act was passed by the US Congress in 1976, its advocates pointed to new generation of genotoxicity tests as a way to systematically screen chemicals for carcinogenicity. However, in the end, TSCA did not require any new testing of commercial chemicals, including these rapid laboratory screens. In addition, although the Environmental Protection Agency was to make public data about the health effects of industrial chemicals, companies routinely used the agency’s obligation to protect (...) confidential business information to prevent such disclosures. This paper traces the contested history of TSCA and its provisions for testing, from the circulation of the first draft bill in the Nixon administration through the debates over its implementation, which stretched into the Reagan administration. The paucity of publicly available health and environmental data concerning chemicals, I argue, was a by-product of the law and its execution, leading to a situation of institutionalized ignorance, the underside of regulatory knowledge. (shrink)

This chapter contains sections titled: The Stricter‐Law Argument Learning from History Objections to the Stricter‐Law Argument An Interim Solution? Putting the Pieces Together.

A great deal has been made of the question of whether nano-materials provide a unique set of ethical challenges. Equally important is the question of whether they provide a unique set of regulatory challenges. In the last 18 months, the US Environmental Protection Agency has begun the process of trying to meet the regulatory challenge of nano using the Toxic Substances Control Act (1976)(TSCA). In this central piece of legislation, ‘newness’ is a critical concept. Current EPA policy, (...) we argue, does not adequately (or ethically) deal with the novelty of nano. This paper is an exploration of how to do a better job of accounting for nanomaterials as ‘new.’ We explore three alternative ways that nanomaterials might be made to fall under the TSCA regulatory umbrella. Since nanomaterials are of interest precisely because of the exciting new properties that emerge at the nano-scale, each of these three alternatives must meet what we call the ‘novelty condition’ and avoid what we call the ‘central paradox’ of existing regulatory policy. Failure to meet either of these conditions is a moral failure. We examine both the strengths and weaknesses of each alternative in order to illuminate the conceptual, practical, and moral challenges of novelty. (shrink)

Pharmacists, physicians, and other health care personnel practice within an integrated system of laws and regulations that influence many treatment modalities. Capitation, managed care, and other controls strain these relationships by mandating greater oversight of how health care is delivered. From a pharmacists’s perspective, any use of medication requites knowledge of three omnipresent factors: regulatory control, formularies, and economic decision making. My objective is to raise awareness of these issues as they relate to the prescription of pain medication and (...) to pain management generally.All practice-oriented drug law and regulation is based on the federal Controlled Substances Act of 1970. The Act, also known as Title II, is part of a much larger piece of legislation, the Comprehensive Drug Abuse Prevention and Control Act of 1970. CSA was enacted to regulate the manufacturing, distribution, dispensing, and delivery of drugs or substances that are subject to, or have the potential for, abuse or physical or psychological dependence. (shrink)

Pharmacists, physicians, and other health care personnel practice within an integrated system of laws and regulations that influence many treatment modalities. Capitation, managed care, and other controls strain these relationships by mandating greater oversight of how health care is delivered. From a pharmacists’s perspective, any use of medication requites knowledge of three omnipresent factors: regulatory control, formularies, and economic decision making. My objective is to raise awareness of these issues as they relate to the prescription of pain medication and (...) to pain management generally.All practice-oriented drug law and regulation is based on the federal Controlled Substances Act of 1970. The Act, also known as Title II, is part of a much larger piece of legislation, the Comprehensive Drug Abuse Prevention and Control Act of 1970. CSA was enacted to regulate the manufacturing, distribution, dispensing, and delivery of drugs or substances that are subject to, or have the potential for, abuse or physical or psychological dependence. (shrink)

Limitations on reproductive decision making, including forced sterilization and involuntary birth control, raise significant ethical challenges. In the United States, these issues are further complicated by a disturbing history of the abuse and victimization of vulnerable populations. One particularly fraught challenge is the risk of teratogenicity posed by moodstabilizing psychiatric medications in patients who are incapable of appreciating such dangers. Long-acting reversible contraception (LARC) offers an intervention to prevent pregnancy among individuals who receive such treatments, but at a cost (...) to their reproductive autonomy. This article examines the ethical issues involved in the use of involuntary LARC for patients on teratogenic psychiatric medications (TPMs) and argues that such an approach can only be justified as a last resort after a careful consideration of the alternatives and an assessment of potential risks and benefits. (shrink)

We can think about the use of controlled substances in the treatment of anxiety disorders in two simple but diametrically opposed ways. First, we can say that anxiety disorders are trivial and require only acts of willpower, or, if anxiety disorders do require treatment, they are better treated without the use of benzodiazepines. When BZs are used to treat anxiety, they pose grave risks of addiction to the patients to whom these medicines are prescribed; they relieve patients’ symptoms, but (...) are the equivalent of a pharmacological “roach motel,” a haven into which many unsuspecting patients enter, but from which few emerge without becoming addicted. Patients must then face terrible struggles to free themselves of dependence on BZs, and this compounds the problem for which they sought treatment. Furthermore, the large number of prescriptions for BZs are a threat to the public health because these drugs are widely abused by alcoholics and drug addicts. (shrink)

We can think about the use of controlled substances in the treatment of anxiety disorders in two simple but diametrically opposed ways. First, we can say that anxiety disorders are trivial and require only acts of willpower, or, if anxiety disorders do require treatment, they are better treated without the use of benzodiazepines. When BZs are used to treat anxiety, they pose grave risks of addiction to the patients to whom these medicines are prescribed; they relieve patients’ symptoms, but (...) are the equivalent of a pharmacological “roach motel,” a haven into which many unsuspecting patients enter, but from which few emerge without becoming addicted. Patients must then face terrible struggles to free themselves of dependence on BZs, and this compounds the problem for which they sought treatment. Furthermore, the large number of prescriptions for BZs are a threat to the public health because these drugs are widely abused by alcoholics and drug addicts. (shrink)

Two significant, apparently unrelated, trends have emerged in American society and medicine. First, American medicine is reexamining its approach to dying. The Institute of Medicine, the American Medical Association and private funding organizations have recognized that too many dying people suffer from pain and other distress that clinicians can prevent or relieve. Second, this past decade has marked a sharp increase in the number of physicians prosecuted for criminal negligence based on arguably negligent patient care. The case often cited as (...) a watershed is People u. Einaugfer, which involved a New York nursing home patient whose physician was convicted in 1993 of two criminal misdemeanors after he ordered an elderly dialysis patient to be tube fed through a peritoneal dialysis Catheter.How is the growing awareness of dying patients’ pain and the increasing willingness of prosecutors to charge physicians with crimes connected? Pain at the end of life is frequently treated with narcotics, prescription drugs that are closely regulated by state and federal law. That complex web of laws—and a growing fear of legal sanctions—has deterred physicians from prescribing controlled substances. As those legal sanctions move from disciplinary actions to criminal charges, physicians’ fears may expand. (shrink)

Two significant, apparently unrelated, trends have emerged in American society and medicine. First, American medicine is reexamining its approach to dying. The Institute of Medicine, the American Medical Association and private funding organizations have recognized that too many dying people suffer from pain and other distress that clinicians can prevent or relieve. Second, this past decade has marked a sharp increase in the number of physicians prosecuted for criminal negligence based on arguably negligent patient care. The case often cited as (...) a watershed is People u. Einaugfer, which involved a New York nursing home patient whose physician was convicted in 1993 of two criminal misdemeanors after he ordered an elderly dialysis patient to be tube fed through a peritoneal dialysis Catheter.How is the growing awareness of dying patients’ pain and the increasing willingness of prosecutors to charge physicians with crimes connected? Pain at the end of life is frequently treated with narcotics, prescription drugs that are closely regulated by state and federal law. That complex web of laws—and a growing fear of legal sanctions—has deterred physicians from prescribing controlled substances. As those legal sanctions move from disciplinary actions to criminal charges, physicians’ fears may expand. (shrink)

According to what I call the reductive standard-causal theory of agency, the exercise of an agent's power to act can be reduced to the causal efficacy of agent-involving mental states and events. According to a non-reductive agent-causal theory, an agent's power to act is irreducible and primitive. Agent-causal theories have been dismissed on the ground that they presuppose a very contentious notion of causation, namely substance-causation. In this paper I will assume, with the proponents of the agent-causal approach, that substance-causation (...) is possible, as I will argue against that theory on the ground that it fails as a theory of agency. I will argue that the non-reductive agent-causal theory fails to account for agency, because it fails to account for agential control: it cannot explain why the stipulated irreducible relation between the agent and an action constitutes the agent's exercise of control over the action. This objection, I will argue, applies to the agent-causal theory in particular, and to the non-reductive approach in general. (shrink)

In the early 1970s, the idea of precaution—of heeding rather than ignoring scientific evidence of harm when there is uncertainty, and taking action that errs on the side of safety—was so appealing that the US Congress used it as the basis of the toxics provisions of the Clean Water Act of 1972, the federal Environmental Protection Agency based its proposals for implementing those provisions on it, and the courts frequently tended toward it when resolving conflicts over the implementation of pollution (...) control law. In other words, precaution was written into toxic water pollutant control law and was beginning to be written into policy and regulations. By 1976, the tables were completely turned. The EPA abandoned the safety-providing approach in the implementation of the law, even though the law required it, and adopted a risk-taking approach in the creation of standards for the vast majority of toxic water pollutants. The article examines how this change was brought about. It builds on recent work on undone science as an obstacle to regulation and contributes to the development of an account of the creation of the regulatory system, with both its achievements and its limitations. (shrink)

Lithuania’s legislation, establishing criminal liability for illegal disposition of narcotic drugs and psychotropic substances, uses two different terms while identifying the subject matter for criminal deeds: “narcotic and psychotropic substances” and “plants, incorporated into the lists of controlled substances.” The legislation in article 269 of the Lithuanian criminal code explains that narcotic and psychotropic substances, indicated in the respective chapter of the Lithuanian criminal code, shall be those substances that are included in the lists of (...) narcotic and psychotropic substances as approved by the Ministry of Health of the Republic of Lithuania. Plants having narcotic drugs and psychotropic substances are not introduced into this definition although the exception of the coca bush is enumerated in the lists of controlled substances. This described present position brings in a certain intricacy when deciding when a perpetrator should be punished only for illegal cultivation of plants and when he should be punished also for other illegal acts with narcotic and psychotropic substances. (shrink)

This paper describes the construction of the visual space of surveillance by the global anti-doping apparatus, it is a space inhabited daily by professional cyclists. Two principal mechanisms of this apparatus will be discussed—the Whereabouts System and the Biological Passport; in order to illustrate how this space is constructed and how it visualises the invisible act of doping. These mechanisms act to supervise and govern the professional cyclist and work to classify them as either clean or dirty in terms of (...) the use of prohibited doping substances or methods. Contrary to the analysis of liberal anti-doping scholars such as Hanstad, Loland and Møller this paper argues that Foucault’s Panopticon paradigm is a useful tool for the analysis of this apparatus. The Whereabouts System and Biological Passport are the instruments by which the anti-doping apparatus intensifies the construction of the space of surveillance in professional sport. This space of surveillance not only locates and makes visible the physical location of each individual cyclist, but it also makes visible their internal bodily functions, in this case the composition and the fluctuations of the composition of their blood. In making the cyclist visible the instruments do not allow the cause of doping, or the event of doping to be known or observed. Rather what they do is cast the body in terms of abnormalities of time, place or blood. In the case of an abnormality of the cyclist’s blood, the cause itself cannot be identified with any certainty, all that is made visible is a suggestion, or a probability, that doping may have occurred. The ultimate effects are twofold—an internalisation and continual monitoring of one’s self as well as by the authorities, and a radical change in the nature and the definition of the offence of doping. No longer is it positive evidence of doping that is punishable, but what becomes punishable is an abnormality, in the cyclist’s location, or their body, which suggests a probability that the invisible act of doping may have occurred. In the course of this process accepted manners of proving an offence by the use of scientific evidence and expert commentary are transformed. The Whereabouts System and the Biological Passport open up a new manner in which the invisible can be visualised. Through the discourse and the attendant commentary of the expert a new alliance between doping and the law is constructed. The result is a redistribution of the way in which the law visualises and treats the symptoms (the signifier) and the signified act of doping. The Whereabouts System and Biological Passport are the instruments by which the anti-doping apparatus intensifies the construction of the space of surveillance in professional sport. This space of surveillance not only locates and makes visible the physical location of each individual cyclist, but it also makes visible their internal bodily functions, in this case the composition and the fluctuations of the composition of their blood. In making the cyclist visible the instruments do not allow the cause of doping, or the event of doping to be known or observed. Rather what they do is cast the body in terms of abnormalities of time, place or blood. In the case of an abnormality of the cyclists’s blood, the cause itself cannot be identified with any certainty, all that is made visible is a suggestion, or a probability, that doping may have occurred. The ultimate effects are twofold—an internalisation and continual monitoring of one’s self as well as by the authorities, and a radical change in the nature and the definition of the offence of doping. No longer is it positive evidence of doping that is punishable, but what becomes punishable is an abnormality, in the cyclist’s location, or their body, which suggests a probability that the invisible act of doping may have occurred. In the course of this process accepted manners of proving an offence by the use of scientific evidence and expert commentary are transformed. The Whereabouts System and the Biological Passport open up a new manner in which the invisible can be visualised. Through the discourse and the attendant commentary of the expert a new alliance between doping and the law is constructed. The result is a redistribution of the way in which the law visualises and treats the symptoms (the signifier) and the signified act of doping. (shrink)

Résumé On sait comment le choix du terme latin substantia est inséparable d’une interprétation de l’ ousia aristotélicienne comme d’un sujet (stable) recevant des propriétés ou accidents. Cette interprétation de l’étant n’a toutefois pas été exclusive chez les premiers auteurs latins qui se sont approprié la doctrine aristotélicienne des catégories. Marius Victorinus et Boèce se sont en effet attachés, l’un comme l’autre, mais selon des approches distinctes, à un autre sens de l’être : dans cette optique, ce qui est demande (...) à être envisagé, non pas en termes de sujet (subiectum), mais en termes d’acte ( actus, mais aussi opus/operatio ). L’article examine la manière dont cette attention portée à l’acte transmet sans doute, mais en même temps modifie la thématique aristotélicienne de l’ ousia hôs energeia. (shrink)

Rachlin overlooks that free will determines when and in what direction acts that appear impulsive will occur. Because behavioral patterns continuously evolve, animals are not guaranteed when they will, or how to, maximize larger-later reinforcements. An animal therefore uses self-control to emit free acts to vary behavioral patterns to optimize larger-later rewards.

Recent studies indicate that mammalian chromosomes contain discretecis‐acting loci that control replication timing, mitotic condensation, and stability of entire chromosomes. Disruption of the large non‐coding RNA gene ASAR6 results in late replication, an under‐condensed appearance during mitosis, and structural instability of human chromosome 6. Similarly, disruption of the mouse Xist gene in adult somatic cells results in a late replication and instability phenotype on the X chromosome. ASAR6 shares many characteristics with Xist, including random mono‐allelic expression and asynchronous replication (...) timing. Additional “chromosome engineering” studies indicate that certain chromosome rearrangements affecting many different chromosomes display this abnormal replication and instability phenotype. These observations suggest that all mammalian chromosomes contain “inactivation/stability centers” that control proper replication, condensation, and stability of individual chromosomes. Therefore, mammalian chromosomes contain four types ofcis‐acting elements, origins, telomeres, centromeres, and “inactivation/stability centers”, all functioning to ensure proper replication, condensation, segregation, and stability of individual chromosomes. (shrink)

When the Environmental Protection Agency banned DDT late in 1972, environmentalists hailed the decision. Indeed, the DDT ban became a symbol of the power of environmental activism in America. Since the ban, several species that were decimated by the effects of DDT have significantly recovered, including bald eagles, peregrines, ospreys, and brown pelicans. Yet a careful reading of Rachel Carson’s Silent Spring reveals DDT to be but one of hundreds of chemicals in thousands of formulations. Carson called for a reduction (...) in the use of all chemical insecticides. Carson’s recommendations notwithstanding, policymakers focused on DDT and other chlorinated hydrocarbons, culminating in the DDT ban, passage of the Federal Environmental Pesticide Control Act of 1972, and subsequent bans on aldrin and dieldrin. Similarly, the history of pesticides has focused inordinately on DDT, providing a myopic image of the ongoing challenges of pesticides in agricultural practice and ongoing environmental protection efforts in the modern world. “Pesticides and the perils of synecdoche” argues that focusing on DDT oversimplified the environmental risks of chemical insecticides and narrowed the parameters of the debate, and in the process both policy and subsequent histories neglected the highly toxic organophosphate insecticides, which dominated agriculture in the United States and the world after the DDT ban, with unintended consequences for farmworkers and wildlife. (shrink)

In April 2011, the Korea Centers for Disease Control and Prevention announced the results of an epidemiological investigation that an unknown cause of lung disease that occurred throughout Korea was caused by humidifier disinfectants. The unprecedented social catastrophe caused by humidifier disinfectants, a household chemical, has so far reported 1,784 deaths and 5,984 survivors in South Korea. This study was designed to investigate the multi-layer relationships between psychological symptoms and adaptive functioning in survivors of the Humidifier disinfectants in South (...) Korea caused by chemical toxic substances. Specifically, this study aimed to explore how psychological symptoms affect actual interpersonal relationships and job adjustment with two variable sets, six internalizing and externalizing subscales, and three adaptation subscales. A total of 224 survivors recruited from a program to support humidifier disinfectant survivors by the government participated in this study. This research was approved by the Institutional Review Board of one of the Universities in South Korea. The age range of the participants was 18–73 years, 37.1% were male, and 62.9% were female. The participants responded to the Adult Self-Report of the Achenbach System of Empirically Based Assessment. A Canonical Correlation Analysis generated three unique patterns in the relationships between psychological symptoms and adaptive functions. Humidifier disinfectant survivors in the first pattern were more vulnerable to psychological symptoms and showed maladaptive functioning in life. Survivors in the second pattern showed intrusive behaviors and appeared to be adaptive in relationships with friends. Finally, survivors in the third pattern showed aggressive behaviors and reported poor partner relationships while showing good relationships with friends. The practical implications of the interventions are also discussed. (shrink)

Sensations of acting and control have been neglected in theory of action. I argue that they form the core of action and are integral and indispensible parts of our actions, participating as they do in feedback loops consisting of our intentions in acting, the bodily movements required for acting and the sensations of acting. These feedback loops underlie all activities in which we engage when we act and generate our control over our movements.The events required for action according (...) to the causal theory, or Searle. (shrink)

I argue that when determining whether an agent ought to perform an act, we should not hold fixed the fact that she’s going to form certain attitudes (and, here, I’m concerned with only reasons-responsive attitudes such as beliefs, desires, and intentions). For, as I argue, agents have, in the relevant sense, just as much control over which attitudes they form as which acts they perform. This is important because what effect an act will have on the world depends not (...) only on which acts the agent will simultaneously and subsequently perform, but also on which attitudes she will simultaneously and subsequently form. And this all leads me to adopt a new type of practical theory, which I call rational possibilism. On this theory, we first evaluate the entire set of things over which the agent exerts control, where this includes the formation of certain attitudes as well as the performance of certain acts. And, then, we evaluate individual acts as being permissible if and only if, and because, there is such a set that is itself permissible and that includes that act as a proper part. Importantly, this theory has two unusual features. First, it is not exclusively act-orientated, for it requires more from us than just the performance of certain voluntary acts. It requires, in addition, that we involuntarily form certain attitudes. Second, it is attitude-dependent in that it holds that which acts we’re required to perform depends on which attitudes we’re required to form. I then show how these two features can help us both to address certain puzzling cases of rational choice and to understand why most typical practical theories (utilitarianism, virtue ethics, rational egoism, Rossian deontology, etc.) are problematic. (shrink)

There is a wide variety of cases of alienation, including (a) when an agent is alienated from her own motivational states and (b) deviant causal cases when an agent's motivational states cause her intended actions but via a deviant causal pathway. Reflecting on the variety of kinds of alienation reveals that action explanation still needs to account for the positive role that agents play in non-alienated actions in general. To fill this gap, this paper identifies a sui generis but crucial (...) notion of control, what I call “synchronic executive control,” where agents act on their reasons, which must be distinguished from (a) endorsing one's reasons as reasonable or as the reasons for action (from the autonomy literature), and (b) other, diachronic notions of executive control such as competence, skills-based control, planning-based control, and counterfactual control generally (from especially the deviant causation literature). The presence of such executive control is crucial for explaining the role of agents in non-alienated actions, and its absence explains the lack of agency in alienation cases. The result is the identification of a relationship agents have with their reasons which unifies the variety of non-alienated actions in a novel way. (shrink)

The relationship between science, law and justice has become a pressing issue with US Supreme Court decisions beginning with Daubert v. Merrell-Dow Pharmaceutical. How courts review scientific testimony and its foundation before trial can substantially affect the possibility of justice for persons wrongfully injured by exposure to toxic substances. If courts do not review scientific testimony, they will deny one of the parties the possibility of justice. Even if courts review evidence well, the fact and perception of greater (...) judicial scrutiny increases litigation costs and attorney screening of clients. Mistaken review of scientific evidence can decrease citizen access to the law, increase unfortunate incentives for firms not to test their products, lower deterrence for wrongful conduct and harmful products, and decrease the possibility of justice for citizens injured by toxic substances. This book introduces these issues, reveals the relationships that pose problems, and shows how justice can be denied. (shrink)

Regarding Rachlin's behavioral act/pattern theory of self-control, it is argued that some cases of self-control involve pattern/ pattern conflicts rather than merely act/pattern conflicts and that some patterns must be viewed as internal representational states of mind (plans) rather than merely as patterns of actual overt behavior.

Focusing mainly on two passages from the Summa theologiae, the article first argues that, on Aquinas’s view, an individual substance, which is the proper subject of being, can and normally does have a certain multiplicity of acts of being . It is only “a certain” multiplicity because the substance has only one unqualified act of being, its substantial being, which belongs to it through its substantial form. The others are qualified acts of being, added on to the substantial being through (...) accidental forms. Having established this thesis, the rest of the article uses it as a basis for an approach to the so-called real distinction between act of being and essence or between act of being and substantial form. This approach is meant to be effective even in an Aristotelian setting where there may seem to be no place for a substantial act distinct from substantial form. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Gonzales v. Oregon and the Politics of MedicineRonald A. Lindsay (bio)Throughout 2005, the morbid joke on Capitol Hill was that the twin inevitabilities of "death and taxes" had been replaced by "death politics and taxes." There seemed to be some truth in this observation given the highly publicized intervention by some members of Congress in the Schiavo case and the continuing controversy over government regulation of end-of-life care. The (...) Supreme Court's recent decision in Gonzales v. Oregon (74 U.S.L.W. 4068 (17 January 2006)) has resolved one of the critical issues relating to this controversy by holding that a physician may prescribe controlled substances to provide assistance in dying if such a practice is authorized by state law and not expressly prohibited by federal law. However, other issues remain. In fact, the Court's decision has underscored some of the reasons why there is not only continuing controversy over end-of-life care, but also over other aspects of the practice of medicine. First, it is apparent there is no consensus among health care professionals about the precise boundaries of the legitimate practice of medicine. Second, the regulation of the practice of medicine traverses ill-defined legal territory. In particular, there is significant uncertainty concerning the implications of some regulations as well as the allocation of regulatory authority between and within state and federal governments. This uncertainty leaves substantial room for political maneuvers.Before discussing the politics of medicine, it is worth looking at the regulation of controlled substances in some detail both because this review will provide the necessary background for understanding the ruling in Gonzales v. Oregon and because it will illustrate the uncertainty resulting from multiple sources of regulatory authority.Federal and State Regulation of Controlled SubstancesSince the Pure Food and Drug Act of 1906, the federal government has regulated certain aspects of the distribution and administration of drugs deemed susceptible to abuse. The current primary vehicle for federal regulation is the Comprehensive Drug Abuse Prevention and Control Act, enacted in 1970, of which Title II is known as the Controlled Substances Act (CSA) (21 U.S.C. § 801 et seq.). A [End Page 99] "controlled" substance is just that, a substance that is regulated under the CSA. The CSA classifies controlled substances in five categories or schedules based on their potential for abuse, their accepted medical use, and the risks associated with their use under medical supervision. Schedule I substances have a high potential for abuse and have no currently accepted use in medical treatment. Schedule II-V substances are approved for medical use but are subject to a descending hierarchy of restrictions on their use. To give a lawful prescription for a controlled substance, a physician must be registered with the appropriate federal agency, currently the Drug Enforcement Administration (DEA). Moreover, to be valid, such a prescription must be issued for "a legitimate medical purpose" (21 U.S.C. § 830(b)(3)(A)(ii)).There is little dispute that the primary purposes of the CSA are to control drug abuse and to eliminate illicit trafficking in drugs. In accomplishing these objectives, there is a division of responsibility among various federal agencies, in particular the Department of Health and Human Services and the Department of Justice. Of particular relevance to the controversy in Gonzales v. Oregon is the Attorney General's authority to revoke a physician's registration for prescribing controlled substances if the physician's registration would be inconsistent with the public interest.All 50 states have their own statutes and regulations that address various aspects of the distribution and administration of controlled substances. Most states have adopted versions of the model Uniform Controlled Substances Act, which largely mimics federal law, but several states have placed additional restrictions on a physician's ability to prescribe controlled substances, including time limits on the validity of a prescription and limits on the quantity of a drug that can be prescribed. States are the primary, but by no means the exclusive, source of regulation of medical practice in general. States license physicians, establish boards and agencies to regulate the actions of physicians, and promulgate rules and guidelines to which physicians... (shrink)

Doug Husak has argued, persuasively I think, that there is no literal ‘act requirement’ in Anglo-American law. I begin by reviewing Husak’s reasons for rejecting the act requirement, and provide additional reasons to think he is right to do so. But Husak’s alternative, the ‘control condition’, I argue, is inadequate. The control requirement is falsified by the widespread practice of holding extremely intoxicated offenders liable for criminal conduct they engage in even if they lack control over their (...) conduct at the time of the offense, and even if they are acting involuntarily. I provide examples from Canadian, US and German law to flesh out our legal practices with respect to intoxicated offenders. I then argue that, at least with respect to one class of intoxicated offenders–those known as ‘grand schemers’, who plan their criminal offending prior to rendering themselves incapable of voluntary control over their conduct–we are morally justified in imposing liability. I then propose an alternative to both the act and control requirements: what I call the ‘agency requirement’. I argue that our law does and should impose liability for conduct that is expressive of or constitutive of the defendant’s practically rational agency. Adopting an agency view allows us to expand our focus from just the moment of the offense to temporally extended instances of agency, such as is involved in planned offending by grand schemers. (shrink)

Background: Chronic Pain (CP) has serious medical and social consequences, and leads to economic burden that threatens the sustainability of healthcare services. Thus, optimized management of pain tools to support CP patients in adjusting to their condition and improving quality of life is timely. Although Acceptance and Commitment Therapy (ACT) is considered an evidence-based psychological approach for CP, evidence for the efficacy of online-delivered ACT for CP is still scarce. At the same time, studies suggest that self-compassion mediates the change (...) in disability and psychopathological symptoms in ACT interventions for CP, although self-compassion is not a specific target in ACT. Thus, an explicit focus on self-compassion might increase the efficacy of ACT interventions for CP, although this hypothesis has not been tested. This study aims to develop an eHealth ACT and compassion-based self-management intervention for CP, the iACTwithPain, and to compare its efficacy in improving health outcomes to a similar ACT-only intervention and a waiting list group. Methods: The eHealth platform that will host the interventions will be developed using a flat design identity and will be interactive. The iACTwithPain intervention will comprise 8 weekly self-management sessions, and will be developed taking into consideration the psychological flexibility model applied to CP, with the addition of explicit compassion-based components. To analyse whether the iACTwithPain intervention will present superiority in improving CP’s impact and related health markers over the two other conditions, this study will follow a RCT design with three arms. CP patients will be recruited through direct contact with patient associations and healthcare services and a national press release in Portugal. Outcome measurement will be conducted at baseline, post-intervention and at 3- and 6-months follow-ups. The interventions’ acceptability will also be assessed. Discussion: The iACTwithPain intervention is expected to improve CP patients’ psychosocial functioning, quality of life, and empowerment, by promoting adaptive disease management and regulation of pain-related internal experiences. Results will contribute to a better understanding on the pertinence of adding compassion elements to ACT for CP and to reach an optimized intervention for CP. (shrink)

Physicians’ fear of criminal prosecution for prescribing opioid analgesics is a major reason why many chronic pain patients are having an increasingly difficult time obtaining medically appropriate pain relief. In Ruan v. United States, 142 S. Ct. 2370 (2022), the Supreme Court unanimously vacated two federal convictions under the Controlled Substances Act. The Court held that the government must prove that the defendant knowingly or intentionally acted in an unauthorized manner.

I hope to show that, although belief is subject to two quite robust forms of agency, "believing at will" is impossible; one cannot believe in the way one ordinarily acts. Further, the same is true of intention: although intention is subject to two quite robust forms of agency, the features of belief that render believing less than voluntary are present for intention, as well. It turns out, perhaps surprisingly, that you can no more intend at will than believe at will.