In this article I attempt to examine the justification for the mandatory drug testing of employees. The justification commonly assumes the form of the productivity argument which states that an employer has a proprietary right to regulate the purchased time of the employee. Since the employer may be rightfully concerned with the employee''s productive output, so this argument goes, the employer retains the right to motivate production. By extension, the employee''s behavior outside of the workplace which affects his (...) or her productive capacity may also be regulated, including drug use which may affect this capacity. Thus it is claimed that the employer has the right to test employees for drug use and to impose sanctions when it is discovered.I argue that the implications of the productivity argument lead to unacceptable consequences and thus must be rejected. The productivity argument can be examined in light of a thought-experiment in which the reader is asked to imagine the discovery of two drugs, both of which enhance employee productivity. Calling these drugs hedonine and pononine, I imagine the first to be pleasurable to the employee while the second is accompanied by a degree of pain and discomfort. Since the mandated use of both of these imagined drugs would be consistent with the productivity argument, I maintain that the productivity argument thereby fails and so must be rejected. As employee drug testing is justified by this argument, it must also be rejected. (shrink)

As drug testing has become increasingly used to maximize corporate profits by minimizing the economic impact of employee substance abuse, numerous arguments have been advanced which draw the ethical justification for such testing into question, including the position that testing amounts to a violation of employee privacy by attempting to regulate an employee's behavior in her own home, outside the employer's legitimate sphere of control. This article first proposes that an employee's right to privacy is violated (...) when personal information is collected or used by the employer in a way which is irrelevant to the terms of employment. This article then argues that drug testing is relevant and therefore ethically justified within the terms of the employment agreement, and therefore does not amount to a violation of an employee's right to privacy. Arguments to the contrary, including the aforementioned appeal to the employer's limited sphere of control, do not account for reasonable constraints on employee privacy which are intrinsic to the demands of the workplace and implicit in the terms of the employment contract. (shrink)

Various kinds of alcohol and drug testing, such as preemployment, routine, and for-cause testing, are commonly performed by employers. While healthcare organizations usually require preemployment drug testing, they vary on whether personnel will be subjected to further testing. Recently, a call has gone out for postincident testing among physicians who are involved in serious, preventable events, especially ones leading to a patient's death. This article will offer a number of counterarguments to that proposal (...) and discuss an alternate approach: that health institutions can better improve patient safety and employees’ well-being by implementing an organizational policy of “speaking up” when system operators notice work behaviors or environmental factors that threaten harm or peril. The article will conclude with a description of various strategies that facilitate speaking up, and why the practice constitutes a superior alternative to mandatory alcohol and drug testing in the wake of serious, harm-causing m.. (shrink)

By some estimates one-third of American corporations now require their employees to be tested for drug use. These requirements are compatible with general employment law while promoting the public's interest in fighting drug use. Moreover, the United States Supreme Court has ruled that drug testing programs are constitutionally permissible within both the public and the private sectors. It appears mandatory drug testing is a permanent fixture of American corporate life. (Bakaly, C. G., Grossman, (...) J. M. 1989). (shrink)

By some estimates one-third of American corporations now require their employees to be tested for drug u se. The se requ iremen ts are com patible with general employment law while prom oting the public's in terest in figh ting drug use. Mo reover , the Unite d State s Supreme Court has ruled that drug tes ting prog rams a re cons titutionally p ermiss ible within both the public and the private sectors. It appears (...) m andatory drug tes ting is a permanent fixture of American corporate life. (Bakaly, C. G., Grossman, J. M. 1989). (shrink)

Employers and governments are interested in the use of serological testing to allow people to return to work before there is a vaccine for SARS-CoV-2. We articulate the preconditions needed for the implementation of antibody testing, including the role of the U.S. Food & Drug Administration.

In late May 1984, Irish citizens were perturbed to hear that a thirty-one year old man died while participating, as a paid volunteer, in a clinical drug trial at the Institute of Clinical Pharmacology in Dublin. At the inquest, held in September 1984, the State Pathologist, Dr John Harbison, affirmed that the cause of death was the reaction of the trial drug Eproxindine 4/0091 with a major tranquillizer which had been given less than fifteen hours earlier as part (...) of regular treatment for a psychiatric disorder. The mixture of the two drugs, he went on to say, increased their effect by between twenty and thirty times their normal strength, and the volunteer had died of cardiac depression. (shrink)

Industrial drug design methodology has undergone remarkable changes in the recent history. Up to the 1970s, the screening of large numbers of randomly selected substances in biological test system was often a crucial step in the development of novel drugs. From the early 1980s, such ‘blind’ screening was increasingly rejected by many pharmaceutical researchers and gave way to ‘rational drug design’, a method that grounds the design of new drugs on a detailed mechanistic understanding of the drug (...) action. Surprisingly, however, the chance-based method of random screening returned to center stage of industrial drug development in the 1990s in the form of ‘high-throughput screening’ (HTS). I will argue in this paper that this to-and-fro in the prominence of random screening comes with fundamental changes in the epistemic significance of chance experiments in pharmaceutical development. While up to the 1970s, random screening used to be chosen as an empirical search strategy primarily because suffi- cient knowledge of the mechanistic basis of drug action was lacking, it has turned with high-throughput screening into an experimental method that employs chance variation and testing to illuminate this mechanistic basis. As a consequence, research into the underlying mechanisms of drug action and the development of new drugs have become closely integrated. The rise of HTS therefore not only shows how chance experiments have assumed a new epistemic role in drug development. It also allows for a detailed study of the much debated emergence of a new relationship between scientific understanding and the development of technological artifacts. (shrink)

Issues of privacy and employee health screening rank as two of the most important ethical concerns organizations will face in the next five years. Despite the increasing numbers of social scientists researching personal privacy and the current focus on workplace privacy rights as one of the most dynamic areas of employment law, the concept of privacy remains relatively abstract. Understanding how the courts define privacy and use the expectation of privacy standards is paramount given the strategic importance of the (...) law as a legal socializing agent. This article reports on two federal court decisions involving employer drug and HIV testing whose determinations relied on assumptions about the psychological dimensions of privacy. How the courts define privacy, the outcome of this definition and the ethical ramifications as it affects the employee/employer relationship are discussed. (shrink)

Book reviewed in this article: Ethical Issues in Drug Testing, Approval and Pricing: The Clot‐Dissolving Drugs. By Baruch Brody.

In recent years, the biopharmaceutical industry has seen an increase in the development of so-called orphan drugs for the treatment of rare and neglected diseases. This increase has been spurred on by legislation in the United States, Europe, and elsewhere designed to promote orphan drug development. In this article, we examine the drivers of corporate social responsibility (CSR) activities in orphan drug markets and the extent to which biopharmaceutical firms engage in these activities with a strategic orientation. The (...) unique context of orphan drugs constitutes a research opportunity to test the applicability of existing theoretical perspectives on CSR and strategic CSR. Using Schwartz and Carroll’s (Bus Ethics Q, 13(4):503–530, 2003) three-domain approach to CSR and the literature on strategic CSR as a theoretical background, we employ a combination of semi-structured interviews and a quantitative website content analysis to study practices of biopharmaceutical firms in the United States and European Union. Our findings show that both US- and EU-based companies engaged in orphan drugs development perceive their involvement as a responsible business activity beyond the economic dimension of CSR. However, for the majority of these companies their CSR activities do not qualify as strategic according to the criteria established in the literature. We also find significant differences between larger and smaller firms in their use of CSR. Based on these findings, we make several suggestions regarding orphan drug legislation and other measures that might help firms exploit strategic CSR benefits. (shrink)

Business in Ethical Focus is a compilation of classical and contemporary essays on business ethics. Approximately 50 essays are organized into five units: Corporate Social Responsibility; Rights and Obligations of Employees and Employers; Justice and Fair Practice; Distributive Justice; and Advertising, Marketing, and the Consumer. Readers will become acquainted with seminal ideas from important thinkers such as Milton Friedman on corporate social responsibility and Amartya Sen on whether business ethics makes economic sense. They will also find classic readings on distributive (...) justice by Thomas Hobbes, John Locke, Karl Marx, John Rawls, and Robert Nozick. Other topics include drug testing, sexual harassment, environmental responsibility, bribery, and ethical issues in advertising and marketing. The editors provide thoughtful commentary, case studies, and study questions for each unit, enabling readers to clearly understand the growing discipline of business ethics. (shrink)

The proposed article provides an overview of European and North American states’ legislation, which regulates the procedure for pre-clinical research, clinical trials and state registration of medicinal products, as well as responsibility for its violation, analysis of the problems and prospects of adaptation of the national legislation to European legal space, particularly in the field of criminal and legal regulation of relations in the sphere of pre-clinical trials, clinical trials and state registration of medicine. The emphasis is put on the (...) matter that inclusion of Article 321-2 into the Criminal Code of Ukraine leads to a false concurrence with other provisions of the Code. The author proposes to introduce recent EU legislation (Acquis Communautaire) on legal regulation of clinical trials and circulation of medicine into the law of Ukraine, clarify terminology related to Fundamentals of Ukrainian Legislation on Health Protection and the Special Part of criminal law, introduce criminal liability for legal entities that will provide effective control over negative effects of research centers’ activity. It is suggested to develop legislative proposals to improve the provisions of the Criminal Code of Ukraine, which provide legal protection of relations arising in connection with pre-clinical research, clinical trials and state registration of medicinal products. (shrink)

The University of Tehran English Proficiency Test (UTEPT) is a high-stakes entrance examination taken by more than 10,000 master’s degree holders annually. The examinees’ scores have a significant influence on the final decisions concerning admission to the University of Tehran Ph.D. programs. As a test validation investigation, the present study, which is a bias detection research in nature, utilized multistep logistic regression (LR) procedure to examine the presence of gender differential item functioning (DIF) in the UTEPT with a sample of (...) 6,555 examinees who took the test in November 2006. Specifically, the LR DIF two-degree of freedom Chi-squared test of significance was employed to test the significance of DIF. Following what has been recently suggested in the literature, the test of significance for DIF was accompanied by a measure of magnitude, namely the R-squared effect size for LR DIF, for the interpretation of which the two widely accepted classification schemes were used comparatively. The results reveal that 39 of the 100 items in the test display significant gender differences. However, these group differences are viewed as “negligible” based on both of the schemes. Accordingly, it could be argued that the UTEPT is a gender DIF-free test, though the Reading Comprehension section of the test remains in need of further analysis as it seems that the general trend of DIF indices at the item level may hint at an inclination towards males. (shrink)

Background and objectivesThe study of brain functional connectivity alterations in children with Attention-Deficit/Hyperactivity Disorder has been the subject of considerable investigation, but the biological mechanisms underlying these changes remain poorly understood. Here, we aim to investigate the brain alterations in patients with ADHD and Typical Development children and accurately classify ADHD children from TD controls using the graph-theoretical measures obtained from resting-state fMRI.Materials and methodsWe investigated the performances of rs-fMRI data for classifying drug-naive children with ADHD from TD controls. (...) Fifty six drug-naive ADHD children and 56 age matched TD controls were included in this study. The graph measures extracted from rs-fMRI functional connectivity were used as features. Extracted network-based features were fed to the RFE feature selection algorithm to select the most discriminating subset of features. We trained and tested Support Vector Machine, Random Forest, and Gradient Boosting using Peking center data from ADHD-200 database to classify ADHD and TD children using discriminative features. In addition to the machine learning approach, the statistical analysis was conducted on graph measures to discover the differences in the brain network of patients with ADHD.ResultsAn accuracy of 78.2% was achieved for classifying drug-naive children with ADHD from TD controls employing the optimal features and the GB classifier. We also performed a hub node analysis and found that the number of hubs in TD controls and ADHD children were 8 and 5, respectively, indicating that children with ADHD have disturbance of critical communication regions in their brain network. The findings of this study provide insight into the neurophysiological mechanisms underlying ADHD.ConclusionPattern recognition and graph measures of the brain networks, based on the rs-fMRI data, can efficiently assist in the classification of ADHD children from TD controls. (shrink)

There is consensus that children have questionable decisional capacity and, therefore, in general a parent or a guardian must give permission to enroll a child in a research study. Moreover, freedom from duress and coercion, the cardinal rule in research involving adults, is even more important for children. This principle is embodied prominently in the Nuremberg Code and is embodied in various federal human research protection regulations. In a program named "SATURN", each school in the Oregon public-school system may implement (...) a mandatory drug-testing program for high school student athletes. A prospective study to identify drug use among student-athletes, SATURN is designed both to evaluate the influence of random drug testing and to validate the survey data through identification of individuals who do not report drug use. The enrollment of students in the drug-testing study is a requirement for playing a school sport. In addition to the coercive nature of this study design, there were ethically questionable practices in recruitment, informed consent, and confidentiality. This article concerns the question of whether research can be conducted with high school students in conjunction with a mandatory drug-testing program, while adhering to prevailing ethical standards regarding human-subjects research and specifically the participation of children in research. (shrink)

Employers seeking to control employee behavior outside of working hours is nothing new. However, recent developments have extended efforts to control employee behavior into new areas, with new significance. Employers seek to control legal behavior by employees outside of working hours, to have significant influence over employee’s health-related behavior, and to monitor and control employee’s social media, even when this behavior has nothing to do with the workplace. In this article, I draw on the work of political theorists Jon Elster, (...) Gerald Gaus and Michael Walzer, and privacy scholars Daniel Solove and Anita Allen, to show what is wrong with this extension of employer control of employee’s outside of work behavior. I argue that there are ethical limits on the controls that employers may put on their employees’ out of work behavior, and that many of these limits should be enshrined into legal protections which would prevent employers from conditioning employment on the regulations criticized. -/- (Please note that the version of this paper on SSRN is a pre-publication version. Please cite and refer to the published version when possible.). (shrink)

These essays, first presented at a conference, “Coping with Sickness,” held in Italy in 1997, address ethical and regulatory medical issues within a historical context. Many of the essays, while addressing interesting topics, combine policy analysis and critical cultural theory. Critical cultural theory can be intellectually engaging at times but is generally irrelevant to public officials concerned with specific policy issues.Coping with Sickness is the third and final volume derived from a series of conferences cosponsored by the European Science Foundation (...) and the Euroconferences Activity of the European Union. The eight essays are organized chronologically and cover a range of disparate topics: medical practitioners and the Spanish Inquisition , the history of autopsy legislation in German since 1800 , the history of “sadism” as a medical term in the nineteenth century , folk medicine in Holland in the late nineteenth century , abortion in Weimar Germany , drug testing in Africa in the early twentieth century , comparative policies toward STDs , and the debate over brain death in Germany . As might be expected in an anthology of this sort, the quality varies considerably. Nonetheless, the subjects addressed in this volume are engaging—much to the credit of the editors.Two pieces in particular represent the range of these collected essays. In “Vacher the Ripper and the Construction of the Nineteenth‐Century Sadist,” Angus McLaren, one of the best historians writing on the history of sexuality today, explores the “discovery” of sadism in the late nineteenth century by focusing on the dramatic trial of Joseph Vacher, who was charged in 1895 for the brutal sexual murder of a woman in Champuis. He later confessed to the murder and the sexual violation of another seven females and four males. Vacher had a long history of mental illness; indeed, he had been institutionalized in July 1893 following a failed attempt at suicide that left a bullet lodged in his head. At the trial the criminologist Alexandre Lacassagne was brought in as an expert witness to testify that Vacher was not insane but an antisocial sadist, as revealed by his dabbling in anarchism, vagabondism, and homosexuality. As a consequence, Vacher was found guilty and given a death sentence.McLaren finds in this trial an example of the social construction of a new medical concept, “sadism.” The emergence of the concept of sadism, he argues, reflected a “gendered notion” of defining appropriate male and female behavior; physicians at the turn of the century believed that “civilized men were most threatened, not by excess passion, but by the enervation spawned by urban life” . The concept of sadism was also employed by doctors to enhance their own authority and to alert the public to the dangers of a male manifesting “feminine traits” and to “beat back” homosexuality.There is much interesting conjecture to McLaren's study, but what policy lessons should be drawn from this remains unclear. If every concept is actually a social construction, reflecting the social anxieties of the age, then is the fashionable concept of social construction itself socially constructed to enhance the authority of the medical historian?More interesting methodologically is Claudia Wiesemann's absorbing essay on the historical debate in Germany over “brain death.” Relying on Ulrich Beck's social theory of simple and reflexive modernization, she shows that, when confronted with complex scientific questions, the public has to decide between competing plausible scientific claims; as a result, political groups make use of scientific expertise and counterexpertise to push their favorite practical and legal solutions. (shrink)

There is consensus that children have questionable decisional capacity and, therefore, in general a parent or a guardian must give permission to enroll a child in a research study. Moreover, freedom from duress and coercion, the cardinal rule in research involving adults, is even more important for children. This principle is embodied prominently in the Nuremberg Code (1947) and is embodied in various federal human research protection regulations. In a program named "SATURN" (Student Athletic Testing Using Random Notification), each (...) school in the Oregon public-school system may implement a mandatory drug-testing program for high school student athletes. A prospective study to identify drug use among student-athletes, SATURN is designed both to evaluate the influence of random drug testing and to validate the survey data through identification of individuals who do not report drug use. The enrollment of students in the drug-testing study is a requirement for playing a school sport. In addition to the coercive nature of this study design, there were ethically questionable practices in recruitment, informed consent, and confidentiality. This article concerns the question of whether research can be conducted with high school students in conjunction with a mandatory drug-testing program, while adhering to prevailing ethical standards regarding human-subjects research and specifically the participation of children in research. (shrink)

Most of the debate about drug testing in the workplace has focused on the right to privacy. Proponents of testing have had to tackle difficult questions concerning the nature, extent, and weight of the privacy rights of employees. This paper examines a different kind of argument — the claim that because corporations are responsible for harms committed by employees while under the influence of drugs, they are entitled to test for drug use. This argument has considerable (...) intuitive appeal, because it seems, at least at first glance, to bypass the issue of privacy rights altogether. The argument turns, not on rights, but on the nature and conditions of responsibility. We may therefore call it an ought implies can argument.In spite of its initial appeal, however, the argument does not succeed in circumventing the claims of privacy rights. Even responsibility for the actions of others does not entitle us to do anything at all to control their behavior; we must look to rights, among other things, to determine what sorts of controls are morally permissible. In addition, the argument rests on unjustified assumptions about the connection between drug testing and the prevention of drug-related harm. (shrink)

Programs of drug testing welfare recipients are increasingly common in US states and have been considered elsewhere. Though often intensely debated, such programs are complicated to evaluate because their aims are ambiguous – aims like saving money may be in tension with aims like referring people to treatment. We assess such programs using a proportionality approach, which requires that for ethical acceptability a practice must be: reasonably likely to meet its aims, sufficiently important in purpose as to outweigh (...) harms incurred, and lower in costs than feasible alternatives. In the light of empirical findings, we argue that the programs fail the three requirements. Pursuing recreational drug users is not important in the light of costs incurred, while dependent users who may require referral are usually identifiable without testing and typically need a broader approach than one focussing on drugs. Drug testing of welfare recipients is therefore not ethically acceptable policy. (shrink)

There is consensus that children have questionable decisional capacity and, therefore, in general a parent or a guardian must give permission to enroll a child in a research study. Moreover, freedom from duress and coercion, the cardinal rule in research involving adults, is even more important for children. This principle is embodied prominently in the Nuremberg Code (1947) and is embodied in various federal human research protection regulations. In a program named "SATURN" (Student Athletic Testing Using Random Notification), each (...) school in the Oregon public-school system may implement a mandatory drug-testing program for high school student athletes. A prospective study to identify drug use among student-athletes, SATURN is designed both to evaluate the influence of random drug testing and to validate the survey data through identification of individuals who do not report drug use. The enrollment of students in the drug-testing study is a requirement for playing a school sport. In addition to the coercive nature of this study design, there were ethically questionable practices in recruitment, informed consent, and confidentiality. This article concerns the question of whether research can be conducted with high school students in conjunction with a mandatory drug-testing program, while adhering to prevailing ethical standards regarding human-subjects research and specifically the participation of children in research. (shrink)

George Will, the well-known pundit, once observed: “A society's recreation is charged with moral significance. Sport—and a society that takes it seriously—would be debased if it did not strictly forbid things that blur the distinction between the triumph of character and the triumph of chemistry.” In opposition, Dan Duchaine, the highly publicized “steroid guru” and counter-culture columnist, declared: “There comes a time for many in competitive athletics where winning is more important than those initial goals of health, recreation, and relaxation.” (...) The parallels of these two philosophies to life in general are patent simply by substituting “sports” and “winning” for “career” and “success,” respectively.This paper will review the basis for banning anabolic steroids in athletics, and consider especially the recent medical findings that support this prohibition. This survey leads into a discussion of the available deterrents, and the secondary, but essential, role of random drug testing as a final safeguard. (shrink)

It is common for physicians who prescribe opioids for chronic pain to have their patients sign an opioid contract in order to receive opioid therapy. A vast majority of these contracts contain a stipulation requiring patients to submit to random drug testing which screens for both licit and illicit drugs. Physicians who prescribe opioids may be concerned about prosecution and disciplinary actions; medication abuse and misuse; and addiction. Steven Passik et al. write, “…physicians still fear the risk of (...) abuse or addiction as well as the potential legal consequences of their prescribing.”Issues surrounding OC/RDT need a closer look with a focus on enforceability and efficacy of the opioid contract; accuracy and complications of drug screens and their interpretation; and the importance of trust between patient and physician. In addition, it is vital to dispel fears with facts regarding prosecutions, nonmedical use of prescription opioids, and addiction. (shrink)

Although testing for substance abuse can be intrusive, inaccurate, and ineffective at ferreting out those who are a threat to others, it can be morally justified in certain carefully circumscribed cases.

Improvements in the health capital of citizens are central to the development of countries. By exploiting steep decreases in antiretroviral drug prices and the subsequent increases in antiretroviral therapy (ART) coverage, we test whether the resulting improvements in the health of the population are associated with the prevalence of entrepreneurial activity and whether entrepreneurial activity strengthens the relationship between ART coverage and a country’s development. Drawing on a sample of 87 low- and middle-income countries (2006–2019), we find that a (...) 1% increase in ART coverage is associated with a 1.5% increase in the number of newly registered limited liability firms; however, there is no significant relationship with (male or female) self-employment. Higher ART coverage is particularly associated with development—as proxied by gross domestic product (GDP) per capita and the Human Development Index—in countries with low levels of new business formation and high proportions of self-employment. (shrink)

This balanced and thorough study of the loyalty programs reviews the history of prosecutions and the dismissals under them, and makes detailed proposals for their revision.--R. F. T.

This study concerns the ethical problems of personal data protection at work. The aim of this project is the analysis of the law structures, which determine the range of protection personal data of the employee and the candidate to work and the rights of data collecting and processing by the employer. The employee privacy protection at work is the principle of labour law expressed in Article 11 of the Labour Code. However personal data protection problem is directly regulated by Article (...) 22 of the Labour Code, which entitle employers to demand certain personal data from the employees and the candidates to work. The regulation determine the list of data, which may be the subject of legal actions by employer in the field of collecting and processing of personal data. The most important issue is connected with the treatment of sensitive information, such as health data, drug testing and genetic testing, sex life, racial or ethnic origin, political opinions, religious or philosophical beliefs, trade-union membership. Personal data protection means the necessity of cooperation between the employee and the employer not only in the field determined by the law but on the basis of ethical values as well. Hence the employer’s obligation to keep from actions which directly interfere in employee’s protected personal effects. But the employee is obliged to give true information about himself in order to protect his health and life at work. (shrink)

Background: Evidence suggesting adverse drug reactions often emerges unsystematically and unpredictably in form of anecdotal reports, case series and survey data. Safety trials and observational studies also provide crucial information regarding the (un-)safety of drugs. Hence, integrating multiple types of pharmacovigilance evidence is key to minimising the risks of harm. Methods: In previous work, we began the development of a Bayesian framework for aggregating multiple types of evidence to assess the probability of a putative causal link between drugs and (...) side effects. This framework arose out of a philosophical analysis of the Bradford Hill Guidelines. In this article, we expand the Bayesian framework and add “evidential modulators,” which bear on the assessment of the reliability of incoming study results. The overall framework for evidence synthesis, “E-Synthesis”, is then applied to a case study. Results: Theoretically and computationally, E-Synthesis exploits coherence of partly or fully independent evidence converging towards the hypothesis of interest (or of conflicting evidence with respect to it), in order to update its posterior probability. With respect to other frameworks for evidence synthesis, our Bayesian model has the unique feature of grounding its inferential machinery on a consolidated theory of hypothesis confirmation (Bayesian epistemology), and in allowing any data from heterogeneous sources (cell-data, clinical trials, epidemiological studies), and methods (e.g., frequentist hypothesis testing, Bayesian adaptive trials, etc.) to be quantitatively integrated into the same inferential framework. Conclusions: E-Synthesis is highly flexible concerning the allowed input, while at the same time relying on a consistent computational system, that is philosophically and statistically grounded. Furthermore, by introducing evidential modulators, and thereby breaking up the different dimensions of evidence (strength, relevance, reliability), E-Synthesis allows them to be explicitly tracked in updating causal hypotheses. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Mild Cognitive Impairment:What's in a Name?Steven R. Sabat (bio)Keywordslabeling, mild cognitive impairment, recall memory, selfhood, stereotype threatCorner and Bond (2006) raise a number of important conceptual issues related to the problems involved in defining mild cognitive impairment (MCI), differentiating it from normal aging, the definition of normal aging itself, and ethical issues surrounding the possible adverse effects of a diagnosis of MCI on the individuals thus described. It would (...) seem that portentous ramifications are involved and that clarifying the conceptual issues would be of great value, not only to researchers but also to the ever-growing population of elderly people. In what follows, I address some of these issues further.Problems of Definition and MeasurementOne of the problems that the authors discuss at the outset of their article concerns what methods are appropriate for detecting those with MCI: "Neuropsychological tests alone do not discriminate between normal aged-related memory loss and MCI or dementia and clinical judgment remains central to diagnosis" (Corner and Bond 2006, 5). Of course, to be able to discriminate between normal aged-related memory problems and MCI, we must first be able to define the former. What exactly is normal? As the authors correctly point out, the term has different meanings, one being normative (usual), another being nonpathologic. Is it normal (usual) for some sort of breakdown to occur in brain systems as a function of increased age? If so, is there a threshold age below which the very same physiologic breakdown is unusual? Would such a threshold age, if one existed, be the same for everyone, regardless of genotype and the cumulative interactive effects of nutrition, health, and stress-related factors over a period of decades? In effect, is some sort of memory impairment part of the natural (usual) process of aging for some people at particular ages rather than for others? And exactly what does it mean to be mildly impaired in the cognitive domain?Hogan and McKeith (2001) presented a working group's definition characterizing MCI such that people who complain about memory problems and who also provide objective evidence of such problems, yet who simultaneously display "normal general cognitive function and intact activities of daily living" (Hogan and McKeith 2001, 1131), should be identified and followed. Here again, however, we confront the problem of defining "normal general cognitive function" as well as "normal activities of daily living." Can one have normal general cognitive function without normal memory function? If so, what exactly constitutes [End Page 13] general cognitive function and on what conceptual or theoretical basis is such a definition valid? Furthermore, what sort of memory function are we talking about? Memory can be said to involve a number of stages: encoding, storage, and retrieval. Retrieval can be of the explicit type (conscious recall or recognition of specific information) with which people with Alzheimer's disease (AD) often reveal deficits or of the implicit type (a change in behavior as a result of previous experience of which the person may have no conscious recollection) as demonstrated in people with AD (Knopman and Nissen 1987). That is, people with AD can display deficits in explicit memory functions without similar deficits simultaneously in implicit memory functions.A partial answer to the question about memory loss in MCI may be found in the use of the Mini-Mental State Examination (MMSE; Folstein, Folstein, and McHugh 1975), originally intended to be used as a screening device, but employed more and more frequently as an outcome measure to assess cognitive decline as well as the efficacy of drug treatments. Although the examination purports to test orientation, registration, attention, calculation, recall, language (naming, repeating, reading, writing, three-stage command), and construction, a task analysis reveals that the test is not quite as "global" in the cognitive domain as it is purported to be. For example, ten of the maximum thirty points on the examination are earned for "orientation" in time and place. Yet, all of the questions in this section of the test require intact recall of the relevant information. For example, if a person is asked, "What day of the week is this?" and replies "I don't know," the... (shrink)

As a response to the opioid epidemic in the United States, the Centers for Disease Control and Prevention (CDC) published the CDC Guideline for Prescribing Opioids for Chronic Pain in 2016. This document served as a means to reduce risks and address harms of opioid use by recommending that clinicians conduct periodic urine drug testing for patients on chronic opioid therapy. As an unintended result of this recommendation, providers began using unexpected urine drug test results as a (...) reason to dismiss patients from practice, both out of concern for their patients’ wellbeing as well as their own legal risks. Using Husserl’s and Heidegger’s phenomenology, we argue that this science-based, black-and-white practice does not heed the patient as a whole person. Instead, we recommend a more contextual, patient-centered approach that can help us to better understand and manage patient needs in such contexts. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Protecting Human Research SubjectsThe Office for Protection from Research RisksJoan Paine Porter (bio)The office for Protection from Research Risks (OPRR), located within the National Institutes of Health, has two divisions: Human Subject Protections and Animal Welfare. This article will address the overall responsibilities and current projects relating to human subject protections.OPRR implements the Department of Health and Human Services' (HHS) regulations for the protection of human subjects (45 CFR (...) 46 (1991)). These regulations fulfill the responsibilities set forth in the Public Health Service (PHS) Act with regard to institutional review boards (IRB) and other protections for human subjects involved in biomedical and behavioral research conducted or supported by HHS. The PHS Act also mandates a program to clarify ethical issues in biomedical research involving human subjects and to address violations of the rights of human subjects of research (P.L. 99-158 (1985)).OPRR staff negotiate assurances of compliance with institutions conducting Federally-supported research involving human subjects. The assurances describe the policies and procedures each institution will follow to fulfill the requirements of the regulations, including specific IRB composition and functions.In addition, OPRR cosponsors with the Food and Drug Administration and awardee institutions a series of regional workshops that address human subject protections issues. These are attended by IRB members, institutional officials, research investigators, and others involved with human subject protections.Current ActivitiesNumerous activities are underway in OPRR. The following describes only a few of the initiatives and studies aimed at helping develop policies and procedures to protect human subjects of research."Points to Consider" DocumentsOPRR is currently working with the National Center for Human Genome Research (NCHGR) to develop a "points to consider" document for IRBs and others involved in large genetic pedigree studies. Many questions have emerged [End Page 279] on topics such as how subjects should be recruited, with whom information should be shared about others in the family, social risks of disclosure in employment and insurance, the circumstances and timing of informing subjects about study results, and involvement of children. OPRR and NCHGR hope to assemble a group this fall to review and refine the points that are now being developed jointly. A conference in South Carolina organized by the American Association for Advancement in the Sciences entitled "Project on the Ethical and Legal Implications of Genetic Testing," helped generate advice, and identified some of the more controversial issues in design and conduct of genetic research that involves large groups of family members.Another "points to consider" effort concerns enrollment of women and minorities in research. The PHS has established a policy that members of these groups must be included in research projects unless there are valid scientific justifications for their exclusion which can be made on a project by project basis (ADAMHA/NIH Policy 1990; NIH/ADAMHA Policy 1990). OPRR has commissioned several scholarly papers to help in developing "points to consider" for IRBs as they balance issues of equitable selection of subjects and protection of these selected individuals. Concerns about enrolling women of childbearing age in research that may be harmful to a fetus, and liability issues frequently dominate discussion in this area. The papers will address ethical, legal, and statistical aspects of enrollment of minorities and women as well as provide a description of various practices and roles of IRBs in addressing goals of fair selection of participants and appropriate protections.OPRR is also working with the PHS Panel on Women, Adolescents and Children to produce a document, also in the form of "points to consider" guidance, concerning enrollment of children who are wards of the state in HIV-related research. Subpart D of the regulations for the protection of human subjects (45 CFR 46) specifically addresses research involving children who are wards of the state, including the special protections that must be provided. State and local officials who have authority to enroll foster care children in research have indicated a desire to obtain advice in this area.The IRB GuidebookA major project that is now being completed under contract to the Poynter Center at Indiana University is the IRB Guidebook. It will revise and expand the current IRB Guidebook produced in the 1980s... (shrink)

ABSTRACT I argue that this examination and appreciation for the shift to abductive reasoning should be extended to the intersection of neuroscience and novel brain-computer interfaces too. This paper highlights the implications of applying abductive reasoning to personalized implantable neurotechnologies. Then, it explores whether abductive reasoning is sufficient to justify insurance coverage for devices absent widespread clinical trials, which are better applied to one-size-fits-all treatments. INTRODUCTION In contrast to the classic model of randomized-control trials, often with a large number of (...) subjects enrolled, precision medicine attempts to optimize therapeutic outcomes by focusing on the individual.[i] A recent publication highlights the strengths and weakness of both traditional evidence-based medicine and precision medicine.[ii] Plus, it outlines a tension in the shift from evidence-based medicine’s inductive reasoning style (the collection of data to postulate general theories) to precision medicine’s abductive reasoning style (the generation of an idea from the limited data available).[iii] The paper’s main example is the application of precision medicine for the treatment of cancer.[iv] I argue that this examination and appreciation for the shift to abductive reasoning should be extended to the intersection of neuroscience and novel brain-computer interfaces too. As the name suggests, brain-computer interfaces are a significant advancement in neurotechnology that directly connects someone’s brain to external or implanted devices.[v] Among the various kinds of brain-computer interfaces, adaptive deep brain stimulation devices require numerous personalized adjustments to their settings during the implantation and computation stages in order to provide adequate relief to patients with treatment-resistant disorders. What makes these devices unique is how adaptive deep brain stimulation integrates a sensory component to initiate the stimulation. While not commonly at the level of sophistication as self-supervising or generative large language models,[vi] they currently allow for a semi-autonomous form of neuromodulation. This paper highlights the implications of applying abductive reasoning to personalized implantable neurotechnologies. Then, it explores whether abductive reasoning is sufficient to justify insurance coverage for devices absent widespread clinical trials, which are better applied to one-size-fits-all treatments.[vii] ANALYSIS I. The State of Precision Medicine in Oncology and the Epistemological Shift While a thorough overview of precision medicine for the treatment of cancer is beyond the scope of this article, its practice can be roughly summarized as identifying clinically significant characteristics a patient possesses (e.g., genetic traits) to land on a specialized treatment option that, theoretically, should benefit the patient the most.[viii] However, in such a practice of stratification patients fall into smaller and smaller populations and the quality of evidence that can be applied to anyone outside these decreases in turn.[ix] As inductive logic helps to articulate, the greater the number of patients that respond to a particular therapy the higher the probability of its efficacy. By straying from this logical framework, precision medicine opens the treatment of cancer to more uncertainty about the validity of these approaches to the resulting disease subcategories.[x] Thus, while contemporary medical practices explicitly describe some treatments as “personalized”, they ought not be viewed as inherently better founded than other therapies.[xi] A relevant contemporary case of precision medicine out of Norway focuses on the care of a patient with cancer between the ventricles of the heart and esophagus, which had failed to respond to the standard regimen of therapies over four years.[xii] In a last-ditch effort, the patient elected to pay out-of-pocket for an experimental immunotherapy (nivolumab) at a private hospital. He experienced marked improvements and a reduction in the size of the tumor. Understandably, the patient tried to pursue further rounds of nivolumab at a public hospital. However, the hospital initially declined to pay for it given the “lack of evidence from randomised clinical trials for this drug relating to this [patient’s] condition.”[xiii] In rebuttal to this claim, the patient countered that he was actually similar to a subpopulation of patients who responded in “open‐label, single arm, phase 2 studies on another immune therapy drug” (pembrolizumab).[xiv] Given this interpretation of the prior studies and the patient’s response, further rounds of nivolumab were approved. Had the patient not had improvements in the tumor’s size following a round of nivolumab, then pembrolizumab’s prior empirical evidence in isolation would have been insufficient, inductively speaking, to justify his continued use of nivolumab.[xv] The case demonstrates a shift in reasoning from the traditional induction to abduction. The phenomenon of ‘cancer improvement’ is considered causally linked to nivolumab and its underlying physiological mechanisms.[xvi] However, “the weakness of abductions is that there may always be some other better, unknown explanation for an effect. The patient may for example belong to a special subgroup that spontaneously improves, or the change may be a placebo effect. This does not mean, however, that abductive inferences cannot be strong or reasonable, in the sense that they can make a conclusion probable.”[xvii] To demonstrate the limitations of relying on the abductive standard in isolation, commentators have pointed out that side effects in precision medicine are hard to rule out as being related to the initial intervention itself unless trends from a group of patients are taken into consideration.[xviii] As artificial intelligence (AI) assists the development of precision medicine for oncology, this uncertainty ought to be taken into consideration. The implementation of AI has been crucial to the development of precision medicine by providing a way to combine large patient datasets or a single patient with a large number of unique variables with machine learning to recommend matches based on statistics and probability of success upon which practitioners can base medical recommendations.[xix] The AI is usually not establishing a causal relationship[xx] – it is predicting. So, as AI bleeds into medical devices, like brain-computer interfaces, the same cautions about using abductive reasoning alone should be carried over. II. Responsive Neurostimulation, AI, and Personalized Medicine Like precision medicine in cancer treatment, computer-brain interface technology similarly focuses on the individual patient through personalized settings. In order to properly expose the intersection of AI, precision medicine, abductive reasoning, and implantable neurotechnologies, the descriptions of adaptive deep brain stimulation systems need to deepen.[xxi] As a broad summary of adaptive deep brain stimulation, to provide a patient with the therapeutic stimulation, a neural signal, typically referred to as a local field potential,[xxii] must first be detected and then interpreted by the device. The main adaptive deep brain stimulation device with premarket approval, the NeuroPace Responsive Neurostimulation system, is used to treat epilepsy by detecting and storing “programmer-defined phenomena.”[xxiii] Providers can optimize the detection settings of the device to align with the patient’s unique electrographic seizures as well as personalize the reacting stimulation’s parameters.[xxiv] The provider adjusts the technology based on trial and error. One day machine learning algorithms will be able to regularly aid this process in myriad ways, such as by identifying the specific stimulation settings a patient may respond to ahead of time based on their electrophysiological signatures.[xxv] Either way, with AI or programmers, adaptive neurostimulation technologies are individualized and therefore operate in line with precision medicine rather than standard treatments based on large clinical trials. Contemporary neurostimulation devices are not usually sophisticated enough to be prominent in AI discussions where the topics of neural networks, deep learning, generative models, and self-attention dominate the conversation. However, implantable high-density electrocorticography arrays (a much more sensitive version than adaptive deep brain stimulation systems use) have been used in combination with neural networks to help patients with neurologic deficits from a prior stroke “speak” through a virtual avatar.[xxvi] In some experimental situations, algorithms are optimizing stimulation parameters with increasing levels of independence.[xxvii] An example of neurostimulation that is analogous to the use of nivolumab in Norway surrounds a patient in the United States who was experiencing both treatment-resistant OCD and temporal lobe epilepsy.[xxviii]Given the refractory nature of her epilepsy, implantation of an adaptive deep brain stimulation system was indicated. As a form of experimental therapy, her treatment-resistant OCD was also indicated for the off-label use of an adaptive deep brain stimulation set-up. Another deep brain stimulation lead, other than the one implanted for epilepsy, was placed in the patient’s right nucleus accumbens and ventral pallidum region given the correlation these nuclei had with OCD symptoms in prior research. Following this, the patient underwent “1) ambulatory, patient-initiated magnet-swipe storage of data during moments of obsessive thoughts; (2) lab-based, naturalistic provocation of OCD-related distress (naturalistic provocation task); and (3) lab-based, VR [virtual reality] provocation of OCD-related distress (VR provocation task).”[xxix] Such signals were used to identify when to deliver the therapeutic stimulation in order to counter the OCD symptoms. Thankfully, following the procedure and calibration the patient exhibited marked improvements in their OCD symptoms and recently shared her results publicly.[xxx] In both cases, there is a similar level of abductive justification for the efficacy of the delivered therapy. In the case study in which the patient was treated with adaptive deep brain stimulation, they at least had their neural activity tested in various settings to determine the optimum parameters for treatment to avoid them being based on guesswork. Additionally, the adaptive deep brain stimulation lead was already placed before the calibration trials were conducted, meaning that the patient had already taken on the bulk of the procedural risk before the efficacy could be determined. Such an efficacy test could have been replicated in the first patient’s cancer treatment, had it been biopsied and tested against the remaining immunotherapies in vitro. Yet, in the case of cancer with few options, one previous dose of a drug that appeared to work on the patient may justify further doses. However, as the Norwegian case presents, corroboration with known responses to a similar drug (from a clinical trial) could be helpful to validate the treatment strategy. (It should be noted that both patients were resigned to these last resort options regardless of the efficacy of treatment.) There are some elements of inductive logic seen with adaptive deep brain stimulation research in general. For example, abductively the focus could be that patient X’s stimulation parameters are different from patient Y’s and patient Z’s. In contrast, when grouped as subjects who obtained personalized stimulation, patients X, Y, and Z demonstrate an inductive aspect to this approach’s safety and/or efficacy. The OCD case holds plenty of abductive characteristics in line with precision medicine’s approach to treating cancer and as more individuals try the method, there will be additional data. With the gradual integration of AI into brain-computer interfaces in the name of efficacy, this reliance on abduction will continue, if not grow, over time. Moving forward, if a responsive deep brain stimulation treatment is novel and individualized (like the dose of nivolumab) and there is some other suggestion of efficacy (like clinical similarities to other patients in the literature), then it may justify insurance coverage for the investigative intervention, absent other unrelated reasons to deny it. III. Ethical Implications and Next Steps While AI’s use in oncology and neurology is not yet as prominent as its use in other fields (e.g., radiology), it appears to be on the horizon for both.[xxxi] AI can be found in both the functioning of the neurotechnologies as well as the implementation of precision medicine. The increasing use of AI may serve to further individualize both oncologic and neurological therapies. Given these implications and the handful of publications cited in this article, it is important to have a nuanced evaluation of how these treatments, which heavily rely on abductive justification, ought to be managed. The just use an abductive approach may be difficult as AI infused precision medicine is further pursued. At baseline, such technology relies on a level of advanced technology literacy among the general public and could exclude populations who lack access to basic technological infrastructure or know-how from participation.[xxxii] Even among nations with adequate infrastructure, as more patients seek out implantable neurotechnologies, which require robust healthcare resources, the market will favor patient populations that can afford this complex care.[xxxiii] If patients already have the means to pay for an initial dose/use of a precision medicine product out of pocket, should insurance providers be required to cover subsequent treatments?[xxxiv] That is, if a first dose of a cancer drug or a deep brain stimulator over its initial battery life is successful, patients may feel justified in having the costs of further treatments covered. The Norwegian patient’s experience implies there is a precedent for the idea that some public insurance companies ought to cover successful cancer therapies, however, insurance companies may not all see themselves as obligated to cover neurotechnologies that rely on personalized settings or that are based on precision/abductive research more than on clinical trials. CONCLUSION The fact that the cases outlined above rely on abductive style of reasoning implies that there may not be as strong a justification for coverage by insurance, as they are both experimental and individualized, when compared to the more traditional large clinical trials in which groups have the same or a standardized protocol (settings/doses). If a study is examining the efficacy of a treatment with a large cohort of patients or with different experimental groups/phases, insurance companies may conclude that the resulting symptom improvements are more likely to be coming from the devices themselves. A preference for inductive justification may take priority when ruling in favor of funding someone’s continued use of an implantable neurostimulator. There are further nuances to this discussion surrounding the classifications of these interventions as research versus clinical care that warrant future exploration, since such a distinction is more of a scale[xxxv] than binary and could have significant impacts on the “right-to-try” approach to experimental therapies in the United States.[xxxvi] Namely, given the inherent limitations of conducting large cohort trials for deep brain stimulation interventions on patients with neuropsychiatric disorders, surgically innovative frameworks that blend abductive and inductive methodologies, like with sham stimulation phases, have traditionally been used.[xxxvii] Similarly, for adaptive brain-computer interface systems, if there are no large clinical trials and instead only publications that demonstrate that something similar worked for someone else, then, in addition to the evidence that the first treatment/dose worked for the patient in question, the balance of reasoning would be valid and arguably justify insurance coverage. As precision approaches to neurotechnology become more common, frameworks for evaluating efficacy will be crucial both for insurance coverage and for clinical decision making. ACKNOWLEDGEMENT This article was originally written as an assignment for Dr. Francis Shen’s “Bioethics & AI” course at Harvard’s Center for Bioethics. I would like to thank Dr. Shen for his comments as well as my colleagues in the Lázaro-Muñoz Lab for their feedback. - [i] Jonathan Kimmelman and Ian Tannock, “The Paradox of Precision Medicine,” Nature Reviews. Clinical Oncology 15, no. 6 (June 2018): 341–42, https://doi.org/10.1038/s41571-018-0016-0. [ii] Henrik Vogt and Bjørn Hofmann, “How Precision Medicine Changes Medical Epistemology: A Formative Case from Norway,” Journal of Evaluation in Clinical Practice 28, no. 6 (December 2022): 1205–12, https://doi.org/10.1111/jep.13649. [iii] David Barrett and Ahtisham Younas, “Induction, Deduction and Abduction,” Evidence-Based Nursing 27, no. 1 (January 1, 2024): 6–7, https://doi.org/10.1136/ebnurs-2023-103873. [iv] Vogt and Hofmann, “How Precision Medicine Changes Medical Epistemology,” 1208. [v] Wireko Andrew Awuah et al., “Bridging Minds and Machines: The Recent Advances of Brain-Computer Interfaces in Neurological and Neurosurgical Applications,” World Neurosurgery, May 22, 2024, S1878-8750(24)00867-2, https://doi.org/10.1016/j.wneu.2024.05.104. [vi] Mark Riedl, “A Very Gentle Introduction to Large Language Models without the Hype,” Medium (blog), May 25, 2023, https://mark-riedl.medium.com/a-very-gentle-introduction-to-large-language-models-without-the-hype-5 f67941fa59e. [vii] David E. Burdette and Barbara E. Swartz, “Chapter 4 - Responsive Neurostimulation,” in Neurostimulation for Epilepsy, ed. Vikram R. Rao (Academic Press, 2023), 97–132, https://doi.org/10.1016/B978-0-323-91702-5.00002-5. [viii] Kimmelman and Tannock, 2018. [ix] Kimmelman and Tannock, 2018. [x] Simon Lohse, “Mapping Uncertainty in Precision Medicine: A Systematic Scoping Review,” Journal of Evaluation in Clinical Practice 29, no. 3 (April 2023): 554–64, https://doi.org/10.1111/jep.13789. [xi] Kimmelman and Tannock, “The Paradox of Precision Medicine.” [xii] Vogt and Hofmann, 1206. [xiii] Vogt and Hofmann, 1206. [xiv] Vogt and Hofmann, 1206. [xv] Vogt and Hofmann, 1207. [xvi] Vogt and Hofmann, 1207. [xvii] Vogt and Hofmann, 1207. [xviii] Vogt and Hofmann, 1210. [xix] Mehar Sahu et al., “Chapter Three - Artificial Intelligence and Machine Learning in Precision Medicine: A Paradigm Shift in Big Data Analysis,” in Progress in Molecular Biology and Translational Science, ed. David B. Teplow, vol. 190, 1 vols., Precision Medicine (Academic Press, 2022), 57–100, https://doi.org/10.1016/bs.pmbts.2022.03.002. [xx] Stefan Feuerriegel et al., “Causal Machine Learning for Predicting Treatment Outcomes,” Nature Medicine 30, no. 4 (April 2024): 958–68, https://doi.org/10.1038/s41591-024-02902-1. [xxi] Sunderland Baker et al., “Ethical Considerations in Closed Loop Deep Brain Stimulation,” Deep Brain Stimulation 3 (October 1, 2023): 8–15, https://doi.org/10.1016/j.jdbs.2023.11.001. [xxii] David Haslacher et al., “AI for Brain-Computer Interfaces,” 2024, 7, https://doi.org/10.1016/bs.dnb.2024.02.003. [xxiii] Burdette and Swartz, “Chapter 4 - Responsive Neurostimulation,” 103–4; “Premarket Approval (PMA),” https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P100026. [xxiv] Burdette and Swartz, “Chapter 4 - Responsive Neurostimulation,” 104. [xxv] Burdette and Swartz, 126. [xxvi] Sean L. Metzger et al., “A High-Performance Neuroprosthesis for Speech Decoding and Avatar Control,” Nature 620, no. 7976 (August 2023): 1037–46, https://doi.org/10.1038/s41586-023-06443-4. [xxvii] Hao Fang and Yuxiao Yang, “Predictive Neuromodulation of Cingulo-Frontal Neural Dynamics in Major Depressive Disorder Using a Brain-Computer Interface System: A Simulation Study,” Frontiers in Computational Neuroscience 17 (March 6, 2023), https://doi.org/10.3389/fncom.2023.1119685; Mahsa Malekmohammadi et al., “Kinematic Adaptive Deep Brain Stimulation for Resting Tremor in Parkinson’s Disease,” Movement Disorders 31, no. 3 (2016): 426–28, https://doi.org/10.1002/mds.26482. [xxviii] Young-Hoon Nho et al., “Responsive Deep Brain Stimulation Guided by Ventral Striatal Electrophysiology of Obsession Durably Ameliorates Compulsion,” Neuron 0, no. 0 (October 20, 2023), https://doi.org/10.1016/j.neuron.2023.09.034. [xxix] Nho et al. [xxx] Nho et al.; Erik Robinson, “Brain Implant at OHSU Successfully Controls Both Seizures and OCD,” OHSU News, accessed March 3, 2024, https://news.ohsu.edu/2023/10/25/brain-implant-at-ohsu-successfully-controls-both-seizures-and-ocd. [xxxi] Awuah et al., “Bridging Minds and Machines”; Haslacher et al., “AI for Brain-Computer Interfaces.” [xxxii] Awuah et al., “Bridging Minds and Machines.” [xxxiii] Sara Green, Barbara Prainsack, and Maya Sabatello, “The Roots of (in)Equity in Precision Medicine: Gaps in the Discourse,” Personalized Medicine 21, no. 1 (January 2024): 5–9, https://doi.org/10.2217/pme-2023-0097. [xxxiv] Green, Prainsack, and Sabatello, 7. [xxxv] Robyn Bluhm and Kirstin Borgerson, “An Epistemic Argument for Research-Practice Integration in Medicine,” The Journal of Medicine and Philosophy: A Forum for Bioethics and Philosophy of Medicine 43, no. 4 (July 9, 2018): 469–84, https://doi.org/10.1093/jmp/jhy009. [xxxvi] Vijay Mahant, “‘Right-to-Try’ Experimental Drugs: An Overview,” Journal of Translational Medicine 18 (June 23, 2020): 253, https://doi.org/10.1186/s12967-020-02427-4. [xxxvii] Michael S. Okun et al., “Deep Brain Stimulation in the Internal Capsule and Nucleus Accumbens Region: Responses Observed during Active and Sham Programming,” Journal of Neurology, Neurosurgery & Psychiatry 78, no. 3 (March 1, 2007): 310–14, https://doi.org/10.1136/jnnp.2006.095315. (shrink)

As a clinical geneticist I have been amazed at the speed of discovery over the past 20 years. The specific genetic causes of thousands of rare genetic conditions have been defined due to improvements in genomic sequencing, computing power and international collaborations to phenotype individuals with similar clinical features. This knowledge has resulted in an increased ability to make accurate molecular diagnoses which informs optimal treatment and clinical care, can remove the need for unnecessary investigations and informs reproductive decision-making. However (...) for any given individual, this genetic testing can often take weeks or months before the initial genetic diagnosis is made within a family. Occasionally genetic information is required more quickly to define a clinical action. For years point of care testing (POCT) has been a mainstay of clinical care, for example, in confirming pregnancy or monitoring blood glucose. I had been keen to explore scenarios where a genetic POCT could be employed in clinical practice. To me, an obvious example appeared to be neonatal testing to avoid gentamicin-induced hearing loss. Here was a situation where we had known about the genetic …. (shrink)

An increasing number of drugs removed from the market because of unacceptable toxicity raises concerns regarding preapproval testing of drug safety. In the present paper it is postulated that the non-inferiority type of trial should be abandoned in favor of the superiority trial with active controls and less stringent (p<0.1, both for efficacy and toxicity) statistics. This approach will increase sensitivity of detection of drug-induced adverse effects at the expense of increasing false positive results regarding the difference (...) in efficacy between the tested and reference drug. Such a move will increase the protection of future patients. In addition, the proposed design is far more acceptable from the clinical (e.g. no need to specify the statistically expected “unimportant” number of deaths) and ethical points of view, as well as being favored by the strong incentive of involved parties. In the second part of this paper arguments are presented in favor of the hypothesis that placebo (still used in some superiority trials) does not induce adverse effects. The assertion that placebo may induce adverse effects is probably biased by the nature of the clinical experiment. Such a conclusion is supported by studies indicating that placebo-induced adverse effects are disease — and treatment — specific. The modification of clinical trials according to the proposed changes may increase the trials’ sensitivity at detecting adverse effects of drugs. (shrink)

Drug abuse is a growing social problem in Poland and is a particularly serious problem in the Military. The conditions of military service may be a factor that stimulates drug addiction among soldiers, particularly those who are psychically and physically weak and not adapted to team work. The psychical stress that results from the abrupt breaking of existing bonds and social relationships (family, colleagues, partners) is intensified by spatial limits (military barracks), and the character of military units (personal (...) freedom limitation). Another important aspect is, natural in this situation, access to weapons and the nature of tasks performed by a modern army. Yet the army continues to recruit young people who are physically and mentally weaker and weaker. In face of this problem, the commanders, supervisors and teachers are required to possess not only psychological and pedagogical knowledge, but also ethical and moral awareness. The article is based on empirical results of the test conducted in 2007 among 100 conscription soldiers of the Lublin Garrison of the Polish Army. (shrink)

The study investigated the conduct of university’s congregation election following the general complaints by university staff of poor organization and conduct. The population consisted of all principal officers and all graduates employed by the various universities in the three geo-political zones of Nigerian federation: North-Central, Southeast, and Southwest. From these zones, a sample of two federal and two state universities were selected by stratified random sampling method for the study. A stratified random sampling method was used to select 200 (100 (...) academic and 100 non-academic) staff from each of federal government universities while 100 (50 academic and 50 non-academic) staff was selected from state universities. A total sample of 900 academic staff (450 males and 450 females) and 900 administrative staff (450males and 450 females) participated in the study. The data of the study were collected using questionnaire. The questionnaire was titled Management of Congregation Election Inventory (MCEI). It was made up of two parts – Part A was demographic while Part B contained 12 questions bothering on organization of previous elections, management and outcome of previous election results. The validity of the questionnaire was made by the experts in educational administration and planning and also in political Science. The reliability of the instrument was tested using a Split-Half Method. The Correlation Coefficient was corrected by the use of Spearman Brown Formula. The Pearson Product Moment Correlation was .75 and final Spearman Brown Formula yielded 0.82. The major finding was that election was poorly organized and conducted, Based on the findings, the major recommendation was a surgical change in the organization and conduct of congregation election. (shrink)

John Worrall and Nancy Cartwright have both argued that randomized controlled trials are “testing the wrong theory.” They claim that RCTs are designed to test inferences about the causal relationships in the study population, but this does not guarantee a justified inference about the causal relationships in the more diverse population in clinical practice. In this article I argue that the epistemology of theory testing in trials is more complicated than either Worrall’s or Cartwright’s accounts suggest. I illustrate (...) this more complex theoretical structure with case studies in medical theory testing from Alzheimer’s research and anticancer drugs in personalized medicine. (shrink)

Genetic testing in the workplace is a technology both full of promise and fraught with ethical peril. Though not yet common, it is likely to become increasingly so. We survey the key arguments in favour of such testing, along with the most significant ethical worries. We further propose a set of pragmatic criteria, which, if met, would make it permissible for employers to offer (but not to require) workplace genetic testing.