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.

After the initial surge in cases of coronavirus, the outbreak has been managed differently in different countries. In the USA, it has been managed in many different ways between states, cities and even counties. This disparity is slowly becoming more and more pronounced with the advent of antibody testing. Although many argue over the potential merits of antibody testing as an immunity passport to allow the economy to restart, there are other implications that stand at the (...) heart of the bioethical debate that are often overlooked. Particularly with COVID-19, there are many uncertainties and the discourse alone of antibodies presumes misinformation that may outweigh the epidemiological benefits of antibody testing. Although this paper does not seek to eliminate antibody testing, it does highlight the need for appropriate counselling both on a personal level with each patient but on a more global level. This moral standard of appropriate education is key to allowing the continued autonomy needed during this pandemic. (shrink)

Emergence of the novel pathogenic coronavirus SARS‐CoV‐2 and its rapid pandemic spread presents challenges that demand immediate attention. Here, we describe the development of a semi‐quantitative high‐content microscopy‐based assay for detection of three major classes (IgG, IgA, and IgM) of SARS‐CoV‐2 specific antibodies in human samples. The possibility to detect antibodies against the entire viral proteome together with a robust semi‐automated image analysis workflow resulted in specific, sensitive and unbiased assay that complements the portfolio of SARS‐CoV‐2 serological assays. Sensitive, specific (...) and quantitative serological assays are urgently needed for a better understanding of humoral immune response against the virus as a basis for developing public health strategies to control viral spread. The procedure described here has been used for clinical studies and provides a general framework for the application of quantitative high‐throughput microscopy to rapidly develop serological assays for emerging virus infections. (shrink)

Correct interpretation of the data from integral laboratory tests, including Thrombin Generation Test, requires biochemistry-based mathematical models of blood coagulation. The purpose of this study is to describe the experimental TGT data from healthy donors and hemophilia A and B patients. We derive a simplified ODE model and apply it to analyze the TGT data from healthy donors and HA/HB patients with in vitro added tissue factor pathway inhibitor antibody. This model allows the characterization of hemophilia patients in the (...) space of three most important model parameters. The proposed approach may provide a new quantitative tool for the analysis of experimental TGT. Also, it gives a reduced model of coagulation verified against clinical data to be used in future theoretical large-scale modeling of thrombosis in flow. (shrink)

Point-of-care testing (POCT) is a sensitive, specific and rapid form of testing for the presence of HIV antibodies. Post-exposure prophylaxis for HIV infection can reduce seroconversion rates by up to 80%. Needlestick injuries are the second commonest cause of occupational injury in the NHS and 20% of these occur during operations. In the NHS, in order to protect staff and patients from the risk of bloodborne viruses such as HIV, it is mandatory to report such injuries; however, numerous (...) studies have shown that many groups, particularly doctors, are reluctant to do so. This article outlines the arguments for and against the introduction of preoperatively seeking consent from patients to have their blood tested for HIV via POCT in order to improve the reporting rates of needlestick injuries incurred during surgery and to protect staff from infection. (shrink)

An Institute of Medical Ethics working party supports the view that explicit permission should normally be sought in the case of testing for HIV antibody. It discusses this in relation to anonymised HIV testing for epidemiological purposes, concluding that this is to be welcomed, given certain safeguards. It next argues that pregnant women may have a greater and more immediate need than others to know their HIV status. It concludes that this need does not justify testing (...) them without their permission, but can be met by voluntary diagnostic testing on an 'opting-out' basis, supported by adequate briefing. (shrink)

This article considers the experiences of health consumers who have undergone testing for human immunodeficiency virus antibodies, T cells, and viral load. These HIV-related tests are deployed for the purposes of making definitive diagnoses; yet some test consumers experience ambiguous outcomes. Drawing on an analysis of differing end-user experiences of these tests, where consumers' knowledge reflected the multiplicity and heterogeneity in test design, the author explores how these experiences reflect particular knowledges about these tests. The article contributes to efforts (...) analyzing how health consumers are active end users co-constructing the social meaning of technologies in mutual relationship with other users. The author discusses how this new knowledge can be used to delineate a greater role for consumer evaluation of medical testing within a broader understanding of test design and performance. Relevant links are made to issues such as genetic testing and assessing claims about the efficacy of medical tests. (shrink)

A longstanding philosophical premise perceives simplicity as a desirable attribute of scientific theories. One of several raised justifications for this notion is that simple theories are more likely to indicate the true makeup of natural systems. Qualitatively parsimonious hypotheses and theories keep to a minimum the number of different postulated entities within a system. Formulation of such ontologically simple working hypotheses proved to be useful in the experimental probing of narrowly defined bio systems. It is less certain, however, whether qualitatively (...) parsimonious theories are effective indicators of the true nature of complex biological systems. This paper assesses the success of ontologically simple theories in envisaging the makeup of three complex systems in bacteriology, immunology, and molecular biology. Evidence shows that parsimonious theories completely misconstrued the actual ontologically complex constitutions of the three examined systems. Since evolution and selective pressures typically produce ontologically intricate rather than simple bio systems, qualitatively parsimonious theories are mostly inapt indicators of the true nature of complex biological systems. (shrink)

IntroductionLittle is known about risk factors for both Long COVID and somatic symptoms that develop in individuals without a history of COVID-19 in response to the pandemic. There is reason to assume an interplay between pathophysiological mechanisms and psychosocial factors in the etiology of symptom persistence.ObjectiveTherefore, this study investigates specific risk factors for somatic symptom deterioration in a cohort of German adults with and without prior SARS-CoV-2 infection.MethodsGerman healthcare professionals underwent SARS-CoV-2 IgG antibody testing and completed self-rating questionnaires (...) at baseline and 21 months later between April 2020 and February 2022. Differences in variables between the time points were analyzed and a regression analysis was performed to predict somatic symptom deterioration at follow-up.ResultsSeven hundred fifty-one adults completed both assessments. Until follow-up, n = 58 had contracted SARS-CoV-2 confirmed by serology. Between baseline and follow-up, signs of mental and physical strain increased significantly in the sample. Symptom expectations associated with COVID-19 and a self-reported history of COVID-19, but not serologically confirmed SARS-CoV-2 infection, significantly predicted somatic symptom deterioration at follow-up. A further predictor was baseline psychological symptom burden.ConclusionsThis study supports a disease-overarching biopsychosocial model for the development of burdensome somatic symptoms during the COVID-19 pandemic and supports research findings that symptom burden may be more related to the psychosocial effects of the pandemic than to infection itself. Future studies on Long COVID should include SARS-CoV-2 negative control groups and consider symptom burden prior to infection in order to avoid an overestimation of prevalence rates. (shrink)

Recent social and cultural theory has emphasized that in risk culture the achievement of a reflexive self-identity is a key resource, for example, in terms of employment, citizenship and intimacy. Commentators on shifts in the organization of health have also stressed the significance of achieving a self-reflexive identity. So, for example, knowing, self-monitoring subjects have emerged as optimal citizens in relation to health. While there is certainly some critical commentary on these kinds of moves, nevertheless reflexive sexual subjects in relation (...) to health have received less critical attention. In this article, through an analysis of HIV antibody testing and, in particular, by looking at the making of reflexivity through the practice of testing, I consider the emergence of a heterosexuality defined in terms of reflexivity. In so doing I suggest that reflexivity should not be understood - as many commentators suggest - as an effect but rather as constitutive of risk culture. (shrink)

The AIDS crisis poses a special challenge for American health care, which depends heavily on private insurance to pay medical bills. Can we provide adequate health care to all who need it and still meet the financial requirements of the private health insurance industry? More insurance carriers are turning to antibody testing in order to eliminate poor risks from non‐group, direct‐pay pools. Some cost‐conscious employers have attempted to fire AIDS patients summarily or to exclude AIDS coverage from group (...) insurance policies. Various remedies are available for spreading the financial risks of the epidemic, such as covering persons with AIDS under Medicare or in state‐sponsored health insurance pools. Ethical questions about cost and access may also rekindle the debate about the need for national health insurance. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:The National Commission on AIDSDonald S. Goldman (bio) and Jeff Stryker (bio)A decade after the first cases were recognized in the United States, AIDS continues to vex policymakers and fascinate the public. It has been said that AIDS acts as a prism, refracting a spectrum of controversial topics. For bioethicists, these topics include: equity in the allocation of resources for treatment and research; forgoing life-sustaining care and proxy decision (...) making; informed consent in the context of HIV testing and screening; the ethical duties of health care workers to provide care for persons with HIV disease; and competing obligations of health care professionals to patients and to third parties who may be put at risk.The Role of CommissionsIf AIDS is the quintessential case study for bioethicists, it is a potential quagmire for politicians. The association of HIV disease with drug use and sexual behavior makes it a topic that all but the most courageous (or the most homophobic) politicians shy away from. A frequent political response is to form a commission.Alexander Capron, who was executive director of the President's Commission for the Study of Ethical Problems in Medicine, has described some roles commissions play: a watchdog, overseeing the work of particular government agencies; a crucible, providing a means for "publicly hammering out conclusions on controversial issues when consensus, both in the public and in the relevant disciplines, is not yet apparent"; and "a lightning rod for public concern—or viewed less charitably, dumping ground for an issue that is too difficult for the ordinary political process to handle" (Capron 1983, p. 9).Nearly every state has created a gubernatorial-level task force or commission on AIDS. The National Commission on AIDS was established under the Health Omnibus Program Extension (HOPE) Act of 1988, which was signed by President Reagan on November 4, 1988. The official charter of the commission was approved August 2, 1989 and its original two-year term was extended for a third year. The mission statement crafted by the commission to reflect its Congressional mandate reads: [End Page 339]The National Commission on Acquired Immune Deficiency Syndrome is an independent body of 15 members created to advise the President and Congress. The Commission seeks to build a broad public understanding on the magnitude, scope and urgency of the HIV/AIDS epidemic; provide and inspire leadership at all levels of both the public and private sectors; empower individuals and communities; and advocate for effective, cooperative and non-discriminatory resources required for prevention, comprehensive care, and the research necessary to halt the epidemic.As the mission statement implies, the National Commission on AIDS has viewed itself from the outset not only as a crucible for policy analysis, but also as a forum for those affected by HIV disease. In site visits and hearings the commissioners have met with hundreds of people living with HIV disease, and with caregivers on the front lines. This odyssey has taken the commission on visits to homeless shelters in New York City; to "shooting galleries" where intravenous drug users congregate in Seattle; to Native American communities in four states; to private homes in rural Georgia; and to hospitals, HIV antibody testing centers, drug treatment clinics, and hemophilia treatment centers throughout the nation. It quickly became clear during the commission's travels that HIV disease cannot be understood outside the context of the racism, homophobia, poverty and unemployment that provide the medium that fosters its spread. It also became apparent that issues of HIV prevention, care and treatment, and clinical research are inextricably intertwined and must be dealt with as such.Early InitiativesUnder the leadership of Chairperson June Osborn and Vice-chairperson David Rogers, the commission decided that the problems it saw in its first few meetings were too urgent to await a full-length annual report. Hence the commission entered the fray with a series of brief interim reports on particular aspects of AIDS. These reports enabled the commission to draw attention to urgent problems of limitations in access to health care and to underscore the plight of people with HIV disease who might otherwise garner little media attention, such as prisoners and drug users (National Commission... (shrink)

Responses to outbreaks, epidemics and pandemics involves a heterogeneous set of activities that aim to address threats to public health. In addition to research, non-research activities, such as prevention and control interventions, and surveillance, are conducted. The boundaries between research and non-research responses can rapidly blur during a public health emergency such as the COVID-19 pandemic. There may be common elements between these types of activities, and they may draw on the same resources and infrastructure. Non-research activities, such as surveillance (...) and emergency non-research use of unproven interventions, and research activities must all be undertaken in an ethical manner as components of emergency response. However, care is needed to distinguish between non-research public health activities and research, because research often has considerations and requirements for its ethical conduct which are distinct from non-research public health activities. Research aims to produce generalizable knowledge, and mechanisms such as participant consent and independent ethics review aim to ensure that the rights and interests of research participants are respected. Ensuring that research and non-research activities are appropriately distinguished can additionally promote proper coordination of such activities, and increase trust and social accountability in pandemic responses. Consequently, it is important to distinguish between these different activities on the basis of their primary aim, and to consider whether their implementation is justifiable, based on their aims and the relevant ethical framework for each type of activity, and how they are coordinated as part of the larger collective activity of emergency response and management. Complex questions arise about how the different stakeholders involved in decision-making should make valid and justifiable decisions about whether the response activity is research or non-research. The cases in this chapter invite consideration about how such decisions should be made, and their implications, in the context of applications to conduct retrospective research into the outcomes of emergency uses of unproven interventions outside clinical trials, and of characterising antibody-testing initiatives and systematic data collection activities as surveillance or research. (shrink)

The COVID-19 pandemic has led a number of countries to introduce restrictive ‘lockdown’ policies on their citizens in order to control infection spread. Immunity passports have been proposed as a way of easing the harms of such policies, and could be used in conjunction with other strategies for infection control. These passports would permit those who test positive for COVID-19 antibodies to return to some of their normal behaviours, such as travelling more freely and returning to work. The introduction of (...) immunity passports raises a number of practical and ethical challenges. In this paper, we seek to review the challenges relating to various practical considerations, fairness issues, the risk to social cooperation and the impact on people’s civil liberties. We make tentative recommendations for the ethical introduction of immunity passports. (shrink)

Reduced self-awareness is a well-known phenomenon investigated in patients with vascular disease; however, its impact on neuropsychological functions remains to be clarified. Importantly, selective vascular lesions provide an opportunity to investigate the key neuropsychological features of reduced self-awareness in neurocognitive disorders. Because of its rarity, we present an unusual case of a woman affected by a combined polar and paramedian bilateral thalamic infarction. The patient underwent an extensive neuropsychological evaluation to assess cognitive, behavioral, and functional domains, with a focus on (...) executive functions. She was assessed clinically in the acute phase and after 6 months from the stroke, both clinically and by magnetic resonance imaging. The patient developed a cognitive impairment, characterised by prevalent executive dysfunction associated with reduced self-awareness and mood changes, in terms of apathy and depression. Such condition persisted after 6 months. In May 2020, the patient underwent the serology test in chemiluminescence to detect IgG antibodies against SARS-CoV-2. The result of the quantitative test highlighted a high probability of previous contact with the virus. We suggest that reduced self-awareness related to executive dysfunction and behavioral changes may be due to combined polar and paramedian bilateral thalamic lesion. Metacognitive–executive dysfunction affecting the instrumental abilities of everyday life might make people less able to take appropriate precautions, facilitating the risk of SARS-CoV-2 contagion. (shrink)

Qualitative validation consists in showing that a model is able to mimic available observed data. In population level biological models, the available data frequently represent a group status, such as pool testing, rather than the individual statuses. They are aggregated. Our objective was to explore an approach for qualitative validation of a model with aggregated data and to apply it to validate a stochastic model simulating the bovine viral-diarrhoea virus (BVDV) spread within a dairy cattle herd. Repeated measures of (...) the level of BVDV-specific antibodies in the bulk-tank milk (total milk production of a herd) were used to summarise the BVDV herd status. First, a domain of validation was defined to ensure a comparison restricted to dynamics of pathogen spread well identified among observed aggregated data (new herd infection with a wide BVDV spread). For simulations, scenarios were defined and simulation outputs at the individual animal level were aggregated at the herd level using an aggregation function. Comparison was done only for observed data and simulated aggregated outputs that were in the domain of validation. The validity of our BVDV model was not rejected. Drawbacks and ways of improvement of the approach are discussed. (shrink)

This hypothesis is that anorexia nervosa is a biologically driven disorder, and mammalian hibernation may offer clues to its pathogenesis. Using this approach, this hypothesis offers suggestions for employing heart rate variability as an early diagnostic test for anorexia nervosa; employing the ketogenic diet for refeeding patients, attending to omega 3:6 ratio of polyunsaturated fatty acids in the refeeding diet; and exploring clinical trials of the endocannabinoid-like agent, palmitoylethanolamde for patients with anorexia nervosa. This hypothesis also explores the role of (...) lipids and autoimmune phenomena in anorexia nervosa, and suggest a lipodomics study to search for antibodies in the serum on patients with anorexia nervosa. (shrink)

Just when molecular biology is arguably delivering on some of its long‐promised medical applications—think mRNA vaccines, monoclonal antibody drugs, PCR testing, and gene therapies—the history of molecular biology has lost much of its shine. What not too long ago seemed like a burgeoning field of research with endless possibilities, is now often reduced to the “central dogma” that saw its apotheosis in the effort to sequence the human genome but has since unraveled. The essay will discuss several possible (...) answers to this apparent paradox. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:On the NoseDavid F. Bell (bio)I recently underwent a COVID test. As the technician inserted the rather ominous cotton-tipped probe into my nostril, she told me that it was going to feel as if she were tickling my brain. Indeed… This experience, shared by many during the past three years, and likely multiple times, prompted me to think about my nose. Not since cocaine reentered American mainstream culture in (...) the 1970s and '80s—and found its way into countless movies that reflect the trend—has the nose been so central to a certain state of public life. It's difficult to find a film dealing with American culture from that period and beyond, from Scarface to The Wolf of Wall Street, in which there is not a scene depicting characters snorting the obligatory line or spoon of cocaine. Yes, snorting, sniffing, sneezing, ingesting the line through the nose and finishing leftover dust by collecting it with a moist finger, rubbing it lovingly against the front gum of the mouth. Freud's "Über Coca" looms ominously in the background, the work of a phase in Freud's professional career complicated by his obscure relationships with Parke-Davis (now a subsidiary of Pfizer) and Merck, pharmaceutical companies that supplied him with early samples to tickle his nose (Freud; Merkel). The Sacklers of the moment. In our day, Pfizer wants to transform our noses into defenses against the virus rather than conduits toward mind-altering dreams. In the wake of the Freud and William Halsted cocaine addictions chronicled by Howard Merkel, the irony of the contemporary link between Pfizer and the nose is patent.The nose: that orifice through which the virus creeps, the first stage in breathing, the first filter for air-borne pollutants. Recently, important immunological analyses of COVID have focused on the question of viral load, how much virus is necessary to overcome the nose's filtering function and reach the deeper airways leading to the lungs. The processes triggered by any of the major vaccines prepare antibody blueprints and actual antibodies that can be dispatched to the linings of the nose to counter the virus as soon as the body detects its presence. The Delta, Omicron, and subsequent variants remind us that the virus has mechanisms to challenge this response, namely, increased viral load that intensifies transmissibility and the potential to overwhelm antibodies. It seems, however, that [End Page 231] so-called breakthrough infections are still well controlled by the body's vaccinated immune system. Hysteria about the dangers of such incursions is partially a product of biased and often incorrect or incomplete media coverage of the COVID vaccine, which has terrified the vaccinated and fueled the skepticism of the unvaccinated.The virus tries to overpower and confuse the filtering nose in another way, more immediately apparent to our conscious selves. As many as eighty-five percent of COVID infections result in the loss of smell, generally recovered in about two to three weeks in sickened people who overcome the infection. About five percent of COVID victims, however, have not recovered their sense of smell six months or more after they have shed the virus.1 What might it mean to lose one's sense of smell? In our vision-oriented culture, both sound (the ear) and smell (the nose) have been less recognized as primary defense mechanisms than in other cultures. When one hears a sound, the first reaction is to prepare for a threat, before the sonic source is seen or understood. Orientation in the world, knowing from which direction the sound emanates, is key to preparing the body for an encounter with an unknown phenomenon: "To sound (an alarm) means to warn. Isn't any emerging sound understood as a warning? Any unexpected sonic occurrence is seen as an indication of something that is to come and that must be clarified rapidly" (Deshays 34). By the same token, to sample surroundings by sniffing what is in the air signals whether one should inhale or somehow try to hold one's breath in search of cleaner, more palatable air. Without olfaction, we are at potentially heightened risk of asphyxiation. We are more likely to... (shrink)

Different immunotherapeutic approaches are in the pipeline for the treatment of drug dependence. “Drug vaccines” aim to induce the immune system to produce antibodies that bind to drugs and prevent them from inducing rewarding effects in the brain. Drugs of abuse currently being tested using these new approaches are opioids, nicotine, cocaine, and methamphetamine. In human clinical trials, “cocaine and nicotine vaccines” have been shown to induce sufficient antibody levels while producing few side effects. Studies in humans, determining how (...) these vaccines interact in combination with their target drug, are underway. However, although vaccines can become a reasonable treatment option for drugs of abuse, there are several disadvantages that must be considered. These include i) great individual variability in the formation of antibodies, ii) the lack of protection against a structurally dissimilar drug that produces the same effects as the drug of choice, and iii) the lack of an effect on the drug desire that may predispose an addict to relapse. In addition, a comprehensive overview of several crucial ethical issues has not yet been widely discussed in order to have not only a biological approach to immunotherapy of addiction. Overall, immunotherapy offers a range of possible treatment options: the pharmacological treatment of addiction, the treatment of overdoses, the prevention of toxicity to the brain or the heart, and the protection of the fetus during pregnancy. So far, the results obtained from a small-scale experiment using vaccines against cocaine and nicotine suggest that a number of important technical challenges still need to be overcome before such vaccines can be approved for clinical use. (shrink)

Multidrug-resistant Acinetobacter baumannii is recognized to be among the most difficult antimicrobial-resistant gram negative bacilli to control and treat. One of the major challenges that the pathogenic bacteria face in their host is the scarcity of freely available iron. To survive under such conditions, bacteria express new proteins on their outer membrane and also secrete iron chelators called siderophores. Antibodies directed against these proteins associated with iron uptake exert a bacteriostatic or bactericidal effect against A. baumanii in vitro, by blocking (...) siderophore mediated iron uptake pathways. Attempts should be made to discover peptides that could mimic protein epitopes and possess the same immunogenicity as the whole protein. Subsequently, theoretical methods for epitope prediction have been developed leading to synthesis of such peptides that are important for development of immunodiagnostic tests and vaccines. The present study was designed to in silico resolving the major obstacles in the control or in prevention of the diseases caused by A. baumannii. We exploited bioinformatic tools to better understand and characterize the Baumannii acinetobactin utilization structure of A. baumannii and select appropriate regions as effective B cell epitopes. In conclusion, amino acids 26–191 of cork domain and 321–635 of part of the barrel domain including L4–L9, were selected as vaccine candidates. These two regions contain functional exposed amino acids with higher score of B cell epitopes properties. Majority of amino acids are hydrophilic, flexible, accessible, and favorable for B cells from secondary structure point of view. (shrink)

Ludwik Fleck is widely recognized as a precursor of Science and Technology Studies, but his case study on the development of the Wassermann reaction as a test for detecting syphilis has never been subjected to detailed empirical scrutiny. The fact that Fleck?s monograph is based on a limited set of documentary sources makes his work vulnerable to uncharitable critics. The problematic relation between thought collective and individual scientists in Fleck?s theoretical approach is another reason for a systematic re-examination of his (...) case study, using materials on the early period in the history of the Wassermann reaction (1906?1912). My re-examination highlights several problems in Fleck?s account: a misinterpretation of the switch from antigen detection to antibody detection; a neglect of the ?clinical connection?; an overemphasis on the importance of collective experience leading to implausible views on gross retrospective distortions supposedly inflicted by this experience upon the memories of individual participants; and, finally, a misjudgement of the significance of the acrimonious dispute over the intellectual ownership of the Wassermann reaction. What remains unscathed is Fleck?s picture of a zig-zag course of development from false initial assumptions via detours and cul-de-sacs to a clinically usable test in the end. (shrink)

During multiple testing, researchers often adjust their alpha level to control the familywise error rate for a statistical inference about a joint union alternative hypothesis (e.g., “H1,1 or H1,2”). However, in some cases, they do not make this inference. Instead, they make separate inferences about each of the individual hypotheses that comprise the joint hypothesis (e.g., H1,1 and H1,2). For example, a researcher might use a Bonferroni correction to adjust their alpha level from the conventional level of 0.050 to (...) 0.025 when testing H1,1 and H1,2, find a significant result for H1,1 (p < 0.025) and not for H1,2 (p > .0.025), and so claim support for H1,1 and not for H1,2. However, these separate individual inferences do not require an alpha adjustment. Only a statistical inference about the union alternative hypothesis “H1,1 or H1,2” requires an alpha adjustment because it is based on “at least one” significant result among the two tests, and so it refers to the familywise error rate. Hence, an inconsistent correction occurs when a researcher corrects their alpha level during multiple testing but does not make an inference about a union alternative hypothesis. In the present article, I discuss this inconsistent correction problem, including its reduction in statistical power for tests of individual hypotheses and its potential causes vis-à-vis error rate confusions and the alpha adjustment ritual. I also provide three illustrations of inconsistent corrections from recent psychology studies. I conclude that inconsistent corrections represent a symptom of statisticism, and I call for a more nuanced inference-based approach to multiple testing corrections. (shrink)

An increasing number of people seek medical attention for mild cognitive symptoms at older age, worried that they might develop Alzheimer’s disease. Some clinical practice guidelines suggest offering biomarker testing in such cases, using a brain scan or a lumbar puncture, to improve diagnostic certainty about Alzheimer’s disease and enable an earlier diagnosis. Critics, on the other hand, point out that there is no effective Alzheimer treatment available and argue that biomarker tests lack clinical validity. The debate on the (...) ethical desirability of biomarker testing is currently polarized; advocates and opponents tend to focus on their own line of arguments. In this paper, we show how the method of reflective equilibrium can be used to systematically weigh the relevant arguments on both sides of the debate to decide whether to offer Alzheimer biomarker testing. In the tradition of RE, we reflect upon these arguments in light of their coherence with other argumentative elements, including relevant facts, ethical principles, and theories on societal ideals or relevant concepts, such as autonomy. Our stance in the debate therefore rests upon previously set out in-depth arguments and reflects a wide societal perspective. (shrink)

Avia Pasternak argues that intentional citizens who are genuine participants of their state should share the liability for state wrongdoings. In real-world states, how prevalent is intentional citizenship? This commentary concerns the application of the theoretical model. I argue that there are two problems with Pasternak’s proposal of testing intentional citizenship in reality. First, the difficulty of distinguishing citizens’ ambiguous internal attitudes towards their citizenship is underestimated. Second, the objective aspect of citizens’ status in society, namely, the way they (...) are treated by their state, is more important than their subjective attitudes, but this aspect is neglected by Pasternak. (shrink)

Some monothematic types of delusions may arise because subjects have unusual experiences. The role of this experiential component in the pathogenesis of delusion is still not understood. Focussing on delusions of alien control, we outline a model for reality testing competence on unusual experiences. We propose that nascent delusions arise when there are local failures of reality testing performance, and that monothematic delusions arise as normal responses to these. In the course of this we address questions concerning the (...) tenacity with which delusions are maintained, their often bizarre content, the patients' inability to dismiss them, and their often circumscribed character. (shrink)

In recent years, the genetic testing and selection of IVF embryos, known as preimplantation genetic testing (PGT), has gained much traction in clinical assisted reproduction for preventing transmission of genetic defects. However, a more recent ethically and morally controversial development in PGT is its possible use in selecting IVF embryos for optimal intelligence quotient (IQ) and other non–disease-related socially desirable traits, such as tallness, fair complexion, athletic ability, and eye and hair colour, based on polygenic risk scores (PRS), (...) in what is referred to as PGT-P. Artificial intelligence (AI) and machine learning–based analysis of big data sets collated from genome sequencing of specific human ethnic populations can be used to estimate an individual embryo’s likelihood of developing such multifactorial traits by analysing the combination of specific genetic variants within its genome. Superficially, this technique appears compliant with Islamic principles and ethics. Because there is no modification of the human genome, there is no tampering with Allah’s creation (taghyīr khalq Allah). Nevertheless, a more critical analysis based on the five maxims of Islamic jurisprudence (qawa'id fiqhiyyah) that are often utilized in discourses on Islamic bioethics, namely qaṣd (intention), yaqın̄ (certainty), ḍarar (injury), ḍarūra (necessity), and `urf (custom), would instead reveal some major ethical and moral flaws of this new medical technology in the selection of non–disease-related socially desirable traits, and its non-compliance with the spirit and essence of Islamic law (shariah). Muslim scholars, jurists, doctors, and biomedical scientists should debate this further and issue a fatwa on this new medical technology platform. (shrink)

Informed by a search of the literature about the usage of genetic testing information (GTI) by insurance companies, this paper presents a practical ethical analysis of several distinct public policy options that might be used to govern or constrain GTI usage by insurance providers. As medical research advances and the extension to the Human Genome Project (2016, https://en.wikipedia.org/wiki/human_genome_project_-_write) moves to its fullness over the next decade, such research efforts will allow the full synthesis of human DNA to be connected (...) to predictive health dispositions. As testing costs fall, there will be ever more pressure for citizens to disclose GTI. Genetic testing information is integral to future medical care because it can be used to better assess individually tailored medical therapies as well as to allow a more informed risk analysis by the insurance industry, which in some countries such as the USA underwrites a majority of citizen medical expenses. As discussed in this examination, the revelation of people’s uniquely personal GTI to insurers has enormous societal implications. The major contribution of the paper is to offer policy makers and concerned citizens a nuanced articulation of the basic options to regulate GTI, with a special consideration for ethical fairness and equity. As genetic-based medicine blossoms and pressures to reduce healthcare costs increase, there will be an ever greater impetus for countries to revisit their genetic testing policies. Organizations and policy makers striving to create GTI oversights perceived to be both “fair and effective” need to be aware of the ethical perspectives discussed in this paper. (shrink)

In recent times, informed consent has been adopted worldwide as a cornerstone to ensure autonomy during HIV testing. However, there are still ongoing debates on whether the edifice on which informed consent requirements are grounded, that is, personal autonomy, is philosophically, morally, and practically sound, especially in countries where HIV is an epidemic and/or may have a different ontological perspective or lived reality. This study explores the views of participants from Zambia. In-depth and focus group discussions were conducted at (...) various locations in Lusaka and Chongwe, Zambia. Participants came from various demographics, including people living with HIV, healthcare professionals and workers, policymakers, pregnant women, churchgoers, teachers, rural-based persons, and police officers. Data were manually analysed by conducting inductive and deductive thematic analyses. Results show that participants were not in favour of HIV policies that promote personal autonomy at the expense of pursuit of the common good. Participants viewed interdependence, not autonomy, as an essential characteristic of being human. The participants’ views have a realistic potential to provide a contextual and appropriate ethical, respectful, and realistic foundation for HIV testing policies. (shrink)