Attention deficit hyperactivity disorder is a developmental disorder with an age onset prior to 7 years. Children with ADHD have significantly lower ability to focus and sustain attention and also score higher on impulsivity and hyperactivity. Stimulants, such as methylphenidate, have remained the mainstay of ADHD treatment for decades with evidence supporting their use. However, recent years have seen emergence of newer drugs and drug delivery systems, like osmotic release oral systems and transdermal patches, to mention a few. The (...) use of nonstimulant drugs like atomoxetine and various other drugs, such as a-agonists, and a few antidepressants, being used in an off-label manner, have added to the pharmacotherapy of ADHD. This review discusses current trends in drug therapy of ADHD and highlights the promise pharmacogenomics may hold in the future. (shrink)

ABSTRACTIn April of 2000, Diana Levine went to a clinic in Vermont suffering from a migraine headache. She was given the drug Demerol for the migraine symptoms and Phenergan for nausea. Complications with the administration of Phenergan ultimately resulted in Ms. Levine contracting gangrene, necessitating the amputation of her right arm. Ms. Levine sued the drug maker, Wyeth Pharmaceutical, in state court and prevailed. The lower court's decision was appealed by Wyeth to the state supreme court where the ruling was (...) confirmed. Wyeth next appealed to the U.S. Supreme Court which, to the surprise of many observers, affirmed the judgment of the state supreme court. At issue was the fundamental question of the ability of consumers to obtain redress against negligent manufacturers in state courts. Wyeth's arguments to the Court were based upon preemption: Foodand Drug Administration approval of a drug preempts the ability of injured consumers like Ms. Levine to recover in state courts despite years of precedent to the contrary. Ability to recover damages in state courts represents, perhaps, the most important safety net available to consumers injured by defective products. A ruling by the Supreme Court that FDA‐approved labeling of pharmaceuticals preempts the reach of the state courts would have severely compromised the balance of power between consumers and producers. (shrink)

Among American adults 20 years and older, 59 percent take at least one prescription drug on a regular basis. Unlike most branded drugs, which are generally drugs that have a trade name and are protected by a patent, off‐patent generic drugs make up approximately 90 percent of prescriptions annually filled in the United States; yet in 2017, generic drugs made up only 23 percent of total drug costs in the U.S. The U.S. Food and Drug Administration (...) has taken the lead in encouraging increased competition in the nation's prescription drug marketplace, most recently with its release of the agency's Drug Competition Action Plan, but also with its regulatory guidance and enforcement efforts to eliminate “gaming” of the regulatory process by both branded and generic pharmaceutical manufacturers. Such “gaming” activities include “pay‐for‐delay” agreements involving financial compensation between branded and generic pharmaceutical manufacturers to forestall the emergence into the market of generic pharmaceuticals to compete against a formerly patent‐protected branded drug. A combination of new enabling legislation, federal judicial guidance, and agency regulatory activities show promise in encouraging increased competition in the prescription drug marketplace, with the American consumer the ultimate beneficiary of lower health care costs and improved overall personal health. (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)

Studies have reported high rates of childhood maltreatment among individuals with drug addiction problems; however, investigation about the potentially protective factors to mitigate the effects of maltreatment experiences on motivation to engage in addiction treatment has received less attention. This study aims at exploring the mediating effects of forgiveness and self-efficacy on the association between childhood maltreatment and treatment motivation among drug addicts. A total of 360 male drug addicts were recruited from three mandatory inpatient rehabilitation centers in Malaysia. Participants (...) completed a package of self-report questionnaires including measures of childhood maltreatment experiences, forgiveness, self-efficacy, and motivation for treatment. The analysis conducted using the structural equation model revealed that childhood maltreatment significantly predicted lower treatment motivation, while forgiveness and self-efficacy played a fully mediating role regarding the effect of childhood maltreatment on treatment motivation. In conclusion, these findings suggest that combining the element of forgiveness and self-efficacy in treatment programs appears to benefit the drug addicts with childhood maltreatment history. (shrink)

While there has been a significant amount of scholarship done on health and risk in relation to public health and disease prevention, relatively little attention has been paid to therapeutic interventions which seek to manage risks as bodily, and biological, matters. This article elucidates the distinct qualities and logics of these two different approaches to risk management, in relation to Michel Foucault’s conception of the two poles of biopower, that is, a biopolitics of the population and an anatomo-politics of the (...) human body. Using a case study of contemporary addiction biomedicine, the article examines the development and deployment of treatments for addiction that seek to reduce the risks of relapse to drug use, and relates this case to other risk-reducing (but non-curative) medications, particularly cholesterol-reducing medications. The notion of a ‘disease of risk’ is developed in order to identify a range of medical conditions that bear a family resemblance, insofar as they are pharmaceutically managed with risk-reducing medications, and bound up within what is described as a contemporary ‘risk anatomo-politics’. (shrink)

Causes often influence their effects via multiple routes. Moderate alcohol consumption can raise the level of HDL ('good') cholesterol, which in tum reduces the risk of heart disease. Unfortunately, moderate alcohol consumption can also increase the level of homocysteine, which in tum increases the risk of heart disease. The net or overall effect of alcohol consumption on heart disease will depend upon both of these routes, and no doubt upon many others as well. This is a familiar fact of life (...) for engineers and policy makers, one that often gives rise to unintended consequences. Suppose, for example, that the American Federal Aviation Administration were to institute new regulations requiring that aeroplanes be equipped with some expensive new safety feature. Would this regulation save lives? Not necessarily. Every dollar (or pound, or euro, or yen ... ) that an airline spends to upgrade its fleet is a dollar that must be recouped in some way, most likely through higher fares. Higher fares may, in tum, persuade some travellers to drive instead of fly- especially on shorter routes. But it is inherently more dangerous to drive a given route than to fly it, so the net effect of the new regulation may cost lives, rather than saving them (Glassner 1999: 188). (shrink)

Equality before the law is one of the fundamental guarantees citizens expect in a just and fair society. We argue that recent trend toward mass incarceration, which has had vastly disproportionate impact on African Americans, is undermining this claim to fairness and raises a serious legitimacy problem for the legal system as a whole. Using original data from the Race, Crime and Public Opinion study we show that African Americans view the 'War on Drugs" as racially biased in its (...) implementation. This perception of bias consequentially undermines legal system legitimacy by lowering blacks' expectations for police performance in their communities and encouraging receptivity to appeals for jury nullification based on race. (shrink)

Antibiotic resistance, arising when bacteria develop defences against antibiotics, is creating a public health threat of massive proportions. This raises challenging questions for standard notions in bioethics when suitable policy is to be characterized and justified. We examine the particular proposal of expediting innovation of new antibiotics by cutting various forms of regulatory ‘red tape’ in the standard system for the clinical introduction of new drugs. We find strong principled reasons in favour of such a lowering of the ethical (...) standards of research and the clinical introduction of new antibiotic formulas. However, this support is undermined by pragmatic challenges owing to expected responses from stakeholders, creating uncertainty about which policies could actually be effectively implemented. We describe an underlying dilemma on how to rationally justify compromises between ideal ethical justification and pragmatic risks that needs to be further addressed in this light. We suggest a solution to this dilemma related to proposals of expediting antibiotic drug innovation. (shrink)

Recent research conducted in Australia shows that many oncologists withhold information about expensive unfunded drugs in what the authors of the study suggest is unacceptable medical paternalism. Surprised by the Australian results, we ran a version of the study in New Zealand and received very different results. While the percentages of clinicians who would prescribe the drugs described in the scenarios were very similar (73–99% in New Zealand and 72–94% in Australia depending on the scenario) the percentage who (...) would not discuss expensive unfunded drugs was substantially lower in New Zealand (6.4–11.1%) than it was in Australia (28–41%). This seems surprising given the substantial similarities between the two countries, and the extensive interaction between their medical professions. We use the contrast between the two studies to examine the generalisability of the Australian results, to identify influences on clinicians' decisions about what treatment information to give patients, and so the tendency towards medical paternalism and, more pragmatically, about how such decisions might be influenced. (shrink)

Given the past two decades of over 40 failed trials of amyloid-lowering therapies in Alzheimer’s Disease (AD), many of which succeeded in lowering amyloid as designed, we present an ethical argument for emptying the drug pipeline of tests of amyloid-lowering agents so as to end the historical dominance of the amyloid-reducing therapeutic approach in AD.

BackgroundThis study aimed to determine the elements and the extent of information that child participants and their parents would like to read in an informed assent form /informed consent form of a pediatric drug trial.MethodsA descriptive survey was conducted to determine the perceived importance of each element of the ICF content from child participants and their parents who underwent informed assent/consent of a multi-center pediatric drug trial. The respondents were asked to indicate the level of importance of each item in (...) a questionnaire, by giving a rating scale from 1 to 5.ResultsA total of 22 families, 17 child participants with the diagnosis of hematology or oncology diseases and 27 parents, were enrolled. Among 30 items, risk–benefit aspects were perceived to be of most concerning items from both child participants’ and parents’ viewpoint. None of the items were considered ‘slightly important’ or lower by more than 20% of the respondents.ConclusionsFor pediatric drug trials, risk–benefit information should be made a salient feature of an IAF/icf. This empirical data could help related stakeholders arrange essential information in order of importance and tailor an IAF/icf to better suit child participants’ and parents’ needs, particularly for pediatric drug trials involving children with the diagnosis of hematology or oncology diseases. (shrink)

Imagine a drug—let's call it Curebitt—that is safe, cheap, and very effective: take a pill once a day and you will be healthier. Curebitt's taste is so unpleasant, so bitter, however, that a significant proportion of patients cannot bring themselves to ingest the pill regularly. Now suppose that after some time, another drug, Curesweet, hits the market. This drug is clinically equivalent to Curebitt and costs the same, but it is much more palatable, so adherence rates for it are significantly (...) higher than for Curebitt. Should physicians continue prescribing Curebitt, now that Curesweet is available? No, prescribing the bitter pill puts patients at a greater risk of nonadherence and ultimately results in reduced clinical benefit for a significant proportion of patients, whereas prescribing Curesweet benefits more patients and increases the probability that any given patient's health will improve. The Curebitt versus Curesweet scenario draws our attention to how a physician can fail her patients by prescribing drugs with lower adherence rates when equivalent drugs with higher adherence rates are available. What does this fictional case tell us about the real world? A lot. We know that adherence rates vary with out‐of‐pocket costs. Name‐brand drugs carry higher out‐of‐pocket costs than their generic counterparts; as a result, when name‐brand drugs are prescribed rather than their generic counterparts, fewer patients receive health benefits. If prescribing Curebitt is unethical, then so is prescribing the name‐brand drug. (shrink)

Asia is the most diverse continent in the world in terms of culture, religion, population size, finance, education, health care, academic research, general population skills, and governmental drug regulations. Each Asian country has its own unique qualities when it comes to attracting industry sponsored clinical trials. Factors that influence selecting location of a study site for a sponsored trial are mainly population size, infrastructure, education levels, and quality of health care, cost and drug regulatory platform. Conducting research in traditional countries (...) like Pakistan adds another dimension to the problems in assuring that research conducted in an ethical manner. The indigenous layer of the cultural values makes it even more difficult task, but this is the task that we are morally and ethically bound to shoulder. (shrink)

Several functional magnetic resonance imaging studies have demonstrated abnormalities in static intra- and interhemispheric functional connectivity among diverse brain regions in patients with major depressive disorder. However, the dynamic changes in intra- and interhemispheric functional connectivity patterns in patients with MDD remain unclear. Fifty-eight first-episode, drug-naive patients with MDD and 48 age-, sex-, and education level-matched healthy controls underwent resting-state fMRI. Whole-brain functional connectivity, analyzed using the functional connectivity density approach, was decomposed into ipsilateral and contralateral functional connectivity. We computed (...) the intra- and interhemispheric dynamic FCD using a sliding window analysis to capture the dynamic patterns of functional connectivity. The temporal variability in functional connectivity was quantified as the variance of the dFCD over time. In addition, intra- and interhemispheric static FCD patterns were calculated. Associations between the dFCD variance and sFCD in abnormal brain regions and the severity of depressive symptoms were analyzed. Compared to HCs, patients with MDD showed lower interhemispheric dFCD variability in the inferior/middle frontal gyrus and decreased sFCD in the medial prefrontal cortex/anterior cingulate cortex and posterior cingulate cortex/precuneus in both intra- and interhemispheric comparisons. No significant correlations were found between any abnormal dFCD variance or sFCD at the intra- and interhemispheric levels and the severity of depressive symptoms. Our results suggest intra- and interhemispheric functional connectivity alterations in the dorsolateral prefrontal cortex and default mode network regions involved in cognition, execution and emotion. Furthermore, our study emphasizes the essential role of altered interhemispheric communication dynamics in the DLPFC in patients with MDD. These findings contribute to our understanding of the pathophysiology of MDD. (shrink)

This article analyzes the bioethical implications of using a control/placebo group when conducting clinical trials (CTs) investigating the treatment of periodontitis. For this, the deductive method was used, proposing the interrelation of values, and a scoping systematic review was carried out. A total of 53% of the CTs reviewed were performed in low- and middle-income (LMI) countries, and 92% used a control/placebo group as a comparison group. Although there is a gold standard for the adjunctive treatment of periodontitis, the research (...) ethics committees of most of the analyzed studies approved the use of control/placebo groups for the performance of CTs that did not explore new therapeutic alternatives. In some cases, the CT protocols were not approved by ethics committees, nor was informed consent used. In the LMI countries, a shorter period of recruitment was observed for patients who attended universities and public hospitals. Likewise, most of the CTs reviewed had public funding, a significant amount of which came from the pharmaceutical industry. Only one CT reported the low economic and educational level of its participants. Furthermore, none of the authors of the reviewed CTs declared conflicts of interest. Although the axiology of techno-science always takes into account at least the epistemic, technical and economic value systems, the hegemony of the economic values imposed by the pharmaceutical industry is evident in the performance of CTs investigating the treatment of periodontitis in LMI countries. (shrink)

This article analyzes the bioethical implications of using a control/placebo group when conducting clinical trials (CTs) investigating the treatment of periodontitis. For this, the deductive method was used, proposing the interrelation of values, and a scoping systematic review was carried out. A total of 53% of the CTs reviewed were performed in low- and middle-income (LMI) countries, and 92% used a control/placebo group as a comparison group. Although there is a gold standard for the adjunctive treatment of periodontitis, the research (...) ethics committees of most of the analyzed studies approved the use of control/placebo groups for the performance of CTs that did not explore new therapeutic alternatives. In some cases, the CT protocols were not approved by ethics committees, nor was informed consent used. In the LMI countries, a shorter period of recruitment was observed for patients who attended universities and public hospitals. Likewise, most of the CTs reviewed had public funding, a significant amount of which came from the pharmaceutical industry. Only one CT reported the low economic and educational level of its participants. Furthermore, none of the authors of the reviewed CTs declared conflicts of interest. Although the axiology of techno-science always takes into account at least the epistemic, technical and economic value systems, the hegemony of the economic values imposed by the pharmaceutical industry is evident in the performance of CTs investigating the treatment of periodontitis in LMI countries. (shrink)

This article analyzes the bioethical implications of using a control/placebo group when conducting clinical trials (CTs) investigating the treatment of periodontitis. For this, the deductive method was used, proposing the interrelation of values, and a scoping systematic review was carried out. A total of 53% of the CTs reviewed were performed in low- and middle-income (LMI) countries, and 92% used a control/placebo group as a comparison group. Although there is a gold standard for the adjunctive treatment of periodontitis, the research (...) ethics committees of most of the analyzed studies approved the use of control/placebo groups for the performance of CTs that did not explore new therapeutic alternatives. In some cases, the CT protocols were not approved by ethics committees, nor was informed consent used. In the LMI countries, a shorter period of recruitment was observed for patients who attended universities and public hospitals. Likewise, most of the CTs reviewed had public funding, a significant amount of which came from the pharmaceutical industry. Only one CT reported the low economic and educational level of its participants. Furthermore, none of the authors of the reviewed CTs declared conflicts of interest. Although the axiology of techno-science always takes into account at least the epistemic, technical and economic value systems, the hegemony of the economic values imposed by the pharmaceutical industry is evident in the performance of CTs investigating the treatment of periodontitis in LMI countries. (shrink)

This article analyzes the bioethical implications of using a control/placebo group when conducting clinical trials (CTs) investigating the treatment of periodontitis. For this, the deductive method was used, proposing the interrelation of values, and a scoping systematic review was carried out. A total of 53% of the CTs reviewed were performed in low- and middle-income (LMI) countries, and 92% used a control/placebo group as a comparison group. Although there is a gold standard for the adjunctive treatment of periodontitis, the research (...) ethics committees of most of the analyzed studies approved the use of control/placebo groups for the performance of CTs that did not explore new therapeutic alternatives. In some cases, the CT protocols were not approved by ethics committees, nor was informed consent used. In the LMI countries, a shorter period of recruitment was observed for patients who attended universities and public hospitals. Likewise, most of the CTs reviewed had public funding, a significant amount of which came from the pharmaceutical industry. Only one CT reported the low economic and educational level of its participants. Furthermore, none of the authors of the reviewed CTs declared conflicts of interest. Although the axiology of techno-science always takes into account at least the epistemic, technical and economic value systems, the hegemony of the economic values imposed by the pharmaceutical industry is evident in the performance of CTs investigating the treatment of periodontitis in LMI countries. (shrink)

A possible explanation for policy implementation failure is that the views of the policy’s target groups are insufficiently taken into account during policy development. It has been argued that involving these groups in an interactive process of policy development could improve this. We analysed a project in which several target populations participated in workshops aimed to optimise the utilisation of an expensive novel drug (interferon beta) for patients with Multiple Sclerosis. All participants seemed to agree on the appropriateness of establishing (...) a central registry of Multiple Sclerosis patients and developing guidelines. Nevertheless, these policy measures were not implemented. Possible explanations include (1) the subject no longer had high priority when the costs appeared lower than expected, (2) the organisers had paid insufficient attention to the perceived problems of parties involved, and (3) changes within the socio-political context. The workshops in which representatives of the policy’s target populations participated did not provide enough interactivity to prevent policy implementation failure. (shrink)

I first met Van Potter nearly 40 years ago when I was 17 and entering the University of Wisconsin as a new freshman. During the summer of 1963, Van was a participant in a series of evening seminars designed to familiarize premed students to the community at the University of Wisconsin Medical School. I was immediately struck by Van's unique ability to cut straight to the core of virtually any issue having to do with biomedicine. As with many of his (...) students, I quickly found myself in a father-son relationship of both our making. Van has been a source of inspiration and guidance to me ever since. (shrink)

The present discussion of dialectic thought is an extension of Van's original discussion of “realism” as the dialectic synthesis of conservatism (theism) and liberalism (empiricism) as approaches to thought.

Bioethics and Global Bioethics are currently among the most visible programs in ethics in the global academic community. It was my good fortune to have met Dr. Van Rensselaer Potter in 1963, long before he coined the term “Bioethics” and emerged as America's first Bioethicist, maintaining “The Wisconsin Tradition” established by John Muir and Aldo Leopold. Van believed that all ethics are properly based on a pan-cultural scientific knowledge base. How it is that ethics are related to knowledge, and to (...) values and morals, is the subject of this discussion. (shrink)

Dr. Van Rensselaer Potter was always quick to point out that a viable ethics must be based upon a viable scientific knowledge base. The implications are clear, that a global ethics must be based upon a global philosophy. The present discussion provides the conceptual basis for a Global Philosophy, specifically a global theology with criteria of belief for a mature Global Bioethics.

Some individuals facing dementia contemplate hastening their own death: weighing the possibility of living longer with dementia against the alternative of dying sooner but avoiding the later stages of cognitive and functional impairment. This weighing resonates with an ethical and legal consensus in the United States that individuals can voluntarily choose to forgo life‐sustaining interventions and also that medical professionals can support these choices even when they will result in an earlier death. For these reasons, whether and how a terminally (...) ill individual can choose to control the timing of their death is a topic that cannot be avoided when considering the dementia trajectory. With a focus on the U.S. context, this landscape review considers the status of provisions that would legally permit people facing dementia to hasten death with appropriate support from medical professionals. This review can be used to plan and guide clinical and legal practitioner discussion and policy development concerning evolving questions not fully covered by existing medical decision‐making provisions. (shrink)

In The Ethics of Food, Gregory E. Pence brings together a collection of voices who share the view that the ethics of genetically modified food is among the most pressing societal questions of our time. This comprehensive collection addresses a broad range of subjects, including the meaning of food, moral analyses of vegetarianism and starvation, the safety and environmental risks of genetically modified food, issues of global food politics and the food industry, and the relationships among food, evolution, and human (...) history. (shrink)

Children who experience well-being are engaging more confidently and positively with their caregiver and peers, which helps them to profit more from available learning opportunities and support current and later life outcomes. The goodness-of-fit theory suggests that children’s well-being might be a result of the interplay between their temperament and the environment. However, there is a lack of studies that examined the association between children’s temperament and well-being in early childhood education and care, and whether this association is affected by (...) ECEC process quality. Using a multilevel random coefficient approach, this study examines the association between toddlers’ temperament and well-being in Norwegian ECEC and investigates whether process quality moderates this association. Results reveal an association between temperament and well-being. Staff-child conflict moderates the association between shyness and well-being, and between activity and well-being. Moreover, high emotional behavioral support moderates the association between activity and well-being. Extra attention should be paid by the staff to these children’s needs. (shrink)

How should we punish criminal offenders? One prima facie attractive punishment is administering a mandatory neurointervention—interventions that exert a physical, chemical or biological effect on the brain in order to diminish the likelihood of some forms of criminal offending. While testosterone-lowering drugs have long been used in European and US jurisdictions on sex offenders, it has been suggested that advances in neuroscience raise the possibility of treating a broader range of offenders in the future. Neurointerventions could be a cheaper, (...) and more effective method of punishment. They could also be more humane. Nevertheless, in this paper we provide an argument against the use of mandatory neurointerventions on offenders. We argue that neurointerventions inflict a significant harm on an offender that render them a morally objectionable form of punishment in a respect that incarceration is not. Namely, it constitutes an objectionable interference with the offender’s mental states. However, it might be thought that incarceration also involves an equally objectionable interference with the offender’s mental states. We show that even if it were the case that the offender is harmed to the same extent in the same respect, it does not follow that the harms are morally equivalent. We argue that if one holds that intended harm is more difficult to justify than harm that is unintended but merely foreseen, this means neurointerventions could be morally objectionable in a significant respect that incarceration is not. (shrink)

Definition of the problem: In 1997, Percutaneous Transluminal Coronary Angioplasty (PTCA) was performed in 138.001 cases in Germany. The standard indications, single vessel disease and badly controlled angina, are more and more extended to multivessel disease with and without severe angina, unstable or preinfarction angina, and acute myocardial infarction (AMI) itself. Dilating asymptomatic stenoses of more than 70–80% is a widely used indication, intending prophylaxis of complete occlusion and AMI. Actually there is no generally accepted guideline for the different new (...) indications, conservative versus invasive treatment schedule. It is difficult for the patient to get appropriate information before his decision between mechanical procedures and conservative methods; authentic informed consent actually seems to be in a very bad position. In 1992 the working group called ”Arbeitsgemeinschaft leitender kardiologischer Krankenhausärzte (ALKK)” decided to start a registry of all PTCA procedures, in order to gain knowledge about the present status of PTCA in Germany. Up to March 1999, 198.608 PTCA are logged.Arguments: Each PTCA was included on an intention-to-treat basis. The registry succeeded in a nearly complete recording with 98,6% of all PTCA procedures complete on March 17th, 1999. 93,5% of stenosed and 72,2% of the total occluded vessels were successfully dilated. In 4.729 cases (2,63%) the PTCA caused severe complications. The overall in-hospital mortality was only 0,5%, if the procedures done for AMI were excluded (including AMI it was 1,1%). The calculation of complications should be an essential part of the patients informed consent.Conclusion: Complete recording of all PTCA procedures is feasible even on a nationwide basis. Some results of the registry, as the indication control and the complication rate may help to realize a better doctor-patient-conversation on risks and benefits of either concept. The trend of many CHD patients is ”modern”: It should be done what can be done (mechanically), with results at once. Although said somehow paternalistic, this point of view cannot be tolerated: Proper informed consent today includes the realistic alternative of modern medicaments, especially those with an aggressive cholesterol lowering potency. (shrink)

The lipid‐bilayer component of cell membranes is an aqueous bimolecular aggregate characterized by a heterogeneous lateral organization of its molecular constituents. The heterogeneity may be sustained statically as well as dynamically. On the basis of recent experimental and theoretical progress in the study of the physical properties of lipid‐bilayer membranes, it is proposed that the dynamically heterogeneous membrane states are important for membrane functions such as transport of matter across the membrane and enzymatic activity. The heterogeneous membrane states undergo significant (...) structural changes in response to changes in compositional, thermodynamic, and environmental conditions. The diverse effects of a variety of molecular Compounds interacting with membranes, such as Cholesterol and drugs like anaesthetics, may be understood in terms of the ability of these compounds to affect and modulate the dynamic membrane heterogeneity. (shrink)

Catholic Social Teaching, in considering economic and patient justice, calls for “participating in patient care.” Corporations often are accused of not paying their fair share, which in turn has led to demands for government regulation to lower drug prices in the United States. Meanwhile, the millions of dollars spent by pharmaceutical foundations to help lower-income patients is not seen as corporations’ taking such responsibility to assist patients. The view that CST demands lower costs for prescription pharmaceuticals from corporations that make (...) excess profits misapplies CST principles and does not consider the pricing structure for drugs on a global scale. While a preferential option for the poor is needed, there needs to be a better definition of the poor. This paper looks to broaden the view of CST in regard to corporations and the preferential option for the poor when applied to the current cost of pharmaceuticals. (shrink)

Psychedelic drugs such as psilocybin, LSD and DMT are known to induce powerful alterations in phenomenology. Perhaps of most philosophical and scientific interest is their capacity to disrupt and even “dissolve” one of the most primary features of normal experience: that of being a self. Such “peak” or “mystical” experiences are of increasing interest for their potentially transformative therapeutic value. While empirical research is underway, a theoretical conception of the mechanisms underpinning these experiences remains elusive. In the following paper, (...) psychedelic-induced ego-dissolution is accounted for within an active inference framework, as a collapse in the “temporal thickness” of an agent’s deep temporal model, as a result of lowered precision on high-level priors. The argument here is composed of three moves: first, a view of the self-model is proposed as arising within a temporally deep generative model of an embodied organism navigating an affordance landscape in the service of allostasis. Next, a view of the action of psychedelics as lowering the precision of high-level priors within the generative model is unpacked in terms of a high Bayesian learning rate. Finally, the relaxation of high-level priors is argued to cause a “collapse” in the temporal thickness of the generative model, resulting in a collapse in the self-model and a loss of the ordinary sense of being a self. This account has implications for our understanding of ordinary self-consciousness and disruptions in self-consciousness present in psychosis, autism, depression, and dissociative disorders. The philosophical, theoretical and therapeutic implications of this account are touched upon. (shrink)

Cuba faces a dilemma between continuing its current portfolio of biotechnology drugs and vaccines with lower profitability or renewing its product portfolio with the associated costs and risks.

Most of the discussion in bioethics and health policy concerning social responsibility for health has focused on society’s obligation to provide access to healthcare. While ensuring access to healthcare is an important social responsibility, societies can promote health in many other ways, such as through sanitation, pollution control, food and drug safety, health education, disease surveillance, urban planning and occupational health. Greater attention should be paid to strategies for health promotion other than access to healthcare, such as environmental and public (...) health and health research.Lifestyle plays a major role in most of the illnesses in industrialised nations.1 Six of the 10 leading factors contributing to the global burden of disease are lifestyle related: unsafe sex, high blood pressure, tobacco use, alcohol use, high cholesterol and obesity.2 Lifestyle-related illnesses also contribute to the rising costs of healthcare. Spending on healthcare accounts for about 16% of the gross domestic product in the USA, or US$1.9 trillion.3 Although smoking has declined steadily there since the 1960s, smoking-related medical expenses are still about US$75.5 billion per year.4 Obesity, which has been climbing in the past two decades, accounts for about US$75 billion in healthcare costs there each year.5 Alcoholism and drug addiction in the USA account for annual healthcare costs of about US$22.5 billion and US$12 billion, respectively.6,7 Federal government spending on healthcare relating to HIV/AIDS is over US$13 billion per year.8Given the well-documented relationship between lifestyle, disease burden and healthcare costs, it makes economic and medical sense to hold individuals morally responsible for their health-related choices. While this view has a great deal of intuitive appeal, it also faces numerous objections.9–12 First, holding individuals entirely responsible for their own health conflicts with medicine’s obligation to treat the sick and society’s obligation …. (shrink)

Science progresses through debate and disagreement, and scientific controversies play a crucial role in the growth of scientific knowledge. However, not all controversies and disagreements are progressive in science. Sometimes, controversies can be pseudoscientific; in fact, bogus controversies, and what seem like genuine scientific disagreements, can be a distortion of science set up by non-scientific actors. Bogus controversies are detrimental to science because they can hinder scientific progress and eventually bias science-based decisions. The first goal of this paper is to (...) elucidate the distinction between bogus and genuine scientific controversies and provide a qualitative methodology, based on the literature on expertise, for distinguishing between the two. We will illustrate six epistemic criteria for distinguishing bogus from genuine scientific debates in science and medicine. This heuristic strategy applies directly to scientific reports, and it relies mostly on the social structure of science. We will then apply the above criteria to a case study: the controversy over statins, which are widely prescribed drugs for reducing the level of cholesterol and preventing cardiovascular disease. (shrink)

More than ever, the way we live our lives has become subject to our own decisionmaking. Our whole way of living, in particular what we do to our body, has become the expression of personal lifestyle choices. Because we can make changes to our body according to our own individual preferences, every aspect of our life begins to be seen as the result of individual and voluntary decisions. The comparison with advertising is pertinent here: we should no longer accept the (...) way we are but can choose from a variety of options. Go to any supermarket and look around: innumerable products are promoted because of their healthy ingredients, whether to lower our cholesterol or heighten our natural resistance. And, of course, we buy what is on offer. (shrink)