A relatively healthy forty-six-year-old woman with mild hypertension receives a prescription for an antihypertensive medication. One of the medication's adverse effects is its potential to cause severe depression. Four months later, she is diagnosed with anxiety, an early manifestation of depression. An antianxiety drug is prescribed, but her anxiety worsens. Her physician then diagnoses her as having a depressive disorder, and prescribes a new antidepressant medication. She is still on the same antihypertensive.A seventy-two-year-old man is given furosemide and digoxin (...) to control a mild case of congestive heart failure and hypertension. Because furosemide deletes potassium from the body, his physician also places him on a potassium supplement. Six months later, the physician tells the patient to stop taking the furosemide and prescribes an angiotensin converting enzyme inhibitor. An effect of ACE inhibitors is to reduce the body's excretion of potassium thereby reducing the digoxin's effectiveness. (shrink)

A relatively healthy forty-six-year-old woman with mild hypertension receives a prescription for an antihypertensive medication. One of the medication's adverse effects is its potential to cause severe depression. Four months later, she is diagnosed with anxiety, an early manifestation of depression. An antianxiety drug is prescribed, but her anxiety worsens. Her physician then diagnoses her as having a depressive disorder, and prescribes a new antidepressant medication. She is still on the same antihypertensive.A seventy-two-year-old man is given furosemide and digoxin (...) to control a mild case of congestive heart failure and hypertension. Because furosemide deletes potassium from the body, his physician also places him on a potassium supplement. Six months later, the physician tells the patient to stop taking the furosemide and prescribes an angiotensin converting enzyme inhibitor. An effect of ACE inhibitors is to reduce the body's excretion of potassium thereby reducing the digoxin's effectiveness. (shrink)

We conducted a scoping review to map and critically examine the knowledge, perceptions and utilization of generics and biosimilars, among physicians, pharmacists, patients, the general population, and other stakeholders from LAC.

This commentary reviews the effects of nicotine on mood and cognition in support of the drug utilization concept of Müller & Schumann (M&S). Specifically, it amplifies the concept with the nicotine utilization hypothesis (NUH), which opposes the nicotine withdrawal hypothesis (NWH). Evidence against NWH comes from changes in mood after abstinence and the performance effects of nicotine supporting drug utilization.

In the “olden days,” only a few years ago, physicians were free to order virtually any service they believed their patients needed, confident that virtually everything would be paid for. Reimbursernent was retrospective, fee-for-service and generous, essentially a cost-plus system in which insurers only rarely challenged medical decisions. That system is now gone. Uncontrolled escalations in the cost of health care have prompted those who pay its costs—primarily governments, businesses, and insurers—to initiate a broad array of cost controls in hopes (...) of at least restraining the rise of their expenditures, even if not actually reducing them. Among the most prominent cost-containment mechanisms is utilization review (UR).Insurers have always engaged in retrospective review, denying payment for services that are not medically necessary, or not covered by the patient's policy, or not documented in the patient's records. Recently, however, payers have added prospective review, in which physician and patient must secure advance payer approval for certain interventions if they wish to ensure reimbursement. (shrink)

This article describes the ethical conflicts that a sample of US nurse utilization reviewers faced in their work, and also each nurse’s self-reported ethical orientation that was used to resolve the dilemmas. Data were collected from a sample of 97 registered nurses who were working at least 20 hours per week as utilization reviewers. Respondents were recruited from three managed care organizations that conduct utilization reviews in a large midwestern city. A cross-sectional survey design was used to (...) collect demographic data and to ask closed-response, short-answer and open-ended questions. Ethical conflicts reported by nurses were similar across utilization review settings and many were justice orientated. Self-reported ethical orientations were similar across organizations, with beneficence dominating. Implications of these findings are discussed. (shrink)

In recent years, the issue of accepting a higher cost per health improvement for orphan drugs has been the subject of discussion in health care policy agencies and the academic literature. This article aims to provide an analysis of broadly egalitarian arguments for and against accepting higher costs per health improvement. More specifically, we aim to investigate which arguments one should agree upon putting aside and where further explorations are needed. We identify three kinds of arguments in the literature: considerations (...) of substantial equality, formal equality, and opportunity cost. We argue that considerations of substantial equality do not support higher costs per health improvement orphan drugs, even if such considerations are considered valid. On the contrary, arguments of formal equality may support accepting a higher cost per health improvement for orphan drugs. However, in order to do so, a number of both normative and empirical issues must be resolved; these issues are identified in the article. For instance, it must be settled to what extent the opportunity cost in terms of foregone health for other patients is acceptable in order to uphold formal equality. We conclude that certain arguments can be set aside, and future focus should be put on the unresolved normative and empirical issues related to formal equality and opportunity cost. (shrink)

Clinical Pharmacology is a specialty with many attributes and our association with the subject has allowed us to acquire, apply and disseminate myriad aspects of research and practice. Though clinical pharmacologists are conspicuous by virtue of their small number, recent years have shown a growing need for the course. In the review below we navigate through several aspects of the subject as we encountered them from time to time. From critical appraisal of literature, to application of knowledge of drugs, (...) to clinical practice; moving on to clinical and basic research, to drug development process, to policy making - these are but a few of the many fields which constitute the scope of clinical pharmacology. The importance of the subject lies in allowing a trainee to develop a broad overview of the entire process, from drug generation to drug distribution to drug utilization, a process meant for the greater common goal of better health for all. We foresee a bright future for the subject though with a slight skepticism thrown in. In the present article, we make use of personal experiences and reference from literature to help you get a broad view of what clinical pharmacology means to us. (shrink)

Despite its lack of conceptual clarity and uniform definition, the term drug‐seeking is used frequently by nurses from a variety of practice environments. The drugs patients are referred to as seeking are often pain medications. This is important because nursing has widely adopted a patient‐centric definition of pain. Nursing also has a robust ethical code that places high value on human dignity and nurses’ role in patient advocacy. A review of literature was conducted with the aims of describing (...) whether/how the term drug‐seeking has changed over time and to determine whether the use of the term in nursing literature is consistent with nursing values. Use of the term has shifted from objective counts of patient requests for medication to a confusing mixture of observable patient behavior and subjective interpretations of patient motivation. Its use is not consistent with nursing values. It is, in fact, a good illustration of stigmatization in nursing. Stigmatization is contrary to nursing values. Nurses in practice, research, education, authors, reviewers, and editors all have a role in ending this stigmatization. (shrink)

Douglas N. Husak, Drugs and Rights. Cambridge: Cambridge University Press, 1992, vii + 312 pp.

Through the 1960s, many people claimed that drug advertising was educational and physicians often relied on it. Continuing Medical Education (CME) was developed to provide an alternative. However, because CME relied on grants, industry funders chose the subjects offered. Now policymakers worry that drug firms support CME to promote sales and that commercial support biases prescribing and fosters inappropriate drug use. A historical review reveals parallel problems between advertising and industry-funded CME. To preclude industry influence and (...) improve CME, we should ensure independent funding by taxing medical industries, facilities and physicians. Independent public and professional authorities should create CME curricula. An independent agency should allocate all funds to educational institutions for approved curricula. (shrink)

Public policy tries to promote appropriate drug use by allowing firms to market drugs in interstate commerce only for uses that the Food and Drug Administration has found to be safe and effective. Because of their medical knowledge, physicians are authorized to prescribe drugs even for uses unapproved by the FDA. Nevertheless, physicians have relied on drug firms for information on appropriate prescribing despite the inherent tension between drug firm dissemination of information to promote sales and (...) rational prescribing. In the past, physicians often relied particularly on drug firm advertising for information on drug use. Today, physicians rely on drug firms to finance continuing medical education. A historical review reveals connections between these two different ways commercial interests have influenced the information that physicians receive and points the way to needed reforms. (shrink)

Dr Peter Sjöstedt-H reviews Dr Andrew R. Gallimore's book, Alien Information Theory. -/- This was published on PsyPressUK on 13 June 2019.

Mark Kleiman, Against Excess: Drug Policy for Results New York: Basic Books, 1992. 474 pp. + xvi.

This important book was the first serious work of philosophy to address the question: Do adults have a moral right to use drugs for recreational purposes? Many critics of the 'war on drugs' denounce law enforcement as counterproductive and ineffective. Douglas Husak argues that the 'war on drugs' violates the moral rights of adults who want to use drugs for pleasure, and that criminal laws against such use are incompatible with moral rights. This is not a polemical tract but a (...) scrupulously argued work of philosophy that takes full account of all available data concerning drug use in the United States today. The author is careful to describe the properties a recreational drug would have to possess before the state would be justified in prohibiting it. Since criminal laws against the use of recreational drugs are justified neither by the harm users cause to themselves nor by the harm users cause to each other, Professor Husak concludes that such laws are, in almost all cases, unjustified. (shrink)

Brian Earp’s and Julian Savulescu’s provocatively titled “Love Drugs: The Chemical Future of Relationships” is a philosophically rigorous, scientifically informed, and yet wholly accessible study o...

Submission of study protocols to research ethics committees constitutes one of the earliest stages at which planned trials are documented in detail. Previous studies have investigated the amendments requested from researchers by RECs, but the type of issues raised during REC review have not been compared by sponsor type. The objective of this study was to identify recurring shortcomings in protocols of drug trials based on REC comments and to assess whether these were more common among industry-sponsored or (...) non-industry trials. (shrink)

U.S. law imposes strict recording and reporting requirements on all entities that manufacture and distribute controlled substances. As a result, the prescription opioid crisis has unfolded in a data-saturated environment. This article asks why the systematic documentation of opioid transactions failed to prevent or mitigate the crisis. Drawing on a recently disclosed trove of 1.4 million internal records from Mallinckrodt Pharmaceuticals, a leading manufacturer of prescription opioids, we highlight a phenomenon we propose to call data diversion, whereby data ostensibly generated (...) or collected for the purpose of regulating the distribution of controlled substances were repurposed by the industry for the opposite aim of increasing sales at all costs. Systematic data diversion, we argue, contributed substantially to the scale of drug diversion seen with opioids and should become a focus of policy intervention. (shrink)

The primary responsibility of the US Food and Drug Administration is to protect public health by ensuring the safety of the food supply. To that end, it sometimes conducts risk assessments of novel food products, such as genetically modified food. The FDA describes its regulatory review of GM food as a purely scientific activity, untainted by any normative considerations. This paper provides evidence that the regulatory agency is not justified in making that claim. It is argued that the (...) FDA’s policy stance on GM food is shaped by neoliberal considerations. The agency’s review of a genetically engineered animal, the AquAdvantage salmon, is used as a case study to track the influence of neoliberalism on its regulatory review protocol. After that, an epistemic argument justifying public engagement in the risk assessment of new GM food is outlined. It is because risk evaluations involve normative judgments, in a democracy, layperson representatives of informal epistemic communities that could be affected by a new GM food should have the opportunity to decide the ethical, political or other normative questions that arise during the regulatory review of that entity. (shrink)

This is a review and discussion of Ask Vest Christiansen’s book Gym Culture, Identity and Performance-Enhancing Drugs: Tracing a Typology of Steroid Use. As indicated by the title, the book...

Alzheimer’s disease (AD), the devastating and most prevailing underlying cause for age-associated dementia, has no effective disease-modifying treatment. The last approved drug for the relief of AD symptoms was in 2003. The recent approval of sodium oligomannate (GV-971, 2019) in China and the human antibody aducanumab in the USA (ADUHELM, 2021) therefore represent significant breakthroughs, albeit ones that are fraught with controversy. Here, we explore potential scientific ethics issues associated with GV-971 and aducanumab’s development and approval. While these issues (...) may be belied by socioeconomic and political complexities in the heady business of commercial drug development, they are of fundamental importance to scientific integrity and ultimately, welfare of patients. We posit that the push for approval of both AD drugs based on incomplete research and unconvincing marginal effectiveness is ethically unsound. Regardless of how both these drugs shall perform in the market for the years to come, the scientific ethics issues and potentially questionable research practices should therefore be duly noted and lessons learned. (shrink)

In many countries, health technology assessment organizations determine the economic value of new drugs and make recommendations regarding appropriate pricing and coverage in national health systems. In the US, recent policy proposals aimed at reducing drug costs would link drug prices to six countries: Australia, Canada, France, Germany, Japan, and the UK. We reviewed these countries’ methods of HTA and guidance on price and coverage recommendations, analyzing methods and guidance documents for differences in the methodologies HTA organizations use (...) to conduct their evaluations and considerations they use when making recommendations. We found important differences in the methods, interpretations of HTA findings, and condition-specific carve-outs that HTA organizations use to conduct evaluations and make recommendations. These variations have ethical implications because they influence the recommendations of HTA organizations, which affect access to the drug through national insurance and price negotiations with manufacturers. The differences in HTA approaches result from the distinct political, social, and cultural contexts of each organization and its value judgments. New cost-containment policies in the US should consider the ethical implications of the HTA reviews that they are considering relying on to negotiate drug prices and what values should be included in US pricing policy. (shrink)

In the United States, screening the urine of employees or job applicants for the presence of drugs has become commonplace. A survey of 794 large- and mediumsized companies, conducted by the American Management Association in January 1994, found that 87 percent of them now test job applicants for drug use. In 1987, a similar survey found that 22 percent screened job applicants. Federally mandated drug testing programs with random testing requirements affect millions of workers in the transportation industry, (...) the nuclear power industry, and the United States civil and military services.As some of these programs pass their fifth anniversary since being instituted, it is important to assess the forces that led to their creation. Whether or not these programs are considered successful depends on what one expects to achieve by such widespread testing. (shrink)

In the United States, screening the urine of employees or job applicants for the presence of drugs has become commonplace. A survey of 794 large- and mediumsized companies, conducted by the American Management Association in January 1994, found that 87 percent of them now test job applicants for drug use. In 1987, a similar survey found that 22 percent screened job applicants. Federally mandated drug testing programs with random testing requirements affect millions of workers in the transportation industry, (...) the nuclear power industry, and the United States civil and military services.As some of these programs pass their fifth anniversary since being instituted, it is important to assess the forces that led to their creation. Whether or not these programs are considered successful depends on what one expects to achieve by such widespread testing. (shrink)