ethique_TM

Legitimising values

Mon, 23 May 2022 04:00:44 -0400

While apparently helpful concepts such as "best interests" appear to have the virtue of simplicity, they are really place holders for the communication, time and listening that’s required to understand what truly matters to patients and others involved in healthcare. When we know what matters to a patient, we can have confidence that we have a "legitimate" view of what’s important to them. Two papers in this issue of the Journal of Medical Ethics explore different ways in which values can be legitimised and applied consistently in healthcare.

When a patient can no longer say what it is that matters to them and a significant decision needs to be made, the values that will inform what should happen next need to be legitimised in some way. Common ways of doing that include proxy decision makers or advanced directives. In this issue Jacob Appel calls for the ways in which...

Trial by Triad: substituted judgment, mental illness and the right to die

Mon, 23 May 2022 04:00:44 -0400

Substituted judgment has increasingly become the accepted standard for rendering decisions for incapacitated adults in the USA. A broad exception exists with regard to patients with diminished capacity secondary to depressive disorders, as such patients’ previous wishes are generally not honoured when seeking to turn down life-preserving care or pursue aid-in-dying. The result is that physicians often force involuntary treatment on patients with poor medical prognoses and/or low quality of life (PMP/LQL) as a result of their depressive symptoms when similarly situated incapacitated patients without such depressive symptoms would have their previous wishes honoured via substituted judgment. This commentary argues for reconsidering this approach and for using a substituted judgment standard for a subset of EMP/LQL patients seeking death.

What money cant buy: an argument against paying people to get vaccinated

Mon, 23 May 2022 04:00:44 -0400

This paper considers the proposal to pay people to get vaccinated against the SARS-CoV-2 virus. The first section introduces arguments against the proposal, including less intrusive alternatives, unequal effects on populations and economic conditions that render payment more difficult to refuse. The second section considers arguments favouring payment, including arguments appealing to health equity, consistency, being worth the cost, respect for autonomy, good citizenship, the ends justifying the means and the threat of mutant strains. The third section spotlights long-term and short-term best practices that can build trust and reduce ‘vaccine hesitancy’ better than payment. The paper concludes that people who, for a variety of reasons, are reluctant to vaccinate should be treated like adults, not children. Despite the urgency of getting shots into arms, we should set our sights on the long-term goals of strong relationships and healthy communities.

Is the international regulation of medical complicity with torture largely window dressing? The case of Israel and the lessons of a 12-year medical ethical appeal

Mon, 23 May 2022 04:00:44 -0400

This is the account of an ongoing appeal initiated in 2009 by 725 doctors from 43 countries concerning medical complicity with torture in Israel. It has been underpinned by a voluminous and still accumulating evidence base from reputable international and regional human rights organisations, quoted below, and has spanned the terms of office of four World Medical Association (WMA) presidencies and two UN special rapporteurs on torture. This campaign has been a litmus test of whether international medical codes regarding doctors and torture actually matter, and are applied rigorously and even-handededly, particularly when compelling evidence incriminates a WMA member association. Our findings in the case of Israel suggest that this is not true, and that impunity largely operates. The WMA seems in partisan violation of its mandate to be the official international watchdog on the ethical behaviour of doctors. And as the IMA case demonstrates, by their inaction national medical associations or other regulatory bodies appear to function at base as buttresses and shields of the state.

The unnaturalistic fallacy: COVID-19 vaccine mandates should not discriminate against natural immunity

Mon, 23 May 2022 04:00:44 -0400

COVID-19 vaccine requirements have generated significant debate. Here, we argue that, on the evidence available, such policies should have recognised proof of natural immunity as a sufficient basis for exemption to vaccination requirements. We begin by distinguishing our argument from two implausible claims about natural immunity: (1) natural immunity is superior to ‘artificial’ vaccine-induced immunity simply because it is ‘natural’ and (2) it is better to acquire immunity through natural infection than via vaccination. We then briefly survey the evidence base for the comparison between naturally acquired immunity and vaccine-induced immunity. While we clearly cannot settle the scientific debates on this point, we suggest that we lack clear and convincing scientific evidence that vaccine-induced immunity has a significantly higher protective effect than natural immunity. Since vaccine requirements represent a substantial infringement of individual liberty, as well as imposing other significant costs, they can only be justified if they are necessary for achieving a proportionate public health benefit. Without compelling evidence for the superiority of vaccine-induced immunity, it cannot be deemed necessary to require vaccination for those with natural immunity. Subjecting them to vaccine mandates is therefore not justified. We conclude by defending the standard of proof that this argument from necessity invokes, and address other pragmatic and practical considerations that may speak against natural immunity exemptions.

Wrong question and the wrong standard of proof

Mon, 23 May 2022 04:00:44 -0400

I have two concerns about Pugh et al’s case that vaccine requirements without a natural immunity exception are unjustified.1 First, the scientific question they suggest must be answered to justify the policy is in my view the wrong one, or at least not the only relevant one. Second, the authors set up a standard for public health regulation that will be often (and specifically in this case) unattainable, risking paralysis of public health authorities.

Pugh et al suggest two legitimate bases for vaccine mandates: ‘the prevention of severe outcomes from COVID-19 and the reduction of viral transmission.’ Governments and employers have a legitimate interest in protecting the health of their citizens and workers, respectively. To maximally accomplish these goals, the relevant scientific question for whether people with prior infection should be subject to a vaccine mandate is: in persons who have been previously infected, does vaccination enhances...

No right answer: officials need discretion on whether to allow natural immunity exemptions

Mon, 23 May 2022 04:00:44 -0400

In their thoughtful, nuanced and interesting discussion, Jonathan Pugh, Julian Savulescu, Rebecca Brown and Dom Wilkinson argued that officials should recognise proof of prior infection as a valid exemption from vaccination requirements.1 This commentary agrees with parts of their analysis, but argues that the case for the exemption is less clear than the authors suggest, and the better approach is to allow officials flexibility: an exemption for natural immunity may be appropriate or may not.

In part, the disagreements may stem from different experiences in different societies. The authors are in the UK, and their experience may differ from the USA in multiple ways, three very glaring. First, the UK broadly used the AstraZeneca vaccine, which has higher risks than the mRNA vaccines, so our assessment of vaccine risks differs. Second, the UK has universal health insurance, so some of the access to testing issues that I...

Who commits the unnaturalistic fallacy?

Mon, 23 May 2022 04:00:44 -0400

According to G E Moore,1 we commit the naturalistic fallacy when we infer ‘x is good’ from non-evaluative premises involving x such as ‘x is pleasant’ or ‘x is desired’. On Moore’s view, the mistake is to think that we can reduce moral goodness to anything else or explain it in any other terms. We cannot analyse ‘good’, Moore thought, because goodness is simple, non-natural and sui generis.

If Moore were alive today, and if he were to ask contemporary bioethicists the right questions, he would probably find that many of them commit the naturalistic fallacy when they move from empirical premises to normative conclusions or when they articulate complex notions of the good. Pugh et al2 might commit the naturalistic fallacy themselves when they conclude that people with natural immunity to COVID-19 should be exempt from vaccine mandates because such exemptions would achieve desired...

Vaccine mandates need a clear rationale to identify which exemptions are appropriate

Mon, 23 May 2022 04:00:44 -0400

The rapid development and roll-out of COVID-19 vaccines has been a surprising success of the pandemic and has likely saved hundreds of thousands of lives. Although most people were eager to receive a vaccine, many jurisdictions introduced mandates to ensure rapid uptake in the population, especially among key workers including healthcare workers. In some instances, individuals who can prove they have recovered from COVID-19 have been exempt from vaccine mandates, but in other cases such exemptions have not been made. Pugh et al argue that such exemptions for those already immune ought to be included in COVID-19 vaccine mandates.1 They review the evidence on infection-induced and vaccine-induced immunity and show that that there is not evidence that vaccines offer better protection against severe COVID-19 or of SARS-CoV-2 infection (and subsequently risk of transmission). They argue that to treat people differently based on the source of their COVID-19...

Beyond individualisation: towards a more contextualised understanding of womens social egg freezing experiences

Mon, 23 May 2022 04:00:44 -0400

Recently, Petersen provided in this journal a critical discussion of individualisation arguments in the context of social egg freezing. This argument underlines the idea that it is morally problematic to use individual technological solutions to solve societal challenges that women face. So far, however, there is a lack of empirical data to contextualise his central normative claim that individualisation arguments are implausible. This article discusses an empirical study that supports a contextualised reading of the normative work of Petersen. Based on a qualitative interview study, we found that most women could make sense of this argument but addressed other concerns that are overlooked in the premises of moral individualisation arguments, for instance, the influence of relationship formation on the demand of egg freezing. Furthermore, women did not experience social egg freezing as morally problematic. Nonetheless, the interviewees pointed to a need of more societal solutions and even actively advocated for efforts to increase accessibility such as a partial reimbursement and better quality of information. The implications of these findings for empirical bioethics are discussed. While more research is needed, we argue that, in order to better address individualisation arguments and related ethical concerns, we need to contextualise normative evaluations within women’s moral reasoning.

Developing a competency framework for health research ethics education and training

Mon, 23 May 2022 04:00:44 -0400

Health research ethics (HRE) training programmes are being developed and implemented globally, often with a goal of increasing local capacity to assure ethical conduct in health-related research. Yet what it means for there to be sufficient HRE capacity is not well-defined, and there is currently no consensus on outcomes that HRE training programmes should collectively intend to achieve. Without defining the expected outcomes, meaningful evaluation of individual participants and programmes is challenging. In this article, we briefly describe the evolution of formal education in HRE, articulate the need for a framework to define outcomes for HRE training programmes, and provide guidance for developing HRE competency frameworks that define outcomes suited to their contexts. We detail critical questions for developing HRE competency frameworks using a six-step process: (1) define the purposes, intended uses and scope of the framework; (2) describe the context in which practice occurs; (3) gather data using a variety of methods to inform the competency framework; (4) translate the data into competencies that can be used in educational programmes; (5) report on the competency development process and results and (6) evaluate and update the competency framework. We suggest that competency frameworks should be feasible to develop using this process, and such efforts promise to contribute to programmatic advancement.

Should healthcare workers be prioritised during the COVID-19 pandemic? A view from Madrid and New York

Mon, 23 May 2022 04:00:44 -0400

While COVID-19 has generated a massive burden of illness worldwide, healthcare workers (HCWs) have been disproportionately exposed to SARS-CoV-2 coronavirus infection. During the so-called ‘first wave’, infection rates among this population group have ranged between 10% and 20%, raising as high as one in every four COVID-19 patients in Spain at the peak of the crisis. Now that many countries are already dealing with new waves of COVID-19 cases, a potential competition between HCW and non-HCW patients for scarce resources can still be a likely clinical scenario. In this paper, we address the question of whether HCW who become ill with COVID-19 should be prioritised in diagnostic, treatment or resource allocation protocols. We will evaluate some of the proposed arguments both in favour and against the prioritisation of HCW and also consider which clinical circumstances might warrant prioritising HCW and why could it be ethically appropriate to do so. We conclude that prioritising HCW’s access to protective equipment, diagnostic tests or even prophylactic or therapeutic drug regimes and vaccines might be ethically defensible. However, prioritising HCWs to receive intensive care unit (ICU) beds or ventilators is a much more nuanced decision, in which arguments such as instrumental value or reciprocity might not be enough, and economic and systemic values will need to be considered.

Framework for evaluation research on clinical ethical case interventions: the role of ethics consultants

Mon, 23 May 2022 04:00:44 -0400

Evaluation of clinical ethical case consultations has been discussed as an important research task in recent decades. A rigid framework of evaluation is essential to improve quality of consultations and, thus, quality of patient care. Different approaches to evaluate those services appropriately and to determine adequate empirical endpoints have been proposed. A key challenge is to provide an answer to the question as to which empirical endpoints—and for what reasons—should be considered when evaluating the quality of a service. In this paper, we argue for an approach that adopts the role of ethics consultants as its point of departure. In a first step, we describe empirical and ethical characteristics of evaluating clinical ethical case. We show that the mode of action and the explicit normative character of the interventions constitute two characteristics which pose challenges to the selection of appropriate quality criteria and require special attention. In a second step, we outline the way in which an analysis of the role of ethics consultants in the context of a clinical ethical case consultation services can account for the existing challenges by linking empirically measurable endpoints with normative theory. Finally, we discuss practical implications of our model for evaluation research.

Moral status of the fetus and the permissibility of abortion: a contractarian response to Thomsons violinist thought experiment

Mon, 23 May 2022 04:00:44 -0400

Judith Jarvis Thomson famously argued that abortion is permissible even if we accept that a fetus qualifies as a person and possesses a right to life. The current paper presents two arguments that undermine Thomson’s position. First, the paper sketches a contractarian argument that explores Thomson’s violinist thought experiment from behind a veil of ignorance, which suggests that if we had an equal likelihood of being an unwanted fetus and a pregnant woman, it would be rational for us to oppose abortion. Second, the paper discusses the hypothetical self-aborting fetus, a thought experiment that reverses the dependence relationship between a woman and a fetus. It is argued that in this scenario, where fetuses have agency of their own, Thomson’s position would counterintuitively prohibit a woman from temporarily curtailing the freedom of her fetus even to save her own life.

Abortion and the veil of ignorance: a response to Minehan

Mon, 23 May 2022 04:00:44 -0400

In a recent JME paper, Matthew John Minehan applies John Rawls’ veil of ignorance against Judith Thomson’s famous violinist argument for the permissibility of abortion. Minehan asks readers to ‘imagine that one morning you are back to back in bed with another person. One of you is conscious and the other unconscious. You do not know which one you are’. Since from this position of ignorance, you have an equal chance of being the unconscious violinist and the conscious person attached to him, it would be rational to oppose a right for detachment. Likewise, behind the veil of ignorance, it is rational to oppose abortions since you could be the fetus, Minehan claims. This paper provides a plausible reply to this argument.

Rawlsian justice in healthcare: a response to Cox and Fritz

Mon, 23 May 2022 04:00:44 -0400

Cox and Fritz state the central problem as the absence of a framework for healthcare policy decisions; but, they overlook the theoretical underpinnings of public law. In response, they propose a two-step procedure to guide fair decision-making. The first step relies on Thomas Scanlon’s ‘contractualism’ for stakeholders to consider whether, or not, they could reasonably reject policy proposals made by others; then in the second step, John Rawls’s principles of justice are applied to these proposals; a fair policy requires to pass both steps. I argue that Cox and Fritz misinterpret Rawls. His theory has two stages: first, public reason is used to generate principles of justice; second, public reason is used to interpret and apply these principles. The second stage requires that proposals are based on the principles of justice from the first stage, and these proposals have to be acceptable to reasonable persons. Thus, Rawls’s theory does not need Scanlonian supplementation. Moreover, the application of Rawls’s theory in Cox and Fritz’s model is confusing. In any case, the problems with applying Rawlsian justice to healthcare can be located elsewhere. First, Rawls’s theory would treat healthcare simply as a ‘primary good’ or resource. Social justice ought to, instead, consider healthcare as an opportunity, in the manner conceived by Amartya Sen. Second, Rawlsian justice rests, ultimately, on the conception of a reasonable person; until and unless the characteristics of reasonable stakeholders are clarified, any model of health justice will remain hostage to the unreasonable.

In defence of our model for just healthcare systems: why an explicit philosophy is needed in addition to the law, and how Scanlon helps derive just policies

Mon, 23 May 2022 04:00:44 -0400

In a recent response to our paper on developing a philosophical framework to guide the design and delivery of a just health service, Sarela raises several objections. We feel that although Sarela makes points which are worthy of discussion, his critique does not undermine either the need for, or the worth of, our proposed model. First, the law does not negate the need for ethics in determining just healthcare policy. Reliance on legal processes can drive inappropriate focus on ensuring policies avoid judicial review, as opposed to ensuring they are truly just; the law affords protection against unjust policies but does not put a commitment to avoiding them at the heart of policy-making. We defend the need for Scanlonian supplementation by emphasising the practical value of adding a step based on reasonable rejection, particularly in ensuring that the views of vulnerable stakeholders are robustly considered. We discuss the similarities and differences between the work of Daniels and Sen in considering the relationship between health and opportunity, concluding that Sen’s capability approach is both valuable and compatible with our proposed model. Finally, the practical use of our model requires consideration of what constitutes a reasonable person. Our model is explicitly intended to help develop a healthcare system which is just to all its users. With this in mind, we suggest that those involved in decision-making should meet Scanlon’s definition of reasonable: they should be motivated to justify their actions to, and seek agreement with, others.

Value assessment frameworks: who is valuing the care in healthcare?

Mon, 23 May 2022 04:00:44 -0400

Many healthcare agencies are producing evidence-based guidance and policy that may determine the availability of particular healthcare products and procedures, effectively rationing aspects of healthcare. They claim legitimacy for their decisions through reference to evidence-based scientific method and the implementation of just decision-making procedures, often citing the criteria of ‘accountability for reasonableness’; publicity, relevance, challenge and revision, and regulation. Central to most decision methods are estimates of gains in quality-adjusted life-years (QALY), a measure that combines the length and quality of survival. However, all agree that the QALY alone is not a sufficient measure of all relevant aspects of potential healthcare benefits, and a number of value assessment frameworks have been suggested. I argue that the practical implementation of these procedures has the potential to lead to a distorted assessment of value. Undue weight may be ascribed to certain attributes, particularly those that favour commercial or political interests, while other attributes that are highly valued by society, particularly those related to care processes, may be omitted or undervalued. This may be compounded by a lack of transparency to relevant stakeholders, resulting in an inability for them to participate in, or challenge, the decisions. The makes it likely that costly new technologies, for which inflated prices can be justified by the current value frameworks, are displacing aspects of healthcare that are highly valued by society.

Ethics briefing

Mon, 23 May 2022 04:00:44 -0400

British Medical Association launches new report on emerging threats to global health-related rights

On 7 April 2022 – coinciding with World Health Day – the British Medical Association (BMA) launched its new report, Health and human rights in the new world (dis)order.1 Written during the global upheaval triggered by the COVID-19 pandemic, and published just weeks after the Russian invasion of Ukraine, the report responds to a range of emerging and intensifying threats to health-related human rights globally.

As the report establishes, human rights in health and healthcare matter because human suffering, and its relief, are fundamental moral issues. As relief of human suffering is the primary purpose of medicine, it follows that doctors and other health professionals are often active in times of human challenge and extremity. During conflict, humanitarian crises, and, as we have so recently seen, global public health emergencies, health professionals are...

Suicide Risk Assessments: A Scientific and Ethical Critique

Sun, 22 May 2022 20:00:00 -0400

Abstract

There are widely held premises that suicide is almost exclusively the result of mental illness and there is “strong evidence for successfully detecting and managing suicidality in healthcare” (Hogan and Grumet, 2016). In this context, ‘zero-suicide’ policies have emerged, and suicide risk assessment tools have become a normative component of psychiatric practice. This essay discusses how suicide evolved from a moral to a medical problem and how, in an effort to reduce suicide, a paternalistic healthcare response emerged to predict those at high risk. The evidence for the premises is critiqued and shown to be problematic; and it is found that strong paternalistic interventions are being used more often than acknowledged. Using a Principles approach, the ethics of overriding autonomy in suicide prevention is considered. Ethical concerns are identified with the current approach which are potentially amplified by the use of these risk assessments. Furthermore, it is identified that the widespread use of risk assessments in health settings is equivalent to screening without regard to the ethical principles of screening. The essay concludes that this is unethical; that we should abandon the use of standardized suicide risk assessments and ‘zero-suicide’ policy; and that this may improve outcomes.

Response to Open Peer Commentaries: On Social Harms, Big Tech, and Institutional Accountability

Thu, 19 May 2022 23:10:06 -0400

The End of Roe v. Wade

Thu, 19 May 2022 23:07:57 -0400

The Right Recognition of Rights

Thu, 19 May 2022 08:08:53 -0400

Hastings Center Report, EarlyView.

Ethics & Behavior, Vol. 32 Issue 5 - Jul2022

Wed, 18 May 2022 07:44:22 -0400

Relational autonomy and the clinical relationship in dementia care

Mon, 16 May 2022 20:00:00 -0400

Abstract

The clinical relationship (or doctor-patient relationship) has been underexplored in dementia care. This is in part due to the way that the clinical relationship has been articulated and understood in bioethics. Robert Veatch’s social contract model is representative of a standard view of the clinical relationship in bioethics. But dementia presents formidable challenges to the standard clinical relationship, including ambiguity about when the clinical relationship begins, how it weathers changes in narrative identity of patients with dementia, and how the intimate involvement of family fits alongside a paradigmatically dyadic relationship. Drawing on work in recent feminist theory, a critique is offered of the standard clinical relationship in bioethics as underwritten by an individualistic conception of autonomy. An alternative view of the clinical relationship in dementia, one that embraces a relational account of autonomy, is put forward.

Seven Points for Athletes to Consider Before Using a Dietary Supplement

Sun, 15 May 2022 20:00:00 -0400

AMA J Ethics. 2022 May 1;24(5):E443-451. doi: 10.1001/amajethics.2022.443.

ABSTRACT

Performance-enhancing drugs (PEDs) have been used by athletes for as long as sporting competitions have existed. To protect the health and safety of athletes and promote fair play, banned substance lists were developed that include several classes of PEDs. Evidence shows that a majority of athletes use dietary supplement products to aid their training and support their health. Evidence also indicates that use of some dietary supplements carries a risk because the products may contain banned PEDs. Consumers and athletes should weigh a number of considerations before purchasing and consuming dietary supplements to protect their health, reputation, and the spirit of fair competition.

PMID:35575576 | DOI:10.1001/amajethics.2022.443

Reimagining Roles of Dietary Supplements in Psychiatric Care

Sun, 15 May 2022 20:00:00 -0400

AMA J Ethics. 2022 May 1;24(5):E437-442. doi: 10.1001/amajethics.2022.437.

ABSTRACT

Despite impressive pharmaceutical advances, mental illness remains a leading cause of suffering and disability. Although some dietary supplements appear to respond to some needs not met by prescription medications, several obstacles prevent their study or use. This article proposes government-supported review and safety monitoring of supplements' use in caring for patients with mental illness.

PMID:35575575 | DOI:10.1001/amajethics.2022.437

How Long Have Supplements Promised to Make Us Slim, Sexy, and Virile?

Sun, 15 May 2022 20:00:00 -0400

AMA J Ethics. 2022 May 1;24(5):E419-436. doi: 10.1001/amajethics.2022.419.

ABSTRACT

The American Medical Association's Historic Health Fraud and Alternative Medicine Collection provides a glimpse into the origins of America's cosmetic and supplement industry and the advertising practices that sustain it.

PMID:35575574 | DOI:10.1001/amajethics.2022.419

Which Features of Dietary Supplement Industry, Product Trends, and Regulation Deserve Physicians' Attention?

Sun, 15 May 2022 20:00:00 -0400

AMA J Ethics. 2022 May 1;24(5):E410-418. doi: 10.1001/amajethics.2022.410.

ABSTRACT

Patients expect that dietary supplements they purchase-and physicians expect that dietary supplements they recommend-are safe, accurately labeled, quality products. Since many dietary supplements, especially vitamins and minerals, are key parts of evidence-based interventions for patients with many conditions, illegal, fraudulent, adulterated, or improperly labeled products should be regarded as sources of clinical and ethical concern. Adverse events (AEs) can occur and, when they do, relevant data should be carefully collected and analyzed. This article considers how many physicians' and patients' confusion about dietary supplement regulation can undermine quality caregiving and responses to AEs. This article also summarizes a recent American Medical Association Council on Science and Public Health report on dietary supplement supply and marketing practices and on physicians' roles in guiding patients when dietary supplement use is clinically indicated.

PMID:35575573 | DOI:10.1001/amajethics.2022.410

What Should Dietary Supplement Oversight Look Like in the US?

Sun, 15 May 2022 20:00:00 -0400

AMA J Ethics. 2022 May 1;24(5):E402-409. doi: 10.1001/amajethics.2022.402.

ABSTRACT

Most American adults who use dietary supplements (eg, vitamins, minerals, plant and animal extracts, hormones, and amino acids) ingest them orally. The market for these products has grown rapidly and significantly over the last 25 years, but consumer protection regulations have not kept pace. In the United States, supplements' safety is regulated by the US Food and Drug Administration (FDA), but statutory limitations prevent the FDA from effectively regulating these products, exacerbate public health risk, and have generated numerous calls for reform. This article considers key features of reforms likely to strengthen the FDA's capacity to promote safety and consumer protection.

PMID:35575572 | DOI:10.1001/amajethics.2022.402

Does Regulating Dietary Supplements as Food in a World of Social Media Influencers Promote Public Safety?

Sun, 15 May 2022 20:00:00 -0400

AMA J Ethics. 2022 May 1;24(5):E396-401. doi: 10.1001/amajethics.2022.396.

ABSTRACT

Social media influencers promote a wide variety of products, including dietary supplements. Dietary supplements are regulated as foods, not drugs, by the US Food and Drug Administration and the Federal Trade Commission. This article details weaknesses in administrative and common law regulatory approaches to addressing some influencers' negligent misrepresentation claims about dietary supplements.

PMID:35575571 | DOI:10.1001/amajethics.2022.396

Is My Patient Taking an Unsafe Dietary Supplement?

Sun, 15 May 2022 20:00:00 -0400

AMA J Ethics. 2022 May 1;24(5):E390-395. doi: 10.1001/amajethics.2022.390.

ABSTRACT

Dietary supplements do not require premarket approval by the US Food and Drug Administration (FDA), yet they can have side effects; interact with medications, food, or other supplements; or be unsafe, so it is important for clinicians to discuss dietary supplement use with patients. This article provides an overview of dietary supplement requirements related to safety, manufacturing, labeling, advertising, and adverse event reporting; discusses tainted supplements and the FDA's and Federal Trade Commission's enforcement actions against dietary supplements; and offers recommendations to clinicians on matters of key clinical and ethical importance during clinical encounters.

PMID:35575570 | DOI:10.1001/amajethics.2022.390

What Should Clinicians Know About Dietary Supplement Quality?

Sun, 15 May 2022 20:00:00 -0400

AMA J Ethics. 2022 May 1;24(5):E382-389. doi: 10.1001/amajethics.2022.382.

ABSTRACT

Increase in dietary supplement use in the United States suggests a great need for clinicians to be aware of the range of supplements' quality parameters. Regulatory requirements exist, but specific quality parameters for each ingredient are not set by regulators. This article considers how clinicians can evaluate dietary supplement product quality, assess manufacturers' adherence to public quality standards, and encourage use of verification and certification programs.

PMID:35575569 | DOI:10.1001/amajethics.2022.382

Do You Know How to Assess Risks Posed by Over-the-Counter Vitamin A Supplements?

Sun, 15 May 2022 20:00:00 -0400

AMA J Ethics. 2022 May 1;24(5):E376-381. doi: 10.1001/amajethics.2022.376.

ABSTRACT

Dietary supplements are regulated as foods by the US Food and Drug Administration (FDA) and, despite their potentially harmful effects, are not subject to labeling rules that apply to prescription medications. This commentary responds to a case about vitamin A supplement safety. The commentary compares regulation of vitamin A-derivative prescription medications, such as isotretinoin, to regulation of high-dose vitamin A supplements, illuminating both products' potential for causing birth defects. Label analysis is key to educating patients about risks of vitamin A-containing supplements. The commentary also suggests the need for more FDA oversight of the dietary supplement industry.

PMID:35575568 | DOI:10.1001/amajethics.2022.376

How Does Cognitive Bias Affect Conversations With Patients About Dietary Supplements?

Sun, 15 May 2022 20:00:00 -0400

AMA J Ethics. 2022 May 1;24(5):E368-375. doi: 10.1001/amajethics.2022.368.

ABSTRACT

Many patients use dietary supplements but do not inform their clinicians. Some allopathic clinicians' conscious and unconscious cognitive and emotional biases against complementary and alternative medicine can affect whether patients disclose details about dietary supplement use, the quality of communication during clinical encounters, and the information clinicians draw upon to make decisions and recommendations. This article describes 6 cognitive biases that can influence patient-clinician communication and shared decision making about dietary supplements and suggests 6 ways to mitigate biases' negative effects on patient-clinician relationships.

PMID:35575567 | DOI:10.1001/amajethics.2022.368

How Should Clinicians Respond to Patient Interest in Dietary Supplements to Treat Serious Chronic Illness?

Sun, 15 May 2022 20:00:00 -0400

AMA J Ethics. 2022 May 1;24(5):E361-367. doi: 10.1001/amajethics.2022.361.

ABSTRACT

The Centers for Disease Control and Prevention's National Health and Nutrition Examination Survey data reveal that consumption of over-the-counter vitamins, minerals, and herbals is widespread. Many clinicians, however, lack critical information about their patients' use of dietary supplements. Particularly clinically relevant are supplement ingredients' interactions with prescription medications, supplements' questionable effectiveness in treating serious conditions, and their potential for causing harm. This article considers how clinicians might address dietary supplements' safety, efficacy, and appropriate use with patients.

PMID:35575566 | DOI:10.1001/amajethics.2022.361

Should Clinicians Prescribe Non-FDA Regulated Dietary Supplements When Caring for Children With Hypovitaminosis D?

Sun, 15 May 2022 20:00:00 -0400

AMA J Ethics. 2022 May 1;24(5):E353-360. doi: 10.1001/amajethics.2022.353.

ABSTRACT

Hypovitaminosis D is a prevalent micronutrient deficiency that can be severe and hard to treat in children with short bowel syndrome, a condition treated with substantial bowel resection. Surgically altered bowel anatomy then results in iatrogenic digestion and absorption limitations that require short- and long-term management and follow-up. Care of children with hypovitaminosis D standardly includes prescription dietary micronutrient supplementation, sometimes in irregularly high doses. This commentary responds to a pediatric case of vitamin D toxicity and suggests micronutrient-prescribing risk mitigation strategies in light of the absence of regulatory oversight of over-the-counter dietary supplements, inadequate insurance coverage, and easily available commercial retail products.

PMID:35575565 | DOI:10.1001/amajethics.2022.353

Should Clinicians Ever Recommend Supplements to Patients Trying to Lose Weight?

Sun, 15 May 2022 20:00:00 -0400

AMA J Ethics. 2022 May 1;24(5):E345-352. doi: 10.1001/amajethics.2022.345.

ABSTRACT

Helping patients lose weight can mitigate their risk of chronic disease and improve their quality of life. Over-the-counter dietary supplements for weight loss, however, are not reviewed or approved for safety or efficacy, nor does evidence support their clinical use. This commentary on a case suggests 3 reasons why clinicians cannot ethically recommend these supplements to patients: these products' safety and efficacy are unknown, ingredient lists might not be complete, and advertising could be misleading. This article reviews facts clinicians should know regarding over-the-counter weight loss products and explains how they can support, educate, and promote culturally and individually sensitive weight-management strategies.

PMID:35575564 | DOI:10.1001/amajethics.2022.345