RESUMO
Importance: Interest in administering psychedelic agents as mental health treatment is growing rapidly. As drugmakers invest in developing psychedelic medicines for several psychiatric indications, lawmakers are enacting legal reforms to speed access globally, and health agencies are preparing to approve these treatments. Meanwhile, US states, such as Oregon and Colorado, are making psychedelics available for supervised use outside the conventional health care system. Observations: Despite legal change and potentially imminent regulatory approval in some countries, standards for integrating psychedelics into health care have lagged, including norms for designing and implementing informed consent processes. Informed consent is complicated by the unique features of psychedelics and their means of administration. Because no governments have approved any classic psychedelics for general medical or psychiatric use, only clinical researchers have obtained informed consent from trial participants. Accordingly, there is an unmet need for informed consent processes tailored to the challenges of administering psychedelics in nonresearch settings. Conclusions and Relevance: Analysis of the challenges of designing and implementing psychedelic informed consent practices revealed 7 essential components, including the possibility of short- and long-term perceptual disturbances, potential personality changes and altered metaphysical beliefs, the limited role of reassuring physical touch, the potential for patient abuse or coercion, the role and risks of data collection, relevant practitioner disclosures, and interactive patient education and comprehension assessment. Because publicly available informed consent documents for psychedelic clinical trials often overlook or underemphasize these essential elements, sample language and procedures to fill the gap are proposed.
RESUMO
This Viewpoint discusses the Alabama Supreme Court's opinion on in vitro fertilization and how it plays into a larger push for fetal and embryonic personhood.
Assuntos
Política , Direitos Sexuais e Reprodutivos , Criança , Humanos , Alabama , Estados Unidos , Direitos Sexuais e Reprodutivos/legislação & jurisprudência , Estruturas EmbrionáriasRESUMO
This Viewpoint examines current state-level approaches to addressing the increased incidence of violence against health care workers, as well as how laws are adapting to protect health care personnel.
Assuntos
Pessoal de Saúde , Violência , Violência no Trabalho , Humanos , Violência/prevenção & controle , Violência no Trabalho/prevenção & controle , Governo , Política PúblicaRESUMO
This Viewpoint describes key provisions of the Pregnant Workers Fairness Act and discuss the proposed Equal Employment Opportunity Commission rule, as well as its application to health care employment in particular.
Assuntos
Emprego , Preconceito , Humanos , Gravidez , FemininoRESUMO
This Viewpoint discusses the litigation strategy of state-initiated lawsuits alleging illegal and immoral conduct regarding the pricing of insulin by pharmaceutical companies and pharmacy benefit managers.
Assuntos
Insulina , Humanos , Insulina/uso terapêuticoRESUMO
The Medicare Advantage Program, home to nearly half of the eligible Medicare population, has recently come under increased scrutiny. The Government Accountability Office called on the Centers for Medicare & Medicaid Services to monitor "disenrollment of MA beneficiaries in the last year of life, validate MA-provided encounter data, and strengthen audits used to identify and recover improper payments to MA plans." The House Subcommittee on Oversight and Investigations of the Committee on Energy & Commerce, dedicated a hearing to "Protecting America's Seniors: Oversight of Private Sector Medicare Advantage Plans." In addition, a recently conducted audit of the Office of the Inspector General of the Department of Health and Human Services raised concerns over "denials of prior authorization requests" and "beneficiary access to medically necessary care." In this article we consider the backdrop for the growing scrutiny of the MA program and the implications thereof to its future trajectory.
Assuntos
Medicare Part C , Idoso , Humanos , Estados UnidosAssuntos
Aborto Induzido , Turismo Médico , Gravidez , Feminino , Humanos , Acesso aos Serviços de Saúde , ViagemRESUMO
Recently in Israel, a woman was mistakenly implanted with an embryo that is genetically related to another couple. Unfortunately, this case is not an isolated occurrence, as other cases of embryo mix-ups have been reported in several countries, including the USA, China, the UK and various other countries within the European Union. Cases of mixed-up embryos are ethically and legally complex: the woman who carried the pregnancy and the woman who is genetically related to the resulting child-both of whom endured emotionally and physically demanding infertility treatments-along with their partners, may be unwilling to relinquish parental rights over the child.This article explores four possible approaches, found in numerous common law jurisdictions, which can be used to address cases involving embryo mix-ups. Our analysis reveals several avenues through which legal parentage can be established. It can be done through gestation and the marital presumption, genetic connections, by adhering to the principle of the best interests of the child, or by recognising multiple individuals as legal parents. We review the advantages and disadvantages of each approach, but we have one clear recommendation: resolving embryo mix-up cases should be done proactively through the establishment of legislation and guidelines, rather than relying on post hoc individual court decisions. Such legislation and guidelines should guarantee the consistency of values throughout diverse reproductive contexts and mandate that fertility clinics and medical professionals provide individuals with comprehensive information regarding the potential risks associated with assisted reproductive treatments.
RESUMO
In August 2023, a federal appeals court issued an opinion in Alliance for Hippocratic Medicine v FDA, a case wherein a group of antiabortion medical organizations and physicians have challenged U.S. Food and Drug Administration (FDA) approval and regulation of mifepristone. This opinion contained some good news for the FDA, drug makers, and patients: the appeals court declined to halt the marketing of mifepristone altogether (as the trial court judge would have). But the court also decided that the FDA's 2016 and 2021 actions expanding the indication for mifepristone, lowering the drug's dose, and loosening restrictions on its distribution and use were likely unlawful, and it thus affirmed the trial court's order staying these actions. In this article, we explain key aspects of the opinion to health care professionals and consider the ways in which the appeals court's reasoning and conclusions, if followed by the Supreme Court, could undermine abortion access and public health going forward.
Assuntos
Aborto Induzido , Mifepristona , Gravidez , Feminino , Estados Unidos , Humanos , United States Food and Drug Administration , Problemas SociaisRESUMO
This Viewpoint discusses benefits and risks of using conversational artificial intelligence platforms to deliver psychotherapy to adolescents.
Assuntos
Inteligência Artificial , Saúde Mental , Adolescente , HumanosRESUMO
Rules are needed for human research in commercial spaceflight.
Assuntos
Experimentação Humana , Sujeitos da Pesquisa , Voo Espacial , Humanos , Voo Espacial/ética , Experimentação Humana/ética , Experimentação Humana/legislação & jurisprudênciaRESUMO
In recent years, there has been rapid increase in the availability of elective sex selection via genetic testing of preimplantation embryos created through in vitro fertilization. We explore the standing of this ethically controversial practice in the context of a changing legal landscape after the Dobbs v Jackson Women's Health decision by the US Supreme Court.