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Although prisons provide on-site primary care, the corrections system relies on external hospitals to provide a variety of healthcare services. Compared to the general population, incarcerated patients experience higher rates of chronic medical conditions, mental illness, substance abuse, cancer, traumatic brain injury, assault, and communicable disease. Certain specialties of clinicians are likely to encounter patients who are incarcerated, which makes it important for clinicians to understand how medical decision-making may differ when the patient is a prisoner. The corrections system retains custody of inmates and is responsible for their welfare, including facilitating necessary medical care. However, this does not permit corrections personnel or a warden to automatically assume the role of the patient's medical decision-maker. Except for narrow exceptions, prisoners do not lose their rights to medical decision-making. In some instances, corrections staff or the prison warden have improperly asserted authority to act as the patient's medical decision-maker, such as when the patient lacks decision-making capacity. This violates ethical principles of bodily integrity, respect, and fairness. This paper provides an overview of medical decision-making for incarcerated patients, how surrogate decision-maker hierarchies apply to incarcerated patients without decision-making capacity, and special considerations for this subset of patients. [ABSTRACT FROM AUTHOR]

Some stakeholders called on medical boards to sanction physicians for spreading misinformation during COVID-19 and discussing off-label medications. In 2022, California passed AB 2098, which classifies physician dissemination of misinformation as unprofessional conduct subject to discipline by the state medical board. This article describes the purpose and function of state medical boards, the law relating to off-label prescribing, and why using medical boards to discipline physicians for discussing controversial opinions exceeds the traditional role of state medical boards. Though physicians do have a duty to provide accurate information to the public, defining misinformation is difficult and poses five distinct problems. Although California's law was repealed, this article asserts that disciplining physicians for disseminating misinformation could pose Constitutional concerns, hinder physicians' ability to practice medicine, or suppress information that is important to the public interest. [ABSTRACT FROM AUTHOR]

Objective: To develop an ethically, legally, and clinically appropriate ventilator allocation policy for AdventHealth Tampa and AdventHealth Carrollwood in Tampa, Florida, which could be enacted swiftly during the Covid-19 pandemic. Methods: During Spring 2020, a subcommittee of the Medical Ethics Committee established consensus on the fundamental principles of the policy, then built on existing ethical, legal, and clinical guidance. Results : The plan was finalized in May 2020. The plan triages patients based on exclusion criteria (imminent mortality), prognosis and expected benefit of ventilation (using the Sequential Organ Failure Assessment), and change in prognosis over time. Decisions are made by committee in order to minimize moral distress among individual patient care providers. Conclusions: Due to international concerns about healthcare resource shortages during the Covid-19 pandemic, hospitals need allocation policies informed by the crisis standard of care, the hospital's ethical duty to plan for an emergency, and federal civil rights laws Policy Implications: This type of policy can serve as a model for other institutions to develop crisis standards of care resource allocation policies, which are a necessary component of disaster planning. [ABSTRACT FROM AUTHOR]

In 2016, Mylan made headlines when it spiked the price of its EpiPen AutoInjector by 400%, raising the price from an average of $57 to $500. Critics called the price hike "outrageous, "brutal" and "corrupt." Public outcries fueled a demand for a Congressional investigation, and Mylan negotiated a settlement with the United States Department of Justice over alleged violations of the False Claims Act. Although competition self-corrected and similar products entered the marketplace, this case - and other similar cases involving generic drugs and insulin - highlighted the skyrocketing costs of prescription drugs in the United States. In 2019, United States outpatient spending on prescription drugs totaled $369.7 billion. Despite massive expenditures, the United States ranks below comparable countries on health outcomes. This article traces the reasons for high medication prices; describes two key lawsuits alleging patterns of anticompetitive pricing, collusion, and fraud; and analyzes how corporate practices contribute to unnecessary and harmful healthcare costs through the pharmacological imperative. Industry practices described in this article reflect a pattern of organizational business ethics that contravenes market guardrails through both alleged and admitted dishonesty and illegal conduct. This article proposes solutions that will improve patient health, reduce healthcare costs, and uphold market fairness by reforming the expectations of corporate conduct. [ABSTRACT FROM AUTHOR]

In 2019, three-year-old Noah McAdams in Hillsborough County, Florida captured headlines when his parents stopped providing him chemotherapy for leukemia. His parents asserted they wanted alternative treatments, citing concerns about the side effects of chemotherapy. The state quickly intervened, removed Noah from his parents' custody, and ordered Noah to complete recommended treatment. Stakeholders often portray such cases in binary terms, characterizing parents as irrational for denying their child a life-saving medical treatment. Multiple articles in the literature describe similar cases: courts can intervene when (1) a child has a life-threatening medical condition, (2) there is an effective treatment, and (3) the benefits of treatment outweigh the risks. Deeper examination of these cases, however, reveals complex considerations: uncertainty of the child's diagnosis or prognosis, how to balance potentially significant treatment benefits with very serious risks, and varied success of treatment. Agreeing to a specific treatment may mean a potential chance at saving the child's life and the certainty of exhausting available medical interventions. But treatment interventions may also subject the child to unnecessary pain, serious risks, or suffering, without sufficient assurance the child will survive. Intervening in children's medical decision-making implicates a constellation of interests, including: familial privacy, the state's duty of parens patriae to protect children, and courts' determination of what constitutes the child's best interest. This article advocates for a model of resolution in pediatric decision-making cases that balances competing legal interests, provides de-escalation strategies, and establishes a procedural framework to improve clinical communication. [ABSTRACT FROM AUTHOR]

Whether physicians are being trained or encouraged to commit fraud within corporatized organizational cultures through contractual incentives (or mandates) to optimize billing and process more patients is unknown. What is known is that upcoding and misrepresentation of clinical information (fraud) costs more than $100 billion annually and can result in unnecessary procedures and prescriptions. This article proposes fraud mitigation strategies that combine organizational cultural enhancements and deployment of transparent compliance and risk management systems that rely on front-end data analytics. [ABSTRACT FROM AUTHOR]

As multiple stakeholders rush to address the opioid epidemic, federal policy definitively asserts Medication Assisted Treatment (MAT) constitutes the most effective solution and should be expanded to all persons with Opioid Use Disorder (OUD). This article traces how federal policy strategically collapsed different categories of persons who misuse opioids - those with physiological dependence along with persons with addiction - and why discounting relevant differences contradicts current research. Delving into controversial presumptions weaving addiction science, healthy policy, and law, this article explains the intersection between addiction and crime, personal choice and neurobiology, and analyzes how current evidence in fact demonstrates critical flaws underlying the premise of MAT. Media reports, litigation, and case law exemplify the tragic outcomes of MAT's failures when Opioid Treatment Providers offer insufficient care to address patients' underlying addiction. As a result, patients merely obtain an additional substance that fuels active polysubstance abuse, resulting in patient impairment undermining individual recovery and posing a threat to public safety and welfare. [ABSTRACT FROM AUTHOR]

The article focuses on the laws governing mitochondrial replacement therapy around the globe. Topics discussed include analysis of safety, efficacy, and risk related to mitochondrial biology, oocyte modification, and oocyte donation; enactment of Great Britain's Human Fertilisation and Embryology Act and Canada's Assisted Human Reproduction Act for addressing the same; and commercial interests of technological innovation.

The FDA does not conduct pre-market review of chemicals contained in cosmetics--which encompasses not only makeup but also numerous personal care products including shampoo, lotion, perfume, aftershave, and shaving cream. Every day, consumers use cosmetic products that contain a variety of synthetic ingredients, none of which the FDA has approved for safety but each of which are being ingested, absorbed, and inhaled into our bodies and accumulating in our tissue. Many of these products contain endocrine disrupting chemicals ("EDCs"), which emerging research links to an increased risk of cancer as well as immune and neurological dysfunction. This Article examines how the current risk-based regulatory system enables manufacturers to market products containing toxicants that cause preventable cancer while promising product safety. In addition to increasing cancer risk, EDCs have the potential to induce both epigenetic marks and transgenerational epigenetic damage, increasing the risk of cancer and widespread adverse health consequences for future generations never exposed to the toxicant. This Article asserts that we have an ethical duty to enact precautionary regulations governing cosmetics that would protect the integrity of the human genome against preventable, environmentally mediated damage. [ABSTRACT FROM AUTHOR]