Category: Patient Care

WASHINGTON, DC - OCT. 8, 2019: Rally for LGBTQ rights outside Supreme Court as Justices hear oral arguments in three cases dealing with discrimination in the workplace because of sexual orientation.

Affirming Nondiscrimination Rights: HHS Needs to Acknowledge a Private Right of Action for Section 1557 Violations

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By Cathy Zhang

Last week, on the heels of attacks on trans youth and their families in Texas, the Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR) issued a notice and guidance expressing support for transgender and gender nonconforming youth and highlighting the civil rights and privacy laws surrounding gender affirming care.

OCR all but names the Texas attacks as unlawful under Section 1557 of the Affordable Care Act, which prohibits discrimination on the basis of race, color, national origin, sex, age, and disability by federally funded health programs or activities. It notes that for federally funded entities, restricting medically necessary care on the basis of gender — such as doctors reporting parents of patients to state authorities — “likely violates Section 1557.”

The guidance directs those who have been discriminated against on the basis of gender identity or disability in seeking access to gender-affirming health care to file a complaint through OCR. HHS can go further, however, by formally acknowledging that individuals have a legal right to enforce Section 1557 when they have experienced prohibited health care discrimination.

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Healthcare concept of professional psychologist doctor consult in psychotherapy session or counsel diagnosis health.

A Precautionary Approach to Touch in Psychedelic-Assisted Therapy

The Petrie-Flom Center Staff Leave a comment

By Neşe Devenot, Emma Tumilty, Meaghan Buisson, Sarah McNamee, David Nickles, and Lily Kay Ross

Amid accelerating interest in the use of psychedelics in medicine, a spate of recent exposés have detailed the proliferation of abuse in psychedelic therapy, underscoring the urgent need for ethical guidance in psychedelic-assisted therapies (P-AT), and particularly relating to touch and consent.

Acknowledging the need for such guidance, McLane et al. outline one set of approaches to touch in a recent Journal of Medical Ethics blog. However, we find their piece at odds with the available information in the fields of P-AT and psychotherapy. We explain three major concerns: consent and autonomy, risk mitigation, and evidence and reasoning. In our view, these concerns merit a precautionary approach to touch in P-AT, given the current state of research on touch-based interventions.

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WASHINGTON MAY 21: Pro-choice activists rally to stop states’ abortion bans in front of the Supreme Court in Washington, DC on May 21, 2019.

Tennessee on My Mind: Reflections on the Reinstated Abortion ‘Reason Bans’

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By Cathy Zhang

In February, the Sixth Circuit Court of Appeals issued a one-sentence order allowing Tennessee’s “reason ban” abortion restrictions to go into effect. The restrictions make it a felony for a provider (or any other person) to perform an abortion if the provider “knows” the patient is seeking an abortion on account of the fetus’s sex, race, or probable diagnosis of Down syndrome.

The court below had previously enjoined the Tennessee law, which also includes a pre-viability abortion ban. This order leaves the previability ban in place while lifting the injunction on the reason bans; the reason bans will remain in effect until the Supreme Court makes a further ruling on abortion in Dobbs. In her dissent, Circuit Judge Karen Nelson Moore charged that the court’s order “subvert[s] the normal judicial process” and reflects a growing tendency of federal courts “to delay the adjudication of laws that significantly impair constitutional rights.”

Numerous health organizations, racial justice groups, and disability advocates alike have warned against the harms that the reason bans will inflict on people of color and disabled persons. Statements from these groups, along with 19 states and the District of Columbia, a host of constitutional law scholars, and other amici make clear that the law’s purported concern for marginalized groups belies an effort to restrict abortion access at the expense of pregnant people’s health and constitutional rights.

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Physical therapist helps person in wheelchair.

Balancing Patient Rights and Costs in Medical Malpractice Claims

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By John Tingle and Amanda Cattini

The issue of the high and increasing costs of clinical negligence (medical malpractice) in the National Health Service (NHS) in England has long been a contentious one. There are common themes in the debate. The economic arguments supporting reform explain that the NHS is spending a considerable amount of money out of its health budget on malpractice claims, which otherwise could be put into front line health care services.  While the economic arguments are important, others contend that the patient’s voice must be heard more widely in the reform debate. They emphasize that it is important to look deeper as to what compensation means to victims of clinical negligence, and caution against unnecessarily fettering patients’ reasonable pursuit of claims.

Two recently published reports provide several key perspectives on these issues.

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DUQUE DE CAXIAS,(BRAZIL),MAY,20,2020: doctors take care of patients with covid-19 and an intensive care unit (ICU) at hospital são josé specialized in the treatment of covid-19.

A Novel Approach to Crisis Standards of Care

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By Stephen Wood

The provision of scarce resources such as intensive care unit (ICU) beds, antivirals, and ventilators during this pandemic has been an ongoing topic of discussion. Repeatedly, states and hospital systems have considered implementing crisis standards of care, which establish triage protocols for scarce resources.

Though crisis standards of care are meant to provide an ethics-based approach to the complex process of allocating scarce health care resources, in reality, they fall short.

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Child with bandaid on arm.

Reflections on Procedural Barriers to Pediatric COVID Vaccine Access

The Petrie-Flom Center Staff Leave a comment

By Fatima Khan

When news broke last week that Pfizer-BioNTech was submitting for Emergency Use Authorization (EUA) a two-dose COVID vaccine regimen for children under 5 to the U.S. Food and Drug Administration (FDA), many parents felt a glimmer of hope after a long time.

Up until a few days before, the public was expecting approval to possibly drag into summer. While the regimen would likely require a third dose, it became a possibility that children could start getting some level of protection as early as March. Finally children were acknowledged during a time when their needs have often been neglected or even ignored.

The shift in the FDA’s decision process is a critical moment to reflect on how we got here, and what we should strive for to ensure children aren’t repeatedly left behind amidst our new COVID reality.

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Medical student textbooks with pencil and multicolor bookmarks and stethoscope isolated on white.

We Need to Evaluate Ethics Curricula

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By Leah Pierson

Health professions students are often required to complete training in ethics. But these curricula vary immensely in terms of their stated objectives, time devoted to them, when during training students complete them, who teaches them, content covered, how students are assessed, and instruction model used. Evaluating these curricula on a common set of standards could help make them more effective.

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New York, USA, November 2021: Pfizer Covid-19 Paxlovid treatment box isolated on a white background.

How to Fairly Allocate Scarce COVID-19 Therapies

Govind Persad Leave a comment

By Govind Persad, Monica Peek, and Seema Shah

Vaccines are no longer our only medical intervention for preventing severe COVID-19. Over the past few months, we have seen the arrival and wider availability of treatments such as monoclonal antibodies (mAbs), and more recently, of novel oral antiviral drugs like Paxlovid and molnupiravir.

The recent Delta and Omicron surges have made these therapies scarce. The Delta variant led the federal government to resume control over mAb supply and promulgate allocation guidelines. The Omicron variant exacerbated scarcity because only one of the currently available mAbs, sotrovimab, appears to be effective against it. While Paxlovid and molnupiravir are effective against Omicron, both will likely be in short supply for many months. Paxlovid is currently constrained by a lengthy manufacturing process. Molnupiravir — which is substantially less effective — is contraindicated for use in patients under 18 and not recommended for use during pregnancy.

To allocate COVID-19 vaccines, the CDC’s Advisory Committee on Immunization Practices, the National Academies of Sciences, Engineering and Medicine (NASEM), and the World Health Organization (WHO) identified ethical goals for prioritization, such as maximizing benefit and minimizing harm, mitigating health inequities, and reciprocity. These committees, particularly the NASEM and WHO committees, included ethics experts as well as experts in social science, biology, and medicine. Current federal guidelines for therapy allocation, in contrast, do not identify ethical objectives or involve ethics expertise.

In an open-access Viewpoint in Clinical Infectious Diseases, we identify ethical goals for the allocation of scarce therapies. We argue that the same ethical goals identified for vaccine allocation–in particular maximizing benefit, minimizing harm, and mitigating health inequities — are also relevant for therapy allocation. Because many people have now taken steps to mitigate pandemic scarcity, for instance by protecting themselves through vaccination, we argue that reciprocity is also relevant.

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Baby held in someone's arms.

Remember the Babies: The Need for Off-Label Pediatric Use of COVID-19 Vaccines

Carmel Shachar Leave a comment

By Carmel Shachar

As trials stall and the omicron variant surges, the U.S. Centers for Disease Control and Prevention (CDC) is failing parents by preventing off-label use of our existing COVID-19 vaccines in the under-five set.

The cries of frustration, anger, and fear from parents of small children have reached a new pitch amidst the ruckus of 2022. Parents of children under five years old need to navigate omicron-fueled rising pediatric hospitalization rates while their kids remain entirely unvaccinated. They must also juggle childcare and work responsibilities amid unpredictable, lengthy daycare and schooling closures. Give us the vaccine to help protect our kids, shorten quarantines, and keep children in care they all clamor.

But where are the vaccines for the pediatric set — the same vaccines that have been proven safe, both in adult populations and in older children? So far the story has focused on disappointing efficacy results and delays in studies from Pfizer and Moderna. But that is not the entire explanation for why parents of small children are blocked from vaccinating their offspring.

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