Digital Commons Network^™

Unpatenting Product Hops, Michael S. Sinha

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On July 9, 2021, President Joseph R. Biden signed Executive Order 14036 (“Promoting Competition in the American Economy”), which directed the U.S. Food and Drug Administration (FDA) and the U.S. Patent and Trademark Office (USPTO) to collaborate on new approaches to increasing competition and lowering prices in the pharmaceutical marketplace. In response, the USPTO outlined several new initiatives, among them an intent to improve the robustness and reliability of issued patents.

A major impetus for the Executive Order was the pervasive nature of pharmaceutical product hopping, which occurs when manufacturers introduce new follow-on versions of lucrative pharmaceutical products to the …

Reproductive Rights And Medico-Legal Education Post-Dobbs: A Fireside Chat, Michael S. Sinha, Anna Krotinger, Maya A. Phan, Louise P. King

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The Supreme Court’s 2022 decision in Dobbs v. Jackson Women’s Health Organization was a pivotal moment that reshaped the landscape of abortion policy and delivery of abortion care in the United States. To create a space for critical reflection on the implications of Dobbs for the teaching and learning of abortion care in both medical and legal education, the authors engage in a dialogue highlighting the varied perspectives of professionals and professionals-in-training in both the medical and legal professions. As new attacks on reproductive autonomy continue at both state and federal levels, we foreshadow a tumultuous landscape for abortion policy …

Ai Renaissance: Pharmaceuticals And Diagnostic Medicine, Ty J. Feeney, Michael S. Sinha

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The explosive growth of Artificial Intelligence (AI) in the modern era has led to significant advancements in the world of medicine. In drug discovery, AI technology is used to classify proteins as drug targets or non-targets for specific diseases, more accurately interpret and describe pharmacology in a quantitative fashion, and predict protein structures based on only a protein sequence for input. AI methods are used in drug development to generate predictive models for drug screening purposes, refine and modify candidate structures of drugs to optimize compounds, and predict a drug’s physiochemical properties, bioactivity, and toxicity. For medical devices, the advancement …

The Relationship Between Balance Confidence And Center Of Pressure In Lower-Limb Prosthesis Users, Gary Guerra, John Smith, Eun-Jung Yoon

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Background: Agreement between the activities-specific balance confidence scale (ABC) and center of pressure (CoP) in prosthesis users is still very much unknown. The purpose of this study was to investigate the agreement between ABC and CoP in lower-limb prosthesis users. Methods: Twenty-one individuals with lower-limb prostheses were recruited. Participants were provided with the ABC scale and performed static balance tasks during eyes opened (EO) and eyes closed (EC) conditions whilst standing on a force platform. Pearson product moment coefficients between CoP displacements and ABC scores were performed. Participants were also stratified by those who had better (≥80 on ABC scale) …

Promoting Pelvic Health: Strategies In Your Toolbox, Carlin D. Reaume, Lindsey Vestal

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No abstract provided.

The Psychology Of Science Denialism And Lessons For Public Health Authorities, Brenna Moreno, Molly J. Walker Wilson

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As it wreaked tragedy on the world, the outbreak of COVID-19 helped expose a pandemic of a different kind, one steeped in distrust and contrarianism. This movement, termed science denialism, has been lurking and undermining public health efforts for decades. Specifically, it is “the employment of rhetorical arguments to give the appearance of legitimate debate where there is none, an approach that has the ultimate goal of rejecting a proposition on which a scientific consensus exists.” Unlike skepticism, which is “doubt as to the truth of something” and works to progress both science and society, denialism is characterized by individuals’ …

Public Health Product Hops, Michael S. Sinha

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Pharmaceutical product hops are anticompetitive maneuvers that often represent a last-ditch effort by brand manufacturers to preserve market share in the face of generic competition. An integral part of product life cycle management strategies, product hops may offer marginal benefits to patients but can substantially increase costs to payers and patients alike. Yet industry advocates maintain that this is essential follow-on research and development, resulting in the development of novel products that would otherwise never reach the market.

Is there a middle ground between these two diametrically opposed views? Might certain product hops be considered beneficial, perhaps if they furthered …

Know Thyself: A Cultural Humility Framework For Diabetes Education For Lesbian, Gay, Bisexual, Transgender, And Queer (Lgtbq) Individuals, Katie Savin, Theresa Garnero

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The lesbian, gay, bisexual, transgender, and queer (LGBTQ) community is a diverse and vulnerable population that, aware or not, diabetes care and education specialists encounter on a regular basis. According to Smith and Gates’s analysis of the 2000 United States Census Data, gay and lesbian families live in 99.3 percent of all counties in the United States, which is likely an undercount. In Northern California, where LGBTQ visibility is better than in many places in our nation, it’s astounding to hear some colleagues comment that they only have heterosexual patients. You can’t “tell” who belongs to this group just by …

Pandemic Federalism, Cary Coglianese

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Legislators, agency officials, and the public have a lot to learn from the United States’ experience in responding to the COVID-19 pandemic. If policymakers take seriously their responsibility to identify past mistakes, and then act now to prepare for future viral outbreaks, the nation can do better in the next crisis. One needed change will take the form of clarifying the essential role for the national government and its leadership in responding to pandemics. The United States needs to create a structure for a pandemic federalism that temporarily but responsively allows for a reconfiguration of public health authority, such that …

What Covid-19 Laid Bare: Adventures In Workers’ Compensation Causation, Michael C. Duff

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This essay performs a close analysis of workers’ compensation coverage of COVID-19 and arrives at the conclusion that it should not be “impossible” to prove in a legal sense that an employee’s COVID-19 was caused by work. Scientific proof is not the same as legal proof: workers’ compensation law has never required that claims must be supported by irrefutable scientific proof of workplace causation. Yet repeatedly one heard this suggestion during public discussion on workers’ compensation coverage of employees.

Still, there is good evidence that even when workers’ compensation undisputedly covers work-related disease employers seldom pay benefits (and states do …

“Now I Feel A Little Bit More Secure”: The Impact Of Snap Enrollment On Older Adult Ssi Recipients, Katie Savin, Alena Morales, Ronli Levi, Dora Alvarez, Hilary Seligman

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In June 2019, California expanded Supplemental Nutrition Assistance Program (SNAP) eligibility to Supplemental Security Income (SSI) beneficiaries for the first time. This research assesses the experience and impact of new SNAP enrollment among older adult SSI recipients, a population characterized by social and economic precarity. We conducted semi-structured, in-depth interviews with 20 SNAP participants to explore their experiences with new SNAP benefits. Following initial coding, member-check groups allowed for participants to provide feedback on preliminary data analysis. Findings demonstrate that SNAP enrollment improved participants’ access to nutritious foods of their choice, contributed to overall budgets, eased mental distress resulting from …

Author Correction To: Corticostriatal Functional Connectivity Of Bothersome Tinnitus In Single-Sided Deafness (Scientific Reports, (2019), 9, 1, (19552), 10.1038/S41598-019-56127-1), Jennifer Henderson-Sabes, Yingying Shang, Philip L. Perez, Jolie L. Chang, Seth E. Pross, Anne M. Findlay, Danielle Mizuiri, Leighton B. Hinkley, Srikantan S. Nagarajan, Steven W. Cheung

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An amendment to this paper has been published and can be accessed via a link at the top of the paper.

Peer Teaching In An Interprofessional Education Activity Focused On Professional Skills Development., Tracey Delnero, Deepti Vyas

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The purpose of this study was to assess the impact of a peer-taught interprofessional education (IPE) activity on pharmacy and physician assistant (PA) student self-assessed confidence and attitudes related to professional skills. First-year pharmacy (n = 210) and PA (n = 45) students participated in a two-hour IPE activity. Forty-five teams consisting of one PA and at least four pharmacy students completed three peer-teaching stations focused on diabetes device education, pulmonary device teaching/case workup, and physical assessment skills. Students completed a pre- and post-activity confidence survey and a post-activity attitudes survey. For pharmacy students, highest confidence gains were …

Comparison Of An In-Person Versus A Virtual Interprofessional Education Activity Focused On Professional Communication., Tracey Delnero, Deepti Vyas

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Early provision of interprofessional education (IPE) is imperative to ensure effective communication between healthcare professionals. However, there are several barriers to offering adequate IPE, including space restrictions and lack of human resources, prompting exploration of alternative modalities. In 2019, an IPE activity was offered in person with 213 pharmacy and 45 physician assistant (PA) students participating in one-on-one team huddles focusing on managing an acutely ill patient. In 2020, the same IPE activity, including 194 pharmacy and 45 PA students, was offered virtually. Peer evaluations, an attitudes survey, and confidence surveys were administered to evaluate the impact of the IPE …

Erratum: Against Personal Ventilator Reallocation-Addendum (Cambridge Quarterly Of Healthcare Ethics : Cq : The International Journal Of Healthcare Ethics Committees (2021) 30 2 (272-284)), Joel Michael Reynolds, Laura Guidry-Grimes, Katie Savin

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No abstract provided.

Against Personal Ventilator Reallocation, Joel Michael Reynolds, Laura Guidry-Grimes, Katie Savin

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The COVID-19 (Coronavirus disease of 2019) pandemic has led to intense conversations about ventilator allocation and reallocation during a crisis standard of care. Multiple voices in the media and multiple state guidelines mention reallocation as a possibility. Drawing upon a range of neuroscientific, phenomenological, ethical, and sociopolitical considerations, the authors argue that taking away someone's personal ventilator is a direct assault on their bodily and social integrity. They conclude that personal ventilators should not be part of reallocation pools and that triage protocols should be immediately clarified to explicitly state that personal ventilators will be protected in all cases.

Psychosocial Determinants Of Health In Recreational, Tactical, And Competitive Athletes: Implications For Physical Therapists, Todd E. Davenport, John J. Fraser, Jenna Sawdon-Bea

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Neuromusculoskeletal (NMSK) injuries are ubiquitous in recreational, tactical, and competitive athletes. Many athletes who sustain a NMSK injury progress to develop chronic conditions that can limit physical activity and result in substantial long-term disability. Both social and psychological factors may drive care-seeking and treatment compliance following NMSK injury, as well as contribute to the chronification of injury. In turn, each of these factors could result in long-term cardiovascular consequences that contribute to morbidity and mortality over a lifetime. Physical therapists have a professional duty to work in communities, operational military units, and in competitive athletic programs to increase accessibility, foster …

How Ancestral Trauma Informs Patients' Health Decision Making, Tina K. Sacks, Katie Savin, Quenette L. Walton

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This article considers intergenerational trauma by drawing on the experience of a 37-year-old Black woman whose great-grandfather died as a result of involuntary involvement in the US Public Health Service Syphilis Study at Tuskegee. Although she never met her great-grandfather, the abuse, exploitation, and human rights violations he suffered at the hands of the US government profoundly influenced her health experiences. This article contextualizes her experiences in light of past medical abuse and microethics.

Vaccine Clinical Trials And Data Infrastructure, Ana Santos Rutschman

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We find ourselves at a momentous turn in the history of vaccines. The COVID-19 pandemic triggered a quasi-global vaccine race that not only compressed vaccine research and development (R&D) timelines, but also paved the way for the administration of a new type of vaccine technology – mRNA vaccines, which work in substantially different ways from the vaccines in use before the pandemic.

While the process of bringing emerging COVID-19 vaccines to market has taken place in an unusually short timeframe, it was largely predicated on the same scientific and regulatory processes that govern the development, approval and deployment of new …

Property And Intellectual Property In Vaccine Markets, Ana Santos Rutschman

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As biopharmaceutical forms of technology, vaccines constitute one of the most important tools for the promotion and maintenance of public health. Tolstoy famously wrote that [h]appy families are all alike; every unhappy family is unhappy in its own way.¹ Vaccine markets offer perhaps one of the most extreme embodiments of Tolstoy's principle² in the field of biopharmaceutical innovation.

Dental And Physical Therapy Faculty Collaborate In Assessing And Educating Dental Students On Musculoskeletal Disorders, Noëlle M. Santucci, Justin Jellin, Todd E. Davenport

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Introduction: Research shows 54% to 93% of practicing dentists suffer from musculoskeletal disorders (MSDs), with many developing afflictions early in their careers. Studies also show that dental students are developing MSDs early in their professional education. Objective: The research goal was to quantify the prevalence, anatomical location and initial onset of MSDs among first-year dental students. The study also assessed the students’ self-reported opinion as to whether there were enough educational touchpoints to improve their ergonomics in daily activities. Methods: At the conclusion of a 9-month preclinical restorative course, that included 2 lectures on MSDs, ergonomics, and postural cueing sessions, …

Is There A Cure For Vaccine Nationalism?, Ana Santos Rutschman

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“[V]accine nationalism . . . should serve as a reality check for the status of global health cooperation in the twenty-first century.”

Protecting The Rights And Wellbeing Of People With Disabilities During The Covid-19 Pandemic, Elizabeth Pendo

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The COVID-19 pandemic has exposed and exacerbated significant inequities experienced by people with disabilities. It has also emphasized the value of legal protections against discrimination based on disability. The Americans with Disabilities Act was enacted 30 years ago to eliminate discrimination against people with disabilities and ensure equal opportunity across major areas of American life (ADA, 2008). Together with an earlier law, the Rehabilitation Act of 1973 Rehabilitation Act, 2012), this landmark civil rights law impacts a broad range of issues raised by the COVID-19 pandemic and protects a large and growing number of Americans. This Chapter focuses on application …

Disparities In Health Care: The Pandemic’S Lessons For Health Lawyers, Danielle Pelfrey Duryea, Nicole Huberfeld, Ruqaiijah Yearby

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Population-level disparities in health and health care came to the forefront of U.S. public consciousness in 2020. As the racial, ethnic, and socioeconomic stratification of COVID-19 infection and death rates emerged with chilling clarity, the Black Lives Matter protests of the summer focused millions of Americans on the complex, structural nature of inequity and its long-lasting effects.

Access to quality health care is a “social determinant of health,” meaning that it is one of the “non-medical factors that influence health outcomes . . . the conditions in which people are born, grow, work, live, and age, and the wider set …

The Intellectual Property Of Covid-19, Ana Santos Rutschman

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The response to COVID-19 is indissolubly tied to intellectual property. In an increasingly globalized world in which infectious disease pathogens travel faster and wider than before, the development of vaccines, treatments and other forms of medical technology has become an integral part of public health preparedness and response frameworks. The development of these technologies, and to a certain extent the allocation and distribution of resulting outputs, is informed by intellectual property regimes. These regimes influence the commitment of R&D resources, shape scientific collaborations and, in some cases, may condition the widespread availability of emerging technologies. As seen throughout this chapter, …

Lessons Learned: Strengthening Medicaid To Address Health And Economic Emergencies, Nicole Huberfeld, Sidney Watson

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COVID-19 has disproportionately harmed low-income people, especially Black and Latino populations, seniors, and people with disabilities. Medicaid plays an essential role in providing coverage and access to care for these populations. As COVID-19 disrupted employment, earnings, and insurance coverage, Medicaid enrollment increased, in part because Congress offered states increased Medicaid funding in return for maintaining eligibility and enrollment for the duration of the public health emergency (PHE). At the same time, many states expanded eligibility and streamlined enrollment to assure that people could secure and keep coverage. Such policies resulted in more than 5.3 million more Americans having Medicaid coverage …

Covid-19 Employee Health Checks, Remote Work, And Disability Law, Elizabeth Pendo

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The Americans with Disabilities Act (ADA) prohibits discrimination against people with disabilities, about 61 million individuals in the U.S. The law’s protections in the workplace are especially important during COVID-19, which has worsened pre-existing disparities experienced by people with disabilities. The ADA also applies to new strategies to reduce the risk of COVID-19 infection in the workplace. This Chapter will focus on two strategies that impact individuals with and without disabilities – employee health screening, testing and vaccination policies, and new or expanded remote work programs.

Social Media Self-Regulation And The Rise Of Vaccine Misinformation, Ana Santos Rutschman

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This essay examines the main characteristics and shortcomings of mainstream social media responses to vaccine misinformation and disinformation. Parts I and II contextualize the recent expansion of vaccine information and disinformation in the online environment. Part III provides a survey and taxonomy of ongoing responses to vaccine misinformation adopted by mainstream social media. It further notes the limitations of current self-regulatory modes and illustrates these limitations by presenting a short case study on Facebook—the largest social media vehicle for vaccine-specific misinformation, currently estimated to harbor approximately half of the social media accounts linked to vaccine misinformation. Part IV examines potential …

Gaps In Worker Protections That Increase Essential Workers’ Exposure To Covid-19, Ruqaiijah Yearby

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States and localities designated more than 55 million Americans as essential workers. Essential workers not only comprise those employed by the health care and food and agriculture industry, but also include teachers, grocery store workers, transit and airline workers, mail and delivery workers, energy sector and utility workers, and domestic workers (Petition for Emergency, 2020). Racial and ethnic minorities are disproportionately employed as essential workers, with Black Americans the most likely to be essential workers (Petition for Emergency, 2020). Essential workers have been left vulnerable to workplace COVID-19 infections and deaths in large part due to the federal and state …

Administrative Law In A Time Of Crisis: Comparing National Responses To Covid-19, Cary Coglianese, Neysun A. Mahboubi

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Beginning in early 2020, countries around the world successively and then together faced the same rapidly emerging threats from the COVID-19 virus. The shared experience of this global pandemic affords scholars and policymakers a comparative lens through which to view how differences in countries’ governance structures and administrative responses affected their ability to manage the various crisis posed by the pandemic. This article introduces a special series of essays in the Administrative Law Review written by leading administrative law experts across the globe. Case studies focus on China, Chile, Germany, Italy, New Zealand, South Africa, and the United States, as …