Is It Time to Reevaluate Off-Label Usage?

by Aaron Johnston, WFU JD Candidate ’21

When I was just starting to move out of the “weed-out” engineering college courses—calculus, physics, circuits, and chemistry—and into the core tenets of bioengineering, one conversation with my professor has always stuck out in my mind. I had to write a final paper in the form of a National Institute of Health-style proposal. The goal was to think outside the box and attempt to put something together from the building blocks we had at the time. After one class, I wandered up to the front of the room, apparently with a half-concerned, half-perplexed look on my face.

          “What’s wrong?” my Professor asked.

          “Well, I wanted to run this methodology by you to see what you thought. I’m not sure it will work.” I started sketching out my revolutionary idea. I knew it wouldn’t live up to an NIH proposal, but nevertheless, I was proud of it.

          “. . . and then I’ll use BMP-2 to . . .”

          “Wait, BMP-2? I’d be careful about BMP-2, people have been having issues with it.”

          “But I thought BMP-2 was great for stimulating bone growth in mesenchymal stem cells.”

          “It is, but one thing you will eventually learn is that once people are afraid of something, research is stifled. Go take a look at Medtronic.”

I didn’t think much about that conversation at the time: it was right after new studies about BMP-2 had come to light. Four years later, however, upon entering my first torts class in law school and having our first discussion of products liability, the thought of Medtronic came to mind again. If BMP-2 was such a great, new, innovative method of stimulating bone growth, what could have possibly gone wrong? It turns out, a lot.

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Triggered

by Allison Spears, WFU JD Candidate ’22

The silence creeps in as the psychiatrist, Dr. Good, approaches my family in the waiting room. An uncomfortable pause and sideward glances are exchanged between us. The room feels like ice and smells like stinging alcohol. Nobody knows what to say or do at this moment. I mean, how could we? I know I never wanted to have to face something like this in my life. I can’t even imagine how my parents are feeling. The reality of my sister’s condition was frightening. Even more so because we were all in the dark for so long while she was struggling with something that we didn’t even know existed. The feeling was equivalent to how it feels when you are about to take the first plummet on a rollercoaster. My stomach felt like it was going to come up and out of my mouth. We all felt that way – uneasy and uncertain. Who would have known one event could put her in a downward spiral in the blink of an eye? I think we all blame ourselves.

***

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COVID-19 Has Laid Bare Our Inhumane Treatment of Incarcerated People and Their Families

by Kristen Kovach, WFU JD Candidate ’21

Michael opened his email on a dreary Tuesday morning. Casually scrolling through the spam messages between sips of coffee, his eyes paused on one message sent to him in the early hours of the morning. “I think your brother is dead,” the subject line read.

Michael froze. His heart pounded in his chest. Sweat beaded on his forehead and dampened his palms. His brother, Todd, had been in prison for drug possession since 2018. The brothers had not spoken in a while. But that’s because it’s just hard to get in contact with prisoners, Michael thought. There’s no way he’s dead.

The email came from his brother’s cellmate, Greg, who said that Michael’s brother had been sick for a while. Todd had been coughing terribly, complaining that his chest hurt, and suffering from a bad fever. Todd thought he had COVID. Two weeks ago, the medics came for Todd. Yesterday, the guards came for Todd’s belongings. Todd never came back.

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Right to Treatment During the COVID-19 Pandemic

By Oluwatemilorun Adenipekun, WFU S.J.D. Candidate ’21

COVID-19 is a serious global challenge, but it is also a wake-up call for the revitalization of universal human rights principles. Governments should ensure that response measures to this novel virus do not target or discriminate against any groups, and that responses are inclusive of and respect the rights of marginalized groups, including people with disabilities and the elderly. Also, governments should guarantee equal access to emergency services for these groups, while working on combating stigma and discrimination by using mass media and school networks to expand public awareness of human rights, recognizing that the virus knows no boundaries and recognizes no distinction.

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Let’s Continue to Reap the Benefits of Telehealth After the COVID-19 Public Health Emergency

by James Hughes, WFU JD Candidate ’22

Due to the infectious nature of COVID-19, our health care system has been forced to evolve in order to appropriately serve patients during this deadly pandemic. Before the public health emergency, roughly 13,000 Medicare beneficiaries received fee-for-service telehealth services per week, while almost 1.7 million Medicare beneficiaries utilized telehealth services in the last week of April, according to Centers for Medicare & Medicaid Services (“CMS”) data. Further, telehealth coverage should be a permanent fixture in our health care system, and the federal government should support telehealth coverage beyond the COVID-19 public health emergency.

Before the public health emergency, the U.S. Department of Health and Human Services (“HHS”) did not provide Medicare reimbursements for audio-visual telehealth visits unless the patient lived in a qualified rural area or was within the confines of certain medical facilities. Reimbursement has historically been the primary obstacle to telehealth services. The Telehealth Services During Certain Emergency Periods Act of 2020 allowed for HHS to modify or waive rules for telehealth under Medicare during the public health emergency, and recently, the American Medical Association asked President Trump, HHS, and Congress to extend some of the telehealth policies used during COVID-19 beyond this public health emergency.  

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North Carolina’s Extended Limits of Confinement: Woefully Underutilized in the Face of COVID-19

by Remy Servis, WFU JD/MA in Bioethics Candidate ’22

Amidst the 2020 COVID-19 pandemic in the United States, incarcerated people have been one of the most at-risk subgroups[1], contracting the virus at a rate five times higher than the national average.[2] Due to overcrowded conditions in prisons and jails, this population has limited opportunity to effectively socially distance, and infection rates are exacerbated by squalid conditions, limited testing, and violence within correctional facilities.[3] Incarcerated persons represent a more vulnerable sector of the population, reflecting the disparities in social determinants of health that affect groups more likely to be incarcerated: racial minorities, those with unstable housing, and those with mental illness.[4] In particular, prisoners over the age of fifty-five experience a uniquely threatening sum of risk due to the uncontroverted finding that COVID-19 has been particularly deadly to older adults, with 80% of deaths in US occurring in patients aged sixty-five and older.[5]

Early in the pandemic, advocates across the country began to call for the early release of incarcerated people who pose a low risk to society, including the elderly and nonviolent.[6] Scholars highlighted how this type of release would assist with “flattening the curve” by removing volume from correctional institutions which are “notorious incubators and amplifiers of infectious diseases.”[7] Regarding the provision of early release, North Carolina has two laws on the books: “Medical Release of Inmates”, passed in 2008 and codified at N.C. Gen. Stat. § 15A-1369, and N.C. Gen. Stat. § 148-4, which provides for state discretion in granting “Extended Limits of Confinement” (ELC). Both of these statutory options have their strengths and weaknesses, but the state has chosen to utilize its more amorphous powers under ELC to mitigate the release of select inmates. However, due to disappointingly narrow release criteria, only about 300 inmates (out of 34,000 total in state facilities) have been granted this ELC privilege.[8] Meanwhile, 3,000 inmates, or close to 10% of the prison population, have tested positive.[9] The ELC law, as it is currently formulated, is a lackluster response from the state of North Carolina to the threat of coronavirus in the state prison population. These ELC policies and eligibility criteria should be appropriately modified given the deadly context of this pandemic and any future virulent public health emergencies.

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Convalescing in the Era of COVID-19

by Carley Fisher, WFU JD Candidate ’21

COVID-19 reached U.S. shores sometime early this year; the first laboratory confirmed test was discovered on January 20, 2020 and reported to the CDC two days later.  To date, the number of COVID-19 cases in the United States has risen to over 8 million, with over 200,000 lives tragically lost.

The end of the disease is not yet in sight, and while countries have remained innovative in their approach to caretaking, an early concern still exists: will patients be able to obtain hospital access? This question is as important to non-COVID-19 related patients as it is to COVID-19 patients, and the issue becomes especially acute in the face of a pandemic surge.

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The Disproportionate Impact of the COVID-19 Pandemic on Black Americans

by Madison Woschkolup, WFU JD Candidate ’21

The impact of the COVID-19 pandemic on the United States is immense, but this impact has been disproportionately felt by Black communities. In thirty-three states and the District of Columbia, Black people comprise a higher proportion of COVID-19 cases relative to the percentage of the state’s population they make up.[1] In Maine, for example, Black people account for 21% of the state’s total COVID cases, even though only 1% of the state’s total population is Black.[2] In comparison, in all fifty states and the District of Columbia, the percentage of each state’s total COVID cases attributable to white people remains well below the relative percentage of white people in the state. This state-by-state trend extends nationally as well. As of June 2020, the Centers for Disease Control and Prevention (CDC) reported that 21.8% of COVID-19 cases in the United States were Black individuals, despite the fact that this group only represents 13% of the total population.

It is widely recognized that health outcomes of communities of color are objectively worse than those of white communities.[3] In addition to experiencing an increased risk of contracting the virus, Black Americans are also experiencing the highest actual COVID-19 mortality rates nationwide, more than double the mortality rate of their white counterparts.[4] As of August, 1 in 1,125 Black Americans has died from COVID-19, or 88.4 deaths per 100,000.[5] For perspective, the mortality rate for white Americans was 40.4 deaths per 100,000.[6] This gap only increases when the data are adjusted for age differences within the race groups.[7]

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Homelessness and COVID-19

by Nathalie Freeman, WFU JD/MA in Bioethics Candidate ’21

This year over half a million people in the United States are experiencing homelessness.  Between 25% and 50% of these homeless people work, and during the COVID-19 pandemic, many of these individuals are serving as low-wage essential workers.  Even without considering the current pandemic, individuals who consistently stay in homeless shelters, or live on the streets, have a lower life expectancy, higher rates of addiction, and more underlying health conditions.  With COVID-19 sweeping the country, homeless people are more vulnerable to the virus than housed individuals due to cramped conditions in homeless shelters, lack of access to basic sanitation materials, pre-existing comorbidities, and a general lack of access to health care.  Additionally, a large portion of the homeless population is elderly and already suffering from pre-existing conditions, like chronic heart or lung disease, which make them more likely to succumb to the coronavirus. 

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The Human Thrift Store: An Introduction Into Organ Procurement and Donation

By John Talbot, WFU JD/MA in Bioethics Candidate ’21

History

The first successful organ transplant occurred in 1954, when one twenty-three-year-old male donated his kidney to his identical twin brother.[1]  Since this first successful transplant, advances in science have allowed more widespread access to transplants, a greater variety of organs capable of transplantation,  and better longevity and transport of the organs.[2]  Following the exponential growth in organ transplant capabilities since the 1950s, there was a clear need for a national regulatory structure to govern the procurement and distribution of all donated organs.  In an attempt to address this issue, transplant professionals created the Southeast Organ Procurement Foundation in 1968, which subsequently developed into a fairly crude computer-based network in 1977 for sharing matching information.[3]  Understanding the need for a more uniform matching system that could be used across the nation, Congress passed the National Organ Transplant Act in 1984.[4]  This Act created the Organ Procurement and Transplantation Network (OPTN) which was required to be operated by a non-profit under a federal contract.[5] The United Network for Organ Sharing (UNOS) was initially offered the contract in 1986, and continues to administer the OPTN to this day.[6]

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