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.

Continue reading “Is It Time to Reevaluate Off-Label Usage?”

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.

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

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]

Continue reading “The Human Thrift Store: An Introduction Into Organ Procurement and Donation”

Treating Gun Violence as a Public Health Problem: Exploring Intersecting Root Causes

By: Professor Christine Coughlin, Wake Forest University School of Law

Photo by Fabrice Florin

Run, hide in the closet.”  Little eyes fill with tears and arms stretch out. The teacher gives the children tootsie roll candies and whispers for them to be quiet.  A fifth-grade boy starts to pray.  The children all hold hands as the teacher hugs them.  They huddle in the closet in the music room and wait. . .  

That day, these children were all safe, thanks to the brave teachers and administrators who quickly instituted a lock down, the resilient children who stayed calm, and the fast-acting police force.  For this, I will always be grateful, as this was the scene described to me by daughter, now fourteen, about events that happened to her when she was ten.

I write, in part, because it helps me make sense of a world where alternative facts have become our reality.  However, there are no alternative facts for the events that took place this week in Parkland, Florida:  an 18-year-old with an assault rifle and 17 innocent lives lost.

Continue reading “Treating Gun Violence as a Public Health Problem: Exploring Intersecting Root Causes”

Let’s Honor the Mothers of Modern Gynecology

By: Katie Baiocchi, JD Candidate at Wake Forest University School of Law

Image from Pearson Museum, Southern Illinois University School of Medicine

In August, my Facebook News Feed was flooded with images of the violence and hate that descended upon Charlottesville, Virginia, motivated directly by controversy surrounding the protest and subsequent removal of Confederate monuments across the South. However, during this tumultuous time, one particular post[1] caught my attention because the monument being protested was not one erected to honor Confederate soldiers, but rather to honor the “Father of Modern Gynecology.” Furthermore, the statue being protested was not located in the South like the others, but rather Central Park, in the heart of New York City. The statue at issue celebrates a man who mutilated the bodies of black women without their consent, rather than memorializing and honoring the brave young women who suffered at his hands. I was deeply moved by the image before me and immediately disgusted by the fact that I had lived in ignorance so long about the horrors performed at the hands of Dr. James Marion Sims. Continue reading “Let’s Honor the Mothers of Modern Gynecology”

Their Stories Matter: Effectively Counseling Clients with Breast Cancer

By: Beth Gianopulos, Esq., Wake Forest Baptist Medical Center

In the early 1980s, when a woman was diagnosed with breast cancer it felt like a death sentence.  At least that was the way I felt, as a 10-year-old, when my mother told me that she had breast cancer.  I immediately thought, “My mom is going to die.” After the shock of the initial diagnosis, my mother discussed treatment.  She would have a mastectomy, and all of her lymph nodes would be removed.  The results of her surgery would set the course for additional treatment.

At the time, hospitals did not allow children in hospital rooms.  After the trauma of having her breast removed and recovering from a bad reaction to anesthesia, the only way that my mother could see me, her only child, was to come down to the public lobby in a wheelchair. As I look back now, I am impressed by my mother’s strength, and saddened by the healthcare provider’s lack of understanding.  Fortunately, with new developments like family-centered care, a situation like the one my mother faced has become a rarity in today’s hospitals.  Now, children are allowed to visit their mothers in their rooms, and we involve families in the care and decisions that are made.

Over the past 20 years, enormous strides have been made in the treatment of breast cancer.  Not only is breast cancer no longer a death sentence, but many women are able to have lumpectomies or less radical surgeries.  Reconstructive surgeries have improved, and the overall understanding of the physical impact of breast cancer has grown.  However, despite these strides, a diagnosis of breast cancer still carries with it huge emotional, spiritual, mental, and physical issues.  The legal community is now beginning to understand the complexity of these issues, including the legal issues that breast cancer patients face.  Because the impact of a breast cancer diagnosis is so personal, the best way to get a glimpse of the issues facing breast cancer patients is to speak to them and hear their stories.

With the background of my personal experience with breast cancer, I decided to interview breast cancer patients to identify three or four recurring themes related to their care and treatment.  I anticipated that the patients would face a number of emotional and other issues that they may not realize could have legal implications. Of course, these issues are not isolated to only breast cancer patients, but with my mother’s experience, I felt most familiar with their experiences and am emotionally vested in this specific topic.  However, I was not prepared for the wide range of experiences I learned about, and I quickly realized that while there are many common themes for the patients, each individual’s breast cancer journey is unique. Continue reading “Their Stories Matter: Effectively Counseling Clients with Breast Cancer”

Legality and Morality of Physician-Assisted Suicide: Perspectives on Choice in Relation to Theology, Conviction, and Medical Ethics

By: Milan K. Sheth, M.A. in Biomedicine-Eastern Mennonite University

The legality and ethics of palliative physician-assisted suicide (PAS) has been a controversial debate as individuals continue to question the righteousness of doctors assisting in the suicide of patients with a life expectancy of six months or less (1).

The purpose of this article is to explore the theological, ethical, and scientific perspectives of both sides of the debate; one side asserts that PAS protects those who are sick and promotes holistic health in the final stages of life, while the other side states that PAS is unethical, blasphemous, and sinful. Both arguments rely on exploring respect for individual autonomy; it is by choice and with recognition of the rights of competent people to choose the timing and manner of their death when faced with terminal illness. Continue reading “Legality and Morality of Physician-Assisted Suicide: Perspectives on Choice in Relation to Theology, Conviction, and Medical Ethics”

Community Event: Am I My Brother’s Medical Keeper?

Brothers Medical Keeper-2.jpg

The debate over the Affordable Care Act during President Obama’s administration and the ongoing debate over the future of the ACA today makes very clear how divided we are over who should fund health care and how, what it means to provide access to good quality health care, what choices individuals and families should have regarding their health care coverage, the obligations we have to others in our community, who counts as a community member, and the trade-offs we should make in shaping the U.S. health care system. At its heart, this divide is about differing views on what sort of good health care is, what it is for, and how a health care system should and can work.  But that value question is rarely addressed head on in debates about whether the ACA should be replaced and, if so, by what. The panel discussion and interactive demonstration we have planned will help us explore these issues as a community.

Dinner will be served from 5-5:30 pm. The panel and hands-on interactive demonstration will begin at 5:30 pm.

Registration is required and space is limited:  https://wfu.cvent.com/d/wtqkf4/1Q Continue reading “Community Event: Am I My Brother’s Medical Keeper?”

Better Babies: A Commentary on Modern Eugenics with the History of Virginia

Paco, Abiad.JPGBy: Paco Abiad, B.A. Global Public Health student at University of Virginia

I could feel it again – my mother’s gaze examining me as we sat at the coffee table. I had just updated her on my current medical status: my ongoing battle against the deadly duo of severe allergies and ever present eczema. I often joke of my unfortunate circumstances, but the one person who will never take my health lightly is my mom. She finally broke the awkward silence between us: “You know I’m so hard on you about your health because I feel guilty, right? I see you suffering and I feel responsible because I gave you bad genes.Continue reading “Better Babies: A Commentary on Modern Eugenics with the History of Virginia”