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 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]

Continue reading “The Disproportionate Impact of the COVID-19 Pandemic on Black Americans”

The Evergreen Forests of Insulin Patents

By: Connor Christensen

The prices of insulin have risen to unconscionable levels in just a little over two decades. What used to be a relatively minor expense for Americans with diabetes  has, for some, become an insurmountable obstacle to living a normal life, or, in some cases living at all. The purpose of this brief commentary is to address just one of the many issues attributed to the stark increase in insulin prices: patent evergreening.

People with Type I and Type II diabetes constantly depend on insulin injections to supplement their insufficient natural production of the blood-sugar regulating hormone in their pancreas.[1]  Without this hormone, a diabetic person’s life expectancy is short and riddled with many serious health complications.[2]  For many decades insulin was readily accessible and affordable for those who needed it.  Recently, however, things have changed.

Continue reading “The Evergreen Forests of Insulin Patents”

Sequence

Sequence

By

John Allen Riggins*

*The playwright has included a series of Director’s Notes throughout that are designed to aid the directors’ and actors’ insight into the science and symbolism of Sequence.

SCENE 1

THREE COUPLES, ALL OF SIMILAR AGE, ARE DOWNSTAGE LEFT, CENTER, AND RIGHT IN COMPLETE DARKNESS. A SPOTLIGHT FADES IN AND ILLUMINATES THE COUPLE STAGE LEFT. BOTH ARE LYING ON THE GROUND, AND SHE HAS HER HEAD ON HIS CHEST WHILE HOLDING AN ULTRASOUND.

THATCHER:

(RUBBING WIFE’S STOMACH) Poor thing, he got your forehead.

ADELAIDE:

And your grainy eyes! He’ll pull them off well enough though. Imagine what they’ll see, Thatch.

THE SPOTLIGHT DISAPPEARS FROM THEM AND RISES ON THE COUPLE DOWNSTAGE CENTER. THEY ARE SEATED IN CHAIRS ACROSS FROM A DOCTOR WHO HAS A PICTURE OF EDWARDS SYNDROME. THE HUSBAND HAS HIS ARM AROUND HIS WIFE AND BOTH ARE CRYING.

Continue reading “Sequence”

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”

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”

Environmental Federalism and the Protection and Preservation of Florida’s Coral Reefs

By: Charlee Fox, federal judicial clerk for the United States Court of Appeals

This commentary is an excerpt of a longer paper written for an environmental law course. 

Ten percent of the world’s coral reefs, including those found in Florida, have been destroyed beyond restoration.[1] It was estimated in 2000 that thirty percent of the world’s reefs were in critical condition.[2] Causes of corral reef depletion include: pollution, over-fishing and over-exploitation of resources, destructive fishing practices (e.g. dynamite fishing), dredging and shoreline modification (e.g. coastal development), vessel groundings and anchoring, disease outbreaks, and global climate change causing effects such as bleaching and mortality.[3] The coral reefs are protected by both state and federal regulations. Thus, it is relevant to analyze whether state regulations or environmental federalism have a greater impact on the conservation and protection of the United States coral reefs. Continue reading “Environmental Federalism and the Protection and Preservation of Florida’s Coral Reefs”