Addressing the Organ Shortage

By Yadira Onate-Ayala and Razil Fernandes, Global High School Fellows (Signature School ‘24 — Evansville, Indiana + Dwight-Englewood School ‘24 — Cloister, New Jersy)

1. INTRODUCTION

Currently, “105,800 … men, women, and children [are] on the national transplant waiting list,” and about “17 people die each day waiting for an organ transplant.” Throughout the years, organ transplant processes and donation services have become more widespread. The history of laws regarding organ transplants dates back to 1983 with the National Organ Transplant Act, which came about due to growing concerns about demand, allocation, and payment for organs that were meant to go towards transplants. NOTA, in turn, authorized the creation of the Organ Procurement Treatment and Transplantation Network (OPTN), which is known as a “public-private partnership” that creates a link between the professionals involved in the United States’s donation and transplantation system. The system is often considered a complex web of organizations encompassing the HRSA, Centers for Medicare & Medicaid Services (CMS), Centers for Disease Control and Prevention, Food and Drug Administration, National Institutes of Health, and National Academies of Sciences, Engineering, and Medicine. This takes into account already established organizations within the United States, and the disparities only widen as borders are crossed. There is inequality amongst the different groups of individuals, including, but not limited to, their different locations, ethnicities, gender, and age. Tremendous research has explored and examined the role that these factors, in addition to other variables like financial hardships, have on the accessibility of organ transplant services, which may help to obtain a response to the following questions: To what extent do factors such as organ type, race, and location, as well as age and gender, affect disparities formed and the accessibility of organ transplants to patients? As a result, what can individuals and organizations do to reform the current established system to increase accessibility to transplants, keeping in mind these factors and financial hardships? Despite the various reasons that could arise, these factors of organ type, race, and location, as well as age and gender, tend to have a large impact on the inequity present and the lack of accessibility of organ transplants to patients. In order to reform the current system, individuals and organizations must advocate for new legislation and improvement upon the pre-existing legislation.

2. ORGAN TYPES AND PROFESSIONAL QUOTES

In the organ donation system of today, the amount of time, as well as the process and prices of each individual service that needs to be provided, greatly varies, often driving even greater inconsistency amongst individuals. The main organs taken into consideration include the kidney, liver, pancreas, heart, and lungs. The average wait for a kidney transplant is around 3–6 months, and that is if you have decided to go the route of finding a living donor, rather than a deceased donor. It also may take from 3–5 years for those that involve a deceased donor route. For kidney transplants, having the accessibility to a living donor will diminish the amount of time that one will have to wait in order to receive their transplant, as there will be a higher chance of getting the right blood group and a common tissue type, as well as antibodies that are more alike to those that were previously present in the receiver. Another factor to take into consideration is the difference between a living and a deceased donor for the kidney, as a live donor kidney will tend to be able to avoid having to go into dialysis from failure, while a deceased donor kidney is at a higher risk of needing even more quality care to survive on their own. Similarly, livers are the only other organ that can be donated from a live individual, which allows for a slight shortening of the wait as it reduces the time that it takes to find a match with respect to all the different factors. The average wait for a liver transplant can be anywhere from less than a month to over 5 years. However, for livers, the process is a bit more complicated, as the individual must be between the ages of 18 and 60 and must have an emotional tie of some sort to the receiver. For the pancreas, heart, and lungs, a deceased donor is required, which means that there must be a disparity between the waiting times of these organs and those of the liver and kidney. For the individuals needing a pancreas transplant, the average wait time in the New England area, which tends to have larger accessibility to these sorts of treatments, will be about 1 to 5 years (1 to 2 years if done in conjunction with another transplant, such as a kidney and a pancreas transplant at the same time), and this doesn’t take into account the outside factors that could affect the timeline. For example, blood type O or B will take significantly longer in comparison to blood type A or AB. Those in need of heart transplants, need more specialized matching, meaning that there really is no average time for the transplant to be received due to the multiple variables that can vary quite greatly from person to person. Factors that have to be looked out for in terms of being able to be matched are the extent of illness, antibody types and counts, blood type (as with every organ transplant), as well as this time body size and weight, which may affect the body’s ability to keep the heart functioning. In contrast with other organ transplants, lung transplants depend upon the urgency to receive either one or two lungs. When only one lung is needed, there will be a minimum of a two-year wait, whereas the wait can be up to three years in the case of two lungs. Sometimes, a patient may even consider a lung transplant from a living person close to death if possible, as this is often the transplant with the most complications and difficulty to recover for transplant, as it is highly susceptible. In addition, the complexity of the system means that it takes a long period of time for transplants to be approved. The current liver allocation policy included a 25-day public comment period; the 2017 liver allocation policy included two separate 62-day and 64-day public comment periods; and the current lung allocation policy had a retroactive 61-day public comment period (GAO, 2020).

A limitation with respect to these findings is the length of time that was available in which we were able to find the interviewees. Within the span of over a couple of months, we found that not many doctors or surgeons were available to participate in an interview that we were planning on setting up. Moreover, we decided to perform a systematic review of the literature and research case studies as well that had a significant role or outcome and advanced the world of the ethics of organ transplants.

3. RACE AND ETHNICITY AS FACTORS

The current system of organ-to-recipient matching is based on blood group and body size. A survey performed in 2019, known as the National Survey of Organ Donation Attitudes and Practices considered the opinions of the public on the organ transplant system. 86.3% of people agreed that “All people who need an organ transplant should be able to receive a transplant.” Despite this majority, multiple statistics serve as evidence of disparities in the likeliness of receiving an organ transplant. For instance, “black persons are almost three times more likely to develop kidney failure than whites in the United States but are significantly less likely to receive kidney transplants.” This further elucidates the wide dichotomy that exists between black individuals and other races.

In comparing white and black Americans: “the total number of white Americans on organ transplant waiting lists is about 1.4 times greater than that of Black people, but the number of candidates waiting for a kidney transplant is almost the same between the two groups.” Dr. James E.K Hildreth, president and CEO of Meharry Medical College, one of the colleges part of the HBCU consortium that created a new initiative last year to combat disparities, says, “By the time they [black candidates] get on the list, there’s a great deal of urgency. And because of the long waits, many of them, of course, don’t make it to get a transplant.” At the heart of this issue is the long-standing racial disparities in healthcare and the underrepresentation of black Americans in medicine, especially in the fields of doctors and transplant surgeons.

Moreover, Black candidates enter the kidney transplant waiting list with double the length of dialysis time than White candidates and consequently have increased medical urgency as evidenced by their increased risk of mortality without transplantation. It is likely that this disparity will only continue as the current kidney organ distribution system prioritizes those who have been waiting in line the longest rather than which cases are most urgent. This brings up the question of “What determines urgency?” and how, as a society, individuals can ethically re-engineer organ allocation methods to make them more fair and accessible to others.

Another study found that Hispanics, who are the “fastest-growing minority group,” frequently have conditions such as diabetes and hypertension that make them predisposed to developing kidney failure through end-stage renal disease (ESRD). Other factors that further the disparities in organ transplants are related, in particular, to living donor kidney transplantation (LDKT), which has been recommended over deceased donor kidney transplantation, as it often greatly decreases the wait time, as there is a higher chance overall of finding a match in a significantly shorter amount of time. In Chicago and Illinois, the Hispanic Kidney Transplant Program (HKTP) was implemented to make transplants both more accessible and more understandable for Hispanics, as there are often issues in translation about what exactly the procedures are and how to go about aftercare and such. For example, the program provides educational support to individuals and their families so that family members will be more likely to serve as living donors. The program also offers patients treatment in their preferred language either English or Spanish to bridge the disparity of speaking different languages. The results at Northwestern Medicine appeared highly favorable as the number of LDKTs that were performed grew from 100 to 174 after HKTP was introduced.

Asian Americans, another quickly growing minority group, have one of the lowest organ donation registration rates in the United States. While Asian Americans make up 8% of the organ waiting list, only 2.5% of deceased organ donors self-identify as Asian-American. Similar to Hispanics, the lack of knowledge about organ transplants contributed to low registration rates, which may be due to the misinformation that they may have been exposed to. Additionally, cultural values such as filial piety and the importance of keeping the body intact can play a role in determining if they will go through with these life-saving procedures. Other reasons for low rates include fears about organ transplantation and a lack of trust in the healthcare system. Religious reasons are becoming less prevalent today; however, other related barriers continue to permeate among Chinese and Korean Americans, in particular, which has led to a decrease in organ registration rates.

Data on transplants received by Native Hawaiians/Pacific Islanders reveal further healthcare inconsistencies within the different ethnicities and racial groups. The racial group is known to have high diabetes and obesity rates, as well as seven times greater instances of chronic liver diseases as compared to whites living in Hawaii. Though there is limited data on Pacific Islanders, current data points out that they receive kidney transplants at a rate four times lower than the rate at which they suffer from kidney failure. Countless Pacific Islanders have died as a result of waiting years to receive a transplant, of which there are countless reasons. For instance, a Micronesian patient in her late 20s was brought in by different family members for appointments and met all the strict criteria, but her application was denied because she did not designate one main caregiver. The specific medical facility ignored that caretaking is a big part of Hawaiian cultural norms. Another possible reason for the disparity in organ transplants received correlates with other criteria such as weight limits, no smoking, drugs, or drinking in excess. Donor rates are especially low with this group and this could be because so much of the population is likely to develop organ disease, leaving few with entirely healthy organs.

4. DISABILITIES AS A FACTOR

Many families’ worst fear is their loved one going through a denial of receiving a transplant due to a heart defect Down’s Syndrome or another invisible disability individuals are born with, such as autism. The United States enacted the Americans with Disabilities Act in 1990 to curb such discrimination and today 36 states have anti-disability discrimination laws in place. “Under state laws, patients can appeal to local courts for an emergency injunction or restraining order. These hearings can be conducted quickly, allowing a judge to decide whether to compel an institution to add a person to the transplant list”; This allows for more legal involvement in the healthcare system to prevent bias, and despite this, discrimination continues to persist heavily in the present day.

An example case study is the Kulczewski family. They had an eight-year-old son with Down Syndrome, named Malix, and were given three options when Malix went into heart failure: do nothing, perform corrective surgery, or do full repair. However, among these options, a heart transplant was not included. Malix’s parents, Tom and Michelle Kulczewski, were told that due to “reduced quality of life,” in reference to his Down Syndrome — a genetic condition that cannot be fixed, even through the current-day DNA test — their child would not qualify for a transplant. According to a CBS News article, “Tom and Michelle Kulczewski were the driving force behind Wisconsin Act 113 — also known as Malix’s Law — signed into law by Governor Tony Evers on December 3, 2021.” It was also found that “many physicians and organ transplant centers worry that patients with intellectual or neurodevelopmental disabilities are more likely to have co-occurring conditions that would make a transplant dangerous.” In reality, most patients with disabilities are typically just as physically able to benefit from an organ transplant as those without disabilities.

5. LOCATION AS A FACTOR

Figure 1. Global transplantation activities (organ transplants) in 2020

SOURCE: Global Observatory and Transplantation Map Production

Geographically speaking, South Africa has the least transplant activity across the board for kidney, heart, and liver transplants due to a handful of factors, which encompass the lack of knowledge, lack of organs, and presence of cultural or religious reasons (see Figure 1). In other words, organ transplants are often seen as taboo. America and Europe have the highest rates of transplant activities with Spain being second to the United States in 2021 and taking the reins as one of the top organ donation countries.

“A large part of Spain’s success comes down to the activity of the National Transplant Organization (ONT) and the implementation of the so-called Spanish model. This model comprises a series of measures aimed at encouraging organ donation and has made it possible to greatly increase the number of donors since it was first introduced. In fact, several countries have adopted this model to a greater or lesser extent.”

Such a model is helpful in creating more consistency within the organ transplant system and has created more stability and reliability as other countries follow Spain’s model.

5.1 HISTORY AND FUTURE OF TRANSPLANT SYSTEMS

Adopting the 2007 World Health Organization Regional Consultation recommendations of establishing national legal frameworks, self-sufficient organ donation and transplantation in each country, as well as transparent transplantation practice, and prevention of commercialized transplantation alongside national establishments of registries of organ transplantation are a proposed solution that could greatly improve the current systems of today.

In regards to the United States, the current transplant system functions under the Organ Procurement and Transplantation Network (OPTN), which creates policies to regularize and make a more efficient and equitable system for obtaining and distributing organs. The National Organ Transplant Act (NOTA), adopted in 1984, regulates OPTN and outlines the functions OPTN must perform, which encompass: “work[ing] actively to increase the supply of donated organs” and “carry[ing] out studies and demonstration projects for the purpose of improving procedures for organ donation, procurement, and allocation…and attempt[ing] to increase transplantation among populations with special needs, including children and individuals who are members of racial or ethnic minority groups and among populations with limited access to transportation.”

Such a goal acts as a starting point toward reaching greater equity; it denotes an action plan to combat organ transplant discrepancies among individuals across a varied assortment of ages and races that is more specific than what has been outlined in the past. According to the National Council on Disability, “there are six types of organs that can be donated through this system: the heart, lungs, kidneys, liver, pancreas, and intestine. UNOS/OPTN runs a national waiting list and creates the medical and geographic criteria that determine how the organs are matched with recipients.”

OPTN manages the ever-growing wait list of patients and, additionally, aids in collecting data for the various U.S. transplant centers. The OPTN board encompasses the many individuals who play a significant role in the transplantation process, including transplant physicians, transplant candidates, and the recipients themselves. Despite the advancement of the OPTN system since its integration, the United States is still a “complex web” of organizations that oversee the regulation of its organ transplant systems. During a testimony to the OPTN committee in 2021, Dr. Jayme Locke, an abdominal transplant surgeon at the University of Birmingham, commented on this messiness or complexity, stating, “We have to make our processes more nimble. I think everyone in this system, no matter who we represent, is all extremely well-intentioned. But, when we get it wrong, we have to own it and do better.”

The figure below maps the 5 main organizations involved with the approval process, which include the U.S. Department of Health and Human Services (HHS), the Health Resources and Services Administration (HRSA)/Health Systems Bureau (HSB)/Division of Transplantation, the Organ Procurement and Transplantation Network (OPTN), and also mentions the SRTR and OPTN Contractors and this role that they play in conducting services between the different organizations (see Figure 2).

Figure 2. Relationship between HHS, HRSA, OPTN, and SRTR Contractors and OPTN.

SOURCE: HRSA

Figure 3 outlines the OPTN policy development process and the extensive steps a proposal must endure in order to receive approval. While the inclusion of crucial variables such as public feedback during steps five and six is advantageous, the numerous steps involved due to so many various overseeing organizations causes it to take a long time to approve a policy. For example, a project on liver distribution redesign modeling in 2017 took 6.4 years from committee project approval to board approval. Recently, there has been a decrease in the amount of time required for such projects. A 2021 lung policy took 2.6 years to develop, not including implementation time. One recommendation to shorten the time further as precious lives are kept from receiving transplants would be to instill more strict timelines and deadlines throughout each step of the process. Another recommendation is that OPTN work with “an external organization, such as the NQF or the National Academy of Public Administration, with expertise in guiding federal programs through unique challenges in leadership and stakeholder collaboration.” Doing so could ensure priorities can be established so that issues that are more urgent are resolved earlier on.

Figure 3. OPTN Policy Development Steps Diagram

SOURCE: The National Academies Press

5.2: OTHER COUNTRIES’ SYSTEMS

Spain formed the Organizacio´n Nacional de Transplantes (ONT) under the Spanish Ministry of Health. The ONT emphasizes professional medical education for its doctors and is a highly organized system. It functions under a “presumed consent” model which assumes that the deceased is comfortable with organ donation if they never objected to it. Singapore, a country in Asia, also followed the presumed consent model since it was introduced in 1987, but as highlighted earlier, “a major barrier faced by Asian transplant programs is the difference in cultural and societal values and practices. For instance, the Confucian idea of keeping an intact body during funeral rites outweighs the importance of organ donation.” On the other hand, Africa has a weak framework in that there are “62 transplant centers across seven countries” which is an access barrier to treatment, along with “generally inadequate infrastructures, insufficient institutional support, lack of technical expertise, including competent human resources and technology.” Figure 4 aligns with Figure 1 in that the countries without national organization and policies surrounding organ transplants are largely the same countries with the least transplant activity.

Figure 4. Distribution of countries with a specific organization overseeing organ transplant system

SOURCE: Global Observatory and Transplantation Map Production

6. GENDER

Other disparities exist, namely gender. “Women are less likely to receive a liver transplant than men, regardless of other factors including race, geography, education, body mass index, and weight.”

A recent 2021 article pointed out that legislation has properly addressed the inequity in accessibility to transplants that women have experienced for more than two decades. For one, women encounter waitlist mortality at a higher rate than men, with waitlist mortality referring to the number of patients removed from the list due to death. A MELD (model for end-stage liver disease) score estimates “a patient’s chances of surviving their disease during the next three months.” Lower body mass contributes to women having a lower MELD score and serum creatinine levels as well since women have on average 17% lower levels of serum creatinine than men, leading MELD scores for women to be 1 to 2.4 points lower than men.

Also, frailty, a syndrome associated with physical decline, is more likely in women and is one factor that may explain the higher waitlist mortality as they have higher frailty on the Liver Frailty Index and doctors would be less likely to approve them thinking they would not benefit from the transplant. A small weight and overall size may also limit the organ transplant that is acceptable for women.

Another factor is height. Recipients under 165 cm (5’4) were around 10–15% less likely to receive a liver transplant. Even the women who were much taller received liver transplants at rates lower than men of the same height. One study found that short women faced higher organ offer decline rates compared to short men.

Still, regardless of the reasons stated above in correlation to weight and height, it was found that even tall women received liver transplants at a lower rate than men of around the same height. Likewise, small women were less likely to receive an organ transplant compared to similarly small men.

7. AGE

Age is a prominent factor in discrimination and bias exists against older patients as doctors may consider them less likely to survive post-transplant. A 2015 Yale Editorial noted that MELD does not take into account age. There are two proposed methods: age matching and age mapping. The latter method was tested and it turned out that the liver allocation strategy successfully “decreases the years of life lost (YLL) between younger and older recipients by 33% (from 12.3% to 8.3%) and achieves a 14% overall reduction in YLL (73 years).” On the other hand, with age matching allocation is random so allocation does not take into account how many candidates from one age group are receiving transplants compared to other age groups. As a result, “proportionally more organs go to candidates younger than the mean donor age (i.e., 55 years in the current study) and fewer organs go to older candidates.” The age mapping system, in contrast, is more fair as it “distributes livers proportionately to all age groups.” According to the editorial, the algorithm is designed to have candidates of any age be able to receive a transplant during any year. It ensures that there is a restriction from one age group receiving more or less liver transplants. Additionally, the National Health Organization in the UK believes that “Children and young people under 18 years of age have shorter waiting times than adults, on average.”

8. DEVELOPMENTS/INNOVATION AS POTENTIAL SOLUTIONS

Many scientists and politicians alike today have strived to inform individuals that attempting to build solutions to reduce the ever-growing number of individuals needing transplants “‘… doesn’t seem futuristic, it seems like the future is here now’” (CBS Mornings). In 2007, there was an adoption of the World Health Organization Regional Consultation recommendations to establish a national legal framework, self-sufficient organ donation and transplantation in each country, alongside transparent transplantation practice, and prevention of commercialized transplantation, which greatly aided the effort to reduce the waiting list number. Moving forward, in the future, an establishment of national registries of organ transplantation is essential to the process, in order to provide individuals with help for their specific organ transplant needs.

Just a year ago the push began towards animal-based transplants in order to supplement the growing number of individuals needing transplants. On October 21st, 2021, the US also saw the first genetically engineered pig kidney be transplanted successfully into a human body. This event surfaced at NYU Langone’s Transplant Institute and was led by the scientist Dr. Robert Montgomery, who was interviewed by CBS alongside a bioethicist, Dr. Art Kaplan. When asked about the ethical dilemma surrounding the usage of animal parts as a basis for humans, Kaplan simply believed that “we should be doing it more often.” From this, one can gather that Kaplan believes there isn’t much ethically wrong with using animal parts to help in the direction of reducing the number of individuals who need organ transplants. In order to make this process possible, scientists have been attempting to create a “genetically modified … pig kidney to make it more compatible, [since] the human immune system rejects organs from animals.” This is an astonishing step in the direction towards reducing the number of individuals that again need transplants, as using animals has the potential to greatly reduce the shortage that goes hand in hand with access to organs and organ grafts. Additionally, with pigs specifically, the organs tend to be anatomically similar to where a bit of genetic modification can help to fix any rejections that might arise. This idea of utilizing organs from animals, rather than waiting on donors to pass away and be a match “could mean that no one will have to die waiting for an organ anymore.”

3D Bioprinting is another innovative option that uses computer-aided design to create crosslinked models that are both flexible and viable options for building organs. Scientists are in the process of creating real-life organs like hearts that are fully functional.

Conclusion

With recommendations to enhance equity in the organ transplant system and even the possibility of animals for organ grafts, there still remain upgrades and improvements left to make in the realm of organ donation and transplantation around the world. Acknowledgment of the problem is the first step towards such advancements and the eventual redesign of organ transplant systems.