By Cameron Davies
Published 12:30 EST, Tues December 7th, 2021
The question I am aiming to answer is “Is modern-day US legislation on the allocation of organs for transplantation fair, or corrupt?“
For the past 67 years, the ability to donate viable organs to a recipient in need, known more commonly as organ transplantation, has been a life-saving treatment for those living on the edge of life. It is said to be ‘one of the greatest advances in modern medicine’(1): a second chance made possible by our predecessors, and saving the lives of thousands of people each year, by providing them with everything from bone marrow and corneas to hearts. But, with great advances comes great imperfection – whilst organ transplants give so many people the opportunity of a second chance, others die waiting for the organs they need; 21 people on the organ transplant list die every day in the US alone.(1) And with the unequivocally difficult decisions of allocation, many physicians ask themselves the question: is the current legislation fair? Is it just to prioritise other people for certain criteria? Although there has been much turmoil over the solution to these questions, UNOS claims to have the final system that satisfies all the controversy.
UNOS, the United Network for Organ Sharing, in collaboration with the OPTN, the Organ Procurement and Transplantation Network and the Congress of the United States governs the legislation and guidelines surrounding the status of different patients, and the distribution of the tiny supply of healthy organs around the country. Of course, there are several types of donations that can be made: one can make a directed donation to a friend or family, either alive (by giving their liver, nerves, or kidneys) or deceased. Finally there is kidney-pairing which can be performed (whereby a certain number of people donate their kidneys to others and swap), or non-directed donations can be made.(2) This makes the process of choosing what goes where incredibly difficult, and in the past, there have been several incidences where a great deal of uproar has been instigated by physicians and surgeons across the nation as a result of UNOS’ and OPTN’s failure to deliver a comprehensive and fair system of how organs should be donated to people who need it the most.
Although the first successful organ transplants were performed back in 1953, it wasn’t until the 1960s when the government got involved with producing solid regulations on how to allocate organs; this was due to an exponential rise in the demand for transplants.(3) A principle belief of the congress as well as the OPTN was striking a balance between ‘utility’ and ‘justice,’ a prospect which they considered ‘a struggle to provide.’(3)
What it means at heart is that when choosing how to give out the limited supply of organs, UNOS cannot just give them to the sickest patients, despite the length of time they spend waiting. Instead, whilst this is taken into account, they should also reason how beneficial an organ transplant would be in a pool of potential patients; for example, if a heart was to go to a 92-year old with poor vascular functionality, it would be rather wasteful, as it is likely the patient would need either a second transplant or would die soon after their procedure. Similarly however, giving a kidney to a patient who is non-emergent and could wait longer than someone who’s been on dialysis for months is a wreckless method of allocation similarly. Therefore, the controversy as to how to approach the sitaution arises. All the while, during this period, figures show that the number of people waiting for organs increases:
Figure 1. graph comparing the number of donors providing organs versus the number of patients waiting.(4)
This rise of demand is alarming and still in today’s society are we seeing an astronomical gap between the number of people needing organs and those giving them, despite all the other treatment options emerging in the present day.
Finally, the HHS final rule (US Department of Health and Human Services) of 1987 was set out to override all the current rules given by OPTN, ordering that organs should only be given to the sickest patients regardless of geographical location.(3) This was a surprising change of legislation and was only met with fire from the community of physicians across the country.
Although the prospect of giving organs to those that are in dire need of them sounds emotionally just, it is still not balancing the need for utility and justice, which was such a clear principle of the network prior to the HHS rule. Some statistics were given in addition to the verbal response, explaining that the death rates, number of ischemic organs due to transport, and status issues were changing disadvantageously:
Figure 2. graph showing survival rate decrease in years after transplant procedure. (5)
Figure 3. graph showing the number of days waiting for transplant based on medical status. (5)
Figure 4. projected change in patient waiting times for liver transplantation under HHS policy. (5)
UNOS made the decision to implement more organ-specific regulations that would look closely at the medical specifics behind each patient in order to make a decision as to what status they should be regarded as. This took the form of a 1A, 1B etc. system, however, the need to consider geographical location as well was a problem. The system used can be seen here:
Figure 5. A map of the US showing several patients and they’re medical information
also taking into account distance from the donor hospital. (7)
Figure 5 shows that the metric for medical urgency used is arbitrary – instead of an actual score, instead the rubric is ‘low,’ ‘medium’ and ‘high.’ It seems this may bring to light some fault with the legislation considering that a patient may be borderline between medium and high, but lose out on a transplant because they missed the criteria by a small increment.
This is continued with the candidate biology and 1 year survival after transplant thus showing that when putting all this information together in a table as shown here, it is incredibly difficult to make a decision which can be justified scientifically and reasonably, as a result of a lack of clarity from the system’s criteria.
However, in 2017, UNOS and OPTN emerged with a new system proposal as to the reform of organ transplantation, which was called ‘continuous distribution.’ The philosophy behind the change was that up until this period, as we concluded above, there was no single criterion available to judge whether a patient was worthy for a particular transplant, which made it difficult to decide whether a particular person met the parameters needed to make them deserving of the organ. The new system aimed to change that by using a points system to determine the status of a patient which took into account all of the criteria which would need to be considered for a transplant in one.(6) It was illustrated by UNOS as follows:
Figure 6. An equation showing all the factors taken into account to create the patient’s composite allocation score (6)
The composite allocation score first takes into account medical urgency, which is based on a number of specific scores, for example blood type, white blood cell count, and other advanced metrics used in everyday medicine. Post-transplant survival is also incredibly important as it allows the idea of utility to be considered in addition to justice, whereby their medical state and general health is taken into account to decide how long they would survive with the transplant. The candidate biology is another crucial piece of information to determine the score, which is basically the patient’s compatibility with the organ being donated; this refers to the possibility of post-transplant rejection (this is where the patient does not respond correctly to the organ, and it does not function correctly), which happens in 10-15% transplant patients.(8) If this evidence was not considered, the number of rejections would increase, making the system invalid again.
Patient access directly relates to recipients who are minors, or those who were donors before becoming patients. Finally, placement efficiency looks at the more budgetal approach to the transplant; the importance of making sure resources are not wasted when transporting and completing the transplant procedure is another factor of importance when determining the worthiness of a patient to be transplanted.(5) When taking this all into account, it is clear that by looking at a variety of vital factors the score is a more representative and finally strikes the balance between utility and justice.
UNOS claims that by implementing this policy, which was scheduled and completed first in January 2019 for lungs (and proceeded with other organs with the heart scheduled for January 2023), the utilitarian concept of giving the greatest benefit for the greatest people is satisfied, as well as creating a fair policy.(6) In addition, it proposes to correct the survival rates and transportation costs etc. which faulted the HHS policy. Although many will agree that this new policy is an almost perfect approach to organ allocation legislation, there are a few discrepancies within the OPTN regulations which remain ever-frustrating amongst the medical community based on other factors, which are yet to be addressed.
This revolves mainly around the conflict between lifestyle choices of recipients and whether everyone that needs a transplant deserves one regardless of what their medical status and other factors are.First argued by an article in 2014 by the Nursing Times, where it was argued that in a hypothetical situation, where a drunk driver perpetrated an accident, and both the victims and the driver himself needed a lung transplant, is it ethically right to deny the driver access to the organs despite him having a higher composite allocation score than the victims? (9) Of course, as with any ethical dilemma, there are two equal arguments suggesting that both the driver is still human and deserves equal treatment medically as any other person, but also the lack of justice is present through the denial of victims organs which could possibly save their life for someone who is reckless with it. Thus, this means the policies and regulations set out by the network, whilst appearing to be sound, have small issues which cannot easily be resolved – because, of course, it comes down to the emotions and opinions of each individual. Sometimes, it is possible to employ an ethics committee for one-off situations whereby a group of people, impartial to either patients, decide whether a particular patient should receive an organ or not, but, the unrelenting rule of medicine at the end of the day is that all people should be treated equally, despite their lifestyle choices.
That said, UNOS has made some changes to policies regarding what non-emergent patients are eligible for transplants, including a decision that smokers or alcoholics cannot be added to the transplant list unless they have been out of rehabilitation for at least 6 months. It seems to many that this is a sensible rule, and reduces the number of people receiving transplants who then go back to drinking and need another, thus limiting the resources available being wasted. However, it could be argued also that the 6-month period is not long enough to avoid the recipients going back to abusing alcohol following their transplant. (10) As a result, this gives us another reason why regardless of the policy changes, organ transplantation will always be a controversial form of treatment.
In conclusion, it is clear to see that incredible advances have been made in the U.S. regarding the policies and legislation surrounding organ transplantation – although the number of donors available will never match the number of people waiting for transplants, the new continuous distribution plan, pioneered by UNOS, which is now being implemented across the country, is a more clear and precise way of measuring the score of each patient and seeing exactly whether a patient deserves a transplant before another. This way, the previous HHS and OPTN policies, suggesting lower survival rates and lack of utility, are corrected, and the principles which were set out back in the beginning are being upheld in a way that makes it fair for everyone. However, the transplant allocation system brings the truth closer to us, that there isn’t always a ‘right’ decision in medicine, despite the ‘yes’ and ‘no’ nature of science. And, because of our ever changing society, there will always be someone who perceives it was wrong.
Cameron Davies, Youth Medical Journal 2021
(1) Cleveland Clinic (2000). Organ Donation Facts & Info | Organ Transplants | Cleveland Clinic. [online] Cleveland Clinic. Available at: https://my.clevelandclinic.org/health/articles/11750-organ-donation-and-transplantation.
(2) Anon (2014). Living Donation Facts and Resources from UNOS | Living Donor Transplants. [online] UNOS. Available at: https://unos.org/transplant/living-donation/.
(3) Van Meter C. H. (1999). The organ allocation controversy: how did we arrive here?. The Ochsner journal, 1(1), 6–11.
(4) UNOS (June 2, 1994) | The UNOS Statement of Principles and Objectives of Equitable Organ Allocation, pp. 165
(5) UNOS (May 1, 1998) Congressional Staff Briefing: Impact of HHS OFl“ Regulations.
(6) UNOS (2019). Organ distribution – UNOS. [online] UNOS. Available at: https://unos.org/policy/organ-distribution/.
(7) OPTN (2018). Continuous Distribution – OPTN. [online] optn.transplant.hrsa.gov. Available at: https://optn.transplant.hrsa.gov/governance/key-initiatives/continuous-distribution/ [Accessed 28 Oct. 2021].
(8) Donor Alliance. (2020). Preventing organ and tissue rejection. [online] Available at: https://www.donoralliance.org/newsroom/donation-essentials/preventing-organ-and-tissue-rejection/#:~:text=With%20these%20new%20medications%2C%20rejection [Accessed 30 Oct. 2021].
(9) Bedford, S. and Jones, E. (2014). Should lifestyle choices affect access to transplant? Nursing Times, [online] 23 Jul., pp.16–18. Available at: https://cdn.ps.emap.com/wp-content/uploads/sites/3/2014/07/230714-Should-lifestyle-choices-affect-access-to-transplant.pdf [Accessed 28 Oct. 2021].
(10) Hedin, M. (2019). Alcohol Relapse Rate Among Liver Transplant Recipients Identical Whether or Not There is A 6-Month Wait Before Transplant. [online] Johns Hopkins Medicine Newsroom. Available at: https://www.hopkinsmedicine.org/news/newsroom/news-releases/alcohol-relapse-rate-among-liver-transplant-recipients-identical-whether-or-not-there-is-a-6-month-wait-before-transplant.