Eva Nieder, MPH candidate

Spring 2006

Public Health and Policy Issues in Organ Transplant

Introduction:

In a given year, approximately 90,000 people are waiting for an organ transplant, while, on average, just under one-third of those expecting transplantation will actually receive the needed organ. The United Network for Organ Sharing (UNOS) maintains the national Organ Procurement and Transplantation Network (OPTN), through which organ donors are matched to waiting recipients 24 hours a day, 365 days a year. The major human organs that are recoverable for donation include the cornea, heart, lungs, liver, kidney, pancreas, and intestines. In addition, many tissues are also transplantable. Kidneys by far are the most common type of organ transplant. The prevailing issue surrounding organ donation is the scarcity of donor organs relative to the number of patients on organ donations waiting lists. For example, in the United States, the waiting list for organ transplant is around 90,000 people long¹. Many on the waiting list die waiting for receipt of a suitable organ². Further, more than 60,000 people await kidney donation and are listed on the United Network of Organ Sharing (UNOS) recipient registry, and nearly one-third of patients with willing donors are excluded from kidney transplantation because of blood-type and other incompatibilities⁵. Organs may come from people of all ages, both live and cadaveric donors. Cadaveric organs are those belonging to a brain-dead person whose families have consented to donate, while living donors are usually close relatives with compatible blood and tissue types. In general, organ transplantation is the optimal treatment for many types of end-state organ failure⁴.

According the U.S. Department of Health and Human Services, in August 2003, approximately 90,000 people were on the national organ transplantation waiting list, and each day, 63 people received and organ transplant, while 16 people on the waiting list died because organs were not available.

Organ	Frequency of Transplant (2004)	People on Waiting List
Kidney	15,999	61,623
Liver	6,167	17,269
Lung	1,173	3,692
Heart	2,016	3,187
Pancreas	603	1,685
Intestine	152	193
Heart&Lung	39	164
Kidney&Pancreas	880	2,462
Total Patients		88,176

Table 1. Most common organs transplanted in the U.S. and frequency of transplants. Approximate number of people on waiting list for cadaveric organs as of April 27,2005 included^8,9. This list excludes transplants of skin (grafts), cornea, and bone marrow, among those that are commonly transplanted.

Bioethical Issues in Organ Donation:

With respect to the notion of moral obligation, some groups oppose organ donation on religious grounds, though most world religions support organ donation as an act of charity benefiting humanity. Nonetheless, issues surrounding patient autonomy, living wills, and guardianship prevent involuntary organ donation¹. However, with respect to the organ shortage, there is a case for public health and public interest overruling patient autonomy. More clinical bioethical issues arise when considering priority for organ receipt. For example, in the cases of patients testing positive for HIV, with Downes Syndrome, alcoholics, and convicted criminals or inmates serving life-sentences, there is continuing debate over whether such patients should be eligible for organ transplantation. There are also extremely controversial issues regarding how organs, once available, are allocated between patients. For example, some believe that livers should not be given to alcoholics in danger of reversion, while some view alcoholism as a medical condition like diabetes¹.

Furthermore, there is the issue of the transplant trade outside the United States, referred to as the black market. It can be argued that the problem of the imbalance in the trade is attributed to the very fact that it is illegal. It can further be argued that the sole existence of the black market is on account of its ability to provide for an urgent need. As discussed, the wait for legal organs is indeterminable, as many die in the very process of waiting for a legal organ. However, because the black market is illegal, it cannot be regulated, and thus, the problematic imbalance, where those selling organs are often very poor and those making the purchase are often very rich, cannot be addressed. Yet it is unknown whether legalizing the organ trade would solve this (part of the) problem, since one component of the problem is satisfying the requirement of voluntariness as put forth in the Belmont Report (1974)⁶. That is, financial incentive, or payment for organ donation may pose an undue influence for obtaining the compliance to recover the donor’s organs.

Efforts aimed at legalizing the trade of organs and at keeping such trade illegal are matters of serious controversy. Paying people to donate organs is often proposed or justified as a way to increase the supply of organs and help the seller. For this reason, providing financial incentives to families has been proposed as a way to increase the supply of cadaveric organs in the United States¹⁰. Yet another alternative is to provide such a financial incentive to living-unrelated donors. In India, for example, the argument for the purchase of kidneys from living-unrelated donors justifies the practice as a way to save the life of patients with no other treatment options, while simultaneously helping the poor donor overcome extreme poverty. The argument is drawn further in suggesting that the seller has the right to choose the fate of his or her own kidney, and that taking away this option may financially harm the seller¹¹. Nonetheless, the argument against allowing the legal sale of transplantable organs is supplied by critics who present that purchasing organs amounts to exploitation of the poor, and that the poor do not overcome poverty as a result of the sale, and most of all, that this practice prevents a national cadaveric transplant program from being established¹¹.

The plausibility of applying such a proposal in the U.S. can be examined in the context of the economic and health consequences of selling a kidney in India, where the population is four times greater than that of the United States and only 15,000 kidneys are transplanted annually despite the 50,000 individuals on the waiting list for kidney transplant in India. Proponents of this proposal argue that incentives such as paying for funeral expenses will supplement the altruistic motivations of the donor. Nonetheless, public health concern about exploiting poor families exists, and so far, has prevented such proposals from being implemented in the U.S. Furthermore, the concept that paying for funeral expenses should do no more than supplement whatever altruistic motivations among the donor’s family that are already present is countered by the notion that such incentives will be most effective in weakening altruism¹⁰.

Public Health Recommendations:

Future demand for organ transplants is likely to continue to increase due to the rapid rise in some diseases, such as diabetes and hepatitis B and C, together with the aging population².

As people of all ages may be organ donors, an effective public health campaign that aims to increase the rate of organ donation will have to focus on changing policy at the national level as well as continuing to raise awareness among the general public of the need for increased donation and a change in policy that will be conducive to increasing donation.

With respect to the formation of an effective public health campaign to raise awareness, it is worthwhile to examine the reasons people have for not identifying themselves as donors, and to answer the general question about what stops people from donating. The Australian Bureau of Statistics provided a list of reasons Australians gave for not becoming organ donors. Among these reasons the following were cited: concern about being too old, concern that illnesses might cause a problem, concern about disfigurement of the body, followed by concern that such would be problematic for a funeral, concerns about religious views, concerns about the organ recipient and anonymity, concern that the donor’s family would have to bear costs, concern that the prospective donor might not receive the best possible medical care because of the donation agreement, and the concern that the prospective donor might not be dead¹.

There are a few approaches to addressing the shortfalls of the current system which include provision of a financial incentive for signing up to be a donor, an opt-out system, or policy of presumed consent, and social incentive programs such as LifeSharers or MatchingDonors, whose members sign a legal agreement to direct their organs first to other members of LifeSharers on the waiting list². However, it must be noted that there is a cost for membership in such social programs, and data regarding the cost-effectiveness of membership with respect to time and better outcomes for patients utilizing such services is limited and is yet to be determined.

The Kidney Paired Donation program at Johns Hopkins is an example of a hospital-based program that is working to increase access to suitable organs with respect to time, in what appears to be a highly effective manner. Hopkins’ effective plan allows more people to get the transplants they need, and is likely to dramatically cut health care costs, reduce disruptive and unnecessary travel for patients, and insure that transplanted kidneys have the best possible chance of survival⁵. All in all, this program increases both the number and quality of transplant, while providing the scaffold for an optimized national kidney-paired donation program.

In Japan, both legislation and public health campaigning has increased the number of organ transplant operations being performed. Organ transplants from brain-dead donors have become more frequent since the enforcement of the Organ Transplant Law, which defines brain death as actual death for purposes of organ donation in October 1997. The increasing frequency of transplants can be attributed to the dissemination of donor cards, which indicate a person's willingness to donate his or her organs in the case of brain death. The number of people possessing donor cards has more than tripled in the past 5-6 years, suggesting a rapidly deepening understanding of the issues among the people of Japan¹².

Since the enforcement of the law, the Japan Organ Transplant Network, which undertakes the registration and selection of patients to receive donated organs, and the Health Ministry have been distributing the cards in municipal government offices, public health offices, and other facilities around the country. About 45 million cards had been distributed by the end of May 1999. Since then the cards have also become available in convenience stores, and there are donor seals that can be attached to a driver's license. English-language cards and explanations have also been made for foreigners living in Japan.

“The holder of a donor card indicates on the card whether he or she (1) agrees to donate organs after brain death, (2) agrees to donate organs after the heart ceases to function, or (3) does wish not to donate organs. In the case of either (1) or (2), the holder also circles the organs that he or she agrees to donate. Once the carrier signs the card, it becomes valid as written evidence under the law¹².”

Another example of a successful program is found in Spain’s national transplant system. As one of the most successful programs in the world, however, Spain still experiences the same shortage of organs experienced in the U.S., the demand outstripping the supply. The Spanish system is remarkably effective for reasons which include its national policy of presumed consent, where every corpse may provide organs unless the deceased person has explicitly rejected being an organ donor upon death. Despite this being law, Spanish doctors still ask the family for permission, which is similar to the practice of American doctors. Still, Spain possesses a network for communication and transport that allows for quick extraction and transplant across the country¹.

United States law leaves the regulation of organ donations up to the fifty states, though national policy requires that the donor make an affirmative statement during the donor’s lifetime expressing the wish to be an organ donor. Thus, the practice of one identifying oneself as an organ donor remains an opt-in system in the U.S., in contrast to the opt-out system utilized in Spain¹. Therefore, a successful public health campaign in the U.S. would entail legislation that would change regulation of organ donation to require the organ donor to make a negative statement to confirm wishes to not be a donor. This opt-out system, in place of the current opt-in system, may still allow for family consent to be sought as a safety measure. However, the issue of whether a family’s wishes may override the wishes of the donor exists. Currently, as states have attempted to encourage organ donations by allowing consent to be explicit by means of placing the affirmative statement on the state-issued driver’s license, at the time of the patient’s death the family’s wishes, if in opposition to donation, are respected. Thus, the policy of presumed consent may include an additional stipulation allowing for the wishes of the donor’s family to be regarded insofar as to protect and not oppose the donor’s wishes.

Presently, the best way for a potential organ donor’s wishes to be carried out can be facilitated if the potential donor states intent to be an organ donor on the driver’s license, fills out a donor card and carries it at all times, and tells family, loved ones, the primary health care provider, lawyer, and religious leader of intent to be a donor. It is recommended that the U.S. Public Health system be more aggressive in the issuance of donor registration cards, perhaps, following in the example of Japan where the spread of donor cards has been an important factor contributing to growing awareness of transplant-related issues. In Japan, the cards, about the size of an ordinary business card and easily carried around, indicate whether the holder is willing to donate his or her organs in the case of brain death¹².

In addressing the issues surrounding organ transplant, the priority is to increase the number of donors. Simply put, public health campaigns to do just that aim toward passing legislation in favor of presumed consent, and increasing public knowledge by supplying information to the public about donor participation. Public information includes addressing the reasons why people do not donate, in the example of Australia, in order to dispel prevalent myths, and increasing awareness so that as national understanding is deepened, the supply of available, medically suitable organs can increase, as in the example set forth by Japan’s Health Ministry. Public health campaigns for prevention exist in order to reduce the need for transplants. However, these public health campaigns are the same already employed to target specific unhealthy behaviors. For example, the campaigns against smoking, drug and alcohol abuse, and other behaviors which are risk factors for diabetes and hepatitis, which create the need for organ transplant.

One part of the transplant process evaluates the patient’s fitness, in a sense, to undergo the transplant operation. Recipients of organs are evaluated upon the likeliness that they will survive not only the operation, but live for several more years following transplantation. In a sense, who receives the organ for transplant is determined at least partially, if not mostly, by which patient among the many on the waitlist, in a sense, will be able to best “care for” the organ. For example, the probability of adherence, or compliance to medication, is considered in predicting the recipient’s likeliness to adhere to immunosuppressant therapy. Immunosuppressant therapy is required for the remainder of the recipient’s life in order to prevent the recipient’s bodily rejection of the organ, and consequently render the transplant process undergone for that patient futile.

In 1972, the End State Renal Disease Act paved the way for Medicare coverage of all kidney transplants and coverage for the cost of immunotherapy medication for up to 5 years post-operation. Because those undergoing transplant require immunotherapy for the remainder of their lives, the cost-effectiveness of extending this 5-year period of coverage must be investigated on a case-by-case basis. The end of this 5-year period is the most critical for the transplant recipient on account of the increased and combined probability of the transplanted organ failing around the same time the transplant recipient has become unable to afford the medication that makes living with the organ possible. Critics of this 5-year supply restriction propose that the poor are consequentially less likely to receive kidney transplants based on the priority for transplant assigned to those who can survive as caretakers of the organ received for the longest duration possible.

The transplantation process involves series of steps related to medical suitability (one component of matching), interest in transplantation, pre-transplant workup, and movement up a waiting list to eventual transplantation. Further, there are many different barriers to transplantation among blacks, the women, and the poor⁴. For example, the barriers encountered at each step of the process leading up to cadaveric kidney transplantation are responsible for sociodemographic differences in access. Therefore, it is recommended that efforts to allocate organs equitably address each step of the transplant process⁴.

Figure reproduced from A.R. Sehgal’s The Net Transfer of Transplant Organs across Race, Sex, Age, and Income in the American Journal of Medicine, 2004. The net transfer of organs (percentages and 95% confidence intervals) across income. Unless otherwise indicated, the specified organs are from cadaveric donations. Among seven of eight types of cadaveric transplants, there was a net transfer of organs from lower-income donors to higher-income recipients⁷.

For More Information¹:

1. Transplant Living at http://www.transplantliving.org/
2. The United Network for Organ Sharing (UNOS) at http://www.unos.org/
3. The National Kidney Foundation at http://www.kidney.org/
4. Students for Organ Donation at http://www.studentdonor.org/
5. The President’s Council on Bioethics at http://bioethics.gov/
6. Living Donors at http://www.livingdonorsonline.org/
7. The Centers for Medicare and Medicaid Service at http://www.cms.hhs.gov/home/medicaid.asp

http://www.cms.hhs.gov/center/esrd.asp

8. Organ Donor Card, download and print at www.organdonor.gov/newdonorcard.pdf

There are no age limits on who can donate. However, if under 18, guardian’s consent is necessary.

9. Immunobiology, 5^th Edition. C. Janeway
10. Robbins & Cotran Pathologic Basis of Disease, 7^th Edition. V. Kumar, N. Fausto, A. Abbas.
11. Harrison’s Principles of Internal Medicine, 15^th Edition. E. Braunwald, A.S. Fauci, D.L. Kasper, S.L. Hauser, D.L. Longo, J.L. Jameson

References:

1. http://en.wikipedia.org/wiki/Organ_donation

2. http://www.parliament.uk/documents/upload/POSTpn231.pdf.

3. www.kidney.org

4. G. Caleb Alexander, MD; Ashwini R. Sehgal, MD. Barriers to Cadaveric Renal Transplantation Among Blacks, Women, and the Poor. Journal of American Medicine. 1998;280.

5. http://www.hopkinsmedicine.org/Press_releases/2005/04_19b_05.html

6. http://ohsr.od.nih.gov/guidelines/belmont.html#goc1

7. Ashwini R. Sehgal, MD. The Net Transfer of Transplant Organs across Race, Sex, Age, and Income. American Journal of Medicine. 2004; 117.

8. U.S. Department of Health and Human Services at http://www.4woman.gov/faq/organ_donation.htm#2

9. United Network for Organ Sharing www.unos.org

10. Madhav Goyal, MD, MPH, Ravindra L. Mehta, MBBS, MD, Lawrence J. Schneiderman, MD, Ashwini R. Sehgal, MD. Economic and Health Consequences of Selling a Kidney in India. JAMA. 2002; 288:1580-1593.

11. Schper-Hughes N. The global traffic in human organs. Curr Anthropol. 2000; 41:192-194.

12. The Japan Organ Transplant Network at http://www.jotnw.or.jp/english_top/englishtop.html