To solve a deadly shortage: economic incentives for human organ donation.

• Author: Harris, Curtis E.

ABSTRACT: In this article Dr. Harris and attorney Alcorn propose the establishment of a governmentally regulated, posthumous organ market, with economic incentives for the donors, in order to increase the supply of transplantable organs. The authors review transplant technology, provide a short history of donation and sale of organs, tissues, and cells, discuss the various legislative approaches that have been made to increase the supply of organs, and analyze the problems with the open market approach. They conclude with a proposal for a regulated posthumous organ market.

Currently, 68,000 Americans are waiting for an organ donation, with a name added to the list every' sixteen minutes. Twelve Americans die every day because a needed vital organ is not available. The congressional answer has been the Uniform Anatomical Gift Act, which was designed to promote public awareness, health care provider education, and to prohibit the sale of most human organs.(1)

Where gaps in the law prohibiting the sale of human tissue have been left or allowed, a thriving market exists, meeting the needs of Americans for blood, tissue, and human reproductive cells. However, vital organs are prohibited from sale.

Proposals have been made over the years to adopt free market principles to the open sale of organs, allowing vital organs to be bought and sold for whatever price the market could sustain. The potential for abuse in a system such as this is real and has always prevented the serious consideration of such an open market.

This article proposes a governmentally regulated, posthumous organ market in which licensed brokerage houses operate under the oversight of the Food and Drug Administration. Though regulated, flexibility will be necessary to allow the haws of supply-and-demand to control most aspects of the market. Through this combination of regulation and a free market, needless loss of life can be prevented and equity in organ distribution maintained.

A Brief Overview of Transplant Technology

Doctors in the Soviet Union conducted the first kidney transplant in 1936, using a cadaver. The first successful live kidney transplant was accomplished in the United States in 1956. The first successful heart transplant was accomplished in South Africa in 1967.(2) These early procedures were scientific advances but provided limited medical benefit to the patients. Transplants were always hindered by the recipients' rejection reaction caused by antigenic differences remaining after tissue typing and donor-recipient matching.

The 1980 introduction of Cyclosporin-A was a major break-through in allograft transplants because it controlled the recipient's immune response.(3) The benefit can be seen by noting the increase of one-year transplant survivals during the ten years following the introduction of Cyclosporin, which increases ranged from 25 to 50%, depending on the tissue type.(4)

Immunosuppressants, such as Cyclosporin and more recent drugs, do have a drawback: they suppress all immune responses, leaving the organ recipient vulnerable to certain types of infection. Presently, intensive suppression is only necessary in the first few weeks following a transplant operation. Thereafter, smaller doses may be used, but immunosuppression is necessary for the remainder of the recipient's life.(5)

Sources of tissue other than human tissue have been proposed. Transplantation of animal organs (xenotransplantation) and bio-mechanical organ replacements have received much attention in the popular media recently, though xenotransplantation is not new. Prior to the development of the kidney dialysis machine in the 1960s, there were numerous primate-to-human kidney transplants. Success of these early transplants was, at best, limited. Scientists observed hyperacute rejection in almost every case. In the early 1990s, scientists again looked at xenogenic transplants: this time the focus was on the liver. But to date the most successful transplant has only lived seventy days before rejecting the new organ.(6)

In 1999 German scientists reported completed pig-to-human kidney transplants, with survival lengths up to seventy days. These recent successes have seemed to indicate potential future success in combating hyperacute rejection, but there is still much difficulty with delayed rejection.(7)

Xenogenic kidney transplantation will likely be the first tissue type to enter clinical trial because organ dysfunction or rejection can be safely remedied through currently available dialysis techniques. But even with this capability, there currently are no clinical trials, and scientists are struggling with the problems of cross species disease, public acceptance, and ethical concerns.(8)

Bioengineers have had limited--yet encouraging--success in manufacturing organs. A typical example is a mechanical kidney developed at the University of Michigan. As with a dialysis machine, the mechanical kidney filters the blood of toxic matter, but this device goes further. The mechanical kidney incorporates live kidney cells, which pass sugar and salts back into the blood. Currently, the machine is desk top size and has been tried on dogs.(9)

Both xenotransplants and mechanical devices show possibility, but even their most ardent proponents say that clinical use is twenty years away Neither solution holds much promise as an answer to the current shortage of human organs. Human tissue sources, though scarce, remain the best available answer to organ failures.

What is an Organ?

An organ is a part of the body having a special function as part of an integrated living system.(10) Organs may be divided into two categories: "vital" and "non-vital." Vital organs are those which cannot be removed without loss of function necessary to support life. Examples are heart, lung, liver, pancreas, stomach, and kidneys. One of two paired vital organs can be considered non-vital if the other is functioning properly, such as a kidney.(11)

For the purpose of this article it is important to identify regenerative organs as well as human tissue and cells capable of self replenishment including skin, blood, hair, sperm, and oocytes.(12) Human blood is the best example of a commonly donated regenerative organ. Blood continues to replenish, allowing a person to give blood, leaving the donor in no significantly worse condition than before the donation.(13)

Donation and Sale of Regenerative Organs and Self Replenishing Tissue and Cells: Problems and Answers

Blood

Self replenishment of blood led to transfusions as early as the beginning of the 19th century. But the procedure was frequently unsuccessful in the early days of transfusions, which resulted in the procedure being outlawed in many countries. The world wars drove the need for blood and brought scientific advancements that started to raise the success rate of transfusions to acceptable levels.(14)

The 1960s saw advancements in blood component therapy, which allowed the storage of greater quantities of blood. The ability to store blood components, in turn, allowed the growth of organizations such as the American Red Cross and many community blood banks.

Altruistic donation fell short of demand and, though controversial, the blood market was eventually commercialized. Richard Titmuss has summarized the objections of many to the sale of blood:

[I]t represses the expression of altruism; it erodes the sense of community; it sanctions the making of profits in hospitals and clinical laboratories; it legalizes hostility between doctor and patient; it subjects critical areas of medicine to the laws of the marketplace; it places social costs upon those least able to bear them--the poor, the sick and the inept; it increases the danger of unethical behavior in various sectors of medical science and practice; and it results in situations in which proportionately more and more blood is supplied by the poor, the unskilled, the unemployed. Negroes and other low income groups and categories of exploited human population of high blood yielders so that blood is redistributed from the poor to the rich.(15) Fears over the safety of paid donor blood proved justified as commercial blood banks distributed infected blood, decimating the hemophiliac population of the United States. In 1982 in high risk areas, such as San Francisco, as much as 3% of the donated blood was infected by Human Immunodeficiency Virus (HIV).(16)

This problem was quickly minimized in 1985 by the addition of an HIV screening test. Screening in the past twenty years has become remarkably effective. Currently nine tests for infectious diseases are conducted on each unit of donated blood.(17) Between 1985 and 1997 there were only thirty-eight documented cases of AIDS caused from blood which had been properly screened for HIV. With a national average of three infections a year, there is a one in four million chance of receiving HIV infected blood.(18)

The question no longer concerns a donor being infected before donating blood. Rather, the question has become: has the blood been infected long enough to test positive in screening tests? Most infectious diseases will show positive during the screening process if the donor has been infected for at least two months. Closing this two-month window is now the focus of scientists and medical doctors. One such approach is Nucleic Acid Amplification (NAT). NAT is a research initiative in selected blood banks such as the Oklahoma Blood Institute (OBI) in Oklahoma City NAT allows for direct testing of the genetic material of viruses such as Hepatitis and HIV. Organizations like OBI no longer have to wait for the body's immune response to the antigen but can identify the virus immediately, closing the two-month window.(19)

Irrespective of whether the blood came from a paid donor or from a volunteer, technology has created a sate blood supply Two of the safest and most respected blood banks in the country are commercial operations; Hema Care in...