PhD proposal framework and research objectives

Government Policies and Market Issues Impacting Organ Donations in the United States

While organ donations such as hearts, lungs and kidneys represent a potential life-saving gift for thousands of Americans each year, it remains unclear whether some information approaches increase the rate of organ donation more than other approaches. The purpose of this study is to determine whether or not knowledge-based or value expression-based approaches identified in survey research as positively related to organ donations are significant in field research. From January 2009 to April 2009 over 20,000 citizens of the District of Columbia will be given brochures on organ donations when they obtain a new or renewed driver license at the Department of Motor Vehicles. Each brochure focuses on one of three information approaches: (1) information directed at improving understanding of the need for organ transplantation, (2) information directed at dispelling organ transplantation myths, or (3) information directed at emotional appeals for organ donors.

Government Policies and Market Issues Impacting Organ Donations

In the United States -- Can Organ Donations Be Positively Affected?

Background

The most frequent cause of death in the United States is premature organ failure. According to the American Heart Association, in 2004 (the latest year for which age-adjusted statistics are available), there was an overall age-adjusted death rate of 288 per 100,000 people in the United States, representing 451,326 deaths, making it the single most frequent cause of death in the country today (Heart disease and stroke statistics - 2008 update, 2009). Likewise, the Center for Disease Control and Prevention reports that in 2005 (also the latest year for which age-adjusted statistics are available), lung cancer was responsible for more deaths than breast, prostate, and colorectal cancers combined (Lung cancer initiatives, 2008). Furthermore, 90,139 men and 69,078 women in the United States died of lung cancer in 2005 and 107,416 men and 89,271 women were diagnosed with lung cancer that same year (Lung cancer initiatives, 2009). Although lung cancer death rates for American men are lower than some other countries, lung cancer death rates for women in the United States are among the highest in the world (Lung cancer initiatives, 2009). In addition, the National Cancer Institute (2009) estimates that there will be 49,096 new cases and deaths from kidney (renal cell and renal pelvis) cancer in the United States in 2009 and 11,033 deaths (Kidney cancer, 2009). When organs such as the heart, lungs, or kidneys stop functioning, death quickly follows. Although medical technology, drugs, surgical techniques, and procurement organizations made major strides in the past fifty years and some trends have been reversed to some extent, heart disease is still the biggest killer in the United States.

The Organ Procurement and Transplantation Network (OPTN) and the Scientific Registry of Transplant Recipients (SRTR) generate an annual report containing solid organ transplantation statistics. Based on the 2007 annual report, at the end of 2006, 2,822 candidates were on the heart transplant waiting list. During 2006, 540 were removed from the list before a heart was available, and 2220 received a heart transplant. (Note: The number of recipients plus the number removed do not equal the number of candidates because additional patients were added or removed at some time during the year. The total of 2,822 candidates for 2006 was a snapshot of the number of active candidates on the waiting list at the end of 2006.) the average life expectancy of a person with heart disease is just 5 years, and those with advanced forms of heart disease generally die within a year (Warner & Chang, 2008). The unadjusted one-year and five-year patient survival percentage for heart recipients is 87.8% and 74.4%, respectively. The U.S. Department of Health & Human Services reports that current survival rates for heart transplants show that fully 88% of men are still alive 1 year post-transplant and 69% are still alive 5 years post-transplant; likewise, 86.2% of women were still alive 1 year post-transplant and 69% alive 5 years post-transplant (Heart Kaplan-Meier patient survival rates for transplants performed 1997-2004, 2009). Therefore, if sufficient hearts were available for transplant, heart disease might not be the biggest killer in the United States. At the current rate of hearts available for transplant, we may never know.

The major medical solution to organ failure is organ transplantation. The current (2009) waiting list for heart transplants shows that there are 2,845 candidates (Overall current U.S. waiting list by organ, 2009); however, just 948 hearts were donated and feasible for transplantation in 2009 (Donors recovered in the U.S. By donor type, 2009). According to the OPTN, 2,220 hearts were available in 2005 as a result of accidents, fatal medical conditions, or other diseases and conditions (Donors recovered in the U.S. By donor type, 2009). In 1997, 25% of organ transplants were obtained as a result of traffic fatalities (Healy, 2006). If all or a significantly larger percentage of the victims of traffic fatalities were organ donors, the issue would not be organ availability; however, the current supply of 948 hearts donated and feasible for transplantation represents just 30% of the wait-list demand. If organ transplantation is to be a practical solution to organ failure, the supply should meet the demand. If it really were the solution, approximately 315,900 Americans might not die annually due to lack of an heart for transplantation.

Time is clearly of the essence in this analysis as well. For example, according to Beard, Kaserman and Saba (2004), less than half the waiting list of almost 85,000 candidates in 2004 were expected "to live long enough to receive the needed organs because the expected waiting times are now beginning to stretch into years." (B, K & S; "Limits to Altruism: Organ Supply and Educational Expenditures;" Contemporary Economic Policy, Oct 2004, p. 433).

History of Organ Transplantation

Prior to 1954, organ transplants were attempted but were primarily unsuccessful because the host immune system rejected the implanted organ (Kaserman and Barnett, 2002; Koch, 2002; Chapman, Deierhoi and Wight, 1997; Rothblatt, 2004; Lock, 2002). In 1954, Dr. Joseph E. Murray performed the first successful organ transplant when he transplanted a kidney removed from a healthy monozygotic twin, Ronald Herrick, into his brother, Richard (Organ transplant, 2009). The groundbreaking procedure performed by Murray, who received the Nobel Prize in 1990 for Medicine and Physiology, has been the basis for subsequent organ transplantation efforts (Sherby, 2002). Murray's original procedure, though, involved twins who had the same blood type, immune system and overall genetic compatibility, thereby eliminating the risk of organ rejection by the recipient twin; the donor twin had low mortality risk as only one kidney is needed for a healthy life but the incidence of a twin needing a kidney transplant with a twin who is a willing donor, is not that common (Organ transplant, 2009).

For the next decade, the only available immunosuppressant drug was azathioprine which had limited success (Rothblatt, 2004). Doctors hesitated to recommend kidney transplantation to their patients. As one physician emphasizes, "At that point the supply of donated organs was largely limited to living related donors, a source that still accounts for 25% of kidneys in the United States and 10% of kidneys in Europe" (Ascher, 1996, p. 394 as quoted by Rothblatt, 2004 at p. 6). Kidneys were, and still are, the most logical organ for transplantation because healthy donors possess two of the organs and the donor and recipient both only require one kidney to live a normal life (Narkun-Burgess, DM et al., 1993; Fehrman-Ekholm et al., 1997).

Survival was not the only concern of the first donor twin. For example, Dr. Murray reported that his last postoperative discussion with the recipient twin concerned the long-term effect of the procedure on the health of the recipient twin (Koch, 2002). The hospital told both twins they would not be responsible for their health care. In 1992, Murray wrote, "At the conclusion of the last postoperative discussion, the donor asked whether the hospital would be responsible for his health care for the rest of his life if he decided to donate his kidney. The surgeon for the donor said that the hospital would not be" (quoted in Koch, 2002 at p. 50). Thus began a debate that touches a variety of theories. What are the medical professionals' obligations to an organ donor? What are the obligations of the health care system to the donor and recipient? Everyone in the donor process receives substantial payment for the transplantation except the donor and the donor family.

For the next few decades, lack of organs for transplantation represented natural scarcity. A biological relative was needed as the donor. Even with as similar a hepatic type as possible, long-term success was rare. The organ donor transplantation issue was not complex or controversial because the procedure was a 'last ditch' procedure with a low survival rate unless the procedure involved identical twins or a family member. Natural scarcity also affected the medical community. Few doctors had the expertise to perform the operation or the expertise to teach others how to perform the operation. Few hospitals offered both the expertise and the necessary facilities.

Location of the donor and the recipient also impacted availability. Human organs cool and degenerate quickly when removed from the donor. Transportation in the 50s, 60s, and 70s was in the early stages of rapid jet aircraft travel and was too slow for the transportation of organs. The donor needed to be in close proximity to the recipient which was possible with living family members and donors. Research during this time focused on immunosuppressant drugs and on methods to maintain a viable organ outside the host.

In his discussion of justice in respect to the allocation of scarce goods, Jon Elster (1992) identified three levels of scarcity: natural, quasi-natural and artificial. The availability of twins with one needing a kidney transplant and one willing to donate a kidney generates a natural scarcity similar to the availability of natural black pearls. The issue of donor organ availability began to move towards a quasi-natural scarcity in the 70s and 80s as medical advances resulted in the willingness of more hospitals and doctors to deliver transplantation services.

In the 1960s, Dr. Thomas Starzl performed the first human liver transplant and Dr. Christiaan N. Barnard performed the first successful human heart transplant (www.wikipedia.org) from non-living donors. The survival rate was so low it was measured in days. A major problem continued to be recipient rejection by the body's immune system.

Two major advances in medical research and technology occurred in the 1970s. Cyclosporine was developed in the 1970s and approved for distribution in 1983 (Kaserman and Barnett, 2002). Cyclosporine inhibits the recipient's rejection response which increases long-term survival rates. The second medical advance solved the problem of maintaining organs in a viable state for a longer period or time once removed from the body. In the 1980s Dr. Starzl introduced a procedure for 'core cooling' that extended the viability of donor organs to allow time to excise and then transport donor organs to the host location (www.wikipedia.org). These two advances, cyclosporine and cooling technology for organ transportation, moved organ transplantation into the second level of scarcity, quasi-natural, as organs could now be transplanted based on organ matching criteria with non-living donors rather than on family relationship and living donors. In 2002, 76% to 94% of heart, liver, pancreas and kidney transplant recipients survived one year or more. (Kaserman and Barnett, 1998, Consumer's Research Magazine, p. 10; OPTN/SRTR 2002 Annual Report)

With the identification of solutions for transportation and rejection, attention turned to non-living donors. Organ transplantation centers arose in a number of hospitals. An informal distribution system emerged that relied on personal relations, professional contacts, and the general proximity of a hospital with the prerequisite team and facilities to perform an organ transplant (Fentiman, 1998). The informal system, though, lacked structure, supervision and professional associations -- all of the elements that were required to ensure equity in distribution. According to Fentiman, "The crisis in U.S. organ transplantation is moral and political, not technological. It will not be resolved until Congress and the states move beyond localism to develop a uniform nationwide approach to increase organ donation; identify medically appropriate criteria for transplant recipients; and remove racial, gender, and class barriers to equitable organ allocation" (p. 31). Persons living near a major transport center had a better chance to receive an organ transplant than persons in rural areas or areas without a transplant center. Persons with comprehensive private health insurance could afford an organ transplant, a procedure not yet covered either by private health insurance or by government health programs. Persons with sufficient independent financial resources to pay the cost of the operation and the long-term care and medication were more likely to receive a transplant. The majority of persons in the United States did not have sufficient independent financial resources necessary for an organ transplant. With little likelihood to receive an organ transplant, the majority were not inclined to donate organs. A scarcity existed in donors as well as recipients (Blumstein & Sloan, 1989).

History of End-State Renal Failure and Dialysis

The history of organ transplantation followed to some extent the history of efforts to end deaths resulting from end-stage renal failure. The invention of dialysis in the 1960s provided a non-surgical solution to what had been an inevitably terminal disease (Rothblatt, 204). According to Barnett, Beard and Kaserman (1993), "Patients must remain connected to a dialysis machine for approximately two to five hours generally three times per week. This machine performs two essential functions normally provided by the kidneys -- it filters impurities from the blood and removes excess fluid" (p. 393). At that time of its introduction, dialysis offered a lifesaving solution to thousands who did not have a twin or compatible near relative willing to donate a kidney. Dialysis was expensive and hospitals with the requisite medical team and facilities were scarce. Dialysis met the conditions of quasi-natural scarcity. Demand exceeded supply. Unlike organ transplantations, dialysis was not dependent on immune conditions or any other condition other than the presence of the disease and available medical facilities and equipment. Consequently, anyone with end-stage renal disease who could pay for the treatment could benefit from dialysis.

Similar to the history of organ transplantation, medical facilities with the requisite medical team and dialysis equipment were scarce and expensive in the 1960s. The number of available facilities could not meet the number of persons who needed dialysis. This scarcity resulted in a very controversial issue (Barnett et al., 1993). This scarcity of resources begs the question, "Who would decide which patients should be accepted for dialysis and who should be allowed to die?" The issue received national attention when Life magazine published an article in November 1962, "They Decide Who Lives, Who Dies," about the patients selected for treatment by a Seattle, Washington dialysis committee. The decision-making criteria included social standing, financial resources as well as issues of medical status. Seattle's "God Committee" served a valuable purpose: identifying nationally the problem of distributive justice when medical solutions were scarce (Alexander 1962, p. 125).

These occurrences also highlighted the inability of the American Market economy to solve the problem. As long as the equipment and the lack of medical resources meant access would be limited to the rich and famous, no market solution was available. No equitable solution existed for the scarcity of dialysis availability. End-stage renal disease, however, was much more common and more publicized than the shortage of organ donation. By the 1970s the history of organ transplantation and end-stage renal disease diverged dramatically.

In 1972, national debate and media attention resulted in a vote to fund dialysis centers for all citizens with end-stage renal disease regardless of their financial standing or social position. In this regard, Ford and Kaserman (1993) report that the growth in the dialysis industry and the provision of dialysis to a wider spectrum of American citizens is attributable to a 1972 amendment to the Social Security Act which ". . . authorizes the federal government to pay 80% of the cost of treatment (by either dialysis or kidney transplantation) of all citizens suffering from renal failure. The End Stage Renal Disease (ESRD) program, which is operated under Medicare, grew from $229 million in its initial year (serving 11,000 patients) to $3.7 billion in 1988 (serving 110,000 patients)" (p. 783). During the period from 1988 to 2003, the number of Americans who received dialysis almost doubled, to 325,000 with another 100,000 beginning dialysis treatment every year since meaning that today, approximately 825,000 Americans receive dialysis treatments (McCarthy, 2005). The cost associated with the provision of dialysis for patients today is approximately $66,000 per patient each year, and by 2010, the total costs associated with delivering dialysis will exceed $1 trillion annually (Lysaght, 2002).

Moreover, the increasing costs associated with its delivery are not the only drawback to an equitable provision of dialysis for everyone in the country who needs it to stay alive. Dialysis provides a chronic treatment for kidney disease but not without an adverse impact on the person's quality of life. The treatment restricts the recipient's freedom of movement and requires adherence to a strict treatment routine. Kidneys have been and still are the organs with the largest number of candidates on the organ transplant waiting lists (www.unos.org). Although the treatment extends a person's life, dialysis is not the solution of choice (Rothblatt, 2004).

History of Blood, Semen and Other Fluids and Tissue Donations

Besides organs, a number of fluids and tissues have been transferred successfully from one body to another for purposes ranging from life support to personal preference. For instance, a surgical team from France succeeded in a partial facial transplant procedure in 2005 by replacing damage areas (nose, lips, and chin) of a woman's face with skin and underlying tissues from a dead donor (Medical transplantation, 2007). Further, as recently as November 2008, a face was transferred from a living donor to a recipient with severe facial disfiguration (Altman, 2008). According to Altman, "In a 23-hour operation, transplant surgeons have given nearly an entire new face to a woman with facial damage so severe that she could not eat on her own or breathe without a hole in her windpipe. The highly experimental procedure was the world's fourth partial face transplant, the country's first, and the most extensive and complicated such operation to date" (p. A18). While other transplant procedures have received less attention from these high profile cases, physicians have also achieved successful transplants of knees, the trachea and the larynx in recent years; these procedures, termed "nonvital transplants," have followed the groundbreaking procedures for hearts and lungs described above due in large part to a concomitant improvement in surgical techniques, monitoring of rejection, and pharmacological therapies (Medical transplantation, 2007).

Other transplant procedures, such as skin grafts, are being increasingly accomplished without the need for human donors. For example, Farley (1997) reports that, "When burns are so extensive that more skin is lost than is left, skin grafts become a matter of life or death. For more and more patients, even when burns cover 90% of the body, the verdict is 'life,' thanks to two new types of grafts: synthetic skin and skin actually grown in a laboratory" (p. 28). Yet other researchers are developing methods whereby a patient's own skin can be cultured in the laboratory and perfect genetic matches can be achieved that do not demand the same level of immunosuppression therapy that was required in the past (Farley, 1997). Beyond the foregoing transplantations, there is an increasing use of human livers for transplantation as well, with a single organ being used for two recipients, one adult by using the right hemi-liver and one pediatric recipient by using a left segment graft (Caplan & Coelho, 1998). According to these researchers, "The concept of partial liver transplantation from a living donor evolved from the experience with liver resection for a variety of disease processes, together with the experience in transplantation of reduced-size and split-liver grafts from cadaveric donors" (Caplan & Coelho, 1998, p. 43). Based on the successes to date, there is a growing acceptance among the medical community and general public alike for these procedures. In this regard, Caplan and Coelho conclude, "Recognition of the success of the procedure, coupled with an increased discrepancy between the supply and the demand for liver grafts from brain-dead donors, have been instrumental in the more widespread implementation of the procedure. Human need can cause a change in attitude and values. The ethical issues have not changed; medical acceptance has changed" (p. 45).

Unlike transplantations that rely on a single or multiple organs for success, though, there has been an increasing use of transfers of human eggs and semen for reproductive therapeutic purposes. Although human females have a finite number of eggs, human males can produce virtually limitless quantities of semen during their reproductive years and there has been a market, both legitimate and black market, emerge for these human products as a result in recent years (Wancata, 2003). Ironically, in many cases, treatments for infertility are being used for women who have already had a child or several children (Konrad, 1998). According to Konrad, the process of egg donation and transplantation is fraught with opportunities for misadventure and the entire procedure demand ongoing medical oversight. In this regard, Konrad notes that, "Women who decide to go ahead with donation inevitably find themselves participating in a complex medical regime of corporeal preparation, regulation and bodily change. The treatment consists of highly interventionary processes whereby what is assumed to be a naturally occurring balance of chemical substances within the body requires conversion" (Kondrad, 1998, p. 644).