Rationing Organs

The procurement of human organs for transplantation provides perhaps the clearest example of rationing of health care goods in our society. Nowhere else is it as clear that a liberal state must trade off the negative freedom of individuals for the virtue of equal concern and respect. Scarce organs must be allocated according to explicit criteria. Economics and ethics interact very directly.

The transplantation of organs involves very expensive technology. There are indeed serious questions surrounding the cost-effectiveness of transplantation. Although it is an example of truly impressive technology and is potentially quite useful, one must continually ask whether widespread transplantation of organs is something that is good for society. Hence, transplantation is an obvious target for social rationing.

The history of organ transplantation in this country reveals that the government has played a central role in rationing decisions.59 Most important, the government has financed the transplantation of organs, beginning with kidneys in 1972.60 The End Stage Renal Disease Program stipulates that kidney transplants are to be paid for by the federal government under Medicare. This financing has led to the underwriting of nearly eight thousand kidney transplantations per year in the United States.61 In the mid-1980s, when it became clear that the immunosuppressant drug cyclosporine would increase the survival rate of organ transplant patients, the federal government developed further legislation on the financing of organ transplantations. The National Organ Transplantation Act of 1984 formed a task force to deal with policy issues underlying organ procurement and distribution. In addition, it created the Organ Procurement and Transplantation Network.62 The Act also banned the purchase and sales of human organs. In 1986, Congress again addressed issues of organ transplantation. This legislation established new rules for the procurement of organs. More important, it required that all transplantation programs must

meet a certain set of detailed requirements, including rules regarding staffing patterns and qualifications of surgeons, as well as appropriate survival rates for the patients.

These efforts by the federal government to finance and regulate transplantation address the allocation of scarce resources. For kidney transplantation, the federal government has decided to deal with scarcity by underwriting. However, this program costs more than $300 million per year. Since the costs of kidney transplantations have been so great, the government has been reticent about underwriting in a similar fashion the transplantation of hearts, livers, or bone marrow. Instead, the government has opted for a patchwork of volunteer efforts, matched by spotty funding for certain centers and governed by the statutes noted above.63 In particular, the federal government has been reluctant to underwrite transplantation on a broad basis until it is clear that the therapy is no longer experimental.

This has been particularly true in regard to heart and liver transplantation. Although heart transplantation sparked a great deal of interest in the late 1960s, survival rates were miserable and many centers abandoned the procedure.64 Several researchers did, however, continue to explore heart transplantation and immunosuppression. In particular, Dr. Norman Shumway at Stanford University Medical Center carefully worked out the technical and medical aspects of the transplantation process. Given his increasing success, and the declaration by certain Blue Cross programs that the transplantation process was no longer experimental, the Department of Health and Human Services decided to undertake a complete study of the efficacy of heart transplantation.65 Following on this study, the Health Care Financing Administration (HCFA) began to fund a limited number of heart transplantations in certain centers that could demonstrate good patient outcome. In particular, the HCFA would only pay for heart transplantations of disabled individuals, and would only pay for them at cardiac transplantation programs that had documented evidence of twelve or more surviving patients in the previous two years.66 The same sort of story has evolved for liver transplantation, although its annals have often included more melodramatic episodes.67

In summary, decisions involving organ transplantation in this country reveal a certain admirable rationality. The End Stage Renal Disease program was thought, at the time it was instituted, to be a relatively efficient and not very expensive alternative. The government would simply underwrite the cost of transplantation. With hindsight, it is

now clear that the renal disease program is inordinately expensive; indeed, it is probably not a program that the federal government would underwrite today. While the government is unwilling to pull the rug out from under those who now expect transplantation (and dialysis), the lesson has been learned. Heart transplantation and liver transplantation will only be underwritten insofar as their efficacy can be demonstrated. The government has very carefully selected criteria for underwriting transplantation. Since the procedure is so expensive and since private financing is unavailable in the majority of cases, the government's tightening of its purse strings limits its availability. The government has thus made an explicit decision to ration heart and liver transplantations until it is clear that these procedures are cost effective. In other words, the liberal state has declared that it will not decrease the negative freedom of individuals through higher taxes so that procedures which may not be cost effective can be completed.

None of this, however, sheds much light on the role of physicians in the allocation of scarce resources like organs. It is notable that in other societies, physicians play a particularly central role in the rationing of renal dialysis and kidney transplantation. For instance, in Great Britain, rationing is undertaken at the level of the general, or primary care, practitioner. British practitioners employ few explicit criteria when making these decisions. William Schwartz and Henry Aaron relate that an English consultant, when queried why he had not recommended renal dialysis for a particular patient, replied, "Everyone over 55 is a bit crumbly." In other words, such patients are not really suitable candidates for therapy.68 General practitioners in Great Britain receive signals from nephrologists at major regional centers on the guidelines for transplantation, and they translate these into rationalizations for individual patients.69

While this is the approach in one liberal state, it docs not seem to be the best approach for all liberal states, and is not necessarily a model for just doctoring. The theory of just doctoring involves equal concern and respect for all individuals, as well as consideration of each individual's negative freedom. The use of rationalizations for individual patients, while acceptable in some liberal states, would not be acceptable in ours and would not be acceptable for just doctoring. Open communication as well as altruistic commitment to individual patients is what converts health care into a sphere of moral activity within the liberal state. Thus, just doctors must be honest with their patients about criteria for organ transplantation.

As we concluded in the previous section, the best role for physicians is twofold. First, they should help society develop guidelines for rationing; second, they should honestly apply these guidelines to clinical practice. Physicians have long been involved in the development of such criteria. For instance, in the early 1960s when renal dialysis was just beginning, the artificial kidney center at Swedish Hospital in Seattle, Washington, developed an admission and policy committee. This committee was given charge of decisions about which patients would be granted access to the small number of available dialysis machines. The committee, including several physicians, developed a set of criteria that included marital status, number of dependents, occupation, future potential, and past performances.70 Applying these explicit criteria was quite difficult. Moreover, some of the criteria seemed to be biased in favor of patients who were similar to those individuals who served on the committee. Nonetheless, this approach suggests a role for physicians, at least with regard to biological criteria.

As noted above, we have largely abandoned rationing of kidneys or dialysis. The federal government underwrites the effort. Most individuals who have many medical indications for and no medical contraindication to transplantation can be referred for procedures. The same is not true for heart or liver transplantation. In these cases, all disabled individuals who fit the Medicare criteria must queue up at designated centers and wait for available hearts or livers. Acceptance at these centers must be and is based on severity of the patient's disease, a biological criterion that doctors are best equipped to assess. Thus the just doctor's role should be to monitor the queue and ensure that the line is formed according to severity of the illness, and not according to other factors such as ability to pay, or ability to donate funds to a nonprofit institution.71 This is one aspect of the role of just doctoring in rationing of organs.

The example of bone marrow transplantation reveals another aspect of the role of just doctoring with regard to transplant rationing. Bone marrow transplantation involves providing new bone marrow for those suffering from certain types of cancer. These individuals undergo chemotherapy, which eradicates their cancer burden, but also kills all off the fast-growing cells in the bone marrow. Therefore, they require transplantation of bone marrow after the chemotherapy has eradicated the cancer. This therapy is used most frequently in tumors of the blood-forming system, such as leukemia and multiple myeloma.

One of the biological issues that distinguishes bone marrow trans-

plantation from other forms of transplantation is the abundance of bone marrow. Unlike transplantation of the liver or heart, and in some ways unlike kidney transplantation, bone marrow transplantation does not involve the use of scarce organs (although finding an appropriate match can sometimes be difficult). Moreover, donating bone marrow does not significantly impair the donor. Therefore, there is no scarcity of potential donors as there is for heart or liver transplantation.

As a result, the rationing of bone marrow transplantation has tended to revolve around the health care expenditures required for this technology. Unlike heart and liver transplants, debates on bone marrow transplantation emphasize the total cost of the procedure, rather than the ethical issues surrounding the harvesting of organs or the solicitation of organ donations. It reflects primarily allocation decisions, not the rationing aspects of scarce organs. Like other forms of transplantation, bone marrow transplantation is very expensive. Costs for treatment of lymphoma or leukemia using bone marrow transplantation methods range from $100,000 to $250,000. Many insurers are unwilling to pay for such expensive therapy. Moreover, medical centers that provide bone marrow transplantation are often unwilling to undertake the process unless the patient can provide a large down payment. Yet bone marrow transplantation is now accepted therapy for various types of leukemia and lymphoma. Moreover, long-term survival rates are quite good, especially in treatment. Perhaps most important, bone marrow transplantation is used in certain types of refractory pediatric leukemias.72

The federal government has not assumed a specific role in bone marrow transplantation and docs not underwrite its costs as the government has done for renal transplantation through the End Stage Renal Disease Program. Nor does the federal government regulate the centers that perform bone marrow transplantations in the same manner in which it regulates those that perform heart and liver transplantations. Thus bone marrow transplantation has been left to the control of administrators, scientists, and physicians at the various teaching centers that have pursued this technology.

Like other forms of organ transplantation, the costs associated with bone marrow transplantation have led to emotionally charged individual cases. Consider, for instance, a case from late 1987 in Oregon. A seven-year-old boy with leukemia required a bone marrow transplantation. However, the Oregon legislature had curtailed Medicaid funding for heart, liver, pancreas, and bone marrow transplant pa-

tients, owing to a fiscal shortfall. As a result, the seven-year-old was denied transplantation. Private fund-raising efforts fell short of the $100,000 necessary to guarantee the transplantation. The child died. There is little doubt that his death was related to rationing of health care resources.

The Oregon legislature was well prepared for the public outcry surrounding this case. Since the early 1980s, grass roots organizations in Oregon had attempted to increase public understanding of allocation decisions of health care. In 1982, a conference involving these groups posed two important questions: "How does society value expensive curative medical care relative to preventive services being progressively curtailed in government budget?" and "Can the present implicit rationing of health care be made explicit and concur with community values?"73 After this conference, committees organized a series of town meetings. During several hundred meetings, thousands of citizens exchanged opinions and educated themselves.74 There can be little doubt that the impact of these grass roots agencies played a role in the framing of the problem by the Oregon legislature, and led to the decision to curtail funding for transplants.

Recently, the Oregon legislature has passed a law that would require the governor to appoint a commission to develop a prioritized list of medical services funded by state Medicaid programs. This commission would be guided by citizen input. In return for restrictions on services, the law loosens somewhat stringent eligibility standards for Medicaid, and increases by 77,000 the number of people who are covered by Medicaid. Part of the plan depends on developing scientific data on treatment outcomes and the effectiveness of certain therapies. Only with these data will the commission be able to develop an appropriately prioritized list.

As we discussed in previous chapters, however, the appropriateness of procedures can be very difficult to gauge. There has been very little research into variation in care between geographic regions, but the evidence we do have indicates that appropriateness is an ill-defined concept in medical care.75 For instance, there is very little information on the cost effectiveness or appropriateness of bone marrow transplantation.76 Moreover, it is unclear how many days of our lives are saved per dollar in bone marrow transplantation, as opposed to more preventive services. These vexing problems lie ahead for the Oregon commission now attempting to rank various procedures according to cost effectiveness.77

Nonetheless, the consideration of bone marrow transplantation by grass roots organizations, such as those which have developed in Oregon and other states, provides us with a rational approach to the rationing of health care within the liberal state. Perhaps more important for our purposes, these models suggest explicit roles for medical ethics as just doctoring. As I have argued, just doctoring involves altruistic concerns for the individual patient, as well as respect for that patient's rights and negative freedom. Moreover, the just doctor must show equal concern and respect for the entire class of patients. Finally, just doctoring moves medical ethics beyond the simple doctor-patient relationship, without abandoning the patient for greater societal goods.

Now consider the just doctor who is caring for a seven-year-old child with leukemia. It appears that bone marrow transplantation may prolong the child's life, perhaps even bring about a cure. However, the child's family is poor and the child qualifies only for Medicaid. Moreover, Medicaid in the state where the child lives will not fund bone marrow transplantation. What should a just doctor do? One answer might be that this just doctor should organize fund-raising efforts and try to raise the $100,000 necessary to purchase this child's bone marrow transplantation. Another answer might be that the physician should lobby the medical center to obtain free care for his patient. However, this might trespass the physician's commitment to equal concern and respect for all patients. Why should this one patient receive special treatment at the medical center that is unavailable to other poor children? Indeed, there may be little that the individual physician can do for a child facing death from leukemia.

Just doctoring, however, requires that physicians address the larger social issues. Since we live in a liberal state and since the liberal democracy determines how funds are to be allocated, the just doctor must realize that there will no doubt be limits on the availability of health care. But, the just doctor should assure that whenever those limits do occur, they are distributed in a way that reflects the values central to liberalism, values that solidly the sense of medical care as ethical and altruistic. Joining in grass roots organizations, helping to engage the public's attention, and helping to form lists of priorities are ways in which physicians can discharge their duties as just doctors. Physicians should be encouraged to join these popular movements and to urge their own patients to become involved in these efforts. Encouraging the public's interest and developing priorities in the alloca-

tion of scarce resources is an acknowledgment by members of the liberal state that they themselves must decide how society allocates those resources. Moreover, this kind of participatory democracy emphasizes that health care is a collective good and that priorities in health care must be established by all members of society, not just doctors or politicians. So I would argue that just doctoring goes hand in hand with grass roots efforts to help citizens understand and discuss rationing decisions.

Just doctoring makes an additional ethical demand in this area. This is not a duty that all physicians can discharge, but all should be committed to it. That is, physicians must begin to develop information about the appropriateness and efficacy of individual procedures. For too long the development of health care technology has been driven by the personal interests of researchers and the imperatives of the market. We now have huge numbers of therapies and diagnostic tools in our technological armamentaria. It is time we begin to evaluate these seriously and to provide the kind of baseline data that individual citizens and grass roots organizations will need to prioritize allocations of health resources. Thus, as we mentioned in chapter 5, physicians must be willing to participate in trials that define efficacy and appropriateness.