Moral philosophy, otherwise called ethics, is that branch of philosophy that systematically and formally examines good and evil, the rightness and wrongness of human acts, the logic used in ethical arguments, and the assumptions upon which ethical decisions are based. Reich defines bioethics as the systematic study of the moral dimensions of the life sciences and healthcare -- including moral vision, decisions, conduct, and policies -- employing a variety of ethical methodologies in an interdisciplinary setting.1 Medical ethics deals with these issues as they relate to medical practice, medical research, and public policies related to healthcare issues that impact on society and its culture. In a pluralistic society, there are many bases for an ethics applied to medicine.
Our culture is indebted to the Scottish and German philosophers of the 18th and 19th centuries for the theories and systems that, for the most part, form the bases of our moral philosophy and medical ethics today. We must remember, however, that Aristotle gave us the principles embodying the ethics of virtue in the third century before the common era,2 and the Pythagorean philosophical corpus gave us the Hippocratic oath, which has guided physicians in the ethos of medicine for 2000 years.3
John Locke (d. 1704) wrote A Second Treatise on Government, which is the basis for a libertarian ethics.4 The concept of autonomy came from David Hume's (d. 1776) An Enquiry concerning the Principles of Morals.5 Consequentialism, or the utilitarian ethic, came from John Stuart Mill (d. 1873), who wrote On Liberty.6 Immanuel Kant (d. 1804), the German philosopher, wrote on the categorical imperative, and to him we are indebted for the ethics of duty or "deontology."7 A contemporary American philosopher, John Rawls, has given us an ethics of distributive justice.8 Two other American philosophers, Thomas Beauchamp and James Childress, have developed an ethics based upon Ross's prima facie principles of autonomy, beneficence, nonmaleficence, and justice.9
Principle-based ethics has generally been adopted by medical ethicists as their basic guide for practice today. It is a neutral ethics devoid of the philosophical controversies engendered by one or another of the systems based upon libertarianism, utilitarianism, deontology, distributive justice, or a theology which reflects a given religious creed. Principle-based ethics is able to be used by moral strangers in mutual conversations.
Medical ethicists follow a well-established pattern in analyzing an ethical problem. When properly followed this method allows the ethicist to give advice, render an opinion, or assist in solving a problem. First one must obtain, in so far as possible, knowledge of all the pertinent facts, both medical and social. Then the ethicist must determine which specific ethical issue or issues are pertinent. Then those ethical issues may be framed in the context of several ethical theories or principles concerning the biomedical good of the patient(s), their "higher" goods, which respect their understanding of the ultimate good, their human dignity, and the good of their choices. The good of other specific parties, as well as society in general, must also be considered. The ethicist then situates the issue to determine whether there is an analogous case or cases where a broad moral consensus has been reached. One looks for precedents, paradigmatic cases, and maxims. Then a conclusion must be reached that results from a careful consideration and weighing of all the information available. After these steps have been accomplished, the ethicist must justify the reasoning behind the decision. Only on the basis of such an analysis can the ethicist arrive at closure and render an opinion.
This method of analyzing an ethical problem in medicine will be followed in this article. To illustrate the ethical responsibilities of providing lifesaving and life-extending drugs to the medically indigent, this paper will focus on the difficulties faced by medically indigent patients with HIV/AIDS who wish to obtain the newly developed multidrug treatments for the disease. Combination antiviral drug therapy has been proven to extend significantly the lives of many people with this disease. Partially because of these drug combinations, HIV disease no longer represents a certain and sure course of deterioration of bodily health and functional capacity that results in an almost inevitable death for the patient. Rather, for those with access to all antiviral drugs, HIV infection is becoming more of a chronic disease with which the patient may look forward to continuing increased survival when there is also access to appropriate medical care.
The readers of this journal are acutely aware of the expanding research data on the most effective treatment regimens for HIV/AIDS, as well as the medical and socioeconomic dimensions of the formularies that often govern access to these regimens, their costs, and the characteristics of the population affected. This article will, therefore, focus on the question of what is appropriate medical care for people with HIV disease and the ethical principles involved in providing drugs to the medically indigent for such appropriate medical care. An opinion concerning the ethical issues that the problem raises is given. Then suggestions are made to solve the problem in an ethically acceptable way.
Ethical problems related to providing lifesaving and life-extending drugs to the medically indigent in the United States
If a specific medical resource is scarce in a society, an ethical problem exists when the following determination must be made: Which members of the society who would benefit from receiving the resource should actually receive it?
Scarcity can, of course, have many causes. There may be an absolute limit of a particular resource, such as a limited supply of a drug. On the other hand, there may not be an absolute limit of the resource, but other factors present may prevent its even distribution. One can logically work out the myriad reasons why a resource may not be made available to all members of society who would benefit from it. Of course, one of the biggest potential barriers to equal distribution of such a resource is cost.
When a medical resource is unobtainable for some members of a society, and that resource is not lifesaving, but rather optional, eg, plastic surgery for improving body appearance, then society does not seem to be too exercised over the situation. Funding an optional treatment for someone who cannot afford to pay for it when the treatment involves aesthetics, desire, or inappropriate goals is not an ethical problem.
But when the resource that is unobtainable is absolutely essential for the preservation of life, then society finds itself with real ethical dilemmas. When there is an absolute limit to the resource then the ethical question is: "Who should be treated when not all can be treated?" This question concerns chance, the natural lottery, and fairness of the queue, ie, "first come, first served." When, however, there is an adequate amount of the lifesaving resource, but there are barriers to its distribution to those whose lives would be prolonged or saved by receiving it, then society must consider very different questions concerning human dignity, the common good, justice, and beneficence. Differences of opinion will naturally arise concerning application of these principles. Differences in self-understanding of obligations by the various parties involved in recommending a policy fall under the rubrics of autonomy, paternalism and distributive justice. All these principles can then be considered from the teleological (utilitarian) and deontological (duty) stances, the two most generally accepted ethical systems.
HIV is an uncanny and cunning adversary. It has the ability to develop resistance quickly and in many different ways. The predominant mechanism by which resistance to protease inhibitors develops is mutation at the active site of the enzyme, which results in diminished binding of the inhibitor. Other potential mechanisms include mutation that increases the enzymatic efficiency of the protease molecule and mutational changes that affect the target cleavage sites of the protease enzyme.10 For example, in studies of ritonavir and indinavir, at least three to four mutations need to accumulate before phenotypic resistance can be demonstrated in vitro.11
Adding to the complexity of the protease inhibitor cross resistance debate is the fact that the order in which these agents is administered may determine whether cross resistance occurs. For example, it has been shown that patients treated with ritonavir whose isolates develop multiple ritonavir-associated resistance mutations may exhibit cross resistance to nelfinavir, but initial treatment with nelfinavir may yield nelfinavir-resistant isolates that remain susceptible to ritonavir.12 This illustrates that each choice of an agent within a drug class may have important implications for the subsequent therapeutic options.
Physicians need to tailor the antiviral combination so that it addresses the patient's immediate needs but allows other treatment options if resistance develops to some of the agents in the initial antiviral cocktail. This latter point must be taken into consideration when decisions are made to place patients on combination therapy. Therapy is now lifelong, and patients must be committed to adherence to the plan. Compliance with the difficult and demanding regimen is essential if drug-resistant viruses are not to emerge. Thus, choosing the patient who will comply with this complicated drug regimen is highly problematic. Discussion of these problems involve the ethical principles of paternalism and autonomy.
Unprecedented technological advances in medicine have led to many life-enhancing and life-extending treatments, such as organ transplantation. Feasible surgical procedures have been devised for such transplants. The understanding of host-versus-graft problems (which has emerged from brilliant studies of animal and human immune systems conducted over the last two decades) has now permitted successful organ transplantation of hearts, lungs, livers, and kidneys, among others. Many of the disease processes that damage these organs so severely that they can no longer function adequately to support life are the results of self-destructive behavior by the individual. Cigarette smoking over a prolonged period of time clearly can cause emphysema and cancer of the lung. Some individuals with these conditions are candidates for lung transplant. Likewise excessive imbibing of alcohol over a prolonged period can cause cirrhosis of the liver, which may cause functional hepatic insufficiency for which the only cure is a liver transplant.
Coronary artery disease from atheromatous plaques appears to be preventable if individuals follow a given lifestyle that includes proper diet (particularly avoidance of fats), exercise, weight control, and avoidance of alcohol and tobacco. Likewise, individuals who have had complications or medical consequences related to coronary artery disease (myocardial infarction, bypass procedures, angioplasty, and the like) can avoid progression of the disease, indeed can even experience total reversal of the process, by adhering to a prescribed healthy lifestyle. Addiction to intravenous drugs, nicotine, and alcohol can be ended by lifestyle changes made with medical and psychological support.
Individuals who suffer from such illnesses are treated vigorously in our society. While treatment includes emotional and social support to assist these patients to alter their lifestyles, these patients are still cared for, even if they do not adhere to the prescribed health-producing behavior. Even in this postmodern age we do not ignore their needs. Health insurance underwrites organ transplantation and both angioplasty and coronary bypass procedures in people whose illnesses have resulted from self-destructive behavior. The third-party health insurance programs supported by the government -- Medicare, Medicaid, CHAMPUS, and the medical services of the Department of Veterans Affairs -- likewise provide funding for such care programs.
Nonmonogamous sexual activity is thought by many in our society to constitute self-destructive behavior, because those who engage in such sexual activity often contract sexually transmitted diseases (STD), including HIV. There are some in our society who would include all sexual activity other than heterosexual activity within marriage as self-destructive behavior. However, this categorization is essentially a personal value judgment, since the risk of sexual transmission of STD/HIV is relative to the frequency of unprotected sex with multiple partners. Suggestions have been made by individuals and groups who think this way that care for illness resulting from this type of self-destructive behavior should be funded neither by third party insurance nor by government. This concept has not been adopted by the American people. On the contrary, a significant amount of the healthcare dollar is expended in the treatment of STD and HIV/AIDS.
The ethical principles involved in consideration of self-destructive behavior concern human dignity, autonomy, and the common good.
The lottery, an impersonal mechanism based on chance alone, may be used to distribute benefits and burdens in a social organization. It takes no account of an individual's birth, education, training, achievements, social connections, and the like. It is a random selection system that also takes no account of merit, experience, effort, contributions, or need. Such a system is thought to be unfair by most societies because there have been valid principles of justice worked out for allocating social burdens and benefits.
"Abilities," eg, intelligence or wealth, and "disabilities," eg, genetic disease or poverty, John Rawls says, are a function of either natural or social lotteries. The natural lottery refers to the distribution of advantages and disadvantages by birth. The social lottery refers to the distribution of these advantages and disadvantages by the mechanisms of family, accumulation of wealth, schooling, and the like.
In order to overcome handicapping conditions -- either natural or social -- that are not deserved, Rawls would compensate those with disadvantages. The evening out of handicaps, Rawls insists, is a fundamental part of our shared conception of justice.8
In rationing scarce medical resources, it is morally imperative to take into consideration the concept of medical utility, which embodies the maximization of the welfare of patients in need of treatment. Urgency of need and prospects of success of treatment are to be considered. Medical utility requires that attention be paid to the effective and efficient use of scarce medical resources.
When medical resources are scarce and there are no significant differences in medical utility, and, as Beauchamp and Childress suggest, when selection may determine life or death, fair opportunity, equal respect, and equal evaluation of lives, queuing ("first come, first served"), a lottery, or randomization may be required.9 These chance methods of distributing scarce medical resources are based on justice as equality and fair opportunity. Fair opportunity must be assured in such a method of distributing scarce resources. Some people may not enter the queue in time for lack of knowledge of the opportunity, delay in referral, or overt discrimination. Impersonal mechanisms, such as queuing or a lottery, are, however, quite consistent with either a deontological or a utilitarian perspective.
The principle of human dignity in community has been well articulated by Ashley and O'Rourke.13 This principle, they explain, demands "that all ethical decisions, including those in healthcare, should satisfy both the innate and the cultural needs (biological, psychological, social and spiritual) of every human being as a member of the world community and some national community." Humanity differentiates human health from animal or vegetative health and from the functioning of a well-oiled machine, they point out. Healthcare must serve human beings.
Human health is the physical and psychological well-being of a living organism of the human species, distinguished from other animals by his or her personhood, that is, the organism's capacity for intellectual freedom, which can be actualized only in a truly human community. Such a community must be based primarily on the sharing of human values -- the communication of truth and love -- and only instrumentally on material values.
Human health can be achieved only in a human community. Because of this, healthcare is also political, Ashley and O'Rourke affirm. In a pluralistic society such as that of the US, a politics of ethics demands an effort to increase moral consensus in regard to values and priorities through dialogue among all those who hold diverse value systems. The existing basis of such a consensus is the United Nations' Universal Declaration of Human Rights, based on the principle of human dignity.
Today the unique value of every human being is affirmed by all philosophies of life. The inalienable rights of the person are guaranteed by the constitutions of most governments. These rights seem to be contradicted by several trends that characterize contemporary life. Personhood appears to be lost in bureaucratic healthcare institutions in this postmodern age. The weak and vulnerable in our society -- women, the very young, the very old, the uneducated, the poor, and the defective and "different" persons -- all are treated as nonpersons. Too many successful people in our society also seem to find happiness not in sharing their lives with others, but in private, individualistic satisfactions.
The principle of human dignity in community is anchored in the basic human need that must be satisfied to attain true happiness, namely, the need of every person for society, since it is only in community that this dignity is recognized and supported. Moreover, this satisfaction is required by the human person's dignity itself. Human dignity in community sums up the true goal of human life. Thus all ethical decisions (including those involved in healthcare) must aim at human dignity, that is, the maximal integrated satisfaction of the innate and cultural needs of every human person including his or her biological, psychological, ethical, and spiritual needs as a member of the world and national communities. The President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research emphasized the dignity of the human person when it talked about the uniqueness and sacredness of each human being.14
The common good is the total of all conditions that allow people, either as groups or as individuals, to reach their fulfillment as completely and as easily as possible. Thus, there is a dynamic relationship between the individual and the rest of society in promoting the common good.
When considering the common good, it is easy to fall into the trap of seeing it as somehow opposed to individual rights and freedoms. This is a false dichotomy since individual concerns are inherently contained in considerations of the common good. The common good is not concerned with the good of the community in a way that sets itself in opposition to the rights and freedoms of individual persons. In fact, the common good of the community is harmed when individual rights and freedoms are not respected. On the other hand, the individual is harmed when narrow self-interests and the quest for purely private gain are pursued without reference to the needs and interests of the community as a whole.
The common good has a special place in our nation's understanding of its laws and system of justice. The Constitutional Convention of 1787 voted unanimously against adding a Bill of Rights to the Constitution, considering it unnecessary. It was not that the delegates were against such rights; they simply considered the matter already covered inherently in the Constitution and its parameters for the governance of the nation. As Alexander Hamilton said, an enumeration of rights "would sound much better in a treatise of ethics than in a constitution of government."
Proponents for a specific listing of protected rights, led by Thomas Jefferson, prevailed within two years of the Constitution's ratification and amended the document to include the Bill of Rights. This listing has brought keen awareness of the individual rights that we enjoy in this country. Thus the common good is a fundamental principle which serves as a basic pillar of our nation's understanding of its laws and system of justice.
The timeliness and necessity of recognizing the principle of the common good were recognized recently by three organizations representing some 100 million Americans. A joint statement issued in 1996 by the United States Catholic Conference, the National Council of Churches, and the Synagogue Council of America said: "The common good is an old idea with a new urgency. It is an imperative to put the welfare of the whole ahead of our own narrow interests. It is an imperative which we fervently hope will guide our people and leaders at this new moment. It is an imperative for a national embrace of responsibility and sacrifice of compassion and caring as building blocks for meaningful lives and for a healthy society."
Justice is the moral virtue of constant and firm willingness to give to one's neighbor that which is his or her due. Social justice disposes one to respect the rights of all and to establish in human relations that harmony which promotes the common good and fairness respecting all persons. The President's Commission in 1983 indicated that individuals do not have a right to healthcare, but that society has an obligation to provide equitable care or an adequate level of healthcare. It argued that, because of the special nature of the required care, society has an obligation to assure equitable access to an adequate level of healthcare without excessive burdens for the patient.15 The recent public clamor to eradicate the great mass of uninsured Americans and subsequent federal and state reform proposals suggest a growing consensus that people have a right to basic healthcare.
Joseph Boyle provides a philosophical undergirding for this. He maintains that the right to healthcare flows from the fact that health is a basic good that promotes human flourishing. The pursuit of this good is both individual and communal in nature. As members of the community, individuals have a responsibility to pursue health for the sake of the common good. Although there are many ways to pursue good health, today access to healthcare is integral to the endeavor. Consequently, because of the essential role of healthcare in actualizing the good of health, individuals have a right to "necessary" healthcare. As such, the right to healthcare requires that members of a community committed to health be provided on an equal basis with the medical care they need.16
John Rawls claimed that people are to be treated equally unless there are relevant differences among them or unless an unequal distribution would be to everyone's advantage. This principle is traditionally attributed to Aristotle, who in his Nicomachean Ethics insisted that equals must be treated equally, and unequals must be treated unequally.
Certainly controversies arise over the relevant characteristics of "equal treatment." Beauchamp and Childress call the specification of relevant characteristics "material principles" since "they alone put material content into a theory of justice by identifying relevant properties for distribution."9 They suggested a list of valid material principles, namely:
How are the priorities for the allocation of resources for and in healthcare determined? These must be considered from the standpoints of macro- and micro- allocations. The decisions for macro allocation determine how much should be expended and what goods will be made available to a society. Such decisions are made by the responsible instruments of the appropriate body politic, or health organizations, private foundations, health insurance companies, and, now, managed care organizations. Micro-allocation (sometimes called rationing or triage) decisions determine who will receive the available resources. The necessity of selecting patients under conditions of scarcity is common. Thus, micro-allocation decisions are made by healthcare professionals. Hopefully the decision is always made with the best interests of the patient in the mind of the caregiver. This is what is called paternalism. The standard for best interests of the patient depends on the ratio of benefits to burdens that the treatment imposes on the patient.
Beneficence includes any form of action to benefit another. The Hippocratic oath expresses the duty of beneficence: "I will use treatment to help the sick according to my ability and judgment, but I will never use it to injure or wrong them."3 Under this rubric is included nonmaleficence as noninfliction of harm. Beneficence also includes the obligation to weigh and balance the possible goods against the possible harms of an action. The first principle is denoted as positive beneficence. The second is a version of the principle of utility. This version of the principle of utility is often called the principle of proportionality. It is, of course, not identical to the classical utilitarian principle of utility, which is an absolute principle.
The belief that there is an obligation to provide benefits is unchallenged in healthcare. Promoting the welfare of the patient -- not merely avoiding harm -- is the goal of healthcare. The belief that failure to benefit others (and not simply failure to avoid harm) violates professional and moral obligations is firmly established in the history of medicine.
Mill and Kant viewed beneficence as an imperfect rather than a perfect obligation. This is easily seen when an ethics of individual obligation confronts large-scale social problems. But there is a perfect obligation for those who have made promises or who are in a professional role, ie, those who have professed or promised to do good as a doctor, nurse, lawyer, etc. Such a covenant made with the greater social community imposes this kind of obligation. The American Medical Association's code of ethics emphasizes this kind of obligation. The first principle enumerated is, "a physician shall be dedicated to providing competent medical service with compassion and respect for human dignity."
In providing competent medical service, physicians have special knowledge and training, which they apply, as they see it, in the best interests of the patient. This principle is embodied in the Hippocratic oath, which has guided the practice of medicine for the past two thousand years. This concept of beneficence permitted physicians to rely exclusively on their own judgment concerning the patient's needs for medical care and specific treatment. Thus, the physician was making decisions that impacted upon the patient's good. The patient's consideration of what was the good, however, did not come into the equation.
But since the 1960s, this concept has been challenged by the patient's asserted need to make an independent judgment. Thus paternalism has been confronted by autonomy. The term comes from the ancient Greek autos -- self, and nomos -- rule or law. It originally referred to the self-rule of the Greek city-states where the polis -- the citizens -- made their laws rather than having them imposed upon the city from outside. Autonomy has expanded in its meaning. It is now an equivocal term. It may refer to privacy, personal choice, self-governance, freedom to make one's own choices, liberty to declare one's own preferences, or to cause one's own behavior.
An acting, autonomous person is ruling his or her self, free from limitations or control by other persons or by personal limitations imposed by a lack of pertinent knowledge, illness, mental incompetence, and the like. Autonomous persons must act on their own reasons, which are certainly built and shaped by common experiences and social arrangements shared with others in the society. Virtuous living, role responsibilities, acceptable forms of behavior, and charitable loving usually derive from cultural traditions and are autonomously accepted by the free and self-directed, autonomous acting person.
Respecting the autonomous individual means recognizing the individual's viewpoints and abilities to take actions, hold views, or make choices based on personal values and ideas of "the good." Such respect has historically been connected, as Beauchamp and Childress point out, to the idea that persons possess a value independent of particular circumstances.9 Kant argued that respect for autonomy flows from the recognition that all persons have unconditional worth, and each has the capacity to determine his or her own destiny.17 To violate a person's autonomy is to treat that person merely as a means to an end, ie, to treat that individual in accordance with one's own goals and purposes without any recognition of his or her goals, values, and intended ends. To reject that individual's goals and objectives or to restrict that individual's freedom to act on those goals and purposes is a failure to respect his or her autonomy.
Mill was more concerned about the "individuality" of action and thought. He argued that individuals should be allowed to develop their potential according to their own personal convictions as long as they did not interfere with a like expression of freedom by others. The utilitarian theory espoused by Mill and the deontological theory espoused by Kant may be summarized as follows: Autonomous actions are not to be subjected to controlling constraints by others.
When medical decisions are made in a paternalistic fashion, the physician or appropriate healthcare worker is "Boss." The action is beneficence-based. This implies that patients are unable to make correct decisions about their care. It indicates that the decision maker has specific knowledge and competencies and that the primacy of the patient's good is at the base of his or her action. It also implies that the action entails compassion, honesty, and fidelity to trust on the part of the decision maker and that additionally there is effacement of self-interest by the decision maker. A serious outcome of this action may be that patients receive care they don't want and must live thereafter with the consequences.
Patient sovereignty, on the other hand, indicates that the patient is "Boss." It is clear that no one knows better than the patients what is in their overall best interests. Patients, of course, may suffer the consequences of poor or ill-advised decisions. This presents an easy out for the caregiver, who can wash his or her hands of the outcome of the decided option if there are adverse outcomes.
In modern society shared decision making is best for both the patient and the healthcare worker. The patient and the caregiver work together as a team. The action is autonomy based. It is important to know that patients may need support and knowledge to be sufficiently and truly autonomous. This type of decision making requires great honesty and sensitivity on the part of the healthcare worker to prevent the decision-making procedure from slipping into a paternalistic one.
Distributive justice demands that the allocation of income, wealth, and power in a society be evaluated in light of their effects on persons whose basic material needs are unmet. The government has the responsibility to determine how to administer the various public goods and services to individuals and society. Distributive justice requires that burdens and benefits be distributed in a fair and equitable but not necessarily equal fashion. The principle of the common good, thus, need not demand absolute equalitarianism.
Distributive justice under the guidance of the common good merely insists that all have access to basic necessities, and the provision of such necessities takes priority. Rights to private property and the use of resources are constrained by the needs of the common good and particularly the needs of the poor. A proper balance between the individual and common good suggests this can occur only as long as everyone has access to the basic care necessary to promote human dignity. Unfortunately, restrictions on the right to pursue certain treatments may be needed in the future because today's lack of basic healthcare for the poor indicates that the demands of distributive justice are not being met in our society.16 Healthcare needs and desires are practically without limits.
Any healthcare system is thus going to face either a relative or absolute scarcity of resources at some time. Macro-allocation determines how much of a good will be made available. Micro-allocation determines who will receive that good. These decisions interact and involve the setting of standards, which one hopes will guarantee a right or just outcome. This is difficult, for a procedure may be devised to judge the right outcome of an action that is independent from the standard that is used to obtain a just or right outcome. Rawls has analyzed relations between standards and procedures. Human beings are usually more secure in their judgments about just procedures than in judgments about just outcomes. Perfect procedural justice would entail both an independent standard for a right outcome as well as an independent procedure to guarantee a right outcome. This rarely occurs. Usually we have "imperfect procedural justice," ie, there is an independent standard for a right outcome but no independent procedure to guarantee a right outcome.
Beauchamp and Childress have pointed out that two sets of substantive standards and procedural rules are required for rationing many scarce medical resources.9 First there is the necessity of formulating standards and procedures for determining the relevant pool of potential recipients. Secondly, there is the necessity of developing another set of standards and procedures for the final selection of patients to be the recipients of the scarce resource. They argue that it is easier to secure agreement on initial eligibility than about final selection. Initial selection involves medical criteria that can be determined objectively by medical personnel. Nonetheless, they warn, medical criteria may include arbitrary distinctions and unfounded claims. Controversy will always exist as to whether specific operational criteria are designed to realize medical utility or social utility. Constant public scrutiny through a fair and open process is required. Such controversial examples of operational criteria are age, lifestyle, and social network of support.
The common good is supported when all the members of the society are in good health. Therefore it is for the good of all that if some members of the society are ill or functionally incapacitated that society sees to it that these individuals are treated and cured or are brought to their highest level of functioning. Thus all members will then be able to contribute to the common good to the best of their ability. When there is an epidemic of some infection in the society, it is for the common good that appropriate steps be taken to end that epidemic. Containing the epidemic is good in every way for the society. Therefore, society has a duty both to see that all infected individuals have access to proper therapy and to insure that all appropriate public health measures are taken so that the epidemic may be controlled.
Medical evidence seems to indicate that HIV/AIDS can be treated by agents that suppress HIV replication in the human body. What was a disease process that did not admit of cure, but only care during the late stages of the disease, has now been converted into more of a chronic disease which, though still incurable from our present understanding, can be ameliorated to a very great extent by appropriate therapies. Thus access to these therapies is now a matter of life or death for the individual with HIV disease.
In the United States transmission of the disease for the most part comes from self-destructive behaviors, such as intravenous drug injection and unprotected promiscuous sexual behavior. Contamination of blood and blood products used for therapeutic measures has been almost completely eliminated in the US by proper screening, handling, and treatment of bank blood and bank-blood products. Thus in the US the unrecognized transmission that occurred at the beginning of the epidemic to individuals who did not practice self-destructive behaviors has been almost totally eliminated.
In our society there are many diseases that result from self-destructive behaviors. Our society has never denied treatment to such individuals either as a means of punishment or to correct or eliminate such behaviors. Diseased individuals in our society have always been provided access to proper treatment, regardless of how the disease was acquired. This recognizes the intrinsic human dignity that every person possesses because of his or her humanity.
Our society has tried in many different ways to look to the care of our most vulnerable members. One reason for this is, of course, self-interest. It is in the interest of the common good, and therefore of every individual, to stamp out diseases, especially epidemic diseases, which potentially threaten the lives of all. American society has most always recognized the just claims that human dignity makes for all individuals in the society and, in particular, for the most vulnerable: the sick, the weak, the unborn, the disenfranchised, the homeless, the poor, the elderly, and minorities who are still the object of discrimination by some. It is clear from the deontological perspective that beneficence must be shown to these individuals. The principle of beneficence demands that, because of their vulnerability, they must be helped in whatever way society may be able to help.
From the standpoint of distributive justice, likes must be treated as likes. Society therefore is duty-bound to provide the same opportunities for access to treatment for all patients with HIV/AIDS in a manner consistent with the common good, human dignity, and beneficence. Many people with HIV/AIDS have access to appropriate therapy, either through private health insurance, a government program that supports HIV/AIDS therapy, or treatment programs supported by the pharmaceutical companies.
Access to appropriate therapy is not synonymous to access to private health insurance or government programs. Many of these plans control drug access through formularies and/or contractual agreements that may not allow access to drugs that are included in the concept of appropriate therapy. But many people with HIV/AIDS are medically indigent and thus, by definition, are not eligible for any programs lending assistance in obtaining the expensive combination antiviral therapies. This situation violates distributive justice and is made more odious because now the difference between life or death appears to be dependent upon access to these triple-drug therapies. To have a group of patients who suffer from a disease that can be treated, but who cannot obtain treatment as other sick individuals can, particularly when success in obtaining treatment is dependent upon the common good, is clearly a violation of the principle of distributive justice.
Thus, it would appear from the principles of the common good, human dignity, beneficence, and distributive justice that society must somehow work out a program to provide equal access to combination antiviral drug therapy for patients with HIV/AIDS who are medically indigent and thus denied therapy because of its cost. This denial of therapy because of cost makes the provision of such therapy a problem that may be considered under the rubric of scarce medical resources. While there is no actual absolute physical scarcity of the drugs employed in combination antiviral drug therapy, their cost prohibits the medically indigent from purchasing them, and thus makes them scarce for this segment of the patient population.
The cost of antiviral combination therapy appears to many thoughtful people to be exorbitant. Treatment of one patient costs between $8,000 and $15,000 annually, depending on the regimen prescribed. Some would say that such prohibitive charges should not be permitted the pharmaceutical manufacturing companies when people who are suffering and could benefit from the drug are denied it because of cost. They insist that this violates human dignity. Others would argue that such charges permit the powerful few to take advantage of the rest of society. They would argue that such permitted activity violates the social contract that the "helping" professions and industries have made with society and thus violates the common good. Some would argue that the profits of the pharmaceutical manufacturing companies are unconscionable, for they violate the principle of justice.
These arguments cannot stand, however. While the actions of pharmaceutical manufacturers are subject to the same ethical values as actions by other institutions and individuals, the issue of drug pricing is not relevant. Our advances in healthcare in general and in HIV/AIDS in particular have been made possible in large part by the investment of pharmaceutical companies into medical research. The monies for such investment are made possible by the stockholders of pharmaceutical companies who hold their management to a high standard of performance and profit -- a profit that supports new and sometimes unproductive research and which in part is returned to the stockholders as dividends.
The development, manufacturing, and marketing of new drugs are costly. Many new drugs never make it to market or do not produce the profit that in turn drives further research and development. The significant gains made in life expectancy that have benefited so many with HIV disease have been made possible only through profit-motivated investments in AIDS research.
The rapid development of an increasing number of drugs in the antiviral armamentarium for use in combination therapy raises some serious concerns that could impede this continued development. The use of several drugs in various dosage levels in the antiviral "cocktails" will make it increasingly difficult for many of these drugs to capture a significant market share to guarantee the profits that drive drug development. Some of the current antiviral drugs are being replaced by second-generation drugs whose formulas promise to be more effective. So rather than an average eight years that new drugs have to recover on development costs and earn profits necessary for continued research, some of these drugs may only have a few years of significant sales and a smaller market share. With the introduction of each new antiviral agent, the potential market share of the other drugs in the antiviral armamentarium diminishes.
It should also be noted that the pharmaceutical industry has been a primary source of funding for AIDS service organizations in the US and that many of the advances in consumerism of HIV/AIDS patients are due to educational programs funded by pharmaceutical manufacturers' grants. All the manufacturers of the various drugs used in the treatment of HIV/AIDS have set up assistance programs for indigent patients, available through the clinics that petition the companies for inclusion of some of their patients in these programs. Despite what is reported by the companies as generous donations of such drugs, many patients with AIDS who are totally indigent (homeless particularly) do not have access to these programs.
It has been suggested that pharmaceutical manufacturers, especially those involved in the manufacturing of antiviral drugs, coordinate their indigent drug programs so that the most appropriate antiviral drug cocktail can be made available to the medically indigent who have no other resources. It has also been suggested that pharmaceutical manufacturers provide the general public with information on the number of individuals who are supported through indigent drug programs so that these programs are not used primarily for public relations value. Perhaps through such indigent drug programs and support of AIDS service organizations that pharmaceutical manufacturers can best meet their ethical responsibilities.
The media and subsequently the public have focused on the cost of protease inhibitors and other HIV/AIDS drugs. Some AIDS activists, professional organizations, and politicians have attempted to get drug companies to lower their charges for the drugs produced.18 While the cost estimates for combination antiviral therapy are often made on the basis of average wholesale price costs, the majority of HIV drug sales by pharmaceutical manufacturers are significantly discounted to a variety of government programs, such as Medicaid, CHAMPUS, the Veterans Administration, the Indian Health Service and the AIDS Drug Assistance Program (ADAP) proviso in the Ryan White CARE Act, through which the majority of people with HIV disease in the United States obtain their drugs.
The pharmaceutical manufactures answer criticism with several facts. Industrial developmental costs are high. The pharmaceutical industry is at great monetary risk when testing products for the adverse effects experimental drugs may produce on test subjects. They point out that government recognizes such legitimate costs, for patent laws in this country give protection to that company that expends a great deal of money in developing a drug. Such action, however, excludes the sale of similar drugs at lower prices manufactured by companies outside of the United States.19 A patent allows monopoly pricing on brand-name drugs for the life time of the patent. This is hard to understand for the patient in need.20
Some economists have noted that the price of drugs may have very little impact on access to such drugs, especially for those individuals not covered by Medicare. Some AIDS activists and the media have argued that if the pharmaceutical industry would lower its prices on protease inhibitors by 25 percent, then more patients would be able to afford the drugs. This argument has been directed primarily towards access to drugs through ADAP. The current congressional support of ADAP is $167 million, 44 percent less than the estimated $297 million in funds necessary to provide the full armamentarium of drugs for all US citizens with HIV/AIDS.
Many public policy experts have speculated that if the cost of AIDS drugs were cut by 25 percent, then Congressional funding for ADAP would also be reduced by 25 percent. While drug prices will always be an obstacle to those without prescription drug coverage, the price of drugs is essentially market-driven and changes in the current system could more likely result in more harm than benefit to people with HIV/AIDS.
Government, of course, permits a fair return to the shareholders of profit for the work of the company. Government permits the recovery of the manufacturing costs of the final product by granting the companies patent rights. This sets up a monopoly, and thus prevents another company (usually a foreign one) from selling a similar drug at less cost. But this is fair, for all these actions are permitted by the ethical principle of justice.
Macro-allocation and micro-allocation must both be considered when discussing scarce medical resources. The macro-decisions are for the body politic. Boyle has pointed out above that distributive justice requires the body politic to insure that the basic care necessary to promote human dignity is made available to all the poor. He makes one caveat, however, that certain very costly treatments may need to be restricted so that basic healthcare may be provided for all the poor. The cost of combination antiviral therapy is very high indeed. Thus it might be construed that this costly treatment might fit into the caveat that Boyle has given. However, distributive justice requires that those who are medically indigent be treated equally. Thus they too must be provided with appropriate therapy at government expense, since government, through Medicaid, Medicare, CHAMPUS, and the Veterans Administration, supplies appropriate therapy to HIV patients.
Macro-decisions are societal decisions. This task is one for the body politic in its appropriations and authorizations for government spending. Now at this macro-level careful and prudent judgments are required to balance all the needs of society and their costs to maintain the common good. Marvelous advances in drug therapy and healthcare technology have created expectations that AIDS will eventually be a totally manageable chronic disease. Such a scenario might require even more expensive therapeutic suppression of HIV shortly after infection occurs and might continue through an individual's normal life span as in the case of diabetes.
If this scenario comes to pass, the average lifetime cost of $110,000, based on data that do not reflect the use of protease inhibitors and nonnucleoside reverse transcriptase inhibitors (NNRTIs), could easily triple or quadruple. Such a scenario could result in a disproportionate amount of our gross national product being allocated to the healthcare of one group of individuals at the expense of the competing needs of people with other life-threatening illnesses as well as other social needs. The body politic must place some restrictions on funding for each separate societal need for the maintenance of the common good. We hope this will be done as fairly and as equitably as possible, although sometimes the loudest lobbyists' voices make this process questionable. In setting a macro-allocation, society is defining the total population to be included in the benefits and the circumstances under which they will receive benefits.
Congress has provided partial funding for the cost of appropriate medical therapy for the medically indigent with HIV/AIDS, but each state and municipality receiving ADAP funds determines which drugs will be provided. While some states have formularies that include most of the antiviral, prophylaxis, and treatment drugs for opportunistic infections (OI) necessary for appropriate medical care, other formularies limit the number of protease inhibitors and NNRTIs. In some instances, the formularies will exclude important prophylaxis and OI treatment drugs in lieu of protease inhibitors. The net result of these variations in local ADAP formularies is a limitation of options for appropriate medical care especially for patients who may have resistance to the only antiviral drugs in the formulary and for whom no other antiviral drugs are available. In some instances patients who fail antiviral therapy are not provided with drugs for prophylaxis and the effective treatment of OIs, therapy which has demonstrated to have a significant impact on survival and quality of life.
Such restricted formularies may in fact result in more long-term harm than benefit to medically indigent patients accessing their local ADAP program. The ethical use of government funds to support such inequities must be addressed. Immediate reforms to ADAP are necessary to address this problem. One solution would be to have a federal formulary that would include all FDA approved drugs, so that each person with HIV/AIDS eligible for local ADAP funding will have access to the most appropriate therapies.
States receiving ADAP funds have responded differently to the clamor for triple-drug therapy. Kansas established a waiting list, and a new patient receives treatment only when a previous patient dies or drops out by choice. Washington State's enrollment in the program jumped 76 percent in the first half of 1996. The state expended all its monies and had to stop the program. Former Governor Mike Lowry, responding to public pressure, intervened and reopened the program, but the source of continued payments has not been defined. The program expended $600,000 in 1995. The cost rose to $6 million in 1996.
Seventeen states are not covering any of the protease inhibitors in their ADAP programs. Florida estimated it would cost $18 million a year to provide triple-drug therapy to its AIDS patients and simply could not find its share of the ADAP funds to do this. On the other hand, Maryland offers the drugs, because of an emergency appropriation by the state legislature arranged by Governor Parris Glendening. A study recently conducted by the National Alliance of State and Territorial AIDS Directors and the AIDS Treatment Data Network for the Kaiser Family Foundation showed that many states are capping the number of HIV/AIDS patients that can be enrolled in their ADAP programs. Others have set ceilings on the amount that can be spent for each patient's drugs.
A solution to the lack of ADAP funds is to require that state, county, and municipal recipients of ADAP funds also provide matching funds so that the aggregate of ADAP funds better meet the needs of all those dependent on this program.
It has been estimated, as reported above, that the cost of treating all medically indigent patients with HIV/AIDS in the US from the time of their seroconversion onwards until death could well be $8 billion to $10 billion dollars per year. It is unlikely that government at all levels could (or would if it could) appropriate that sum for appropriate medical care of HIV/AIDS in medically indigent patients. It must appropriate what in its wisdom can be expended for a given task in relation to all other expenditures that contribute to the common good.
Interested groups can keep up lobbying efforts for increases in the appropriated amounts of funds quite legitimately, but society must live in any given year with its macro-allocation decision. Some have argued that it will probably be less costly in the long run for society to invest in suppression of HIV through the most effective antiviral drug combination therapy administered from seroconversion until death than to care for patients with developed AIDS until their deaths. However, this will not sell to the politicians who must make these macro-allocations. Arguments that spending more now will save more later usually fall on deaf ears. Politicians live very much in the present and are held responsible by their constituents for current spending, not future savings.
Lobbying efforts on the part of organized groups interested in particular diseases have had profound results in the past. The organizations interested in kidney disease and renal dialysis were very successful in their long campaign to get end-stage renal disease (ESRD) treatment paid for by the government. Their lobbying got the program for ESRD incorporated into the Medicare program. Other groups have been just as successful. Witness such federal programs as the Sickle Cell Anemia Care Project, and the Supplemental Security program for disabled dependent children. After long years of work, the lobbyists were able to get this latter program included in Medicare.
If the macro-allocation of funds will not be sufficient to provide for all in the defined population who desire a scarce resource, then a fair and equitable means of distribution must be devised as demanded by the principle of justice. The distribution of the resource may be done either by queuing or lottery. Both of these mechanisms are consistent and compatible with the principle of justice. Queuing is a principle best employed in a one-time distribution of scarce resources, but not when periodic distributions of the scarce resource are made, particularly when that resource is lifesaving.
Micro-allocation of scarce health resources, in contrast to macro-allocation, is made on an individual basis. This decision determines who among the grossly defined eligible population is to be given the scarce resource. Micro-allocation also defines the circumstances under which they will be included. Combination antiviral therapy, prophylactic therapy, and treatment of opportunistic infections and cancers have proven to significantly extend the lives of individuals with HIV. In all probability these therapies would be wanted by all eligible individuals as defined by the macro-allocation procedure.
The micro-allocation decision concerning combination antiviral therapy for HIV does, however, require careful professional judgment of the patient's potential for compliance with the demanding drug regimen, as well as its appropriate use by physicians. A growing number of anecdotes tell of possible misuse of antiviral drugs by some physicians who may not keep up with the explosion of information on antiviral drug therapy, including the most appropriate regimens and sequencing of antivirals to reduce the risks of development of resistance and cross resistance. The growing complexities of antiviral therapy may result in the creation of HIV management as a new subspecialty. There have been calls to limit treatment of people with the disease to physicians who are considered AIDS specialists.
Intermittent use of combination antiviral regimens that include protease inhibitors is problematic. Resistant strains of virus emerge when treatment schedules are not followed precisely. Thus, in making a decision regarding which patient will be recommended for treatment, a judgment must be made regarding the patient's ability to comply with the demanding schedule of the treatment regimen. This smacks of paternalism -- the healthcare worker knows best. Yet, for the common good, to protect society from the danger of new resistant strains of HIV, the noncompliant patient must be identified.
One hopes these decisions will not be made in a paternalistic way. These decisions should recognize and respect the autonomy of the individual. They should be free from prejudice or any preconceived notions of social utility in reference to the patient on the part of the healthcare worker. Since many patients with HIV are addicted to drugs, homeless, aesthetically unappealing, or on the fringes of society, they could possibly be judged on bases other than their ability to comply with the regimen. Government has the responsibility to fund studies on compliance. Criteria for judging and selecting who would be a compliant patient would have to be developed by knowledgeable healthcare workers skilled in the treatment of AIDS patients. Some HIV/AIDS specialists, however, oppose this idea.21 These standards would necessarily have to be applied uniformly throughout the country.
Patients judged to be compliant could register for the lottery for full drug treatment, which would be supported by the appropriate federal government program. Patients judged noncompliant could register for a lottery for limited treatment that would not be compromised by noncompliance. Those who demonstrate compliance on alternate regimens could then be enrolled in the full drug treatment plan. Since ADAP is already funded by the federal government and managed by the states, it could run the lottery. Each state would have to use an identical method to manage its lottery, in order to preserve the principle of distributive justice.
Periodically a state would run the lottery, ie, biweekly or monthly, and all patient-citizens of that state who have been judged to be compliant would be eligible to enter repeatedly for an award. The lottery would be run whenever a place became available either through a vacancy in the program (due either to drop out or death of a patient already in the lottery) or when an infusion of more funds was made by the government, which would then permit more spaces to open up.
There is a precedent for such a scheme. A national lottery program was created by the Berlax Company, a pharmaceutical manufacturing company, when it first marketed Beta 1b (a recombinant engineered interferon). At the time, this drug, marketed as Beta Seron, was the newest and most promising treatment for multiple sclerosis. It was in very limited supply and thousands of patients were clamoring for it. The lottery worked very well as long as the supply was very scarce. When the supply became plentiful the lottery was no longer necessary and it was discontinued.
The challenge to government is to either provide adequate funding that would permit appropriate medical care to the medically indigent with HIV/AIDS or design a system that is equitable to all in need and that does not limit the full spectrum of treatment options for mid- or late-stage HIV disease.
John Collins Harvey, M.D., Ph.D., is professor of medicine, emeritus, at Georgetown University and senior research scholar at the Center for Clinical Bioethics, Georgetown University Medical Center.
This article is reprinted from the Journal of the International Association of Physicians in AIDS Care (November 1997, Vol 3, No 11) © 1997, Medical Publications Corp. For more information on the Journal, visit the International Association of Physicians in AIDS Care Web site or send e-mail to Journal@iapac.org.