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The Ethics of AIDS Care
Considerations in providing lifesaving and life-extending drugs
to the medically indigent in the United States
By John
Collins Harvey, M.D., Ph.D.
http://www.thebody.com/content/art12177.html
Introduction
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.
Part 1
Ethical considerations
Ethical
problems related to providing lifesaving and life-extending
drugs to the medically indigent in the United States
The problem of scarce
medical resources
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.
The problem of drug
resistance
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.
The problem of
self-destructive behavior
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.
Consideration of the
specific ethical principles pertinent to providing lifesaving
and life-extending drugs to the medically indigent in the US.
Chance,
natural and social lotteries, and the queue
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.
Human dignity
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
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:
1.
To each
person an equal share.
2.
To each
person according to need.
3.
To each
person according to effort.
4.
To each
person according to contribution.
5.
To each
person according to merit.
6.
To each
person according to free-market exchanges.
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
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."
Paternalism and autonomy
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
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.
Part 2
Discussion
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.
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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.
This
article was provided by
International Association of
Physicians in AIDS Care. It is a part of the
publication Journal of the International Association of
Physicians in AIDS Care.
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