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Original Business Thinking for the Life Sciences |
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Allan M. Green, MD, PhD, JD, LLC Attorney at Law |
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Ethics in the Delivery of Healthcare Services |
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As power shifts between the individual provider and the organization and as different relationships emerge between stakeholders in the healthcare system, new questions about the fairness of emerging equilibria will inevitably arise. Organizational politics leads us to a less familiar inquiry: what is the basis of ethical behavior in a medical world increasingly driven by economics? |
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Ethical Considerations in the Provision of Healthcare Services Allan M. Green, MD,PhD,JD
“Suppose that you and I…differ about a number; do differences of this sort make us enemies…Do we not go at once to arithmetic and put and end to them by a sum?…But what differences are there which cannot be thus decided and which therefore make us angry and set us with enmity with one another?…I will suggest that these enmities arise when the matters of difference are the just and the unjust, good and evil, honorable and dishonorable.”
Socrates, Euthyphro (7c-7d)
Moral philosophy is an uncommon focus of modern thought. Indeed, the term conjures up quaint images of a previous generation’s focus on Greek and Latin linguistics as a link with the past rather than a bridge to the future. Perhaps it is surprising, then, that during the last years there has been an increasing measure of agreement on the damage done to the American economy and the American culture by ethical lapses in the country’s professional life. Recent revelations that dishonesty was more than a little involved with much of the rapid creation-- and equally rapid loss--of incomprehensibly large organizations and personal fortunes have made the formal concern with ethics once again relevant.
The organization and delivery of medical care has itself not been immune from lapses of moral judgement in recent time The denial of autonomous choice to individuals of sound mind horrifically revealed in the tortures of World War II carried out in the name of medical experimentation encouraged the codification of .safeguards for the protection of human experimental subjects in both international and national laws. The all too frequent tendency toward substitution of paternalistic professional judgements for individual choice about important health decisions affecting the course of one’s life has been blunted by the development of professional standards of conduct and specific law and regulation. Confusion between institutional interests and individual interests has begun to be addressed by the development of Patient Bills of Rights which are intended to strike a balance between needed institutional efficiencies and the maintenance of individual self-esteem and autonomy. Biases in the provision of medical services created by provider economic self-interest have been recognized and addressed by law and professional self-regulation. The encroachment of enterprise economics upon physician judgment in the use of resources for individual patient needs presents ongoing concerns. Increasingly, economic drivers have come to influence the manner of healthcare delivery in the United States. As power shifts between the individual provider and the organization and as different relationships emerge between stakeholders in the healthcare system, new questions about the fairness of emerging equilibria will inevitably arise.
This organizational politics leads us to a less familiar inquiry: what is the basis of ethical behavior in a medical world increasingly driven by economics?
One enduring source of morality predates the rise of Western Monotheistic culture. Plato’s recollections of Socrates’ teachings reveal an ancient preoccupation with the concept of piety and justice, with right and wrong. In response to Euthyphro’s definition of piety as that which the Greek gods value, Socrates quietly notes that the gods sometimes disagree about things. To the question of what is the subject of their differences, Socrates suggests the subjects of difference are the just and the unjust, the beautiful and the ugly, the honorable and the dishonorable. So it is today.
Modern ethical behavior—behavior which is sometimes said to be moral or pious—was well outlined by Socrates by 399 BCE when he was adjudged guilty of corrupting Athenian youth by encouraging their rational inquiry into such matters. His approach to ethical behavior—largely embodied in the Hippocratic oath—was for our purposes three-fold:
====Pursuit of Truth
====Providing information to allow individuals rationally to make important decisions about the course of their lives
====Giving them the means to do so.
How can these aspirations be realized? Socratic dialogue famously avoids specific answers to difficult questions. Rather, it is intended to lead one down a rational path of inquiry toward the truth.
Modern society has rather less patience for such a process. Perhaps modernity values efficiency and the concept of the “level playing field” so much that the meandering path of Socratic dialogue, so dependent upon personal idiosyncracy and experience, has become inaccessible. At one time, contemporary medicine relied upon self-governing professional standards that embodied practical ethics of medical practice. However, the American regard for personal autonomy as a central political value has led to an increasing use of civil laws to guide behavior and to resolve disputes.
Moreover, while religion is a formal source of moral authority in much of the world, the American system has enshrined the principle of religious freedom by excluding secular government from any role in religious life. In so doing, religious authority has been distanced from the institutions of political order. Thus, while religion clearly influences political life in the U.S., the moral basis of civil law must be found in secular considerations of fairness, due process and equality.
In the administration of medical services in America, law and regulation now control much of professional life. Police powers, the authority to make rules to assure social order, are given to the States by the Constitution. Thus, common law Tort principles, varying by experience on a state-by-state basis, now guide many inquiries into possibly negligent behavior. State statutes typically deal with physician licensing and institutional licensing and prescribe certain obligations for both in the doctor-patient relationship. At the Federal level, the interest of the Constitutional framers in preventing each State from interfering in the development of a national economy provided an opening for national drug regulation. Thus, the federal Food and Drug Administration (FDA) imposes certain requirements on the availability and testing of “new” drugs and medical devices; and the Drug Enforcement Administration controls drug distribution and prescription. The growth of federal funding of medical research through the National Institutes of Health provided the Federal government the opportunity to prescribe ethical standards for the scope and the conduct of such research.
Ethical behavior certainly requires lawful behavior, and knowledge of applicable law is essential for the identification of ethically acceptable behavior. However, knowing the law without an understanding of the underlying public policy may lead to inappropriate application of such rules. In the Unites States, public laws are the result of more or less vigorous public policy debates among participants with varying interests. It may fairly be said that participation in such debate can help to determine contemporary ethics.
But law and ethics are not co-terminus.. Decisions which are quite lawful may well be perceived as unethical because they violate notions of justice and fair play. Moreover, in the healthcare setting, questions arise which are not clearly addressed by the law.
Ethical issues most commonly arise at the limits of medical care—that is, when practitioners are faced with irresolvable problems which lead only to “bad” choices, that is, choices which all involve a sacrifice of fundamental values or beliefs. Such situations have been called “tragic choices” by Calabresi. When faced with such “tragic choices,” the limits of science are reached and decisionmaking is often overtaken by society’s deeply held symbolic values. Thus, an individual in a permanent “vegetative” state with no reversible pathophysiology presents the dilemma between the continuation of costly life support for a future without the possibility of conscious or autonomous existence and the withdrawal of life support leading to the extinction of a flickering life force. Such decisions will generally be left to the individual practitioner because, as Havighurst has argued, “policy actions that seemed to overtly deny … important value(s) would impose significant costs not only on the politically vulnerable policymakers themselves but also on the society as a whole, whose faith in the benignity of government would be shaken.” The potential for such damage to the fabric of society can be seen in the overt confrontation between political forces in the issues surrounding abortion. Such conflict is reduced by informal decision-making; and many of the wrenching issues surrounding the end of life have been implicitly assigned to the privacy of the doctor-patient/family relationship. Calabresi argues that the absence of a single, visible mechanism of choice in such matters—a mechanism which would unavoidably offend some core value--avoids large scale discontent. However, it is precisely this social preference for avoiding explicit mechanisms for resolving tragic choices which imposes a moral burden on the medical professional. For at times of “tragic choices”, patients and families will often look to a respected third-party for guidance.
At such times, professionals need to fall back on general considerations of ethics. There are few difficult decisions for which modern medicine cannot provide guidance by reference to three principles:
===regard for the truth
===regard for individual autonomy, and
===regard for fair and rational process, readily available.
The remainder of this article will examine several healthcare issues for which bioethics is commonly and specifically considered. Some of these matters have been termed “tragic choices” because all available alternatives may lead to a violation of closely held principles and beliefs.
Tragic Choices
Assisted Suicide and Euthanasia
Euthanasia (eu, meaning good, and thanatos, death), is the hastening of death, either voluntary or involuntary. Suicide and attempted suicide were once considered criminal acts. In Christian theology, Thomas Aquinas believed that life was given by God and could only be taken by God. He also argued that suicide violated a natural inclination to live. By the end of the 1500’s, however, Michel de Montaigne wrote in “A Defense of Legal Suicide” that “Death is a remedy against all evils: It is a most assured haven, never to be feared, and often to be sought; The voluntariest death is the fairest.” Yet, even in this age where individual autonomy is given wide latitude, suicide is still a controversial act. Among healthcare professionals, there is frequently a lingering concern that the choice of suicide is the result, not of a rational choice, but of a failure of the medical community to adequately recognize and treat depression and to adequately treat pain. More sociologically minded observers may voice concern about the effect of poverty and limited education—and the associated decreased access to healthcare resources—on an individual’s perception of helplessness and futility. Finally, some ethicists oppose sanctioned suicide because they are concerned by the notion that allowing physician-assisted suicide leads to a “slippery slope” in which human life is devalued. Current United States law allows states to legislate against physician assisted suicide on the basis of a “rational interest” in the preservation of life and in shielding disabled and terminally ill people from prejudice which might encourage them to end their lives. On the other side of the argument are those who believe that the individual must be allowed to make their own decisions about the limits of pain tolerance, about their willingness to endure other uncontrollable symptoms and, in the final analysis, about their perceptions of their own human dignity.
Euthanasia can be active or passive. Physician assisted suicide is legal only in Oregon in North America and in The Netherlands in Europe. The term is typically used when a physician supplies information and prescription drugs to an individual who has requested them. The resistance in the United States to such formal action is suggested by the fact that in the first full year the law was in effect in Oregon, only 23 individuals requested such help from their physicians; and six of the 23 never used the prescription drugs that were provided. On the other hand, it has been found that one in five individuals in The Netherlands suffering from the incurable neurologic wasting disorder amyotrophic lateral sclerosis (ALS) has died as a result of euthanasia or physician assisted suicide. Active euthanasia in which the healthcare professional actually performs some action at the request of an individual that intentionally results in their death is illegal in the United States. This principal was most famously tested by Dr. Jack Kervorkian who acted indisputably at the request of several terminally ill individuals and who is now serving a sentence for second degree murder.
Passive euthanasia is commonly practiced in medicine. It may take many forms: not performing cardiopulmonary resuscitation (CPR) on terminally ill individuals, of withdrawing respirator support from those for whom recovery is not foreseeable and of withholding nutrients from those with terminal illnesses unable to feed themselves. Perhaps the most common means of passive euthanasia is the prescription of pain killing drugs such a morphine which, while providing effective analgesia and relief of anxiety, depress respiration and frequently hasten death.
Although recent Supreme Court decisions unanimously upheld New York and Washington laws which prohibited physician assisted suicide, it also gave great leeway to states such as Oregon to find their own way in this debate. In the New York decision, Chief Justice Rehnquist wrote: "Throughout the nation, Americans are engaged in an earnest and profound debate about the morality, legality and practicality of physician-assisted suicide. Our holding permits this debate to continue, as it should in an democratic society"
Stem Cell Research and Human Cloning
It is widely recognized that certain cells of the developing embryo have pluripotential capacity: that is, they are primitive cells that can differentiate into cells with very specific specialized functions. Thus, cells from specific regions of the early developing embryo produce the first adult repopulating hematopoietic stem cells which eventually find their way to the bone marrow and continually produce the differentiated cells of the blood. It has been recognized that certain populations of stem cells persist into adult life. Thus, hematopoietic stem cells can be isolated from adult marrow and used to restore the blood system after high dose cancer therapy. In postnatal life, so-called mesenchymal stem cells (MSC) may also be isolated from bone marrow and appear able to self-replicate, proliferate and differentiate into mesenchymal tissues, including bone, fat, tendon, muscle and bone marrow (BM) stroma. Moreover, there have been many reports that suggest that stem cells derived from a variety of adult tissues can differentiate outside their tissue of origin
Possible clinical applications for embryonic stem cells and for adult stem cells have been proposed. These include possible autologous stem cell transplants for currently untreatable conditions such as heart failure, type I diabetes, stroke and other neurologic disorders. While there are early data suggesting that adult stem cells may have some utility is these conditions, there is a widespread scientific belief that embryonic stem cells have the greatest therapeutic potential. Human embryonic stem cell lines have been established that appear to be immortal and pluripotent.
Embryonic stem cells can be harvested from unused donated tissue. As noted above, strong ethical values in North America and Europe attach to reproductive issues. In particular, many believe that even an early human embryo developed ex vivo constitutes a human life. If one believes that such an embryo with the potential of becoming a fully developed infant constitutes a new human life, then its destruction violates a deeply held belief that such actions offend the dignity of life itself. On the other side of the ethical divide are those who see such early embryos lawfully developed and destroyed as a routine clinical matter in reproduction labs worldwide. That group sees the use of such embryos to be a matter of personal choice and believes that their use to provide embryonic stem cells for research which may cure disease is a positive ethical good. The denial to them of such an opportunity violates their deeply held belief in personal autonomy and the importance of struggling to improve life. Since so much research in the United States is funded by the Federal government through grants from the National Institutes of Health (NIH), public policy toward embryonic stem cell research has been a source of intense public debate. The debate as to whether to allow such research has been so intense as to involve the President in the final decision now in force. Currently, Federal funds may be used for research on existing human embryonic stem cell lines as long as prior to the time of the decision in 2001 (1) the derivation process (which commences with the removal of the inner cell mass from the blastocyst) had already been initiated and (2) the embryo from which the stem cell line was derived no longer had the possibility of development as a human being. In addition, the President established the following criteria that must be met: The stem cells must have been derived from an embryo that was created for reproductive purposes; The embryo was no longer needed for these purposes; Informed consent must have been obtained for the donation of the embryo; No financial inducements were provided for donation of the embryo.
The debate about this issue continues. On one side is the concern that any such research diminishes the dignity of human life, and on the other side is the concern that limiting such important research to a handful of human embryonic stem cell lines diminishes the hopes for developing a cure for many whose diseases limit their human potential.
Privacy of Medical Records
The right of patients to have their personal medical records held in private is at least as ancient as Hippocrates: “What I may see or hear in the course of the treatment or even outside of the treatment in regard to the life of men, which on no account one must spread abroad, I will keep to myself, holding such things shameful to be spoken about.”
This pledge is recited by most modern physicians during their graduation ceremonies. But self-governance in such matters has been seen as providing insufficient safeguards to the modern medical consumer. The burgeoning development of genetic testing has lead to heightened concerns about the use and misuse of such data. The demonstrated prejudice that can be attached to those living with HIV lead to diverse state laws protecting the release of such information. The public interest in encouraging treatment for alcohol and drug dependence unless a federal law protecting the release of medical records relating to treatment of those conditions.
A Presidential Commission on privacy protection issued a report in 1977 outlined the case for federal laws to protect individual records. Provisions for maintaining the privacy of medical records proposed by the Secretary of Health and Human Services (HSS) as part of the so-called Health Insurance Portability and Accountability Act (HIPAA) have recently come into force. While an examination of the specifics of this law—whose vast scope has now given rise to a new industry providing guidance to health care workers—is beyond the scope of this discussion, the general effect of the new rules is to provide a specific framework intended to safeguard personal health information in an age of electronic records and heightened governmental and private interest in widespread data gathering for security or economic purposes. Except for releases authorized by the patient, required by law or necessary for ongoing healthcare, the current rules require the amount of medical information released or requested be the “minimum necessary” for the intended purpose. HIPAA has had significant impact in the conduct of clinical investigations. Those issues are addressed in a separate publication
Although individuals have a right to know to whom their medical records have been released, the new HIPAA regulations embody a number of exceptions. Thus, disclosures for use in payment and “health care operations” need not be revealed, nor do disclosures made for national security or intelligence purposes. It should also be noted that state law generally protects the parent-child relationship; and in such states, parents generally will still have access to the medical records of their minor children. Medical privacy concerns will undoubtedly continue to be a core subject of debate to medical ethicists.
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