Ethics USA. Health Care. A resource for the Catholic health ministry. In this Issue. Feature Articles. Resources. Ethical Current.

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1 Volume 15, Number 4 Fall 2007 Health Care Ethics USA A resource for the Catholic health ministry In this Issue Feature Articles PAGE 2 A System s Transition to Next Generation Model of Ethics Gerry Heeley, STD PAGE 5 The CDF Statement on Artificial Nutrition and Hydration: What Should We Make of It? Ron Hamel, PhD From the Field PAGE 8 Sampling of Responses to the CDF Statement on Nutrition and Hydration Resources PAGE 20 A Resource for Evaluating Levels of Authority in Church Teaching PAGE 21 Bibliography: Next Generation Ethics Committees Ethical Current PAGE 22 Donation after Cardiac Death PAGE 15 A Primer for Understanding the CDF s Responses Regarding AANH for the PVS Patient

2 FEATURE ARTICLE A System s Transition to Next Generation Model of Ethics By Gerry Heeley, STD, Vice President, Ethics and Social Justice, Trinity Health, Novi, Mich. In the late 1990s, the system ethicists for Trinity Health were convinced that our ethics committees, although well-intentioned and doing good work, were not organizationally effective. Their three-fold function of education, policy review and case consultation resulted in an annual tally of isolated activities yielding anecdotal successes and little impact on organizational structures. It was not uncommon for ethics case consultation teams to focus solely on a particular patient care situation and not delve into the possible system causes for the ethical dilemma. Ethics committees provided many educational offerings to internal and external audiences but did not measure the effectiveness or impact of the education provided. Assessment of the effectiveness of Trinity Health s ethics committees across the system validated that significant changes were needed. In 1999, the system ethicists decided to explore ethics programs across the country to benchmark the kind of changes necessary to improve the effectiveness of the Trinity Health ethics committees. These efforts resulted in a system decision to adopt a Next Generation Model for all of Trinity Health s ethics committees. 1 Next Generation Model of Clinical Ethics The Next Generation Model is a quality improvement approach to clinical ethics. Those utilizing this model collaborate with others in the health care setting to address ethics issues from a systemic perspective. For Trinity Health ethics committees, the Next Generation Model focuses their work on policy, process and structure improvements that affect the ethical components of the patient care experience. After system wide exposure to the Next Generation Model of Clinical Ethics in January 2002, local ethics committee leaders gave unanimous agreement to adopt the model. This began a period of transitioning from the traditional ethics committee to the Next Generation Model. Resources were developed at the Trinity Health home office to assist ethics committees with the transition, including a Next Generation handbook. Among the resources included in the handbook were the following: A comparison of the old and the new model for ethics committees Foundational principles to advance Next Generation ethics Quality improvement resources and tools Ethics improvement project tracking tools A Closer Look at Next Generation Model: Foundational Principles Trinity Health chose to adopt the Next Generation Model because its foundational principles appeared to address many of the deficiencies that we experienced in the traditional model. 2 The foundational principles shaping the implementation of the Next Generation approach can be stated briefly as: Organizationally integrated Strategically proactive Outcomes focused Mission and values oriented It will be helpful to look at each of these principles in some detail to understand the significant change they required of our ethics committees. Organizationally Integrated Trinity Health s ethics committees, like most others across the country, adopted a structure with inherent operational deficiencies. Traditional ethics committees, although multidisciplinary in membership, were usually isolated in the way they functioned. Most ethics work was performed during the ethics committee meeting. Between meetings, the case consultation service was available to address difficult ethics issues in patient care, and committees responsible for education or policy review may have met. When committees felt isolated, which was often identified as not enough requests for case consultation, they discussed ways to market their services in order to become better known in the organization with the intent of attracting others to recognize and utilize the services of the ethics committee. Marketing the ethics committee occasionally 2

3 resulted in a short burst of interest and activity, which was not usually sustained. Through the years, the isolation of the ethics committee resulted in a tremendous loss of influence and opportunity in the organization. It was rare for the traditional ethics committees to take an outward focus of partnering with others throughout the facility in identifying and addressing process and structure flaws that promote ethical tensions. So, the principle of organizational integration offered significant possibility for improving the isolationist nature of the committees. Strategically Proactive Most ethics committees in our system were competent in their response to requested services. Education was provided to community and staff, policies were reviewed on a regular basis, and case consultations were handled quickly and professionally. So, why were we dissatisfied? Almost every activity of the ethics committees was in response to a request for services. Ethics did not lead, but responded. This approach was disempowering for our committees and limited the influence and impact of the ethics function in the organization. Therefore, becoming proactive, rather than reactive, offered a plausible way of improving the image and effectiveness of the committees. Outcomes Focused Assessing the impact, the valueadded factor, of an ethics committee had always been a difficult task for our committees. It was not unusual for year-end reports from ethics committees to consist of a tally of activities, with little knowledge of the yield of those activities. For example, did the educational sessions result in changed behaviors and an improvement in patient satisfaction scores? For the most part, we didn t know. It was difficult to make the case to administration that ethics committees were involved in important work and ought to have organizational resources when we didn t know how to assess our own performance. Given the inability to meaningfully measure the impact of their performance, it was necessary for our ethics committees to adopt the foundational principle that they are accountable for performance based on demonstrable outcomes, and to take the necessary steps to get there. Mission and Values Oriented A definite strength of most ethics committees, in secular and faith-based organizations, has been their attentiveness to ethical principles, clinical data, patient rights, and legal and regulatory standards. Overt attention to the organization s mission and core values in ethical deliberation had been less frequent. This fourth foundational principle presented a helpful reminder to include in committee discussions and in the analysis of issues appropriate references to the organization s mission and core values. 3 Such attention ensures that deliberations result in actions that are consistent with organizational identity. Transitioning to the Next Generation Model As we embarked on the transition to the Next Generation Model, we were aware that the process involved a significant cultural shift for our ethics committees and for our local health care organizations. We were prepared to be flexible and responsive to the needs of those making the transition. The handbook referenced above proved to be a helpful tool in making the transition. After a year into the changes, it became apparent to the ethics committees that we were involved in a very different approach to ethics and not simply a midcourse correction of the traditional ethics model. Adherence to the model s foundational principles required substantial change for many stakeholders. In order to attend to the foundational principles of the Next Generation Model, ethics committees found it necessary to take several key steps; these included: Reshaping membership to include individuals skilled in quality and change management Deepening committee members knowledge of and relationship with clinical and operational areas of the organization Viewing the scope of their work more broadly to address policy, process and system impediments to ethical patient care delivery Consequently, the ethics committees began to think and behave very differently, particularly in the ways they identified and addressed ethical concerns, collaborated with others in the organization, and evaluated accomplishments. Ethics committees that made the transition more quickly and thoroughly than others were those that kept the foundational principles before them and consistently evaluated their efforts at integrating them into all aspects of committee functioning. 3

4 Obstacles to a Smooth Transition We did not anticipate a flawless transition to the Next Generation Model. However, we didn t have foresight into the kind of challenges that would emerge. After the initial year of transition, it became clear that two types of ethics committees presented the most resistance to converting to the Next Generation Model; namely, successful, or content, committees and committees lacking requisite resources. Successful committees could be identified as engaged committees. They often consisted of professionals who enjoyed working together. They fulfilled the functions of a traditional ethics committee with diligence and accountability. Even with verbal agreement to transition to the Next Generation Model, inertia set in as members contemplated the move to the Next Generation Model. The case had to be made that the pay-off of the transition was worth sacrificing the satisfaction and success of the past. When these committees were reminded of the potential measurable impact of the Next Generation Model on the ethical delivery of patient care, compared to the traditional ethics committee model, it became somewhat easier to embrace the transition. Committees that lacked resources in leadership, knowledge or skill also had a difficult time making the transition. Because the ethics committee leader was indispensable in the transition process, those committees that lacked the dedication of its leader(s) to overseeing and managing the transition had a difficult time leaving the traditional model. Committees that lacked the knowledge and skills of change management or quality management experienced more challenges in moving to the Next Generation Model. Once we were able to identify the obstacles, we were able to collaborate with the ethics committee leadership to advance the transition. Trinity Health mission leaders became key champions as they assisted ethics committee leadership to make the transition. identify root causes and system barriers in patient-specific situations; additionally, ethics committees are recognizing improvement opportunities that traditionally would have been overlooked. Often, ethics committees will learn of ethics improvement opportunities because of their closer integration with clinical and operational departments. Trinity Health continues to advance the Next Generation Model. A FY 08 system goal focuses every ethics committee on the identification of a measurable objective that addresses a health care disparity/inequity in patient care delivery. By attending to an injustice in the delivery of health care services, we intend to make the delivery of patient care more ethical and improve organizational culture. A common commitment across the system will build synergy allowing us to productively collaborate and benefit from the work of each ethics committee. Our collaborative efforts might also yield an increase in justice throughout Trinity Health. In the past year, ethics committees across the system have begun to confidently build on the progress of the past four years. It is a testimony to their focus on the foundational principles and a tenacity to make a difficult cultural shift. As we contemplate the continuous development of our ethics efforts after the past four years of transition, it is beginning to feel like we re standing in the next generation. NOTES 1. See J.W. Ross, et al., Health Care Ethics Committees: The Next Generation, Chicago: American Hospital Publishing, Inc., 1993; David Blake, Reinventing the Healthcare Ethics Committee, HEC Forum 12, no.1 (2000): 8-32; and J. Rueping and Dan Dugan, A Next-Generation Ethics Program in Progress: Lessons from Experience, HEC Forum 12 (March 2000): N. S. Wenger, The HEC Model of the Future Builds on Deficiencies of the Past, HEC Forum 12 (March 2000): See also Glenn Magee, et al., Successes and Failures of Hospital Ethics Committees: A National Survey of Ethics Committee Chairs, Cambridge Quarterly of Healthcare Ethics 11 (Winter 2002): Nancy Bancroft, The Next Generation Model, Health Progress 85 (May- June 2004): 27-30, 55. Rewards of Making the Transition Looking back, it is now much easier to recognize that the pains of the transition (and not all of them are yet behind us) were worth it. Our ethics leaders and committees see the purview of ethics more broadly now. It is not uncommon for our ethics committees to more quickly and easily 4

5 FEATURE ARTICLE The CDF Statement on Artificial Nutrition and Hydration: What Should We Make of It? By Ron Hamel, PhD, Senior Director, Ethics, Catholic Health Association of the United States, St. Louis. During the past few weeks, there has been much conversation within the Catholic health care community and among theologians and ethicists, both within and outside of Catholic health care, about the meaning of the most recent statement from the Vatican s Congregation for the Doctrine of the Faith (CDF) on artificial nutrition and hydration. The statement (or Responses to two specific questions posed by U.S. bishops) and an accompanying Commentary, intended to clarify the meaning of the March 2004 allocution of John Paul II, 1 has actually generated a range of interpretations and a number of questions. In this short essay, I wish to try to sort out a) what seems to be clear in the statement and commentary, b) what seems less clear, and c) what is puzzling. What Seems Clear In the CDF Statement and Commentary One of the most important points in the March 2004 papal allocution, and again in the CDF statement, is that the person who is in a permanent vegetative state (PVS) retains full human dignity and must be treated accordingly. In light of this, the CDF statement says it is not morally permissible to remove artificial nutrition and hydration solely because that person will not likely regain consciousness. Permanent loss of consciousness does not result in a life that is any less valuable or any less worth preserving. Equally clear in the commentary is that it is not morally permissible to withdraw a feeding tube for the explicit purpose of ending the PVS patient s life. This would constitute euthanasia. The moral obligation to provide nutrition and hydration to persons in PVS seems to be a prima facie obligation ( in principle ), that is, it ought to be done barring extraordinary circumstances. Or, put differently, the burden of proof is on those who wish to withdraw. One such circumstance is if and when artificial nutrition and hydration become medically futile, that is, they can no longer be assimilated by the person s body. Another is if they cause significant physical discomfort. While the meaning of this phrase is not explained in the Responses, the commentary states that the possibility is not absolutely excluded that... artificial nourishment and hydration may be excessively burdensome for the patient or may cause significant physical discomfort, for example resulting from complications in the use of the means employed. One would have to assume that such complications refer to chronic infections at the site of the tube, recurring aspiration pneumonia, diarrhea, and the like. Because the person in PVS is believed to be incapable of experiencing anything, one would have to assume that a judgment is being made that persons who are conscious would find these complications to be a significant physical discomfort and so the person in PVS would as well if he or she could experience them. The commentary refers to these occasions as rare cases. One would also have to surmise that if the patient had co-morbidities (e.g., terminal cancer or end-stage heart disease), those co-morbidities would impact an assessment of the burdens and benefits of tube feeding. A final exception, noted in the commentary, but not in the Responses themselves, is if and when artificial nutrition and hydration cannot be provided because they are not available ( very remote places ) or cannot be afforded ( situations of extreme poverty ). There is at least one other consideration that seems to be clear. Like John Paul II s allocution, the CDF statement and commentary are explicitly directed to persons in a permanent vegetative state, not to other types of patients. Hence, what is said in these documents should be limited to PVS patients. A key factor in interpreting Vatican documents is that they should be interpreted narrowly, not broadly. But why only PVS patients? From the perspective of the CDF (and John Paul II), these individuals are not dying and do not have a terminal pathology. In the words of the commentary, they are not facing an imminent death. Instead, 5

6 as some say, they are seriously disabled. Given this limited application, the CDF statement should have very little impact on Catholic health care. Where it will likely have some impact is on long-term care facilities and, there, it will only affect some PVS patients (i.e., those for whom the exceptions do not apply). What Is Less Clear from the CDF Statement and Commentary A question that has arisen and which is not addressed in the CDF statement and commentary (nor was it addressed in John Paul II s allocution) is whether a PVS patient s advance directive can be honored if it explicitly states that the person would not want to be kept alive through artificial nutrition and hydration if in a PVS. It is quite possible that the individual, while still well, considers a lifetime on a feeding tube and/or in an unconscious state to be psychologically abhorrent and excessively burdensome. The judgment is from the future patient s perspective. It is not a judgment that the person has no value nor does it involve a judgment by someone else that the individual s life has no value. Nor is the removal of artificial nutrition and hydration viewed as a means to end one s life. It is simply an expression by the individual that a life maintained through a feeding tube without being able to experience the joys of eating and drinking by mouth is psychologically repugnant and constitutes an excessive burden. Others will likely come to a different conclusion and will argue that such advance directives, in the case of PVS, cannot be honored in a Catholic facility and the patient will need to be transferred. It seems reasonable that these situations will need to be judged on a case-by-case basis. What is Puzzling about the CDF Statement and Commentary The CDF statement and commentary (like the papal allocution of March 2004) raises a number of puzzling questions. These questions are likely to fuel theological debate for some time and, perhaps, even raise concerns among a variety of groups. One such puzzlement is a seeming shift from a 500-yearold theological tradition in the determination of what constitutes ordinary and extraordinary means and, hence, what is and is not morally obligatory. In the theological tradition, no intervention, no matter how simple or basic or readily available, was said to be ordinary or extraordinary apart from an assessment of the burdens and benefits of the intervention on a particular patient. 2 The same intervention could be ordinary for one patient (and, hence, morally obligatory) and extraordinary for another (morally optional) depending on the condition of each patient. Yet, in the CDF documents, artificial nutrition and hydration are said to be an ordinary and proportionate means of preserving life... [and] therefore obligatory, apart from any patientcentered considerations. The only way this could be said not to be a change from the traditional approach is if this statement were to mean in the abstract, feeding tubes are an ordinary means of preserving life and are therefore morally obligatory, but one must always make specific determinations in relationship to the particular patient. Even this, however, would seem to be a somewhat different approach from past formulations because typically assessments of benefits and burdens are to be made by the patient (or at least from the perspective of the patient, to the degree possible) and these judgments are not made in the abstract. 3 Another puzzlement is how benefits and burdens are understood. 4 Benefits in the theological tradition have seemed to be understood broadly. 5 Interventions could result in a variety of benefits to the individual considered, at least implicitly, holistically. But the notion of benefits in the CDF documents seems to be reduced to maintaining physiological existence. Feeding tubes benefit the body, but do they benefit the person considered as a whole emotionally, psychologically, socially, spiritually? In addition, the criterion for judging the benefit of feeding tubes is whether they achieve their purpose (finality), i.e., preserve life. Does this criterion apply only to feeding tubes or does it also apply to other interventions as well? One can think of any number of interventions in a medical context that achieve their purpose, but are really of no benefit to the person considered as a whole in certain situations (e.g., ventilators, dialysis, pressers, etc.). Would it be morally obligatory to continue these interventions simply because they attain their finality? Also, in the theological tradition, an assessment of burdens could include burdens to the family and the community as well as to the individual. 6 But the CDF documents exclude burdens to the family and community as a legitimate consideration in the moral assessment. Granted, the assessment 6

7 of such burdens is generally done by the patient. It is somewhat different, and potentially more dangerous, if family or community members determine that various interventions in the care of a patient are excessively burdensome to themselves. But it is not difficult to imagine situations where the burdens of care become excessive for a particular family, financially and otherwise. How would this differ from the burdens upon a family in the care of a cancer patient or one with Alzheimer s disease where these burdens can be part of a moral assessment? There are any number of other puzzlements that deserve attention, but space does not permit their discussion here. However, I at least wish to note them: Referring to artificial nutrition and hydration as a natural means of preserving life when it consists in a manmade concoction of nutrients delivered through a tube Entirely dissociating the cause of death from the withdrawal of a feeding tube from one of the effects of the brain injury, namely, an inability to reach and grasp, to masticate, and to swallow Not referring to the 500-year-old theological tradition on ordinary and extraordinary means and, instead, only referring to select church documents going back to 1980 Citing only that portion of the Declaration on Euthanasia that refers to imminent death, when, in the text, that is only one instance where treatment might be considered extraordinary and not morally obligatory Insisting that artificial nutrition and hydration are not a medical treatment because they are not intended to cure the inability to swallow when, in fact, there are many interventions in medicine that may not be intended to cure, but rather compensate for some malfunction or inability (e.g., ventilators at times, insulin injections, dialysis) Seeming to foster a certain vitalism as well as the technological imperative There are also questions about the accuracy of the medical assumptions in the CDF statement and commentary and whether what is proposed conflicts with the standard practice of medicine. Other puzzlements are more of a legal nature. As noted above, how should Catholic health care facilities deal with advance directives and the legal requirements associated with them? How should they deal with the statement that artificial nutrition and hydration are not medical treatment when that is how they are understood in medicine, and how they have been defined by some courts, including the U.S. Supreme Court, and some legislatures? These are all issues for theological/ethical discussion and debate. In the meantime, Catholic health care facilities will hopefully take a measured response to the CDF statement, that is, they will take very seriously the fundamental concerns of the CDF honoring the dignity of the person in PVS and not withdrawing artificial nutrition and hydration in order to end the person s life while not going to the extreme of believing that feeding tubes must be continued in every single person in PVS without exception. Every intervention on a patient, whether it is a form of basic care or medical treatment, must be evaluated in relationship to each individual patient and his or her condition (and here the CDF statement can provide some boundaries and some guidance). Such evaluations are at the core of the Catholic theological tradition regarding the duty to preserve life and the limits to that duty. These evaluations and judgments are a vital expression of the wisdom of the Catholic tradition that results in avoiding two extremes hastening death and prolonging life beyond what is reasonable. They are judgments grounded in part in some of the most basic beliefs of our religious tradition that we are finite, that there is a time to die, and that we are ultimately called to eternal communion with the giver of life. NOTES 1. John Paul II, Care for Patients in a Permanent Vegetative State, Origins 33 (April 8, 2004): 737, See Daniel A. Cronin, The Moral Law in Regard to the Ordinary and Extraordinary Means of Conserving Life, in Rev. Russell Smith, ed., Conserving Human Life, Braintree, Mass.: Pope John XXIII Medical-Moral Research and Educational Center, 1989, pp , especially pp For further discussion of this issue, see Ronald Hamel and Michael Panicola, Must We Preserve Life? America (April 19-26, 2004): Ibid. 5. Cronin, pp See, for example, Sacred Congregation for the Doctrine of the Faith, Declaration on Euthanasia, Origins 10 (August 14, 1980):154-56, Part IV. 7

8 FROM THE FIELD Sampling of Responses to the CDF Statement on Nutrition and Hydration The resent statement from the Vatican s Congregation for the Doctrine of the Faith (issued Sept. 14, 2007), concerning artificially administered nutrition and hydration to patients in a persistent vegetative state, has generated a lot of discussion within Catholic health care, resulting in a range of perspectives and interpretations. Following is a sampling of those interpretations and perspectives on the CDF statement. Carol Bayley, PhD, Vice President, Ethics and Justice Education, Catholic Healthcare West, San Francisco On Friday, Sept. 14, 2007, the Congregation for the Doctrine of the Faith (CDF) issued a response to certain questions that had been posed to it by some United States bishops regarding the administration of artificial nutrition and hydration to patients in a permanent vegetative state (PVS). I understand the CDF 3s statement as an answer to questions regarding 1. patients diagnosed to be in PVS 2. who are not ventilator dependent 3. who have artificial nutrition and hydration and 4. for whom the cessation of the artificial nutrition and hydration is being considered The statement itself is short: two questions, two answers, one page. The commentary that came along with it is considerably longer. In spite of the commentary, apparently sent along to help address questions about the meaning of the statement, I m left with more questions than answers. I will share two of them here. First, neither the statement nor the commentary puts the current questions and answers in the rich context of the rest of the church s teaching on care at the end of life, specifically on the withdrawal of treatment. For somewhere close to 500 years, the Catholic Church has taught that some medical treatment could be burdensome to a patient, and if it is too burdensome, the patient is not obligated to undergo it. This patient-centeredness contrasted with our more contemporary focus on a specific kind of treatment. Indeed, in some traditional examples, two persons with the same diagnosis and prognosis might legitimately decide differently about the value of life-sustaining treatment, causing one person to undergo the treatment and the other to allow the disease to overtake him. The difference was not in the treatment; it was in the person. By focusing the answers to the questions about PVS on one particular treatment, the authors of the statement neglected to mention anything about the meaning or value of the treatment to the person, a key feature in all the church s other teaching on end-of-life care. So my first question is exactly how this teaching fits into the much older tradition on end-of-life care. My tentative answer is that since the Catholic Church rarely produces a 180-degree reversal, and since the 500-year-old person-centered tradition is not mentioned, it must be presumed. If that is the case, the statement is not very different from the current Directive 58, the ambiguities of which we have managed for a long time. My second question has to do with the church s response to the average layperson s reading of the statement. To date, I am aware only of the lay press carrying the story in Modern Healthcare and the Chicago Tribune. I have had conversations, however, with administrators, ethicists and lawyers, within and outside of my system, suggesting that an honest (and by that they mean literal) interpretation of the statement will put Catholic hospitals and long-term care facilities squarely in conflict with California law, which specifically has found that nutrition and hydration are medical treatments that, like other medical treatments, may be forgone when they are too burdensome or without value to the patient. To lawyers especially, who are primed for conflict by matters such as abortion and contraception, this appearance of direct conflict, in which people s rights to refuse 8

9 treatment may be overpowered by the monolithic Catholic Church, is unmistakable. It would not surprise me if an enterprising rights lawyer sought a test case, or if a wellmeaning administrator found it necessary to discharge a PVS patient whose family sought discontinuation of nutrition and hydration. How the church responds to such cases may affect the credibility of Catholic hospitals throughout the United States. Because some of the ideas contained in the statement are not obviously just a reiteration of other teachings on the same subject, American bishops and theologians will have to take some time to unpack the meanings and messages contained in the statement before its impact is clear. They will certainly take into consideration, for example, developing American attitudes toward assisted suicide and euthanasia, fueled in many cases by people s fears that unwanted treatment will not be withdrawn. As we know, the ordinary pace of change in the Catholic Church is not... sudden. Until the statement finds its place in the settled, and longheld tradition on care of patients at the end of life, we should probably look at it more for what it restates: that every human person, no matter how diminished, possesses a dignity we must respect. Fr. Joseph Cardone, PhD, Vice President, Mission and Values, St. Vincent Mercy Medical Center, Toledo, Ohio The recent CDF statement Responses to Certain Questions Concerning Artificial Nutrition and Hydration has generated a great deal of discussion. The statement constitutes ordinary authentic teaching, and deserves respect. However, this respect is not simply blind unquestioning acceptance. Because it will impact families and Catholic health care institutions that care for this vulnerable population, we are obligated to engage in critical dialogue and thoughtful questioning. Recently, I stood in an operating room and observed a surgeon perform a percutaneous endoscopic gastrostomy (PEG). He described this medical procedure in the following way: The PEG tube is placed in the endoscopy unit or, less commonly, in the operating room. The procedure requires intravenous sedatives and narcotics. Cardiac and oxygen saturation monitoring are routine. A topical anesthetic is sprayed into the pharynx and an endoscope is passed via the mouth into the esophagus and stomach. While transilluminating the light from the scope through the abdominal wall, a site is selected for the incision. And it went on from there. To argue that this is not a medical treatment is confused and confusing. In some cases, a PEG may be an ordinary and proportionate means of preserving life. But, as is taught in the Ethical and Religious Directives for Catholic Health Care Services, that determination is made by the patient or the patient s health care proxy after weighing the benefits and burdens of the procedure (Directives 25, 32, 56 and 57). To declare that a particular medical treatment is ordinary, proportionate and obligatory is not in keeping with the centuries-old Catholic medical moral tradition. The possible negative impact of the CDF statement on the Catholic health care ministry deeply concerns me. I fear that it could lead many to conclude that the only way to die with dignity is through physician-assisted suicide or direct euthanasia. It could discourage people from residing in Catholic-sponsored retirement centers or extended care facilities because of the fear of being subjected to disproportionate medical procedures at the end of life. Tragically, Catholic-sponsored extended care facilities might need to transfer PVS patients whose advance directives indicate that they do not want medically administered artificial nutrition and hydration. Richard McCormick was prescient 15 years ago when he envisioned the following fanciful scenario: Imagine a 300-bed Catholic hospital with all beds supporting PVS patients maintained for months, even years by gastrostomy tubes.... An observer of the scenario would eventually be led to ask: Is it true that those who operate this facility actually believe in eternal life? (Corrective Vision, Sheed & Ward, Kansas City, MO, 1994, p. 232.) John Collins Harvey, MD, PhD, Professor of Medicine, Emeritus, Georgetown University Medical Center, Center for Clinical Bioethics, Washington, D.C. No Catholic physician would willfully end a patient s life by any act of commission or omission. Catholic physicians would always provide ordinary treatments to patients in 9

10 their care and extraordinary treatments when indicated. When providing extraordinary treatments, the physician will always assess their use by the burdens/benefits ratio of the treatment. If the burdens of the treatment are greater than the benefits, the physician may, in good conscience, withdraw the burdensome treatment. All physicians know that feeding a patient through a nasogastric tube requires careful insertion of such a tube by a trained health care worker to avoid misplacement into the trachea; trauma to the nasopharynx with resultant hemorrhage; undue pressure upon the mucosa of the esophageal gastric junction or the stomach pouch with resultant ulceration and hemorrhage; and possible penetration through the esophageal and or stomach walls causing contamination and subsequent life threatening infection of either the mediastinal and pleural spaces or the peritoneal cavity when fluid is inserted into the tube. Doctors also know that the fluid inserted into the tube used to hydrate and nourish the patient who cannot swallow requires careful preparation by a trained dietitian to insure the proper balance of nutrients to maintain a balanced metabolism and prevent excessive anabolism or catabolism; correct volume and consistency of the fluid makeup to avoid over hydration and anasarca or under hydration and generalized debilitation; proper sterilization of the fluid to avoid inducing a gastrointestinal infection with resultant diarrhea and its complications; and proper monitoring of administration of the fluid by a trained health care professional who is alert to possible regurgitation of the material into the esophagus with the resultant flooding of the lungs and the development of aspiration pneumonia. Pius XII, following a centuries-old Catholic moral tradition around ordinary and extraordinary means and their accompanying burdens and benefits, taught how to evaluate burdens of treatment. In his 1957 address to Catholic physicians and anesthesiologists, he said: Normally one is held to the use only ordinary means according to the circumstances of persons, places, times, and culture that is to say, means that do not involve the grave burdens for oneself or another. A more strict obligation would be too burdensome for most men and would render the attainment of the higher, more important, good too difficult. Life, health, all temporal activities are in fact subordinated to spiritual ends. Pius XII emphasized the principle of totality (extended to the psychological and spiritual dimensions of the whole person) and the importance of consequences in that burdensome treatment is extraordinary, and that families have a role in making decisions for unconscious patients. Pope John Paul II wrote in his 1995 encyclical, The Gospel of Life, that Euthanasia must be distinguished from the decision to forego so-called aggressive medical treatment, in other words, medical procedures which no longer correspond to the real situation of the patient, either because they are by now disproportionate to any expected results or because they impose an excessive burden on the patient and his family.... To forego extraordinary or disproportionate means is not the equivalent of suicide or euthanasia; it rather expresses acceptance of the human condition in the face of death. Patients in an irreversible persistent coma caused by anoxia for a period of time extending more than six minutes have, among the many produced deficits by this cause, death of the cells of the cerebral cortex. As a result, they have no voluntary motor power and the physiological mode of death for such a patient is dehydration, for they do not have the abilities to bring food and fluid to their mouth, nor, if such is put into the mouth, to chew and move it to the posterior part of the tongue nor to swallow it into the esophagus. Physicians can give care to such a sick person, but curing such an individual is beyond the physician s ability. Death is inevitable in these patients when the lower part of the brain ceases to function. Thus, the care of such a patient does not call for extraordinary or disproportionate means but only ordinary or proportionate care. Feeding such a patient by administering nutrition and hydration by nasogastric tube has recently been defined as ordinary care by the Congregation for the Doctrine of the Faith. I think that no Catholic physician in the past would ever, in conscience, have discontinued this treatment with 10

11 the direct intention of procuring the death of the patient, nor do I think that any Catholic physician in the future, in conscience, will ever discontinue this treatment with the direct intention of procuring the death of the patient. If, however, this treatment becomes burdensome because complications have occurred, the physician must judge its continuation or withdrawal upon the calculated burdens/benefits ratio of the treatment. If the burdens exceed the benefits, the treatment may legitimately be discontinued according to the recent teachings of the CDF. Daniel O Brien, PhD, Vice President, Ethics, and John Paul Slosar, PhD, Director, Ethics, Ascension Health, St. Louis As we read it, the CDF Responsum concerning obligations to persons in a persistent vegetative state simply reiterates the two central points of John Paul II s March 2004 allocution. Understood in light of our interpretation of that teaching,* the Responsum affirms and clarifies that Directive 58 applies to persons in a PVS. As the accompanying Commentary makes clear, the new statement does not preclude a judgment of extraordinary or disproportionate means when the artificially delivered nutrition and hydration (ADNH) entails disproportionate burdens or complications in a specific case, when it can no longer be assimilated by the body, or the patient is immanently dying. Like the papal allocution, the Responsum and Commentary do, according to our understanding, preclude unilateral decisions by health care professionals to withdraw nutrition and hydration from persons in a PVS based solely on a determination of no hope of recovery, in those rare cases in which the patient does not have either a surrogate who can speak on his or her behalf or an advance directive. The question of whether or not Catholic health care organizations may still follow advance directives regarding ADNH for PVS patients without any physical complications will likely be the issue around which there will be competing interpretations and the need for further reflection. However, consider the case of an adult devout * See, D. O Brien, J.P. Slosar, A. Tersigni, Utilitarian Pessimism, Human Dignity and the Vegetative State, The National Catholic Bioethics Quarterly 4, 3 (2004): Jehovah s Witness patient who rejects all blood products, even at risk to her own life. Even though in the Catholic tradition blood products would generally, that is, in principle, as the allocution and Responsum say, be consider ordinary means, they are rendered disproportionate means for the Jehovah s Witness patient for reasons of religious belief and conscience. Following this reasoning, we believe that Catholic facilities could still follow advance directives in the present context of concern. Doing so would not necessarily be considered contrary to Catholic teaching and the ERDs, because both specifically recognize the moral right of patients to forgo life-sustaining treatments that in the patient s judgment do not offer a reasonable hope of benefit or entail excessive burdens. Regardless, it is important for patients and staff to realize that this teaching applies only to ADNH for persons in a permanent vegetative state, the issue which the Responsum explicitly addresses, i.e., the manifest mind and intention of its authors.* In other words, and more precisely, this Responsum should not be extrapolated to apply in the context of other medical conditions, e.g., end-stage dementia or cancer, or to other treatment modalities, e.g., antibiotics or ventilators. To do this would be to misconstrue the manifest intention of the CDF and the teaching itself. Michael Panicola, PhD, Corporate Vice President, Ethics, SSM Health Care, St. Louis The recent statement of the Congregation for the Doctrine of the Faith (CDF) regarding the use of nutrition and hydration for patients in a vegetative state has caused quite a stir within the Catholic health ministry. Following the papal allocution of 2004, the CDF asserts that the administration of food and water even by artificial means is, in principle, an ordinary and proportionate means of preserving life. It is, therefore, obligatory insofar as it achieves its purpose, which is the hydration and nourishment of the patient and it may not be discontinued solely because the patient will never regain consciousness. * Regarding how to interpret church teaching with regard to the manifest intention of authors, see Lumen gentium, no 25, Vatican Council II: The Concilar and Post Conciliar Documents, edited by Austin Flannery, O.P. (New York: Costello Publishing Company, 1992),

12 However, in its accompanying commentary, the CDF indicates exceptions to this general rule may apply, namely: 1) where, due to emerging complications, a patient may be unable to assimilate food and liquids, so that their provision becomes altogether useless ; or 2) where, in some rare cases, artificial nourishment and hydration may be excessively burdensome for the patient or may cause significant physical discomfort (emphasis added). Given that the CDF s statement applies only to patients in a vegetative state, which is a relatively rare condition, the net effect on patient care within Catholic settings will be minimal. However, situations will arise on occasion as to whether artificial nutrition and hydration should be continued for patients suffering from this condition. In some, perhaps many, of these situations, I believe the CDF s statement will pose problems for Catholic facilities. The reason I say this is because patients in a vegetative state rarely meet the exceptional criteria that the CDF outlines for discontinuing artificial nutrition and hydration. Though such patients suffer from a severe brain injury, unlike other patient populations, they do not often fail to assimilate the artificial nourishment and hydration. Thus, exception one is out. The CDF does also allow for burdens to be a tilting factor in whether or not to continue artificial nutrition and hydration. But, it s physical burdens to the patient caused by the means, not burdens understood in the traditional sense, which could include familial, communal, and social burdens as well. Most of the evidence to date suggests that patients in a vegetative state do not experience physical burdens in the proper sense. How can this exceptional circumstance ever be met then? In reality, it most often cannot, and the CDF states as much by including in its commentary the phrase in some rare cases prior to allowing for the burden exception. Thus, exception two is out as well. The problem for Catholic facilities is that most people do not want to receive artificial nutrition and hydration if they are permanently unconsciousness, and many who complete advance directives specify this in writing and/or tell their surrogate. They hold this view not because they think the artificial means will fail to provide nourishment and hydration or be too burdensome but because they see no benefit to using such a means if their overall condition cannot be improved. This is precisely what the CDF has eliminated by restricting the notion of benefit to prolonging life and by declaring that nutrition and hydration cannot be discontinued solely because the patient will never regain consciousness. So what are Catholic facilities to do in such situations? The question is hard to answer if you honestly account for what the CDF s statement says and allows. You could argue that in the United States the Ethical and Religious Directives for Catholic Health Care Services (ERDs) are operative and until changed, it s practice as usual. Well that may be, but statements such as the CDF s are meant to illuminate the ERDs, and if this most recent statement is embraced as just such an illumination, it will severely limit the ability of Catholic facilities to discontinue artificial nutrition and hydration from patients in a vegetative state, despite what the patient may have wanted. Unfortunately, I think that for patients who have stated in writing or through a surrogate that they would not want to be kept alive by artificial means if permanently unconscious, or for families who desire as such, Catholic facilities will have to transfer the patient. Otherwise, Catholic facilities will just have to make pastoral exceptions that depart from the theoretical teaching. Mark Repenshek, PhD, Healthcare Ethicist, Columbia St. Mary s Health System, Milwaukee In a 1996 article in Theological Studies, Kevin Wildes addresses the relative norm of excessive expense in the Catholic moral tradition. In that piece, Wildes argues moralists have always taken into account the element of expense. 1 The norm of excessive expense is to take into account the person s economic status and may therefore vary widely. Traditional moral theology, it is argued, recognizes differing economic realities that are part of the human condition and therefore places the determination of excessive expense within the prudential judgment of the patient. 2 It seems the recent Commentary on the Responsum from the Congregation for the Doctrine of the Faith (CDF) constrains this important nuance. The Commentary states that the administration of food and water is morally obligatory in principle, which with regard to the matter of excessive expense suggests, that in principle does not exclude the possibility that, in very remote places or in situations of extreme poverty, the artificial provision of food and 12

13 water may be physically impossible. This statement seems at first blush to significantly constrain the tradition s recognized relative norm concerning the definition of excessive expense. However, I would suggest this statement may be more morally problematic than merely a constraint of what was heretofore a matter solely of prudential judgment of the patient. In 2005, Health Affairs published Illness and Injury as Contributors to Bankruptcy. In that piece, David Himmelstein and co-authors used four criteria to measure Major Medical Bankruptcy. One criterion used to determine major medical bankruptcy was a debtor who reported uncovered medical bills exceeding $1,000 in the past year. 3 The median income in the year prior to bankruptcy filing was $24,500 for an average family of 1.32 debtors and 1.33 dependents. 4 This median income for the average family size reported in the study represents over 200 percent of the 2007 Health and Human Services federal poverty guidelines. 5 Given charge estimates for procedures to enable enteral feeding varying from $1,700 to $2,000, 6 and the possibility that such costs may lead to major medical bankruptcy as Himmelstein s work suggests, it seems disingenuous to suggest that only in very remote places or in situations of extreme poverty might the artificial provision of food and water be of excessive expense. The strength of the Catholic moral position on the matter of excessive expense and disproportionate burden is that it recognizes the economic inequalities that exist as part of the human condition. Furthermore, it recognizes that such economic inequality may be socially constructed and thoroughly unjust when examined in light of Catholic social teaching. It is the nuance of the tradition that allows the patient herself to determine what may constitute excessive expense. In other words, it may very well be that two persons, who of equal income, judge a particular medical intervention as disproportionate based on two very different, and appropriate, understandings of excessive. It is this insight of the Catholic moral tradition that creates the sufficient condition for a determination of disproportionate burden. Specific to the Commentary on the Responsum, the CDF s use of in principle may create a moral impossibility for patients without the financial means to afford the medical interventions proposed by health care providers when such patients fall outside the criteria of geographic remoteness or situations of extreme poverty. NOTES 1. Kevin W. Wildes, Ordinary and Extraordinary Means and the Quality of Life, Theological Studies 57 (1996): ; Daniel A. Cronin, Moral Law in Regard to the Ordinary and Extraordinary Means of Conserving Life, in Conserving Human Life, ed. Russell E. Smith (Braintree, MA: Pope John Center, 1989) 1-145, David U. Himmelstein, Elizabeth Warren, Deborah Thorne, and Steffie Woolhandler, Illness and Injury as Contributors to Bankruptcy, Health Affairs [Web exclusive] (2005): W W Himmelstein, W Federal Register, Vol. 72 (January 24, 2007): The charge estimates are for percutaneous endoscopic gastrostomy tube (PEG tube) and local to the author s point-of-reference and may therefore vary depending upon ministry. Of note is that these charges are only for the procedure to place and do not include the ongoing solution, maintenance, and supportive services after the tube has been placed. Fr. Myles Sheehan, SJ, MD, Senior Associate Dean, Medicine/Geriatrics, Loyola University Health System, Maywood, Ill. I have three reactions to the recent statement of the Congregation of the Faith on Feeding and Hydration in Persistent Vegetative State. First, appreciation for the clarification. Second, in that same spirit of appreciation, I feel gratified that the document is clearly speaking about care of persons in a persistent vegetative state who are already receiving medically assisted feeding and hydration. It says nothing about the placement of feeding tubes or their use in other conditions. This should counter the media s unfortunate misrepresentation about the use of feeding tubes and irresponsible suggestion that the church is teaching that every disorder requires the placement of a gastrostomy tube. Neither John Paul II s statement nor this clarification addresses issues outside of persistent vegetative state. Third, as a Jesuit physician who cares for older persons, I will continue my current practice of recognizing that there is a presumption in favor of medically assisted feeding and hydration, but that presumption can be called into question by a variety of concerns, especially the concern about whether or not the treatment will work. I do not usually place gastrostomy tubes in persons with advanced dementia who have eating disorders, and it is very rare that I place gastrostomy tubes in any individual with a clearly fatal pathology, like cancer. Why? Because I believe these persons are dying and, with some specific exceptions, 13

14 it is my clinical experience that medically assisted feeding and hydration is not effective in cases of this type for prolonging life or treating the underlying pathology. I am vigorous in maintaining oral feeding and hydration, sometimes feeding patients by hand myself. I believe that I am in conformity with the spirit and letter of church teaching. In those persons who are doing well with a feeding tube but cannot swallow, I do not stop the feeding, any more than I stop providing oral feeding and hydration to persons who can swallow. This is nothing new, and was my practice, and I believe the accepted practice of most Catholic health care facilities, with rare exceptions, prior to John Paul II s March 2004 statement or the CDF s recent clarification. Msgr. Stephen Worsley, MD, Vice President, Mission and Ethics, St. Joseph Hospital, Nashua, N.H. The invitation to write about the implications of the CDF statement on nutrition and hydration for PVS patients led me to reflect on how I (and we) respond to such events. When read in context of the other pieces published here I trust this will make sense and may prove helpful to the reader. As a young physician, I was regularly humbled by the limitations of my knowledge. There was so much to learn. Yet nothing left me with a greater feeling of helplessness than the death of a child. We were trained to cure our patients. A child s death was the ultimate failure. With help, I eventually discovered a different reality. Sometimes a family s greatest need for a physician as healer comes after the death of their child. Helping parents realize that their child had received the best of everything because he or she had been loved was probably the most important thing I ever did as a physician. Time and again, I encounter people whose love for a dying family member is palpable. They want to do what is best, but are confused. They fear that they will run afoul of the church s teaching unless they do everything. It seemed so clear when their priest explained all that endof-life stuff in his homily. But now the same priest is in my office. His mother is dying. Is it OK to not...? Together, we walk through her last months. The winter after her funeral, he asks if I will give a talk in his parish. This stuff is not as easy to explain as it used to be. I suggest a topic for the bulletin announcement, Bioethics You May Know More than You Realize. After coffee and donuts, I start the discussion with two questions: Who made you? Why did God make you? They are good questions. Most of the folks recognize them from the first chapter of the old catechism. We talk about their answers for a while. Then we talk about the teachings of Pius XII, John Paul II and Benedict XVI. Finally, we discuss the importance of love and prayer in decision making. I hand out a short bibliography so folks can look up papal teachings and the ERDs on the Internet. The pastor smiles, his confidence renewed. Driving home, I realize what he has taught me: The world needs ethicists as healers. Now. 14

15 FROM THE FIELD A Primer for Understanding the CDF s Responses Regarding AANH for the PVS Patient E DITOR S N OTE The recent statement from the Vatican s Congregation for the Doctrine of the Faith (issued Sept. 14, 2007), concerning artificially administered nutrition and hydration to patients in a persistent vegetative state, has generated a lot of discussion within Catholic health care, resulting in a range of perspectives and interpretations. The following is one organization s attempt to help others in Catholic health care understand this potentially confusing development. On Sept. 4, 2007, the Congregation for the Doctrine of the Faith of the Roman Catholic Church issued Responses and a Commentary to two questions posed in 2005 by the bishops of the United States regarding artificially administered nutrition and hydration for patients in a persistent vegetative state. Since then, many people have raised concerns about its significance for us in Catholic health care. As a way to begin to address these concerns for Providence Health & Services, The Providence Center for Health Care Ethics in the Oregon Region has prepared this primer in a Q&A format. We hope it will be helpful to you in understanding and discussing the documents, as well as be of use to gain insight into what, if any, practical implications they have for you, your facility or department as we carry on the tradition of excellence in health care. Is this new document related to the allocution of Pope John Paul II on this topic in March of 2004? Yes. As a direct result of that allocution, the United States bishops sent two questions in July of 2005 to the Congregation for the Doctrine of the Faith (CDF), the Vatican congregation that deals with these types of issues. The bishops wanted to know first if it is always morally required to provide artificially administered nutrition and hydration (AANH) to a patient in a persistent vegetative state (PVS) as long as the patient s body can assimilate the nutrition or hydration, unless doing so causes significant physical discomfort. Second, they wanted to know if having moral certainty that a patient in PVS will never regain consciousness is a sufficient reason to forgo continued AANH. And the answer? To the first question, the response is yes. AANH is, in principle, an ordinary and proportionate means of preserving life. It is therefore obligatory to the extent to which, and for as long as, it is shown to accomplish its proper finality, which is the hydration and the nourishment of the patient. In the Commentary that accompanied this statement, the CDF clarified that significant physical discomfort may be one of those rare or exceptional instances in which there would be no obligation to provide AANH. In response to the second question, the CDF said that even with moral certainty that the patient will not regain consciousness, the moral obligation to offer AANH, remains. The persistence or permanence of the vegetative state does not change the ethical obligations. Does this statement apply only to patients in PVS, and only to whether they should always receive AANH? Yes, both questions and responses refer explicitly to patients in a PVS, and only to whether they should be offered AANH. The Commentary is quite succinct: the provision of water and food, even by artificial means, is in principle an ordinary and proportionate means of preserving life for patients in a vegetative state [emphasis added.] One aspect of the Catholic moral and legal tradition is that laws and norms should be interpreted narrowly without undermining their purpose. Put differently, an official text says only what it says no more and no less. Suggesting that these Responses apply, say, only to whether or not Terri Schiavo should have had her AANH removed, because the initial allocution was given during the controversy surrounding her death, would be too narrow an interpretation. On the other hand, saying it applies to all patients who cannot take food or water by mouth would be too broad. 15

16 The 2004 allocution, the U.S. bishops questions, and the CDF s Responses speak only to patients who are in PVS, and only to the issue of nutrition and hydration. It does not speak to the issue of patients who, for example, cannot safely swallow due to end-stage progressive dementia, nor does it say anything about how to care for PVS patients who develop pneumonia, renal failure or other life-threatening pathologies. Is the CDF saying something new then? Yes, and no. There has been some debate both within and outside Catholic ethical and medical circles over the years as to whether patients in PVS are a special case when it comes to AANH. Some have held that PVS is a neurological state that cannot be medically managed in such a way as to allow the person to actively live out his or her life. From this perspective, the person in PVS is not unlike the patient with end-stage renal disease dependent on dialysis both can be seen as chronic states not able to be sufficiently medically managed for the patient s benefit. As such, the same moral norms would apply either can be forgone when there is no benefit for the patient. Others have held that the PVS patient is not end-stage, is not suffering from a progressive disease, and is neither terminally ill nor imminently dying. In this case, AANH is considered basic care that should always be offered. What is new, if you want to call it that, is that it has now been clarified that the official position of the ordinary magisterium, the teaching office of the church, is that AANH for the patient who is in a PVS is to be understood as basic care. It is, in principle, morally obligatory for those patients. The Commentary does cite other church documents that speak about AANH, but none of these carries the authority or clarity of these texts. What does it mean to say AANH is in principle obligatory? The expression in principle (in linea principii) means more than as a general rule, as the common English expression might suggest. That makes it sound optional. The expression in principle is similar to the notion of a prima facie obligation: it refers to a duty or obligation that ought to always be fulfilled if it can be fulfilled. In this sense, the obligation to provide AANH for these patients is not optional. As explained in the Commentary however, it is not always possible to fulfill this obligation. The text does not exclude the possibility of circumstances in which it is impossible to fulfill this obligation, or impossible to do so without causing harm, even if this is a rare and exceptional case. When is it not an obligation? The Commentary acknowledges the reality that in remote and poor nations, fulfilling this obligation will be impossible. They further mention the possibility that discomfort related to the provision of AANH may make it imprudent to fulfill this obligation. Although neither the Responses nor the Commentary address the issue explicitly in light of the specific questions being asked, it would also be true that there is no obligation to provide AANH to the PVS patient who develops some other life-threatening pathology or co-morbidity that makes end-of-life care appropriate. Clearly, in the case of a patient dying for example of renal failure, AANH cannot achieve what the first response states is its purpose for the PVS patient: providing nourishment and hydration to sustain life. When AANH cannot sustain the life of the patient who is PVS due to some other underlying life-threatening pathology, it can be forgone as part of palliative or end-oflife care for the patient. 1 Is this statement different from Directive 58 from the Ethical and Religious Directives for Catholic Health Care Services? Yes. Directive 58 speaks of a presumption in favor of providing AANH in all instances, but does not speak of a positive moral obligation to provide AANH in any specific case. The CDF statement makes clear that the standard that may be applied in making AANH decisions for the person with end-stage dementia is not the same standard as shall be used in making AANH decisions for the person in a PVS. What is the authority of the CDF s Responses, and how does it compare to the authority of the ERDs that we already follow? The ERDs are a pastoral statement from the United States bishops. They are intended, as stated in the Introduction, to offer guidance on ethical issues related to health care. Because it is a pastoral document, each bishop may, within 16

17 certain limits, interpret and implement some of the directives in ways he feels is most pastorally appropriate for his diocese. For example, some bishops already understood Directive 58 to apply differently to PVS patients than to non-pvs patients, and some others began to do so after Pope John Paul II s allocution in Other bishops continued to address the issue of AANH for PVS patients in the same way as other patients. These Responses, published by the CDF and approved by Pope Benedict XVI, are classified as a doctrinal document. This means that the text is intended to remove uncertainty regarding the question of AANH for patients in PVS in order to prevent moral error from happening in their care. Origins, a Catholic News Service documentary service that is sponsored by the United States bishops, refers to the text as reaffirming the church s teaching that it is morally obligatory to provide nutrition and hydration in such [PVS] cases [emphasis added]. The text is not irreformable, and is able to be amended at some later time. Nevertheless, it is to be considered as authoritative and carries the expectation that appropriate attention will be given to it. With respect to patients in PVS then, the Responses are different from the pastoral Directive 58. Without in any way diminishing the guidance in Directive 58 for all other patients, there is now understood to be an in principle obligation to provide AANH to PVS patients. It is also interesting to note that the Responses and Commentary, written in Latin, were published not only in English, but also in French, German, Italian, Polish, Portuguese and Spanish. The CDF clearly understands this issue to be one of universal significance. Why is withdrawing AANH seen as morally different from removing a ventilator or stopping dialysis? As seen from the point of view of the CDF statement, interventions like mechanical ventilation or dialysis are interventions that replace or supplement an involuntary biological process stimulated by the activity of the brain stem. For example, people do not decide to breathe or cleanse their blood of impurities these happen as an involuntary biological process. Interventions to address these situations are seen as medical care because they are initiated to address the pathology that undermines this involuntary process. Eating and drinking, on the other hand, are voluntary human acts made possible by the upper cortical part of the brain people can decide whether, how much, when and what to eat or drink. Digestion is an involuntary biological process, but eating and drinking are voluntary human acts. Interventions to replace or supplement the loss of the ability to engage in voluntary human acts do not address the underlying pathology per se, but only the inability to initiate a voluntary human act. They are therefore seen as basic care. In the Commentary and in other writings surrounding the debate, this distinction between the loss of involuntary biological processes and the loss of the ability to perform a voluntary human act is viewed as morally decisive. With patients in PVS, the involuntary biological process of assimilating nourishment remains intact because the brain stem is intact. The voluntary human action of eating is impossible because the upper cortical part of the brain is catastrophically and irretrievably damaged. Specifically, the loss of the ability to engage in the voluntary human act of eating and drinking, while at the same time retaining the involuntary biological digestive process, creates a situation in which it is in principle morally obligatory to provide the nourishment to the patient who cannot take it voluntarily. This understanding as to why AANH is in principle obligatory for PVS patients also makes clear that these Responses do not apply to non-pvs patients, such as the patient in a terminal coma due to a series of strokes or the patient with severe dementia. The Responses mention that significant discomfort may allow for forgoing AANH. Can he or she feel significant physical discomfort, and how are we to understand significant? The importance of the issue of pain or discomfort is acknowledged by both the first question posed by the bishops, and the Commentary. Clinically, it is a matter of debate. A survey of physicians from the American Academy of Neurology and the American Medical Directors Association showed that 30 percent believed PVS patients could experience pain. 2 The 1994 consensus statement of the Multi- Society Task Force was not so definite. 3 In the face of a doubt of fact about the experience of pain, some may hold 17

18 that it is morally prudent to act on the presumption that the patient does experience pain or discomfort. There may be a sense of urgency with this question due to the fact that patients in PVS seem neurologically incapable of demonstrating to us they are in pain, and hence we may cause pain with no way of knowing it. Adding to the moral imperative to be alert to issues of pain are studies that show that somatosensory stimulation of PVS patients, at intensities that elicit pain in non-pvs patients, results in an increase of neuronal activity in the primary somatosensory cortex. 4 Even if we are uncertain whether the PVS patient subjectively experiences pain or discomfort, the fact that neuronal activity experienced as pain in non-pvs patients is observable in PVS patients should cause us to take very seriously the moral imperative to be attentive to the possibility of pain or discomfort in the PVS patient. Painful stimuli may impact PVS patients negatively in the same objective way as non-pvs patients even if we cannot say with certainty that the PVS patient experiences pain subjectively. Regardless of whether PVS patients can feel pain subjectively, we remain ethically obligated by traditional Catholic ethical principles to avoid causing objectively painful or discomforting stimuli. Care for PVS patients should take seriously the statement in the Commentary that the possibility is not absolutely excluded that, in some rare cases, artificial nourishment and hydration may be excessively burdensome for the patient or may cause significant physical discomfort, for example resulting from complications in the use of the means employed. Therefore, if AANH is associated with the objective discomfort that a reasonable person would describe as unacceptable subjective discomfort, the withdrawal of AANH would appear to be permissible. What are some examples of objective discomfort? Development of a reflux that causes irritation of the esophagus, or puts the PVS patient at risk for aspiration and repeated pneumonias might be an example of objective discomfort. If the patient develops diarrhea that cannot be easily managed, that too might constitute unacceptable discomfort. Patents in PVS are also prone to urinary tract infections, which can be a source of significant flank pain. If these infections are chronic and difficult to mange, one might argue that patient is at risk for significant discomfort. Because PVS patients have sleep and wake cycles and display non-purposeful movement, it is also conceivable that the feeding tube could be dislodged from time to time. This could happen even with careful bathing or physical therapy. Dislodgment of the tube might require repeated procedures to replace it, and these procedures might be a source of objective discomfort that a reasonable person would not find acceptable. This is recognized in the Commentary where we read that examples of physical discomfort may result from complications in the use of the means employed. Family members can best inform us as to whether any objective discomfort that might be present is or would be considered by the patient as significant, since they would know best the patient s ability to tolerate discomfort. There can be no moral obligation to subject a patient to objective discomfort that would be judged as subjectively intolerable. If AANH is basic care and not a medical intervention, does it matter if the family says the patient would not want it, or the patient has an advance directive that states they would not want it? This question will be a difficult one for Catholic health care facilities. Patients can legally refuse both medical and basic care, and Catholic health care cannot legally or ethically require patients to accept what they do not want. It should also be said that, while providing nutrition and hydration may be considered basic care, it cannot be overlooked that clinical expertise is needed as part of the provision of that basic care. Therefore, even if AANH is not a clinical intervention in the same way that a ventilator is a clinical intervention, AANH is not basic care in the same way that maintaining good hygiene is basic care. This raises questions: Even if AANH per se is in principle morally obligatory, does this mean that medical interventions necessary to provide that basic care are also in principle obligatory? Can patients through an advanced directive or their surrogate refuse the clinical interventions needed to allow that basic care to be administered even in a Catholic health care setting? Seemingly, a refusal of consent to replace a dislodged tube or to flush a plugged tube would constitute a 18

19 legal prohibition to touch the patient and should be respected. Is it permissible to allow the situation to unfold, or should the patient be transferred? What if there are no facilities available for discharge for the removal of the tube? These are questions with which all Catholic health care providers will have to struggle. Is it material cooperation in or toleration of euthanasia for a Catholic facility to comply with a refusal by a surrogate to allow us to replace a nutrition or hydration source? No. The principle of material cooperation addresses the question of whether or not a person can perform some act that will in some way assist another person in the performance of a wrong act. In the case of a surrogate refusing to allow AANH to continue, we would not be performing any action. Instead, there would be an omission on our part if we complied with that refusal. The ethical principle that deals with omissions is toleration of wrong-doing. But, the principle of toleration asks the question of whether there is an obligation to prevent some wrong from happening when it is possible to prevent that wrong. If a surrogate makes the legally informed decision to forgo flushing or replacing a clogged or dislodged tube, or withdraws consent to replacing the nutritional or hydration source, we are legally prohibited from overriding that decision. It is not toleration in the moral sense because we are legally powerless to do anything about it. Should Catholic health care refuse to admit PVS patients whose surrogate will not agree to continue AANH after admission? This is also a hard question, and will need to be sorted out over time in particular situations. It is hard to maintain, for example, that family members should have to choose between excellent care in a Catholic facility and less optimal care in another facility. It may also be the case that families have few if any other options than the Catholic facility, either due to insurance or the lack of other options. Not allowing certain actions as a condition for admission, such as prohibiting physician aid in dying in a facility, can and should be done in the Catholic setting. However, requiring indefinite consent to even basic care as a condition for admission is not as simple. Certainly upon admission families need to understand our moral stance. Still, in most cases, we are limited in what we can do on this issue because our actions depend on the consent of another, and it will not always be possible, feasible or pastorally desirable to transfer the patient to another facility. It is important that the communities served by Catholic health care understand that the wishes of patients, their health care representatives or surrogate will ultimately be respected as provided by law. If we cannot withdraw AANH for a PVS patient in our care as requested, we will work with the family, health care representative or surrogate to see if the patient can be transferred to a facility where this can be done, and that we will effect this transfer with as little disruption to the patient and his or her loved ones as is humanly possible. Providence Center for Health Care Ethics, October 2007 NOTES 1. This is an important point. Although Terri Schiavo lived 15 years, studies show that mortality rates for patients in PVS are 70 percent at three years and 84 percent at five years due to medical complications. See, The Multi-Society Task Force on PVS, Medical Aspect of the Persistent Vegetative State A Correction. The New England Journal of Medicine 333 (1995) 130-a. 2. Kirk Payne, MD; Robert M. Taylor, MD; Carol Stocking, PhD; and Greg A. Sachs, MD, Physicians Attitudes about the Care of Patients in the Persistent Vegetative State: A National Survey. Annals of Internal Medicine 125 (1996): The Multi-Society Task Force on PVS, Medical Aspect of the Persistent Vegetative State - First of Two Parts. NEJM 330 (1994) See also Medical Aspects of the Persistent Vegetative State - Second of Two Parts. NEJM 330 (1994) S. Laureys, et al., Cortical processing of noxious somatosensory stimuli in the persistent vegetative state. Neuroimage 2002 Oct; 17(2):

20 RESOURCES A Resource for Evaluating Levels of Authority in Church Teaching By Fr. Russell Smith, STD, Senior Director, Ethics, Catholic Health Association of the United States, St. Louis Regarding the weight of documents with regard to a doctrine, it is perhaps easiest to categorize by the agent proposing doctrine, namely the Ecumenical Council, the pope and the Congregation for the Doctrine of the Faith. The Ecumenical Council Dogmatic Constitutions Decrees Declarations Pastoral Constitution (unique to Vatican II) The Pope Infallible doctrine (extraordinary magisterium, defining a doctrine) Infallible doctrine (ordinary magisterium, affirming a doctrine as such) Papal Bull (used widely until the 19th century, affirming a wide variety of things) Apostolic Constitution (a wide variety, so must be read in context) Papal Encyclical (more common since Pope Leo XIII, ) Apostolic Letter Apostolic Exhortation Homilies Audiences (Allocutions) The Congregation for the Doctrine of the Faith With its roots established in the 13th century, and commonly referred to today as the Holy Office, the Congregation for the Doctrine of the Faith (CDF) is unique among the various and varied Vatican dicasteries. Until 1963, the cardinal who oversaw the work of the CDF was its pro-prefect because the actual head of the CDF is the pope himself, and all its plenary sessions were conducted coram Summo, with the pope presiding. Now, the cardinal is designated as prefect and the pope accepts, affirms or approves in a formal manner the matter at hand, in ascending order of importance. Also, until the early 1960s, the CDF often made the theological note of its statements explicit. The documents and communiqués emanating from the CDF are varied. They take the following forms, in descending order of importance: Decrees Declarations Monita ( warnings ) Responsa (answers to questions) Explanations Press Conferences These various documents carry theological weight in accord with the manner of the pope s acceptance, in descending order: In modo specifico (most formally, and in every part, especially assigned to some decrees) Formal acceptance (especially in disciplinary matters) Acceptance The pope s ordering of a document s publication The CDF can produce a document on doctrine (generally with a high theological note); discipline sometimes with penalties; and most recently, it can render a verdict with penalties inasmuch as Pope John Paul II established the CDF as a tribunal to handle cases of priests misconduct, in addition to its long-standing responsibility to review marriage cases involving the Petrine Privilege. For a slightly expanded version of this resource, CHA members can visit the ethics section at 20

21 RESOURCES A SELECT BIBLIOGRAPHY Next Generation Ethics Committees Bancroft, Nancy. The Next Generation Model. Health Progress 85 (May-June 2004): 27-30, 55. Blake, David. Reinventing the Healthcare Ethics Committee. HEC Forum 12, no.1 (2000): Boyle, Philip, et al. Organizational Ethics in Health Care. San Francisco: Josey-Bass, Brinkmann, Bill, et al. Bridging the Gap. Health Progress 87 (November-December 2006): Foglia, Mary Beth, and Robert Pearlman. Integrating Clinical and Organizational Ethics. Health Progress 87 (March-April 2006): Hamel, Ron. Organizational Ethics: Why Bother? Health Progress 87 (November-December 2006): 4-5. Lynn, J., et al. The Ethics of Using Quality Improvement Methods in Health Care. Annals of Internal Medicine 146 (May 1, 2007): Magee, Glen, et al. Successes and failures of Hospital Ethics Committees: A National Survey of Ethics Committee Chairs. Cambridge Quarterly of Healthcare Ethics 11 (Winter 2002): Murphy, Kevin. A Next Generation Ethics Committee. Health Progress 87 (March-April 2006): Piette, M. et al. Integrating Ethics and Quality Improvement: Practical Implementation in the Transitional/Extended Care Setting. Journal of Nursing Care Quality 17 (October 2002): Ross, J.W., et al. Health Care Ethics Committees: The Next Generation. Chicago: American Hospital Publishing, Inc., Rueping, J., and D. Dugan. A Next-Generation Ethics Program in Progress: Lessons from Experience. HEC Forum 12 (March 2000): Talone, Patricia. Starting an Organizational Ethics Committee. Health Progress 87 (November-December 2006): Weber, Leonard. Business Ethics in Health Care. Bloomington: Indiana University Press, Wenger, N.S. The HEC Model of the Future Builds on Deficiencies of the Past. HEC Forum 12 (March 2000): Websites

22 ETHICAL CURRENT DCD Policies: The Devil is Always in the Details By Dan Sulmasy, OFM, MD, PhD, Sisters of Charity Chair in Ethics, John J. Conley Department of Ethics, St. Vincent s Hospital Manhattan, New York Like many Catholic institutions, at St. Vincent s Hospital Manhattan we have approved a policy for organ donation after cardiac death. In drafting the policy, we took what we thought were the usual sorts of precautions strictly separating the decision to discontinue ventilator support from the decision to donate organs, waiting five minutes after the declaration of death before beginning organ retrieval, and prohibiting tests or treatments performed on the potential donor that might significantly risk hastening death. We explicitly forbade the use of regitine and restricted the use of heparin to patients who are not actively bleeding. Recently, however, we have become aware of ante-mortem protocols and procedures that are less commonly discussed in the literature but may also substantially risk hastening death. Organ donor network personnel requested these procedures be performed, appeared to regard them as routine, and were surprised by our institutional push-back. These include the following three procedures: Testing for the likelihood of respiratory arrest within 60 minutes Many protocols actually subject the potential donor to more risk than is routine in testing for brain death. In brain death protocols, for the safety of the patient, 100 percent oxygen is administered before turning off the ventilator in the so-called apnea test. Organ procurement organizations evaluating potential DCD donors, however, routinely supply no oxygen. They simply turn off the ventilator to test for respiratory difficulty, arguing that both low oxygen and high carbon dioxide figure importantly in their predictions. We argued that potential DCD donors should not be subjected to more risk than we currently allow for potential brain death donors. The alternatives are to derive estimates from so-called weaning parameters or to perform the standard apnea test that is used for brain death assessments. Testing the suitability of lungs for transplantation Organ procurement organizations have requested permission for ante-mortem bronchoscopy and lung biopsy on potential DCD donors. We have refused, arguing that this procedure carries a substantial risk. Testing the suitability of the heart for transplantation Organ procurement organizations have requested permission for ante-mortem cardiac catheterization on potential DCD donors. We have refused, arguing that this procedure carries a substantial risk. The bottom line is that one needs to monitor the procedures for antemortem evaluation of potential DCD donors very carefully and decide what tests or treatments might be more risky to the potential donor than one s own policy was designed to permit. 22

23 OF NOTE Study shows women and blacks are less likely to get heart devices. Although clinical trials have shown that implantable cardioverter defibrillators can save people at risk for sudden cardiac death, women are still less likely to receive the devices than men, and black patients overall are less likely to receive them than white patients, two studies have reported. One study reported that among eligible patients, 32.3 out of 1,000 men received a defibrillator within one year of diagnosis, while only 8.6 out of 1,000 women did. The other study found that about 44 percent of eligible white men got a device, compared with only 30 percent of white women. Among eligible black patients, only about 33.5 percent of men and 28 percent of women got one. The new studies are among the first to show underuse and disparities in the use of implantable defibrillators. (USAToday.com, Oct. 3, 2007) Expanded testing for Down syndrome raises concerns. Under a new recommendation from the American College of Obstetricians and Gynecologists, doctors have begun to offer a new, safer Down syndrome screening procedure to all pregnant women, regardless of age. About 90 percent of pregnant women who are given a Down syndrome diagnosis have chosen to have an abortion. A dwindling Down syndrome population, which now stands at about 350,000, could mean less institutional support and reduced funds for medical research. It could also mean a lonelier world for those who remain. A growing group of parents of Down syndrome children are pressing obstetricians to refer couples to them who have been given a prenatal diagnosis of Down syndrome. They see themselves as society s first line of defense against a use of genetic technology that can border on eugenics. Many see expanded testing as a step toward a society where children like theirs would be unwelcome. (The New York Times, May 9, 2007) Death reveals risks in clinical research. Jolee Mohr, a participant in a gene therapy experiment whose chief goal was to test the safety of a novel arthritis treatment that had virtually no chance of helping her, died from massive bleeding and organ failure July 24. A close look at the events leading to Mohr s death reveals failures in the safety net that is supposed to protect people from the risks of medical experimentation. Breaches of clinical research standards and a federal oversight system that allowed key decisions to be made behind closed doors may have helped draw Mohr into an experiment that was not what she thought it was. It was presented to her like this is going to make her knee better, said husband Robb. A two-sentence paragraph halfway through a 15-page consent document that Mohr signed warns of the possibility of unknown side effects, including, in rare circumstances, death. Further in, after long descriptions of how the product may help, a single sentence states: We do not expect you to receive any direct medical benefits from participation in this study. (WashingtonPost.com, Aug. 6, 2007) Patients do not have right to use unapproved drugs. A federal appeals court ruled that patients with terminal illnesses do not have a constitutional right to use medicines that have not yet won regulatory approval. The 8-to-2 decision by the Court of Appeals for the District of Columbia Circuit came in a closely watched and emotional case that pitted desperate patients willing to try unproven, even risky, therapies against those arguing that drugs should be proved safe and effective before they are made available. It was argued that forcing patients to wait years for a drug to go through the process of clinical trials deprived dying patients of their right to self-defense. Judge Thomas B. Griffith, writing for the majority, said a right to experimental drugs was not deeply rooted in the nation s history and tradition. He said the right of self-defense cannot justify creating a constitutional right to assume any level of risk without regard to the scientific and medical judgment expressed through the clinical testing process. (The New York Times, Aug. 8, 2007) Catholic group campaigns for study of adult stem cells. The Michigan Catholic Conference launched a major education campaign aimed at promoting support for research using adult stem cells and clarifying the church s opposition to embryonic stem cell research. The campaign Finding Cures & Protecting Life, described as the largest in history for the conference, includes the distribution of a stem cell DVD and supporting materials to more than 500,000 Catholic households in Michigan and encourages 800 parishes around the state to focus on the issue. Paul Long, vice president for public policy at the conference, said Friday the campaign is intended to counter the hype over embryonic stem cell research that has overshadowed the real hope offered by adult stem cell research. (Detroit Free Press, Sept. 30, 2007) 23

24 Study Links Religion to Medical Treatments. A study by medical ethics experts suggests doctors and patients need to talk about religion. Researchers have examined responses from more than 1,100 doctors. The results show differences between religious doctors and those who are not religious. The co-author of the study, Dr. John Lantos with the Kansas City-based Center for Practical Bioethics, says the results are clear that referral patterns are shaped by the doctors religious beliefs. He says the more religious doctors are likely to refer someone suffering from depression or deep grief to clergy counseling. He says less religious doctors are more likely to send those patients to psychiatrists or psychologists. Lantos says the study found only 10 percent of the doctors surveyed profess no religious affiliation. Forty percent were Protestant, 20 percent Catholic, 14 percent Jewish, with the other 11 percent being Mormon, Muslim, Buddhist or Hindu. (Missourinet.com, Sept. 24, 2007) Religious physicians found not to disproportionately care for the poor. A recently published study examined whether physicians self-reported religious characteristics and sense of calling in their work are associated with practice among the underserved. Researchers found that physicians who are more religious do not appear to disproportionately care for the underserved. Of the 2,000 physicians invited to participate, 63 percent responded. Twenty-six percent of respondents reported that their patient populations are considered underserved. Physicians who were more likely to report practice among the underserved included those who were highly spiritual and those who said the family in which they were raised emphasized service to the poor. Physicians who were more religious in general, as measured by intrinsic religiosity or frequency of attendance at religious services, were much more likely to conceive of the practice of medicine as a calling but not more likely to report practice among the underserved. (Annals of Family Medicine, vol. 5, 2007) New limits debated for organ donation. A debate between surgeons and patient advocates reflects a tension between the need for organ donors and concerns that doctors may be lowering standards for living donors too far or failing to catch problems that could put the donor at unacceptable risk. Proposed new guidelines from the United Network for Organ Sharing include two contentious sets of voluntary guidelines. The first aims to ensure that potential donors are properly screened, both medically and psychologically; that afterward they are followed to ensure no problems develop; and that people who are at increased risk never make it to the operating room. The second lays out recommendations to ensure donors give their informed consent. It s troubling, says David Cronin, a transplant surgeon at Yale University, where he says doctors have dropped their standards for donor blood pressure, weight and diabetes. He argues that even if donors fully consent to overly risky operations, doctors shouldn t do them. Still, Dr. Cronin doesn t believe UNOS should be setting guidelines for medical practice. This is an external agency practicing medicine, he said. You don t see my patient, and you don t see my donor, and you re going to tell me who I can and can t use? (Wall Street Journal, Sept. 13, 2007) Study shows disparities aren t usually due to bias. Two recently released studies added to the increasing weight of evidence suggesting that health care disparities are due mostly to where minorities receive treatment rather than to racism or cultural insensitivity. An Archives of Internal Medicine study examined how 123 teaching hospitals scored on Hospital Quality Alliance measures in caring for more than 320,000 patients. After adjusting for where minority patients were treated, the researchers found racial and ethnic disparities were vastly reduced or even eliminated. And a report released by the Commonwealth Fund, a health care policy nonprofit, surveyed nearly 3,000 patients and determined that those whose physicians provided a medical home received more equitable treatment. An editorial accompanying the Archives article said the study s findings demonstrate that most disparities in the quality of hospital care depend on where you seek care, not on your race [or] ethnicity. (Amednews.com, Aug. 6, 2007) Senate addresses rise in suicide rate in the elderly. Suicide rates among older adults are higher than those in any other age group in the nation, with individuals 85 years and over most at risk. Proposed Senate Bill (S. 1854) is designed to improve early intervention strategies to prevent suicide among the elderly. S would establish an Interagency Mental Health Planning Council to coordinate the delivery of mental health services for the elderly, 24

25 and would empower the Secretary of Health and Human Services to award grants for the development of strategies addressing elder suicide. The bill would also end discriminatory Medicare copayment rates for outpatient mental health services, emphasizing the need for parity in coverage for mental and physical conditions. (Stop Senior Suicide Act, S. 1854, 110th Congress, 2007) States take action to eradicate HPV. The Human Papilloma Virus (HPV) infects tens of millions of Americans. In 2007, 24 states proposed legislation mandating the HPV vaccine for school age children. The HPV vaccine was approved by the FDA and recommended for use by the American Committee on Immunization Practices (ACIP) in Since 2006, 41 states and the District of Columbia have proposed legislation for HPV vaccine funding, distribution or education. Seventeen states have enacted such legislation. Despite states rush to mandate use of the vaccine, many questions still remain, such as the ethical issues surrounding parental rights for exemption and the impact of the vaccine on children s sexual practices. (The National Conference of State Legislatures, August 2007) Senate endorses mental health parity. The Mental Health Parity Act of 2007 was passed unanimously by the Senate in late September. The act requires certain health plans to provide equal coverage for both physical and mental disorders, and will preempt state laws related to mental health parity. If enacted, the federal legislation would require covered plans to provide benefits for mental health and substance abuse treatment equal to those available for medical and surgical services. (The National Conference of State Legislatures, January 2007; The New York Times, Sept. 19, 2007) New Jersey physicians not required to characterize embryo as human being to obtain informed consent for abortion. On Sept. 12, 2007, the Supreme Court of New Jersey unanimously decided that a physician s duty to obtain informed consent, including information about the risks of an abortion procedure, does not include suggestions that the procedure results in the death of a living human being. The plaintiff was advised that carrying a pregnancy to term would endanger her life because of an underlying kidney disease. She subsequently underwent an abortion in her 7th week of pregnancy but later alleged her physician was negligent in not informing her that she would be killing a human being. Because the consent process included material medical information such as gestational age and medical risks, the court dismissed the plaintiff s claims of negligence (based on lack of informed consent) and negligent infliction of emotional distress. (Acuna v. Turkish, 2007 N.J. LEXIS 1058, 2007 WL (N.J. 2007)) HIPAA does not prevent the release of psychotherapy notes in a life insurance dispute. On September 28, 2007, the U.S. District Court for the Middle District of Florida ruled that the Health Insurance Portability and Accountability Act (HIPAA) did not protect psychotherapist notes from discovery in a life insurance dispute. Although the court acknowledged the existence of comments in the final HIPAA regulations suggesting that the notes were private, the court held that this did not outweigh other regulatory language anticipating their production in specific circumstances. (BNA Health Care Daily Report, Oct. 3, 2007) NIH unveils plan to foster research on human embryonic stem cell alternatives. The National Institutes of Health (NIH) released its plan to encourage research on embryonic stem cell alternatives. The plan, entitled Expanding Approved Stem Cell Lines in Ethically Acceptable Ways, was created in response to President Bush s executive order 13435, which was intended to shift research endeavors away from embryonic stem cells. Research is currently eligible for federal funds only when performed on approved embryonic stem cell lines (embryos created prior to August 9, 2001). (BNA Medical Research Law & Policy Report, Oct. 3, 2007) Grand jury refuses to indict doctor for Katrina hospital deaths. Dr. Anna Pou, who was accused of administering a lethal cocktail to four elderly patients at Memorial Medical Center during Hurricane Katrina, will not be charged with the deaths of those individuals. On July 24, 2007, a grand jury declined to indict Pou for either second degree murder or conspiracy to commit murder. Pou gave up her practice after her arrest, but continues to teach at LSU medical school in Baton Rouge, La. (CNN.com, July 24, 2007) Virginia legislators push for easier involuntary commitments. In the wake 25

26 of the Virginia Tech tragedy, legislators in the state of Virginia have proposed a three-part plan to reform the state s mental health system. The most controversial part of the plan would allow a judge to involuntarily commit individuals believed to be a danger to themselves or others, even if not evident at the time of the hearing. Mental health advocates fear the proposal will infringe on the rights of the mentally ill, and may lead to a flooding of the mental health system without an appropriate increase in funding. (WashingtonPost.com, Sept. 7, 2007) State to pay $925,000 to participants of stuttering study. An Iowa state court approved a settlement for $925,000 to the participants of a 1939 University of Iowa stuttering study. The former participants, children from a Davenport home for neglected youths, were part of a five-month study that used negative reinforcement to induce stuttering in otherwise unaffected children. The participants claimed that the study led to a loss of self-confidence and self-esteem, and sought recovery for intentional infliction of emotional distress, invasion of privacy and fraudulent misrepresentation. The settlement awards a total of $925,000 to three of the study s living participants and to the estates of three deceased participants. (BNA Medical Research Law & Policy Report, Sept. 5, 2007) Congress, states address influence of drug and device companies in treatment decisions. New Jersey is the latest in a series of states to examine the impact of drug and device industry gifts on patient care. The Attorney General s Advisory Task Force on Physician Compensation is set to examine data collected by the State Board of Medical Examiners to assess the effects of such gifts on the physician-patient relationship. Congress has also taken note of the potential influence of drug and device companies on consumer purchasing, and may soon debate the appropriateness of direct-to-consumer advertising in proposed legislation from Rep. Rosa L. DeLauro (D-Conn.). (BNA Medical Devices Law & Industry Report, Sept. 26, 2007 and Oct. 10, 2007) Federal officials begin to define bounds of emergency medical care under Medicaid. Federal officials recently informed New York State that emergency Medicaid funds can no longer be used to cover chemotherapy costs for illegal immigrants without other access to chemotherapy. Denise Smith, director of the Center for Medicaid and State Operations at the Centers for Medicare and Medicaid Services, cited a longstanding interpretatio[n] by the agency... that emergency Medicaid benefits are to cover emergencies. However, emergency is not adequately defined and states are therefore forced to construe the term themselves, often resulting in inconsistent interpretation. (The New York Times, Sept. 22, 2007) Emergency department overcrowding adversely impacts patients. According to a recent poll from the American College of Emergency Physicians (ACEP), more than 80 percent of physicians surveyed indicated that emergency department overcrowding had increased either slightly or significantly within the past year. A majority of physicians cited inadequate staffing or resources as the leading cause of concern. Also of concern were long wait times and boarding of patients in the ED. Dr. Linda Lawrence, President of ACEP, expressed concern about patient suffering. We watch it each and every day as they ve lost their privacy and dignity lying in our hallways. (Modern Healthcare, Oct. 10, 2007; NBC Nightly News, Oct. 9, 2007) OIG offers positive opinions on charity care. Two recent opinions by the Department of Health and Human Services Office of the Inspector General (OIG) positively influence charity care. The first opinion, posted September 27, 2007, approved a proposal by a not-forprofit medical center to compensate for emergency department on-call coverage. Payments were aimed at covering the uncompensated care that physicians are expected to provide to the uninsured and underinsured, and was cited by the OIG as having an obvious public benefit. The second opinion, posted October 3, 2007, allowed a charitable group s proposal to establish a foundation to provide grants to financially needy cancer patients, despite the fact that the foundation might generate payments violating anti-kickback prohibitions. (BNA Health Care Fraud Report, Oct. 10, 2007) Students from the Center for Health Law Studies and Student Writers Association at Saint Louis University School of Law contributed to this installment of Of Note. Center Assistant Director, Kelly Dineen supervised the contributions of health law students Heather McCollum, Kristen Reiss, Mark Tolman, Stephanie To and Geeta Wadhwa. 26

27 HealthCare EthicsUSA Health Care Ethics USA 2007 is published quarterly by the Catholic Health Association of the United States (CHA) and the Center for Health Care Ethics (CHCE) at Saint Louis University. Subscriptions to Health Care Ethics USA are free to CHA members. There is a nominal subscription fee for non-cha members. To begin receiving this publication, or to inquire about non-member rates, please contact Scott McConnaha at smcconnaha@chausa.org. Executive editor: Ron Hamel, PhD, CHA senior director of ethics Associate editors: James DuBois, PhD, DSc, CHCE associate professor, department chair, and center director; and Sr. Patricia Talone, RSM, PhD, CHA vice president of mission services Managing editor: Scott McConnaha, editor of CHA s journal Health Progress Please address editorial correspondence to Scott McConnaha at smcconnaha@chausa.org. Editorial Advisory Committee Philip Boyle, PhD, STL, Catholic Health East Bridget Carney, PhD, RN, PeaceHealth Jan Heller, PhD, Providence Health & Services Sandra Johnson, JD, LLM, CHCE Rev. Thomas Kopfensteiner, STD, Catholic Health Initiatives Rev. Thomas Nairn, OFM, Catholic Theological Union Daniel O Brien, PhD, Ascension Health Michael Panicola, PhD, SSM Health Care 4455 Woodson Road St. Louis, MO GOT SOMETHING TO SAY? Future issues of HCEUSA will contain a section titled Readers Forum. If you have comments on things you've seen in this first issue of 2007, please share them with your fellow readers. Send all Readers Forum comments to smcconnaha@chausa.org. Center for Health Care Ethics 221 North Grand Blvd. St. Louis, MO chce.slu.edu Catholic Health Care Ethics: Clinical, Social and Global Concerns This conference addresses the social, anthropological, and methodological foundations of Catholic health care ethics, helping attendees apply conceptual resources to current problems, and to confront moral challenges on the horizon for Catholic health care providers. This program is intended for executive leaders, mission leaders, pastoral care staff, members of ethics committees, clinicians, sponsors, and others in the Catholic health ministry. February 28-29, 2008 Loyola University Chicago Stritch School of Medicine 2160 S. First Avenue Maywood, Ill. Sponsored by: The Neiswanger Institute for Bioethics & Health Policy Loyola University Chicago Stritch School of Medicine and The Catholic Health Association of the United States In Conjunction with the Chicago Medical Society Complete conference schedule and registration available at (Or call ) 27