Showing papers by "Arthur L. Caplan published in 2014"

Accepting Brain Death

Abstract: The cases of Jahi McMath and Marlise Munoz have reopened public debate about brain death. But the law and ethics have long recognized that deferring to medical expertise regarding the diagnosis of brain death is the most reasonable way to manage the process of dying.

Pediatric euthanasia in Belgium: disturbing developments.

Abstract: On February 13, 2014, Belgium’s Parliament approved an amendment of the 2002 Belgium Act on Euthanasia to allow euthanasia for chronically ill children. The amendment, supported by a majority of Belgians and recently signed into law by King Philippe, permits euthanasia for children who are experiencing “constant and unbearable suffering.” In addition to requiring the child’s own voluntary and explicit request for euthanasia, the new law requires parental consent, excludes children with an intellectual disability or mental illness, and mandates a multidisciplinary team carefully examine the child’s capacity for discernment.1 The passage of this law marks the culmination of years of increasing acceptance of euthanasia in the Benelux region. To date, the Netherlands, Belgium, and Luxembourg are the only member states in the European Union in which euthanasia is legal. In Belgium, euthanasia for adults has been lawful since May 2002.1 A study examining the attitudes of physicians involved in the care of Belgian children under the age of 18 years who died between June 2007 and November 2008 revealed that the majority (69%) favored extending the Belgian law on euthanasia to include minors.2 Those physicians favoring extending the law were more likely to engage in practices intended to shorten their patient’s life.2 In March 2005, recognizing the rising incidence of pediatric euthanasia without any legal sanction, physicians at the University Medical Center of Groningen, in the Netherlands, published practice guidelines for the ethical implementation of euthanasia for severely disabled newborns.3 The Groningen protocol stipulates that the provision of active euthanasia is justifiable for a class of infants “with a hopeless prognosis who experience what parents and medical experts deem to be unbearable suffering.”3 The protocol specifies that the termination of a child’s life is acceptable if 4 requirements are met: the presence of hopeless and unbearable suffering, the consent of both parents, consultation with physicians, and the termination procedures comport with “medical standards.”3 In contrast to the Belgium law, the Groningen protocol represents a form of nonvoluntary active euthanasia, in which the patient—a neonate—never possessed the capacity to develop preferences. Meanwhile, US support for physician aid in dying for adult patients is slowly evolving, as evidenced by legislation legalizing the practice in the states of Washington, Oregon, and Vermont and favorable court opinions in Montana and New Mexico.4 Although US laws only apply to competent adult patients, developments in Belgium and the Netherlands may stoke the debate about the ethical permissibility of pediatric euthanasia in the European Union and in the United States.

Functional status and survival after kidney transplantation

Abstract: BACKGROUND Older patients constitute a growing proportion of U.S. kidney transplant recipients and often have a high burden of comorbidities. A summary measure of health such as functional status might enable transplant professionals to better evaluate and counsel these patients about their prognosis after transplant. METHODS We linked United Network for Organ Sharing registry data about posttransplantation survival with pretransplantation functional status data (physical function [PF] scale of the Medical Outcomes Study Short Form-36) among individuals undergoing kidney transplant from June 1, 2000 to May 31, 2006. We examined the relationship between survival and functional status with multivariable Cox regression, adjusted for age. Using logistic regression models for 3-year survival, we also estimated the reduction in deaths in the hypothetical scenario that recipients with poor functional status in this cohort experienced modest improvements in function. RESULTS The cohort comprised 10,875 kidney transplant recipients with a mean age of 50 years; 14% were ≥65. Differences in 3-year mortality between highest and lowest PF groups ranged from 3% among recipients <35 years to 14% among recipients ≥65 years. In multivariable Cox regression, worse PF was associated with higher mortality (hazard ratio, 1.66 for lowest vs. highest PF quartiles; P<0.001). Interactions between PF and age were nonsignificant. We estimated that 11% fewer deaths would occur if kidney transplant recipients with the lowest functional status experienced modest improvements in function. CONCLUSIONS Across a wide age range, functional status was an independent predictor of posttransplantation survival. Functional status assessment may be a useful tool with which to counsel patients about posttransplantation outcomes.

The Ethics of Patient Risk Modification Prior to Elective Joint Replacement Surgery.

Abstract: There are multiple risk factors for complications following elective total joint replacement (TJR) surgery. Certain risk factors, including operating time, implant choice, component positioning, and intraoperative difficulties (e.g., fracture, nerve and vascular damage), are related to the surgeon’s experience and decision-making and are not patient dependent1,2. However, many risk factors for complications after TJR are patient dependent. Bacterial colonization, diabetes control, body mass index (BMI), smoking status, fall risk, narcotic and/or alcohol dependence, physical conditioning, neurocognitive disorders, nutritional status, cardiovascular status, nongenetic thromboembolic risk, and anemia all represent potentially modifiable factors that increase the risk of complication with TJR1-8. Orthopaedic surgeons routinely perform TJR on patients who have one or more of the above-mentioned risk factors. However, this is elective surgery, and some of these risk factors are modifiable prior to surgery. As a result, ethical questions arise. Should patients address these risk factors prior to undergoing TJR, and to what extent should the physician, payer, and health-care institution require the patient to do so? Furthermore, should payers and health-care institutions require that surgeons and patients attempt to modify risk factors prior to these interventions that improve quality of life? If modification of risk is in the best interest of both the patient and the health-care delivery system, the criteria of sufficient patient participation that should be required and what should be done for patients unable to accomplish sufficient risk modification remain unclear. Additionally, who pays for risk factor modification and just how surgeons and patients can be incentivized to maximize the health status of the patient prior to surgery remain unclear. For example, heavy smokers and patients with uncontrolled diabetes have good reasons to improve their health status before surgery. However, is there a moral obligation to ensure that the patient …

Why autonomy needs help

Abstract: Some argue that to be effective in healthcare settings autonomy needs to be strengthened. The author thinks autonomy is fundamentally inadequate in healthcare settings and requires supplementation by experience-based paternalism on the part of doctors and healthcare providers.

Attitudes Toward Vascularized Composite Allotransplantation of the Hands and Face in an Urban Population

Abstract: Background: Almost 100 hand and face transplants have been performed worldwide. Their success has generated enthusiasm within the medical community, however, little is known about public attitudes toward vascularized composite allotransplantation (VCA) of the hands and face as compared to solid organ transplantation. The objective of this survey study was to assess these attitudes and the acceptability and potential barriers to the further growth of these procedures.Methods: Cooper University Hospital Emergency Department (Camden, New Jersey) patients, accompanying family members and friends ≥18 years of age were surveyed about knowledge of and attitudes toward organ, hand, and face transplants as well as preferences as a potential VCA donor or recipient. The socioeconomic aspects of VCA also were assessed.Results: A total of 1,027 individuals participated. Approximately 70% (69.7%) of respondents indicated that they would want to be organ donors, although only 37.1% reported donor registrations on their ...

Ethics of bioengineering organs and tissues

Abstract: Tissue-engineered medical products are now entering the clinical testing phase of development. Therefore, an open discussion is warranted regarding ethical issues that may arise as these novel 'combination' products move forward, such as when to conduct clinical trials, how to regulate such trials, when and how to responsibly introduce these strategies into clinical practice and how to maintain a positive public perception of the tissue-engineering field as a whole. These issues are discussed, and recommendations are provided for conducting first-in-human clinical studies.

Bioethics of Organ Transplantation

Abstract: As the ability to transplant organs and tissues has grown, the demand for these procedures has increased as well--to the point at which it far exceeds the available supply creating the core ethical challenge for transplantation--rationing. The gap between supply and demand, although large, is worse than it appears to be. There are two key steps to gaining access to a transplant. First, one must gain access to a transplant center. Then, those waiting need to be selected for a transplant. Many potential recipients do not get admitted to a program. They are deemed too old, not of the right nationality, not appropriate for transplant as a result of severe mental impairment, criminal history, drug abuse, or simply because they do not have access to a competent primary care physician who can refer them to a transplant program. There are also financial obstacles to access to transplant waiting lists in the United States and other nations. In many poor nations, those needing transplants simply die because there is no capacity or a very limited capacity to perform transplants. Although the demand for organs now exceeds the supply, resulting in rationing, the size of waiting lists would quickly expand were there to suddenly be an equally large expansion in the number of organs available for transplantation. Still, even with the reality of unavoidable rationing, saving more lives by increasing organ supply is a moral good. Current public policies for obtaining organs from cadavers are not adequate in that they do not produce the number of organs that public polls of persons in the United States indicate people are willing to donate.

Was Sarah Murnaghan treated justly

Abstract: Lung transplantation is a potentially life-saving procedure for patients with irreversible lung failure. Five-year survival rates after lung transplantation are >50% for children and young adults. But there are not enough lungs to save everyone who could benefit. In 2005, the United Network for Organ Sharing developed a scoring system to prioritize patients for transplantation. That system considered transplant urgency as well as time on the waiting list and the likelihood that the patient would benefit from the transplant. At the time, there were so few pediatric lung transplants that the data that were used to develop the Lung Allocation Score were inadequate to analyze and prioritize children, so they were left out of the Lung Allocation Score system. In 2013, the family of a 10-year-old challenged this system, claiming that it was unjust to children. In the article, we asked experts in health policy, bioethics, and transplantation to discuss the issues in the Murnaghan case.

Time to ensure that clinical trial appropriate results are actually published.

Abstract: Purpose Outcome reporting bias is a well-known fact in clinical research. It’s critical since readers believe that published articles are reliable and accurate.

Fertility preservation in paediatric nephrology: results of a physician survey

Abstract: SUMMARY Objective Fertility preservation (FP) is a widespread practice in paediatric oncology when gonadotoxic medications such as cyclophosphamide (CPO) are used. FP practice outside of oncology has not been studied, although nephrologists regularly use CPO. This is the first study to explore FP practice by paediatric nephrologists when CPO is used. Design Survey study. Descriptive statistics and chi-squared analyses were employed to analyse the data. Participants US paediatric nephrologists were sent a survey via email. The survey queried participants about FP practice behaviours, FP attitudes and barriers to practice. Main Outcome Measures Of 579 nephrologists invited, 32% responded to the survey. Results CPO was dosed in mg/kg by 23% of physicians, g/m2 by 40% and both by 37%. About 80% agreed that pubertal females should be offered a fertility referral, while 58% report that they actually refer. Factors negatively associated with referral include lack of training, lack of referral network and adherence to gonadotoxic dose limits. Results were similar for male patients. Conclusion The survey showed that FP practice in the United States is widespread among nephrologists. Lack of referral networks is a notable barrier for nephrologists. Perceived adherence to dose limits may be problematic given the variable dosing regimens utilised. This is due to the risk of unintended overdose in large adolescents dosed in mg/kg whose cumulative dose exceeds gonadotoxic limits in g/m2. This paper has implications for nephrology care providers and other specialists who utilise CPO, generalists who care for these patients and oncologists with extant FP referral networks.

The Ethical Implications of Preimplantation Genetic Diagnosis

Abstract: The development of in vitro fertilization in the 1970s has revolutionized the treatment of infertility. In the US, 126 procedures are performed per million people each year. The ability to culture embryos in vitro has allowed the development of preimplantation genetic diagnosis (PGD). PGD is similar to the prenatal diagnosis used to screen for various genetic diseases before birth, but its advantage is that it allows the selection of certain embryos before their transfer back to the uterus and avoids selective pregnancy terminations. For women of advanced maternal age or couples with known genetic mutations, the ability to screen for embryos free of certain genetic mutations is reassuring. As with many medical interventions associated with human reproduction, however, PGD raises many ethical issues. Recently, PGD has been used in new ways, including: HLA typing so that the child's HLA profile matches that of a sick sibling and is thus available for stem cell transplantation; sex selection; and selection of affected embryos so that the child has the same minor disability as the parents (e.g., deafness). We explore the field of PGD with the director of a PGD laboratory, a bioethicist, and an attorney to understand their views on the ethics of PGD. As the director of a PGD laboratory, do you feel laboratories need to consider the moral/ethical and societal implications before developing a new PGD test? Richard T. Scott: The practice in a PGD laboratory is no different from any other area of medicine. Thoughtful and ethical decision-making is mandatory. Any controversial case is first evaluated by all the physicians and scientists in the program. Complex issues are dealt with by the entire team, with the ultimate responsibility falling on the director. We are always mindful that PGD laboratories are unique, in that they analyze embryo biopsies and produce …

Does Patient-Centered Care Mean that Informed Consent is Necessary for Clinical Performance Measures?

Abstract: There is great enthusiasm for new models for health systems that may promote patient-centered decision making, such as patient-centered medical homes.1 The purpose of patient-centered decision making is to allow each patient to make an informed decision, taking into account their preferences while knowing potential harms and benefits; it is an important facet of patient-centered care.2 However, at the same time as patient-centered care is being pursued, clinical performance measures are proliferating (for example, requiring diabetics to have hemoglobin A1Cs ≤ 7).3 Whereas patient-centered care seeks to tailor decisions based on the harms and benefits for individual patients, and how individual patients value those harms and benefits, performance measures seek to standardize care, therefore pushing in the opposite direction. Clinical performance measures serve the vital function of extending the reach of evidence-based interventions that provide clinical benefit. Given the vast reservoir of preventable morbidity and mortality in the United States, clinical performance measures are also crucial for healthcare systems, even though they may occasionally conflict with patient-centered care. How can patient-centered care coexist with clinical performance measures? One approach would be to identify patients with preferences that conflict with a particular clinical performance measure. Such patients would have the option of declining to meet the performance measure, which would remove them from the “denominator” when achieving that performance measure is calculated. It may be noted that if clinical performance measures were constructed to exclude patients who refuse to participate or who are otherwise ‘nonstandard’ (e.g., unusual preferences), this could make them unsuitable candidates for any formal consent process. However, clinical performance measures are generally not constructed or implemented with explicit consideration of nonstandard patients. Consider a typical patient for whom the non-health benefit from declining a performance measure may exceed the health benefit from assenting to that performance measure: a diabetic with a short life expectancy due to multiple chronic diseases, who is well-informed about potential diabetes complications and the importance of complying with the diabetes performance measures (e.g. obtaining a hemoglobin A1C below 7), yet values these health benefits less than the non-health benefits of avoiding the logistical hassles of additional medications and needle sticks. This patient should have the option of refusing to consent to the diabetes performance measure, and to have this refusal documented through an informed consent procedure. Then that patient would be removed from the denominator when that measure is calculated. Patient-centered decisions to ignore performance standards would then not “count against” the physician or the health system by lowering their grades on the particular performance measure. Additionally, requiring a formal “opt-out” process would guard against practitioners “gaming” the system by simply removing all nonadherent patients from their assessments. Of course, competent patients always have the option of declining care. But given that some clinical environments pursue clinical performance measure targets with sufficient zeal so as to nearly constitute a coercive environment, practitioners facing such pressures are less likely to engage in a shared decision involving communication of harms and benefits.

Compassion for Each Individual's Own Sake

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Who is watching the watchmen: Is quality reporting ever harmful?

Abstract: Background:Quality reporting is increasingly used as a tool to encourage health systems, hospitals, and their practitioners to deliver the greatest health benefit. However, quality reporting systems may have unintended negative consequences, such as inadvertently encouraging “cherry-picking” by inadequately adjusting for patients who are challenging to take care of, or underpowering to reliably detect meaningful differences in care. There have been no reports seeking to identify a minimum level of accuracy that ought to be viewed as a prerequisite for quality reporting.Method:Using a decision analytic model, we seek to delineate minimal standards for quality measures to meet, using the simplest assumptions to illustrate what those standards may be.Results:We find that even under assumptions regarding optimal performance of the quality reporting system (sensitivity and specificity of 1), we can identify a minimal level of accuracy required for the quality reporting system to “do no harm”: the increase in h...

Euthanasia for minors in Belgium--reply.

Abstract: Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Bennell reported receiving royalties from an educational DVD on knee osteoarthritis and from a commercially available shoe from ASICS Oceania; being a consultant for Physitrack; and receiving grants from the National Health and Medical Research Council. Dr Abbott reported receiving a grant from the Health Research Council of New Zealand.

Ethical implications of drugs for erectile dysfunction

Abstract: The author examines ethical questions related to the sale and marketing of Viagra and the social ramifications of the drug.

Off the RAC.

Abstract: Should the National Institutes of Health (NIH) Recombinant DNA Advisory Committee (RAC) continue in its advisory role regarding gene therapy? The workshop held August 6, 2013, in Washington, D.C., by the National Academies to assess the value of the RAC elicited a fascinating set of testimonies and comments on the contributions of the RAC since its inception and the potential contributions as gene therapy moves forward. The Institute of Medicine (IOM) Committee on the Independent Review and Assessment of the Activities of the NIH Recombinant DNA Advisory Committee, based in part on the aforementioned testimonies, found sufficient reason for the RAC to continue, albeit in a restricted role (Rebecca N. Koehler, Bruce M. Altevogt, and Lawrence O. Gostin, eds.; Committee on the Independent Review and Assessment of the Activities of the NIH Recombinant DNA Advisory Committee; 2013, in press). Furthermore, they suggested a standing RAC-type entity be empowered to monitor all novel, high-impact, life-sciences technologies. Personally, I remain uncertain about the need for, practicality of, and utility of such an NIH-sponsored general review committee. But that argument is for another day. Let us focus on the RAC and whether or not it should continue. My own view, contrary to the majority of those who testified as well as the committee recommendation, is that while gene therapy still requires careful and informed oversight, I do not think the RAC is the appropriate vehicle to fulfill our needs. I do not believe it can credibly protect subjects in novel genetic research or keep the public well informed about the ethical considerations regarding new forms of gene therapy or gene transfer. The contributions of the RAC in regards to providing oversight for gene therapy is decidedly mixed. It has created useful reports, helped provide scientific input in the assessment of clinical trials that might not otherwise have been available, and, in its earliest days, provided necessary assessments on investigators inclined to move forward with too much speed relative to maintaining the safety and utility of gene therapy (Wivel, current issue, 2014). Yet, despite the RAC spending a good deal of time fine-tuning informed consent documents for human gene therapy trials (Greely, current issue, 2014), the RAC's presence and input did very little to anticipate or avert problems in the gene therapy experiment at the University of Pennsylvania, during which a young subject, 18-year-old Jesse Gelsinger, died. There was a good deal of recrimination about the adequacy of consent used in recruiting Gelsinger, the failure to adequately highlight and clarify conflicts of interest associated with the trial, and the failure of the NIH to adequately monitor subjects in all early gene therapy trials (Stolberg, 2000). The death of Gelsinger, arguably one of the most important instances of the failure of research oversight in the history of human experimentation since the 1970s, contains many lessons for gene therapy researchers (Wenner, 2009). But few have pointed to an enhanced role for the RAC as a key step to ensuring a subject's safety or understanding. The RAC has always been a very unusual regulatory body. It is charged with offering advice to the NIH director, and interested third parties may attend to its insights through public hearings and written reports, but it has never had any formal authority from Congress, the Food and Drug Administration (FDA), or any other federal entity to set limits on research, mandate researcher conduct, or modify institutional behavior. Moreover, its review mandate has been confined to NIH-sponsored research. Neither of these limits permits the RAC to be useful at this point in the evolution of the genetic engineering of human beings for diagnostic and therapeutic purposes. There are major ethical challenges facing the field of gene therapy. Increasingly, research is being sponsored by industry and not the NIH. The presence of powerful industry support, often in partnership with academic institutions, requires the elucidation of management strategies for dealing with conflicts of interest that are outside the ambit and expertise of the RAC. Patients are beginning to show interest in gaining access to gene therapy trials at earlier stages in the research process (Daniak, current issue, 2013; Farmer, current issue, 2013). This requires attention to be paid to the ethics of compassionate use regarding gene therapy. But again, the RAC is not the body to undertake either the assessment of the adequacy of existing rules and policies nor the entity to consider and respond to requests for early access. Issues continue to arise about the permissibility of using gene therapy and transfer that might involve heritable forms of DNA being permanently altered. Again, the RAC is not the right entity to undertake an assessment of therapeutic interventions with momentous significance to society and future generations. And while there is keen interest in future efforts to utilize genetically engineered microbes to treat human disease, again, the RAC is not constituted with the expertise, either scientific or ethical, to provide the best advice on the future of applying synthetic biology or its products to human use. The RAC played a very useful role in its earliest days. By creating the RAC, the NIH staved off Congressional and regulatory activity that, in retrospect, would have stifled important inquiry and set back efforts to advance the health of the public. That said, the RAC has outlived its usefulness. Gene therapy, gene transfer, tweaking genes to silence or activate them, and the genetic engineering of microbes for use in humans has evolved to the point that more regulatory guidance from Congressionally accountable federal agencies such as the FDA; more attention from the Office of Science and Technology Policy (OSTP); more international agreement on how to manage a rapidly growing area of clinical research (Tremblay et al., 2013); and tighter local control by institutional review boards (IRBs), conflict of interest committees, and institutional biosafety committees is essential. The RAC was best suited as a nimble source of quasi-independent advice publicly whispering in the ear of the NIH director. The rapidly maturing and increasingly promising field of human genetic engineering needs more input from wider perspectives and greater independence from the NIH. The rapidly evolving world of privately sponsored research; multisite and multinational clinical trials; and private, independent IRBs and data safety and monitoring boards needs to be brought into line with human genetic engineering and other cutting-edge fields of clinical research. Neither the RAC nor something closely resembling it that is housed inside the NIH and dominated by scientific perspectives identified by the NIH is the place to achieve this important ethical and policy work.