Edward B. Goldman

Committee report: Considerations and recommendations for national guidance regarding the retention and use of residual dried blood spot specimens after newborn screening

Newborn screening programs are state based with variable policies. Guidance regarding the retention, storage, and use of portions of newborn screening dried blood spots that remain after screening (residual specimens) was first published in 1996. Since then, newborn screening programs have paid increased attention to specimen storage and usage issues. Standard residual specimen uses include quality assurance and program evaluation, treatment efficacy, test refinement, and result verification. In all cases, privacy and security are primary concerns. In general, two distinct state practices regarding the storage and use of residual newborn screening specimens exist: (1) short-term storage (<3 years), primarily for standard program uses and (2) long-term storage (>18 years), for standard program uses and possible important public health research uses. Recently, there have been concerns in some consumer communities regarding both the potential uses of residual specimens and patient (newborn and family) privacy. To assist in policy improvements that can protect the individuals privacy and allow for important public health uses of residual newborn screening specimens, the Secretary of Health and Human Services Advisory Committee on Heritable Disorders in Newborns and Children has developed recommendations (with requested action by the Secretary where applicable). This report presents the Committees recommendations and reviews the pertinent associated issues.

Pacemaker Reuse An Initiative to Alleviate the Burden of Symptomatic Bradyarrhythmia in Impoverished Nations Around the World

> Health of body and mind is so fundamental to the good life that if we believe men have any personal rights at all as human beings, they have an absolute right to such a measure of good health as society and society alone is able to give them.n> n> —Aristotle, 330 bcnFor most of the industrialized world, the morbidity and mortality attributed to cardiovascular disease have declined in recent decades as a result of improvements in technology and a greater emphasis on primary and secondary preventative strategies.1 Unfortunately, this dramatic improvement in disease burden has not been witnessed in low- and middle-income countries (LMICs), defined by the World Bank as generating a gross national income per capita lower than US

Safety and efficacy of pacemaker reuse in underdeveloped nations: a case series.

9200.2 Currently, cardiovascular disease is the primary cause of mortality worldwide, accounting for 30% of all global deaths,3 and it has twice the mortality rate of HIV/AIDS, malaria, and tuberculosis combined.4 Secondary treatments are often limited because of a paucity of skilled healthcare providers and, more important, the inability of the patient to afford costly medical procedures.5nnThis great disparity in medical health care is clearly evident in the field of cardiac electrophysiology, specifically pacemaker implantation; this specialty is either severely underdeveloped or entirely nonexistent in many LMICs.6 As a result, many individuals with symptomatic bradycardia experience a decreased quality of life and/or decreased life expectancy because of a lack of resources (personal correspondence, University of Philippines–Philippine General Hospital [UP-PGH], November 15, 2008). As the epidemic of cardiovascular disease continues to alter the demographics of disease in LMICs, healthcare providers with access to medical technology must investigate novel methods of easing the burden of those less fortunate. The purpose of this article is to address the concept of postmortem pacemaker use for those in LMICs who otherwise …

“I would never want to have a mental health diagnosis on my record”: A survey of female physicians on mental health diagnosis, treatment, and reporting☆☆☆

To the Editor:nnThe morbidity and mortality associated with cardiovascular disease (CVD) has been steadily declining in industrialized nations over recent decades due to innovations in technology and widespread access to health care; however, the prevalence of CVD is expected to increase 137%

Medical, ethical, and legal considerations in fertility preservation

INTRODUCTIONnPhysicians have high rates of suicide and depression. Most state medical boards require disclosure of mental health problems on physician licensing applications, which has been theorized to increase stigma about mental health and prevent help-seeking among physicians.nnnMETHODSnWe surveyed a convenience sample of female physician-parents on a closed Facebook group. The anonymous 24-question survey asked about mental health history and treatment, perceptions of stigma, opinions about state licensing questions on mental health, and personal experiences with reporting.nnnRESULTSn2106 women responded, representing all 50 states and the District of Columbia. Most respondents were aged 30-59. Almost 50% of women believed that they had met the criteria for mental illness but had not sought treatment. Key reasons for avoiding care included a belief they could manage independently, limited time, fear of reporting to a medical licensing board, and the belief that diagnosis was embarrassing or shameful. Only 6% of physicians with formal diagnosis or treatment of mental illness had disclosed to their state.nnnCONCLUSIONSnWomen physicians report substantial and persistent fear regarding stigma which inhibits both treatment and disclosure. Licensing questions, particularly those asking about a diagnosis or treatment rather than functional impairment may contribute to treatment reluctance.

Parental Permission for Pilot Newborn Screening Research: Guidelines From the NBSTRN

The past 2 decades have seen a significant rise in cancer survival rates, and an increasing proportion of survivors at reproductive age are interested in childbearing. Although assisted reproduction provides physicians with an array of potential possibilities to help patients whose fertility is compromised by cancer treatment, there is still a dearth of regulation regarding the application of this technology. The present paper reviews the current options for fertility preservation, with a particular focus on the legal and ethical challenges that confront providers of this type of care.

The ethics of pacemaker reuse: might the best be the enemy of the good?

There is broad recognition of the need for population-based research to assess the safety and efficacy of newborn screening (NBS) for conditions that are not on current panels. However, prospective population-based research poses significant ethical, regulatory, and logistical challenges. In the context of NBS, there have been a variety of approaches that address parental decision-making in pilot studies of new screening tests or conditions. This article presents an ethical and legal analysis of the role of parental permission by the Bioethics and Legal Work Group of the Newborn Screening Translational Research Network created under a contract from the National Institute of Child Health and Human Development to the American College of Medical Genetics and Genomics. Circumstances are outlined in which a waiver of documentation of permission or a waiver of permission may be ethically and legally appropriate in the NBS context. These guidelines do not constitute American Academy of Pediatrics policy.

Legal considerations for cryopreservation of sperm and embryos

Symptomatic bradycardia contributes significantly to mortality and decreased functional status in many low and middle income countries (LMIC). In contrast to the developed world, where bradycardia often results from sinus node dysfunction, patients requiring pacemakers in LMIC more commonly present with complete heart block.1–3 Yet many patients in LMIC have little to no access to electrophysiological therapies, as the cost of one device often exceeds the annual income of the average citizen.4 Several countries—including Sweden, India and Canada—have previously explanted and resterilised pacemakers from deceased donors for reutilisation.5–7 With increasing global disparities in medical care, post mortem explantation and reuse of pacemakers presents a potential means for mitigating the rising burden of cardiovascular disease in LMIC.nnRecent survey data indicate that almost 45% of deceased pacemaker patients in the USA have their devices extracted for reasons including family request and risk of device explosion during cremation. Notably, over 80% of these extracted devices are discarded or stored as waste. The vast majority of funeral directors, device patients and the general population support donation of explanted pacemakers to LMIC.8 ‘Project My Heart–Your Heart’ is a proof of concept pacemaker donation initiative that allows funeral directors to send explanted devices to an academic centre for evaluation and resterilisation before donation to underserved patients in LMIC.9 A recent case study of 12 resterilised pacemakers donated through this …

No appointment necessary? Ethical challenges in treating friends and family.

OBJECTIVEnTo summarize the case law for cryopreservation of sperm and embryos and make recommendations for desirable characteristics that should be included in a cryopreservation clinics disposition agreements.nnnDESIGNnA literature review of case law and legal review articles was performed.nnnSETTINGnAcademic research center.nnnPATIENT(S)nNone.nnnINTERVENTION(S)nNone.nnnMAIN OUTCOME MEASURE(S)nNone.nnnRESULT(S)nTwo court cases involving cryopreserved semen and five cases involving cryopreserved embryos are reviewed.nnnCONCLUSION(S)nThe state of the law surrounding cryopreservation is recent and unsettled. Disposition agreements can provide cryopreservation clinics some degree of certainty in this unsettled area of law. Those drafting cryopreservation disposition agreements are assisted by lessons learned from cryopreservation cases and insight gained from law review articles. It is evident that cryopreservation agreements will be most successful and most likely to be enforced if they are unambiguous, consistent with public policy, and include: a duration provision, each individuals contact information, the individuals provisions for use of their gametes in case of death, and responsibilities of cryopreservation clinic and individuals. Individuals must enter into agreements with a true understanding of the contained provisions.

Do Radiology and Other Health Care Presentations Posted on the Internet Contain Accessible Protected Health Information

Physicians may be asked or choose to provide medical care to family members or to give informal or undocumented care to friends, neighbors, or colleagues who are not their patients. Treatment can range from refilling a prescription, discussing a recent injury, or ordering a test to performing major surgeries. The ethical risks of caring for relatives or friends or providing informal and undocumented care are substantial but may be overlooked. Although there may be limited situations in which providing medical treatment for friends and family is acceptable, these situations are often nuanced. We review guidance from professional medical organizations, summarize research on the prevalence and attitudes about physicians’ treatment of friends and family, and review the ethical issues and offer guidance for making decisions about when to provide care. We serve on the pediatric ethics committee at the University of Michigan and were motivated to prepare this article after we were consulted by a pediatric specialist in our institution who was concerned about a referral she had received. The patient (“Elizabeth”) was an 18-yearold who had been referred for evaluation of mental health issues. However, on examining the medical records more closely, the pediatric specialist recognized that despite different last names, the primary care physician making the referral also happened to be Elizabeth’s parent. Given the concern for patient confidentiality, ethical conflicts in roles, and the potentially sensitive issues that could be raised during the consultation, the specialist conferred with our committee. A review of the chart showed that Elizabeth’s parent had served as her de facto primary care physician for many years, and there were multiple case notes in the medical record regarding her well-child examinations and routine care. Elizabeth was seen in a clinic where her parent worked along with several other primary care physicians.