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Contents - JLME - 2014 Volume 42: 2
Table of Contents
  1. Table Of Contents
Letter From The Editor
  1. Letter From The Editor
Introduction
  1. Introduction: Brain Science in the 21st Century: Clinical Controversies and Ethical and Legal Implications
Symposium Articles
  1. Causes and Consequences of Sports Concussion
  2. Concussion in the National Football League: Viewpoint of an Elite Player
  3. Prevention of Stroke in Sickle Cell Anemia
  4. Treating Pain in Sickle Cell Disease with Opioids: Clinical Advances, Ethical Pitfalls
  5. Post-Traumatic Stress Disorder: Ethical and Legal Relevance to the Criminal Justice System
  6. The Role of PTSD in Adjudicating Violent Crimes
  7. PTSD in Active Combat Soldiers: To Treat or Not to Treat
  8. Glioblastoma: Background, Standard Treatment Paradigms, and Supportive Care Considerations
  9. Is It Reasonable to Deny Older Patients Treatment for Glioblastoma?
Independent Articles
  1. A Framework for Analyzing the Ethics of Disclosing Genetic Research Findings
  2. A Systematic Review of State and Manufacturer Physician Payment Disclosure Websites: Implications for Implementation of the Sunshine Act
  3. Genomic Research with the Newly Dead: A Crossroads for Ethics and Policy
  4. Risk Disclosure and the Recruitment of Oocyte Donors: Are Advertisers Telling the Full Story?
  5. Toward a Jurisprudence of Drug Regulation
Columns
  1. Currents in Contemporary Bioethics: Extending the Minimum Necessary Standard to Uses and Disclosures for Treatment
  2. Public Health and the Law: Active Shooters in Health Care Settings: Prevention and Response through Law and Policy
Table of Contents
Table Of Contents
Letter From the Editor
Letter From The Editor
ASLME - [PDF]

In December of 2003 I had been editing the Journal of Law, Medicine & Ethics for all of three months. I was still very much feeling my way around a new publication, new authors, and what was for me an entirely new subject area. The first two issues under my stewardship were a broad collection of independent articles focused on a variety of themes from the medical and legal fields. But in December I received a batch of papers that would become the first JLME symposium issue.
Introductions
Introduction: Brain Science in the 21st Century: Clinical Controversies and Ethical and Legal Implications
Robert M. Sade - [PDF]

Medical knowledge and practice remained virtually stagnant, based on Galen’s views, until modern medical science was initiated by William Harvey in the 17th century. Like the rest of science and medicine, neuroscience developed slowly from Galen’s time through the middle ages, until the invention of the microscope in the 17th century led to better understanding of the brain. The development of neuroscience accelerated even more rapidly with the introduction of electricity into studies of the nervous system in the 18th and 19th centuries. These advances were led by such giants of science as Luigi Galvani, Hermann von Helmholtz, Camillo Golgi, Santiago Ramón y Cajal, Paul Broca, and John Hughlings Jackson.
Symposium Articles
Causes and Consequences of Sports Concussion
Jonathan C. Edwards and Jeffrey D. Bodle - [PDF]

The Consensus Statement of the Third International Congress on Concussion in Sport in November 2008 defined concussion as a "complex pathophysiologic process affecting the brain, induced by traumatic biochemical forces." Definitions of concussion vary slightly between various professional organizations of neurosurgeons, neurologists, and orthopedic surgeons, but all share the common characteristics of trauma affecting the head or body resulting in transient neurologic deficits or symptoms. Underlying the symptoms of concussion is a complex pathophysiologic process at the cellular level. While concussion is typically thought of as resulting from a direct impact to the head, a concussion can also be sustained as a result of an impact to the body causing the force of the impact to be transmitted to and absorbed by the brain.
Concussion in the National Football League: Viewpoint of an Elite Player
Joe DeLamielleure - [PDF]

Concussive injuries to the head and brain are relatively common in the National Football League (NFL). This is not news, since the issue has been covered in many articles in the popular press and many news specials on television. As an NFL offensive lineman for 13 years, I suffered a huge number of hits to the head — an estimated 215,000 at least. Nevertheless, I have fared better than many of the players of my era: many suffered from chronic traumatic encephalopathy (CTE). For example, some of my fellow Hall of Fame players from that era, Mike Webster, Jim Ringo, John Mackey, and Joe Perry, all suffered from CTE and all are now deceased. I count myself lucky that the main malady affecting me after those many blows to the head is a 60% hearing loss in my left ear — probably due to undiagnosed concussions and particularly to thousands of head slaps by defensive players, whose first hit after the snap was often a right-handed blow to the helmet’s open hole over my left ear.
Prevention of Stroke in Sickle Cell Anemia
Robert J. Adams - [PDF]

Sickle cell anemia (SCD) is a disease characterized by abnormal hemoglobin (Hb) structure. There is a mutation in the beta-globin gene that changes the sixth amino acid from glutamic acid to valine causing the mutated hemoglobin (HbS) to polymerize reversibly when deoxygenated to form a gelatinous network of fibrous polymers that stiffen and distort the red blood cell (RBC) membrane. This leads to episodes of microvascular vasoocclusion and premature RBC destruction leading to hemolytic anemia. For reasons that are unclear, some children develop a large artery vasculopathy (gradual narrowing and ultimate occlusion causing deprivation of blood to the brain - a stroke in other words) involving the intracranial arteries supplying the brain.
Treating Pain in Sickle Cell Disease with Opioids: Clinical Advances, Ethical Pitfalls
Wally R. Smith - [PDF]

Sickle cell disease (SCD) is an autosomal recessive hemoglobinopathy found mainly in populations of African and Mediterranean descent, including approximately 100,000 Americans. It is also very common in Spanish-speaking regions of Central America, South America, and parts of the Caribbean, in Saudi Arabia, and in India and Sri Lanka. The disorder is characterized most commonly by lifelong recurrent unpredictable vaso-occlusive pain that may be disabling, and by chronic tissue damage and organ dysfunction. There are several genotypes of the disease. Although SCD pain frequency generally varies between genotypes, it also varies between subjects even within genotype. It may worsen from childhood to adulthood. It may vary by gender. Its location, timing, and severity may be unpredictable.
Post-Traumatic Stress Disorder: Ethical and Legal Relevance to the Criminal Justice System
Kathryn Soltis, Ron Acierno, Daniel F. Gros, Matthew Yoder, and Peter W. Tuerk - [PDF]

New coverage of the recent wars in Afghanistan and Iraq, and the ensuing public education campaigns by the Department of Veterans Affairs and private veterans advocacy groups combine to call the public's attention to the many potential mental health problems associated with traumatic event exposure. Indeed, since 2001, Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF) combat and peacekeeping missions have been characterized by high levels of exposure to acts of extreme violence, with often gruesome effects. Less publically discussed is the fact that a surprisingly large number of United States civilians also report exposure to traumatic events, such as severe interpersonal violence, natural disasters, and serious automobile accidents. In fact, approximately 70% of randomly sampled respondents indicated that they have experienced an incident characterized by significant perceived life threat at some point during their lives.
The Role of PTSD in Adjudicating Violent Crimes
Mark B. Hamner - [PDF]

There are a number of considerations, including ethical and clinical or diagnostic factors, in utilizing the diagnosis of posttraumatic stress disorder (PTSD) in criminal proceedings. The reliability and validity of the diagnosis may be questioned. Legal precedent may consider extant diagnostic criteria for PTSD and comorbid diagnoses. However, these diagnostic criteria are often in flux considering new research findings. For example, the introduction of the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders, published by the American Psychiatric Association, includes some changes in the PTSD diagnostic criteria. How will this affect interpretation of past legal judgments? Moreover, PTSD has significant psychiatric comorbidity, e.g., substance abuse, which in itself may influence violent behavior and its consequences. Some of these comorbid diagnoses also have changes in their diagnostic criteria. The introduction of biological tests in the assessment of PTSD will likely facilitate more objective diagnosis. Advances in the neurosciences will lead to better understanding of the neurobiological substrates of violence in general. This may eventually complement the use of categorical psychiatric diagnoses. However, biological measures are not yet utilized in the PTSD diagnostic criteria. Finally, the effect of psychiatric diagnoses, including PTSD, on the ability to discriminate right from wrong is often at the core of criminal proceedings. This paper summarizes some of the relevant considerations in utilizing the diagnosis of PTSD for adjudicating violent crimes.
PTSD in Active Combat Soldiers: To Treat or Not to Treat
Bethany C. Wangelin and Peter W. Tuerk - [PDF]

Treatment of military-related posttraumatic stress disorder (PTSD) is a major public health care concern. Since 2001 over 2.5 million troops have been deployed to Iraq or Afghanistan, many of whom have experienced direct combat and sustained threat. Estimates of PTSD rates related to these wars range from 8% to over 20%, or 192,000 to 480,000 individuals. Already, nearly 250,000 service members of Operations Enduring Freedom, Iraqi Freedom, and New Dawn (OEF/OIF/OND) have sought VA health care services for PTSD. This recent increased need for mental health services comes in addition to the ongoing needs of Vietnam-era and other veterans who continue to suffer from PTSD. PTSD is related to high co-morbidities of other mental health difficulties, poorer physical health status, and increased medical care utilization. Such high demand for services is an important contributor to the large cost associated with combat-related PTSD. Accordingly, promoting successful, cost-effective treatment strategies for PTSD is a chief public health care priority.
Glioblastoma: Background, Standard Treatment Paradigms, and Supportive Care Considerations
Susan V. Ellor, Teri Ann Pagano-Young, and Nicholas G. Avgeropoulos - [PDF]

While primary malignant brain tumors account for only two percent of all adult cancers, these neoplasms cause a disproportionate amount of cancer-related disabilities and death. The five-year survival rates for brain tumors are the third lowest among all types of cancer. Malignant gliomas (glioblastoma and anaplastic astrocytoma) comprise the most common types of primary central nervous system (CNS) tumors and have a combined incidence of five to eight cases per 100,000 people. The median survival rate of conservatively treated patients with malignant gliomas is 14 weeks; with surgical resection alone, 20 weeks; with surgery and radiation, 36 weeks; and with the addition of newer biochemotherapies such as temozolomide and bevacizumab, upward of 14-18 months.
Is It Reasonable to Deny Older Patients Treatment for Glioblastoma?
Michael K. Gusmano - [PDF]

Is it ever fair to limit treatment for diseases like glioblastoma for which prognosis is poor? Because resources are finite and health care spending limits the other possible uses for those resources, limiting access to an intervention that does not generate benefits is ethically sound. Ignoring the balance of benefits and burdens associated with treatment ignores opportunity costs and leads us to treat some lives as more valuable than others. It also ignores evidence that patients and families, when presented with adequate information about the benefits and burdens of aggressive treatment compared with palliative care, often prefer the palliative care option.
Independent Articles
A Framework for Analyzing the Ethics of Disclosing Genetic Research Findings
Lisa Eckstein, Jeremy R. Garrett, and Benjamin E. Berkman - [PDF]

Over the past decade, there has been an extensive debate about whether researchers have an obligation to disclose genetic research findings, including primary and secondary findings. There appears to be an emerging (but disputed) view that researchers have some obligation to disclose some genetic findings to some research participants. The contours of this obligation, however, remain unclear.
A Systematic Review of State and Manufacturer Physician Payment Disclosure Websites: Implications for Implementation of the Sunshine Act
Alison R. Hwong, Noor Qaragholi, Daniel Carpenter, Steven Joffe, Eric G. Campbell, and Lisa Soleymani Lehmann - [PDF]

Public disclosure of industry payments to physicians is one way to address financial conflicts of interest in medicine. As part of the Patient Protection and Affordable Care Act, the Physician Payment Sunshine Act (PPSA) requires pharmaceutical, medical device, and biologics manufacturers who have at least one product reimbursed by Medicare or Medicaid to disclose payments to physicians and teaching hospitals on a public website starting in 2014. The physician payment data will contain individual physician names, monetary values, and specific products connected to payments.
Genomic Research with the Newly Dead: A Crossroads for Ethics and Policy
Rebecca L. Walker, Eric T. Juengst, Warren Whipple, and Arlene M. Davis - [PDF]

Research uses of human bodies maintained by mechanical ventilation after being declared dead by neurological criteria ("heart-beating cadavers"), were first published in the early 1980s with a renewed interest in research on the newly or nearly dead occurring in about last decade. While this type of research may take many different forms, recent technologic advances in genomic sequencing along with high hopes for genomic medicine, have inspired interest in genomic research with the newly dead. For example, the Genotype-Tissue Expression (GTEx) program through the National Institutes of Health aims to collect large numbers of diverse human tissues with the eventual goal of elucidating the genetic bases of common diseases through a better understanding of the relationship between genetic variation and gene expression. Ethical and policy assessments of such research projects are also evolving. In the U.S., Institutional Review Board (IRB) review is not required for research using deceased "subjects" and, although the Uniform Anatomical Gift Act (UAGA) is applicable, it does not adequately address the ethical issues raised by genomic research with the newly dead. Of particular relevance to these ethical and policy assessments is the, as yet unexplored, way in which genomic research with the newly dead is situated within a nexus of other more established clinical and research practices. In this paper we will consider how this crossroads of practices informed the ethical and policy issues raised by a particular research project within our institution.
Risk Disclosure and the Recruitment of Oocyte Donors: Are Advertisers Telling the Full Story?
Hillary B. Alberta, Roberta M. Berry, and Aaron D. Levine - [PDF]

In vitro fertilization (IVF) using donated oocytes has proven to be an effective treatment option for many prospective parents struggling with infertility, and the usage of donated oocytes in assisted reproduction has increased markedly since the technique was first successfully used in 1984. Data published by the Centers for Disease Control and Prevention (CDC) on the use of assisted reproductive technologies (ARTs) in the United States indicate that approximately 12% of all ART cycles in the country now use donated oocytes. The increased use of oocyte donation in the United States has prompted discussion regarding risks associated with the process and how best to ensure the safety of oocyte donors.
Toward a Jurisprudence of Drug Regulation
Matthew Herder - [PDF]

Efforts to ensure greater transparency in the regulation of "drugs" (used here as a catch-all for pharmaceuticals, biologics, medical devices, and biomarker-based technologies such as genetic testing paired with a pharmaceutical or biologic) are well underway. For example, laws in the United States and Europe now require registration of most clinical trials beyond phase 1. Yet instances of avoidable harm to patients continue to arise. In response, calls for disclosure of clinical trial data in the form of "clinical study reports," not just trial designs and basic results, are growing. In this paper, I argue that disclosure of clinical trial data is necessary but insufficient. Rather, the regulatory decisions that flow from those trial data - whether positive (i.e., product approvals) or negative (i.e., abandoned products, product refusals, and withdrawals) - should also be open to outside scrutiny provided they are final in nature. A jurisprudence5 of drug regulation is, in short, needed.
Columns
Currents in Contemporary Bioethics: Extending the Minimum Necessary Standard to Uses and Disclosures for Treatment
Julie L. Agris - [PDF]

Encouraged by the financial incentives in the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act), electronic health record (EHR) adoption is on the rise. According to a study by the Centers for Disease Control and Prevention published in 2014, 78% of office-based physicians had adopted some type of EHR system, up from 18% in 2001. Implementation of EHRs able to support the Department of Health and Human Services (HHS) "meaningful use" requirements has also significantly increased since 2010. Such a growth in EHR adoption with the capacity to achieve "meaningful use" standards suggests that the goal of nationwide, interoperable health records is moving closer to a reality.
Public Health and the Law: Active Shooters in Health Care Settings: Prevention and Response through Law and Policy
James G. Hodge, Jr. and Kellie Nelson - [PDF]

In September 2010 at the Johns Hopkins Hospital, one of the nation’s elite academic hospitals located in East Baltimore, Maryland, Paul Warren Pardus entered the facility to visit his mother, a patient. During a discussion with her doctor in a hospital hallway, Pardus became “overwhelmed” about the care and condition of his mother, pulled a handgun from his waistband, and shot the doctor in the chest. Pardus then locked himself and his mother in her room, shot and killed her, and committed suicide.