Issues in Law & Medicine最新文献

Objectives: Primary: Analyze the Adverse Events (AEs) reported to the Food and Drug Administration (FDA) after use of mifepristone as an abortifacient. Secondary: Analyze maternal intent after ongoing pregnancy and investigate hemorrhage after mifepristone alone.

Methods: Adverse Event Reports (AERs) for mifepristone used as an abortifacient, submitted to the FDA from September 2000 to February 2019, were analyzed using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAEv3).

Results: The FDA provided 6158 pages of AERs. Duplicates, non-US, or AERs previously published (Gary, 2006) were excluded. Of the remaining, there were 3197 unique, US-only AERs of which there were 537 (16.80%) with insufficient information to determine clinical severity, leaving 2660 (83.20%) Codable US AERs. (Figure 1). Of these, 20 were Deaths, 529 were Life-threatening, 1957 were Severe, 151 were Moderate, and 3 were Mild.

The deaths included: 9 (45.00%) sepsis, 4 (20.00%) drug toxicity/overdose, 1 (5.00%) ruptured ectopic pregnancy, 1 (5.00%) hemorrhage, 3 (15.00%) possible homicides, 1 (5.00%) suicide, 1 (5.00%) unknown. (Table 1).

Retained products of conception and hemorrhage caused most morbidity. There were 75 ectopic pregnancies, including 26 ruptured ectopics (includes one death).

There were 2243 surgeries including 2146 (95.68%) D&Cs of which only 853 (39.75%) were performed by abortion providers.

Of 452 patients with ongoing pregnancies, 102 (22.57%) chose to keep their baby, 148 (32.74%) had terminations, 1 (0.22%) miscarried, and 201 (44.47%) had unknown outcomes.

Hemorrhage occurred more often in those who took mifepristone and misoprostol (51.44%) than in those who took mifepristone alone (22.41%).

Conclusions: Significant morbidity and mortality have occurred following the use of mifepristone as an abortifacient. A pre-abortion ultrasound should be required to rule out ectopic pregnancy and confirm gestational age. The FDA AER system is inadequate and significantly underestimates the adverse events from mifepristone.

A mandatory registry of ongoing pregnancies is essential considering the number of ongoing pregnancies especially considering the known teratogenicity of misoprostol.

The decision to prevent the FDA from enforcing REMS during the COVID-19 pandemic needs to be reversed and REMS must be strengthened.

Peer-reviewed journals in the biological and life sciences literature have published articles that represent the biological view that a human's life begins at fertilization ("the fertilization view"). As those statements are typically offered without explanation or citation, the fertilization view seems to be uncontested by the editors, reviewers, and authors who contribute to scientific journals. However, Americans are split on whether the fertilization view is a "philosophical or religious belief" (45%) or a "biological and scientific fact" (46%), and only 38% of Americans view fertilization as the starting point of a human's life. In the two studies that explored experts' views on the matter, the fertilization view was the most popular perspective held by public health and IVF professionals. Since a recent study suggested that 80% of Americans view biologists as the group most qualified to determine when a human's life begins, experts in biology were surveyed to provide a new perspective to the literature on experts' views on this matter. Biologists from 1,058 academic institutions around the world assessed survey items on when a human's life begins and, overall, 96% (5337 out of 5577) affirmed the fertilization view. The founding principles of the field Science Communication suggest that scientists have an ethical and professional obligation to inform Americans, as well as people around the world, about scientific developments so members of the public can be empowered to make life decisions that are consistent with the best information available. Given that perspective-and a recent study's finding that a majority of Americans believe they deserve to know when a human's life begins in order to make informed reproductive decisions-science communicators should work to increase the level of science awareness on the fertilization view, as it stands alone as the leading biological perspective on when a human's life begins.

Americans have benefited from a declining cancer incidence and improving prognosis over the past two decades, during which time rising prices for anti-cancer drugs have proportionally outstripped rising expenditures for overall cancer care and total national health expenditures. To meet the economic challenges, remedies have been proposed to base compensation on relative survival measurements perhaps taking into account associated drug toxicities, disabilities, and disease progression. While there are advantages for knowing the economic costs determined from so-called, "value-based" methodologies, it must be recognized that the measured values are impersonal, incomplete, and always biased. This article examines value-based costing of anti-cancer drugs in an individual and societal framework and advocates grounding decisions regarding cancer care and pharmaceutical costs on the ethical principles of human dignity and the common good.

Although some persons with minority sexual orientations do not identify as lesbian, gay, or bisexual (LGB), Minority Stress Theory (Meyer, 2003) has largely been developed utilizing LGB-identified samples. We examined a sample (n = 274) of sexual minorities with diverse religious and sexual identity labels to determine if those rejecting versus adopting an LGB identity were different in terms of religious, sexual, relational, and health characteristics. Results suggested those who reject an LGB identity are more likely to be religiously active, full members of their church, and highly intrinsic and theologically conservative in their religious viewpoint. They further reported having slightly more lifetime heterosexual attractions, fantasies, and behaviors; greater internalized homonegativity; and being more interested in having children and a child-centered family life. They were also more likely to be single and celibate or in a heterosexual relationship. Contrary to expectations, these differences were not associated with health differences in depression, anxiety, and social flourishing. LGB-identified participants did report higher life satisfaction than those rejecting an LGB identity, but this difference was not interpretively meaningful when considered in reference to population norms. We conclude with a discussion of the potential implications of our findings for research, legal and professional advocacy, and clinical care.

Introduction: The opioid epidemic resulted in vast increase in neonatal opioid withdrawal syndrome (NOWS). To mitigate NOWS and opioid dependency among women, staff established a gender specific, patient driven, autonomy based, outpatient therapeutic substitution program.

Methods: Prospective observational study of obstetric patients receiving prenatal care 7/1/2016-12/31/2019. Patients underwent universal urine drug screens to identify illicit drug use with dependency and offered addiction counseling with voluntary outpatient therapeutic substitution in an obstetrical-addictions combined clinic to achieve abstinence with oral Buprenorphine tapering protocol. Urine substance screening and cord blood testing were obtained at delivery. Birth outcomes compared among groups who achieved abstinence at birth, were successful at tapering, or continued opioid use.

Results: Of 783 births, 165 (20.9%) demonstrated opioid use with 91 (55.2%) participating at some point in pregnancy in therapeutic substitution program. At birth, 14/94 (14.9%) patients completed the program and achieved opioid abstinence, 22/94 (23.4%) still enrolled and actively tapering. 57/94 (34.5%) patients were lost to follow-up, relapsed, or terminated due to non-compliance. Seventy-four of 67 (44.3%) opioid positive mothers chose not to enroll. Of 14 women who completed the program, 0 babies born with NOWS, compared to 11/22 (50%) still enrolled in program and actively tapering, 29/57 (50.9%) lost to follow-up, relapsed, or terminated due to non-compliance, and 28/74 (37.8%) never enrolled in program.

Conclusion/implications: Outpatient therapeutic substitution with oral Buprenorphine with abstinence is possible in pregnant patients and results zero NOWS. More data are needed to confirm findings and explore methods for enhanced success in obtaining abstinence.

Support: Appalachian Regional Commission and Prevention (ARC) 1^st through Charleston Area Medical Center in cooperation with Charleston Health Education and Research Institute (CHERI).

Although discussions have begun regarding the ways in which healthcare providers and individuals in fields adjacent to healthcare might be exposed to legal sanctions involving COVID-19, the complete scope of the legal risks is still largely unknown. This essay explores how current laws in the United States fail to offer adequate protections: (1) to healthcare workers (HCW) practicing under significantly altered standards of care, and (2) to individuals involved in the allocation of scarce resource decision-making process. Using research on Second Victim Syndrome and Medical Malpractice Stress Syndrome, legal protections are presented to provide HCW a form of "moral buffering" to help prevent further traumatizing them for shouldering extraordinary burdens during the COVID-19 pandemic. In so doing, this article advocates for the passage of appropriate legal protection as not merely a legal issue, but also an ethical one.

The American College of Pediatricians (ACPeds) maintains that it is unethical to intentionally harm an innocent human being even in the absence of the individual's ability to perceive pain. However, in this paper, ACPeds reviews the laboratory and clinical evidence which indicates that as early as 12 weeks gestation (and possibly earlier) exposure to noxious stimuli negatively affects immature human beings. Because of the resulting acute stress responses and subsequent potential long-term negative effects, the ACPeds holds that avoiding, mitigating, and directly treating fetal, neonatal, and pediatric pain is a medical and ethical obligation.

The COVID-19 pandemic has engendered a national discussion regarding scarce life-saving medical resources. These discussions often turn on allocation, reconfiguration, and reallocation of resources during the surge crisis of a declared emergency. Protocols to address these issues are being widely promulgated. From the standpoint of biomedical ethics, the principal concerns in these discussions should center on duty, justification, legality, and underlying moral standards. In this article the author explores general concepts of prioritization and crisis standards of care, physician duties and the conflict of those duties, the problematic nature of reallocation, and legitimate responses to the extreme absolute scarcity of surge crisis.