The intellectual and moral integrity of bioethics: response to commentaries on A case study in unethical transgressive bioethics: \u27Letter of concern from bioethicists\u27 about the prenatal administration of dexamethasone .

In our target article we showed that the Letter of Concern (LoC) fails to meet accepted standards for presenting empirical data for the purpose of supplementing a normative claim and for argument-based normative ethics. The LoC fails to meet the standards of evidence-based reasoning by making false claims, failing to reference data that undermine its key premises, and misrepresenting and misinterpreting the scientific publications it selectively references. The LoC fails to meet the standards of argument-based reasoning by treating as settled matters what are, instead, ongoing controversies, offering “mere opinion” as a substitute for argument, and making contradictory claims. The LoC is methodologically defective and thus a case study in unethical transgressive bioethics. Not withdrawing the LoC will damage the field of bioethics, making this case study in unethical transgressive bioethics important for the entire field

The perils of the imperfect expectation of the perfect baby.

Advances in modern medicine invite the assumption that medicine can control human biology. There is a perilous logic that leads from expectations of medicine\u27s control over reproductive biology to the expectation of having a perfect baby. This article proposes that obstetricians should take a preventive ethics approach to the care of pregnant women with expectations for a perfect baby. We use Nathaniel Hawthorne\u27s classic short story, The Birthmark, to illustrate the perils of the logic of control and perfection through science and then identify possible contemporary sources of the expectation of the perfect baby. We propose that the informed consent process should be used as a preventive ethics tool throughout the course of pregnancy to educate pregnant women about the inherent errors of human reproduction, the highly variable clinical outcomes of these errors, the limited capacity of medicine to detect these errors, and the even more limited capacity to correct them

Ethical Dimensions of Human Immunodeficiency Virus Infection During Pregnancy

Physicians encounter complex and sensitive ethical challenges in the medical care of pregnant women with human immunodeficiency virus (HIV) infection. This paper identifies those ethical challenges and provides concrete clinical guidance for how they should be addressed in obstetric care. The paper begins with a brief historical review, to highlight and to call into question the civil rights model of the ethics of HIV infection that has dominated the literature, clinical practice, and public policy. The authors propose an alternative ethical framework. This framework begins by underscoring the public health obligations of both physicians and pregnant women with HIV infection. The framework is based on a clinical ethics that appeals to both beneficence-based and autonomy-based obligations of the physician to the pregnant woman and the beneficence-based obligations of both the physician and the pregnant woman to the fetal patient. This framework is then deployed in a clinical ethical analysis of termination of pregnancy and contraception, partner notification, disclosure and confidentiality of her serostatus by the patient to the health care team, disclosure and confidentiality of her serostatus to other health care professionals, prevention of vertical transmission, and advance directives

A case study in unethical transgressive bioethics: Letter of concern from bioethicists about the prenatal administration of dexamethasone.

On February 3, 2010, a Letter of Concern from Bioethicists, organized by fetaldex.org, was sent to report suspected violations of the ethics of human subjects research in the off-label use of dexamethasone during pregnancy by Dr. Maria New. Copies of this letter were submitted to the FDA Office of Pediatric Therapeutics, the Department of Health and Human Services (DHHS) Office for Human Research Protections, and three universities where Dr. New has held or holds appointments. We provide a critical appraisal of the Letter of Concern and show that it makes false claims, misrepresents scientific publications and websites, fails to meet standards of evidence-based reasoning, makes undocumented claims, treats as settled matters what are, instead, ongoing controversies, offers mere opinion as a substitute for argument, and makes contradictory claims. The Letter of Concern is a case study in unethical transgressive bioethics. We call on fetaldex.org to withdraw the letter and for co-signatories to withdraw their approval of it

The professonal responsibility model of obstetrical ethics: Avoiding the perils of clashing rights

Obstetric ethics is sometimes represented by polarized views. One extreme asserts the rights of the fetus as the overwhelming ethical consideration. Both assertions are overly simplistic. Such oversimplification is called reductionism. This article explains the fallacy of rights-based reductionism and 2 models of obstetric ethics based on it and explains why the fetal rights reductionism model and the pregnant woman\u27s rights reductionism model result in conceptual and clinical failure and therefore should be abandoned. The article argues for the professional responsibility model of obstetric ethics, which emphasizes the importance of medical science and compassionate clinical care of both the pregnant and fetal patient. The result is that responsible medical care overrides the extremes of clashing rights

Risk factors associated with adverse fetal outcomes in pregnancies affected by Coronavirus disease 2019 (COVID-19): a secondary analysis of the WAPM study on COVID-19.

Objectives To evaluate the strength of association between maternal and pregnancy characteristics and the risk of adverse perinatal outcomes in pregnancies with laboratory confirmed COVID-19. Methods Secondary analysis of a multinational, cohort study on all consecutive pregnant women with laboratory-confirmed COVID-19 from February 1, 2020 to April 30, 2020 from 73 centers from 22 different countries. A confirmed case of COVID-19 was defined as a positive result on real-time reverse-transcriptase-polymerase-chain-reaction (RT-PCR) assay of nasal and pharyngeal swab specimens. The primary outcome was a composite adverse fetal outcome, defined as the presence of either abortion (pregnancy loss before 22 weeks of gestations), stillbirth (intrauterine fetal death after 22 weeks of gestation), neonatal death (death of a live-born infant within the first 28 days of life), and perinatal death (either stillbirth or neonatal death). Logistic regression analysis was performed to evaluate parameters independently associated with the primary outcome. Logistic regression was reported as odds ratio (OR) with 95% confidence interval (CI). Results Mean gestational age at diagnosis was 30.6+/-9.5 weeks, with 8.0% of women being diagnosed in the first, 22.2% in the second and 69.8% in the third trimester of pregnancy. There were six miscarriage (2.3%), six intrauterine device (IUD) (2.3) and 5 (2.0%) neonatal deaths, with an overall rate of perinatal death of 4.2% (11/265), thus resulting into 17 cases experiencing and 226 not experiencing composite adverse fetal outcome. Neither stillbirths nor neonatal deaths had congenital anomalies found at antenatal or postnatal evaluation. Furthermore, none of the cases experiencing IUD had signs of impending demise at arterial or venous Doppler. Neonatal deaths were all considered as prematurity-related adverse events. Of the 250 live-born neonates, one (0.4%) was found positive at RT-PCR pharyngeal swabs performed after delivery. The mother was tested positive during the third trimester of pregnancy. The newborn was asymptomatic and had negative RT-PCR test after 14 days of life. At logistic regression analysis, gestational age at diagnosis (OR: 0.85, 95% CI 0.8-0.9 per week increase; pPeer reviewe

Professionally responsible advocacy for women and children first during the COVID-19 pandemic: Guidance from World Association of Perinatal Medicine and International Academy of Perinatal Medicine

The goal of perinatal medicine is to provide professionally responsible clinical management of the conditions and diagnoses of pregnant, fetal, and neonatal patients. The New York Declaration of the International Academy of Perinatal Medicine, "Women and children First - or Last?"was directed toward the ethical challenges of perinatal medicine in middle-income and low-income countries. The global COVID-19 pandemic presents common ethical challenges in all countries, independent of their national wealth. In this paper the World Association of Perinatal Medicine provides ethics-based guidance for professionally responsible advocacy for women and children first during the COVID-19 pandemic. We first present an ethical framework that explains ethical reasoning, clinically relevant ethical principles and professional virtues, and decision making with pregnant patients and parents. We then apply this ethical framework to evidence-based treatment and its improvement, planned home birth, ring-fencing obstetric services, attendance of spouse or partner at birth, and the responsible management of organizational resources. Perinatal physicians should focus on the mission of perinatal medicine to put women and children first and frame-shifting when necessary to put the lives and health of the population of patients served by a hospital first

The identification, management, and prevention of conflict with faculty and fellows: A practical ethical guide for department chairs and division chiefs

The relationship between chairs and divisions chiefs with faculty colleagues in departments of obstetrics and gynecology has important but heretofore unexplored ethical dimensions. Based on the ethical concept of fiduciary responsibility and contractual obligations, this paper provides ethically justified practical guidance for academic physician leaders in the identification, management, and prevention of conflicts in their relationships with faculty colleagues. The framework is developed in contrast with the fiduciary-contractual dimensions of the physician\u96patient relationship and is articulated in terms of the ethical principles of beneficence, respect for autonomy, and justice. The distinctive nature of the academic physician leader\u96colleague relationship is that beneficence-based obligations and justice-based obligations to colleagues can often justifiably override autonomy-based obligations to colleagues, about which it is crucial for academic leaders to be transparent in making and implementing leadership decisions