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. (shrink)

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 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. (shrink)

Planned home birth has been considered by some to be consistent with professional responsibility in patient care. This article critically assesses the ethical and scientific justification for this view and shows it to be unjustified. We critically assess recent statements by professional associations of obstetricians, one that sanctions and one that endorses planned home birth. We base our critical appraisal on the professional responsibility model of obstetric ethics, which is based on the ethical concept of medicine from the Scottish and (...) English Enlightenments of the 18th century. Our critical assessment supports the following conclusions. Because of its significantly increased, preventable perinatal risks, planned home birth in the United States is not clinically or ethically benign. Attending planned home birth, no matter one’s training or experience, is not acting in a professional capacity, because this role preventably results in clinically unnecessary and therefore clinically unacceptable perinatal risk. It is therefore not consistent with the ethical concept of medicine as a profession for any attendant to planned home birth to represent himself or herself as a “professional.” Obstetric healthcare associations should neither sanction nor endorse planned home birth. Instead, these associations should recommend against planned home birth. Obstetric healthcare professionals should respond to expressions of interest in planned home birth by pregnant women by informing them that it incurs significantly increased, preventable perinatal risks, by recommending strongly against planned home birth, and by recommending strongly for planned hospital birth. Obstetric healthcare professionals should routinely provide excellent obstetric care to all women transferred to the hospital from a planned home birth. The professional responsibility model of obstetric ethics requires obstetricians to address and remedy legitimate dissatisfaction with some hospital settings and address patients’ concerns about excessive interventions. Creating a sustained culture of comprehensive safety, which cannot be achieved in planned home birth, informed by compassionate and respectful treatment of pregnant women, should be a primary focus of professional obstetric responsibility. (shrink)

Chervenak and McCullough, authors of the most acknowledged ethical framework for maternal–fetal surgery, rely on the ‘ethical–obstetrical’ concept of the fetus as a patient in order to determine what is morally owed to fetuses by both physicians and the women who gestate them in the context of prenatal surgery. In this article, we reconstruct the argumentative structure of their framework and present an internal criticism. First, we analyse the justificatory arguments put forward by the authors regarding the moral status (...) of the fetus qua patient. Second, we discuss the internal coherence and consistency of the moral obligations those authors derive from that concept. We claim that some of the dilemmas their approach is purported to avoid, such as the debate about the independent moral status of the fetus, and the foundation of the moral obligations of pregnant women (towards the fetuses they gestate) are not, all things considered, avoided. Chervenak and McCullough construct the obligations of physicians as obligations towards entities with equal moral status. But, at the same time, they assume that the woman has an independent moral status while the moral status of the fetus is dependent on the decision of the woman to present it to a physician for care. According to the logic of their own argumentation, Chervenak and McCullough implicitly admit a different moral status of the woman and the fetus, which will lead to different ascription of duties of the physician than those they ascribed. (shrink)

This article focuses on maternal-fetal surgery (MFS) and on the concept of clinical equipoise that is a widely accepted requirement for conducting randomized controlled trials (RCT). There are at least three reasons why equipoise is unsuitable for MFS. First, the concept is based on a misconception about the nature of clinical research and the status of research subjects. Second, given that it is not clear who the research subject/s in MFS is/are, if clinical equipoise is to be used as a (...) criterion to test the ethical appropriateness of RCT, its meaning should be unambiguous. Third, because of the multidisciplinary character of MFS, it is not clear who should be in equipoise. As a result, we lack an adequate criterion for the ethical review of MFS protocols. In our account, which is based on Chervenak and McCullough's seminal work in the field of obstetric ethics, equipoise is abandoned. and RCT involving MFS can be ethically initiated when a multidisciplinary ethics review board (ERB), having an evidence-based assessment of the risks involved, is convinced that the value of answering the research hypothesis, for the sake of the health interests of future pregnant women carrying fetuses with certain congenital birth defects, justifies the actual risks research participants might suffer within a set limit of low/manageable. (shrink)

Recent preclinical studies have shown the feasibility of specific variants of nuclear transfer to prevent mitochondrial DNA disorders. Nuclear transfer could be a valuable reproductive option for carriers of mitochondrial mutations. A clinical application of nuclear transfer, however, would entail germ-line modification, more specifically a germ-line modification of the mitochondrial genome. One of the most prominent objections against germ-line modification is the fear that it would become possible to alter ‘essential characteristics’ of a future person, thereby possibly violating the child's (...) right to an open future. As only the nuclear DNA would contain the ingredients for individual characteristics, modification of the mtDNA is often considered less controversial than modification of the nuclear DNA. This paper discusses the tenability of this dichotomy. After having clarified the concept of germ-line modification, it argues that modification of the mtDNA is not substantively different from modification of the nuclear DNA in terms of its effects on the identity of the future person. Subsequently the paper assesses how this conclusion affects the moral evaluation of nuclear transfer to prevent mtDNA disorders. It concludes that the moral acceptability of germ-line modification does not depend on whether it alters the identity of the future child—all germ-line modifications do—but on whether it safeguards the child's right to an open future. If nuclear transfer to prevent mtDNA disorders becomes safe and effective, then dismissing it because it involves germ-line modification is unjustified. (shrink)

How did bioethics manage to grow, flourish and ultimately do so well from a very unpromising birth in the 1970s? Many explanations have been advanced. Some ascribe the field9s growth to a puzzling, voluntary abnegation of moral authority by medicine to non-physicians. Some think bioethics survived by selling out to the biomedical establishment—public and private. This transaction involved bestowing moral approbation on all manner of biomedicine9s doings for a seat at a well-stocked funding table. Some see a sort of clever (...) intellectual bamboozlement at work wherein bioethicists pitched a moral elixir of objective expertise that the morally needy but unsophisticated in medicine and the biological sciences were eager to swallow. While each of these reasons has its defenders, I think the main reason that bioethics did well was that it did good. By using the media to move into the public arena, the field engaged the public imagination, provoked dialogue and debate, and contributed to policy changes that benefitted patients and healthcare providers. (shrink)

Oxford Scholarly Classics brings together a number of great academic works from the archives of Oxford University Press. Reissued in a uniform series design, they will enable libraries, scholars, and students to gain fresh access to some of the finest scholarship of the last century.

Randomised clinical trials provide the most valid means of establishing the efficacy of clinical therapeutics. Ethical standards dictate that patients and clinicians should not consent to randomisation unless there is uncertainty about whether any of the treatment options is superior to the others ("equipoise"). However, true equipoise is rarely present; most randomised trials, therefore, present challenging ethical dilemmas. Minimising the tension between science and ethics is an obligation of investigators and clinicians. This article briefly reviews several techniques for addressing this (...) issue and suggests that unbalanced randomisation, a technique rarely employed in current clinical trial practice, may be useful for enhancing the ethical design of human experimentation. (shrink)

To begin with, can we possibly call esthetic activity a cognitive function , that is, do the products of esthetic activity possess, along with their other characteristics, a certain cognitive value?

It would be no exaggeration to say that our art is presently undergoing a revolutionary stage in its development. The revolutionary renewal that has seized all spheres of life is being ever more forcefully represented in artistic culture as well. That culture is beginning to free itself from bureaucratic regimentation, incompetent pressure from above, inflated authorities, lifeless cliches, and opportunism of the moment. Art is actively seeking its place in perestroika, and is in turn in many respects defining the moral (...) climate of perestroika. Recent works such as Fire [Pozhar] by V. Rasputin, the Sad Detective Story [Pechal'nyi detektiv] by V. Astaf'ev, The Execution Block [Plakha] by Ch. Aitmatov, the paintings of G. Korzhev and V. Sidorov, the sculpture of V. Klykov, etc., are actively working for renewal. (shrink)

The essential purpose of the present article is to put forward a new theory concerning the last scene of the Septem, 1005–78. The problem of the play's ending as a whole has been very thoroughly discussed by P. Nicolaus, Die Frage nach der Echtheit der Schlussszene von Aischylos' Sieben gegen Theben ; since I have no wish to duplicate Nicolaus's work I shall deal only very briefly with those aspects of the problem on which I find myself in agreement with (...) him and with other scholars. (shrink)

Книга предназначена для исследователей, специалистов, преподавателей, аспирантов, студентов, а также всех тех, кто интересуется вопросами философии.

We used computer simulations to study the possible role of the dispersion of cellular coupling, refractoriness or both, in the mechanisms underlying cardiac arrhythmias. Local ischemia was first assumed to induce cell to cell dispersion of the coupling resistance (Case 1), refractory period (Case 2), or both of them (Case 3). Our numerical experiments based on the van Capelle and Durrer model showed that vortices could not be induced by cell to cell variations. With cellular properties dispersed in a patchy (...) way within the ischemic zone, a single activation wave could give rise to abnormal activities. This demonstrates the stability of the wave front under small inhomogeneities. Probabilities of reentry, estimated for the three cases cited above showed that a severe alteration of the coupling resistance may be an important factor in the genesis of reentry. Moreover, use of isochronal maps revealed that vortices were both stable and sustained with an alteration of the coupling alone or combined with a reduction of the action potential duration. Conversely, simulations with reduction of the refractoriness alone, inducing only transient patterns, could exhibit functionally determined reentries. (shrink)

jild-i 1. Āzādī va marzʹhāyash -- jild-i 2. Istiqlāl (farhangī).