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International conflicts over patenting human DNA sequences in the United States and the European Union: an argument for compulsory licensing and a fair-use exemption.

The thought of a large biotech company holding an exclusive right to research and manipulate human genetic material provokes many reactions--from moral revulsion to enthusiasm about the possibilities for therapeutic advancement. While most agree that such a right must exist, debate continues over the appropriate extent of its entitlements and preclusive effects. In this Article, Professor Donna Gitter addresses this multidimensional problem of patents on human deoxyribonucleic acid (DNA) sequences in the United States and the European Union. Professor Gitter chronicles not only the development of the law in this area, but also the array of policy and moral arguments that proponents and detractors of such patents raise. She emphasizes the specific issue of patents on DNA sequences whose function has not fully been identified, and the chilling effect these patents may have on beneficial research. From this discussion emerges a troubling realization: While the legal framework governing "life patents" may be similar in the United States and the European Union, the public perceptions and attitudes toward them are not. Professor Gitter thus proposes a dual reform: a compulsory licensing regime requiring holders of DNA sequence patents to license them to commercial researchers, in return for a royalty keyed to the financial success of the product that the licensee develops; and an experimental-use exemption from this regime for government and nonprofit researchers.

Base Sequence↗

Selection of prepubertal goat oocytes using the brilliant cresyl blue test.

Brilliant cresyl blue stain allows us to determine the activity of glucose-6-phosphate dehydrogenase (G6PD), an enzyme synthesized in growing oocytes but with decreased activity in oocytes that have finished their growth phase. The objective of this study was to evaluate the utility of the brilliant cresyl blue (BCB) test as an indirect measure of oocyte growth, in order to select competent prepubertal goat oocytes for in vitro embryo production. Oocytes were exposed to BCB diluted in PBS and were classified according to their cytoplasm coloration: oocytes with a blue cytoplasm or grown oocytes (BCB+) and oocytes without a blue cytoplasm or growing oocytes (BCB-). After exposure to different BCB concentrations, we evaluated in vitro maturation (IVM), in vitro fertilization (IVF) and embryo development parameters. We defined matured oocytes as those oocytes that reached the metaphase II (MII) stage after being cultured for 27 h. Oocytes showing two pronuclei at 20 h post-insemination were classified as normally fertilized oocytes. We assessed embryo development 8 days post-insemination and recorded the percentage of total embryos, morale and blastocysts. The mean percentage of BCB+ oocytes was 29.4%. Mean diameter of BCB+ oocytes (136.6+/-6.3 microm) was higher (P < 0.001) than that of BCB- oocytes (125.5+/-10.2 microm). The percentage of BCB+ oocytes reaching the MII stage (81.4%) was higher (P < 0.05) than that of BCB- (52.5%) and control oocytes (72.4%). Normal fertilization rate of BCB+ oocytes was also higher (23.5%) than that of BCB- (8.2%; P < 0.0001) and control oocytes (11.9%; P < 0.05). The percentages of total embryos undergoing development to >8-cell and the morula plus blastocyst stages were higher (P < 0.05) in the group of BCB+ (41.3 and 12.0%, respectively) than in BCB- oocytes (21.3 and 3.6%, respectively). In conclusion, the BCB test is a useful way to select more competent prepubertal goat oocytes for in vitro embryo production.

Animals↗

Catharsis and moral therapy I: a Platonic account.

This paper aims at analysing the ancient Greek notions of catharsis (clearing up, cleaning), to holon (the whole) and therapeia (therapy, treatment, healing) to assess whether they may be of help in addressing a set of questions concerning the didactics of medical ethics: What do medical students actually experience and learn when they attend classes of medical ethics? How should teachers of medical ethics proceed didactically to make students benefit morally from their teaching? And finally, to what extent and in what forms and formats can the kind of cathartic treatment envisaged by Plato still be considered a necessary preliminary to moral learning? The three questions will be addressed by means of a reconstructive analysis and assessment of the Platonic notions of catharsis and holistic therapy present in the Charmides and the Sophist. Besides, the didactic potential of Plato's dialogue form and moral regimen will be tried out. The ultimate aim is to investigate the possibilities of developing a therapeutic conception of medical ethics.

Adult↗

[Theological moral considerations of advance directives].

The forms for advanced directives vary considerably in respect to content and wording. This article intends to develop ethical criteria for such texts, from the moraltheological point of view, also considering the social context.

Advance Directives↗

[Mental competence in the context of deep brain stimulation].

In a case of Parkinson's disease, the patient was treated with deep brain stimulation of the subthalamic nucleus (STN-DBS). STN-DBS affected the mental competence of the patient and ethical questions were raised about the decision as to the direction of further treatment. The patient was asked for his opinion on the therapeutic options during a phase of non-stimulation and chose to be stimulated and admitted to a psychiatric hospital because of mental incompetence rather than remaining unstimulated, mentally competent but bedridden. Developments in the neurosciences (including STN-DBS) raise a number of different fundamental (theoretical and philosophical) as well as practical questions. STN-DBS can have various unintended (behavioural) effects. In the case presented, more weight was rightly given to the mental competence of the unstimulated patient, although comments can be made with regard to his decision making, as his choice was made in a phase of serious distress. Attention is paid to the relevance of a so-called self-binding directive. STN-DBS is not morally neutral and the case involves a tragic dilemma: a conflict between irreconcilable duties for the physician. The further development and proliferation of STN-DBS requires caution and moral deliberation. It remains important to search for alternative treatment strategies with less undesirable side effects.

Electric Stimulation Therapy↗

A small medical group's journey toward total quality management.

Steven M. Shufro, executive director of Concord Hillside Medical Associates, in Concord, Mass., documents the first year of the group's implementation of a quality program and what the results were. He includes a look at the organizational context of the group, the development of the program and how the Harvard Community Health Plan, the largest pre-paid HMO in New England, assisted them.

Attitude of Health Personnel↗

Imaginative ethics--bringing ethical praxis into sharper relief.

The empirical basis for this article is three years of experience with ethical rounds at Uppsala University Hospital. Three standard approaches of ethical reasoning are examined as potential explanations of what actually occurs during the ethical rounds. For reasons given, these are not found to be satisfying explanations. An approach called "imaginative ethics", is suggested as a more satisfactory account of this kind of ethical reasoning. The participants in the ethical rounds seem to draw on a kind of moral competence based on personal life experience and professional competence and experience. By listening to other perspectives and other experiences related to one particular patient story, the participants imagine alternative horizons of moral experience and explore a multitude of values related to clinical practice that might be at stake. In his systematic treatment of aesthetics in the Critique of Judgement, Kant made use of an operation of thought that, if applied to ethics, will enable us to be more sensitive to the particulars of each moral situation. Based on this reading of Kant, an account of imaginative ethics is developed in order to bring the ethical praxis of doctors and nurses into sharper relief. The Hebraic and the Hellenic traditions of imagination are used in order to illuminate some of the experiences of ethical rounds. In conclusion, it is argued that imaginative ethics and principle-based ethics should be seen as complementary in order to endow a moral discourse with ethical authority. Kantian ethics will do the job if it is remembered that Kant suggested only a modest, negative role of principle-based deliberation.

Ethical Analysis↗

Capacities, context and moral status of animals.

According to a widely shared intuition, normal adult humans require greater moral concern than normal, adult animals in at least some circumstances. Even the most steadfast defenders of animals' moral status attempt to accommodate this intuition, often by holding that humans' higher-level capacities (intellect, linguistic ability, and so on) give rise to a greater number of interests, and thus the likelihood of greater satisfaction, thereby making their lives more valuable. However, the moves from capacities to interests, and from interests to the likelihood of satisfaction, have up to now gone unexamined and undefended. I argue that context plays a morally significant role both in the formation of an individual's capacities, and in the determination of the individual's interests and potential for satisfaction based on those capacities. Claims about an individual's capacities and interests are typically presented as unconditional; but on closer examination, they are revealed to be contingent on tacit assumptions about context. Until we develop an understanding of how to account for the role of context within our moral theories, attempts to defend special moral concern for human beings based on their superior capacities are less firmly grounded than is commonly thought.

Animal Experimentation↗

Practical moral codes in the transgenic organism debate.

In one study funded by the United States Department of Agriculture, people from North Dakota were interviewed to discover which moral principles they use in evaluating the morality of transgenic organisms and their introduction into markets. It was found that although the moral codes the human subjects employed were very similar, their views on transgenics were vastly different. In this paper, the codes that were used by the respondents are developed, compared to that of the academically composed Belmont Report, and then modified to create the more practical Common Moral Code. At the end, it is shown that the Common Moral Code has inherent inconsistency flaws that might be resolvable, but would require extensive work on the definition of terms and principles. However, the effort is worthwhile, especially if it results in a common moral code that all those involved in the debate are willing to use in negotiating a resolution to their differences.

Advisory Committees↗

Viewpoint: teaching professionalism: is medical morality a competency?

The Accreditation Council for Graduate Medical Education (ACGME) has declared medical professionalism to be a competence analogous to competence at medical practice. Medical educators accordingly seek to develop ways in which to teach and assess medical professionalism as they now teach and assess clinical medicine. The author contends that professionalism is medical morality and that while being moral in the world of medical practice can involve skill, morality differs from domain-based skills such as medicine in important respects. The norms of morality are both more exigent and more difficult to live up to than the norms of medical expertise. And any morality we learn in the course of medical education does not simply establish itself in our repertoire as a new skill, but must contend with our preexisting moral outlook. These differences have implications for the inculcation and assessment of professionalism. Professionalism can be taught, but the current model employed by medical education, cognitive engagement followed by supervised practice, will not suffice for its inculcation. Nor will objective cognitive or behavioral testing suffice for its assessment. Medical educators can seek and achieve compliance with professional norms during the formative periods of training (internship and residency). Committed observance of professional norms cannot be coerced but may emerge among trainees through their responsiveness to the lived moral life of virtuous faculty, encouraged by the tacit and explicit invitation of such faculty to imitation over time. To be valid, assessment of professionalism must be subjective, narrative, personal, undertaken during periods of stress, and obtained during routine activity (rather than on special occasions).

Competency-Based Education↗

Values in the choice of treatment: replication and refinement.

The Gortner Values in the Choice of Treatment Inventory is a set of statements based on the moral principles of autonomy and beneficence/nonmaleficence (Beauchamp & Childress, 1979). The inventory was developed and used with cardiac surgery patients and spouses (Gortner, Hudes, & Zyzanski, 1984) and has been replicated with a new sample of coronary artery bypass surgery or value replacement surgery patients and spouses. Significant patient-spouse correlations were obtained for the Autonomy, rs = .26, p = .03, and Beneficence/Nonmaleficence scales, rs = .38, p = .002. Repeated measures analysis of variance showed a significant main effect for the value preference of Autonomy over Beneficence/Nonmaleficence, p = .001, when the family score (arithmetical mean of patient-spouse score) was used as the unit of analysis. A refinement was done on the combined samples from this and the early trial through a separate factor analysis. The final two-factor solution suggests that a common factor and scoring solution, based on 12 inventory items, fits both family and patient data.

Behavioral Research↗

Nurse education in Mbarara, Uganda.

AIM: To describe the establishment of a professional development programme for qualified nurses at Mbarara University Teaching Hospital, Uganda. BACKGROUND: Between 1997 and 1999, a group of hospital-based nurses and university lecturers in Hull, United Kingdom, planned and delivered a series of modules to set the Ugandan nurses on course for continuing professional development. APPROACH: A descriptive account of the delivery of the programme. FINDINGS: Evaluation of the programme indicates that the nurses' morale was raised by satisfactory completion of the modules and that there were visible improvements in the organization of patient care in the hospital. CONCLUSIONS: This professional development programme was a learning experience for all the parties involved. Support from Hull for the education of nurses in Mbarara will continue.

Curriculum↗

Good enough for the Third world.

Over the past two years, much has been made by some governments and the media about the possible callous and racist distribution of Quinacrine by two Americans to sterilize women in the Third World. The main criticism of the practice is that though Quinacrine is unapproved by the developed world's health regulatory agencies for this particular use in the developed world due to inadequate testing for long-term side effects, it is used on defenseless women in the developing world.I argue that the distribution of unapproved medical and other products is morally permissible if it satisfies two conditions: agent-centered utilitarianism and Kant's Categorical Imperative. Roughly, I contend that if the situation will probably improve and no one is treated as a mere means, then it is ethical either to give or to sell the products to those who choose to have them, regardless of where in the world they live.

Caustics↗

The relation between law and morality: children's reasoning about socially beneficial and unjust laws.

This study investigated children's reasoning about laws and legal compliance. A total of 72 children, 24 each at 6, 8, and 10 years of age, made judgments of law evaluation ("Is it a good or bad law?"), legitimacy of legal regulation ("Is it OK or not for government to make a law?"), and law violation ("Is it OK or not for people to break the law?") for three socially beneficial laws (a traffic law, a vaccination law, and a law requiring compulsory education for children under 16) and three unjust laws (denial of education to a class of persons, denial of medical care to the poor, and age discrimination). Participants also evaluated the application of laws in conflict scenarios in which a socially beneficial law infringed on individual freedom. Results showed that children considered a number of factors in their judgments, including the perceived justice of the law, its socially beneficial purpose, and its potential for infringement on individual freedoms and rights. The findings showed that children apply moral concepts of harm, rights, and justice to evaluate laws and to inform their judgments of legal compliance.

Age Factors↗

The basis of privacy and autonomy in medical practice. A model.

Most of the medical literature concerned with privacy seems to be based on the implicit assumptions that there is such a thing as right-to-privacy and that privacy is a worthwhile end unto itself. This paper develops a model which should permit a better and more pragmatic understanding of the moral, ethical and psychosocial bases of these assumptions. Arguments are offered that privacy is, indeed, not mainly an intrinsic value but is more of an instrumental value. It is suggested that privacy, per se, is not an end but is, rather, a means to another end, autonomy. It is important to differentiate autonomy as used here from narcissism; the former is viewed as an advanced stage of cognitive development whereas the latter is a social deviance. The model is developed which states: the analogy of a person is as a unit consisting of a matrix which is unique and autonomous because of its separation from other units by means of a wall-of-privacy; the relationship between persons is measured by their social distance. Derived from this is the 'equation', A approximately equal to (P)(D). Intimacy, substitutive judgement, confidentiality and patient-physician relationship are conceptualized within this model.

Confidentiality↗