Light therapy for seasonal and nonseasonal depression: efficacy, protocol, safety, and side effects

Bright light therapy for seasonal affective disorder (SAD) has been investigated and applied for over 20 years. Physicians and clinicians are increasingly confident that bright light therapy is a potent, specifically active, nonpharmaceutical treatment modality. Indeed, the domain of light treatment is moving beyond SAD, to nonseasonal depression (unipolar and bipolar), seasonal flare-ups of bulimia nervosa, circadian sleep phase disorders, and more. Light therapy is simple to deliver to outpatients and inpatients alike, although the optimum dosing of light and treatment time of day requires individual adjustment. The side-effect profile is favorable in comparison with medications, although the clinician must remain vigilant about emergent hypomania and autonomic hyperactivation, especially during the first few days of treatment. Importantly, light therapy provides a compatible adjunct to antidepressant medication, which can result in accelerated improvement and fewer residual symptoms.     

The Role of Temperament in the Etiology of Child Psychopathology

A substantial proportion of children and adolescents come to suffer from psychological disorders. This article focuses on the temperament factors that are involved in the pathogenesis of child psychopathology. It is argued that besides the reactive temperament factor of emotionality/neuroticism, the regulative process of effortful control also plays an important role in the etiology and maintenance of internalizing and externalizing problems in youths. More specifically, vulnerability to child psychopathology is determined by a temperament that is characterized by high levels of emotionality/neuroticism and low levels of effortful control. Models are hypothesized in which reactive and regulative temperament factors either have interactive or additive effects on the development of psychological disorders in children, and conceptualized in terms of a developmental psychopathology perspective. Directions for future research and clinical implications of this temperamental view on psychopathology are discussed.     

Preadolescent Clues to Understanding Depression in Girls

Between the ages of 10 and 15, increases in depression among girls result in a rate that is twice as high as the rate of depression in boys. This sex difference remains throughout early and middle adulthood. Prior to early adolescence, there is essentially no sex difference in the rate of depression. The aim of the present review is to examine whether the preadolescent period is a time during which precursors to depression in girls can be identified. First, existing areas of research on explaining sex differences in depression, including cognitive and affiliative style and the socialization of emotion, are reviewed. Second, the hypothesis that for some girls, preadolescent precursors to depression take the form of excessive empathy, compliance and regulation of negative emotions is articulated. Third, ways of building on existing models by including the proposed preadolescent precursors are proposed. Finally, approaches to testing the hypotheses that individual differences in these domains during preadolescence may explain later individual differences in adolescent onset depression are explored.     

Epidemiological Measurement of Children's and Adolescents' Exposure to Community Violence: Working with the Current State of the Science

A number of measures have been used in epidemiological studies of children's exposure to community violence, yet the quality of these instruments is not uniformly good. This paper undertakes a systematic review of the most commonly used (or most promising) self-report or interview-administered instruments, with regard to their conceptual bases and psychometric properties. Based on the review, recommendations are made for working with the current state of the science in order to move the field forward. A key recommendation is for sounder conceptualization of work in the field and greater transparency in the reporting of research, in order to facilitate the comparability of studies.     

A call to restructure the drug development process: Government over-regulation and non-innovative late stage (Phase III) clinical trials are major obstacles to advances in health care

The history of drug/vaccine development has included major advances guided primarily by risk/benefit analyses concerning the innovative agent, not by evidence-based clinical trials (Phase I–IV). Because the approval for new drugs is hindered under the present process, the system requires restructuring. The Phase I/II study period should be more flexible, using the “environment of knowledge” about the new agent, plus risk/benefit assessments. Phase III, as presently constructed, does not add new adverse events data, it provides a narrower profile of drug efficacy than properly done Phase II studies, and placebo-controlled trials continue to raise unresolved ethical and social issues. Phase III studies should be abandoned for most drugs, and substituted with properly powered Phase II doseranging studies plus careful post-marketing surveillance. Phase III should be a penalty for poor drug development, not a regulatory requirement. To accomplish efficient drug development, greater cooperation between pharmaceutical companies and governments in developing clinical trials is needed rather than over-regulation. These changes will synchronize the drug development and regulatory process with the current rapid drug discovery process, reduce drug development time and cost, and improve patient care. The author is Adjunct Professor of Medicine, Weill Medical College of Cornell University, New York, New York, USA.     

The immoral gene: Does it really exist?

Over the last years several European patents were opposed for protecting technology violating the morality requirement under Article 53(a) EPC. Attempts have been made by the Appeal Boards of the European Patent Office (EPO), as well as by amendments introduced into the Implementing Regulations of the European Patent Convention (EPC), to address this sensitive patentability requirement more precisely. The most recent hot topic coming up in this context is the patentability of stem cells. It is to be expected that this discussion will still go on in the field of biotechnological inventions for the next several years. An earlier version of this paper was presented at an international conference, “The Ethics of Intellectual Property Rights and Patents,” held in Warsaw, Poland on 23–24 April, 2004.     

Patents and ethics: Is it possible to be balanced?

In this presentation, principles of ethics are confronted with the desire of the inventor to make a profit. To this end the presentation is focused on patent protection. Patents should guarantee the return of an inventor’s investment and profit and, on the other side, ensure availability — by patent disclosure — of the invention for the society when the patent terminates. Recent patent applications made by inventors are infringing this principle and societies are paying an unexpected price for these practices. Patent claims are too broad and disclosures too poor. Extreme examples will be discussed. An earlier version of this paper was presented at an international conference, “The Ethics of Intellectual Property Rights and Patents,” held in Warsaw, Poland on 23–24 April, 2004.     

The growing complexity of international policy in intellectual property

Intellectual property has historically been a self-contained policy at the international level. With the introduction of the TRIPs Agreement in 1994 and developments since the conclusion of the TRIPs Agreement, the relationship between intellectual property policy and other areas of public policy has become much more complex and interactive. This shift reflects the centrality of intellectual property in the knowledge economy, the rapid development of enabling technologies, notably the Internet and biotechnology, and the advent of the networked society. The consequences of this shift are manifold and herald the increased sophistication and complexity that may be expected of intellectual property regimes in the knowledge economy. An earlier version of this paper was presented at an international conference, “The Ethics of Intellectual Property Rights and Patents,” held in Warsaw, Poland on 23–24 April, 2004.     

The gap between law and ethics in human embryonic stem cell research: Overcoming the effect of U.S. Federal policy on research advances and public benefit

Key ethical issues arise in association with the conduct of stem cell research by research institutions in the United States. These ethical issues, summarized in detail, receive no adequate translation into federal laws or regulations, also described in this article. U.S. Federal policy takes a passive approach to these ethical issues, translating them simply into limitations on taxpayer funding, and foregoes scientific and ethical leadership while protecting intellectual property interests through a laissez faire approach to stem cell patents and licenses. Those patents and licenses, far from being scientifically and ethically neutral in effect, virtually prohibit commercially sponsored research that could otherwise be a realistic alternative to the federal funding gap. The lack of federal funding and related data-sharing principles, combined with the effect of U.S. patent policy, the lack of key agency guidance, and the proliferation of divergent state laws arising from the lack of Federal leadership, significantly impede ethical stem cell research in the United States, without coherently supporting any consensus ethical vision. Research institutions must themselves implement steps, described in the article, to integrate addressing ethical review with the many legal compliance issues U.S. federal and state laws create. The opinions expressed in this article are the author’s own, and are not necessarily the opinions of others, including Children’s Hospital Boston. Portions of earlier versions of this article were previously published by the American Bar Association and the New York State Bar Association.     

Introducing ethics across the curriculum at South Dakota school of mines and technology

This paper describes how the Electrical and Computer Engineering Department at South Dakota School of Mines and Technology has chosen to integrate ethics into their curriculum. All university freshmen engineering students are introduced to ethics through the presentation of ethical dilemmas. During this exercise, students are forced to argue both sides (‘for’ and ‘against’) of a hypothetical ethical engineering dilemma. It provides a setting for great discussion with the desired outcome that they learn to carefully analyze a situation before they draw conclusions. In the sophomore year, students are introduced to methods to use the fundamental principles, the fundamental canons, and the suggested guidelines for use with the fundamental canons of ethics when analyzing appropriate action to be taken when confronted with ethical dilemmas. We currently use the ‘sophomore’ method for seniors because the sequencing is just beginning. Next year the seniors will do more indepth analysis of ethical case studies. An earlier version of this paper was presented at the Fourteenth Annual Meeting, Association for Practical and Professional Ethics, February 24–27, 2005.