This project considers whether and how research ethics can contribute to the provision of cost-effective medical interventions. Clinical research ethics represents an underexplored context for the promotion of cost-effectiveness. In particular, although scholars have recently argued that research on less-expensive, less-effective interventions can be ethical, there has been little or no discussion of whether ethical considerations justify curtailing research on more expensive, more effective interventions. Yet considering cost-effectiveness at the research stage can help ensure that scarce resources such as tissue (...) samples or limited subject popula- tions are employed where they do the most good; can support parallel efforts by providers and insurers to promote cost-effectiveness; and can ensure that research has social value and benefits subjects. I discuss and rebut potential objections to the consideration of cost-effectiveness in research, including the difficulty of predicting effectiveness and cost at the research stage, concerns about limitations in cost-effectiveness analysis, and worries about overly limiting researchers’ freedom. I then consider the advantages and disadvantages of having certain participants in the research enterprise, including IRBs, advisory committees, sponsors, investigators, and subjects, consider cost-effectiveness. The project concludes by qualifiedly endorsing the consideration of cost-effectiveness at the research stage. While incorporating cost-effectiveness considerations into the ethical evaluation of human subjects research will not on its own ensure that the health care system realizes cost-effectiveness goals, doing so nonetheless represents an important part of a broader effort to control rising medical costs. (shrink)

Donepezil, an acetylcholinesterase inhibitor used in the treatment of Alzheimer's disease, has been widely cited in media and bioethics literature on cognitive enhancement (CE) as having the potential to improve the cognitive ability of healthy individuals. In both literatures, this claim has been repeatedly supported by the results of a small study published by Yesavage et al. in 2002 on non-demented pilots (30-70 years old). The factors contributing to this specific interpretation of this study's results are unclear.

The hopes and fears expressed in the debate on human enhancement are not always based on a realistic assessment of the expected possibilities. Discussions about extreme scenarios may at times obscure the ethical and policy issues that are relevant today. This paper aims to contribute to an adequate and ethically sound societal response to actual current developments. After a brief outline of the ethical debate concerning neuro-enhancement, it describes the current state of the art in psychopharmacological science and current uses (...) of psychopharmacological enhancement, as well as the prospects for the near future. It then identifies ethical issues regarding psychopharmacological enhancements that require attention from policymakers, both on the professional and on the governmental level. These concern enhancement research, the gradual expansion of medical categories, off-label prescription and responsibility of doctors, and accessibility of enhancers on the Internet. It is concluded that further discussion on the advantages and drawbacks of enhancers on a collective social level is still needed. (shrink)

Authors such as Francis Fukuyama, the President's Council on Bioethics, and George Annas have argued that biotechnological interventions that aim to promote genetic enhancement pose a threat to human nature. This paper clarifies what conclusions these critics seek to establish, and then shows that there is no plausible account of human nature that will meet the conditions necessary to support this position. Appeals to human nature cannot establish a prohibition against the pursuit of genetic enhancement.

This article challenges recent assumptions that physicians may ethically and legally prescribe psychopharmacological enhancement drugs to patients and the counterintuitive notion that in some cases ingesting an enhancement drug constitutes the more ethical choice than forgoing this option. Enhancement proponents have touted modafinil as an ideal mechanism to improve concentration, alertness, and forgo sleep and keep pace with our society's demands. However, patients who use modafinil for these reasons risk potentially severe side effects and addiction, and face unintended consequences related (...) to their cognitive, emotive, and physiological functioning. Importantly, prescribing a controlled substance such as modafinil for performance enhancement and sleep avoidance runs contrary to a physician's ethical duty to the patient and the standard of practice set forth in legal requirements governing the prescription of controlled substances. (shrink)

In the March 2010 edition of Mayo Clinic Proceedings, Drs. Rose and Curry declared that resident physicians have an ethical duty to reduce error during periods of fatigue. Problematically, however, they argued this means ingesting a stimulant for performance enhancement and sleep avoidance during a shift when a resident physician is experiencing fatigue as the more ethical choice than forgoing ingesting a stimulant. Rather than accepting enhancement as an unstoppable technological imperative, this article will examine the underlying motivations for enhancement (...) embedded in our culture and the corresponding legal framework relating to stimulant drugs. Although our society seems to be engaged in a pharmacological arms race of efficiency, competition, and self “betterment,” the FDA has not approved stimulant drugs such as modafinil for PESA. As a result, the off-label use of modafinil for PESA means these individuals are part of a large-scale experiment that poses serious immediate and long-term side effects to the individual user as well as society. (shrink)

The use of psychopharmaceuticals to enhance human mental functioning such as cognition and mood has raised a debate on questions regarding identity and authenticity. While some hold that psychopharmaceutical substances can help users to ‘become who they really are’ and thus strengthen their identity and authenticity, others believe that the substances will lead to inauthenticity, normalization, and socially-enforced adaptation of behaviour and personality. In light of this debate, we studied how persons who actually have experience with the use of psychopharmaceutical (...) medication would view their ‘self’ or their authentic personal identity in relation to the use of medication. We have interviewed a number of adults diagnosed with ADHD and discussed their experiences with medication use in relation to their conceptions of self and identity. In the first part of this paper we illustrate that the concepts of identity and authenticity play an important and sometimes problematic role in experiences of ADHD adults. This shows that the question about identity and psychopharmacology is not merely an ‘academic’ issue, but one that influences everyday lives of real people. In order to answer the question whether psychopharmaceuticals threaten personal identity and authenticity, more than empirical research is needed. We also need to analyse the concepts of personal identity, authenticity and self: what do we mean when we are using statements as ‘a way of living that is uniquely our own’, ‘our true self’, or ‘who we really are’? In the second part of this paper we discuss two important philosophical views on personal identity, authenticity and self: the self-control view as elaborated by Frankfurt, and the self-expression view as proposed by Schechtman. We compare these with the experiences of our respondents to see which view can help us to understand the diverse and often conflicting experiences that people have with medication for ADHD. This will contribute to a better understanding of whether and in which cases personal identity and authenticity are threatened by psychopharmacology. (shrink)