Legal aspects of zebrafish neuropharmacology and neurotoxicology research.

Despite the growing emphasis on translational neuropharmacology and drug discovery research, the legality underlying these fields are seldom considered. The zebrafish (Danio rerio) is an increasingly utilized model organism in neuropharmacology and neurotoxicology. As the acceptance of zebrafish in biomedicine continues to grow, the legal aspects of their applications remain outpaced by this exponential growth. Therefore, there is a need to evaluate the legal aspects of zebrafish applications to CNS drug research. Here, we discuss a wide range of regulatory topics relevant to zebrafish research, such as the bioethics of experimentation (including studies of stress and pain), welfare protection laws, the recent advances in CNS drug discovery, and specific legal aspects of controlled substance research in this aquatic species. The conceptualization and understanding of the zebrafish welfare and its promise as a model in toxicology can also potentially shape environmental protection practices and inform policy making.

Neuropsychopharmacological aesthetics: A theoretical consideration of pharmacological approaches to causative brain study in aesthetics and art.

Recent developments in neuroaesthetics have heightened the need for causative approaches to more deeply understand the mechanism underlying perception, emotion, and aesthetic experiences. This has recently been the topic for empirical work, employing several causative methods for changing brain activity, as well as comparative assessments of individuals with brain damage or disease. However, one area of study with high potential, and indeed a long history of often nonscientific use in the area of aesthetics and art, employing psychopharmacological chemicals as means of changing brain function, has not been systematically utilized. This chapter reviews the literature on this topic, analyzing neuroendocrinological (neurochemical) approaches and mechanisms that might be used to causatively study the aesthetic brain. We focus on four relevant neuromodulatory systems potentially related to aesthetic experience: the dopaminergic, serotonergic, cannabinoid, and the opioidergic system. We build a bridge to psychopharmacological methods and review drug-induced behavioral and neurobiological consequences. We conclude with a discussion of hypotheses and suggestions for future research.

What should we do about student use of cognitive enhancers? An analysis of current evidence.

This article reviews current data on the use of cognition enhancers as study aids in the student population. It identifies gaps and uncertainties in the knowledge required to make a balanced assessment of the need for some form of regulation. The review highlights the weak evidence on the prevalence of use of such drugs, especially outside the US, and the ambiguous evidence for their efficacy in a healthy population. Risks are well documented for the commonly used drugs, but poorly appreciated by users. These include not only the side-effects of the drugs themselves, but risks associated with on-line purchase, which offers no guarantees of authenticity and which for some drugs is illegal. The case for urgent action to regulate use is often linked to the belief that new and more effective drugs are likely to appear in the near future. The evidence for this is weak. However, drugs are not the only possible route to neuroenhancement and action is needed to collect more data on the impact of existing drugs, as well as new technologies, in order to guide society in making a proportionate response to the issue. This article is part of a Special Issue entitled 'Cognitive Enhancers'.

Aprimoramento cognitivo farmacológico: grupos focais com universitários / Pharmacological cognitive enhancement: focal groups with university students

O presente trabalho analisou como os estudantes universitários avaliam o uso de psicofármacos por pessoas que pretendem melhorar o rendimento cognitivo sem apresentar prejuízo nessa habilidade mental. Esse tipo de remédio só pode ser comercializado através de receita médica especial. Dessa forma, o uso não-médico desse tipo de droga, chamado também de aprimoramento neurocognitivo farmacológico, é ilegal. Com o crescimento no número de estudantes universitários americanos e canadenses que utilizam estimulantes para melhorar a performance acadêmica, o tema tornou-se uma preocupação para a Saúde Pública nos respectivos países. O aprimoramento neurocognitivo farmacológico vem sendo muito discutido no campo da Neuroética. Nos debates dessa a prática são avaliados os riscos e benefícios que essa prática pode trazer para o indivíduo e à sociedade. No Brasil, esse assunto é pouco discutido. Assim, a investigação sobre a compreensão e avaliação que estudantes universitários fazem sobre esse tema trouxe informações que podem ampliar o conhecimento sobre tema no Brasil. A investigação foi realizada através de três grupos focais com estudantes universitários. Os resultados indicaram que questões como pressão social(exigência de bons resultados), segurança do medicamento, risco de coerção social, possibilidade de essa prática aumentar a injustiça social foram as principais preocupações da população entrevistada. Alguns aspectos foram compreendidos de maneira bastantes polarizada. Não está claro para os participantes dos grupos focais, por exemplo, se esta é ou não uma prática desonesta e se a melhora no rendimento cognitivo pode ser entendida como sendo legítima da pessoa. Esses e outros dados mostram que a compreensão do tema aprimoramento neurocognitivo farmacológico é muito influenciada por dois aspectos...

When the boss turns pusher: a proposal for employee protections in the age of cosmetic neurology.

Neurocognitive enhancement, or cosmetic neurology, offers the prospect of improving the learning, memory and attention skills of healthy individuals well beyond the normal human range. Much has been written about the ethics of such enhancement, but policy-makers in the USA, the UK and Europe have been reluctant to legislate in this rapidly developing field. However, the possibility of discrimination by employers and insurers against individuals who choose not to engage in such enhancement is a serious threat worthy of legislative intervention. While lawmakers should not prevent individuals from freely pursuing neurocognitive enhancement, they should act to ensure that such enhancement is not coerced. This paper offers one model for such legislation, based upon a proposed US law, the Genetic Information Nondiscrimination Act of 2008, to address precisely this particular pitfall of the impending neuroscience revolution.

Conflict of interest, journal review, and publication policy.

In summary, the journal editors' effort to restore faith in science by financial disclosure has been inadequate to the task. The editors could improve matters by demanding access to the raw data supporting claims for product safety and effectiveness. The recent emphasis on a detailed clinical trials registry anteceding the trial is clearly a breakthrough. The mandated clinical trial registries that include outcome data are even better. How well this works in terms of detailed public knowledge remains to be seen.

[Intervening in the neural basis of one's personality: a practice-oriented ethical analysis of neuropharmacology and deep-brain stimulation]. / Eingriffe in die Grundlagen der Persönlichkeit: Eine praxisorientierte ethische Analyse von Neuropharmaka und Tiefhirnstimulation.

Through the rapid progress in neuropharmacology it seems to become possible to effectively improve our cognitive capacities and emotional states by easily applicable means. Moreover, deep-brain stimulation may allow an effective therapeutic option for those neurological and psychiatric diseases which still can not be sufficiently treated by pharmacological measures. So far, however, both the benefit and the harm of these techniques are only insufficiently understood by neuroscience and detailed ethical analyses are still missing. In this article ethical criteria and most recent empirical evidence are systematically brought together for the first time. This analysis shows that it is irrelevant for an ethical evaluation whether a drug or a brain-machine interface is categorized as "enhancement" or "treatment" or whether it changes "human nature". The only decisive criteria are whether the intervention (1.) benefits the patient, (2.) does not harm the patient and (3.) is desired by the patient. However, current empirical data in both fields, neuropharmacology and deep-brain stimulation are still too sparse to adequately evaluate these criteria. Moreover, the focus in both fields has been strongly misled by neglecting the distinction between "benefit" and "efficacy": In past years research and clinical practice have only focused on physiological effects, but not on the actual benefit to the patient.

The challenges of neuroethics.

This paper presents different conceptions of neuroethics, focusing both on applications of neuroscience aiming to provide access to other people's minds and on the theoretical study of the neural bases of moral judgement and decision making. It is argued that these studies have not yet seriously undermined the traditional view of humans as moral free agents, nor have they accomplished the radical naturalisation of ethics that is sometimes promised or predicted. A few implications for normative ethics and moral epistemology are also discussed.

Cosmetic psychopharmacology and the President's Council on Bioethics.

Advances in neuroscience and biotechnology have heightened the urgency of the debate over "cosmetic psychopharmacology," the use of drugs to enhance mood and temperament in the absence of illness. Beyond Therapy: Biotechnology and the Pursuit of Happiness (2003), the report of the President's Council on Bioethics, has criticized the use of cosmetic psychopharmacology. The Council claimed that cosmetic psychopharmacology will necessarily lead to "severing the link between feelings of happiness and our actions and experiences in the world," but it provided no satisfactory arguments to support this claim and ignored the possibility that cosmetic psychopharmacology might actually enhance the link between happiness and experience. The Council's arguments against cosmetic psychopharmacology depend heavily on the mistaken belief that Prozac and similar antidepressants are mood brighteners in healthy subjects. The empirical evidence, however, clearly indicates that these drugs are not forms of cosmetic psychopharmacology, thus negating much of the Council's arguments. The use of pharmaceutical agents to enhance mood or personality in normal individuals should not be rejected a priori. Instead, the effects of each agent on the individual and on society must be weighed using sound ethical reasoning and the best evidence available.