Physician-assisted suicide: two moral arguments.
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1. Pharmacogenetics refers to the study of genetically controlled variations in drug response. Functional variants caused by single nucleotide polymorphisms (SNPs) in genes encoding drug-metabolising enzymes, transporters, ion channels and drug receptors have been known to be associated with interindividual and interethnic variation in drug response. Genetic variations in these genes play a role in influencing the efficacy and toxicity of medications. 2. Rapid, precise and cost-effective high-throughput technological platforms are essential for performing large-scale mutational analysis of genetic markers involved in the aetiology of variable responses to drug therapy. 3. The application of a pharmacogenetics approach to therapeutics in general clinical practice is still far from being achieved today owing to various constraints, such as limited accessibility of technology, inadequate knowledge, ambiguity of the role of variants and ethical concerns. 4. Drug actions are determined by the interplay of several genes encoding different proteins involved in various biochemical pathways. With rapidly emerging SNP discovery technological platforms and widespread knowledge on the role of SNPs in disease susceptibility and variability in drug response, the pharmacogenetics approach to therapeutics is anticipated to take off in the not-too-distant future. This will present profound clinical, economic and social implications for health care.
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We propose an ethical template for pharmacy benefits and a fair process for using it. The template delineates four levels of decisions about pharmacy coverage, connecting ethically acceptable types of rationales for limits with decisions made at each level. It provides a framework for organizing ethically relevant reasons for coverage (or the tiered copayments). The process for using the template assures accountability for the reasonableness of benefit decisions. It requires transparency and relevance of rationales for limit setting and revisability of decisions, including through fair procedures for appeals. The template and the process facilitate broader public learning about fair limit setting.
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Pharmacogenomics applies genomic technology to discover and develop drugs as well as to treat patients more effectively. This article addresses legal questions raised by pharmacogenomics, from drug development to drug use. Part II defines pharmacogenomics in further detail and explains the use of pharmacogenomics in drug development. Part III identifies potential legal questions raised by this approach to drug development and delivery. Parts IV to VIII offer possible solutions to these potential problems, analyzing the law in both the United States and the European Union (EU).
Information about health and disease has high social value and is, thus, subject to a variety of controls. These influence the freedom of investigators to generate it; of editors and publishers to transmit it; and of professionals and the public to have access to it. Unconstrained research may threaten the social order and evoke legal or political limit setting. Prominent in the present era are the possibilities of dangerous ethical and biological consequences of new knowledge or, perhaps more important, of procedures for obtaining it. Medical information is transmitted through both the mass media and professional journals. Access to both by potential authors is limited by institutionalized mechanisms of social control and the academic-research subculture. An emerging factor is the editor's possible ethical responsibility for material which he accepts for publication. Access to information is determined by what finally is published, as well as membership in informal communication networks. It is also influenced by dependence, due to cost, time limitation and information overload, on prepackaged material presented in texts, anthologies, busy clinician-oriented journals, or commercial, e.g., pharmaceutical firms. The possibility that governments will, in time, become the major distributors as well as generators of medical information raises new questions as to its eventual freedom and control.