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Lords reject legalisation of euthanasia.
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Experiment Perilous: forty-five years as a participant observer of patient-oriented clinical research.
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Digital twins in precision pharmacotherapy: emerging applications, challenges, and future directions.
Digital twin technology, defined as dynamic digital models that represent individual patients, is emerging as a promising paradigm in precision pharmacotherapy. The integration of pharmacokinetic and pharmacodynamic (PK/PD) modeling, clinical data, genomic information, and real-time patient monitoring enables digital twins to shift drug therapy away from population-based averages toward individualized, adaptive decisions. This narrative review explores conceptual frameworks, emerging applications, methodological approaches, clinical value, limitations, and future directions of digital twins in pharmacotherapy, with particular emphasis on the role of clinical pharmacists. Unlike broader digital twin reviews that primarily emphasize technical architectures, disease-specific applications, or pharmaceutical research and development, this review focuses on the clinical-pharmacy translation layer: how digital twin outputs can be interpreted, validated, communicated, and converted into actionable medication decisions at the bedside and across ambulatory care settings. Key applications include precision dosing, polypharmacy management, antimicrobial stewardship, and the optimization of complex therapies, alongside important ethical, regulatory, and implementation challenges.
An appraisal of the ethical issues involved in high-technology cancer pain relief.
... We will turn our attention to the current state of pain relief technology and the ethical questions surrounding the use of advanced technology, otherwise referred to as "high-tech," pain relief. It is obvious that pain may decrease the quality of life for cancer patients. The availability of long-acting narcotics, such as MS Contin or methadone, affords cancer patients long-duration pain relief at minimal cost. The use of adjuvant medications may also be important. Clinical examples of the effective use of adjuvant medications include the addition of a nonsteroidal, anti-inflammatory agent to help patients cope with bone pain and the use of a serotonin blocking agent to reduce the transmission of pain impulses in the spinal cord. Only a small percentage of patients are good candidates for high-tech delivery systems for narcotic administration. In our pain management clinic, all patients are initially placed on oral medications. When the side effects of oral medications become excessive, or the patient becomes unable to take oral medications, high-tech modalities are considered for use.
The concept of the IRB and bureaucratic reality: an exchange of letters.
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FDA's new rule on treatment use and sale of investigational new drugs.
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Proposal for a good clinical practice directive.
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University physician-researcher conflicts of interest: the inadequacy of current controls and proposed reform.
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Ethical issues and legalizing physician-assisted suicide.
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[Pharmacology in critical illness].
Patients suffering from critical illnesses like cardiac arrest with resuscitation and hypovolemic shock often are in need of medication. Under these conditions pharmacokinetics and pharmacodynamics can be markedly altered. In this paper the results of our experimental work in animals on the pharmacology during resuscitation and hypovolemia is discussed. The data show that during cardiopulmonary resuscitation in the dog the kinetics of epinephrine are changed. The administration of the calcium antagonist nimodipine does not result in a cerebroprotective action in a cardiopulmonary arrest model in the rat. The pharmacokinetics and pharmacodynamics of the anesthetics etomidate and propofol were studied in a model of hemorrhagic hypovolemia in the rat. Changes in plasma concentrations as well as in brain sensitivity occur. It is concluded that animal experiments highlight changes in the action of drugs during critical conditions. Such information can be helpful in view of the practical and ethical problems related to the study of the action of drugs in critically ill patients.
Direct-to-consumer advertisements of prescription drugs.
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Medical students' attitudes toward pharmaceutical marketing: possibilities for change.
BACKGROUND: Concerns have been expressed about physicians' acceptance of gifts from pharmaceutical companies, but few studies have examined or attempted to change medical students' attitudes about accepting such gifts. METHODS: We used a questionnaire survey to measure attitudes about accepting such gifts. We then carried out a field experiment to compare changes in second-year medical students' attitudes, seven weeks after a one-hour lecture and discussion about the appropriateness of pharmaceutical gifts, to changes in first-year students who were not exposed to the program. RESULTS: Following the intervention, second-year students became less accepting of these marketing practices; first-year students showed no significant change. The difference between the groups after the intervention was statistically significant (P < .0001). CONCLUSIONS: If medical students' attitudes about accepting gifts from pharmaceutical companies need to be changed, this study suggests that the process may be fostered with little investment of curricular time.
Policy makers ignoring science and scientists ignoring policy: the medical ethical challenges of heroin treatment.
A decade of research in Switzerland, The Netherlands, Germany, and Spain now constitutes a massive body of work supporting the use of heroin treatment for the most difficult patients addicted to opiates. These trials concur on this method's safety and efficacy and are now serving as a prelude to the institution of heroin treatment in clinical practice throughout Europe. While the different sampling and research protocols for heroin treatment in these studies were important to the academic claims about specific results and conclusions that could be drawn from each study, the overall outcomes were quite clear--and uniformly positive. They all find that the use of prescribed pharmaceutical heroin does exactly what it is intended to do: it reaches a treatment refractory group of addicts by engaging them in a positive healthcare relationship with a physician, it reduces their criminal activity, improves their health status, and increases their social tenure through more stable housing, employment, and contact with family. The Canadian trial (NAOMI), now underway for over a year, but not yet completed, now faces a dilemma about what to do with its patients who have successfully completed 12 months of heroin and must be withdrawn from heroin and transferred to other treatments in accordance with the research protocol approved by Government of Canada, federal granting body and host institutions. The problem is that the principal criterion for acceptance to NAOMI was their history of repeated failure in these very same treatment programs to which they will now be referred. The existence of the results from abroad (some of which were not yet available when NAOMI was designed and initiated) now raises a very important question for Canada: is it ethical to continue to prohibit the medical use of heroin treatment that has already been shown to be feasible and effective in numerous medical studies throughout the world? And while this is being worked out, is it acceptable to require patients who have been successfully treated with heroin in Canada, to be forced to move back to less effective treatments (treatments that failed to be efficacious in the past)? This essay discusses this dilemma and places it in the broader context of ethics, science, and health policy. It makes the case for continuation of the current successful patients in heroin treatment and the institution of heroin treatment to all Canadian patients living with active addictions who qualify.
Multiple micronutrient deficiencies: future research needs.
There has been a rising current of calls for a moratorium on international nutritional research in favor of an investment in intervention programs, per se. The topic of multiple-micronutrient supplementation reviewed at the International Workshop on Multi-Micronutrient Deficiency Control in the Life Cycle (May 30-June 1, 2001) has confirmed once again, however, the intimate interaction between program development and a supporting agenda of applied research. The areas of research required to produce successful intervention programs include biologic availability, safety and efficacy, communications and behavior, effectiveness, cost-effectiveness (efficiency), and food and pharmaceutical technology. Attention to safety and surveillance for unintended adverse effects has acquired new relevance as we analyze the multi-center International Research on Infant Supplementation (IRIS) I studies. All professionals involved in research projects in this area must assure both the quality and reliability of investigations and adhere to the highest principles of ethical conduct of research in human studies. The fundamental principles of research design and hypothesis development, quality assurance, reliability of measurements, and sound and unbiased interpretation of findings apply to all experimental science, and must be guaranteed for this mission. Agencies, academic institutions, and industry alike must work to create a system in which researchers can uphold these standards, and realize at the same time that the area of multi-micronutrient supplementation in developing countries can be a fertile area for training future researchers.
Sewage sludge--looking upstream: the precautionary principle.
The health care industry makes a unique contribution to the potential public health and environmental impacts of sewage sludge production and disposal. As materials flow into and out of health care facilities, potentially hazardous substances, like mercury, solvents, and pharmaceutical compounds, are introduced into the waste stream and ultimately into sewage sludge. Although the hazards posed by these practices are often not fully understood or the risks quantified, concern about impacts on public health and the environment is fully justified. How to deal with the uncertainties surrounding the impacts of these practices becomes an ethical as well as a scientific question. A precautionary approach to materials manufacture, use, and disposal encourages us to look upstream and to re-design products and systems in ways that primarily prevent problems rather than dealing with them at the "end of the pipe." Early warning systems, shifting the burden of proof, alternatives assessment, and monitoring programs are suggested as interventions that might be used as part of a precautionary approach to addressing the generation and disposal of sewage in an industrial society.
Pre-marketing authorisation submission assessments in Europe.
The publication of the European Directive 2001/20/EC on the implementation of good clinical practice in trials has far-reaching consequences on the type of data to be submitted for evaluation by the competent authorities and ethics committees, in order to initiate a clinical trial with one or more site(s) in Europe. The ensuing commission guidelines and guidance provided by Member States at the time of national implementation describe the content of an application for a 'clinical trial authorisation' and its maintenance. This review discusses some of the implications for pharmaceutical companies submitting requests for clinical trial authorisations.
Medicine, the media and monetary interests: the need for transparency and professionalism.
Emerging evidence suggests that media coverage of medicine is increasingly promotional in nature. Recent Australian examples include misleading newspaper articles on an experimental cancer vaccine and a high profile television current affairs segment on a new influenza drug, which failed to disclose the industry ties of a key expert featured in the report. There are widening concerns that this problem in medical journalism may be exacerbated by the growing commercialisation of medical and scientific research, and the increasing ties between researchers, doctors and pharmaceutical or biotechnology companies. Closer links between industry and medicine are being explicitly encouraged both in academia and the health care sector for the mutual benefits they bring. However, these partnerships are the cause of growing unease within medicine. In the United States, rigorous legislation governing research protocols is being proposed, and in Australia new ethical guidelines covering industry-profession relationships are being promulgated. If one of the media's roles is informing the community about the business of health and medicine in a fair and accurate way, a cultural change in medical journalism is required.