Search PubMed⌕ Search

SEARCH · Search PubMed

Results for “ETHICS, PHARMACEUTICAL”

Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 1,585 records · Page 88Linked to original sources

The determination of practically useful doses of new drugs: some methodological considerations.

An important aim of Phase 2 clinical trials is the firm determination of the doses and the dose regimes to be used both in later clinical trials and in clinical practice. Comparisons of findings made during clinical development and recommendations contained in the package leaflets of marketed preparations indicate that this objective is rarely achieved. The possible reasons for this difficulty are investigated by reviewing the methodology used in the so-called dose-finding trials performed during drug development. Since the terminology used in this context is frequently misleading, definitions are given and alternative approaches, referring to the direct and indirect methods of bioassay, are suggested. The practical use of these models depends on a number of medical and ethical considerations, on the indications for treatment and on the characteristics of the drug under investigation. Some examples are given, indicating that dose-response relationships can be determined more easily for efficacy, where endpoints more reliably fit commoner distributions, than for tolerability, where the responses frequently follow irregular patterns. This area deserves further investigation to improve the criteria for assessment and to develop adequate statistical methods.

Anti-Bacterial Agents↗

Including the assessment of nontraditional factors in pharmacy school admissions.

OBJECTIVE: To review the relevant literature regarding the predictive ability of cognitive measures (ie, Pharmacy College Admissions Test [PCAT] scores and prepharmacy grade point average [GPA]) on both academic and clinical performance and discuss the inclusion of nontraditional assessment during the admissions process. DATA SOURCES: Articles were identified through searches of International Pharmaceutical Abstracts (1970-April 2004), MEDLINE (1966-January 2004), and ERIC (1966-April 2004) using the key words admissions variables, predictors of success, Pharmacy College Admissions Test, grade point average, cognitive variables, and noncognitive variables. STUDY SELECTION AND DATA EXTRACTION: Cross-sectional, longitudinal, and retrospective studies, as well as reviews, regarding pharmacy school and other higher education admissions' variables were included in this review. DATA SYNTHESIS: Many pharmacy school admissions committees give a majority weight to the traditional cognitive markers of prepharmacy GPA and PCAT scores when selecting viable applicants. Doing so may be problematic due to the magnitude of the relationship between traditional cognitive predictors and pharmacy school performance. CONCLUSIONS: Based on this review, a cogent argument is advanced for the need to examine, in addition to PCAT scores and GPAs, such nontraditional factors as empathy, citizenship, and ethical behavior. This may increase the predictive ability of preadmission factors on pharmacy school didactic and clinical performance. Schools of pharmacy can do this through questionnaires and interviews designed to assess nontraditional variables.

Humans↗

The newborn drug development initiative.

The Best Pharmaceuticals for Children Act (BPCA; Pub L 107-109) was enacted in January 2002 and will sunset in October 2007. The BPCA established processes for studying off-patent and on-patent drugs that are used in pediatric population. Although some drugs have been successfully developed for the neonate (eg, surfactant, nitric oxide), drug development for the youngest, least mature, and most vulnerable pediatric patients is generally lacking. Most drugs are empirically administered to newborns once efficacy has been demonstrated in adults and usefulness is suspected or demonstrated in the older pediatric population. Unfortunately, this process undermines the ability to perform the appropriate studies necessary to demonstrate a drug's short- and long-term safety and efficacy and establish appropriate dosing in neonates. The Newborn Drug Development Initiative Workshop I (held March 29-30, 2004) specifically addressed scientific, clinical, and ethical concerns in the development of trials of pediatric therapeutic agents for neonates. Implementation of the BPCA for all pediatric populations will foster collaboration among federal agencies and academic institutions on scientific investigation, clinical-study design, and consideration of the weight of evidence and address ethical issues related to the performance of drug studies.

Biomedical Research↗

Conflict of interest as seen from a researcher's perspective.

The continuous growth of the pharmaceutical industry is expected to require a considerable output of new drugs, with speedy development and approval processes. This profit-driven expansion of the drug market may broaden the already established erosion of the role of academia in favor of commercial clinical research organizations. Less and less control on the clinical trial design, its conduct and the resulting publication[s] is the likely consequence. Academic medicine and governments should find means to sustain the development of independent clinical research.

Clinical Trials as Topic↗

What is the pharmaceutical industry doing, and what does the pharmaceutical industry want from animal science departments?

Perceived contemporary issues are 1) food safety and food healthfulness, 2) environment, 3) sustainability, 4) biotechnology, 5) animal well-being, 6) animals as food, and 7) research funding. Food safety is the paramount contemporary issue, and environment and sustainability issues can be considered as a single issue. Biotechnology, animal well-being, and animals as food are addressed in this paper as separate issues, but they can be considered as components of food safety and healthfulness. The pharmaceutical industry addresses these issues by providing safe and effective products to the livestock industry. These products are used to treat and prevent disease and to increase livestock production efficiency. These products contribute to a safe food supply, enhance protection of the environment, and increase the sustainability of animal agriculture through increased efficiency of livestock production. The pharmaceutical industry wants the following from animal science departments: 1) students skilled in deductive and inductive thinking and communicating to peers and the public; 2) regional research on food safety, such as irradiation, steaming of carcasses, E. coli contamination, antibiotic resistance, production facilities, and carcass contamination; 3) improved research to identify the food values of animal products and effective communication of that research to the public; 4) research on topics having the greatest potential to increase efficiency of animal production consistent with a positive impact on the environment and sustainability of animal production; 5) leadership in developing and using technologies such as biotechnology, not only as descriptors of biological processes, but as technologies to test hypotheses leading to new understandings of biology; 6) research on animal well-being and production facilities that foster animal well-being; 7) research and education on ethical and moral aspects of animals as food through encouragement of one or more staff members to become effective animal science department spokespersons; and 8) active participation in activities such as FAIR 95, Federation of Animal Science Societies, and multidepartmental and(or) interdisciplinary programs.

Animal Husbandry↗

Doping control from a global and national perspective.

The practice of enhancing athletic performance through foreign substances was known from the earliest Olympic games. In 1967, the International Olympic Committee (IOC) established a Medical Commission responsible for developing a list of prohibited substances and methods. Drug tests were first introduced at the Olympic winter games in Grenoble and at the summer games in Mexico City in 1968. In February 1999, the IOC convened the World Conference on Doping in Sport in Lausanne, Switzerland. The Lausanne Declaration on Doping in Sport recommended creation of an International Anti-Doping Agency. The World Anti-Doping Agency (WADA) was formed in Lausanne, Switzerland on the basis of equal representation from the Olympic movement and public authorities. One of the mandates of WADA was to harmonize the Olympic antidoping code and develop a single code applicable and acceptable for all stakeholders. The world antidoping code developed by WADA included creation of several international standards (IS). The purpose of each IS was harmonization among antidoping organizations. The ISs were developed for laboratories, testing, the prohibited list, and for therapeutic use exemptions (TUE). The objective of this manuscript is to present a brief history of doping in sport and describe creation of WADA in 1999. The components of the World Anti-Doping code (in particular, the Therapeutic Use Exclusion program or TUE) is described. The WADA code defines a TUE as "permission to use, for therapeutic purposes, a drug or drugs which are otherwise prohibited in sporting competition." Experiences of the Canadian Centre for Ethics in Sport Doping Control Review Board are presented because this national TUE committee has been operational for over 12 years. The challenge of developing a rigorous global antidoping program requires acceptance of doping as a problem by sport organizations, athletes, and public authorities. Individual stakeholders must be prepared to preserve the values of sport, which means free from doping. This will require vigilance by all interested parties for the benefit of elite athletes and society overall.

Canada↗

A critique of emerging European legislation in the pharmaceutical industry: a clinical trials analysis.

The objective of this paper is to critique emerging legislation in the pharmaceutical industry, focusing on the clinical trials sector. Possible changes are identified and discussed inrelation to their impact on phase I clinical trials conducted in the UK. It is concluded that smaller contract research organisations, which have benefited in the past from European Union legislative variation, may have resource problems in trying to cope with the changing business environment created through legislative harmonization. These SMEs must use this opportunity to seek clinical trials research partnerships in a new harmonized EU market.

Clinical Trials as Topic↗

Participation of women in clinical trials of drug therapies: a context for the controversies.

Women's participation in clinical trials, particularly those involving drugs, has been said to be both overrepresented and underrepresented. How can this be? Studies of participation are compared and contrasted to elucidate some reasons for this contradiction. The history of women's participation in clinical trials is chronicled through policies and regulations filled with restrictions. Since 1993, however, the National Institutes of Health has mandated, and the Food and Drug Administration has emphasized, inclusion of women in clinical trials, only to be thwarted by other regulations excluding many women. Gender-specific analyses are required to detect gender differences in effects of pharmaceutical and nonpharmaceutical interventions, but they are seldom performed. The exclusion of women from clinical trials means that women's healthcare is compromised by lack of sex-specific information about dosing of drugs and unique uses of drugs. A database, although currently quite limited, tracks the participation of women in clinical trials funded by federal agencies, industries, and nonprofit groups. Federal regulations have recently changed. Additional changes in access to all phases of clinical trials and enhanced monitoring of clinical trials are recommended.

Clinical Trials as Topic↗

Physicians and the pharmaceutical industry: a growing embarrassment and liability.

The pharmaceutical industry, comprising corporate-owned, for-profit enterprises, employs nearly one sales representative with a budget of about $100,000 for each 11 practicing physicians. Physician contact with these individuals, epitomized by the drug company "free lunch," results in non-rational prescribing and increases the overall cost of prescription medication to patients. Other influential methods employed by the industry include sponsorship of tainted journal articles, restrictions on research, and biased continuing medical education. Physicians are often unaware of their vulnerability to these tactics. Remedies are suggested.

Drug Industry↗

A survey of consumer attitudes to the supply and use of human hepatocytes in the United Kingdom.

Human hepatocytes are the model of choice for pharmacotoxicological studies, but their acquisition is often problematic due to ethical and logistical difficulties. The UK Human Tissue Bank is a not-for-profit organisation that acquires and processes human tissue, with a specialist interest in the isolation of human hepatocytes. A recent in-house survey of the processing of liver tissue over 1 year revealed that freshly isolated hepatocytes were underutilised due to mismatched consumer demand, despite the published need for them. We present the results of a telephone survey to investigate the reasons behind this paradox. This survey highlighted some problem areas, including "out of hours" availability of cells and personnel difficulties, but overall, demonstrated the value of such a service, with numerous researchers taking advantage of available good quality human hepatocytes. Although further work is required in optimising long-term storage protocols through cryopreservation, we have demonstrated that tissue handling of this type can be successful and beneficial to the pharmaceutical and biotechnology industries.

Consumer Behavior↗

The distribution of biomedical research resources and international justice.

According to some estimates, less than 10% of the world's biomedical research funds are dedicated to addressing problems that are responsible for 90% of the world's burden of disease. This paper explains why this disparity exists and what should be done about it. It argues that the disparity exists because: 1) multinational pharmaceutical and biotechnology companies do not regard research and development investments on the health problems of developing nations to be economically lucrative; and 2) governmental agencies that sponsor biomedical research face little political pressure to allocate funds for the problems of developing nations. This paper argues that developed nations have an obligation to address disparities related to biomedical research funding. To facilitate this effort, developed countries should establish a trust fund dedicated to research on the health problems of developing nations similar to the Global AIDS Fund.

Biomedical Research↗

[History of professionalization of modern clinical pharmacist (1): pharmaceutical practices in hospice before the French Revolution].

The times around the French Revolution, as E. H. Ackerknecht pointed out, were especially epochmaking in that "the clinical medicine" or 'medicine in the hospital' was born and bred through the days by discarding the medicine of court physicians and the metaphysical medicine that had been dominant for centuries until then. This change is, therefore, very important from the viewpoints of sociopolitical, cultural and medical histories. The medicine practised and taught mainly in Paris in those days based politically on the newborn nationalistic centralization; technically on pathologicoanatomy and biostatistics; and conceptually on the modern medical epistemologoy that made it possible to abstract and see a 'disease' from the sick by observation, description and classification of their common signs and symptoms, and then to ignore a suffering specific to each individual patient instead. Thus those who could believe in the être (entity) of a 'disease' the clinical medicine made it 'visible' were trained for medical professionals such as modern physicians, surgeons and clinical pharmacists, which finally realized the professional monopolization of the medicine. The aim of this paper is to report and analyze the historical process how there came out the modern clinical pharmacist who was permitted by the nation as the only occupation to deal in ethical drugs in the hospital, while excluding many other people who had been treating 'traditional medicines' from the modern pharmacies of hospitals.

Clinical Medicine↗

Personal use of drug samples by physicians and office staff.

CONTEXT: Pharmaceutical samples are commonly used in ambulatory care settings. There is limited research on their use or impact on health care providers and patients. OBJECTIVE: To determine the extent of personal use of drug samples over a 1-year period by physicians and medical office staff. DESIGN, SUBJECTS, AND SETTING: An anonymous cross-sectional survey of all physicians, resident physicians, nursing staff, and office staff in a family practice residency. MAIN OUTCOME MEASURE: Quantity of drug samples taken for personal or family use. RESULTS: Of 55 surveys issued, 53 (96%) were returned. A total of 230 separate drug samples were reported taken in amounts ranging from 1 dose to greater than 1 month's supply. Two respondents reported no use of drug samples, while 4 respondents reported taking more than 10 different samples. CONCLUSION: Drug samples are commonly taken by physicians and office staff for personal and family use. The ethical implications of this practice warrant further discussion.

Advertising↗

Ethical, social and legal implications of pharmacogenomics: a critical review.

OBJECTIVE: My aim was to examine the ethical, social and legal implications of pharmacogenomics. METHODS: I performed a critical review of the literature. The primary focal point is the bioethical principle discussed. The second outcome measure is the perspective of the discussion. RESULTS: This review documents that the pharmacogenomics issues of concern are comparable to issues concerning other genetic developments in general. However, two main issues are particular to the case of pharmacogenomics. Firstly, this review reveals that society, industry, groups and individuals appreciate the prospect of pharmacogenomics very differently. Secondly, there is a lack of research into the post-marketing implications of pharmacogenomics. CONCLUSION: An extensive focus on the ethical, social and legal implications of pharmacogenomics, in terms of both pre- as well as post-marketing issues, is essential. Also, a multidisciplinary approach which includes individual and group opinions in an upfront manner in the research and development process is essential. Otherwise, there is a substantial risk that the positive prospects of pharmacogenomics will not survive due to fear and a lack of acceptance and understanding on the part of the general public.

Attitude↗

Selecting participants when testing new drugs: the implications of age and gender discrimination.

Pharmaceutical products are rigorously tested for safety and efficacy prior to being licensed for use. During this testing process the archetypal research subject is a young male; women and older people are less frequently invited to participate. This is especially true at the early stages, but can also occur in the later phases of drug testing. This paper considers the reasons for the relative under-representation of these groups, and the legal implications of failing to include as research subjects the very types of people who will ultimately consume these drugs.

Age Factors↗

Clinical trials in pediatrics: The drug delivery dimension.

The medical and drug delivery devices needs of children are quite different and unique when compared to that of adults. The practice of off label use and modification of adult devices for pediatric use is widespread. Attendant risk and adverse effects of such practices are poorly documented. Lack of pediatric age appropriate drug formulations constitutes a major impediment to pediatric drug labeling. While novel drug delivery system can help circumvent some of the pediatric formulations issues, the inherent high cost of development, the small size of the pediatric market, and the ethical dilemma of enrolling children in non-therapeutic clinical trials continue to militate against pediatric drug labeling as well medical devices development. Over the past four decades, major breakthroughs and achievements in basic biomedical science have supplied unprecedented potential information for improving human health. The need for properly designed and conducted pediatric clinical trials along with new drug delivery devices has never been greater. However major issues, like slow transition of promising basic scientific discovery into clinical applications, heavy regulatory burden, limited pediatric pharmacology research infrastructure, spiraling costs of health care, disproportionate governmental funding of basic science research over clinical research, conflicts of interest, and shortage of properly trained clinical investigators and willing study subjects continue to constitute major impediments to pediatric clinical trials clinical trials. This paper will seek to review among other things, the current state of affairs and the structure of the pediatric academic research enterprise along with their relationship with the pharmaceutical industry. Impediments to successful implementation of clinical trials in the academic setting will also be closely examined.

Child↗

Research influence on antimalarial drug policy change in Tanzania: case study of replacing chloroquine with sulfadoxine-pyrimethamine as the first-line drug.

INTRODUCTION: Research is an essential tool in facing the challenges of scaling up interventions and improving access to services. As in many other countries, the translation of research evidence into drug policy action in Tanzania is often constrained by poor communication between researchers and policy decision-makers, individual perceptions or attitudes towards the drug and hesitation by some policy decision-makers to approve change when they anticipate possible undesirable repercussions should the policy change as proposed. Internationally, literature on the role of researchers on national antimalarial drug policy change is limited. OBJECTIVES: To describe the (a) role of researchers in producing evidence that influenced the Tanzanian government replace chloroquine (CQ) with sulfadoxine-pyrimethamine (SP) as the first-line drug and the challenges faced in convincing policy-makers, general practitioners, pharmaceutical industry and the general public on the need for change (b) challenges ahead before a new drug combination treatment policy is introduced in Tanzania. METHODS: In-depth interviews were held with national-level policy-makers, malaria control programme managers, pharmaceutical officers, general medical practitioners, medical research library and publications officers, university academicians, heads of medical research institutions and district and regional medical officers. Additional data were obtained through a review of malaria drug policy documents and participant observations were also done. RESULTS: In year 2001, the Tanzanian Government officially changed its malaria treatment policy guidelines whereby CQ--the first-line drug for a long time was replaced with SP. This policy decision was supported by research evidence indicating parasite resistance to CQ and clinical CQ treatment failure rates to have reached intolerable levels as compared to SP and amodiaquine (AQ). Research also indicated that since SP was also facing rising resistance trend, the need for a more effective drug was indispensable but for an interim 5-10 year period it was justifiable to recommend SP that was relatively more cost-effective than CQ and AQ. The government launched the policy change considering that studies (ethically approved by the Ministry of Health) on therapeutic efficacy and cost-effectiveness of artemisinin drug combination therapies were underway. Nevertheless, the process of communicating research results and recommendations to policy-making authorities involved critical debates between policy makers and researchers, among the researchers themselves and between the researchers and general practitioners, the speculative media reports on SP side-effects and reservations by the general public concerning the rationale for policy change, when to change, and to which drug of choice. CONCLUSION: Changing national drug policy will remain a sensitive issue that cannot be done overnight. However, to ensure that research findings are recognised and the recommendations emanating from such findings are effectively utilized, a systematic involvement of all the key stakeholders (including policy-makers, drug manufacturers, media, practitioners and the general public) at all stages of research is crucial. It also matters how and when research information is communicated to the stakeholders. Professional organizations such as the East African Network on Malaria Treatment have potential to bring together malaria researchers, policy-makers and other stakeholders in the research-to-drug policy change interface.

Animals↗

Treatment of epilepsy: existing therapies and future developments.

Epilepsy is a major public health issue, not least because of the aging population in many developed nations and the known increase in the frequency of epilepsy and seizures in later life. Despite the massive scale of the problem and much research, epilepsy remains poorly understood. Despite more than 20 approved drugs in the developed nations and several non-pharmacological options, up to 30% of patients are still refractory to treatment. Despite over a century of pharmacotherapy and neuroscience research, rational design of anti-epileptic drugs (AEDs) is only now starting to yield results, because of the heterogeneity of the disease and our still limited understanding of it. Discovery and development of AEDs has been especially difficult, because of the regulatory issues of satisfactorily proving safety and efficacy, ethical constraints on placebo-controlled trial designs, the fact that seizures are typically widely spaced in time, and the fact that the person undergoing the seizure is typically in no state to remember, let alone assess, what happened. Several non-pharmacological therapies have been developed: brain surgery was first used more than a century ago; the ketogenic diet was first developed 80 years ago; and the vagus nerve stimulator was introduced recently. Pharmacotherapy remains the mainstay of treatment and is effective in most patients. AEDs can be roughly divided according to their time on the market. The first generation extends from the bromides and the barbiturates (the first of which was phenobarbital), to sodium valproate and carbamazepine. The second generation begins with felbamate and includes drugs approved from 1993 to 2000. "Next generation" drugs are still in clinical development and may reach the marketplace in the near future. Intensive research is being conducted both by pharmaceutical and biotech companies and by academic scientists and clinicians; our understanding of the condition is advancing rapidly but many challenges remain in discovering and developing better AEDs.

Animals↗