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At least 1,531 records · Page 85Linked to original sources
PubMed1997

Changing patterns of pharmaceutical practice in the United States.

In the United States, contradictions related to medicine use abound in a social environment in which the pursuit of health has become a cultural project. In a marketplace where over half a million health products are available, choices at once seem to foster agency and encourage dependency on medical fixes. The aggressive marketing of medicines as indispensable commodities co-exits with rising concerns among the lay population about what is safe in the short- and long-term. In this paper we broadly consider medication-related practice in the United States as it is affected by social, cultural, and political-economic factors. We direct attention to changes in medicine use related to product proliferation, lowered thresholds of discomfort, the economics of health care, and a revival of the self-help ethic. We also consider the manner in which the demand for and use of medications reflect deeply embedded cultural ideals and emergent perceptions of need. We juxtapose two trends in American thinking about medicines: (1) the perception that "more is better," associated with cultural impatience with illness; and (2) a growing doubt about medicine necessity, safety, and efficacy.

Attitude to Health↗
PubMedDate not supplied

Current plasmapheresis practice in the United States.

The principal differences of the USA plasmapheresis collection system from most other countries are: it is conducted by the pharmaceutical industry rather than government, it uses remunerated donors, and it draws a larger volume of plasma than is permitted elsewhere. The implications of these features are reviewed in terms of the effects on donors and the effects on the plasma supply. Protein metabolism is reviewed, and the effects of plasmapheresis on overall nitrogen balance are presented.

Adult↗
PubMed2003

Methodological issues and controversies in clinical trials with child and adolescent patients with bipolar disorder: report of a consensus conference.

OBJECTIVE: To achieve consensus among researchers, pharmaceutical industry representatives, federal regulatory agency staff, and family advocates on a template for clinical trials of acute mania/bipolar disorder in children and adolescents. METHOD: The American Academy of Child and Adolescent Psychiatry, in collaboration with Best Practice, convened a group of experts from the key stakeholder communities (including adult psychiatrists with expertise in bipolar disorder) and assigned them to workgroups to examine core methodological issues surrounding the design of clinical trials and, ultimately, to generate a consensus statement encompassing: (1) inclusion/exclusion criteria, (2) investigator training needs and site selection, (3) assessment and outcome measures, (4) protocol design and ethical issues unique to trials involving children/adolescents, and (5) regulatory agency perspectives on these deliberations. RESULTS: Conference participants reached agreement on 18 broad methodological questions. Key points of consensus were to assign priority to placebo-controlled studies of acute manic episodes in children and adolescents aged 10-17 years, who may or may not be hospitalized, and who may or may not suffer from common comorbid psychiatric disorders; to require that specialist diagnostic "gatekeepers" screen youths' eligibility to participate in trials; to monitor interviewer and rater competency over the course of the trial using agreed upon standards; and to develop new tools for assessment, including scales to measure aggression/rage and cognitive function, while using the best available instruments (e.g., Young Mania Rating Scale) in the interim. CONCLUSIONS: Methodologically rigorous, large-scale clinical trials of treatment of acute mania are urgently needed to provide information regarding the safety and efficacy, in youth, of diverse agents with potential mood-stabilizing properties.

Adolescent↗
PubMed2003

Pharmaceutical industry's barriers and preferences to conduct clinical drug trials in Finland: a qualitative study.

The objectives of our study were to explore the barriers, preferences and attitudes of the pharmaceutical industry towards conducting clinical trials in Finland. In-depth semi-structured interviews were conducted with 18 representatives of the pharmaceutical industry with different amounts of experience of clinical trials. The interviews were audiotaped, transcribed verbatim and analysed qualitatively. Overall, the respondents had a positive attitude towards conducting clinical trials in Finland. The major barriers seemed to occur at the beginning of the trial and mostly consisted of bureaucratic obstacles. The informants hoped for a more positive attitude of the public sector, more flexibility in hospitals and professionalism in practical implementation, e.g. having special research centres or site management services. The most dismotivating factors were the high costs and the constraints imposed by bureaucracy. The variety in practices of local ethics committees was considered problematic, and the need for common standard operating procedures was pointed out. The smallest barriers were encountered in subject recruitment by the investigators and their clinical work, documentation, investigational product logistics and communication with the regulatory authorities. The quality, know-how and reliability of the study personnel, the tightening of time lines in general, an investigator register/pool and collaboration with media in disseminating information about clinical trials to the general public were reported as the most appealing factors. Training in GCP, mainly incorporated in the medical education programme, and a certificate or equivalent were generally considered necessary, though a voluntary system was preferred. The barriers and preferences pointed out suggest various improvements and ways to produce high-quality, GCP-compliant clinical drug research and to ensure the availability of sufficient conditions to carry out clinical trials also in the future.

Attitude of Health Personnel↗
PubMed1998

International collaborative calibration of a preparation of equine chorionic gonadotrophin (eCG NZY-01) proposed as a new standard.

A batch of partially purified equine chorionic gonadotrophin (eCG NZY-01) was freeze-dried in vials of 500 iu and characterized in a large number of in vivo and in vitro assays. These assays were performed in eight laboratories in seven countries (Argentina, Belgium, England, France, Germany, Holland and USA). Four of these laboratories were in universities or government research organizations and four were those of pharmaceutical companies. Good correlation between in vivo and in vitro assays was found for unknown samples and for commercial preparations from different sources when performed against eCG NZY-01 as the standard. This result suggests that, in contrast to the WHO IRP2 international standard, the eCG NZY-01 preparation contains all eCG isoforms in proportions roughly similar to those found in serum and commercial preparations. The consistency of the data when using eCG NZY-01 as the reference in all types of in vivo and in vitro assays validates the wide use of in vitro assays which are cheaper, quicker and ethically preferable to in vivo assays. Vials of 500 iu eCG NZY-01 are available to researchers and manufacturers.

Animals↗
PubMed2005

[Drug therapy and pharmacogenomics--hopes and facts].

Recent achievements in molecular genetics, in particular the characterization of a large number of non-synonymous single-nucleotide polymorphisms (ns-SNPs) have led to a substantial accumulation of knowledge about the mechanisms of interindividual variability in drug response. The concept of elucidating drug reactions by genetic analysis is termed "pharmacogenomics". Pharmacogenomics is set to provide a relevant contribution to our understanding of adverse drug reactions and non-responsiveness to drug therapy and may help realize the vision of providing individualized therapies. The greatest challenges for the field of pharmacogenomics relate to the issues of genotype-phenotype- and genotype-environment- interactions, optimal selection of study designs, predictivity and ethical aspects. Although its current impact on the routine of medicine is minimal, it is likely that pharmacogenomics will provide important contributions to the practice of drug therapy. Pharmacogenetic concepts may prove important for approximately 20% of therapeutic drugs.

Adult↗
PubMed2005

Gene therapy bio-safety: scientific and regulatory issues.

We report here the topics discussed during the round table of the 2nd European Conference & Practical Course: Towards Clinical Gene Therapy: Preclinical Gene Transfer Assessment, held in Bellaterra (Spain), 1-14 February, 2004. First, how to predict the risk of pathologies generated by changes of the gene expression after proviral genome integration. In the light of the scientific information that emerged after the SAEs occurred in three X-SCID patients treated in France, (a) it is necessary to take into the account the dose of vector used in transduction protocols, in order to minimize the risk to target potentially pathogenic loci. Namely, low vector doses are recommended to minimize the number of vector genomes inserted per cell. (b) The potency of vector elements (ie promoter and transgene), in terms of activation of undesired cell function(s), should be elucidated to devise safe transduction protocols. (c) Target cells should be better characterized before and after transduction to avoid reinfusion into patients' cells, with proviral integration that may be pathogenic. (d) The possibility of replacing onco-retroviruses with other vector systems should be envisaged, for example, nonintegrative gene correction strategies. Second, adequate animal models are required in preclinical experimentation before going to clinics. Although animal models are not yet predictive for risk assessment of proviral insertion, they allow validation of the proof of principle of gene therapy strategies and pharmacological characterization of gene transfer products. Third, a dialogue between researchers and members of regulatory agencies is necessary to implement the regulatory frame where gene therapy products are to be used as new bio-pharmaceuticals. This will implement the whole gene therapy process development at both preclinic (research, development and clinical designs) and postclinic (follow-up of patients) stages. Hence, a European cooperation between professionals (researchers, physicians, industries, patients' associations, investors, etc) will allow implementation of gene therapy regulation in Eastern European countries.

Animals↗
PubMed2001

A review of data on the health sector of the United States. May 2001.

This report presents data on the state of U.S. health care in early 2001. It provides information on the numbers of uninsured and underinsured and their difficulties in obtaining health care; the increasing costs of care; and medical, social, and economic inequalities. Data are presented on the state of the nations' health maintenance organizations (including Medicare HMOs), pharmaceutical industry, and hospital industry, and on the role of these industries' money in U.S. politics. The author also looks at some proposals on the Congressional agenda, and gives a summary of some reasons why tax credits won't work. Also provided is some recent information on the status of health care and health care systems elsewhere in the world.

Delivery of Health Care↗
PubMedDate not supplied

Between two cultures: the expert clinician and the pharmaceutical industry.

Expert clinicians, valued for their academic status and independence, are used by the pharmaceutical industry for advice, for contract research, and as a means of conveying their message to other clinicians. Both academics and industry depend upon this interaction, but there is a fundamental clash of cultures at the interface between the two. Independence cannot be marketed for a fee, opinion too easily shades into advocacy, and secrecy and science do not mix. Formal guidelines and declarations of interest are inadequate as a means of policing an interface where undisclosed amounts of money change hands so freely. In the absence of effective sanctions, each of us must seek a personal solution to the professional and ethical issues involved.

Conflict of Interest↗
PubMed2005

Administrative and research policies required to bring cellular therapies from the research laboratory to the patient's bedside.

The research process is a balance between the inherent risks of new discoveries and the risks of research participant safety. Conflicts of interest, inherent to the research process, as well as those introduced by emerging cellular therapies, have the potential to compromise safety. The relationship of trust between the researcher and the clinical trial participant facilitates objective decision making, in the best interest of both parties. In the setup of each clinical trial, investigators incorporate ethical, political, legal, financial, and regulatory considerations as protocols are established. Responsibility to abide by these decisions ensures a systematic process and safeguards participants in this process. The integrity of the research process is strengthened by identifying potential conflicting issues with the guiding principles established in the protocols, which may threaten the objectivity of involved parties and jeopardize safety of the participants. The rapid pace and changing paradigms of new discoveries in cellular therapies exaggerate existing conflicts and introduce new ones. Ethical issues raised by emerging cellular therapies include the division of opinions regarding the use of embryonic and fetal tissue to develop stem cell lines for research, the individual versus professional conscience of a researcher, overselling of outcomes as a result of the researcher's desire to be the first to discover a cellular therapy, and therapeutic misconception resulting from a participant's desire for a miracle cure. The basic ethical issue of whether stem cells should be utilized as a cellular therapy raises heated debates because some believe that it is not acceptable to use fetal material as a source of research material for future cures and others feel equally as strong that inaction is unethical because it results in needless suffering and death owing to the absence of this research. Political issues include the divergent position statements of presidential administrations on cellular therapy, variations in individual state laws, and states becoming involved in research funding, such as California's Proposition 71. Legal concerns include expanding private litigation with diversity of lawsuits, expanding lists of defendants, and the use of class-action lawsuits in research cases. Ownership issues also arise in terms of intellectual property, patents, and ownership of stem cells collected from minors, as in umbilical cord blood donations. Situations that challenge the regulatory processes established to ensure participant safety include differences in reporting requirements for private- and public-funded research and the lack of adequate funding and resources to implement and support the institutional review board (IRB) process. Financial considerations influence the development of clinical protocols, because funding is often limited. Financial incentives, personal investment in companies funding research activities, and fundraising pressures may present potential conflicts. In addition, the increasing role of emerging biotechnology start-up companies and pharmaceutical companies in clinical research introduces additional financial considerations. Administrative policies are needed to address these possible conflicts and ensure research participant safety as cellular therapies progress from the research laboratories to the patient's bedside. Administrative policies to ensure minimum standards of quality for emerging products before human clinical trials, policies to enforce consistent reporting requirements for private and public cellular research, policies to minimize financial conflicts of interest, policies to strengthen implementation of the existing IRB process and to structure into the process a consistent, systematic review of these identified conflicts, and policies to limit private litigation will help to preserve the objectivity of the review process and ultimately increase participant safety.

Cell- and Tissue-Based Therapy↗
PubMed2026

Harnessing the Power of Large Language Models for Drug Discovery: A Systematic Review of Current Applications and Future Directions.

INTRODUCTION: The demand for inventive approaches to drug discovery has increased due to the rising costs, time, and failure rates in pharmaceutical research. Large Language Models (LLMs), with their sophisticated natural language processing and generative capabilities, have become potent instruments that have the potential to revolutionize biomedical research. The function of LLMs in different phases of drug development is methodically examined in this article. METHODS: The PRISMA 2020 principles were adhered to in this systematic study. A thorough search for research published between 2018 and 2025 was done using PubMed, Scopus, Web of Science, and Google Scholar. The search terms "large language model," "transformer," "drug discovery," and important sub-domains (such as "de-novo design" and "ADMET") were merged, and two reviewers independently screened the results. Predetermined inclusion and exclusion criteria were used to filter studies for relevance. 98 studies out of the 1,285 records that were initially retrieved met the requirements for the final qualitative synthesis. RESULTS: 98 studies that demonstrated the use of LLMs in various drug discovery domains were found during the review. These covered molecular generation, genomics, protein-ligand modeling, ADME/T and toxicity profiling, drug-target interaction and DTI prediction, and biomedical text mining. 42 different LLM-based tools were mapped, including BioBERT, SciSpacy, Drug- LLM, DNA-BERT, GPT-4, and ChatGPT. Predictive accuracy, hypothesis creation, target prioritization, and multi-modal data integration all showed notable gains with these techniques. DISCUSSION: By providing scalable, precise, and effective solutions for data-driven drug discovery, LLMs are revolutionizing the pharmaceutical industry. They allow for the creation of hypotheses and individualized insights across multi-modal biological data, and they perform better than conventional approaches in a number of subdomains. Improvements in performance were task-dependent; the most consistent gains occurred for biomedical text mining, disease-genedrug relationship mapping and drug-target interaction prediction tasks. Yet most evidence for clinical applications is still derived from retrospective studies and benchmark datasets, suggesting a higher need for prospective validation. CONCLUSION: There is revolutionary potential in incorporating LLMs into drug discovery processes. Clinical translation and regulatory uptake will depend heavily on collaborative validation, ethical deployment, and standardization as models become more multimodal and interpretable. Before normal use, extensive prospective benchmarking and head-to-head comparisons with established chemoinformatics pipelines are necessary.

De novo design↗
PubMed2026

Genetically Modified and Gene-Edited Organisms-Objectives, Public Perception and Applications.

Genetic modification and genome editing have become important tools in agriculture, animal production, biotechnology, and human medicine, but their safety and societal acceptance remain subjects of debate. This review examines genetically modified (GM) and gene-edited organisms, distinguishing transgenesis from precision genome editing technologies, including CRISPR/Cas9, base editing, and prime editing. Representative applications in crops, livestock, pharmaceutical production, and xenotransplantation are discussed, together with their regulatory framework and public perception. Current scientific assessments indicate that approved GM foods are not inherently more hazardous to human health than their conventional counterparts when evaluated case by case. Potential benefits include improved nutritional quality, biofortification, disease resistance, increased agricultural efficiency, production of therapeutic proteins, and applications in animal health and medicine. Possible concerns include allergenicity, toxicity, unintended genetic or phenotypic effects, altered nutritional composition, environmental consequences, animal welfare issues, and uncertainties associated with long-term or large-scale deployment. Public acceptance varies substantially according to geographical region, application, cultural and ethical considerations, regulatory environment, scientific literacy, and institutional trust. Overall, GM and gene-edited organisms should not be considered a homogeneous category. Their benefits, risks, and societal acceptability depend on the specific organism, genetic modification, intended trait, and context of use, supporting a balanced, evidence-based, and case-specific approach.

acceptance↗
PubMed2003

Population genetic studies: is there an emerging legal obligation to share benefits?

It appears that large-scale population genetic studies are the necessary next step in genomics research. Such studies promise to provide correlative data to permit researchers to understand the etiology of a vast array of complex human diseases. Simultaneously, such studies are increasingly seen as yet another mechanism for the developed world to benefit at the expense of the developing world. In fact, a recent World Health Organization Report suggests that "without explicit attention at the international level, the initial technological fruits of genomics are likely to consist primarily of therapeutic and diagnostic applications for conditions affecting large populations in rich countries." (World Health Organization, Genomics and World Health, 2002). In developed and developing countries alike, there are concerns that the pharmaceutical industry stands to gain at the expense of the population(s) from which population genetic data are derived. In light of the current interest concerning ongoing population genetic studies and an increasing interest by many countries, Canada included, in embarking on large-scale population genetic research, it is appropriate to consider the concept of benefit-sharing as a potential mechanism to assuage these concerns. It is the author's position that by virtue of common law equitable principles and developing norms in international law, including the Human Genome Organization Statement on Benefit-Sharing, that there are principled legal and ethical reasons to compel the sharing of benefits that accrue from the commercialization of the resulting data. Using the United Nations Convention on Biological Diversity and the Bonn Guidelines as a model, I suggest that appropriate benefit-sharing mechanisms have been considered in the context of non-human biological materials and that these same mechanisms may be applicable in the context of international and intra-national population genetic studies.

Access to Information↗
PubMed2002

The World Health Organization and the Pharmaceutical Industry. Common areas of interest and differing views.

No article published in the scientific press in the last 10 years reviews the various areas of interest common to the World Health Organization (WHO) and the pharmaceutical industry. Despite a vast amount of information in the public domain, the policies expound the views only of the bodies they represent rather than comparing differing views. An understanding of the factors which affect the interaction between these organisations as well as the organisational structures and the actual areas of intersecting interest, may help to find ways for the industry to assist the WHO in its endeavours in developing countries. Modern drug development is performed initially in and for western society, leaving the areas of infectious or tropical diseases with relatively less industry investment than cancer and cardiovascular disorders. Aspects of the development of an ethical drug, regardless of its therapeutic class (selection of drug name, intellectual property rights, drug safety, marketing and pricing, quality assurance and counterfeiting, generic use, emerging drug donations) are influenced to varying degrees by the triad of money, politics and medical need and the perspectives (each defensible) placed thereon by the WHO and industry. Instead of simply defending their positions combining the best of these strategies to optimise drug development for the needs of developing countries appears logical. Similarly, via its philanthropic initiatives, industry will have donated over $US1 billion in drug and research aid in the period 1995 to 2005. These charitable projects should yield useful information for planning and organising future aid efforts. Global warming, only recently given serious governmental consideration, is an area not yet addressed in drug development policy although along with geographical effects, it is likely to have an impact on the epidemiology of diseases e.g. malaria returning to the Mediterranean, worldwide. With changing disease patterns (and particularly if the western world is affected directly), a shift in emphasis on future medical needs and drug development can be anticipated. Furthermore, given the increased modern interest in herbal medicines and the fact that poorer countries rely heavily on traditional medicines, archiving of botanicals under threat would preserve plants for future medicinal testing or use. Coupled with the environmental and poverty issues that the WHO already attempts to address in developing countries, it is timely for both bodies to work towards certain agreed mutual aims. To work effectively, it is realistic that both bodies must benefit and also make concessions in this interactive process.

Developing Countries↗
PubMed1986

Industry, doctors and bureaucracy.

The central actors on the health arena are industry, doctors and bureaucracy. Whilst general trends towards industrialization, professionalization and bureaucratization are not limited to the health field, developments there have been extremely rapid and show unique features. The three actors often cooperate in harmony despite different goals. On the other hand, bureaucracy is often unable to reach its goals because of resistance from the other two actors. Conflicts, however, occur and are intensive in many third world countries. In industrial countries, too, trade interest in pharmaceuticals may over-ride public health considerations. Conflicts concerning individual drugs have received much publicity. In general, doctors as an organized profession tend to protest against bureaucracy but not against industry. In recent years it has become more and more apparent that health issues cannot be treated as the internal affairs of the actors. New actors have entered the arena. Patients' and consumers' organizations, small groups of doctors and new bodies such as Health Action International have changed the scene. Acting together with fundamental societal changes, this adds a new dimension to the debate and raises the question of including a social element in doctors' ethics. Medical research will also be more directed towards the health care system and become closer to the traditional problems of social science. Social scientists will therefore have contributions to make - studying how the relations between the actors influence the health care system and public health, for instance.

Delivery of Health Care↗
PubMed2005

Medical specialists and pharmaceutical industry-sponsored research: a survey of the Australian experience.

OBJECTIVES: To characterise research relationships between medical specialists and the pharmaceutical industry in Australia. DESIGN AND SETTING: Questionnaire survey of medical specialists listed in the Medical Directory of Australia and believed to be in active practice, conducted in 2002 and 2003. MAIN OUTCOME MEASURES: Details of medical specialists' involvement in pharmaceutical industry-sponsored research, and reports of potentially undesirable research outcomes. RESULTS: Of 2120 specialists approached, 823 (39%) responded. Participation in pharmaceutical industry-sponsored research was more commonly reported by those in salaried practice (49%) than those in private practice (33%); P < 0.001. 216 reported that industry had made initial contact, compared with 117 who had initiated contact with industry. 14.0% of respondents reported premature termination of industry-sponsored trials, which they considered appropriate when in response to concerns about adverse drug effects. 12.3% of respondents reported that industry staff had written first drafts of reports, which they viewed as an acceptable practice for "internal" documents only. Of greatest concern to respondents were instances of delayed publication or non-publication of key negative findings (reported by 6.7% and 5.1% of respondents, respectively), and concealment of results (2.2%). Overall, 71 respondents (8.6%) had experienced at least one event that could represent breaches of research integrity. CONCLUSIONS: These data indicate a high level of engagement in research between the pharmaceutical industry and medical specialists, including those in private practice. Examples of possibly serious research misconduct were reported by 8.6% of respondents, equivalent to 21% of those with an active research relationship with industry.

Australia↗