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Journal of Ethnopharmacology Mar 2021Traditional pharmacopeias have been developed by multiple cultures and evaluated for efficacy and safety through both historical/empirical iteration and more recently... (Review)
Review
ETHNOPHARMACOLOGICAL RELEVANCE
Traditional pharmacopeias have been developed by multiple cultures and evaluated for efficacy and safety through both historical/empirical iteration and more recently through controlled studies using Western scientific paradigms and an increasing emphasis on data science methodologies for network pharmacology. Traditional medicines represent likely sources of relatively inexpensive drugs for symptomatic management as well as potential libraries of new therapeutic approaches. Leveraging this potential requires hard evidence for efficacy that separates science from pseudoscience.
MATERIALS AND METHODS
We performed a review of non-Western medical systems and developed case studies that illustrate the epistemological and practical translative barriers that hamper their transition to integration with Western approaches. We developed a new data analytics approach, in silico convergence analysis, to deconvolve modes of action, and potentially predict desirable components of TM-derived formulations based on computational consensus analysis across cultures and medical systems.
RESULTS
Abstraction, simplification and altered dose and delivery modalities were identified as factors that influence actual and perceived efficacy once a medicine is moved from a non-Western to Western setting. Case studies on these factors highlighted issues with translation between non-Western and Western epistemologies, including those where epistemological and medicinal systems drive markets that can be epicenters for zoonoses such as the novel Coronavirus. The proposed novel data science approach demonstrated the ability to identify and predict desirable medicinal components for a test indication, pain.
CONCLUSIONS
Relegation of traditional therapies to the relatively unregulated nutraceutical industry may lead healthcare providers and patients to underestimate the therapeutic potential of these medicines. We suggest three areas of emphasis for this field: First, vertical integration and embedding of traditional medicines into healthcare systems would subject them to appropriate regulation and evidence-based practice, as viable integrative implementation mode. Second, we offer a new Bradford-Hill-like framework for setting research priorities and evaluating efficacy, with the goal of rescuing potentially valuable therapies from the nutraceutical market and discrediting those that are pseudoscience. Third, data analytics pipelines offer new capacity to generate new types of TMS-inspired medicines that are rationally-designed based on integrated knowledge across cultures, and also provide an evaluative framework against which to test claims of fidelity and efficacy to TMS made for nutraceuticals.
Topics: COVID-19; Data Interpretation, Statistical; Data Science; Delivery of Health Care, Integrated; Humans; Medicine; Medicine, Traditional; Phytotherapy
PubMed: 33098971
DOI: 10.1016/j.jep.2020.113477 -
Pulmonary Pharmacology & Therapeutics Dec 2022COVID-19 medicines, such as molnupiravir are beginning to emerge for public health and clinical practice. On the other hand, drugs display marked variability in their... (Review)
Review
COVID-19 medicines, such as molnupiravir are beginning to emerge for public health and clinical practice. On the other hand, drugs display marked variability in their efficacy and safety. Hence, COVID-19 medicines, as with all drugs, will be subject to the age-old maxim "one size prescription does not fit all". In this context, pharmacogenomics is the study of genome-by-drug interactions and offers insights on mechanisms of patient-to-patient and between-population variations in drug efficacy and safety. Pharmacogenomics information is crucial to tailoring the patients' prescriptions to achieve COVID-19 preventive and therapeutic interventions that take into account the host biology, patients' genome, and variable environmental exposures that collectively influence drug efficacy and safety. This expert review critically evaluates and summarizes the pharmacogenomics and personalized medicine aspects of the emerging COVID-19 drugs, and other selected drug interventions deployed to date. Here, we aim to sort out the hope, hype, and reality and suggest that there are veritable prospects to advance COVID-19 medicines for public health benefits, provided that pharmacogenomics is considered and implemented adequately. Pharmacogenomics is an integral part of rational and evidence-based medical practice. Scientists, health care professionals, pharmacists, pharmacovigilance practitioners, and importantly, patients stand to benefit by expanding the current pandemic response toolbox by the science of pharmacogenomics, and its applications in COVID-19 medicines and clinical trials.
Topics: Humans; Pharmacogenetics; Precision Medicine; Pandemics; COVID-19 Drug Treatment
PubMed: 36265833
DOI: 10.1016/j.pupt.2022.102172 -
Biochimie May 2022Clinicians are increasingly using regenerative medicines to repair, replace, regenerate or rejuvenate lost, damaged or diseased genes, cells, tissues or organs. In South... (Review)
Review
Clinicians are increasingly using regenerative medicines to repair, replace, regenerate or rejuvenate lost, damaged or diseased genes, cells, tissues or organs. In South Africa, access to these novel gene therapies and cell and tissue-based products is limited. The human leukocyte antigen (HLA) diversity and a paucity of suitable HLA-identical unrelated donors, results in limited access to haematopoietic stem and progenitor cell transplantation (HSPCT). Cell-based products could increase this access. Genetic diversity can also manifest in local or region-specific rare congenital disorders, and in vivo gene therapies hold the promise of developing treatments and cures for these debilitating disorders. South Africa has a disproportionate mortality rate due to non-natural causes, with many surviving with permanent injuries and disabilities. Tissue-engineered cell-based products have the potential to restore many of those affected and improve quality of life and productivity. These factors create an urgency for South Africa to develop regenerative medicines to address the country's unique needs and to provide access to these new and innovative treatment modalities. Achieving this objective requires a well-coordinated effort by multiple stakeholders and role players. A critical component of a regenerative medicine ecosystem is establishing an enabling regulatory framework for these new classes of medicines. Here we provide a brief profile of South Africa, including its genetic diversity, economy, the impact of the burden of disease, health policy and the healthcare system. We address the regulation of medicines, how the existing framework can accommodate regenerative medicines, and the steps needed to establish a future regulatory framework.
Topics: Ecosystem; Genetic Therapy; Humans; Quality of Life; Regenerative Medicine; South Africa
PubMed: 35248613
DOI: 10.1016/j.biochi.2022.02.010 -
BMJ (Clinical Research Ed.) Nov 1994
Topics: Humans; Medicine; Physician-Patient Relations; Professional Practice; Social Values
PubMed: 7888834
DOI: 10.1136/bmj.309.6964.1247 -
Lakartidningen Apr 2023Overdiagnosis and overtreatment receive increasing attention. More than 20 percent of health expenditure is without patient benefit, so-called low-value care. Several...
Overdiagnosis and overtreatment receive increasing attention. More than 20 percent of health expenditure is without patient benefit, so-called low-value care. Several national and international initiatives have been launched to minimize low-value care. Arguably, the most widely spread initiative is Choosing Wisely. First launched by the American Board of Internal Medicine in 2012, this campaign has spread to more than 20 countries. The Swedish Society of Medicine has identified low-value care as a significant problem in Swedish health care and has established a working group to investigate if and how a campaign based on Choosing Wisely would be feasible in Sweden. Here, the working group reports on the history of Choosing Wisely, identifies potential challenges for deimplementation generally and in the Swedish context specifically.
Topics: Humans; United States; Sweden; Internal Medicine; Delivery of Health Care
PubMed: 37057979
DOI: No ID Found -
AMA Journal of Ethics Mar 2022Medical education is limited to the biomedical model, omitting critical discourse about racism, the harm it causes minoritized patients, and medicine's foundation and...
Medical education is limited to the biomedical model, omitting critical discourse about racism, the harm it causes minoritized patients, and medicine's foundation and complicity in perpetuating racism. Against a backdrop of historical resistance from medical education leadership, medical students' advocacy for antiracism in medicine continues. This article highlights a medical student-led antiracist curricular effort that moves beyond a biomedical model and uses abolition as the guiding framework in the creation process, the content itself, and iterative reflection through further study and dissemination.
Topics: Education, Medical; Humans; Leadership; Medicine; Racism; Students, Medical
PubMed: 35325520
DOI: 10.1001/amajethics.2022.194 -
Family Medicine and Community Health Apr 2024is a 12-part series of thematically linked mini-essays with accompanying illustrations that explore the many dimensions of family medicine, as interpreted by individual...
is a 12-part series of thematically linked mini-essays with accompanying illustrations that explore the many dimensions of family medicine, as interpreted by individual family physicians and medical educators in the USA and elsewhere around the world. In 'XII: Family medicine and the future of the healthcare system', authors address the following themes: 'Leadership in family medicine', 'Becoming an academic family physician', 'our call to act', 'The paradox of primary care and three simple rules', 'The quadruple aim-melding the patient and the health system', 'Fit-for-purpose medical workforce', 'Universal healthcare-coverage for all', 'The futures of family medicine' and 'The 100 essay.' May readers of these essays feel empowered to be part of family medicine's exciting future.
Topics: Humans; Family Practice; Physicians, Family; Emotions; Health Facilities; Universal Health Care
PubMed: 38609091
DOI: 10.1136/fmch-2024-002829 -
PLoS Medicine Dec 2018Machine Learning Special Issue Guest Editors Suchi Saria, Atul Butte, and Aziz Sheikh cut through the hyperbole with an accessible and accurate portrayal of the...
Machine Learning Special Issue Guest Editors Suchi Saria, Atul Butte, and Aziz Sheikh cut through the hyperbole with an accessible and accurate portrayal of the forefront of machine learning in clinical translation.
Topics: Artificial Intelligence; Diagnosis, Computer-Assisted; Humans; Machine Learning; Medicine
PubMed: 30596635
DOI: 10.1371/journal.pmed.1002721 -
Journal of Translational Medicine Aug 2014Since first sequencing the human genome in 2003, emerging genetic/genomic technologies have ushered in a revolutionary era of medicine that purports to bridge molecular...
Since first sequencing the human genome in 2003, emerging genetic/genomic technologies have ushered in a revolutionary era of medicine that purports to bridge molecular biology and clinical care. The field of translational medicine is charged with mediating this revolution. Sequencing innovations are far outpacing guidelines intended to ease their practice-based applications, including in primary care. As a result, genomic medicine's full integration in primary care settings especially, has been slow to materialize. Researchers and clinicians alike face substantial challenges in navigating contentious ethical issues raised in translation and implementation, namely preserving the spirit of whole-person approaches to care; maintaining respect for persons and communities; and translating genetic risk into clinical actionability. This commentary therefore explores practical barriers to, and ethical implications of, incorporating genomic technologies in the primary care sector. These ethical challenges are both philosophical and infrastructural. From a primary care perspective, the commentary further reviews the ethical, legal and social implications of the Center for Disease Control's proposed model for assessing the validity and utility of genomic testing and family health history applications. Lastly, the authors provide recommendations for future translational initiatives that aim to maximize the capacities of genomic medicine, without compromising primary care philosophies and foundations of practice.
Topics: Ethics, Medical; Genetics, Medical; Genome, Human; Genomics; Human Genome Project; Humans; Inventions; Primary Health Care; Translational Research, Biomedical
PubMed: 25164605
DOI: 10.1186/s12967-014-0238-6 -
Clinical Pharmacology and Therapeutics Jan 2022Basic scientists and drug developers are accelerating innovations toward the goal of precision medicine. Regulators create pathways for timely patient access to... (Review)
Review
Basic scientists and drug developers are accelerating innovations toward the goal of precision medicine. Regulators create pathways for timely patient access to precision medicines, including individualized therapies. Healthcare payors acknowledge the need for change but downstream innovation for coverage and reimbursement is only haltingly occurring. Performance uncertainty, high price-tags, payment timing, and actuarial risk issues associated with precision medicines present novel financial challenges for payors. With traditional drug reimbursement frameworks, payment is based on an assumed randomized controlled trial (RCT) projection of real-world effectiveness, a "trial-and-project" strategy; the clinical benefit realized for patients is not usually ascertained ex post by collection of real-world data (RWD). To mitigate financial risks resulting from clinical performance uncertainty, manufacturers and payors devised "track-and-pay" frameworks (i.e., the tracking of a pre-agreed treatment outcome which is linked to financial consequences). Whereas some track-and-pay arrangements have been successful, inherent weaknesses include the potential for misalignment of incentives, the risk of channeling of patients, and a failure to use the RWD generated to enable continuous learning about treatments. "Precision reimbursement" (PR) intends to overcome inherent weaknesses of simple track-and-pay schemes. In combining the collection of RWD with advanced analytics (e.g., artificial intelligence and machine learning) to generate actionable real-world evidence, with prospective alignment of incentives across all stakeholders (including providers and patients), and with pre-agreed use and dissemination of information generated, PR becomes a "learn-and-predict" model of payment for performance. We here describe in detail the concept of PR and lay out the next steps to make it a reality.
Topics: Evidence-Based Medicine; Forecasting; Humans; Insurance, Health, Reimbursement; Machine Learning; Precision Medicine
PubMed: 34716918
DOI: 10.1002/cpt.2471