scholarly journals Medicines Regulatory Harmonization: International Collaboration as a Key to Improve Public Health

2016 ◽  
Vol 1 ◽  
pp. maapoc.0000001
Author(s):  
Valerio Reggi
Keyword(s):  
Public Health ◽  
International Collaboration ◽  
Pharmaceutical Companies ◽  
Technical Aspects ◽  
Safety And Efficacy ◽  
Regulatory Authorities ◽  
The Past ◽  
National Drug ◽  
Single Set ◽  
Country Specific

Over the past 30 years, many national drug regulatory authorities have embarked on a process of gradual harmonization of all the technical aspects of studies, processes, and tests that generate the data necessary to support claims of quality, safety, and efficacy of medicines. This has been mainly a trade-driven process characterized by “region-specific” harmonization initiatives; the less-resourced authorities started this processes much later than the better-resourced ones. The immediate outcome of harmonized requirements is the eliminating of country-specific tests and studies, and the narrowing of gaps in the interpretation of data. This reduced the costs for pharmaceutical companies by enabling them to develop one single set of data and documentation to be submitted to several different countries. In addition, the harmonization processes are beneficial for public health: open-minded technical discussions and the exchange of ideas and experience among regulators of different countries contributes to strengthening the capacity of national authorities to expedite the assessment of priority medicines, and to filter out unsafe or substandard products.

scholarly journals Disease burden metrics and the innovations of leading pharmaceutical companies: a global and regional comparative study

2020 ◽  
Vol 16 (1) ◽  
Author(s):  
Ye Lim Jung ◽  
JeeNa Hwang ◽  
Hyoung Sun Yoo
Keyword(s):  
Public Health ◽  
Disease Burden ◽  
Income Level ◽  
High Income ◽  
Pharmaceutical Innovation ◽  
Innovation Activity ◽  
Pharmaceutical Companies ◽  
Middle Income ◽  
Innovation Activities ◽  
Country Specific

Abstract Background The recent innovation activities of global top-tier pharmaceutical companies in accordance with global and regional health concerns were investigated in order to identify their innovations contributing to population health. Methods “Innovation activity” was defined as the number of drugs for which R&D activities have been reported within the last three years. Such activities were measured by collecting the data on drug developments and classifying them by developer company, phase of development, therapeutic use, and the country in which the development conducted. Subsequently, we examined and compared the correlations between the global innovation activities of the top 20 pharmaceutical companies and the disease burden measured in disability-adjusted life years (DALYs) by income level and region. In addition, this study analyzed the association between country-specific innovations and DALYs in the corresponding countries. Results At a global level, the innovation activities were not associated with global DALYs. However, when analyzed by income level, the innovation activities were associated with DALYs in high income and upper middle income countries while it was not associated with DALYs in low middle income and low income countries. In terms of region, correlations were found between the innovation activities and DALYs in the European region, the Americas, and the Western Pacific region whereas such correlations were not found in the African, Eastern Mediterranean, and South-East Asian regions. Similar to the analyses by income level and region, correlations between country-specific innovations and DALYs were only found in high income or high GDP countries. In addition, an empirical analysis of several cases including Canada, Germany, South Korea, and the United Kingdom revealed that pharmaceutical innovation is more closely related to market size than disease burden. Conclusions This study identified that discrepancies between pharmaceutical innovation and public health needs, i.e., disease burden values, have persisted until recently. To alleviate this imbalance, both public and private sectors should not only fulfill their respective roles and responsibilities regarding these issues, but also make strategic and collaborative efforts such as Product Development Partnerships (PDPs) directed toward public health improvement.

scholarly journals Kamrai tachycardiák katéterablatiós kezelése

2015 ◽  
Vol 156 (25) ◽  
pp. 995-1002
Author(s):  
Attila Mihálcz ◽  
Tamás Szili-Török ◽  
Kálmán Tóth
Keyword(s):  
Ventricular Tachycardia ◽  
Catheter Ablation ◽  
Diagnostic Tests ◽  
Ventricular Arrhythmias ◽  
Structural Heart Disease ◽  
Technical Aspects ◽  
Safety And Efficacy ◽  
Ventricular Tachycardia Ablation ◽  
The Past ◽  
Ventricular Tachycardias

Catheter ablation of ventricular tachycardias emerged significantly as standard therapy in the past 20 years. In this review recent advances in catheter ablation of ventricular tachycardias are discussed. The authors first present in details the technical aspects of ablation strategies, main indications and contraindications of ventricular tachycardia ablation and the necessary pre- and postinterventional diagnostic tests. Outcome is also discussed in different forms of ventricular tachycardias in detail. The authors summarize the safety and efficacy of catheter ablation of ventricular arrhythmias. They recommend that ablation of ventricular tachycardias should be considered earlier in patients with and without structural heart disease. Orv. Hetil., 2015, 156(25), 995–1002.

Off-Label Drug Use and Promotion: Balancing Public Health Goals and Commercial Speech

2011 ◽  
Vol 37 (2-3) ◽  
pp. 225-257 ◽  
Author(s):  
Aaron S. Kesselheim
Keyword(s):  
Public Health ◽  
Prescription Drugs ◽  
Drug Label ◽  
Safety And Efficacy ◽  
Off Label ◽  
Commercial Speech ◽  
The Past ◽  
Health Goals ◽  
The Subject ◽  
The Universe

Off-label promotion of prescription drugs has become a source of substantial controversy in the past decade. Before a new drug reaches the market, its safety and efficacy must be certified by the Food and Drug Administration (FDA). But the FDA does not simply approve a drug for general use. Rather, it approves drugs for the specific uses requested by manufacturers, who choose the universe of possible indications when they undertake pre-marketing clinical trials. The approval is therefore tied to a particular disease that is the subject of the manufacturer's pre-approval testing and the FDA's formal review. The conditions for which the product is approved are spelled out in the official drug label, including the dose evaluated by the FDA, and the details of administration in which the FDA has determined the drug showed efficacy. The label also describes the safety concerns related to the use.

Scientists’ response to global public health emergencies: A bibliometrics perspective

2021 ◽  
pp. 016555152110308
Author(s):  
Leyan Wu ◽  
Jinqing Yang ◽  
Dan Wang ◽  
Qikai Cheng ◽  
Wei Lu
Keyword(s):  
Public Health ◽  
International Collaboration ◽  
Research Collaboration ◽  
Academic Community ◽  
Collaboration Network ◽  
Health Crisis ◽  
Health Events ◽  
Public Health Emergencies ◽  
The Past ◽  
The Impact

The unprecedented COVID-19 outbreak at the end of 2019 has produced a worldwide health crisis. Scientific research, especially international research collaboration, is crucial to deal successfully with the epidemic. This article aims to review the response modes, and especially the international collaboration characteristic, of the academic community to similar public health events in the past. Based on relevant studies of four major public health emergencies in the past, the major public health emergencies were regarded as ‘new knowledge’ in the academic field. By using knowledge diffusion indicators, such as the breadth and speed of diffusion, and combined with the development characteristics of the event, this article explores the diffusion characteristics of the four major public health emergencies in the academic exchange system and then identifies the academic community’s response mode to the outbreaks. In addition, the characteristics of international collaboration in response to the public health events and the impact of international collaboration on the academic community’s response are analysed. Through the analysis of the international collaboration network, the cooperative groups and core countries in the research collaboration network related to the major public health emergencies are obtained. In terms of COVID-19, it is found that the response speed and intensity of scientists have been significantly improved, but more focus should be given to international collaboration. Our findings could be beneficial to both decision-makers and researchers in policy formulation and conducting research, respectively, to optimally deal with COVID-19 and possible outbreaks in the future.

LGBTQ Intimate Partner Violence

2017 ◽  
Author(s):  
Adam M. Messinger
Keyword(s):  
Public Health ◽  
Intimate Partner Violence ◽  
Partner Violence ◽  
Intimate Partner ◽  
Sexual Relationships ◽  
Evidence Based ◽  
Policy Practice ◽  
The Past ◽  
Victim Services ◽  
Public Health Threat

Many nations today recognize intimate partner violence (IPV) in romantic-sexual relationships as a major public health threat, yet not all victims are treated equally. Contrary to myths, lesbian, gay, bisexual, trans*, and queer (LGBTQ) people are more likely to experience IPV than heterosexual-cisgender people. Unfortunately, LGBTQ victims face major barriers to reaching safety in a world that too often stigmatizes their identities and overlooks their relationships when forming victim services and policies. Offering a roadmap forward, LGBTQ Intimate Partner Violence: Lessons for Policy, Practice, and Research is the first book to synthesize nearly all existing research from the past forty years on this pressing issue. At once highly organized and engaging, it provides evidence-based tips for academic and nonacademic audiences alike.

Coronary Intervention with the Excimer Laser: Review of the Technology and Outcome Data

2016 ◽  
Vol 11 (1) ◽  
pp. 27
Author(s):  
John Rawlins ◽  
◽  
◽  
◽  
◽  
...  
Keyword(s):  
Excimer Laser ◽  
Coronary Intervention ◽  
Outcome Data ◽  
Boston Scientific ◽  
Technical Aspects ◽  
Safety And Efficacy ◽  
Percutaneous Coronary ◽  
Short Period ◽  
Complex Lesions

Excimer laser coronary atherectomy (ELCA) is a long-established adjunctive therapy that can be applied during percutaneous coronary intervention (PCI). Technical aspects have evolved and there is an established safety and efficacy record across a number of clinical indications in contemporary interventional practice where complex lesions are routinely encountered. The role of ELCA during PCI for thrombus, non-crossable or non-expandable lesions, chronic occlusions and stent under-expansion are discussed in this review. The key advantage of ELCA over alternative atherectomy interventions is delivery on a standard 0.014-inch guidewire. Additionally, the technique can be mastered by any operator after a short period of training. The major limitation is presence of heavy calcification although when rotational atherectomy (RA) is required but cannot be applied due to inability to deliver the dedicated RotaWire™ (Boston Scientific), ELCA can create an upstream channel to permit RotaWire passage and complete the case with RA – the RASER technique.

Preventive aspect of ayurveda and yoga towards newly emerging disease COVID-19

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Ranjeet S. Sawant ◽  
Bharat D. Zinjurke ◽  
Sandeep V. Binorkar
Keyword(s):  
Public Health ◽  
Severe Acute Respiratory Syndrome ◽  
Medical Care ◽  
Supportive Therapy ◽  
Prophylactic Therapy ◽  
Current Line ◽  
Therapeutic Aspect ◽  
The Past

Abstract The ongoing coronavirus pandemic is caused by severe acute respiratory syndrome coronavirus 2 (SARS CoV 2) and unique in various facets. The earlier experience from the past severe acute respiratory syndrome (SARS) epidemics seem to be insufficient and there is need for better strategies in public health and medical care. Ayurved & Yog are well known for their preventive and therapeutic aspect, but not getting utilized properly for prevention of Covid 19 crisis which may also be helpful as supportive therapy along with current line of management. This paper is aimed at unrevealing the role of Ayurved and Yoga guidelines established by Department of AYUSH for prevention from SARS-CoV-2 by providing help to improving the quality of supportive/prophylactic therapy in relation with their immunity.

scholarly journals Is academia becoming more localised? The growth of regional knowledge networks within international research collaboration

2021 ◽  
Vol 6 (1) ◽  
Author(s):  
John Fitzgerald ◽  
Sanna Ojanperä ◽  
Neave O’Clery
Keyword(s):  
Economic Development ◽  
International Collaboration ◽  
International Research ◽  
Research Collaboration ◽  
Learning By Doing ◽  
Knowledge Networks ◽  
Collaboration Network ◽  
International Research Collaboration ◽  
The Past ◽  
Capability Building

AbstractIt is well-established that the process of learning and capability building is core to economic development and structural transformation. Since knowledge is ‘sticky’, a key component of this process is learning-by-doing, which can be achieved via a variety of mechanisms including international research collaboration. Uncovering significant inter-country research ties using Scopus co-authorship data, we show that within-region collaboration has increased over the past five decades relative to international collaboration. Further supporting this insight, we find that while communities present in the global collaboration network before 2000 were often based on historical geopolitical or colonial lines, in more recent years they increasingly align with a simple partition of countries by regions. These findings are unexpected in light of a presumed continual increase in globalisation, and have significant implications for the design of programmes aimed at promoting international research collaboration and knowledge diffusion.

scholarly journals Trends in breastfeeding practices and mothers’ experience in the French NutriNet-Santé cohort

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Frédéric Courtois ◽  
Sandrine Péneau ◽  
Benoît Salanave ◽  
Valentina A. Andreeva ◽  
Marie Françoise Roland-Cachera ◽  
...  
Keyword(s):  
Public Health ◽  
Census Data ◽  
Breastfeeding Duration ◽  
Breastfeeding Initiation ◽  
Breastfeeding Support ◽  
The Public ◽  
The Past ◽  
Breastfeeding Practices ◽  
Breastfeeding Education ◽  
Breastfeeding Cessation

Abstract Background France has one of the lowest rates in the world regarding breastfeeding initiation and duration. Few studies have explored breastfeeding practices in France since the middle of the twentieth century, or following from initiation to cessation. The purpose of our study was to determine trends in breastfeeding over the past decades regarding public health recommendations, and to examine mothers’ perceptions about factors known to have an impact on breastfeeding support and cessation. Methods From the NutriNet-Santé cohort, 29,953 parous women (launched in 2009 to study relation between nutrition and health), were included in the present study. Using web-questionnaires, they were asked retrospectively if they had breastfed their youngest child or not, and if so, the duration of exclusive and total breastfeeding. For those who had breastfed, we investigated their perceptions about support at initiation and during the entire breastfeeding period and reasons for breastfeeding cessation. We also asked those who did not breastfeed about their perceptions and reasons for infant formula feeding their youngest child. Analyses were weighted according to the French census data. Results In the NutriNet-Santé cohort, 67.3% of mothers breastfed their youngest child. The proportion of breastfed children increased over the past few decades, from 55.0% (95% CI 54.3, 55.6) in the 1970s to 82.9% (82.4, 83.4) in the 2010s. Total and exclusive breastfeeding duration went from 3.3 months and 2.4 months respectively in the 1970s to 5.9 months and 3.2 months respectively in the 2010s. Most mothers felt supported at initiation and during the breastfeeding period. A reported desire to have breastfed longer than two months was 59.5%. Mothers who did not breastfeed did it by choice (64.3%). They did not feel guilty (78.2%) and did not perceive a problem not to breastfeed (58.8%), but almost half of them would have liked to have breastfed (45.9%). Conclusion Breastfeeding duration has increased in the past decades but did not reach the public health recommendations threshold. Targets other than mothers have to be considered for breastfeeding education, like the partner and her environment, to increase breastfeeding practices. Trial registration The study was registered at ClinicalTrials.gov (NCT03335644).

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