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5.
Medicine (Baltimore) ; 100(12): e24816, 2021 Mar 26.
Artículo en Inglés | MEDLINE | ID: mdl-33761642

RESUMEN

ABSTRACT: Antihypertensive drugs have been of significant interest to the pharmaceutical industry due to increasing sales opportunities in a global market. The financial relationships between pharmaceutical companies and the Japanese Society of Hypertension (JSH) have a possible influence on clinical practices in Japan. This study examined the distribution of pharmaceutical payments made to the authors of the revised Guidelines for the Management of Hypertension (JSH2019) and the transparency of the Conflict of Interest disclosure that each author made.We retrospectively obtained publicly available data regarding payments made by Japanese pharmaceutical companies to all authors of the JSH2019 in 2016. We also collected data on individual financial disclosure of JSH2019 authors to investigate whether their self-reported financial relationship with companies were compliant to the financial disclosure policy of JSH2019.The total and mean payment values reported by pharmaceutical companies were $4,246,436 and $21,447, respectively. Of the 198 authors, 171 (86.4%) authors received at least 1 payment. Of 74 authors required to disclose their conflict of interest (COI) the authors, one-third failed to follow the COI policy covering the clinical guidelines.Major pharmaceutical companies selling antihypertensive drug products in the Japanese market had a significant financial connection with the JSH2019 authors. Financial relationships between pharmaceutical companies and authors or Japanese medical societies are raising significant concerns about the credibility of clinical guidelines and the potentially biases and undue influences that they may cause, especially with respect to adverse prescription patterns.


Asunto(s)
Conflicto de Intereses/economía , Industria Farmacéutica/economía , Hipertensión/tratamiento farmacológico , Guías de Práctica Clínica como Asunto , Sociedades Científicas/economía , Antihipertensivos/normas , Antihipertensivos/uso terapéutico , Revelación/ética , Revelación/estadística & datos numéricos , Industria Farmacéutica/ética , Industria Farmacéutica/estadística & datos numéricos , Humanos , Japón , Sesgo de Publicación , Estudios Retrospectivos , Sociedades Científicas/ética , Sociedades Científicas/normas
8.
Global Health ; 17(1): 24, 2021 03 03.
Artículo en Inglés | MEDLINE | ID: mdl-33658050

RESUMEN

OBJECTIVE: The COVID-19 pandemic is a biosecurity threat, and many resource-rich countries are stockpiling and/or making plans to secure supplies of vaccine, therapeutics, and diagnostics for their citizens. We review the products that are being investigated for the prevention, diagnosis, and treatment of COVID-19; discuss the challenges that countries in sub-Saharan Africa may face with access to COVID-19 vaccine, therapeutics, and diagnostics due to the limited capacity to manufacture them in Africa; and make recommendations on actions to mitigate these challenges and ensure health security in sub-Saharan Africa during this unprecedented pandemic and future public-health crises. MAIN BODY: Sub-Saharan Africa will not be self-reliant for COVID-19 vaccines when they are developed. It can, however, take advantage of existing initiatives aimed at supporting COVID-19 vaccine access to resource-limited settings such as partnership with AstraZeneca, the Coalition for Epidemic Preparedness and Innovation, the Global Alliance for Vaccine and Immunisation, the Serum Institute of India, and the World Health Organization's COVID-19 Technology Access Pool. Accessing effective COVID-19 therapeutics will also be a major challenge for countries in sub-Saharan Africa, as production of therapeutics is frequently geared towards profitable Western markets and is ill-adapted to sub-Saharan Africa realities. The region can benefit from pooled procurement of COVID-19 therapy by the Africa Centres for Disease Control and Prevention in partnership with the African Union. If the use of convalescent plasma for the treatment of patients who are severely ill is found to be effective, access to the product will be minimally challenging since the region has a pool of recovered patients and human resources that can man supportive laboratories. The region also needs to drive the local development of rapid-test kits and other diagnostics for COVID-19. CONCLUSION: Access to vaccines, therapeutics, and diagnostics for COVID-19 will be a challenge for sub-Saharan Africans. This challenge should be confronted by collaborating with vaccine developers; pooled procurement of COVID-19 therapeutics; and local development of testing and diagnostic materials. The COVID-19 pandemic should be a wake-up call for sub-Saharan Africa to build vaccines, therapeutics, and diagnostics manufacturing capacity as one of the resources needed to address public-health crises.


Asunto(s)
/provisión & distribución , Industria Farmacéutica/organización & administración , África del Sur del Sahara/epidemiología , /tratamiento farmacológico , Humanos
9.
Rev Med Liege ; 76(3): 216-220, 2021 Mar.
Artículo en Francés | MEDLINE | ID: mdl-33682392

RESUMEN

The pharmaceutical industry faces, as many other public and private sectors, a significant deficit in trust (medication considered too expensive, not always readily available, even if it is deemed essential, lack of financial transparency). Moreover, we are more than very surprised by the lack of efficiency (colossal investments, compared to the modest final output). Not a single human activity sector can afford the luxury of such a situation. In these moments of doubts, industrial leaders are pushed to reinvent the whole sector, starting from research and development, through production and commercialization, to finish with retail. They are massively investing in new disruptive technologies (artificial intelligence, connected health, big data), redesigning the way clinical trials are elaborated and performed.


Asunto(s)
Inteligencia Artificial , Industria Farmacéutica , Humanos
11.
AAPS PharmSciTech ; 22(3): 82, 2021 Feb 23.
Artículo en Inglés | MEDLINE | ID: mdl-33624199

RESUMEN

Current trends in the pharmaceutical industry led to a demand for more flexible manufacturing processes with smaller batch sizes. Prepackaged nested vials that can be processed as a unit were introduced into the market to fulfill this need. However, vial nests provide a different thermal environment for the vials compared to a hexagonal packaging array and could therefore influence product temperature profiles, primary drying times, and product quality attributes. Polymer caps with the possibility of vial closure inside the freeze-drying chamber were developed to remove the risks and need of a crimping process. A general concern with the use of such caps is the possibility of an increase in resistance to water vapor flow out of the vial. This case study investigated the effect of the LyoSeal® and PLASCAP® polymer caps and EZ-fill® nests on the freeze-drying process. Amorphous and partially crystalline model formulations were freeze-dried. Process data and product quality attributes were compared for regularly stoppered vials and vials with polymer caps as well as vials in a hexagonal packaging array and nested vials. The results indicated no increased resistance or impeded water vapor flow by the polymer caps. Differences in the macro- and microscopic appearances of products and a trend towards lower product temperatures were observed for the investigated nest type compared to a regular hexagonal packaging array. Consequently, the polymer caps could be used as an alternative to regular stoppers without affecting freeze-drying process data or product quality attributes, while the different thermal environment of nested vials should be considered.


Asunto(s)
Industria Farmacéutica/normas , Embalaje de Medicamentos/normas , Polímeros/normas , Desecación/métodos , Industria Farmacéutica/métodos , Embalaje de Medicamentos/métodos , Liofilización/métodos , Liofilización/normas , Temperatura
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