Involvement of the European Medicines Agency in multi-stakeholder regulatory science research projects: experiences of staff members and project coordinators.

Background: The European Medicines Agency (EMA) interacts with many different stakeholders involved in the development of drugs, including academic researchers. In recent years, EMA has collaborated more closely with academia, inter alia by taking part in external research projects such as those set up under the Horizon 2020 program in general and the Innovative Medicines Initiative in particular. The aim of this study was to evaluate the perceived added value of EMA's involvement in these projects, both from the perspective of the Agency's participating Scientific Officers and of the coordinators of the consortia that undertook them. Methods: Semi-structured interviews were conducted with the coordinators of 21 ongoing or recently finalized projects in which EMA has participated, as well as with the Agency experts contributing to them. Results: In total, 40 individuals were interviewed, of whom 23 were project coordinators and 17 were EMA staff members. While most of the projects were reported to suffer from delays due to the SARS-CoV-2 pandemic, the consortia adapted to the circumstances and their members still expected to deliver on their objectives. EMA's input into the projects ranged from providing guidance by reviewing documents and attending meetings to creating project materials and disseminating them. The frequency of communication between EMA and the consortia varied widely. The projects generated a diverse set of outputs, which encompassed new or improved medicinal products, methodological standards, research infrastructures, and educational tools. All of the coordinators expressed that EMA's contributions to their projects had increased the scientific relevance of their consortium's work, and the EMA experts found that the knowledge and the deliverables produced by the projects were valuable, taking into consideration the time they had invested into them. In addition, interviewees highlighted some actions which could be taken to increase the regulatory significance of the project outcomes. Conclusion: EMA's engagement in external research projects benefits the consortia conducting them and supports the Agency's mission to foster scientific excellence and advance regulatory science.

The Relationship Between the COVID-19 Pandemic and Vaccine Hesitancy: A Scoping Review of Literature Until August 2021.

Background: Vaccines have been contributing to eradicate or drastically reduce the incidence of common diseases. Simultaneously, vaccine hesitancy is considered among the top ten global health threats. The COVID-19 pandemic has caused a tremendous impact on health, economics, and society worldwide, while also reinforcing faulty beliefs about the necessity of vaccine programs as a whole. This study aims to synthesise evidence on the impact of the COVID-19 pandemic on vaccine hesitancy. Methods: A scoping review of literature between 1 January 2020 and 1 August 2021 was performed. Results: COVID-19 vaccine acceptance decreased from more than 70 to <50% in 8 months starting from January 2020. Healthcare professionals demonstrate higher rates of vaccine receptivity than the public, which was more influenced by (social) media. The circulation of misinformation was associated with increased fear of side effects related to COVID-19 vaccines. Regarding other vaccines coverage, parents' intentions to vaccinate their children against influenza increased 15.8% during the COVID-19 pandemic so far. Nonetheless, the number of vaccines administered decreased, influenced by factors like fear of being exposed to the virus at healthcare facilities and restrictions. Conclusions: Several efforts should be undertaken to improve vaccine acceptance and coverage now and beyond the pandemic to optimal population protection.

Moral hazard and the demand for health services: a matching estimator approach.

We estimate the impact of extra health insurance coverage beyond a National Health System on the demand for several health services. Traditionally, the literature has tried to deal with the endogeneity of the private (extra) insurance decision by finding instrumental variables. Since a priori instrumental variables are hard to find we take a different approach. We focus on the most common health insurance plan in Portugal, ADSE, which is given to all civil servants and their dependents. We argue that this insurance is exogenous, i.e., not correlated with the beneficiaries' health status. This identifying assumption allows us to estimate the impact of having ADSE coverage on the demand for three different health services using a matching estimator technique. The health services used are number of visits, number of blood and urine tests, and the probability of visiting a dentist. Results show large positive effects of ADSE coverage for number of visits and tests among the young (18-30 years old) but only the latter is statistically significantly different from zero. The effects represent 21.8% and 30% of the average number of visits and tests for the young. On the contrary, we find no evidence of moral hazard on the probability of visiting a dentist.

Talco de Psidium guayaba en la fase irritativa de las úlceras por presión: Manzanillo, 2003-2004 / Psidium guava talcum for the irritative phase in pressure sores: Manzanillo, 2003-2004

Ensayo clínico fase III, aleatorizado, a doble ciega en 166 pacientes de la UCI del Hospital Celia Sánchez, Manzanillo, desde enero 2003 a diciembre 2004, para evaluar la eficacia del Talco de Guayaba en la fase irritativa de úlceras por presión. Se estableció un grupo estudio tratado de Talco de Guayaba y un grupo control con placebo. La respuesta se midió en: respuesta al tratamiento, estado nutricional, tiempo para la curación, localización y tamaño de la lesión. Utilizamos prueba de hipótesis para diferencia de proporciones. El grupo estudio obtuvo respuesta satisfactoria al tratamiento en 92,8 por ciento, los normopesos obtuvieron mejor respuesta satisfactoria, la localización sacra y lesiones < 5 cm fueron más frecuentes, necesitando de 1–10 días para curar, las mayores de 10 cm demoraron más de 10 días. Similares resultados en el grupo control, aunque en menos pacientes y en un período de tiempo mayor. El Talco de Guayaba es eficaz en el tratamiento de estas lesiones(AU)

A clinical trial, phase III was carried out to 166 patients of Intensive Care Unit that were taken at random from Celia Sanchez Manduley hospital Manzanillo, since January 2003 to December 2004, to evaluate the efficiency of Guava talcum for the irritation phase in pressure sores. It was created an experimental group treated with guava talcum and a control group treated with placebo. The answer was measured into: treatment response, nutritional stage, time for healing, location and injure magnitude. The hypothesis test was used to obtain the proportion differences. The experimental group reached a favourable answer for the treatment with 92,8 per cent, the normal weight obtained the best favourable answer, the sacra location and injures < 5 cm were more frequent requiring from 1 to 10 days to be healed, but those injures larger than 10 cm lasted more than 10 days. In the control group there were obtained similar results but with less patients and in longer period of time. Guava talcum is efficient for the treatment of these injures(EU)

Substance abuse treatment, what do we know? An economist's perspective.

The literature on treating substance abuse has dealt basically with four important questions: (a) Is treatment effective? (b) Are all programs equally effective? (c) Why do programs differ in their effectiveness? (d) Which treatments are more cost-effective? This paper reviews the substance abuse treatment literature around these four questions and discusses methodological issues that hinder the interpretation and generalization of results to date. The answer to the first question is a sounding "yes," treatment is effective but not all programs are equally effective. Researchers have moved beyond the "black box" literature that concentrated on patient and program characteristics as explanations for differences in effectiveness and search for the "active" ingredients of treatment. These include, for example, the treatment philosophy of the program's director and staff attitudes towards patients. Cost-effectiveness studies are less common, and their conclusions are mixed. In general, it is probably safe to say that for the majority of patients, outpatient or shorter programs are more cost-effective.