The Istituto Superiore di Sanità, the organization responsible for the evaluation and accreditation of food product testing laboratories

Laboratories in charge of food control play a pivotal role within the actions planned for the safety of food products, the latter identified as a fundamental strategic priority in the European Union Food safety white paper 2000. They are demanded to comply with specific criteria to demonstrate the use of an appropriate quality system, technical competence and production of technically reliable and valid results. Precise guidance is set forth in the Italian law DL. vo 156/97 which requires that official test laboratories should comply with European Standard UNI CEI EN 45001, currently replaced by UNI CEI EN ISO/IEC 17025. and with some of the OECD principles of good laboratory practice. The Istituto Superiore di Sanità, the Italian National Health Institute, was designated by the Ministerial Decree of 12 May 1999 as the organism responsible for evaluation and accreditation of official food product control laboratories.     

Control of congenital toxoplasmosis in Italy: The project of the Istituto Superiore di Sanità

Toxoplasma gondii infection during pregnancy is a public health concern; many resources are used in diagnostic and therapeutic activities, sometime with a low benefit/cost due to lack of standardization in practices. In the lack of suitable epidemiological knowledge at national level regarding the congenital toxoplasmosis trend in Italy, an evaluation of the public health impact of this pathology is required. The Istituto Superiore di Sanità (ISS) has worked out a project on a prevalence-incidence study at national level, performing standard reference methods for diagnosis and both case definition and case management. Furthermore, the ISS urges all the involved centers on congenital toxoplasmosis to set up a network for an active collaboration to this project.     

Scientific research on human subjects and ethics procedures at the Istituto Superiore di Sanità: a survey of the articles issued in 2001

Principles promoting the protection of subjects involved in biomedical research are interpreted differently within the scientific community. The purpose of this paper is to describe the attitudes of researchers working at the Istituto Superiore di Sanità (ISS) regarding the ethical implications of studies involving human beings, with particular emphasis on aspects concerning informed consent (IC) and ethics committee (EC) review. In 2001, ISS researchers published a total of 733 articles, 93 (12.7%) of which were studies involving human beings. Nearly 2/3 (60/93) were epidemiological, while the remaining 35.5% were based on laboratory data. Half (47/93) reported physical or psychological interventions or treatments on study subjects. 40.9% of articles mentioned that informed consent had been obtained and only 12.9% that approval had been given by an ethics committee. The low proportion of articles on which a protocol had been submitted the EC was due in part to the type of studies, but also to the absence of an institutional EC prior to 2001. Ethical procedures were more present in laboratory than in epidemiologic studies (IC: 69.7% vs 25.0%, p < 0.001) (EC: 27.3% vs 5.0% p = 0.004). Those differences were more likely due to the less interventionist nature of the epidemiologic studies rather than in poor ethical awareness on the part of epidemiologists. Further efforts are needed to develop and enforce clear institutional policies regarding ethical procedures.     

The role of the Istituto Superiore di Sanità as the competent authority for Phase I trials in the translation of advanced therapies

Advanced therapy medicinal products (ATMP) can offer new, effective therapeutic options for the treatment of severe illnesses, including cancer, neurodegenerative and cardiovascular diseases. Translation of advanced therapies to the clinic has been slow despite significant academic research from academia and foundations. The implementation of 2001/20 Directive in Italy established that the development of an ATMP should follow the GXP rules - good manufacturing practice (GMP) for production, good laboratory practice (GLP) for non clinical safety studies and good clinical practice (GCP) for clinical trials. The high costs of GCP application and the needs for GMP facilities are perceived as the most important bottlenecks for the development of ATMP. Here it is pointed out that a strategic cooperation between different actors (academia, industry and experts in regulatory issues) is strongly needed. In particular, it is highlighted that the Istituto Superiore di Sanità, as the competent authority for the authorization of Phase I clinical trials, has a specific responsibility in fostering the translation of safe and effective therapies for human diseases.     

Housing and overdose: an opportunity for the scale-up of overdose prevention interventions?

Background

North America is currently experiencing an overdose epidemic due to a significant increase of fentanyl-adulterated opioids and related analogs. Multiple jurisdictions have declared a public health emergency given the increasing number of overdose deaths. In the province of British Columbia (BC) in Canada, people who use drugs and who are unstably housed are disproportionately affected by a rising overdose crisis, with close to 90% of overdose deaths occurring indoors. Despite this alarming number, overdose prevention and response interventions have yet to be widely implemented in a range of housing settings.

Overdose prevention interventions

There are few examples of overdose prevention interventions in housing environments. In BC, for example, there are peer-led naloxone training and distribution programs targeted at some housing environments. There are also “supervised” spaces such as overdose prevention sites (similar to supervised consumption sites (SCS)) located in some housing environments; however, their coverage remains limited and the impacts of these programs are unclear due to the lack of evaluation work undertaken to date. A small number of SCS exist globally in housing environments (e.g., Germany), but like overdose prevention sites in BC, little is known about the design or effectiveness, as they remain under-evaluated.

Conclusions

Implementing SCS and other overdose prevention interventions across a range of housing sites provides multiple opportunities to address overdose risk and drug-related harms for marginalized people who use drugs. Given the current overdose crisis rising across North America, and the growing evidence of the relationship between housing and overdose, the continued implementation and evaluation of novel overdose prevention interventions in housing environments should be a public health priority. A failure to do so will simply perpetuate what has proven to be a devastating epidemic of preventable death.

     

Climate change and rising energy costs: a threat but also an opportunity for a healthier future?

Health problems caused by overconsumption, growing inequalities and diminished well-being are issues that have been attributed to the prioritization of economic growth as the central purpose of society. It is also known that climate change and rising energy prices will inevitably bring changes to the globe's economic models. Doctors and the wider public health community have campaigned successfully in the past on issues such as the threat of nuclear war. Is it now time for this constituency to make its distinctive contribution to these new threats to health?     

The neonatal period: A missed opportunity for the prevention of iron deficiency and its associated neurological consequences?

Iron deficiency is the most common micronutrient deficiency worldwide. Iron is essential for the development of multiple organ systems, most especially the developing brain. Iron deficiency, particularly during sensitive periods of brain development, such as in early childhood, is associated with long‐lasting adverse consequences for cognition, motor function and behaviour. Little consideration has been given to iron deficiency in newborn infants and its potential health consequences. Fetal iron accretion is compromised by pregnancy complications such as pre‐term birth and gestational diabetes mellitus, and our work has identified an increased risk of low iron stores at birth from maternal lifestyle factors such as smoking and obesity. Early‐life events, including Caesarean section delivery, further add to the cumulative risk of neonatal iron deficiency, which can persist throughout infancy into early childhood. While investigations into the long‐term neurological consequences of neonatal iron deficiency are limited, there is evidence of poorer memory, motor function and language ability in children born iron deficient. Recently, we also identified significant behavioural consequences of neonatal deficiency persisting from 2 to 5 years of age, with effects particularly apparent in ‘high‐risk’ children born to obese or smoking mothers or delivered by Caesarean section. Interventions targeting the fetal/neonatal period could therefore represent a key opportunity for the prevention of iron deficiency and its associated long‐term health consequences. A dual approach is required, comprising public health strategies targeting prevention, to improve health in women of reproductive age, and the development of screening strategies for the early detection of iron deficiency in newborn infants.     

Pandemic and seasonal vaccine coverage and effectiveness during the 2009–2010 pandemic influenza in an Italian adult population

Objectives

To evaluate the response to pandemic vaccination and seasonal and pandemic vaccine effectiveness (VE) in an Italian adult population, during the 2009?C2010 influenza season.

Methods

Data were recorded by interviewing 19,275 subjects (??35?years), randomly recruited from the general population of the Moli-sani project. Events [influenza-like illness (ILI), hospitalization and death], which had occurred between 1 November 2009 and 31 January 2010 were considered. VE was analyzed by multivariable Poisson regression analysis.

Results

Pandemic vaccine coverage was very low (2.4%) in subjects at high-flu risk, aged 35?C65?years (N?=?8,048); there was no significant preventive effect of vaccine against ILI. Seasonal vaccine coverage was 26.6% in the whole population (63% in elderly and 21.9% in middle-aged subjects at high-flu risk). There was a higher risk to develop ILI in middle-age [VE: ?17% (95% CI: ?35,?1)] or at high flu-risk [VE: ?17% (95% CI: ?39, 2)] vaccinated groups.

Conclusions

Coverage of pandemic vaccine was very low in a Southern Italy population, with no protective effect against ILI.     

The Problem With the Phrase Women and Minorities: Intersectionality—an Important Theoretical Framework for Public Health

Intersectionality is a theoretical framework that posits that multiple social categories (e.g., race, ethnicity, gender, sexual orientation, socioeconomic status) intersect at the micro level of individual experience to reflect multiple interlocking systems of privilege and oppression at the macro, social-structural level (e.g., racism, sexism, heterosexism). Public health’s commitment to social justice makes it a natural fit with intersectionality’s focus on multiple historically oppressed populations. Yet despite a plethora of research focused on these populations, public health studies that reflect intersectionality in their theoretical frameworks, designs, analyses, or interpretations are rare. Accordingly, I describe the history and central tenets of intersectionality, address some theoretical and methodological challenges, and highlight the benefits of intersectionality for public health theory, research, and policy.The term women and minorities is ubiquitously wedded in public health discourse, policy, and research. Take, for example, the NIH [National Institutes of Health] Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research.1 The 2001 amended guidelines provide guidance on including women and minorities as participants in research and reporting on sex/gender and racial/ethnic differences. The problem with the “women and minorities” statement or the “ampersand problem”2^(p22) is the implied mutual exclusivity of these populations. Missing is the notion that these 2 categories could intersect, as they do in the lives of racial/ethnic minority women.Further compounding the issue is that the word minority is multidefinitional. Although it typically modifies race/ethnicity in the United States, minority also can reference populations such as lesbian, gay, bisexual, and transgender (LGBT) people; people with physical and mental disabilities; or, depending on geographic context, White people. Thus, in addition to being vague, the term minority in conjunction with women obscures the existence of multiple intersecting categories as exemplified by, for instance, a low-income Latina lesbian with a physical disability.The notion that social identities are multiple and interlocking is not limited to the women and minorities discourse. The introduction to the US Department of Health and Human Service’s (DHHS’s) recent HHS Action Plan to Reduce Racial and Ethnic Health Disparities acknowledges that

characteristics such as race or ethnicity, religion, SES [socioeconomic status], gender, age, mental health, disability, sexual orientation or gender identity, geographic location, or other characteristics historically linked to exclusion or discrimination are known to influence health status.3^(p2)

This acknowledgment illustrates another conjunction problem—that of the “or.” Pursuant to this logic, one’s sexual orientation or gender identity or race/ethnicity may have an adverse effect on health, but nowhere in the report is there any indication of how the intersection of being, for example, a low-income Black gay or bisexual man might influence health. Acknowledging the existence of multiple intersecting identities is an initial step in understanding the complexities of health disparities for populations from multiple historically oppressed groups. The other critical step is recognizing how systems of privilege and oppression that result in multiple social inequalities (e.g., racism, heterosexism, sexism, classism) intersect at the macro social-structural level to maintain health disparities.Enter intersectionality. Intersectionality is a theoretical framework for understanding how multiple social identities such as race, gender, sexual orientation, SES, and disability intersect at the micro level of individual experience to reflect interlocking systems of privilege and oppression (i.e., racism, sexism, heterosexism, classism) at the macro social-structural level.4–7 Far from being just an exercise in semantics, intersectionality provides the discipline of public health with a critical unifying interpretive and analytical framework for reframing how public health scholars conceptualize, investigate, analyze, and address disparities and social inequality in health. The aforementioned DHHS report on health disparities and the even newer National Prevention Strategy8 assert that the reduction and elimination of health disparities are a top national public health priority. This priority is further reflected in public health and biomedical journals, which are replete with health disparities research. Yet a key omission from most policy and research is first and foremost the recognition of multiple intersecting social identities and next an acknowledgment of how the intersection of multiple interlocking identities at the micro level reflects multiple and interlocking structural-level inequality at the macro levels of society.The need for intersectionality as a unifying public health framework is further underscored by the relative dearth of theory and research that specifically address the multiple and interlocking influence of systems of privilege and oppression such as racism, sexism, and heterosexism. Instead, most public health research typically examines each system independently, “thus impairing efforts to understand the health of people whose lives cut across these diverse realisms of experiences.”9^(p99) Accordingly, I advocate for a greater awareness of intersectionality within public health. Intersectionality, I assert, provides a critical, insightful, and unifying theoretical framework for guiding public health theory, research, surveillance, and policy. Hereafter, I refer to intersectionality synonymously as a theoretical framework or perspective.     

The deep web,dark matter,metabundles and the broadband elites: do you need an informaticist?

The World Wide Web (WWW) is growing in size and is becoming a substantial component of life. This seems especially true for US professionals, including social workers. It will require effort by these professionals to use the WWW effectively and efficiently. One of the main issues that these professionals will encounter in these efforts is the quality of materials located on the WWW. This paper reviews some of the factors related to improving the quality of information obtained from the WWW by social workers.     

"Quick and dirty numbers"? The reliability of a stated-preference technique for the measurement of preferences for resource allocation

We investigated the reliability of an internet-based stated-preference survey to elicit preferences for priority setting using a conjoint study like approach. Preferences were elicited among members of an Internet survey panel in an experimental "allocation of points" task at two times. The main finding is that the survey showed good reliability and most participants consistently adjusted their allocations of points to differences in presented scenarios. At the repetition of the survey, respondents were more likely to prioritize between new treatment programs competing for funding and those that did prioritize discriminated stronger between programs. We found no evidence that respondents were making easy choices or arbitrarily "clicked" through the survey.