247 research outputs found
Scientific Evidence and the Law: An Objective Bayesian Formalisation of the Precautionary Principle in Pharmaceutical Regulation
No full textThe paper considers the legal tools that have been developed in German pharmaceutical regulation as a result of the precautionary attitude inaugurated by the Contergan decision (1970). These tools are (i) the notion of "well-founded suspicion", which attenuates the requirements for safety intervention by relaxing the requirement of a proved causal connection between danger and source, and the introduction of (ii) the reversal of proof burden in liability norms. The paper focuses on the first and proposes seeing the precautionary principle as an instance of the requirement that one should maximise expected utility. In order to maximise expected utility certain probabilities are required and it is argued that objective Bayesianism offers the most plausible means to determine the optimal decision in cases where evidence supports diverging choices
Safety vs. efficacy assessment of pharmaceuticals: Epistemological rationales and methods
No full textAbstractIn their comparative analysis of Randomised Clinical Trials and observational studies, Papanikoloau et al. (2006) assert that “it may be unfair to invoke bias and confounding to discredit observational studies as a source of evidence on harms”. There are two kinds of answers to the question why this is so. One is based on metaphysical assumptions, such as the problem of causal sufficiency, modularity and other statistical assumptions. The other is epistemological and relates to foundational issues and how they determine the constraints we put on evidence. I will address here the latter dimension and present recent proposals to amend evidence hierarchies for the purpose of safety assessment of pharmaceuticals; I then relate these suggestions to a case study: the recent debate on the causal association between paracetamol and asthma. The upshot of this analysis is that different epistemologies impose different constraints on the methods we adopt to collect and evaluate evidence; thus they grant “lower level” evidence on distinct grounds and at different conditions. Appreciating this state of affairs illuminates the debate on the epistemic asymmetry concerning benefits and harms and sets the basis for a foundational, as opposed to heuristic, justification of safety assessment based on heterogeneous evidence
Prevalence and risk factors for thermotolerant species of Campylobacter in poultry meat at retail in Europe
No full textThe thermotolerant species Campylobacter
jejuni, Campylobacter coli, Campylobacter lari
and Campylobacter upsaliensis are the causative agents
of the human illness called campylobacteriosis. This infection
represents a threat for the health of consumers
in Europe. It is well known that poultry meat is an
important food vehicle of Campylobacter infection. As
emerged from the reported scientific literature published
between 2006 and 2016, poultry meat sold at
retail level in Europe represents an important source
of the pathogen. The contamination level of poultry
meat sold at retail can vary depending on pre- and
post-harvest factors. Among the pre-harvest measures,
strict biosecurity practices must be guaranteed; moreover,
among post-harvest control measures scalding,
chilling and removal of faecal residues can reduce the
contamination level of Campylobacter. An additional issue
is represented by increasing proportion of Campylobacter
isolates resistant to tetracyclines, ciprofloxacin,
and nalidixic acid, thus feeding a serious concern on the
effectiveness of antibiotic treatment for human campylobacteriosis
in a near future
Principio di Precauzione e Causalità Incerta: per una Formalizzazione Bayesiana della Procedura Decisionale in Ambito Farmaceutico
No full textFermentation of House Crickets (Acheta domesticus): Boosting Quality and Functionality in Cricket-Based Food Ingredients
No full textThis review examines the nutritional and functional potential of Acheta domesticus, the impact of fermentation on its biochemical and microbiological properties, and its application in food ingredients and products. Relevant literature was reviewed on the composition, fermentation behavior, product development, and consumer perceptions related to cricket-based ingredients, with a focus on fermented applications and microbiota interaction. Fermentation improves the safety, digestibility, flavor, and nutritional value of cricket powder. Lactic acid bacteria (e.g., Lactiplantibacillus plantarum and Latilactobacillus curvatus) enhanced substrate acidification, reduced biogenic amines and acrylamide levels, and contributed to desirable volatile compounds production. Additionally, fermentation using yeasts like Yarrowia lipolytica and Debaryomyces hansenii resulted in the production of antimicrobial substances, reduction in chitin, and an increase in the matrix digestibility. Fermented cricket-based ingredients have been successfully applied to bread, biscuits, yogurt, and beverages. Protein hydrolysates produced by fermentation exhibited antioxidant, anti-aging, and preservative properties, expanding potential beyond food. Consumer acceptance was highest when insects were integrated into familiar and visually unobtrusive food formats. To conclude, A. domesticus shows great promise as a sustainable and functional food ingredient. Fermentation offers a key strategy to overcome safety, sensory, and acceptability barriers
Relationship between RANKL/OPG system and bone mineral density in children with inflammatory bowel diseases: A DXA study.
No full textPharmacovigilance as Personalized Evidence
No full textPersonalized medicine relies on two points: (1) causal knowledge about the possible effects of X in a given statistical population; (2) assignment of the given individual to a suitable reference class. Regarding point 1, standard approaches to causal inference are generally considered to be characterized by a trade-off between how confidently one can establish causality in any given study (internal validity) and extrapolating such knowledge to specific target groups (external validity). Regarding point 2, it is uncertain which reference class leads to the most reliable inferences.
Instead, pharmacovigilance focuses on both elements of the individual prediction at the same time, that is, the establishment of the possible causal link between a given drug and an observed adverse event, and the identification of possible subgroups, where such links may arise. We develop an epistemic framework that exploits the joint contribution of different dimensions of evidence and allows one to deal with the reference class problem not only by relying on statistical data about covariances, but also by drawing on causal knowledge. That is, the probability that a given individual will face a given side effect, will probabilistically depend on his characteristics and the plausible causal models in which such features become relevant. The evaluation of the causal models is grounded on the available evidence and theory
Trends in the quality and hygiene parameters of bulk Italian Mediterranean buffalo (Bubalus bubalis) milk: a three year study
No full textBuffalo milk represents an indispensable source of nourishment in many
parts of the world and it is the second most consumed milk worldwide.
Buffalo milk is actually used for the production of many dairy products such
as pasteurized or concentrated milk, butter, yogurt, ice-cream, dehydrated
milk products, and cheeses. Due to its high nutritional value and the
presence of natural bioactive substances, buffalo milk can also provide
health benefits to consumers. In Italy, buffalo milk is used only for cheese
making, mainly mozzarella PDO (Protected Designation of Origin), which is
a highly valued dairy product. This three-year study, carried out between
2011 and 2013, was aimed at evaluating the quality of bulk Italian
Mediterranean buffalo milk by monitoring physico-chemical parameters,
somatic cell and total bacterial counts. A total of 51 samples of bulk milk
were collected from one herd throughout the monitored period. Analysis of
variance, carried out to test month, season, and year main effects,
highlighted remarkable seasonal effects for fat, protein, and lactose
content, as well as for predicted Mozzarella cheese yield, and somatic cell
counts. The calculation of simple correlations allowed the identification of
positive correlations between estimated cheese yield and fat and protein
content
Rapid disease progression in HIV-1 perinatally infected children born to mothers receiving zidovudine monotherapy during pregnancy. The Italian register for HIV Infection in Children
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