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Bentivoglio, Italy

Mandrioli D.,Ramazzini Institute
Environmental Health Perspectives | Year: 2016

Background: The most essential goal of medicine and public health is to prevent harm (primum non nocere). This goal is only fully achieved with primary prevention, which requires us to identify and prevent harms prior to human exposure through research and testing that does not involve human subjects. For that reason, public health policies place considerable reliance on nonhuman toxicological studies. However, toxicology as a field has often not produced efficient and timely evidence for decision making in public health. In response to this, the U.S. National Research Council called for the adoption of evidence-based methods and systematic reviews in regulatory decision making. The U.S. Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), and the European Food Safety Agency (EFSA) have recently endorsed these methods in their assessments of safety and risk. Objectives: In this commentary we summarize challenges and problems in current practices in toxicology as applied to decision making. We compare these practices with the principles and methods utilized in evidence-based medicine and health care, with emphasis on the record of the Cochrane Collaboration. Discussion: We propose a stepwise strategy to support the development, validation, and application of evidence-based toxicology (EBT). We discuss current progresses in this field produced by the Office of Health Assessment and Translation (OHAT) of the National Toxicology Program and the Navigation Guide works. We propose that adherence to the Cochrane principles is a fundamental prerequisite for the development and implementation of EBT. Conclusion: The adoption of evidence-based principles and methods will enhance the validity, transparency, efficiency, and acceptance of toxicological evidence, with benefits in terms of reducing delays and costs for all stakeholders (researchers, consumers, regulators, and industry). © 2015, Public Health Services, US Dept of Health and Human Services. All rights reserved.

Tassinari M.,Charity Association for Person Centered Medicine Moral Entity Registered Office | Mandrioli D.,Ramazzini Institute | Gaggioli N.,Charity Association Menieres Disease Patients Together AMMI | Roberti Di Sarsina P.,Charity Association for Person Centered Medicine Moral Entity Registered Office | Roberti Di Sarsina P.,University of Milan Bicocca
Audiology and Neurotology | Year: 2015

Ménière's disease is a disorder of the inner ear affecting hearing and balance to a varying degree. It is characterized by episodes of vertigo, low-pitched tinnitus, and hearing loss. There is currently no gold standard treatment for Ménière's disease. We conducted a systematic search of the Cochrane Database, as a high-quality source of evidence-based therapies, for reviews on the efficacy of etiological therapy or on Ménière's disease or its symptoms. Following recent positive experiences reported by other research teams, we decided to involve a patients' representative in the assessment and analysis of the evidence retrieved in the literature in order to achieve a more patient-centered evaluation of the therapies. Evidence confirms that an effective treatment of Ménière's disease is still missing, but recent discoveries on the microvascular etiology of Ménière's disease may be assimilated by new evidence-based therapeutic approaches. © 2015 S. Karger AG, Basel.

Thoolen B.,Global Pathology Support | Maronpot R.R.,Maronpot Consulting LLC | Harada T.,Institute of Environmental Toxicology | Nyska A.,Haharuv 18 | And 12 more authors.
Toxicologic Pathology | Year: 2010

The INHAND Project (International Harmonization of Nomenclature and Diagnostic Criteria for Lesions in Rats and Mice) is a joint initiative of the Societies of Toxicologic Pathology from Europe (ESTP), Great Britain (BSTP), Japan (JSTP) and North America (STP) to develop an internationally-accepted nomenclature for proliferative and non-proliferative lesions in laboratory animals. The purpose of this publication is to provide a standardized nomenclature and differential diagnosis for classifying microscopic lesions observed in the hepatobiliary system of laboratory rats and mice, with color microphotographs illustrating examples of some lesions. The standardized nomenclature presented in this document is also available for society members electronically on the internet (http://goreni.org). Sources of material included histopathology databases from government, academia, and industrial laboratories throughout the world. Content includes spontaneous and aging lesions as well as lesions induced by exposure to test materials. A widely accepted and utilized international harmonization of nomenclature for lesions of the hepatobiliary system in laboratory animals will decrease confusion among regulatory and scientific research organizations in different countries and provide a common language to increase and enrich international exchanges of information among toxicologists and pathologists. © 2010 by The Author(s).

Soffritti M.,Ramazzini Institute | Tibaldi E.,Ramazzini Institute | Padovani M.,Ramazzini Institute | Hoel D.G.,Medical University of South Carolina | And 8 more authors.
International Journal of Radiation Biology | Year: 2016

In 2002 the International Agency for Research on Cancer classified extremely low frequency magnetic fields (ELFMF) as a possible carcinogen on the basis of epidemiological evidence. Experimental bioassays on rats and mice performed up to now on ELFMF alone or in association with known carcinogens have failed to provide conclusive confirmation.Objectives To study the carcinogenic effects of combined exposure to sinusoidal-50 Hz (S-50Hz) magnetic fields and acute γ radiation in Sprague-Dawley rats.Methods We studied groups of male and female Sprague-Dawley rats exposed from prenatal life until natural death to 20 or 1000 T S-50Hz MF and also to 0.1 Gy γ radiation delivered as a single acute exposure at 6 weeks of age.Results The results of the study showed significant carcinogenic effects for the mammary gland in males and females and a significant increased incidence of malignant schwannomas of the heart as well as increased incidence of lymphomas/leukemias in males.Conclusions These results call for a re-evaluation of the safety of non-ionizing radiation. © 2016 Taylor and Francis.

Panzacchi S.,Ramazzini Institute | Boiani S.,Ramazzini Institute | Mandrioli D.,Ramazzini Institute | Piccioli M.,University of Bologna | Belpoggi F.,Ramazzini Institute
European Journal of Oncology | Year: 2013

Recent advances in molecular biology and pathology have opened new opportunities for refining our knowledge of pathophysiologic events and biomarkers. Particular interest in applying these novel methods to current and archived tissues collected in experimental and epidemiological/clinical studies is evident. Until now, it has not always been possible to use archived alcohol-fixed paraffin-embedded (AFPE) tissues for immunohistochemisty (IHC), because AFPE slices and blocks were not often amenable to standard IHC methods. In order to solve this problem, we developed a simple method of post-fixation, which allows to use, on AFPE slices, standard IHC protocols already used for formalin-fixed paraffin-embedded (FFPE) samples. For the assessment of post-fixation processing and to test the feasibility of IHC, we selected the spleen from Sprague-Dawley rats as a demonstrative tissue. Antibodies to PAX5, CD3, CD68 and Ki- 67, were tested on FFPE, AFPE and AFPE post-fixed spleen samples. The specificity of antibodies to bind different epitopes expressed in spleen tissue was maintained in FFPE and AFPE post-fixed sections, according to anatomical localization. Post-fixation of AFPE samples did not affect tissue morphology and IHC results were comparable to the FFPE sections in terms of sensitivity, specificity and intensity of staining. In addition to providing an opportunity to use archived tissues, this new post-fixation method would dramatically reduce the use of formaldehyde during histopathology procedures, thus minimizing worker exposure to this dangerous carcinogenic substance. © Mattioli 1885.

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