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Background: The need for highly effective therapies in rheumatologic diseases has led to the widespread and growing use of a heterogeneous class of molecules called biological agents. The increasing experience with biological agents has raised concerns about safety and efficacy issues that need to be discussed in the informed consent acquisition process. Methods: The authors performed a review of the literature on biological agents focusing on their most important characteristics concerning the informed consent procedures. Results: No studies specifically addressed the issue of informed consent in patients receiving biological agents. Several studies reported data about off‐label use of biological agents usually with no obvious attention to informed consent shortcomings. Conclusion: The reported association between biological agents and serious infections or malignancies, including reactivation of latent tuberculosis, needs specific disclosure in informed consent acquisition, together with information about the possible efficacy in clinical contexts often characterized by resistance to previous treatments. Ethical and clinical issues bound to the need for experimenting with new agents with potentially serious adverse effects deserve specific attention. Studies aimed at evaluating mental capacity to consent in subjects receiving biological agents are required. [ABSTRACT FROM AUTHOR]

A rare case of lethal idiopathic plasmacytic lymphadenopathy ( IPL) with polyclonal hyperimmunoglobulinemia with chronic renal failure is described. A 40-year-old woman who had suffered from upper airways disease was admitted to the Emergency Room with acute renal failure and hypergammaglobulinemia. She developed pericardial effusion, a pruritic rash, splenomegaly and fell into a coma after 6 days. Multiple myeloma, infection, collagenopathy, and coagulopathy were ruled out. Finally, a form of malignant hypergammapathy was suspected. At autopsy, lymph nodes were infiltrated by polyclonal plasma cells and lymphocytes, with erythrophagocytosis features; immunohistochemistry confirmed the plasma cells (CD138+), with a prevalence of kappa-positive cells, B (CD20+) and T (CD3+) cells. Kidneys showed advanced glomerulosclerosis containing similar infiltrates. The cause of death was IPL with polyclonal hypergammaglobulinemia and advanced renal failure. Similar cases are unusual, and possible medical liability associated with failure to diagnose and treat idiopathic plasmacytic lymphadenopathy deserves discussion and further studies. [ABSTRACT FROM AUTHOR]

Chest skeletal injuries are the most frequent complications of external chest massage ( ECM) during cardiopulmonary resuscitation, but heart and great vessels lacerations that are indeed very rare. We report the case of a 35-year-old workman who collapsed and underwent ECM by his co-workers for almost 30 min. At autopsy, no external injuries, fractures or bruises of the ribs or sternum, were observed. A hemopericardium with a rupture of the heart was found, with no signs of pre-existent cardiac disease. Bruises of thoracic aortic wall, lung petechiae, a contusion of the liver, and bruises of lumbar muscles were found. The cause of death was due to sudden cardiac death with an extensive cardiac rupture. This is an unusual report of massive heart damage without any skeletal or muscle chest injuries, secondary to cardiopulmonary resuscitation. This kind of cardiac lesions may be considered when thoracic-abdominal trauma, or medical history, is unclear. [ABSTRACT FROM AUTHOR]

Folie à deux is a rare clinical syndrome characterized by the transference of delusional ideas from one person to one or more other people in close association with the primary affected patient. Mummification indicates the preservation of the corpse of a person for a variable period of time. A brief review of the literature in this field is presented, and an exceptional case is described, characterized by the association of both these rare phenomena. The case is an example of folie à fammille which developed out of a condition of extreme religiousness and seclusion of an entire family. The shared psychosis led to the horrible death of some of the family members, while the last surviving member of the family lived for more than a year and a half with their mummified remains. The Judge commissioned a forensic psychiatry assessment to verify the survivor's ability to bear witness. The development of the psychiatric syndrome and its consequences are extensively discussed. [ABSTRACT FROM AUTHOR]

Background Many drugs used for neonates are unlicensed or off-label. An increased risk of medication errors and unexpected adverse drug reactions is associated with their use. This risk is even higher in preterm newborns, because of their physiological immaturity and the exposure to many different medicines. The objective of this study was to evaluate the use of unlicensed or off-label drugs in eight tertiary-level neonatal intensive care units ( NICU) from two different southern Italian regions. Methods All drugs prescribed to newborns admitted to each NICU, during 1 month of observation, were recorded and classified as licensed, unlicensed or off-label, according, respectively, first, to their license status and, then, their indications, dose, treatment route, and duration of treatment specified in each specific marketing authorization. Results A total of 126 newborns were treated with at least one drug during the observation period. A total of 483 prescriptions referred to 87 different drugs, classified as licensed, unlicensed or off-label. Each newborn was exposed to three (median) different drugs; 88.6% were licensed and 11.4% unlicensed (range, according to different NICU, 1.9-26.7%). Among licensed drugs, 37.4% were used as off-label (range, 27.3-53.4%). Conclusions The use of unlicensed or off-label drugs use is common practice in NICU, with wide variation in local policies and newborn characteristics. Well-designed and -conducted pharmaceutical studies in newborns are needed to increase the number of licensed drugs, thereby reducing any risk for patients due to over- or under-treatment, and also legal issues for clinicians. [ABSTRACT FROM AUTHOR]

Traumatic brain injury is the leading cause of morbidity and mortality among children suspected of child abuse. Penetrating cranio-facial injuries are generally rare in the pediatric age group and are caused by both accidental and inflicted mechanisms. We report an unusual case of a 2-year-old female who was admitted to a pediatric emergency room with an industrial stainless steel coat hanger impaled in her skull. Pertinent clinical forensic medicine examination, coupled with home inspection and interviews by the local law enforcement, revealed a horrible episode of domestic violence. [ABSTRACT FROM AUTHOR]