Massimo Niola

Limiting the access to direct-acting antivirals against HCV: an ethical dilemma

ABSTRACT Introduction: Hepatitis C virus (HCV) infection affects about 200 million people worldwide and represents a leading cause of liver-related mortality. Eradication of HCV infection, achieved mainly through direct-acting antivirals (DAA), results in a decrease of mortality and an improvement of quality of life. These drugs have a maximal efficacy and an optimal tolerability. However, their high cost precludes a universal access even in wealthy countries. Areas covered: This article deals with the policies adopted for the use of the new anti-HCV drugs, especially in Europe and most of all in Italy, supposedly the developed country with the highest HCV prevalence. The literature search was performed using Pubmed and Web of Science. Moreover, national regulatory institutional websites were consulted. Expert commentary: The current policy of limitation to the access of the DAA presents a series of ethical issues that makes it non-applicable. A ‘treat-all’ strategy should resolve all ethical dilemmas, by virtue of the wide benefits of anti-HCV treatment not only for the advanced stage of infection, but also for the initial stages. A reduction in price of the drugs is the actual condition to achieve such a change.

La responsabilità professionale in odontoiatria: analisi di una casistica interdipartimentale

Riasunto Obiettivi L’incremento degli addebiti di responsabilita professionale in ambito sanitario, unitamente alla diffusione di dati espressivi di una differente distribuzione percentuale dei settori odontoiatrici coinvolti nel contenzioso, ha indotto gli autori a condurre un’analisi conoscitiva del fenomeno attraverso lo studio di una casistica interdipartimentale di accertata responsabilita professionale odontoiatrica in ambito civilistico. Materiali e metodi E stata condotta un’analisi descrittiva di tipo poliparametrico su un campione costituito da 436 casi di errata condotta odontoiatrica accertata, promossi da soggetti di eta compresa tra 14 e 70 anni. Risultati Il settore odontoiatrico in cui e piu frequentemente ravvisato un errore tecnico-deontologico e quello protesico e implantoprotesico, seguito da quelli endodontico- conservativo e ortognatodontico. Nella maggioranza dei casi si e accertata la carenza della documentazione sanitaria descrittiva dello stato anteriore, in assenza di un modulo di consenso informato al trattamento odontoiatrico. Il danno ha riguardato piu frequentemente strutture dentarie, concretizzandosi in un danno permanente alla persona ≤ 4% in oltre due terzi dei casi, con un importo del danno emergente quasi sempre (97%) Conclusioni Gli autori propongono un decalogo comportamentale al fine di ridurre i possibili addebiti di responsabilita professionale o, comunque, utile a documentare la corretta condotta tecnico- deontologica.

On the comparison of age determination methods based on dental development radiographic studies in a sample of Italian population

Abstract Objectives This study investigated the degree of reliability, complexity of use and possibility of further refinement of eight radiographic methods for the age determination of subjects in the growth phase, applied on a sample of Italian population. Materials and methods Each considered method was tested on a sample of 178 digitized panoramic radiographs (97 males and 81 females, aged 5 to 22 years). The obtained data were processed by statistical analysis. Results The overall Absolute Mean Error (AME) was on average equal to 0.89 years; within this error range fell approximately 61% of the subjects in our sample. The overall average of AME plus 1 standard deviation (SD) was equal to approximately 1.70 years, in the context of which fell about 84.5% of the sample investigated. Conclusions The statistical analysis of the data obtained by applying on our sample the considered methods showed, for each of them, the level of reliability in terms of absolute error with the relative SD (i.e., exact match between the age determined by the evaluators and the actual age, in terms of absolute value).

Medicolegal implications of surgical errors and complications in neck surgery: A review based on the Italian current legislation

Abstract Aim of the present paper is the review of the principal complications associated to endocrine neck surgery considering how expertise, full adoption of guidelines, appropriate technology and proper informed consent may limit the medicolegal claims at the light of the incoming new regulation of the medical professional legal responsibility. A literature search, using the Medline/PubMed database for full-length papers, was used. Postoperative recurrent laryngeal nerve (RLN) palsy and hypoparathy-roidism remain the principal causes of surgical malpractice claims . In the procedure of neck lymphadenctomy intra-operative haemorrhage, thoracic duct injury, injuries to loco-regional nerves can be observed and can be source of claims. After many years of increased medicolegal litigations, the Italian government is proposing a drastic change in the regulations of supposed medical malpractice in order to guarantee the patient’s right to a safe treatment and in the meantime to defend clinicians from often unmotivated and prejudicial legal cases. Surgical errors and complications in neck surgery are a relevant clinical issue. Only the combination of surgical and clinical expertise, application of guidelines, appropriate technology and a routinely use of specific informed consent can contain potential medicolegal implications.

Early Medical Skull Surgery for Treatment of Post-Traumatic Osteomyelitis 5,000 Years Ago

Here we describe the findings of a unique example of the early techniques adopted in neurosurgery around 5000 years ago, consisting in a double well healed skull trephination associated with a post-cranial traumatic event occurring intra vitam to a young male from the Early Chalcolithic cemetery of Pontecagnano (South Italy, ca. 4,900 - 4,500 cal BP). Morphological, X-ray and 3D-CT scan skull-cap evaluation revealed that the main orifice was produced by scraping, obtained by clockwise rotary motion of a right-handed surgeon facing the patient, while the partial trephination was carried out by using a stone point as a drilling tool. In both cases, bone regrowth is indicative of the individuals prolonged postoperative survival and his near-complete recovery. The right femur shows a poorly healed mid-shaft fracture presumably induced by a high energy injury, and a resulting chronic osteomyelitis, affecting both femurs by hematogenous spread of the infection. Our observations on the visual and radiological features of skull and femur lesions, along with evidence on the timing of experimental bone regrowth vs. healing of lower limb fractures associated to long-term bone infections now suggest that this young man underwent a double skull trephination in order to alleviate his extremely painful condition induced by chronic osteomyelitis, which is thought to have been the cause of death.

Voluntary termination of pregnancy (medical or surgical abortion): forensic medicine issues

Abstract In Italy, Law 194 of 22 May 1978 provides for and regulates the voluntary termination of pregnancy (VTP). Medical abortion became popular nationwide after Mifepristone (RU-486) was authorized for the market by AIFA (Italian Drug Agency) in July 2009. We searched articles in medical literature database with these terms: “medical abortion”, “RU486”, “surgical abortion”. We also searched laws and judgments concerning abortion in national legal databases. Ministerial guidelines were searched on official website of Italian Ministry of Health. We found many medical studies about medical and surgical abortion. We found also ministerial and regional guidelines, which were analyzed. From the point of view of legal medicine, the issues related to abortion with the pharmacological method consist in verifying compatibility and consistency with the safety principles and the parameters imposed by Law n. 194 of 1978, using off-label Misoprostol, what inpatient care should be used and informed consent. The doctor’s job is to provide the patient with comprehensive and clear information about how the procedure will be performed, any complications and the time period needed for both procedures.

Informed consent in robotic surgery: quality of information and patient perception

Abstract Introduction Obtaining a valid informed consent in the medical and surgical field is a long debated issue in the literature. In robotic surgery we believe in the necessity to follow three arrangements to make the informed consent more complete. Material and methods This study presents correlations and descriptions based on forensic medicine concepts research, literature review, and the proposal of an integration in the classic concept of informed consent. Conclusion In robotic surgery we believe in the necessity to follow three arrangements to make the IC more complete. Integrate the information already present in the informed consent with data on the surgeon’s experience in RS, the number of procedures of the department and the regional map of expertises by procedure.

Contralateral risk reducing mastectomy in Non-BRCA-Mutated patients

Abstract The use of contralateral risk reducing mastectomy (CRRM) is indicated in women affected by breast cancer, who are at high risk of developing a contralateral breast cancer, particularly women with genetic mutation of BRCA1, BRCA2 and P53. However we should consider that the genes described above account for only 20-30% of the excess familiar risk. What is contralaterally indicated when genetic assessment results negative for mutation in a young patient with unilateral breast cancer? Is it ethically correct to remove a contralateral “healthy” breast? CRRM rates continue to rise all over the world although CRRM seems not to improve overall survival in women with unilateral sporadic breast cancer. The decision to pursue CRRM as part of treatment in women who have a low-to-moderate risk of developing a secondary cancer in the contralateral breast should consider both breast cancer individual-features and patients preferences, but should be not supported by the surgeon and avoided as first approach with the exception of women highly worried about cancer. Prospective studies are needed to identify cohorts of patients most likely to benefit from CRRM.

Iatrogenic splenic injury: review of the literature and medico-legal issues

Abstract Introduction Iatrogenic splenic injury is a recognized complication in abdominal surgery. The aim of this paper is to understand the medico-legal issues of iatrogenic splenic injuries. We performed a literature review on PubMed and Scopus using iatrogenic splenic or spleen injury and iatrogenic splenic rupture as keywords. Iatrogenic splenic injury cases were identified. Most cases were related to colonoscopy, but we also identified cases related to upper gastrointestinal procedures, colonic surgery, ERCP, left nephrectomy and/or adrenalectomy, percutaneous nephrolithotomy, vascular operations involving the abdominal aorta, gynecological operation, left lung biopsy, chest drain, very rarely spinal surgery and even cardiopulmonary resuscitation. There are several surgical procedures that can lead to a splenic injury. However, from a medico-legal point of view, it is important to assess whether the cause can be attributed to a technical error of the operator rather than being an unpredictable and unpreventable complication. It is important for the medico-legal expert to have great knowledge on iatrogenic splenic injuries because it is important to evaluate every step of the first procedure performed, how a splenic injury is produced, and whether the correct treatment for the splenic injury was administered in a judgment.

Cosmetic surgery: Medicolegal considerations

Abstract Cosmetic surgery is one of the two branches of plastic surgery. The characteristic of non-necessity of this surgical speciality implies an increased severity in the evaluation of the risk-benefit balance. Therefore, great care must be taken in providing all the information necessary in order to obtain valid consent to the intervention. We analyzed judgments concerning cosmetic surgery found in national legal databases. A document of National Bioethics Committee (CNB) was also analyzed. Conclusion: The receipt of valid, informed consent is of absolute importance not only to legitimise the medical-surgical act, but it also represents the key element in the question concerning the existence of an obligation to achieve certain results/use of certain methods in the cosmetic surgery.