Health risks related to illegal and on-line sale of drugs and food supplements: results of a survey on marketed products in Italy from 2011 to 2013

Objectives. The increasing illegal and on-line market of medicines and food supplements is helping the widespread diffusion of harmful counterfeit and forbidden products among consumers of developed countries. The objectives of this survey were the description of the main frauds recognized by public officers and the detection of illegal or counterfeit drugs and food supplements.Methods. Medicines and food supplements found by Police forces on the illegal market or resulting from seizures made by Italian Customs authorities were visually inspected and analysed to evaluate their quality and the presence of other undeclared substances.Results. The visual inspection and the chemical analysis revealed unsuitable packaging (mostly lacking of adequate information for consumers), absence of the declared active substances and presence of undeclared active substances. Products containing doping agents, illegal substances and active ingredients requiring medical supervision were found.Conclusion. The present work confirmed the health risk associated with assumption of medicines purchased on the Internet and from the illegal supply chain and evidenced a new threat to consumer safety related to the presence of pharmaceutical active ingredients in food supplements claiming to contain only “natural ingredients”.

Small renal masses initially managed using Active surveillance: Results from a retrospective study with long-term follow-up

Background The purpose of the study was to evaluate the relationships between the patients' clinical characteristics and the growth pattern of SRMs, and to investigate the predictive factors of tumor growth rates in patients initially managed with AS. Materials and Methods We retrospectively reviewed data from our prospectively collected database of 70 patients diagnosed with 72 SRMs between 1996 and 2013. Clinical and demographic data, and linear and volumetric growth rates were recorded for each patient. A Pearson correlation test was used to evaluate initial tumor size and linear or volumetric growth rate. Logistic regression models were used to evaluate the predictive factors affecting tumor growth kinetics. Results The mean age was 76 \ub1 6.8 years, and 47 (67.1%) of patients were male. The mean (\ub1 SD) and the median (interquartile range [IQR]) tumor size at presentation were 2.1 \ub1 1.3 and 2.7 (1.8-3.7) cm, respectively. The mean (\ub1 SD) and the median (IQR) linear growth rate were 0.5 \ub1 0.3 and 0.6 (0.4-1.5) cm per year, respectively. Patients treated with delayed surgery experienced a significantly greater mean linear growth rate (1.4 vs. 0.3 cm per year) than those observed in the AS group (P <.001). Male sex (HR, 1.70; P =.04) and symptomatic presentation (HR, 1.85; P =.02) were found to be significant predictors of tumor growth rates during AS. Conversely, age, Charlson Comorbidity Index, and initial tumor size failed to predict growth kinetics. Conclusion Male sex and symptomatic presentation are associated with faster growth rates in patients managed with AS after long-term follow-up

Non-small cell lung cancer after surgery and chemoradiotherapy: follow-up and response assessment.

The imaging techniques in patients treated for lung cancer may be challenging to interpret. Radiologists are often asked to evaluate computed tomography (CT) scans after surgery, and this interpretation requires an understanding of both the timing and type of the surgical procedure. However, follow-up strategies are still not well defined. The assessment of tumor response to chemoradiotherapy relies on a tight integration of CT and clinical findings. Positron emission tomography-computed tomography (PET-CT) with fluorodeoxyglucose may help to exclude tumor recurrence when the sole CT scan is equivocal. More efforts are needed to validate the tools for volumetric tumor measurement in routine practice and to demonstrate their superiority compared to the Response Evaluation Criteria in Solid Tumors (RECIST). Familiarity with the assessment of lung cancer perfusion is also important because of the increasing use of cytostatic therapy. In this review, we outlined the imaging assessment of tumor recurrence after surgery and the role of CT, magnetic resonance imaging, and PET-CT in the follow-up after chemotherapy, radiotherapy, and radiofrequency ablation

Counterfeit drugs detection by measurement of tablets and secondary packaging colour

The growth of pharmaceutical counterfeiting is a major public health problem. This growth is resulting in a proportional increase in the number of samples that medicines control laboratories have to test. Thus the need for simple and affordable preliminary screening methods to be used by inspectors to decide in the field whether to collect a sample for further laboratory analysis or not. This paper intends to evaluate the possibility to employ for preliminary examinations of suspicious samples an optical spectrophotometer (colorimeter) used in the graphic industry, capable of measuring the reflectance visible spectrum of solid materials. The colorimeter was tested on original and counterfeited Viagra, Cialis and Levitra by measuring the colour of tablets' surface and of a specific spot of the packages. Various batches of the original drugs were employed both to investigate precision and robustness of the technique and to build spectral libraries. These libraries were used to compare suspicious samples to the corresponding original by means of a wavelength distance pattern recognition method. The method was eventually tested on suspicious samples sized by police authorities in order to evaluate its effectiveness. The device resulted precise and robust toward ambient conditions changes, although some limits emerged: the libraries of original samples need a frequent update and a lower precision is to be expected for tablets which surface is extremely convex. (C) 2010 Elsevier B.V. All rights reserved

Procedural and Long-Term Outcomes of Bioresorbable Scaffolds Versus Drug-Eluting Stents in Chronic Total Occlusions

Background-There is little evidence regarding the efficacy and safety of bioresorbable scaffolds (BRS) for the percutaneous treatment of chronic total occlusions.Methods and Results-We performed a multicenter registry of consecutive chronic total occlusion patients treated with BRS (Absorb; Abbott Vascular) and second-generation drug-eluting stents (DES) at 5 institutions. Long-term target-vessel failure (a composite of cardiac death, target-vessel myocardial infarction, and ischemia-driven target-lesion revascularization) was the primary end point. Inverse probability of treatment weight-adjusted Cox regression was used to account for pretreatment differences between the 2 groups. A total of 537 patients (n=153 BRS; n=384 DES) were included. BRS patients were younger and had lower prevalence of comorbidities. Overall mean Japan-Chronic Total Occlusion (J-CTO) score was 1.43 +/- 1.16, with no differences between groups. Procedural success was achieved in 99.3% and 96.6% of BRS-and DES-treated patients, respectively (P=0.07). At a median follow-up of 703 days, there were no differences in target-vessel failure between BRS and DES (4.6% versus 7.7%; P=0.21). By adjusted Cox regression analysis, there were still no significant differences between BRS and DES (hazard ratio, 1.54; 95% confidence interval, 0.69-3.72; P=0.34). However, secondary analyses suggested a signal toward higher ischemia-driven target-lesion revascularization with BRS.Conclusions-Implantation of BRS versus second-generation DES in chronic total occlusion was associated with similar risk of target-vessel failure at long-term follow-up. However, a signal toward increased ischemia-driven target-lesion revascularization with BRS was observed. Large randomized studies should confirm these findings

Procedural and Long-Term Outcomes of Bioresorbable Scaffolds Versus Drug-Eluting Stents in Chronic Total Occlusions The BONITO Registry (Bioresorbable Scaffolds Versus Drug-Eluting Stents in Chronic Total Occlusions)

Background-There is little evidence regarding the efficacy and safety of bioresorbable scaffolds (BRS) for the percutaneous treatment of chronic total occlusions.Methods and Results-We performed a multicenter registry of consecutive chronic total occlusion patients treated with BRS (Absorb; Abbott Vascular) and second-generation drug-eluting stents (DES) at 5 institutions. Long-term target-vessel failure (a composite of cardiac death, target-vessel myocardial infarction, and ischemia-driven target-lesion revascularization) was the primary end point. Inverse probability of treatment weight-adjusted Cox regression was used to account for pretreatment differences between the 2 groups. A total of 537 patients (n=153 BRS; n=384 DES) were included. BRS patients were younger and had lower prevalence of comorbidities. Overall mean Japan-Chronic Total Occlusion (J-CTO) score was 1.43 +/- 1.16, with no differences between groups. Procedural success was achieved in 99.3% and 96.6% of BRS-and DES-treated patients, respectively (P=0.07). At a median follow-up of 703 days, there were no differences in target-vessel failure between BRS and DES (4.6% versus 7.7%; P=0.21). By adjusted Cox regression analysis, there were still no significant differences between BRS and DES (hazard ratio, 1.54; 95% confidence interval, 0.69-3.72; P=0.34). However, secondary analyses suggested a signal toward higher ischemia-driven target-lesion revascularization with BRS.Conclusions-Implantation of BRS versus second-generation DES in chronic total occlusion was associated with similar risk of target-vessel failure at long-term follow-up. However, a signal toward increased ischemia-driven target-lesion revascularization with BRS was observed. Large randomized studies should confirm these findings

ESTIMation of the ABiLity of prophylactic central compartment neck dissection to modify outcomes in low-risk differentiated thyroid cancer: a prospective randomized trial

Abstract Background Prophylactic central neck dissection in clinically low-risk cT1bT2N0 papillary thyroid carcinoma is controversial, due to a large number of conflicting retrospective studies, some showing an advantage in terms of locoregional recurrence, others showing no advantage. These previous studies all show high rates of excellent response. We aim to demonstrate the non-inferiority of thyroidectomy alone as compared to total thyroidectomy with prophylactic central neck dissection in conjunction with adjuvant RAI 30 mCi with rTSH stimulation in terms of excellent response at 1 year. Trial design and methods Prospective randomized open multicenter phase III trial including patients with 11–40-mm papillary thyroid carcinoma (Bethesda VI) or suspicious cytology (Bethesda V) confirmed malignant on intra-operative frozen section analysis, with no suspicious lymph nodes on a specialized preoperative ultrasound examination. Patients will be randomized 1:1 into two groups: the reference group total thyroidectomy with bilateral prophylactic central neck dissection, and the comparator group total thyroidectomy alone. All patients will receive an ablative dose of 30mCi of radioactive iodine (RAI) within 4 months of surgery. The primary outcome is to compare the rate of excellent response at 1 year after surgery between the groups, as defined by an unstimulated serum thyroglobulin (Tg) level ≤ 0.2 ng/mL with no anti-Tg antibodies, an normal neck ultrasound and no ectopic uptake on the post-RAI scintiscan. Non-inferiority will be demonstrated if the rate of patients with excellent response at 1 year after randomization does not differ by more than 5%. Setting the significance level at 0.025 (one-sided) and a power of 80% requires a sample size of 598 patients (299 per group). Secondary outcomes are to compare Tg levels at 8 +/− 2 postoperative weeks, before RAI ablation, the rate of excellent response at 3 and 5 years, the rate of other responses at 1, 3, and 5 years (biochemical incomplete, indeterminate, and structurally incomplete responses), complications, quality of life, and cost-utility. Discussion (potential implications) If non-inferiority is demonstrated with this high-level evidence, prophylactic neck dissection will have been shown to not be necessary in clinically low-risk papillary thyroid carcinoma. Trial registration NCT 03570021. June 26,201

Correction: ESTIMation of the ABiLity of prophylactic central compartment neck dissection to modify outcomes in low-risk differentiated thyroid cancer: a prospective randomized trial

International audienceNo abstract availabl